CN102847094A - Preparation process of integration-type novel formulation of Cinnamomum cassia and Paeonia lactiflora decoction and production method thereof - Google Patents
Preparation process of integration-type novel formulation of Cinnamomum cassia and Paeonia lactiflora decoction and production method thereof Download PDFInfo
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Abstract
The invention relates to a preparation process of integration-type novel formulation of Cinnamomum cassia and Paeonia lactiflora decoction and a production method thereof. The effective components of the novel formulation are made from the following raw materials (by weight parts): Cinnamomum cassia twig 9, Paeonia lactiflora 18, Radix Glycyrrhizae Preparata 6, Ziziphus jujuba (Fructus Jujubae) 12 and Zingiber officinale 9. The production method includes the steps of supersonic airstream pulverization, alcohol-water extraction, ultrasonic pulverization and extraction, water decoction and concentration, supersonic spray-drying, nano-scale grinding, high-pressure emulsion and homogenization and nanoparticle preparation. The production method integrates the advantageous of the nano-carrier combination technique, such as multi-component synergism and multi-target. The large-scale production can greatly reduce the production cost, greatly improve the product quality and enhance the target property and sustained/controlled-release property of drugs. The novel formulation is administered by oral intake and external application during four time periods respectively based on the midnight-noon tidal flow and human qi-blood flow rule. The novel formulation is also processed to membranes and transdermal delivery agents which are applied to different parts of human body respectively according to the midnight-noon tidal flow and human qi-blood flow rule and can be directly absorbed by the skin.
Description
Technical field
The present invention relates to a kind of cassia twig and herbaceous peony soup dosage form preparation technology, the invention still further relates to a kind of cassia twig and herbaceous peony 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.
Cassia twig and herbaceous peony soup comes from the treatise on Febrile Diseases of Han dynasty Zhang Zhongjing.Square by 3 liang of Ramulus Cinnamomi (peeling), 6 liang of Radix Paeoniaes, 2 liang in Radix Glycyrrhizae (processing), 12 pieces in Fructus Jujubae (thumb), Rhizoma Zingiberis Recens 3 liang (cutting) forms.Effect: separate the table of the sun outward, lunar interior deficiency of interior accent.Harmonizing yingfen and weifen, the relieving spasm to stop pain of holding concurrently.Cure mainly: this TAI YANG syndrome, cure anti-purgation, Yin Er distention of the abdomen with intermittent pain person belongs to also lunar.Tired, floating and rapid pulse is without hard completely shape person; Abdominal distention purgation with drugs of cold nature, or aversion to cold.We were mainly used in treating digestive system disease modern age.
Later age, the doctor was to we's application:
1) " the square utmost point ": we control syndrome of decoction GUI ZHI (Ramulus cinnamomi) and abdomen contracture play person.
2) " square machine ": tired, floating and rapid pulse is expired the shape person without hard, the abdominal distention purgation with drugs of cold nature, floating pulse, or aversion to cold, or distention of the abdomen with intermittent pain person, the cassia twig and herbaceous peony soup master it.
3) " territory, side ": its people Su You mass in the abdomen addiction, because causing intrinsic poison, dysentery does stomachache person, and this side is host for it.In case suffering from abdominal pain because of dyspepsia, the still more than person that suffers from abdominal pain afterwards that vomits and diarrhoea, this intrinsic poison is done also.The lid cassia twig and herbaceous peony soup is not only controlled the dysentery poison, only pain very, or the dysentery poison both separated and pain is more than and so on, all by intrinsic poison also.This side master's.
