CN100391500C - Chinese medicine preparation for treating wind-heat syndrome of acute pharyngitis and its preparation process - Google Patents
Chinese medicine preparation for treating wind-heat syndrome of acute pharyngitis and its preparation process Download PDFInfo
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- CN100391500C CN100391500C CNB2005100345756A CN200510034575A CN100391500C CN 100391500 C CN100391500 C CN 100391500C CN B2005100345756 A CNB2005100345756 A CN B2005100345756A CN 200510034575 A CN200510034575 A CN 200510034575A CN 100391500 C CN100391500 C CN 100391500C
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- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The present invention relates to a Chinese medical preparation for curing acute pharyngitis wind-heat syndromes and a preparation method thereof. The Chinese medical preparation is mainly prepared from Mussaenda, common andrographis herb, gardenia, common achyranthes herb, scrophularia root and artificial bezoar; the preparation method comprises the steps that Mussaenda, common andrographis herb, gardenia, common achyranthes herb, scrophularia root and artificial bezoar are taken, the common andrographis herb is pulverized into fine powder, other four meshes of Mussaenda, gardenia, common achyranthes herb, scrophularia root, etc., except the artificial bezoar are decocted by water for twice, each time of decoction is kept for 2 hours, and the decocted solutions are combined; the mixed medicine solution is filtered and is formed into an ointment through concentration; the artificial bezoar and the fine powder of the common andrographis herb are added, a proper amount of auxiliary materials are added, and tablets, granules, syrup, capsules, pellets, oral liquid, etc. are prepared by mixing. The Chinese medical preparation has the functions of removing heat and relieving superficial evils, reducing pharyngeal swelling and benefiting throats, and is used for acute pharyngitis, syndromes of wind-heat invading lungs, and acute pharyngitis having the syndromes of pharyngalgia, dry and burning throats, dysphagia, thirst, fever, aversion to wind, pharyngeal reddish swelling, reddish tongue tips, white and thin tongue fur or yellow and thin tongue fur, and rapid floating pulses. The Chinese medical preparation has the advantages of high safety and obvious effect.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation, particularly a kind of Chinese medicine preparation for the treatment of wind-heat syndrome of acute pharyngitis and preparation method thereof.
Background technology
Acute pharyngitis is common laryngopharyngeal diseases, disease see laryngopharynx swelling and pain, dry mouth and throat, itching of the throat and cough, hoarseness, aphonia etc., acute pharyngitis, acute laryngitis.Tcm diagnosis mainly show as 1, the wind-heat syndrome acute inflammation of the throat: pharyngalgia, dryness and heat, dysphagia, heating, slight chill, pharyngeal red slightly or scarlet, edema, uvula redness, pharynx rear wall follicle hypertrophy, tongue tip side of red, white and thin fur, floating and rapid pulse.2, wind-heat syndrome acute hoarseness: low voice and thick, hoarse, dry laryngopharynx, pain, cough is coughed up phlegm, Se Bai or little Huang, micro evil wind, heating, tongue tip side of red, white and thin fur, floating and rapid pulse.Doctor trained in Western medicine is summed up as acute pharyngolaryngitis with it, and pathogenic factor is by suffering from cold, overfatigue, and tobacco and wine are excessive, malnutrition, the stimulation of various physics and chemistry, the low grade of passive protective physical fitness causes.Wherein the symptom of acute pharyngitis is: onset is more anxious, and pharyngeal drying, scorching hot, pain or odynophagia, heating, fear of cold, inappetence, extremities aching pain are checked common pharyngeal mucosa hyperemia, and color is scarlet; Pharynx rear wall lymph follicle and lateral pharyngeal band redness, local or have Huang, white secretions to adhere to; Uvula, soft palate edema; Pharyngeal secretions is cultivated can pathogenic bacterium or feminine gender.The symptom of acute laryngitis: throat is itched, hypodynia, and throat has foreign body to stop up sense, hoarseness, the effort of speaking, weight person is bordering on and cries out, and brings up phlegm when one coughs.Weight person can have General Symptomies such as aversion to cold, heating, headache, tired, inappetence.The hyperemia of the common larynx mucosa of indirect laryngoscopy diffusivity, swelling, the most obvious with vocal cords and Wood-scoop epiglottis wrinkle wall, the initial stage vocal cords are pale red, crossfade into peony, or ecchymosis occurs, the vocal cords edge thickens, glottic insufficiency during pronunciation, vocal area can be thick secretions and adhere to.Throat has foreign body to stop up sense when acute pharyngolaryngitis is serious, and hoarseness brings up phlegm when one coughs, even symptoms such as heating, fear of cold, general malaise, inappetence, headache, nape and extremities aching pain occur.
The normal medicine that uses to the acute laryngopharyngitis western medical treatment is an antibiotics at present, as penicillin, erythromycin, cephalosporin, midecamycin, tetracycline etc.; Though Western medicine and antibiotics are better to treatment for diseases effect caused by the bacteria, if commonly used and abuse antibiotics not only can make some antibacterials produce drug-resistant effects, the intravital beneficial bacteria of people can not be survived, and cause that other disease occurs or increases the weight of.The Chinese medicine of many treatment upper respiratory tract and local skin infection is summed up and excavated to folks of china for thousands of years, Chinese herbal medicine commonly used has Herba Andrographis, Rhizoma Coptidis, Cortex Phellodendri, Fructus Forsythiae, Flos Lonicerae, Herba Houttuyniae, Herba Violae, Flos Chrysanthemi, Spica Prunellae, the Radix Pulsatillae, Herba Lobeliae Chinensis etc., these Chinese medicines have played certain effect to the treatment acute laryngopharyngitis respectively, but single Chinese medicine has limitation, have to just working than hypopathia disease, effect was relatively poor when disease was heavy.In secular medical practice, people get up some Chinese medicine composition, be made into Chinese medicine preparation, Chinese medicine preparation commonly used has Herba Pileae Scriptae Tabellae, JIANMIN YINHOU PIAN, the benzydamine sheet, YINHUANG PIAN, Radix Isatidis granules, Qinghuozhimaipian etc., these Western medicine, Chinese medicine and Chinese medicine preparation are coughed up phlegm to patient's cough, the nasal obstruction watery nasal discharge, rhinocnesmus sneeze, have sore throat, hoarseness, heating, headache, dry pharynx is scorching hot, pharyngeal hyperemia, symptom and signs such as vocal congestion and pharyngeal tonsils hyperemia all have clear improvement, but the treatment oral cavity of selling on many open source literatures and the market and the Chinese medicine of laryngopharyngeal diseases or beverage great majority can only take stopgap measures, can not effect a permanent cure, particularly can not treat the state of an illness increases the weight of, cause headache, heating, the patient of general malaise.At present, people still continue many Chinese medicines are studied, and to excavate more Chinese medicine, make the Chinese medicine preparation of treatment various diseases, are mankind's service.
In recent years, public publication is as " Chinese medicine ", and " Chinese herbal medicine " waits the medicine of also reporting many treatments oral cavity and laryngopharyngeal diseases on some magazines, Chinese patent (application number) 94112228 discloses with Radix Platycodonis, Radix Glycyrrhizae, Flos Lonicerae, Flos Chrysanthemi, Herba Menthae, FRUCTUS TERMINALIAE IMMATURUS or semen sterculiiae lychnophorae, green tea, Gan Yeju are that the Chinese medicine bag of Main Ingredients and Appearance is made tea, to the treatment pharyngalgia, hoarseness has certain effect; Chinese patent (application number) 97111786 also discloses a kind of cleaning throat and moistening larynx eliminating inflammation and expelling toxin beverage, form by Fructus Crataegi, Flos Chrysanthemi, Fructus Lycii, Flos Lonicerae, Fructus Schisandrae Chinensis, Radix Glycyrrhizae and Mel or sucrose, pure water, can heat-clearing and toxic substances removing, cleaning throat and moistening larynx, play certain antiinflammatory, antidotal purpose.Chinese patent (application number) 01128346, a kind of health medicine for the treatment of oral cavity and laryngopharyngeal diseases and preparation method thereof provides a kind of health medicine for the treatment of oral cavity and laryngopharyngeal diseases and preparation method thereof, it comprises Flos Lonicerae, Flos Chrysanthemi, Radix Isatidis, Herba Hedyotidis Diffusae, Radix Platycodonis, Periostracum Cicadae, Flos Ilicis Asprellae, Herba Taraxaci, raw material of Chinese medicine such as Radix Glycyrrhizae, its preparation method is in proportion above-mentioned nine kinds of Chinese herbal medicine to be cleaned (disregarding Mel), pulverize and cross 200 mesh sieves, make medicated powder, perhaps adopt alcohol extracting method, the water extraction effective component extracting, make oral liquid again, buccal tablet, tablet, capsule, pill, this health medicine can be eliminated the inflammation that the evil poison of each internal organs causes in the human body, can treat oral cavity and laryngopharyngeal diseases such as pharyngolaryngitis, tonsillitis, oral ulcer, gingivitis, upper respiratory tract infection.Medicine of 02,112,835 1 kinds of acute and chronic pharyngitis of treatment of Chinese patent (application number) and preparation method thereof discloses a kind of medicine for the treatment of acute and chronic pharyngitis, mainly make: bright Fructus Canarii 60-70% by following component, Radix Scrophulariae 10-20%, Radix Rehmanniae 10-20%, Mentholum 1-2%.Its preparation method is: it is whole to get bright Fructus Canarii, adds water 100ml, and the squeezing extracting juice is standby; Radix Scrophulariae, Radix Rehmanniae etc. add 5 times of water gagings and decoct secondary, and 2 hours for the first time, 1.5 hours for the second time; Filter merging filtrate vacuum concentration to 1: 1; It is an amount of to add ethanol, leaves standstill, and gets supernatant concentration and becomes fluid extract, and relative density is 1.2-1.3 (heat is surveyed); Add Sucus Canarii and stir evenly, add right amount of auxiliary materials, granulate; Cold drying, granulate sprays into the Mentholum alcoholic solution, adds an amount of magnesium stearate again, mixing, tabletting.Prove that through clinic trial this medicine is used to treat that acute pharyngitis belongs