CN102895627A - Preparation technology and production method for integrated new formulation of radix bupleuri, cassia twig and dry ginger decoction - Google Patents

Preparation technology and production method for integrated new formulation of radix bupleuri, cassia twig and dry ginger decoction Download PDF

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CN102895627A
CN102895627A CN2011102145603A CN201110214560A CN102895627A CN 102895627 A CN102895627 A CN 102895627A CN 2011102145603 A CN2011102145603 A CN 2011102145603A CN 201110214560 A CN201110214560 A CN 201110214560A CN 102895627 A CN102895627 A CN 102895627A
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杨洪舒
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Suzhou Zhiweitang Biotechnology Co Ltd
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Abstract

The present invention relates to a preparation technology and a production method for an integrated new formulation of a radix bupleuri, cassia twig and dry ginger decoction, wherein the raw materials of active ingredients comprise: 8 parts by weight of radix bupleuri, 3 parts by weight of cassia twig, 2 parts by weight of dry ginger,4 parts by weight of snakegourd root, 3 parts by weight of radix scutellariae, 2 parts by weight of oyster, and 2 parts by weight of honey-fried licorice root. 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 radix bupleuri, cassia twig and dry ginger 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 radix bupleuri, cassia twig and dry ginger 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 radix bupleuri, cassia twig and dry ginger 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

A kind of Chaihu Guizhi Ganjiang Tang dosage form preparation technology
Technical field
The present invention relates to the integrated novel form of a kind of Chaihu Guizhi Ganjiang Tang, the invention still further relates to a kind of Chaihu Guizhi Ganjiang Tang dosage form preparation technology.
Background technology
Chinese medicine decocting liquid compound recipe drug effect chemical reaction is too many because of chemical constituent, 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 Chaihu Guizhi Ganjiang Tang prescription derives from treatise on Febrile Diseases.The party's ingredients is half jin of Radix Bupleuri, 3 liang of Ramulus Cinnamomi (peeling), 2 liang of Rhizoma Zingiberiss, 4 liang of radices trichosanthises, 3 liang of Radix Scutellariaes, 2 liang of Concha Ostreaes (enduring), 2 liang in Radix Glycyrrhizae (processing).Usage and dosage: with 2 liters of water 1 buckets, boil and get 6 liters, go dregs, take again 3 liters, 1 liter of decoction being taken warmly, day 3 times.Just take light vexation, the taking another dose sweating is just healed.Function: treating SHAO YANG disease by mediation, the double drink that reduces phlegm.Cure mainly: typhoid fever 4-5 day, fever with adversion to wind, stiffness of the neck, the little knot of fullness in the chest and hypochondrium, thirst but no vomiting, sweating over the head only, alternate attacks of chills and fever, and male malaria, malaria with general debility, malaria person more of a specified duration.Now be used for hepatitis, sinus tachycardia, coronary heart disease bradycardia, menoxenia, climacteric syndrome, Behcet's syndrome, acne, cystic hyperplasia of breast etc.
