CN1605349A - Chinese traditional medicine for treating cough and variable asthma after cold and its preparation - Google Patents
Chinese traditional medicine for treating cough and variable asthma after cold and its preparation Download PDFInfo
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Abstract
The Chinese medicinal composition for treating cough after cold and cough variant asthma consists of effective component prepared with Chinese ephedra, leaf of purple perilla, seed of purple perilla, earthworm, etc. and pharmaceutically acceptable carrier. It may be prepared into any preparation form. The Chinese medicinal composition has obvious effects of relieving cough, resisting inflammation, relieving asthma, eliminating phlegm, immunizing, etc. and can raise the reaction threshold and Dmin of respiratory tract on acetyl methyl choline and lower sGrs and EOS, ECP and IL-5 of peripheral blood. The present invention also relates to the preparation process of the Chinese medicinal composition.
Description
Invention field
The present invention relates to a kind of Chinese medicine composition, is a kind of Chinese medicine composition for the treatment of postinfectious cough and cough variant asthma specifically; The invention still further relates to the preparation method of this Chinese medicine composition.
Background technology
(Cough variant asthma CVA) claims conceal type asthma or cough property asthma again to cough variant asthma, is a kind of specific type of asthma.Its particularity just is it almost without any panting or the dyspnea symptom, so often failed to pinpoint a disease in diagnosis, mistaken diagnosis, wrong treatment, many patients are caused state of an illness delay to increase the weight of by prolonged and repeated antibiotic and the antitussive medicine ineffectually used.It has following clinical characters: 1. age of onset is not limit, and always thinks that in the past cough variant asthma sends out in the child well, and in fact each age group all can be fallen ill, and for intractable cough, if can get rid of pulmonary or diseases of the five sense organs, should at first consider the diagnosis of primary disease; 2. most patient a guy or family's allergies, the spring and autumn pilosity, all can fall ill the whole year; 3. clinically mainly show as paroxysmal dry cough, choke and cough, do not have expectorant or a small amount of white sticking expectorant, part is with itching throat, nasal obstruction, watery nasal discharge, uncomfortable in chest, apnea difficulty and stridulate very then sustainable several years or many decades; 4. the airway hyperreactivity test is positive; 5. use antibiotic, general antitussive is all invalid, and uses anti-asthmatic, hormone effective, but after the drug withdrawal, cough often can be recurred again, and can produce other side effect; 6. anaphylactogen test can have in various degree or the positive reaction of kind; 7. often bring out, as oil smoke, motion, cold air, anaphylactogen or upper respiratory tract infection because of relevant inducement.
The CVA pathogeny may infect irritated factor with some and cause that inflammatory reaction and bronchial smooth muscle are shunk in the air flue and stimulated the cough sensor relevant.With the dry cough that continues repeatedly outbreak, choke and cough reason for outstanding symptom and have 1. that airway reactivity increases (BHR) and cough is by due to the same stimulus of receptor.When there is chronic inflammatory disease in air flue or sucks specific antigen, the local participation inflammatory mediators such as histamine, Kallidin I and various neuropeptides that reacting cells discharged act on vagal end sensor slightly, cause bronchoconstriction by axon reflex, when local bronchoconstriction, then irritative cough's sensor causes bronchoconstriction by axon reflex; Same process vagus nerve causes the reflex cough; 2. the excited threshold value of cough sensor reduces under the CVA patient airway mucosa, and various stimulation sensitivity are increased; 3. environmental factors is one of major reason in the acquired airway hyper-reaction factor day after tomorrow, when inflammatory mediator damage air flue mucous epithelium, in a single day the cough sensor contacts indoor allergen (indoor dust, animal allergen, fungus etc.) and outdoor allergen (pollen, cold air, industrial waste gas etc.), these materials can make IgE antibody increase, promote the airway epithelia cell to produce cytokines such as granulocyte-macrophage colony stimutaing factor (GM-GSF) and IL-8, cause airway inflammation and airway hyper-reaction.The treatment of CVA can be selected spasmolytic, anti-inflammatory treatment for use.Common drug has the use in conjunction of bronchodilator such as beta 2 receptor analeptic, theophylline class and Anticholinergics medicine, and to remove the bronchospasm state, glucocorticoid can suppress the airway inflammation reaction, stablizes mast cell membrane.Doctor trained in Western medicine still reduces BHR with the anapnotherapy of exogenous glucocorticoid at present, but can cause the BHR recurrence after the drug withdrawal, and certain side effect is arranged, and portion C VA patient is also arranged because the sugar skin hormone acceptor quantity reduces, or dysfunction, produces hormonal resistance.This mainly is only to pay attention to the adjustment that partial antiinflammatory has been ignored whole body owing to glucocorticoid sucks treatment, so late result and prognosis are still certainly difficult.
In recent years, along with the progressively intensification of people to CVA understanding, Chinese medicine is being obtained good effect aspect the treatment CVA.In traditional Chinese medical science tradition book, not with the complete corresponding name of disease of CVA.Ancient medicine is owing to be subjected to the restriction of prevailing condition, can only be from the whole angle understanding cause of disease of macroscopic view, and from many cough symptoms, do not divide difference CVA as yet and be disease independently.This disease main clinical manifestation is dry cough, few expectorant, itching throat, and very uncomfortable in chest, asthma etc. can appear in the person; And primary disease has chronic delay again, and obstinate refractory reaches characteristics such as outbreak repeatedly.From the generation of this disease, the clinical sign characteristic analysis that development is shown, the inventor thinks that CVA is when belonging to the traditional Chinese medical science " wind is coughed " category.
