CN101890054A - Method for preparing Chinese medicinal injection - Google Patents
Method for preparing Chinese medicinal injection Download PDFInfo
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- CN101890054A CN101890054A CN2009101432425A CN200910143242A CN101890054A CN 101890054 A CN101890054 A CN 101890054A CN 2009101432425 A CN2009101432425 A CN 2009101432425A CN 200910143242 A CN200910143242 A CN 200910143242A CN 101890054 A CN101890054 A CN 101890054A
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Abstract
The invention relates to a method for preparing Chinese medicinal injection, which comprises the following steps of: 1) selecting components; 2) separately extracting active ingredients and effective parts or dry extracts from medicinal materials, and simultaneously making an inner quality standard of the extracts; and 3) quantitatively adding the medicinal materials based on the active ingredient content to prepare the Chinese medicinal injection. Through reasonable components, extraction and separation of the active ingredients and quantitative addition of the dry extracts, the safe, effective, stable and controllable Chinese medicinal injection can be prepared.
Description
Technical field
The present invention relates to the preparation method of Chinese medicine preparation, be specifically related to a kind of preparation method of Chinese medicine.
Background technology
Chinese medicine means with the Chinese medical theory to be guidance, adopt the modern science and technology method, the sterilization preparation that uses in Gong the injections body that the active substance that extracts is made and the sterilized powder or the concentrated solution of the clinical preceding obtain solution of confession from the folk prescription of Chinese medicine, natural drug or compound recipe.With respect to traditional form of Chinese drug, Chinese medicine has bioavailability height, good effect, rapid-action because of it, and applicable to characteristics such as patient that can not oral administration, clinical practice more and more widely, especially to patient with severe symptoms and cardiovascular and cerebrovascular disease, tumor, viral infection etc., the application of Chinese medicine is more extensive.Therefore, the advantage of Chinese medicine is that other conventional dosage forms is irreplaceable, and Chinese medicine is one of developing direction of the modern Chinese medicine dosage form of generally acknowledging in the industry, is the indispensable dosage form of Chinese traditional treatment emergency case.Therefore exploitation and production definite effective Chinese medicine are still the inherent requirement that China's pharmaceuticals industry improves international competitiveness, also are the trends of the times that realizes the modernization of Chinese medicine.
But the Chinese medicine incidence rate of adverse reaction and the order of severity all are higher than other form of Chinese drug.Relevant discovering, in the untoward reaction that all Chinese medicines cause, the untoward reaction ratio is the highest, harm is maximum surely belongs to injection, account for 7 one-tenth more than.The untoward reaction of its generation is multiple and universality, the clinical symptoms performance differs and characteristics such as the difference between batch opposite sex.See skin allergy and anaphylactic shock, severe patient even appearance are dead more, and as puerarin injection, Herba Houttuyniae injectio, Radix Et Caulis Acanthopanacis Senticosi injection etc., Chinese medicine has been listed in the excessive risk management of product at present.
" complex chemical composition, backward, the quality standard shortcoming of preparation technology " is the main cause that causes Chinese medicine generation untoward reaction.Conventional Chinese medicine prescription flavour of a drug are more, and contain the indefinite medical material of more effective ingredient, cause end product quality and untoward reaction poor controllability.At present, the preparation technology of China's Chinese medicine is less than 10 classes.These technologies mainly contain the effective component extracting monomer, extract effective site, decocting in water alcohol deposition method, ethanol extract from water precipitation, steam distillation, synthetic method etc.In listing 109 kinds of Chinese medicines of national standard in, remove 12 secret kind technologies unknown outside, in all the other 97 kinds, the application of new method, new technique and new technology is arranged seldom.The widespread usage of these old technologies, extract obtained in active constituent content low, directly have influence on the steady quality of Chinese medicine and safe in utilization.Remove outside 6 monomeric kinds of effective component extracting and other indivedual kinds, comprise most kinds of extracting effective site and synthetic method preparation, all are full presciption medicine material mixed extraction, specific aim is not strong, be difficult to remove impurity and invalid components, the while also sneaks into more other impurity unavoidably and causes the finished product ingredient complicated.In addition, in preparation process, owing to generally adopt repeatedly precipitate with ethanol and charcoal treatment, when removing some impurity, many effective ingredient also are unable to escape the destiny of losing.The inner quality standard that lacks extract and intermediate quantitatively feeds intake not according to extract or effective ingredient, especially the uncontrollable main cause of Chinese medicine end product quality.
Summary of the invention
The preparation method that the purpose of this invention is to provide a kind of Chinese medicine, by reasonable formula, the extraction separation of effective ingredient, dry extract quantitatively feeds intake, and prepares Chinese medicine safe and effective, stable and controllable.
Purpose of the present invention is achieved through the following technical solutions:
A kind of preparation method of Chinese medicine, it comprises the steps:
1), prescription is selected;
2), the independent effective component extracting of every flavor medical material, effective site or dry extract, set up the inner quality standard of extract simultaneously;
3), every flavor medical material is quantitatively fed intake by active constituent content make Chinese medicine.
