CN102526604A - Preparation technology and production method of novel integrated costustoot decoction dosage form - Google Patents
Preparation technology and production method of novel integrated costustoot decoction dosage form Download PDFInfo
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Abstract
The invention relates to a preparation technology and production method of a novel integrated costustoot decoction dosage form. The novel integrated dosage form comprises the following raw materials containing active ingredients in parts by weight: 3 parts of costustoot, 3 parts of green tangerine peel, 5 parts of turmeric, 5 parts of malt, 11 parts of baked liquorice, 4 parts of zedoary and 11 parts of fried salt. 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 Radix Aucklandiae soup, the invention still further relates to integrated novel form technology of preparing of a kind of Radix Aucklandiae soup 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.
Radix Aucklandiae soup derives from " Song's formulary of peaceful benevolent dispensary ".Square by the Radix Aucklandiae, Pericarpium Citri Reticulatae Viride, each three jin; Rhizoma Curcumae Longae, Fructus Hordei Germinatus (stir-fry), each five jin; Radix Glycyrrhizae (stir-fry), salt (stir-fry), each 11 jin; Four jin of compositions of fluffy Rhizoma Curcumae.Function cures mainly: control chest and diaphragm painful abdominal mass plug, and trusted subordinate's twinge, side of body rib distension, diet reduces, the eructation acid regurgitation, vomiting is choked vexed, all gas diseases, and all control it.Method for making: go up to last.The purposes consumption: every clothes one money, the soup point that boils clothes are when disregarding.
The pharmacological action of the Radix Aucklandiae:
Guinea-pig isolated trachea and lung perfusion experiment prove, Radix Aucklandiae water extract, alcohol extract, volatile oil and total alkaloids can cause the convulsion effect to trachea and bronchial to antihistamine and acetylcholine.The lactone composition such as contained total lactone, constuslactone, dihydrocostulactone and the bronchoconstriction effect of going lactone volatile oil all can cause antihistamine, acetylcholine and barium chloride are wherein stronger with the dihydrocostulactone effect in the volatile oil.Intraperitoneal injection has protective effect to sucking lethal dose histamine or acetylcholine aerosol Cavia porcellus, can prolong to cause and breathe heavily incubation period, reduces mortality rate, and above result shows that its expansion bronchus smoothing effect characteristics are similar with opium poppy alkali.Think due to direct effect and the smooth muscle.Intrathoracic sleeve pipe is thrust the anesthetized cat pleural space trace breathing, the bronchiectasis reaction can appear in the intravenous injection saussurine.With administration is then invalid again after the animal brain destruction, point out its effect and fan to walk maincenter and suppress relevant.Water extract, alcohol extract, volatile oil, go lactone volatile oil and the quiet notes of total alkaloids that anesthetized dog is breathed certain inhibitory action is arranged.Wherein stronger with the volatile oil effect, contained each the lactone composition of volatile oil does not have obviously influence to breathing.The dog mechanical stimulus causes to cough and experiment showed, in the volatile oil each lactone composition and go lactone volatile oil not have antitussive effect.
Radix Aucklandiae water extract, volatile oil and total alkaloids have slight excitation earlier to the mice rat small intestine in vitro, and tonicity and rhythmicity obviously reduce subsequently.Myenteron spasm due to acetylcholine, histamine and the barium chloride there is antagonism.Low dose of decoct does not have certain regularity to the effect of rat small intestine in vitro, and heavy dose then is inhibitory action.Volatile oil also can suppress the isolated rabbit intestinal motility, makes its rhythm and pace of moving things slack-off, shrinks irregular.Go lactone volatile oil, total lactone and constuslactone, dihydrocostulactone volatile oil and dihydrocostulactone effect stronger.
