CN102846753A - Preparation process of integration-type novel formulation of Radix Puerariae, Rhizoma Coptidis and Scutellaria baicalensis decoction and production method thereof - Google Patents

Abstract

The invention relates to a preparation process of integration-type novel formulation of Radix Puerariae, Rhizoma Coptidis and Scutellaria baicalensis decoction and a production method thereof. The effective components of the novel formulation are made from the following raw materials (by weight parts): Radix Puerariae (Pueraria lobata and/or Pueraria thomsonii) 30, Rhizoma Coptidis 20, Scutellaria baicalensis 30, and Radix Glycyrrhizae 5. The production method includes the steps of supersonic airstream pulverization, alcohol-water extraction, ultrasonic pulverization and extraction, water decoction and concentration, supersonic spray-drying, nano-scale grinding, high-pressure emulsion and homogenization and nanoparticle preparation. The production method integrates the advantageous of the nano-carrier combination technique, such as multi-component synergism and multi-target. The large-scale production can greatly reduce the production cost, greatly improve the product quality and enhance the target property and sustained/controlled-release property of drugs. The novel formulation is administered by oral intake and external application during four time periods respectively based on the midnight-noon tidal flow and human qi-blood flow rule. The novel formulation is also processed to membranes and transdermal delivery agents which are applied to different parts of human body respectively according to the midnight-noon tidal flow and human qi-blood flow rule and can be directly absorbed by the skin.

Description

A kind of GEGEN QINLIAN TANG dosage form preparation technology and production method thereof

Technical field

The present invention relates to a kind of GEGEN QINLIAN TANG dosage form preparation technology, the invention still further relates to a kind of GEGEN QINLIAN TANG 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.GEGEN QINLIAN TANG comes from the treatise on Febrile Diseases of Han dynasty Zhang Zhongjing.The side is by half jin of Radix Puerariae, and two liang in Radix Glycyrrhizae is processed three liang of Radix Scutellariaes, three liang of compositions of Rhizoma Coptidis.Effect: clearing away interior-heat, expelling pathogenic factors from muscles is loose evil.Cure mainly: exterior syndrome is not separated, and pathogenic heat enter the interior syndrome.Fever of the body, diarrhea is smelly dirty, breast gastral cavity dysphoria with smothery sensation, xerostomia is done thirsty, dyspnea and sweating, red tongue with yellow fur, rapid pulse or short.We's disease is for experiencing due to the damp and hot heresy.The heresy of Radix Puerariae expelling pathogenic factors from muscles table in the side, the bright heat of clear sun; The Radix Scutellariae nature and flavor are poor, are apt to control damp and hot for suffering from; Rhizoma Coptidis is principal agent, and energy pathogenic fire reducing cold in nature and dry dry thick intestinal dysentery relieving; Radix Glycyrrhizae detoxifcation and in, coordinating the actions of various ingredients in a prescription.All medicines share, and play altogether the interior-heat of inducing sweat, the thick intestinal of bowel relieving, the effect of dampness detoxifcation.

Modern pharmacological research disease is bright, and Radix Puerariae has powerful heat clearing away effect, and the local excitation of alleviation and antiinflammation are arranged.Radix Scutellariae has wider antimicrobial spectrum.The effective ingredient of Rhizoma Coptidis is bark of a cork tree alkali, can bacteriostasis and sterilization.And it can strengthen the phagocytic activity of leukocyte and liver reticuloendothelial system, and the dysbolismus that produces because of infection is recovered to some extent.Radix Scutellariae, Rhizoma Coptidis two medicine compatibilities have preferably synergism, obviously strengthen antibacterial and bactericidal effect.Fang Yi: the 34th of treatise on Febrile Diseases: " TAI YANG syndrome, syndrome of decoction GUI ZHI (Ramulus cinnamomi) are cured anti-purgation, sharp satisfy incessantly, and the irregularly rapid pulse person shows not solution also, dyspnea and sweating, the Gegen Huangqin Huanglian Tang master it." existing many referred to as GEGEN QINLIAN TANG.It is generally acknowledged that we have the merit of expelling pathogen from the exterior and clearing up internal heat, cure mainly the fever of the body diarrhea, breast gastral cavity dysphoria with smothery sensation is made yearningly the disease of dyspnea and sweating in mouthful.

