CN102100895A - Technology for preparing novel integrative dosage form of decoction for tonifying middle-Jiao and Qi - Google Patents
Technology for preparing novel integrative dosage form of decoction for tonifying middle-Jiao and Qi Download PDFInfo
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Abstract
The invention relates to a technology for preparing a novel integrative dosage form of a decoction for tonifying middle-Jiao and Qi. The decoction of the novel integrative dosage form comprises the following effective component of raw materials in weight proportion: 15 parts of astragalus root, 15 parts of ginseng, 10 parts of largehead atractylodes rhizome, 15 parts of prepared licorice root, 10 parts of Chinese angelica, 6 parts of dried tangerine or orange peel, 6 parts of skunk bugbane, 12 parts of Chinese thorowax root, 9 parts of dried ginger and 6 parts of Chinese date. A production process comprises the steps of: extracting with alcohol and water, ultrasonically crushing and extracting, extracting with microwave, spray-drying, grinding in a nano manner, preparing nano particles and the like. In the invention, the advantages that nano Chinese medicines have multiple synergy and multiple target functions and the like are emphasized. After industrial scale production, production cost can be greatly reduced, product quality can be improved, and the targeting property and the slow controlled release property of medicines are enabled to be stronger. After the decoction for tonifying middle-Jiao and Qi is prepared into a film preparation, the film preparation can be applied to the skin of a human body so as to realize trandermal absorption therapy.
Description
Technical field
The present invention relates to the integrated novel form of a kind of BUZHONG YIQI TANG, the invention still further relates to the integrated novel form technology of preparing of a kind of BUZHONG YIQI 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.
BUZHONG YIQI TANG comes from Jin Dynasty well-known doctor Li Dongyuan " Treatise on the spleen and stomach " volume, and Radix Astragali invigorating the spleen and replenishing QI in the side, yang invigorating consolidating superficial resistance are monarch; Radix Ginseng, the Rhizoma Atractylodis Macrocephalae, the sweet temperature QI invigorating of Radix Glycyrrhizae, strengthening the spleen and stomach is minister; The Pericarpium Citri Reticulatae regulating functional activities of qi, Chinese angelica blood supplementing and battalion are assistant; Rhizoma Cimicifugae, the collaborative ginseng of Radix Bupleuri, the clear sun of stilbene elevate a turnable ladder are for making.Comprehensive full side, air making-up and spleen enlivening first makes day after tomorrow biochemistry active, and all cards of deficiency of spleen-QI and stomach-QI are from fully recovering; Ascending spleen-QI first, the function of burnt lifting in the recovery, make down take off, sagging its position of card runback.Cure mainly deficiency of spleen-QI and stomach-QI, deficiency of QI with disinclination to talk, myasthenia of limbs, sleepy few food, diet is dull, and it is tired not endure hardships, moving then breathe hard; Or fever due to deficiency of QI, upward adverse flow of QI and breathing heavily, fever of the body and being tired of, thirsty desire for hot drinks, its full and large pulse, unable by it, skin is not appointed wind and cold, and gives birth to the cold and heat headache; Or collapse of QI, the chronic diarrhea proctoptosis.Now be used for uterine prolapse; Gastroptosis or other visceroptosis person.BUZHONG YIQI TANG is to stress ulcer, and pyloric ligation ulcer, reserpine ulcer model all have good protective action, acetic acid method gastric ulcer model are had the effect of obvious promotion ulcer healing.Its mechanism of action and this side suppress stomachial secretion, suppress the stomach motion, increase gastric mucosal blood flow and certain central inhibitory action relevant.
The modern pharmacology experimentation shows: BUZHONG YIQI TANG is in body or isolated uterine and the selective excitation of surrounding tissue thereof.BUZHONG YIQI TANG can be excited myocardium in a small amount, the excessive inhibitory action that then is.Effect to small intestinal is complicated, presents inhibitory action when hyperperistalsis, makes it wriggling and slows down, and tension force reduces; When intestinal tube is in inhibitory state, then makes it wriggling and strengthen.Thereby confirmed that we have dual regulation.From experiment, also can find out, in the preparation that Rhizoma Cimicifugae, Radix Bupleuri are arranged, obvious to the effect of animal.And remove liter, during bavin, its effect weakens, and illustrates that this two medicine can strengthen the action intensity of other medicines, especially with more obvious to the enterokinesia effect.(2) we have anti-gene mutation and antitumor action, and we can also regulate body's immunity, prolong the animals survived time.When using antineoplastic chemotherapy medicine clinically, fit applications we can improve curative effect, reduce the chemotherapeutics toxicity.
