CN102895623A - Preparation technology and production method for integrated new formulation of magnolia bark-ephedra decoction - Google Patents
Preparation technology and production method for integrated new formulation of magnolia bark-ephedra decoction Download PDFInfo
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Abstract
The present invention relates to a preparation technology and a production method for an integrated new formulation of a Magnolia Bark-Ephedra decoction, wherein the raw materials of active ingredients comprise by weight: 9 grams of magnolia bark, 12 grams of ephedra, 9 grams of gypsum, 10 grams of apricot kernel, 10 grams of pinellia, 6 grams of dried ginger, 6 grams of as arum, 30 grams wheat, and 6 grams of Chinese magnoliavine. The production process of the integrated new formulation comprises the following steps of: supersonic air-jet crushing, alcohol-water extraction, ultrasonic crushing extraction, water decocting concentration, supersonic spray drying, nanometer grinding, high pressure homogenization, nano particle preparation and the like. According to the invention, the advantages, such as multi-synergism, multi-target, embodied by a nano-carrier coupling technique, are focused to be taken of. After the integrated new formulation of magnolia bark-ephedra decoction is subjected to scale production, the production cost can be greatly reduced, the quality of products is greatly improved and the targeting property and the sustained and controlled release performance of the medicament are enhanced. The internal and external administration of the integrated new formulation of magnolia bark-ephedra decoction can be realized simultaneously, and can be respectively taken in four time slices according to midnight-noon ebb-flow and qi and blood flowing rule of a human body. The integrated new formulation of magnolia bark-ephedra decoction can be further prepared into films and transdermal agents which are respectively stuck to different parts of a human body according to the midnight-noon ebb-flow and qi and blood flowing rule of the human body and can be directly absorbed through skin.
Description
Technical field
The present invention relates to a kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation, the invention still further relates to a kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation and production method thereof.
Background technology
Chinese medicine decocting liquid compound recipe drug effect chemical reaction is too many because of chemical composition, temporary transient not revealed its Mysterious Veil also, but some mysterious black box drug actions are just ensconced in the Chinese medicine decocting liquid in the Chinese medicinal formulae, can not ask simply Chinese medicine westernization, the modernization of Chinese medicine most and only use monomer and effective site.The Chinese medicine water drug-decocting concentrating liquid could not be given it up! When the Chinese medicinal formulae water decocts, because prescription closes chemical environment complicated in high temperature when frying in shallow oil and the solution, the reaction such as complexation, hydrolysis, oxidation, reduction between intrinsic material may occur in solution, thereby some novel substance that did not originally have in the generation solution, these novel substances produce the 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 improving Chinese medicine compound and new drug level, progressively dwindle Chinese medicine compound and new Chinese medicine and international gap, very important meaning is arranged, also increased new way and new source for the research and development new Chinese medicine simultaneously.
China's drug control relevant laws and regulations regulation changes dosage form and manages as new drug research.The backwardness of preparation level not only affects the performance of curative effect of medication, and cause the medicine added value low, directly affecting the market competition and industrial economy benefit, is to cause China's medical industry product quantity to occupy prostatitis, the world and the output value only is equivalent to the one of the main reasons of one or two transnational drugmaker.
New drug, novel form development level can embody economy and the technical strength of the medical industry of a country.China's 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.
Cortex Magnoliae Officinalis Ephedrae Decoction prescription derives from " Medical Treasures of the Golden Chamber " volume.Ingredients: Cortex Magnoliae Officinalis 9 grams, Herba Ephedrae 12 grams, Gypsum Fibrosum 9 grams, Semen Armeniacae Amarum 10 grams, the Rhizoma Pinelliae 10 grams, Rhizoma Zingiberis 6 grams, Herba Asari 6 grams, Semen Tritici aestivi 30 grams, Fructus Schisandrae Chinensis 6 grams.Usage: upper nine flavors, with 1.2 liters in water, boil first Semen Tritici aestivi ripe, go dregs, receive all medicines, take 700 milliliters, 100 milliliters of decoction being taken warmly, three times on the one.Function: ventilating lung qi for lowering adverse qi, dissipating fluid-retention cough-relieving.Cure mainly: cold fluid-retention heat-transformation pathogenic fluid-retention superinverse.Card is seen the cough dyspnea, and fullness in the chest is irritated, discomfort in the throat, and expectorant sound is filtered, white, slippery and moist fur, floating pulse person.
The side separates:
The Cortex Magnoliae Officinalis Ephedrae Decoction is that XIAOQINGLONG TANG is closed Herba Ephedrae Semen Armeniacae Amarum Gypsum Fibrosum glycyrrhiza decoction, and take Cortex Magnoliae Officinalis sending down the abnormal ascending QI sputum eliminating to stop asthma as monarch, minister is helped with warming the lung dissipating fluid-retention such as Herba Ephedrae, Gypsum Fibrosum, Semen Armeniacae Amarum, the Rhizoma Pinelliae, Herba Asari, Fructus Schisandrae Chinensis, and the sending down the abnormal ascending QI the chest stuffiness relieving is controlled cold fluid-retention and gloomy lung and pressed from both sides hot fullness in the chest card.
