CN102526646A - Preparation technology and production method of novel sweet osmanthus decoction integrated dosage form - Google Patents
Preparation technology and production method of novel sweet osmanthus decoction integrated dosage form Download PDFInfo
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Abstract
The invention relates to a preparation technology and a production method of a novel sweet osmanthus decoction integrated dosage form. The novel sweet osmanthus decoction integrated dosage form consists of the following raw material active ingredients in parts by weight: 0.6 part of dried ginger, 9 parts of cassia bark core, 9 parts of liquoric root and 3.9 parts of contracted fructus amomi. The production process comprises ultrasonic speed fluid energy milling, alcohol-water extraction, ultrasonic wave smashing and extracting, water decoction concentration, ultrasonic speed spray drying, nanometer grinding, high-pressure homogenization, nanoparticle preparation and the like. In the invention, the advantages of multi-coordination, multi-targeting and the like represented in a nano-carrier coupling technique are utilized. After large-scale production is performed, the production cost can be reduced greatly, the product quality can be enhanced greatly, and the targeting property and controlled release property of a medicament can be enhanced. A sweet osmanthus decoction can be administrated internally and externally, and can be taken at four time intervals according to midnight-noon ebb-flow and the qi-blood flow rule of a human body. The sweet osmanthus decoction can be prepared into a film forming agent and a transdermal agent which are attached to different positions of a human body respectively according to midnight-noon ebb-flow and the qi-blood flow rule of the human body and can be directly absorbed through skin.
Description
Technical field
The present invention relates to the integrated novel form technology of preparing of a kind of Flos Osmanthi Fragrantis soup, the invention still further relates to integrated novel form technology of preparing of a kind of Flos Osmanthi Fragrantis 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.
Flos Osmanthi Fragrantis soup derives from " Song's formulary of peaceful benevolent dispensary ".Nine liang of Fang Youqian Rhizoma Zingiberis Recens (big gun), Cortex Cinnamomi, Radix Glycyrrhizae (stir-fry), each nine jin; Three jin of 14 liang of compositions of Fructus Amomi contract.Function cures mainly: control all cold air, and trusted subordinate's twinge, the chest and diaphragm painful abdominal mass is vexed, side of body rib distension, vomiting is felt sick, poor appetite.Method for making: on fry 14 jin of salt, be all the end.The purposes consumption: every clothes one money, the soup point that boils clothes are before the food.
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.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.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.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 hyperplasia.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.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.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.
The pharmacological action of Cortex Cinnamomi:
Cortex Cinnamomi is a kind of in the Cortex Cinnamomi, says that generally Cortex Cinnamomi is the skin of cassia tree, and dry back be a tubbiness, claim " osmanthus is logical ", and " Cortex Cinnamomi " that you say is " osmanthus is logical " of removing outer rough bark, and also writing " Gui Xin " is similar to the curative effect of " Cortex Cinnamomi "! Cortex Cinnamomi property toil, nontoxic (or doing sweet dry greatly).Go into heart spleen channel.The Cortex Cinnamomi YANG invigorating is invigorated blood circulation and is apt to control trusted subordinate's cold type of pain, can draw blood antiperspirant again and suppurate, the surgery usefulness of making expelling the toxic substance from the body with tonic carbuncle variola commonly used.The cinnamic aldehyde that contains in the Cortex Cinnamomi has tangible sedation to mice.Use mice press anal spine to swash or lumbar injection acetic acid observe turn round the body motion the method proof it analgesic activity is arranged.Cinnamic aldehyde and Fortificar all have refrigeration function.External and the in vivo test of Cortex Cinnamomi all has the effect of the inductive rat platelet aggregation of obvious inhibition ADP, and in vitro tests shows that Cortex Cinnamomi water decoction and solution and methanol partly have stronger anticoagulation.Oleum Cinnamomi stimulates olfactory sensation, can promote the stomach function reflectingly, also can directly to gastric mucosa demulcent stimulation be arranged, and secretion is increased, and wriggling strengthens, and is the armaticity digestion promoting function.Oleum Cinnamomi gives rabbit oral, can promote bowel movement, makes intestinal tube excited.The isolated rabbit intestinal tube is also had same purpose, be ancients' warming the spleen and stomach, remove cold long-pending saying and made good explanation.A large amount of Oleum Cinnamomis can cause metremia, show the effect of stimulating the menstrual flow, and this fetal abortion effect of saying for ancient book on Chinese herbal medicine provides an experimental basis.Oleum Cinnamomi has powerful bactericidal action, and is better than negative patient to the effect of Gram-positive bacterium, and because of zest is arranged, seldom as antibacterials, but external application can be treated stomachache, flatulence angor etc.Take orally and can do to be good for the stomach and carminative.Tangible fungicidal action is also arranged, once use the mixture treatment tinea capitis that contains 1.5% Oleum Cinnamomi and 0.5% thymol.Cinnamic aldehyde and Fortificar can cause that frog foot web film vasodilation and rabbit leukocyte increase.Oleum Cinnamomi absorbs the back is discharged by lung, makes the mucus dilution, presents the eliminating phlegm and relieving cough effect.Cortex Cinnamomi is from the kidney discharge and cause local excitation, shows certain diuresis.Natrium cinnamicum has anti-radiation function.Diterpenes composition in the Cortex Cinnamomi has anticomplementary action.
