CN102895630A - Preparation technology and production method for integrated new formulation of astragalus and cinnamon twig five agents decoction - Google Patents
Preparation technology and production method for integrated new formulation of astragalus and cinnamon twig five agents decoction Download PDFInfo
- Publication number
- CN102895630A CN102895630A CN2011102146165A CN201110214616A CN102895630A CN 102895630 A CN102895630 A CN 102895630A CN 2011102146165 A CN2011102146165 A CN 2011102146165A CN 201110214616 A CN201110214616 A CN 201110214616A CN 102895630 A CN102895630 A CN 102895630A
- Authority
- CN
- China
- Prior art keywords
- medicine
- chinese
- nano
- drug
- parts
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Abstract
The present invention relates to a preparation technology and a production method for an integrated new formulation of an astragalus and cinnamon twig five agents decoction, wherein the raw materials of active ingredients comprise: 9 parts by weight of astragalus, 9 parts by weight of Chinese herbaceous peony, 9 parts by weight of cinnamon twig, 18 parts by weight of ginger, and 4 parts by weight of Chinese-date. The production process of the integrated new formulation comprises the following steps of: supersonic air-jet crushing, alcohol-water extraction, ultrasonic crushing extraction, water decocting concentration, supersonic spray drying, nanometer grinding, high pressure homogenization, nano particle preparation and the like. According to the invention, the advantages, such as multi-synergism, multi-target, embodied by a nano-carrier coupling technique, are focused to be taken of. After the integrated new formulation of astragalus and cinnamon twig five agents decoction is subjected to scale production, the production cost can be greatly reduced, the quality of products is greatly improved and the targeting property and the sustained and controlled release performance of the medicament are enhanced. The internal and external administration of the integrated new formulation of astragalus and cinnamon twig five agents decoction can be realized simultaneously, and can be respectively taken in four time slices according to midnight-noon ebb-flow and qi and blood flowing rule of a human body. The integrated new formulation of astragalus and cinnamon twig five agents decoction can be further prepared into films and transdermal agents which are respectively stuck to different parts of a human body according to the midnight-noon ebb-flow and qi and blood flowing rule of the human body and can be directly absorbed through skin.
Description
Technical field
The present invention relates to a kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology, the invention still further relates to a kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology and production method thereof.
Background technology
Chinese medicine decocting liquid compound recipe drug effect chemical reaction is too many because of chemical composition, temporary transient not revealed its Mysterious Veil also, but some mysterious black box drug actions are just ensconced in the Chinese medicine decocting liquid in the Chinese medicinal formulae, can not ask simply Chinese medicine westernization, the modernization of Chinese medicine most and only use monomer and effective site.The Chinese medicine water drug-decocting concentrating liquid could not be given it up! When the Chinese medicinal formulae water decocts, because prescription closes chemical environment complicated in high temperature when frying in shallow oil and the solution, the reaction such as complexation, hydrolysis, oxidation, reduction between intrinsic material may occur in solution, thereby some novel substance that did not originally have in the generation solution, these novel substances produce the drug actions such as potentiation, attenuation or modification to full side.New component forms the research of mechanism, stability and drug effect thereof in the reinforcement Chinese medicinal formulae decocting liquid, to improving Chinese medicine compound and new drug level, progressively dwindle Chinese medicine compound and new Chinese medicine and international gap, very important meaning is arranged, also increased new way and new source for the research and development new Chinese medicine simultaneously.
China's drug control relevant laws and regulations regulation changes dosage form and manages as new drug research.The backwardness of preparation level not only affects the performance of curative effect of medication, and cause the medicine added value low, directly affecting the market competition and industrial economy benefit, is to cause China's medical industry product quantity to occupy prostatitis, the world and the output value only is equivalent to the one of the main reasons of one or two transnational drugmaker.
New drug, novel form development level can embody economy and the technical strength of the medical industry of a country.China's oral formulations accounts for 2/3 of various whole body drug-delivery preparations, and accelerating development and promoting oral sustained-release preparation is the work that current urgent need will be done.
The Huangqi Guizhi Wuwu Tang prescription derives from " Medical Treasures of the Golden Chamber ".Another name: Radix Astragali Ramulus Cinnamomi five thing soup, Radix Astragali soup, Radix Astragali five thing soup, Ramulus Cinnamomi five thing soup, five thing soup.The party's ingredients is the Radix Astragali three liang of [9g], Radix Paeoniae three liang of [9g], Ramulus Cinnamomi three liang of [9g], Rhizoma Zingiberis Recens six liang of [18g], 12 pieces in Fructus Jujubaes [4 pieces].Preparation method: medicine-feeding, with six liters in water, boil and get two liters, decoction being taken warmly seven closes, taking medicine three times daily.Function: take good care of Rong Wei, dispel the wind loose evil; QI invigorating warming the meridian, and blood blood stasis dispelling.Cure mainly: arthralgia due to stagnation of blood.Faintness in both YIN and YANG, the exterior symptoms numbness of the skin is meciless, symptoms similar to the migratory arthralgia.Feeble pulse at GUAN portion, CHI-pulse being slightly tense, faint and hesitant pulse and tight.We are clinical to be usually used in treating nervous system disease, scapulohumeral periarthritis, rheumatic arthritis, periostitis, dermatitis, peripheral neuritis, apoplexy sequela or hemihidrosis, wasting, shortness of breath and fatigue and puerperal, through after general pain etc.
The side separates:
Because the four stages in the course of an epidemic febrile disease is not enough, can not moisten foster skin, add wind and cold invasion blood vessels, make blood not smooth, move not smooth, the skin apathy that becomes.Radix Astragali QI invigorating is real among the we defends; The Ramulus Cinnamomi warming the meridian for promoting the flow of YANG QI; The Radix Paeoniae Alba and nutrition blood; The Radix Astragali, Ramulus Cinnamomi mutually 5 QI invigorating activate yang; Rhizoma Zingiberis Recens, Fructus Jujubae both share that adjustable battalion defends, but again spleen invigorating and in, reuse Rhizoma Zingiberis Recens and can help Ramulus Cinnamomi with the dispersing wind and cold promoting blood circulation.Full side's compatibility gets up, but both the replenishing vital QI with drugs of warm nature defensive-qi-nutrient-blood with righting, but again dispersing wind and cold, promoting blood circulation, eliminating pathogens.
Each is discussed:
1, " gold mirror ": with Radix Astragali Gu Wei; The Radix Paeoniae yin nourishing; The Ramulus Cinnamomi harmonizing yingfen and weifen holds in the palm real the exterior and the interior, gets rid of evils and goes out; Assistant is declared stomach with Rhizoma Zingiberis Recens; The Fructus Jujubae strengthening the spleen is controlling also that most suitable and not subject to change.
2, " Synopsis of Prescriptions of the Golden Chamber literal sense ": " Huangqi Guizhi Wuwu Tang can be controlled in migratory arthralgia, also can control also in arthralgia due to stagnation of blood.Take the Radix Astragali as main consolidating superficial resistance invigorating middle warmer, assistant is with Fructus Jujubae; Control with Ramulus Cinnamomi and to defend yang invigorating, assistant is with Rhizoma Zingiberis Recens; With the Radix Paeoniae treating blood disorders of joining the army, U.S. altogether becomes to faint.Five things and seek Wei Jianli, and table battalion defends the inner gastrointestinal reason of also holding concurrently.Wind is also held concurrently and is managed in the integumentary musculature person among pushing away.Admittedly needn't ask his method also more.”
