CN102895457A - Preparation technology and production method for integrated new formulation of golden chamber kidney qi pill - Google Patents

Abstract

The present invention relates to a preparation technology and a production method for an integrated new formulation of a golden chamber kidney qi pill, wherein the raw materials of active ingredients comprise 24 parts by weight of prepared rehmannia root, 12 parts by weight of dried Chinese yam, 12 parts by weight of dogwood fruit, 9 parts by weight of alismatis rhizome, 9 parts by weight of poria, 9 parts by weight of moutan bark, 3 parts by weight of monkshood, and 3 parts by weight of cinnamon twig. The production process of the integrated new formulation of the integrated new formulation of golden chamber kidney qi pill 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 golden chamber kidney qi pill 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 golden chamber kidney qi pill 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 golden chamber kidney qi pill 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

A kind of JINGUI SHENQI WAN dosage form preparation technology and production method thereof

Technical field

The present invention relates to a kind of JINGUI SHENQI WAN dosage form preparation technology, the invention still further relates to a kind of JINGUI SHENQI WAN 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 constituent, 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 JINGUI SHENQI WAN prescription derives from " Medical Treasures of the Golden Chamber ".Have another name called Cui Shi eight flavor balls, GUIFU DIHUANG WAN, BAWEI SHENQQI WAN, JISHENG SHENQI WAN.The party's ingredients be each three liang of Ramulus Cinnamomi Radix Aconiti Lateralis Preparata (big gun) of each four liang of Rhizoma Alismatis Poria Cortex Moutan of eight liang of Fructus Corni Rhizoma Dioscoreaes of Radix Rehmanniae each one or two.Upper eight flavors, the end, refined honey and ball, Firmiana simplex seed is large, 15 balls under the wine, taking medicine twice a day.Modern with reference to consumption and usage: Radix Rehmanniae Preparata 24g, dried Rhizoma Dioscoreae 12g, Fructus Corni 12g, Rhizoma Alismatis 9g obtains Siberian cocklebur 9g, Cortex Moutan 9g Radix Aconiti Lateralis Preparata, each 3g of Ramulus Cinnamomi.Grind to the powder altogether, making pellets by mixing medical powder with honey, each 9g, every day 2～3 times, warm water or dilute salt water take.Also can be decocted in water for oral dose, consumption cuts down according to the circumstance in former side's ratio.Function: kidney tonifying gas, mend the gate of vitality.Cure mainly: the soreness of the waist and knees of insufficiency of kidney-YANG, extremity cold of the limbs, cramp and pain in the lower abdomen cold type of pain, dysuria or nocturia are long clearly, the diseases such as dyspnea with rapid and short breath is breathed hard, umbilicus lower abdominal pain.Modern times are usually used in the person that has the insufficiency of kidney-YANG such as chronic nephritis, diabetes, lumbar muscle strain and sexual neurasthenie.

