CN102526651A - Preparation technology and production method of novel integrated Yumi decoction dosage form - Google Patents
Preparation technology and production method of novel integrated Yumi decoction dosage form Download PDFInfo
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Abstract
The invention relates to preparation technology and production method of a novel integrated Yumi decoction dosage form. The novel integrated dosage form comprises the following raw materials containing active ingredients in parts by weight: 10 parts of magnolia officinalis, 5 parts of poppy shells, 5 parts of Indian buead, 5 parts of baked liquorice, 3 parts of ginseng and 3 parts of dried ginger. The production process comprises the following steps: supersonic jet milling, alcohol-water extraction, ultrasonic milling and extraction, decoction in water and concentration, supersonic spray drying, nanoscale grinding, high-pressure homogenization, nanoparticle preparation and the like. According to the invention, the advantages of multiple collaboration, multiple targets and the like embodied by utilizing the nano carrier combined technology are emphasized; after large scale production, the production cost can be substantially lowered, the product quality can be greatly improved and the targeting and slow/controlled release property of the medicines is enhanced; the dosage form can be simultaneously administrated internally and externally and can be taken in four time periods 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 which can be 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 by skin.
Description
Technical field
The present invention relates to the integrated novel form technology of preparing of a kind of imperial rice water, the invention still further relates to integrated novel form technology of preparing of a kind of imperial rice water and production method thereof.
Background technology
Chinese medicine decocting liquid compound recipe drug effect chemical reaction is too many because of chemical constituent; Temporarily also do not disclosed 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 and the solution when frying in shallow oil; Reaction such as complexation, hydrolysis, oxidation, reduction between intrinsic material possibly 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.
Imperial rice water derives from " Song's formulary of peaceful benevolent dispensary ".Square by ten liang of Cortex Magnoliae Officinalis (removing rough bark, stir-fry, processed with Rhizoma Zingiberis Recens), Pericarpium Papaveris (processed with honey), Poria (peeling), Radix Glycyrrhizae (processing), each five liang; Radix Ginseng (going reed), universe Rhizoma Zingiberis Recens (big gun), each two two halves is formed.Function cures mainly: control trouble dysentery of a specified duration, red or white, pain in the abdomen Hou is weighed down, and sends out and has a rest when no, and the day and night are immoderate, and hematochezia endlessly, do not go into food entirely, and all lead it.The purposes consumption: every clothes three money, water one and half, three in Rhizoma Zingiberis Recens, three pieces of big Huaihe River Fructus Jujubaes, one of Fructus Mume is fried in shallow oil to one, removes slag, and is hollow, port clothes before the food.As old and seven, 80 years old, every clothes two a lot of money; Every clothes one money of children's half is fried in shallow oil according to preceding method, more measures youngster year plus-minus.
The pharmacological action of Cortex Magnoliae Officinalis:
The Cortex Magnoliae Officinalis warming middle-JIAO, the therapeutic method to keep the adverse QI flowing downwards, dampness, expectorant.Control breast abdomen feeling of fullness distending pain, regurgitation, vomiting, dyspepsia does not disappear, and phlegm retention is breathed with cough, the cold-damp dysentery.It is active that magnolol and iso-agnolol have special and persistent central muscular flaccidity.Magnocurarine has the striped muscle blocking effect, and the evidence of Bufo siccus motor end plate is because the block nerves impulsion in the transmission of soleplate, makes the motor nerve ending paralysis, causes the paralysis phenomenon of the loose property of whole body motion.The Cortex Magnoliae Officinalis decoct has broad-spectrum antibacterial action, and external all have inhibitory action to staphylococcus aureus, Hemolytic streptococcus, diphtheria corynebacterium, bacillus subtilis, dysentery bacterium, Canis familiaris L. budlet spore tinea bacterium, homocentricity trichophyton, trichophyton, trichophyton etc.; Certain anti-anthrax bacillus effect is arranged in the Cavia porcellus body.In addition, Cortex Magnoliae Officinalis is regulated effects such as smooth muscle, antiulcer, maincenter inhibition, blood pressure lowering, resisting pathogenic microbes, antitumor in addition.