The volatile oil of Radix Aucklandiae of low concentration and from volatile oil isolated various lactone parts all can suppress the activity of Cavia porcellus and rabbit isolated heart to some extent, isolated frog heart is also had inhibitory action.Low dose of water extract and the excitement of alcohol extraction fluid power are at the body frog heart and the dog heart, and heavy dose then has inhibitory action.Saussurine 1-2mg intravenous injection can be excited at the body cat heart, and is more obvious than the atrium to the excitation of ventricle.
The stripped rabbit ear and rat hindlimb blood vessel perfusion experiment also show, remove lactone volatile oil, total lactone, and significantly vasorelaxation action is arranged.Other lactone part effects are less.The expansible stripped rabbit ear blood vessel of low dose of total alkaloids, heavy dose causes contractile response on the contrary.Water extract and alcohol extract have slight booster reaction for the anesthetized dog intravenous injection; Anti-ly go intravenous injections such as lactone volatile oil, total lactone, constuslactone, dihydrocostulactone and dehydrocostuslactone can make the anaesthetized dog blood pressure moderate reduce (30-40mmHg), and hypotensive effect is more lasting.With neck spinal cord and both sides vagus nerve cut-out or atropinization or all do not change above-mentioned blood pressure lowering reaction for ganglion blocker, antiadrenergic drug or antihistaminic.Think that tentatively its negative booster is built in due to heart inhibition and blood vessel dilating.1: 3000 concentration of volatile oil can suppress the growth of streptococcus, golden yellow and white grapes, and is faint to escherichia coli and diphtheria corynebacterium effect; Total alkaloids does not have antibiotic effect.These article decoct is except that the paratyphoid fever bacillus is had the slight inhibitory action, and is invalid to 7 kinds of pathogenic bacterium such as staphylococcus aureus, dysentery bacteriums.Other has report, and decoct has inhibitory action to 10 kinds of funguses such as oidium schoenleinii and Mongolian mutation thereof
The pharmacological action of Pericarpium Citri Reticulatae Viride:
The appearance Kui finds that GTPI can significantly shorten Bufo siccus at the systemic heart cardiac cycle length, and the difference average is-72.73 before and after the administration, and significance,statistical is arranged.Can shorten simultaneously the excited conduction time in hole chamber, 4 phase depolarization times of venous sinus action potential and ventricular muscles action potential duration, APD (APD) and effective refractory period (ERP), and neophryn does not have influence to These parameters.GTPI and neophryn can strengthen myocardial contraction equally, but significant difference is not remarkable.There is the scholar to think that GT-PI boosting mechanism is excited adrenergic a receptor, does not find excitement and retardation to beta receptor or M-cholinoceptor.The quiet notes of discovery GTPI, subcutaneous injection and intramuscular injection such as Chen Lian all can make blood pressure increase, but intragastric administration 1g/kg does not have boosting, inject and to observe the 1.5h blood pressure 1.92kPa that on average raises behind the duodenum 1g/kg.Quiet (8～12min drips off) boosting kept longer.GTPI has powerful Antishock function to losing blood property, traumatic, blood transfusion property, Chinese medicine muscle relaxant, endotoxin and various shocks such as anesthetic accident and hypnotics poisoning.Blood pressure is risen to more than the foundation level rapidly at the shock animals blood pressure below the 5.37kPa.GTPI object rabbit, the acute anaphylactic shock of Cavia porcellus does not have therapeutical effect, but can prolong the death time.The Pericarpium Citri Reticulatae Viride Antishock function is also confirmed by clinical trial.These article are to pre-excitation syndrome, and PSVT is all effective due to the hypertension organic heart disease.
