CN102895620A - Preparation technology and production method for integrated new formulation of licorice heart-draining decoction - Google Patents
Preparation technology and production method for integrated new formulation of licorice heart-draining decoction Download PDFInfo
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Abstract
The present invention relates to a preparation technology and a production method for an integrated new formulation of a licorice heart-draining decoction, wherein the raw materials of active ingredients comprise: 15 parts by weight of licorice, 9 parts by weight of radix scutellariae, 6 parts by weight of coptis, 12 parts by weight of radix codonopsis, 9 parts by weight of pinellia ternate, 9 parts by weight of dried ginger, and 4 parts by weight of jujube. The production process of the integrated new formulation of licorice heart-draining decoction 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 licorice heart-draining 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 licorice heart-draining 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 licorice heart-draining decoction can be further prepared into films and transdermal agents which are respectively stuck to different parts of a human body according to the midnight-noon ebb-flow and qi and blood flowing rule of the human body and can be directly absorbed through skin.
Description
Technical field
The present invention relates to a kind of Glycyrrhizae Decoction for Purging Stomach-Fire dosage form preparation technology, the invention still further relates to a kind of Glycyrrhizae Decoction for Purging Stomach-Fire dosage form preparation technology and production method thereof.
Background technology
Chinese medicine decocting liquid compound recipe drug effect chemical reaction is too many because of chemical composition, temporary transient not revealed its Mysterious Veil also, but some mysterious black box drug actions are just ensconced in the Chinese medicine decocting liquid in the Chinese medicinal formulae, can not ask simply Chinese medicine westernization, the modernization of Chinese medicine most and only use monomer and effective site.The Chinese medicine water drug-decocting concentrating liquid could not be given it up! When the Chinese medicinal formulae water decocts, because prescription closes chemical environment complicated in high temperature when frying in shallow oil and the solution, the reaction such as complexation, hydrolysis, oxidation, reduction between intrinsic material may occur in solution, thereby some novel substance that did not originally have in the generation solution, these novel substances produce the drug actions such as potentiation, attenuation or modification to full side.New component forms the research of mechanism, stability and drug effect thereof in the reinforcement Chinese medicinal formulae decocting liquid, to improving Chinese medicine compound and new drug level, progressively dwindle Chinese medicine compound and new Chinese medicine and international gap, very important meaning is arranged, also increased new way and new source for the research and development new Chinese medicine simultaneously.
China's drug control relevant laws and regulations regulation changes dosage form and manages as new drug research.The backwardness of preparation level not only affects the performance of curative effect of medication, and cause the medicine added value low, directly affecting the market competition and industrial economy benefit, is to cause China's medical industry product quantity to occupy prostatitis, the world and the output value only is equivalent to the one of the main reasons of one or two transnational drugmaker.
New drug, novel form development level can embody economy and the technical strength of the medical industry of a country.China's oral formulations accounts for 2/3 of various whole body drug-delivery preparations, and accelerating development and promoting oral sustained-release preparation is the work that current urgent need will be done.
The Glycyrrhizae Decoction for Purging Stomach-Fire prescription derives from treatise on Febrile Diseases, " Medical Treasures of the Golden Chamber ".Note: " Medical Treasures of the Golden Chamber " has three liang of Radix Ginsengs.The party's ingredients is 4 pieces in Radix Glycyrrhizae 15g, Radix Scutellariae 9g, Rhizoma Coptidis 6g, Radix Codonopsis 12g, Rhizoma Pinelliae 9g, Rhizoma Zingiberis 9g, Fructus Jujubae.Upper seven flavors with 2 liters in water, boil and get 1.2 liters, go dregs, take 600 milliliters again.200 milliliters of decoction being taken warmly, three times on the one.Function: QI invigorating stomach function regulating, the painful abdominal mass that disappears preventing or arresting vomiting.Cure mainly: the typhoid fever syndrome of feeling fullness and distension in the upper abdomen, a little less than the insufficiency of stomach-QI, active borhorygmus, diarrhea, indigestion, epigastric oppression and rigidity and expire the retch unable to be quiet due to vexation.Be usually used in treating oral erosion, acute/chronic gastroenteritis, hu huo syndrome (behcet's syndrome), acne, folliculitis, pudendum erosion of the oral mucosa, chronic diarrhea, insufficiency of stomach constipation etc.