Each is discussed: 1. " typhoid fever string of pearls collection ": thus the outer heresy that enters of Ramulus Cinnamomi, so the Radix Paeoniae peace is hindered purgation the moon also.Press " gold is deficient " cloud: typhoid fever YANG pulse being hesitant, YIN pulse being stringy, method is as the spasm and pain in the abdomen person, with Xiao Jianzhong Tang; The person that is not recovered is with Herba Sidae Rhombifoliae soup.This also evil fall in the moon therefore.And Ramulus Cinnamomi adds Radix Paeoniae, and the meaning in also little the building without glue maltosemalt sugar person, with its abdominal distention, is not wanted more to increase full ear with sugariness.2. " the ancient prescription choosing is annotated ": cassia twig and herbaceous peony soup, this uses the Yin and Yang method also, and it is wonderful namely with the side of the sun, the lunar disease of seeking medical advice.Distention of the abdomen with intermittent pain, vagina void also with extraordinarily 3 liang of Radix Paeoniae 1 flavors, are helped with Radix Glycyrrhizae, and acid is sweet mutually auxiliary, just closes lunar principal agent; And extraordinarily Radix Paeoniae can supervise again Ramulus Cinnamomi deeply cloudy minute, and its sun of elevate a turnable ladder is warded off the sun and is absorbed in lunar heresy.Have again Rhizoma Zingiberis Recens, Fructus Jujubae to be in harmonious proportion for it, then YANG collateral of TAI YANG meridian is evil, is not detained in lunar.
Clinical practice:
Dysentery " Shandong College of Traditional Chinese Medicine's journal " (1977; 1:27): the king so-and-so, man, 46 years old.Suffer from bacillary dysentery, subtracted through controlling at that time, after again recurrence, touchingly do not heal, become chronic bacillary dysentery, every day 3-4 time at least, 5-6 time at most, defecation is very anxious, not as good as entering the lavatory, dirty clothing then, defecation is not well again after so stepping on the lavatory, lower heavy difficulty is led to, the shape of defecating is shapeless, and red white mucus is arranged; Extremely anxious, with stomachache, the diseases such as borborygmus.Deep and stringy pulse and sliding, the red tongue tongue is white, sees it and takes side, cold must a kind of reed mentioned in ancient books, companys, Re Bijiang, attached mends with ginseng, art, puckery such as prunus mume (sieb.) sieb.et zucc., scold, the almost everywhere of tasting, settled nothing is imitated.This is the taste disorder of YIN and YANG still, hepatic depression and take advantage of card.Method for the treatment of: the spleen and stomach regulating negative and positive, and the flat wood of Yu Tuzhong.Side's medicine: Ramulus Cinnamomi 3 money, the Radix Paeoniae Alba 6 money, 12 pieces of Radix Glycyrrhizae Preparata 3 money, Rhizoma Zingiberis Recens 3 money, Fructus Jujubae.Take 2 doses, dysentery reduces to 1-2 time, and photograph side takes again 2 doses and fully recover.
Cao Shi treats 1 example and have stomachache, and immediate cause feelings will is not relaxed, and advances raw food again and causes the gastric abscess recurrence, and that presses seemingly feels alleviation of pain, and abdominal part expands, after the food more so, the nausea nausea, belch is indigestion and loss of appetite, xerostomia is wish drink person not, plan cassia twig and herbaceous peony soup the spleen and stomach regulating, the liver processed contraction of relaxing.Behind five doses of medicines, pain is separated swollen disappearing, and takes food as usual.
Li Shi reports 1 example, and gastrointestinal is weak usually, suffers from again gastrointestinal disease, pain during abdomen, and the stool diarrhea is not well, and the little existing contracture of rectus abdominis m. has succussion splash under the heart.After taking 7 doses of cassia twig and herbaceous peony soups, the stomachache diarrhea is namely healed.