Novelty and breakthrough that the present invention has essence are to have found out the key point that 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.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.Will play important exemplary role for traditional traditional Chinese medical science promotes scientific and technological content.
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 BUZHONG YIQI 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 industrialization report 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, the present invention is an advantage separately of having integrated 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.
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 BUZHONG YIQI 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 BUZHONG YIQI TANG, wherein: this integrated novel form raw materials of effective components and weight proportion---
15 parts of the Radixs Astragali, 15 parts of Radix Ginsengs, 10 parts of the Rhizoma Atractylodis Macrocephalaes, 15 parts of Radix Glycyrrhizae Preparata, 10 parts of Radix Angelicae Sinensis, 6 parts of Pericarpium Citri Reticulataes, 6 parts of Rhizoma Cimicifugaes, 12 parts of Radix Bupleuri, 9 parts in Rhizoma Zingiberis Recens, 6 parts in Fructus Jujubae.
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 BUZHONG YIQI 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 BUZHONG YIQI 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 BUZHONG YIQI 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 BUZHONG YIQI 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 excipient substance, pharmaceutical carrier.And can mix its one or more as required.
The integrated novel form technology of preparing of a kind of BUZHONG YIQI 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% the Radix Astragali, Radix Ginseng, Rhizoma Atractylodis Macrocephalae 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% Radix Glycyrrhizae Preparata, Radix Angelicae Sinensis, Pericarpium Citri Reticulatae 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% Rhizoma Cimicifugae, Radix Bupleuri, Rhizoma Zingiberis Recens, Fructus Jujubae 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: above-mentioned gained medicine 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 BUZHONG YIQI 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 BUZHONG YIQI 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 BUZHONG YIQI 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 BUZHONG YIQI 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:
Novelty and breakthrough that the present invention has essence are to have found out the key point that nanometer BUZHONG YIQI TANG Chinese and western medicine theory combines, 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 BUZHONG YIQI 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 industrialization report 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.Be to adopt Chinese medicine crude drug nano-powder, monomer, effective site, effective part group, Chinese medicine concentrated extract, water drug-decocting concentrating liquid, nano-medicament carrier etc. to unite use on the compatibility.These various Chinese medicine nanometer particle size major parts of filling a prescription are the granule of 50～1000 nanometers.Adopting different nano-medicament carriers to be prepared into nanoparticle, nanosphere, nanocapsule, solid ester matter nanoparticle, nano-emulsion, vesicle, pharmacosomes, microcapsule, nanoparticle, millimicro ball, millimicro assists etc.Its particle size distribution is in 10 nanometers---between 10 microns.According to difference, the difference and the traditional Chinese medical science monarch theory of slow controlled release time of pharmacology, targeting, reasonable compatibility mixes, and is 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, 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 BUZHONG YIQI TANG, its special feature is: making the raw materials of effective components composition is by weight ratio---
15 parts of the Radixs Astragali, 15 parts of Radix Ginsengs, 10 parts of the Rhizoma Atractylodis Macrocephalaes, 15 parts of Radix Glycyrrhizae Preparata, 10 parts of Radix Angelicae Sinensis, 6 parts of Pericarpium Citri Reticulataes, 6 parts of Rhizoma Cimicifugaes, 12 parts of Radix Bupleuri, 9 parts in Rhizoma Zingiberis Recens, 6 parts in Fructus Jujubae.
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% the Radix Astragali, Radix Ginseng, Rhizoma Atractylodis Macrocephalae 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% Radix Glycyrrhizae Preparata, Radix Angelicae Sinensis, Pericarpium Citri Reticulatae 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% Rhizoma Cimicifugae, Radix Bupleuri, Rhizoma Zingiberis Recens, Fructus Jujubae 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.Above-mentioned gained medicine 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---
15 parts of the Radixs Astragali, 15 parts of Radix Ginsengs, 10 parts of the Rhizoma Atractylodis Macrocephalaes, 15 parts of Radix Glycyrrhizae Preparata, 10 parts of Radix Angelicae Sinensis, 6 parts of Pericarpium Citri Reticulataes, 6 parts of Rhizoma Cimicifugaes, 12 parts of Radix Bupleuri, 9 parts in Rhizoma Zingiberis Recens, 6 parts in Fructus Jujubae.
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---
15 parts of the Radixs Astragali, 15 parts of Radix Ginsengs, 10 parts of the Rhizoma Atractylodis Macrocephalaes, 15 parts of Radix Glycyrrhizae Preparata, 10 parts of Radix Angelicae Sinensis, 6 parts of Pericarpium Citri Reticulataes, 6 parts of Rhizoma Cimicifugaes, 12 parts of Radix Bupleuri, 9 parts in Rhizoma Zingiberis Recens, 6 parts in Fructus Jujubae.
