CN101172155A - New formulation of pulse-activating gallbladder-warming decoction and production method thereof - Google Patents

The invention belongs to the technical field of traditional Chinese medicine preparations and production methods thereof. The new formulation of the pulse-activating gallbladder-warming decoction is an oral Chinese medicinal preparation which is developed by applying a modern Chinese medicinal theory and a new process, a new technology and new equipment for producing the Chinese medicinal preparation on the basis of the formulation of the pulse-activating gallbladder-warming decoction of the traditional prescription, can fully embody the characteristics of the Chinese medicament and can effectively control the product quality. In particular to a new oral Chinese medicinal preparation product of pulse-activating gallbladder-warming decoction, which is developed by taking eleven Chinese medicinal materials of pinellia tuber, ginger, bamboo shavings, immature bitter orange, dried orange peel, liquorice, tuckahoe, Chinese date, ginseng, dwarf lilyturf tuber, Chinese magnoliavine fruit and the like as main raw materials, has the functions of supplementing qi and nourishing yin, and removing dampness and clearing heat, and is used for treating coronary heart disease, ventricular premature beat, cardiogenic shock and other diseases. The novel oral preparation of the pulse-activating gallbladder-warming decoction keeps the inherent characteristics of the original decoction, has the advantages of small dosage, easy taking, accurate dosage and stable quality, and is suitable for commercial mass production. Overcomes the defects of large dosage, inconvenient carrying, non-long storage, non-commercial production and the like of the decoction preparation of the pulse-activating gallbladder-warming decoction.

Novel dosage forms of pulse-activating gallbladder warming soup and production method thereof

Technical field

The invention belongs to Chinese medicine preparation and production method technical field thereof.

Novel dosage forms of pulse-activating gallbladder warming soup is on the dosage form basis of traditional prescription pulse-activating gallbladder warming soup decoction, use modern Chinese medicine is theoretical and Chinese medicine preparation is produced new technology, new technique and new equipment, the a kind of of development can either demonstrate fully the Chinese medicine characteristic, can effectively control the novel dosage forms of pulse-activating gallbladder warming soup oral Chinese medicine preparation of product quality again.Specifically adopt the Rhizoma Pinelliae, Rhizoma Zingiberis Recens, Caulis Bambusae In Taenia, Fructus Aurantii Immaturus, Pericarpium Citri Reticulatae, Radix Glycyrrhizae, Poria, Fructus Jujubae, Radix Ginseng, Radix Ophiopogonis and Fructus Schisandrae Chinensis etc. ten simply Chinese crude drug be primary raw material, that develops a kind ofly has supplementing QI and nourishing YIN, removes the damp and clearing heat effect, is used for the novel dosage forms of pulse-activating gallbladder warming soup oral Chinese medicine preparation new product of diseases such as coronary heart disease, ventricular premature contraction, cardiogenic shock.

Background technology

Coronary heart disease belongs to sick categories such as the traditional Chinese medical science " thoracic obstruction, pained, precordial pain with cold limbs ".Its mortality rate accounts for heart disease 10%--15%.In recent years Incidence of CHD is on the rise, and the age shifts to an earlier date to some extent.Therefore, both at home and abroad the physician all primary disease as important research contents.Chinese medicine has been brought into play the advantage of oneself in this respect, obtains significant curative effect [Liu Peijin, the differentiation of tcm progress of coronary heart disease, Beijing traditional Chinese medical science, 1998; 5:60-61].For the treatment of cardiovascular disease, mainly be the easy trouble factor of correcting at present, adjust life style and western medicine.Drug therapy mainly comprises nitrate esters, calcium channel blocker and angiotensin converting enzyme inhibitor etc., and these medicines are generally rapid-action, and curative effect is reliable, then can produce drug resistance or generation untoward reaction in various degree but use repeatedly.

Pulse-activating gallbladder warming soup has supplementing QI and nourishing YIN, removes the damp and clearing heat effect, and clinical practice is in diseases such as treatment coronary heart disease, ventricular premature contraction, cardiogenic shock, and is evident in efficacy.

Wang Haizhou [Wang Haizhou; Pulse-activating gallbladder warming soup treatment Chinese and Western, angina pectoris 235 routine Zhejiang magazine, 1991; 26 (9): 392] treat 235 routine angina pectoris with pulse-activating gallbladder warming soup, total effective rate is 84%.Control angina pectoris obvious curative effects is arranged.

[Wu Zhanguang, heart and gallbladder rule together and treat coronary heart disease 104 routine observation of curative effect, practical medical journal, 1998 Wu Zhanguang; (14) 4:304-305] utilization pulse-activating gallbladder warming soup sanction, in conjunction with loosing, 104 routine coronary heart disease are treated observation from intending wide hat, obtain comparatively promising result.

Acute viral myocarditis, modern medicine think that it belongs to immunologic function degression, and impression virus simultaneously causes.The traditional Chinese medical science belongs to it categories such as " cardiopalmus ", " thoracic obstruction ".The curative effect that Li Yi etc. [Li Yi etc., the 166 routine clinical observations of Chinese medicine and western medicine coupling treatment acute viral myocarditis, Jiangsu Chinese medicine, 2004:25 (5): 19-20] have observed pulse-activating gallbladder warming soup plus-minus cooperation western medicine acute viral myocarditis.Employing pulse-activating gallbladder warming soup plus-minus cooperates Western medicine myocardial nutrition agent treatment acute viral myocarditis 166 examples, and is aided with 83 routine contrasts that antiarrhythmic drug is treated with the agent of Western medicine myocardial nutrition.As a result, the cardinal symptom of treatment group and matched group, sign, electrocardiogram recovers normally relatively to have significant difference (P＜0.05).Conclusion, pulse-activating gallbladder warming soup plus-minus cooperate western medicine acute viral myocarditis curative effect better.