Rhizoma Zingiberis, Herba Asari is warm cold retained fluid, Rhizoma Pinelliae lowering the adverse-rising QI and eliminating phlegm, and the cough-relieving of Semen Armeniacae Amarum sending down the abnormal ascending QI, trimethyl gallic acid is received, and 5, one loose one holds back mutually with Herba Ephedrae, and its purpose is depressed lung-energy dispersing but not diaphoresis.The hot cold of Gypsum Fibrosum is led off in the lung hot and suffocating with relieving restlessness, and the Semen Tritici aestivi regulating the spleen and stomach is just being supported.Full side is intended to loose drink sending down the abnormal ascending QI, relieving cough and asthma.Its compatibility focuses on logical lung road, the temperature drink that reduces phlegm of transferring.
Each is discussed:
1, " doctor Men Fajin ": its arteries and veins is also floating if cough, and then exopathogen is in the majority, and loose beyond complete is main, and usage is namely gone Ramulus Cinnamomi, Radix Paeoniae, Radix Glycyrrhizae in XIAOQINGLONG TANG, add Cortex Magnoliae Officinalis, Gypsum Fibrosum, Semen Tritici aestivi, still for the purpose of the pneumonopathy.With therefore the heat of Ramulus Cinnamomi, the receipts of Radix Paeoniae, Radix Glycyrrhizae is slow, generally show need not, and add the following gas of Cortex Magnoliae Officinalis, Gypsum Fibrosum is with heat clearing away, Semen Tritici aestivi is introduced in the stomach, helps it to rise the gas of sending out, at one stroke and table solution normal pulse, in the power of putting in primary disease, then overwhelming force can become ear.Once cut out drinking, soar and go if directly make the little Green Dragon carry pneumonopathy.
2, " Shen notes Medical Treasures of the Golden Chamber ": this drifts along with feeling pulse and the battalion of minute lung defends and is subjected to disease also.Cough and floating pulse, ailment said due to cold or exposure is being defended, i.e. pulmonary distension and so on, and its disease is still shallow, and is evil in showing out when making.Therefore with Cortex Magnoliae Officinalis, let out in the heart QI excess under the Semen Armeniacae Amarum, Herba Ephedrae opens that the natural fibre line of meat is got rid of evils, Gypsum Fibrosum is with the warm of fresh breeze, hot, half, the double cold and clearing away phlegm drink of visitor that drives of Rhizoma Zingiberis, the five tastes are received the heat of lung, Semen Tritici aestivi is to transfer taste also.
3, " the ancient prescription choosing is annotated ": the Cortex Magnoliae Officinalis Ephedrae Decoction, the change side of the large and small Green Dragon also.Cough and dyspnea is uttered a word, and the floating pulse person is to belong to the aqueous vapor superinverse that exopathogen is agitated the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels, defends without relating to Ramulus Cinnamomi, Radix Paeoniae, Radix Glycyrrhizae and battalion.Therefore add Cortex Magnoliae Officinalis to fall adverse rising of stomach-QI, Semen Tritici aestivi is taken advantage of to fall the motive, fiber crops, Fructus Pruni, Gypsum Fibrosum still expel the heat-evil from lung meridian and deposit the moon, Herba Asari, the Rhizoma Pinelliae deeply cloudy minute, the aproll of dispelling is cold, and Rhizoma Zingiberis, the five tastes are taken the photograph the sun and are supervised that it is contrary, at one stroke and the therapeutic method to keep the adverse QI flowing downwards that expels the heat-evil, the merit that loose heresy consolidates is all standby, then the clear respectful order of lung meridian voluntarily, what suffers from the cough with dyspnea not tranquil person that uttered a word?
Clinical practice:
We can be used for treating bronchitis, bronchopneumonia, bronchial asthma, emphysema, the disease such as pulmonary heart disease and see above-mentioned card machine person.
Pharmacological research:
The Cortex Magnoliae Officinalis Ephedrae Decoction for the coughing of chronic panting property lung pattern disease acute attack stage, expectorant, breathe heavily, the symptom such as vexed has the rapid recovery effect.3 of the model cases of chronic the panting property lung pattern disease acute attack stage of clinical application Cortex Magnoliae Officinalis Ephedrae Decoction treatment are arranged, analyze dialectical thinking and the plus-minus medication of the party in this type of lysis for the treatment of.Finally reach a conclusion: the Cortex Magnoliae Officinalis Ephedrae Decoction closes symptom for the lung road heap soil or fertilizer over and around the roots that chronic panting property lung pattern disease acute attack stage occurs, and has the effect of opening the lung road, recovering the normal elevating function of lung qi, and it is evident in efficacy.
