CN102846790A - Preparation process of integration-type novel formulation of DACHENGQI decoction and a production method thereof - Google Patents
Preparation process of integration-type novel formulation of DACHENGQI decoction and a production method thereof Download PDFInfo
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Abstract
The invention relates to a preparation process of integration-type novel formulation of DACHENGQI decoction and a production method thereof. The effective components of the novel formulation are made from the following raw materials: by weight, 12 parts of Radix Et Rhizoma Rhei, 15 parts of Magnolia officinalis, 12 parts of Fructus Aurantii Immaturus (Citrus aurantium and/or Citrus sinensis), and 9 parts of mirabilite. The production method includes the steps of supersonic airstream pulverization, alcohol-water extraction, ultrasonic pulverization and extraction, water decoction and concentration, supersonic spray-drying, nano-scale grinding, high-pressure emulsion and homogenization and nanoparticle preparation. The production method integrates the advantageous of the nano-carrier combination technique, such as multi-component synergism and multi-target. The large-scale production can greatly reduce the production cost, greatly improve the product quality and enhance the target property and sustained/controlled-release property of drugs. The novel formulation is orally administrated or externally applied during four time periods respectively based on the midnight-noon tidal flow and human qi-blood flow rule. The novel formulation is also processed to membranes and transdermal delivery agents which are applied to different parts of human body respectively according to the midnight-noon tidal flow and human qi-blood flow rule and can be directly absorbed by the skin.
Description
Technical field
The present invention relates to a kind of DACHENGQI TANG dosage form preparation technology, the invention still further relates to a kind of DACHENGQI TANG dosage form preparation technology and production method thereof.
Background technology
Chinese medicine decocting liquid compound recipe drug effect chemical reaction is too many because of chemical composition, temporary transient not revealed its Mysterious Veil also, but some mysterious black box drug actions are just ensconced in the Chinese medicine decocting liquid in the Chinese medicinal formulae, can not ask simply Chinese medicine westernization, the modernization of Chinese medicine most and only use monomer and effective site.The Chinese medicine water drug-decocting concentrating liquid could not be given it up! When the Chinese medicinal formulae water decocts, because prescription closes chemical environment complicated in high temperature when frying in shallow oil and the solution, the reaction such as complexation, hydrolysis, oxidation, reduction between intrinsic material may occur in solution, thereby some novel substance that did not originally have in the generation solution, these novel substances produce the drug actions such as potentiation, attenuation or modification to full side.New component forms the research of mechanism, stability and drug effect thereof in the reinforcement Chinese medicinal formulae decocting liquid, to improving Chinese medicine compound and new drug level, progressively dwindle Chinese medicine compound and new Chinese medicine and international gap, very important meaning is arranged, also increased new way and new source for the research and development new Chinese medicine simultaneously.
China's drug control relevant laws and regulations regulation changes dosage form and manages as new drug research.The backwardness of preparation level not only affects the performance of curative effect of medication, and cause the medicine added value low, directly affecting the market competition and industrial economy benefit, is to cause China's medical industry product quantity to occupy prostatitis, the world and the output value only is equivalent to the one of the main reasons of one or two transnational drugmaker.
New drug, novel form development level can embody economy and the technical strength of the medical industry of a country.China's oral formulations accounts for 2/3 of various whole body drug-delivery preparations, and accelerating development and promoting oral sustained-release preparation is the work that current urgent need will be done.
DACHENGQI TANG comes from the treatise on Febrile Diseases of Han dynasty Zhang Zhongjing.Ingredients: four liang of Radix Et Rhizoma Rhei (wine is washed), half jin of Cortex Magnoliae Officinalis (processing peeling), five pieces of Fructus Aurantii Immaturuss (processing), Natrii Sulfas three closes.A pipeful of with water, boil first two things, get five liters, go dregs, receive Radix Et Rhizoma Rhei, more boil and get two liters, go dregs, receive Natrii Sulfas, upper low baking temperature one or two boils, and a minute temperature takes again.Must descend remaining not clothes.Function: drastic purgation accumulation of heat.Cure mainly: 1. excess syndrome of YANG MING FU-organ is demonstrate,proved.Constipation, the frequency passing of flatus, gastral cavity abdomen feeling of fullness abdominal pain with tenderness, that presses is then hard, even the hectic fever delirium, the right sweating of brothers Ji, dry and yellowish fur plays thorn, or burned black cracking from dryness, deep and forceful pulse.2. diarrhea.Diarrhea with watery stool, pure green colour, its gas is smelly dirty, and umbilicus abdomen pain hardly has piece, dry mouth and parching tongue, a rolling and forceful pulse by it.3. the cold limbs due to intense heat in the interior of excess syndrome of interior-heat, convulsive diseases or go mad etc.Modern times are usually used in acute simplex intestinal obstruction, acute cholecystitis, acute appendicitis etc.
