CN102100884A - Preparation technology of new integrative formulation of minor green-blue dragon decoction - Google Patents
Preparation technology of new integrative formulation of minor green-blue dragon decoction Download PDFInfo
- Publication number
- CN102100884A CN102100884A CN2009102631568A CN200910263156A CN102100884A CN 102100884 A CN102100884 A CN 102100884A CN 2009102631568 A CN2009102631568 A CN 2009102631568A CN 200910263156 A CN200910263156 A CN 200910263156A CN 102100884 A CN102100884 A CN 102100884A
- Authority
- CN
- China
- Prior art keywords
- medicine
- parts
- preparing
- nanometer
- technology
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Abstract
The invention relates to the preparation technology of a new integrative formulation of minor green-blue dragon decoction. The minor green-blue dragon decoction comprises the following raw materials in part by weight: 9 parts of ephedra herb, 9 parts of white paeony root, 6 parts of manchurian wildginger, 6 parts of dried ginger, 6 parts of honey-fried liquoric root, 9 parts of cassia twig, 6 parts of Chinese magnoliavine fruit and 9 parts of pinellia tuber. The production process comprises the following steps of: alcohol/water extracting, ultrasonic crushing extracting, microwave extracting, spray drying, nanometer grinding, nanometer particle preparation and the like. The preparation technology has the advantages of multi-synergetic effect, multi-targeting effect and the like of nanometer traditional Chinese medicines. By large-scale industrial production, the production cost can be reduced substantially, the quality of products can be improved, and the targeting and slow controlled release properties of medicaments are higher; and a prepared membrane agent also can be applied to the skin of human bodies for treatment by transdermal absorption.
Description
Technical field
The present invention relates to the integrated novel form of a kind of XIAOQINGLONG TANG, the invention still further relates to the integrated novel form technology of preparing of a kind of XIAOQINGLONG TANG.
Background technology
The backwardness of preparation level not only influences the performance of curative effect of medication, and cause the medicine added value low, directly influencing the market competition and industrial economy benefit, is to cause China's medical industry product quantity to occupy prostatitis, the world and the output value only is equivalent to the one of the main reasons of one or two transnational drugmaker.New drug, novel form exploitation level can embody the economy and the technical strength of the medical industry of a country.At China's national situation, oral formulations accounts for 2/3 of various whole body drug-delivery preparations, and accelerating development and promoting oral sustained-release preparation is the work that current urgent need will be done.China's drug control relevant laws and regulations regulation changes dosage form and manages as new drug research.
The principal mode of tcm clinical practice medication is a Chinese medicine compound, it is the concrete utilization of traditional Chinese medical science principle-method-recipe-medicines, embody Chinese traditional treatment and paid attention to strengthening vital QI to eliminate pathogenic factors, the rule of whole sight such as treating both the principal and secondary aspects of a disease, systematology and determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, be multisystem, many target spots and the Therapeutic Method of bringing into play comprehensive drug action at many levels, all these non-single component can be summarized and reached.The compound recipe drug effect is not only relevant with effective substance or effective substance group, and also relevant with auxiliary element.
When the Chinese medicinal formulae water decocts, because prescription closes chemical environment complicated in high temperature when frying in shallow oil and the solution, reaction such as complexation, hydrolysis, oxidation, reduction between intrinsic material may take place in solution, thereby some novel substance that did not have originally in the generation solution, these novel substances produce drug actions such as potentiation, attenuation or modification to full side.New component forms the research of mechanism, stability and drug effect thereof in the reinforcement Chinese medicinal formulae decocting liquid, to quickening new Chinese medicine developmental research speed, improve Chinese medicine compound and new drug level, progressively dwindle Chinese medicine compound and new Chinese medicine and international gap, crucial meaning is arranged, also increased new way and new source simultaneously for the research and development new Chinese medicine.
XIAOQINGLONG TANG comes from the treatise on Febrile Diseases of Han dynasty Zhang Zhongjing, still has definite clinical guidance meaning so far.The traditional Chinese medical science is thought, have volt in the diseases caused by retention of fluid (referring to that improper water liquid stops in the human body) in patient's body, if no external wind and cold priming can be kept at human body under the situation of water liquid homergy, then latent fluid-retention heresy can not cause harm in this.If affection of exogenous wind-cold, yang-energy is anti-evil, and lining YANG deficiency, YANG QI deficiency are to keep the homergy of water liquid, and the diseases caused by retention of fluid incubative pathogen that have in the body then is easy to cause harm, and cough with asthma occurs, forms the disease of " wind and cold visitor table, fluid-retention stagnating in the interior ".The basic function of XIAOQINGLONG TANG is the cold expelling that induces sweat, warming the lung to resolve fluid-retention.Cure mainly the cold in the exterior and fluid-retention in the interior card.Fever with aversion to cold, head-body-pain, lossless, to breath with cough, sputum is clear rare and amount is many, and the feeling of stuffiness in chest, or retch, or phlegm retention breathes with cough must not be put down for sleeping inly, or health is painful heavy, women's head-ornaments extremity edema, white and slippery fur, floating pulse.Side's epheday intermedia, Ramulus Cinnamomi mutual reinforcement between be monarch, and the diaphoresis cold expelling to be separating pathogenic factor in the exterior, and Herba Ephedrae can declare a lung qi again and relieving asthma and cough, and the Ramulus Cinnamomi promote the circulation of qi and water is in order to the change of lining drink.Rhizoma Zingiberis, Herba Asari are minister, warming the lung to resolve fluid-retention, and it is double that to help fiber crops, osmanthus to induce sweat eliminating evil.Yet have phlegm retention, spleen lung deficiency in origin is if the hot temperature of pure usefulness is dispersed, probably consume impairing the lung gas, Gu Zuo is with Fructus Schisandrae Chinensis astringing lung-QI and relieving cough, Radix Paeoniae and nutrition blood, and two medicines match with the hot product that loose, one diffusing one receives, and both can strengthen the merit of relieving cough and asthma, can restrict the hot warm-dryness syndrome fraud too of loosing of all medicines again; Rhizoma Pinelliae drying dampness to eliminate phlegm, regulating the stomach and sending down the abnormal ascending QI also is an adjuvant drug.Radix Glycyrrhizae Preparata is held concurrently to assistant makes it medicine, but both QI invigorating and in, can be in harmonious proportion the product of the hot acid receipts of loosing again.Though medicine eight flavors, compatibility is rigorous, in loosing receipts is arranged, and closes in opening, and wind and cold is separated, and diseases caused by retention of fluid goes, Xuan Jiangfu, then all disease self-balancing.