Pulse-activating gallbladder warming soup treatment angina pectoris is evident in efficacy, on the basis of Coryza Treated by Syndrome Differentiation, also will pay attention to the research of novel dosage forms of pulse-activating gallbladder warming soup pharmaceutical preparation, in the hope of obtaining the Therapeutic Method and the medicine of comparatively effectively typing, is convenient to clinical application.Reform pulse-activating gallbladder warming soup dosage form, widen route of administration, with prevention with delay the generation of coronary heart disease, accelerate the performance speed of its curative effect, change the situation that the angina pectoris critical illness mainly relies on Western medicine.

Coronary heart disease is the local patholoic change in the integral body, should be conceived to the part, also answers great attention to whole.Chinese traditional treatment coronary heart disease advantage is to regulate the allomeric function of human body, pays attention to the relation of QI and blood, improves the variation of body to internal and external environment.Grasp logical and benefit, local with whole Dialectic Relationship not only is conceived to the topical therapeutic of heart, and considers the improvement of integral body.Therefore, novel dosage forms of pulse-activating gallbladder warming soup Chinese medicine preparation treatment coronary heart disease has broad application prospects.

Pulse-activating gallbladder warming soup is to be combined by SHENGMAI SAN and the former side of WEIDANTANG, has supplementing QI and nourishing YIN, removes the effect of damp and clearing heat.

SHENGMAI SAN comes from " differentiation on endogenous " that gold dollar Lee in period east wall is shown, and is made up of Radix Ginseng, Radix Ophiopogonis, Fructus Schisandrae Chinensis, has the effect of supplementing QI for promoting the production of body fluid, nourishing yin and recovering vein.Modern study thinks that we have the myocardial metabolism of improvement, protection cardiac muscle, blood pressure regulation, Antishock function, and the multiple disease of extensive use clinical treatment aspect the treatment cardiovascular disease, obtains significant curative effect especially.

WEIDANTANG head sees Prescriptions Worth Thousand Gold for Emergencies.WEIDANTANG in " Sanyin Ji Yi Bingzheng Fang Lun " is made up of the Rhizoma Pinelliae, Pericarpium Citri Reticulatae, Fructus Aurantii Immaturus, Caulis Bambusae In Taenia, Radix Glycyrrhizae, Poria, Rhizoma Zingiberis Recens, Fructus Jujubae, and logical effect of falling stomach internal organs, expelling phlegm and resolving turbidity, clearing gallbladder stomach function regulating is arranged.Grand because of its medicine letter effect, over the past thousands of years, the treatment patient is countless, and extremely institute of doctor family is liked.Ancient Chinese medicine doctor has the usefulness of prolonging more, even to this day, performance is arranged especially more.WEIDANTANG has coronary artery dilator, and coronary blood flow increasing improves the effect of blood supply of cardiac muscle, and can reduce sympathetic excitability, and enhancing body with the cardiac muscle of protection to the anoxia sensitivity, is eased the symptom of coronary heart disease to anoxybiotic toleration.In addition, WEIDANTANG is strengthened myocardial contraction in addition, increases cardiac output, blood pressure regulation, the effect of microcirculation improvement.

Pulse-activating gallbladder warming soup is the traditional Chinese medicine compound decoction of China, aspects such as the effective ingredient of its decoction dosage form, drug effect, quality control and mechanism of action also lack the quantizating index of science, in safety, effectively, aspect such as stable also lacks standardization and standardization, is difficult to obtain the approval in market.Therefore, we use modern scientific method and advanced Chinese medicine preparation production technology has been carried out the research of the modern production technology of novel dosage forms of pulse-activating gallbladder warming soup, develop and can either embody the Chinese medicine characteristic, can effectively control the manufacturing technique method of product quality again.

Pulse-activating gallbladder warming soup is carried out the dosage form transformation of the way, and developing its oral formulations novel form is the important measures that guarantee product quality.The active component of research pulse-activating gallbladder warming soup, preparation technology, drug effect, pharmacology, toxicity, dosage form etc., standardization is carried out in aspects such as special extraction at novel dosage forms of pulse-activating gallbladder warming soup, separation, purification, preparation process, accomplish quantitative analysis, develop efficient, high-quality, safety, stablize, taking convenience, new product with novel dosage forms of pulse-activating gallbladder warming soup oral Chinese medicine preparation of new generation of high technology content, high added value, to satisfy clinical demand, significant.

Novel dosage forms of pulse-activating gallbladder warming soup oral Chinese medicine preparation, its product dosage is accurate, steady quality, is applicable to the big production of commercialization.The consumption that has overcome pulse-activating gallbladder warming soup decoction dosage form is big, carry inconvenience, can not store for a long time, can't commercialization production etc. shortcoming.