It possibly be to realize through the epinephrine beta receptor that acts on the uterine smooth muscle cell membrane that the Pericarpium Citri Reticulatae Viride water decoction is stranded active inhibition to the spontaneous receipts of the high body uterine smooth muscle of rat.Moreover, Pericarpium Citri Reticulatae Viride also has inhibitory action to the uterus tonic contraction that pituitrin causes.Pericarpium Citri Reticulatae Viride decoct and GTPI can suppress the contraction of gastrointestinal smooth muscle, can resist the Mus intestinal tube tonic contraction that physostigmine salicylate, histamine cause.Pericarpium Citri Reticulatae Viride is not only influential to the gastrointestinal mechanical activity, and is also influential to its electrical activity.Pericarpium Citri Reticulatae Viride not only makes solids content increase in normal rat bile flow and the bile, and the rat bile flow of CCI4 hepatic injury is increased, and this function of Pericarpium Citri Reticulatae Viride is favourable to preventing to hinder the formation that binds stone.The function that the soothing liver-QI of Pericarpium Citri Reticulatae Viride loses heart is relevant with the promotion bile secretion.GTPI has obvious relexation to the spastic contraction of bronchus chain that causes because of histamine, and can resist the lung perfusion flow that causes because of histamine and reduce.Pericarpium Citri Reticulatae Viride can improve chronic hypoxia mice keto consumpting speed and the school system of breathing rate, and the creatine kinase vigor that significantly raises reduces hepatocyte energy charge value.Flavonoid compounds IV, V have tangible active anticancer to various cancerous cell lines.Compound IV can reduce erythrocyte in vitro and build up and sedimentation.
The pharmacological action of Rhizoma Curcumae Longae:
Rhizoma Curcumae Longae decoct and 2% hydrochloric acid leachate are excitation to mice and guinea pig in vitro uterus, and rabbit is also had contraction in the body uterus, and holding time to reach several hours.Rhizoma Curcumae Longae water extract and petroleum ether extract have 100% antifertility action to female rats.Rhizoma Curcumae Longae extract has the reduction effect to experimental hypercholesterolemia.Rhizoma Curcumae Longae extract, Rhizoma Curcumae Longae volatile oil and curcumin are irritated stomach all can reduce the total cholesterol of blood plasma, beta lipoprotein and content of triglyceride to high fat rat model, and makes total cholesterol in the aorta, content of triglyceride reduction.Curcumin can suppress the lipid peroxidation of mouse brain tissue, and can suppress the lipid peroxidation of the heart, liver,kidney,spleen tissue.Rhizoma Curcumae Longae ethanol extract and volatile oil and curcumin can suppress sarcina, Gao Fuke bacterium, corynebacterium and clostridium and many staphylococcuses, streptococcus and bacillus cereus; Ethanol extract and volatile oil show bactericidal action to staphylococcus, and curcumin only shows inhibitory action.Volatile oil has stronger antifungal effect, and the inhibitory action of black being brought up bacterium is the strongest.Curcumin still has the effect of antiplatelet aggregation and blood viscosity lowering.
The pharmacological action of Fructus Hordei Germinatus:
Fructus Hordei Germinatus starch contained therein enzyme can become maltose and dextrin with amylolysis, and its decoct has slight facilitation to gastric acid and pepsic secretion; A kind of pancreatic amylase activator is proposed in the water decoction, also can be aid digestion; Because of the amylase non-refractory, Fructus Hordei Germinatus parching to brown and go into decoct and will reduce its vigor.Oral rabbit and the normal person's blood glucose of making of Fructus Hordei Germinatus preserved material reduces; Its injection can make blood glucose reduce by 40% or more.Expansible female molluscum contagiosum acinus of Fructus Hordei Germinatus and increase milk fullness degree then act on after the process of preparing Chinese medicine and weakening; The two-way function key of Fructus Hordei Germinatus galactopoiesis and lactogenic do not lie in give birth to or fry usefulness, and be the difference of dosage size, promptly low dose of lactogenic, heavy dose of galactopoiesis, as be used to suppress galactopoiesis (galactopoiesis) consumption should be more than 30g; Fructus Hordei Germinatus has similar bromocriptine class material, can suppress prolactin secretion.The similar ephedrine of the pharmacological action of hordenine, wherein A and B also have antifungic action.