to wind heat deficiency of YIN disease and chronic pharyngitis belongs to the hyperactivity of deficient fire disease, curative effect is fabulous, and effective percentage is more than 98.3%, and is safe in utilization.Medicine of Chinese patent (application number) 99114946 treatment upper respiratory diseases and preparation method thereof is a kind of medicine for the treatment of upper respiratory disease and preparation method thereof.Make by certain technology by the following weight proportion raw material: Radix Anemones Rivularis 20-30, Radix Scrophulariae 15-25, Rhizoma Belamcandae 15-25, Fructus Arctii 15-25, Herba Clematidis Meyenianae 15-25, Radix Platycodonis 10-20, Pericarpium Citri Reticulatae 10-20, Radix Glycyrrhizae 10-20.Characteristics of the present invention are to formulate on the basis and form excavating and sorting out ethnic drug among the people, have obvious anti-inflammatory and anti, the relieving cough and reducing sputum, and antibacterial action is treatment acute/chronic pharyngitis, tonsillitis, the medicine of upper respiratory diseases such as bronchitis.Symptoms such as the laryngopharynx swelling and pain that causes for wind heat disease and lung excess of the stomach heat symptom-complex, cough, abundant expectoration, heating, bitter taste, nasal obstruction have therapeutical effect preferably.96,114,394 1 kinds of Chinese patent medicines for the treatment of pharyngitis of Chinese patent (application number) are that treatment pharyngitis later stage pharyngeal cavity lymph follicle hamartoplasia is main Chinese patent medicine preparation, belong to Chinese patent drug technique field.Contain Radix Sophorae Tonkinensis 50-100. Radix Isatidis 50-100. Rhizoma Belamcandae 30-60. Fructus Canarii 40-80. Borax 40-80. Sanguis Draxonis 20-40. crystal sugar 1000-2500 in this preparation.Six-element Chinese patent medicine composition can be made into the containing of caked sugar of different shaped shape.This preparation also can hold concurrently treating tonsillitis, cough due to pathogenic wind-heat, oral ulcer, periodontitis, prevent and treat viral influenza, have that preparation method is simple, a determined curative effect, characteristics such as easy to use, without any side effects.The Yanbinghanhuatang total effective rate is 100%, and wherein obvious effective rate is 90.5%.The applicant Guangxi Chunzhengtang Pharmaceutical Factory is a few years ago in order to treat acute inflammation of the throat, acute hoarseness (acute laryngopharyngitis), also succeeded in developing a kind of yuye qinghuo Chinese medicine preparation, and be applied to clinically, applied for patent of invention at present, number of patent application 200510055521.8 to State Intellectual Property Office, its primary raw material comprises Radix Mussaendae, Herba Andrographis, Fructus Gardeniae, Herba Ecliptae, Radix achyranthis asperae (Herba Achyranthis Asperae), its preparation method is to get Radix Mussaendae, Herba Andrographis, Fructus Gardeniae, Herba Ecliptae, Radix achyranthis asperae (Herba Achyranthis Asperae) five tastes medical material is ground into fine powder with Herba Andrographis and Fructus Gardeniae earlier, three flavor medical materials such as residue Herba Andrographis and all the other Radix Mussaendae, decoct with water secondary, collecting decoction filters, and concentrates, make tablet then, capsule, pill, granule, oral liquid, this Chinese medicine preparation has clearing away heat and expelling pathogen in the exterior, reducing swelling and alleviating pain, the effect of clearing throat.Be used for wind-heat syndrome acute inflammation of the throat, acute hoarseness and cough and disease is seen laryngopharynx swelling and pain, dry mouth and throat, itching of the throat, disease such as hoarseness, aphonia, total effective rate is 95.0%.
Summary of the invention
In order to treat acute pharyngolaryngitis wind heat disease better, the inventor is from the prescription of tradition Chinese herbal treatment among the people, through test for many years, discovery and arrangement, prescription in conjunction with Guangxi treatment acute pharyngolaryngitis wind heat diseases more among the people, experiment repeatedly, contrast, and by modern detection and treatment means, on the basis of yuye qinghuo Chinese medicine preparation, sum up a kind ofly to treating the Chinese medicine preparation of common acute pharyngolaryngitis wind card disease again, and make, pass through clinical trial with modern pharmaceutical technology, proved that this medicine produce effects is fast, subjective symptoms and sign are obviously improved, and not seeing has side effect, and are difficult for recurrence.A kind of new excellent drug is provided for the disease of treatment by Chinese herbs wind-heat syndrome of acute pharyngitis.
The present invention treats the Chinese medicine preparation of wind-heat syndrome of acute pharyngitis and is made by Radix Mussaendae, Herba Andrographis, Fructus Gardeniae, Radix achyranthis asperae (Herba Achyranthis Asperae), Radix Scrophulariae, artificial Calculus Bovis's Huang, and its parts by weight of raw materials array becomes as follows:
Radix achyranthis asperae (Herba Achyranthis Asperae) 5-20 part Herba Andrographis 15-30 part Fructus Gardeniae 5-20 part
Radix Scrophulariae 5-20 part Radix Mussaendae 30-50 part artificial Calculus Bovis 0.5-2 part.
The optimum weight umber of the Chinese medicine preparation of treatment wind-heat syndrome of acute pharyngitis of the present invention is composed as follows:
10 parts of 20 portions of Fructus Gardeniaes of 10 parts of Herba Andrographis of Radix achyranthis asperae (Herba Achyranthis Asperae)
1 part of 40 parts of artificial Calculus Bovis of 10 parts of Radix Mussaendae of Radix Scrophulariae
It is composed as follows that the Chinese medicine preparation of treatment wind-heat syndrome of acute pharyngitis of the present invention is used for clinical optimum weight content:
Radix achyranthis asperae (Herba Achyranthis Asperae) 100g Herba Andrographis 200g Fructus Gardeniae 100g
Radix Scrophulariae 100g Radix Mussaendae 400g artificial Calculus Bovis 10g
Above-mentioned raw materials is made 1000 tablets of tablets or 1000 capsules with existing pharmaceutical methods.
Chinese medicine preparation of the present invention comprises granule, tablet, syrup, capsule, slow releasing capsule, pill, oral liquid, soft capsule, drop pill, big honeyed pills or pharmaceutically said other dosage form, and its preparation method is as follows:
The preparation method of granule
Get above Radix Mussaendae, Herba Andrographis, Fructus Gardeniae, Radix achyranthis asperae (Herba Achyranthis Asperae), Radix Scrophulariae, artificial Calculus Bovis's Six-element medical material, except that the artificial Calculus Bovis, with Herba Andrographis; the five tastes such as Radix Mussaendae decoct with water twice, and each 2 hours, collecting decoction; filter; filtrate is concentrated into the clear paste that relative density is 1.32～1.34 (56 ℃), adds the artificial Calculus Bovis, makes granule, drying by per kilogram medical material adding 1-2 kilogram cane sugar powder and adding appropriate amount of auxiliary materials then; granulate; packing, check obtains product.
The described adjuvant of above granule is that the Pharmacopoeia of the People's Republic of China records, composition and content meet the every requirement of index down of national standard.
The preparation method of tablet
Get above Radix Mussaendae, Herba Andrographis, Fructus Gardeniae, Radix achyranthis asperae (Herba Achyranthis Asperae), Radix Scrophulariae, artificial Calculus Bovis's Six-element medical material; except that the artificial Calculus Bovis; Herba Andrographis is ground into fine powder; four flavors such as all the other Radix Mussaendae decoct with water twice; each 2 hours, collecting decoction filtered; filtrate is concentrated into the clear paste that relative density is 1.32～1.34 (56 ℃); it is an amount of to add artificial Calculus Bovis, Herba Andrographis fine powder and 8% starch slurry, 50% syrup and dextrin, makes granule, drying; granulate; compacting is in blocks, coating, packing; check obtains product.
The described adjuvant of above tablet is what the Pharmacopoeia of the People's Republic of China recorded, and composition and content meet the every requirement of index down of national standard.
Capsular preparation method
Get above Radix Mussaendae, Herba Andrographis, Fructus Gardeniae, Radix achyranthis asperae (Herba Achyranthis Asperae), Radix Scrophulariae, artificial Calculus Bovis's Six-element medical material, except that the artificial Calculus Bovis, Herba Andrographis is ground into fine powder, four flavors such as all the other Radix Mussaendae decoct with water twice; each 2 hours, collecting decoction filtered; filtrate is concentrated into the clear paste that relative density is 1.32～1.34 (56 ℃), adds artificial Calculus Bovis, Herba Andrographis fine powder, adds appropriate amount of auxiliary materials then; mix homogeneously is made granule, drying; granulate, capsule is filled, polishing; packing, check obtains product.
The described adjuvant of above capsule is what the Pharmacopoeia of the People's Republic of China recorded, and composition and content meet the every requirement of index down of national standard.
The preparation method of syrup
Get above Radix Mussaendae, Herba Andrographis, Fructus Gardeniae, Radix achyranthis asperae (Herba Achyranthis Asperae), Radix Scrophulariae, artificial Calculus Bovis's Six-element medical material; except that the artificial Calculus Bovis; decoct with water twice; each 2 hours; collecting decoction; precipitate with ethanol; reclaim ethanol; concentrate, filter, filtrate is concentrated into the clear paste that relative density is 1.32～1.34 (56 ℃); add the artificial Calculus Bovis; add the antiseptic of 0.1-0.3% such as sorbitol or ethyl hydroxybenzoate then and, obtain syrup by weight the 1-2 sucrose solution doubly or the distilled water or the pure water of sweeting agent and 2 times.The preparation method of pill
Get above Radix Mussaendae, Herba Andrographis, Fructus Gardeniae, Radix achyranthis asperae (Herba Achyranthis Asperae), Radix Scrophulariae, artificial Calculus Bovis's Six-element medical material; except that the artificial Calculus Bovis; Herba Andrographis is ground into fine powder; four flavors such as all the other Radix Mussaendae decoct with water twice; each 2 hours; collecting decoction; filter; filtrate is concentrated into the clear paste that relative density is 1.32～1.34 (56 ℃); add artificial Calculus Bovis, Herba Andrographis fine powder; add the sorbitol of excipient, 0.1-0.3% or ethyl hydroxybenzoate then and 10～100% sucrose or refined honey and dry adjuvant are made water-honeyed pill, big honeyed pills, concentrated pill product by weight.
