CN1626129A - Medicine for treating obstruction of qi in the chest and heartache - Google Patents
Medicine for treating obstruction of qi in the chest and heartache Download PDFInfo
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- CN1626129A CN1626129A CN 200310107288 CN200310107288A CN1626129A CN 1626129 A CN1626129 A CN 1626129A CN 200310107288 CN200310107288 CN 200310107288 CN 200310107288 A CN200310107288 A CN 200310107288A CN 1626129 A CN1626129 A CN 1626129A
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- Prior art keywords
- adjuvant
- medicine
- starch
- volatile oil
- borneolum syntheticum
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Abstract
A medicine for treating obstruction of Qi in the chest, coronary heart disease and angina pectoris is disclosed. Its advantages are high safety and lower toxic by-effect.
Description
Technical field
The present invention relates to field of medicaments, particularly, relating to Chinese medicine is the pharmaceutical preparation of the treatment obstruction of qi in the chest and cardialgia made of raw material.
Background technology
The thoracic obstruction (pained) refers to because of the breast YANG deficiency, YIN-cold, the turbid thorax of crouching that stays of expectorant, or deficiency of heart-QI, agitate weak, due to QI and blood numbness resistance, the heart being lost blood support.Primary disease is the sick class disease of internal organs numbness of main performance with ambition uncomfortable in chest and ictal pain.Primary disease is equivalent to alleged coronary heart disease of modern medicine and ischemic heart desease.Department of Medical Administration of State Administration of Traditional Chinese Medicine thoracic obstruction emergency case cooperative groups is through repeatedly academic discuss, the viewpoint that doctor trained in Western medicine " coronary heart disease " is equivalent to the traditional Chinese medical science " chest-rheumatism " is proposed, and determine to be equivalent to the relevant name of disease of the traditional Chinese medical science according to the Clinical types of coronary heart disease, promptly " angina pectoris " is equivalent to " obstruction of qi in the chest and cardialgia ".
Primary disease is not smooth with heart arteries and veins, and it is main that the breast sun is not declared.It demonstrate,proves many simulataneous insufficiency and excessive, or void is main, or real be main, but that apoplexy due to deficiency is held concurrently more is real, also in fact have void more.In the thoracic obstruction pathological process, can concurrent severe palpitation, disease such as heart failure.The person of being dangerously ill, the big pain in ambition suddenly, and for faint [very] pained.Chinese juniper beach wormwood Bulbus Allii Macrostemonis Chinese liquor soup, Chinese juniper beach wormwood Bulbus Allii Macrostemonis Rhizoma Pinelliae soup, zhishi xiebai guizhi decoction, Ginseng Decoction, Fructus Citri tangerinae trifoliate orange ginger decoction more and more are difficult to adapt to needs of society because of the restriction of its dosage form; And spreaded all over each corner of human lives as modern medicine synthetic chemical substance commonly used, chemical synthetic drug becomes the main flow of medicine, yet, appearance along with multiple difficult serious symptom miscellaneous diseases, western medical treatment presents imperfect, the human lives and the healthy reality and the up-to-date successes achieved in research have all proposed query to this situation, particularly along with the continuous appearance of chemical drugs toxic and side effects, the change of spectrum of disease and conversion of medical, make modern medicine be subjected to unprecedented challenge, and people also place hope in the application and development of traditional medicine on gradually.Advocate back to nature, pay attention to plant amedica use, hanker after traditional remedies, the trend of advocating natural drug forms, making full use of natural materials is human best selections.
At present, in the world, natural drug all has certain market, along with people increasing and the aging of population to the health requirements level of understanding, sub-health stateization, people thirst for back to nature more, the problem of utilize the high Drug therapy of pure natural degree, preventing some chemical synthetic drugs cann't be solved, so the background that exceeds its original traditional national culture has been expanded in the application of natural plant.From natural drug, seek the little and inexpensive medicine of side effect and become the target that countries in the world pharmaceutical manufacturer is chased.The European Community has carried out unified legislation to medical herbs, state medical herbs status such as Canada and Australia have legalized, U.S. government has also drafted the plant amedica management method, the compound recipe mix preparation that begins to accept natural drug is as curative, and these provide good international environment for Chinese medicine enters international medical market as curative.On the other hand, along with the quickening of global economic integration progress, particularly China becomes a full member of WTO, and Chinese Medicine market incorporates the breadth and depth of international medical big market and will further aggravate.Face the enormous impact of Asian countries's traditional medicine product such as the keen competition of powerful transnational medical group and Japan, Korea S, India, Thailand and European countries' plant amedica such as Germany, France, numerous products that China's Chinese medicine produces are owing to still can not meet the standard of international medical market and requirement and being kept outside of the door.
Expansion and human back to nature requirement along with the market global range, use the low medicine of toxic and side effects, especially pure natural medical more and more becomes people's first-selection, dropping pill formulation be a kind of have efficient, quick-acting new medicine preparations, it has overcome the shortcoming and deficiency of Chinese medicine preparation in the past, but present dropping pill formulation generally faces following problem: 1, drop pill adjuvant pure natural degree is not high: at present, drop pill substrate adjuvant mostly is synthetic, natural degree is lower, the searching of new alternative substrate adjuvant, the searching of the alternative substrate adjuvant that particularly natural degree is high and preparation technology thereof determine, it is again very difficult thing, because the required preparation condition of at present common possible natural substrates adjuvant succedaneum is very harsh, it all is to influence the key that drop pill prepares molding that adjuvant temperature and drop pill thereof drip the system condition.The too high then viscosity of adjuvant melt temperature is low, and poor plasticity is though the adjuvant melt temperature is crossed lowplastcity by force, but drop pill has shortcomings such as easily sticking ball, distortion, therefore, seek pure natural degree height, and the adjuvant that is suitable for substituting existing drop pill substrate is a very job of hardships.2, the drop pill outlet encounters problems: along with expanding economy, more and more internationalize in market, China is also just making great efforts to adapt to this trend, present Chinese medicine dripping pills preparation as health food, successful export to many countries, but also face many problems at present, because different countries is different to the approval of the selected adjuvant of Chinese medicine dropping pill formulation, especially industrial flourishing Europe, more strict to food adjuvant and medical auxiliary materials, and as the selected chemosynthesis adjuvant (as Polyethylene Glycol) of the dropping pill formulation of health food outlet not in the catalogue of some national food additive, it is very unfavorable that this moves towards the international market to the Chinese medicine dropping pill formulation, becomes the stumbling-block that Chinese medicine enters the international market, therefore, seek the new of one or more, can be particularly important, also very urgent for the substrate adjuvant that the international market is accepted.3, the shortcoming of mouthfeel and onset speed: the mouthfeel of Chinese medicine and preparation thereof is relatively poor to be the big characteristics of one, people when taking some drugs to the frightened of disagreeable taste that medicine had even be better than fear far away to disease, What is more, some patients are because can not overcome the poor taste of Chinese medicine or its preparation or abnormal smells from the patient and abandon the treatment of Chinese medicine, though can improve mouthfeel as medicine being made capsule or sugar coated tablet, reducing stimulates, but disintegration rate prolongs, be unfavorable for the rapid onset of medicine, to some disease, particularly need the disease of the rapid onset of medicine inapplicable.4, the preparation process difficulty of drop pill suitability for industrialized production: in the replacement process of dropping pill formulation adjuvant, determining of the preparation process of its suitability for industrialized production is very difficult something, as the ratio of the melt temperature of substrate adjuvant, the proportioning of dripping system temperature, adjuvant and medicine, dropper bore, condensing agent etc. all are the factors that influence drop pill, therefore, the replacement of substrate and to be suitable for suitability for industrialized production be a job consuming time, as to expend substantial contribution.
In order to change drop pill substrate adjuvant for a long time based on the situation of chemosynthesis adjuvant, it is low to solve the pure natural degree that present drop pill substrate faced, and can not satisfy more and more that people require back to nature, take low toxicity, the problem of the pure natural medical that has no side effect; Also can solve some problems that Chinese medicine preparation, particularly dropping pill formulation are run in exit procedure, strengthen the competitiveness of international market; The present invention has invented the pure Chinese medicine dripping pills preparation that a kind of toxic and side effects is low, evident in efficacy, moderate, adapt to industrialized great production by a large amount of tests and the research of preparation process.
Summary of the invention
The purpose of this invention is to provide a kind of treatment obstruction of qi in the chest and cardialgia, coronary heart disease, anginal medicine with the preparation of new type natural substrate adjuvant.
Another object of the present invention provides a kind of preparation method for the treatment of obstruction of qi in the chest and cardialgia, coronary heart disease, angina drug preparation.
The present invention is the new pharmacological action that the qi-blood relationship theory learned according to Chinese traditional medicine and modern medicine are found various institutes of Chinese materia medica, according to " symptomatic treatment in acute condition, radical treatment in chronic case; set upright based on reinforcing; " leading to " just must not hinder, " benefit " must not be detained, treating both the principal and secondary aspects of a disease.The medicine of producing according to this method has late result again, and finally reaches the healing purpose the existing short term effect of the treatment of coronary heart disease, and generation without any side effects.The selected substrate adjuvant of the present invention is resulting by a large amount of tests, it is little to have molecular weight, soluble in water, and molten diffusing speed is faster, pure natural degree height, toxic and side effects is lower, and can reduce the medicine irritation abnormal smells from the patient, has the oral cavity of improvement acid-base value during the buccal of oral cavity, improve the characteristics of oral cavity smell, the used substrate adjuvant of the present invention is the agent of food sedan-chair flavor, takes that mouthfeel is good, the acceptant characteristics of patient, is the direction of following substrate adjuvant development.