Modern pharmacological research shows that XIAOQINGLONG TANG is being brought into play different effects on each the different links at the asthma morbidity.Have experiment to show, XIAOQINGLONG TANG can significantly improve experimental rat model of asthma lung tissue glucocorticoid receptor (GR) (GCR), β-adrenergic receptor, and (β-AR) and cycli phosphate gland sweet (CAMP) level have the effect of the adrenal cortex function that improves experimental rat model of asthma.XIAOQINGLONG TANG has apparent improvement effect to the pathological change in the stingy road of periphery.XIAOQINGLONG TANG ultramicro decoction piece pastille serum causes that to antihistaminic the EC50 that guinea pig tracheal smooth muscle is shunk is 52.9% of traditional decoction pieces serum EC50.XIAOQINGLONG TANG mainly contain relieving asthma, effect such as antiallergic, analgesic, cough-relieving, be usually used in treating diseases such as the bronchial asthma that belongs to the card that stops in the traditional Chinese medical science cold fluid-retention, tracheitis, pertussis, pulmonary heart disease, pneumonia, pulmonary heart disease, allergic rhinitis, catarrhal ophthalmia, catarrhal otitis media.
The present invention will in time fill up both at home and abroad and use " nano-carrier multiple techniques " and researching and developing the blank in " the integrated novel form of XIAOQINGLONG TANG " field with theory of integrated Chinese and western medicine, product has the targeting advantage such as wide that distributes, and does not have identical or similar bibliographical information both at home and abroad.Research and development have reached world lead level.Show substantive progressive and novelty of the present invention by international one-level novelty assessment report and patent data library searching.Utilize domestic and international data base to carry out update search, comprehensive domestic and foreign literature is read, analyzing contrast obtains to draw a conclusion: " the integrated novel form of multiple techniques research and development Nano medication " project, its innovative point: 1) adopt the Chinese medicine nano-powder that is rich in trace element, the medicine monomer, effective site, effective part group, Chinese medical concrete, water drug-decocting concentrating liquids etc. go out the nanosphere of different-grain diameter size with the different pharmaceutical preparing carriers, nanocapsule, polymer micelle, solid ester matter nanoparticle, magnetic nano particle, the immune nano grain, nano-emulsion, suspensoid, vesicle, pharmacosomes, microcapsule, nanoparticle, the millimicro ball, millimicro is assisted etc., and mixing is respectively charged into soft then, unite simultaneously in the hard capsule and use and be prepared into a kind of integrated novel form or be prepared into the integrated novel form of other types according to above method; 2) utilization nano-carrier multiple techniques and theory of integrated Chinese and western medicine research and development " the integrated novel form of Nano medication ", product have characteristics such as targeting distributes extensively, slow controlled release properties is strong; Do not see open report at home in the document, these project complex art characteristics have certain novelty and novelty.
Summary of the invention:
Purpose of the present invention is exactly in order to solve the above-mentioned problems in the prior art, provides a kind of XIAOQINGLONG TANG integrated novel form technology of preparing.
Purpose of the present invention is achieved through the following technical solutions:
The integrated novel form technology of preparing of a kind of XIAOQINGLONG TANG, wherein: this integrated novel form raw materials of effective components and weight proportion---
9 parts in Herba Ephedrae, 9 parts of the Radix Paeoniae Albas, 6 parts of Herba Asaris, 6 parts of Rhizoma Zingiberiss, 6 parts of Radix Glycyrrhizae Preparatas, 9 parts of Ramulus Cinnamomi, 6 parts of Fructus Schisandrae Chinensis, 9 parts of the Rhizoma Pinelliaes.
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, organic selenium.The integrated novel form technology of preparing of above-mentioned a kind of XIAOQINGLONG TANG, wherein: medicine is become medicine support material medicine with preparing carriers, crude drug can be one or more combinations in nanoparticle, nanoparticle, micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanometer suspension liquid, the microcapsule etc., and can one or more be mixed according to different needs.
Further, the integrated novel form technology of preparing of above-mentioned a kind of XIAOQINGLONG TANG, wherein: the drug carrier material that this novel form is selected for use, activating agent, help Emulsion, excipient substances such as dispersant are gelatin, albumin and starch and derivant thereof, alginate, beta-schardinger dextrin-, protein, chitosan and derivant thereof, lactose, hydroxypropyl emthylcellulose, ethyl cellulose, cellulose acetate phthalate, the metering system acetate, polylactic acid and cyanoacrylate, the semisolid poe, triglyceride is (as three stearic acid, three Palmic acids, three lauric acids, in three oleic acid etc., the glyceride of long-chain fatty acid), glyceride is (as glyceryl monostearate, contain list, two, the synthetic glyceride of triglyceride), steroidal class (cholesterol etc.), Polyethylene Glycol, wax class (microcrystalline wax, whale ester type waxes), erythrocyte, Montmorillonitum, in the bentonite etc. one or more.