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 toxic action in addition.
The contract pharmacological action of Fructus Amomi: green shell sand core 2.5～5mg (crude drug)/ml can make Cavia porcellus and rat intestinal tube smooth muscle excited, and escalated dose is inhibitory state.0.5g the oral dose of youngster g can make the intestinal ahead running of mice accelerate.Seed extract 0.5～4g/L has potentiation to the shrinkage amplitude and the frequency of isolated ileum segments in guinea pigs pipe rhythmicity, and along with the increase of concentration, effect strengthens.300～600mg/kg/ mouse stomach has tangible antiulcer action.Writhing response due to the 300mg, 600mg, 1200mg/kg mouse stomach, Dichlorodiphenyl Acetate all has significant analgesia role.Irritate stomach 0.6g/kg reach the 1.2g/kg rabbit, the rabbit platelet aggregation that is brought out by ADP is had the obvious suppression effect, increase with dosage, prolong action time relatively.These article have the significant protection effect to the death of mice that arachidonic acid or collagen and epinephrine intermixture bring out.
Novelty and breakthrough that the present invention has essence are to have found out the key point that Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis soup and production method thereof, wherein: this integrated novel form raw materials of effective components and weight proportion---
0.6 part of universe Rhizoma Zingiberis Recens, 9 parts of Cortex Cinnamomi, 9 parts in Radix Glycyrrhizae, 3.9 parts of Fructus Amomis contract.
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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis 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% universe Rhizoma Zingiberis Recens, Cortex Cinnamomi 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, the Fructus Amomi powder and micron contracts; 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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis soup and production method thereof, its special feature is: processing the raw materials of effective components composition does by weight ratio---
0.6 part of universe Rhizoma Zingiberis Recens, 9 parts of Cortex Cinnamomi, 9 parts in Radix Glycyrrhizae, 3.9 parts of Fructus Amomis contract.
Further; Play the synergy of standing like the legs of a tripod on the integrated new drug formulation compatibility of Flos Osmanthi Fragrantis soup of the present invention: 1, prepare nanometer, micro-powder, the bioavailability after strengthening Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis 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% universe Rhizoma Zingiberis Recens, Cortex Cinnamomi powder and micron doubly measure with 6-12, reflux, extract, 3 times is extracted water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility simultaneously, recovered alcohol, extract with subsequent use.Get 60% Radix Glycyrrhizae, the Fructus Amomi powder and micron contracts; 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---
0.6 part of universe Rhizoma Zingiberis Recens, 9 parts of Cortex Cinnamomi, 9 parts in Radix Glycyrrhizae, 3.9 parts of Fructus Amomis contract.
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---
0.6 part of universe Rhizoma Zingiberis Recens, 9 parts of Cortex Cinnamomi, 9 parts in Radix Glycyrrhizae, 3.9 parts of Fructus Amomis contract.
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---
0.6 part of universe Rhizoma Zingiberis Recens, 9 parts of Cortex Cinnamomi, 9 parts in Radix Glycyrrhizae, 3.9 parts of Fructus Amomis contract.
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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis soup and production method thereof is characterized in that: this novel form raw materials of effective components and weight proportion---
0.6 part of universe Rhizoma Zingiberis Recens, 9 parts of Cortex Cinnamomi, 9 parts in Radix Glycyrrhizae, 3.9 parts of Fructus Amomis contract.
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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis 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% universe Rhizoma Zingiberis Recens, Cortex Cinnamomi 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, the Fructus Amomi powder and micron contracts; 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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis 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 Flos Osmanthi Fragrantis 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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