The consumption of drug component of the present invention and the selection of adjuvant thereof also grope to sum up to draw through the inventor in a large number, and each component raw material survival dose all has curative effect preferably in following ranges:
50～90 parts of Cortex Moutans, 10～90 parts of Rhizoma Chuanxiongs, 0.1～15 part of Borneolum Syntheticum, appropriate amount of auxiliary materials are made, wherein adjuvant comprises filler and plasticity substrate, said filler is selected from the natural adjuvant of following one or more plant origins: erythritol, sorbitol, fructose, D-ribonic acid-gamma lactone, arabitol, trehalose, D-ribose, low melting-point agarose, Lac, xylitol, Raffinose, glucose, malic acid, citric acid, isomalt, lactose, maltose etc., and they contain the water of crystallization chemical compound; Said plasticity substrate is selected from the natural adjuvant of following one or more plant origins: starch and derivant thereof, cellulose and derivant thereof, arabic gum, dextran, chitin, sesbania gum, carrageenan, Ficus elastica, Furcellaran, tragakanta, carrageenin, tamarind gum, pectin, xanthan gum, alginic acid and salt thereof, dextrin, cyclodextrin, agar, lactose; Described starch and derivant thereof such as pregelatinized Starch, modified starch, hydroxypropyl starch, carboxymethyl starch, described cellulose and derivant thereof such as methylcellulose, microcrystalline Cellulose, sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose, cross-linking sodium carboxymethyl cellulose, hydroxyethylmethyl-cellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose; The consumption of preferred drug component of the present invention and adjuvant thereof are that 60～80 parts of Cortex Moutans, 15～55 parts of Rhizoma Chuanxiongs, 0.5～10 part of Borneolum Syntheticum, appropriate amount of auxiliary materials are made, filler adjuvant wherein is selected from the natural adjuvant of following one or more plant origins: sorbitol, xylitol, lactose, maltose, and they contain the water of crystallization chemical compound; Plasticity substrate wherein is selected from the natural adjuvant of following one or more plant origins: pregelatinized Starch, carboxymethyl starch, methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose, arabic gum, alginic acid, dextrin, cyclodextrin, agar, lactose; The consumption of best drug component of the present invention and adjuvant thereof are that 65～70 parts of Cortex Moutans, 20～35 parts of Rhizoma Chuanxiongs, 0.8～5 part of Borneolum Syntheticum, appropriate amount of auxiliary materials are made, and filler adjuvant wherein is selected from the natural adjuvant of following one or more plant origins: xylitol, lactose; Plasticity substrate wherein is selected from the natural adjuvant of following one or more plant origins: starch, arabic gum
In above-mentioned substrate adjuvant, can also contain; Chemosynthesis adjuvant and animal origin adjuvant phenylglycol, hexadecanol, octadecanol, sodium stearate, tristerin, tripalmitin, carbamide, polyoxyethylene monostearate, polyoxyethylene alkyl ether etc.
Also comprise some plasticity substrate adjuvants in the substrate adjuvant of the present invention; Preferred plasticity substrate adjuvant is selected from following one or more adjuvant: starch and derivant thereof, cellulose and derivant thereof, arabic gum, dextran, chitin, sesbania gum, carrageenan, Ficus elastica, Furcellaran, tragakanta, carrageenin, tamarind gum, pectin, xanthan gum, alginic acid and salt thereof, dextrin, cyclodextrin, agar, lactose; Described starch and derivant thereof such as pregelatinized Starch, modified starch, hydroxypropyl starch, carboxymethyl starch, described cellulose and derivant thereof such as methylcellulose, microcrystalline Cellulose, sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose, cross-linking sodium carboxymethyl cellulose, hydroxyethylmethyl-cellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose; Best plasticity substrate adjuvant is selected from following one or more adjuvant: pregelatinized Starch, carboxymethyl starch, methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose, arabic gum, alginic acid, dextrin, cyclodextrin, agar, lactose.
In above-mentioned plasticity substrate adjuvant, can also contain chemosynthesis adjuvant and animal origin adjuvant such as polyvinylpyrrolidone, crospolyvinylpyrrolidone, carbomer, polyvinyl alcohol, acrylic resin, poloxamer, gelatin etc.
In screening to above adjuvant, we find: plant colloid such as carrageenan, the tragakanta, pectin, agar, arabic gum, Ficus elastica, tamarind gum, locust bean gum, Pseudobulbus Bletillae (Rhizoma Bletillae) glue, guar gum, Konjac glucomannan, it is big that plant colloids such as POLY-karaya have viscosity, mobile poor, characteristics such as do not solidify after the condensation, and arabic gum has high dense low sticking character, can be mixed with the aqueous solution of 50% concentration and still have flowability, this is one of not available characteristics of other hydrophilic colloid, arabic gum has at high temperature, under the low concentration, can ooze, but not condensation, at low temperature, under the high concentration, be difficult for oozing, but characteristics such as energy condensation.Polysaccharide such as polysaccharide such as starch and derivant thereof (as gelling starch, carboxymethyl starch etc.), cellulose derivative (as methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose etc.), alginic acid, dextrin, cyclodextrin, lactose, in screening, find alginic acid have viscosity big, be the fruit jelly sample, dextrin has the colloid sample, characteristics such as lactose coagulability difference; And starch and derivant thereof are materials commonly used in the medical science adjuvant, thus in polysaccharide preferred starch and derivant thereof.Polyhydric alcohol such as sorbitol (88～102 ℃), xylitol (88～94.5 ℃), lactose (70～80 ℃), mannitol (166～169 ℃), maltose alcohol (135～140 ℃), isomalt polyhydric alcohol such as (98～103 ℃) screen, and find that it has following characteristics as drop pill substrate: sorbitol, lactose, isomalt are mobile poor; Mannitol, maltose alcohol fusing point are too high; The xylitol coagulability is poor slightly.After Preliminary screening, preferred xylitol, lactose, sorbitol in the selection of polyhydric alcohol, the best is an xylitol.Xylitol has following characteristics as drop pill substrate: in the time of 91 ℃, molten condition has appearred in xylitol, but not fusion fully, cooling rapidly, it separates out crystallization very soon, xylitol mixes the back good fluidity with extractum at certain proportion, can drip and can condensation, but be condensed into Powdered thing, loosely organized, the toughness extreme difference, that pinches is promptly broken.Organic acid and salt, alkali such as citric acid (100 ℃), sorbic acid (133 ℃), succinic acid (181～189 ℃), sodium acetate organic acid such as (58 ℃) and salt, alkali, its as drop pill substrate have fusing point too high, with Chinese medical concrete can't mixing etc. shortcoming.
Because of above single adjuvant existing shortcoming in as the drop pill preparation process, particularly we by above-mentioned Preliminary screening after, determine two kinds of adjuvants are used and screen: mainly be that above various adjuvants are carried out combined sorting, final determine following several: the plant colloid cooperates with the plant colloid, the cooperating of polyhydric alcohol and polyhydric alcohol, polyhydric alcohol and plant colloidally cooperate, the cooperating of the cooperating of xylitol and arabic gum, lactose and arabic gum, based on the composite auxiliary material of xylitol.Find preferred the cooperation to be xylitol, lactose and the compound use of other adjuvant, this kind combination has following characteristics: make up with mannitol: can drip not condensation; Make up with sorbic acid: both do not dissolve each other; Make up with lactose: can drip the energy condensation, but frangible; Make up with pomelo-pectin, tragakanta, sodium alginate: viscosity is big, can't drip; Make up with arabic gum: can drip, coagulability is poor slightly; Make up with dextrin: can drip, coagulability is poor slightly; Make up with starch: can drip, coagulability is also better.Determine that at last best of breed is that xylitol cooperates with arabic gum with starch, xylitol with starch, lactose.
At xylitol and starch, lactose and starch, in the research of xylitol and arabic gum combination, xylitol and starch Application of composite being prepared some required in the process of drop pill factors investigated, mainly is to the xylitol type, condensed fluid, condensate temperature influences the drop pill mouldability, xylitol and starch proportion influence mouldability, temperature is to the influence of drop pill mouldability, the extractum amount influences the drop pill mouldability, mixing time influences the drop pill mouldability, the dropper bore is to the influence of drop pill particle diameter, the formulation optimization of drop pill, the Preliminary Determination of drop pill, dissolve scattered time limit is investigated.Find that the solid xylitol has three types of powder, granular and crystallinity, and the easiest fusion of powder xylitol, again can fine dissolving be dispersed in the mixed liquor that starch, extractum forms, good fluidity, drippage is easy, and granular and crystalline xyhose alcohol is difficult for fusion, solubility property is also slightly poor, the mix flow that they and starch, extractum form is relatively poor, viscosity is very big, almost cannot drip, and therefore drips first-selected powder xylitol in the system process at drop pill.
