CN102895393A - Preparation technology and production method for integrated new formulation of aluminite decoction - Google Patents
Preparation technology and production method for integrated new formulation of aluminite 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 an aluminite decoction, wherein the raw materials of active ingredients comprise: 3 parts by weight of aluminite, 9 parts by weight of raw rehmannia root, and 3 parts by weight of sophora flavescens. The production process of the integrated new formulation aluminite 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 aluminite 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 aluminite 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 aluminite 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 Alumen soup dosage form preparation technology, the invention still further relates to a kind of Alumen soup 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 Alumen soup recipe derives from " outer platform " volume and 22 draws " must efficacious prescriptions ", and name is seen " the total record of full Ji " volume one by one six.The party's ingredients is 1 liang of Alumen, 3 liang of Radix Rehmanniae, 1 liang of Radix Sophorae Flavescentis.Usage and dosage: on cut.Close with water 8, boil and get 3 and close, filter it with silk floss.In the some nose, every day, the 3-5 degree more ended slightly.Effect: the dampness of eliminating the phlegm, the removing dampness detumescence is relieved oedema or abdominal distension through diuresis or purgation and is protected the heart, heat-clearing and toxic substances removing, antidiarrheal hemostasis.Cure mainly: intranasal steam is given birth to skin ulcer, has pus smelly, and worm is arranged.
Side's opinion:
" Shengji Zonglu " [rolling up the 116 nose door] infantile malnutrition worm-eaten nose is given birth to skin ulcer, and opinion is said the five internal organs all worm, and worm gets wind and then changes, and lung opening at nose, lung meridian are both empty, and wind heat is taken advantage of it, and nose gas is jammed, and must not declare logically, and then the infantile malnutrition worm is because corroding, and skin ulcer is given birth between nose.Control that chancre has worm in the nose, Alumen soup side Alumen (burning make juice is withered to be ground) Radix Sophorae Flavescentis (each one or two) Radix Rehmanniae (three liang) upper three flavor files two flavors as numb bean are large, mix thoroughly with Alumen, and with the water octadentate, take three and close, new continuous the filtration, porcelain is received Sheng, time point intranasal.Alumen abnormal smells from the patient acid, cold, nontoxic.Return lung; Spleen; Liver; Large intestine; Urinary bladder channel.Cure mainly: apoplexy; Epilepsy; Sore throat; The scabies eczema; Swollen ulcer drug; Burn due to hot liquid or fire; Aphtha of the mouth and tongue; The marginal blepharitis eye; The Ting discharging ear; Polyp in the nose; Skin ulcer hemorrhoid pain; Metrorrhagia; Epistaxis; Bleeding due to trauma; Chronic diarrhea nine dysentery; Leukorrhagia pudendal pruritus; Proctoptosis; Uterine prolapse.
Alumen is name alunite stone, plumage alunite, plumage pool, Ba Shi also, light Bai Zheming Semen Salicis babylonicae cum pilus vitriol.Be the mineral alunite, refine the crystallization that forms through processing.Alunitization studies and is divided into alkaline potassium aluminum sulfate [KAl3 (SO4) 2 (OH) 6], potassium oxide (K2O) 11.4% wherein, aluminium oxide (Al2O3) 37.0%, sulfur trioxide (SO3) 38.6%, water (H2O) 13.0%.Alumen is aqueous sulfuric acid aluminum potassium [Kal (SO4) 212H2O].
Each is discussed:
1, " Cheng Fang cuts usefulness ": Alumen removing dampness detoxifcation, therefore take as external treatment, so to the centre of punch, also can control it, lid beriberi and the centre of punch that arrives, all by kidney water pinch gas to insult the heart, get the but water of Alumen, and gesture is from can not insulting mutually, so the merit that the heart of protecting arranged is also.
2, " medical science acupuncture needle ": it is dry strong that Alumen is sour and astringent, removing dampness gas, and native dryness reaches, and then recovers, and these side's hundred examinations hundred are tested.
3, " not Lu ": except solid heat in the marrow, remove polyp in the nose.
4, " Changsha medicine solution ": Alumen, enter spleen of Foot-Taiyin, bladder meridian, kind removing dampness is excessive, and blood stasis dispelling is turbid, and black subcutaneous ulcer can disappear, and leucorrhea can remove.
5, " a thousand pieces of gold " Alumen ball is controlled cardiac beriberi, with its dampness also.Alumen is sour and astringent cracks from dryness, removing dampness gas and blood stasis dispelling is rotten, and the kind lower old expectorant place drink of telling, the edge sputum condenses, and viscous is between upper lower orifices tunnel, and the jail is not movable, and Alumen is collected and is mopped up it, loses force from root, and Zang Fu does not allow, high person's aytemesia, low person is from lower, real non-ly tells the purgation thing also.It is kind controls carbuncle person, does not lose with middle gas, and carbuncle is sent out outward, and the rotten pus of meat is let out, and new flesh growth, and from without the remaining matter, the sun soil that declines is wet, and middle gas is declining, and carbuncle can not be sent out outward, caves in and hinders Fu Zang, is with extremely also, and the water at Alumen collection mansion is wet, and soil is dry and gas reaches, and is with more also.
