CN101152379A - Traditional Chinese medicine for treating cough and technique of preparing the same - Google Patents
Traditional Chinese medicine for treating cough and technique of preparing the same Download PDFInfo
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Abstract
The present invention relates to a Chinese medicine for treating cough and a preparation process, pertaining to the art of medicine technology. The present invention includes 15 to 18 portion of Chinese ephedra, 15 to 18 portion of bitter almond, 15 to 18 portion of purified pinellia, 18 to 20 portion of pummelo peel, 20 to 30 portion of oriental waterplantain rhizome, 20 to 30 portion of tatarian aster root, 15 to 18 portion of perilla fruit (fried), 15 to 18 portion of fried radish seed (fried), 12 to 18 portion of mustard seed (fried), 15 to 18 portion of radix cynanchi, 20 to 30 portion of loquat leaf and 15 to 18 portion of inula flower. The present invention is prepared through partial water boiling and extraction, partial ethanol extraction, then mixing, drying and grinding. With less medicinal ingredients, simple and reasonable preparation process, the present invention has antitussive, expectorant, anti-asthma, antibacterial, antiviral and anti-inflammatory effects and enhances the immune function with small toxicity and strong safety according to Pharmacodynamics and Toxicology tests. Clinical test proves that the Chinese medicine has notable curative effect on cough caused by cold lung and wet phlegm.
Description
(technical field)
The present invention relates to a kind of Chinese medicine and preparation technology thereof, specifically a kind of Chinese medicine and preparation technology thereof who treats cough belongs to field of pharmaceutical technology, comprises preparation technology.
(background technology)
Cough is a kind of common clinical symptoms, can betide the various respiratory tract disease, brings many miseries to the patient.Cough is the common symptoms of many lung pattern diseases, is more common in diseases such as respiratory tract infection, acute bronchitis, chronic bronchitis, bronchiectasis, pneumonia.In recent years, along with Ecological environment worsening, sickness rate is in rising trend.Motherland's medical science is divided into exogenous cough and endogenous cough with cough, though exogenous cough's treatment easily is inappropriate if repeated multiple times is suffered from or recuperated under medical treatment after being ill, then can transfer the endogenous cough to.With the passing of time the endogenous cough does not heal, and then can cause lung, spleen, deficiency of the kidney void, and developing becomes pulmonary distension, and this disease is touching, and prolonged difficulty more.China is the Chinese medicine place of origin, utilizing Chinese medicine long history to be arranged aspect curing the disease, with the treatment by Chinese herbs cough a lot of prescriptions is arranged also, these medicines all have certain antitussive action, but these Chinese medicines ratio of component aspect the treatment cough is more, and effect is not clearly, and the healing cycle is relatively long.
(summary of the invention)
The present invention is aging in order to solve existing Chinese medicine treatment cough dosage form, and prescription is unreasonable, and therapeutic effect is poor, and toxic and side effects is bigger, shows effect repeatedly easily and propose a kind of new medicament composing prescription and preparation technology in the healing back.
The present invention is made up of raw material Herba Ephedrae, Semen Armeniacae Amarum, Rhizoma Pinelliae, Exocarpium Citri Grandis, Poria, CHAISUZI, Semen Raphani, Semen Sinapis, Folium Eriobotryae, Flos Inulae, Radix Asteris, Rhizoma Cynanchi Stauntonii, adopt dispersing and descending lung-QI, preventing phlegm from forming and stopping coughing method of treatment, be used for accumulateing the cough (cough that the acute attack of acute bronchitis, chronic bronchitis causes) that causes in affection by exopathogenic cold-wind, the stagnation of expectorant food, the phlegm-damp.
The present invention realizes by following scheme:
Raw material is formed:
15～18 parts of 15～18 portions of Semen Armeniacae Amarums of Herba Ephedrae
18～20 parts of 15～18 parts of Exocarpium Citri Grandises of Rhizoma Pinelliae
20～30 parts of 20～30 portions of Radix Asteriss of Poria
15～18 parts of 15～18 parts of Semen Raphanis of Fructus Perillae (stir-fry) (stir-fry)
15～18 parts of 12～18 parts of Rhizoma Cynanchi Stauntoniis of Semen Sinapis (stir-fry)
15～18 parts of 20～30 parts of Flos Inulaes of Folium Eriobotryae.
Preparation technology is:
A, Herba Ephedrae be with 60% alcohol reflux 3 times, after the drying fine powder;
B, Exocarpium Citri Grandis decoct with water, concentrate clear paste;
C, Semen Armeniacae Amarum, Rhizoma Pinelliae, Poria, Fructus Perillae (stir-fry), Semen Raphani (stir-fry), Semen Sinapis (stir-fry), Folium Eriobotryae, Flos Inulae 8 flavor raw material mixing and water addings decoct 3 times, collecting decoction, and filtration, filtrate concentrate, and precipitate with ethanol leaves standstill, and gets supernatant;
D, Radix Asteris, Rhizoma Cynanchi Stauntonii mix with 70% alcohol reflux 3 times;
E, the clear paste among the b is mixed with supernatant among the c, dry between 55～65 ℃, be ground into 60～100 order fine-powdered;
F, the fine powder among a, fine powder, a epheday intermedia among the e are extracted fine powder and dextrin, saccharin sodium mix in right amount, stir evenly granulation, promptly.
All dosage forms that the dosage form of the medicament that above-mentioned raw materials is made is on the pharmaceutics to be comprised.
