CN102895632A - Preparation technology and production method for integrated new formulation of life-prolonging decotion - Google Patents
Preparation technology and production method for integrated new formulation of life-prolonging decotion 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 life-prolonging decoction, wherein the raw materials of active ingredients comprise: 2 parts by weight of honey-fried licorice, 2 parts by weight of cassia bark core, 2 parts by weight of Chinese angelica, 2 parts by weight of ginseng, 2 parts by weight of gypsum, 2 parts by weight of dried ginger, 3 parts by weight of ephedra stem, 1 part by weight of Sichuan lovage root, and 40 parts by weight of apricot kenel. 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 life-prolonging 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 life-prolonging 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 life-prolonging 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 decoction to stimulate a dying person dosage form preparation technology, the invention still further relates to a kind of decoction to stimulate a dying person dosage form preparation technology 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.
The decoction to stimulate a dying person prescription derives from " outer platform " volume 14 and draws " at all times record is tested ".The party's ingredients is 2 liang in Radix Glycyrrhizae (processing), 2 liang of Cortex Cinnamomi, 2 liang of Radix Angelicae Sinensis, 2 liang of Radix Ginsengs, 2 liang in Gypsum Fibrosum (broken, silk floss is wrapped up in), 2 liang of Rhizoma Zingiberiss, 3 liang in Herba Ephedrae (removing joint), 1 liang of rhizome of chuanxiong, 40 pieces in Semen Armeniacae Amarum (removing the peel sharp two core).Usage and dosage: " upper nine flavors, a pipeful of with water, boil and get four liters, one liter of decoction being taken warmly, when little antiperspirant, the thin ridge that covers, with several seats, sweating is then healed; Antiperspirant does not more take.Decoction to stimulate a dying person, see " Medical Treasures of the Golden Chamber. apoplexy severe and migratory arthralgia abnormal pulse card also controls the 5th " the rear attached side of a piece of writing: " " at all times record is tested " decoction to stimulate a dying person is controlled middle hemiplegia after apoplexy, and health can not be held from receiving, aphasia, dazing with inability to point out the location of pain, or inability of turning body due to contracture.Cure mainly: large numbness, not with, an or half body arm on the other hand, aphasia makes bold not knowing the people, does not know sore spot, unconsciously sufferings all over the body; And treat upper gas cough with dyspnea, and appearance is swollen greatly, but must lie prostrate, must not crouch, and middle hemiplegia after apoplexy, health can not be received certainly, or inability of turning body due to contracture; Hold concurrently to treat puerpera do not dehematize greatly person and children's old man; Cough with dyspnea, the appearance serious edema.Modern clinic cures mainly cerebral thrombosis.
The side separates:
Herba Ephedrae Ramulus Cinnamomi Gypsum Fibrosum Radix Glycyrrhizae Rhizoma Zingiberis ginseng and Chinese angelica root (each three liang) Rhizoma Chuanxiong (one or two 5 money) Semen Armeniacae Amarum (40 pieces) is a pipeful of with water, boils and gets four liters, one liter of decoction being taken warmly.When little antiperspirant.Thin multiple ridge with several seats, (is sat then to rise and is sent out yang-energy, be enough to oppose evil outer loose.) sweating then heals.Antiperspirant does not more take nothing and prohibits, and does not work as wind.(this also the Chinese revise " gold deficient " attached side, non-Zhong Jing side is also.Right its side quite closes the purport of Zhong Jing, therefore select it.) " record is tested " continuous life (soup) numb osmanthus Rhizoma Zingiberis Recens, rhizome of chuanxiong is returned Fructus Pruni grass stone ginseng.Apoplexy contracture (ailment said due to cold or exposure enters network) becomes hemiplegia after apoplexy, and (" miliaria " comes into disuse also.) this method is good according to legend for modern Gu.(side name " continuous life " person has the merit of preventing disease and prolonging life also.)