Each is discussed:
1. " concise exposition on febrile disease ": " interior warp " said: heat is excessive in interior, sends out it with hardship.The hardship of Radix Bupleuri, Radix Scutellariae is with the heresy of Xie Chuanli; Sweet and pungent flavors inducing perspiration and pertaining to yang, the suffering of Ramulus Cinnamomi, Radix Glycyrrhizae is sweet, to be dispersed in the heresy of table; Salty with soft it, Concha Ostreae salty is with expiring of the breast side of body that disappears; Hot to moisten it, the suffering of Rhizoma Zingiberis is with the antiperspirant of Guyang void; Deficiency of body fluid and be thirsty, bitter with heavily fortified point, the hardship of Fructus Trichosanthis is with born fluid.2. " ancient prescription choosing annotate ": with the heresy that the capable sun of Ramulus Cinnamomi does not stop, reuse the pivot that Radix Bupleuri, Radix Scutellariae turn few sun, assistant is with Rhizoma Zingiberis, Radix Glycyrrhizae, and the knot that the Kaiyang is bright makes with pollen, and the assistant Concha Ostreae is deeply few cloudy, draws liquid and rises, and rescues the heat of three sun.Needn't control the moon of fainting, and three constipation caused by accumulation of heats are evil, all separate from herbal classic one by one.With Radix Bupleuri and YANG collaterals of SHAO YANG meridian, namely use Radix Scutellariae and inner; With Ramulus Cinnamomi and YANG collateral of TAI YANG meridian, namely use Concha Ostreae and inner; With the sun of Rhizoma Zingiberis and Yang Ming, namely use Radix Trichosanthis and inner; Make with Radix Glycyrrhizae, YIN and YANG balance regulating, its minutes two sun minute solely heavy Radix Bupleuri person, with positive malaria not from the few sun of hands not yet; Cloudy medicine solely overweights pollen person, the malaria that the moon loses, take rescue liquid as urgent task also.3. " gold mirror ": few positive the exterior and the interior is not separated, thus with Radix Bupleuri Ramulus Cinnamomi mixture the master, i.e. the political reform of Herba Sidae Rhombifoliae soup is also.The person that goes to the Radix Ginseng, because of its healthy energy not empty; The summer person that reduces by half does not vomit with it, probably helps dry yet.Add radices trichosanthis, can quench the thirst with it and hold concurrently born fluid also; Times Radix Bupleuri adds Ramulus Cinnamomi, with the table of main few sun; Add Concha Ostreae, with the knot of soft few sun.Rhizoma Zingiberis assistant Ramulus Cinnamomi, cold with loose contact; Radix Scutellariae Zuo Chaihu, with except the heat of contact, and can Rhizoma Zingiberis processed not beneficial also vexed.The cold temperature of all medicines differs, essential Radix Glycyrrhizae with and it.Just take light vexation, the efficacy of a drug does not reach; The taking another dose sweating i.e. person more, and this demonstrate,proves non-no relieving of symptom after perspiration also as can be known.4. " cold warm bar is distinguished ": Radix Bupleuri is except the cold and heat of few sun, and is evil after the Ramulus Cinnamomi solution sun, the thirsty heat of pollen Che Yangming, and Rhizoma Zingiberis goes the stuffy sensation with restlessness of the breast side of body, and Radix Glycyrrhizae transfers the antiperspirant purgation to accidentally injure, and the method for the treatment of of these few Yang Yangming two solutions is also.5. " gold deficient beautiful letter through two notes ": be monarch with Radix Bupleuri, the sun of its strongly fragrant volt; Assistant is with Ramulus Cinnamomi, Rhizoma Zingiberis, the numbness of loose its flesh table; Radices trichosanthis, Concha Ostreae are minister, except staying heat, repercussive blood; Assistant helps Radix Bupleuri with Radix Scutellariae, controls half exterior and half interior; Radix Glycyrrhizae with all medicines, regulate yin-yang also.Antiperspirant then numbness is evil loose, heat in blood row and the ear of recovering.5. " Chinese medicine voluminous dictionary ": Radix Bupleuri, Ramulus Cinnamomi, Radix Scutellariae, and turn the pivot of few sun, and reach primodial spirit; Concha Ostreae is then opened the gas of the moon of fainting, to separate the knot of the breast side of body; Radices trichosanthis diversion liquid rises, and ends excessive thirst; After under the antiperspirant, middle gas must be empty, so with in the Radix Glycyrrhizae reason.