Name of product of the present invention is " coughing upright peaceful granule ", " Fructus Pruni aster cough-stopping granule ".Fructus Pruni is meant Semen Armeniacae Amarum, and aster is meant Radix Asteris.
The advantage that the present invention had is: the Chinese crude drug prescription is rigorous, flavour of a drug are few, have only 12 flavor raw material of Chinese medicine, preparation technology's advantages of simple, prove that by pharmacodynamics and toxicology test this medical instrument has antitussive, it is antibacterial to eliminate the phlegm, relieving asthma, antiviral, antiinflammatory, the effect of human body immunity improving function, toxic and side effects is very little, and safety in utilization is very strong.The clinical trial proof is to accumulateing the cough curative effect highly significant that causes in wind-cold affecting lung, the phlegm-damp.
(specific embodiment)
The raw material prescription is got according to weight in grams (g):
Embodiment 1:(selects 3 prescription points)
Herba Ephedrae 15g Semen Armeniacae Amarum 15g
Rhizoma Pinelliae 15g Exocarpium Citri Grandis 18g
Poria 20g Radix Asteris 20g
Fructus Perillae (stir-fry) 15g Semen Raphani (stir-fry) 15g
Semen Sinapis (stir-fry) 12g Rhizoma Cynanchi Stauntonii 15g
Folium Eriobotryae 20g Flos Inulae 15g.
Embodiment 2:
Herba Ephedrae 17g Semen Armeniacae Amarum 17g
Rhizoma Pinelliae 17g Exocarpium Citri Grandis 20g
Poria 30g Radix Asteris 25g
Fructus Perillae (stir-fry) 17g Semen Raphani (stir-fry) 17g
Semen Sinapis (stir-fry) 15g Rhizoma Cynanchi Stauntonii 17g
Folium Eriobotryae 25g Flos Inulae 17g.
Embodiment 3:
Herba Ephedrae 18g Semen Armeniacae Amarum 18g
Rhizoma Pinelliae 18g Exocarpium Citri Grandis 20g
Poria 30g Radix Asteris 30g
Fructus Perillae (stir-fry) 18g Semen Raphani (stir-fry) 18g
Semen Sinapis (stir-fry) 18g Rhizoma Cynanchi Stauntonii 18g
Folium Eriobotryae 30g Flos Inulae 18g.
The dosage form of the medicament made from above-mentioned prescription is a granule.
Three kinds of production methods that embodiment adopted and step all are:
Herba Ephedrae is extracted 3 times with 60% alcohol reflux, time was respectively 1,1,0.5 hour, and the solvent consumption is followed successively by 7,6,5 times, merge extractive liquid,, left standstill 10-12 hour, get supernatant and reclaim ethanol, be concentrated into relative density and be 1.30～1.32 clear paste, 60～70 ℃ of temperature, cold drying, 60～65 ℃ of temperature are ground into 80 order fine powders, and are standby; Exocarpium Citri Grandis decocts with water 2 times, and the time was respectively 3,2 hours, and amount of water is followed successively by 18,9 times, collecting decoction, and it is 1.30 clear paste that filtrate is condensed into relative density, 65 ℃ of temperature are standby; Radix Asteris, Rhizoma Cynanchi Stauntonii two flavors are with 70% alcohol reflux 3 times, and the time was respectively 3,2,1 hours, and the solvent consumption is followed successively by 5,4,3 times, merges backflow, filtration, filtrate for later use; Semen Armeniacae Amarum, Rhizoma Pinelliae, Poria, Fructus Perillae (stir-fry), Semen Raphani (stir-fry), Semen Sinapis (stir-fry), Folium Eriobotryae, Flos Inulae eight flavor raw materials mix and decoct with water 3 times, time is respectively 2.5,2,1.5 hour, amount of water is followed successively by 7,6,5 times, collecting decoction filters, and filtrate was left standstill 10 hours, getting supernatant concentration to relative density is 1.10, add ethanol and reach 60%, stir evenly, leave standstill and made its precipitation in 9 hours to containing the alcohol amount, divide and get supernatant, the ethanol 30000ml that precipitates 8 hours reuse 60% washs 1 time, leaves standstill 9 hours, merges supernatant twice, with Radix Asteris, the Rhizoma Cynanchi Stauntonii extracting solution merges, reclaim ethanol, be concentrated into relative density and be 1.30 clear paste, 65 ℃ of temperature, merge with the Exocarpium Citri Grandis clear paste, cold drying, dry between 60～65 ℃, be ground into 80 order fine powders, extract the fine powder mixing with Herba Ephedrae, add dextrin 4200g, saccharin sodium is an amount of, and it is an amount of to add 85% ethanol, and packing promptly.
Pharmacodynamics test
One, test objective
It is a kind of pure Chinese medicinal preparation that the name that the present invention produced is called " coughing upright peaceful granule ", has effects such as dispersing and descending lung-QI, preventing phlegm from forming and stopping coughing, is mainly used in the cough due to accumulateing in wind-cold affecting lung, the phlegm-damp.The requirement of this test basis " study of tcm new drug guide ", to its carry out antitussive, eliminate the phlegm, relieving asthma, aspect tests such as antiinflammatory, antibacterial, antiviral, analgesic, raise immunity, cough upright peaceful particulate main pharmacodynamics effect to illustrate the present invention, for clinical practice provides experimental basis.