Apoplexy one card from etiology, was seted forth one's views mainly with " in the interior exogenous pathogen " before the Tang and Song Dynasty, thus " gold is deficient ", " a thousand pieces of gold ", " outer platform " etc. all main decoction to stimulate a dying person for controlling.Gold dollar is outstanding take " endogenous wind " as main later on, for the large turn point on the etiology, and such as Liu, Lee, Zhu Sanzi, one main " heart-fire is cruelly very ", one main " healthy energy is from empty ", one main " damp-phlegm is given birth to heat ".Carry out proposition to Ming Dynasty king and should divide " very " " apoplexy due to endogenous wind ", Zhang Jingyue is more advocated saying of " non-wind ".Should note Liu, Lee, Zhu Sanzi, though give main to some extent, but still dare not hastyly negate the antapoplectic practice of decoction to stimulate a dying person, so it is correct for the vertical theory that proves oneself to advocate the Zhang Jingyue of " non-wind ", criticize that they say " only strange three sub-persons; both all sayed this sick non-wind in middle air door, and what is in this first xiaoxuming decoction all? " since then, decoction to stimulate a dying person just withdraws from antapoplectic ranks gradually.The present age, Classical Prescriptions School great master Hu Xishu also said: " this Fang Dangshen of clinical apoplexy ", " we are difficult to control this disease.”
Modern times are rarely seen scattered case report, and such as Zhao Xiwu, Zhao Shouzhen, Wang Zhanxi, Lv Bingren, Cao Huaxun etc. control case, and all effect speed is and efficacious, and carry according to " state of Chinese medicine in Japan " again: right and wrong rapids profound the first day of the lunar month was in the apoplexy with this side healing Mikado in 1583.And make me notice that this side is by remaining state pretty work " Succession of Teachers of Chinese Medicine record " (in April, 2006 front page) and " road of my traditional Chinese medical science " (in June, 2007 front page).These two secretaries have stated he master and apprentice three generations and have used the many cases of this side's treatment acute myelitis, brain stem encephalitis, guillain-Barre syndrome and barium chloride poisoning to test case.Effect is said sth. with certainty one anti-thousand year unjust verdict such as the small wooden raft drum.As far back as " Chinese medicine journal " fourth phase in 1984, the old docter of TCM Jiang Erxun of master worker's Leshan hospital of Yu Shi write articles this side had been discussed, and does not cause that but common people pay attention to." human body and disease-dialogue large doctor Lee can " (in March, 2008 front page) of field original work but in the book Lee old Mr. one anti-he in the viewpoint of " anxious critical illness difficult disease experience special edition " treatment apoplexy usefulness Zhengan Xifeng Tang and so on, but praise highly energetically decoction to stimulate a dying person, and say " way of suppressing the hyperactive liver to arrest the wind syndrome; do not cure a routine stroke patient; does not all have; acute they just do not come yet ", and say that oneself two Mr. and Mrs closely suffers stroke, take simultaneously xiaoxuming decoction good, the former theory in author field: " use if it were not for your insight makes it; perhaps more nobody has known it, and elite has often been missed like this." present less people knows that this side is true, but be not that Li old Mr. " insight " makes it and uses, and Lee old Mr. probably also is after the Yu Guojun recommendation, just is careful this side.
There is head more than 20 side (large and small, Xi Zhou) that runs after fame with " continuous life " from the ancient prescription book, is roughly a few class ingredients: one, hot temperature class: Herba Ephedrae, Ramulus Cinnamomi (Cortex Cinnamomi) Herba Asari, Radix Angelicae Pubescentis, Rhizoma Zingiberis, Radix Aconiti Lateralis Preparata, Radix Saposhnikoviae, Rhizoma Zingiberis Recens; Two, nourshing blood and promoting blood circulation class: Radix Angelicae Sinensis, rhizome of chuanxiong Qiong, Radix Paeoniae; Three, QI invigorating class: Radix Ginseng, the Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae, Poria; Four, cold and cool class: Gypsum Fibrosum, Radix Scutellariae, Radix Puerariae, JINGLI; Also have in addition: Semen Armeniacae Amarum, FANGQI etc., but be noted that all decoction to stimulate a dying person have Herba Ephedrae, Ramulus Cinnamomi (Cortex Cinnamomi), rhizome of chuanxiong Qiong, Rhizoma Zingiberis Recens or Rhizoma Zingiberis.Call the continuous life of heat to pure usefulness temperature medicine later age, adds cool continuous life of being called of cold and cool medicine.
Square book before the Tang Dynasty can find out that decoction to stimulate a dying person is the very current main formula of controlling the apoplexy hemiplegia after apoplexy of a head, and " medical secrets of official " said: " all testing of all wind clothes ... this side is will of all soup." open " a thousand pieces of gold ", " outer platform " can see the prescription of controlling wind, even do not claim " continuous life ", but mostly square Chinese medicine is roughly the same to continue life.