The Cortex Magnoliae Officinalis decoct has inhibitory action to streptococcus pneumoniae, diphtheria corynebacterium, Hemolytic streptococcus, staphylococcus aureus, bacillus subtilis, will Hayes and Amur dysentery bacterium, anthrax bacillus and some dermatophytess.Magnocurarine, iso-agnolol have obvious central myorelaxant effects.Magnocurarine, the magnocurarine striped muscle that can relax.To intestinal tube, low dose of appearance is excited, and heavy dose is then for suppressing.Magnolol has preventive and therapeutic effect to Experimental Gastric Ucler.Cortex Magnoliae Officinalis has hypotensive activity, and reflexive ground causes respiratory stimulant during blood pressure lowering, and heart rate increases.
The tangible novelty of tool of the present invention and breakthrough are to have found out the key point that Cortex Magnoliae Officinalis Ephedrae Decoction modern Chinese medicine novel form Chinese and western medicine theory combines, the present invention will in time fill up both at home and abroad and use " nano-carrier multiple techniques " and researching and developing the blank in " the integrated novel form of Cortex Magnoliae Officinalis Ephedrae Decoction " field with theory of integrated Chinese and western medicine, product has the targeting advantage such as wide that distributes, both at home and abroad without same or similar bibliographical information.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 retrieval.Utilize domestic and foreign databases to carry out update search, comprehensive domestic and foreign literature is read, analyzing contrast obtains drawing 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 body that is rich in trace element, the medicine monomer, effective site, effective part group, Chinese medical concrete, water drug-decocting concentrating liquids etc. are prepared the nanosphere of different-grain diameter size with the different pharmaceutical carrier, nanocapsule, polymer micelle, solid ester matter nanoparticle, magnetic nano particle, immunonanoparticles, nano-emulsion, suspensoid, vesicle, pharmacosomes, microcapsule, nanoparticle, nanoparticles, millimicro is assisted etc., and then mixing is respectively charged into soft, 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) use nano-carrier multiple techniques and theory of integrated Chinese and western medicine research and development " the integrated novel form of Nano medication ", product has the characteristics such as targeting distributes extensively, slow controlled release properties is strong; Have no at home open report in the document, these project complex art characteristics have certain novelty and novelty.Look into new numbering: 200921c0704948.
Further: this dosage form preparation technology is the advantage separately of having integrated the traditional Chinese medical science, doctor trained in Western medicine, take the organic conception of theory of Chinese medical science and pay attention to collaborative idea between medicine and determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs as the overall strategy tactical thinking, in conjunction with modern western pharmacology, pharmacokinetics, toxicology, pharmaceutics scheduling theory, pay attention to effectiveness and the therapeutic effect of certified Chinese medicine one matter monomer in treating, pay attention to the mass action that Chinese medicine active substance, effective site and active materials play the treatment disease.Pay attention to the assosting effect that the contained trace element of Chinese medicine plays the treatment disease.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 using nano-carrier multiple techniques development modern Chinese medicine.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 a kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation and production method thereof are provided.
Purpose of the present invention is achieved through the following technical solutions:
A kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation and production method thereof, wherein: the raw material of this integrated novel form effective ingredient and weight proportion---
6 parts of Cortex Magnoliae Officinalis 9 grams, Herba Ephedrae 12 grams, Gypsum Fibrosum 9 grams, Semen Armeniacae Amarum 10 grams, the Rhizoma Pinelliae 10 grams, Rhizoma Zingiberis 6 grams, Herba Asari 6 grams, Semen Tritici aestivi 30 grams, Fructus Schisandrae Chinensis.
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.Above-mentioned a kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation and production method thereof, wherein: medicine and carrier are prepared into the pharmaceutical carrier crude drug, 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, nanosuspension, the microcapsule etc., and can as required one or more be mixed.Described protection domain is not only the said medicine support material medicine in the described scope, is also included within to prepare on its basis or add the curative effect that other do not affect its disease of controlling, and just makes the pharmaceutical carrier crude drug of its better efficacy.Further, above-mentioned a kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation and production method thereof, wherein: the drug carrier material that this novel form is selected, activating agent, help Emulsion, the excipient substances such as dispersant are gelatin, albumin, 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, cyanoacrylate, the semisolid poe, triglyceride is (such as three stearic acid, three Palmic acids, three lauric acids, in three oleic acid etc., the glyceride of long-chain fatty acid), glyceride (such as glyceryl monostearate, contains list, two, the synthetic glyceride of triglyceride), cholesterol, Polyethylene Glycol, microcrystalline wax, the whale ester type waxes, erythrocyte, Montmorillonitum, in the tea powder etc. one or more.Described excipient substance is not only the said medicine adjuvant in the described scope, and other do not affect its disease of controlling to be also included within the upper interpolation in its basis, and just make the excipient substance of its better efficacy.