We are the important prescription of purgation with drugs of cold nature.All 19 of the syndrome of controlling of institute in treatise on Febrile Diseases, therapeutic domain is extensive, but with the evil bright internal organs of sun that passes of typhoid fever, enters inner heat-transformation, ties mutually the excess syndrome of interior-heat that forms for curing mainly emphasis with stercoroma in the intestinal.Because excess-heat and stagnant mutually knot, the foul smell filling, FU QI being obstructed, thus constipation, passing of flatus frequently, gastral cavity abdomen feeling of fullness pain, the interior-heat bright body fluid that disappears, the waste matter knot is poly-, and dry excrement amasss in intestinal, therefore the hard full and tenderness of stomachache.In pathogenic heat was contained in, disturbing the mind upwards was therefore see delirium.It is bright in sun that extremity are reported gas, and positive bright excessive heat in the interior steams urgent body fluid and leaks the then right sweating of brothers Ji.Knot in the intenseness of heat impairment of body fluid, dry reality, thus see dry and yellowish fur, even burned black thorn, deep and forceful pulse." fecal impaction with watery discharge due to heat accumulation " is because of excessive heat in the interior, and stercoroma is tied in intestinal and do not drawn, but watery stool, and the blue or green and smelly dirty not audible of color, and see the umbilicus abdominal pain hardly has a piece by it; The heat body fluid that burns, cloudy essence is large hinders, can not on hold, therefore dryness of the mouth and throat, tongue fur is sallow cracks from dryness.If the stagnant impatency of excess-heat is in interior, yang-energy is held back, and must not reach in extremity, then the card of visible cold limbs due to intense heat in the interior; Intense heat in the interior, the large wound of cloudy liquid, the muscle arteries and veins loses supports, can have a convulsion again, even fullness in the chest and trismus, unable of lying flat on the back due to opisthotonus, the convulsive diseases of muscle spasm of the leg and foot; As disturbing in the pathogenic heat, visible coma then, even go mad.
Side opinion: Wu Kun " hospital examines " volume 1: " in the typhoid fever YANG pathogen enters, painful abdominal mass, full, dry, reality, hard complete all persons are anxious with this side master's.The seasoning CHENGQI TANG is not made feeling of fullness without trifoliate orange, plain person with it, and the vigour of probably hindering the part of the body cavity above the diaphragm housing the heart and lungs nihility generative forces of heaven and earth of using also; Xiao Chengqi Tang is without the Natrii Sulfas person, and with in fact and not hard, that uses probably hinders the Kidney-Yin of part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels blood system, and meaning is not cut down its root yet.Then the upper, middle and lower three warmers are all sick for this, and painful abdominal mass, full, dry, reality, heavily fortified point are all complete, therefore main this side is to control it.The bitter temperature of Cortex Magnoliae Officinalis is to go painful abdominal mass, and the Fructus Aurantii Immaturus bitter cold is full to let out, and Natrii Sulfas is salty-cold with moistening for dryness and softening hard mass, and the Radix Et Rhizoma Rhei bitter cold is to let out real reducing phlegm and internal heat.
The clinical application example: oral and enema treatment acute ileus 30 examples of DACHENGQI TANG obtain good efficacy.Mechanical intestinal obstruction 18 examples wherein, paralytic ileus 12 examples; The course of disease is the longest 5 days, and is the shortest 6 hours.Its typical symptom is: stomachache, abdominal distention, vomiting, constipation; Have a medical check-up: the abdominal part mild tenderness, visible peristalsis visible intestinal peristalsis and peristaltic wave, intestinal toot sound is hyperfunction or weaken metallic sound and gur gling; X-ray is taken the photograph sheet: small intestinal pneumatosis hydrops.With 2 doses of Radix Et Rhizoma Rhei 12 gram Natrii Sulfas 30 gram Fructus Aurantii Immaturuss, each 15 grams of Cortex Magnoliae Officinalis, dense frying in shallow oil respectively, every dose of 100 milliliters of oral and retention enemas.As do not prove effective, fry in shallow oil again 2 doses after 12 hours, dose doubles, and cooperates simultaneously gastrointestinal decompression, fluid infusion and infection.The result: produce effects 16 examples, effective 6 examples, total effective rate 73.3%, wherein 18 routine paralytic ileuses are all effective, and 12 routine mechanical intestinal obstructiones also have 4 examples effectively.