At ratio of adjuvant molding is found in the sex research, in the combination of xylitol and starch, lactose and starch, xylitol and arabic gum, low melting point substrate adjuvant is 1: 0～1: 1.5 with the ratio of the weight of plasticity substrate adjuvant, be preferably 1: 0.1～1: 0.9, the best is 1: 0.1～1: 0.5.Low melting point substrate adjuvant of being formed within this scope and plasticity substrate adjuvant, the drug matrices fused solution all can ooze, and can condensation.Specific to each combination, xylitol is preferably 1: 0.2 with the ratio of the weight of starch～1: 0.3, and lactose is preferably 1: 0.2 with the ratio of the weight of starch～1: 0.3, and the ratio of the weight of xylitol and arabic gum is preferably 1: 0.2～and 1: 0.4.Find that in the research of temperature temperature is big especially to the influence of drop pill mouldability to the influence of drop pill mouldability, when temperature is too low, owing to the too big effect that oozes that influences drop pill of viscosity of substrate, when temperature is too high, not condensation of drop pill.Find that mixing time can have influence on the mouldability of drop pill in mixing time in to the sex research of drop pill molding, mixing time is too short, and mobile poor, influence oozes, and mixing time is oversize, influences the condensation of drop pill.Dripping under the system temperature, mixing time in 1～120 minute all can, suitable mixing time was at 10～30 minutes.Consider that mixing time can not be too short in the suitability for industrialized production, adopt the method that low temperature stirs for a long time, high temperature drips system.Find that in the research of dropper bore to the influence of drop pill particle diameter the dropper bore influences the size of drop pill and the flowability of fusion substrate, the system effect is dripped in influence.Drop pill diminishes and diminishes along with bore, but after 1.4 millimeters, along with the bore change of size that diminishes is not obvious, but the matrix flow reduction, system is dripped in influence.
So in the preparation method of preparation, medicine mixes mixing time with the substrate adjuvant be 10～30 minutes; The mixed heating and melting temperature of medicine and substrate adjuvant is 45～115 ℃, dripping the system temperature is 45～95 ℃, and liquid coolant is liquid paraffin, methyl-silicone oil or vegetable oil (Oleum Glycines, Semen Ricini wet goods), and the temperature of liquid coolant is-20～25 ℃, dropper mouth internal diameter is 1.0～4.0 millimeters; Preferred heating and melting temperature is 60～85 ℃, and dripping a system temperature is 60～85 ℃, and condensing agent is liquid paraffin, methyl-silicone oil, and the condensing agent temperature is 0～18 ℃, and the dropper bore is 1.1～3.5 millimeters, and the difference of dropper mouth external diameter and internal diameter is less for well; Best heating and melting temperature is that to make temperature be that 64 ℃, dropper bore are that 1.2～2.5 millimeters, condensing agent are 0 ℃ methyl-silicone oil to 64 ℃, droplet.
The substrate adjuvant of the best of the present invention is xylitol and starch, and xylitol is 1: 0.2～1: 0.3 with the ratio of the weight of starch; Or be lactose and starch, lactose is 1: 0.2～1: 0.3 with the ratio of the weight of starch; Or be xylitol and arabic gum, the ratio of the weight of xylitol and arabic gum is 1: 0.2～1: 0.4.
Xylitol is a kind of natural plant sweetening agent, approve through World Health Organization (WHO), xylitol is a kind of safest sweeting agent, countries in the world are extensive use of in fields such as food and oral-cavity articles, xylitol enters the help that need not insulin in the cell, when sugar utilizes obstacle, can not cause blood sugar increasing yet, can improve diabetics symptom, have the ketoplastic effect of powerful inhibition, can promote the generation of liver glycogen, directly infiltrate the Developmental and Metabolic Disorder that tissue is participated in metabolism, can be corrected protein, fat and steroid; Xylose is the internal metabolism intermediate product, and body has higher toleration to it.Clinical practice proves: the highest oral dosis tolerata can reach 220g every day, and intravenous drip every day can reach 100g.The oral 25700mg/Kg of median lethal dose(LD 50) (LD50) mice, quiet notes 6400mg/Kg, the quiet notes of rat 6200mg/Kg.
Medicine mesostroma adjuvant of the present invention and amount of drug are than can being the scope that allows on the galenic pharmacy, medicine described here can be that crude drug also can be the effective ingredient extract, in order to adapt to industrialized great production, the ratio range of mesostroma adjuvant of the present invention and medicine refers to the weight proportion of adjuvant and extract drugs extractum, and the substrate adjuvant is 1: 0.1～1: 1 with the ratio of the weight of drug extract; Preferred substrate adjuvant is 1: 0.1～1: 0.6 with the ratio of the weight of extract drugs extractum; Best substrate adjuvant is 1: 0.2～1: 0.4 with the ratio of the extraction extractum weight of medicine.
Medicine of the present invention can adopt the preparation of Chinese medicine preparation conventional method.The preparation of effective ingredient of the present invention can be adopted following method: water extraction, decoction and alcohol sedimentation technique, extraction, infusion process, percolation, reflux extraction, continuous backflow extraction method, macroreticular resin absorbing method preparation.For example, these crude drug pulverize mix homogeneously can be made powder takes after mixing it with water; Also can be with these medicines decocting together, the condensed water decocting liquid is made oral liquid then; But, preferably adopt following technology to extract, but this can not limit protection scope of the present invention to raw material in order to make each crude drug of this medicine better bring into play drug effect.
The preparation method of medicine of the present invention is as follows:
(a) it is standby to take by weighing 50～90 parts of each crude drug Cortex Moutans, 10～90 parts of Rhizoma Chuanxiongs, 0.1～15 part of Borneolum Syntheticum by proportioning;
(b) Rhizoma Chuanxiong extracts volatile oil, and volatile oil device is in addition collected, and the medicinal residues decocting boils secondary, is 0.5～5 hour for the first time, be 0.5～4 hour for the second time, collecting decoction is concentrated into that relative density is 1.10～1.35 in the time of 30～70 ℃, adds equivalent ethanol and makes precipitation, draw supernatant, filter, worry liquid is standby; Get the Cortex Moutan coarse powder, prepare its active component, make solvent with 70～95% ethanol according to the percolation under Chinese Pharmacopoeia 95 editions appendix IO fluid extract and the extractum item, flood and carry out percolation after 12～36 hours, collect percolate, merge with the Rhizoma Chuanxiong filtrate, reclaim ethanol, concentrate; Get volatile oil, Borneolum Syntheticum, add ethanol and dissolve in right amount, add an amount of solubilizing agent, make solubilising liquid;
(c) in appropriate amount of auxiliary materials, add above-mentioned clear paste, Borneolum Syntheticum and volatile oil, fully mix, mixture is at 45～115 ℃ of heating and meltings, stir, mixing time is 1～120 minute, insulation, at 45～95 ℃ of temperature following system, dropper bore is 1.0～4.0 millimeters, splash in-20～25 ℃ liquid paraffin, methyl-silicone oil or the vegetable oil, with the drop pill drop to the greatest extent and wipe liquid coolant, promptly.
Preferred manufacturing procedure comprises the following steps:
(a) it is standby to take by weighing 60～80 parts of each crude drug Cortex Moutans, 15～55 parts of Rhizoma Chuanxiongs, 0.5～10 part of Borneolum Syntheticum by proportioning;
(b) Rhizoma Chuanxiong extracts volatile oil, and volatile oil device is in addition collected, and the medicinal residues decocting boils secondary, is 1～4 hour for the first time, be 1～3 hour for the second time, collecting decoction is concentrated into that relative density is 1.15～1.30 in the time of 40～60 ℃, adds equivalent ethanol and makes precipitation, draw supernatant, filter, worry liquid is standby; Get the Cortex Moutan coarse powder, prepare its active component according to the percolation under Chinese Pharmacopoeia 95 editions appendix IO fluid extract and the extractum item, make solvent with 75～90% ethanol, flood and carry out percolation after 18～30 hours, collect the about 1000～3000ml of percolate, merge with the Rhizoma Chuanxiong filtrate, reclaim ethanol, be concentrated into 50～150ml; Get volatile oil, Borneolum Syntheticum, add ethanol and dissolve in right amount, add an amount of solubilizing agent, make solubilising liquid;
(c) in appropriate amount of auxiliary materials, add above-mentioned clear paste, Borneolum Syntheticum and volatile oil, fully mix, mixture is at 60～85 ℃ of heating and meltings, stir, mixing time is 10～30 minutes, insulation, at 60～85 ℃ of temperature following system, dropper bore is 1.1～3.5 millimeters, splash in 0～18 ℃ the liquid paraffin, methyl-silicone oil, with the drop pill drop to the greatest extent and wipe liquid coolant, promptly.