Summary of the invention

Novel dosage forms of pulse-activating gallbladder warming soup is on the dosage form basis of traditional prescription pulse-activating gallbladder warming soup decoction, a kind of novel dosage forms of pulse-activating gallbladder warming soup oral Chinese medicine preparation new product of development.The invention provides a kind of manufacturing technique method that has supplementing QI and nourishing YIN, removes the oral preparation of Chinese traditional medicinal new product of damp and clearing heat effect.

Production Technology of the present invention can be extracted the effective substance in the prescription fully, has kept distinctive curative effect of former prescription and essence; The cure the disease characteristics of comprehensive composition effect of the traditional Chinese medical science have been demonstrated fully; Control the quality of the pharmaceutical preparations with monomer component, formulation products has advantages of excellent stability, is suitable for industrialized great production.

1, goal of the invention

One of purpose of the present invention is to provide a kind of taking convenience, determined curative effect, steady quality; Have supplementing QI and nourishing YIN, remove the novel dosage forms of pulse-activating gallbladder warming soup oral Chinese medicine preparation new product of damp and clearing heat effect,, meet clinical needs to overcome the defective in existing product field.

Two of purpose of the present invention is to provide a kind of Rhizoma Pinelliae, Rhizoma Zingiberis Recens, Caulis Bambusae In Taenia, Fructus Aurantii Immaturus, Pericarpium Citri Reticulatae, Radix Glycyrrhizae, Poria, Fructus Jujubae, Radix Ginseng, Radix Ophiopogonis and Fructus Schisandrae Chinensis etc. ten manufacturing technique method of a kind of novel dosage forms of pulse-activating gallbladder warming soup oral Chinese medicine preparation new product of Chinese crude drug preparation simply that adopts.Modern science and technology are combined the advanced technology of Development and Production, stay-in-grade novel dosage forms of pulse-activating gallbladder warming soup oral Chinese medicine preparation new product with the advantage characteristic of traditional Chinese medicinal formulae.

Three of purpose of the present invention, be to provide a kind of and can guarantee product quality, be suitable for the technical condition of production technology of the novel dosage forms of pulse-activating gallbladder warming soup oral Chinese medicine preparation of industrialized great production, for the modernization of quality that improves novel dosage forms of pulse-activating gallbladder warming soup oral Chinese medicine formulation products and realization production technology, significant.

Four of purpose of the present invention, being to provide a kind of can extract the effective substance of prescription to greatest extent, to keep distinctive curative effect of prescription and essence; Demonstrate fully the cure the disease characteristics of comprehensive composition effect of the traditional Chinese medical science; Manufacturing technique method with monomer component control novel dosage forms of pulse-activating gallbladder warming soup oral Chinese medicine preparation new product.

2, technical scheme

Pulse-activating gallbladder warming soup is made up of the Rhizoma Pinelliae, Rhizoma Zingiberis Recens, Caulis Bambusae In Taenia, Fructus Aurantii Immaturus, Pericarpium Citri Reticulatae, Radix Glycyrrhizae, Poria, Fructus Jujubae, Radix Ginseng, Radix Ophiopogonis and Fructus Schisandrae Chinensis, and former dosage form is a decoction, exist to use inconvenience, dosage is inaccurate, quality is unstable, can't commercialization etc. problem.

Novel dosage forms of pulse-activating gallbladder warming soup is on the basis of pulse-activating gallbladder warming soup decoction dosage form, a kind of novel dosage forms of pulse-activating gallbladder warming soup Chinese medicine preparation new product of development.Specifically adopt the Rhizoma Pinelliae, Rhizoma Zingiberis Recens, Caulis Bambusae In Taenia, Fructus Aurantii Immaturus, Pericarpium Citri Reticulatae, Radix Glycyrrhizae, Poria, Fructus Jujubae, Radix Ginseng, Radix Ophiopogonis and Fructus Schisandrae Chinensis etc. ten simply Chinese crude drug be primary raw material, use a kind of that the modern pharmaceutical production Technology develops and have supplementing QI and nourishing YIN, remove the damp and clearing heat effect, be used for the novel dosage forms of pulse-activating gallbladder warming soup Chinese medicine preparation new product of diseases such as coronary heart disease, ventricular premature contraction, cardiogenic shock.

Adopt the uniform Design experiment arrangement, determine the best manufacturing technology condition.In development process, find out the influence factor at different prescriptions, preparation technology, select the optimal formulation process conditions and work up quality control standard, make its stability be in optimum state, improve the quality of preparation.Embody in the extraction of prescription effective substance the characteristics of performance active mixture comprehensive function.This production technology is easy, and is with short production cycle, effective ingredient yield height; Increase the dissolubility that leaches composition, and improve the stability of product, have broad application prospects.Adopting high performance liquid chromatography and TLC scanning method etc. to measure content of effective and qualitative identification, is that a kind of qualitative identification specificity is strong, easy fast, quantitative analysis accurately, favorable reproducibility, product quality control method that precision is good.

3, advantage and effect

One of advantage of the present invention is: the product taking convenience, have the advantage of the former medicine of former side, determined curative effect, constant product quality.

Novel dosage forms of pulse-activating gallbladder warming soup and decoction dosage form relatively owing to removed invalid components and tissue substance, have improved the concentration of effective ingredient, reduced dose, and mouthfeel are good, easily accept for patient.

Two of advantage of the present invention is: production technology is suitable for the big production of industrial scale, constant product quality.