Modern study:
1. increase gastrointestinal tract and advance function and intestinal volume " Tianjin medical magazine " 1965 (10): 790～791, DACHENGQI TANG is significantly increased the effect that digestive tract advances the property motion behind the white mice oral administration medicine supplying, and in dispensing rear 10 minutes, effect was just obvious.But through the intravenously administrable group, the charcoal end is at the gastrointestinal advance distance, there are no enhancing.Oral administration is given DACHENGQI TANG, and is significantly increased the effect of intestinal volume.
2. promote also receiving of intestinal intussusception, " Tianjin medical magazine " 1965 (10): 792～793 blocked in releasing, in the observation DACHENGQI TANG experiment of removing ileac general action mechanism is shown, 10 rabbit of administration group (artificial intestinal intussusception) fully also receive, the time of on average also receiving is 15 minutes and 30 seconds, also receive rate 100%, in the matched group only 3 also receive.Test and also think, DACHENGQI TANG is to the effect of intestinal tube, take the part as main.
Because decoction is used inconvenience, it is very significant for a certain or certain several sick kind we being developed to modern preparation, will bring huge Social benefit and economic benefit.
The tangible novelty of tool of the present invention and breakthrough are to have found out the key point that DACHENGQI TANG modern Chinese medicine novel form Chinese and western medicine theory combines, the present invention will in time fill up both at home and abroad and use " nano-carrier multiple techniques " and researching and developing the blank in " the integrated novel form of DACHENGQI TANG " field with theory of integrated Chinese and western medicine, product has the targeting advantage such as wide that distributes, both at home and abroad without same or similar bibliographical information.Research and development have reached world lead level.Show substantive progressive and novelty of the present invention by international one-level novelty assessment report and patent retrieval.Utilize domestic and foreign databases to carry out update search, comprehensive domestic and foreign literature is read, analyzing contrast obtains drawing a conclusion: " the integrated novel form of multiple techniques research and development Nano medication " project, its innovative point: 1) adopt the Chinese medicine nano powder body that is rich in trace element, the medicine monomer, effective site, effective part group, Chinese medical concrete, water drug-decocting concentrating liquids etc. are prepared the nanosphere of different-grain diameter size with the different pharmaceutical carrier, nanocapsule, polymer micelle, solid ester matter nanoparticle, magnetic nano particle, immunonanoparticles, nano-emulsion, suspensoid, vesicle, pharmacosomes, microcapsule, nanoparticle, nanoparticles, millimicro is assisted etc., and then mixing is respectively charged into soft, unite simultaneously in the hard capsule and use and be prepared into a kind of integrated novel form or be prepared into the integrated novel form of other types according to above method; 2) use nano-carrier multiple techniques and theory of integrated Chinese and western medicine research and development " the integrated novel form of Nano medication ", product has the characteristics such as targeting distributes extensively, slow controlled release properties is strong; Have no at home open report in the document, these project complex art characteristics have certain novelty and novelty.Science and technology is looked into new numbering: 200921c0704948.
Further: this dosage form preparation technology is the advantage separately of having integrated the traditional Chinese medical science, doctor trained in Western medicine, take the organic conception of theory of Chinese medical science and pay attention to collaborative idea between medicine and determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs as the overall strategy tactical thinking, in conjunction with modern western pharmacology, pharmacokinetics, toxicology, pharmaceutics scheduling theory, pay attention to effectiveness and the therapeutic effect of certified Chinese medicine one matter monomer in treating, pay attention to the mass action that Chinese medicine active substance, effective site and active materials play the treatment disease.Pay attention to the assosting effect that the contained trace element of Chinese medicine plays the treatment disease.The effective ingredient of the used Chinese medicine of this Chinese medicine compound is clear and definite, and medicine effect has obtained admitting of modern medicine.Pay attention to using nano-carrier multiple techniques development modern Chinese medicine.These will promote the development of China's Chinese Medicine Industry.
Summary of the invention:
Purpose of the present invention is exactly in order to solve the above-mentioned problems in the prior art, and a kind of DACHENGQI TANG dosage form preparation technology and production method thereof are provided.
Purpose of the present invention is achieved through the following technical solutions:
A kind of DACHENGQI TANG dosage form preparation technology and production method thereof, wherein: the raw material of this integrated novel form effective ingredient and weight proportion---
12 parts of Radix Et Rhizoma Rhei, 15 parts of Cortex Magnoliae Officinalis, 12 parts of Fructus Aurantii Immaturuss, 9 parts in Natrii Sulfas.
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.
