CN102100899A - Preparation technology of new integrative formulation of prepared common monkshood daughter root decoction for regulating middle - Google Patents
Preparation technology of new integrative formulation of prepared common monkshood daughter root decoction for regulating middle Download PDFInfo
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Abstract
The invention relates to the preparation technology of a new integrative formulation of prepared common monkshood daughter root decoction for regulating middle. The prepared common monkshood daughter root decoction for regulating the middle comprises the following raw materials in part by weight: 9 parts of prepared common monkshood daughter root, 9 parts of Szechwan tangshen root, 9 parts of largehead atractylodes rhizome, 9 parts of honey-fried liquoric root and 9 parts of dried ginger. 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 Radix Aconiti Lateralis Preparata lizhong decoction, the invention still further relates to the integrated novel form technology of preparing of a kind of Radix Aconiti Lateralis Preparata lizhong decoction.
Background technology
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.
The Radix Aconiti Lateralis Preparata lizhong decoction comes from " Sanyin Ji Yi Bingzheng Fang Lun " volume two.Form by Radix Aconiti Lateralis Preparata, Radix Codonopsis, Rhizoma Zingiberis, the Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae Preparata.Square with the Radix Codonopsis invigorating the spleen and replenishing QI, the Rhizoma Zingiberis warming spleen and stomach for dispelling cold, the Rhizoma Atractylodis Macrocephalae is good for activating the spleen soil; Radix Glycyrrhizae is assumed personal Central Region; The big heat of Radix Aconiti Lateralis Preparata Da Xin is mended kidney-yang with warming YANG.Middle gas is both upright, and then clearing heat in QI system is from rising, and foul smell is fallen certainly, and vomits the diarrhea self-balancing.Has the tonify deficiency recuperating depleted YANG, the warming spleen and stomach for dispelling cold effect.This product is applicable to Deficiency and coldness of spleen and stomach, air-cooled multiplying each other, the coldness and pain in the epigastrium that YANG QI deficiency causes, vomiting and diarrhoea, abdominal swelling, loss of appetite, hands and feet coolness, pained, disease and asthenia of both the spleen and kidney such as cholera vomiting and diarrhea convulsion, tired mind due to cold coagulation is not changed, coldness of the body with chills, anorexia, coldness and pain in the epigastrium, diarrhea with loose stool, the clear rare disease of waiting of leukorrhagia.Modern times are usually used in treating oneself poisoning of gastroenteritis, gastroatonia, gastroptosis, malignant histocytosis, children's, atonic bleeding, dyspepsia, sinus bradycardia, anaphylactoid purpura, recurrent oral ulceration etc.
Modern pharmacology effect: 1. regulate gastrointestinal movement: can obviously strengthen stomach tension force and gastric peristalsis, accelerate gastric emptying; This medicine also can be resisted the ileum motion that ileum spasm that acetylcholine causes and epinephrine cause and suppress.2. physical strength reinforcing and cold tolerance: zoopery finds that animals with spleen deficiency is after treatment, and swimming time obviously prolongs in 4 ℃ of cold water, shows that this medicine can significantly strengthen the muscle power and the cold tolerance of animals with spleen deficiency.3. the mice stomachache that causes of Fuzi Lizhong Wan Dichlorodiphenyl Acetate has significant analgesia role, can also significantly improve the immunologic function of animals with spleen deficiency.Also obviously antagonism epinephrine and acetic acid choline have dual regulation to the effect of rabbit intestine in vitro to the kinestate of intestine in vitro, i.e. the obvious ileum spasm that the ileum motion suppresses and acetylcholine causes that causes of antagonism epinephrine.
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 Radix Aconiti Lateralis Preparata lizhong decoction " 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 Radix Aconiti Lateralis Preparata lizhong decoction 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 Radix Aconiti Lateralis Preparata lizhong decoction, wherein: this integrated novel form raw materials of effective components and weight proportion---
9 parts of Radix Aconiti Lateralis Preparatas, 9 parts of Radix Codonopsis, 9 parts of the Rhizoma Atractylodis Macrocephalaes, 9 parts of Radix Glycyrrhizae Preparatas, 9 parts of Rhizoma Zingiberiss.
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, organic selenium.The above-mentioned integrated novel form technology of preparing of a kind of Radix Aconiti Lateralis Preparata lizhong decoction, 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 above-mentioned integrated novel form technology of preparing of a kind of Radix Aconiti Lateralis Preparata lizhong decoction, 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 above-mentioned integrated novel form technology of preparing of a kind of Radix Aconiti Lateralis Preparata lizhong decoction, 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 above-mentioned integrated novel form technology of preparing of a kind of Radix Aconiti Lateralis Preparata lizhong decoction, 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 Radix Aconiti Lateralis Preparata lizhong decoction, 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% Radix Aconiti Lateralis Preparata, Radix Codonopsis 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 Atractylodis Macrocephalae 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% Radix Glycyrrhizae Preparata, Rhizoma Zingiberis 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 above-mentioned integrated novel form technology of preparing of a kind of Radix Aconiti Lateralis Preparata lizhong decoction, 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 above-mentioned integrated novel form technology of preparing of a kind of Radix Aconiti Lateralis Preparata lizhong decoction, 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 above-mentioned integrated novel form technology of preparing of a kind of Radix Aconiti Lateralis Preparata lizhong decoction, 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 above-mentioned integrated novel form technology of preparing of a kind of Radix Aconiti Lateralis Preparata lizhong decoction, 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 Radix Aconiti Lateralis Preparata lizhong decoction " 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, the present invention has found out the key point of the Radix Aconiti Lateralis Preparata lizhong decoction combination of Chinese and Western medicine, 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 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.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 Radix Aconiti Lateralis Preparata lizhong decoction, its special feature is: making the raw materials of effective components composition is by weight ratio---
9 parts of Radix Aconiti Lateralis Preparatas, 9 parts of Radix Codonopsis, 9 parts of the Rhizoma Atractylodis Macrocephalaes, 9 parts of Radix Glycyrrhizae Preparatas, 9 parts of Rhizoma Zingiberiss.