An important feature of the present invention is: being to provide a kind of can extract the effective substance of prescription to greatest extent, has kept distinctive curative effect of former prescription and essence; Demonstrated fully the cure the disease characteristics of comprehensive composition effect of the traditional Chinese medical science, and product quality control method that can enough monomer component control qualities of the pharmaceutical preparations.

The oral novel form of pulse-activating gallbladder warming soup has kept the intrinsic characteristic of original decoction, and have dosage few, easily take, absorb advantage such as fast, good effect, the present invention is that new technology, the new technique of and Chinese medicine preparation production theoretical with modern Chinese medicine is support, the oral novel form product of developing of pulse-activating gallbladder warming soup, the novel form formulation products has advantages of excellent stability, is fit to suitability for industrialized production.

The specific embodiment

The pulse-activating gallbladder warming soup oral liquid formulations is by the Rhizoma Pinelliae, Rhizoma Zingiberis Recens, Caulis Bambusae In Taenia, Fructus Aurantii Immaturus, Pericarpium Citri Reticulatae, Radix Glycyrrhizae, Poria, Fructus Jujubae, Radix Ginseng, Radix Ophiopogonis and Fructus Schisandrae Chinensis etc. ten Chinese crude drug extract and suitable pharmaceutic adjuvant merging simply, makes pulse-activating gallbladder warming soup oral liquid, granule, pill, capsule and tablet.

Concrete enforcement is to be foundation with the modern Chinese medicine theory, draw motherland's traditional medicine, modern medicine and pharmaceutical engineering technology, and make it organically to combine, choose and meet that " Rhizoma Pinelliae, Rhizoma Zingiberis Recens, Caulis Bambusae In Taenia, Fructus Aurantii Immaturus, Pericarpium Citri Reticulatae, Radix Glycyrrhizae, Poria, Fructus Jujubae, Radix Ginseng, Radix Ophiopogonis and the Fructus Schisandrae Chinensis etc. ten that 2005 editions continuous items of Chinese pharmacopoeia require down are Chinese crude drug simply, uses a kind of pulse-activating gallbladder warming soup modern Chinese medicine oral liquid formulations new product of modern preparation production technique method development.

The Rhizoma Pinelliae, Rhizoma Zingiberis Recens, Caulis Bambusae In Taenia, Fructus Aurantii Immaturus, Pericarpium Citri Reticulatae, Radix Glycyrrhizae, Poria, Fructus Jujubae, Radix Ginseng, Radix Ophiopogonis and Fructus Schisandrae Chinensis etc. ten Chinese crude drug simply all are that " the important Chinese medicine material commonly used that Chinese pharmacopoeia is recorded, correctives, pharmaceutic adjuvant etc. all meet " the quality standard under the continuous item of the relevant laws and regulations of Chinese pharmacopoeia and country.

The Rhizoma Pinelliae: according to " the 78th page of Rhizoma Pinelliae item of Chinese pharmacopoeia version in 2005 is check down, should be up to specification.The Rhizoma Pinelliae is the dry tuber of aroid Rhizoma Pinelliae Pinelliaternata (Thunb.) Breit., and head is stated from Shennong's Herbal, the medication history in existing several thousand.It is warm in nature, and acrid in the mouth is slightly poisonous, returns spleen, stomach, lung meridian.Has drying dampness to eliminate phlegm, stopping nausea and vomiting by lowering the adverse flow of QI, the merit of dissolving lump and resolving mass.Be used for the abundant expectoration cough with asthma, phlegm retention vertigo and palpitation, dizziness due to wind-phlegm, syncope due to accumulation of phlegm headache, vomiting regurgitation, feeling of oppression and fullness in the chest and epigastrium, globus hystericus etc.The Rhizoma Pinelliae contains Rhizoma Pinelliae starch 75.74%, alkaloid, cupreol, glucoside, daucosterol, calcium oxalate, pinellin, aminoacid, fatty acid, inorganic elements, Rhizoma Pinelliae trypsininhibitory substance, choline etc.Wherein, 16 kinds of aminoacid meters have multiple fatty acid such as aspartic acid, threonine, serine, glutamic acid, glycine, alanine, arginine, lysine such as Palmic acid, stearic acid, oleic acid, A-linolenic acid, β-linolenic acid etc.18 kinds of inorganic elements meters have Al, Fe, Ca, Mg, K, Na, Ti, Mn, P, Zn etc.; Alkaloids is as, left-handed ephedrine hydrochloride etc.Rhizoma Pinelliae clinical practice is very extensive, has crucial medical value.

Caulis Bambusae In Taenia: according to " the 93rd page of Caulis Bambusae In Taenia item of Chinese pharmacopoeia version in 2005 is check down, should be up to specification.Caulis Bambusae In Taenia is the dry intermediate layer of the stem stalk of grass bambusa breviflora Munro Bambusa tuldoioles Munro, major part allusion quotation bamboo Sinocalamus beecheyanus (Munro) McClare var.pu bescens P.F.Li or phyllostachys nigra (lodd.ex lindl.) munro var.henonis (miff.) spapf et rendle Phyl2lostachys nigra (lodd) Munro var.henonisStapf, spread to strand or chip, cold nature, sweet in the mouth is returned lung stomach warp.Be usually used in interior, youngster, each section's treatment of diseases of woman because of heat-phlegm causes.The Caulis Bambusae In Taenia expelling the excess with mild diaphoretic, cold can be reduced phlegm and internal heat, and hardship can be fallen, and specially clearing away phlegm is the dissipating depression of QI good merchantable brand of allaying excitement.It is clinical indispensable medicine commonly used.Caulis Bambusae In Taenia is the traditional simply removing heat-phlegm medicine of the traditional Chinese medical science, but relieving restlessness emesis, logical and venation.The main component of Caulis Bambusae In Taenia extract is flavone glycoside and coumarin lactone, and they are the effective free radical scavenger and the Natural antioxidant.