Further, the integrated novel form technology of preparing of above-mentioned a kind of XIAOQINGLONG TANG, wherein: finally the end product that can form is: integrated novel forms such as tablet, powder, suppository, stick, granule, soft capsule, hard capsule, effervescent, drop pill, aerosol, injection, unguentum, oral solution, slow releasing tablet, controlled release tablet.
Again further, the integrated novel form technology of preparing of above-mentioned a kind of XIAOQINGLONG TANG, wherein: indexs such as said integrated novel form is moving according to pharmacology, drug effect, the medicine of traditional Chinese medical science global theory, compatibility theory and medicine, toxicity, adopt medicament nano powder body, micro-powder, monomer, effective ingredient, effective site, active substance group, Chinese medical concrete, water drug-decocting concentrating liquid to unite use with different pharmaceutical carriers.And can mix its one or more as required.
The integrated novel form technology of preparing of a kind of XIAOQINGLONG TANG, it may further comprise the steps:
Step 1: get each prepared slices of Chinese crude drugs pretreatment, insert pulverizer after the weighing and be crushed to the 80-200 order, adopt supersonic airstream to be crushed to the 1-10 micron then, get different Chinese medicine micropowder, standby.
Step 2: get 30%-90% alcohol-water solution that 60% Herba Ephedrae, Radix Paeoniae, Herba Asari micropowder doubly measure with 6-12 and mix and soaked 1-2 days, reflux, extract, 3 times, extract water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility simultaneously, recovered alcohol gets extract with standby.
Step 3: get 60% Rhizoma Zingiberis, Radix Glycyrrhizae micropowder, adopt the high-frequency ultrasonic of independent research to disperse the pulverizing extraction equipment to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz-120KHz, to pulverize extraction time be 10-100 minute, Chinese medicine extract with standby.
Step 4: get 60% Ramulus Cinnamomi, the Rhizoma Pinelliae, Fructus Schisandrae Chinensis micropowder, adopted ball mill grinding 4-16 hour, particle size distribution be the nano powder of 50-1000 nanometer, standby.
Step 5: get each Chinese medicine micropowder of 40% and mix, boiled 3 times with the traditional Chinese medicine extracting machine decocting after being soaked in water two hours, decocting liquid merges and filters, and filtrate concentrates, and gets Chinese medical concrete or water drug-decocting concentrating liquid with standby.
Step 6: with step 2, step 3, step 4 gained Chinese medicine extract, nano powder difference according to different needs and the property of medicine, pharmacology, " the corresponding code requirement of standard preparation adopts technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared respectively in the Chinese pharmacopoeia, gets medicine materials such as different pharmaceutical monomer, effective site, active substance by latest edition.
Step 7: the said medicine raw material is adopted different excipient substances, and " preparation part of standards standard is with " the even method of high pressure breast is adopted in the requirement among the Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " etc. respectively in the Chinese pharmacopoeia by latest edition, inclusion technique, solid state technology, polishing, solvent-fusion method, the Double helix squeezing and pressing method, complex coacervation, emulsion-crosslinking method, the polymerization dispersion method, fusion method, technology such as freeze-drying are prepared into nanoparticle, nanoparticle, the micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanometer suspension liquid, crude drug such as microcapsule.The crude drug particle size distribution of preparing is between 10 nanometers-10 micron.
Step 8: by " preparation part of standards code requirement in the Chinese pharmacopoeia is got in the crude drug such as step 5 gained Chinese medical concrete or water drug-decocting concentrating liquid and step 7 gained nanoparticle, nanoparticle, micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanometer suspension liquid, microcapsule one or more and mixed.
Step 9: in GMP10000 level toilet, with above-mentioned mixed raw materials medicine adopt the fully-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can by latest edition " Chinese pharmacopoeia related preparations standard criterion is made the above-mentioned end product of other type.
Step 10: the end product of making is carried out several respectively, bottles, adorns box, seals, pastes labeling, plays exterior and interior packings such as sign indicating number, vanning.Packaged product is transported to the appointed place by production batch and unifies instantaneously sterilising, and opens the sterilization report.
The integrated novel form technology of preparing of above-mentioned a kind of XIAOQINGLONG TANG, wherein: the Chinese medicine of using in described step 1, step 2, the step 3 is pulverized and extracting method, described above-mentioned technology of preparing and the method for not only referring to, as required, be also included within add on its basis or use other better effects if, more economical, upgrade, more advanced breaking method, extracting method and technology.
Further, the integrated novel form technology of preparing of above-mentioned a kind of XIAOQINGLONG TANG, wherein: the medicine monomer in the described step 6, active substance, effective site technology of preparing, described above-mentioned technology of preparing and the method for not only referring to, as required, be also included within add on its basis or use other better effects if, more economical, upgrade, more advanced preparation method and technology.
Further, the integrated novel form technology of preparing of above-mentioned a kind of XIAOQINGLONG TANG, wherein: the dissimilar crude drug such as nanoparticle that adopt the different pharmaceutical adjuvant to be prepared in the described step 7, described above-mentioned technology of preparing and the method for not only referring to, as required, be also included within add on its basis or use other better effects if, more economical, upgrade, more advanced preparation method and technology.
Again further, the integrated novel form technology of preparing of above-mentioned a kind of XIAOQINGLONG TANG, wherein: its key point is the different and property of medicine and use the different of carrier according to the nanometer particle size of crude drug, can produce the different targeting controlled capability that eases up.