The side separates:
Glycyrrhizae Decoction for Purging Stomach-Fire is the sides for the treatment of taste.Because of about insufficiency of stomach can not nurse one's health, therefore the oral ulcer of getting angry occurs, lower cold diarrhea, middle Jiao's taste feeling of fullness.So use Glycyrrhizae Decoction for Purging Stomach-Fire, can above treating dental ulcer, the lower diarrhea of controlling, in control the taste distension.If run into clinically get angry, the disease of lower cold, fullness in the epigastrium and abdomen, can use Glycyrrhizae Decoction for Purging Stomach-Fire and solve.
Pathological analysis:
From we's compatibility of drugs analysis, the patient must be first deficiency of spleen-QI and stomach-QI, and middle burnt diseases caused by retention of fluid gathers, Yu Huare of a specified duration, and heat is steamed again water, satisfies into damp and hot card.Damp and hot heresy is without definite residence, becomes more than Vulpes, therefore ancients are referred to as hu huo syndrome also.Its card is more common in nine orifices part or hair part.The elder generation that Zhong Shi controls is with Rhizoma Zingiberis Recens ginseng Fructus Jujubae grass invigorating the spleen and replenishing QI Zhi Qiben; The Rhizoma Pinelliae dispel middle Jiao's pathogenic water double reduce phlegm wet, then in Jiao Kean; A kind of reed mentioned in ancient books is joined the Rhizoma Zingiberis Recens hardship and is fallen and hot rise damp and hot heresy nothing and hide also.
Each is discussed:
1. " ancient prescription choosing annotate ": the Radix Glycyrrhizae removing pathogen in the heart, the non-stagnation of pathogenic heat that rushes down because of about insufficiency of stomach can not adjust, causes the cold superinverse of water, intimately must not descend, and becomes painful abdominal mass.Therefore monarch is with the moon of Radix Glycyrrhizae, Fructus Jujubae stomach function regulating, Rhizoma Zingiberis, the Rhizoma Pinelliae open the sun of stomach, assume personal the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels courteous, make not superinverse; Still with a kind of reed mentioned in ancient books, company, with contrary for the gas of painful abdominal mass rushes down but gently, and painful abdominal mass is into Thailand.
2. Golden Mirror of Medicine: gentle meaning is got with the Radix Glycyrrhizae nomenclator by the side.With the sweet temperature of Radix Glycyrrhizae, Fructus Jujubae, the invigorating middle warmer emergency is controlled the benefit of painful abdominal mass very; The suffering of the Rhizoma Pinelliae, on broken visitor is contrary from; A kind of reed mentioned in ancient books, connect and to rush down the sunken painful abdominal mass heat of sun, the loose cloudy solidifying painful abdominal mass of Rhizoma Zingiberis is trembled with fear.Emergency is broken contrary, rushes down the painful abdominal mass cold and heat, and standby its controlled.
3. " Medical Treasures of the Golden Chamber lexical or textual analysis ": damp and hot liver-fire is infested and be oral-anal-genital ulcer syndrome card, thus should clearing away damp-heat, the suppressing the hyperactive liver fire; Because worm is handed over disorderly in stomach, work as again protecting stomach-QI, because of the people take gastric qi as, therefore select Glycyrrhizae Decoction for Purging Stomach-Fire.The monarch Radix Glycyrrhizae is with protecting stomach-QI; Company, a kind of reed mentioned in ancient books eliminating heart-fire, remuval of damp and hot.Coming also non-one day of worm disease, its dirty must be empty, lying in bed restlessly, intimate god rather owes, therefore mend dirty the moon, tranquilizing mind with Radix Ginseng; Fructus Jujubae with and taste; With Rhizoma Zingiberis Recens, summer person, worm gets Xin Zefu also.
Clinical practice:
1. acute gastroenteritis: will not add and subtract with we, only increase the weight of in proportion its dosage; Radix Glycyrrhizae 60g, Rhizoma Zingiberis 45g, Fructus Jujubae 30g (enucleation), Rhizoma Coptidis 15g (smashing), Rhizoma Pinelliae 100g, Radix Scutellariae 45g treats 60 routine acute gastroenteritiss altogether.Wherein without western medicine person 49 examples, through western medical treatment nonresponder 11 examples; The shortest person of the course of disease 4 hours, elder 15 days.All cure with we.Wherein take 1 dose and person's 8 examples more, 2 doses and person's 23 examples more, 3 doses and person's 18 examples more, 4 doses and more the person forget example, 5 doses and person's 6 examples more.