The preparation method of oral liquid
Get above Radix Mussaendae; Herba Andrographis; Fructus Gardeniae; Radix achyranthis asperae (Herba Achyranthis Asperae); Radix Scrophulariae; artificial Calculus Bovis's Six-element medical material; except that the artificial Calculus Bovis; with Herba Andrographis; the five tastes such as Radix Mussaendae decoct with water twice; each 2 hours; collecting decoction; precipitate with ethanol reclaims ethanol, concentrates; filter; filtrate is concentrated into the clear paste that relative density is 1.32～1.34 (56 ℃), adds the artificial Calculus Bovis, adds antiseptic such as sorbitol or the ethyl hydroxybenzoate of 0.1-0.3% then; with by weight the 0.5-1 sucrose solution doubly or the distilled water or the pure water of sweeting agent and 2 times; the sorbitol of 0.1-0.3% or ethyl hydroxybenzoate, fill obtains product.
The using method of Chinese medicine preparation of the present invention, oral, 3 times on the one, a 5-10 gram, children's is cut down according to the circumstance, 5 days courses of treatment.
Cure mainly: wind-heat syndrome of acute pharyngitis
Function: clearing away heat and expelling pathogen in the exterior, relieving sore throat and diminishing swelling.Be used for acute inflammation of the throat, syndrome of wind-heat invading lung, disease is seen pharyngalgia, dryness and heat, dysphagia, mouth is little thirsty, fever and aversion to wind, red swelling of the pharynx, tongue tip side of red, white and thin fur or BOHUANG, floating and rapid pulse.Acute pharyngitis is seen above patient.
The performance and the effectiveness of above-mentioned each composition of Chinese medicine are as follows:
1, Radix Mussaendae has another name called blank sheet of paper fan, Ramulus et Folium Mussaendae Pubescentis, BAIHU butterfly etc.Be the dry stem of Maguireothamnus speciosus Radix Mussaendae mussaenda pubescensAit.f.Have effects such as clearing away heat and removing summer-heat, removing pathogenic heat from blood and toxic substance from the body, be used for disease functions such as flu, administration, enteritis, oedema due to nephritis, laryngopharynx swelling and pain and Gelsemium elegans Benth., Maninot esculenta crantz., the poisoning of wild bacterium and cure mainly: clearing away heat-damp and promoting diuresis, removing toxic substances and promoting subsidence of swelling.Be used for flu, heatstroke, enteritis, oedema due to nephritis, laryngopharynx swelling and pain, bronchitis.See " Guangxi Chinese crude drug standard ".
2, Herba Andrographis (nndrographis Paniculata Nees) is Acanthaceae Herba Andrographis platymiscium, and medicinal leaf or herb are tapped when stem and leaf is luxuriant at the beginning of the autumn, dry.Effects such as heat-clearing and toxic substances removing, reducing swelling and alleviating pain are arranged.Cheese compounds in its effective ingredient mainly contains andrographolide etc.Function cures mainly: heat-clearing and toxic substances removing, removing heat from blood, detumescence.Be used for cold, fever, laryngopharynx swelling and pain, aphtha of the mouth and tongue, pertussis chronic cough, the disease of having loose bowels dysentery, the puckery pain of pyretic stranguria, venom.
3, Fructus Gardeniae (having another name called SHANZHIZI, Yellow Fructus Gardeniae) (G.jasminoides Ellis) is the common ornamental plant of China's south garden, its fruit medicine, and the successive dynasties, main book on Chinese herbal medicine was all on the books, used till today; Also dye thing with its fruit ancient times, and the modern times also are used to extract industrial dye and food coloring.SHANZHIZI is the principal item of Fructus Gardeniae class medical material, and is wild or cultivate in the hillside, is distributed in each province on the south the Changjiang river, main product in Jiangxi, ground such as Hubei, Fujian, Hunan, Guangxi, Guangdong, Yunnan, Sichuan, Guizhou.Function cures mainly: pathogenic fire purging relieving restlessness, clearing away heat and promoting diuresis, cool detoxifcation.It is vexed to be used for calentura, the jaundice dark coloured urine, and blood strangury and dry pain, heat in blood is told nosebleed, conjunctival congestion and swelling pain, pathogenic fire,toxin and furuncles." Chinese pharmacopoeia.
4, Radix achyranthis asperae (Herba Achyranthis Asperae), the dry herb of amaranthaceous plant Radix achyranthis asperae (Herba Achyranthis Asperae) Adhyranthesa speaL.Function cures mainly: clearing away heat and expelling pathogen in the exterior, diuretic is invigorated blood circulation.The heating that cures cold, laryngalgia etc.Close at " Chinese medicine voluminous dictionary " volume two.
5, Radix Scrophulariae, removing heat from blood YIN nourishing, eliminating fire and detoxication.Be used for consumption of YIN caused by febrile disease, excessive thirst falls in tongue, maculae caused by violent heat pathogen, and constipation is hindered in Tianjin, conjunctival congestion, pharyngalgia, carbuncle sore tumefacting virus.
6, artificial Calculus Bovis clears away heart-fire, and eliminating phlegm is had one's ideas straightened out, cool liver, endogenous wind stopping, detoxifcation.Be used for the calentura coma, middle wind-phlegm fan, laryngopharynx swelling and pain, aphtha of the mouth and tongue, carbuncle furuncle.Quality standard is the Sanitation Ministry medicine standard WS3-132 (Z-122)-98.
The specific embodiment
Embodiment 1
Get 200 kilograms of Radix Mussaendae, 100 kilograms of Herba Andrographis, 50 kilograms of Fructus Gardeniaes, 50 kilograms of Radix achyranthis asperae (Herba Achyranthis Asperae)s, 50 kilograms of Radix Scrophulariaes, 5 kilograms of artificial Calculus Boviss; except that the artificial Calculus Bovis; the five tastes such as Herba Andrographis, Radix Mussaendae are decocted with water twice; each 2 hours; collecting decoction; filter; filtrate is concentrated into the clear paste that relative density is 1.32～1.34 (56 ℃); add the artificial Calculus Bovis, add 1-2 kilogram cane sugar powder and add appropriate amount of auxiliary materials by the per kilogram medical material then and make granule, drying; granulate; packing, check obtains product.Product called after " the clear granule of pyretic toxicity ".
The preparation method of tablet
1. get 40 kilograms of Radix Mussaendae; 20 kilograms of Herba Andrographis; 10 kilograms of Fructus Gardeniaes; 10 kilograms of Radix achyranthis asperae (Herba Achyranthis Asperae)s; 10 kilograms of Radix Scrophulariaes; 1 kilogram of artificial Calculus Bovis; except that the artificial Calculus Bovis; Herba Andrographis is ground into fine powder; four flavors such as all the other Radix Mussaendae decoct with water twice; each 2 hours, collecting decoction filtered; filtrate is concentrated into the clear paste that relative density is 1.32～1.34 (56 ℃); add the artificial Calculus Bovis; Herba Andrographis fine powder and 8% starch slurry 4kg; 50% syrup 4kg; appropriate amount of auxiliary materials is made granule, drying, granulate; add magnesium stearate 200g mix homogeneously; be pressed into 100,000, coating, packing; check obtains product.Product called after " the clear sheet of pyretic toxicity ".
2. get 50 kilograms of Radix Mussaendae; 30 kilograms of Herba Andrographis; 20 kilograms of Fructus Gardeniaes; 20 kilograms of Radix achyranthis asperae (Herba Achyranthis Asperae)s; 20 kilograms of Radix Scrophulariaes; 2 kilograms of artificial Calculus Boviss; except that the artificial Calculus Bovis; Herba Andrographis is ground into fine powder; four flavors such as all the other Radix Mussaendae decoct with water twice; each 2 hours, collecting decoction filtered; filtrate is concentrated into the clear paste that relative density is 1.32～1.34 (56 ℃); add the artificial Calculus Bovis; Herba Andrographis fine powder and 8% starch slurry 5kg; 50% syrup 5kg; appropriate amount of auxiliary materials is made granule, drying, granulate; add magnesium stearate 300g mix homogeneously; be pressed into 150,000, coating, packing; check obtains product.Product called after " the clear sheet of pyretic toxicity ".
The used starch of above tablet, dextrin, etc. adjuvant all meet the every requirement of index down of the Pharmacopoeia of the People's Republic of China.
Described disintegrating agent is adjuvants such as sodium carboxymethyl cellulose and pharmaceutic adjuvant with water swelling; The pharmaceutic adjuvant of described magnesium stearate, Pulvis Talci and tool lubrication.
Capsular preparation method
1. get Radix achyranthis asperae (Herba Achyranthis Asperae) 100 grams, Herba Andrographis 200 grams, Fructus Gardeniae 100 grams, Radix Scrophulariae 100 grams, artificial Calculus Bovis's 10 grams, Radix Mussaendae 400 grams; except that the artificial Calculus Bovis, Herba Andrographis is ground into fine powder, four flavors such as all the other Radix Mussaendae decoct with water twice; each 2 hours; collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.32～1.34 (56 ℃); add artificial Calculus Bovis, Herba Andrographis fine powder; add appropriate amount of auxiliary materials then, mix homogeneously is made granule; dry; granulate, the dress capsule is made 1000; polishing; packing, check obtains product.Product called after " the clear clearing capsule of pyretic toxicity ".