The outstanding substantive distinguishing features and the obvious improvement of technical solution of the present invention is mainly reflected in:
The present invention will in time fill up both at home and abroad and use " nano-carrier multiple techniques " and researching and developing the blank in " the integrated novel form of XIAOQINGLONG TANG " field with theory of integrated Chinese and western medicine, product has the targeting advantage such as wide that distributes, and does not have identical or similar bibliographical information both at home and abroad.Research and development have reached world lead level.Show substantive progressive and novelty of the present invention by international one-level novelty assessment report and patent data library searching.Utilize domestic and international data base to carry out update search, comprehensive domestic and foreign literature is read, analyzing contrast obtains to draw a conclusion: " the integrated novel form of multiple techniques research and development Nano medication " project, its innovative point: 1) adopt the Chinese medicine nano-powder that is rich in trace element, the medicine monomer, effective site, effective part group, Chinese medical concrete, water drug-decocting concentrating liquids etc. go out the nanosphere of different-grain diameter size with the different pharmaceutical preparing carriers, nanocapsule, polymer micelle, solid ester matter nanoparticle, magnetic nano particle, the immune nano grain, nano-emulsion, suspensoid, vesicle, pharmacosomes, microcapsule, nanoparticle, the millimicro ball, millimicro is assisted etc., and mixing is respectively charged into soft then, unite simultaneously in the hard capsule and use and be prepared into a kind of integrated novel form or be prepared into the integrated novel form of other types according to above method; 2) utilization nano-carrier multiple techniques and theory of integrated Chinese and western medicine research and development " the integrated novel form of Nano medication ", product have characteristics such as targeting distributes extensively, slow controlled release properties is strong; Do not see open report at home in the document, these project complex art characteristics have certain novelty and novelty.
Further, this integrated novel form technology of preparing is to have integrated the advantage separately of the traditional Chinese medical science, doctor trained in Western medicine, with the organic conception of theory of Chinese medical science and collaborative idea and the determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs of paying attention between medicine is the overall strategy tactical thinking, in conjunction with modern western pharmacology, pharmacokinetics, toxicology, pharmaceutics scheduling theory, pay attention to the effectiveness and the therapeutic effect of certified Chinese medicine one matter monomer treatment, pay attention to Chinese medicine active substance, effective site and active substance group the treatment assosting effect that disease played.Pay attention to the contained trace element of Chinese medicine to the treatment assosting effect that disease played.The effective ingredient of the used Chinese medicine of this Chinese medicine compound is clear and definite, and medicine effect has obtained admitting of modern medicine.Pay attention to the different nano-carrier dosage form technologies of preparing of Chinese medicine and unite use.Its particle size distribution is in 10 nanometers---between 10 microns.Then according to the difference of pharmacology, targeting, difference and the traditional Chinese medical science monarch theory of slow controlled release time, reasonable compatibility mixes, difference according to the dissolving of capsule material, disintegrate, jitter time can be prepared into targeted systems such as RE targeted system, stomach mucosa absorption system, small intestinal absorption system, colon absorption system respectively.Be respectively charged among hard capsule and the soft capsule.Also can be made into other dosage form as required.Compare Chinese medicine and medicine monomer, the drug targeting of the overall coordination therapeutical effect of this Chinese medicine compound novel form, slow controlled capability are stronger, and curative effect is more outstanding, and toxic and side effects still less.Having broken through the traditional monarch compatibility theory of the traditional Chinese medical science, is the innovation and the model of Chinese medicine tradition compatibility theory and traditional Chinese medical science pharmaceutics, in be western usefulness, westernly a practical effective novel form compatibility program has been proposed for middle usefulness.Be to have substantial technological break-through and theory of integrated Chinese and western medicine breakthrough.Will promote scientific and technological content and traditional Chinese medical science reform plays important exemplary role for the traditional traditional Chinese medical science.Also will promote the development of China's Chinese medicine industry.
Purpose of the present invention, advantage and characteristics will make an explanation by the non-limitative illustration of following preferred embodiment.These embodiment only are the prominent examples of using technical solution of the present invention, and all technical schemes of taking to be equal to replacement or equivalent transformation and forming all drop within the scope of protection of present invention.
The specific embodiment
The integrated novel form technology of preparing of a kind of XIAOQINGLONG TANG, its special feature is: making the raw materials of effective components composition is by weight ratio---
9 parts in Herba Ephedrae, 9 parts of the Radix Paeoniae Albas, 6 parts of Herba Asaris, 6 parts of Rhizoma Zingiberiss, 6 parts of Radix Glycyrrhizae Preparatas, 9 parts of Ramulus Cinnamomi, 6 parts of Fructus Schisandrae Chinensis, 9 parts of the Rhizoma Pinelliaes.
Further, play the synergy of standing like the legs of a tripod on the new drug formulation compatibility of the present invention: 1, prepare nano-powder, strengthen its not clear active substance group's therapeutical effect with this with the prepared slices of Chinese crude drugs; 2, with Chinese medicine extract and select suitable pharmaceutical carrier, prepare different Chemistry for Chinese Traditional Medicine monomers, effective ingredient, effective site etc., confirm and strengthen pharmacology, the efficacy of the chemical substance of Chinese medicine with this; 3, prepare Chinese medical concrete, water drug-decocting concentrating liquid with the prepared slices of Chinese crude drugs, the temporary transient unpredictable drug effect of bringing with this reaction such as complexation, hydrolysis, oxidation, reduction of strengthening the Chinese medicine compound uniqueness also keeps and has strengthened traditional Chinese medical science organic conception, monarch notion.More than three aspects associatings compatibility use, different according to Nano medication particle diameter and character, can reach effects such as many targeting, many collaborative, slow controlled releases, and play useful effect to strengthening the medicine pharmacologically active, effective ingredient pharmacological action effect is significantly higher than conventional formulation.