Clinical practice:
1. oppressive feeling and dizziness " achievement record ": more than the farmer, Nian Sanshi, rose last year, sends out during oppressive feeling and dizziness, sometimes slightly spit blood, and night sweat, alternate attacks of chills and fever, little thirsty and other activity palpitation of umbilicus is given that we control and is healed.2. hepatitis " Liu crosses the boat case ": Liu so-and-so, man, 54 years old.Suffer from hepatitis and abdominal distention is done to rush down loss of appetite, hypochondriac pain and the back of the body.It is countless to take medicine, and effect is not aobvious.Certain monarch asks Yu Weizhi.Stringy pulse and delaying, pale tongue with white fur, this is hepatopathy and spleen, what the spleen sun declined first resembles.For dredging Chaihu Guizhi Ganjiang Tang: Radix Bupleuri 12g, Radix Scutellariae 4.5g, Radix Glycyrrhizae Preparata 9g, Rhizoma Zingiberis 9g, pollen 12g, Concha Ostreae 12g.All 4 clothes and abdominal distention with rush down all ending, diet before is many, spirit also take a favorable turn.Transfer altogether with the liver spleen afterwards, assistant is with the product of invigorating spleen to remove dampness, and the liver function chemical examination is increasingly normally healed.3. sinus tachycardia " Beijing traditional Chinese medical science " (1988; 3:19): health, man, 20 years old.Chest distress and palpitation symptoms is more than over the past half year, the thin flushed cheeks of shape, and pulsation of the large collateral of the stomach causing vibration of shirt under the left breast, then coldness of the body shiver with cold at per nightfall, to fever of the body recovery following sweating after midnight, day, the gastral cavity painful abdominal mass was indigestion and loss of appetite without cold and heat, dry mouth with parched lips, red tongue, tongue body are slightly fat, and be bitter thin white, stringy and thready pulse disease number.Electrocardio diagram: sinus tachycardia, heart rate 110 times/minutes.Give Chaihu Guizhi Ganjiang Tang and add Os Draconis 30g, Fructus Schisandrae Chinensis 10g.Taking medicine, cardiopalmus subtracts greatly after 3 doses, and cold and heat end, and receives to increase, and arteries and veins turns gentle (90 times/minutes).Top dosage reduces by half, and gives 3 doses and heal again.4. coronary heart disease bradycardia " Beijing traditional Chinese medical science " (1988; 3:19): Zhao, woman, 60 years old.Be diagnosed as coronary heart disease before 3 years, existing hollow severe palpitation in the heart, slightly (Zhan Xin) (Zhan Xin) is moving greatly namely in the heart in action, can not walk with descending, has a surplus January, once takes the Chinese medicine and western medicine such as sorbitrate, heart pellet alive and does not imitate.Electrocardiogram: heart rate 50 times/minutes, ST section III, V5 move down 0.05.Accompany dizzy fever of the body, slight chill, the time from sweating, the xerostomia hardship is wish drink not, the food of receiving is fair, look gloomy, knot when half congealed during stool.Body is rich, and reddish tongue is slightly fat, the little Huang of white and thin fur, and slow pulse is slow.Throw Radix Bupleuri osmanthus ginger decoction and add Fructus Schisandrae Chinensis 6g, 3 doses, be decocted in water for oral dose.Medicine to the greatest extent all diseases all subtracts, Go to ground activity, normal pulse slow (60-70 time/divide).Fructus Schisandrae Chinensis is removed in the top, adds Bulbus Fritillariae Cirrhosae 10g, Fructus Hordei Germinatus (parched) 15g, and continuing takes 3 doses, visits so far and does not send out again.5. menoxenia " ancient prescription brief guide ": a married woman, usually menoxenia, its adverse QI rushing upwards, the anxious contracting of two sides of body, waist is unbearably painful, in row, pain under the umbilicus, lower to fermented bean drink, namely ended more than ten years in one day or half day.Examine it, feeling of fullness and disecomfort in the chest and hypochondrium, activity palpitation is very given we on the umbilicus, the several months of clothes, frontly demonstrate,proves more.3. cystic cyclomastopathy " new medicine and pharmacology magazine " (1979; 1:33): Wang, woman, 39 years old.There is a lump the outer top of left breast, and large such as Semen Juglandis, lump nearby, large several the little lumps of Semen Glycines are arranged, and there are a lump such as Fructus Jujubae shape in the slightly inclined to one side outside, top in the right breast, that touches has a pain, and matter is hard, and what push away can move, obscure boundary, and two axillary lymphs are tied not enlargement, are diagnosed as nodules of the breast (cystic cyclomastopathy), give we, after taking 20 doses, the both sides lump in breast disappears entirely, and subjective symptoms disappears and fully recovers.Follow up a case by regular visits to after 3 years, have no recurrence.