Above-mentioned a kind of DACHENGQI TANG dosage form preparation technology and production method thereof, wherein: medicine and carrier are prepared into the pharmaceutical carrier crude drug, crude drug can be one or more combinations in nanoparticle, nanoparticle, micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanosuspension, the microcapsule etc., and can as required one or more be mixed.Described protection domain is not only the said medicine support material medicine in the described scope, is also included within to prepare on its basis or add the curative effect that other do not affect its disease of controlling, and just makes the pharmaceutical carrier crude drug of its better efficacy.Further, above-mentioned a kind of DACHENGQI TANG dosage form preparation technology and production method thereof, wherein: the drug carrier material that this novel form is selected, activating agent, help Emulsion, the excipient substances such as dispersant are gelatin, albumin, starch and derivant thereof, alginate, beta-schardinger dextrin-, protein, chitosan and derivant thereof, lactose, hydroxypropyl emthylcellulose, ethyl cellulose, cellulose acetate phthalate, the metering system acetate, polylactic acid, cyanoacrylate, the semisolid poe, triglyceride is (such as three stearic acid, three Palmic acids, three lauric acids, in three oleic acid etc., the glyceride of long-chain fatty acid), glyceride (such as glyceryl monostearate, contains list, two, the synthetic glyceride of triglyceride), cholesterol, Polyethylene Glycol, microcrystalline wax, the whale ester type waxes, erythrocyte, Montmorillonitum, in the tea powder etc. one or more.Described excipient substance is not only the said medicine adjuvant in the described scope, and other do not affect its disease of controlling to be also included within the upper interpolation in its basis, and just make the excipient substance of its better efficacy.
Further, above-mentioned a kind of DACHENGQI TANG dosage form preparation technology and production method thereof, wherein: said integrated novel form adopts medicament nano powder body, micro-powder, medicine monomer, effective ingredient, effective site, active materials, Chinese medical concrete, water drug-decocting concentrating liquid to unite use with different excipient substance, pharmaceutical carrier according to indexs such as the pharmacology of traditional Chinese medical science global theory, compatibility theory and medicine, drug effect, medicine generation, toxicitys.And can mix its one or more according to the preparation needs.
Again further, above-mentioned a kind of DACHENGQI TANG dosage form preparation technology and production method thereof, wherein: the integrated novel form end product that finally can form is: tablet, powder, suppository, stick, granule, soft capsule, hard capsule, effervescent, drop pill, aerosol, unguentum, oral solution, slow releasing tablet, controlled release tablet.
A kind of DACHENGQI TANG dosage form preparation technology and production method thereof, it may further comprise the steps:
Step 1: get each prepared slices of Chinese crude drugs pretreatment, insert pulverizer after the weighing and be crushed to the 80-200 order, then adopt supersonic jet mill to the 1-10 micron, get different Chinese medicine micropowder, for subsequent use.
Step 2: get 30%--90% alcohol-water solution that 60% Radix Et Rhizoma Rhei, Cortex Magnoliae Officinalis micropowder doubly measure with 6-12 and mix and soaked 1-2 days, reflux, extract, 3 times, extract simultaneously water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility, recovered alcohol gets extract with for subsequent use.
Step 3: get 60% Fructus Aurantii Immaturus, Natrii Sulfas micropowder, adopt the ultrasound wave dispersion extractor of independent research to disperse respectively to extract, ultrasonic power is: 800W--3000W, supersonic frequency: 28KHz--120KHz, to pulverize extraction time be 10-100 minute, gets extract with for subsequent use.
Step 4: with step 2, step 3 gained Chinese medicine extract, adopt the nanon ball-mill of independent research 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 DACHENGQI TANG dosage form preparation technology and production method thereof; wherein: the Chinese medicine of using in described step 1, step 2, the step 3 is pulverized and extracting method; described protection domain is not only described technology of preparing and method; as required, be also included within and add on its basis or use other better effects if, more economical, renewal, breaking method more advanced, more environmental protection, extracting method and technology.
Further, above-mentioned a kind of DACHENGQI TANG dosage form preparation technology and production method thereof, wherein: the crude drug such as the dissimilar nanoparticle that employing different pharmaceutical adjuvant is prepared in the medicine monomer in the described step 6, active substance, effective site technology of preparing and the described step 7, nano-emulsion.The described protection domain of this claim is not only described technology of preparing and method, as required, be also included within add on its basis or use other better effects if, more economical, upgrade, preparation method more advanced, more environmental protection and technology.
Further, above-mentioned a kind of DACHENGQI TANG dosage form preparation technology and production method thereof, wherein: its key point 1 is different utilization nano-carrier multiple techniques different according to the particle diameter of crude drug and the property of medicine, can produce the gentle controlled capability of different targetings.
Again further, above-mentioned a kind of DACHENGQI TANG dosage form preparation technology and production method thereof, wherein: its key point 2 is to develop simultaneously by interior external administration, can take four time periods respectively by midnight-noon and ebb-flow doctrine, energy and blood of human body flowing law.Also can be prepared into membrane, transdermal agent is attached to respectively the human body different parts by the energy and blood of human body flowing law, directly absorb by skin.