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.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.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.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 Rhizoma Curcumae:
Rhizoma Curcumae another name: Rhizoma Curcumae, fluffy art, Qiang seven, wide art, evil mind Rhizoma Zingiberis Recens, Rhizoma Curcumae.The nature and flavor temperature; Hot, bitter; Return liver, spleen channel.Function cures mainly: removing blood stasis circulation of qi promoting, removing food stagnancy pain relieving.Be used for abdominal mass abdominal mass mass in the abdomen, blood stasis amenorrhea, food stagnation distending pain; Early cervical carcinoma etc.Chemical constituent: contain volatile oil, contain a-pinene, camphene, pinene, limonene, 1-8-cineole, a-terpinene, linalool, Borneolum Syntheticum, Camphora, linalyl acetate, eugenol etc. in the oil.Pharmacological action: the Rhizoma Curcumae volatile oil preparation can strengthen specific immunity through immune system again and obtain tangible immunoprotection effect, thereby have antitumaous effect the existing direct destruction of multiple cancerous cell.The temperature Rhizoma Curcumae volatile oil can suppress the growth of various pathogens; 1% Oleum Curcumae has inhibitory action to animal acetic acid property peritonitis, and mice local edema, inflammation are had inhibitory action.Oleum Curcumae has tangible anti-gastric-ulcer effect.But water extract anticoagulant promotes the arteriole restoration of blood flow, stops arteriole to shrink fully, obviously promotes local microcirculation to recover; Rhizoma Curcumae water extracting alcohol liquid is formed with inhibitory action to thrombus in vivo.Rhizoma Curcumae has direct deactivation to respiratory syncytial virus in addition, and Oleum Curcumae has and significantly protects the liver and the antiearly pregnancy effect.Rhizoma Curcumae also usually is used to treat ischemic encephalopathy, colpitis mycotica, cervical erosion, skin ulcer, neurodermatitis, infantile rotavirus enteritis, infantile acute upper respiratory infection, chronic bronchitis etc.
Novelty and breakthrough that the present invention has essence are to have found out the key point that Radix Aucklandiae soup 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 " the integrated novel form of Radix Aucklandiae soup " 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 Radix Aucklandiae soup 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 Radix Aucklandiae soup and production method thereof, wherein: this integrated novel form raw materials of effective components and weight proportion---3 parts of the Radix Aucklandiae, 3 parts on Pericarpium Citri Reticulatae Viride, 5 parts in Rhizoma Curcumae Longae, 5 parts in Fructus Hordei Germinatus, 11 parts of Radix Glycyrrhizae Preparatas, 4 parts of Rhizoma Curcumae, 11 parts of stir-fry salt.
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.Above-mentioned integrated novel form technology of preparing of a kind of Radix Aucklandiae soup 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; Above-mentioned integrated novel form technology of preparing of a kind of Radix Aucklandiae soup 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; Above-mentioned integrated novel form technology of preparing of a kind of Radix Aucklandiae soup 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; Above-mentioned integrated novel form technology of preparing of a kind of Radix Aucklandiae soup 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 Radix Aucklandiae soup 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% the Radix Aucklandiae, Pericarpium Citri Reticulatae Viride, Rhizoma Curcumae Longae, Fructus Hordei Germinatus 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, Rhizoma Curcumae 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.
Above-mentioned integrated novel form technology of preparing of a kind of Radix Aucklandiae soup 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; Above-mentioned integrated novel form technology of preparing of a kind of Radix Aucklandiae soup 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; Above-mentioned integrated novel form technology of preparing of a kind of Radix Aucklandiae soup 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, above-mentioned integrated novel form technology of preparing of a kind of Radix Aucklandiae soup 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 the key point that Radix Aucklandiae soup Chinese and western medicine theory combines; The present invention will in time fill up the blank of researching and developing " the integrated novel form of Radix Aucklandiae soup " 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 Radix Aucklandiae soup and production method thereof, its special feature is: processing the raw materials of effective components composition does by weight ratio---3 parts of the Radix Aucklandiae, 3 parts on Pericarpium Citri Reticulatae Viride, 5 parts in Rhizoma Curcumae Longae, 5 parts in Fructus Hordei Germinatus, 11 parts of Radix Glycyrrhizae Preparatas, 4 parts of Rhizoma Curcumae, 11 parts of stir-fry salt.