The Zhou Shi report is achieved good results with we's treatment 1 routine chronic dysentery.The patient suffers from bacillary dysentery, does not thoroughly cure, and the touching chronic dysentery that becomes is defecated shapeless, and red white mucus is arranged, and every day 3 to 6 times, defecation is very anxious and not well, and lower heavy difficulty is logical, the borborygmus of companion's stomachache.Once cold, the heat of clothes, benefit, puckery prescription did not all produce effects.Cut its deep and stringy pulse and slide, the red tongue tongue is white.Intend cassia twig and herbaceous peony soup: Ramulus Cinnamomi 9g, Radix Paeoniae Alba 18g, Radix Glycyrrhizae Preparata 9g, Rhizoma Zingiberis Recens 9g, Fructus Jujubae are 12 pieces in vain.Take 2 doses, dysentery reduces to day first and second, and photograph side takes again 2 doses and fully recover.
Zhu Shi report is take cassia twig and herbaceous peony soup as main formula, adds Radix Angelicae Sinensis, Herba Cistanches is treated the greatly after being ill large wound of cloudy liquid of 1 example, and constipation is difficult to resolve, 10 Yu Ri delegation, receive and very lack the person, serve on 6 doses, stool is whenever daily arranged, appetite increases, spirit takes a turn for the better, and joins the continuous clothes of honeyed pill with former side's medicine is ground into powder, to consolidate curative effect.
Hayes also have constipation with we treatment 1 example, feels again wind and cold, and disease is had a headache and fever, perspiration and aversion to wind, and slight asthma, the delegation on the 5th of defecate, pain person during the abdominal part distension, the side intends cassia twig and herbaceous peony soup and helps less Semen Armeniacae Amarum with harmonizing yingfen and weifen, doublely leads to spleen network, sharp lung qi and obtains effect.
The tangible novelty of tool of the present invention and breakthrough are to have found out the key point that cassia twig and herbaceous peony 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 cassia twig and herbaceous peony 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 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 cassia twig and herbaceous peony 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 cassia twig and herbaceous peony soup dosage form preparation technology and production method thereof, wherein: the raw material of this integrated novel form effective ingredient and weight proportion---
9 parts of Ramulus Cinnamomi, 18 parts of Radix Paeoniaes, 6 parts of Radix Glycyrrhizae Preparatas, 12 parts in Fructus Jujubae, 9 parts in Rhizoma Zingiberis Recens.
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.Above-mentioned a kind of cassia twig and herbaceous peony 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 cassia twig and herbaceous peony 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 cassia twig and herbaceous peony 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 cassia twig and herbaceous peony 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.
A kind of cassia twig and herbaceous peony 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% Ramulus Cinnamomi, Radix Paeoniae, Radix Glycyrrhizae Preparata micropowder doubly measures 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 Jujubae, Rhizoma Zingiberis Recens micropowder, adopt the ultrasound wave dispersion extractor to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz-120KHz, to pulverize extraction time be 10-100 minute, gets extract with for subsequent use.
Step 4: with step 2, step 3 gained Chinese medicine extract, adopt nanon ball-mill to grind 4-16 hour, get the nano powder that particle size distribution is the 50-1000 nanometer, for subsequent use.
Step 5: get each Chinese medicine micropowder of 40%, boiled 3 times with the traditional Chinese medicine extracting machine decocting after being soaked in water two hours, decocting liquid merges and filters, and filtrate is concentrated, gets Chinese medical concrete or water drug-decocting concentrating liquid with for subsequent use.
Step 6: with step 2, step 3, step 4 gained Chinese medicine extract, nano powder as required with and the different property of medicine, pharmacological actions, can adopt respectively the technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared, obtain the medicine materials such as different medicine monomers, effective site, active materials.
Step 7: adopt different excipient substances by version in 2010 " preparation part of standards standard and " the even method of high pressure breast is adopted respectively in the requirement in 2005 version Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " etc. in the Chinese pharmacopoeia above-mentioned gained medicine material, inclusion technique, solid state technology, polishing, solvent-fusion method, squeezing and pressing method, complex coacervation, emulsion-crosslinking method, the polymerization dispersion method, fusion method, the technology such as freeze-drying are prepared into nanoparticle, nanoparticle, the micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanosuspension, the crude drug such as microcapsule.The crude drug particle diameter is between 10 nanometers-10 micron.