The pharmacological action of Pericarpium Papaveris:
The Pericarpium Papaveris nature and flavor are flat; Sour, puckery; Return lung, large intestine, kidney channel; Poison.Function cures mainly: astringe the lung, astringing intestine to stop diarrhea, pain relieving.Be used for chronic cough, chronic diarrhea, proctoptosis, epigastric pain.Usage and dosage: for oral administration: as to fry in shallow oil soup, 3～10g; Or go into ball, loose.Taboo: cough, dysentery are from the beginning of, or stagnant careful clothes of the person of not disappearing of chronic dysentery.These article are prone to addiction, unsuitable informal dress; Child's forbidding.Pharmacological action: the morphine in the Pericarpium Papaveris, codeine, narcotine and papaverine are clinical alkaloid commonly used.Its pharmacological action is mainly: morphine has significant analgesic activity, and the selectivity of height is arranged, and during analgesia, not only patient's consciousness is uninfluenced, and other sensations also exist.Morphine has syngignoscism, but shallow and easy the waking up of sleeping can not be regarded as real hypnotic.Codeine does not then cause sleep.Morphine has the high selectivity inhibitory action to respiratory center, when being lower than the analgesic dose, to breathing existing the inhibition.At this moment, respiratory center reduces the sensitivity of carbon dioxide, can be used for treating dyspnea (cardiac asthma).The frequency that shows as at first of respiration inhibition reduces, the compensation that strengthen owing to the degree of depth this moment, and ventilation volume does not still have influence.Owing to suppress to deepen, frequency reduces too far during poisoning, and the degree of depth of then breathing strengthens also can not be compensatory, and serious anoxia occurs.The respiratory center paralysis is morphinistic direct cause of death.Codeine is light to the effect of respiration inhibition far beyond morphine.
Morphine can make the reactive raising of the chemoreceptor of carotid body, and this is that respiration inhibition causes anoxybiotic result.During morphinism, keeping of breathing depends on the stimulation of anoxia to chemoreceptor.This moment as suck pure oxygen or the oxygen of high concentration can make Self-breathing stop immediately, so answer pedestrian worker's breathing during oxygen supply.Papaverine can act on carotid sinus and chemoreceptor of aortic body and slight excited effect of breathing is arranged, but in treatment, does not have clear meaning.Morphine can suppress coughing centre, and stronger antitussive action is arranged.The required dosage of the cough-relieving dosage more required than pain relieving is little.Narcotine has the antitussive effect that equates with codeine, but does not have other central inhibitory actions, can not produce the dependency of the spirit or the human body, also do not suppress to breathe, and to animal, the anti-effect that excited breathing is arranged when a large amount of.Morphine has the little blood vessel of diastole periphery and discharges the effect of histamine.Hypovolemic patient uses morphine and causes hypotension easily, and morphine and phenothiazines drug combination have synergism to respiration inhibition, and has and cause hypotensive danger.Pulmonary heart disease people uses morphine once had the report that causes death.The papaverine heavy dose can suppress the cardiac muscle conduction and prolong refractory stage, and therapeutic dose does not have obvious influence to electrocardiogram, and high dose can prevent the fibrillation of heart that chloroform-epinephrine causes.Narcotine also can suppress smooth muscle and cardiac muscle, but when antitussive dosage, these effects do not occur.Morphine causes constipation easily, and its reason is that gastrointestinal tract and sphincter tone thereof improve, and adds that digestive juice secretion reduces and just anticipates bluntly, thereby the motion that gastrointestinal content is pushed ahead delays greatly.The morphine of therapeutic dose can make pressure of biliary tract significantly increase, and patient feels epigastric discomfort, and biliary colic very then takes place.
Morphine can make oddi's sphincter shrink, and stops emptying, and it is intrinsic pressure to improve pipe, so should not use (or use together with the spasmolytic medicine) during the biliary tract spasm.Papaverine has certain influence to reaching heart monoamine neurotransmitter metabolism in the rat brain; The metabolite dihydrobenzene acetic acid and the 4-hydroxy-3-methoxy-.alpha.-toluic acid. of rat striatum and marginal zone dopamine significantly increased (about 50-70% raises), make the metabolite 5-hydroxyindoleacetic acid of 5-hydroxy tryptamine increase about 3%.But the monoamine neurotransmitter content to brain and heart is not then seen obvious influence.Use morphine (general continuous is taken 2-3 after week) repeatedly and can produce toleration, toleration disappeared in a couple of days to fortnight after the drug withdrawal.If reuse, toleration produces faster for the second time.The addiction person of acquired tolerance, the 20-200 that dosage can be used therapeutic dose doubly even have 1 and use to 5g and poisoner not.But have only morphine that the inhibitory action of maincenter is had toleration, like analgesia, hypnosis, inhibition breathing etc.; Its to the excitation of maincenter with and the effect of pupil, smooth muscle etc. then do not had toleration.Someone thinks, due to general because some nervous tissue of the generation of toleration reduces the sensitivity of morphine.