2. get Radix achyranthis asperae (Herba Achyranthis Asperae) 50 grams, Herba Andrographis 150 grams, Fructus Gardeniae 50 grams, Radix Scrophulariae 50 grams, artificial Calculus Bovis's 5 grams, Radix Mussaendae 300 grams; except that the artificial Calculus Bovis, Herba Andrographis is ground into fine powder, four flavors such as all the other Radix Mussaendae decoct with water twice; each 2 hours; collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.32～1.34 (56 ℃); add artificial Calculus Bovis, Herba Andrographis fine powder; add appropriate amount of auxiliary materials then, mix homogeneously is made granule; dry; granulate, the dress capsule is made 500; polishing; packing, check obtains product.Product called after " the clear clearing capsule of pyretic toxicity ".
More than the described adjuvant of preparation capsule is starch, dextrin, carboxymethyl starch etc., and other pharmaceutic adjuvants; Described disintegrating agent is sodium carboxymethyl cellulose, hydroxypropyl cellulose and pharmaceutic adjuvant with water swelling; Described fluidizer is a magnesium stearate etc., and other has the physiologically acceptable excipient substance of fluidizer effect.
The preparation method of slow releasing capsule
Get 40 kilograms of above Radix Mussaendae; 20 kilograms of Herba Andrographis; 10 kilograms of Fructus Gardeniaes; 10 kilograms of Radix achyranthis asperae (Herba Achyranthis Asperae)s; 10 kilograms of Radix Scrophulariaes; 1 kilogram of artificial Calculus Bovis; except that the artificial Calculus Bovis; Herba Andrographis is ground into fine powder; four flavors such as all the other Radix Mussaendae decoct with water twice; each 2 hours; collecting decoction; filter; filtrate is concentrated into the clear paste that relative density is 1.32～1.34 (56 ℃); add the artificial Calculus Bovis; the Herba Andrographis fine powder; add binding agent and make microcapsule,, make 2 respectively with spermaceti or other blocker coating; 4; 6; 8 hours slow-release pills; every kind of piller is distinguished with different color and lusters; pack into behind the mix homogeneously in the capsulae vacuus, make 100,000, be packaged into box or be hot pressed into aluminium-plastic panel and obtain product.Product called after " the clear slow releasing capsule of pyretic toxicity ".
The preparation method of syrup
1. get 40 kilograms of Radix Mussaendae, 20 kilograms of Herba Andrographis, 10 kilograms of Fructus Gardeniaes, 10 kilograms of Radix achyranthis asperae (Herba Achyranthis Asperae)s, 10 kilograms of Radix Scrophulariaes, 1 kilogram of artificial Calculus Bovis; except that the artificial Calculus Bovis; decoct with water twice; each 2 hours; collecting decoction; filter; concentrate; precipitate with ethanol; reclaim ethanol, filtrate is concentrated into the clear paste that relative density is 1.32～1.34 (56 ℃), adds the artificial Calculus Bovis, adds antiseptic such as sorbitol or the ethyl hydroxybenzoate of 0.1-0.3% then; with by weight the 1-2 sucrose solution doubly or the distilled water or the pure water of sweeting agent and 2 times, obtain syrup.Product called after " the clear syrup of pyretic toxicity ".
2. get 30 kilograms of Radix Mussaendae, 18 kilograms of Herba Andrographis, 15 kilograms of Fructus Gardeniaes, 15 kilograms of Radix achyranthis asperae (Herba Achyranthis Asperae)s, 8 kilograms of Radix Scrophulariaes, 1.5 kilograms of artificial Calculus Boviss; except that the artificial Calculus Bovis; decoct with water twice; each 2 hours; collecting decoction; filter; concentrate; precipitate with ethanol; reclaim ethanol, filtrate is concentrated into the clear paste that relative density is 1.32～1.34 (56 ℃), adds the artificial Calculus Bovis, adds antiseptic such as sorbitol or the ethyl hydroxybenzoate of 0.1-0.3% then; with by weight the 1-2 sucrose solution doubly or the distilled water or the pure water of sweeting agent and 2 times, obtain syrup.Product called after " the clear syrup of pyretic toxicity ".
The preparation method of pill
Get 40 kilograms of above Radix Mussaendae; 20 kilograms of Herba Andrographis; 10 kilograms of Fructus Gardeniaes; 10 kilograms of Radix achyranthis asperae (Herba Achyranthis Asperae)s; 10 kilograms of Radix Scrophulariaes; 1 kilogram of artificial Calculus Bovis; except that the artificial Calculus Bovis; Herba Andrographis is ground into fine powder; four flavors such as all the other Radix Mussaendae decoct with water twice; each 2 hours; collecting decoction; filter; filtrate is concentrated into the clear paste that relative density is 1.32～1.34 (56 ℃); add the artificial Calculus Bovis; the Herba Andrographis fine powder; add excipient then; the sorbitol of 0.1-0.3% or ethyl hydroxybenzoate and 10～100% sucrose or refined honey and dry adjuvant are made water-honeyed pill by weight; big honeyed pills; the concentrated pill product.Product called after " the clear ball of pyretic toxicity ".
The preparation method of oral liquid
Get 40 kilograms of above Radix Mussaendae; 20 kilograms of Herba Andrographis; 10 kilograms of Fructus Gardeniaes; 10 kilograms of Radix achyranthis asperae (Herba Achyranthis Asperae)s; 10 kilograms of Radix Scrophulariaes; 1 kilogram of artificial Calculus Bovis; except that the artificial Calculus Bovis; with Herba Andrographis; the five tastes such as Radix Mussaendae decoct with water twice; each 2 hours; collecting decoction; filter, concentrate precipitate with ethanol; reclaim ethanol; filtrate is concentrated into the clear paste that relative density is 1.32～1.34 (56 ℃), adds the artificial Calculus Bovis, adds antiseptic such as sorbitol or the ethyl hydroxybenzoate of 0.1-0.3% then; with by weight the 0.5-1 sucrose solution doubly or the distilled water or the pure water of sweeting agent and 2 times; the sorbitol of 0.1-0.3% or ethyl hydroxybenzoate, fill obtains product.Product called after " the clear oral liquid of pyretic toxicity ".
Clinical trial of the present invention
Clinical trial unit: Nanjing Traditional Chinese Medicine Univ. affiliated hospital, first Affiliated Hospital of Colleges Of Traditional Chinese Medicine Of Guangxi, Xiyuan Hospital, Chinese Medicine Academy of China, date of test: in February, 200 2-July, II clinical trial phase
(the clinical research official written reply is called the yuye qinghuo sheet, to call the clear sheet of pyretic toxicity in the following text to estimate the clear sheet of pyretic toxicity with the WANTONG YANKANG PIAN contrast.) the treatment wind-heat syndrome of acute pharyngitis
Pilot project: the effectiveness safety at random, parallel control, two the region between the heart and the diaphragm dual analog, multiple center clinical study
According to the 200IZL229 of State Food and Drug Administration official written reply, on July 24,4 days～2002 February in 2002 the clear sheet treatment of the Chinese medicine three kind new medicine pyretic toxicity wind-heat syndrome of acute pharyngitis that the applicant Guangxi Chunzhengtang Pharmaceutical Factory bids to host is carried out the II clinical trial phase by three tame hospitals, final report is as follows.
One, test objective
Observe the effectiveness of the clear sheet treatment of pyretic toxicity wind-heat syndrome of acute pharyngitis, its main purpose: the evaluation test medication is scorching hot to pharyngalgia, dry pharynx, the curative effect of pharyngeal mucous membrane uvula redness: secondary objective: the evaluation test medication is to heating, pharynx rear wall lymph follicle, lateral pharyngeal band redness, aversion to wind, tongue arteries and veins etc., the curative effect that blood leukocytes sum and classification, throat swab are checked.
Safety evaluatio.
Two, test method
(1) EXPERIMENTAL DESIGN type, principle and test procedure
1. EXPERIMENTAL DESIGN type: parallel at random group control design.
2. EXPERIMENTAL DESIGN principle
(1) case load: press II clinical trial phase contrast in 1: 1 principle, consider to be no more than 20% the rate that withdraws from, total inverse is defined as 120 pairs of totally 240 examples.Each test center is distributed 80 examples, and test group equates with matched group example number, respectively is 40 examples.
(2) random packet method: adopt center layering, district's group method of randomization.Produce the random arrangement that 240 routine experimenters accept to handle (investigational agent and contrast medicine) by the SAS statistical analysis system, promptly listing serial number is that 001～240 pairing treatment distributes (attached randoming scheme).The continuous programming code medicine that each central dispense 80 example is connected mutually.
This test is worked in coordination with 3 hospitals and is finished.Specify test center number (according to SAS output result) at random: Nanjing Traditional Chinese Medicine Univ. affiliated hospital is 02, and Xiyuan Hospital, Chinese Medicine Academy of China is 03, and first Affiliated Hospital of Colleges Of Traditional Chinese Medicine Of Guangxi is 01.
(3) contrast: the contrast medicine is selected WANTONG YANKANG PIAN for use.Reason: function wind and heat dispersing sore-throat relieving cures mainly wind-heat syndrome of acute pharyngitis.
This medicine function cures mainly close with trial drug, is the comparatively sure similar medicine of present domestic curative effect, and curative effect is sure, meets to generally acknowledge effective, comparable principle.
(4) blind method design; Because two kinds of medicine method of administration of investigational agent and contrast medicine are different, so " double blinding dual analog " method of employing.Two groups add respectively and use placebo.The placebo dosage form of test group, outward appearance etc. are consistent with the contrast medicine, and the placebo dosage form of matched group, outward appearance etc. are consistent with investigational agent.Trial drug is produced, packs, is provided according to random assortment harmony in the exterior double blinding principle by bidding person.The first order is each case number pairing group (as A and a B group), and the second level is two groups of pairing processing (test group and matched groups).The random cipher table is set up by group leader unit, and the blind end of two-stage is sealing separately respectively, and each is duplicate, and preserve separately group leader Yu unit clinical drug is studied carefully base office and bidding person.