Step 8: " preparation part of standards code requirement in the Chinese pharmacopoeia was got in the crude drug such as step 5 gained Chinese medical concrete or water drug-decocting concentrating liquid and step 7 gained nanoparticle, liposome, nano-emulsion, microcapsule one or more and is mixed by formula proportion by version in 2010.
Step 9: in GMP10000 level toilet, with the above-mentioned crude drug that mixes adopt full-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can by version in 2010 " Chinese pharmacopoeia related preparations standard criterion is made the above-mentioned end product of other type.
Step 10: the end product of making is carried out respectively several, bottling, mounted box, sealing, stickup labeling, plays the exterior and interior packings such as code, vanning.Packaged product is transported to the appointed place by production batch and unifies instantaneously sterilising, and opens the sterilization report.
Above-mentioned a kind of cassia twig and herbaceous peony 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 cassia twig and herbaceous peony 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 cassia twig and herbaceous peony 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 cassia twig and herbaceous peony 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 the cassia twig and herbaceous peony 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 cassia twig and herbaceous peony 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 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 cassia twig and herbaceous peony 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---
9 parts of Ramulus Cinnamomi, 18 parts of Radix Paeoniaes, 6 parts of Radix Glycyrrhizae Preparatas, 12 parts in Fructus Jujubae, 9 parts in Rhizoma Zingiberis Recens.
Further, play the synergy of standing like the legs of a tripod on the integrated new drug formulation compatibility of cassia twig and herbaceous peony soup of the present invention: 1, prepare nanometer, micro-powder with the prepared slices of Chinese crude drugs, the bioavailability after strengthening the cassia twig and herbaceous peony 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 cassia twig and herbaceous peony 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 cassia twig and herbaceous peony 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.Getting 30%--90% alcohol-water solution that 60% Ramulus Cinnamomi, Radix Paeoniae, Radix Glycyrrhizae Preparata micropowder doubly measures with 6-12 mixes 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.Get 60% Fructus Jujubae, Rhizoma Zingiberis Recens micropowder, adopt the ultrasound wave dispersion extractor to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz--120KHz, extraction time are 10-100 minute, get extract with for subsequent use.With above-mentioned gained Chinese medicine extract, adopt nanon ball-mill to grind 4-16 hour, get the nano powder that particle size distribution is 50 nanometers-1000 nanometer, for subsequent use.Get each Chinese medicine micropowder of 40% and mix, boiled 3 times with the traditional Chinese medicine extracting machine decocting after being soaked in water two hours, decocting liquid merges and filters, and filtrate concentrates, and gets Chinese medical concrete or water drug-decocting concentrating liquid with for subsequent use.With above-mentioned gained Chinese medicine extract, nano powder as required with and the different property of medicine, pharmacological actions, can adopt respectively the technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared, obtain the medicine materials such as different medicine monomers, effective site, active materials.Adopt different excipient substances and carrier by version in 2010 " related preparations part of standards standard and " the even method of high pressure breast is adopted respectively in the requirement in 2005 version Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " etc. in the Chinese pharmacopoeia above-mentioned gained medicine material, inclusion technique, solid state technology, polishing, solvent-fusion method, squeezing and pressing method, complex coacervation, emulsion-crosslinking method, the polymerization dispersion method, fusion method, the technology such as freeze-drying are prepared into nanoparticle, nanoparticle, the micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanosuspension, the crude drug such as microcapsule.The crude drug particle size distribution of preparing is between 10 nanometers-10 micron." preparation part of standards code requirement in the Chinese pharmacopoeia was got in the crude drug such as above-mentioned gained Chinese medical concrete or water drug-decocting concentrating liquid and above-mentioned gained nanoparticle, liposome, nano-emulsion, microcapsule one or more and is mixed by formula proportion by version in 2010.In GMP10000 level toilet, with the above-mentioned crude drug that mixes adopt full-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can make by the related preparations standard criterion the above-mentioned end product of other type.The end product of making is carried out respectively several, bottling, mounted box, sealing, stickup labeling, plays the exterior and interior packings such as code, vanning.Packaged product is transported to the appointed place by production batch and unifies instantaneously sterilising, and opens the sterilization report.