Each is discussed: bright. Xu Hong: and the TAI YANG syndrome syndrome of decoction GUI ZHI (Ramulus cinnamomi), should send out the antiperspirant of flesh table, cure anti-purgation, interior-deficiency association is hot, then continuous diarrhea.The irregularly rapid pulse person, for pathogenic factor in the exterior is not separated, not instantly and due to the purgation also; The dyspnea and sweating person is namely due to the interior-heat QI rising in reverse order.Therefore be monarch with Radix Puerariae, to activate yang bright Tianjin and loose pathogenic factor in the exterior; Take Rhizoma Coptidis as minister, Radix Scutellariae is assistant, with the heat of Tongli gas, and pathogenic fire reducing clearing heat in the lung, and subinverse gas; Radix Glycyrrhizae is for making, with slow wherein and and transfer all medicine persons also.And this side also can the large hot diarrhea person of Zhi Yangming, can control again people's dyspnea of heat type person that is addicted to drink, and takes not thoroughly also.(" platform side's view in the golden mirror ")

Clearly. Ke Qin: syndrome of decoction GUI ZHI (Ramulus cinnamomi), this delays arteries and veins, and anti-short behind the erroneous administration of purgatives, YANG QI being excessive is as can be known.Evil Shu Yubiao, sun is disturbed in interior, therefore dyspnea and sweating; Profit is satisfied more than person, and this spouting diarrhea with tenesmus belongs to heat, and the diarrhea due to interior-heat accompanied by exterior syndrome person is different from faint and weak pulse.Though exterior heat is not separated, and in large heat entered, thus non-Ramulus Cinnamomi, Radix Paeoniae institute can and, also non-Cortex Magnoliae Officinalis, Semen Armeniacae Amarum can be separated.Therefore the Radix Puerariae of monarch's gas lightweight weight, end with expelling pathogenic factors from muscles sharp, clear respectful a kind of reed mentioned in ancient books, companys of assistant bitter cold, with hidroschesis except breathing heavily, use Radix Glycyrrhizae with in.Boil first Radix Puerariae, rear interior all medicines, the power of expelling pathogenic factors from muscles is excellent, and the gas in clear is sharp, again with society in widely different different by black magic.(" renewal of treatise on febrile disease. the attached wing of typhoid fever ")

Clearly. You Yi: the wind syndrome of TAI YANG heating, should have induce sweat by Ramulus Cinnamomi, and anti-purgation, interior deficiency heresy enters, and is sharp then more than, and it demonstrate,proves then dyspnea and sweating.The husband is short to be the excess of YANG, and the irregularly rapid pulse person knows and shows not solution also.No perspiration but asthma is for trembling with fear at table; Dyspnea and sweating, for heat in the interior also.Be its heresy sink into inner person ten seven, and stay in table person ten three, it is sick to be the exterior and the interior and the disease that is subjected to, therefore the method that its method also should relieving exterior-interior syndrome.The Radix Puerariae expelling pathogenic factors from muscles is in table, a kind of reed mentioned in ancient books, connects heat clearing away in inner, Radix Glycyrrhizae then close the exterior and the interior and and and ear.In lid ailment said due to cold or exposure junior middle school, disease be to show, and one enters innerly, then becomes hot.Therefore the person that controls the table must be cool with the suffering of Radix Puerariae; Control inner person, secret with a kind of reed mentioned in ancient books, bitter cold also.(" typhoid fever string of pearls collection ")

Case is collected: 1) hematodiarrhoea.Certain boy, 5 years old.Generate heat 39 ℃, sweating is irritated, thirst and drinking, dysentery pus and blood, tenesmus, stomachache, burning sensation of the anus.The stool chemical examination: pus cell (+++), red, leukocyte (++).Be diagnosed as acute bacillary dysentery, with gentamycin, bactrim treatment 3 days, disease feelings such as front.Susceptibility: to gentamycin, kanamycin and the equal drug resistance of sulfonamides antibiotic.The infant scorching fever, headache is irritated, refreshing knowledge unconsciousness, sweating asthma, again and again thirsty drink is let out profit stomachache, red tongue with yellow fur, the sliding disease of pulse condition.Card belongs to the time of closing in the fulminant dysentery excess-heat, the Western medicine of stopping using is controlled it, the GEGEN QINLIAN TANG sanction with the detoxifcation assistant that expels the heat-evil: Radix Puerariae, Fructus Forsythiae, Flos Lonicerae, Rhizoma Coptidis, each 9g of the Radix Pulsatillae in clear, Herba Eupatorii, Radix Scutellariae, Cortex Moutan, Radix Aristolochiae, the Radix Paeoniae Alba, each 6g of Radix Glycyrrhizae, Herba Portulacae 10g.Decocting rushes Cornu rhinocerotis end 1.5g at every turn, takes medicine 1 time 1 dose of every day in 4 hours.Thirsty ending moved back in 3 doses of after heat, and mind is revived, and dysentery alleviates, and can drink gruel; Advance again 3 doses and heal.(the Shaanxi traditional Chinese medical science, 1988,2:76)