Clinical application:
We are multiplex in patients such as treatment internal hemorrhoid, proctoptosis, tunica vaginalis of testis edema, hemoptysis of pulmonary tuberculosis, control burn wound charrin's disease, gastroduodenal ulcer, leukorrhagia, pudendal pruritus, chronic bacillary dysentery, manic type psychosis, epilepsies.Also can be used for treating scabies, eczema, foot's swelling etc. and belong to above-mentioned card machine person.It is square foundation with we with catechu, the Pseudobulbus Bletillae (Rhizoma Bletillae), Borneolum Syntheticum, Galla Chinensis that report is arranged, and adds flavor treatment cervical erosion with disease; The diseases such as treatment sweaty foot all obtain good result.
The modern pharmacological research confirmation, Alumen soup has antibiotic, anti-trichomonas vaginitis effect.
The Alumen pharmacological action:
1. antibacterial action: staphylococcus aureus and Bacillus proteus are had inhibitory action (test tube method).To escherichia coli, bacillus pyocyaneus, anthrax bacillus, dysentery bacterium (Fu Shi, will Hayes), Bacillus typhi, paratyphoid fever bacillus, Bacillus proteus, and staphylococcus, Candida albicans etc. also have obvious inhibition to render a service (paper dish, flat band method); The strongest to viridans streptococci, Hemolytic streptococcus, streptococcus pneumoniae, diphtheria corynebacterium effect; Cattle type Brucella, bordetella pertussis, meningococcus effect are taken second place, to hemophilus influenza without the effect (paper disk method).The high concentration alum steep also has inhibitory action to human-like (H37RV) and bacillus tuberculosis bovis.
2. anti-trichomonas vaginitis effect: 10% alum steep in vitro (culture fluid is 1: 1 with the ratio of medicinal liquid) has obvious anti-trichomonas vaginitis effect.
3. the effect of coagulated protein: Alumen has the effect of strong coagulated protein, in serum, splash into several Alumen water, can see immediately and be combined into the slightly solubility material and precipitate, low concentration has convergence, antiinflammatory, antisepsis, high concentration causes again tissue fester, because zest for oral administration is large, generally is used externally only.
4. choleretic effect: Alumen 0.6g/kg duodenal administration obviously increases bile flow to anesthetized rat.
5. local irritant effect: local irritation is very large, and local injection 15% solution 0.3-0.5ml makes the manic uneasiness of rabbit, local red and swollen, ulceration, and the 0.3ml intravenous injection makes rabbit shiver, breathe urgently, and peripheral vessel purpling color is anoxia phenomenon.
6. other effects: Alumen has astriction, and zest for oral administration is very large, therefore except being used for saturnine colic, general equal external can hidroschesis, sclerosis skin (foot); Still can be used for leukorrhagia, ulcer (concentration is 1-5%).Then need make the albumin bound agent as being used for binding film.In addition, can be used for hemostasis, directly be put in the petechia with Alumen rod or powder, can soak molten dense the plug in the nostril of saturated Alumen with cotton balls during such as epistaxis.
Alumen sour-puckery flavor cold in nature has stronger astriction.The traditional Chinese medical science thinks, Alumen has the detoxifcation parasite killing, and is quick-fried wet antipruritic, hemostasis antidiarrheal, the effect of heat clearing away expectorant.Studies confirm that in recent years, Alumen also have the effects such as antibiotic, anti-trichomonas vaginitis.Medical Alumen is treated the diseases such as hyperlipemia, duodenal ulcer, hemoptysis of pulmonary tuberculosis in some.
The tangible novelty of tool of the present invention and breakthrough are to have found out the key point that Alumen soup 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 Alumen soup " 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 powder, soft, hard capsule, unite simultaneously in the dropping liquid agent etc. 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; Document has no open report at home, and 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 Alumen soup 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 Alumen soup dosage form preparation technology and production method thereof, wherein: the raw material of this integrated novel form effective ingredient and weight proportion---
3 parts of Alumen, 9 parts of Radix Rehmanniae, 3 parts of Radix Sophorae Flavescentiss.
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.
Above-mentioned a kind of Alumen soup 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 Alumen soup 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 Alumen soup 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 Alumen soup dosage form preparation technology and production method thereof, wherein: the integrated novel form end product that finally can form is: tablet, powder, suppository, stick, granule, soft capsule, hard capsule, effervescent, drop pill, aerosol, unguentum, oral solution, slow releasing tablet, controlled release tablet, dropping liquid agent.