Wherein, it is that the characteristics and the clinical application of curing the disease in conjunction with Chinese medicine are necessary that step 1 prescription is selected, select basic research more abundant, the drug component that effective ingredient is clear and definite substantially, the combination principle of embody Chinese medicine monarch, minister, helping, make, the function of its pharmacological action and whole prescription cures mainly and adapts, based on the secondary development of tradition name side, classical prescription, proved recipe.Preferred prescription taste of Chinese medicine is controlled at below 7 flavors.
Wherein, step 2 is the principles according to " confirming effective component extracting with the side according to card ", every flavor medical material ingredient physicochemical property in the prescription is analyzed, adopt different extraction separation methods, every flavor medical material is extracted separately, remove impurity and invalid components as far as possible, obtain effective ingredient, effective site or dry extract, set up the inner quality standard of extract simultaneously.
Wherein, the main modern Chinese medicine extraction separation new technique that adopts of step 2, comprise in dynamic countercurrent extraction, microwave extraction, supercritical liquid extraction technique, high speed centrifugation and hyperfiltration technique, various preparative hplc technology, liquid-liquid technique, macroporous adsorption resin technology, crystallization and the recrystallization technology at least a, to the prescription in every flavor medical material extract separately.
Wherein, step 3 is that the preparation prescription of dry extract preparation is pressed in conversion, quantitatively feeds intake by dry extract (or in active constituent content) according to the refining yield situation of the every flavor medicinal material extract of step 2, through dissolving, be incubated, take off operations such as charcoal, filtration, embedding, sterilization, make Chinese medicine.
The invention has the advantages that:
1, prescription refine.Select for use through clinical verification and write out a prescription safely and effectively, according to the characteristics of Chinese medicine, add and subtract flavour of a drug again, reasonable compatibility reaches the clinical requirement that is used for critical severe disease treatment.
2, effective ingredient purity height in the extract.This method mainly adopts modern Chinese medicine extraction separation new technique that the every flavor medical material in the prescription is extracted separately, serious, the problems such as impurity content is high, poor stability of loss of effective components that overcome that mixed that conventional Chinese medicine production adopts carried, water extract-alcohol precipitation, alcohol extracting-water precipitating or two lifting manipulation cause have improved the safety of the clinical use of Chinese medicine.
3, stable and controllable for quality.Effective ingredient, effective site or dry extract that this method adopts extraction to obtain quantitatively feed intake and make Chinese medicine, overcome the influence of quality of medicinal material fluctuation to preparation, and by formulating and carrying out strict extract inner quality standard and fingerprint pattern technology, guaranteed that injection is criticized with criticize between quality of stability and homogeneity.
Description of drawings
Fig. 1 is conventional Chinese medicine preparation mode flow chart.
Fig. 2 is a Chinese medicine preparation mode flow chart of the present invention.
The specific embodiment
Describe the present invention by the following examples in detail, but itself and be used to limit protection scope of the present invention.
The preparation of embodiment tanreqin injection
Prescription is to increase flavour of a drug (Fel Ursi powder and Cornu Naemorhedi) on SHUANGHUANGLIAN ZHUSHEYE prescription basis, tradition name side, has strengthened effects for removing toxic heat, has increased the relieving cough and resolving phlegm effect, is used for wind-warm lung-heat disease and belongs to the accumulation of phlegm-heat in the lung card.Radix Scutellariae is a monarch drug, and contained flavones ingredient based on baicalin is its main effective ingredient, has very strong resisting pathogenic microbes effect, antiallergic action and antiinflammatory action, blood pressure lowering and sedation, reaches refrigeration function.Fel Ursi powder, Cornu Naemorhedi are ministerial drug; wherein the main effective ingredient of Fel Ursi powder is the bile acids; the highest with tauroursodeoxycholic acid content; secondly be Taurochenodeoxycholic Acid, these cholic acid constituents have good function of gallbladder promoting, spasmolytic, convulsion, detoxifcation, antibacterial, antiinflammatory, antiallergic, antitussive, eliminate the phlegm and antiasthmatic effect.Cornu Naemorhedi mainly contains keratin, can obtain various active aminoacid behind acid hydrolysis, and pharmacological testing shows, these hydrolysis amino acids have very strong analgesic, analgesia, calmness, convulsion, detoxifcation and the effect of diastole bronchial smooth muscle.Effective ingredient of honeysuckle is organic acids such as chlorogenic acid and isochlorogenic acid, and these organic acid have the effect of broad-spectrum disease resistance pathogenic microorganism, antiinflammatory and refrigeration function, reach immunoregulation effect, are adjuvant drug with the Flos Lonicerae, to help heat-clearing and toxic substances removing, diffusing lung, relieving exterior syndrome effect.The Fructus Forsythiae effective ingredient has the effect of broad-spectrum disease resistance pathogenic microorganism, refrigeration function, antiinflammatory action, hepatic cholagogic effect etc. based on phillyrin, and we get its eliminating heart-fire, go all heat of the part of the body cavity above the diaphragm housing the heart and lungs, doublely draws all medicines to go into lung meridian be messenger drug.Full side's five tastes compatibility is reasonable, plays heat-clearing and toxic substances removing altogether, the relieving convulsion effect of reducing phlegm.