2. oral-anal-genital ulcer syndrome: Guo so-and-so, the woman, 36 years old, are diagnosed as mouthful in certain hospital, eye, genitals syndrome oral cavity and vulval ulcer half a year, once used hormone therapy, effect is bad.According to its arteries and veins disease, examine and be hu huo syndrome, adopt Glycyrrhizae Decoction for Purging Stomach-Fire to add flavor, the side uses: Radix Glycyrrhizae 30g, Radix Codonopsis 18g, Rhizoma Zingiberis Recens 6g, Rhizoma Zingiberis 3g, Rhizoma Pinelliae 12g, Rhizoma Coptidis 6g, Radix Scutellariae 9g, 7 pieces in Fructus Jujubae, Radix Rehmanniae 30g is decocted in water for oral dose 12 doses.Use Radix Glycyrrhizae 12g in addition, Radix Sophorae Flavescentis 12g fries in shallow oil water for 4 doses, the washout pudendum.Oral cavity and vulval ulcer heal substantially during further consultation, still take 14 doses by the place ahead again, 4 doses of washout sides, and the patient is again further consultation not.
3. chronic diarrhea: Liu so-and-so, man, 36 years old.First visit on October 23 in 1979.4 years causes are got ill from overeating and are caused diarrhoea, are cured after controlling.Take food slightly many or the slightly greasy i.e. recurrence of oil-feed but meet.Gastral cavity abdominal distention is vexed when sending out, intestinal gurgling sound, and loose stool has been held indigestion thing or mucus under the arm, day 2-3 time; And had palpitation, insomnia, dizzy, deep-thready pulse, tongue fur Bai Erwei is greasy, and abdomen is flat soft, all mild tenderness of umbilicus.Give Glycyrrhizae Decoction for Purging Stomach-Fire and add the Rhizoma Atractylodis Macrocephalae, Cortex Magnoliae Officinalis.Take 3 doses, stool is shaped, and receives to increase, and the sleep amelioration still has borborygmus, cardiopalmus.Former side goes Cortex Magnoliae Officinalis to add Ramulus Cinnamomi, continues to take 6 doses, and stool is normal.Follow up a case by regular visits to after 23 months, not recurrence.Use this ruling by law to treat 22 routine chronic diarrheas, all obtain better effects.Its course of disease has from 5 months-6 years, and 1-3 is many, counts 15 examples.Not again recurrence of 18 routine transference cures after controlling, 2 examples occurred repeatedly after half a year, and 2 examples are invalid.
4. insufficiency of stomach constipation: Guo, woman, 21 years old.The main suit: just heavily fortified point be difficult to resolve, 4-5 day delegation, 5-6 all need use charthartic at every turn, defecate still dryness accumulated in the stomach and intestine such as sheep stool; The epigastric oppression plug is obstructed, does not know famine, and loss of appetite is slept and feel unwell night, and mouth is not thirsty, and urine is normal; Light red tongue, the little Huang of thin fur Bletilla striata (Thunb.ex A.Murray)Rchb.f., rolling pulse.Then throw Glycyrrhizae Decoction for Purging Stomach-Fire.Radix Glycyrrhizae Preparata 12g, Rhizoma Pinelliae 10g, Rhizoma Zingiberis 5g, Rhizoma Coptidis 3g (taking after mixing it with water), Radix Scutellariae 10g, Radix Codonopsis 12g, 10 pieces in Fructus Jujubae.5 doses, be decocted in water for oral dose.Stool is unimpeded behind the medicine, and borborygmus increase.Give 5 doses, free movement of the bowels is received and is increased again, and the epigastric oppression plug removes, and all diseases are known more.
5. behcet's syndrome: the author with oral ulcer, external genitalia or anal ulcer, the cardinal symptoms such as heating, skin lesion of feeling cold, thinks it namely is " gold is deficient " hu huo syndrome according to this disease.Treat 60 examples with we, all effective.It adds and is kept to: loss of appetite adds Herba Eupatorii; Throat ulcer adds Rhizoma Cimicifugae, Cornu rhinocerotis; Thirsty, remove the Rhizoma Pinelliae, add pollen; Conjunctival congestion adds Radix Paeoniae Rubra, Faeces Vespertilionis; Mouth and nose gas heat adds Gypsum Fibrosum, the Rhizoma Anemarrhenae; The fullness in the chest and hypochondrium pain adds Radix Bupleuri; Wet inclined to one side Sheng person adds red Siberian cocklebur, Caulis Akebiae; Heat is Sheng person partially, with the easy Rhizoma Zingiberis of Rhizoma Zingiberis Recens; Constipation adds Radix et Rhizoma Rhei (processed with wine); Dysphoria with feverish sensation in the chest palms and soles adds Rhizoma Picrorhizae.Use simultaneously " gold is deficient " kuh-seng soup washout, the loose burning of Realgar smoked anus.