Further, play the synergy of standing like the legs of a tripod on the new drug formulation compatibility of the present invention: 1, prepare the Nano Chinese medicine powder body, 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: 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% Radix Aconiti Lateralis Preparata, Radix Codonopsis 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 Atractylodis Macrocephalae 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% Radix Glycyrrhizae Preparata, Rhizoma Zingiberis 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---
9 parts of Radix Aconiti Lateralis Preparatas, 9 parts of Radix Codonopsis, 9 parts of the Rhizoma Atractylodis Macrocephalaes, 9 parts of Radix Glycyrrhizae Preparatas, 9 parts of Rhizoma Zingiberiss.
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 of Radix Aconiti Lateralis Preparatas, 9 parts of Radix Codonopsis, 9 parts of the Rhizoma Atractylodis Macrocephalaes, 9 parts of Radix Glycyrrhizae Preparatas, 9 parts of Rhizoma Zingiberiss.
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 of Radix Aconiti Lateralis Preparatas, 9 parts of Radix Codonopsis, 9 parts of the Rhizoma Atractylodis Macrocephalaes, 9 parts of Radix Glycyrrhizae Preparatas, 9 parts of Rhizoma Zingiberiss.
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: integrated novel form of the present invention and technology of preparing and production method thereof, its novelty and breakthrough with essence is to have found out the key point that Radix Aconiti Lateralis Preparata lizhong decoction nanometer Chinese medicine 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.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.Will promote scientific and technological content and traditional Chinese medical science reform plays important exemplary role for the traditional traditional Chinese medical science.
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.
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 Radix Aconiti Lateralis Preparata lizhong decoction " 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.Prove that complex art characteristics of the present invention have certain novelty and novelty.
Claims (10)
1. integrated novel form technology of preparing of Radix Aconiti Lateralis Preparata lizhong decoction is characterized in that: this integrated novel form raw materials of effective components and weight proportion---
9 parts of Radix Aconiti Lateralis Preparatas, 9 parts of Radix Codonopsis, 9 parts of the Rhizoma Atractylodis Macrocephalaes, 9 parts of Radix Glycyrrhizae Preparatas, 9 parts of Rhizoma Zingiberiss.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 Radix Aconiti Lateralis Preparata lizhong decoction 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 Radix Aconiti Lateralis Preparata lizhong decoctions, 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 Radix Aconiti Lateralis Preparata lizhong decoction, 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 Radix Aconiti Lateralis Preparata lizhong decoction, 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 Radix Aconiti Lateralis Preparata lizhong decoction 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% Radix Aconiti Lateralis Preparata, Radix Codonopsis 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 Atractylodis Macrocephalae 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% Radix Glycyrrhizae Preparata, Rhizoma Zingiberis 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 Radix Aconiti Lateralis Preparata lizhong decoction 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 Radix Aconiti Lateralis Preparata lizhong decoction 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 Radix Aconiti Lateralis Preparata lizhong decoction 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 Radix Aconiti Lateralis Preparata lizhong decoction 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 (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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| 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 |
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| CN104274547A (en) * | 2014-10-28 | 2015-01-14 | 贵州黄平美娘冲民族服饰有限公司 | Foot bath powder for treating cold-damp diarrhea |
| CN109260452A (en) * | 2018-12-14 | 2019-01-25 | 新乡医学院第附属医院 | A kind of Chinese medicine composition for preventing gastrointestinal convulsion and preparation method thereof, oral solution and application |
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- 2009-12-17 CN CN2009102631905A patent/CN102100899A/en active Pending
Cited By (6)
| 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 |
| CN103830709A (en) * | 2014-03-12 | 2014-06-04 | 张勇 | Traditional Chinese medicine for treating aphtha caused by deficiency cold in spleen and stomach and reversal of moisture and preparation method thereof |
| CN104189873A (en) * | 2014-09-29 | 2014-12-10 | 洛阳御平国生物科技有限公司 | Traditional Chinese medicine formula for treating acute gastroenteritis |
| CN104274547A (en) * | 2014-10-28 | 2015-01-14 | 贵州黄平美娘冲民族服饰有限公司 | Foot bath powder for treating cold-damp diarrhea |
| CN109260452A (en) * | 2018-12-14 | 2019-01-25 | 新乡医学院第附属医院 | A kind of Chinese medicine composition for preventing gastrointestinal convulsion and preparation method thereof, oral solution and application |
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Application publication date: 20110622 |