It is a kind of clinical manifestation form of common cough that wind is coughed, its clinical manifestation is for lasting or repeated relapsing cough, few expectorant or do not have expectorant, choke and cough (especially suck cold air, drink cold drink and motion postemphasis or bring out), gargalesthesia between pharynx, sense is itched promptly to happen suddenly and is coughed, the cough aggravation, battle array is done endlessly, and night is heavier.Owing to having itching throat, choking and cough few expectorant, meet the air-cooled paroxysmal and ictal such as work of coughing, meet the characteristics of the traditional Chinese medical science " changes of wind having the nature of shifting number ", so " wind is coughed " of meaning, its pathogenesis is many because of ailment said due to cold or exposure invasion and attack lung system, causes lung system to be declared and respectful falling due to the malfunction.Wind is coughed very high sickness rate in the crowd, be common in postinfectious cough and cough type asthma, the sickness rate of postinfectious cough is increasing in recent years gradually, mainly showing as postinfectious cough does not understand, have itching throat, choke and cough few expectorant, meet air-cooled and cough the characteristics that paroxysmal such as work and wind such as ictal are coughed, take antibiotic and cough suppressing medicine can not alleviate; And cough type asthma is a kind of disease of harm public health in the world wide, be meant with the asthma of cough as main clinical sign, because of having cough, this disease do not have asthma again, so be called " cough variant asthma ", it is a kind of special type of bronchial asthma, it is that bronchitis, other respiratory tract diseases, throat cough are coughed etc. that past often is mistaken as, and therapeutic effect is not good enough.Its clinical manifestation is consistent with above-mentioned postinfectious cough mostly, is considered to also belong to the category of " wind is coughed ".Cough property asthma and postinfectious cough all have airway reactivity and increase (Bronahial Hypes pensiveness BHR) this feature, are the indirect reactions of airway inflammation.Cough property asthma often betides after the flu, causes airway reactivity and improves, and the anaphylaxis body constitution in the endogenous cause of ill is also often arranged, and its performance has the said wind card of the traditional Chinese medical science, become as the benefaction number of outbreak, the time end throat air flue gargalesthesia etc. when sending out.Therefore use the new method that the unique theoretical system of the traditional Chinese medical science examines outbreak because of dialectical and treatment based on differentiation of disease control cough variant asthma, improves clinical efficacy and start the treatment cough variant asthma significant meaning is all arranged.
The inventor proposes CVA and conforms to the character of ailment said due to cold or exposure " change of benefaction number " " wind being the primary exopathogen "; Ailment said due to cold or exposure is from natural not just gas, and the easy combined pathogens of wind is caused harm, and exogenous wind also should comprise sensitizing agents such as various pollen, fungus, cold air, zest volatile material and even antibacterial, virus except that wind and cold, wind heat.Its pathogenesis is: ailment said due to cold or exposure violate lung, a surname fall not normal, air flue contraction anxious due to; Its method of treatment is: methods such as dispelling wind and ventilating the lung, spasmolytic cough-relieving, nourishing YIN and moistening the lung, play the effect of dispersing obstructed lung-QI, emergency spasmolytic cough-relieving sending down the abnormal ascending QI altogether, the airway epithelia cell injury is repaired, the air flue homeostasis is rebuild, adjust the purpose for the treatment of both the principal and secondary aspects of a disease to reach whole.Pass through a large amount of clinical verifications, thereby finished the invention of medicine of the present invention.
Summary of the invention
Purpose of the present invention just provides a kind of Chinese medicine composition for the treatment of postinfectious cough and cough variant asthma.
Another object of the present invention provides the preparation method of this Chinese medicine composition.
Chinese medicine composition of the present invention is made up of effective ingredient and/or acceptable accessories.
It at first is selection to effective ingredient.
The inventor is according to having determined that to the pathogenesis analysis of postinfectious cough and cough variant asthma the treatment rule is dispelling wind and ventilating the lung, spasmolytic cough-relieving, nourishing YIN and moistening the lung, and the effective ingredient of Chinese medicine composition of the present invention selects for use dispelling wind and ventilating the lung medicine, spasmolytic antitussive and nourishing YIN and moistening the lung medicine prescription to make exactly.
The inventor selects Herba Ephedrae, Folium Perillae and Fructus Perillae as monarch drug, and this is that Xin Wen goes into lung meridian because of Herba Ephedrae.Expelling wind and cold, depressed lung-energy dispersing, dispersing accompanied by descending.Shennong's Herbal is said: Herba Ephedrae " is ended cough with dyspnea, removes cold and heat ".Say Herba Ephedrae " controlling asthma due to stagnation of phlegm pants " in the essentials of Matea Medica.Pharmacological research shows: ephedrine has tangible relexation to bronchial smooth muscle, and its volatile oil has very strong inhibitory action to influenza virus.
Folium Perillae, Xin Wen goes into the spleen lung meridian, dispersing wind and cold, dispersing lung-QI and dissipating phlegm." book on Chinese herbal medicine justice " is called it and " is evacuated lung and close, the logical flesh table of a surname, incessant sweating due to affection by pathogenic wind heresy "." the southern regions of the Yunnan Province book on Chinese herbal medicine " record Folium Perillae can " expectorant, surely shout breathe heavily ".Compendium of Material Medica is said " Fructus Perillae and leaf are together " under Folium Perillae leaf bar.Illustrate Folium Perillae have reduce phlegm, cough-relieving, the effect of relievining asthma.Fructus Perillae, essentials of Matea Medica " acrid in the mouth is gone into the lung meridian edema caused by disorder of QI, sharp lung Dingchuan, therapeutic method to keep the adverse QI flowing downwards antitussive ".Pharmacological research: Fructus Perillae can reduce bronchus secretion, alleviates the bronchospasm effect, and Folium Perillae, Fructus Perillae and Herba Ephedrae mutually 5 not only strengthens the power of dispelling wind, and can strengthen lifting and assist mutually, a surname of lung is fallen recovered.Both bring out the best in each other, and are all the key medicine that treatment wind is coughed, and are monarch drug altogether.
It is ministerial drug that the inventor selects Pheretima for use, and this is because Pheretima, salty-cold drop-down, and the relieving spasm by calming endogenous wind Dingchuan, promoting blood circulation by removing wind, the emergency relieving convulsion, with Herba Ephedrae 5, one Wen Yihan mutually, one declares one to fall, and brings out the best in each other.Pharmacological research confirms, extracts a kind of nitrogenous effective ingredient from Pheretima, and rat and rabbit lung perfusion are had tangible bronchorelaxing activity, and the bronchoconstriction that can cause antihistaminic and pilocarpine.The compatibility Periostracum Cicadae is dispelling wind pathogens but also can sore-throat relieving antipruritic not only.Two medicines reduce the spasticity of trachea with having tangible diastole bronchus, and can cause the bronchoconstriction effect by antihistaminic.