2) mouse typhus.Stone, woman, 1 years old half.Heating first quarter moon, body temperature are more than 39 ℃, and diarrhoea day more than 10 is inferior, yellowish-brown Mucous Stool, abdominal distention and little diet, bowel sound hyperaction.Hemogram: leukocyte 25.5 * 109/L, neutrality 87%, lymph 13%; The stool chemical examination: 18～20 of pus cells, stool are cultivated the bacillus typhi murium growth.Red tongue, yellow and greasy fur, slippery and rapid pulse.After treating 5 days with penicillin, gentamycin etc., the disease feelings do not subtract.Card belongs to retention of damp-heat in the interior, injures large intestine.Control suitable heat clearing away, dampness, detoxifcation.Prescription: Radix Puerariae, each 6g of Radix Scutellariae, Rhizoma Coptidis 5g.After 3 doses of the decoctions, symptom is slightly light, alternate attacks of chills and fever occurs, therefore close Herba Sidae Rhombifoliae soup.Cool skin is moved back in 3 doses of after heat, and stool day 2 times, yellow skin matter is soft.Close Zhuye Shigao Tang, Lophatherum and Gypsum Dectoction with we kind thereafter, stool continuous culture 3 times is without bacterial growth.(the Shaanxi traditional Chinese medical science, 1984,12:20)

3) proctoptosis.Car, man, 52 years old.Because of desiring defecation constantly, face the lavatory and exert and earn and archoptosis.Begin then with can also receiving behind the hand push, hand push also was difficult to also receive afterwards.Once more than the BUZHONG YIQI TANG treatment moon, imitated.Disease is seen the worn-out abdominal distention of breast, the dysphoria with smothery sensation bitter taste, and limb is stranded refreshing tired, oliguria with reddish urine, constipation, tongue tip side of red, the tongue center is yellow greasy, the stringy and rolling pulse number.Card belongs to damp and hot retardance the intestines and stomach, and ascending or descending movement of vital Qi is not normal.Control suitable clearing away heat and eliminating dampness, dredge the promoting the circulation of QI machine.Prescription: Radix Puerariae 30g, Radix Scutellariae, Rhizoma Coptidis, each 10g of Semen Armeniacae Amarum, Fructus Cannabis 15g, Radix Glycyrrhizae, each 5g of the Radix Aucklandiae.5 doses of decoctions, abdominal distention uncomfortable in chest alleviates, free movement of the bowels, rectum can also be received voluntarily after an action of the bowels.Defence's conditioning first quarter moon, the proctoptosis recovery from illness.Followed up a case by regular visits to 1 year, and had no recurrence.(Beijing Journal of Traditional Chinese Medicine, 1987,2:36) 4) infantile pneumonia.Hu, man, 5 years old.Shiver with cold heating 2 days, 39 ℃ of body temperature, thirsty, cough with asthma is rough, paroxysmal pain in the abdomen, diarrhoea day 6～7 times, red tongue, yellow fur is little greasy, slippery and rapid pulse.Leukocyte 14.7 * 109/L; Chest X-rays: right side pneumonia.This is that pathogenic warmth caves in, and the lung stomach is red-hot, the card of diarrhea due to interior heat with exterior syndrome.Control the method with expelling pathogen from the exterior and clearing up internal heat, bitter cold consolidating YIN, Gegen Qinlian Tonga flavor: Radix Puerariae 10g, Rhizoma Coptidis, each 5g of Radix Scutellariae, Radix Glycyrrhizae, each 3g of Herba Ephedrae (processed), Fructus Forsythiae 6g, Caulis Lonicerae, each 15g of Herba Commelinae.3 doses of decoctions, all diseases subtract.The place ahead goes Herba Ephedrae to add Radix Paeoniae Alba 10g, advances again 3 doses of heat and moves back, and diarrhoea is ended.Intend again Gegen Qinlian Tonga Semen Armeniacae Amarum, Fructus Perillae, Cortex Mori, Radix Glehniae, cough Zhichuan for 3 doses and put down.Chest X-rays: the right side pneumonia absorbs.Giving made from radix adenophorea, tuber of dwarf lilyturf Tonga flavor deals with problems arising from an accident.(Journal of Traditional Chinese Medicine, 1985,5:26)

Clinical practice: GEGEN QINLIAN TANG is ended sharp effect with its remarkable heat clearing away consolidating YIN, not only is subject to the generally attention of ancient medicine, also is the modern clinic extensive use.With regard to its modern Application scope, still with the digestive system disease heart of attaching most importance to, and then extend and in the other system disease.