Two, test material
1, be subjected to the reagent thing: " coughing upright peaceful granule " medicine is to be provided by 505 pharmaceutcal corporation, Ltds, lot number 961120, and every 1g extractum contains crude drug 3.46g, represents with g crude drug/kg body weight in the test, is made into suspension with distilled water during test.Positive control drug: GUILONG KECHUANNING JIAONANG, Gui Long pharmaceutical Co. Ltd in Shanxi produces, and lot number 960607-3 represents with g medicated powder/kg body weight in the test, does not indicate contained crude drug amount, is made into suspension with distilled water during test.
2, animal: white mice, the Kunming kind, the quality certification number: moving 08-013 number of doctor, rat, the SD kind, the quality certification number: moving 08-014 number of doctor, Cavia porcellus, rabbit etc. provides by The Fourth Military Medical University's Experimental Animal Center.
3, strain and virus:
Antibacterial: staphylococcus aureus (ATCC 6638), beta hemolytic streptococcus (32210-16), bacillus pyocyaneus (ATCC 27316), Diplococcus pneumoniae (31109) identify that by the Ministry of Public Health biological product institute provides, and pneumobacillus (western 97-17413) is by own separation and Culture.
Virus: parainfluenza virus III type (PFV-3), respiratory syncytial virus long strain (RSV), influenza virus 68 strains (IFV-68), Coxsackie virus B organizes 3 types (COx B3), adenovirus type III (Ad3).Above virus is the viral suspension that propagation obtains in cell culture.
Strain and virus provide by microorganism teaching and research room of Xian Medical Univ.
4, reagent and instrument:
Isoproterenol injection (BJ Pharmaceutical Co., Ltd., lot number 83102320); Chinese holly Citron acid (Beijing Chemical Plant, lot number 950609); Dimethylbenzene (Xi'an chemical reagent factory, lot number 940808); RPMI-1640 cell culture fluid (production of U.S. SIGMA company); Hundred, white, broken (Vaccinum Pertussis et Toxoidum Diphthero Tetanicum Adsorbatum, diphtheria, tetanus toxin mix preparation, Ministry of Public Health Lanzhou institute of Biological Products is produced, lot number 951113); Hydrocortisone (Changzhou pharmaceutical factory, lot number 960709); Salicylic acid (Shaanxi white deer pharmaceutical factory produces, lot number 961023).
SR-115S respiration energy converting device, SEN03201 electrostimulator (producing), XWT-164 balance recorder (Shanghai Dahua Instrument and Meter Plant) by Japanese photoelectricity company.
Three, method and result
1, to the inhibitory action of the cough due to the ammonia
The female Kunming mouse of healthy adult, body weight 18-22g, 60, by body weight at random equilibrium be divided into 6 groups, 10 every group.Cough upright peaceful granule divide little, in, big three dosage groups (2.5,5.0,10.0g/kg), positive controls: GUILONG KECHUANNING 5.0g/kg, codeine 30.0mg/kg.Below respectively organize equal gastric infusion, 0.2ml/10g, once a day, continuous 3 days.Matched group is given and is waited the capacity tap water.30min puts 900cm with mice after the last administration
3In the container, splash into the 0.2ml strong aqua ammonia, observe the incubation period of cough and from the cough number of times of coughing to 2min for first.Data are represented with means standard deviation, carry out the t check between group.
The result: cough upright peaceful granule mouse cough prolongation of latency, cough number of times are reduced, wherein big or middle dosage group is compared its difference with matched group have the highly significant meaning.Codeine phosphate and GUILONG KECHUANNING group also can prolong the incubation period of cough, reduce the cough number of times, see table 1 for details.
Table 1 cough the upright peaceful granule antitussive effect cough caused to the mice strong aqua ammonia (
) (n=10)
| Group | Dosage (g/kg) | Cough latent period (min) | The cough number of times |
| Matched group is coughed the upright upright upright peaceful GUILONG KECHUANNING codeine phosphate of rather coughing of rather coughing | 2.5 5.0 10.0 5.0 0.03 | 1.21±0.63 1.87±0.80 2.59±0.93 ** 2.51±0.62 ** 2.52±1.33 * 4.00±1.64 *** | 15.8±8 9±6 8±3 * 6±2 ** 8±5 * 4±3 *** |
Annotate: carry out the t check between group, with the matched group ratio,
*P＜0.05,
*P＜0.01,
* *P＜0.001
2, to the influence of guinea pig cough due to the citric acid
Cavia porcellus 250～280g, 60, male and female half and half are divided 6 groups by the sex body weight is balanced at random, and 10 every group, except that phosphoric acid codeine lumbar injection (0.05g/kg) administration, all the other respectively organize equal gastric infusion, and dosage is the same, once a day, for three days on end.1h after the last administration puts into the glass bell jar of 3L with Cavia porcellus, sprays into 17.5% citric acid soln, and spraying 1min observes the cough number of times of Cavia porcellus in the 10mm.
Result: cough the cough number of times that upright three dosage groups of peaceful granule and codeine phosphate group all reduce Cavia porcellus very significantly; GUILONG KECHUANNING is not seen obvious influence to the guinea pig cough due to the citric acid spraying under this experiment condition, sees table 2 for details.