The ancient prescription JINGUI SHENQI WAN is the holy Zhang Zhongjing of doctor (Eastern Han Dynasty) initiative, be stated from " Medical Treasures of the Golden Chamber ", two names are arranged, i.e. " Cui Shi eight flavor balls " in this book " apoplexy severe and migratory arthralgia abnormal pulse card also controls the 5th " piece of writing and " shenqi pill " in " the miscellaneous internal diseases in woman arteries and veins card also controls the 22 " piece of writing in this book.Prescription is comprised of Radix Rehmanniae, Fructus Corni, Rhizoma Dioscoreae, Rhizoma Alismatis, Poria, Cortex Moutan, Ramulus Cinnamomi, Radix Aconiti Lateralis Preparata (big gun) eight flavor medicines, is used for the treatment of " entering lower abdominal numbness on the beriberi " and women's " anuria during pregnancy ".The people such as Song dynasty Chen Shiwen give imperial decree write " formulary of peaceful benevolent dispensary " (become book in 1110) the party is improved, change Ramulus Cinnamomi into Cortex Cinnamomi, Radix Rehmanniae changes Radix Rehmanniae Preparata into, and strengthen the consumption of Cortex Cinnamomi and Radix Aconiti Lateralis Preparata, make this medicine drug effect that the raising of matter arranged, it is weary more to be mainly used in deficiency of kidney-QI, is named " eight flavor balls ", records in this book " five of volume is controlled all void (attached hectic fever due to YIN-deficiency) ".Because the party comes from " Medical Treasures of the Golden Chamber " the earliest, and compares with LIUWEI DIHUANG WAN, many Cortex Cinnamomi, Radix Aconiti Lateralis Preparata two flavor medicines are called JINGUI SHENQI WAN, GUIFU DIHUANG WAN, Rehmanniae Bolus of Eight Ingredients so practise again later age.And Southern Song Dynasty doctor my father with and (go reed " JINGUI SHENQI WAN " basis adding Radix Cyathulae, steeping in wine), Semen Plantaginis (wine steaming), and Rhizoma Dioscoreae fried usefulness, addition or subtraction of changes is made " Jiawei Shenqi Wan ", and record in its " Yan's prescriptions for succouring sick " (, be called for short recipes for Saving Lives, become book in 1253) in, later age, habit was referred to as JISHENG SHENQI WAN, controlled the heavy sensation in the waist of suffering from a deficiency of the kidney, swelling of the feet, dysuria.JISHENG SHENQI WAN is the development to JINGUI SHENQI WAN.This prescription medication is steadily practical, enjoys funeral affairs doctor family to praise highly, and JINGUI SHENQI WAN of today is that its development forms.

The present side's GUIFU DIHUANG WAN quality standard records in " one one of Chinese Pharmacopoeia 2005 version, prescription form with the Song dynasty JINGUI SHENQI WAN side basic identical, is formed thought Cortex Cinnamomi, Radix Aconiti Lateralis Preparata consumption reduce by half (close with Zhong Jing shenqi pill side) by Cortex Cinnamomi, Radix Aconiti Lateralis Preparata, Radix Rehmanniae Preparata, Fructus Corni (system), Cortex Moutan, Rhizoma Dioscoreae, Poria, Rhizoma Alismatis eight flavor medicines.Warming and recuperating the kidney-YANG is used for insufficiency of kidney-YANG.Cortex Cinnamomi, Radix Aconiti Lateralis Preparata two flavor medicines consumption in the side is less, is intended to mend fire from the gater of life, namely gives birth to kidney qi.The present side's JINGUI SHENQI WAN quality standard records in " Drug Standard of Ministry of Public Health of the Peoples Republic of China Traditional Chinese medicine historical preparation " the 20, mainly formed by Radix Rehmanniae, Rhizoma Dioscoreae, Fructus Corni (wine is processed), Poria, Cortex Moutan, Rhizoma Alismatis, Ramulus Cinnamomi, Radix Aconiti Lateralis Preparata (processing), Radix Achyranthis Bidentatae (decaptitating), Semen Plantaginis (salt is processed) ten flavor medicines, warming and recuperating the kidney-YANG, promote the circulation of qi and water, be used for edema due to deficiency of the kidney, soreness of the waist and knees, dysuria etc.Ancient prescription " JINGUI SHENQI WAN " the prescription composition that forms with eight flavor medicines differs widely, approaches with ancient prescription " JISHENG SHENQI WAN ".