Fructus Aurantii Immaturus: according to " the 172nd page of Fructus Aurantii Immaturus item of Chinese pharmacopoeia version in 2005 is check down, should be up to specification.Fructus Aurantii Immaturus is the dry immature fruit of rutaceae (citrus aurantium L.) Citrus aurantium Linn. and variety thereof or the dry young fruit of Fructus Citri sinensis (C.sinensisosbeck).Mainly contain volatile oil, Neosynephrine, N-methyltyramine, hesperidin, vitamin C and vitamin D etc.Have the dispelling the stagnated QI removing food stagnancy, the effect of painful abdominal mass of loosing of reducing phlegm.Be used for stopping in stagnant, diseases such as weight, constipation, blocked-up chest, gastroptosis, proctoptosis, uterine prolapse after the feeling of fullness distending pain, dysentery.Clinical aspect gastroenteropathy and cardiovascular disease, use comparatively extensive.

Pericarpium Citri Reticulatae: according to " the 132nd page of Pericarpium Citri Reticulatae item of Chinese pharmacopoeia version in 2005 is check down, should be up to specification.Pericarpium Citri Reticulatae is the dry mature skin of rutaceae orange Citrus reticulate Blanco and variety thereof.Bitter in the mouth, suffering, warm in nature, return lung, spleen channel.Effect with regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.Be usually used in fullness in the epigastrium and chest, lack of appetite and vomiting, cough ant phlegm.Pericarpium Citri Reticulatae contains effective ingredient such as volatile oil and Hesperidin.

Radix Glycyrrhizae: according to " the 59th page of Radix Glycyrrhizae item of Chinese pharmacopoeia version in 2005 is check down, should be up to specification.Radix Glycyrrhizae (Radixglycyrrhizae) is the dry root and the stem of glycyrrhizic legume (Glycyrrhiza uralensis Fisch), Glycyrrhiza inflata Bat. (Glycyrrhizainflate Bat.) or Glycyrrhiza glabra L. (Glycyrrhiza glabra L.), is very important Chinese crude drug simply.Effect with invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, relieving spasm to stop pain.Mainly contain chemical constituents such as glycyrrhizic acid (glycyrrhizic acid), enoxolone, flavone, alkaloid, aminoacid in the Radix Glycyrrhizae, have physiologically active widely.Glycyrrhizic acid is wherein of paramount importance chemical constituent (its content reaches as high as 14%), also be study the earliest, maximum chemical constituent.Be used for detoxifcation, antiinflammatory, antiallergic, antiulcer, antitussive, antitumor and prevent and treat diseases such as viral hepatitis, hyperlipidemia and cancer.

Poria: according to " the 166th page of Poria item of Chinese pharmacopoeia version in 2005 is check down, should be up to specification.Poria (Poriacocos (Schw.) Wolf) is as traditional Chinese crude drug, and the beginning is stated from Shennong's Herbal, is listed in top grade.Slightly sweet flavor, property is flat, the spleen invigorating invigorating middle warmer is arranged, tranquilizing by nourishing the heart, the function of promoting diuresis to eliminate damp pathogen.Its medicinal part is a poria cocos sclerotium, contains pachyman and is about 93%.Main chemical compositions is: polysaccharide, triterpene, fatty acid, sterol, enzyme etc.Pachyman has and promotes cell division, complement activation, antitumor, biological activity such as anticancer.Cure mainly retention of water-damp, dysuria, edema distension, anorexia and loose stool, palpitation and insomnia.

Rhizoma Zingiberis Recens: according to " the 66th page of Rhizoma Zingiberis Recens item of Chinese pharmacopoeia version in 2005 is check down, should be up to specification.Rhizoma Zingiberis Recens is the fresh rhizome of zingiber (Zingiber officinale Rosc.), is food, is again the Chinese medicine of wide clinical application.Property and flavor of peppery and warm has that expelling cold and relieving exterior syndrome, warming middle-JIAO to stop vomiting, recuperating depleted YANG are promoted blood circulation, the effect of dampness expectorant.Can be used for exterior syndrome due to wind-cold, cough, consumptive lung disease, gastrofrigid vomiting, the thoracic obstruction and syndrome of feeling fullness and distension in the upper abdomen etc.Many poison among the people with its solving toxin of fish and crab and Rhizoma Pinelliae, Rhizoma Arisaematis.The Rhizoma Zingiberis Recens master contains volatile oil and pungent composition.Its fragrance and pungent composition can directly stimulate oral cavity and gastric mucosa to cause that local blood circulation improves, and gastric secretion increases, and gastric activity, ptyalin enzymatic activity increase, and gastrointestinal peristalsis strengthens, and helps appetite stimulator and facilitating digestion to absorb, and discharges gastrointestinal pneumatosis.After the piquancy component that contains in the Rhizoma Zingiberis Recens is absorbed by the body, can suppress the generation of cylinder super-oxidation lipid, have antidotal function.

