CN102284024A - Preparation technology of integrated novel Weijing decoction dosage form - Google Patents
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Abstract
The invention relates to preparation technology of an integrated novel Weijing decoction dosage form. The novel dosage form comprises the following active ingredients in parts by weight: 60 parts of rhizoma phragmitis, 30 parts of coix seeds, 24 parts of white gourd seeds and 9 parts of peach seeds. The production process comprises the following steps: supersonic jet milling, extraction in aqueous alcohol, ultrasonic milling and extraction, decoction in water and concentration, nanoscale grinding, high-pressure homogenization, nanoparticle preparation and the like. The preparation technology and production method have the following characteristics and progresses: the advantages of multiple collaboration, multiple targets and the like embodied by utilizing a nano carrier combined technology are emphasized; after large scale production, the production cost can be substantially lowered, the product quality can be substantially improved and the targeting and slow/controlled release properties of medicaments are stronger; the dosage form can be simultaneously administrated internally and externally and can be taken in four time slots respectively according to the midnight-noon ebb-flow and the human blood flow rule; and the dosage form can be prepared into film agents and transdermal agents and then the agents are respectively stuck to different parts of human bodies according to the midnight-noon ebb-flow and the human blood flow rule and can be directly absorbed through skins.
Description
Technical field
The present invention relates to the integrated novel form of a kind of weijing decoction, the invention still further relates to the integrated novel form technology of preparing of a kind of weijing decoction.
Background technology
Chinese medicine decocting liquid compound recipe drug effect chemical reaction is too many because of chemical constituent, temporarily also not revealed its mysterious veil, but some mysterious black box drug actions are just ensconced in the Chinese medicine decocting liquid in the Chinese medicinal formulae, can not ask Chinese medicine westernization, the modernization of Chinese medicine simply 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, reaction such as complexation, hydrolysis, oxidation, reduction between intrinsic material may take place in solution, thereby some novel substance that did not have originally in the generation solution, these novel substances produce 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, crucial meaning is arranged, also increased new way and new source simultaneously for the research and development new Chinese medicine.
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 influences the performance of curative effect of medication, and cause the medicine added value low, directly influencing 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 exploitation level can embody the 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.
Weijing decoction comes from Tang's Sun Simiao Prescriptions Worth Thousand Gold for Emergencies and rolls up 17.The side is made up of Rhizoma Phragmitis (Rhizoma Phragmitis) 60 grams, Semen Coicis 30 grams, Semen Benincasae 24 grams, Semen Persicae 9 grams.Rhizoma Phragmitis one medicine in the side, the modern times are used Rhizoma Phragmitis clinically, and using fresh herb stem person is that the custom of medication at all times difference makes so.Function: removing heat from the lung and dissipating phlegm, removing blood stasis evacuation of pus.Cure mainly lung abscess, pyretic toxicity is stopped up stagnant, syndrome of intermin-gled phlegm and blood stasis.Slight fever, cough with copious phlegm is very then coughed and is told stench pus and blood, has a dull ache red tongue with yellowish and greasy fur, slippery and rapid pulse in the heart.We are usually used in pulmonary abscess, lobar pneumonia, bronchitis, pertussis etc. and belong to lung-heat phlegm and blood stasis person.