Emergent mail: the trial drug of each numbering all has corresponding emergent mail, in the emergent mail paper slip which kind of class this numbering medicine belongs to is housed, so that in emergency circumstances broken blind usefulness takes place.
3. test procedure
See Appendix, in the research case history " clinical trial flow chart ".
(2) case is selected
1. formulating of " the acute inflammation of the throat diagnosis criterion of therapeutical effect " that diagnostic criteria reference " the clinical research guideline of new drug (Chinese medicine) treatment acute pharyngitis ", Chinese Chinese medicine department of otorhinolaryngology Professional Committee of association (Hangzhou meeting in 1991) formulate with higher medical universities and colleges teaching materials " traditional Chinese medical science otolaryngology " (traditional Chinese medical science five editions), " otolaryngology " (five editions).
(1) Western medicine diagnose standard
Medical history: onset is anxious, often have suffer from cold, the inducements such as stimulation of tired, excessive, the various physics of tobacco and wine and chemistry.
Symptom: a. primary symptom: pharyngeal drying, scorching hot, pharyngalgia or odynophagia.B. inferior disease: heating, fear of cold, inappetence, extremities aching pain.
Sign: the hyperemia of a. pharyngeal mucosa, color is scarlet.B. swallow rear wall lymph follicle and lateral pharyngeal band redness, or pharyngeal mucous membrane there is the diffusing shape of yellow-white secretions to distribute.C. uvula, soft palate congestion and edema.D submandibular lymph nodes enlargement or tenderness is arranged.E. pharyngeal secretions inspection can have pathogenic bacterium or feminine gender.
During diagnosis the acute attack history must be arranged, symptomatology or partial symptoms (primary symptom must be arranged) have among the sign a.b.c. any one concurrently, or one or more.
(2) Chinese medical discrimination standard
Primary symptom: pharyngalgia or odynophagia, dry pharynx is scorching hot, pharyngeal red slightly or scarlet, edema, uvula redness.
Inferior disease: heating, slight chill, pharynx rear wall follicle hypertrophy, visible tongue tip side of red, white and thin fur, floating and rapid pulse.
(3) symptom and sign quantitative criteria
Primary symptom
Pharyngalgia did not have in normal 0 minute
Pharyngalgia was lighter in slight 3 minutes, did not influence and swallowed
6 fens odynophagia of moderate does not influence rest
Severe pain when severe was swallowed in 9 minutes, influence are had a rest and are slept
Scorching hot normal 0 minute of dry pharynx
Pharynx in slight 3 minutes is little to be done
6 fens dry pharynxs of moderate are scorching hot, the desire drink
9 fens dry pharynx polydipsia of severe are desired cold drink
Red and swollen normal 0 minute of pharyngeal mucous membrane, uvula
Slight 3 minutes pharyngeal mucous membrane, uvula are little red little swollen
6 fens pharyngeal mucous membrane of moderate, uvula congestion and edema are obvious
9 fens pharyngeal mucous membrane of severe, the hyperemia of uvula diffusivity, color is scarlet, and edema is heavy
Inferior disease
Generate heat and do not have heating in normal 0 minute
Slight 1 minute 37.4 ℃～37.9 ℃
38.0 ℃～38.5 ℃ of moderates 2 minutes
3 minutes＞38.5 ℃ of severes
Pharynx rear wall lymph did not have congested enlargement hypertrophy in normal 0 minute
Folliculus is slight 1 fen mild hyperaemia
2 fens obvious congested enlargement hypertrophy of moderate
3 fens serious congested enlargement hypertrophy of severe, or there is yellow-white point-like secretions at the center
Lateral pharyngeal band did not have congested swelling in red and swollen normal 0 minute
The swelling of slight 1 fen lateral pharyngeal band mild hyperaemia
2 fens lateral pharyngeal bands of moderate are obviously red and swollen
3 fens lateral pharyngeal band rednesses of severe have yellow-white secretions
Micro evil wind did not have in 0 minute
Had in 1 minute
Tongue tip side of red, white and thin fur or BOHUANG, floating pulse or floating and rapid pulse (pulse frequency 〉=85 time/minute): have or not or other
(4) severity extent grade scale
Slightly: any one primary symptom index reaches slightly in total points≤12 minute or " the symptom and sign scalar quantization standard ", but does not reach the above person of moderate.
Moderate: any one primary symptom index reaches moderate in total points＞12 minute ,≤24 minutes or " symptom and sign scalar quantization standard ", but does not reach severe person.
Severe: any one primary symptom index reaches severe person in total points＞24 minute or " the symptom and sign scalar quantization standard ".
2. include standard in
(1) meets acute pharyngitis diagnostic criteria and the dialectical standard person of traditional Chinese medical science wind-heat syndrome.
(2) age between 18～65 years old, male or female.
(3) Acute onset, the course of disease is in 2 days.
(4) informed consent, aspiration is tried.Obtain the Informed Consent Form process and should meet the GCP regulation.
3. exclusion standard
(1) pharyngeal symptom or the inflammation that causes because of measles, scarlet fever, influenza, agranulocytosis, infectious monocytosis, leukemia, acute carotid arteritis etc.
(2) heating is＞38 ℃; Or occur together pneumonia and bronchitis; Suppurative flat choosing stopped inflammation.
(3) used the Chinese and western drugs of other treatment acute pharyngitis after this is fallen ill.
(4) age is under-18s or over-65s person, or is trimester of pregnancy, women breast-feeding their children.
(5) have serious constitutional cardiovascular pathological changes, hepatic lesions, nephropathy, hematology's pathological changes, pneumonopathy or influence the serious disease of its existence, as tumor or acquired immune deficiency syndrome (AIDS).
(6) following lab index is unusual: 1. serum creatinine＞150u mo/L, carbamide＞10mmol/L or/and albuminuria＞+, or/and erythrocyturia＞+(urine Hb is not as judge index).2. ALT, ALP surpass the normal value upper limit more than one times.The arrhythmia that 3. clinical meaning is arranged.
(7) spirit or jural disabled patient.
(8) suspect or truly have ethanol, drug dependence medical history, perhaps according to the judgement of researcher, have to reduce and go into to organize probability or make into other complicated pathological changes of group, as working environment often change etc. easily cause the situation of visiting of losing.
(9) known to this medicine composition allergy sufferers.
(10) participating in the patient of other drug clinical trial.
4. the experimenter withdraws from the condition (summary) of test
5. premature termination experimental condition (summary)
6. case comes off and processing
(1) standard that comes off: all have been filled in Informed Consent Form and have screened the qualified experimenter who enters randomized test, and no matter when what is because of withdrawing from, and the short of experimenter who finishes the observation cycle of scheme defined is all as the case that comes off.The drug withdrawal person voluntarily less than 1 state of an illness recovery from illness course of treatment is as coming off case.
(2) the come off processing of case
After the experimenter comes off, researcher should take to visit, preengage follow up a case by regular visits to, modes such as phone, mail, get in touch with the experimenter as far as possible, the inquiry reason, write down last medicine time, finish the evaluation item that can finish.Because of anaphylaxis, untoward reaction, fail to respond to any medical treatment and withdraw from the test case, researcher should be taked the corresponding treatment measure according to being tried practical situation.
7. the rejecting of case
(1) " violation legitimacy " refers to that promptly case selects to have violated the group standard, and this should not carry out randomization.
(2) not service test medication.
(3) after randomization without any data.
Before the data statistics analyse, judge by statistician and main researcher discussion whether case is rejected.
(3) therapeutic scheme
1. test medication title and specification
The test medication: the clear sheet of pyretic toxicity is provided by bidding person Guangxi Chunzhengtang Pharmaceutical Factory.Prescription is made up of 6 flavor Chinese medicines such as Radix Mussaendae, Herba Andrographis, Fructus Gardeniae, Radix achyranthis asperae (Herba Achyranthis Asperae), Radix Scrophulariae, artificial Calculus Bovis.Specification: 24 in every box, lot number 20011231.
The contrast medicine: WANTONG YANKANG PIAN, Wantong Pharmaceutical Co., Ltd., Guangxi produces, and prescription is made up of Radix Picriae felterrae, Herba Sarcandrae.Specification: 24 in every box, lot number 20011025.
2. test and use drug package
Bidding person packs the test medication according to scheme adnexa " test medication packing list and packing regulation ", and has the special messenger to check, and packaging process has record.
3. test medication random coded is blind with volume
Bidding person carries out random coded according to scheme adnexa " clinical trial randoming scheme " to the test medication.Test medication random coded is experimenter's unique identifier.Each coding medicine is joined an emergent mail, is used for urgent broken blind.Monitor and researcher must be in blind attitude from start to finish.
4. the test medication distributes
According to the sequence of test center random coded and trial drug random coded, and the case load that distributes, the test medication distributed.
Each research unit specifies a test medication manager.Researcher screens qualified experimenter, and through informed consent, write research case history after, send out medicine (will destroy randomization) by example to big order by test medication manager from small to large according to go to a doctor sequencing and medicine coding of experimenter, and be registered in " the medicinal log of clinical trial " if run counter to this regulation; Concentrate return to bid to host unit or follow procedure destruction residual drug.
5. the test medication is checked
When following up a case by regular visits to for the last time, researcher need write down test medication experimenter should take dose and the actual amount of giving back.
Experimenter's drug compliance=(actual dose/should dose) * 100%.Actual dose=dose-residue amount of giving back and loss amount.Should send out the number of times that medicine should take to this prescription on individual diagnosis * at every turn stipulate dose dose=last time.
6. method of administration
Test group: the clear sheet of pyretic toxicity, oral, each 3,3 times on the one.WANTONG YANKANG PIAN (placebo), oral, each 2, each 3 of serious symptom, 3 times on the one.