Best preparation method comprises the following steps:
(a) it is standby to take by weighing 65～70 parts of each crude drug Cortex Moutans, 20～35 parts of Rhizoma Chuanxiongs, 0.8～5 part of Borneolum Syntheticum by proportioning;
(b) Rhizoma Chuanxiong extracts volatile oil, and volatile oil device is in addition collected, and the medicinal residues decocting boils secondary, is 2.5 hours for the first time, is 2 hours for the second time, and collecting decoction is concentrated into that relative density is 1.25 in the time of 50 ℃, adds equivalent ethanol and makes precipitation, draws supernatant, filters, and it is standby to consider liquid; Get the Cortex Moutan coarse powder, prepare its active component, make solvent with 80% ethanol according to the percolation under Chinese Pharmacopoeia 95 editions appendix IO fluid extract and the extractum item, flood and carry out percolation after 24 hours, collect the about 2200ml of percolate, merge with the Rhizoma Chuanxiong filtrate, reclaim ethanol, be concentrated into 70ml; Get volatile oil, Borneolum Syntheticum, add ethanol and dissolve in right amount, add the 4ml tween 80, make solubilising liquid;
(c) get 500 parts of adjuvants, adding above-mentioned clear paste, Borneolum Syntheticum and volatile oil fully mixes, mixture is at 64 ℃ of heating and meltings, stir, mixing time is 10～30 minutes, insulation, at 64 ℃ of temperature following system, dropper bore is 1.2～2.5 millimeters, splash in 0 ℃ the methyl-silicone oil, with the drop pill drop to the greatest extent and wipe liquid coolant, promptly.
The best preparation method of medicine of the present invention is:
(a) it is standby to take by weighing 65～70 parts of each crude drug Cortex Moutans, 20～35 parts of Rhizoma Chuanxiongs, 0.8～5 part of Borneolum Syntheticum by proportioning;
(b) Rhizoma Chuanxiong extracts volatile oil, and volatile oil device is in addition collected, and the medicinal residues decocting boils secondary, is 2.5 hours for the first time, is 2 hours for the second time, and collecting decoction is concentrated into that relative density is 1.25 in the time of 50 ℃, adds equivalent ethanol and makes precipitation, draws supernatant, filters, and it is standby to consider liquid; Get the Cortex Moutan coarse powder, prepare its active component, make solvent with 80% ethanol according to the percolation under Chinese Pharmacopoeia 95 editions appendix IO fluid extract and the extractum item, flood and carry out percolation after 24 hours, collect the about 2200ml of percolate, merge with the Rhizoma Chuanxiong filtrate, reclaim ethanol, be concentrated into 70ml; Get volatile oil, Borneolum Syntheticum, add ethanol and dissolve in right amount, add the 4ml tween 80, make solubilising liquid;
(c) get 500 parts of xylitol and starch, xylitol is 1: 0.2～1: 0.3 with the ratio of the weight of starch; Or adding lactose and starch, lactose is 1: 0.2～1: 0.3 with the ratio of the weight of starch; Or adding xylitol and arabic gum, the ratio of the weight of xylitol and arabic gum is 1: 0.2～1: 0.4 a adjuvant, add above-mentioned clear paste, Borneolum Syntheticum and volatile oil and fully mix, mixture stirs at 64 ℃ of heating and meltings, mixing time is 10～30 minutes, insulation is 1.2～2.5 millimeters at 64 ℃ of temperature following system, dropper bore, splashes in 0 ℃ the methyl-silicone oil, with the drop pill drop to the greatest extent and wipe liquid coolant, promptly.
More than form when producing and to increase or to reduce according to corresponding ratio, as large-scale production can be unit with kilogram or with the ton, small-scale production can be unit with the gram also, and weight can increase or reduce, but the crude drug material weight proportion constant rate between each composition.
More than each single medicinal material, especially adjuvant drug, messenger drug or adjuvant drug and messenger drug in forming, can be replaced by suitable Chinese medicine individually or simultaneously with the identical property of medicine, effect, it is constant to replace back Chinese medicine preparation and drug effect thereof.
Medicine of the present invention can be determined usage and dosage according to patient's situation in use, but every day 1-3 time, and every day, each crude drug consumption was as the criterion with the state-promulgated pharmacopoeia dosage, was no more than the pharmacopeia ormal weight.
The drop pill that the present invention is prepared, conventional drop pill advantage is simple as preparing except having, steady quality, can make liquid medicine solidification, convenient drug administration, efficient, quick-acting, its biggest advantage is:
1, the selected adjuvant pure natural of the present invention degree height: the substrate adjuvant that employed substrate adjuvant derives from natural plants or originates based on natural plants among the present invention, selected substrate adjuvant is xylitol and starch or lactose and starch or xylitol and arabic gum, this substrate adjuvant has pure natural degree height, toxic and side effects is low, mouthfeel is good, dissolve scattered time limit is short, rapid-action, it is a kind of new medium adjuvant, can be used for substituting present chemosynthesis adjuvant, the drop pill made from this kind adjuvant, it is low to solve the pure natural degree that present drop pill substrate faced, and more and more can not satisfy people and require back to nature, take low toxicity, the problem of the pure natural medical that has no side effect.
2, some problems in the outlet of solution Chinese medicine: medicine of the present invention also can solve Chinese medicine preparation, some problems of in exit procedure, being run into of dropping pill formulation particularly, solve because different countries, especially the European countries of industry prosperity are to the difference identification of the selected adjuvant of Chinese medicine dropping pill formulation, overcome as the selected adjuvant Polyethylene Glycol of the dropping pill formulation of the health food outlet defective in some national food additive catalogue not, improve the Chinese medicine dripping pills preparation and move towards the international market, strengthen the competitiveness of international market.
3, solve the relatively poor problem of dropping pill formulation taste and further improve drug effect speed (dissolve scattered time limit): the medicinal dropping ball made from this kind substrate adjuvant of the present invention, can improve Chinese medicine preparation, the particularly present not good shortcoming of dropping pill formulation taste, improve mouthfeel, more easy for patients to accept, and the drop pill that adopts the selected adjuvant of medicine of the present invention to make has shorter dissolve scattered time limit, making drug effect faster, is the medicine that coronary heart disease, angina pectoris, myocardial ischemia, obstruction of qi in the chest and cardialgia are treated in a kind of onset faster.
4, higher safety and solve some problems in the drop pill storage process: the selected substrate of the present invention is not only additive, nutrient commonly used in the food industry, and can do medicinal, but do not see that it uses as the drug matrices adjuvant, therefore, with regard to substrate, be perfectly safe, have no side effect, a large amount of evidences, the drop pill made from this adjuvant can reduce effective ingredient separating out in storage process, the sticking ball of drop pill, easy shortcomings such as moisture absorption deliquescing, but the big production of suitability for industrialized.
The present invention is under instruction of Chinese Medicine theory, preparation technology's test that process is a large amount of and pharmacology, the resulting preparation of pharmacodynamics test.Clinical symptoms such as the present invention is evident in efficacy, has removing heat from blood and promoting blood circulation, and the effect of the chest stuffiness relieving pain relieving is used for the treatment of obstruction of qi in the chest and cardialgia clinically, as diseases such as treatment coronary heart disease, angina pectoris, myocardial ischemia, is applicable to light, moderate obstruction of qi in the chest and cardialgia especially, and dysphoria with smothery sensation is thirsty.Reasonable recipe of the present invention, poisonous side effect of medicine is low, and it is bigger to have overcome western medicine obstruction of qi in the chest and cardialgia toxic and side effects, and the Chinese medicine curative effect is low, flavour of a drug are many, the shortcoming of incompatibility large-scale production, is the medicine of the treatment obstruction of qi in the chest and cardialgia determined of a kind of economy, material benefit, curative effect.
In order to understand the present invention better, dissolve scattered time limit, weight differential, drop pill soft durometer, the drop pill with the quick-acting cardiac pain drop pill glues test explanation advantages of the present invention such as ball below.
Test example 1: dissolve scattered time limit, weight differential contrast experiment's example
In vitro tests
The present invention be that the quick-acting cardiac pain drop pill that adjuvant is made compares with the Polyethylene Glycol, by measuring dissolve scattered time limit, investigate its good releasing effect; By measuring indexs such as the ball method of double differences is different, whether ripe, whether be fit to suitability for industrialized production if investigating its preparation technology.
1. test medication: the new substrate quick-acting cardiac pain of the present invention drop pill (newly) is the quick-acting cardiac pain drop pill (old) that adjuvant is made with the Polyethylene Glycol.
2. method and result:
Dissolve scattered time limit: by " method is measured under this item of Chinese pharmacopoeia; The ball method of double differences is different: by " method is measured under this item of Chinese pharmacopoeia.Result of the test sees Table 1.