The outstanding substantive distinguishing features of technical solution of the present invention and significant progressive being mainly reflected in:
The tangible novelty of tool of the present invention and breakthrough are to have found out the key point that the DACHENGQI TANG Chinese and western medicine theory combines, the present invention will in time fill up both at home and abroad and use " nano-carrier multiple techniques " and researching and developing the blank in " the integrated novel form of DACHENGQI TANG " field with theory of integrated Chinese and western medicine, product has the targeting advantage such as wide that distributes, both at home and abroad without same or similar bibliographical information.Show substantive progressive and novelty of the present invention by international one-level novelty assessment report and Patent database searching.Utilize domestic and foreign databases to carry out update search, comprehensive domestic and foreign literature is read, analyzing contrast obtains drawing a conclusion: " the integrated novel form of multiple techniques research and development Nano medication " project, its innovative point: 1) adopt the Chinese medicine nano powder body that is rich in trace element, the medicine monomer, effective site, effective part group, Chinese medical concrete, water drug-decocting concentrating liquids etc. are prepared the nanosphere of different-grain diameter size with the different pharmaceutical carrier, nanocapsule, polymer micelle, solid ester matter nanoparticle, magnetic nano particle, immunonanoparticles, nano-emulsion, suspensoid, vesicle, pharmacosomes, microcapsule, nanoparticle, nanoparticles, millimicro is assisted etc., and then mixing is respectively charged into soft, unite simultaneously in the hard capsule and use and be prepared into a kind of integrated novel form or be prepared into the integrated novel form of other types according to above method; 2) use nano-carrier multiple techniques and theory of integrated Chinese and western medicine research and development " the integrated novel form of Nano medication ", product has the characteristics such as targeting distributes extensively, slow controlled release properties is strong; Have no at home open report in the document, these project complex art characteristics have certain novelty and novelty.Science and technology is looked into new numbering: 200921c0704948.
Further, this dosage form preparation technology and production method thereof are to have integrated the advantage separately of the traditional Chinese medical science, doctor trained in Western medicine, take the organic conception of theory of Chinese medical science and pay attention to collaborative idea between medicine and determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs as the overall strategy tactical thinking, in conjunction with modern western pharmacology, pharmacokinetics, toxicology, pharmaceutics scheduling theory, pay attention to effectiveness and the therapeutic effect of certified Chinese medicine one matter monomer in treating, pay attention to the assosting effect that Chinese medicine active substance, effective site and active materials play the treatment disease.Pay attention to the assosting effect that the contained trace element of Chinese medicine plays the treatment disease.The effective ingredient of the used Chinese medicine of this Chinese medicine compound is clear and definite, and medicine effect has obtained admitting of modern medicine.Pay attention to the different nano-carrier dosage form technologies of preparing of Chinese medicine and unite use.To adopt Chinese medicine crude drug nano-powder, monomer, effective site, effective part group, traditional Chinese drug inspissation extractum, water drug-decocting concentrating liquid, nano-medicament carrier etc. to unite use on the compatibility.These various Chinese traditional powder particle diameter major parts of filling a prescription are the granule of 50～1000 nanometers.Adopting different nano-medicament carriers to be prepared into nanoparticle, nanosphere, nanocapsule, solid ester matter nanoparticle, nano-emulsion, vesicle, pharmacosomes, microcapsule, nanoparticle, nanoparticles, millimicro assists etc.Its particle size distribution is in 10 nanometers---between-10 microns.Then theoretical according to difference, the difference of slow controlled release time and the traditional Chinese medical science monarch of pharmacology, targeting, reasonable compatibility mixes, and is respectively charged among hard capsule and the soft capsule.Difference according to the dissolving of capsule material, disintegrate, jitter time can be prepared into respectively the targeted systems such as RE targeted system, stomach mucosa absorption system, intestinal absorption system, colon absorption system.Compare Chinese medicine and medicine monomer, the target-oriented drug of the overall coordination therapeutical effect of this Chinese medicine compound novel form, slow controlled capability are stronger, and curative effect is more outstanding, and toxic and side effects still less.Multichip carrier and multiple medicines thing monomer etc. are united use, have broken through the traditional monarch compatibility theory of the traditional Chinese medical science, for the modern Chinese medicine development provides a practical effective novel form compatibility program.To have substantial technological innovation to break through.
Purpose of the present invention, advantage and disadvantage will make an explanation by the non-limitative illustration of following preferred embodiment.These embodiment only are the prominent examples of using technical solution of the present invention, and all technical schemes of taking to be equal to replacement or equivalent transformation and forming all drop within the scope of protection of present invention.