So being the Chinese crude drug raw material of preparation Chinese medicine composition effective ingredient of the present invention, a technical scheme of Chinese medicine composition of the present invention contains Herba Ephedrae, Folium Perillae, Fructus Perillae and Pheretima.Wherein their consumption is following weight portion: Herba Ephedrae 4-6, Folium Perillae 4-6, Fructus Perillae 2-4 and Pheretima 4-6.Be preferably Herba Ephedrae 5, Folium Perillae 5, Fructus Perillae 3 and Pheretima 5.Herba Ephedrae is preferably Herba Ephedrae (processed).
Another one technical scheme of the present invention is to add the effect of other dispelling wind and ventilating the lung medicines with the dispelling wind and ventilating the lung of enhancing Herba Ephedrae and Folium Perillae leaf in the Chinese crude drug raw material of preparation Chinese medicine composition effective ingredient of the present invention, lung qi must be declared like this, airway patency then, against being so incensed that to fall, reach the function that the lung qi dispersing that dispels the wind is decided convulsion.Dispelling wind and ventilating the lung medicine as herein described is meant and is selected from Periostracum Cicadae, Fructus Arctii, Folium Mori, Herba Menthae, Radix Saposhnikoviae, the Radix Angelicae Dahuricae, the Rhizoma Ligustici etc. one or more, preferred Periostracum Cicadae and Fructus Arctii.The consumption that they add is that Periostracum Cicadae is the 3-5 weight portion, and Fructus Arctii is the 4-6 weight portion, and preferred Periostracum Cicadae is 4 weight portions, and Fructus Arctii is 5 weight portions.
Thereby another one optimal technical scheme of the present invention is can also add other preventing phlegm from forming and stopping coughing medicines to strengthen the function of relieving cough and calming asthma of Fructus Perillae and Pheretima in the Chinese crude drug raw material of preparation Chinese medicine composition effective ingredient of the present invention, and effect is better.Preventing phlegm from forming and stopping coughing medicine as herein described is meant and is selected from Radix Platycodonis, Radix Peucedani, Rhizoma Typhonii, Rhizoma Cynanchi Stauntonii, Bulbus Fritillariae Uninbracteatae, Folium Eriobotryae, Flos Farfarae, Semen Armeniacae Amarum, the Radix Stemonae, Cortex Mori etc.Can add wherein one or more.Preferred Radix Peucedani and Folium Eriobotryae.If select for use, their consumption is a Folium Eriobotryae 4-6 weight portion, and Radix Peucedani is the 3-5 weight portion.More preferably, Folium Eriobotryae is 5 weight portions, and Radix Peucedani is 4 weight portions.Folium Eriobotryae is preferably Folium Eriobotryae (processed).
Another optimal technical scheme of the present invention is can also add the nourishing YIN and moistening the lung medicine in the Chinese crude drug raw material of preparation Chinese medicine composition effective ingredient of the present invention, nourishing YIN and moistening the lung medicine that acid is received and compatibilities such as the hot Herba Ephedrae that looses, Folium Perillae, both can restrict the diffusing property of suffering of Herba Ephedrae etc., the sweet compatibility of theobromine again, remove spasm, by one one opposing each other and yet also complement each other of holding back, promote that a surname of lung qi is logical simultaneously, effect is better.Nourishing YIN and moistening the lung medicine as herein described is meant and is selected from a kind of in Fructus Schisandrae Chinensis, Colla Corii Asini, Radix Adenophorae (Radix Glehniae), Radix Ophiopogonis, Radix Asparagi, Rhizoma Polygonati, the Bulbus Lilii etc.Preferred Fructus Schisandrae Chinensis.If select for use, the addition of Fructus Schisandrae Chinensis is the 3-5 weight portion, and the best is 4 weight portions.
Highly preferred technical scheme of the present invention is to select Herba Ephedrae, Folium Perillae, Fructus Perillae, Pheretima, Periostracum Cicadae, Radix Peucedani, Fructus Arctii and Fructus Schisandrae Chinensis for use.This be because:
Periostracum Cicadae is sweet in flavor and cold in property, and the light property of body is floating, can go into lung meridian, can dredge evil in lung qi dispersing.Lung qi must be declared, and then airway patency against being so incensed that to fall, reaches the function that the lung qi dispersing that dispels the wind is decided convulsion.Periostracum Cicadae is roared with controlling cough with asthma, application is promptly arranged, as " the total little opinion side of children's's health " Cicadae shell soup, " Bo Jifang " Semen Armeniacae Amarum ball etc. in the ancient prescription.Pharmacological research shows: Periostracum Cicadae has the effect of the bronchial muscular spasm of releasing.So with Herba Ephedrae (processed), Pheretima mutually 5, with the power of enhancing spasmolytic.
Radix Peucedani " book on Chinese herbal medicine " " the special therapeutic method to keep the adverse QI flowing downwards of merit, the next inflammation of gas is fallen expectorant and disappeared " is controlled the expectorant asthma of heat type and is breathed heavily, the cough vomiting.Modern pharmacological research: Radix Peucedani extract can suppress bronchial smooth muscle and shrink, and can increase the secretion of respiratory mucus, and phlegm-dispelling functions is arranged.
Process the rake leaf, replenishing YIN and removing heat is moisturized, the lowering the adverse-rising QI to subdue asthma cough-relieving is contrary.
Fructus Arctii: hot, bitter, cold.Attach to the lung and stomach meridians.Dispelling wind and ventilating the lung, resolving toxin and disinhibiting the throat.Adding medicine to shared is adjuvant drug, helps Folium Perillae and the cough-relieving of Herba Ephedrae dispelling wind, the relieving convulsion emergency.
Fructus Schisandrae Chinensis, sour, sweet, warm, go into lung, kidney, heart channel, the energy supplementing QI for promoting the production of body fluid is restrained astringent or styptic treatment for spontaneous sweating.Have and astringe the lung, discongest the effect of air flue contraction urgency." herbal classic " puts down in writing its " main QI invigorating, cough with dyspnea ".Modern pharmacological research finds that the extraction of Fructus Schisandrae Chinensis ether has antitussive, phlegm-dispelling functions, and can strengthen cellular immune function.Fructus Schisandrae Chinensis that acid is received and compatibilities such as the hot Herba Ephedrae that looses, Folium Perillae both can restrict the diffusing property of suffering of Herba Ephedrae etc., and the sweet compatibility of theobromine is removed spasm again, simultaneously by one one opposing each other and yet also complement each other of holding back, promotes a surname of lung qi to lead to.Be messenger drug.