Side's opinion:

We respectively take a morsel take Radix Aconiti Lateralis Preparata, Ramulus Cinnamomi as principal agent, get the meaning of " junior fire supporting vital QI ", are intended to slightly mend fire with yang-energy in the kidney of inspiring virtual loss, mend fire from the gater of life, let the fire back to its origin; Be aided with again the six medicaments nourishing kidney yins such as Radix Rehmanniae, short living cloudy liquid; So composition of prescription is the principle in line with interdependence between yin and yang, tonifying both YIN and YANG, so that " positive cloudy helping, and biochemical infinite ", the YANG invigorating effect is more firm, more lasting.Be further treatment insufficiency of kidney-YANG edema, this medicine also compatibility Radix Achyranthis Bidentatae, Semen Plantaginis with clearing away heat and promoting diuresis, eliminating dampness by diuresis is treating stranguria, conducting blood to flow downwards, the insufficiency of kidney-YANG edema symptoms such as treatment edema overflow, dysuria, soreness of the waist and knees.Ten kinds of precise and appropriate compatibilities of medicine make it have temperature compensating below element, strong kidney Yiyang, and activating QI to promote diuresis, detumescence is quenched the thirst, the effect of let the fire back to its origin.

Reuse the Radix Rehmanniae enriching yin and nourishing kidney in the JINGUI SHENQI WAN side.Fructus Corni, Rhizoma Dioscoreae tonifying liver spleen and benefiting essence-blood; Radix Aconiti Lateralis Preparata, Ramulus Cinnamomi are hot, help the gate of vitality with the warming YANG activating QI.Rhizoma Alismatis, Poria promoting diuresis to eliminate damp pathogen are let out turbid, and Cortex Moutan is let out clearly liver-fire.It is YANG invigorating and nourishing YIN compatibility that we's compatibility characteristics have two: one, tonifying both YIN and YANG, and take YANG invigorating as main; Two for allocating a small amount of osmanthus among the YIN nourishing, being accompanied by warming YANG, and purpose is treating YANG within YIN, junior fire supporting vital QI.We's method for the treatment of has embodied the reason of Wang Bing " nourishing renal yang to restrict excessive yin is with the be shaded or hidden for foliage that disappears ".

In " Medical Treasures of the Golden Chamber " book, have five places and use shenqi pill, consumptive disease with lumbago, quench one's thirst, phlegm retention, beriberi, the anuria during pregnancy.Lumbago due to all deficiency of kidney-QI, cold extremities, edema, dysuria or frequently, quench one's thirst, cough with asthma, cardiopalmus, the disease such as dizzy, all can select with disease.Therefore JINGUI SHENQI WAN mainly is that it is best to take effect in insufficiency of kidney-YANG.Insufficiency of kidney-YANG card, the lumbago foot is soft, and body often has creeping chill below half, cramp and pain in the lower abdomen, dysuria, or urine is anti-many, becoming severe at night, impotence and premature ejaculation, light red tongue and fat, deficient and weak pulse, chi section is heavy thin, and phlegm retention, and edema is quenched one's thirst, beriberi, the anuria during pregnancy etc.Waist is house of kidney, and the kidney being the origin of congenital constitution.Insufficiency of kidney-YANG can not the replenishing vital QI with drugs of warm nature part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels, so the lumbago foot is soft, body often has creeping chill below half; Can not activating QI to promote diuresis, water retention is in interior, so dysuria, cramp and pain in the lower abdomen does not relax.Suffer from a deficiency of the kidney and can not evaporate, retrain water liquid, then urine is anti-many, etc.According to the legislation principles of " deficiency syndrome should be treated by tonifying method ", " junior fire supporting vital QI ", work as reinforcing the kidney and supporting YANG.Adhere to taking then and one receive surely ideal effect.

Radix Rehmanniae Preparata energy Zishen fill fine in the JINGUI SHENQI WAN, Fructus Corni yin nourishing arresting seminal emission, Rhizoma Dioscoreae spleen reinforcing controlling nocturnal emission with astringent drugs.More than three medicines cooperate can nourishing kidney-yin, nourishing the liver blood, strengthening the spleen the moon and arresting seminal emission, Rhizoma Alismatis can let out clearly the kidney fire, and the greasy effect of the taste that can prevent Radix Rehmanniae Preparata, Cortex Moutan energy clearing away liver-fire, and can prevent the warm-dryness syndrome of Fructus Corni, the light spleen that oozes of Poria wets, and can help the effect of Rhizoma Dioscoreae spleen invigorating, mainly plays following several respects effect:

1, JINGUI SHENQI WAN can improve SOD, is improved hypophysis--the adrenal cortex function effect.Delaying sanility, regain one's vigor.2, improve lipid metabolism, enhancing nerve--the effects such as body fluid conciliation, anti-cataract.3, blood sugar lowering improves macrophage phagocytic function, atherosclerosis is improved producing good efficacy.