Table 2 cough upright peaceful granule to the influence of guinea pig cough due to the citric acid (
) (n=10)
| Group | Dosage (g/kg) | The cough number of times | Suppress (%) with the matched group ratio |
| Matched group is coughed the upright upright upright peaceful GUILONG KECHUANNING codeine phosphate of rather coughing of rather coughing | 2.5 5.0 10.0 5.0 0.05 | 24±9 11±7 ** 8±9 ** 9±5 ** 21±8 11±10 ** | 54.17 66.67 62.50 12.50 54.17 |
Annotate: carry out the t check between group, with the matched group ratio,
*P＜0.01
3, to the cough caused antitussive effect of Cavia porcellus electricity irritation superior laryngeal nerve
Cavia porcellus 250-350g, 60, male and female are regardless of, and are divided into 6 groups, and 10 every group, dosage is the same, all duodenal administration.Under urethane and chloralose combined anesthesia, dorsal position is fixed, and abdominal part median line otch takes out duodenum, plugs in tee T in order to administration; Cut at the neck middle part, isolates trachea and superior laryngeal nerve, and advanced circulation of qi promoting cannula also connects RS-115S respiration energy converting device, and output signal is imported the XWT-164 balance recorder, and superior laryngeal nerve puts the platinum stimulating electrode and connects the SEN-3201 electronic stimulator.Stimulus parameter is frequency 10 times/second, and the wide 500ms of ripple postpones 50ms, stimulates 10 seconds at every turn, and stimulation voltage is ascending, brings up to the cough threshold value gradually (v).Carry out cough threshold's pH-value determination pH before the administration, stimulate once every 5min after the administration, observe 2h continuously, record different time cough threshold value, and different time cough threshold value changing value after the calculating administration, its difference is organized a t check.
The result: the cough threshold value slightly fluctuates after the matched group administration, and is constant substantially; Cough upright peaceful groups of grains the cough threshold value is raise, large, medium and small dosage group is compared with matched group, and its difference has the significance meaning.GUILONG KECHUANNING and codeine phosphate group also can make the cough threshold value raise.
Pharmacodynamics test
With cough upright peaceful granule with 2.5,5.0, three dosage groups of 10.0g crude drug/kg give laboratory animal ig administration, observe itself and the treatment relevant main pharmacodynamics effect of coughing.
(1) antitussive effect
The product that the present invention produced is coughed upright peaceful granule can prolong the cough latent period that mice ammonia causes significantly, reduces the cough number of times; Reduce guinea pig cough's number of times that citric acid causes significantly; Cavia porcellus electricity irritation superior laryngeal nerve cough threshold is raise, and have the central antitussive effect.
(2) phlegm-dispelling functions
Cough upright large, medium and small three the dosage groups of peaceful granule, all can promote significantly phenol redly to discharge, show that it has phlegm-dispelling functions from bronchus.
(3) antiasthmatic effect
The result of the test of relievining asthma shows, under this experimental condition, this medicine has the effect incubation period of prolongation to panting of causing of histamine phosphate, leaves the isolated helical strips of guinea contraction that experiment has anti-acetylcholine, histamine to cause.
(4) antibiotic, antivirus action
In-vitro antibacterial test shows, this medicine has bacteriostasis to beta hemolytic streptococcus, Diplococcus pneumoniae, staphylococcus aureus, pneumobacillus, bacillus pyocyaneus, and (MIC is respectively 0.56,0.35,0.56,0.56,0.42g crude drug/ml); Antibacterial tests shows that this medicine is to the protective rate of Diplococcus pneumoniae lethal infection in the body, and large, medium and small dosage group is respectively 35%, 25%, 20%, medicine median effective dose (ED
50) be 2.15g extractum/kg, 7.44g crude drug/kg; Large, medium and small three the dosage groups of the protective rate of staphylococcus aureus lethal infection are respectively 40%, 35%, 15%, medicine median effective dose (ED
50) be 2.86g extractum/kg, 9.90g crude drug/kg.Coughing upright peaceful granule has inhibitory action to Coxsackie virus B3, and inhibition index is 2.67.
(5) antiinflammatory action
Rat paw edema all has remarkable inhibitory action due to large, medium and small three dosage group xylol induced mice auricle edemas of this medicine and the carrageenin, shows that it has antiinflammatory action.
(6) immunity function research
This medicine carbon powder that can raise is very significantly proofreaied and correct and to be cleaned up index, caused immunosuppressant has tangible antagonism to hydrocortisone, lysozyme content, the coagulation antibody that can improve pouring changes index, serum and spleen tired, hemolytic antibody is tired, and shows that it has the effect that improves nonspecific immunity and specific cellular immunity and humoral immune function.
(7) refrigeration function
Analgesic result of the test shows, this medicine to hundred, white, the broken hyperpyrexia that causes do not have antipyretic effect.
Above pharmacodynamic study result shows, coughs upright peaceful granule and has antitussive, eliminates the phlegm, relievings asthma, effects such as antibacterial, antiviral, antiinflammatory, human body immunity improving function, but do not have refrigeration function.
Animal toxicity test research
(1) acute toxicity test research
Result of the test shows that this medicine mice lavage can not asked LD
50, toxicity is extremely low, and the oral administration maximum tolerated dose is 138.4g/kg (in a crude drug), is equivalent to according to the weight be grown up try out 138.4 times of dosage 1g/kg.