Fructus Jujubae: according to " the 16th page of Fructus Jujubae item of Chinese pharmacopoeia version in 2005 is check down, should be up to specification.Fructus Jujubae is the mature fruit of Rhamnaceae plant (Zizp Husjujuba Miil), and Fructus Jujubae is as medicinal, and is with a long history.Be described in treatise on Febrile Diseases, " Medical Treasures of the Golden Chamber ", the Compendium of Material Medica more, in Shennong's Herbal, classify as top gradely, all record in the successive dynasties book on Chinese herbal medicine.Be invigorating the spleen and replenishing QI, nourishing blood to tranquillize the mind, the conventional Chinese medicine of the mitigation property of medicine.The acids that Fructus Jujubae contains has malic acid, tartaric acid, belulinic acid Betulinic acid etc.; Saccharide has polysaccharide and water-soluble saccharides D-fructose, D-glucose, oligosaccharide, araban, half hole an aromatic plant metioned in ancient books polysaccharide, sucrose etc.; The Organic substance class has several amino acids, vitamin A, B2, C, P and adenosine phosphates (cAMP) such as protein, aspartic acid, paddy aminoacid; Alkaloids has phenyl isoquinolin quinoline type, Ah pouncing on's coffee type, thick Ah pouncing on's coffee type, zizyphine and zizyphinine etc.; Flavone compound has swertisin (Swertisin), flavone-C-glucoside (Spniosin), acetyl SpinosinA, B, C etc.Study carefully the earliest.Fructus Jujubae has effects such as enrich blood, brain-strengthening, anticancer and spleen invigorating are kept fit.

Radix Ginseng: according to " the 7th page of Radix Ginseng item of Chinese pharmacopoeia version in 2005 is check down, should be up to specification.Radix Ginseng is the traditional famous and precious medicine of China, is applied to the history in existing more than 2,000 year of tcm clinical practice.Nourishing, strong, resisting fatigue, expansion blood vessel, Fructus Alpiniae Oxyphyllae, many-sided effect such as anticancer are arranged.The ginsenoside is the main effective ingredient of Radix Ginseng, and nerve system of human body, cardiovascular system, hormonal system, immune system etc. are had wide biological activity, is widely used in clinical practice.Recent studies proof ginsenoside all has far-reaching clinical meaning to aspects such as the multiple disease of cardiovascular system such as ischemic heart desease, arrhythmia, heart failure, and is evident in efficacy, and untoward reaction is few.

Radix Ophiopogonis: according to " Chinese pharmacopoeia version in 2005 item one one the 106th page Radix Ophiopogonis is check down, should be up to specification.Be the liliaceous plant root piece of Radix Ophiopogonis Radix Ophiopogonis, sweet, the little hardship of the property of medicine, is slightly cold, and returns stomach, lung heart channel, has the effect that YIN nourishing and the production of body fluid promoting, lung moistening clear away heart-fire.Have multiple pharmacological effect Radix Ophiopogonis, have very high medicinal and health care to be worth.Be widely used in cardiovascular and cerebrovascular vessel, show as protective effect, protection myocardial ischemia and myocardial infarction the endotheliocyte of the traditional Chinese medical science " blood stasis " card; Immunomodulating and oncotherapy and diabetes etc.Not only obtain remarkable effect as single medicinal material to treatment of diseases Radix Ophiopogonis, and as principal agent and other Chinese medicine composition compound medicines disease treatment has also been obtained certain development.

Fructus Schisandrae Chinensis: according to " the 44th page of five tastes subitem of Chinese pharmacopoeia version in 2005 is check down, should be up to specification.Fructus Schisandrae Chinensis is a conventional Chinese medicine, and commodity have Radix Schisandrae Bicoloris, and former plant is Fructus Schisandrae Chinensis (Schisandra chinensis (Turcz.) Baill.) and Fructus Schisandrae Sphenantherae, and former plant is schisandra chinensis (Schisandra sphenantheraRe2hd.etwils.).Fructus Schisandrae Chinensis is listed in top grade in Shennong's Herbal, has the effect of convergence, astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, kidney calming, is traditional Chinese medical science strengthening by means of tonics medicine commonly used.Fructus Schisandrae Chinensis is Magnoliaceae Radix Schisandrae Bicoloris platymiscium Fructus Schisandrae Chinensis Schsandra chinensis (Turcz.) Bail, with fruit medicine.This product five tastes possess, and go into the lung kidney channel.Fructus Schisandrae Chinensis has to be strengthened and adjusting myocardial cell, the heart, renal artery and energy metabolism, improves myocardial nutrition and function.The SALLRSIPA SAL ADNF-9 schizronol schisanhenol Wheat Protein can directly be removed reactive oxygen free radical.

The object of the present invention is achieved like this:

Novel dosage forms of pulse-activating gallbladder warming soup is by the Rhizoma Pinelliae, Rhizoma Zingiberis Recens, Caulis Bambusae In Taenia, Fructus Aurantii Immaturus, Pericarpium Citri Reticulatae, Radix Glycyrrhizae, Poria, Fructus Jujubae, Radix Ginseng, Radix Ophiopogonis and Fructus Schisandrae Chinensis etc. ten Chinese crude drug simply, decoct with water, collecting decoction, concentrate, adjustment, drying etc., add suitable pharmaceutic adjuvant again, make pulse-activating gallbladder warming soup oral liquid, granule, capsule, pill and tablet.