Clinical practice:

JINGUI SHENQI WAN is usually used in treating the disease due to the insufficiency of kidney-YANG clinically,, cough cold such as the acid of waist knee joint, sexual impotence, premature ejaculation, chronic nephritis, diabetes aldosteronism, renal edema, the lumbago lower limb that hypocorticoidism disease, hypothyroidism, chronic bronchial asthma, climacteric syndrome etc. show is soft, health is afraid of cold, the disease such as lower abdomen contracture, clear urine in large amounts, light red tongue are fat, thready pulse without strength.Clinical Practice with studies confirm that the JINGUI SHENQI WAN effect also has defying age, enhancing immunity, improves the fat and sugar metabolism, the auxiliary treatment of dystrophic edema, diabetes, chronic bronchitis, oral ulcer, neurasthenia, prolapse of lumbar intervertebral disc etc.JINGUI SHENQI WAN also has following effect except clinical main application: can treat chronic lambago and skelalgia: human pieces of Jin ' gui shenqi pill for curing chronic lambago and skelalgia is arranged, execute and control 61 examples, after medication 2～4 courses for the treatment of, cure 52 examples, 6 examples take effect, invalid 3 examples, total effective rate are 95.1%.The method that takes this medicine is: each oral 9 grams, take every day 2 times, and 2 weeks were a course for the treatment of.

Can treat prostatic hyperplasia: the traditional Chinese medical science thinks that prostatic hyperplasia belongs to the category of " difficulty in urination ".Due to lung, spleen, kidney three dirty disturbance in functioning of QI.Human pieces of Jin ' gui shenqi pill for curing prostatic hyperplasia is arranged, execute and control 35 examples, cure 27 examples, 3 examples that take effect, invalid 5 examples, total effective rate is 85.7%.The method that takes this medicine is: each serving 18 grams, and early, middle and late servicing once, 10 days is a course for the treatment of, general 1～3 of medication can make the state of an illness be eased or cure the course for the treatment of.

Can treat senile vaginitis: this disease is owing to after women's menopause, its hypo-ovaria, and estrogen level reduces, and the vaginal wall atrophy descends the resistance of vagina part, causes the caused colpitis of bacterial invasion.Someone adopts this disease of pieces of Jin ' gui shenqi pill for curing, executes and controls 45 examples, 3 examples that take a turn for the better, and invalid 2 examples, total effective rate is 95.6%.The method that takes this medicine is: each serving 18 grams, take every day 3 times, 7 days is a course for the treatment of, and general medication can make the state of an illness be eased after 3 courses for the treatment of or cure.

Can treat senile urinary incontinence: the senile urinary incontinence of human pieces of Jin ' gui shenqi pill for curing is arranged, execute and control 36 examples, after 3～5 courses for the treatment of of taking medicine, cure 28 examples, 7 examples that take effect, invalid 1 example, total effective rate is 97.2%.The method that takes this medicine is: each serving 18 grams, and early, middle and late servicing once, 7 days is a course for the treatment of, general medication can make the state of an illness be clearly better a course for the treatment of.

Can treat gynecomastia: human pieces of Jin ' gui shenqi pill for curing gynecomastia is arranged, execute and control 42 examples, after 2～4 courses for the treatment of of taking medicine, cure 35 examples, 4 examples that take effect, invalid 3 examples, total effective rate is 92.9%.The method that takes this medicine is: each serving 9 grams, take every day 3 times, 20 days is a course for the treatment of, and general medication can take effect a course for the treatment of.

