CN102100755A - Preparation technology of integrated ephedra, aconite and asarum decoction novel dosage form - Google Patents
Preparation technology of integrated ephedra, aconite and asarum decoction novel dosage form Download PDFInfo
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Abstract
The invention relates to a preparation technology of an integrated ephedra, aconite and asarum decoction novel dosage form. The novel dosage form comprises the following active ingredients in parts by weight: 6 parts of ephedra, 9 parts of aconite and 6 parts of asarum. The production process comprises the following steps: extraction in aqueous alcohol, ultrasonic grinding and extraction, microwave extraction, decoction in water and concentration, spray drying, high-pressure homogenizing, nanoscale grinding, nanoparticle preparation and the like. In the method, the stress is laid on the advantages of multi-synergy and multi-target effects of nano traditional Chinese medicines. After scale industrial production, the production cost can be substantially lowered, the product quality can be improved and the targeting and slow/controlled release properties of the medicines are stronger. After the novel dosage form is prepared into films, the films can be stuck to the skins of the human bodies and are used for treating the diseases through percutaneous absorption.
Description
Technical field
The present invention relates to the integrated novel form of a kind of Mahuang Fuzi Xixin Tang, the invention still further relates to the integrated novel form technology of preparing of a kind of Mahuang Fuzi Xixin Tang.
Background technology
New drug, novel form exploitation level can embody the economy and the technical strength of the medical industry of a country.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.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.
Mahuang Fuzi Xixin Tang comes from the treatise on Febrile Diseases of Han dynasty Zhang Zhongjing.The side is made up of Herba Ephedrae, Radix Aconiti Lateralis Preparata, Herba Asari three flavor Chinese medicines.Cure mainly the few YIN syndrome of typhoid fever, begin it, reverse fevering, deep pulse person.Be the few cloudy medicine of foot.Herba Ephedrae, the Xin Wen heating can be shown dispersing wind and cold, can open lung qi dispersing gas; Radix Aconiti Lateralis Preparata can kidney-Yang invigorating, fonifying life-gate fire, and it can be received by the cold-evil who gets deeply stuck in; Herba Asari can be walked through scurrying network, and we are called, and Herba Asari is " tire is original ", and it is deep that it can go into marrow, can open and close and have one's ideas straightened out, and it both can help Herba Ephedrae to be used to show dispersing wind and cold, can open the clear key of the part of the body cavity above the diaphragm housing the heart and lungs, also helped Radix Aconiti Lateralis Preparata to go the warm gate of vitality, removed to stir machine key in the kidney.In the few the moon of Radix Aconiti Lateralis Preparata temperature; Herba Ephedrae opens the table of the sun, promptly is to open closing of profound mansion; Herba Asari is directly gone into Shao Yin, and the holder heresy is passed through inside.So this side of Mahuang Fuzi Xixin Tang, it has extremely powerful lung qi dispersing cold expelling, the logical lung sun of temperature, the power of having one's ideas straightened out and opening and closing.Modern clinical be usually used in treating flu, heating, allergic rhinitis, tracheitis, asthma, pneumonia, sinus syndrome, hypertensive renal angor, pertussis, losslessly levy, diseases such as hypotension, myasthenia gravis, fatigue syndrome, bradycardia, sciatica, arthromyodynia, nephrotic syndrome.