The pharmacological action of Poria:
Poria contains B-pachyman, pachymic acid, lecithin and sterol etc.The property of medicine is sweet, light, equal, return lung, stomach, kidney channel.Drug effect: anticancer, the diuretic dissipating fluid-retention of relieving internal heat, spleen invigorating mind calming.Promoting diuresis to eliminate damp pathogen, spleen invigorating is reduced phlegm, mind tranquilizing and the heart calming.
The pharmacological action of Poria: Poria diuresis machine changes not clear, and compound recipe is obvious than the single medicinal material effect.The Poria decoct is injected mouse peritoneal, can suppress spontaneous activity, and can resist caffeine induced mice superexcitation, and the anesthesia of barbital is had synergism.The Poria ethanol extraction is strengthened myocardial contraction, and heart rate increases.Poria has the significant protection effect for the caused mouse liver injury of carbon tetrachloride.
Pachyman has inhibitory action to murine sarcoma, and its effect is relevant with thymus, can activate local complement.Have active anticancer in vivo, and can promote the immunologic function of human body; Contained pachyman can reach 96.88% to the inhibition efficient of sarcoma S-180.The preserved material of Poria has diuresis to normal rabbit as lumbar injection; Ether or ethanol extraction can make isolated frog heart shrink reinforcement, to tame rabbit blood glucose rising are then reduced.Poria cum Radix Pini's decoct has sedation to mice, and the sedation of Poria is inferior to Poria cum Radix Pini.
The pharmacological action of Radix Glycyrrhizae:
Radix Glycyrrhizae property is flat, and sweet in the mouth is returned 12 warps.Detoxifcation arranged, eliminate the phlegm, pain relieving, spasmolytic be so that pharmacological action such as anticancer.On the traditional Chinese medical science, the Radix Glycyrrhizae invigorating the spleen and replenishing QI is grown and to be coughed lung moistening, and the emergency detoxifcation is in harmonious proportion hundred medicines.The pharmacological action of Radix Glycyrrhizae: remove that flavonoid glycosides has obvious protective effect to the rat experiment ulcer in extractum and the Radix Glycyrrhizae of glycyrrhizin.Radix Glycyrrhizae extractum, glycyrrhizin and enoxolone all have promotion sodium to healthy subjects and animal, the effect of water retention; Low dose of glycyrrhizin (every 100ug) can make rat chest gland atrophy and adrenal gland's weight increase, and produces the effect of glucocorticoid cortisone appearance. and then the effect of glucocorticoid appearance is not obvious when heavy dose of, only presents the effect of mineralocorticoid appearance.Radix Glycyrrhizae extractum and glycyrrhizin all have certain detoxification ability to some drugs poisoning, alimentary toxicosis, interior metabolism product poisoning. and the effective ingredient of Detoxication is a glycyrrhizin; Detoxification machine is made as glycyrrhizin has adsorption to poisonous substance; Glycyrrhizin hydrolyzate glucuronic acid can combine with poisonous substance; And GLYCYRRHIN have the effect of adrenocortical hormone appearance, the result of the aspect combined factors effects such as detoxification ability of enhancing liver.Enoxolone has tangible central antitussive effect, and heavy dose of enoxolone can make mouse breathing suppress. and glycyrrhizin, glycyrrhetate still have anti-inflammatory and antiallergic, anti-liver injury, anti-promoting, antibiotic, anti AIDS virus (glycyrrhizin) effect in addition.
The pharmacological action of Radix Ginseng:
Radix Ginseng has calm and excited two-way function, and neural functional status has relation during with medication, and is also relevant with the heterogeneity of dosage size and Radix Ginseng.The mixture of calm and excited two-way function ginsenoside Rb and Rc has inhibition, stable, analgesic activity to the central nervous system of mice, and effects such as central is of flaccid muscles, cooling, minimizing spontaneous activity.The Radix Ginseng water decoction has antagonism to a lot of beta stimulants.Can alleviate the inhibitory action of central depressant (chloral hydrate, chlorpromazine etc.).The mixture of ginsenosideRg 1, Rg 2 and Rg 3 is excitation to the central nervous system, and heavy dose then is inhibitory action.Radix Ginseng can increase the nonspecific resistance of body.Radix Ginseng all can increase the resistance of body to the harmful effect of (various toxic agent, the anaesthetic etc.) of (freezing, high temperature, hyperkinesia, high pressure or the low pressure) of various harmful factors such as physics, chemistry, biological (foreign sera, antibacterial, transplanted tumor etc.).