Matched group: WANTONG YANKANG PIAN, oral, each 2, each 3 of serious symptom, 3 times on the one.The clear sheet (placebo) of pyretic toxicity, oral, each 3,3 times on the one.
Taking medicine continuously 5 days is 1 course of treatment.Be 1 course of treatment observing time.After clinical trial finishes, by routine clinical method treatment.
7. medicine is preserved and is reclaimed
Test medication special counter is locked, and room temperature preservation keeps dry.
The residue test medication that researcher reclaims is deposited separately, and goes up the registration volume residual at " clinical trial medication service recorder table ", and when clinical trial finishes, concentrates and return bidding person or destruction.
8. drug combination
Except that the test medication, viewing duration bans use of the Chinese medicine of other treatment acute pharyngitis to treat relevant other treatment with Western medicine and with primary disease.
The doctor should require the patient all medicines of taking must to be brought when following up a case by regular visits to, to check patient's drug combination.Merge the medicine that disease institute must continue to take, or other treatment must be in research medical history record medicine name (or other therapies name), consumption, access times and time etc., so that analyzed during summary and report.
(4) curative effect and safety observation index
1. main curative effect index
Primary symptom: pharyngalgia, scorching hot, the pharyngeal mucous membrane uvula redness of dry pharynx.
2. secondary efficacy index
Inferior disease: heating, pharynx rear wall lymph follicle, lateral pharyngeal band redness, aversion to wind, tongue arteries and veins etc.
The physico-chemical examination index: blood leukocytes sum and classification, throat swab is cultivated.
3. comprehensive therapeutic effect
4. safety is observed
Adverse events.Blood, routine urinalysis, stool routine examination.Electrocardiogram, liver function (ALT), renal function (BUN, Scr).
(5) curative effect and safety assessment standard
1. comprehensive therapeutic effect evaluation criteria (with reference to the efficacy assessment standard of " the new clinical research guideline of Chinese medicine " the 3rd volume) is according to formula (total mark one treatment back total mark before the treating)/preceding total mark of treatment * 100%
Clinical recovery: body temperature, blood leukocytes counting recovered normal with interior symptom and sign disappearance in 5 days in medication.The symptom and sign total mark is 0 minute.
Produce effects: the curative effect integration reduces 〉=67%
Progressive: the curative effect integration reduces 〉=33%,＜67%
Invalid: the curative effect integration reduces≤33%
2, primary symptom efficacy assessment standard
Clinical recovery: symptom and sign keeps the score=and 0
Produce effects: curative effect minimizing 〉=66% of keeping the score
Progressive: curative effect minimizing 〉=33% of keeping the score,＜66%
Invalid: curative effect minimizing＜33% of keeping the score
3, safety evaluatio standard
1 grade: safety, there is not any untoward reaction.
2 grades: compare safety,, need not do any processing and can continue administration if any untoward reaction.
3 grades: safety issue is arranged, moderate untoward reaction is arranged, can continue administration after processing.
4 grades: because of test is ended in untoward reaction.
4, adverse events light and heavy degree criterion
Slightly: the experimenter can stand, and does not influence treatment, does not need special processing, and experimenter's rehabilitation is not had influence.
Moderate: the experimenter is difficult to stand, and needs withdrawal to end to test or do special handling, and experimenter's rehabilitation is had a direct impact.
Severe: jeopardize experimenter's life, cause death or disable, need withdrawal immediately or do emergent management.
The data of report are accurate, complete errorless, and guarantee test is followed scheme, " the clinical drug trial management regulation " and relevant rules of approved.
(6) test mass control and assurance (summary)
(7) data management (summary)
(8) statistical analysis
1, statistical analysis plan book and statistical software
After testing program is determined, be responsible for making the statistical analysis plan book through consultation with main researcher by the statistics personnel.Adopt the SAS6.12 software statistics.
2, the selection of analytical data collection (summary).
3, statistical analysis content
Actual two groups of subject enrollment quantity come off and reject case situation, demography and other baseline characteristic, compliance, efficacy analysis and safety analysis.
4, statistical analysis technique
Descriptive statistical analysis, qualitative index be with frequency table, and percentage rate or constituent ratio are described: quantitative target is with mean, standard deviation, or median, and lower quartile (Q1), upper quartile (Q3) is described.
Two groups of relative analyses, qualitative data adopts X 2 test, the accurate probabilistic method of Fisher, Wilcoxon rank test, CMHX2 check, WLS covariance.Quantitative data meets normal distribution and (carries out homogeneity test of variance between group with the T check, with 0.05 as inspection level, select for use the Satterthwaite method to carry out gauged t check during heterogeneity of variance), do not meet normal distribution Wiicoxon rank test, the Wilcoxon signed rank sum test.Testing of hypothesis is unified uses two-sided test, provides statistic of test and corresponding P value thereof, with P≤0.05 as statistical significance is arranged, with P≤0.01 as highly statistical significance is arranged.
Three, result of the test
(1) reality is respectively organized subject enrollment quantity
Group 240 examples, 1 example that comes off, expulsion rate 0.42% are gone in test.Meet scheme collection 239 examples, safety collection 240 examples.See Table 1-1,1-2,1-3,1-4.
Table 1-1: test case situation
Table 1-2: the test case comes off or rejecting situation and statistical disposition
Table 1-3: statistics case situation
Table 1-4: statistics case situation
(2) demography and other baseline characteristic, compliance situation (summary)
Table 2-1-2: clinical physical data report before two groups of treatments
2. two groups of experimenter's drug compliances relatively
The difference not statistically significant of two groups of experimenter's drug compliances sees Table 2-2.
Table 2-2: the report of two groups of experimenter's drug compliances
(3) observation index result and analysis
The main curative effect index of 1-1
The difference for the treatment of the 3rd day, the 6th day two groups of scorching hot change-in-score values of dry pharynx has statistical significance. see Table 3-1-2.
Table 3-1-1: two groups of pharyngalgia situation of change (PPS) of keeping the score
Table 3-1-2: two groups of scorching hot situations of change of keeping the score of dry pharynx (PPS)
Table 3-1-3: two groups of pharyngeal mucous membrane, uvula rednesses situation of change (PPS) of keeping the score
Table 3-1-4: two groups of positive symptom sign disappearance rate situations (PPS)
1-2. primary symptom integration
Difference all has the height statistical significance in the group before two groups of each time points of primary symptom integration and the treatment.See Table 3-1-5.
Table 3-1-5: symptom primary symptom integration situation of change (PPS) before and after two groups of treatments
2-1 secondary efficacy index (summary)
Two groups of situations of change (PPS) (summary) of keeping the score of generating heat of table 3-2-1
Table 3-2-2: two groups of pharynx rear wall lymph follicles situation of change (PPS) (summary) of keeping the score
Table 3-2-3: two groups of lateral pharyngeal band rednesses situation of change (PPS) (summary) of keeping the score
Two groups of micro evil wind of table 3-2-4 are kept the score situation of change (PPS) slightly
Table 3-2-5: two groups of positive symptom sign disappearance rate situations (PPS)
Index item A group B group statistic P value
The 2nd day accurate probabilistic method P=0.9056 of heating disappearance rate situation
Example number (disappearance) 6 (0) 7 (0)
(example, %) 5 (83.33) 6 (85.71) disappear
(example, %) 1 (16.67) 1 (14.29) do not disappear
The 5th day accurate probabilistic method P=0.3352 of heating disappearance rate situation
Example number (disappearance) 6 (0) 7 (0)
(example, %) 6 (100.00) 6 (85.71) disappear
(example, %) 0 (0.00) 1 (14.29) do not disappear
The 2nd day accurate probabilistic method P=1.0000 of pharynx rear wall lymph follicle disappearance rate situation
Example number (disappearance) 113 (0) 113 (0)
(example, %) 14 (12.39) 14 (12.39) disappear
(example, %) 99 (87.61) 99 (87.61) do not disappear
The 5th day accurate probabilistic method P=0.1016 of pharynx rear wall lymph follicle disappearance rate situation
Example number (disappearance) 113 (0) 113 (0)
(example, %) 75 (66.37) 63 (55.75) disappear
(example, %) 38 (33.63) 50 (44.25) do not disappear
The 2nd day accurate probabilistic method P=0.4288 of the red and swollen disappearance rate situation of lateral pharyngeal band
Example number (disappearance) 108 (0) 109 (0)
(example, %) 34 (31.48) 29 (26.61) disappear
(example, %) 74 (68.52) 80 (73.39) do not disappear
The 5th day accurate probabilistic method P=0.3422 of the red and swollen disappearance rate situation of lateral pharyngeal band
Example number (disappearance) 108 (0) 109 (0)
(example, %) 74 (68.52) 68 (62.39) disappear
(example, %) 34 (31.48) 41 (37.61) do not disappear
The 2nd day accurate probabilistic method P=0.3422 of micro evil wind disappearance rate situation
Example number (disappearance) 21 (0) 28 (0)
(example, %) 18 (85.71) 28 (100.00) disappear
(example, %) 3 (14.29) 0 (0.00) do not disappear
The 5th day accurate probabilistic method P=of micro evil wind disappearance rate situation
Example number (disappearance) 21 (0) 28 (0)
(example, %) 21 (100.00) 28 (100.00) disappear
2-2 symptom and sign total mark
Difference all has the height statistical significance in the group before two groups of each time points of primary symptom integration and the treatment.See Table 3-2-6.