3, because the four stages in the course of an epidemic febrile disease is not enough, can not moisten foster skin, add wind and cold invasion blood vessels, make blood not smooth, move not smooth, the skin apathy that becomes.Radix Astragali QI invigorating is real among the we defends; The Ramulus Cinnamomi warming the meridian for promoting the flow of YANG QI; The Radix Paeoniae Alba and nutrition blood; The Radix Astragali, Ramulus Cinnamomi mutually 5 QI invigorating activate yang; Rhizoma Zingiberis Recens, Fructus Jujubae both share that adjustable battalion defends, but again spleen invigorating and in, reuse Rhizoma Zingiberis Recens and can help Ramulus Cinnamomi with the dispersing wind and cold promoting blood circulation.Full side's compatibility gets up, but both the replenishing vital QI with drugs of warm nature defensive-qi-nutrient-blood with righting, but again dispersing wind and cold, promoting blood circulation, eliminating pathogens.
4, arthralgia due to stagnation of blood card is by element this " weak bone skin Shengs ", labor and sweating, and opening of sweat pores is subjected to mild wind, evilly satisfies the visitor in blood vessels, causes numbness of the skin meciless, and shape such as migratory arthralgia, but painless are the differences with migratory arthralgia, and that faint and hesitant pulse is held concurrently is tight, and evil stagnant blood vessels be describeds, coagulates puckery obstructed." Plain Questions numbness opinion " said: " ying-qi is empty, and is then meciless." therefore with the QI invigorating warming the meridian, and blood blood stasis dispelling and making laws.The Radix Astragali is monarch in the side, and sweet temperature QI invigorating is mended the gas of defending at table.Ramulus Cinnamomi dispersing wind and cold and warming the meridian blood stasis dispelling, with Radix Astragali compatibility, the QI invigorating warming YANG, and blood stimulates the menstrual flow.Ramulus Cinnamomi gets Radix Astragali QI invigorating and rouses oneself Wei Yang; The Radix Astragali gets Ramulus Cinnamomi, consolidating superficial resistance and the unlikely heresy of staying.Radix Paeoniae is nourished blood and seeks and logical arthralgia due to stagnation of blood, share with Ramulus Cinnamomi, transfer battalion to defend and and the exterior and the interior, two medicines are minister.The hot temperature of Rhizoma Zingiberis Recens, dispelling wind pathogens is to help the power of Ramulus Cinnamomi; The sweet temperature of Fructus Jujubae, nourishing blood and invigorating qi is as a means of the merit of the Radix Astragali, Radix Paeoniae; Associate with Rhizoma Zingiberis Recens, can defend with battalion again, transfer all medicines, think that assistant makes.Side's medicine five tastes, compatibility is precise and appropriate, plays altogether the QI invigorating warming the meridian, and the effect of blood blood stasis dispelling.
Clinical practice:
1. numbness:, cold physique, chiropodalgia, muscle are gradually swollen, labour's walking, and yang-energy is injured, invades in the exopathogen, and battalion defends and becomes estranged.Imitative " office side " " numbness is at extremity, and sweating yang deficiency person is with Radix Astragali five thing soup ".Radix Astragali, Ramulus Cinnamomi, Poria, Radix Glycyrrhizae Preparata, Radix Angelicae Sinensis, Roast Rhizoma Zingiberis Recens, southern Fructus Jujubae.
2. affection by exogenous wind: scanning this disease, is that wind is had a pain in the joint, so to its pain person, be that QI and blood is resisted mutually with ailment said due to cold or exposure, non-complete unconsciously pain with hemiplegia person, its wonderful sore spot that is, the righting of being not difficult is to shield heresy, book claims middle finger numb, and anti-suffering stroke in 3 years is therefore belong to the palm of the hand through also with middle finger.The numb part of modern good fortune with forefinger, thumb for very, be the uncomfortable of lung and large intestine gas, there is no large evil, right wind benefaction and parameter must be controlled it early, if so at this moment fertile wind medicine with prevention of stroke, be that suitable catching the wind got, be as good as by means of bandit soldier and steal together grain, should go out all seriously, be sure not rashly to show off with figure one, should use Radix Astragali five thing soup.Radix Astragali 2 money, RAMULUS CINNAMOMI 2 money, Radix Paeoniae Alba 2 money, Rhizoma Zingiberis Recens 4 money, 2 pieces in Fructus Jujubae, same decoction.
3. apoplexy sequela: an old woman, card is seen right half body paralysis, mouthful eye tiltedly, numb hand and foot, numbness, right half body is from sweating.Blood pressure: 150/100 millimetres of mercury.This is that the four stages in the course of an epidemic febrile disease is thanks to empty, and the yang-energy resistance is closed, and passages through which vital energy circulates loses the card in nutrition.Give Radix Astragali Ramulus Cinnamomi five thing soup and control it.Take altogether 15 doses, blood pressure: 140/90 millimetres of mercury, the arteries and veins tongue is normal.All diseases are removed, just like ordinary person.Visit after 4 years, do not remake eventually.
4. arthralgia due to stagnation of blood: Liu, suffered from numb limbs and tense tendons more than 1 year, night is more so.With vitamin B12 and vitamin B1; Intramuscular injection more than 60 days, curative effect is not obvious.After change acupuncture and moxibustion therapy into, first pin has little effect, that continues is invalid.Card is seen the lazy speech of the deficiency of vital energy, and more very, buttocks is sent out cold with upper limb for fatigue and weak, numb limbs and tense tendons.Arteries and veins is two heavy thin, pale and tender tongue, white and thin fur.Get Radix Astragali Ramulus Cinnamomi five thing soup and control it.Take 15 doses, all cards are all exempted from.
5. spontaneous perspiration: patient, woman, 31 years old.The workman.Dysentery is follow-up sees sweating, more than 2 years.Moving then dripping sweat is suddenly cold and suddenly hot, frequent aversion to wind, and borborygmus appear, and feed is namely rushed down accidentally, and dizzy unable, pale tongue with thin fur is white, and unable cun of arteries and veins is floating large.Examine through certain hospital and to be " autonomic nervous dysfunction ", control repeatly and deceive effect.Satisfy with the Radix Astragali Ramulus Cinnamomi five thing Tonga Rhizoma Atractylodis Macrocephalaes, Fructus Schisandrae Chinensis, 4 doses of decoctings, spontaneous perspiration obviously improves behind the clothes, with the Ramulus Cinnamomi decrement, the Rhizoma Atractylodis Macrocephalae increases system, make it outer and help Radix Astragali with consolidating superficial resistance, in reach spleen invigorating to receive merit.Go on 6 doses, borborygmus disappear.Advance 3 doses, all disease knowing are removed again.