The persistent period of Radix Ginseng ability significant prolongation mice swimming, glycoside is an effective ingredient, and along with the polarity of glycoside increases and the effect reduction.Radix Ginseng can significantly reduce the mortality rate of mice under high temperature, low temperature, low pressure state.Radix Ginseng ability blood pressure regulation, heart tonifying, protection cardiac muscle.Radix Ginseng is to anesthetized animal, and low dose can make animal blood pressure rise, and heavy dose then makes blood pressure drops; The glycoside of Radix Ginseng is slight blood pressure lowering in short-term to anesthetized animal.The Radix Ginseng water decoction has the effect of similar cardiotonic glycoside.The myocardial necrosis that Radix Ginseng total saponins causes isoproterenol all has the protection cardiac muscle, alleviates the effect that disease is decreased.The ginsenoside has the effect of indirect promotion adrenal cortex function.Alcohol extract has antidiuretic activity to rat.Has the effect of GTH appearance.Radix Ginseng has effects such as blood sugar lowering.The panaxynol extract has hypoglycemic activity to the laboratory animal hyperglycemia that alloxan causes, Radix Ginseng total saponins, polysaccharide panaxans A and B, Ginsenoside Rb 2, ginseng polypeptide are effective ingredient.Radix Ginseng extract can be promoted the activity of liver rna polymerase.Radix Ginseng extract has appreciable stimulating action to lipid metabolism.The alcohol of Radix Ginseng or water extract can make the content of erythropoietin such as rabbit bone marrow, liver, spleen raise.Radix Ginseng total saponins is made up of two types Saponin of tool hemolytic and anti-hemolysis property.Effects such as antiinflammatory, immunity, antitumor are still arranged in addition.
The pharmacological action of Rhizoma Zingiberis:
The Rhizoma Zingiberis acrid in the mouth, hot in nature.Return spleen, stomach, the heart, lung meridian.Rhizoma Zingiberis has warming spleen and stomach for dispelling cold, and recuperating depleted YANG is promoted blood circulation, the effect of dampness expectorant.Rhizoma Zingiberis contains volatile oil, and main component is a zingiberene.The Rhizoma Zingiberis pharmacological action:
1. to the influence of digestive system: Rhizoma Zingiberis adds ethanol property, salt acidity and ligation pylorus gastric ulcer to stress ulcer, indomethacin all has obvious inhibitory action.Rhizoma Zingiberis contains armaticity volatile oil, and digestive tract is had slight stimulation, intestinal tension force, the rhythm and pace of moving things and wriggling is strengthened, thereby promote the gastrointestinal digestive function.Rhizoma Zingiberis can also strengthen salivation, strengthens the eupepsy to starch.Rhizoma Zingiberis extractum can suppress the emetic action of copper sulfate, but to pigeon by Folium Digitalis Purpureae, the vomiting unrestraint effect that dog is brought out by apomorphine, tell and acts in prompting Rhizoma Zingiberis town is tip property.The mixture of zingiberone and ginger ketenes is the effective ingredient that tell in the town.
2. to the influence of cardiovascular system: Rhizoma Zingiberis can make guinea-pig heart room autonomic movement strengthen, and its heart tonifying composition is gingerol and ginger ketenes.Contain the Rhizoma Zingiberis rat blood serum and the better protect effect is arranged cultivating the scarce sugar property damage of neonatal rat myocardial cell anoxia.The shogaol intravenous injection can make rat blood pressure be three phasic properties and change.Rhizoma Zingiberis Recens volatile oil, gingerol and shogaol can distend the blood vessels, blood circulation promoting.Shogaol can suppress the contraction of norepinephrine (NA) to mesenteric vein.