The pharmacological action of weijing decoction: mainly contain the enhancing macrophage phagocytic function, cold resistance, resisting fatigue is improved effects such as hemorheological property.We's decocting liquid in the mouse stomach administration, after January, can significantly improve Mouse Liver, the splenic macrophage intake to carbon granule by clinical consumption every day 2 times, and illustrating originally can activation equipment body macrophage system, the enhancing human body immunity ability.We's decocting liquid is with above-mentioned dosage and administering mode administration, behind the medicine 30 days with 60 days, all can the significant prolongation mice life span in-I ℃ frozen water, demonstration this product has tangible cold resistance effect.We's the same dosage of decocting liquid and mode administration, behind the medicine 30 days with 60 days, also can the swimming time of significant prolongation mice in 25 ℃ of deep water, with the matched group ratio, the percentage ratio that the administration group prolongs swimming time is 90.7% (30 days) and 105.7% (60 days), shows that we have antifatigue effect.We are decocted in water for oral dose, day is obeyed 1 dose, took medicine 22, pulmonary heart disease acute attack stage disease is seen that the stasis of blood resembles innings patient of insufficiency of QI of the lung and kidney diseases caused by exogenous pathogenic factor partial heat type and treats, the clinical stasis of blood resembles and is clearly better behind the medicine, Determination of Blood Rheology result shows, with compare before the administration, originally can obviously reduce erythrocyte sedimentation rate (ESR), blood flow equation K value and packed cell volume (Ht), improve erythrocyte electrophoresis rate (EPM), thereby reduce blood cell aggregation, haemoconcentration, improve the erythrocyte membrane electrology characteristic, improve blood circulation, the stasis of blood is resembled be improved.In addition in the side single medicinal material still have antibiotic, antiinflammatory, analgesic, ease pain, eliminate the phlegm, effect such as antitussive.
The pharmacological action of Rhizoma Phragmitis: Rhizoma Phragmitis one medicine, the modern times are used Rhizoma Phragmitis clinically, and using fresh herb stem person is that the custom of medication at all times difference makes so.Rhizoma Phragmitis is sweet, and is cold.Attach to the lung and stomach meridians.Has clearing away heat-fire, promoting the production of body fluid to quench thirst, relieving restlessness, preventing or arresting vomiting, diuretic effect.The immunocompetent polysaccharide chemical compounds of multiple tool such as xylan are arranged in the Rhizoma Phragmitis institute carbohydrate containing, and contain poly alcohol, betanin, Coixol, free dried meat aminoacid, asparagine and flavone compound tricin etc.That Rhizoma Phragmitis has is analgesic, calm, analgesia, blood pressure lowering, blood sugar lowering, antioxidation and the effect of estrogen sample, and Beta-hemolytic streptococcus is had inhibitory action, and contained Coixol has inhibitory action to skeletal muscle, and tricin has relexation to intestinal tube.Report is arranged, and at a simmer twice with the dried Rhizoma Phragmitis 300g of single, extracting juice divides and takes for 3 times, the treatment lung abscess, all obtain recovery from illness (the Zhejiang Journal of Traditional Chinese Medicine, 1995,2:87).Can be the clearly saturating lung gastric qi of Rhizoma Phragmitis be divided excess-heat, again can promoting the production of body fluid to quench thirst, relieving restlessness, thus the available consumption of body fluid caused by febrile disease of controlling, dysphoria with smothery sensation thirster.
The pharmacological action of Semen Coicis: Semen Coicis have more weak central inhibitory action, and mice and rat are had sedation, and can with caffeine antagonism mutually; (afterbody electrostimulation) has analgesic activity in rat test, and intensity is similar to aminophenazone.Also have refrigeration function, better to the refrigeration function of T.T.G. bacteria preparation (refining complex polysaccharide class) heat pyrexia; The heating that dinitrophenol causes there is not obvious effect.Multisynaptic reflex there is temporary inhibitory action.But can not reduce the lethal effect of strychnine or pentetrazole.Semen Coicis oil (being mainly Palmic acid and ester thereof) is to breathing, and excited in a small amount, a large amount of paralysis (central) can make the lung blood vessel significantly expand.The Semen Coicis oil low concentration is excitation to the isolated heart of the frog, and high concentration is the paralysis effect.To the rabbit vein injection, can cause blood pressure drops.The Semen Coicis oil low concentration has excitation to skeletal muscle and the motor nerve ending of the frog, and high concentration then is the paralysis effect.Also can reduce contracture, and shorten its fatigue curve at the body and the frog muscle that exsomatizes.Coixol has inhibitory action to striped muscle.The oxygen picked-up and the anaerobic glycolysis of the caused contractile response of electricity irritation and the rat diaphram of frog neuromuscular specimen can be suppressed, and the reaction of actomyosin-adenosine triphosphate system can be suppressed.During the Semen Coicis oil low concentration rabbit intestine in vitro is excitation, is momentary excitement during high concentration earlier and then benumbs; The UT of rabbit and Cavia porcellus is increased, and amplitude increases, and this excitation can be overturn by epinephrine.Coixol has inhibitory action to the motion of rabbit intestinal tube.The Coixol subcutaneous injection can make blood glucose slightly descend.Experiment showed, that Semen Coicis has inhibitory action to cancerous cell.