6. oral erosion: Chen, man, 48 years old, peasant.Aphthous stomatitis more than 20 days, dark coloured urine, full and rapid pulse gives 2 doses of daochi powders invalid, defecates and does not separate in 3rd, adds 2 doses of Liangge Sans in former side.Stool is separated, and aphthous stomatitis is satisfied more.Recur behind the first quarter moon, symptom is front to be acute, deep red tongue, and there is abscess on the limit, yellowish urine.Priority is all invalid with Radix Asparagi and Radix Ophiopogonis manna drink, six drugs containing rehmanniae Tonga Cortex Cinnamomi.Full lip white rot occurs, the tongue abscess increases, and can not eat saline taste, allay one's hunger to eat cold medicated porridge, and scorching hot dried pain in mouthful, happiness is gargled with cold water.So second mashed the controlling of the contained erosion of the oral mucosa of Yin Siri people's " Fructus Citri tangerinae window printed matter that indicates the type form or partial content of books and periodicals " test, and thinks that assertive evidence belongs to due to the disorder of the stomach, uses Glycyrrhizae Decoction for Purging Stomach-Fire.Radix Glycyrrhizae Preparata 12g, Rhizoma Zingiberis 5g, the Rhizoma Pinelliae, Radix Scutellariae, each 9g of Radix Codonopsis, Rhizoma Coptidis 6g, 6 pieces in Fructus Jujubae, 2 doses.Scorching hot erosion alleviates in the medicine deutostoma, must not gargle water, still gives 2 doses of former sides and heals.
Prescription research:
Glycyrrhizae Decoction for Purging Stomach-Fire is used as the treatment hu huo syndrome in " Medical Treasures of the Golden Chamber " special side uses.Hu huo syndrome is similar to the Behcet's syndrome of modern medicine.Due to illness send out in women's head-ornaments and perineum, have again person to be ultimate comprehensive card.Yet, the special side of Glycyrrhizae Decoction for Purging Stomach-Fire as hu huo syndrome treated, as if do not disclose yet the essence that we cure mainly.Hu huo syndrome is take the oral cavity and the reproduction mucosal injury is primary symptom.Therefore, can use we as the treatment membrane disease, namely Glycyrrhizae Decoction for Purging Stomach-Fire is the cell migration agent.With regard to regard to the scope for for the whole body mucosa, not only comprise oral cavity, throat, gastrointestinal, anus, external genitalia, also comprise urinary system mucosa and even respiratory mucosa, eye conjunctiva etc.With regard to the pathological changes type, both can be the general breakage of mucosa, can be again congested, rotten to the corn, also can be ulcer.Clinical manifestation or itch or pain or exudate and secretions unusual etc., because its diseased region difference shows different.
" unfavorable day tens of row of its people, indigested food in the treatise on Febrile Diseases." namely be that gastrointestinal mucosa is put in poison due to damage influence digests and assimilates.Clinically, Glycyrrhizae Decoction for Purging Stomach-Fire both can be used for treating recurrence type oral ulcer, behcets disease, also can be used for the treatment of chronic gastritis, gastric ulcer and colitis, rectal ulcer, anal fissure, hemorrhoid etc.Conjunctival ulcer, ulcer of vagina also can be used.No matter be mucosa infection where, all can cause patient's dysphoria and insomnia, this may be responsive relevant to stimulating with mucosa.Radix Glycyrrhizae is our principal agent, and the mucosa effect of repairing is arranged, and controls pharyngalgia such as treatise on Febrile Diseases with Radix Glycyrrhizae simply, and namely being that the bottleneck throat mucous hyperemia is scorching becomes.The simply old medicine " carbenoxolone " of western medicine gastric ulcer namely is glycyrrhiza preparation.In a word, we's clinical application will be good at drawing inferences about other cases from one instance, and can not be lived eyes by the clause of " ulceration appearing in the throat ", " ulceration at external genitals " barrier.
Glycyrrhizae Decoction for Purging Stomach-Fire " other sources:
1. [" Sheng Hui " rolls up ten to Glycyrrhizae Decoction for Purging Stomach-Fire.]