Further, above-mentioned a kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation and production method thereof, wherein: said integrated novel form adopts medicament nano powder body, micro-powder, medicine monomer, effective ingredient, effective site, active materials, Chinese medical concrete, water drug-decocting concentrating liquid to unite use with different excipient substance, pharmaceutical carrier according to indexs such as the pharmacology of traditional Chinese medical science global theory, compatibility theory and medicine, drug effect, medicine generation, toxicitys.And can mix its one or more according to the preparation needs.
Again further, above-mentioned a kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation and production method thereof, 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, unguentum, oral solution, slow releasing tablet, controlled release tablet.
A kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation 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, then adopt supersonic jet mill to the 1-10 micron, get different Chinese medicine micropowder, for subsequent use.
Step 2: get 30%--90% alcohol-water solution that 60% Cortex Magnoliae Officinalis, Herba Ephedrae, Gypsum Fibrosum, Semen Armeniacae Amarum, Rhizoma Pinelliae 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, recovered alcohol gets extract for subsequent use.
Step 3: get 60% Rhizoma Zingiberis, Herba Asari, Semen Tritici aestivi, Fructus Schisandrae Chinensis micropowder, adopt the ultrasound wave dispersion extractor to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz--120KHz, to pulverize extraction time be 10-100 minute, gets extract for subsequent use.
Step 4: with step 2, step 3 gained Chinese medicine extract, adopt nanon ball-mill to grind 4-16 hour, get the nano powder that particle size distribution is the 50-1000 nanometer, for subsequent use.
Step 5: get each Chinese medicine micropowder of 40%, 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 is concentrated, gets extractum or water drug-decocting concentrating liquid with for subsequent use.
Step 6: with step 2, step 3, step 4 gained Chinese medicine extract, nano powder as required with and the different property of medicine, pharmacological actions, can adopt respectively the technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared, obtain the medicine materials such as different medicine monomers, effective site, active materials.
Step 7: adopt different excipient substances by version in 2010 " preparation part of standards standard and " the even method of high pressure breast is adopted respectively in the requirement in 2005 version Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " etc. in the Chinese pharmacopoeia above-mentioned gained medicine material, inclusion technique, solid state technology, polishing, solvent-fusion method, squeezing and pressing method, complex coacervation, emulsion-crosslinking method, the polymerization dispersion method, fusion method, the 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, nanosuspension, the crude drug such as microcapsule.The crude drug particle diameter is between 10 nanometers-10 micron.
Step 8: " preparation part of standards code requirement in the Chinese pharmacopoeia was got in the crude drug such as step 5 gained Chinese medical concrete or water drug-decocting concentrating liquid and step 7 gained nanoparticle, liposome, nano-emulsion, microcapsule one or more and is mixed by formula proportion by version in 2010.
Step 9: in GMP10000 level toilet, with the above-mentioned crude drug that mixes adopt full-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can by version in 2010 " 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 respectively several, bottling, mounted box, sealing, stickup labeling, plays the exterior and interior packings such as code, vanning.Packaged product is transported to the appointed place by production batch and unifies instantaneously sterilising, and opens the sterilization report.
Above-mentioned a kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation and production method thereof; wherein: the Chinese medicine of using in described step 1, step 2, the step 3 is pulverized and extracting method; described protection domain is not only described technology of preparing and method; as required, be also included within and add on its basis or use other better effects if, more economical, renewal, breaking method more advanced, more environmental protection, extracting method and technology.
Further, above-mentioned a kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation and production method thereof, wherein: the crude drug such as the dissimilar nanoparticle that employing different pharmaceutical adjuvant is prepared in the medicine monomer in the described step 6, active substance, effective site technology of preparing and the described step 7, nano-emulsion.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, preparation method more advanced, more environmental protection and technology.
Further, above-mentioned a kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation and production method thereof, wherein: its key point 1 is different utilization nano-carrier multiple techniques different according to the particle diameter of crude drug and the property of medicine, can produce the gentle controlled capability of different targetings.
Again further, above-mentioned a kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation and production method thereof, wherein: its key point 2 is to develop simultaneously by interior external administration, can take four time periods respectively by midnight-noon and ebb-flow doctrine, energy and blood of human body flowing law.Also can be prepared into membrane, transdermal agent is attached to respectively different parts by the energy and blood of human body flowing law, directly absorb by skin.