The pharmacological action of Semen Persicae: have report to point out that Semen Persicae has certain anticoagulation, can improve cAMP level in the platelet, suppress blood coagulation.Experiment shows: Semen Persicae can promote primipara's uterine contraction and uterine hemostasis, and its effect is better than peptide, and is particularly to the anastalsis in uterus, stronger than peptide.Semen Persicae still has haemolysis.Clinical observation proves that Semen Persicae has the improvement effect to blood flow retardance, the capable obstacle of blood, can make each internal organs respectively organize functional recovery normal.Zoopery proves that Semen Persicae has the inflammation of promotion Absorption.To the inflammation initial stage, stronger exudation effect is arranged, but a little less than the anti-granulation formation effect.Amygdalin in the Semen Persicae also has antiinflammatory action.Semen Persicae has anti-allergic effects, and its water extract can suppress the skin-sensitizing antibodies in the mice serum and the generation of house mouse spleen hemolytic cell.Amygdalin has certain selectivity to tumor cell.The hydrocyanic acid and the benzaldehyde that generate after the amygdalin hydrolysis have sedation to respiratory center.Experiment showed, that Semen Persicae extract all has in various degree improvement to hepatic necrosis degeneration and fibrosis.Have report to point out, the almond glycoside that extracts in the Semen Persicae has the liver collagen content of reduction and portal area fibrosis effect to the schistosomal cirrhosis rabbit.Contain 45% fatty oil in the Semen Persicae, can improve the lubricity of intestinal and make and be convenient to greatly discharge.Therefore, clinical with Semen Persicae as a kind of laxative prescription, be used for old people or valetudinarian, invalid's weakness constipation.
The pharmacological action of Semen Benincasae: Semen Benincasae oil-containing 14%, wherein the content of triglyceride is between 72%-96%, and contained main fatty acid is linoleic acid, oleic acid, stearic acid, Palmic acid.The medical value of Fructus Benincasae seed is very high, has lung heat clearing to go the merit of expectorant, have no side effect, but melon seed must be that sub-core is full.Materials such as linoleic acid in the vegetable oil that Semen Benincasae contained are the enamels of moist skin.Unsaturated fatty acid can make the ruddy gloss of appearance, and the skin delicacy is soft and moist, the pitch-black light of hair.So Semen Benincasae has quite high its cosmetic values.Modern nutrient research finds that contain compositions such as Saponin, fat, citrulline, unsaturated fatty acid, oleic acid in the Semen Benincasae, these compositions can reduce fat and cholesterol level in the blood effectively, to preventing and treating cardiovascular disease positive effect are arranged.
Novelty and breakthrough that the present invention has essence are to have found out the key point that weijing decoction 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 weijing decoction " field with theory of integrated Chinese and western medicine, product has the targeting advantage such as wide that distributes, and does not have identical or similar bibliographical information both at home and abroad.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 international data base to carry out update search, comprehensive domestic and foreign literature is read, analyzing contrast obtains to draw 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 that is rich in trace element, the medicine monomer, effective site, effective part group, Chinese medical concrete, water drug-decocting concentrating liquids etc. go out the nanosphere of different-grain diameter size with the different pharmaceutical preparing carriers, nanocapsule, polymer micelle, solid ester matter nanoparticle, magnetic nano particle, the immune nano grain, nano-emulsion, suspensoid, vesicle, pharmacosomes, microcapsule, nanoparticle, the millimicro ball, millimicro is assisted etc., and mixing is respectively charged into soft then, 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) utilization nano-carrier multiple techniques and theory of integrated Chinese and western medicine research and development " the integrated novel form of Nano medication ", product have characteristics such as targeting distributes extensively, slow controlled release properties is strong; Do not see open report at home in the document, these project complex art characteristics have certain novelty and novelty.Science and technology is looked into new numbering: 200921c0704948.