2. [side goes out " the military medical experience of Zhao's stannum ", and name is seen " at all times recipe " volume two to add sweet in the mouth grass XIEXIN TANG.]
The tangible novelty of tool of the present invention and breakthrough are to have found out the key point that Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae Decoction for Purging Stomach-Fire " 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 Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae Decoction for Purging Stomach-Fire dosage form preparation technology and production method thereof, wherein: 15 parts in the raw material of this integrated novel form effective ingredient and weight proportion---Radix Glycyrrhizae, 9 parts of Radix Scutellariaes, 6 parts of Rhizoma Coptidis, 12 parts of Radix Codonopsis, 9 parts of the Rhizoma Pinelliaes, 9 parts of Rhizoma Zingiberiss, 4 parts in Fructus Jujubae.
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.Above-mentioned a kind of Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae Decoction for Purging Stomach-Fire dosage form preparation technology and production method thereof, it may further comprise the steps:
Step 1: get each prepared slices of Chinese crude drugs pretreatment, insert pulverizer after the weighing and be crushed to the 80-200 order, then adopt supersonic jet mill to the 1-10 micron, get different Chinese medicine micropowder, for subsequent use.
Step 2: get 30%--90% alcohol-water solution that 60% Radix Glycyrrhizae, Radix Scutellariae, Rhizoma Coptidis, Radix Codonopsis micropowder doubly measure with 6-12 and mix and soaked 1-2 days, reflux, extract, 3 times, extract water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility, recovered alcohol gets extract for subsequent use.
Step 3: get 60% the Rhizoma Pinelliae, Rhizoma Zingiberis, Fructus Jujubae micropowder, adopt the ultrasound wave dispersion extractor to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz--120KHz, to pulverize extraction time be 10-100 minute, gets extract for subsequent use.
Step 4: with step 2, step 3 gained Chinese medicine extract, adopt nanon ball-mill to grind 4-16 hour, get the nano powder that particle size distribution is the 50-1000 nanometer, for subsequent use.
Step 5: get each Chinese medicine micropowder of 40%, boiled 3 times with the traditional Chinese medicine extracting machine decocting after being soaked in water two hours, decocting liquid merges and filters, and filtrate is concentrated, gets Chinese medical concrete or water drug-decocting concentrating liquid with for subsequent use.
Step 6: with step 2, step 3, step 4 gained Chinese medicine extract, nano powder as required with and the different property of medicine, pharmacological actions, can adopt respectively the technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared, obtain the medicine materials such as different medicine monomers, effective site, active materials.
Step 7: adopt different excipient substances by version in 2010 " preparation part of standards standard and " the even method of high pressure breast is adopted respectively in the requirement in 2005 version Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " etc. in the Chinese pharmacopoeia above-mentioned gained medicine material, inclusion technique, solid state technology, polishing, solvent-fusion method, squeezing and pressing method, complex coacervation, emulsion-crosslinking method, the polymerization dispersion method, fusion method, the technology such as freeze-drying are prepared into nanoparticle, nanoparticle, the micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanosuspension, the crude drug such as microcapsule.The crude drug particle diameter is between 10 nanometers-10 micron.
Step 8: " preparation part of standards code requirement in the Chinese pharmacopoeia was got in the crude drug such as step 5 gained Chinese medical concrete or water drug-decocting concentrating liquid and step 7 gained nanoparticle, liposome, nano-emulsion, microcapsule one or more and is mixed by formula proportion by version in 2010.
Step 9: in GMP10000 level toilet, with the above-mentioned crude drug that mixes adopt full-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can by version in 2010 " Chinese pharmacopoeia related preparations standard criterion is made the above-mentioned end product of other type.
Step 10: the end product of making is carried out respectively several, bottling, mounted box, sealing, stickup labeling, plays the exterior and interior packings such as code, vanning.Packaged product is transported to the appointed place by production batch and unifies instantaneously sterilising, and opens the sterilization report.
Above-mentioned a kind of Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae Decoction for Purging Stomach-Fire " 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 Glycyrrhizae Decoction for Purging Stomach-Fire dosage form preparation technology and production method thereof, its special feature is: the raw material composition of making effective ingredient is by weight ratio---15 parts in Radix Glycyrrhizae, 9 parts of Radix Scutellariaes, 6 parts of Rhizoma Coptidis, 12 parts of Radix Codonopsis, 9 parts of the Rhizoma Pinelliaes, 9 parts of Rhizoma Zingiberiss, 4 parts in Fructus Jujubae.