The famous expert discusses: Ke Qin says: in few cloudy master, should not have exterior syndrome, diseases occurring in YIN meridians or ZANG FU-organs, exterior cold should be arranged, and the modern few cloudy beginning is subjected to the cold-evil and reverse fevering is to have in few the moon, and the table that has the sun concurrently also, and the table arteries and veins of the sun should not sink, modern deep pulse person, be the card of the sun is arranged and the arteries and veins of seeing few the moon also, so though body heat arteries and veins is then heavy also, so TAI YANG syndrome and arteries and veins is anti-heavy, just use cold limbs with first aid in it, and this SHAO YIN syndrome is shown anti-heat, be convenient to show add in the agent Radix Aconiti Lateralis Preparata with pre-admittedly in it, husband's fever without perspiration, the table of the sun is had to out, deep pulse indicating interior syndrome, the pivot of few the moon has to again consolidate, and establishes and uses Herba Ephedrae loosing the interspaces of skin and muscles, the Herba Asari superficial heat of loosing, and not having Radix Aconiti Lateralis Preparata with the primordial QI reinforcing sun, the body fluid of then few the moon runs off little sun of the sun and dies outward, goes life just far away, only Radix Aconiti Lateralis Preparata and Herba Ephedrae are also used, though then the cold-evil looses and sun is not died, sick and table in this, deep pulse and as diaphoresis person, with the disease being located in the exterior, floating pulse and diaphoresis person is also very unlike, if the table slight fever, it is also light then to catch cold, so little its antiperspirant with the easy Herba Asari of Radix Glycyrrhizae, sweet flavor has the effect of relaxing is with the person of suffering to loose, between lacking again.Money pool " typhoid fever trace to the source collection " volume 9: " send out the antiperspirant of the sun with Herba Ephedrae, to separate its cold-evil at table; In the few the moon of Radix Aconiti Lateralis Preparata temperature, to mend its gate of vitality's kidney-Yang; Specially walk few cloudy person with the temperature acrid in the mouth of Herba Asari again, disperse to help its hot temperature.The three share, double the executing of mend loosing, though inducing perspiration slightly, without detriment to yang-energy, thus be dispelling cold by warming the meridian refreshing agent also." " Treatise on Febrile Diseases is distinguished SHAO YIN syndrome arteries and veins card and controls ": " and SHAO YIN syndrome, begin it, reverse fevering, deep pulse person, Ephedra asarum Radix Aconiti Lateralis Preparata soup master it.”
Now pharmacological research shows that the effective ingredient of Herba Ephedrae is an ephedrine, and is can excited epinephrine neural and palpitating speed, myocardial contraction are strengthened; The Radix Aconiti Lateralis Preparata heart tonifying strengthens coronary flow, thereby heart rate is accelerated; Herba Asari contains methyleugenol volatile oil, and Xin Xiang walks to scurry, and has to rise a floating property, interior can be up, the gas of the horizontal whole body of walking to pass through is assisted Radix Aconiti Lateralis Preparata the kidney warming invigorating YANG again; Outward can warm dispersing wind and cold, go into the kidney improving inspiration by invigorating kidney-QI again, for controlling the key medicine of breathing with cough, common warming the meridian reaches table, strengthening vital QI to eliminate pathogenic factors.We's pharmacological action mainly contains antiinflammatory, antiallergic, antioxidation.1. antiinflammatory: 100 μ g/ml are added in the suspension of peritoneal macrophage with Mahuang Fuzi Xixin Tang, present the rising that concentration dependent suppresses calcium ion (Ca2+) concentration in Calcium ionophore (CaI) A23187 (1 μ g/ml) or platelet activating factor (PAF) the 1ng/ml peritoneal macrophage due to stimulating, compare significant difference with non-interpolation group.Show that its cell membrane may have certain stability action.2. antiallergic: (1) is to the effect of histamine release: the Mahuang Fuzi Xixin Tang 0.4mg/ml that extracts with water, ethanol or acetone and methanol mixed (1: 1) solvent, all can significantly suppress specific antigen (ascidean) or non-specific antigen stimulates basophilic leukocyte to discharge histamine, and its suppression ratio changes according to DM.(2) to the effect of lipoxygenase activity: the Mahuang Fuzi Xixin Tang granule or powder preparation to be taken after being infused in boiling water that above three kinds of solvents extract makes [1-14C] arachidonic acid regulating liver-QI hydroperoxyl-6 respectively, 8,11, the generation of 14-two tetradecene alkyd [5-HETE] obviously reduces, the activity of lipoxygenase in leukaemia's cytosol in the inhibition solution.3. antioxidation: the active oxygen that the Mahuang Fuzi Xixin Tang granule or powder preparation to be taken after being infused in boiling water that above three kinds of solvents extract makes neutrophil(e) cell system, the smart oxidase system of Hemerocallis citrina Baroni color produce respectively obviously reduces; Because of this side does not suppress cytophagous metabolism, point out this side to have the effect of the active oxygen of removing body part generation.
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 and abroad in the document, the 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 therapeutical 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.At present, there is not identical or similar bibliographical information both at home and abroad.Proof the present invention research and development have reached world lead level.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, and integrated novel form technology of preparing of a kind of Mahuang Fuzi Xixin Tang and production method thereof are provided.