6. the thoracic obstruction: patient, woman, 51 years old, cadre.Sick just conscious sensation of oppression over the chest with shortness of breath, sense dull pain when continuing then the anterior pectorial region, and shoulder back of the body radiation left, pain exaggerated by catching cold, more than 2 years.Electrocardiogram is examined and is " coronary insufficiency ".Give Radix Astragali Ramulus Cinnamomi five thing Tonga Bulbus Allii Macrostemonis, Radix Glycyrrhizae Preparata, take altogether more than 30 agent, all cards of chest pain are controlled, and electrocardiogram is bordering on normally.
7. gastric abscess: patient, woman, 42 years old, workman.Sense dull pain meets Lao Yuhan more so during gastral cavilty, and about 5 years, barivm meal fluoroscopy (screem) is examined and is " antral gastritis ".Once took repeatly the hot product of regulating the flow of vital energy of large agent, and gradually caused abdominal distension and anorexia, half congealed during stool, the whole body is weak, light red tongue profit, deep pulse stringy and slow pulse.Side's Radix Astragali Ramulus Cinnamomi five thing Tonga Radix Glycyrrhizae Preparatas, Rhizoma Zingiberis, after taking medicine, a stomachache solution.Meal with wine goes Rhizoma Zingiberis, adds Pericarpium Arecae and Poria is used alternatingly, and gives spleen invigorating, due to illness old for a long time, slowly figure controls.Continuing takes more than 20 agent, all card convalesces.
8. low grade fever: Zhu, women .35 year, teacher.Low grade fever more than 2 years, body temperature are everlasting about 37.5 ℃, reach once in a while 38 ℃.Be afraid of cold with timid wind, from sweaty, low voice is breathed hard, poor appetite, and large loose stool is thin, the weak card that waits in the whole body.Thin white fur of tongue, body of the tongue is light red and fat, and thready and moderate pulse is unable.Card belongs to qi-asthenia fever.Plan is got the relieving high fever with drugs of sweet flavour and warm nature method, Radix Astragali Ramulus Cinnamomi five thing Tonga Rhizoma Atractylodis Macrocephalae preparatas, Radix Glycyrrhizae Preparata.Behind 12 doses of the clothes tops, symptom disappears substantially.Use BUZHONG YIQI WAN instead and be taken after mixing with liquid first quarter moon to deal with problems arising from an accident, follow up a case by regular visits to so far and do not send out.
Modern pharmacological research: mainly contain antiinflammatory, analgesia, blood vessel dilating increases vascular flow, and blood circulation promoting and blood stasis dispelling strengthens immunity, promotes the effects such as cellular metabolism.
1. antiinflammatory, analgesia: Radix Paeoniae, Rhizoma Zingiberis Recens, Ramulus Cinnamomi have antiinflammatory, analgesic activity in the side.Radix Paeoniae, Rhizoma Zingiberis Recens to rat experiment after the toes edema obvious antiinflammatory, detumescence effect are all arranged.The pain that Radix Paeoniae, Ramulus Cinnamomi, Rhizoma Zingiberis Recens cause writhing method, hot plate method has obvious analgesic activity.
2. blood vessel dilating increases the vascular flow amount, blood circulation promoting and blood stasis dispelling: the Radix Astragali, Ramulus Cinnamomi, Radix Paeoniae can increase the vascular flow amount in the side, improve circulation, organize amount of blood supply thereby increase, and accelerate patient's recovery.
3. strengthen immunity, promote cellular metabolism: the Radix Astragali can strengthen the phagocytic function of reticuloendothelial system in the side, strengthens humoral immunization and cellular immunization, can also resist the inhibitory action of immunosuppressant.The Radix Astragali can make body viable count showed increased, and Growth of Cells is vigorous, and cell survival prolongs, and the physiological metabolism effect of cell is strengthened.Studies have shown that, viral chronic persistent hepatitis belongs to yang deficiency patient, its interleukin II (IL-2) activity is starkly lower than the normal person, and irrelevant with sex and age, add and subtract treatment after 1-2 month with we, can make the active obviously rising of its IL-2, be 3015 ± 22.04% before the treatment, be 61.87 ± 30.87% after the treatment, the two difference highly significant, patient's liver function also improves simultaneously, points out this medicine to be improved the effect of viral chronic persistent hepatitis yang deficiency patient Immune Function.
The tangible novelty of tool of the present invention and breakthrough are to have found out the key point that Huangqi Guizhi Wuwu Tang modern Chinese medicine novel form Chinese and western medicine theory combines, the present invention will in time fill up both at home and abroad and use " nano-carrier multiple techniques " and researching and developing the blank in " the integrated novel form of Huangqi Guizhi Wuwu Tang " field with theory of integrated Chinese and western medicine, product has the targeting advantage such as wide that distributes, both at home and abroad without same or similar bibliographical information.Research and development have reached world lead level.Show substantive progressive and novelty of the present invention by international one-level novelty assessment report and patent retrieval.Utilize domestic and foreign databases to carry out update search, comprehensive domestic and foreign literature is read, analyzing contrast obtains drawing a conclusion: " the integrated novel form of multiple techniques research and development Nano medication " project, its innovative point: 1) adopt the Chinese medicine nano powder body that is rich in trace element, the medicine monomer, effective site, effective part group, Chinese medical concrete, water drug-decocting concentrating liquids etc. are prepared the nanosphere of different-grain diameter size with the different pharmaceutical carrier, nanocapsule, polymer micelle, solid ester matter nanoparticle, magnetic nano particle, immunonanoparticles, nano-emulsion, suspensoid, vesicle, pharmacosomes, microcapsule, nanoparticle, nanoparticles, millimicro is assisted etc., and then mixing is respectively charged into soft, unite simultaneously in the hard capsule and use and be prepared into a kind of integrated novel form or be prepared into the integrated novel form of other types according to above method; 2) use nano-carrier multiple techniques and theory of integrated Chinese and western medicine research and development " the integrated novel form of Nano medication ", product has the characteristics such as targeting distributes extensively, slow controlled release properties is strong; Have no at home open report in the document, these project complex art characteristics have certain novelty and novelty.Look into new numbering: 200921c0704948.
Further: this dosage form preparation technology is the advantage separately of having integrated the traditional Chinese medical science, doctor trained in Western medicine, take the organic conception of theory of Chinese medical science and pay attention to collaborative idea between medicine and determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs as the overall strategy tactical thinking, in conjunction with modern western pharmacology, pharmacokinetics, toxicology, pharmaceutics scheduling theory, pay attention to effectiveness and the therapeutic effect of certified Chinese medicine one matter monomer in treating, pay attention to the mass action that Chinese medicine active substance, effective site and active materials play the treatment disease.Pay attention to the assosting effect that the contained trace element of Chinese medicine plays the treatment disease.The effective ingredient of the used Chinese medicine of this Chinese medicine compound is clear and definite, and medicine effect has obtained admitting of modern medicine.Pay attention to using nano-carrier multiple techniques development modern Chinese medicine.These will promote the development of China's Chinese Medicine Industry.
Summary of the invention:
Purpose of the present invention is exactly in order to solve the above-mentioned problems in the prior art, and a kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology and production method thereof are provided.
Purpose of the present invention is achieved through the following technical solutions:
A kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology and production method thereof, wherein: the raw material of this integrated novel form effective ingredient and weight proportion---
9 parts of the Radixs Astragali, 9 parts of Radix Paeoniaes, 9 parts of Ramulus Cinnamomi, 18 parts in Rhizoma Zingiberis Recens, 4 parts in Fructus Jujubae.
