CN103479963A - Traditional Chinese medicine capsules for treating rheumatoid arthritis and preparation method thereof - Google Patents

Abstract

The invention discloses traditional Chinese medicine capsules for treating rheumatoid arthritis and a preparation method thereof. The traditional Chinese medicine capsules are prepared from traditional Chinese medicines including hot rhizoma cibotii, zaocys dhumnades, obscured homalomena rhizome, periploca forrestii schltr, caulis sinomenii, panax pseudoginseng, rhizoma curcumae longae, radix paeoniae alba, liquorice and microcrystalline cellulose. The traditional Chinese medicine capsules disclosed by the invention are exact in curative effect, safe and reliable, convenient to take, quick in drug release, economical and practical in price and convenient to carry, thereby bringing more medication choices to the patients.

Description

A kind of Chinese medicinal capsule for the treatment of rheumatoid arthritis and preparation method thereof

Technical field

The present invention relates to technical field of Chinese medicines, particularly relate to a kind of Chinese medicinal capsule for the treatment of rheumatoid arthritis and preparation method thereof.

Background technology

Rheumatoid arthritis is one of clinical modal rheumatism immunological disease, and its morbidity is filled with disability rate high, and in onset 1 year, disability rate can reach 60% in up to 20%, 10 year, is to cause in the world one of disabled principal disease, and the title of " dead cancer " is arranged.China's RA annual morbidity is about 0.32-0.36%, and the onset peak age is 45-55 about year, and its prevalence increases with the increase at age.According to estimates, there is the about 400-500 ten thousand of adult RA patient in China, and its person in middle and old age RA accounts for 1,200,000, and at China l3 more than hundred million in population, the RA patient Ke Da 400,000 newly increased every year.Foreign data shows, because of medical expense and joint, disables and loses the financial burden that work causes to society, has influence on the population of global 0.5%-1%.Due to its pathogenetic uncertainty, at present treatment mainly take alleviate arthralgia, the control disease progression is main purpose, common drug is as nonsteroidal antiinflammatory drug, glucocorticoid, immunosuppressant etc., because of the toxic and side effects of these medicines large, cause a lot of patients to be difficult to adhere to medication, although the biological preparation that recent years abroad is introduced has shown good therapeutic effect as tumor necrosis factor antagonists etc., but because Time To Market is short, lack long-term adverse reaction monitoring, add expensive, most of patient is difficult to bear, and clinical practice is restricted.And it is also rare to use Chinese medicine preparation to treat the active drug of this disease, how to make the vast Chinese medicine of motherland can apply to the treatment field of this disease, become traditional Chinese medical science worker's a urgent task.

Summary of the invention

Technical problem to be solved by this invention is the defect that overcomes prior art, and a kind of determined curative effect is provided, safe and reliable, taking convenience, release is rapid, easy to carry, Chinese medicinal capsule of the treatment rheumatoid arthritis of price economy material benefit and preparation method thereof, select for the patient provides more medication.

In order to solve the problems of the technologies described above, the present invention adopts following technical scheme:

According to listed as parts by weight, the Chinese medicinal capsule that the present invention treats rheumatoid arthritis is to scald Rhizoma Cibotii 200～400g Zaocys 100～300g Rhizoma Homalomenae 200～400g Heiguteng exract 150～350g Caulis Sinomenii 500～700g Radix Notoginseng 40～100g Rhizoma Curcumae Longae 300～500g Radix Paeoniae Alba 500～700 g Radix Glycyrrhizae 80～160g microcrystalline Cellulose 60～110g by raw material of Chinese medicine to be prepared from.

Preferably, above-mentioned Chinese medicinal capsule is by boiling hot Rhizoma Cibotii 312.5g Zaocys 208.3g Rhizoma Homalomenae 312.5g

Heiguteng exract 187.5g Caulis Sinomenii 625.0g Radix Notoginseng 62.5g Rhizoma Curcumae Longae 416.7g Radix Paeoniae Alba 625.0g Radix Glycyrrhizae 125.0g microcrystalline Cellulose 85g is prepared from.