Further: this integrated novel form technology of preparing is to have integrated the advantage separately of the traditional Chinese medical science, doctor trained in Western medicine, with the organic conception of theory of Chinese medical science and collaborative idea and the determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs of paying attention between medicine is the overall strategy tactical thinking, in conjunction with modern western pharmacology, pharmacokinetics, toxicology, pharmaceutics scheduling theory, pay attention to the effectiveness and the therapeutic effect of certified Chinese medicine one matter monomer treatment, pay attention to Chinese medicine active substance, effective site and active substance group the treatment mass action that disease played.Pay attention to the contained trace element of Chinese medicine to the treatment assosting effect that disease played.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 utilization 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, provides a kind of weijing decoction integrated novel form technology of preparing.
Purpose of the present invention is achieved through the following technical solutions:
The integrated novel form technology of preparing of a kind of weijing decoction, wherein: this integrated novel form raw materials of effective components and weight proportion---
60 parts of Rhizoma Phragmitiss, 30 parts of Semen Coiciss, 24 parts of Semen Benincasaes, 9 parts in Semen Persicae.
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.The integrated novel form technology of preparing of above-mentioned a kind of weijing decoction, wherein: medicine is become medicine support material medicine with preparing carriers, 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, nanometer suspension liquid, 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 influence its disease of controlling, and just makes the pharmaceutical carrier crude drug of its better efficacy.
Further, the integrated novel form technology of preparing of above-mentioned a kind of weijing decoction, wherein: the drug carrier material that this novel form is selected for use, activating agent, help Emulsion, 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 (as three stearic acid, three Palmic acids, three lauric acids, in three oleic acid etc., the glyceride of long-chain fatty acid), glyceride (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 influence its disease of controlling to be also included within its basic upward interpolation, and just make the excipient substance of its better efficacy.
Further, the integrated novel form technology of preparing of above-mentioned a kind of weijing decoction, wherein: said integrated novel form adopts medicament nano powder body, micro-powder, medicine monomer, effective ingredient, effective site, active substance group, 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, the integrated novel form technology of preparing of above-mentioned a kind of weijing decoction, 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.
The integrated novel form technology of preparing of a kind of weijing decoction, 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, adopt supersonic airstream to be crushed to the 1-10 micron then, get different Chinese medicine micropowder, standby.
Step 2: get 30%--90% alcohol-water solution that 60% Rhizoma Phragmitis, Semen Coicis micropowder doubly measure with 6-12 and mix and soaked 1-2 days, reflux, extract, 3 times, extract water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility simultaneously, recovered alcohol gets extract with standby.
Step 3: get 60% Semen Benincasae, Semen Persicae micropowder, adopt the ultrasonic dispersing extraction equipment 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, extract with standby.
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 particle size distribution and be the nano powder of 50-1000 nanometer, standby.
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 concentrates, Chinese medical concrete or water drug-decocting concentrating liquid with standby.
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 technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared respectively, obtain medicine materials such as different medicine monomers, effective site, active substance group.
Step 7: adopt different excipient substances by version in 2010 " preparation part of standards standard and " requirement of version Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " in 2005 in waiting adopts the high pressure breast to spare method respectively 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, 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, nanometer suspension liquid, 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 above-mentioned mixed raw materials medicine adopt the fully-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 several respectively, bottles, adorns box, seals, pastes labeling, plays exterior and interior packings such as sign indicating number, vanning.Packaged product is transported to the appointed place by production batch and unifies instantaneously sterilising, and opens the sterilization report.
The integrated novel form technology of preparing of above-mentioned a kind of weijing decoction; 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, the integrated novel form technology of preparing of above-mentioned a kind of weijing decoction, wherein: 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, the integrated novel form technology of preparing of above-mentioned a kind of weijing decoction, 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 targeting.
Again further, the integrated novel form technology of preparing of above-mentioned a kind of weijing decoction, 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 the human body different parts respectively by the energy and blood of human body flowing law, can directly absorb by skin.