Production method of the present invention may further comprise the steps: at first, gets each prepared slices of Chinese crude drugs pretreatment, inserts pulverizer after the weighing and be crushed to the 80-200 order, adopt supersonic airstream to be crushed to the 1-10 micron then, get different Chinese medicine micropowder, and standby.Get 30%-90% alcohol-water solution that 60% Herba Ephedrae, Radix Paeoniae, Herba Asari micropowder doubly measure with 6-12 and mix and soaked 1-2 days, reflux, extract, 3 times is extracted water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility simultaneously, recovered alcohol, extract with standby.Get 60% Rhizoma Zingiberis, Radix Glycyrrhizae micropowder, adopt the ultrasonic dispersing pulverizing extraction equipment of independent research to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz-120KHz, to pulverize extraction time be 10-100 minute, Chinese medicine extract with standby.Get 60% Ramulus Cinnamomi, the Rhizoma Pinelliae, Fructus Schisandrae Chinensis micropowder, adopted ball mill grinding 4-16 hour, obtain the nano powder that particle size distribution is the 50-1000 nanometer, standby.Get each Chinese medicine micropowder of 40% and mix, boiled 3 times with the traditional Chinese medicine extracting machine decocting after being soaked in water two hours, decocting liquid merges and filters, and filtrate concentrates, and gets Chinese medical concrete or water drug-decocting concentrating liquid with standby.With above-mentioned gained Chinese medicine extract, nano powder difference according to different needs and the property of medicine, pharmacology, " the corresponding code requirement of standard preparation adopts technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared respectively in the Chinese pharmacopoeia, gets medicine materials such as different pharmaceutical monomer, effective site, active substance by latest edition.The said medicine raw material is adopted different excipient substances, and " preparation part of standards standard is with " the even method of high pressure breast is adopted in the requirement among the Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " etc. respectively in the Chinese pharmacopoeia by latest edition, inclusion technique, solid state technology, polishing, solvent-fusion method, the Double helix squeezing and pressing method, complex coacervation, emulsion-crosslinking method, the polymerization dispersion method, fusion method, technology such as freeze-drying are prepared into nanoparticle, nanoparticle, the micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanometer suspension liquid, crude drug such as microcapsule.The crude drug particle size distribution of preparing is between 10 nanometers-10 micron.By " preparation part of standards code requirement in the Chinese pharmacopoeia is got in above-mentioned gained Chinese medical concrete or water drug-decocting concentrating liquid and each crude drug of above-mentioned gained one or more and mixed.In GMP10000 level toilet, with above-mentioned mixed raw materials medicine adopt the fully-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can by latest edition " Chinese pharmacopoeia related preparations standard criterion is made the above-mentioned end product of other type.The end product of making is carried out several respectively, bottles, adorns box, seals, pastes labeling, plays exterior and interior packings such as sign indicating number, vanning.Packaged product is transported to the appointed place by production batch and unifies instantaneously sterilising, and opens the sterilization report.
" embodiment one "
Press the following crude drug of preceding method preparation:
Extractum, nanoparticle, microcapsule, nanoparticle.
It makes the raw materials of effective components composition---
9 parts in Herba Ephedrae, 9 parts of the Radix Paeoniae Albas, 6 parts of Herba Asaris, 6 parts of Rhizoma Zingiberiss, 6 parts of Radix Glycyrrhizae Preparatas, 9 parts of Ramulus Cinnamomi, 6 parts of Fructus Schisandrae Chinensis, 9 parts of the Rhizoma Pinelliaes.
Its manufacture process is as follows:
In GMP10000 level toilet with extractum, nanoparticle, microcapsule, nanoparticle in 4: 2: 2: after 2 ratios are mixed, adopt latest edition " Chinese pharmacopoeia preparation part hard capsule standard, do not add adjuvant, antiseptic, adopt fully-automatic capsule filling machine fill hard capsule, make hard capsule.Carry out several again, bottle, seal, paste labeling, play exterior and interior packings such as sign indicating number, vanning.Unify instantaneously sterilising by production batch at last, and open the sterilization report.
" embodiment two "
Press the following crude drug of preceding method preparation:
Water drug-decocting concentrating liquid, nanometer liposome, nano-emulsion, microemulsion, nanometer suspension liquid.
It makes the raw materials of effective components composition---
9 parts in Herba Ephedrae, 9 parts of the Radix Paeoniae Albas, 6 parts of Herba Asaris, 6 parts of Rhizoma Zingiberiss, 6 parts of Radix Glycyrrhizae Preparatas, 9 parts of Ramulus Cinnamomi, 6 parts of Fructus Schisandrae Chinensis, 9 parts of the Rhizoma Pinelliaes.
Its manufacture process is as follows:
In GMP10000 level toilet with water drug-decocting concentrating liquid, nanometer liposome, nano-emulsion, microemulsion, nanometer suspension liquid in 5: 1: 1: after ratio was mixed in 2: 1, adopt latest edition " Chinese pharmacopoeia preparation part soft capsule standard, do not add adjuvant, antiseptic, adopt full-automatic soft capsule filling machine packing soft capsule, make soft capsule.Carry out several again, bottle, seal, paste labeling, play exterior and interior packings such as sign indicating number, vanning.Unify instantaneously sterilising by production batch at last, and open the sterilization report.
" embodiment three "
Press the following crude drug of preceding method preparation:
Extractum, solid lipid nanoparticle, nano-emulsion.
It makes the raw materials of effective components composition---
9 parts in Herba Ephedrae, 9 parts of the Radix Paeoniae Albas, 6 parts of Herba Asaris, 6 parts of Rhizoma Zingiberiss, 6 parts of Radix Glycyrrhizae Preparatas, 9 parts of Ramulus Cinnamomi, 6 parts of Fructus Schisandrae Chinensis, 9 parts of the Rhizoma Pinelliaes.