The quick-acting cardiac pain drop pill (newly) that three batches in table 1 is made with the new medium adjuvant with the polyethylene glycol 6000 be quick-acting cardiac pain drop pill (old) dissolve scattered time limit made of adjuvant, weight differential relatively
| 0 month | January | February | March | June | December | 18 months | ||
| 1 batch | Criterion | The result | ||||||
| Weight differential (± 15%) | All in 10% | All in 10% | All in 10% | All in 10% | All in 10% | All in 10% | All in 10% | |
| Dissolve scattered time limit (newly) (30 minutes) (old) | ??2′2″ ????5′0″ | ??2′1″ ????5′6″ | ??2′5″ ????5′1″ | ??2′2″ ????5′4″ | ??2′8″ ????5′3″ | ??2′9″ ????5′2″ | ??2′10″ ????5′5″ | |
| 2 batches | Weight differential (± 15%) | All in 10% | All in 10% | All in 10% | All in 10% | All in 10% | All in 10% | All in 10% |
| Dissolve scattered time limit (newly) (30 minutes) (old) | ??2′1″ ???5′0″ | ??2′3″ ????5′10″ | ??2′2″ ????5′1″ | ??2′5″ ????5′1″ | ??2′8″ ????5′2″ | ??2′10″ ????5′4″ | ??2′10″ ????5′3″ | |
| 3 batches | Weight differential (± 15%) | All in 10% | All in 10% | All in 10% | All in 10% | All in 10% | All in 10% | All in 10% |
| Dissolve scattered time limit (newly) (30 minutes) (old) | ??2′3″ ????5′0″ | ??2′4″ ????5′1″ | ??2′6″ ????5′3″ | ??2′2″ ????5′8″ | ??2′7″ ????5′6″ | ??2′9″ ????5′0″ | ??2′9″ ????5′3″ | |
Test data shows, the dissolve scattered time limit of new substrate quick-acting cardiac pain drop pill is that the quick-acting cardiac pain drop pill made of adjuvant is few with the Polyethylene Glycol; The ball method of double differences of the quick-acting cardiac pain drop pill that new and old substrate is made is different all to be controlled in the pharmacopeia prescribed limit.Result of the test explanation, the molten diffusing speed of the quick-acting cardiac pain drop pill made from novel adjuvant is faster, is more conducive to medicine and plays a role in the shortest time; The ball method of double differences is different all to be controlled in the pharmacopeia prescribed limit, and the alternative present chemosynthesis adjuvant of this natural substrates adjuvant is described, but suitability for industrialized production.
Test example 2: the present invention with the polyethylene glycol 6000 be the sticking ball comparative observation of quick-acting cardiac pain drop pill soft durometer, drop pill that adjuvant is made
1. test medication: the new substrate quick-acting cardiac pain of the present invention drop pill (newly) is the quick-acting cardiac pain drop pill (old) that adjuvant is made with the Polyethylene Glycol.
2. method and result: three batches of the things of getting it filled are loaded in the porcelain vase respectively, and use the bottle stopper good seal.Putting it into the bottom has in the exsiccator of saturated Nacl (humidity 75%) solution, exsiccator is put into 40 ℃ of drying baker of constant temperature again, and timing sampling is observed situations such as drop pill soft durometer, the sticking ball of drop pill, the results are shown in Table 2.1, table 2.2.
Three batches in table 2.1 is that the quick-acting cardiac pain drop pill reserved sample observing that adjuvant is made compares with the polyethylene glycol 6000
| 0 month | January | February | March | June | December | 18 months | ||
| 1 batch | Criterion | The result | ||||||
| Sticking ball | Not sticking | Not sticking | Not sticking | Not sticking | Not sticking | Sticking slightly | Sticking slightly | |
| Soft durometer | Firmly | Firmly | Firmly | Firmly | Firmly | Harder | Harder | |
| 2 batches | Sticking ball | Not sticking | Not sticking | Not sticking | Not sticking | Not sticking | Not sticking | Sticking slightly |
| Soft durometer | Firmly | Firmly | Firmly | Firmly | Firmly | Harder | Harder | |
| 3 batches | Sticking ball | Not sticking | Not sticking | Not sticking | Not sticking | Not sticking | Sticking slightly | Sticking slightly |
| Soft durometer | Firmly | Firmly | Firmly | Firmly | Firmly | Harder | Harder | |
Table 2.2: the three batches of quick-acting cardiac pain drop pill made from the new medium adjuvant (newly) with the polyethylene glycol 6000 be quick-acting cardiac pain drop pill (old) character observation made of adjuvant relatively
| 0 month | January | February | March | June | December | 18 months | ||
| Criterion | The result | |||||||
| 1 batch | Sticking ball | Sticking (old) do not glue (newly) | Sticking (old) do not glue (newly) | Sticking (old) do not glue (newly) | Sticking (old) do not glue (newly) | Sticking (old) do not glue (newly) slightly | Sticking (old) glues (newly) slightly slightly | Sticking (old) be sticking (newly) slightly |
| Soft durometer | (old) hard (newly) firmly | (old) hard (newly) firmly | (old) hard (newly) firmly | (old) hard (newly) firmly | Hard (old) hard (newly) | Hard slightly (old) hard (newly) | Hard slightly (old) be hard (newly) slightly | |
| 2 batches | Sticking ball | Sticking (old) do not glue (newly) | Sticking (old) do not glue (newly) | Sticking (old) do not glue (newly) | Sticking (old) do not glue (newly) | Sticking (old) do not glue (newly) | Sticking (old) do not glue (newly) slightly | Sticking (old) glues (newly) slightly slightly |
| Soft durometer | (old) hard (newly) firmly | (old) hard (newly) firmly | (old) hard (newly) firmly | (old) hard (newly) firmly | Hard (old) hard (newly) | Hard slightly (old) hard (newly) | Hard slightly (old) be hard (newly) slightly | |
| 3 batches | Sticking ball | Sticking (old) do not glue (newly) | Sticking (old) do not glue (newly) | Sticking (old) do not glue (newly) | Sticking (old) do not glue (newly) | Sticking (old) do not glue (newly) slightly | Sticking (old) do not glue (newly) slightly | Sticking (old) be sticking (newly) slightly |
| Soft durometer | (old) hard (newly) firmly | (old) hard (newly) firmly | (old) hard (newly) firmly | (old) hard (newly) firmly | (old) hard (newly) firmly | Hard slightly (old) hard (newly) | Hard slightly (old) be hard (newly) slightly | |
Test data shows, the soft durometer of new substrate quick-acting cardiac pain drop pill changes and be that the quick-acting cardiac pain drop pill made of adjuvant is similar, strong slightly with the Polyethylene Glycol; Sticking ball variation, the firmness change of new substrate quick-acting cardiac pain drop pill and be that the quick-acting cardiac pain drop pill made of adjuvant is similar with the Polyethylene Glycol.Presentation of results, the sticking ball of the quick-acting cardiac pain drop pill that new and old substrate adjuvant is made changes, firmness change is similar, and the alternative present chemosynthesis adjuvant of this natural substrates adjuvant is described, but suitability for industrialized production.
The specific embodiment
Embodiment 1
(a) get each crude drug Cortex Moutan 90g, Rhizoma Chuanxiong 80g, Borneolum Syntheticum 2g, xylitol 400g, starch 100g is standby;
(b) Rhizoma Chuanxiong extracts volatile oil, and volatile oil device is in addition collected, and the medicinal residues decocting boils secondary, is 5 hours for the first time, be 4 hours for the second time, collecting decoction is concentrated into that relative density is 1.10～1.25 in the time of 30 ℃, adds equivalent ethanol and makes precipitation, draw supernatant, filter, worry liquid is standby; Get the Cortex Moutan coarse powder, prepare its active component, make solvent, flood and carry out percolation after 36 hours, collect percolate, merge, reclaim ethanol, concentrate with the Rhizoma Chuanxiong filtrate with 80～95% ethanol according to the percolation under Chinese Pharmacopoeia 95 editions appendix IO fluid extract and the extractum item; Get volatile oil, Borneolum Syntheticum, add ethanol and dissolve in right amount, add an amount of solubilizing agent, make solubilising liquid;
(c) in xylitol and starch mixture adjuvant, add above-mentioned clear paste, Borneolum Syntheticum and volatile oil, fully mix, mixture is at 100～105 ℃ of heating and meltings, stir, mixing time is 10 minutes, insulation, at 95 ℃ of temperature following system, dropper bore is 1.0～3.0 millimeters, splash in-10～5 ℃ the liquid methyl silicone oil, with the drop pill drop to the greatest extent and wipe liquid coolant, promptly.
Embodiment 2
(a) get each crude drug Cortex Moutan 50g, Rhizoma Chuanxiong 80g, Borneolum Syntheticum 1g, xylitol 480g, starch 20g is standby;
(b) Rhizoma Chuanxiong extracts volatile oil, and volatile oil device is in addition collected, and the medicinal residues decocting boils secondary, is 3 hours for the first time, be 2 hours for the second time, collecting decoction is concentrated into that relative density is 1.15～1.25 in the time of 25 ℃, adds equivalent ethanol and makes precipitation, draw supernatant, filter, worry liquid is standby; Get the Cortex Moutan coarse powder, prepare its active component, make solvent, flood and carry out percolation after 18 hours, collect percolate, merge, reclaim ethanol, concentrate with the Rhizoma Chuanxiong filtrate with 80～85% ethanol according to the percolation under Chinese Pharmacopoeia 95 editions appendix IO fluid extract and the extractum item; Get volatile oil, Borneolum Syntheticum, add ethanol and dissolve in right amount, add an amount of solubilizing agent, make solubilising liquid;
(c) in xylitol, starch supplementary material, add above-mentioned clear paste, Borneolum Syntheticum and volatile oil, fully mix, mixture is at 90～115 ℃ of heating and meltings, stir, mixing time is 1～120 minute, insulation, at 45～95 ℃ of temperature following system, dropper bore is 1.20～2.5 millimeters, splash in 8～15 ℃ the liquid paraffin, with the drop pill drop to the greatest extent and wipe liquid coolant, promptly.