The outstanding substantive distinguishing features and the obvious improvement of technical solution of the present invention is mainly reflected in:
Novelty and breakthrough that the present invention has essence are to have found out the key point that the weijing decoction 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 weijing decoction " field with theory of integrated Chinese and western medicine, product has the targeting advantage such as wide that distributes, and does not have identical or similar bibliographical information both at home and abroad.Show substantive progressive and novelty of the present invention by international one-level novelty assessment report and patent data library searching.Utilize domestic and international data base to carry out update search, comprehensive domestic and foreign literature is read, analyzing contrast obtains to draw 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 that is rich in trace element, the medicine monomer, effective site, effective part group, Chinese medical concrete, water drug-decocting concentrating liquids etc. go out the nanosphere of different-grain diameter size with the different pharmaceutical preparing carriers, nanocapsule, polymer micelle, solid ester matter nanoparticle, magnetic nano particle, the immune nano grain, nano-emulsion, suspensoid, vesicle, pharmacosomes, microcapsule, nanoparticle, the millimicro ball, millimicro is assisted etc., and mixing is respectively charged into soft then, 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) utilization nano-carrier multiple techniques and theory of integrated Chinese and western medicine research and development " the integrated novel form of Nano medication ", product have characteristics such as targeting distributes extensively, slow controlled release properties is strong; Do not see open report at home in the document, these project complex art characteristics have certain novelty and novelty.Science and technology is looked into new numbering: 200921c0704948.
Further, this integrated novel form technology of preparing is to have integrated the advantage separately of the traditional Chinese medical science, doctor trained in Western medicine, with the organic conception of theory of Chinese medical science and collaborative idea and the determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs of paying attention between medicine is the overall strategy tactical thinking, in conjunction with modern western pharmacology, pharmacokinetics, toxicology, pharmaceutics scheduling theory, pay attention to the effectiveness and the therapeutic effect of certified Chinese medicine one matter monomer treatment, pay attention to Chinese medicine active substance, effective site and active substance group the treatment assosting effect that disease played.Pay attention to the contained trace element of Chinese medicine to the treatment assosting effect that disease played.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.Be to adopt Chinese medicine crude drug nano-powder, monomer, effective site, effective part group, Chinese medicine concentrated extract, 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, millimicro ball, millimicro assists etc.Its particle size distribution is between 10 microns of 10 nanometers----.According to difference, the difference and the traditional Chinese medical science monarch theory of slow controlled release time of pharmacology, targeting, reasonable compatibility mixes, and is respectively charged among hard capsule and the soft capsule then.Difference according to the dissolving of capsule material, disintegrate, jitter time can be prepared into targeted systems such as RE targeted system, stomach mucosa absorption system, small intestinal absorption system, colon absorption system respectively.Compare Chinese medicine and medicine monomer, the drug targeting 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.Be to have substantial technological innovation to break through.
Purpose of the present invention, advantage and characteristics 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
The integrated novel form technology of preparing of a kind of weijing decoction, its special feature is: making the raw materials of effective components composition is by weight ratio---
60 parts of Rhizoma Phragmitiss, 30 parts of Semen Coiciss, 24 parts of Semen Benincasaes, 9 parts in Semen Persicae.
Further, play the synergy of standing like the legs of a tripod on the integrated new drug formulation compatibility of weijing decoction of the present invention: 1, prepare nanometer, micro-powder, the bioavailability after strengthening the weijing decoction curative effect and significantly improve prepared slices of Chinese crude drugs cell wall breaking with this with the prepared slices of Chinese crude drugs; 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 weijing decoction 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 weijing decoction Chinese medicine compound uniqueness also keeps and has strengthened traditional Chinese medical science organic conception, monarch notion.More than three aspects associatings compatibility use, different according to Nano medication particle diameter and character, can reach effects such as many targeting, many collaborative, slow controlled releases, 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, adopt supersonic airstream to be crushed to the 1-10 micron then, get different Chinese medicine micropowder, standby.Get 30%--90% alcohol-water solution that 60% Rhizoma Phragmitis, Semen Coicis 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, recovered alcohol, extract with standby.Get 60% Semen Benincasae, Semen Persicae micropowder, adopt the ultrasonic dispersing extraction equipment 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 standby.With step 2, step 3 gained Chinese medicine extract, adopt the nanon ball-mill of independent research to grind 4-16 hour, get particle size distribution and be the nano powder of 50 nanometers-1000 nanometer, standby.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 standby.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 technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared respectively, obtain medicine materials such as different medicine monomers, effective site, active substance group.Adopt different excipient substances and carrier by version in 2010 " related preparations part of standards standard and " requirement of version Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " in 2005 in waiting adopts the high pressure breast to spare method respectively 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, 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, nanometer suspension liquid, 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 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.In GMP10000 level toilet, with above-mentioned mixed raw materials medicine adopt the fully-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can make the above-mentioned end product of other type by the related preparations standard criterion.The end product of making is carried out several respectively, bottles, adorns box, seals, pastes labeling, plays exterior and interior packings such as sign indicating number, 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.