All medicines share, hot temperature lung qi dispersing, and the dispelling wind spasmolytic, sensible sending down the abnormal ascending QI, eliminating phlegm is relievingd asthma, the wind expectorant contraction that disappears of loosing is separated, and lung qi is declared to fall, and radicallys reform, and Each performs its own functions, then mechanism of qi is unobstructed, plays altogether to alleviate airway inflammation, reduces airway hyperreactivity, thereby reaches the purpose of fundamentally curing cough variant asthma.
The selection of these amount of drug scopes is preferably following weight portion:
Herba Ephedrae (processed) 4-6, Folium Perillae 4-6, Pheretima 4-6, Folium Eriobotryae (processed) 4-6,
Fructus Perillae 2-4, Periostracum Cicadae 3-5, Radix Peucedani 3-5, Fructus Arctii 4-6 and Fructus Schisandrae Chinensis 3-5
The best effective ingredient of making Chinese medicine composition of the present invention for following parts by weight of Chinese traditional medicine material:
Herba Ephedrae (processed) 5, Folium Perillae 5, Pheretima 5, Folium Eriobotryae (processed) 5, Fructus Perillae 3, Periostracum Cicadae 4, Radix Peucedani 4, Fructus Arctii 5 and Fructus Schisandrae Chinensis 4.
The contained effective ingredient of medicine of the present invention can prepare with the following step: with the dry pulverize of above-mentioned Chinese crude drug, mixing obtains effective ingredient.
The contained effective ingredient of medicine of the present invention can also prepare with the following step: above-mentioned Chinese crude drug is decocted with water, perhaps decoction liquor is added ethanol again and make and contain alcohol amount and reach 70%, filter, reclaim ethanol, obtain effective ingredient.
The contained effective ingredient of medicine of the present invention preferably prepares with the following step:
Folium Perillae, Radix Peucedani are extracted volatile oil, collect volatile oil, standby, the aqueous solution after distillation device is in addition collected, and is standby;
Herba Ephedrae, Fructus Schisandrae Chinensis add 60-90% ethanol, reflux three times, and each 1.5 hours, merging filtrate reclaimed ethanol, and was condensed into 50 ℃ of thick pastes and surveys relative density and be 1.25-1.30, and is standby;
The five tastes such as all the other Pheretimas decoct with water three times, merging filtrate, filter, the aqueous solution after filtrate and the above-mentioned distillation merges, and being concentrated into 50 ℃ of survey relative densities is 1.10, adding ethanol makes and contains alcohol amount and reach 70%, cold preservation filters filtrate recycling ethanol, and be condensed into thick paste, 50 ℃ are surveyed relative density is 1.25-1.30;
Merge with above-mentioned thick paste, drying under reduced pressure becomes dry extract, and above-mentioned volatile oil merges, and mixing promptly.
The preparation technology of the effective ingredient that medicine of the present invention is contained also can preferably prepare with the following step:
Folium Perillae, Radix Peucedani are soaked, extracted volatile oil, collect volatile oil, the aqueous solution after distillation device is in addition collected; Volatile oil beta-schardinger dextrin-inclusion dry below 40 ℃, is ground into fine powder;
Herba Ephedrae, Fructus Schisandrae Chinensis add 80% ethanol, reflux three times, and each 1.5 hours, merging filtrate reclaimed ethanol, and was condensed into 50 ℃ of thick pastes and surveys relative density and be 1.25-1.30, and is standby;
In all the other five kinds of medical materials such as Pheretima, add water, decoct merging filtrate three times, filter, the aqueous solution after filtrate and the above-mentioned distillation merges, and being concentrated into 50 ℃ of survey relative densities is 1.10, add ethanol and make and contain alcohol amount and reach 70%, cold preservation filters, filtrate recycling ethanol, and be condensed into thick paste, 50 ℃ are surveyed relative density is 1.25-1.30, merges with above-mentioned thick paste, drying under reduced pressure becomes dry extract, dry extract is broken into fine powder, merges with above-mentioned fine powder, adds appropriate amount of auxiliary materials, mixing, granulate, drying is sieved, behind the granulate, the dress capsule promptly.
The contained effective ingredient the best of medicine of the present invention prepares with the following step:
Folium Perillae, Radix Peucedani were soaked 1 hour, extracted volatile oil 8 hours, collect volatile oil, the aqueous solution after distillation device is in addition collected; Volatile oil beta-schardinger dextrin-inclusion dry below 40 ℃, is ground into fine powder.Herba Ephedrae, Fructus Schisandrae Chinensis add 80% ethanol, reflux three times, add for the first time 8 times of amounts and extracted 1.5 hours, add 6 times of amounts for the second time and extracted 1.5 hours, add 6 times of amounts for the third time and extracted 1.5 hours, filter, merging filtrate reclaim ethanol, and (relative density is 1.25-1.30 to be condensed into thick paste, 50 ℃ of surveys), standby.The five tastes such as all the other Pheretimas decoct with water three times, add 10 times of amounts for the first time and decoct 1 hour, add 8 times of amounts for the second time and decoct 1 hour, adding 8 times of amounts for the third time decocted 1 hour, filter, the aqueous solution after filtrate and the above-mentioned distillation merges, and being concentrated into relative density is 1.10 (50 ℃ of surveys), adding ethanol makes and contains alcohol amount and reach 70%, cold preservation 24 hours filters filtrate recycling ethanol, and (relative density is 1.25-1.30 to be condensed into thick paste, 50 ℃ of surveys), merge with above-mentioned thick paste, drying under reduced pressure becomes dry extract below 70 ℃, dry extract is broken into fine powder, merge with above-mentioned fine powder, add appropriate amount of starch, mixing, granulate in right amount with 90-95% ethanol, drying behind the 18 mesh sieve granulate, incapsulates excessively, make 1000, promptly.