(2) long-term toxicity test for animals
Cough with the present invention produced upright peaceful granule in 12.0,24.0, three dosage of 48.0g/kg (with crude drug) (press body surface area and calculate, be equivalent to per day for adults and try out 2.06,4.10,8.22 times of dosage 70g crude drug/d; Calculate by kg body weight, be equivalent to 12,24,48 times of per day for adults dosage on probation) give the continuous gastric infusion of rat two months.Result of the test shows that rat body weight and matched group are not seen notable difference.Cough upright peaceful granule and do not influence rats eating, drinking-water and free movable; Each dosage group rat behavior is active, the fur Smooth and moist; The heart of rat, liver, spleen, lung, kidney, brain, thymus, adrenal gland, ovary, testis, seminal vesiculo-prostate, uterus, preputial glands index and matched group are not seen notable difference, this medicine is not seen notable difference to every biochemical indicators such as the hepatic and renal function of rat, cholesterol, blood glucose and matched group, and the every index of hematology is not had harmful effect yet.Histopathologic examination shows: coughing upright peaceful granule does not all have the pathologic damage to the heart, liver, spleen, lung, kidney, brain, thymus, adrenal gland, ovary, uterus, testis, seminal vesiculo-prostate, hypophysis, pancreas, stomach, duodenum, breastbone, and the poisoning target organ is not found in test.Drug withdrawal recovers two weeks and does not see that delayed toxicity takes place.This medicine is safety non-toxic under used dosage.
Animal acute toxicity test
One, test objective
Observe the white mice orally give and cough the acute toxic reaction of upright peaceful extractum extract.
Two, be subjected to the reagent thing
Title: cough upright peaceful extractum (extract); The unit of providing: Xianyang Atiage Inst., Shaanxi; Lot number: 961120; Content: 1 gram extractum is equivalent to crude drug 3.46 grams, represents with g crude drug/kg body weight in the test; Character: black extractum, soluble in water; Solvent: distilled water.
The preparation using method: per 1 gram extractum becomes 2ml with distilled water diluting, is Cmax, and promptly the 100ml medicinal liquid contains 173g crude drug (1g extractum * 3.46g crude drug ÷ 2ml), gastric infusion.
Three, animal
Healthy adult Kunming kind white mice, body weight 20.78 ± 1.38g, totally 20, male and female half and half are provided by The Fourth Military Medical University's animal center, the animal quality certification number: the moving card of doctor 08-013 number.
Four, experimental technique
The prerun of process animal acute toxicity: get 3 mouse stomaches 3 times with the medicinal liquid of 173% concentration, each 0.8ml/20g, 3 hours at interval, do not cause death, can not ask LD
50With 20 white mice sub-cage rearings, give solid feed, natural lighting, exhaust fan ventilates, and laboratory is provided with air-conditioning, room temperature 21 ℃ ± 2, relative humidity about 64%.The white mice drinking-water of freely ingesting.Water is can't help in experiment fasting evening before that day, gavage 173% the upright peaceful extractum of coughing at twice in testing 9:30 on the same day, 14:00, the administration volume is 0.8ml/20g, and the sign that according to the form below is observed animal after the administration changes and mice ingests, drinking-water, feces, spontaneous activity etc.Observed altogether 7 days, content sees Table 3.After experiment in the 8th day finishes, weigh, put to death important organs such as the zootomy and the perusal heart, liver, spleen, lung, kidney, stomach, intestinal, thymus, adrenal gland, testis, ovary, uterus and have or not pathologic to change.
Table 3 animal acute toxicity test is observed table
| Observation item | Performance and symptom |
| Spontaneous activity muscular movement muscular tension reaction vegetative nerve is breathed dead symptom of skin color death time | Increase, minimizing, play, tired crouch motionlessly tremble, tic, paralysis, ataxia strengthen, weaken, loose nervous, the perpendicular hair of bradykinesia of myotonia, flesh, shed tears, sialorrhea, protruding eye, diarrhoea, writhing response suppress, rapid, depleted pale, cyanosis, congested sudden death, slow extremely struggle, opisthotonus |
Five, result of the test
Mouse stomach is coughed behind the upright peaceful extractum movable as usual, and it is normal to ingest, drink water, and does not have diarrhoea and takes place, ataxia phenomenons such as mice does not have convulsions, runs, twitches, trembles, paralysis, instability of gait; Apnea is rapid, lip and afterbody cyanosis phenomenon; Do not have perpendicular hair, shed tears, sialorrhea, protruding eye, turn round to embody and resemble; Do not have and scurry race, shout and sting the frame phenomenon mutually; Do not have and enrage and aggressive behavior; Mice fur Smooth and moist, activity freely.Observed none animal dead altogether 7 days.Body weight is 20.78 ± 1.38g before the administration, when putting to death in the 8th day body weight be 24.40 ± 1.96g (means standard deviation, n=20).
The execution mice is separated and cuts each important organ, the perusal heart, liver, spleen, lung, kidney, stomach, intestinal, thymus, adrenal gland, testis, ovary, all no abnormal pathological change of each important organ of uterus.
Six, conclusion
Coughing upright peaceful extractum can not ask LD for the mice lavage administration
50, the gastric infusion maximum tolerated dose is 138.4g/kg (crude drug).
Computational methods
(1) every gram clear paste is made into 2ml, and promptly 100ml contains 50 gram clear paste, is equivalent to 100ml and contains crude drug in whole 173g (50g clear paste * 3.46g);
(2) maximum tolerated dose is:
0.8ml/20g body weight * 50 * 2 time/day * 173g crude drug in whole/100ml=138.4g/kg body weight;
(3) be equivalent to the per day for adults multiple of measuring on probation according to the weight:
138.4g crude drug in whole/kg body weight * 70kg body weight ÷ 70g crude drug in whole/day (Coming-of-Age Day amount on probation)=138.4 (doubly).