1, pulse-activating gallbladder warming soup oral liquid and production method thereof:

Pulse-activating gallbladder warming soup oral liquid and production method thereof, it is characterized in that: be by the Rhizoma Pinelliae, Rhizoma Zingiberis Recens, Caulis Bambusae In Taenia, Fructus Aurantii Immaturus, Pericarpium Citri Reticulatae, Radix Glycyrrhizae, Poria, Fructus Jujubae, Radix Ginseng, Radix Ophiopogonis and Fructus Schisandrae Chinensis etc. ten Chinese crude drug extract simply, add suitable pharmaceutic adjuvant and make the pulse-activating gallbladder warming soup oral liquid formulations.

Pulse-activating gallbladder warming soup oral liquid and production method thereof is characterized in that: the weight percent content of medical material is: the 4-14% Rhizoma Pinelliae, 4-14% Caulis Bambusae In Taenia, 4-14% Fructus Aurantii Immaturus, 7-21% Pericarpium Citri Reticulatae, 2-7% Radix Glycyrrhizae, 4-11% Poria, 4-15% Radix Ginseng, 4-11% Rhizoma Zingiberis Recens, 2-7% Fructus Jujubae, 7-21% Radix Ophiopogonis and 4-14% Fructus Schisandrae Chinensis etc. amount to ten simply.

Pulse-activating gallbladder warming soup oral liquid and production method thereof is characterized in that: medical material is decocted with water, collecting decoction, concentrates etc., again with the proper quantity of medicinal auxiliary material mixing, adjust, make the process of pulse-activating gallbladder warming soup oral liquid formulations.

Pulse-activating gallbladder warming soup oral liquid and production method thereof is characterized in that: medicinal substances extract, correctives, antiseptic and water etc. are formed simply by the Rhizoma Pinelliae, Rhizoma Zingiberis Recens, Caulis Bambusae In Taenia, Fructus Aurantii Immaturus, Pericarpium Citri Reticulatae, Radix Glycyrrhizae, Poria, Fructus Jujubae, Radix Ginseng, Radix Ophiopogonis and Fructus Schisandrae Chinensis etc. ten.

Pulse-activating gallbladder warming soup oral liquid and production method thereof, it is characterized in that: be to adopt the Rhizoma Pinelliae, Rhizoma Zingiberis Recens, Caulis Bambusae In Taenia, Fructus Aurantii Immaturus, Pericarpium Citri Reticulatae, Radix Glycyrrhizae, Poria, Fructus Jujubae, Radix Ginseng, Radix Ophiopogonis and Fructus Schisandrae Chinensis etc. ten medicinal substances extract simply, add correctives, antiseptic etc., add water and adjust; Be prepared from through production technologies such as canned, sterilization, check, packings.

Pulse-activating gallbladder warming soup oral liquid and production method thereof, it is characterized in that: the weight percent content of herbal extract, correctives, antiseptic and water is medicinal substances extract 2-99%, correctives 0.1-15%, antiseptic 0.01-1% and water 50-98%, is equivalent to contain the crude drug amount of 0.2-12 gram in the every ml liquid of pulse-activating gallbladder warming soup oral liquid.

Pulse-activating gallbladder warming soup extract and suitable pharmaceutic adjuvant are made the pulse-activating gallbladder warming soup oral liquid, it is characterized in that pharmaceutic adjuvant comprises correctives, antiseptic; Correctives is a kind of in sucrose, saccharin sodium, sodium cyclamate, stevioside, LaspartylLphenylalanine methylester, acesulfame potassium, the Oleum menthae (alcohol) or two kinds; Antiseptic is a kind of in Oleum Caryophylli, sorbitol, sorbic acid methyl ester, benzoic acids, the parabens.

Pulse-activating gallbladder warming soup oral liquid and production method thereof is characterized in that: the production technology of taking following steps: earlier medical material is soaked, the reuse decocting boils 2-3 time; Perhaps, do first with the water of pH1-2 and fry in shallow oil, the water of pH8-10 is done second and third and is fried in shallow oil, and decocts; Collecting decoction filters, and removes residue, and filtrate decompression concentrates; Add ethanol, leave standstill, filter out impurities, reclaim ethanol, standby; Perhaps, will extract filtrate and use seperator centrifugal, get supernatant, and add water and adjust, through the ultrafilter ultrafiltration, standby; Add correctives etc., stir, mix; Adding water adjusts to preparation amount; Through technologies such as sterilization, canned, check, packings, promptly get the pulse-activating gallbladder warming soup oral liquid.

2, pulse-activating gallbladder warming soup granule, pill, capsule and tablet and production method thereof:

Pulse-activating gallbladder warming soup granule, pill, capsule and tablet and production method thereof is characterized in that: when preparation granule or pill or capsule or tablet, used pharmaceutic adjuvant comprises diluent, binding agent, lubricant; Diluent comprises one or more in starch, lactose, dextrin, microcrystalline Cellulose, the calcium stearate; Binding agent comprises one or more in water, macromolecular material, the ethanol; Lubricant comprises one or more in magnesium stearate, Pulvis Talci, the stearic acid.

Pulse-activating gallbladder warming soup granule, pill, capsule and tablet and production method thereof, it is characterized in that: when preparation granule or pill or capsule or tablet, with medical material decoct with water, collecting decoction, concentrate, after the drying, with the proper quantity of medicinal auxiliary material mixing, adding binding agent etc. is made soft material, make granule with granulator, dry, granulate promptly get granule; Or the process pellet processing machine is made pill; Or process hard capsule filling machine is made capsule; Or the process tablet machine is made tablet.