" embodiment one "
Press the following crude drug of preceding method preparation: extractum, nanoparticle, microcapsule, nanoparticle.
Its raw material of making effective ingredient forms---
9 parts of Ramulus Cinnamomi, 18 parts of Radix Paeoniaes, 6 parts of Radix Glycyrrhizae Preparatas, 12 parts in Fructus Jujubae, 9 parts in Rhizoma Zingiberis Recens.
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---
9 parts of Ramulus Cinnamomi, 18 parts of Radix Paeoniaes, 6 parts of Radix Glycyrrhizae Preparatas, 12 parts in Fructus Jujubae, 9 parts in Rhizoma Zingiberis Recens.
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---
9 parts of Ramulus Cinnamomi, 18 parts of Radix Paeoniaes, 6 parts of Radix Glycyrrhizae Preparatas, 12 parts in Fructus Jujubae, 9 parts in Rhizoma Zingiberis Recens.
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 cassia twig and herbaceous peony 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 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 cassia twig and herbaceous peony soup 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 cassia twig and herbaceous peony 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---
9 parts of Ramulus Cinnamomi, 18 parts of Radix Paeoniaes, 6 parts of Radix Glycyrrhizae Preparatas, 12 parts in Fructus Jujubae, 9 parts in Rhizoma Zingiberis Recens.
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.
2. a kind of cassia twig and herbaceous peony 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 cassia twig and herbaceous peony 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 cassia twig and herbaceous peony 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 cassia twig and herbaceous peony 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.
6. a cassia twig and herbaceous peony 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% Ramulus Cinnamomi, Radix Paeoniae, Radix Glycyrrhizae Preparata micropowder doubly measures 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 Jujubae, Rhizoma Zingiberis Recens micropowder, adopt the ultrasound wave dispersion extractor to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz--120KHz, extraction time are 10-100 minute, get extract with for subsequent use.
Step 4: with step 2, step 3 gained Chinese medicine extract, adopt nanon ball-mill to grind 4-16 hour, get the nano powder that particle size distribution is the 50-1000 nanometer, for subsequent use.
Step 5: get each Chinese medicine micropowder of 40%, boiled 3 times with the traditional Chinese medicine extracting machine decocting after being soaked in water two hours, decocting liquid merges and filters, and filtrate is concentrated, gets extractum or water drug-decocting concentrating liquid with for subsequent use.
Step 6: with step 2, step 3, step 4 gained Chinese medicine extract, nano powder as required with and the different property of medicine, pharmacological actions, can adopt respectively the technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared, obtain the medicine materials such as different medicine monomers, effective site, active materials.
Step 7: adopt different excipient substances and carrier by version in 2010 " related preparations part of standards standard and " the even method of high pressure breast is adopted respectively in the requirement in 2005 version Chinese pharmacopoeia appendix KIXE " 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 cassia twig and herbaceous peony 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 cassia twig and herbaceous peony soup 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 cassia twig and herbaceous peony 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 cassia twig and herbaceous peony soup dosage form preparation technology according to claim 9 and production method thereof, it is characterized in that: 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.
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| CN105288521A (en) * | 2014-06-23 | 2016-02-03 | 沈如琴 | Traditional Chinese medicine for treating constipation |
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| CN105288521A (en) * | 2014-06-23 | 2016-02-03 | 沈如琴 | Traditional Chinese medicine for treating constipation |
| CN104208653A (en) * | 2014-10-10 | 2014-12-17 | 施瑞客（天津）生物技术有限公司 | Traditional Chinese medicine composition for treating piglet yellow-white dysentery and preparation method for same |
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