3. antiinflammatory: the water of Rhizoma Zingiberis, ether extract all have tangible antiinflammatory action; All can suppress the doctor that ear swelling that xylene causes and carrageenin cause | learn education network and collect the arrangement rat paw edema; The rare ketone of Rhizoma Zingiberis Recens can obviously suppress histamine and acetic acid induced mice capillary permeability increases, and suppresses granulation and once gave birth to.Rhizoma Zingiberis water extract, Rhizoma Zingiberis volatile oil or Rhizoma Zingiberis phenolic acid property position, the antiphlogistic while can significantly be reduced ascorbic content among the rat adrenal gland, and the antiinflammatory action of Rhizoma Zingiberis possibly produce through promoting adrenocortical function.
4. analgesia: Rhizoma Zingiberis ether extract, water extract all have analgesic activity, can reduce acetic acid and cause the mouse writhing reaction times, and be dose-effect relationship.Simultaneously can also prolong the mice thermostimulation response latency.
5. antithrombotic: the Rhizoma Zingiberis water extract has the obvious suppression effect to ADP, the inductive platelet aggregation of collagenase, postpones experimental thrombosis and forms, and ginger ketenes generation also active to tame rabbit platelet Cycloxygenase and TXA2 has inhibitory action.Rhizoma Zingiberis volatile oil also has antithrombotic effect, and can obviously prolong the kaolin APFI.
Novelty and breakthrough that the present invention has essence are to have found out to drive the key point that rice water modern Chinese medicine novel form Chinese and western medicine theory combines; The present invention will in time fill up the blank of researching and developing " driving the integrated novel form of rice water " field both at home and abroad in utilization " nano-carrier GC-MS " 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 through 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, is analyzed contrast and obtains to draw a conclusion: " the integrated novel form of GC-MS research and development Nano medication " project; Its innovative point: nanosphere, nanocapsule, polymer micelle, solid ester matter nanoparticle, magnetic nano particle, immune nano grain, nano-emulsion, suspensoid, vesicle, pharmacosomes, microcapsule, nanoparticle, millimicro ball, the millimicro that 1) adopts the Chinese medicine nano-powder be rich in trace element, medicine monomer, effective site, effective part group, Chinese medical concrete, water drug-decocting concentrating liquid etc. to go out the different-grain diameter size with the different pharmaceutical preparing carriers assisted etc., and mixing is respectively charged into to unite simultaneously in soft, the hard capsule and uses 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 then; 2) utilization nano-carrier GC-MS 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 public reported in the document at home, this Project Comprehensive technical characterstic has 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 crowd 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 GC-MS development modern Chinese medicine.These will promote the development of China's Chinese medicine industry.
Summary of the invention:
The object of the invention is exactly the problems referred to above that exist in the prior art in order to solve, and integrated novel form technology of preparing of a kind of imperial rice water and production method thereof are provided.
The object of the invention is realized through following technical scheme:
Integrated novel form technology of preparing of a kind of imperial rice water and production method thereof, wherein: this integrated novel form raw materials of effective components and weight proportion---10 parts of Cortex Magnoliae Officinalis, 5 parts of Pericarpium Papaveriss, 5 parts of Porias, 5 parts of Radix Glycyrrhizae Preparatas, 3 parts of Radix Ginsengs, 3 parts of universe Rhizoma Zingiberis Recens.
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.
Integrated novel form technology of preparing of above-mentioned a kind of imperial rice water and production method thereof; 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 said 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; Integrated novel form technology of preparing of above-mentioned a kind of imperial rice water and production method thereof; Wherein: the drug carrier material that this novel form is selected for use, activating agent, help excipient substances such as Emulsion, dispersant be gelatin, albumin, starch and derivant thereof, alginate, beta-schardinger dextrin-, protein, chitosan and derivant thereof, lactose, hydroxypropyl emthylcellulose, ethyl cellulose, cellulose acetate phthalate, metering system acetate, polylactic acid, cyanoacrylate, semisolid poe, triglyceride (as in three stearic acid, three Palmic acids, three lauric acids, three oleic acid etc., the glyceride of LCFA), in glyceride (, containing the synthetic glyceride of list, two, triglyceride), cholesterol, Polyethylene Glycol, microcrystalline wax, whale ester type waxes, erythrocyte, Montmorillonitum, tea powder etc. one or more like glyceryl monostearate.Described excipient substance is not only the said medicine adjuvant in the said 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; Integrated novel form technology of preparing of above-mentioned a kind of imperial rice water and production method thereof; Wherein: said integrated novel form adopts medicament nano powder body, micro-powder, medicine monomer, effective ingredient, effective site, active substance crowd, Chinese medical concrete, water drug-decocting concentrating liquid and different drug adjuvant, pharmaceutical carrier to unite use 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; Integrated novel form technology of preparing of above-mentioned a kind of imperial rice water 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.