Be to determine best water extract-alcohol precipitation condition, adopting to measure Arctiin is index, to influence the principal element that decocting extracts: amount of water, the decocting time, the decoction number of times, it is preferred to have carried out orthogonal experiment; To influencing the principal element of precipitate with ethanol: alcohol precipitation concentration, the concentrated solution relative density is screened.Result of the test shows determines decocting extraction process condition for extracting 3 times, and each 1 hour, adding the water multiple was 10,8,8; Alcohol precipitation process adopts 70% ethanol, concentrates relative density is that 1.10 (50 ℃) carry out precipitate with ethanol.
Be to determine best alcohol extraction condition, adopting to measure ephedrine is index, to influencing the principal element of alcohol extraction: concentration of alcohol, extraction time, solvent load, it is preferred to have carried out orthogonal experiment.Test shows that best extraction conditions is for 80% ethanol extraction 3 times; Alcohol adding amount is followed successively by 8,6,6 times; Each 1.5 hours.
Effective ingredient of the present invention can be made any dosage form pharmaceutically with acceptable accessories, and these dosage forms comprise oral formulations such as tablet, capsule, oral liquid, electuary etc., intravenous formulations such as injection, injectable powder, infusion solutions etc.The preferred oral preparation.
Preferred by to the research of paste-forming rate and adjuvant, and by three batches of pilot scales, test shows after adding an amount of corn starch mixes with dry extract uses the 90-95% alcohol granulation, No. 0 capsule of packing into after the drying is made the 0.45g capsule.
Requirement according to new drug (Chinese medicine) stability test, employing simulates commercially available aluminium plastic membrane and is packaged in reserved sample observing under the room temperature condition, three batch samples (lot number 020401,020402,020403) according to the project and the method for quality standard draft specifies, have been carried out 3 months by a definite date preliminarily stabilised investigation.The result shows that between storage life, every detection index is not seen significant change, steady quality to sample under normal temperature condition.
Three batch samples show that through 3 months preliminarily stabilised investigation this preparation performance is more stable, no significant change.
Irritate stomach with effective ingredient 14.0,7.0 of the present invention, 3.5g crude drug/kg and give mice, 7.0,3.5,1.2g crude drug/kg irritates stomach and give rat, 6.0,3.0,1.5g crude drug/kg irritates stomach and give Cavia porcellus.Prove that by experiment medicine of the present invention has:
(1) cough latent period of its significant prolongation mice of antitussive action and Cavia porcellus reduces the cough number of times of Cavia porcellus, improves ammonia spraying is caused the antitussive intensity of coughing mice.
(2) effect of anti-airway inflammation and general inflammation it can reduce egg protein and cause leukocyte count, eosinophilic granulocyte's percentage rate and abdominal cavity mast cell degranulation in the asthmatic model guinea pig bronchial lung-douching fluid; Improve bronchus, the variation of lung tissue pathology; And can significantly suppress chondrus ocellatus Holmes colloidality rat paw edema; Obviously alleviate Oleum Tiglii induced mice auricle edema.
(3) equivalent mixed liquor of its significant prolongation acetylcholine of antiasthmatic effect and histamine causes the incubation period that Cavia porcellus twitches, and obviously reduces normal guinea pig tracheal smooth muscle tension force
(4) its three dosage of phlegm-dispelling functions all can increase the phenol red output of mice.
(5) immunization it can obviously improve the phagocytic function of immunologic hypofunction mice reticuloendothelial system, show that medicine has certain regulating action to immunologic function.
More than test shows, medicine of the present invention has tangible cough-relieving, antiinflammatory, relieving asthma, reduce phlegm and effect such as immunity.
Medicine of the present invention is irritated stomaches three times and is given mice with continuous in the dose of the tolerant Cmax of animal, maximum volume one day, and totally 20, male and female half and half, maximum dosage-feeding is 408.0g crude drug/kg, is equivalent to 611.7 times of clinical consumption.At once observe reaction of animals after the administration, and observed continuously 7 days.Death takes place, and the animal body weight average increases, and the overt toxicity reaction is not seen in perusal.
Rat is irritated stomach respectively and gives effective ingredient 34.0,17.0 of the present invention, 8.5g crude drug/kg/d, in (be equivalent to people's clinical medicine dose 50.0,25.0 and 12.5 times) continuous 9 weeks, observes for 2 weeks after the drug withdrawal.Except that increasing rat body weight, medicine high dose group of the present invention has the obvious suppression, all the other each group comprises that high dose group is to rat ordinary circumstance, food-intake, peripheral hemogram, ten biochemical indicators, electrocardiogram, organ index is compared with matched group, equal no significant difference, main organs does not have tangible pathological change.No obvious toxicity in the yellow capsule against cough of Soviet Union, in the low dosage scope is described, relatively safer.
We have carried out clinical observation on the therapeutic effect to medicine of the present invention, because domestic still do not have a diagnostic criteria, so diagnostic criteria with reference to U.S.'s cough variant asthma, specifically referring to Fujimura M, et al.Detection ofeosinophils in hypertonic saline induced sputum in patients with chronicnonproductive cough.J Asthma, 1997; 34 (2): 119, from deriving from clinical this sick patient that is diagnosed as, observe 157 examples (referring to Luo Shewen etc. the clinical observation of cough variant asthma is treated in dispelling wind and ventilating the lung ruling by law. Chinese Medicine journal 2002; 17 (8): 473).Be divided into Chinese drug-treated group (treatment group) and theophylline+becotide spray (matched group) at random, measure and patient's peripheral blood eosinophilic granulocyte (EOS) absolute value counting ECP so that the gentle road of cough calibration standard is reactive, IL-5 assays etc. are as MAIN OUTCOME MEASURES, treatment and observation of curative effect have been carried out the CVA patient who meets the scientific research and design standard, observe before and after the treatment, clinical symptoms (main) by cough calibration standard, airway reactivity, peripheral blood eosinophilic granulocyte (EOS), serum total IgE level, IL-5, situations of change such as ITV anaphylactogen are carried out the therapeutic evaluation analysis.The result shows: the control of treatment group shows rate, total effective rate is respectively 72.83% and 90%, and the matched group control shows rate, total effective rate and is respectively the apparent rate comparison of 55.38% and 87.69%, two group of control there were significant differences (P＜0.05); General curative effect changes no significant difference between two groups, and (p＞0.05) illustrates that comprehensive therapeutic effect is suitable between two groups.We obtain on measurement of bronchial responsiveness: the measured value of two groups of treatment front and back Dmin all is significantly improved, and sGrs all has obvious decline, and significant difference (P＜0.01) is relatively arranged before and after the wherein treatment group.Compare the same period after treatment group and the treatment of control group, and there were significant differences (P＜0.05); Outside blood EOS, ECP, IL-5 all significantly descended (P＜0.01) before and after two groups of smeltings were treated, and the treatment group is better than matched group (P＜0.01) to the improvement of ECP, IL-5.And the experiment of IVT anaphylactogen shows that this medicine treatment back obviously reduces the sensitivity of multiple external source anaphylactogen, has compared significant difference (p＜0.01) with matched group before and after the treatment.This illustrates that also this medicine not only can improve cough variant asthma patient's symptom, and can improve patient's atopy body constitution to a great extent, reduces airway hyper-reaction and hypersensitivity.