The composition of decoction to stimulate a dying person, see it later age, peculiar difficulty is bright, says just as the teacher ancestral Chen Ding three of Yu Shi: " this side has inconceivable wonderful, and the person of being much experienced in one's life is also bright." the existing hot temperature of this side disperses, and benefiting vital QI and blood is arranged again, existing cold and cool heat clearing away has again the warming the interior invigorating YANG.Make most the person of reputation later age, quote the classics, in many ways annotate solution, in order to prove the wonderful of this side, seek foundation from " interior warp ", Difficult Classic, favourable own meaning person is elaborated performance, no matter manager Yu person of not conforming to then abandons.Mostly think dispersing wind-cold, harmonizing yingfen and weifen.Yu Shi master and apprentice's explanation is then said: " we focus on Gypsum Fibrosum, Rhizoma Zingiberis and usefulness, and transfer the negative and positive of taste, lid because of hemiplegia after apoplexy take suddenly paralysis of extremity as feature, and main extremity person what? say: taste are also.”
We card is said: " control middle hemiplegia after apoplexy; health can not be held certainly; aphasia, dazing with inability to point out the location of pain, or inability of turning body due to contracture; ... and control volt and must not crouch; cough with dyspnea, the edema of the face ", the spinal nerves pathological changes of real and the present etc. are similar, such as motor neuron, multiple sclerosis, Guillain-Barre syndrome, acute myelitis etc.Class later age it " myopathy " is arranged, be not equal to cerebrovascular, visible ancients are through trickle observation and repeatedly practise checking and sum up out, the reasoning of non-later age, and degree of recalling is comparable.
Each is discussed:
1. " Principle and Prohibition for Medical profession ": miliaria be numbness another name also, wind enters and its Rong Wei of numbness, namely health can not be from receiving, aphasia, dazing with inability to point out the location of pain, or contracture can not be changed one's position also.The right Wei Youxu of battalion has reality, and empty person gets it from internal injury, and real person gets it from diseases caused by exogenous pathogenic factor.This Fang Ze controls its Rong Wei person of numbness of diseases caused by exogenous pathogenic factor, therefore to get little antiperspirant as expensive.So become more slave girl's system, and added rhizome of chuanxiong, return and nourish blood, the Radix Ginseng QI invigorating.Its internal injury and cause the numbness person of the Rong Wei, in the medicine that fills blood, loose slightly wind medicine is system, more as can be known.
2. " gold mirror ": Zhao Liang says, the miliaria patient, the Rong Wei QI and blood is not supported in inside and outside, thus health need not, office is unfavorable, spirit is not controlled, and so is that card has void that reality is arranged, empty person from the sense of diet exhaustion due to sexual indulgence seven emotions it.As take by force in " interior warp " what is called faint then for Dumb miliaria and so on be also.Reality person from the sense of wind and cold heat-damp in summer it.Void person cannot control in fact, and the rule for the treatment of is more fallen apart in QI and blood.Modern this side's explicit word apoplexy, miliaria be belong to Rong Wei excess pathogen also, therefore use decoction to stimulate a dying person, be the change person of the Ephedrae Decoction, add Rhizoma Zingiberis and be subjected to the cold-evil to open blood, Gypsum Fibrosum is subjected to ailment said due to cold or exposure with expelling pathogenic factors from muscles, Radix Angelicae Sinensis and blood; The Radix Ginseng QI invigorating, the loose wind of Rhizoma Chuanxiong promoting the circulation of blood also.Itself and control cough with dyspnea puffy face person also for due to the wind and cold also.
Clinical practice:
This side's treatment apoplexy curative effect of apoplexy is very magical.The author once met a rural migrant worker and was the carpenter in my middle school on limit, clinic, the urine of getting up midnight is right hurriedly, and the extremity fistula is more unable falls down to the ground, suddenly go to anxious treasure toward me, see that the mind language is all normal, seemingly for being an excessively property paralysis, suddenly send city's large hospital anxious precious, because handing over 5,000 yuan out, prepare to send back to the native place, Sichuan, its fellow-villager please is its infusion treatment, I see its disease such as hemiplegia after apoplexy disease, then throw large agent decoction to stimulate a dying person one note, advise decoction being taken warmly to get antiperspirant, next day is unexpectedly such as ordinary person, unexpectedly can go to precious institute and thank you, if this disease of the clinical chance of all colleagues should speed be thrown we, also can throw we such as facial paralysis in addition.