Clinical pre-test result
What the present invention produced coughs upright peaceful granule through clinical prerun 64 examples of Affiliated Hospital of Shaanxi College of Traditional Chinese Medicine, the result, and 11 examples of fully recovering account for 17.19%, produce effects 29 examples, total obvious effective rate is 62.5%, total effective rate is 96.88%, does not find untoward reaction.Observed result shows, the present invention cough upright peaceful granule have evident in efficacy, taking convenience, characteristics such as safe and reliable.
The II clinical trial phase
This test is MethodsThe cases enrolled 288 examples altogether, comprise acute tracheobronchitis 144 examples, acute episode of chronic bronchitis 144 examples.Wherein in acute tracheobronchitis 144 examples, 4 examples that come off, expulsion rate 2.78% is rejected 5 examples, and rejecting rate 3.47% meets scheme collection 135 examples.In acute episode of chronic bronchitis 144 examples, 2 examples that come off, expulsion rate 1.39% is rejected 5 examples, and rejecting rate 3.47% meets scheme collection 137 examples.
Efficacy analysis
1, the acute tracheobronchitis health giving quality is analyzed
Curative effect of disease
(1) FAS data set statistical result
The cure rate of test group is 50.0%, and cure-remarkable-effectiveness rate is 74.30%, and total effective rate is 94.30%; The cure rate of matched group is 34.80%, and cure-remarkable-effectiveness rate is 58.0%, and total effective rate is 89.90%.Relatively, difference all has statistical significance (P＜0.05) between two groups of cure rates, cure-remarkable-effectiveness rate group, and test group is better than matched group.
(2) PP data set statistical result
The cure rate of test group is 50.7%, and cure-remarkable-effectiveness rate is 75.40%, and total effective rate is 94.20%; The cure rate of matched group is 36.40%, and cure-remarkable-effectiveness rate is 60.60%, and total effective rate is 92.40%.Between two groups of cure rates, cure-remarkable-effectiveness rate, total effective rate group relatively, the equal not statistically significant of difference (P＞0.05).
Therapeutic effect of syndrome
(1) FAS data set statistical result
The clinic control rate of test group is 45.70%, and it is 75.70% that control shows rate, and total effective rate is 95.70%; The clinic control rate of matched group is 30.40%, and it is 62.30% that control shows rate, and total effective rate is 87.00%.Relatively, difference has statistical significance (P＜0.05) between two groups of clinic control rate groups, and test group is better than matched group.
(2) PP data set statistical result
The clinic control rate of test group is 46.40%, and it is 76.80% that control shows rate, and total effective rate is 95.70%; The clinic control rate of matched group is 31.80%, and it is 65.20% that control shows rate, and total effective rate is 89.40%.Two groups of clinic control rates, controls show between rate, total effective rate group and compare, the equal not statistically significant of difference (P＞0.05).
2, acute episode of chronic bronchitis
Curative effect of disease
(1) FAS data set statistical result
The clinic control rate of test group is 36.60%, and it is 63.40% that control shows rate, and total effective rate is 85.90%; The clinic control rate of matched group is 22.10%, and it is 52.90% that control shows rate, and total effective rate is 80.90%.Two groups of clinic control rates, controls show between rate, total effective rate group and compare, the equal not statistically significant of difference (P＞0.05).
(2) PP data set statistical result
The clinic control rate of test group is 37.70%, and it is 65.20% that control shows rate, and total effective rate is 88.40%; The clinic control rate of matched group is 22.10%, and it is 52.90% that control shows rate, and total effective rate is 80.90%.Relatively, difference has statistical significance (P＜0.05) between two groups of clinic control rate groups, and test group is better than matched group.
Therapeutic effect of syndrome
(1) FAS data set statistical result
The clinic control rate of test group is 36.60%, and it is 60.60% that control shows rate, and total effective rate is 85.90%; The clinic control rate of matched group is 22.10%, and it is 50.00% that control shows rate, and total effective rate is 80.90%.Two groups of clinic control rates, controls show between rate, total effective rate group and compare, the equal not statistically significant of difference (P＞0.05).
(2) PP data set statistical result
The clinic control rate of test group is 37.70%, and it is 62.30% that control shows rate, and total effective rate is 88.40%; The clinic control rate of matched group is 22.10%, and it is 50.50% that control shows rate, and total effective rate is 80.90%.Relatively, difference has statistical significance (P＜0.05) between two groups of clinic control rate groups, and test group is better than matched group.
3, health giving quality is checked index analysis
Test group can reduce total white blood cells and the neutrophilic granulocyte counting that the part patient raises, and can improve pulmonary's hello sound of part patient.
4, safety analysis
Clinical practice safety of the present invention is not found abnormal examination index relevant with trial drug and significantly untoward reaction after the off-test.
5, conclusion
II clinical trial phase result of the present invention shows, the medicine that this invention is produced is that a kind of treatment affection of exogenous wind-cold, phlegm-damp accumulate lung card cough (acute tracheobronchitis, acute episode of chronic bronchitis) effective and safe drug, the III clinical trial phase be can carry out, its curative effect and safety further estimated.
The III clinical trial phase
This test is MethodsThe cases enrolled 490 examples altogether, comprise acute tracheobronchitis 244 examples, acute episode of chronic bronchitis 246 examples.Wherein: in acute tracheobronchitis 244 examples, reject 4 examples, rejecting rate 1.64% meets scheme collection 240 examples.In acute episode of chronic bronchitis 246 examples, reject 1 example, rejecting rate 0.41% meets scheme collection 245 examples.
The III clinical trial phase does not have the case of coming off, and the FAS data set is identical with the PP data set, thus the FAS analysis result with the PP analysis result, content is identical.