Further, play the synergy of standing like the legs of a tripod on the integrated new drug formulation compatibility of Glycyrrhizae Decoction for Purging Stomach-Fire of the present invention: 1, prepare nanometer, micro-powder with the prepared slices of Chinese crude drugs, the bioavailability after strengthening the Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae, Radix Scutellariae, Rhizoma Coptidis, Radix Codonopsis 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, and recovered alcohol gets extract for subsequent use.Get 60% the Rhizoma Pinelliae, Rhizoma Zingiberis, Fructus Jujubae micropowder, adopt the ultrasound wave dispersion extractor to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz--120KHz, extraction time are 10-100 minute, get extract for subsequent use.With above-mentioned gained Chinese medicine extract, adopt nanon ball-mill to grind 4-16 hour, get the nano powder that particle size distribution is 50 nanometers-1000 nanometer, for subsequent use.Get each Chinese medicine micropowder of 40% and mix, boiled 3 times with the traditional Chinese medicine extracting machine decocting after being soaked in water two hours, decocting liquid merges and filters, and filtrate concentrates, and gets Chinese medical concrete or water drug-decocting concentrating liquid with for subsequent use.With above-mentioned gained Chinese medicine extract, nano powder as required with and the different property of medicine, pharmacological actions, can adopt respectively the technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared, obtain the medicine materials such as different medicine monomers, effective site, active materials.Adopt different excipient substances and carrier by version in 2010 " related preparations part of standards standard and " the even method of high pressure breast is adopted respectively in the requirement in 2005 version Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " etc. in the Chinese pharmacopoeia above-mentioned gained medicine material, inclusion technique, solid state technology, polishing, solvent-fusion method, squeezing and pressing method, complex coacervation, emulsion-crosslinking method, the polymerization dispersion method, fusion method, the technology such as freeze-drying are prepared into nanoparticle, nanoparticle, the micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanosuspension, the crude drug such as microcapsule.The crude drug particle size distribution of preparing is between 10 nanometers-10 micron." preparation part of standards code requirement in the Chinese pharmacopoeia was got in the crude drug such as above-mentioned gained Chinese medical concrete or water drug-decocting concentrating liquid and above-mentioned gained nanoparticle, liposome, nano-emulsion, microcapsule one or more and is mixed by formula proportion by version in 2010.In GMP10000 level toilet, with the above-mentioned crude drug that mixes adopt full-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can make by the related preparations standard criterion the above-mentioned end product of other type.The end product of making is carried out respectively several, bottling, mounted box, sealing, stickup labeling, plays the exterior and interior packings such as code, vanning.Packaged product is transported to the appointed place by production batch and unifies instantaneously sterilising, and opens the sterilization report.
" embodiment one "
Press the following crude drug of preceding method preparation: extractum, nanoparticle, microcapsule, nanoparticle.
Its raw material of making effective ingredient forms---15 parts in Radix Glycyrrhizae, 9 parts of Radix Scutellariaes, 6 parts of Rhizoma Coptidis, 12 parts of Radix Codonopsis, 9 parts of the Rhizoma Pinelliaes, 9 parts of Rhizoma Zingiberiss, 4 parts in Fructus Jujubae.
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---15 parts in Radix Glycyrrhizae, 9 parts of Radix Scutellariaes, 6 parts of Rhizoma Coptidis, 12 parts of Radix Codonopsis, 9 parts of the Rhizoma Pinelliaes, 9 parts of Rhizoma Zingiberiss, 4 parts in Fructus Jujubae.
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---15 parts in Radix Glycyrrhizae, 9 parts of Radix Scutellariaes, 6 parts of Rhizoma Coptidis, 12 parts of Radix Codonopsis, 9 parts of the Rhizoma Pinelliaes, 9 parts of Rhizoma Zingiberiss, 4 parts in Fructus Jujubae.