It makes the raw materials of effective components composition---60 parts of Rhizoma Phragmitiss, 30 parts of Semen Coiciss, 24 parts of Semen Benincasaes, 9 parts in Semen Persicae.
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 fully-automatic capsule filling machine fill hard capsule, make hard capsule.Carry out several again, bottle, seal, paste labeling, play exterior and interior packings such as sign indicating number, 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.
It makes the raw materials of effective components composition---60 parts of Rhizoma Phragmitiss, 30 parts of Semen Coiciss, 24 parts of Semen Benincasaes, 9 parts in Semen Persicae.
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 several again, bottle, seal, paste labeling, play exterior and interior packings such as sign indicating number, 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.
It makes the raw materials of effective components composition---60 parts of Rhizoma Phragmitiss, 30 parts of Semen Coiciss, 24 parts of Semen Benincasaes, 9 parts in Semen Persicae.
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.Adorn box again, seal, paste labeling, play exterior and interior packings such as sign indicating number, 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: positions such as neck, chest, back part, abdominal part, shank, foot bottom, Ashi point.
By above-mentioned text description as can be seen: novelty and breakthrough that the present invention has essence are to have found out the key point that weijing decoction 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 Zhou Yi, Taoism, Huang di's Canon of Medicine, is simple philosophy doctrine thought, also is the 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 the easy homology of doctor, skill of a doctor homology.This precise and tiny circle of the present invention just melts integration theoretical 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 substance group, extractum, water drug-decocting concentrating liquid, prepared slices of Chinese crude drugs nano-particle etc., can produce soft, hard capsule or dosage forms such as nanometer membrane, transdermal agent.Can develop simultaneously, can take four time periods respectively by interior external administration by midnight-noon and ebb-flow doctrine, energy and blood of human body flowing law.Can also do film former to nanometer Chinese medicine, transdermal agent is attached to the human body different parts, can directly absorb by skin.
See that further 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, millimicro ball, little assist etc.Its particle size distribution is between 10 microns of 10 nanometers----.According to difference, the difference and the traditional Chinese medical science monarch theory of slow controlled release time of medicine pharmacology, targeting, reasonable compatibility mixes, and can be respectively charged among hard capsule and the soft capsule then.Difference according to the dissolving of capsule material, disintegrate, jitter time can be prepared into targeted systems such as RE targeted system, stomach mucosa absorption system, small intestinal absorption system, colon absorption system respectively.Compare Chinese medicine and medicine monomer or Western medicine, overall coordination therapeutical effect of this integrated novel form and drug targeting, 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 the innovation and the model of Chinese medicine tradition compatibility theory and traditional Chinese medical science pharmaceutics, for the preparation of weijing decoction modern Chinese medicine and production have proposed a practical effective novel form compatibility program.Be to have substantial preparation consolidation and innovation and technological break-through.
Claims (10)
1. integrated novel form technology of preparing of weijing decoction is characterized in that: this novel form raw materials of effective components and weight proportion---
60 parts of Rhizoma Phragmitiss, 30 parts of Semen Coiciss, 24 parts of Semen Benincasaes, 9 parts in Semen Persicae.
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.