The present invention also provides the preferred preparation method of aforementioned Chinese medicinal capsule: it is standby that Radix Notoginseng breaks into fine powder, the water soaking that all the other 8 flavor medicines add 9.3 times of amounts for the first time decocted 0.5 hour after 1 hour, the decocting that second and third time respectively adds 8 times of amounts boils, each 0.5 hour, merge decocting liquid 3 times, filter, it is 1.35～1.40(60 ℃ that the filtrate normal pressure is concentrated into relative density) thick extractum, be placed in 80 ℃ of constant pressure and dries, broken mistake 65 mesh sieves of dried cream powder are mixed homogeneously with Radix Notoginseng powder, microcrystalline Cellulose, the 0# hard capsule and get final product of packing into.

Trade name of the present invention: Golden Crow Jiangu capsule for strengthening bone

Monarch drug of the present invention scalds Rhizoma Cibotii invigorating the liver and kidney, strong spinal column, wind-damp dispelling, the Zaocys wind-damp dispelling, restores menstrual flow and invigorates blood circulation; Ministerial drug Rhizoma Homalomenae, Heiguteng exract, Caulis Sinomenii wind-expelling pain-stopping, strengthening the tendons and bones; Adjuvant drug Radix Notoginseng, Rhizoma Curcumae Longae promoting blood circulation and stopping pain; Make the medicine Radix Paeoniae Alba, the Radix Glycyrrhizae stomach function regulating that nourishes blood, relieving spasm to stop pain.Full side has the effect of reinforcing the kidney to strengthen the bone, promoting blood circulation, dredging meridian and relieving pain, make that muscles and bones is strong, loose through ruton, strongly fragrant heresy, blood stasis, heresy is moved back and is not just being hindered, from the kidney invigorating, strong muscle, strong bone, invigorate blood circulation, nourish blood, dispel the wind, the multi-angle prescriptions such as dredging collateral, analgesic therapy, shape is loose and power is special, coordinates precise and appropriate.The inventor confirms that in clinical research the strong bone side of the Golden Crow has good efficacy to the treatment of RA, especially alleviate RA patient clinical symptom, reduce antirheumatic and shown clinical efficacy preferably as the toxic and side effects aspect of methotrexate etc., it is furtherd investigate, inquire into its treatment mechanism, improve treatment, the quality of making the life better of RA, there is wide potential applicability in clinical practice.

Usage and consumption: oral each 4, every day 3 times.

experiment one: preparation process research

One, the selection foundation of process route

(1) prescription drug physicochemical property and pharmacological research

scald Rhizoma Cibotii(Dicksoniaceae plant Rhizoma Cibotii cibotium barometz(L.) dry rhizome of J. Sm., remove silt, remove hard root, petiole and golden yellow fine hair, cut sheet, drying is scalded method according to appendix II D of Chinese Pharmacopoeia version in 2010 again, with stir-baking in sand, to heaving, removes remaining fine hair after cooling) according to documents and materials, boiling hot Rhizoma Cibotii chemical composition is summed up and mainly contains following a few class: volatile oil: main component is higher fatty acids, and what content was the highest is Palmic acid, linoleic acid; The pterosin class: gold hair pterosin, onychin-2 '-O-β-D-pyranglucoside, onychin-15 '-O-β-D-pyranglucoside; Water-soluble phenolic compounds: protocatechuic acid, caffeic acid; Aromatic compound: protocatechuic acid, protocatechualdehyde, the old element of the luxuriant Di Bo of (3R)-go-O-methyl, Rhizoma Cibotii glycosides; Flavonoid: kaempferide; Saponins: Rhizoma Cibotii saponin; Glucide compounds: n-Butyl-β-D-fructopyranoside, glucose, sucrose, maltose, 5 hydroxymethyl furfural, 3-hydroxyl-gamma-pyrone; Also contain aminoacid (aspartic acid, glutamic acid and proline content are higher); (content with K is the highest for inorganic elements, next is Mn), and the compounds such as cupreol, cupreol-3-O-(6 '-positive palmityl oxygen base)-3-β-D-Glucose glycosides, cupreol-3-O-(6 '-positive n acyloxy)-β-D-Glucose glycosides, cupreol-β-D-Glucose glycosides (daucosterol), stearic acid, tannin, acetanilide phosphatidylcholine (PC).