Pharmacological research:
1. the impact of Endocrine gland " pharmaceutical journal " (1980; 6:602,607): experimentation confirms that we and single Radix Bupleuri can make the effective ingredient saikoside of the internal organs generation weight change, particularly Radix Bupleuri such as adrenal gland and thymus can make the adrenal gland loose, cause atrophy of thymus gland, and the effect of Saikosaponin d is the most remarkable.2. hepatoprotective effect " pharmaceutical journal " (1984; 7:798): experimental hepatic injury confirms, behind the lumbar injection D-galactosamine, gives respectively and the Radix Bupleuri prescriptions such as we and Herba Sidae Rhombifoliae soup, can suppress serum transaminase (GPT, GOT) rising (suppression ratio 60%).3. antiepileptic action " pharmacognosy magazine " (1978; 4:273): the solution that we add Radix Paeoniae has inhibitory action to the ganglionic cell of Mollusca (Limax), and experiment shows anti-pentetrazole (PTZ) effect, and Radix Paeoniae, Rhizoma Zingiberis Recens in the side, Ramulus Cinnamomi has adds the identical anti-PTZ effect of Radix Paeoniae with we.The mice audiogenic convulsion is significant inhibition, has confirmed clinically antiepileptic curative effect.
The tangible novelty of tool of the present invention and breakthrough are to have found out the key point that Chaihu Guizhi Ganjiang Tang 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 Chaihu Guizhi Ganjiang Tang " 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 identical 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 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 Chaihu Guizhi Ganjiang Tang dosage form preparation technology is provided.
Purpose of the present invention is achieved through the following technical solutions:
A kind of Chaihu Guizhi Ganjiang Tang dosage form preparation technology, wherein: 8 parts of the raw material of this integrated novel form effective ingredient and weight proportion---Radix Bupleuri, 3 parts of Ramulus Cinnamomi, 2 parts of Rhizoma Zingiberiss, 4 parts of radices trichosanthises, 3 parts of Radix Scutellariaes, 2 parts of Concha Ostreaes, 2 parts of Radix Glycyrrhizae Preparatas.
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.Above-mentioned a kind of Chaihu Guizhi Ganjiang Tang dosage form preparation technology, 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 Chaihu Guizhi Ganjiang Tang dosage form preparation technology, 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 Chaihu Guizhi Ganjiang Tang dosage form preparation technology, 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 Chaihu Guizhi Ganjiang Tang dosage form preparation technology, 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 Chaihu Guizhi Ganjiang Tang dosage form preparation technology, 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 Bupleuri, Ramulus Cinnamomi, Rhizoma Zingiberis, radices trichosanthis micropowder doubly measures 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, it is for subsequent use to get extract.
Step 3: get 60% Radix Scutellariae, Concha Ostreae, Radix Glycyrrhizae Preparata 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, and it is for subsequent use to get extract.
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 Chaihu Guizhi Ganjiang Tang dosage form preparation technology; 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 Chaihu Guizhi Ganjiang Tang dosage form preparation technology, 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 Chaihu Guizhi Ganjiang Tang dosage form preparation technology, 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 Chaihu Guizhi Ganjiang Tang dosage form preparation technology, 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 Chaihu Guizhi Ganjiang Tang Chinese and western medicine theory combines, the present invention will in time fill up both at home and abroad and use " nano-carrier multiple techniques " and researching and developing the blank in " the integrated novel form of Chaihu Guizhi Ganjiang Tang " 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 identical 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 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 Chaihu Guizhi Ganjiang Tang dosage form preparation technology, its special feature is: the raw material composition of making effective ingredient is by weight ratio---8 parts of Radix Bupleuri, 3 parts of Ramulus Cinnamomi, 2 parts of Rhizoma Zingiberiss, 4 parts of radices trichosanthises, 3 parts of Radix Scutellariaes, 2 parts of Concha Ostreaes, 2 parts of Radix Glycyrrhizae Preparatas.
Further, play the synergy of standing like the legs of a tripod on the integrated new drug formulation compatibility of Chaihu Guizhi Ganjiang Tang of the present invention: 1, prepare nanometer, micro-powder with the prepared slices of Chinese crude drugs, the bioavailability after strengthening the Chaihu Guizhi Ganjiang Tang 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 Chaihu Guizhi Ganjiang Tang 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 Chaihu Guizhi Ganjiang Tang 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.