The outstanding substantive distinguishing features of technical solution of the present invention and significant progressive being mainly reflected in:
The tangible novelty of tool of the present invention and breakthrough are to have found out the key point that Cortex Magnoliae Officinalis Ephedrae Decoction Chinese and western medicine theory combines, the present invention will in time fill up both at home and abroad and use " nano-carrier multiple techniques " and researching and developing the blank in " the integrated novel form of Cortex Magnoliae Officinalis Ephedrae Decoction " field with theory of integrated Chinese and western medicine, product has the targeting advantage such as wide that distributes, both at home and abroad without same or similar bibliographical information.Show substantive progressive and novelty of the present invention by international one-level novelty assessment report and Patent database searching.Utilize domestic and foreign databases to carry out update search, comprehensive domestic and foreign literature is read, analyzing contrast obtains drawing 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 body that is rich in trace element, the medicine monomer, effective site, effective part group, Chinese medical concrete, water drug-decocting concentrating liquids etc. are prepared the nanosphere of different-grain diameter size with the different pharmaceutical carrier, nanocapsule, polymer micelle, solid ester matter nanoparticle, magnetic nano particle, immunonanoparticles, nano-emulsion, suspensoid, vesicle, pharmacosomes, microcapsule, nanoparticle, nanoparticles, millimicro is assisted etc., and then mixing is respectively charged into soft, 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) use nano-carrier multiple techniques and theory of integrated Chinese and western medicine research and development " the integrated novel form of Nano medication ", product has the characteristics such as targeting distributes extensively, slow controlled release properties is strong; Have no at home open report in the document, these project complex art characteristics have certain novelty and novelty.Science and technology is looked into new numbering: 200921c0704948.
Further, this dosage form preparation technology and production method thereof are to have integrated the advantage separately of the traditional Chinese medical science, doctor trained in Western medicine, take the organic conception of theory of Chinese medical science and pay attention to collaborative idea between medicine and determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs as the overall strategy tactical thinking, in conjunction with modern western pharmacology, pharmacokinetics, toxicology, pharmaceutics scheduling theory, pay attention to effectiveness and the therapeutic effect of certified Chinese medicine one matter monomer in treating, pay attention to the assosting effect that Chinese medicine active substance, effective site and active materials play the treatment disease.Pay attention to the assosting effect that the contained trace element of Chinese medicine plays the treatment disease.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.To adopt Chinese medicine crude drug nano-powder, monomer, effective site, effective part group, traditional Chinese drug inspissation extractum, water drug-decocting concentrating liquid, nano-medicament carrier etc. to unite use on the compatibility.These various Chinese traditional powder particle diameter 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, nanoparticles, millimicro assists etc.Its particle size distribution is in 10 nanometers---between-10 microns.Then theoretical according to difference, the difference of slow controlled release time and the traditional Chinese medical science monarch of pharmacology, targeting, reasonable compatibility mixes, and is respectively charged among hard capsule and the soft capsule.Difference according to the dissolving of capsule material, disintegrate, jitter time can be prepared into respectively the targeted systems such as RE targeted system, stomach mucosa absorption system, intestinal absorption system, colon absorption system.Compare Chinese medicine and medicine monomer, the target-oriented drug 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.Multichip carrier and multiple medicines thing monomer etc. are united use, have broken through the traditional monarch compatibility theory of the traditional Chinese medical science, for the modern Chinese medicine development provides a practical effective novel form compatibility program.To have substantial technological innovation to break through.
Purpose of the present invention, advantage and disadvantage 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
A kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation and production method thereof, its special feature is: the raw material composition of making effective ingredient is by weight ratio---
6 parts of Cortex Magnoliae Officinalis 9 grams, Herba Ephedrae 12 grams, Gypsum Fibrosum 9 grams, Semen Armeniacae Amarum 10 grams, the Rhizoma Pinelliae 10 grams, Rhizoma Zingiberis 6 grams, Herba Asari 6 grams, Semen Tritici aestivi 30 grams, Fructus Schisandrae Chinensis.
Further, play the synergy of standing like the legs of a tripod on the integrated new drug formulation compatibility of Cortex Magnoliae Officinalis Ephedrae Decoction of the present invention: 1, prepare nanometer, micro-powder with the prepared slices of Chinese crude drugs, the bioavailability after strengthening Cortex Magnoliae Officinalis Ephedrae Decoction curative effect and significantly improve prepared slices of Chinese crude drugs cell wall breaking with this; 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 Cortex Magnoliae Officinalis Ephedrae Decoction 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 Cortex Magnoliae Officinalis Ephedrae Decoction Chinese medicine compound uniqueness also keeps and has strengthened traditional Chinese medical science organic conception, monarch concept.Above three aspects: associating compatibility uses, different according to Nano medication particle diameter and character, can reach many targeting, many collaborative, slow controlled release texts, and play useful effect to strengthening the medicine pharmacologically active, effective ingredient pharmacological action effect is significantly higher than conventional formulation.