Its manufacture process is as follows:
After in the GMP10000 level toilet extractum, solid lipid nanoparticle, nano-emulsion being mixed in 4: 3: 3 ratios, " Chinese pharmacopoeia preparation part membrane standard, filmogen adopts polyvinyl alcohol, makes membrane to adopt latest edition.Adorn box again, seal, paste labeling, play exterior and interior packings such as sign indicating number, vanning.Unify instantaneously sterilising by production batch at last, and open the sterilization report.Every membrane area size is the 2-40 square centimeter, and content of dispersion is the 1.2-5 gram, and every medicine film pasted 12-72 hour, pasted the medicine position: positions such as neck, chest, back part, abdominal part, shank, foot bottom, Ashi point.
By above-mentioned text description as can be seen: novelty and breakthrough that the present invention has essence are to have found out the key point that XIAOQINGLONG TANG nanometer Chinese medicine compound Chinese and western medicine theory combines.Among the present invention: monomer, effective site, nanoparticulate carriers etc. be strange, be tiny, be cloudy.Traditional Chinese medical science organic conception thought, Chinese medical concrete, water drug-decocting concentrating liquid etc. be just, be grand, be the sun.Very just be harmonious then negative and positive intercommunication, the negative and positive intercommunication is then coordinating water and fire, is the optimum balance attitude.Doctor trained in Western medicine research is precise and tiny, and theory of Chinese medical science is that circle melts, and both are harmonious, and have just really embodied the organic conception of the combination of Chinese and Western medicine, and " close " is that " integration " is for holding.The tidemark that greatness lies in the capacity, the coordinating water and fire the present invention of being only asked most.This integrated novel form is by the reasonable compatibility of Chinese medicine monomer, effective site, active substance, Chinese medicine active substance group, extractum, water drug-decocting concentrating liquid, prepared slices of Chinese crude drugs nano-particle etc., can produce soft, hard capsule or dosage forms such as nanometer membrane, transdermal agent.Can develop simultaneously, can take four time periods respectively by interior external administration by midnight-noon and ebb-flow doctrine, energy and blood of human body flowing law.Can also do film former to nanometer Chinese medicine, transdermal agent is attached to the human body different parts, can directly absorb by skin.The various Chinese medicine nanometer particle size major parts that the present invention prepares are the granule of 50～1000 nanometers.Adopting different nano-medicament carriers to be prepared into nanoparticle, nanosphere, nanocapsule, solid ester matter nanoparticle, magnetic nano particle, immune nano grain, nano-emulsion, vesicle, pharmacosomes, microcapsule, nanoparticle, millimicro ball, millimicro assists etc.Its particle size distribution is between 10 microns of 10 nanometers----.According to difference, the difference and the traditional Chinese medical science monarch theory of slow controlled release time of medicine pharmacology, targeting, reasonable compatibility mixes, and can be respectively charged among hard capsule and the soft capsule then.Difference according to the dissolving of capsule material, disintegrate, jitter time can be prepared into targeted systems such as RE targeted system, stomach mucosa absorption system, small intestinal absorption system, colon absorption system respectively.Compare Chinese medicine and medicine monomer or Western medicine, overall coordination therapeutical effect of this integrated novel form and drug targeting, slow controlled capability are stronger, and curative effect is more outstanding, and toxic and side effects still less.Having broken through the traditional monarch compatibility theory of the traditional Chinese medical science, is the innovation and the model of Chinese medicine tradition compatibility theory and traditional Chinese medical science pharmaceutics, in be western usefulness, westernly a practical effective novel form compatibility program has been proposed for middle usefulness.Be to have substantial technological break-through and theory of integrated Chinese and western medicine breakthrough.
Further, this integrated novel form technology of preparing is to have integrated the advantage separately of the traditional Chinese medical science, doctor trained in Western medicine, with the organic conception of theory of Chinese medical science and collaborative idea and the determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs of paying attention between medicine is the overall strategy tactical thinking, in conjunction with modern western pharmacology, pharmacokinetics, toxicology, pharmaceutics scheduling theory, pay attention to the effectiveness and the therapeutic effect of certified Chinese medicine one matter monomer treatment, pay attention to Chinese medicine active substance, effective site and active substance group the treatment mass action that disease played.Pay attention to the contained trace element of Chinese medicine to the treatment assosting effect that disease played.The effective ingredient of the used Chinese medicine of this Chinese medicine compound is clear and definite, and medicine effect has obtained admitting of modern medicine.Pay attention to the different nano-carrier dosage form technologies of preparing of Chinese medicine and unite use.These will promote the development of China's Chinese medicine industry.
Claims (10)
1. integrated novel form technology of preparing of XIAOQINGLONG TANG is characterized in that: this integrated novel form raw materials of effective components and weight proportion---
9 parts in Herba Ephedrae, 9 parts of the Radix Paeoniae Albas, 6 parts of Herba Asaris, 6 parts of Rhizoma Zingiberiss, 6 parts of Radix Glycyrrhizae Preparatas, 9 parts of Ramulus Cinnamomi, 6 parts of Fructus Schisandrae Chinensis, 9 parts of the Rhizoma Pinelliaes.Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, organic selenium.
2. the integrated novel form technology of preparing of a kind of XIAOQINGLONG TANG according to claim 1, it is characterized in that: medicine is become medicine support material medicine with preparing carriers, crude drug can be one or more combinations in nanoparticle, nanoparticle, micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanometer suspension liquid, the microcapsule etc., and can one or more be mixed according to different needs.