Continuous life decoction made from powder " a thousand pieces of gold is rolled up eight all air doors ", this prescription is write in the time of nearly 100 years old the Sun Simiao elder person, his apoplexy, surrounded by patient all day, tired.Then just to have fallen ill, what performance does this disease have? I tastes apoplexy, and speech is puckery by force, and extremity are munched, and goes out this side, and (he opens himself, allows his disciple fry in shallow oil to him) day takes four clothes, and it is without cease that take ten nights on the ten, must heal.Write book ancient times, write out after whom does not also have oneself get sick, so this disease, Sun Simiao is had a say most.
Pharmacological research:
1. pharmacological action observes decoction to stimulate a dying person to the impact of clotting time of mice; 2. decoction to stimulate a dying person is on the impact of rat suppository formation; 3. through life soup ADP is induced the impact of rat platelet aggregation; 4. decoction to stimulate a dying person is on the pause impact of interior blood flow volume, cerebral vascular resistance, blood pressure and heart rate of Canis familiaris L..Found that: the decoction to stimulate a dying person gavage can prolong clotting time of mice on 5th, suppressed rat suppository and formed; In vitro administration can obviously suppress the rat platelet maximum agglutination rate that ADP induces, and prolongs for 50% maximum gathering time; Intravenously administrable can increase Canis familiaris L. ICAF amount, reduces cerebral vascular resistance, slightly accelerates heart rate, the not obvious blood pressure that affects.
The tangible novelty of tool of the present invention and breakthrough are to have found out the key point that decoction to stimulate a dying person 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 decoction to stimulate a dying person " 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.Science and technology is looked 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 decoction to stimulate a dying person dosage form preparation technology and production method thereof are provided.
Purpose of the present invention is achieved through the following technical solutions:
A kind of decoction to stimulate a dying person dosage form preparation technology and production method thereof, wherein: 2 parts of the raw material of this integrated novel form effective ingredient and weight proportion---Radix Glycyrrhizae Preparatas, 2 parts of Cortex Cinnamomi, 2 parts of Radix Angelicae Sinensis, 2 parts of Radix Ginsengs, 2 parts in Gypsum Fibrosum, 2 parts of Rhizoma Zingiberiss, 3 parts in Herba Ephedrae, 1 part of rhizome of chuanxiong, 40 parts in Semen Armeniacae Amarum.
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.Above-mentioned a kind of decoction to stimulate a dying person dosage form preparation technology 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 decoction to stimulate a dying person dosage form preparation technology 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 decoction to stimulate a dying person dosage form preparation technology 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 decoction to stimulate a dying person dosage form preparation technology 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, dropping liquid agent.
A kind of decoction to stimulate a dying person dosage form preparation technology 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% Radix Glycyrrhizae Preparata, Cortex Cinnamomi, Radix Angelicae Sinensis, Radix Ginseng, Gypsum Fibrosum 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 Ephedrae, rhizome of chuanxiong, Semen Armeniacae Amarum 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 Chinese medical concrete 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 decoction to stimulate a dying person dosage form preparation technology 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 decoction to stimulate a dying person dosage form preparation technology 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 decoction to stimulate a dying person dosage form preparation technology 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 decoction to stimulate a dying person dosage form preparation technology 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 the human body 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 the decoction to stimulate a dying person 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 decoction to stimulate a dying person " 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 decoction to stimulate a dying person dosage form preparation technology and production method thereof, its special feature is: the raw material composition of making effective ingredient is by weight ratio---
2 parts of Radix Glycyrrhizae Preparatas, 2 parts of Cortex Cinnamomi, 2 parts of Radix Angelicae Sinensis, 2 parts of Radix Ginsengs, 2 parts in Gypsum Fibrosum, 2 parts of Rhizoma Zingiberiss, 3 parts in Herba Ephedrae, 1 part of rhizome of chuanxiong, 40 parts in Semen Armeniacae Amarum.
Further, play the synergy of standing like the legs of a tripod on the integrated new drug formulation compatibility of decoction to stimulate a dying person of the present invention: 1, prepare nanometer, micro-powder with the prepared slices of Chinese crude drugs, the bioavailability after strengthening the decoction to stimulate a dying person 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 decoction to stimulate a dying person 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 decoction to stimulate a dying person 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% Radix Glycyrrhizae Preparata, Cortex Cinnamomi, Radix Angelicae Sinensis, Radix Ginseng, Gypsum Fibrosum 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 Ephedrae, rhizome of chuanxiong, Semen Armeniacae Amarum 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 Chinese medical concrete 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---
2 parts of Radix Glycyrrhizae Preparatas, 2 parts of Cortex Cinnamomi, 2 parts of Radix Angelicae Sinensis, 2 parts of Radix Ginsengs, 2 parts in Gypsum Fibrosum, 2 parts of Rhizoma Zingiberiss, 3 parts in Herba Ephedrae, 1 part of rhizome of chuanxiong, 40 parts in Semen Armeniacae Amarum.