Further; Play the synergy of standing like the legs of a tripod on the integrated new drug formulation compatibility of Radix Aucklandiae soup of the present invention: 1, prepare nanometer, micro-powder, the bioavailability after strengthening Radix Aucklandiae soup 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 the 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 Radix Aucklandiae soup with this; 3, prepare Chinese medical concrete, water drug-decocting concentrating liquid with the prepared slices of Chinese crude drugs, strengthen the temporary transient unpredictable drug effect that reactions such as the unique complexation of Radix Aucklandiae soup Chinese medicine compound, hydrolysis, oxidation, reduction bring with this and keep and 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 powder and micron, subsequent use.Get 30%--90% alcohol-water solution mixed soaking 1-2 days that 60% the Radix Aucklandiae, Pericarpium Citri Reticulatae Viride, Rhizoma Curcumae Longae, Fructus Hordei Germinatus 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, Rhizoma Curcumae 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---3 parts of the Radix Aucklandiae, 3 parts on Pericarpium Citri Reticulatae Viride, 5 parts in Rhizoma Curcumae Longae, 5 parts in Fructus Hordei Germinatus, 11 parts of Radix Glycyrrhizae Preparatas, 4 parts of Rhizoma Curcumae, 11 parts of stir-fry salt.
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---3 parts of the Radix Aucklandiae, 3 parts on Pericarpium Citri Reticulatae Viride, 5 parts in Rhizoma Curcumae Longae, 5 parts in Fructus Hordei Germinatus, 11 parts of Radix Glycyrrhizae Preparatas, 4 parts of Rhizoma Curcumae, 11 parts of stir-fry salt.
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 the 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---3 parts of the Radix Aucklandiae, 3 parts on Pericarpium Citri Reticulatae Viride, 5 parts in Rhizoma Curcumae Longae, 5 parts in Fructus Hordei Germinatus, 11 parts of Radix Glycyrrhizae Preparatas, 4 parts of Rhizoma Curcumae, 11 parts of stir-fry salt.
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 the key point that Radix Aucklandiae soup Chinese medicine compound Chinese and western medicine theory combines, and the compound compatibility of modern Chinese medicine and technology of preparing can change the pharmacokinetic parameter of medicine monomer, effective ingredient or effective part group.This has proved the scientific meaning of Chinese medicine compound compatibility from the pharmacokinetics level." very just being harmonious; negative and positive intercommunication, coordinating water and fire, precise and tiny circle melt; greatness lies in the capacity " is the elite in the classical works such as Chinese 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, for Radix Aucklandiae soup modern Chinese medicine prepares and production has proposed a practical effective novel form compatibility program.Be to have substantial innovation and technological break-through.
Claims (10)
1. integrated novel form technology of preparing of Radix Aucklandiae soup and production method thereof is characterized in that: 3 parts of this novel form raw materials of effective components and weight proportion---the Radix Aucklandiae, 3 parts on Pericarpium Citri Reticulatae Viride, 5 parts in Rhizoma Curcumae Longae, 5 parts in Fructus Hordei Germinatus, 11 parts of Radix Glycyrrhizae Preparatas, 4 parts of Rhizoma Curcumae, fry 11 parts of salt.
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 Radix Aucklandiae soup 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 Radix Aucklandiae soup 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 Radix Aucklandiae soup 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 Radix Aucklandiae soup 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 Radix Aucklandiae soup 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% the Radix Aucklandiae, Pericarpium Citri Reticulatae Viride, Rhizoma Curcumae Longae, Fructus Hordei Germinatus 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, Rhizoma Curcumae 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 Radix Aucklandiae soup 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 Radix Aucklandiae soup 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 Radix Aucklandiae soup 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 Radix Aucklandiae soup 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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| Title |
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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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