3. according to claim 1, the integrated novel form technology of preparing of 2 described a kind of XIAOQINGLONG TANG, it is characterized in that: the drug carrier material that this novel form is selected for use, activating agent, help Emulsion, excipient substances such as dispersant are gelatin, albumin and starch and derivant thereof, alginate, beta-schardinger dextrin-, protein, chitosan and derivant thereof, lactose, hydroxypropyl emthylcellulose, ethyl cellulose, cellulose acetate phthalate, the metering system acetate, polylactic acid and cyanoacrylate, the semisolid poe, triglyceride is (as three stearic acid, three Palmic acids, three lauric acids, in three oleic acid etc., the glyceride of long-chain fatty acid), glyceride is (as glyceryl monostearate, contain list, two, the synthetic glyceride of triglyceride), steroidal class (cholesterol etc.), Polyethylene Glycol, wax class (microcrystalline wax, whale ester type waxes), erythrocyte, Montmorillonitum, in the bentonite etc. one or more.
4. according to claim 1 or 2 or 3 any integrated novel form technologies of preparing of described a kind of XIAOQINGLONG TANG, it is characterized in that: finally the end product that can form is: integrated novel forms such as tablet, powder, suppository, stick, granule, soft capsule, hard capsule, effervescent, drop pill, aerosol, injection, unguentum, oral solution, slow releasing tablet, controlled release tablet.
5. according to claim 1 or 2 or 3 or 4 any integrated novel form technologies of preparing of described a kind of XIAOQINGLONG TANG, it is characterized in that: indexs such as said integrated novel form is moving according to pharmacology, drug effect, the medicine of traditional Chinese medical science global theory, compatibility theory and medicine, toxicity, adopt medicament nano powder body, micro-powder, monomer, effective ingredient, effective site, active substance group, Chinese medical concrete, water drug-decocting concentrating liquid to unite use with different pharmaceutical carriers.And can mix its one or more as required.
6. integrated novel form technology of preparing of XIAOQINGLONG TANG is characterized in that may further comprise the steps:
Step 1: get each prepared slices of Chinese crude drugs pretreatment, insert pulverizer after the weighing and be crushed to the 80-200 order, adopt supersonic airstream to be crushed to the 1-10 micron then, get different Chinese medicine micropowder, standby.
Step 2: get 30%--90% alcohol-water solution that 60% Herba Ephedrae, Radix Paeoniae, Herba Asari micropowder doubly measure with 6-12 and mix and soaked 1-2 days, reflux, extract, 3 times, extract water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility simultaneously, recovered alcohol gets extract with standby.
Step 3: get 60% Rhizoma Zingiberis, Radix Glycyrrhizae micropowder, adopt the high-frequency ultrasonic of independent research to disperse the pulverizing extraction equipment to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz--120KHz, to pulverize extraction time be 10-100 minute, Chinese medicine extract with standby.
Step 4: get 60% Ramulus Cinnamomi, the Rhizoma Pinelliae, Fructus Schisandrae Chinensis micropowder, adopted ball mill grinding 4-16 hour, particle size distribution be the nano powder of 50-1000 nanometer, standby.
Step 5: get each Chinese medicine micropowder of 40% and mix, boiled 3 times with the traditional Chinese medicine extracting machine decocting after being soaked in water two hours, decocting liquid merges and filters, and filtrate concentrates, and gets Chinese medical concrete or water drug-decocting concentrating liquid with standby.
Step 6: with step 2, step 3, step 4 gained Chinese medicine extract, nano powder difference according to different needs and the property of medicine, pharmacology, " the corresponding code requirement of standard preparation adopts technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared respectively in the Chinese pharmacopoeia, gets medicine materials such as different pharmaceutical monomer, effective site, active substance by latest edition.
Step 7: the said medicine raw material is adopted different excipient substances, and " preparation part of standards standard is with " the even method of high pressure breast is adopted in the requirement among the Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " etc. respectively in the Chinese pharmacopoeia by latest edition, inclusion technique, solid state technology, polishing, solvent-fusion method, the Double helix squeezing and pressing method, complex coacervation, emulsion-crosslinking method, the polymerization dispersion method, fusion method, technology such as freeze-drying are prepared into nanoparticle, nanoparticle, the micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanometer suspension liquid, crude drug such as microcapsule.The crude drug particle size distribution of preparing is between 10 nanometers-10 micron.
Step 8: by " preparation part of standards code requirement in the Chinese pharmacopoeia is got in the crude drug such as step 5 gained Chinese medical concrete or water drug-decocting concentrating liquid and step 7 gained nanoparticle, nanoparticle, micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanometer suspension liquid, microcapsule one or more and mixed.
Step 9: in GMP10000 level toilet, with above-mentioned mixed raw materials medicine adopt the fully-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can by latest edition " Chinese pharmacopoeia related preparations standard criterion is made the above-mentioned end product of other type.
Step 10: the end product of making is carried out several respectively, bottles, adorns box, seals, pastes labeling, plays exterior and interior packings such as sign indicating number, vanning.Packaged product is transported to the appointed place by production batch and unifies instantaneously sterilising, and opens the sterilization report.
7. the integrated novel form technology of preparing of a kind of XIAOQINGLONG TANG according to claim 6; it is characterized in that: the Chinese medicine of using in described step 1, step 2, the step 3 is pulverized and extracting method; the described protection domain of this claim is not only described technology of preparing and method; as required, be also included within add on its basis or use other better effects if, more economical, upgrade, more advanced breaking method, extracting method and technology.
8. the integrated novel form technology of preparing of a kind of XIAOQINGLONG TANG according to claim 7; it is characterized in that: the medicine monomer in the described step 6, active substance, effective site technology of preparing; the described protection domain of this claim is not only described technology of preparing and method; as required, be also included within add on its basis or use other better effects if, more economical, upgrade, more advanced preparation method and technology.