1) digestive system: let out dysentery and tool interior-heat sign person examines the card main points as it take stomachache, be widely used in the clinical treatment of chronic non-specific ulcerative colitis, hemorrhagic enteritis, infant rotavirus enteritis, Children Poisoning enteritis, infant summer diarrhea, dyspepsia, typhoid fever and paratyphoid fever, acute and chronic dysentery, alimentary toxicosis, acute or chronic gastritis and other multiple alimentary infection sexually transmitted disease (STD) diseases, evident in efficacy, reliable rapidly, the medical personnel is liked usefulness by modern clinic.

200 examples are made a definite diagnosis typhoid fever to the application such as Zhu Shi we and the paratyphoid fever patient treats, and establish matched group 50 examples.Chinese drug-treated group is with Gegen Qinlian Tangyuan County side, and matched group is with conventional western medical treatments such as ampicillin, and 15 days was 1 course for the treatment of.The result shows: in 195 examples that Chinese drug-treated group body temperature reduces, average temperature fall time is 9.179 ± 4.641 days, and in 47 examples that Western medicine group body temperature reduces, average temperature fall time is 13.213 ± 4.533 days, (P＜0.01).Turn out cloudy after the Chinese drug-treated group 143 routine Patients with Positive Blood Cultures treatments, be 12.66 days average time; 128 routine widal's reaction positive patients average times of turning out cloudy is 16.50 days; Western medicine group 43 routine Patients with Positive Blood Cultures average times of turning out cloudy is 16.82 days; Positive 35 examples of fertile Da Shi average times of turning out cloudy is 20.12 days.Chinese drug-treated group produce effects 116 examples (58%), effective 82 examples (41%), total effective rate 99%; Western medicine group produce effects 15 examples (30%), effective 32 examples (64%), total effective rate 94%.

According to another report, obtain good result with 48 examples of having loose bowels behind we's treatment malignant tumor chemotherapy.Selected case Chinese medical discrimination all belongs to diarrhea due to damp-heat, writes out a prescription to add Semen Plantaginis for GEGEN QINLIAN TANG.Produce effects 34 examples as a result, effective 12 examples, total effective rate reaches 95.8%; 2 examples were fully recovered more than 6 days, had so affected normal chemotherapy, by invalid statistics, accounted for 4.2%.

2) respiratory system: it is outside its basic effect that we end profit divided by bowel relieving, and still tool is dismissed the merit of pathogenic factor in the exterior, therefore also be usually used in the treatment of respiratory disorder.Whenever see the hot sign person of intestinal as its selection standard take the disturbance of lung-QI dyspnea with rapid and short breath clinically, with controlling bronchopneumonia, lobar pneumonia, viral pneumonia, pulmonary abscess etc.In addition, we's available encephalitis B, poliomyelitis, infectious high heat, cystitis, newborn diapers rash, toothache, epidemic conjunctivitis, proctoptosis, leukorrhagia, auditory vertigo, measles etc. controlled still.We end the superior efficacy of profit with the heat clearing away consolidating YIN and famous, so with regard to the later age clinical application, and the non-intestinal that only is confined to of its function, i.e. lung-heat heap soil or fertilizer over and around the roots Sheng person is every multiselect usefulness also, actually for controlling the bright agent of the lunar sun of hands.

The tangible novelty of tool of the present invention and breakthrough are to have found out the key point that GEGEN QINLIAN 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 GEGEN QINLIAN 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 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 GEGEN QINLIAN TANG 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 GEGEN QINLIAN TANG dosage form preparation technology and production method thereof, wherein: the raw material of this integrated novel form effective ingredient and weight proportion---

30 parts of Radix Puerariaes, 20 parts of Rhizoma Coptidis, 30 parts of Radix Scutellariaes, 5 parts in Radix Glycyrrhizae.

Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.Above-mentioned a kind of GEGEN QINLIAN TANG 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 GEGEN QINLIAN TANG 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 GEGEN QINLIAN TANG 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 GEGEN QINLIAN TANG 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.

A kind of GEGEN QINLIAN TANG 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 Puerariae, Rhizoma Coptidis micropowder doubly measure with 6-12 and mix and soaked 1-2 days, reflux, extract, 3 times, extract simultaneously water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility, recovered alcohol gets extract with for subsequent use.