A kind of Alumen soup 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 Rehmanniae micropowder doubly measures 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.
Step 3: get 60% Radix Sophorae Flavescentis 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 40% Radix Rehmanniae, Radix Sophorae Flavescentis micropowder, add and boil 3 times with the traditional Chinese medicine extracting machine decocting after the Alumen micropowder was 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 automatic filling machine respectively fill become powder and dropping liquid agent.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 Alumen soup 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 Alumen soup 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 Alumen soup 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 Alumen soup 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 Alumen soup 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 Alumen soup " 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 powder, soft, hard capsule, unite simultaneously in the dropping liquid agent etc. 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 powder, dropping liquid agent, 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 Alumen soup dosage form preparation technology and production method thereof, its special feature is: the raw material composition of making effective ingredient is by weight ratio---
3 parts of Alumen, 9 parts of Radix Rehmanniae, 3 parts of Radix Sophorae Flavescentiss.
Further, play the synergy of standing like the legs of a tripod on the integrated new drug formulation compatibility of Alumen soup of the present invention: 1, prepare nanometer, micro-powder with the prepared slices of Chinese crude drugs, the bioavailability after strengthening Alumen soup 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 Alumen soup 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 Alumen soup 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 Rehmanniae micropowder doubly measures 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% Radix Sophorae Flavescentis 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 40% Radix Rehmanniae, the Radix Sophorae Flavescentis micropowder is mixed, and adds and boils 3 times with the traditional Chinese medicine extracting machine decocting after the Alumen micropowder was soaked in water two hours, decocting liquid merges and filters, 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 automatic filling machine respectively fill become powder and dropping liquid agent.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---
3 parts of Alumen, 9 parts of Radix Rehmanniae, 3 parts of Radix Sophorae Flavescentiss.
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 powder standard in 2010, do not add adjuvant, antiseptic, adopt the automatic filling machine fill to make powder.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---
3 parts of Alumen, 9 parts of Radix Rehmanniae, 3 parts of Radix Sophorae Flavescentiss.
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 dropping liquid agent standard in 2010, do not add adjuvant, antiseptic, adopt the automatic filling machine packing to make the dropping liquid agent.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---
3 parts of Alumen, 9 parts of Radix Rehmanniae, 3 parts of Radix Sophorae Flavescentiss.
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 Alumen soup 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 the dosage forms such as powder, soft, hard capsule or dropping liquid agent, 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 powder, dropping liquid agent, hard capsule and the soft capsule.Difference according to the dissolving of dosage form 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 Alumen soup modern Chinese medicine preparation and production have proposed a practical effective novel form compatibility program.To have substantial innovation and technological break-through.
Resemble the such classics side of Alumen soup and be 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, go through bimillennium and do 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. an Alumen soup dosage form preparation technology and production method thereof is characterized in that: the raw material of this novel form effective ingredient and weight proportion---
3 parts of Alumen, 9 parts of Radix Rehmanniae, 3 parts of Radix Sophorae Flavescentiss.
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.
2. a kind of Alumen soup 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 Alumen soup 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 Alumen soup 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 Alumen soup dosage form preparation technology of 3 or 4 any one and production method thereof, it is characterized in that: the integrated novel form end product that finally can form is: tablet, powder, suppository, stick, granule, soft capsule, hard capsule, effervescent, drop pill, aerosol, unguentum, oral solution, slow releasing tablet, controlled release tablet, dropping liquid agent.
6. an Alumen soup 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 Rehmanniae micropowder doubly measures 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.
Step 3: get 60% Radix Sophorae Flavescentis 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 40% Radix Rehmanniae, Radix Sophorae Flavescentis Chinese medicine micropowder, add and boil 3 times with the traditional Chinese medicine extracting machine decocting after Alumen was 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 automatic filling machine respectively fill become powder and dropping liquid agent.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 Alumen soup 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 Alumen soup dosage form preparation technology according to claim 7 and production method thereof; it is characterized in that: the crude drug such as the dissimilar nanoparticle that employing different pharmaceutical adjuvant is prepared in the medicine monomer in the described step 6, active substance, effective site technology of preparing and the described step 7, nano-emulsion; the described protection domain of this claim is not only described technology of preparing and method; as required, be also included within add on its basis or use other better effects if, more economical, upgrade, preparation method more advanced, more environmental protection and technology.
9. a kind of Alumen soup 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 Alumen soup 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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| WO2003101389A2 (en) * | 2002-05-29 | 2003-12-11 | Bio-Defense Nutritionals | Relief of aids symptoms |
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