The specific embodiment
A kind of DACHENGQI TANG dosage form preparation technology and production method thereof, its special feature is: the raw material composition of making effective ingredient is by weight ratio---
12 parts of Radix Et Rhizoma Rhei, 15 parts of Cortex Magnoliae Officinalis, 12 parts of Fructus Aurantii Immaturuss, 9 parts in Natrii Sulfas.
Further, play the synergy of standing like the legs of a tripod on the integrated new drug formulation compatibility of DACHENGQI TANG of the present invention: 1, prepare nanometer, micro-powder with the prepared slices of Chinese crude drugs, the bioavailability after strengthening the DACHENGQI TANG curative effect and significantly improve prepared slices of Chinese crude drugs cell wall breaking with this; 2, with Chinese medicine extract and select suitable pharmaceutical carrier, prepare different Chemistry for Chinese Traditional Medicine monomers, effective ingredient, effective site etc., confirm and strengthen pharmacology, the efficacy of the chemical substance of DACHENGQI TANG with this; 3, prepare Chinese medical concrete, water drug-decocting concentrating liquid with the prepared slices of Chinese crude drugs, the temporary transient unpredictable drug effect of bringing with this reaction such as complexation, hydrolysis, oxidation, reduction of strengthening DACHENGQI TANG Chinese medicine compound uniqueness also keeps and has strengthened traditional Chinese medical science organic conception, monarch concept.Above three aspects: associating compatibility uses, different according to Nano medication particle diameter and character, can reach many targeting, many collaborative, slow controlled release texts, and play useful effect to strengthening the medicine pharmacologically active, effective ingredient pharmacological action effect is significantly higher than conventional formulation.
Production method of the present invention may further comprise the steps:
At first, get each prepared slices of Chinese crude drugs pretreatment, insert pulverizer after the weighing and be crushed to the 80-200 order, then adopt supersonic jet mill to the 1-10 micron, get different Chinese medicine micropowder, for subsequent use.Get 30%--90% alcohol-water solution that 60% Radix Et Rhizoma Rhei, Cortex Magnoliae Officinalis micropowder doubly measure with 6-12 and mix and soaked 1-2 days, reflux, extract, 3 times is extracted water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility simultaneously, and recovered alcohol gets extract with for subsequent use.Get 60% Fructus Aurantii Immaturus, Natrii Sulfas micropowder, adopt the ultrasound wave dispersion extractor of independent research to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz--120KHz, extraction time are 10-100 minute, get extract with for subsequent use.With above-mentioned gained Chinese medicine extract, adopt the nanon ball-mill of independent research 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---
12 parts of Radix Et Rhizoma Rhei, 15 parts of Cortex Magnoliae Officinalis, 12 parts of Fructus Aurantii Immaturuss, 9 parts in Natrii Sulfas.
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---
12 parts of Radix Et Rhizoma Rhei, 15 parts of Cortex Magnoliae Officinalis, 12 parts of Fructus Aurantii Immaturuss, 9 parts in Natrii Sulfas.
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---
12 parts of Radix Et Rhizoma Rhei, 15 parts of Cortex Magnoliae Officinalis, 12 parts of Fructus Aurantii Immaturuss, 9 parts in Natrii Sulfas.
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 DACHENGQI TANG Chinese medicine compound Chinese and western medicine theory combines, and the compound compatibility of modern Chinese medicine and technology of preparing can change the pharmacokinetic parameter of medicine monomer, effective ingredient or effective part group.This has proved the scientific meaning of Chinese medicine compound compatibility from the pharmacokinetics level." very just being harmonious; negative and positive intercommunication, coordinating water and fire, precise and tiny circle melt; greatness lies in the capacity " is the elite in the classical works such as Chinese Charltons, Taoism, Huang di's Canon of Medicine, is simple philosophy doctrine thought, also is research and development thinking and the basic guiding theory of the integrated novel form of this medicine.The traditional Chinese medical science always just has saying of Medicine and Changes sharing the same origin, skill of a doctor homology.This just precise and tiny circle of the present invention melt the Integration Theory basis.Among the present invention: monomer, effective site, nanoparticle and carrier etc. be strange, be tiny, be cloudy.Traditional Chinese medical science organic conception, Chinese medical concrete, water drug-decocting concentrating liquid etc. be just, be grand, be the sun.Very just be harmonious then negative and positive intercommunication, the negative and positive intercommunication is then coordinating water and fire, is the optimum balance attitude.Doctor trained in Western medicine research is precise and tiny, and theory of Chinese medical science is that circle melts, and both very just are harmonious, and have just really embodied the organic conception of the combination of Chinese and Western medicine, and " close " is that " integration " is for holding.The tidemark that greatness lies in the capacity, the coordinating water and fire the present invention of being only asked most.This integrated novel form is by the reasonable compatibility of Chinese medicine monomer, effective site, active substance, Chinese medicine active materials, extractum, water drug-decocting concentrating liquid, prepared slices of Chinese crude drugs nano-particle etc., can produce soft, hard capsule or the dosage forms such as nanometer membrane, transdermal agent.Can develop simultaneously, can take four time periods respectively by midnight-noon and ebb-flow doctrine, energy and blood of human body flowing law by interior external administration.Can also do film former to nano traditional Chinese medicine, transdermal agent is attached to the human body different parts, can directly absorb by skin.