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.Above-mentioned a kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology and production method thereof, wherein: medicine and carrier are prepared into the pharmaceutical carrier crude drug, crude drug can be one or more combinations in nanoparticle, nanoparticle, micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanosuspension, the microcapsule etc., and can as required one or more be mixed.Described protection domain is not only the said medicine support material medicine in the described scope, is also included within to prepare on its basis or add the curative effect that other do not affect its disease of controlling, and just makes the pharmaceutical carrier crude drug of its better efficacy.
Further, above-mentioned a kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology and production method thereof, wherein: the drug carrier material that this novel form is selected, activating agent, help Emulsion, the excipient substances such as dispersant are gelatin, albumin, starch and derivant thereof, alginate, beta-schardinger dextrin-, protein, chitosan and derivant thereof, lactose, hydroxypropyl emthylcellulose, ethyl cellulose, cellulose acetate phthalate, the metering system acetate, polylactic acid, cyanoacrylate, the semisolid poe, triglyceride is (such as three stearic acid, three Palmic acids, three lauric acids, in three oleic acid etc., the glyceride of long-chain fatty acid), glyceride (such as glyceryl monostearate, contains list, two, the synthetic glyceride of triglyceride), cholesterol, Polyethylene Glycol, microcrystalline wax, the whale ester type waxes, erythrocyte, Montmorillonitum, in the tea powder etc. one or more.Described excipient substance is not only the said medicine adjuvant in the described scope, and other do not affect its disease of controlling to be also included within the upper interpolation in its basis, and just make the excipient substance of its better efficacy.
Further, above-mentioned a kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology and production method thereof, wherein: said integrated novel form adopts medicament nano powder body, micro-powder, medicine monomer, effective ingredient, effective site, active materials, Chinese medical concrete, water drug-decocting concentrating liquid to unite use with different excipient substance, pharmaceutical carrier according to indexs such as the pharmacology of traditional Chinese medical science global theory, compatibility theory and medicine, drug effect, medicine generation, toxicitys.And can mix its one or more according to the preparation needs.
Again further, above-mentioned a kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology and production method thereof, wherein: the integrated novel form end product that finally can form is: tablet, powder, suppository, stick, granule, soft capsule, hard capsule, effervescent, drop pill, aerosol, unguentum, oral solution, slow releasing tablet, controlled release tablet.
A kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology and production method thereof, it may further comprise the steps:
Step 1: get each prepared slices of Chinese crude drugs pretreatment, insert pulverizer after the weighing and be crushed to the 80-200 order, then adopt supersonic jet mill to the 1-10 micron, get different Chinese medicine micropowder, for subsequent use.
Step 2: get 30%--90% alcohol-water solution that 60% the Radix Astragali, Radix Paeoniae, Ramulus Cinnamomi micropowder doubly measure with 6-12 and mix and soaked 1-2 days, reflux, extract, 3 times, extract water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility, recovered alcohol gets extract for subsequent use.
Step 3: get 60% Rhizoma Zingiberis Recens, Fructus Jujubae micropowder, adopt the ultrasound wave dispersion extractor to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz--120KHz, to pulverize extraction time be 10-100 minute, gets extract for subsequent use.
Step 4: with step 2, step 3 gained Chinese medicine extract, adopt nanon ball-mill to grind 4-16 hour, get the nano powder that particle size distribution is the 50-1000 nanometer, for subsequent use.
Step 5: get each Chinese medicine micropowder of 40%, boiled 3 times with the traditional Chinese medicine extracting machine decocting after being soaked in water two hours, decocting liquid merges and filters, and filtrate is concentrated, gets extractum or water drug-decocting concentrating liquid with for subsequent use.
Step 6: with step 2, step 3, step 4 gained Chinese medicine extract, nano powder as required with and the different property of medicine, pharmacological actions, can adopt respectively the technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared, obtain the medicine materials such as different medicine monomers, effective site, active materials.
Step 7: adopt different excipient substances by version in 2010 " preparation part of standards standard and " the even method of high pressure breast is adopted respectively in the requirement in 2005 version Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " etc. in the Chinese pharmacopoeia above-mentioned gained medicine material, inclusion technique, solid state technology, polishing, solvent-fusion method, squeezing and pressing method, complex coacervation, emulsion-crosslinking method, the polymerization dispersion method, fusion method, the technology such as freeze-drying are prepared into nanoparticle, nanoparticle, the micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanosuspension, the crude drug such as microcapsule.The crude drug particle diameter is between 10 nanometers-10 micron.
Step 8: " preparation part of standards code requirement in the Chinese pharmacopoeia was got in the crude drug such as step 5 gained Chinese medical concrete or water drug-decocting concentrating liquid and step 7 gained nanoparticle, liposome, nano-emulsion, microcapsule one or more and is mixed by formula proportion by version in 2010.
Step 9: in GMP10000 level toilet, with the above-mentioned crude drug that mixes adopt full-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can by version in 2010 " Chinese pharmacopoeia related preparations standard criterion is made the above-mentioned end product of other type.
Step 10: the end product of making is carried out respectively several, bottling, mounted box, sealing, stickup labeling, plays the exterior and interior packings such as code, vanning.Packaged product is transported to the appointed place by production batch and unifies instantaneously sterilising, and opens the sterilization report.
Above-mentioned a kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology and production method thereof; wherein: the Chinese medicine of using in described step 1, step 2, the step 3 is pulverized and extracting method; described protection domain is not only described technology of preparing and method; as required, be also included within and add on its basis or use other better effects if, more economical, renewal, breaking method more advanced, more environmental protection, extracting method and technology.
Further, above-mentioned a kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology and production method thereof, wherein: the crude drug such as the dissimilar nanoparticle that employing different pharmaceutical adjuvant is prepared in the medicine monomer in the described step 6, active substance, effective site technology of preparing and the described step 7, nano-emulsion.The described protection domain of this claim is not only described technology of preparing and method, as required, be also included within add on its basis or use other better effects if, more economical, upgrade, preparation method more advanced, more environmental protection and technology.
Further, above-mentioned a kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology and production method thereof, wherein: its key point 1 is different utilization nano-carrier multiple techniques different according to the particle diameter of crude drug and the property of medicine, can produce the gentle controlled capability of different targetings.
Again further, above-mentioned a kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology and production method thereof, wherein: its key point 2 is to develop simultaneously by interior external administration, can take four time periods respectively by midnight-noon and ebb-flow doctrine, energy and blood of human body flowing law.Also can be prepared into membrane, transdermal agent is attached to respectively different parts by the energy and blood of human body flowing law, directly absorb by skin.