Scald Rhizoma Cibotii bitter in the mouth, sweet, warm in nature.Return liver, kidney channel.There is wind-damp dispelling, invigorating the liver and kidney, strong waist knee joint.For rheumatic arthralgia, soreness of the waist and knees, weakness of the lower extremities.Miao ethnic group's medicine is thought " nest have to add slip " (Rhizoma Cibotii) bitter in the mouth, sweet, and property is cold, enters hot warp.The modern pharmacological research data shows, Rhizoma Cibotii may have the bone of increasing activation frequency and stimulate osteoplastic effect, prevents and treats osteoporosis.Water soluble ingredient in the stir-baking in sand Rhizoma Cibotii, significantly anticoagulant.Rhizoma Cibotii and processed product thereof and Rhizoma Cibotii hair have analgesic activity and the effect of invigorating blood circulation in various degree.Rhizoma Cibotii can improve adjuvant arthritis rats and insufficiency of kidney-YANG adjuvant arthritis rats hemorheological property, by blood circulation promoting and blood stasis dispelling, plays certain therapeutical effect, and stir-baking in sand acts on and strengthening after concocting.The fragrant acids composition protocatechuic acid of water solublity and caffeic acid, have antiinflammatory, antiheumatic pharmacologically active.Onychin has hepatoprotective effect, also can remove peroxide and free radical.In vitro tests shows, Rhizoma Cibotii has certain bacteriostasis, and infected by influenza, Diplococcus pneumoniae have inhibitory action.

zaocys(Colubridae animal Zaocys zaocys dhumnades(Cantor) dry body) according to documents and materials, the Zaocys chemical composition is mainly amino acids: mainly containing aspartic acid, threonine, serine, glutamic acid, proline, glycine, alanine, cystine, cysteine, valine, methionine, isoleucine, tyrosine, phenylalanine, lysine, histidine, methionine, leucine, arginine, γ-aminobutyric acid etc.; And inorganic elements, protein, fat, ester of Harden Young esterase, Serpentis flesh aldehyde lyase and collagen protein etc.Separate and obtain from the methanolic extract of Zaocys, brachystemidines A, butyl phthalate isobutyl ester, dihydro ferulic acid, cupreol, thymus pyrimidine, 4-hydroxy benzaldehyde.

The Zaocys sweet in the mouth, property is flat.Return Liver Channel.Have and dispel the wind, dredging collateral, the effect of relieving convulsion.For rheumatoid stubborn weakness, numbness Spasm, oblique of outlet eye , hemiplegia, convulsions convulsions, tetanus, leprosy, scabies.Miao ethnic group's medicine is thought " can lattice emit " (Zaocys) salty in the mouth, the property slight fever.Enter slow warp, half of warp.Modern pharmacological research shows, Zaocys has calmness, anti-frightened, analgesia, antiinflammatory action.Zaocys II Collagen Type VI has identical immunoregulation effect with cattle II Collagen Type VI, and both can lower rats with arthritis peripheral blood TNF-a level, anti-II Collagen Type VI antibody titer and CD ₄+/CD ₈+ ratio, the effect that improves the IL-10 level, infer that Zaocys II Collagen Type VI may be the active pharmaceutical component of Zaocys treatment RA.Zaocys hydrolyzed solution treatment rheumatoid arthritis total effective rate is 64.2%, and obvious effective rate is 16.7%, apparently higher than 38.3%, 6.7% of placebo group.Its suitableeest pattern of syndrome is intermingled phlegm and blood stasis type.