Integrated novel form technology of preparing of a kind of imperial rice water 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, adopt supersonic airstream to be crushed to the 1-10 micron then, get different Chinese medicine powder and micron, subsequent use.
Step 2: get 30%--90% alcohol-water solution mixed soaking 1-2 days that 60% Cortex Magnoliae Officinalis, Pericarpium Papaveris, Poria powder and micron doubly measure with 6-12; Reflux, extract, 3 times; Extract water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility simultaneously, recovered alcohol gets extract with subsequent use.
Step 3: get 60% Radix Glycyrrhizae Preparata, Radix Ginseng, universe Rhizoma Zingiberis Recens powder and micron; 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 subsequent use.
Step 4: with step 2, step 3 gained Chinese medicine extract, adopt the nanon ball-mill of independent research to grind 4-16 hour, get particle size distribution and be the nano powder of 50-1000 nanometer, subsequent use.
Step 5: get each Chinese medicine powder and micron 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 filtrating concentrates, Chinese medical concrete or water drug-decocting concentrating liquid with 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 technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to prepare respectively, obtain medicine materials such as different drug monomer, effective site, active substance crowd.
Step 7: above-mentioned gained medicine material is adopted the different drug adjuvant, and " preparation part of standards standard was with " 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 by version in 2010; 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 processed the above-mentioned end product of other type.
Step 10: the end product of processing 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.
Integrated novel form technology of preparing of above-mentioned a kind of imperial rice water and production method thereof; Wherein: the Chinese medicine of using in said step 1, step 2, the step 3 is pulverized and method for distilling; Described protection domain 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, breaking method, method for distilling and the technology of more advanced, more environmental protection.
Further; Integrated novel form technology of preparing of above-mentioned a kind of imperial rice water and production method thereof, wherein: crude drug such as the dissimilar nanoparticle that employing different pharmaceutical adjuvant is prepared in the medicine monomer in the said step 6, active substance, effective site technology of preparing and the said 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, the method for preparing and the technology of more advanced, more environmental protection.
Further; Integrated novel form technology of preparing of above-mentioned a kind of imperial rice water and production method thereof; Wherein: its key point 1 is different utilization nano-carrier GC-MSs different according to the particle diameter of crude drug and the property of medicine, can produce the gentle controlled capability of different targeting property.
Again further, integrated novel form technology of preparing of above-mentioned a kind of imperial rice water 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 the human body different parts respectively by the energy and blood of human body flowing law, can directly absorb through skin.
The outstanding substantive distinguishing features and the obvious improvement of technical scheme of the present invention is mainly reflected in:
Novelty and breakthrough that the present invention has essence are to have found out to drive the key point that the rice water Chinese and western medicine theory combines; The present invention will in time fill up the blank of researching and developing " driving the integrated novel form of rice water " field both at home and abroad in utilization " nano-carrier GC-MS " 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 through 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, is analyzed contrast and obtains to draw a conclusion: " the integrated novel form of GC-MS research and development Nano medication " project; Its innovative point: nanosphere, nanocapsule, polymer micelle, solid ester matter nanoparticle, magnetic nano particle, immune nano grain, nano-emulsion, suspensoid, vesicle, pharmacosomes, microcapsule, nanoparticle, millimicro ball, the millimicro that 1) adopts the Chinese medicine nano-powder be rich in trace element, medicine monomer, effective site, effective part group, Chinese medical concrete, water drug-decocting concentrating liquid etc. to go out the different-grain diameter size with the different pharmaceutical preparing carriers assisted etc., and mixing is respectively charged into to unite simultaneously in soft, the hard capsule and uses 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 then; 2) utilization nano-carrier GC-MS 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 public reported in the document at home, this Project Comprehensive technical characterstic has certain novelty and novelty.Science and technology is looked into new numbering: 200921c0704948.
Further; This integrated novel form technology of preparing and production method thereof are 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 crowd 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----.Theoretical according to difference, the difference of slow controlled release time and the traditional Chinese medical science monarch of pharmacology, targeting then, 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 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 property 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.