The outstanding substantive distinguishing features of technical solution of the present invention and significant progressive being mainly reflected in:
The tangible novelty of tool of the present invention and breakthrough are to have found out the key point that the Huangqi Guizhi Wuwu Tang Chinese and western medicine theory combines, the present invention will in time fill up both at home and abroad and use " nano-carrier multiple techniques " and researching and developing the blank in " the integrated novel form of Huangqi Guizhi Wuwu Tang " field with theory of integrated Chinese and western medicine, product has the targeting advantage such as wide that distributes, both at home and abroad without same or similar bibliographical information.Show substantive progressive and novelty of the present invention by international one-level novelty assessment report and Patent database searching.Utilize domestic and foreign databases to carry out update search, comprehensive domestic and foreign literature is read, analyzing contrast obtains drawing a conclusion: " the integrated novel form of multiple techniques research and development Nano medication " project, its innovative point: 1) adopt the Chinese medicine nano powder body that is rich in trace element, the medicine monomer, effective site, effective part group, Chinese medical concrete, water drug-decocting concentrating liquids etc. are prepared the nanosphere of different-grain diameter size with the different pharmaceutical carrier, nanocapsule, polymer micelle, solid ester matter nanoparticle, magnetic nano particle, immunonanoparticles, nano-emulsion, suspensoid, vesicle, pharmacosomes, microcapsule, nanoparticle, nanoparticles, millimicro is assisted etc., and then mixing is respectively charged into soft, unite simultaneously in the hard capsule and use and be prepared into a kind of integrated novel form or be prepared into the integrated novel form of other types according to above method; 2) use nano-carrier multiple techniques and theory of integrated Chinese and western medicine research and development " the integrated novel form of Nano medication ", product has the characteristics such as targeting distributes extensively, slow controlled release properties is strong; Have no at home open report in the document, these project complex art characteristics have certain novelty and novelty.Science and technology is looked into new numbering: 200921c0704948.
Further, this dosage form preparation technology and production method thereof are to have integrated the advantage separately of the traditional Chinese medical science, doctor trained in Western medicine, take the organic conception of theory of Chinese medical science and pay attention to collaborative idea between medicine and determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs as the overall strategy tactical thinking, in conjunction with modern western pharmacology, pharmacokinetics, toxicology, pharmaceutics scheduling theory, pay attention to effectiveness and the therapeutic effect of certified Chinese medicine one matter monomer in treating, pay attention to the assosting effect that Chinese medicine active substance, effective site and active materials play the treatment disease.Pay attention to the assosting effect that the contained trace element of Chinese medicine plays the treatment disease.The effective ingredient of the used Chinese medicine of this Chinese medicine compound is clear and definite, and medicine effect has obtained admitting of modern medicine.Pay attention to the different nano-carrier dosage form technologies of preparing of Chinese medicine and unite use.To adopt Chinese medicine crude drug nano-powder, monomer, effective site, effective part group, traditional Chinese drug inspissation extractum, water drug-decocting concentrating liquid, nano-medicament carrier etc. to unite use on the compatibility.These various Chinese traditional powder particle diameter major parts of filling a prescription are the granule of 50～1000 nanometers.Adopting different nano-medicament carriers to be prepared into nanoparticle, nanosphere, nanocapsule, solid ester matter nanoparticle, nano-emulsion, vesicle, pharmacosomes, microcapsule, nanoparticle, nanoparticles, millimicro assists etc.Its particle size distribution is in 10 nanometers---between-10 microns.Then theoretical according to difference, the difference of slow controlled release time and the traditional Chinese medical science monarch of pharmacology, targeting, reasonable compatibility mixes, and is respectively charged among hard capsule and the soft capsule.Difference according to the dissolving of capsule material, disintegrate, jitter time can be prepared into respectively the targeted systems such as RE targeted system, stomach mucosa absorption system, intestinal absorption system, colon absorption system.Compare Chinese medicine and medicine monomer, the target-oriented drug of the overall coordination therapeutical effect of this Chinese medicine compound novel form, slow controlled capability are stronger, and curative effect is more outstanding, and toxic and side effects still less.Multichip carrier and multiple medicines thing monomer etc. are united use, have broken through the traditional monarch compatibility theory of the traditional Chinese medical science, for the modern Chinese medicine development provides a practical effective novel form compatibility program.To have substantial technological innovation to break through.
Purpose of the present invention, advantage and disadvantage will make an explanation by the non-limitative illustration of following preferred embodiment.These embodiment only are the prominent examples of using technical solution of the present invention, and all technical schemes of taking to be equal to replacement or equivalent transformation and forming all drop within the scope of protection of present invention.
The specific embodiment
A kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology and production method thereof, its special feature is: the raw material composition of making effective ingredient is by weight ratio---
9 parts of the Radixs Astragali, 9 parts of Radix Paeoniaes, 9 parts of Ramulus Cinnamomi, 18 parts in Rhizoma Zingiberis Recens, 4 parts in Fructus Jujubae.
Further, play the synergy of standing like the legs of a tripod on the integrated new drug formulation compatibility of Huangqi Guizhi Wuwu Tang of the present invention: 1, prepare nanometer, micro-powder with the prepared slices of Chinese crude drugs, the bioavailability after strengthening the Huangqi Guizhi Wuwu Tang curative effect and significantly improve prepared slices of Chinese crude drugs cell wall breaking with this; 2, with Chinese medicine extract and select suitable pharmaceutical carrier, prepare different Chemistry for Chinese Traditional Medicine monomers, effective ingredient, effective site etc., confirm and strengthen pharmacology, the efficacy of the chemical substance of Huangqi Guizhi Wuwu Tang with this; 3, prepare Chinese medical concrete, water drug-decocting concentrating liquid with the prepared slices of Chinese crude drugs, the temporary transient unpredictable drug effect of bringing with this reaction such as complexation, hydrolysis, oxidation, reduction of strengthening Huangqi Guizhi Wuwu Tang Chinese medicine compound uniqueness also keeps and has strengthened traditional Chinese medical science organic conception, monarch concept.Above three aspects: associating compatibility uses, different according to Nano medication particle diameter and character, can reach many targeting, many collaborative, slow controlled release texts, and play useful effect to strengthening the medicine pharmacologically active, effective ingredient pharmacological action effect is significantly higher than conventional formulation.
Production method of the present invention may further comprise the steps:
At first, get each prepared slices of Chinese crude drugs pretreatment, insert pulverizer after the weighing and be crushed to the 80-200 order, then adopt supersonic jet mill to the 1-10 micron, get different Chinese medicine micropowder, for subsequent use.Get 30%--90% alcohol-water solution that 60% the Radix Astragali, Radix Paeoniae, Ramulus Cinnamomi micropowder doubly measure with 6-12 and mix and soaked 1-2 days, reflux, extract, 3 times is extracted water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility, and recovered alcohol gets extract for subsequent use.Get 60% Rhizoma Zingiberis Recens, Fructus Jujubae micropowder, adopt the ultrasound wave dispersion extractor to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz--120KHz, extraction time are 10-100 minute, get extract for subsequent use.With above-mentioned gained Chinese medicine extract, adopt nanon ball-mill to grind 4-16 hour, get the nano powder that particle size distribution is 50 nanometers-1000 nanometer, for subsequent use.Get each Chinese medicine micropowder of 40% and mix, boiled 3 times with the traditional Chinese medicine extracting machine decocting after being soaked in water two hours, decocting liquid merges and filters, and filtrate concentrates, and gets extractum or water drug-decocting concentrating liquid with for subsequent use.With above-mentioned gained Chinese medicine extract, nano powder as required with and the different property of medicine, pharmacological actions, can adopt respectively the technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared, obtain the medicine materials such as different medicine monomers, effective site, active materials.Adopt different excipient substances and carrier by version in 2010 " related preparations part of standards standard and " the even method of high pressure breast is adopted respectively in the requirement in 2005 version Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " etc. in the Chinese pharmacopoeia above-mentioned gained medicine material, inclusion technique, solid state technology, polishing, solvent-fusion method, squeezing and pressing method, complex coacervation, emulsion-crosslinking method, the polymerization dispersion method, fusion method, the technology such as freeze-drying are prepared into nanoparticle, nanoparticle, the micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanosuspension, the crude drug such as microcapsule.The crude drug particle size distribution of preparing is between 10 nanometers-10 micron." preparation part of standards code requirement in the Chinese pharmacopoeia was got in the crude drug such as above-mentioned gained Chinese medical concrete or water drug-decocting concentrating liquid and above-mentioned gained nanoparticle, liposome, nano-emulsion, microcapsule one or more and is mixed by formula proportion by version in 2010.In GMP10000 level toilet, with the above-mentioned crude drug that mixes adopt full-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can make by the related preparations standard criterion the above-mentioned end product of other type.The end product of making is carried out respectively several, bottling, mounted box, sealing, stickup labeling, plays the exterior and interior packings such as code, vanning.Packaged product is transported to the appointed place by production batch and unifies instantaneously sterilising, and opens the sterilization report.