Table 3-2-6: symptom total mark situation of change before and after two groups of treatments
Index item A group B group statistic P value
Head examines symptom total mark Z=1.60 P=0.1089
Example number (disappearance) 119 (0) 120 (0)
Mean (standard deviation) 15.47 (4.59) 14.55 (4.15)
Median (P25-P75) 15.00 (11-19) 14.00 (11-18)
Minima-maximum 7-34 8-24
The 2nd day symptom total mark Z=0.75 P=0.4517
Example number (disappearance) 119 (0) 120 (0)
Mean (standard deviation) 9.69 (3.87) 9.40 (3.67)
Median 0P25-P75) 10.00 (7-11) 10.00 (7-11)
Minima-maximum 3-33 3-22
The 5th day symptom total mark Z=1.49 P=0.1359
Example number (disappearance) 119 (0) 120 (0)
Mean (standard deviation) 3.84 (4.18) 4.39 (3.92)
Median (P25-P75) 3.00 (0-6) 4.00 (0-7)
Minima-maximum 0-22 0-17
The 2nd day symptom total mark drop-out value Z=1.21 P=0.2244
Example number (disappearance) 119 (0) 120 (0)
Mean (standard deviation) 5.78 (3.11) 5.15 (2.86)
Median (P25-P75) 5.00 (3-8) 4.00 (3-7)
Minima-maximum 0-13-2-12
Symbols Z=3277.5 3270
P＝ 0.0000 0.0000
The 5th day symptom total mark drop-out value Z=1.59 P=0.1120
Example number (disappearance) 119 (0) 120 (0)
Mean (standard deviation) 11.63 (5.27) 10.16 (4.05)
Median (P25-P75) 11.00 (8-14) 11.00 (7-13)
Minima-maximum 0-23 0-19
Symbols Z=3451.5 3510.5
P＝ 0.0000 0.0000
2-3, physico-chemical examination index
Table 3-2-7: two groups of positive disappearance rate situations (summary) of throat swab
Table 3-2-8: the two groups of blood leukocytes sums and the rising disappearance rate situation of classifying
Index item A group B group statistic P value
Test proleukocyte rising person tests the accurate probabilistic method P=0.6947 of back situation
Example number (disappearance) 19 (0) 24 (0)
(example, %) 18 (94.74) 22 (91.67) disappear
(example, %) 1 (5.26) 2 (8.33) do not disappear
Neutrophilic granulocyte rising person tests the accurate probabilistic method P=0.0874 of back situation before the test
Example number (disappearance) 37 (0) 47 (0)
(example, %) 21 (56.76) 35 (74.47) disappear
(example, %) 16 (43.24) 12 (25.53) do not disappear
3, comprehensive therapeutic effect analysis
Meet scheme collection test group cure rate and be 33%, total effective rate 72.27%, matched group is respectively 26.67%, 64.17%.The equal not statistically significant of difference of two groups of comprehensive therapeutic effects, cure rate, total effective rate sees Table 3-3-1.
Table 3-3-1: two groups of comprehensive therapeutic effects (PPS)
Index item A group B group statistic P value
Comprehensive therapeutic effect CNHX2=2.20 P=0.5313
Example number (disappearance) 119 (0) 120 (0) Z=2.13 P=0.1444
Recovery from illness (example, %) 40 (33.61) 32 (26.67)
Produce effects (example, %) 46 (38.66) 45 (37.50)
Progressive (example, %) 26 (21.85) 34 (28.33)
Invalid (example, %) 7 (5.88) 9 (7.50)
The accurate probabilistic method P=0.2419 of cure rate
Example number (disappearance) 119 (0) 120 (0)
Recovery from illness (example, %) 40 (33.61) 32 (26.67)
Other (example, %) 79 (66.39) 88 (73.33)
The accurate probabilistic method p=0.2419 of total effective rate
Example number (disappearance) 119 (0) 120 (0)
Effectively (example, %) 86 (72.27) 77 (64.17)
Other (example, %) 33 (27.73) 43 (35.83)
Table 3-3-2: compare (PPS) by two groups of comprehensive therapeutic effects of hospital's layering
Index item A group B group statistic P value
The first center C NHX2=3.49 P=0.3218
Example number (disappearance) 40 (0) 40 (0) Z=1.19 P=0.2751
Recovery from illness (example, %) 17 (42.50) 14 (35.00)
Produce effects (example, %) 15 (37.50) 12 (30.00)
Progressive (example, %) 6 (15.00) 13 (32.50)
Invalid (example, %) 2 (5.00) 1 (2.50)
The second center C NHX2=1.05 P=0.7887
Example number (disappearance) 39 (0) 40 (0) Z=0.28 P=0.5990
Recovery from illness (example, %) 9 (23.08) 7 (17.50)
Produce effects (example, %) 16 (41.03) 18 (45.00)
Progressive (example, %) 12 (30.77) 11 (27.50)
Invalid (example, %) 2 (5.13) 4 (10.00)
The 3rd center C NHX2=0.72 P=0.8694
Example number (disappearance) 40 (0) 40 (0) Z=0.71 P=0.3983
Recovery from illness (example, %) 14 (35.00) 11 (27.50)
Produce effects (example, %) 15 (37.50) 15 (37.50)
Progressive (example, %) 8 (20.00) 10 (25.00)
Invalid (example, %) 3 (7.50) 4 (10.00)
Compare CMHX2=2.03 P=0.1547 by two groups of comprehensive therapeutic effects of hospital's layering
Table 3-3-3: compare (PPS) by two groups of comprehensive cure rates of hospital's layering
Index item A group B group statistic P value
The accurate probabilistic method P=0.4912 in first center
Example number (disappearance) 40 (0) 40 (0)
Recovery from illness (example, %) 17 (42.50) 14 (35.00)
Other (example, %) 23 (57.50) 26 (65.00)
The accurate probabilistic method P=0.4912 in second center
Example number (disappearance) 39 (0) 40 (0)
Recovery from illness (example, %) 9 (23.08) 7 (17.50)
Other (example, %) 30 (76.92) 33 (82.50)
The accurate probabilistic method P=0.4693 in the 3rd center
Example number (disappearance) 40 (0) 40 (0)
Recovery from illness (example, %) 14 (35.00) 11 (27.50)
Other (example, %) 26 (65.00) 29 (72.50)
Compare CMHX2=1.36 P=0.2439 by two groups of cure rates of hospital's layering
Table 3-3-4: compare (PPS) by two groups of comprehensive total effective rates of hospital's layering
Index item A group B group statistic P value
The accurate probabilistic method P=0.1330 in first center
Example number (disappearance) 40 (0) 40 (0)
Effectively (example, %) 32 (80.00) 26 (65.00)
Other (example, %) 8 (20.00) 14 (35.00)
The accurate probabilistic method P=0.8825 in second center
Example number (disappearance) 39 (0) 40 (0)
Effectively (example, %) 25 (64.10) 25 (62.50)
Other (example, %) 14 (35.90) 15 (37.50)
The accurate probabilistic method P=0.4693 in the 3rd center
Example number (disappearance) 40 (0) 40 (0)
Effectively (example, %) 29 (72.50) 26 (65.00)
Other (example, %) 11 (27.50) 14 (35.00)
Compare CMHX2=1.78 P=0.1822 by two groups of total effective rates of hospital's layering
(4) safety and adverse events analysis
1, physico-chemical examination, clinical manifestation
Security inspection physics and chemistry quantitative target changes, and sees Table 4-1-1.
All do not have the abnormal conditions of adverse events meaning after the security inspection treatment.See Table 4-1-2,4-1-3,4-1-4.
Table 4-1-1: security inspection physics and chemistry quantitative target changes
Before treating before the treatment
Index item example number average value median minima maximum example number average value median minima maximum
Leukocyte (* 109/L)
A organizes 120 6.80 6.1 3.9 16.8 119 6.23 5.8 3.4 10.3
B organizes 120 7.29 6.75 3.2 18.3 119 6.32 5.9 3 13
Centriole cell (%)
A organizes 120 63.83 64.2 33 88 119 61.29 60.9 32 85
B organizes 120 66.0 66 61 889.2 119 61.84 63.5 13 86
Hemoglobin (g/L)
A organizes 120 133.72 133 95 175 119 133.72 134 93 173
B organizes 120 131.83 132.5 87 166 119 131.14 130 93 167
Erythrocyte (* 1012/L)
A organizes 120 4.50 4.44 3.31 6.72 119 4.46 4.42 2.89 5.94
B organizes 120 4.36 4.315 2.51 5.84 119 4.40 4.38 2.26 5.96
Paddy third transaminase (U/L)
A organizes 116 22.00 22 6 51 116 22.56 22.5 7 51
B organizes 120 22.30 21 5 68 118 21.75 21 5 58
Blood urea nitrogen (mmol/L)
A organizes 119 4.74 4.73 1.9 8.01 119 4.69 4.7 2.2 7.09
B organizes 120 4.87 4.605 1.9 8.4 119 4.74 4.6 1.89
Blood creatinine (μ mol/L)
A organizes 119 90.01 92 25 170 119 88.45 92.1 25 168
B organizes 120 91.04 90.3 32 186 119 89.61 90.5 23 169
Table 4-1-2: situation of change before and after the laboratory safety inspection treatment
Index item example number * is just/just different/just different/different/just changeing unusual rate changes natural rate of interest
Leukocyte
A organizes 119 95 15 18 5.00 94.74
B organizes 119 89 26 22 6.32 91.67
Hemoglobin
A organizes 119 107 273 6.14 60.00
B organizes 119 108 236 2.70 75.00
Erythrocyte
A organizes 119 114 041 3.39 100.00
B organizes 119 115 112 0.86 66.67
Paddy third transaminase
A organizes 116 113 012 0.88 100.00
B organizes 118 115 012 0.86 100.00
Blood urea nitrogen
A organizes 119 119 000.
B organizes 119 119 000.
Blood creatinine
A organizes 119 118 001. and 100.00
B organizes 119 116 003. and 100.00
Routine urinalysis
A organizes 119 119 000 0.00.
B organizes 119 118 010 0.84.
Stool routine examination 0
A organizes 67 67 000.
B organizes 68 68 000.