Can treat infertility: human pieces of Jin ' gui shenqi pill for curing is arranged by the infertility that hyperprolactinemia causes, execute and control 27 examples, after 3 months, 12 example gestation are arranged through medication, all the other 15 routine patients' serum prolactin antagonist level also is down to normally.The method that takes this medicine is: each oral 9 grams take twice every day.

Can treat recurrent oral ulceration: human pieces of Jin ' gui shenqi pill for curing medical history is arranged more than half a year, and the kidney yang deficiency oral ulcer of repeatedly showing effect, execute and control 60 examples, after 5 days, all patients all obtain recovery from illness through medication.The method that takes this medicine is: whenever inferior to oral 18 grams half an hour ante cibum, take every day 3 times.

The Japan medical science research worker is found: this medicine of long-term taking, not only can improve old people's autoimmune ability, and also can improve the visual deterioration symptom that causes because of aging.General recommendations half a year is a course for the treatment of.

Modern pharmacological research:

The employing Y maze methods such as nervous system Cheng Jia skill, avoid bounce technique and observed respectively yang deficiency mice that JINGUI SHENQI WAN causes for hydrocortisone and the impact of 18 monthly ages above naturally-aged learning and memory in rats ability, find that JINGUI SHENQI WAN can obviously strengthen the learning and memory function of yang deficiency mice and old rats.Measured simultaneously the level of mitochondrion lipid peroxide in the experiment mice cerebral tissue, the result shows, JINGUI SHENQI WAN can significantly be resisted the mouse brain that hydrocortisone causes and organize mitochondrial lipid peroxidation thing the level rise.Wang Dongfang etc. are by detecting the brainstem auditory evoked potential (ABR) of Cavia porcellus, and the antagonism of JINGUI SHENQI WAN for the gentamicin cochlear toxicity infringement inquired in the change of outward appearance behavior, body temperature variation, oxygen consumption and the stress ability of observation animal etc.The result shows, JINGUI SHENQI WAN also has good effect for the reparation of integral animal functional status when obviously reducing ear poison Cavia porcellus brainstem auditory evoked potential.

Immune system Liu Xu instrument etc. has been observed the impact of JINGUI SHENQI WAN decocting liquid on female Swiss immune function of mice, finds originally can obviously strengthen the phagocytic function of Turnover of Mouse Peritoneal Macrophages.Experimental result shows, the Peritoneal macrophage function for the treatment of group mice, phagocytic index be all apparently higher than the normal water matched group, Different therapeutical effect significantly (P＜0.01) between group.

Hormonal system Zhou Chaofan etc. points out, the human or animal of insufficiency of kidney-YANG may show the dysfunction of hypo_pit_adr cortex, and after taking the pieces of Jin ' gui shenqi pill for curing, even the improvement that above-mentioned pathological changes often can obtain in various degree recovers normal fully.Illustrate that warming and recuperating the kidney-YANG class medicine when having cortisone sample positive interaction, avoided the side reaction of hormone medicine, and feedback that can the antagonism exogenous hormones suppresses, prevent adrenocortical atrophy.

Reproductive system Chen Qing equality is with 8% JINGUI SHENQI WAN aqueous solution 1ml/20g gastric infusion, every day 1 time, continuous 8 weeks, observed the impact of we on sex hormone level in the fertility Mice Body in latter stage, find that this can significantly improve testosterone, follicle stimulating hormone level in the Mice Body.Cheng Jiayi etc. have observed the impact of JINGUI SHENQI WAN for sex hormone level in the old rats body.The result shows that JINGUI SHENQI WAN can obviously improve the content of aged male rats Serum testosterone and old female rats serum estradiol, and can significantly increase aged male rats bilateral testes weight.Di Junying etc. [7] research finds that JINGUI SHENQI WAN can obviously improve the cAMP level in the impaired testis tissue of rat, explanation is regulated to play to adjust the hormone in vivo level and recover endocrine function by the content of second message,second messenger cAMP and is acted on normally, may be one of mechanism of action of JINGUI SHENQI WAN.