" embodiment one "
Press the following crude drug of preceding method preparation: extractum, nanoparticle, microcapsule, nanoparticle.
Its raw material of making effective ingredient forms---
9 parts of the Radixs Astragali, 9 parts of Radix Paeoniaes, 9 parts of Ramulus Cinnamomi, 18 parts in Rhizoma Zingiberis Recens, 4 parts in Fructus Jujubae.
Its manufacture process is as follows: in GMP10000 level toilet with extractum, nanoparticle, microcapsule, nanoparticle in 4: 2: 2: after 2 ratios are mixed, adopt a version " preparation part of Chinese pharmacopoeia hard capsule standard in 2010, do not add adjuvant, antiseptic, adopt full-automatic capsule filling machine fill hard capsule, make hard capsule.Carry out again several, bottle, seal, paste labeling, play the exterior and interior packings such as code, vanning.Unify instantaneously sterilising by production batch at last, and open the sterilization report.
" embodiment two "
Press the following crude drug of preceding method preparation: water drug-decocting concentrating liquid, nanometer liposome, nano-emulsion, microemulsion.
Its raw material of making effective ingredient forms---
9 parts of the Radixs Astragali, 9 parts of Radix Paeoniaes, 9 parts of Ramulus Cinnamomi, 18 parts in Rhizoma Zingiberis Recens, 4 parts in Fructus Jujubae.
Its manufacture process is as follows: in GMP10000 level toilet with water drug-decocting concentrating liquid, nanometer liposome, nano-emulsion, microemulsion in 4: 2: 2: after 2 ratios are mixed, adopt a version " preparation part of Chinese pharmacopoeia soft capsule standard in 2010, do not add adjuvant, antiseptic, adopt full-automatic soft capsule filling machine packing soft capsule, make soft capsule.Carry out again several, bottle, seal, paste labeling, play the exterior and interior packings such as code, vanning.Unify instantaneously sterilising by production batch at last, and open the sterilization report.
" embodiment three "
Press the following crude drug of preceding method preparation: extractum, nanoparticle, nano-emulsion.
Its raw material of making effective ingredient forms---
9 parts of the Radixs Astragali, 9 parts of Radix Paeoniaes, 9 parts of Ramulus Cinnamomi, 18 parts in Rhizoma Zingiberis Recens, 4 parts in Fructus Jujubae.
Its manufacture process is as follows: after in the GMP10000 level toilet extractum, nanoparticle, nano-emulsion being mixed in 4: 3: 3 ratios, " a preparation part of Chinese pharmacopoeia membrane standard, filmogen adopts polyvinyl alcohol, makes membrane to adopt version in 2010.Carry out again mounted box, sealing, stickup labeling, play the exterior and interior packings such as code, vanning.Unify instantaneously sterilising by production batch at last, and open the sterilization report.Every membrane area size is the 2-40 square centimeter, and every medicine film pasted 12-72 hour, pasted the medicine position: the positions such as neck, chest, back part, abdominal part, shank, foot bottom, Ashi point.
Can find out by above-mentioned text description: the tangible novelty of tool of the present invention and breakthrough are to have found out the key point that Huangqi Guizhi Wuwu Tang 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 be harmonious, negative and positive intercommunication, coordinating water and fire, precise and tiny circle melt, and greatness lies in the capacity " is that the precise and tiny circle of the integrated novel form of this medicine melts Integration Theory basis and guiding theory.Among the present invention: monomer, effective site, nanoparticle and carrier etc. be strange, be tiny, be cloudy.Traditional Chinese medical science organic conception, Chinese medical concrete, water drug-decocting concentrating liquid etc. be just, be grand, be the sun.Very just be harmonious then negative and positive intercommunication, the negative and positive intercommunication is then coordinating water and fire, is the optimum balance attitude.Doctor trained in Western medicine research is precise and tiny, and theory of Chinese medical science is that circle melts, and both very just are harmonious, and have just really embodied the organic conception of the combination of Chinese and Western medicine, and " close " is that " integration " is for holding.The tidemark that greatness lies in the capacity, the coordinating water and fire the present invention of being only asked most.This integrated novel form is by the reasonable compatibility of Chinese medicine monomer, effective site, active substance, Chinese medicine active materials, extractum, water drug-decocting concentrating liquid, prepared slices of Chinese crude drugs nano-particle etc., can produce soft, hard capsule or the dosage forms such as nanometer membrane, transdermal agent.Can develop simultaneously, can take four time periods respectively by midnight-noon and ebb-flow doctrine, energy and blood of human body flowing law by interior external administration.Can also do film former to nano traditional Chinese medicine, transdermal agent is attached to the human body different parts, can directly absorb by skin.
Further see, the various Chinese medicine particle diameter major parts that the present invention prepares are the granule of 50～1000 nanometers.Adopt different nano-medicament carriers and technology can be prepared into nanoparticle, nanosphere, solid ester plastid, nano-emulsion, pharmacosomes, microgranule, nanoparticles, little assist etc.Its particle size distribution is in 10 nanometers---between-10 microns.Then theoretical according to difference, the difference of slow controlled release time and the traditional Chinese medical science monarch of medicine pharmacology, targeting, reasonable compatibility mixes, and can be respectively charged among hard capsule and the soft capsule.Difference according to the dissolving of capsule material, disintegrate, jitter time can be prepared into respectively the targeted systems such as RE targeted system, stomach mucosa absorption system, intestinal absorption system, colon absorption system.Compare Chinese medicine and medicine monomer or Western medicine, the overall coordination therapeutical effect of this integrated novel form and target-oriented drug, slow controlled capability are stronger, and curative effect is more outstanding, and toxic and side effects still less.For Huangqi Guizhi Wuwu Tang modern Chinese medicine preparation and production have proposed a practical effective novel form compatibility program.To have substantial innovation and technological break-through.