The object of the invention, advantage and characteristics will make an explanation through the non-limitative illustration of following preferred embodiment.These embodiment only are the prominent examples of using technical scheme 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 requirement protection of the present invention.
The specific embodiment
Integrated novel form technology of preparing of a kind of imperial rice water and production method thereof, its special feature is: processing the raw materials of effective components composition does by weight ratio---10 parts of Cortex Magnoliae Officinalis, 5 parts of Pericarpium Papaveriss, 5 parts of Porias, 5 parts of Radix Glycyrrhizae Preparatas, 3 parts of Radix Ginsengs, 3 parts of universe Rhizoma Zingiberis Recens.
Further; Play the synergy of standing like the legs of a tripod on the integrated new drug formulation compatibility of imperial rice water of the present invention: 1, prepare nanometer, micro-powder, strengthen the bioavailability after driving the rice water curative effect and significantly improving 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 the suitable pharmaceutical carrier, prepare different Chemistry for Chinese Traditional Medicine monomers, effective ingredient, effective site etc., confirm and strengthen driving pharmacology, the efficacy of the chemical substance of rice water with this; 3, prepare Chinese medical concrete, water drug-decocting concentrating liquid with the prepared slices of Chinese crude drugs, strengthen driving the temporary transient unpredictable drug effect that reactions such as the unique complexation of rice water Chinese medicine compound, hydrolysis, oxidation, reduction bring and keep and strengthened traditional Chinese medical science organic conception, monarch notion with this.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 powder and micron, subsequent use.Get 30%--90% alcohol-water solution mixed soaking 1-2 days that 60% Cortex Magnoliae Officinalis, Pericarpium Papaveris, Poria powder and micron doubly measure with 6-12; Reflux, extract, 3 times; Extract water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility simultaneously, recovered alcohol gets extract with subsequent use.Get 60% Radix Glycyrrhizae Preparata, Radix Ginseng, universe Rhizoma Zingiberis Recens powder and micron; 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 subsequent use.With above-mentioned 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, subsequent use.Get each Chinese medicine powder and micron 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 filtrating concentrates, and gets Chinese medical concrete or water drug-decocting concentrating liquid with subsequent use.With above-mentioned 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 prepare respectively, obtain medicine materials such as different drug monomer, effective site, active substance crowd.Above-mentioned gained medicine material is adopted different drug adjuvant and carrier, and " related preparations part of standards standard was with " 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 by version in 2010; 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 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 above-mentioned mixed raw materials medicine adopt the fully-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can process the above-mentioned end product of other type by the related preparations standard criterion.The end product of processing 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 processes the raw materials of effective components composition---10 parts of Cortex Magnoliae Officinalis, 5 parts of Pericarpium Papaveriss, 5 parts of Porias, 5 parts of Radix Glycyrrhizae Preparatas, 3 parts of Radix Ginsengs, 3 parts of universe Rhizoma Zingiberis Recens.
Its manufacture process is following: 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, process 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 processes the raw materials of effective components composition---10 parts of Cortex Magnoliae Officinalis, 5 parts of Pericarpium Papaveriss, 5 parts of Porias, 5 parts of Radix Glycyrrhizae Preparatas, 3 parts of Radix Ginsengs, 3 parts of universe Rhizoma Zingiberis Recens.
Its manufacture process is following: 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, process 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 its sterilization report.
" embodiment three "
Press the following crude drug of preceding method preparation: extractum, nanoparticle, nano-emulsion.
It processes the raw materials of effective components composition---10 parts of Cortex Magnoliae Officinalis, 5 parts of Pericarpium Papaveriss, 5 parts of Porias, 5 parts of Radix Glycyrrhizae Preparatas, 3 parts of Radix Ginsengs, 3 parts of universe Rhizoma Zingiberis Recens.
Its manufacture process is following: 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, processes 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.
Can find out through above-mentioned text description: novelty and breakthrough that the present invention has essence are to have found out to drive the key point that rice water 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 the doctor to be prone to saying of homology, 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 through the reasonable compatibility of Chinese medicine monomer, effective site, active substance, Chinese medicine active substance crowd, 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 through 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----.Theoretical according to difference, the difference of slow controlled release time and the traditional Chinese medical science monarch of medicine pharmacology, targeting then, 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 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 property, 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, has proposed a practical effective novel form compatibility program for driving preparation of rice water modern Chinese medicine and production.Be to have substantial innovation and technological break-through.