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 Glycyrrhizae Decoction for Purging Stomach-Fire Chinese medicine compound Chinese and western medicine theory combines, and the compound compatibility of modern Chinese medicine and technology of preparing can change the pharmacokinetic parameter of medicine monomer, effective ingredient or effective part group.This has proved the scientific meaning of Chinese medicine compound compatibility from the pharmacokinetics level." very just be harmonious, negative and positive intercommunication, coordinating water and fire, precise and tiny circle melt, and greatness lies in the capacity " is that the precise and tiny circle of the integrated novel form of this medicine melts Integration Theory basis and guiding theory.Among the present invention: monomer, effective site, nanoparticle and carrier etc. be strange, be tiny, be cloudy.Traditional Chinese medical science organic conception, Chinese medical concrete, water drug-decocting concentrating liquid etc. be just, be grand, be the sun.Very just be harmonious then negative and positive intercommunication, the negative and positive intercommunication is then coordinating water and fire, is the optimum balance attitude.Doctor trained in Western medicine research is precise and tiny, and theory of Chinese medical science is that circle melts, and both very just are harmonious, and have just really embodied the organic conception of the combination of Chinese and Western medicine, and " close " is that " integration " is for holding.The tidemark that greatness lies in the capacity, the coordinating water and fire the present invention of being only asked most.This integrated novel form is by the reasonable compatibility of Chinese medicine monomer, effective site, active substance, Chinese medicine active materials, extractum, water drug-decocting concentrating liquid, prepared slices of Chinese crude drugs nano-particle etc., can produce soft, hard capsule or the dosage forms such as nanometer membrane, transdermal agent.Can develop simultaneously, can take four time periods respectively by midnight-noon and ebb-flow doctrine, energy and blood of human body flowing law by interior external administration.Can also do film former to nano traditional Chinese medicine, transdermal agent is attached to the human body different parts, can directly absorb by skin.
Further see, the various Chinese medicine particle diameter major parts that the present invention prepares are the granule of 50～1000 nanometers.Adopt different nano-medicament carriers and technology can be prepared into nanoparticle, nanosphere, solid ester plastid, nano-emulsion, pharmacosomes, microgranule, nanoparticles, little assist etc.Its particle size distribution is in 10 nanometers---between-10 microns.Then theoretical according to difference, the difference of slow controlled release time and the traditional Chinese medical science monarch of medicine pharmacology, targeting, reasonable compatibility mixes, and can be respectively charged among hard capsule and the soft capsule.Difference according to the dissolving of capsule material, disintegrate, jitter time can be prepared into respectively the targeted systems such as RE targeted system, stomach mucosa absorption system, intestinal absorption system, colon absorption system.Compare Chinese medicine and medicine monomer or Western medicine, the overall coordination therapeutical effect of this integrated novel form and target-oriented drug, slow controlled capability are stronger, and curative effect is more outstanding, and toxic and side effects still less.For Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae Decoction for Purging Stomach-Fire is the imbody of the theoretical marrow of differentiation of tcm, and the party has a wide range of applications in the different field of tcm clinical practice, goes through bimillennium and does not wane.Therefore, its full side is carried out further developmental research important in inhibiting.This just need us Emancipate the mind and seek truth from facts from Chinese medical theory, strengthen the research and development dynamics of traditional Chinese medical science ancient prescription, make these ancient prescriptions obtain more adequately and reasonably using.
Claims (10)
1. a Glycyrrhizae Decoction for Purging Stomach-Fire dosage form preparation technology and production method thereof is characterized in that: 15 parts in the raw material of this novel form effective ingredient and weight proportion---Radix Glycyrrhizae, 9 parts of Radix Scutellariaes, 6 parts of Rhizoma Coptidis, 12 parts of Radix Codonopsis, 9 parts of the Rhizoma Pinelliaes, 9 parts of Rhizoma Zingiberiss, 4 parts in Fructus Jujubae.
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.
2. a kind of Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae Decoction for Purging Stomach-Fire dosage form preparation technology and production method thereof is characterized in that may further comprise the steps:
Step 1: get each prepared slices of Chinese crude drugs pretreatment, insert pulverizer after the weighing and be crushed to the 80-200 order, then adopt supersonic jet mill to the 1-10 micron, get different Chinese medicine micropowder, for subsequent use.
Step 2: get 30%--90% alcohol-water solution that 60% Radix Glycyrrhizae, Radix Scutellariae, Rhizoma Coptidis, Radix Codonopsis micropowder doubly measure with 6-12 and mix and soaked 1-2 days, reflux, extract, 3 times, extract water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility, recovered alcohol gets extract for subsequent use.
Step 3: get 60% the Rhizoma Pinelliae, Rhizoma Zingiberis, Fructus Jujubae micropowder, adopt the ultrasound wave dispersion extractor to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz--120KHz, extraction time are 10-100 minute, get extract for subsequent use.