1, curative effect of disease
(1) acute tracheobronchitis
Test group 89 examples of fully recovering, produce effects 44 examples, effective 39 examples, invalid 10 examples; Matched group 18 examples of fully recovering, produce effects 14 examples, effective 19 examples, invalid 7 examples.Cure rate 48.9% example of test group, cure-remarkable-effectiveness rate is 73.1%, total effective rate is 94.5%; The cure rate of matched group is 31.0%, and cure-remarkable-effectiveness rate is 55.2%, and total effective rate is 87.9%.Relatively, difference all has statistical significance (P＜0.05) between two groups of cure rates, cure-remarkable-effectiveness rate group, and test group is better than matched group.
(2) acute episode of chronic bronchitis
Test group clinic control 61 examples, produce effects 57 examples, effective 58 examples, invalid 7 examples; Matched group clinic control 11 examples, produce effects 20 examples, effective 25 examples, invalid 6 examples.The clinic control rate of test group is 33.3%, and it is 64.5% that control shows rate, and total effective rate is 96.2%; The clinic control rate of matched group is 17.7%, and it is 50.0% that control shows rate, and total effective rate is 90.3%.Two groups of clinic control rates, controls show between the rate group and compare, and difference all has statistical significance (P＜0.05), and test group is better than matched group.
2, tcm syndrome curative effect
(1) acute tracheobronchitis
Test group clinic control 78 examples, produce effects 48 examples, effective 43 examples, invalid 13 examples; Matched group clinic control 19 examples, produce effects 11 examples, effective 21 examples, invalid 7 examples.The clinic control rate 42.9% of test group, it is 69.2% that control shows rate, total effective rate is 92.9%; The clinic control rate of matched group is 32.8%, and it is 51.7% that control shows rate, and total effective rate is 87.9%.Two groups of clinic control rates, controls show between the rate group and compare, and difference all has statistical significance (P＜0.05), and test group is better than matched group.
(2) acute episode of chronic bronchitis
Test group clinic control 54 examples, produce effects 55 examples, effective 66 examples, invalid 8 examples; Matched group clinic control 10 examples, produce effects 20 examples, effective 26 examples, invalid 6 examples.The clinic control rate 29.5% of test group, it is 59.6% that control shows rate, total effective rate is 95.6%; The clinic control rate of matched group is 16.1%, and it is 48.4% that control shows rate, and total effective rate is 90.3%.Relatively, difference has statistical significance (P＜0.05) between two groups of clinic control rate groups, and test group is better than matched group.
3, health giving quality is checked index
Test group can reduce total white blood cells and the neutrophilic granulocyte counting that the part patient raises, and can improve pulmonary's hello sound of part patient.
4, safety analysis
Clinical practice safety of the present invention is not found abnormal examination index relevant with trial drug and significantly untoward reaction after the off-test.
5, conclusion
III clinical trial phase result of the present invention shows that the medicine that this invention is produced is that a kind of treatment affection of exogenous wind-cold, phlegm-damp accumulate lung card cough (acute tracheobronchitis, acute episode of chronic bronchitis) effective and safe drug, and suggestion is applied for the registration of.
Experimental results show that: the present invention coughs upright peaceful granule and has significant antitussive effect, and preparation technology is scientific and reasonable.Pharmacodynamics and toxicology test show, effect such as this medical instrument has antitussive, eliminates the phlegm, relievings asthma, antibiotic, antiviral, antiinflammatory, human body immunity improving function, safety non-toxic.Clinical prerun is evident in efficacy to accumulateing the cough that causes in wind-cold affecting lung, the phlegm-damp.
Claims (5)
1. Chinese medicine for the treatment of cough is characterized in that the medicament of being made according to weight portion by following raw materials according:
15～18 parts of 15～18 portions of Semen Armeniacae Amarums of Herba Ephedrae
18～20 parts of 15～18 parts of Exocarpium Citri Grandises of Rhizoma Pinelliae
20～30 parts of 20～30 portions of Radix Asteriss of Poria
15～18 parts of 15～18 parts of Semen Raphanis of Fructus Perillae (stir-fry) (stir-fry)
15～18 parts of 12～18 parts of Rhizoma Cynanchi Stauntoniis of Semen Sinapis (stir-fry)
15～18 parts of 20～30 parts of Flos Inulaes of Folium Eriobotryae.
2. a kind of Chinese medicine for the treatment of cough according to claim 1 is characterized in that the medicament of being made according to weight portion by following raw materials according:
17 parts of 17 portions of Semen Armeniacae Amarums of Herba Ephedrae
20 parts of 17 parts of Exocarpium Citri Grandises of Rhizoma Pinelliae
25 parts of 30 portions of Radix Asteriss of Poria
17 parts of 17 parts of Semen Raphanis of Fructus Perillae (stir-fry) (stir-fry)
17 parts of 15 parts of Rhizoma Cynanchi Stauntoniis of Semen Sinapis (stir-fry)
17 parts of 25 parts of Flos Inulaes of Folium Eriobotryae.
3. all dosage forms that a kind of Chinese medicine for the treatment of cough according to claim 1 and 2, the dosage form that it is characterized in that the medicament made by above-mentioned raw materials are on the pharmaceutics to be comprised.