Specific embodiment
Embodiment 1: the preparation of powder
The raw material of the following consumption of weighing: Herba Ephedrae (processed) 650g, Folium Perillae 550g, Pheretima 450g, Fructus Perillae 350g; With above-mentioned Chinese crude drug drying, pulverize, to grind into powder, mix homogeneously is made.
Embodiment 2: the preparation of tablet
Take by weighing the Chinese crude drug of following consumption:
Herba Ephedrae 600g, Folium Perillae 600g, Pheretima 600g, Fructus Perillae 400g, Periostracum Cicadae 500g, Fructus Arctii 600g and Fructus Schisandrae Chinensis 500g;
Above-mentioned Chinese crude drug is pulverized, mixed, add water logging and cross powder, heating decocted 1 hour, filtered, and filtering residue adds water and decocts half an hour, merged decocting liquid, concentrated, and added starch, granulated tabletting.
Embodiment 3: capsular preparation
Take by weighing the Chinese crude drug of following consumption:
Herba Ephedrae (processed) 600g, Folium Perillae 600g, Pheretima 600g, Folium Eriobotryae (processed) 600g, Fructus Perillae 400g, Periostracum Cicadae 500g, Radix Peucedani 500g and Fructus Schisandrae Chinensis 500g;
Above-mentioned Chinese crude drug is pulverized, mixed, add water logging and cross powder, heating decocted 1 hour, filtered, and filtering residue adds water and decocts half an hour, merged decocting liquid, concentrated, and added starch, granulated, and incapsulated.
Embodiment 4: the preparation of powder
The raw material of the following consumption of weighing: Herba Ephedrae 400g, Folium Perillae 400g, Pheretima 400g, Folium Eriobotryae 400g, Fructus Perillae 200g, Periostracum Cicadae 300g, Radix Peucedani 300g, Fructus Arctii 400g and Fructus Schisandrae Chinensis 300g;
With above-mentioned Chinese crude drug drying, pulverize, to grind into powder, mix homogeneously is made.
Embodiment 5: the preparation of tablet
Take by weighing the Chinese crude drug of following consumption:
Herba Ephedrae 600g, Folium Perillae 600g, Pheretima 600g, Folium Eriobotryae 600g, Fructus Perillae 400g, Periostracum Cicadae 500g, Radix Peucedani 500g, Fructus Arctii 600g and Fructus Schisandrae Chinensis 500g;
Above-mentioned Chinese crude drug is pulverized, mixed, add water logging and cross powder, heating decocted 1 hour, filtered, and filtering residue adds water and decocts half an hour, merged decocting liquid, concentrated, and added starch, granulated tabletting.
Embodiment 6: the preparation of capsule
Take by weighing the raw material of following consumption:
Herba Ephedrae 600g, Folium Perillae 400g, Pheretima 500g, Folium Eriobotryae 550g, Fructus Perillae 300g, Periostracum Cicadae 300g, Radix Peucedani 400g, Fructus Arctii 550g and Fructus Schisandrae Chinensis 400g;
Folium Perillae, Radix Peucedani were soaked 1 hour, extracted volatile oil 8 hours, collect volatile oil, the aqueous solution after distillation device is in addition collected; Volatile oil beta-schardinger dextrin-inclusion dry below 40 ℃, is ground into fine powder.Herba Ephedrae, Fructus Schisandrae Chinensis add 80% ethanol, reflux three times, add for the first time 8 times of amounts and extracted 1.5 hours, add 6 times of amounts for the second time and extracted 1.5 hours, add 6 times of amounts for the third time and extracted 1.5 hours, filter, merging filtrate reclaim ethanol, and (relative density is 1.25-1.30 to be condensed into thick paste, 50 ℃ of surveys), standby.In all the other five kinds of medical materials such as Pheretima, add water, decoct three times, add 10 times of amounts for the first time and decocted 1 hour, add for the second time 8 times of amounts and decocted 1 hour, add 8 times of amounts for the third time and decocted 1 hour, filter, aqueous solution after filtrate and the above-mentioned distillation merges, being concentrated into relative density is 1.10 (50 ℃ of surveys), adds ethanol and makes and contain alcohol amount and reach 70%, cold preservation 24 hours, filter, filtrate recycling ethanol, and be condensed into thick paste (relative density is 1.25-1.30,50 ℃ of surveys), merge with above-mentioned thick paste, drying under reduced pressure becomes dry extract below 70 ℃, and dry extract is broken into fine powder, merges with above-mentioned fine powder, add appropriate amount of starch, mixing is granulated drying in right amount with 90-95% ethanol, after crossing 18 mesh sieve granulate, incapsulate, make 1000, promptly.
Embodiment 7: capsular preparation
Take by weighing the raw material of following consumption:
Herba Ephedrae (processed) 556g, Folium Perillae 556g, Pheretima 556g, Folium Eriobotryae (processed) 556g, Fructus Perillae 332g, Periostracum Cicadae 444g, Radix Peucedani 444g, Fructus Arctii 556g and Fructus Schisandrae Chinensis 444g;
Preparation process is made capsule according to embodiment 6 described same steps as.