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---
15 parts of the Radixs Astragali, 15 parts of Radix Ginsengs, 10 parts of the Rhizoma Atractylodis Macrocephalaes, 15 parts of Radix Glycyrrhizae Preparata, 10 parts of Radix Angelicae Sinensis, 6 parts of Pericarpium Citri Reticulataes, 6 parts of Rhizoma Cimicifugaes, 12 parts of Radix Bupleuri, 9 parts in Rhizoma Zingiberis Recens, 6 parts in Fructus Jujubae.
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 guizhi decoction nanometer Chinese medicine compound Chinese and western medicine theory combines, and the compound compatibility of nanometer Chinese medicine can change the pharmacokinetic parameter of effective ingredient or parts formulation.This has proved the scientific meaning of Chinese medicine compound compatibility from the pharmacokinetics level." very just being harmonious; negative and positive intercommunication, coordinating water and fire, precise and tiny circle melt; greatness lies in the capacity " is the elite in the classical works such as Chinese Zhou Yi, Tai Ji, Buddhism, Taoism, Huang di's Canon of Medicine, is simple philosophic thinking, also is the research and development thinking and the basic guiding theory of the integrated novel form of this medicine.The traditional Chinese medical science always just has saying of the easy homology of doctor, road doctor's homology.This theoretical basis of the present invention just.Among the present invention: medicine 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.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.Will promote scientific and technological content and traditional Chinese medical science reform plays important exemplary role for the traditional traditional Chinese medical science.
Further see, 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 BUZHONG YIQI 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 industrialization report 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.The present invention does not see open report in the document at home and abroad, proves that complex art characteristics of the present invention have certain novelty and novelty.
Claims (10)
1. integrated novel form technology of preparing of BUZHONG YIQI TANG is characterized in that: this integrated novel form raw materials of effective components and weight proportion---
15 parts of the Radixs Astragali, 15 parts of Radix Ginsengs, 10 parts of the Rhizoma Atractylodis Macrocephalaes, 15 parts of Radix Glycyrrhizae Preparata, 10 parts of Radix Angelicae Sinensis, 6 parts of Pericarpium Citri Reticulataes, 6 parts of Rhizoma Cimicifugaes, 12 parts of Radix Bupleuri, 9 parts in Rhizoma Zingiberis Recens, 6 parts in Fructus Jujubae.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 BUZHONG YIQI 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 BUZHONG YIQI 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 BUZHONG YIQI 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 BUZHONG YIQI 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 excipient substance, pharmaceutical carrier.And can mix its one or more as required.
6. integrated novel form technology of preparing of BUZHONG YIQI 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% the Radix Astragali, Radix Ginseng, Rhizoma Atractylodis Macrocephalae 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% Radix Glycyrrhizae Preparata, Radix Angelicae Sinensis, Pericarpium Citri Reticulatae 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% Rhizoma Cimicifugae, Radix Bupleuri, Rhizoma Zingiberis Recens, Fructus Jujubae 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: above-mentioned gained medicine 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 BUZHONG YIQI 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 BUZHONG YIQI 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 BUZHONG YIQI 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 BUZHONG YIQI 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.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102895385A (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 bugbane rhizome and turtle shell decoction |
| CN103028106A (en) * | 2012-12-25 | 2013-04-10 | 山西医科大学 | Traditional Chinese medicine preparation for recovering body strength after strenuous exercise |
| CN103610812A (en) * | 2013-06-03 | 2014-03-05 | 陈元祥 | Chinese medicine for treating stomach illness |
| CN106938025A (en) * | 2017-03-27 | 2017-07-11 | 成都海青生物科技有限公司 | One kind is used for antasthmatic new medicine composition and preparation method thereof |
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2009
- 2009-12-17 CN CN2009102631816A patent/CN102100895A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102895385A (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 bugbane rhizome and turtle shell decoction |
| CN103028106A (en) * | 2012-12-25 | 2013-04-10 | 山西医科大学 | Traditional Chinese medicine preparation for recovering body strength after strenuous exercise |
| CN103610812A (en) * | 2013-06-03 | 2014-03-05 | 陈元祥 | Chinese medicine for treating stomach illness |
| CN106938025A (en) * | 2017-03-27 | 2017-07-11 | 成都海青生物科技有限公司 | One kind is used for antasthmatic new medicine composition and preparation method thereof |
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Application publication date: 20110622 |