The pharmacological action of Jin Kui Shen Qi Oral Liquid for cardiovascular system that blood circulation Zhang Jianxin etc. have passed through animal experimental observation.Experimental result shows, Jin Kui Shen Qi Oral Liquid can obviously prolong the mice normal pressure anoxia enduring time-to-live, can significantly improve Acute Myocardial Ischemia in Rats due to the pituitrin, can obviously reduce the incidence rate of chloroform induced mice ventricular fibrillation, but the time that significant prolongation Aconitine Induced rat ventricular occurs, the aggregation capability that can obviously suppress rat platelet is for clinical practice the party prevention and cure of cardiovascular disease provides experimental basis.

The impact of pieces of Jin ' gui shenqi extract of bolus for the anti-sugared ability of rat inquired in the filial piety of substance metabolism carbohydate metabolism Shimadzu: make the oral load of glucose and vein stress test to rat under the condition without anesthesia, analyze simultaneously the dynamic change situation of glucose and insulin in the blood, so as to observing JINGUI SHENQI WAN for the impact of the anti-sugared ability of rat.Experimental result shows that JINGUI SHENQI WAN may produce blood sugar decreasing effect by acting on sympathetic nervous system.

The remaining U.S. beautiful grade of lipid metabolism has been observed the impact of JINGUI SHENQI WAN for Carnis Coturnicis japonicae bait hyperlipemia.Experimental result shows, the serum total cholesterol of JINGUI SHENQI WAN group (TCH) and triglyceride (TG) content all are lower than high fat group significantly, Serum High-Density Lipoprotein-Cholesterol (HDL-ch) and alpha-lipoprotein content are compared then with high fat group significantly to be increased, show that JINGUI SHENQI WAN can improve high lipid diet animal serum HDL-ch and alpha-lipoprotein content, have certain inhibitory action for the formation of animal hypercholesterolemia, hypertriglyceridemia.

The amino acid metabolism zoopery proves that GSH (reduced glutathion) and GSSG (oxidized form of glutathione) content significantly reduce in its crystalline lens of cataractous eye patient.Ocean, little once family report, take 24 months aged Wistar rats as laboratory animal, by every day 1g/kg dosage give oral JINGUI SHENQI WAN extract, continuous 12 months, the metabolism situation of rat body glutathion inside during 36 monthly age after the research administration.Find that GSH, GSSG content significantly rise in JINGUI SHENQI WAN group rat lens and the spermary, GSH content also obviously raises in the blood plasma, and the experimental basis that provides of the party's prevention oculopathy is provided.

The fragrant grade of antifatigue effect Jiang Zhu got 30 of Kunming mouses, the male and female dual-purpose, and random packet has been observed respectively the antifatigue effect of JINGUI SHENQI WAN and Jin Kui Shen Qi Oral Liquid.Behind the gastric infusion 30 minutes, do swimming test (anti-fatigue test), the result shows that JINGUI SHENQI WAN and Jin Kui Shen Qi Oral Liquid all can make the mouse survival rate improve more than 50%.

Anti-aging effects Liu Hong sun waits and has observed the anti-aging effects of JINGUI SHENQI WAN decocting liquid for all ages and classes white mice.Experimental result shows that this can alleviate the damage of radical pair hepatic tissue, thereby makes hepatic lipid peroxidation thing (LPO) content decrease; Simultaneously, the party also has the active effect of certain inhibition brain monoamine oxidase, MAO (MAO), thereby the explanation JINGUI SHENQI WAN may be a kind of good anatrophic.

The bright and beautiful grade of antimutagenic effect king is take the medullary cell of the purebred mice of ICR as experiment material, SCE (SCE) has been observed the impact of JINGUI SHENQI WAN for ICR bone marrow cells in mice SCE as the detection index due to inducing with the mutagenic agent cyclophosphamide (CPP) of generally acknowledging.Find that JINGUI SHENQI WAN has obvious inhibitory action for SCE, thereby the prompting the party has potential value aspect prophylaxis of tumours.