Production method of the present invention may further comprise the steps:
At first, get each prepared slices of Chinese crude drugs pretreatment, insert pulverizer after the weighing and be crushed to the 80-200 order, then adopt supersonic jet mill to the 1-10 micron, get different Chinese medicine micropowder, for subsequent use.Getting 30%--90% alcohol-water solution that 60% Cortex Magnoliae Officinalis, Herba Ephedrae, Gypsum Fibrosum, Semen Armeniacae Amarum, Rhizoma Pinelliae micropowder doubly measure with 6-12 mixes and soaked 1-2 days, reflux, extract, 3 times, extract water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility, recovered alcohol gets extract for subsequent use.Get 60% Rhizoma Zingiberis, Herba Asari, Semen Tritici aestivi, Fructus Schisandrae Chinensis micropowder, adopt the ultrasound wave dispersion extractor to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz--120KHz, extraction time are 10-100 minute, get extract for subsequent use.With above-mentioned gained Chinese medicine extract, adopt nanon ball-mill to grind 4-16 hour, get the nano powder that particle size distribution is 50 nanometers-1000 nanometer, for subsequent use.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 extractum or water drug-decocting concentrating liquid with for subsequent use.With above-mentioned gained Chinese medicine extract, nano powder as required with and the different property of medicine, pharmacological actions, can adopt respectively the technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared, obtain the medicine materials such as different medicine monomers, effective site, active materials.Adopt different excipient substances and carrier by version in 2010 " related preparations part of standards standard and " the even method of high pressure breast is adopted respectively in the requirement in 2005 version Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " etc. in the Chinese pharmacopoeia above-mentioned gained medicine material, inclusion technique, solid state technology, polishing, solvent-fusion method, squeezing and pressing method, complex coacervation, emulsion-crosslinking method, the polymerization dispersion method, fusion method, the 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, nanosuspension, the crude drug such as microcapsule.The crude drug particle size distribution of preparing is between 10 nanometers-10 micron." preparation part of standards code requirement in the Chinese pharmacopoeia was got in the crude drug such as above-mentioned gained Chinese medical concrete or water drug-decocting concentrating liquid and above-mentioned gained nanoparticle, liposome, nano-emulsion, microcapsule one or more and is mixed by formula proportion by version in 2010.In GMP10000 level toilet, with the above-mentioned crude drug that mixes adopt full-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can make by the related preparations standard criterion the above-mentioned end product of other type.The end product of making is carried out respectively several, bottling, mounted box, sealing, stickup labeling, plays the exterior and interior packings such as code, 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.
Its raw material of making effective ingredient forms---
6 parts of Cortex Magnoliae Officinalis 9 grams, Herba Ephedrae 12 grams, Gypsum Fibrosum 9 grams, Semen Armeniacae Amarum 10 grams, the Rhizoma Pinelliae 10 grams, Rhizoma Zingiberis 6 grams, Herba Asari 6 grams, Semen Tritici aestivi 30 grams, Fructus Schisandrae Chinensis.
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 a version " preparation part of Chinese pharmacopoeia hard capsule standard in 2010, do not add adjuvant, antiseptic, adopt full-automatic capsule filling machine fill hard capsule, make hard capsule.Carry out again several, bottle, seal, paste labeling, play the exterior and interior packings such as code, 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.
Its raw material of making effective ingredient forms---
6 parts of Cortex Magnoliae Officinalis 9 grams, Herba Ephedrae 12 grams, Gypsum Fibrosum 9 grams, Semen Armeniacae Amarum 10 grams, the Rhizoma Pinelliae 10 grams, Rhizoma Zingiberis 6 grams, Herba Asari 6 grams, Semen Tritici aestivi 30 grams, Fructus Schisandrae Chinensis.
Its manufacture process is as follows: in 10000 grades of toilets of GMP with water drug-decocting concentrating liquid, nanometer liposome, nano-emulsion, microemulsion in 4: 2: 2: after 2 ratios are mixed, adopt a version " preparation part of Chinese pharmacopoeia soft capsule standard in 2010, do not add adjuvant, antiseptic, adopt full-automatic soft capsule filling machine packing soft capsule, make soft capsule.Carry out again several, bottle, seal, paste labeling, play the exterior and interior packings such as code, 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, nanoparticle, nano-emulsion.
Its raw material of making effective ingredient forms---
6 parts of Cortex Magnoliae Officinalis 9 grams, Herba Ephedrae 12 grams, Gypsum Fibrosum 9 grams, Semen Armeniacae Amarum 10 grams, the Rhizoma Pinelliae 10 grams, Rhizoma Zingiberis 6 grams, Herba Asari 6 grams, Semen Tritici aestivi 30 grams, Fructus Schisandrae Chinensis.
Its manufacture process is as follows: after in the GMP10000 level toilet extractum, nanoparticle, nano-emulsion being mixed in 4: 3: 3 ratios, " a preparation part of Chinese pharmacopoeia membrane standard, filmogen adopts polyvinyl alcohol, makes membrane to adopt version in 2010.Carry out again mounted box, sealing, stickup labeling, play the exterior and interior packings such as code, 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 every medicine film pasted 12-72 hour, pasted the medicine position: the positions such as neck, chest, back part, abdominal part, shank, foot bottom, Ashi point.