rhizoma Homalomenae(aroid Rhizoma Homalomenae homalomena occulta(Lour.) dry rhizome of Schoot, two seasons of spring and autumn excavate, and clean, and remove crust, dry) according to documents and materials, from Rhizoma Homalomenae chloroform and ethyl acetate extract, separate and identify 7 compounds, cupreol, β-daucosterol; Other 5 is sesquiterpenoids, is respectively sesquiterpene (1) oplodiol, (2) oplopanone, (3) homalomenol C, (4) bullatantriol and (5) 1 β, 4 β, 7 α-trihy-droxyeudesmane; Be divided into from and identified 6 compounds from petroleum ether and n-butanol portion, three compounds comprising petroleum ether part, be respectively: Alpha-hydroxy 25 carbonic acid, three compounds of Palmic acid and 15 carbonic acid and n-butanol portion, they are respectively: glucose, D-galactitol and red bright alcohol; Volatile ingredient is: γ-terpinene, linalool, terpineol-4, acetic acid Lignum cinnamomi camphorae alcohol ester, γ-Cananga odorata oil alkene, β-caryophyllene, α-humulene, α-selinene, (-)-α-Cananga odorata oil alkene, α-purple favour Chinese scholartree alkene, δ-cadinene, α-cedrol, tertiary cadinol, tertiary fragrant cananga oleyl alcohol, (Z)-6,10-dimethyl-5,9-decadinene-2-ketone, 2-amino-3-hydroxy formic acid etc.

Rhizoma Homalomenae bitter in the mouth, suffering, warm in nature.Return liver, kidney channel.There is wind-damp dispelling, the effect of strengthening bone and muscle.For anemofrigid-damp arthralgia, chills and pain of the waist and kness, the contracture numbness, the muscles and bones flaccidity is soft.The modern pharmacological research data shows that Rhizoma Homalomenae has following pharmacological action: (1) is antibiotic, antiviral: the experiment of filter paper flat band method shows that Essential Oil from Homalomena Occulta Schott by GC-MS can suppress the growth of Brucella fully; The Rhizoma Homalomenae water extract is external can also suppress I type herpes simplex virus (HSV-1); (2) antiinflammatory, analgesia: the Rhizoma Homalomenae methanolic extract can obviously suppress the rat toes swelling that carrageenin causes, also can effectively suppress the mouse writhing reaction that acetic acid causes; (3) antihistamine: the guinea-pig isolated trachea Faxian shows the guinea pig tracheal smooth muscle contraction that homalomenol extract energy antagonism histamine causes; (4) anticoagulation: the Rhizoma Homalomenae water extract has stronger blood coagulation resisting function; (5) other: Rhizoma Homalomenae also has the activity that suppresses calcium channel blocker receptor and angiotensin-ii receptor.

heiguteng exract(asclepiadaceae plant Caulis et Radix Periplocae Forrestii periploca forrestiischltr. dry root) according to documents and materials research, the contained compound of Heiguteng exract mainly contains following a few class: rhizome is containing the cardenolide Ginkgolide Component Yunnan P. sepium Bunge former times A of unit and Yunnan periplocoside, daucosterol, ursolic acid, 8-hydroxyl periplogenin, periplogenin, periplocoside, periploca sepium glycosides; Diterpene quinone: Tanshinone I I _a; Glycosides compound, be respectively: emodin-8-O-β-D-Glucose glycosides, physcione-8-O-β-D-Glucose glycosides, Kaempferol-O-β-D-galactoside, Kaempferol-O-α-L-arabopyranose glycosides, Quercetin-3-O-β-D-pyranglucoside, Quercetin-3-O-α-L-arabopyranose glycosides.Extract Guizhou Province by steam distillation and produce Heiguteng exract Herb volatile oil, utilize the retrieval in GC-MS multiple techniques combined standard spectrum storehouse, from 44 compounds that obtain, identified 27 kinds of compositions, detect composition and account for 93. 2% of volatile oil component.Wherein palmitic acid content is the highest, accounts for 45. 6% of volatile oil total amount.Heiguteng exract volatile oil component and content thereof are produced in clear and definite Guizhou Province, for improving its comprehensive development and utilization, provide experimental basis.