Purpose of the present invention is achieved through the following technical solutions:
The integrated novel form technology of preparing of a kind of Mahuang Fuzi Xixin Tang, wherein: this nanometer Chinese medicine raw materials of effective components and weight proportion---
6 parts in Herba Ephedrae, 9 parts of Radix Aconiti Lateralis Preparatas, 6 parts of Herba Asaris
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 Mahuang Fuzi Xixin 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 Mahuang Fuzi Xixin 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.Described excipient substance is not only the said medicine adjuvant in the described scope, and other do not influence its disease of controlling to be also included within its basic upward interpolation, and just make the excipient substance of its better efficacy.
Further, the integrated novel form technology of preparing of above-mentioned a kind of Mahuang Fuzi Xixin Tang, wherein: the integrated novel form end product that finally can form is: 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 Mahuang Fuzi Xixin Tang, wherein: indexs such as said integrated novel form is moving according to pharmacology, drug effect, the medicine of traditional Chinese medical science global theory, compatibility theory and medicine, toxicity, adopt medicament nano powder body, micro-powder, monomer, effective ingredient, effective site, active substance group, Chinese medical concrete, water drug-decocting concentrating liquid to unite use with different pharmaceutical carriers.And can mix its one or more as required.
Integrated novel form technology of preparing of a kind of Mahuang Fuzi Xixin Tang and production method thereof, it may further comprise the steps:
Step 1: get each prepared slices of Chinese crude drugs pretreatment, insert pulverizer after the weighing and be crushed to the 80-200 order, adopt supersonic airstream to be crushed to the 1-10 micron then, get different Chinese medicine micropowder, standby.
Step 2: get 30%-90% alcohol-water solution that 60% Herba Ephedrae micropowder doubly measures 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.
Step 3: get 60% Radix Aconiti Lateralis Preparata 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% Herba Asari micropowder, adopt the swing nanon ball-mill of independent research to grind 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 Mahuang Fuzi Xixin 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 Mahuang Fuzi Xixin 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 Mahuang Fuzi Xixin 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 Mahuang Fuzi Xixin Tang, wherein: its key point is the different and property of medicine and use the different of carrier according to the nanometer particle size of crude drug, can produce the different targeting controlled capability that eases up.
The outstanding substantive distinguishing features and the obvious improvement of technical solution of the present invention is mainly reflected in:
The present invention will in time fill up both at home and abroad and use " nano-carrier multiple techniques " and researching and developing the blank in " the integrated novel form of Mahuang Fuzi Xixin Tang " field with theory of integrated Chinese and western medicine, product has the targeting advantage such as wide that distributes, and research and development have reached world lead level.No both at home and abroad identical or similar industrialization report.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 the targeting characteristics such as wide that distribute; Do not see open report at home and abroad in the document, the 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 Mahuang Fuzi Xixin Tang, its special feature is: making the raw materials of effective components composition is by weight ratio---
6 parts in Herba Ephedrae, 9 parts of Radix Aconiti Lateralis Preparatas, 6 parts of Herba Asaris
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% Herba Ephedrae micropowder doubly measures 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 Aconiti Lateralis Preparata 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% Herba Asari micropowder, adopt the swing nanon ball-mill of independent research to grind 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---
6 parts in Herba Ephedrae, 9 parts of Radix Aconiti Lateralis Preparatas, 6 parts of Herba Asaris
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---
6 parts in Herba Ephedrae, 9 parts of Radix Aconiti Lateralis Preparatas, 6 parts of Herba Asaris
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---
6 parts in Herba Ephedrae, 9 parts of Radix Aconiti Lateralis Preparatas, 6 parts of Herba Asaris
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, to have the novelty and the breakthrough of essence be to have found out the key point that nanometer Chinese medicine compound Chinese and western medicine theory combines in the present invention.Simultaneously, utilization nano-carrier multiple techniques and theory of integrated Chinese and western medicine research and development " the integrated novel form of Mahuang Fuzi Xixin Tang ", product has characteristics such as targeting distributes extensively, slow controlled release properties is strong." 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: monomer, effective site, nanoparticulate carriers etc. be strange, be tiny, be cloudy.Traditional Chinese medical science organic conception thought, Chinese medical concrete, water drug-decocting concentrating liquid etc. be just, be grand, be the sun.Very just be harmonious then negative and positive intercommunication, the negative and positive intercommunication is then coordinating water and fire, is the optimum balance attitude.Doctor trained in Western medicine research is precise and tiny, and theory of Chinese medical science is that circle melts, and both are harmonious, and have just really embodied the organic conception of the combination of Chinese and Western medicine, and " close " is that " integration " is for holding.The tidemark that greatness lies in the capacity, the coordinating water and fire the present invention of being only asked most.This integrated novel form is by the reasonable compatibility of Chinese medicine monomer, effective site, active substance, Chinese medicine active substance group, extractum, water drug-decocting concentrating liquid, prepared slices of Chinese crude drugs nano-particle etc., can produce soft, hard capsule or dosage forms such as nanometer membrane, transdermal agent.Can develop simultaneously, can take four time periods respectively by interior external administration by midnight-noon and ebb-flow doctrine, energy and blood of human body flowing law.Can also do film former to nanometer Chinese medicine, transdermal agent is attached to the human body different parts, can directly absorb by skin.The various Chinese medicine nanometer particle size major parts that the present invention prepares are the granule of 50～1000 nanometers.Adopting different nano-medicament carriers to be prepared into nanoparticle, nanosphere, nanocapsule, solid ester matter nanoparticle, magnetic nano particle, immune nano grain, nano-emulsion, vesicle, pharmacosomes, microcapsule, nanoparticle, millimicro ball, millimicro assists etc.Its particle size distribution is 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 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.