Extracting refining is to extract separately according to the character of the contained effective ingredient of every flavor medical material, and Radix Scutellariae adopts water extraction, acidify, and alkali dissolution, pure crystallization, washing, drying obtains content at the baicalin more than 90%; Fel Ursi powder adopts and extracts, acidify, and dissolving, decolouring, crystallization and recrystallization, drying obtains content at the total urso cholic acid more than 90%; Cornu Naemorhedi adopts hydrolysis, neutralization, and washing, refining, concentrate, drying obtains content at the total amino acids more than 60%; Flos Lonicerae is adopted water extraction, alkali precipitation, and alcohol extraction, column chromatography, extraction, drying obtains containing chlorogenic acid at the dry extract more than 50%; Fructus Forsythiae adopts water extraction, precipitate with ethanol, and column chromatography, extraction, drying obtains containing phillyrin at the dry extract more than 30%.Remove impurity effectively, guaranteed the purity of effective ingredient.
The finished product preparation is to count prescription with above-mentioned five kinds of dry extracts by content, quantitatively feeds intake, and dissolves respectively, total mixing, and the insulation decolouring, common filtration, aseptic filtration, ultrafiltration gets semi-finished product, after the assay was approved, and embedding, sterilization, lamp inspection, packing, promptly.
Above preparation process guaranteed fully that tanreqin injection is criticized and batch between quality of stability and concordance, the finished product active constituent content measuring the results are shown in Table one.
Three batches of tanreqin injection assays of table one result
More than the preparation method of Chinese medicine provided by the present invention is described in detail.It is to be noted; the described content of the specific embodiment be for better implement the present invention preferred embodiment; protection scope of the present invention is not limited to the described technical scheme of above-mentioned embodiment; and should be as the criterion with the described flesh and blood of claims, any possible technologic change is only otherwise the scope that the flesh and blood that breaks away from claim of the present invention all belongs to the present invention to be protected.
Claims (4)
1. the preparation method of a Chinese medicine, it comprises the steps:
1), prescription is selected;
2), the independent effective component extracting of every flavor medical material, effective site or dry extract, set up the inner quality standard of extract simultaneously;
3), every flavor medical material is quantitatively fed intake by active constituent content make Chinese medicine.
2. preparation method according to claim 1 is characterized in that the described prescription taste of Chinese medicine of step 1) is controlled at below 7 flavors.
3. preparation method according to claim 1, it is characterized in that step 2) the independent mainly employing modern Chinese medicine extraction separation new technique that extracts of described every flavor medical material, comprise in dynamic countercurrent extraction, microwave extraction, supercritical liquid extraction technique, high speed centrifugation and hyperfiltration technique, various preparative hplc technology, liquid-liquid technique, macroporous adsorption resin technology and crystallization and the recrystallization technology at least a.
4. preparation method according to claim 1 is characterized in that step 3) is that every flavor medical material is quantitatively fed intake by dry extract in active constituent content, through dissolving, be incubated, take off charcoal, filtration, embedding, sterilization process, makes Chinese medicine.
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| CN2009101432425A CN101890054A (en) | 2009-05-21 | 2009-05-21 | Method for preparing Chinese medicinal injection |
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| CN2009101432425A CN101890054A (en) | 2009-05-21 | 2009-05-21 | Method for preparing Chinese medicinal injection |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102872174A (en) * | 2012-10-26 | 2013-01-16 | 郑州百瑞动物药业有限公司 | Method for preparing bupleurum injection |
| CN104189335A (en) * | 2014-09-02 | 2014-12-10 | 张会英 | Lacrimal passage flushing fluid for caring infantile dacryocystitis and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6083932A (en) * | 1997-04-18 | 2000-07-04 | Cv Technologies Inc. | Pharmaceutical compositions derived from ginseng and methods of treatment using same |
| CN1947746A (en) * | 2005-10-14 | 2007-04-18 | 上海凯宝药业有限公司 | Tanreqing medicine for cleaning phlegm-heat and its pren. method |
| CN101084924A (en) * | 2006-06-06 | 2007-12-12 | 上海凯宝药业有限公司 | Method for preparing goat's horn extraction |
-
2009
- 2009-05-21 CN CN2009101432425A patent/CN101890054A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6083932A (en) * | 1997-04-18 | 2000-07-04 | Cv Technologies Inc. | Pharmaceutical compositions derived from ginseng and methods of treatment using same |
| CN1947746A (en) * | 2005-10-14 | 2007-04-18 | 上海凯宝药业有限公司 | Tanreqing medicine for cleaning phlegm-heat and its pren. method |
| CN101084924A (en) * | 2006-06-06 | 2007-12-12 | 上海凯宝药业有限公司 | Method for preparing goat's horn extraction |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102872174A (en) * | 2012-10-26 | 2013-01-16 | 郑州百瑞动物药业有限公司 | Method for preparing bupleurum injection |
| CN104189335A (en) * | 2014-09-02 | 2014-12-10 | 张会英 | Lacrimal passage flushing fluid for caring infantile dacryocystitis and preparation method thereof |
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Application publication date: 20101124 |