Preparation 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 Bupleuri, Ramulus Cinnamomi, Rhizoma Zingiberis, radices trichosanthis micropowder doubly measures 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, it is for subsequent use to get extract.Get 60% Radix Scutellariae, Concha Ostreae, Radix Glycyrrhizae Preparata 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, and it is for subsequent use to get extract.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---8 parts of Radix Bupleuri, 3 parts of Ramulus Cinnamomi, 2 parts of Rhizoma Zingiberiss, 4 parts of radices trichosanthises, 3 parts of Radix Scutellariaes, 2 parts of Concha Ostreaes, 2 parts of Radix Glycyrrhizae Preparatas.
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---8 parts of Radix Bupleuri, 3 parts of Ramulus Cinnamomi, 2 parts of Rhizoma Zingiberiss, 4 parts of radices trichosanthises, 3 parts of Radix Scutellariaes, 2 parts of Concha Ostreaes, 2 parts of Radix Glycyrrhizae Preparatas.
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---8 parts of Radix Bupleuri, 3 parts of Ramulus Cinnamomi, 2 parts of Rhizoma Zingiberiss, 4 parts of radices trichosanthises, 3 parts of Radix Scutellariaes, 2 parts of Concha Ostreaes, 2 parts of Radix Glycyrrhizae Preparatas.
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 Chaihu Guizhi Ganjiang Tang 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.
See that further 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 Chaihu Guizhi Ganjiang Tang modern Chinese medicine preparation and production have proposed a practical effective novel form compatibility program.To have substantial innovation and technological break-through.
Classics side resemble the Chaihu Guizhi Ganjiang Tang is the imbody of the theoretical marrow of differentiation of tcm, goes through bimillennium and does not wane.Therefore, obtain more adequately and reasonably using for making these ancient prescriptions, by the biological nano technology to its further developmental research utilization with important in inhibiting.

Claims (10)

1. a Chaihu Guizhi Ganjiang Tang dosage form preparation technology is characterized in that: 8 parts of the raw material of this novel form effective ingredient and weight proportion---Radix Bupleuri, 3 parts of Ramulus Cinnamomi, 2 parts of Rhizoma Zingiberiss, 4 parts of radices trichosanthises, 3 parts of Radix Scutellariaes, 2 parts of Concha Ostreaes, 2 parts of Radix Glycyrrhizae Preparatas.
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.
2. a kind of Chaihu Guizhi Ganjiang Tang dosage form preparation technology according to claim 1, 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 Chaihu Guizhi Ganjiang Tang dosage form preparation technologies, 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 Chaihu Guizhi Ganjiang Tang dosage form preparation technology of 3 any one, 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 Chaihu Guizhi Ganjiang Tang dosage form preparation technology of 3 or 4 any one, 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. Chaihu Guizhi Ganjiang Tang dosage form preparation technology 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 Bupleuri, Ramulus Cinnamomi, Rhizoma Zingiberis, radices trichosanthis micropowder doubly measures 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, it is for subsequent use to get extract.
Step 3: get 60% Radix Scutellariae, Concha Ostreae, Radix Glycyrrhizae Preparata 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, and it is for subsequent use to get extract.
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 Chaihu Guizhi Ganjiang Tang dosage form preparation technology according to claim 6; 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 Chaihu Guizhi Ganjiang Tang dosage form preparation technology according to claim 7; 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 Chaihu Guizhi Ganjiang Tang dosage form preparation technology according to claim 8, 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 Chaihu Guizhi Ganjiang Tang dosage form preparation technology according to claim 9 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.
CN2011102145603A 2011-07-29 2011-07-29 Preparation technology and production method for integrated new formulation of radix bupleuri, cassia twig and dry ginger decoction Pending CN102895627A (en)

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CN111494598A (en) * 2020-06-02 2020-08-07 郭宝云 Oral and external traditional Chinese medicine for treating liver-stagnation and spleen-deficiency type acne and preparation method thereof

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CN105362977A (en) * 2014-08-29 2016-03-02 李丹 Traditional Chinese medicine preparation clearing away internal heat
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