Step 4: with step 2, step 3 gained Chinese medicine extract, adopt nanon ball-mill to grind 4-16 hour, get the nano powder that particle size distribution is the 50-1000 nanometer, for subsequent use.
Step 5: get each Chinese medicine micropowder of 40%, boiled 3 times with the traditional Chinese medicine extracting machine decocting after being soaked in water two hours, decocting liquid merges and filters, and filtrate is concentrated, gets extractum or water drug-decocting concentrating liquid with for subsequent use.
Step 6: with step 2, step 3, step 4 gained Chinese medicine extract, nano powder as required with and the different property of medicine, pharmacological actions, can adopt respectively the technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared, obtain the medicine materials such as different medicine monomers, effective site, active materials.
Step 7: adopt different excipient substances and carrier by version in 2010 " related preparations part of standards standard and " the even method of high pressure breast is adopted respectively in the requirement in 2005 version Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " etc. in the Chinese pharmacopoeia above-mentioned gained medicine material, inclusion technique, solid state technology, polishing, solvent-fusion method, squeezing and pressing method, complex coacervation, emulsion-crosslinking method, the polymerization dispersion method, fusion method, the technology such as freeze-drying are prepared into nanoparticle, nanoparticle, the micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanosuspension, the crude drug such as microcapsule.The crude drug particle diameter is between 10 nanometers-10 micron.
Step 8: " preparation part of standards code requirement in the Chinese pharmacopoeia was got in the crude drug such as step 5 gained Chinese medical concrete or water drug-decocting concentrating liquid and step 7 gained nanoparticle, liposome, nano-emulsion, microcapsule one or more and is mixed by formula proportion by version in 2010.
Step 9: in GMP10000 level toilet, with the above-mentioned crude drug that mixes adopt full-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can by version in 2010 " Chinese pharmacopoeia related preparations standard criterion is made the above-mentioned end product of other type.
Step 10: the end product of making is carried out respectively several, bottling, mounted box, sealing, stickup labeling, plays the exterior and interior packings such as code, vanning.Packaged product is transported to the appointed place by production batch and unifies instantaneously sterilising, and opens the sterilization report.
7. a kind of Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae Decoction for Purging Stomach-Fire 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 Glycyrrhizae Decoction for Purging Stomach-Fire dosage form preparation technology according to claim 9 and production method thereof is characterized in that: its key point 2 be can in external administration develop simultaneously, can take four time periods respectively by midnight-noon and ebb-flow doctrine, energy and blood of human body flowing law.Also can be prepared into membrane, transdermal agent is attached to respectively the human body different parts by the energy and blood of human body flowing law, directly absorb by skin.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104352686A (en) * | 2014-10-13 | 2015-02-18 | 洛阳御平国生物科技有限公司 | Traditional Chinese medicine formula for treating epifolliculitis |
| CN107080826A (en) * | 2017-04-18 | 2017-08-22 | 登封市红依艺术制品有限公司 | Radix glycyrrhizae clears away heart-fire decoction |
| CN108578375A (en) * | 2018-07-11 | 2018-09-28 | 广州志道经方科技有限公司 | A kind of preparation process of Glycyrrhizae Decoction for Purging Stomach-Fire solid pharmaceutical preparation |
| CN113082188A (en) * | 2021-04-28 | 2021-07-09 | 重庆市畜牧科学院 | Preparation method of veterinary drug for resisting gastrointestinal inflammation |
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2011
- 2011-07-29 CN CN 201110214529 patent/CN102895620A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104352686A (en) * | 2014-10-13 | 2015-02-18 | 洛阳御平国生物科技有限公司 | Traditional Chinese medicine formula for treating epifolliculitis |
| CN107080826A (en) * | 2017-04-18 | 2017-08-22 | 登封市红依艺术制品有限公司 | Radix glycyrrhizae clears away heart-fire decoction |
| CN108578375A (en) * | 2018-07-11 | 2018-09-28 | 广州志道经方科技有限公司 | A kind of preparation process of Glycyrrhizae Decoction for Purging Stomach-Fire solid pharmaceutical preparation |
| CN108578375B (en) * | 2018-07-11 | 2021-02-02 | 广州志道经方科技有限公司 | Preparation process of licorice heart-fire-purging decoction solid preparation |
| CN113082188A (en) * | 2021-04-28 | 2021-07-09 | 重庆市畜牧科学院 | Preparation method of veterinary drug for resisting gastrointestinal inflammation |
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