Step 3: get 60% Radix Scutellariae, Radix Glycyrrhizae 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 with 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 GEGEN QINLIAN TANG 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 GEGEN QINLIAN TANG 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 GEGEN QINLIAN TANG 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 GEGEN QINLIAN TANG 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 GEGEN QINLIAN 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 GEGEN QINLIAN 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 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 GEGEN QINLIAN TANG dosage form preparation technology and production method thereof, its special feature is: the raw material composition of making effective ingredient is by weight ratio---

30 parts of Radix Puerariaes, 20 parts of Rhizoma Coptidis, 30 parts of Radix Scutellariaes, 5 parts in Radix Glycyrrhizae.

Further, play the synergy of standing like the legs of a tripod on the integrated new drug formulation compatibility of GEGEN QINLIAN TANG of the present invention: 1, prepare nanometer, micro-powder with the prepared slices of Chinese crude drugs, the bioavailability after strengthening the GEGEN QINLIAN 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 GEGEN QINLIAN 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 GEGEN QINLIAN 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.

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.Get 30%--90% alcohol-water solution that 60% Radix Puerariae, Rhizoma Coptidis micropowder doubly measure with 6-12 and mix and soaked 1-2 days, reflux, extract, 3 times is extracted water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility simultaneously, and recovered alcohol gets extract with for subsequent use.Get 60% Radix Scutellariae, Radix Glycyrrhizae 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 with 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---

30 parts of Radix Puerariaes, 20 parts of Rhizoma Coptidis, 30 parts of Radix Scutellariaes, 5 parts in Radix Glycyrrhizae.

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---

30 parts of Radix Puerariaes, 20 parts of Rhizoma Coptidis, 30 parts of Radix Scutellariaes, 5 parts in Radix Glycyrrhizae.

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---

30 parts of Radix Puerariaes, 20 parts of Rhizoma Coptidis, 30 parts of Radix Scutellariaes, 5 parts in Radix Glycyrrhizae.

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 GEGEN QINLIAN 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 being harmonious; negative and positive intercommunication, coordinating water and fire, precise and tiny circle melt; greatness lies in the capacity " is the elite in the classical works such as Chinese Charltons, Taoism, Huang di's Canon of Medicine, is simple philosophy doctrine thought, also is research and development thinking and the basic guiding theory of the integrated novel form of this medicine.The traditional Chinese medical science always just has saying of Medicine and Changes sharing the same origin, skill of a doctor homology.This just precise and tiny circle of the present invention melt the Integration Theory basis.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.Having broken through the traditional monarch compatibility theory of the traditional Chinese medical science, is innovation and the model of Chinese medicine tradition compatibility theory and traditional Chinese medical science pharmaceutics, for the preparation of GEGEN QINLIAN TANG modern Chinese medicine and production have proposed a practical effective novel form compatibility program.To have substantial innovation and technological break-through.

Claims (10)

1. a GEGEN QINLIAN TANG dosage form preparation technology and production method thereof is characterized in that: the raw material of this novel form effective ingredient and weight proportion---

30 parts of Radix Puerariaes, 20 parts of Rhizoma Coptidis, 30 parts of Radix Scutellariaes, 5 parts in Radix Glycyrrhizae.

Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.

2. a kind of GEGEN QINLIAN TANG 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 GEGEN QINLIAN TANG 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 GEGEN QINLIAN TANG 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 GEGEN QINLIAN TANG 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.

6. a GEGEN QINLIAN TANG 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 Puerariae, Rhizoma Coptidis micropowder doubly measure with 6-12 and mix and soaked 1-2 days, reflux, extract, 3 times, extract simultaneously water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility, recovered alcohol gets extract with for subsequent use.

Step 3: get 60% Radix Scutellariae, Radix Glycyrrhizae 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 with 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 GEGEN QINLIAN TANG 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 GEGEN QINLIAN TANG dosage form preparation technology according to claim 7 and production method thereof; it is characterized in that: the medicine monomer in the described step 6; active substance; the dissimilar nanoparticle that adopts the different pharmaceutical adjuvant to be prepared in effective site technology of preparing and the described step 7; the crude drug such as nano-emulsion; the described protection domain of this claim is not only described technology of preparing and method; as required, be also included within and add on its basis or use other better effects if; more economical; upgrade; more advanced; the more preparation method of environmental protection and technology.

9. a kind of GEGEN QINLIAN TANG 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 GEGEN QINLIAN TANG 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.