The little big grade of Antiradiation injury Zheng has been observed the protective action of JINGUI SHENQI WAN for SD rat chronic ionization radiation injury, the result shows that JINGUI SHENQI WAN can obviously reduce radiation induced rat bone marrow cell chromosome aberrations rate, can correct well the caused rat leukocyte sum of radiation and descend, show that this ball has the good effect that alleviates radiation damage.

From obtaining documents and materials, the pharmacological research of relevant JINGUI SHENQI WAN report is many from the impact of a certain system or a certain pathological changes index is started with, and observes the party's therapeutic effect and inquires into mechanism of action.In experiment, how carry out copying of animal model according to the modern medicine etiopathogenesis or on the original animal model of western medicine basis, improve a little and make pathological model.This research method no doubt can be in certain aspect discloses certain body of Chinese medicine compound action rule, but because characteristic and the advantage of Chinese medicine self are grasp macroscopical and integrally-regulated, its clinical basic thinking of sending medicinal side is that determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs and side's card are corresponding, and the treatment the criterion obvious and traditional Chinese medical science " diagnosis and prescription " of the pharmacology of Chinese materia medica experiment research take " disease " as the starting point differs greatly.Although since the establishment of the nation, numerous scholars have carried out positive exploration in the research field of animal model with TCM syndrome, yet up to now, the animal model of ripe final conclusion is actually rare.If can start with from improving animal model from now on, actively excavate the internal relation between modern medicine disease and the Syndrome Differentiation of Traditional Chinese Medicine, set up as early as possible the objective comprehensive index system of tcm syndrome, and then copy the animal model with TCM syndrome that meets this index system, set about medication from side's angle corresponding to card, base oneself upon integral body, hold the overall situation, with comprehensive, at many levels, the index of many target spots detects the Drug efficacy evaluation standard of including in, from multidisciplinary, multisystem, many sick angles of planting are inquired into Drug therapy mechanism, test the result for controlling of action principle in the body of accurate assurance Chinese medicine compound and objective evaluation Chinese medicine compound, will more authoritative and cogency.

The tangible novelty of tool of the present invention and breakthrough are to have found out the key point that JINGUI SHENQI WAN 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 JINGUI SHENQI WAN " 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 identical 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.Science and technology is looked 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 JINGUI SHENQI WAN 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 JINGUI SHENQI WAN dosage form preparation technology and production method thereof, wherein: 24 parts of the raw material of this integrated novel form effective ingredient and weight proportion---Radix Rehmanniae Preparata, 12 parts of dried Rhizoma Dioscoreaes, 12 parts of Fructus Corni, 9 parts of Rhizoma Alismatis, 9 parts in Poria, 9 parts of Cortex Moutans, 3 parts of Radix Aconiti Lateralis Preparatas, 3 parts of Ramulus Cinnamomi.

Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.

Above-mentioned a kind of JINGUI SHENQI WAN 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 JINGUI SHENQI WAN 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 JINGUI SHENQI WAN 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 JINGUI SHENQI WAN 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 JINGUI SHENQI WAN 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% Radix Rehmanniae Preparata, dried Rhizoma Dioscoreae, Fructus Corni, Rhizoma Alismatis 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, it is for subsequent use to get extract.

Step 3: get 60% Poria, Cortex Moutan, Radix Aconiti Lateralis Preparata, Ramulus Cinnamomi 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, and it is for subsequent use to get extract.

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 JINGUI SHENQI WAN 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 JINGUI SHENQI WAN 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 JINGUI SHENQI WAN 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 JINGUI SHENQI WAN 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 the human body 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 JINGUI SHENQI WAN 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 JINGUI SHENQI WAN " 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 identical 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 JINGUI SHENQI WAN dosage form preparation technology and production method thereof, its special feature is: the raw material composition of making effective ingredient is by weight ratio---

24 parts of Radix Rehmanniae Preparata, 12 parts of dried Rhizoma Dioscoreaes, 12 parts of Fructus Corni, 9 parts of Rhizoma Alismatis, 9 parts in Poria, 9 parts of Cortex Moutans, 3 parts of Radix Aconiti Lateralis Preparatas, 3 parts of Ramulus Cinnamomi.