Embodiment 3
(a) get each crude drug Cortex Moutan 75g, Rhizoma Chuanxiong 55g, Borneolum Syntheticum 8g, xylitol 312.5g, arabic gum 187.5g is standby;
(b) Rhizoma Chuanxiong extracts volatile oil, and volatile oil device is in addition collected, and the medicinal residues decocting boils secondary, is 2 hours for the first time, be 2 hours for the second time, collecting decoction is concentrated into that relative density is 1.20～1.35 in the time of 30～40 ℃, adds equivalent ethanol and makes precipitation, draw supernatant, filter, worry liquid is standby; Get the Cortex Moutan coarse powder, prepare its active component, make solvent, flood and carry out percolation after 24 hours, collect percolate, merge, reclaim ethanol, concentrate with the Rhizoma Chuanxiong filtrate with 80～85% ethanol according to the percolation under Chinese Pharmacopoeia 95 editions appendix IO fluid extract and the extractum item; Get volatile oil, Borneolum Syntheticum, add ethanol and dissolve in right amount, add an amount of solubilizing agent, make solubilising liquid;
(c) in xylitol, arabic gum mixture, add above-mentioned clear paste, Borneolum Syntheticum and volatile oil, fully mix, mixture is at 75～85 ℃ of heating and meltings, stir, mixing time is 20 minutes, insulation, at 60～70 ℃ of temperature following system, dropper bore is 1.0～3.0 millimeters, splash in 0～15 ℃ the methyl-silicone oil, with the drop pill drop to the greatest extent and wipe liquid coolant, promptly.
Embodiment 4
(a) get each crude drug Cortex Moutan 80g, Rhizoma Chuanxiong 15g, Borneolum Syntheticum 0.5g, lactose 385g, starch 95g, xanthan gum 20g are standby;
(b) Rhizoma Chuanxiong extracts volatile oil, and volatile oil device is in addition collected, and the medicinal residues decocting boils secondary, is 4 hours for the first time, be 3 hours for the second time, collecting decoction is concentrated into that relative density is 1.25～1.30 in the time of 60 ℃, adds equivalent ethanol and makes precipitation, draw supernatant, filter, worry liquid is standby; Get the Cortex Moutan coarse powder, prepare its active component, make solvent with 85～90% ethanol according to the percolation under Chinese Pharmacopoeia 95 editions appendix IO fluid extract and the extractum item, flood and carry out percolation after 30 hours, collect the about 3000ml of percolate, merge with the Rhizoma Chuanxiong filtrate, reclaim ethanol, be concentrated into 70ml; Get volatile oil, Borneolum Syntheticum, add ethanol and dissolve in right amount, add an amount of solubilizing agent, make solubilising liquid;
(c) in lactose, starch and xanthan gum mixtures, add above-mentioned clear paste, Borneolum Syntheticum and volatile oil, fully mix, mixture is at 70～75 ℃ of heating and meltings, stir, mixing time is 10～30 minutes, insulation, at 60～65 ℃ of temperature following system, dropper bore is 1.21～2.5 millimeters, splash in 0～18 ℃ the liquid paraffin, with the drop pill drop to the greatest extent and wipe liquid coolant, promptly.
Embodiment 5
(a) take by weighing each crude drug Cortex Moutan 60g, Rhizoma Chuanxiong 55g, Borneolum Syntheticum 10g, lactose 365g, Furcellaran 75g, carboxymethyl starch 60g are standby;
(b) Rhizoma Chuanxiong extracts volatile oil, and volatile oil device is in addition collected, and the medicinal residues decocting boils secondary, is 3.5 hours for the first time, be 2.5 hours for the second time, collecting decoction is concentrated into that relative density is 1.15～1.20 in the time of 55 ℃, adds equivalent ethanol and makes precipitation, draw supernatant, filter, worry liquid is standby; Get the Cortex Moutan coarse powder, prepare its active component, make solvent with 80% ethanol according to the percolation under Chinese Pharmacopoeia 95 editions appendix IO fluid extract and the extractum item, flood and carry out percolation after 18 hours, collect the about 1000ml of percolate, merge with the Rhizoma Chuanxiong filtrate, reclaim ethanol, be concentrated into 50ml; Get volatile oil, Borneolum Syntheticum, add ethanol and dissolve in right amount, add an amount of solubilizing agent, make solubilising liquid;
(c) in lactose, Furcellaran and carboxymethyl starch mixture, add above-mentioned clear paste, Borneolum Syntheticum and volatile oil, fully mix, mixture is at 60～70 ℃ of heating and meltings, stir, mixing time is 15 minutes, insulation, at 60～70 ℃ of temperature following system, dropper bore is 1.1～3.5 millimeters, splash in-10～10 ℃ the methyl-silicone oil, with the drop pill drop to the greatest extent and wipe liquid coolant, promptly.
Embodiment 6
(a) take by weighing each crude drug Cortex Moutan 75g, Rhizoma Chuanxiong 5g, Borneolum Syntheticum 3g, xylitol 333g, Ficus elastica 169g is standby;
(b) Rhizoma Chuanxiong extracts volatile oil, and volatile oil device is in addition collected, and the medicinal residues decocting boils secondary, is 2 hours for the first time, be 2 hours for the second time, collecting decoction is concentrated into that relative density is 1.25～1.30 in the time of 40～45 ℃, adds equivalent ethanol and makes precipitation, draw supernatant, filter, worry liquid is standby; Get the Cortex Moutan coarse powder, prepare its active component, make solvent with 75～80% ethanol according to the percolation under Chinese Pharmacopoeia 95 editions appendix IO fluid extract and the extractum item, flood and carry out percolation after 20 hours, collect the about 2000ml of percolate, merge with the Rhizoma Chuanxiong filtrate, reclaim ethanol, be concentrated into 100ml; Get volatile oil, Borneolum Syntheticum, add ethanol and dissolve in right amount, add an amount of solubilizing agent, make solubilising liquid;
(c) in xylitol and Ficus elastica mixture, add above-mentioned clear paste, Borneolum Syntheticum and volatile oil, fully mix, mixture is at 75～85 ℃ of heating and meltings, stir, mixing time is 15 minutes, insulation, at 60～65 ℃ of temperature following system, dropper bore is 2.2～3.5 millimeters, splash in 0～18 ℃ the liquid vegetable oil, with the drop pill drop to the greatest extent and wipe liquid coolant, promptly.
Embodiment 7
(a) take by weighing each crude drug Cortex Moutan 60～80g, Rhizoma Chuanxiong 15～55g, Borneolum Syntheticum 0.5～10g is standby;
(b) Rhizoma Chuanxiong extracts volatile oil, and volatile oil device is in addition collected, and the medicinal residues decocting boils secondary, is 1～4 hour for the first time, be 1～3 hour for the second time, collecting decoction is concentrated into that relative density is 115～1.30 in the time of 40～60 ℃, adds equivalent ethanol and makes precipitation, draw supernatant, filter, worry liquid is standby; Get the Cortex Moutan coarse powder, prepare its active component according to the percolation under Chinese Pharmacopoeia 95 editions appendix IO fluid extract and the extractum item, make solvent with 75～90% ethanol, flood and carry out percolation after 18～30 hours, collect the about 1000～3000ml of percolate, merge with the Rhizoma Chuanxiong filtrate, reclaim ethanol, be concentrated into 50～150ml; Get volatile oil, Borneolum Syntheticum, add ethanol and dissolve in right amount, add an amount of solubilizing agent, make solubilising liquid;
(c) in appropriate amount of auxiliary materials, add above-mentioned clear paste, Borneolum Syntheticum and volatile oil, fully mix, mixture is at 60～85 ℃ of heating and meltings, stir, mixing time is 10～30 minutes, insulation, at 60～85 ℃ of temperature following system, dropper bore is 1.1～3.5 millimeters, splash in 0～18 ℃ the liquid paraffin, methyl-silicone oil, with the drop pill drop to the greatest extent and wipe liquid coolant, promptly.
Embodiment 8
(a) take by weighing each crude drug Cortex Moutan 65g, Rhizoma Chuanxiong 65g, Borneolum Syntheticum 1g, sorbitol 425g, starch 65g, tragakanta 10g are standby;
(b) Rhizoma Chuanxiong extracts volatile oil, and volatile oil device is in addition collected, and the medicinal residues decocting boils secondary, is 3 hours for the first time, be 2 hours for the second time, collecting decoction is concentrated into that relative density is 1.15～1.20 in the time of 40～60 ℃, adds equivalent ethanol and makes precipitation, draw supernatant, filter, worry liquid is standby; Get the Cortex Moutan coarse powder, prepare its active component, make solvent with 85～90% ethanol according to the percolation under Chinese Pharmacopoeia 95 editions appendix IO fluid extract and the extractum item, flood and carry out percolation after 18 hours, collect the about 1000ml of percolate, merge with the Rhizoma Chuanxiong filtrate, reclaim ethanol, be concentrated into 120ml; Get volatile oil, Borneolum Syntheticum, add ethanol and dissolve in right amount, add an amount of solubilizing agent, make solubilising liquid;
(c) mixture adds above-mentioned clear paste, Borneolum Syntheticum and volatile oil in sorbitol, starch, tragakanta, fully mix, mixture is at 60～65 ℃ of heating and meltings, stir, mixing time is 10 minutes, insulation, at 60 ℃ of temperature following system, dropper bore is 1.5～2.5 millimeters, splash in 0 ℃ the liquid paraffin, with the drop pill drop to the greatest extent and wipe liquid coolant, promptly.