Claims (10)
1. integrated novel form technology of preparing of imperial rice water and production method thereof is characterized in that: 10 parts of this novel form raw materials of effective components and weight proportion---Cortex Magnoliae Officinalis, 5 parts of Pericarpium Papaveriss, 5 parts of Porias, 5 parts of Radix Glycyrrhizae Preparatas, 3 parts of Radix Ginsengs, 3 parts of universe Rhizoma Zingiberis Recens.
Wherein, said each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.
2. integrated novel form technology of preparing of a kind of imperial rice water according to claim 1 and production method thereof; 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, 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.The described protection domain of this claim is not only the said medicine support material medicine in the said 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 1,2 integrated novel form technology of preparing of described a kind of imperial rice water and production methods thereof; It is characterized in that: the drug carrier material that this novel form is selected for use, activating agent, help excipient substances such as Emulsion, dispersant be gelatin, albumin, starch and derivant thereof, alginate, beta-schardinger dextrin-, protein, chitosan and derivant thereof, lactose, hydroxypropyl emthylcellulose, ethyl cellulose, cellulose acetate phthalate, metering system acetate, polylactic acid, cyanoacrylate, semisolid poe, triglyceride (as in three stearic acid, three Palmic acids, three lauric acids, three oleic acid etc., the glyceride of LCFA), in glyceride (, containing the synthetic glyceride of list, two, triglyceride), cholesterol, Polyethylene Glycol, microcrystalline wax, whale ester type waxes, erythrocyte, Montmorillonitum, tea powder etc. one or more like glyceryl monostearate.The described protection domain of this claim is not only the said medicine adjuvant in the said 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 technology of preparing of described a kind of imperial rice water and production methods thereof; It is characterized in that: said integrated novel form adopts medicament nano powder body, micro-powder, medicine monomer, effective ingredient, effective site, active substance crowd, Chinese medical concrete, water drug-decocting concentrating liquid and different drug adjuvant, pharmaceutical carrier to unite use 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 technology of preparing of described a kind of imperial rice water and production methods 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. integrated novel form technology of preparing of imperial rice water 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, adopt supersonic airstream to be crushed to the 1-10 micron then, get different Chinese medicine powder and micron, subsequent use.
Step 2: get 30%--90% alcohol-water solution mixed soaking 1-2 days that 60% Cortex Magnoliae Officinalis, Pericarpium Papaveris, Poria powder and micron doubly measure with 6-12; Reflux, extract, 3 times; Extract water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility simultaneously, recovered alcohol gets extract with subsequent use.
Step 3: get 60% Radix Glycyrrhizae Preparata, Radix Ginseng, universe Rhizoma Zingiberis Recens powder and micron; 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 subsequent use.
Step 4: with step 2, step 3 gained Chinese medicine extract, adopt the nanon ball-mill of independent research to grind 4-16 hour, get particle size distribution and be the nano powder of 50-1000 nanometer, subsequent use.
Step 5: get each Chinese medicine powder and micron 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 filtrating concentrates, extractum or water drug-decocting concentrating liquid with 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 technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to prepare respectively, obtain medicine materials such as different drug monomer, effective site, active substance crowd.
Step 7: above-mentioned gained medicine material is adopted different drug adjuvant and carrier, and " related preparations part of standards standard was with " 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 by version in 2010; 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 processed the above-mentioned end product of other type.
Step 10: the end product of processing 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. integrated novel form technology of preparing of a kind of imperial rice water according to claim 6 and production method thereof; It is characterized in that: pulverizing of using in said step 1, step 2, the step 3 and method for distilling; 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, breaking method, method for distilling and the technology of more advanced, more environmental protection.
8. integrated novel form technology of preparing of a kind of imperial rice water according to claim 7 and production method thereof; 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 said step 6, active substance, effective site technology of preparing and the said 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, the method for preparing and the technology of more advanced, more environmental protection.
9. integrated novel form technology of preparing of a kind of imperial rice water according to claim 8 and production method thereof; It is characterized in that: its key point 1 is different utilization nano-carrier GC-MSs different according to the particle diameter of crude drug and the property of medicine, can produce the gentle controlled capability of different targeting property.
10. integrated novel form technology of preparing of a kind of imperial rice water according to claim 9 and production method thereof 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 through skin.
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| 宋 太平惠民和剂局编，刘景源点校: "《太平惠民和剂局方》", 31 October 1985, 人民卫生出版社 * |
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