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 Mahuang Fuzi Xixin Tang " field with theory of integrated Chinese and western medicine, product has the targeting advantage such as wide that distributes, do not see open report at home and abroad in the document, the complex art characteristics have certain novelty and novelty.Proof the present invention research and development have reached world lead level.
Claims (10)
1. integrated novel form technology of preparing of Mahuang Fuzi Xixin Tang is characterized in that: this integrated novel form raw materials of effective components and weight proportion---
6 parts in Herba Ephedrae, 9 parts of Radix Aconiti Lateralis Preparatas, 6 parts of Herba Asaris.
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 Mahuang Fuzi Xixin 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.
3. according to claim 1, the integrated novel form technology of preparing of 2 described a kind of Mahuang Fuzi Xixin Tangs, 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.The described protection domain of this claim is not only the said medicine adjuvant in the described scope, and other do not influence its disease of controlling to be also included within its basic upward interpolation, and just make the excipient substance of its better efficacy.
4. according to claim 1 or 2 or 3 any integrated novel form technologies of preparing of described a kind of Mahuang Fuzi Xixin 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 Mahuang Fuzi Xixin Tang, it is characterized in that: indexs such as said integrated novel form is moving according to pharmacology, drug effect, the medicine of traditional Chinese medical science global theory, compatibility theory and medicine, toxicity, adopt medicament nano powder body, micro-powder, monomer, effective ingredient, effective site, active substance group, Chinese medical concrete, water drug-decocting concentrating liquid to unite use with different pharmaceutical carriers.And can mix its one or more as required.
6. integrated novel form technology of preparing of Mahuang Fuzi Xixin Tang is characterized in that may further comprise the steps:
Step 1: get each prepared slices of Chinese crude drugs pretreatment, insert pulverizer after the weighing and be crushed to the 80-200 order, adopt supersonic airstream to be crushed to the 1-10 micron then, get different Chinese medicine micropowder, standby.
Step 2: get 30%--90% alcohol-water solution that 60% Herba Ephedrae micropowder doubly measures 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.
Step 3: get 60% Radix Aconiti Lateralis Preparata 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% Herba Asari micropowder, adopt the swing nanon ball-mill of independent research to grind 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 Mahuang Fuzi Xixin 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 Mahuang Fuzi Xixin 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 Mahuang Fuzi Xixin 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 Mahuang Fuzi Xixin Tang according to claim 9, it 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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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102526287A (en) * | 2010-12-15 | 2012-07-04 | 苏州知微堂生物科技有限公司 | Preparation technology and production method of novel yellow decoction integrated dosage form |
| CN102895393A (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 aluminite decoction |
| CN102895329A (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 Chinese angelica powder |
| CN102895394A (en) * | 2011-07-29 | 2013-01-30 | 苏州知微堂生物科技有限公司 | Preparation technology for integrated new formulation of radix stephaniae tetrandrae and rehmannia decoction |
| CN103272011A (en) * | 2013-06-09 | 2013-09-04 | 杨勇 | Pharmaceutical composition for treating flu and preparation method of pharmaceutical composition |
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| CN103432222A (en) * | 2013-08-16 | 2013-12-11 | 包头中药有限责任公司 | Medicine for treating allergic rhinitis |
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Application publication date: 20110622 |