Further, play the synergy of standing like the legs of a tripod on the integrated new drug formulation compatibility of JINGUI SHENQI WAN of the present invention: 1, prepare nanometer, micro-powder with the prepared slices of Chinese crude drugs, the bioavailability after strengthening the JINGUI SHENQI WAN 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 JINGUI SHENQI WAN 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 JINGUI SHENQI WAN 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.Getting 30%-90% alcohol-water solution that 60% Radix Rehmanniae Preparata, dried Rhizoma Dioscoreae, Fructus Corni, Rhizoma Alismatis micropowder doubly measure with 6-12 mixes 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, it is for subsequent use to get extract.Get 60% Poria, Cortex Moutan, Radix Aconiti Lateralis Preparata, Ramulus Cinnamomi 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, and it is for subsequent use to get extract.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---

24 parts of Radix Rehmanniae Preparata, 12 parts of dried Rhizoma Dioscoreaes, 12 parts of Fructus Corni, 9 parts of Rhizoma Alismatis, 9 parts in Poria, 9 parts of Cortex Moutans, 3 parts of Radix Aconiti Lateralis Preparatas, 3 parts of Ramulus Cinnamomi.

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---

24 parts of Radix Rehmanniae Preparata, 12 parts of dried Rhizoma Dioscoreaes, 12 parts of Fructus Corni, 9 parts of Rhizoma Alismatis, 9 parts in Poria, 9 parts of Cortex Moutans, 3 parts of Radix Aconiti Lateralis Preparatas, 3 parts of Ramulus Cinnamomi.

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---

24 parts of Radix Rehmanniae Preparata, 12 parts of dried Rhizoma Dioscoreaes, 12 parts of Fructus Corni, 9 parts of Rhizoma Alismatis, 9 parts in Poria, 9 parts of Cortex Moutans, 3 parts of Radix Aconiti Lateralis Preparatas, 3 parts of Ramulus Cinnamomi.

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 JINGUI SHENQI WAN 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.

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, 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 JINGUI SHENQI WAN 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 JINGUI SHENQI WAN 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 JINGUI SHENQI WAN dosage form preparation technology and production method thereof is characterized in that: 24 parts of the raw material of this novel form effective ingredient and weight proportion---Radix Rehmanniae Preparata, 12 parts of dried Rhizoma Dioscoreaes, 12 parts of Fructus Corni, 9 parts of Rhizoma Alismatis, 9 parts in Poria, 9 parts of Cortex Moutans, 3 parts of Radix Aconiti Lateralis Preparatas, 3 parts of Ramulus Cinnamomi.Wherein, described each Chinese medicine is rich in one or more trace element such as organic zinc, selenium.

2. a kind of JINGUI SHENQI WAN 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 JINGUI SHENQI WAN 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 JINGUI SHENQI WAN 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 JINGUI SHENQI WAN 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 JINGUI SHENQI WAN 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% Radix Rehmanniae Preparata, dried Rhizoma Dioscoreae, Fructus Corni, Rhizoma Alismatis 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, it is for subsequent use to get extract.

Step 3: get 60% Poria, Cortex Moutan, Radix Aconiti Lateralis Preparata, Ramulus Cinnamomi 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, and it is for subsequent use to get extract.

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 JINGUI SHENQI WAN 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 JINGUI SHENQI WAN 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 JINGUI SHENQI WAN 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 JINGUI SHENQI WAN dosage form preparation technology according to claim 9 and production method thereof is characterized in that: its key point 2 be can in external administration develop simultaneously, 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 the human body different parts by the energy and blood of human body flowing law, directly absorb by skin.