Classics side resemble the Huangqi Guizhi Wuwu Tang is the imbody of the theoretical marrow of differentiation of tcm, and the party has a wide range of applications in the different field of tcm clinical practice, goes through bimillennium and does not wane.Therefore, its full side is carried out further developmental research important in inhibiting.This just need us Emancipate the mind and seek truth from facts from Chinese medical theory, strengthen the research and development dynamics of traditional Chinese medical science ancient prescription, make these ancient prescriptions obtain more adequately and reasonably using.
Claims (10)
1. a Huangqi Guizhi Wuwu Tang dosage form preparation technology and production method thereof is characterized in that: the raw material of this novel form effective ingredient and weight proportion---
9 parts of the Radixs Astragali, 9 parts of Radix Paeoniaes, 9 parts of Ramulus Cinnamomi, 18 parts in Rhizoma Zingiberis Recens, 4 parts in Fructus Jujubae.
Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.
2. a kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology according to claim 1 and production method thereof, it is characterized in that: medicine and carrier are prepared into the pharmaceutical carrier crude drug, crude drug can be one or more combinations in nanoparticle, nanoparticle, micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanosuspension, the microcapsule etc., and can as required one or more be mixed.The described protection domain of this claim is not only the said medicine support material medicine in the described scope, is also included within to prepare on its basis or add the curative effect that other do not affect its disease of controlling, and just makes the pharmaceutical carrier crude drug of its better efficacy.
3. according to claim 1,2 described a kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology and production methods thereof, it is characterized in that: the drug carrier material that this novel form is selected, activating agent, help Emulsion, the excipient substances such as dispersant are gelatin, albumin, starch and derivant thereof, alginate, beta-schardinger dextrin-, protein, chitosan and derivant thereof, lactose, hydroxypropyl emthylcellulose, ethyl cellulose, cellulose acetate phthalate, the metering system acetate, polylactic acid, cyanoacrylate, the semisolid poe, triglyceride is (such as three stearic acid, three Palmic acids, three lauric acids, in three oleic acid etc., the glyceride of long-chain fatty acid), glyceride (such as glyceryl monostearate, contains list, two, the synthetic glyceride of triglyceride), cholesterol, Polyethylene Glycol, microcrystalline wax, the whale ester type waxes, erythrocyte, Montmorillonitum, in the tea powder etc. one or more.The described protection domain of this claim is not only the said medicine adjuvant in the described scope, and other do not affect its disease of controlling to be also included within the upper interpolation in its basis, and just make the excipient substance of its better efficacy.
4. according to claim 1 and 2 or the described a kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology of 3 any one and production method thereof, it is characterized in that: said integrated novel form adopts medicament nano powder body, micro-powder, medicine monomer, effective ingredient, effective site, active materials, Chinese medical concrete, water drug-decocting concentrating liquid to unite use with different excipient substance, pharmaceutical carrier according to indexs such as the pharmacology of traditional Chinese medical science global theory, compatibility theory and medicine, drug effect, medicine generation, toxicitys.And can mix its one or more according to the preparation needs.
5. according to claim 1 and 2 or the described a kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology of 3 or 4 any one and production method thereof, it is characterized in that: the integrated novel form end product that finally can form is: tablet, powder, suppository, stick, granule, soft capsule, hard capsule, effervescent, drop pill, aerosol, unguentum, oral solution, slow releasing tablet, controlled release tablet.
6. a Huangqi Guizhi Wuwu Tang dosage form preparation technology and production method thereof is characterized in that may further comprise the steps:
Step 1: get each prepared slices of Chinese crude drugs pretreatment, insert pulverizer after the weighing and be crushed to the 80-200 order, then adopt supersonic jet mill to the 1-10 micron, get different Chinese medicine micropowder, for subsequent use.
Step 2: get 30%--90% alcohol-water solution that 60% the Radix Astragali, Radix Paeoniae, Ramulus Cinnamomi micropowder doubly measure with 6-12 and mix and soaked 1-2 days, reflux, extract, 3 times, extract water solublity, pure dissolubility, three kinds of active drug compositions of ester dissolubility, recovered alcohol gets extract for subsequent use.
Step 3: get 60% Rhizoma Zingiberis Recens, Fructus Jujubae micropowder, adopt the ultrasound wave dispersion extractor to disperse respectively to extract, ultrasonic power is: 800W-3000W, supersonic frequency: 28KHz--120KHz, extraction time are 10-100 minute, get extract for subsequent use.
Step 4: with step 2, step 3 gained Chinese medicine extract, adopt nanon ball-mill to grind 4-16 hour, get the nano powder that particle size distribution is the 50-1000 nanometer, for subsequent use.
Step 5: get each Chinese medicine micropowder of 40%, boiled 3 times with the traditional Chinese medicine extracting machine decocting after being soaked in water two hours, decocting liquid merges and filters, and filtrate is concentrated, gets extractum or water drug-decocting concentrating liquid with for subsequent use.
Step 6: with step 2, step 3, step 4 gained Chinese medicine extract, nano powder as required with and the different property of medicine, pharmacological actions, can adopt respectively the technology such as leafing, macroporous absorption, gel molecular screening, mould separation, ultracentrifugation to be prepared, obtain the medicine materials such as different medicine monomers, effective site, active materials.
Step 7: adopt different excipient substances and carrier by version in 2010 " related preparations part of standards standard and " the even method of high pressure breast is adopted respectively in the requirement in 2005 version Chinese pharmacopoeia appendix XIXE " microcapsule; microsphere; with the Liposomal formulation guideline " etc. in the Chinese pharmacopoeia above-mentioned gained medicine material, inclusion technique, solid state technology, polishing, solvent-fusion method, squeezing and pressing method, complex coacervation, emulsion-crosslinking method, the polymerization dispersion method, fusion method, the technology such as freeze-drying are prepared into nanoparticle, nanoparticle, the micron liposome, nanometer liposome, solid lipid nanoparticle, nanometer polymer micelle, pharmacosomes, nano-emulsion, lipid microsphere, microcapsule, microemulsion, lipid liquid, nanometer film, nanosuspension, the crude drug such as microcapsule.The crude drug particle diameter is between 10 nanometers-10 micron.
Step 8: " preparation part of standards code requirement in the Chinese pharmacopoeia was got in the crude drug such as step 5 gained Chinese medical concrete or water drug-decocting concentrating liquid and step 7 gained nanoparticle, liposome, nano-emulsion, microcapsule one or more and is mixed by formula proportion by version in 2010.
Step 9: in GMP10000 level toilet, with the above-mentioned crude drug that mixes adopt full-automatic capsule filling machine respectively fill become hard capsule and soft capsule.Also can by version in 2010 " Chinese pharmacopoeia related preparations standard criterion is made the above-mentioned end product of other type.
Step 10: the end product of making is carried out respectively several, bottling, mounted box, sealing, stickup labeling, plays the exterior and interior packings such as code, vanning.Packaged product is transported to the appointed place by production batch and unifies instantaneously sterilising, and opens the sterilization report.
7. a kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology according to claim 6 and production method thereof; it is characterized in that: the pulverizing of using in described step 1, step 2, the step 3 and extracting method; the described protection domain of this claim is not only described technology of preparing and method; as required, be also included within and add on its basis or use other better effects if, more economical, renewal, breaking method more advanced, more environmental protection, extracting method and technology.