9. the integrated novel form technology of preparing of a kind of XIAOQINGLONG TANG according to claim 8; it is characterized in that: the dissimilar crude drug such as nanoparticle that adopt the different pharmaceutical adjuvant to be prepared in the described step 7; the described protection domain of this claim is not only described technology of preparing and method; as required, be also included within add on its basis or use other better effects if, more economical, upgrade, more advanced preparation method and technology.
10. the integrated novel form technology of preparing of a kind of XIAOQINGLONG TANG according to claim 9 is characterized in that: its key point is the different and property of medicine and use the different of carrier according to the nanometer particle size of crude drug, can produce the different targeting controlled capability that eases up.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009102631568A CN102100884A (en) | 2009-12-17 | 2009-12-17 | Preparation technology of new integrative formulation of minor green-blue dragon decoction |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009102631568A CN102100884A (en) | 2009-12-17 | 2009-12-17 | Preparation technology of new integrative formulation of minor green-blue dragon decoction |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102100884A true CN102100884A (en) | 2011-06-22 |
Family
ID=44154084
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2009102631568A Pending CN102100884A (en) | 2009-12-17 | 2009-12-17 | Preparation technology of new integrative formulation of minor green-blue dragon decoction |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102100884A (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102895335A (en) * | 2011-07-29 | 2013-01-30 | 苏州知微堂生物科技有限公司 | Preparation technology and production method for integrated new formulation of radix aconiti lateralis preparata powder |
| CN102895334A (en) * | 2011-07-29 | 2013-01-30 | 苏州知微堂生物科技有限公司 | Preparation technology and production method for integrated new formulation of licorice and monkshood decoction |
| CN107751094A (en) * | 2017-10-26 | 2018-03-06 | 孝感市鲁建农业开发有限公司 | A kind of cultural method for improving cavy meat |
| WO2020107210A1 (en) * | 2018-11-27 | 2020-06-04 | 深圳市得道健康管理有限公司 | Chinese herbal medicine composition for treating asthma, preparation method therefor and pharmaceutical use thereof |
-
2009
- 2009-12-17 CN CN2009102631568A patent/CN102100884A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102895335A (en) * | 2011-07-29 | 2013-01-30 | 苏州知微堂生物科技有限公司 | Preparation technology and production method for integrated new formulation of radix aconiti lateralis preparata powder |
| CN102895334A (en) * | 2011-07-29 | 2013-01-30 | 苏州知微堂生物科技有限公司 | Preparation technology and production method for integrated new formulation of licorice and monkshood decoction |
| CN107751094A (en) * | 2017-10-26 | 2018-03-06 | 孝感市鲁建农业开发有限公司 | A kind of cultural method for improving cavy meat |
| WO2020107210A1 (en) * | 2018-11-27 | 2020-06-04 | 深圳市得道健康管理有限公司 | Chinese herbal medicine composition for treating asthma, preparation method therefor and pharmaceutical use thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN102100885A (en) | Preparation technology and production method of integrated minor bupleurum decoction novel dosage form | |
| CN102283895A (en) | Preparation technology and production method of integrated novel Lingguizhugan decoction dosage form | |
| CN102100899A (en) | Preparation technology of new integrative formulation of prepared common monkshood daughter root decoction for regulating middle | |
| CN102284015A (en) | Integrated novel form preparation technology for powder with marvellous effect and production method thereof | |
| CN102100894A (en) | Preparation technology of new integrative formulation of free wanderer powder and production method thereof | |
| CN102100884A (en) | Preparation technology of new integrative formulation of minor green-blue dragon decoction | |
| CN102100751A (en) | Preparation technology of new integrative formulation of largetrifoliolious bugbane rhizome and kudzuvine root decoction and production method thereof | |
| CN102100813A (en) | Preparation technology of new integrative formulation of poria five powder and production method thereof | |
| CN102100815A (en) | Preparation technology of new formulation of integrative six gentlemen decoction and production method thereof | |
| CN102100883A (en) | Preparation technology of new integrative formulation of middle regulating decoction | |
| CN102100886A (en) | Technology and method for preparing novel combined formulation of relieving-edema decoction | |
| CN102100895A (en) | Technology for preparing novel integrative dosage form of decoction for tonifying middle-Jiao and Qi | |
| CN102100888A (en) | Preparation technology and production method of new integrative formulation of major green-blue dragon decoction | |
| CN102283944A (en) | Technology for preparing novel integrated dosage form of lung heat expelling powder and production method thereof | |
| CN102100892A (en) | Preparation technology and production method of integrated Xiaojianzhong decoction novel dosage form | |
| CN102895631A (en) | Preparation technology and production method for integrated new formulation of maidservant from Yue plus white atractylodes decoction | |
| CN102100768A (en) | Preparation technique for ephedra decoction in novel formed formulation and production method thereof | |
| CN102100762A (en) | Preparation technology of new integrative formulation of baical skullcap root decoction and production method thereof | |
| CN102284024A (en) | Preparation technology of integrated novel Weijing decoction dosage form | |
| CN102895335A (en) | Preparation technology and production method for integrated new formulation of radix aconiti lateralis preparata powder | |
| CN102895358A (en) | Preparation technology and production method for integrated new formulation of three-yellow decoction | |
| CN102847085A (en) | Preparation process and production method for Magnolia Officinalis Seven-Ingredient Decoction preparation in an integrated new dosage form | |
| CN102100890A (en) | Preparation technology of new integrative formulation of cassia twig decoction and production method thereof | |
| CN102100769A (en) | Preparation technique for ephedra and bighead atractylodes rhizome decoction in novel formed formulation and production method thereof | |
| CN102526647A (en) | Preparation technology and production method of novel dual-purpose decoction integrated dosage form |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20110622 |