Can find out by above-mentioned text description: the tangible novelty of tool of the present invention and breakthrough are to have found out the key point that Cortex Magnoliae Officinalis Ephedrae Decoction Chinese medicine compound Chinese and western medicine theory combines, and the compound compatibility of modern Chinese medicine and technology of preparing can change the pharmacokinetic parameter of medicine monomer, effective ingredient or effective part group.This has proved the scientific meaning of Chinese medicine compound compatibility from the pharmacokinetics level." very just be harmonious, negative and positive intercommunication, coordinating water and fire, precise and tiny circle melt, and greatness lies in the capacity " is that the precise and tiny circle of the integrated novel form of this medicine melts Integration Theory basis and guiding theory.Among the present invention: monomer, effective site, nanoparticle and carrier etc. be strange, be tiny, be cloudy.Traditional Chinese medical science organic conception, 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 very just 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 materials, extractum, water drug-decocting concentrating liquid, prepared slices of Chinese crude drugs nano-particle etc., can produce soft, hard capsule or the dosage forms such as nanometer membrane, transdermal agent.Can develop simultaneously, can take four time periods respectively by midnight-noon and ebb-flow doctrine, energy and blood of human body flowing law by interior external administration.Can also do film former to nano traditional Chinese medicine, transdermal agent is attached to the human body different parts, can directly absorb by skin.
Further see, the various Chinese medicine particle diameter major parts that the present invention prepares are the granule of 50～1000 nanometers.Adopt different nano-medicament carriers and technology can be prepared into nanoparticle, nanosphere, solid ester plastid, nano-emulsion, pharmacosomes, microgranule, nanoparticles, little assist etc.Its particle size distribution is in 10 nanometers---between-10 microns.Then theoretical according to difference, the difference of slow controlled release time and the traditional Chinese medical science monarch of medicine pharmacology, targeting, reasonable compatibility mixes, and can be respectively charged among hard capsule and the soft capsule.Difference according to the dissolving of capsule material, disintegrate, jitter time can be prepared into respectively the targeted systems such as RE targeted system, stomach mucosa absorption system, intestinal absorption system, colon absorption system.Compare Chinese medicine and medicine monomer or Western medicine, the overall coordination therapeutical effect of this integrated novel form and target-oriented drug, slow controlled capability are stronger, and curative effect is more outstanding, and toxic and side effects still less.For Cortex Magnoliae Officinalis Ephedrae Decoction modern Chinese medicine preparation and production have proposed a practical effective novel form compatibility program.To have substantial innovation and technological break-through.
Claims (10)
1. a Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation and production method thereof is characterized in that: 6 parts of the raw material of this novel form effective ingredient and weight proportion---Cortex Magnoliae Officinalis 9 grams, Herba Ephedrae 12 grams, Gypsum Fibrosum 9 grams, Semen Armeniacae Amarum 10 grams, the Rhizoma Pinelliae 10 grams, Rhizoma Zingiberis 6 grams, Herba Asari 6 grams, Semen Tritici aestivi 30 grams, Fructus Schisandrae Chinensis.Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.
2. a kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation according to claim 1 and production method thereof, it is characterized in that: medicine and carrier are prepared into the pharmaceutical carrier crude drug, 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, nanosuspension, the microcapsule etc., and can as required one or more be mixed.The described protection domain of this claim is not only the said medicine support material medicine in the described scope, is also included within to prepare on its basis or add the curative effect that other do not affect its disease of controlling, and just makes the pharmaceutical carrier crude drug of its better efficacy.
3. according to claim 1,2 described a kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation and production methods thereof, it is characterized in that: the drug carrier material that this novel form is selected, activating agent, help Emulsion, the excipient substances such as dispersant are gelatin, albumin, 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, cyanoacrylate, the semisolid poe, triglyceride is (such as three stearic acid, three Palmic acids, three lauric acids, in three oleic acid etc., the glyceride of long-chain fatty acid), glyceride (such as glyceryl monostearate, contains list, two, the synthetic glyceride of triglyceride), cholesterol, Polyethylene Glycol, microcrystalline wax, the whale ester type waxes, erythrocyte, Montmorillonitum, in the tea powder 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 affect its disease of controlling to be also included within the upper interpolation in its basis, and just make the excipient substance of its better efficacy.
4. according to claim 1 and 2 or the described a kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation of 3 any one and production method thereof, it is characterized in that: said integrated novel form adopts medicament nano powder body, micro-powder, medicine monomer, effective ingredient, effective site, active materials, Chinese medical concrete, water drug-decocting concentrating liquid to unite use with different excipient substance, pharmaceutical carrier according to indexs such as the pharmacology of traditional Chinese medical science global theory, compatibility theory and medicine, drug effect, medicine generation, toxicitys.And can mix its one or more according to the preparation needs.