Embodiment 9
(a) get each crude drug 65g, Rhizoma Chuanxiong 35g, Borneolum Syntheticum 0.8g, xylitol 400g, starch 100g is standby;
(b) Rhizoma Chuanxiong extracts volatile oil, and volatile oil device is in addition collected, and the medicinal residues decocting boils secondary, is 2.5 hours for the first time, is 2 hours for the second time, and collecting decoction is concentrated into that relative density is 1.25 in the time of 50 ℃, adds equivalent ethanol and makes precipitation, draws supernatant, filters, and it is standby to consider liquid; Get the Cortex Moutan coarse powder, prepare its active component, make solvent with 80% ethanol according to the percolation under Chinese Pharmacopoeia 95 editions appendix IO fluid extract and the extractum item, flood and carry out percolation after 24 hours, collect the about 2200ml of percolate, merge with the Rhizoma Chuanxiong filtrate, reclaim ethanol, be concentrated into 70ml; Get volatile oil, Borneolum Syntheticum, add ethanol and dissolve in right amount, add the 4ml tween 80, make solubilising liquid;
(c) get above-mentioned xylitol and starch mix homogeneously, adding above-mentioned clear paste, Borneolum Syntheticum and volatile oil fully mixes, mixture is at 64 ℃ of heating and meltings, stir, mixing time is 10～30 minutes, insulation, at 64 ℃ of temperature following system, dropper bore is 1.2～2.5 millimeters, splash in 0 ℃ the methyl-silicone oil, with the drop pill drop to the greatest extent and wipe liquid coolant, promptly.
Embodiment 10
(a) get each crude drug 70g, Rhizoma Chuanxiong 25g, Borneolum Syntheticum 5g, xylitol 416.6g, starch 83.4 is standby;
(b) Rhizoma Chuanxiong extracts volatile oil, and volatile oil device is in addition collected, and the medicinal residues decocting boils secondary, is 2.5 hours for the first time, is 2 hours for the second time, and collecting decoction is concentrated into that relative density is 1.25 in the time of 50 ℃, adds equivalent ethanol and makes precipitation, draws supernatant, filters, and it is standby to consider liquid; Get the Cortex Moutan coarse powder, prepare its active component, make solvent with 80% ethanol according to the percolation under Chinese Pharmacopoeia 95 editions appendix IO fluid extract and the extractum item, flood and carry out percolation after 24 hours, collect the about 2200ml of percolate, merge with the Rhizoma Chuanxiong filtrate, reclaim ethanol, be concentrated into 70ml; Get volatile oil, Borneolum Syntheticum, add ethanol and dissolve in right amount, add the 4ml tween 80, make solubilising liquid;
(c) getting above-mentioned xylitol and starch mixes evenly, adding above-mentioned clear paste, Borneolum Syntheticum and volatile oil fully mixes, mixture is at 64 ℃ of heating and meltings, stir, mixing time is 10～30 minutes, insulation, at 64 ℃ of temperature following system, dropper bore is 1.2～2.5 millimeters, splash in 0～5 ℃ the liquid paraffin, with the drop pill drop to the greatest extent and wipe liquid coolant, promptly.
Embodiment 11
(a) get each crude drug 65g, Rhizoma Chuanxiong 33g, Borneolum Syntheticum 1g, lactose 476g, alginic acid 24g is standby;
(b) Rhizoma Chuanxiong extracts volatile oil, and volatile oil device is in addition collected, and the medicinal residues decocting boils secondary, is 2.5 hours for the first time, is 2 hours for the second time, and collecting decoction is concentrated into that relative density is 1.25 in the time of 50 ℃, adds equivalent ethanol and makes precipitation, draws supernatant, filters, and it is standby to consider liquid; Get the Cortex Moutan coarse powder, prepare its active component, make solvent with 80% ethanol according to the percolation under Chinese Pharmacopoeia 95 editions appendix IO fluid extract and the extractum item, flood and carry out percolation after 24 hours, collect the about 2200ml of percolate, merge with the Rhizoma Chuanxiong filtrate, reclaim ethanol, be concentrated into 70ml; Get volatile oil, Borneolum Syntheticum, add ethanol and dissolve in right amount, add the 4ml tween 80, make solubilising liquid;
(c) getting lactose and alginic acid mixes evenly, add above-mentioned clear paste, Borneolum Syntheticum and volatile oil, fully mix, mixture stirs at 65 ℃ of heating and meltings, mixing time is 10～30 minutes, insulation is 1.2～2.5 millimeters at 64 ℃ of temperature following system, dropper bore, splashes in 0 ℃ the methyl-silicone oil, with the drop pill drop to the greatest extent and wipe liquid coolant, promptly.
Embodiment 12
Prepare volatile oil and Cortex Moutan, Rhizoma Chuanxiong extractum by the method for 19 quick-acting cardiac pain drop pill of drug standard Chinese traditional patent formulation preparation;
Get extractum 87.5g, volatile oil 5ml/ xylitol 233g, starch 59g;
It is evenly mixed to get xylitol, starch, adds above-mentioned clear paste, Borneolum Syntheticum and volatile oil, fully mixes, and mixture stirs at heating and melting, and insulation in following system of 60～90 ℃ of temperature, splash in 0～5 ℃ the liquid paraffin, droplet is made ball, promptly.
Embodiment 13
(a) get Cortex Moutan 79g, Rhizoma Chuanxiong 20g, Borneolum Syntheticum 1g, xylitol 370g, hydroxyethylmethyl-cellulose 50g, starch 75g are standby;
(b) Rhizoma Chuanxiong extracts volatile oil, and volatile oil device is in addition collected, and the medicinal residues decocting boils secondary, is 2.5 hours for the first time, is 2 hours for the second time, and collecting decoction is concentrated into that relative density is 1.25 in the time of 50 ℃, adds equivalent ethanol and makes precipitation, draws supernatant, filters, and it is standby to consider liquid; Get the Cortex Moutan coarse powder, prepare its active component, make solvent with 80% ethanol according to the percolation under Chinese Pharmacopoeia 95 editions appendix IO fluid extract and the extractum item, flood and carry out percolation after 24 hours, collect the about 2200ml of percolate, merge with the Rhizoma Chuanxiong filtrate, reclaim ethanol, be concentrated into 70ml; Get volatile oil, Borneolum Syntheticum, add ethanol and dissolve in right amount, add the 4ml tween 80, make solubilising liquid;
(c) getting xylitol, hydroxyethylmethyl-cellulose and starch mixes evenly, adding above-mentioned clear paste, Borneolum Syntheticum and volatile oil fully mixes, mixture is at 64 ℃ of heating and meltings, stir, mixing time is 10～30 minutes, insulation, at 64 ℃ of temperature following system, dropper bore is 1.2～2.5 millimeters, splash in 10 ℃ the methyl-silicone oil, with the drop pill drop to the greatest extent and wipe liquid coolant, promptly.
Embodiment 14
Prepare volatile oil and Cortex Moutan, Rhizoma Chuanxiong extractum by the method for 19 quick-acting cardiac pain drop pill of drug standard Chinese traditional patent formulation preparation;
Get extractum 84g, volatile oil 10ml, xylitol 385g, starch 115g;
It is evenly mixed to get xylitol, starch, adds above-mentioned clear paste, Borneolum Syntheticum and volatile oil, fully mixes, and mixture stirs at heating and melting, and insulation in following system of 60～90 ℃ of temperature, splash in 0～5 ℃ the liquid paraffin, droplet is made ball, promptly.
Claims (13)
1, a kind of medicine for the treatment of obstruction of qi in the chest and cardialgia, it is characterized in that it is by 50～90 parts of Cortex Moutans, 10～90 parts of Rhizoma Chuanxiongs, 0.1～15 part of Borneolum Syntheticum, appropriate amount of auxiliary materials is made, wherein adjuvant comprises filler and plasticity substrate, said filler is selected from the natural adjuvant of following one or more plant origins: erythritol, sorbitol, fructose, D-ribonic acid-gamma lactone, arabitol, trehalose, D-ribose, low melting-point agarose, Lac, xylitol, Raffinose, glucose, malic acid, citric acid, isomalt, lactose, maltose etc., and they contain the water of crystallization chemical compound; Said plasticity substrate is selected from the natural adjuvant of following one or more plant origins: starch and derivant thereof, cellulose and derivant thereof, arabic gum, dextran, chitin, sesbania gum, carrageenan, Ficus elastica, Furcellaran, tragakanta, carrageenin, tamarind gum, pectin, xanthan gum, alginic acid and salt thereof, dextrin, cyclodextrin, agar, lactose; Described starch and derivant thereof such as pregelatinized Starch, modified starch, hydroxypropyl starch, carboxymethyl starch, described cellulose and derivant thereof such as methylcellulose, microcrystalline Cellulose, sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose, cross-linking sodium carboxymethyl cellulose, hydroxyethylmethyl-cellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose.
2, the medicine of treatment obstruction of qi in the chest and cardialgia according to claim 1, it is characterized in that it is to be made by 60～80 parts of Cortex Moutans, 15～55 parts of Rhizoma Chuanxiongs, 0.5～10 part of Borneolum Syntheticum, appropriate amount of auxiliary materials, filler adjuvant wherein is selected from the natural adjuvant of following one or more plant origins: sorbitol, xylitol, lactose, maltose, and they contain the water of crystallization chemical compound; Plasticity substrate wherein is selected from the natural adjuvant of following one or more plant origins: pregelatinized Starch, carboxymethyl starch, methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose, arabic gum, alginic acid, dextrin, cyclodextrin, agar, lactose.