4. the described a kind of preparation technology who treats the Chinese medicine of cough of production claim 3 is characterized in that being prepared from by following method:
A, Herba Ephedrae be with 60% alcohol reflux 3 times, after the drying fine powder;
B, Exocarpium Citri Grandis decoct with water, concentrate clear paste;
C, Semen Armeniacae Amarum, Rhizoma Pinelliae, Poria, Fructus Perillae (stir-fry), Semen Raphani (stir-fry), Semen Sinapis (stir-fry), Folium Eriobotryae, Flos Inulae 8 flavor raw material mixing and water addings decoct 3 times, collecting decoction, and filtration, filtrate concentrate, and precipitate with ethanol leaves standstill, and gets supernatant;
D, Radix Asteris, Rhizoma Cynanchi Stauntonii mix with 70% alcohol reflux 3 times;
E, the clear paste among the b is mixed with supernatant among the c, dry between 55～65 ℃, be ground into 60～100 order fine-powdered;
F, the fine powder among a, fine powder, a epheday intermedia among the e are extracted fine powder and dextrin, saccharin sodium mix in right amount, stir evenly granulation, promptly.
5. a kind of preparation technology who treats the Chinese medicine of cough according to claim 4 is characterized in that being prepared from by following method:
Herba Ephedrae is with 60% alcohol reflux 3 times, time was respectively 1,1,0.5 hour, and the solvent consumption is followed successively by 7,6,5 times, merge extractive liquid,, left standstill 10-12 hour, get supernatant and reclaim ethanol, be concentrated into relative density and be 1.30～1.32 clear paste, 60～70 ℃ of temperature, cold drying, 60～65 ℃ of temperature are ground into 80～100 order fine powders, and are standby; Exocarpium Citri Grandis decocts with water 2 times, and the time was respectively 3,2 hours, and amount of water is followed successively by 18,9 times, collecting decoction, and it is 1.30～1.32 clear paste that filtrate is condensed into relative density, 60～70 ℃ of temperature are standby; Radix Asteris, Rhizoma Cynanchi Stauntonii two flavors are with 70% alcohol reflux 3 times, and the time was respectively 3,2,1 hours, and the solvent consumption is followed successively by 5,4,3 times, merges backflow, filtration, filtrate for later use; Semen Armeniacae Amarum, Rhizoma Pinelliae, Poria, Fructus Perillae (stir-fry), Semen Raphani (stir-fry), Semen Sinapis (stir-fry), Folium Eriobotryae, Flos Inulae eight flavor raw materials mix and decoct with water 3 times, time is respectively 2.5,2,1.5 hour, amount of water is followed successively by 7,6,5 times, collecting decoction, filter, filtrate was left standstill 8-12 hour, and getting supernatant concentration to relative density is 1.10-1.20, added ethanol and reached 60% to containing the alcohol amount, stir evenly, leave standstill and made its precipitation in 8-10 hour, divide and get supernatant, the ethanol 30000ml that precipitates 4-10 hour reuse 60% washs 1 time, left standstill 8-10 hour, merge supernatant twice, with Radix Asteris, the Rhizoma Cynanchi Stauntonii extracting solution merges, and reclaims ethanol, be concentrated into relative density and be 1.30～1.32 clear paste, 60～70 ℃ of temperature merge cold drying with the Exocarpium Citri Grandis clear paste, 60～65 ℃ of temperature, be ground into 80～100 order fine powders, extract the fine powder mixing, add 4200 parts in dextrin with Herba Ephedrae, saccharin sodium is an amount of, it is an amount of to add 85%～90% ethanol, make granule, drying, packing is promptly.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101874626A (en) * | 2010-06-30 | 2010-11-03 | 福建农林大学 | Compound loquat leaf extract and preparation method thereof |
| CN104547515A (en) * | 2014-12-24 | 2015-04-29 | 广东化州中药厂制药有限公司 | Tangerine pear syrup and preparation method thereof |
| CN104547493A (en) * | 2015-01-16 | 2015-04-29 | 解耀锃 | Chinese medicinal composition for treating acute exacerbation of chronic bronchitis |
| CN111773348A (en) * | 2020-08-19 | 2020-10-16 | 王国斌 | Traditional Chinese medicine composition for treating cough and preparation method and application thereof |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100534510C (en) * | 2004-12-16 | 2009-09-02 | 神奇梵净山铜仁药业有限公司 | Loquat leaf extractum for nourishing lung and relieving cough |
| CN1824099A (en) * | 2005-12-15 | 2006-08-30 | 北京阜康仁生物制药科技有限公司 | Diffusing-freeing lung rectifying medicinal preparation and its new preparation method |
| CN1824097A (en) * | 2005-12-27 | 2006-08-30 | 广西桂西制药有限公司 | Chinese medicinal preparation for treating cough and its preparation method |
-
2006
- 2006-09-26 CN CN2006101046366A patent/CN101152379B/en not_active Expired - Fee Related
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101874626A (en) * | 2010-06-30 | 2010-11-03 | 福建农林大学 | Compound loquat leaf extract and preparation method thereof |
| CN101874626B (en) * | 2010-06-30 | 2012-05-23 | 福建农林大学 | Compound loquat leaf extract and preparation method thereof |
| CN104547515A (en) * | 2014-12-24 | 2015-04-29 | 广东化州中药厂制药有限公司 | Tangerine pear syrup and preparation method thereof |
| CN104547493A (en) * | 2015-01-16 | 2015-04-29 | 解耀锃 | Chinese medicinal composition for treating acute exacerbation of chronic bronchitis |
| CN111773348A (en) * | 2020-08-19 | 2020-10-16 | 王国斌 | Traditional Chinese medicine composition for treating cough and preparation method and application thereof |
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| CN101152379B (en) | 2010-04-14 |
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