Embodiment 8: the preparation of capsule
Take by weighing the raw material of following consumption:
Herba Ephedrae (processed) 556g, Folium Perillae 556g, Pheretima 556g, Folium Eriobotryae (processed) 556g, Fructus Perillae 332g, Periostracum Cicadae 444g, Radix Peucedani 444g, Fructus Arctii 556g and Rhizoma Polygonati 444g;
Folium Perillae, Radix Peucedani are extracted volatile oil, collect volatile oil, standby, the aqueous solution after distillation device is in addition collected, and is standby;
Herba Ephedrae, Rhizoma Polygonati add 60-90% ethanol, reflux three times, and each 1.5 hours, merging filtrate reclaimed ethanol, and was condensed into 50 ℃ of thick pastes and surveys relative density and be 1.25-1.30, and is standby;
In all the other five kinds of medical materials such as Pheretima, add water, decoct three times, merging filtrate filters, aqueous solution after filtrate and the above-mentioned distillation merges, being concentrated into 50 ℃, to survey relative densities be 1.10, adds ethanol and make and contain the alcohol amount and reach 70%, cold preservation, filter, filtrate recycling ethanol, and be condensed into thick paste, 50 ℃ are surveyed relative density is 1.25-1.30;
Merge with above-mentioned thick paste, drying under reduced pressure becomes dry extract, and above-mentioned volatile oil merges, and mixing is granulated, and incapsulates.
Claims (21)
1. Chinese medicine composition for the treatment of postinfectious cough and cough variant asthma, it is made up of effective ingredient and/or pharmaceutically acceptable carrier, it is characterized in that preparing described effective ingredient Chinese crude drug raw material and comprises:
Herba Ephedrae 4-6 weight portion, Folium Perillae 4-6 weight portion, Fructus Perillae 2-4 weight portion and Pheretima 4-6 weight portion.
2. according to the described pharmaceutical composition of claim 1, the Chinese crude drug raw material for preparing described effective ingredient comprises Herba Ephedrae 5 weight portions, Folium Perillae 5 weight portions, Fructus Perillae 3 weight portions and Pheretima 5 weight portions.
3. according to the described pharmaceutical composition of claim 1, the Chinese crude drug raw material for preparing described effective ingredient also has the dispelling wind and ventilating the lung medicine.
4. according to the described pharmaceutical composition of claim 3, wherein the dispelling wind and ventilating the lung medicine of Jia Ruing is Periostracum Cicadae 3-5 weight portion and Fructus Arctii 4-6 weight portion.
5. according to the described pharmaceutical composition of claim 4, wherein the Chinese crude drug raw material consumption of Jia Ruing is Periostracum Cicadae 4 weight portions and Fructus Arctii 5 weight portions.
6. according to any one described pharmaceutical composition among the claim 1-5, the Chinese crude drug raw material for preparing described effective ingredient also has the preventing phlegm from forming and stopping coughing medicine.
7. according to the described pharmaceutical composition of claim 6, preventing phlegm from forming and stopping coughing medicine wherein is Folium Eriobotryae 4-6 weight portion and Radix Peucedani 3-5 weight portion.
8. according to the described pharmaceutical composition of claim 7, wherein the Chinese crude drug raw material consumption of Jia Ruing is Folium Eriobotryae 5 weight portions and Radix Peucedani 4 weight portions.
9. according to any one described pharmaceutical composition among the claim 1-8, the Chinese crude drug raw material for preparing described effective ingredient also has the nourishing YIN and moistening the lung medicine.
10. according to the described pharmaceutical composition of claim 9, wherein the nourishing YIN and moistening the lung medicine of Jia Ruing is a Fructus Schisandrae Chinensis 3-5 weight portion.
11. according to the described pharmaceutical composition of claim 9, wherein the nourishing YIN and moistening the lung medicine of Jia Ruing is Fructus Schisandrae Chinensis 4 weight portions.
12. the described pharmaceutical composition of claim 10, the Chinese crude drug raw material for preparing described effective ingredient is:
Herba Ephedrae (processed) 4-6 weight portion, Folium Perillae 4-6 weight portion, Pheretima 4-6 weight portion, Folium Eriobotryae (processed) 4-6 weight portion, Fructus Perillae 2-4 weight portion, Periostracum Cicadae 3-5 weight portion, Radix Peucedani 3-5 weight portion, Fructus Arctii 4-6 weight portion and Fructus Schisandrae Chinensis 3-5 weight portion.
13. according to the described pharmaceutical composition of claim 12, the Chinese crude drug raw material for preparing described effective ingredient is Herba Ephedrae (processed) 5 weight portions, Folium Perillae 5 weight portions, Pheretima 5 weight portions, Folium Eriobotryae (processed) 5 weight portions, Fructus Perillae 3 weight portions, Periostracum Cicadae 4 weight portions, Radix Peucedani 4 weight portions, Fructus Arctii 5 weight portions and Fructus Schisandrae Chinensis 4 weight portions.
14. according to the described pharmaceutical composition of claim 12, the Chinese crude drug raw material for preparing described effective ingredient is:
Herba Ephedrae (processed) 600g, Folium Perillae 400g, Pheretima 500g, Folium Eriobotryae (processed) 550g, Fructus Perillae 300g, Periostracum Cicadae 300g, Radix Peucedani 400g, Fructus Arctii 550g and Fructus Schisandrae Chinensis 400g.
15. according to the described pharmaceutical composition of claim 12, the Chinese crude drug raw material for preparing described effective ingredient is:
Herba Ephedrae (processed) 556g, Folium Perillae 556g, Pheretima 556g, Folium Eriobotryae (processed) 556g, Fructus Perillae 332g, Periostracum Cicadae 444g, Radix Peucedani 444g, Fructus Arctii 556g and Fructus Schisandrae Chinensis 444g.
16. according to the described pharmaceutical composition of claim 12, the Chinese crude drug raw material for preparing described effective ingredient is:
Herba Ephedrae (processed) 556g, Folium Perillae 556g, Pheretima 556g, Folium Eriobotryae (processed) 556g, Fructus Perillae 332g, Periostracum Cicadae 444g, Radix Peucedani 444g, Fructus Arctii 556g and Rhizoma Polygonati 444g.
17. the preparation method of any described Chinese medicine composition among the claim 1-16, it comprises that mixing obtains effective ingredient with the dry pulverize of above-mentioned Chinese crude drug.