3, the medicine of treatment obstruction of qi in the chest and cardialgia according to claim 1 and 2, it is characterized in that it is to be made by 65～70 parts of Cortex Moutans, 20～35 parts of Rhizoma Chuanxiongs, 0.8～5 part of Borneolum Syntheticum, appropriate amount of auxiliary materials, filler adjuvant wherein is selected from the natural adjuvant of following one or more plant origins: xylitol, lactose; Plasticity substrate wherein is selected from the natural adjuvant of following one or more plant origins: starch, arabic gum.
4, as the medicine of claim 1,2 or 3 described treatment obstruction of qi in the chest and cardialgia, it is characterized in that it can also contain chemosynthesis adjuvant and animal origin adjuvant in above-mentioned dressing, wherein filler comprises phenylglycol, hexadecanol, octadecanol, sodium stearate, tristerin, tripalmitin, carbamide, polyoxyethylene monostearate, polyoxyethylene alkyl ether; Wherein plasticity substrate comprises polyvinylpyrrolidone, crospolyvinylpyrrolidone, carbomer, polyvinyl alcohol, acrylic resin, poloxamer, gelatin.
5, the medicine of treatment obstruction of qi in the chest and cardialgia as claimed in claim 3 is characterized in that adjuvant described in this medicine is xylitol and starch, and xylitol is 1: 0.2～1: 0.3 with the ratio of the weight of starch.
6, the medicine of treatment obstruction of qi in the chest and cardialgia as claimed in claim 3 is characterized in that adjuvant described in this medicine is lactose and starch, and lactose is 1: 0.2～1: 0.3 with the ratio of the weight of starch.
7, the medicine of treatment obstruction of qi in the chest and cardialgia as claimed in claim 3 is characterized in that adjuvant described in this medicine is xylitol and arabic gum, and the ratio of the weight of xylitol and arabic gum is 1: 0.2～1: 0.4.
8,, it is characterized in that the adjuvant and the ratio of the weight of extract drugs extractum are 1: 0.1～1: 1 as the medicine of claim 1,2 or 3 described treatment obstruction of qi in the chest and cardialgia.
9,, it is characterized in that the adjuvant and the ratio of the weight of extract drugs extractum are 1: 0.1～1: 0.6 as the medicine of claim 1,2 or 3 described treatment obstruction of qi in the chest and cardialgia.
10,, it is characterized in that the adjuvant and the ratio of the weight of extract drugs extractum are 1: 0.2～1: 0.4 as the medicine of claim 1,2 or 3 described treatment obstruction of qi in the chest and cardialgia.
11, the preparation method of claim 1,2 or 3 described treatment obstruction of qi in the chest and cardialgia medicines is characterized in that this method comprises the steps:
(a) it is standby to take by weighing 50～90 parts of each crude drug Cortex Moutans, 10～90 parts of Rhizoma Chuanxiongs, 0.1～15 part of Borneolum Syntheticum by proportioning;
(b) Rhizoma Chuanxiong extracts volatile oil, and volatile oil device is in addition collected, and the medicinal residues decocting boils secondary, is 0.5～5 hour for the first time, be 0.5～4 hour for the second time, collecting decoction is concentrated into that relative density is 1.10～1.35 in the time of 30～70 ℃, adds equivalent ethanol and makes precipitation, draw supernatant, filter, worry liquid is standby; Get the Cortex Moutan coarse powder, prepare its active component, make solvent with 70～95% ethanol according to the percolation under Chinese Pharmacopoeia 95 editions appendix IO fluid extract and the extractum item, flood and carry out percolation after 12～36 hours, collect percolate, merge with the Rhizoma Chuanxiong filtrate, reclaim ethanol, concentrate; Get volatile oil, Borneolum Syntheticum, add ethanol and dissolve in right amount, add an amount of solubilizing agent, make solubilising liquid;
(c) in appropriate amount of auxiliary materials, add above-mentioned clear paste, Borneolum Syntheticum and volatile oil, fully mix, mixture is at 45～115 ℃ of heating and meltings, stir, mixing time is 1～120 minute, insulation, at 45～95 ℃ of temperature following system, dropper bore is 1.0～4.0 millimeters, splash in-20～25 ℃ liquid paraffin, methyl-silicone oil or the vegetable oil, with the drop pill drop to the greatest extent and wipe liquid coolant, promptly.
12, the preparation method of treatment obstruction of qi in the chest and cardialgia medicine as claimed in claim 11 is characterized in that this method comprises the steps:
(a) it is standby to take by weighing 60～80 parts of each crude drug Cortex Moutans, 15～55 parts of Rhizoma Chuanxiongs, 0.5～10 part of Borneolum Syntheticum by proportioning;
(b) Rhizoma Chuanxiong extracts volatile oil, and volatile oil device is in addition collected, and the medicinal residues decocting boils secondary, is 1～4 hour for the first time, be 1～3 hour for the second time, collecting decoction is concentrated into that relative density is 1.15～1.30 in the time of 40～60 ℃, adds equivalent ethanol and makes precipitation, draw supernatant, filter, worry liquid is standby; Get the Cortex Moutan coarse powder, prepare its active component according to the percolation under Chinese Pharmacopoeia 95 editions appendix IO fluid extract and the extractum item, make solvent with 75～90% ethanol, flood and carry out percolation after 18～30 hours, collect the about 1000～3000ml of percolate, merge with the Rhizoma Chuanxiong filtrate, reclaim ethanol, be concentrated into 50～150ml; Get volatile oil, Borneolum Syntheticum, add ethanol and dissolve in right amount, add an amount of solubilizing agent, make solubilising liquid;
(c) in appropriate amount of auxiliary materials, add above-mentioned clear paste, Borneolum Syntheticum and volatile oil, fully mix, mixture is at 60～85 ℃ of heating and meltings, stir, mixing time is 10～30 minutes, insulation, at 60～85 ℃ of temperature following system, dropper bore is 1.1～3.5 millimeters, splash in 0～18 ℃ the liquid paraffin, methyl-silicone oil, with the drop pill drop to the greatest extent and wipe liquid coolant, promptly.
13, the preparation method of treatment obstruction of qi in the chest and cardialgia medicine as claimed in claim 11 is characterized in that this method comprises the steps:
(a) it is standby to take by weighing 65～70 parts of each crude drug, 20～35 parts of Rhizoma Chuanxiongs, 0.8～5 part of Borneolum Syntheticum by proportioning;
(b) Rhizoma Chuanxiong extracts volatile oil, and volatile oil device is in addition collected, and the medicinal residues decocting boils secondary, is 2.5 hours for the first time, is 2 hours for the second time, and collecting decoction is concentrated into that relative density is 1.25 in the time of 50 ℃, adds equivalent ethanol and makes precipitation, draws supernatant, filters, and it is standby to consider liquid; Get the Cortex Moutan coarse powder, prepare its active component, make solvent with 80% ethanol according to the percolation under Chinese Pharmacopoeia 95 editions appendix IO fluid extract and the extractum item, flood and carry out percolation after 24 hours, collect the about 2200ml of percolate, merge with the Rhizoma Chuanxiong filtrate, reclaim ethanol, be concentrated into 70ml; Get volatile oil, Borneolum Syntheticum, add ethanol and dissolve in right amount, add the 4ml tween 80, make solubilising liquid;
(c) get 500 parts of adjuvants, adding above-mentioned clear paste, Borneolum Syntheticum and volatile oil fully mixes, mixture is at 64 ℃ of heating and meltings, stir, mixing time is 10～30 minutes, insulation, at 64 ℃ of temperature following system, dropper bore is 1.2～2.5 millimeters, splash in 0 ℃ the methyl-silicone oil, with the drop pill drop to the greatest extent and wipe liquid coolant, promptly.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2003101072884A CN100553617C (en) | 2003-12-11 | 2003-12-11 | A kind of medicine for the treatment of obstruction of qi in the chest and cardialgia |
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2003101072884A CN100553617C (en) | 2003-12-11 | 2003-12-11 | A kind of medicine for the treatment of obstruction of qi in the chest and cardialgia |
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| CN100553617C CN100553617C (en) | 2009-10-28 |
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| CN104688838A (en) * | 2013-12-06 | 2015-06-10 | 天津中新药业集团股份有限公司第六中药厂 | Preparation method of Suxiaoxintong oral liquid |
| CN104688841A (en) * | 2013-12-06 | 2015-06-10 | 天津中新药业集团股份有限公司第六中药厂 | Preparation method of Suxiaoxintong granules |
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2003
- 2003-12-11 CN CNB2003101072884A patent/CN100553617C/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104688837A (en) * | 2013-12-06 | 2015-06-10 | 天津中新药业集团股份有限公司第六中药厂 | Preparation method of Suxiaoxintong tablets |
| CN104688838A (en) * | 2013-12-06 | 2015-06-10 | 天津中新药业集团股份有限公司第六中药厂 | Preparation method of Suxiaoxintong oral liquid |
| CN104688841A (en) * | 2013-12-06 | 2015-06-10 | 天津中新药业集团股份有限公司第六中药厂 | Preparation method of Suxiaoxintong granules |
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