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---
2 parts of Radix Glycyrrhizae Preparatas, 2 parts of Cortex Cinnamomi, 2 parts of Radix Angelicae Sinensis, 2 parts of Radix Ginsengs, 2 parts in Gypsum Fibrosum, 2 parts of Rhizoma Zingiberiss, 3 parts in Herba Ephedrae, 1 part of rhizome of chuanxiong, 40 parts in Semen Armeniacae Amarum.
Its manufacture process is as follows: in GMP10000 level toilet 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---
2 parts of Radix Glycyrrhizae Preparatas, 2 parts of Cortex Cinnamomi, 2 parts of Radix Angelicae Sinensis, 2 parts of Radix Ginsengs, 2 parts in Gypsum Fibrosum, 2 parts of Rhizoma Zingiberiss, 3 parts in Herba Ephedrae, 1 part of rhizome of chuanxiong, 40 parts in Semen Armeniacae Amarum.
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 1272 hours, 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 decoction to stimulate a dying person 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 decoction to stimulate a dying person 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 decoction to stimulate a dying person dosage form preparation technology and production method thereof is characterized in that: 2 parts of the raw material of this novel form effective ingredient and weight proportion---Radix Glycyrrhizae Preparatas, 2 parts of Cortex Cinnamomi, 2 parts of Radix Angelicae Sinensis, 2 parts of Radix Ginsengs, 2 parts in Gypsum Fibrosum, 2 parts of Rhizoma Zingiberiss, 3 parts in Herba Ephedrae, 1 part of rhizome of chuanxiong, 40 parts in Semen Armeniacae Amarum.Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.
2. a kind of decoction to stimulate a dying person dosage form preparation technology 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 decoction to stimulate a dying person dosage form preparation technology 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 decoction to stimulate a dying person dosage form preparation technology 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 decoction to stimulate a dying person dosage form preparation technology 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, dropping liquid agent.
6. a decoction to stimulate a dying person dosage form preparation technology 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% Radix Glycyrrhizae Preparata, Cortex Cinnamomi, Radix Angelicae Sinensis, Radix Ginseng, Gypsum Fibrosum 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 Ephedrae, rhizome of chuanxiong, Semen Armeniacae Amarum 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 decoction to stimulate a dying person dosage form preparation technology 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 decoction to stimulate a dying person dosage form preparation technology according to claim 7 and production method thereof; it is characterized in that: 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.
9. a kind of decoction to stimulate a dying person dosage form preparation technology 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 decoction to stimulate a dying person dosage form preparation technology 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 the human body different parts by the energy and blood of human body flowing law, directly absorb by skin.
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| CN104096018A (en) * | 2014-07-01 | 2014-10-15 | 栾淑丽 | Traditional Chinese medicine composition for treating facial neural paralysis |
| CN106983849A (en) * | 2017-05-20 | 2017-07-28 | 苏州市皎朝纳米科技有限公司 | A kind of Chinese medicine for treating apoplexy and application |
| CN107137682A (en) * | 2017-05-20 | 2017-09-08 | 佛山市领卓科技有限公司 | A kind of Chinese medicine composition for treating apoplexy and application |
| CN109172789A (en) * | 2018-09-28 | 2019-01-11 | 广东志道医药科技有限公司 | A kind of preparation process of xiaoxuming decoction solid pharmaceutical preparation |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104096018A (en) * | 2014-07-01 | 2014-10-15 | 栾淑丽 | Traditional Chinese medicine composition for treating facial neural paralysis |
| CN106983849A (en) * | 2017-05-20 | 2017-07-28 | 苏州市皎朝纳米科技有限公司 | A kind of Chinese medicine for treating apoplexy and application |
| CN107137682A (en) * | 2017-05-20 | 2017-09-08 | 佛山市领卓科技有限公司 | A kind of Chinese medicine composition for treating apoplexy and application |
| CN109172789A (en) * | 2018-09-28 | 2019-01-11 | 广东志道医药科技有限公司 | A kind of preparation process of xiaoxuming decoction solid pharmaceutical preparation |
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Application publication date: 20130130 |