18. the preparation method of any described Chinese medicine composition of claim 1-16, it comprises above-mentioned Chinese crude drug is decocted with water, and perhaps decoction liquor is added ethanol again and makes and contain the alcohol amount and reach 70%, filters, and reclaims ethanol, obtains effective ingredient.
19. the preparation method of any described Chinese medicine composition of claim 1-16, it comprises extracts volatile oil with Folium Perillae leaf, Radix Peucedani, collects volatile oil, and standby, the aqueous solution after distillation device is in addition collected, and is standby;
Herba Ephedrae, Fructus Schisandrae Chinensis add 60-90% ethanol, reflux three times, and each 1.5 hours, merging filtrate reclaimed ethanol, and was condensed into 50 ℃ of thick pastes and surveys relative density and be 1.25-1.30, and is standby;
In all the other five kinds of medical materials such as Pheretima, add water, decoct three times, merging filtrate filters, aqueous solution after filtrate and the above-mentioned distillation merges, being concentrated into 50 ℃, to survey relative densities be 1.10, adds ethanol and make and contain the alcohol amount and reach 70%, cold preservation, filter, filtrate recycling ethanol, and be condensed into thick paste, 50 ℃ are surveyed relative density is 1.25-1.30; Merge with above-mentioned thick paste, drying under reduced pressure becomes dry extract, and above-mentioned volatile oil merges, and mixing promptly.
20. according to the preparation method of the described Chinese medicine composition of claim 19, it comprises soaks Folium Perillae leaf, Radix Peucedani, extracts volatile oil, collects volatile oil, the aqueous solution after distillation device is in addition collected; Volatile oil beta-schardinger dextrin-inclusion dry below 40 ℃, is ground into fine powder;
Herba Ephedrae, Fructus Schisandrae Chinensis add 80% ethanol, reflux three times, and each 1.5 hours, merging filtrate reclaimed ethanol, and was condensed into 50 ℃ of thick pastes and surveys relative density and be 1.25-1.30, and is standby;
In all the other five kinds of medical materials such as Pheretima, add water, decoct merging filtrate three times, filter, the aqueous solution after filtrate and the above-mentioned distillation merges, and being concentrated into 50 ℃ of survey relative densities is 1.10, add ethanol and make and contain alcohol amount and reach 70%, cold preservation filters, filtrate recycling ethanol, and be condensed into thick paste, 50 ℃ are surveyed relative density is 1.25-1.30, merges with above-mentioned thick paste, drying under reduced pressure becomes dry extract, dry extract is broken into fine powder, merges with above-mentioned fine powder, adds appropriate amount of auxiliary materials, mixing, granulate, drying is sieved, behind the granulate, the dress capsule promptly.
21. according to. the preparation method of claim 19 or 20 described Chinese medicine compositions, it comprises soaks Folium Perillae leaf, Radix Peucedani 1 hour, extracts volatile oil 8 hours, collects volatile oil, and the aqueous solution after distillation device is in addition collected; Volatile oil beta-schardinger dextrin-inclusion dry below 40 ℃, is ground into fine powder; Herba Ephedrae, Fructus Schisandrae Chinensis add 80% ethanol, and reflux three times adds 8 times of amounts for the first time and extracted 1.5 hours, adds 6 times of amounts for the second time and extracts 1.5 hours, add 6 times of amounts for the third time and extracted 1.5 hours, filter merging filtrate, reclaim ethanol, and concentrated thick paste becomes 50 ℃ to survey relative densities and be 1.25-1.30, standby; In all the other five kinds of medical materials such as Pheretima, add water, decoct three times, add 10 times of amounts for the first time and decocted 1 hour, adding for the second time 8 times of amounts decocted 1 hour, add 8 times of amounts for the third time and decocted 1 hour, filter, the aqueous solution after filtrate and the above-mentioned distillation merges, being concentrated into 50 ℃ of survey relative densities is 1.10, add ethanol and make and contain alcohol amount and reach 70%, cold preservation 24 hours filters, filtrate recycling ethanol, and being condensed into 50 ℃, to survey relative densities be the thick paste of 1.25-1.30, merges with above-mentioned thick paste, and drying under reduced pressure becomes dry extract below 70 ℃, dry extract is broken into fine powder, merge with above-mentioned fine powder, add appropriate amount of starch, mixing, granulate in right amount with 90-95% ethanol, drying behind the 18 mesh sieve granulate, incapsulates excessively, make 1000, promptly.
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| CN100404037C (en) * | 2006-01-19 | 2008-07-23 | 上海交通大学 | Chinese ephedra and earthworm composition for treating cough and gasp, and its preparation method |
| CN102512495A (en) * | 2012-01-05 | 2012-06-27 | 严一文 | Allergic cough oral liquid |
| CN103070966A (en) * | 2012-12-31 | 2013-05-01 | 青岛农业大学 | Chinese veterinary drug preparation for preventing or curing poultry respiratory diseases |
| CN103989798A (en) * | 2014-06-09 | 2014-08-20 | 北京东方运嘉科技发展有限公司 | Traditional Chinese medicine granular suspension preparation for treating cough post influenza and cough variant asthma and preparation method thereof |
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| CN102512495A (en) * | 2012-01-05 | 2012-06-27 | 严一文 | Allergic cough oral liquid |
| CN102512495B (en) * | 2012-01-05 | 2013-11-27 | 严一文 | Allergic cough oral liquid |
| CN103070966A (en) * | 2012-12-31 | 2013-05-01 | 青岛农业大学 | Chinese veterinary drug preparation for preventing or curing poultry respiratory diseases |
| CN104007222A (en) * | 2014-06-03 | 2014-08-27 | 扬子江药业集团北京海燕药业有限公司 | Method for detecting ephedra-perilla leaf cough relieving capsule |
| CN103989798A (en) * | 2014-06-09 | 2014-08-20 | 北京东方运嘉科技发展有限公司 | Traditional Chinese medicine granular suspension preparation for treating cough post influenza and cough variant asthma and preparation method thereof |
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| CN104983881A (en) * | 2015-07-01 | 2015-10-21 | 北京东方运嘉科技发展有限公司 | Traditional Chinese medicine composition for relieving cough and asthma as well as preparation method and application of traditional Chinese medicine composition |
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