Pulse-activating gallbladder warming soup granule, pill, capsule and tablet and production method thereof is characterized in that: in every gram granule of pulse-activating gallbladder warming soup granule, pill, capsule and tablet, be equivalent to contain the crude drug amount of 1-35 gram.

Novel dosage forms of pulse-activating gallbladder warming soup product of the present invention, preparation according to the method described above, its optimised process and component are provided by the following example, but protection scope of the present invention is not limited to this.

Embodiment:

Embodiment 1 (pulse-activating gallbladder warming soup oral liquid):

Get 12 kilograms of Rhizoma Pinelliaes of recipe quantity, 12 kilograms of Caulis Bambusae In Taenia, 12 kilograms of Fructus Aurantii Immaturuss, 18 kilograms of Pericarpium Citri Reticulataes, 6 kilograms of Radix Glycyrrhizaes, 10 kilograms of Poria, 12 kilograms of Radix Ginsengs, 10 kilograms of Rhizoma Zingiberis Recenss, 6 kilograms of Fructus Jujubaes, 18 kilograms of Radix Ophiopogonis and 12 kilograms of Fructus Schisandrae Chinensis etc. ten medical material simply, soaked 0.5 hour; Decoct with water again 2 times; The 1st 2.5h, the 2nd 1h; Collecting decoction filters, and filtrate decompression concentrates, and adds 95% ethanol and makes and contain the alcohol amount and reach 65%, leaves standstill 48h, reclaims ethanol, and adding distil water stirs evenly to total amount 20L, filters, and transfers pH to 6.5, embedding, and sterilization, promptly.

Embodiment 2 (pulse-activating gallbladder warming soup oral liquid):

Get the various medical materials of recipe quantity, decoct with water 2 times.The 1st 2.5h, the 2nd 1h.Collecting decoction filters, and filtrate decompression concentrates, and adds 95% ethanol and makes and contain the alcohol amount and reach 65%, leaves standstill 48h, reclaims ethanol, and adding distil water stirs evenly to total amount 1000L, and cold preservation 24h filters, and transfers pH to 6.5, embedding, and sterilization, promptly.

Embodiment 3 (pulse-activating gallbladder warming soup oral liquid):

Get the various medical materials of recipe quantity, decoction for the first time adds the pH1 decocting and boils 1h, and decoction for the second time adds the pH9 decocting and boils 2h; Collecting decoction filters, and filtrate decompression is concentrated into 1: 2, adds 95% ethanol and makes and contain the alcohol amount and reach 60%, leaves standstill 48h, reclaims ethanol, and adding distil water stirs evenly to total amount, and cold preservation 24h filters, adjust pH, and embedding, sterilization, promptly.

Embodiment 4 (pulse-activating gallbladder warming soup oral liquid):

Get the various medical materials of recipe quantity, decoction for the first time adds the pH2 decocting and boils 1h, and decoction for the second time adds the pH9 decocting and boils 2h; Collecting decoction filters, and filtrate decompression is concentrated into 1: 1, with channel separator centrifugal (15000rmin), gets supernatant, and adding distil water is to 1000ml, through the ultrafilter ultrafiltration, and ultrafiltration pressure 0.2MPa, the ultrafiltrate embedding, sterilization, promptly.

Embodiment 5 (pulse-activating gallbladder warming soup oral liquid):

Earlier medical material was soaked 0.5 hour, the reuse decocting boils 3 times; Do first with the water of pH2 and fry in shallow oil, the water of pH8 is done second and third and is fried in shallow oil, and decocts; Collecting decoction filters, and removes residue; It is centrifugal with seperator to extract filtrate, gets supernatant, adds water and adjusts, through the ultrafilter ultrafiltration, standby; Add correctives etc., stir, mix; Adding water adjusts to preparation amount; Through technologies such as sterilization, canned, check, packings, promptly get the pulse-activating gallbladder warming soup oral liquid.

Embodiment 6 (pulse-activating gallbladder warming soup granule): content is by weight percentage:

Pulse-activating gallbladder warming soup extract: 16-95%

Starch: 1-45%

Dextrin: 5-55%

Sucrose: 5-55%

35% ethanol: an amount of.

Embodiment 7 (pulse-activating gallbladder warming soup pill): content is by weight percentage:

Pulse-activating gallbladder warming soup extract: 15-95%

Starch: 5-55%

Mel: 5-25%

Dextrin: 5-40%

Stearic acid: 1-15%

Water: an amount of.

Embodiment 8 (pulse-activating gallbladder warming soup capsule): content is by weight percentage:

Pulse-activating gallbladder warming soup extract: 10-95%

Starch: 5-55%

Magnesium stearate: 0.001-0.5%

Water: an amount of.

Embodiment 9 (pulse-activating gallbladder warming soup tablet): content is by weight percentage:

Pulse-activating gallbladder warming soup extract: 25-95%

Starch: 5-45%

Dextrin: 5-55%

Pulvis Talci: 0.1-3%

45% ethanol: an amount of.

The preparation technology of embodiment and prescription are only for the present invention is further illustrated, and the restriction that the protection domain of product of the present invention is not limited to by this optimised process and prescription.