2. the integrated novel form technology of preparing of a kind of weijing decoction according to claim 1, it is characterized in that: medicine is become medicine support material medicine with preparing carriers, crude drug can be one or more combinations in nanoparticle, Bo microgranule, micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanometer suspension liquid, 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 influence its disease of controlling, and just makes the pharmaceutical carrier crude drug of its better efficacy.
3. according to claim 1, the integrated novel form technology of preparing of 2 described a kind of weijing decoctions, it is characterized in that: the drug carrier material that this novel form is selected for use, activating agent, help Emulsion, 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 (as three stearic acid, three Palmic acids, three lauric acids, in three oleic acid etc., the glyceride of long-chain fatty acid), glyceride (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 influence its disease of controlling to be also included within its basic upward interpolation, and just make the excipient substance of its better efficacy.
4. according to claim 1 or 2 or 3 any integrated novel form technologies of preparing of described a kind of weijing decoction, it is characterized in that: said integrated novel form adopts medicament nano powder body, micro-powder, medicine monomer, effective ingredient, effective site, active substance group, 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 or 2 or 3 or 4 any integrated novel form technologies of preparing of described a kind of weijing decoction, 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. integrated novel form technology of preparing of weijing decoction 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, adopt supersonic airstream to be crushed to the 1-10 micron then, get different Chinese medicine micropowder, standby.
Step 2: get 30%--90% alcohol-water solution that 60% Rhizoma Phragmitis, Semen Coicis micropowder doubly measure with 6-12 and mix and soaked 1-2 days, reflux, extract, 3 times, extract water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility simultaneously, recovered alcohol gets extract with standby.
Step 3: get 60% Semen Benincasae, Semen Persicae micropowder, adopt the ultrasonic dispersing extraction equipment 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 standby.
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 particle size distribution and be the nano powder of 50-1000 nanometer, standby.
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 concentrates, extractum or water drug-decocting concentrating liquid with standby.
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 technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared respectively, obtain medicine materials such as different medicine monomers, effective site, active substance group.
Step 7: adopt different excipient substances and carrier by version in 2010 " related preparations part of standards standard and " requirement of version Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " in 2005 in waiting adopts the high pressure breast to spare method respectively 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, 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, nanometer suspension liquid, 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 above-mentioned mixed raw materials medicine adopt the fully-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 several respectively, bottles, adorns box, seals, pastes labeling, plays exterior and interior packings such as sign indicating number, vanning.Packaged product is transported to the appointed place by production batch and unifies instantaneously sterilising, and opens the sterilization report.
7. the integrated novel form technology of preparing of a kind of weijing decoction according to claim 6; it is characterized in that: 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. the integrated novel form technology of preparing of a kind of weijing decoction according to claim 7; it is characterized in that: crude drug such as the dissimilar nanoparticle that employing different pharmaceutical adjuvant is prepared in the medicine monomer in the described step 6, active substance, effective site technology of preparing and the described step 7, nano-emulsion; the described protection domain of this claim is not only described technology of preparing and method; as required, be also included within add on its basis or use other better effects if, more economical, upgrade, preparation method more advanced, more environmental protection and technology.
9. the integrated novel form technology of preparing of a kind of weijing decoction according to claim 8 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 targeting.
10. the integrated novel form technology of preparing of a kind of weijing decoction according to claim 9 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 the human body different parts respectively by the energy and blood of human body flowing law, can directly absorb by skin.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103263059A (en) * | 2013-05-23 | 2013-08-28 | 珠海圣原生物科技有限公司 | Solid beverage for clearing away lung-heat, promoting diuresis, reducing phlegm and relieving cough and preparation method thereof |
| CN107568554A (en) * | 2017-09-30 | 2018-01-12 | 朱昱光 | A kind of solid beverage |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103263059A (en) * | 2013-05-23 | 2013-08-28 | 珠海圣原生物科技有限公司 | Solid beverage for clearing away lung-heat, promoting diuresis, reducing phlegm and relieving cough and preparation method thereof |
| CN107568554A (en) * | 2017-09-30 | 2018-01-12 | 朱昱光 | A kind of solid beverage |
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Application publication date: 20111221 |