5. according to claim 1 and 2 or the described a kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation of 3 or 4 any one and production method thereof, it is characterized in that: the integrated novel form end product that finally can form is: tablet, powder, suppository, stick, granule, soft capsule, hard capsule, effervescent, drop pill, aerosol, unguentum, oral solution, slow releasing tablet, controlled release tablet.
6. a Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation and production method thereof 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, then adopt supersonic jet mill to the 1-10 micron, get different Chinese medicine micropowder, for subsequent use.
Step 2: get 30%--90% alcohol-water solution that 60% Cortex Magnoliae Officinalis, Herba Ephedrae, Gypsum Fibrosum, Semen Armeniacae Amarum, Rhizoma Pinelliae 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, recovered alcohol gets extract for subsequent use.
Step 3: get 60% Rhizoma Zingiberis, Herba Asari, Semen Tritici aestivi, Fructus Schisandrae Chinensis micropowder, adopt the ultrasound wave dispersion extractor to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz--120KHz, extraction time are 10-100 minute, get extract for subsequent use.
Step 4: with step 2, step 3 gained Chinese medicine extract, adopt nanon ball-mill to grind 4-16 hour, get the nano powder that particle size distribution is the 50-1000 nanometer, for subsequent use.
Step 5: get each Chinese medicine micropowder of 40%, 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 is concentrated, gets extractum or water drug-decocting concentrating liquid with for subsequent use.
Step 6: with step 2, step 3, step 4 gained Chinese medicine extract, nano powder as required with and the different property of medicine, pharmacological actions, can adopt respectively the technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared, obtain the medicine materials such as different medicine monomers, effective site, active materials.
Step 7: adopt different excipient substances and carrier by version in 2010 " related preparations part of standards standard and " the even method of high pressure breast is adopted respectively in the requirement in 2005 version Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " etc. in the Chinese pharmacopoeia above-mentioned gained medicine material, inclusion technique, solid state technology, polishing, solvent-fusion method, squeezing and pressing method, complex coacervation, emulsion-crosslinking method, the polymerization dispersion method, fusion method, the 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, nanosuspension, the crude drug such as microcapsule.The crude drug particle diameter is between 10 nanometers-10 micron.
Step 8: " preparation part of standards code requirement in the Chinese pharmacopoeia was got in the crude drug such as step 5 gained Chinese medical concrete or water drug-decocting concentrating liquid and step 7 gained nanoparticle, liposome, nano-emulsion, microcapsule one or more and is mixed by formula proportion by version in 2010.
Step 9: in GMP10000 level toilet, with the above-mentioned crude drug that mixes adopt full-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can by version in 2010 " 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 respectively several, bottling, mounted box, sealing, stickup labeling, plays the exterior and interior packings such as code, vanning.Packaged product is transported to the appointed place by production batch and unifies instantaneously sterilising, and opens the sterilization report.
7. a kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation according to claim 6 and production method thereof; it is characterized in that: the pulverizing of using in described step 1, step 2, the step 3 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 and add on its basis or use other better effects if, more economical, renewal, breaking method more advanced, more environmental protection, extracting method and technology.
8. a kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation according to claim 7 and production method thereof; it is characterized in that: the medicine monomer in the described step 6; active substance; the dissimilar nanoparticle that adopts the different pharmaceutical adjuvant to be prepared in effective site technology of preparing and the described step 7; the crude drug such as nano-emulsion; the described protection domain of this claim is not only described technology of preparing and method; as required, be also included within and add on its basis or use other better effects if; more economical; upgrade; more advanced; the more preparation method of environmental protection and technology.
9. a kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation according to claim 8 and production method thereof, it is characterized in that: its key point 1 is different utilization nano-carrier multiple techniques different according to the particle diameter of crude drug and the property of medicine, can produce the gentle controlled capability of different targetings.
10. a kind of Cortex Magnoliae Officinalis preparation technique for ephedra decoction in novel formed formulation according to claim 9 and production method thereof is characterized in that: its key point 2 be can in external administration develop simultaneously, can take four time periods respectively by midnight-noon and ebb-flow doctrine, energy and blood of human body flowing law.Also can be prepared into membrane, transdermal agent is attached to respectively different parts by the energy and blood of human body flowing law, directly absorb by skin.
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| CN102100661A (en) * | 2009-12-17 | 2011-06-22 | 苏州知微堂生物科技有限公司 | Process for preparing novel formulation of integrative traditional Chinese medicine and production method thereof |
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| CN105435185A (en) * | 2015-12-28 | 2016-03-30 | 杨玲林 | Medicine used for treating cough caused by excessive internal heat |
| CN110227141A (en) * | 2019-07-17 | 2019-09-13 | 赵亚泽 | It is a kind of for alleviating the fermented type Chinese materia medica preparation and preparation method of livestock and poultry Rheology due to caused by bacterium or virus |
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