Further see, the various Chinese medicine particle diameter major parts that the present invention prepares are the granule of 50～1000 nanometers.Adopt different nano-medicament carriers and technology can be prepared into nanoparticle, nanosphere, solid ester plastid, nano-emulsion, pharmacosomes, microgranule, nanoparticles, little assist etc.Its particle size distribution is in 10 nanometers---between-10 microns.Then theoretical according to difference, the difference of slow controlled release time and the traditional Chinese medical science monarch of medicine pharmacology, targeting, reasonable compatibility mixes, and can be respectively charged among hard capsule and the soft capsule.Difference according to the dissolving of capsule material, disintegrate, jitter time can be prepared into respectively the targeted systems such as RE targeted system, stomach mucosa absorption system, intestinal absorption system, colon absorption system.Compare Chinese medicine and medicine monomer or Western medicine, the overall coordination therapeutical effect of this integrated novel form and target-oriented drug, slow controlled capability are stronger, and curative effect is more outstanding, and toxic and side effects still less.Having broken through the traditional monarch compatibility theory of the traditional Chinese medical science, is innovation and the model of Chinese medicine tradition compatibility theory and traditional Chinese medical science pharmaceutics, for the preparation of DACHENGQI TANG modern Chinese medicine and production have proposed a practical effective novel form compatibility program.To have substantial innovation and technological break-through.
Claims (10)
1. a DACHENGQI TANG dosage form preparation technology and production method thereof is characterized in that: the raw material of this novel form effective ingredient and weight proportion---
12 parts of Radix Et Rhizoma Rhei, 15 parts of Cortex Magnoliae Officinalis, 12 parts of Fructus Aurantii Immaturuss, 9 parts in Natrii Sulfas
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.
2. a kind of DACHENGQI TANG dosage form preparation technology according to claim 1 and production method thereof, it is characterized in that: medicine and carrier are prepared into the pharmaceutical carrier crude drug, crude drug can be one or more combinations in nanoparticle, nanoparticle, micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanosuspension, the microcapsule etc., and can as required one or more be mixed.The described protection domain of this claim is not only the said medicine support material medicine in the described scope, is also included within to prepare on its basis or add the curative effect that other do not affect its disease of controlling, and just makes the pharmaceutical carrier crude drug of its better efficacy.
3. according to claim 1,2 described a kind of DACHENGQI TANG dosage form preparation technology and production methods thereof, it is characterized in that: the drug carrier material that this novel form is selected, activating agent, help Emulsion, the excipient substances such as dispersant are gelatin, albumin, starch and derivant thereof, alginate, beta-schardinger dextrin-, protein, chitosan and derivant thereof, lactose, hydroxypropyl emthylcellulose, ethyl cellulose, cellulose acetate phthalate, the metering system acetate, polylactic acid, cyanoacrylate, the semisolid poe, triglyceride is (such as three stearic acid, three Palmic acids, three lauric acids, in three oleic acid etc., the glyceride of long-chain fatty acid), glyceride (such as glyceryl monostearate, contains list, two, the synthetic glyceride of triglyceride), cholesterol, Polyethylene Glycol, microcrystalline wax, the whale ester type waxes, erythrocyte, Montmorillonitum, in the tea powder etc. one or more.The described protection domain of this claim is not only the said medicine adjuvant in the described scope, and other do not affect its disease of controlling to be also included within the upper interpolation in its basis, and just make the excipient substance of its better efficacy.
4. according to claim 1 and 2 or the described a kind of DACHENGQI TANG dosage form preparation technology of 3 any one and production method thereof, it is characterized in that: said integrated novel form adopts medicament nano powder body, micro-powder, medicine monomer, effective ingredient, effective site, active materials, Chinese medical concrete, water drug-decocting concentrating liquid to unite use with different excipient substance, pharmaceutical carrier according to indexs such as the pharmacology of traditional Chinese medical science global theory, compatibility theory and medicine, drug effect, medicine generation, toxicitys.And can mix its one or more according to the preparation needs.