Electrocardiogram
A organizes 119 115 301. and 25.00
B organizes 119 118 100. and 0.00
Table 4-1-3: the unusual report (summary) in normal treatment back before security inspection is treated
Table 4-1-4: all unusual report (summary) after treating before security inspection is treated
2, safety evaluatio
The no bad event report of this prison bed test.Two groups of safety evaluatios are 1 grade.See Table 4-2.
Table 4-2: two groups of safety evaluatio reports
| Index item | The A group | The B group | Statistic | The P value |
| Example number (disappearance) | 120(0) | 120(0) | Z＝0.00 | P＝1.0000 |
| 1 grade (example, %) | 120(100.00) | 120(100.00) |
Four, discuss
Two groups of difference for the treatment of the 3rd day, the 6th day scorching hot change-in-score value of dry pharynx have statistical significance, and test group is better than matched group.
Comprehensive therapeutic effect (meeting the scheme collection): test group clinical recovery rate is 33.61%, and total effective rate 72.27%: matched group is respectively 26.67%, 64.17%.Two groups of difference not statistically significants.
Safety evaluatio: this safety of clinical trials evaluation is 1 grade, does not see the heart, liver, renal damage.
Five, conclusion (of pressure testing)
The clear sheet of pyretic toxicity has curative effect preferably to wind-heat syndrome of acute pharyngitis patient's the scorching hot symptom of dry pharynx.Adverse events does not take place in this clinical trial.Suggestion continues the III clinical trial phase.
Claims (12)
1. Chinese medicine preparation for the treatment of wind-heat syndrome of acute pharyngitis, it is characterized in that: this Chinese medicine preparation is by Radix Mussaendae, Herba Andrographis, Fructus Gardeniae, Radix Scrophulariae, Radix achyranthis asperae (Herba Achyranthis Asperae), the artificial Calculus Bovis makes as pharmacodynamic raw materials, and the parts by weight of crude drug are as follows:
Radix achyranthis asperae (Herba Achyranthis Asperae) 5-20 part Herba Andrographis 15-30 part Fructus Gardeniae 5-20 part
Radix Scrophulariae 5-20 part Radix Mussaendae 30-50 part artificial Calculus Bovis 0.5-2 part
The dosage form of this Chinese medicine preparation is granule, tablet, syrup, capsule, pill or oral liquid, perhaps pharmaceutically said other dosage form.
2. the Chinese medicine preparation of a treatment wind-heat syndrome of acute pharyngitis as claimed in claim 1, it is characterized in that: described capsule is hard capsule, slow releasing capsule or soft capsule.
3. the Chinese medicine preparation of a treatment wind-heat syndrome of acute pharyngitis as claimed in claim 1, it is characterized in that: described pill is water-honeyed pill, big honeyed pills or concentrated pill.
4. the Chinese medicine preparation of a treatment wind-heat syndrome of acute pharyngitis as claimed in claim 1, it is characterized in that: the parts by weight of crude drug are:
10 parts of 20 portions of Fructus Gardeniaes of 10 parts of Herba Andrographis of Radix achyranthis asperae (Herba Achyranthis Asperae)
1 part of 40 parts of artificial Calculus Bovis of 10 parts of Radix Mussaendae of Radix Scrophulariae.
5. the Chinese medicine preparation of a treatment wind-heat syndrome of acute pharyngitis as claimed in claim 1, it is characterized in that: the parts by weight of crude drug are:
Radix achyranthis asperae (Herba Achyranthis Asperae) 100g Herba Andrographis 200g Fructus Gardeniae 100g
Radix Scrophulariae 100g Radix Mussaendae 400g artificial Calculus Bovis 10g.
6. the preparation method of the Chinese medicine preparation of a treatment wind-heat syndrome of acute pharyngitis as claimed in claim 1; it is characterized in that: the preparation process of granule is: get Radix Mussaendae, Herba Andrographis, Fructus Gardeniae, Radix achyranthis asperae (Herba Achyranthis Asperae), Radix Scrophulariae and artificial Calculus Bovis's Six-element medical material; except that the artificial Calculus Bovis; all the other five tastes decoct with water twice; each 2 hours; collecting decoction; filter; relative density was 1.32～1.34 clear paste when filtrate was concentrated into 56 ℃, added artificial Calculus Bovis, cane sugar powder and appropriate amount of auxiliary materials and made granule, drying; granulate; packing, check obtains product.
7. the preparation method of the Chinese medicine preparation of a treatment wind-heat syndrome of acute pharyngitis as claimed in claim 1; it is characterized in that: the preparation process of tablet is: get Radix Mussaendae; Herba Andrographis; Fructus Gardeniae; Radix achyranthis asperae (Herba Achyranthis Asperae); Radix Scrophulariae and artificial Calculus Bovis's Six-element medical material; except that the artificial Calculus Bovis; Herba Andrographis is ground into fine powder; all the other four flavors decoct with water twice; each 2 hours; collecting decoction filters, and relative density was 1.32～1.34 clear paste when filtrate was concentrated into 56 ℃; add the artificial Calculus Bovis; the Herba Andrographis fine powder; 8% starch slurry; 50% syrup and an amount of dextrin; mix homogeneously is made granule, drying, granulate; add the magnesium stearate mix homogeneously; compacting is in blocks, coating, packing; check obtains product.
8. the preparation method of the Chinese medicine preparation of a treatment wind-heat syndrome of acute pharyngitis as claimed in claim 2; it is characterized in that: the preparation process of hard capsule is: get Radix Mussaendae; Herba Andrographis; Fructus Gardeniae; Radix achyranthis asperae (Herba Achyranthis Asperae); Radix Scrophulariae and artificial Calculus Bovis's Six-element medical material; except that the artificial Calculus Bovis, Herba Andrographis is ground into fine powder, all the other four flavors decoct with water twice; each 2 hours; collecting decoction filters, and relative density was 1.32～1.34 thick paste when filtrate was concentrated into 56 ℃; add the artificial Calculus Bovis; Herba Andrographis fine powder and appropriate amount of auxiliary materials mix homogeneously are made granule, drying; granulate; in incapsulating, polishing, packing; check obtains product.
9. the preparation method of the Chinese medicine preparation of a treatment wind-heat syndrome of acute pharyngitis as claimed in claim 1; it is characterized in that: the preparation process of syrup is: get Radix Mussaendae; Herba Andrographis; Fructus Gardeniae; Radix achyranthis asperae (Herba Achyranthis Asperae); Radix Scrophulariae and artificial Calculus Bovis's Six-element medical material; except that the artificial Calculus Bovis; all the other five tastes decoct with water twice; each 2 hours; collecting decoction; precipitate with ethanol; reclaim ethanol; filter, relative density was 1.32～1.34 clear paste when filtrate was concentrated into 56 ℃, added the artificial Calculus Bovis; add the antiseptic of 0.1-0.3% then and, obtain syrup by weight the 1-2 sucrose solution doubly or the distilled water or the pure water of sweeting agent and 2 times.
10. the preparation method of the Chinese medicine preparation of a treatment wind-heat syndrome of acute pharyngitis as claimed in claim 3; it is characterized in that: the preparation process of pill is: get Radix Mussaendae; Herba Andrographis; Fructus Gardeniae; Radix achyranthis asperae (Herba Achyranthis Asperae); Radix Scrophulariae and artificial Calculus Bovis's Six-element medical material; except that the artificial Calculus Bovis; Herba Andrographis is ground into fine powder; all the other four flavors decoct with water twice; each 2 hours; collecting decoction; filter; relative density was 1.32～1.34 clear paste when filtrate was concentrated into 56 ℃, added artificial Calculus Bovis and Herba Andrographis fine powder, added excipient then; 10～100% sucrose or refined honey sugar and appropriate amount of auxiliary materials by weight, mix homogeneously is made water-honeyed pill; big honeyed pills or concentrated pill product.
11. the preparation method of the Chinese medicine preparation of a treatment wind-heat syndrome of acute pharyngitis as claimed in claim 1; it is characterized in that: the preparation process of oral liquid is: get Radix Mussaendae; Herba Andrographis; Fructus Gardeniae; Radix achyranthis asperae (Herba Achyranthis Asperae); Radix Scrophulariae and artificial Calculus Bovis's Six-element medical material; except that the artificial Calculus Bovis; all the other five tastes are decocted with water twice; each 2 hours; collecting decoction; filter; relative density was 1.22 clear paste when filtrate was concentrated into 56 ℃; precipitate with ethanol; reclaim ethanol, promptly get thick paste, add the artificial Calculus Bovis; add then 0.1-0.3% antiseptic and by weight 0.5-1 doubly sucrose solution or the distilled water or the pure water of sweeting agent and 2 times of amounts; the sorbitol of 0.1-0.3% or ethyl hydroxybenzoate, fill obtains product.
12. the preparation method of the Chinese medicine preparation of a treatment wind-heat syndrome of acute pharyngitis as claimed in claim 2; it is characterized in that: the preparation process of slow releasing capsule is: get Radix Mussaendae; Herba Andrographis; Fructus Gardeniae; Radix achyranthis asperae (Herba Achyranthis Asperae); Radix Scrophulariae and artificial Calculus Bovis; except that the artificial Calculus Bovis; Herba Andrographis is ground into fine powder; all the other four flavors decoct with water twice; each 2 hours; collecting decoction; filter; relative density was 1.32～1.34 clear paste when filtrate was concentrated into 56 ℃; add the artificial Calculus Bovis; Herba Andrographis fine powder and binding agent are made microcapsule; with spermaceti or other blocker coating, make 2 respectively; 4; 6; 8 hours slow-release pills, every kind of piller is distinguished with different color and lusters; pack into behind the mix homogeneously in the capsulae vacuus, be packaged into box or be hot pressed into aluminium-plastic panel and obtain product.
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| 国家中成药标准汇编中成药地方标准上升国家标准部分耳鼻喉科分册. 国家药品监督管理局编，144-145. 2002 |
| 国家中成药标准汇编中成药地方标准上升国家标准部分耳鼻喉科分册. 国家药品监督管理局编，144-145. 2002 * |
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