8. a kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology according to claim 7 and production method thereof; it is characterized in that: the medicine monomer in the described step 6; active substance; the dissimilar nanoparticle that adopts the different pharmaceutical adjuvant to be prepared in effective site technology of preparing and the described step 7; the crude drug such as nano-emulsion; the described protection domain of this claim is not only described technology of preparing and method; as required, be also included within and add on its basis or use other better effects if; more economical; upgrade; more advanced; the more preparation method of environmental protection and technology.
9. a kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology according to claim 8 and production method thereof, it is characterized in that: its key point 1 is different utilization nano-carrier multiple techniques different according to the particle diameter of crude drug and the property of medicine, can produce the gentle controlled capability of different targetings.
10. a kind of Huangqi Guizhi Wuwu Tang dosage form preparation technology according to claim 9 and production method thereof, it is characterized in that: its key point 2 is to develop simultaneously by interior external administration, can take four time periods respectively by midnight-noon and ebb-flow doctrine, energy and blood of human body flowing law.Also can be prepared into membrane, transdermal agent is attached to respectively different parts by the energy and blood of human body flowing law, directly absorb by skin.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011102146165A CN102895630A (en) | 2011-07-29 | 2011-07-29 | Preparation technology and production method for integrated new formulation of astragalus and cinnamon twig five agents decoction |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011102146165A CN102895630A (en) | 2011-07-29 | 2011-07-29 | Preparation technology and production method for integrated new formulation of astragalus and cinnamon twig five agents decoction |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102895630A true CN102895630A (en) | 2013-01-30 |
Family
ID=47568315
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2011102146165A Pending CN102895630A (en) | 2011-07-29 | 2011-07-29 | Preparation technology and production method for integrated new formulation of astragalus and cinnamon twig five agents decoction |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102895630A (en) |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104258362A (en) * | 2014-10-20 | 2015-01-07 | 薛伟 | Traditional Chinese medicine preparation for treating peripheral neuritis |
| CN108686175A (en) * | 2018-06-21 | 2018-10-23 | 浙江美丽禾生物科技有限公司 | A kind of Chinese medicine preparation and preparation method for treating postpartum joint pain |
| CN109331067A (en) * | 2018-11-13 | 2019-02-15 | 杭州仁德医药有限公司 | The herbal mixture emplastrum for treating osteoarthritis |
| CN109364228A (en) * | 2018-12-03 | 2019-02-22 | 湖南新汇制药股份有限公司 | A kind of Huangqi Guizhi Wuwu Tang, preparation method and applications |
| CN115025154A (en) * | 2022-07-11 | 2022-09-09 | 程水泉 | A Chinese medicinal composition and its preparation method |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102100661A (en) * | 2009-12-17 | 2011-06-22 | 苏州知微堂生物科技有限公司 | Process for preparing novel formulation of integrative traditional Chinese medicine and production method thereof |
-
2011
- 2011-07-29 CN CN2011102146165A patent/CN102895630A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102100661A (en) * | 2009-12-17 | 2011-06-22 | 苏州知微堂生物科技有限公司 | Process for preparing novel formulation of integrative traditional Chinese medicine and production method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 范永升: "《金匮要略》", 31 January 2003 * |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104258362A (en) * | 2014-10-20 | 2015-01-07 | 薛伟 | Traditional Chinese medicine preparation for treating peripheral neuritis |
| CN108686175A (en) * | 2018-06-21 | 2018-10-23 | 浙江美丽禾生物科技有限公司 | A kind of Chinese medicine preparation and preparation method for treating postpartum joint pain |
| CN109331067A (en) * | 2018-11-13 | 2019-02-15 | 杭州仁德医药有限公司 | The herbal mixture emplastrum for treating osteoarthritis |
| CN109364228A (en) * | 2018-12-03 | 2019-02-22 | 湖南新汇制药股份有限公司 | A kind of Huangqi Guizhi Wuwu Tang, preparation method and applications |
| CN115025154A (en) * | 2022-07-11 | 2022-09-09 | 程水泉 | A Chinese medicinal composition and its preparation method |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN102846934A (en) | Preparation technology and production method for an integrated new formulation of warming channel decoction | |
| CN102895630A (en) | Preparation technology and production method for integrated new formulation of astragalus and cinnamon twig five agents decoction | |
| CN102283895A (en) | Preparation technology and production method of integrated novel Lingguizhugan decoction dosage form | |
| CN102847087A (en) | Preparation process of integration-type novel formulation of Cinnamomum cassia, Paeonia lactiflora and Anemarrhena asphodeloides decoction and production method thereof | |
| CN102895409A (en) | Preparation technology and production method for integrated new formulation of wu zi yan zong pill | |
| CN102895538A (en) | Preparation technology and production method for integrated new formulation of white tiger and genseng decoction | |
| CN102846790A (en) | Preparation process of integration-type novel formulation of DACHENGQI decoction and a production method thereof | |
| CN102895632A (en) | Preparation technology and production method for integrated new formulation of life-prolonging decotion | |
| CN102847090A (en) | Preparation process of integration-type novel formulation of Flos Inulae and hematite decoction and production method thereof | |
| CN102846767A (en) | Preparation process of integration-type novel formulation of MAXINGGANSHI decoction and production method thereof | |
| CN102100763A (en) | Preparation technology of new integrative formulation of counterflow decoction and production method thereof | |
| CN102895629A (en) | Preparation technology and production method for integrated new formulation of cassia twig and oyster decoction | |
| CN102895635A (en) | Preparation technology and production method for integrated new formulation of astragalus center-fortifying decoction | |
| CN102895631A (en) | Preparation technology and production method for integrated new formulation of maidservant from Yue plus white atractylodes decoction | |
| CN102895627A (en) | Preparation technology and production method for integrated new formulation of radix bupleuri, cassia twig and dry ginger decoction | |
| CN102895621A (en) | Preparation technology and production method for integrated new formulation of turtle shell decocted pill | |
| CN102895334A (en) | Preparation technology and production method for integrated new formulation of licorice and monkshood decoction | |
| CN102895628A (en) | Preparation technology and production method for integrated new formulation of licorice and dried ginger decoction | |
| CN102895625A (en) | Preparation technology and production method for integrated new formulation of cassia twig-monkshood decoction | |
| CN102847085A (en) | Preparation process and production method for Magnolia Officinalis Seven-Ingredient Decoction preparation in an integrated new dosage form | |
| CN102895335A (en) | Preparation technology and production method for integrated new formulation of radix aconiti lateralis preparata powder | |
| CN102846853A (en) | Preparation technique and production method for SHIZAO decoction in novel integrative dosage form | |
| CN102847092A (en) | Preparation process of integration-type novel formulation of Evodia rutaecarpa decoction and production method thereof | |
| CN102895614A (en) | Preparation technology and production method for integrated new formulation of cinnamon twig plus genseng decoction | |
| CN102847094A (en) | Preparation process of integration-type novel formulation of Cinnamomum cassia and Paeonia lactiflora decoction and production method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| DD01 | Delivery of document by public notice |
Addressee: Suzhou Zhiweitang Biotechnology Co.,Ltd. Document name: Notification that Application Deemed to be Withdrawn |
|
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20130130 |