5. according to claim 1 and 2 or the described a kind of DACHENGQI TANG dosage form preparation technology of 3 or 4 any one and production method thereof, it is characterized in that: the integrated novel form end product that finally can form is: tablet, powder, suppository, stick, granule, soft capsule, hard capsule, effervescent, drop pill, aerosol, unguentum, oral solution, slow releasing tablet, controlled release tablet.
6. a DACHENGQI TANG dosage form preparation technology and production method thereof is characterized in that may further comprise the steps:
Step 1: get each prepared slices of Chinese crude drugs pretreatment, insert pulverizer after the weighing and be crushed to the 80-200 order, then adopt supersonic jet mill to the 1-10 micron, get different Chinese medicine micropowder, for subsequent use.
Step 2: get 30%--90% alcohol-water solution that 60% Radix Et Rhizoma Rhei, Cortex Magnoliae Officinalis micropowder doubly measure with 6-12 and mix and soaked 1-2 days, reflux, extract, 3 times, extract simultaneously water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility, recovered alcohol gets extract with for subsequent use.
Step 3: get 60% Fructus Aurantii Immaturus, Natrii Sulfas micropowder, adopt the ultrasound wave dispersion extractor of independent research to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz--120KHz, extraction time are 10-100 minute, get extract with for subsequent use.
Step 4: with step 2, step 3 gained Chinese medicine extract, adopt the nanon ball-mill of independent research 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 DACHENGQI TANG dosage form preparation technology according to claim 6 and production method thereof; it is characterized in that: the pulverizing of using in described step 1, step 2, the step 3 and extracting method; the described protection domain of this claim is not only described technology of preparing and method; as required, be also included within and add on its basis or use other better effects if, more economical, renewal, breaking method more advanced, more environmental protection, extracting method and technology.
8. a kind of DACHENGQI TANG dosage form preparation technology according to claim 7 and production method thereof; it is characterized in that: the medicine monomer in the described step 6; active substance; the dissimilar nanoparticle that adopts the different pharmaceutical adjuvant to be prepared in effective site technology of preparing and the described step 7; the crude drug such as nano-emulsion; the described protection domain of this claim is not only described technology of preparing and method; as required, be also included within and add on its basis or use other better effects if; more economical; upgrade; more advanced; the more preparation method of environmental protection and technology.
9. a kind of DACHENGQI TANG dosage form preparation technology according to claim 8 and production method thereof, it is characterized in that: its key point 1 is different utilization nano-carrier multiple techniques different according to the particle diameter of crude drug and the property of medicine, can produce the gentle controlled capability of different targetings.
10. a kind of DACHENGQI TANG dosage form preparation technology according to claim 9 and production method thereof is characterized in that: its key point 2 be can in external administration develop simultaneously, can take four time periods respectively by midnight-noon and ebb-flow doctrine, energy and blood of human body flowing law.Also can be prepared into membrane, transdermal agent is attached to respectively the human body different parts by the energy and blood of human body flowing law, directly absorb by skin.
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| CN103239533A (en) * | 2013-05-10 | 2013-08-14 | 山东省中医药研究院 | Flavoured qi infusing decoction for treating simple intestinal obstruction and preparation method thereof |
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| CN107898851A (en) * | 2017-12-12 | 2018-04-13 | 佛山市弘泰药物研发有限公司 | A kind of appendicitis particle and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103239533A (en) * | 2013-05-10 | 2013-08-14 | 山东省中医药研究院 | Flavoured qi infusing decoction for treating simple intestinal obstruction and preparation method thereof |
| CN104758422A (en) * | 2015-04-01 | 2015-07-08 | 沈阳赛镝医疗器械有限公司 | Traditional Chinese medicinal ultrasonic coupled patch |
| CN104758422B (en) * | 2015-04-01 | 2017-12-08 | 沈阳赛镝医疗器械有限公司 | Chinese medicine ultrasonic coupling paster |
| CN105477141A (en) * | 2015-12-30 | 2016-04-13 | 孙世林 | Traditional Chinese medicine for treating palate carbuncle due to yang-ming fu-viscera excess |
| CN107898851A (en) * | 2017-12-12 | 2018-04-13 | 佛山市弘泰药物研发有限公司 | A kind of appendicitis particle and preparation method thereof |
| CN110243965A (en) * | 2019-06-25 | 2019-09-17 | 四川大学华西医院 | A kind of detection method of tiger fur dachengqi decoction |
| CN110243965B (en) * | 2019-06-25 | 2021-09-03 | 四川大学华西医院 | Detection method of Tiger skin Dachengqi soup |
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