Heiguteng exract bitter in the mouth, suffering, cool in nature; Slightly poisonous.Miao ethnic group's medicine is thought " the big plug of the frog " (Heiguteng exract) acrid in the mouth, hardship, hot in nature; Slightly poisonous.Enter cold warp.There is relaxing muscles and tendons to promote blood circulation, the effect of expelling wind and removing dampness.Cure mainly rheumatic arthralgia, amenorrhea, acute mastitis, injury from falling down, fracture, stomatitis, stomachache, dyspepsia, malaria.The modern pharmacology research data shows: α ₂amyrin and β-Amyrin acetas has obvious antagonism to arthritis; α-Amyrin acetas and β-Amyrin acetas can suppress granuloma induced by implantation of cotton pellets, and its effect is similar to hydrocortisone; β-Amyrin acetas can make liver homogenate ATP phosphohydrolase obviously raise, this and Heiguteng exract antiinflammatory actionmatch.Ursolic acid has and suppresses active gram positive bacteria, negative bacterium, yeast in vitro, can obviously reduce the normal body temperature of rat, and stable effect (antibacterial action) is arranged.Emodin has the effect of stronger anti-tumor activity and cell death inducing, and emodin is by activating p ₅₃, p ₂₁expression, can effectively suppress hepatoma carcinoma cell HepG in vitro ₂propagation and induce its apoptosis, its half-inhibition concentration 130 μ mol/L.Emodin can also be induced lung cancer cell line H ₄₆₀, CL ₅apoptosis.β-daucosterol is a kind of antitumor drug, has antifungal activity.Therefore the chemical substance basis of Heiguteng exract medical value has been illustrated in the discovery of these compounds to a certain extent.Propose total glycosides in the fresh peel of stem of Heiguteng exract, through the frog heart in place and Cor Leporis, Cor Leporis electrograph and guinea-pig heart test, prove cardiotonic, the similar strophanthoside G of its cardiotonic characteristics, and the Columba livia mean lethal dose (MLD) is 5.9 ± 1.0 mg/Kg.Adopt mouse writhing method and hot plate method, Heiguteng exract has obvious analgesic activity.By the experiment of mice caused by dimethylbenzene xylene auricle swelling degree, each extract part of Heiguteng exract all can make the mice ear degree reduce in various degree; Cause the experiment of mice capillary permeability by acetic acid, Heiguteng exract has the effect that capillary permeability increases that suppresses.HGT-5A 100～500 mgKg ^-1the chmice acute ear swelling that gastric infusion brings out Oleum Tiglii has obvious inhibitory action, 100～500 mgKg ^-1the DTH reaction that gastric infusion is induced DNCB has obvious inhibitory action, and breeder reaction all has obvious inhibitory action to DTH model mice splenocyte.Heiguteng exract has good anti-RA effect, its mechanism of action may with regulate immune organ function and proinflammatory cytokine IL-1 β, IL-6, the contents level of TNF-α is relevant.

caulis Sinomenii (the menispermaceous plants Sinomenium acutum sinomenium acutum(Thunb.) Rehd. et Wils. and hair Sinomenium acutum s. acutum(Thunb.) Rehd. et Wils. var. cinereumrehd. the dry rattan of et Wils..Time of the year when autumn changes into winter taps, binding or cut long section, dry) according to the rattan of documents and materials Caulis Sinomenii mainly containing the alkaloids composition: sinomenine, sinoacutine, the Sinomenium acutum menispermine, N-demethyl Sinomenium acutum menispermine, N-oxidation sinomenine, N-demethyl sinomenine, sharp sinoacutine falls, disinomenine, the tetrahydrochysene epiberberine, soil rattan alkali, magnoflorine, isosinomenine, michelalbine, stepharine, 8, 14-dihydro Sa Lutaliding alkali, sinomendine, stepharanine alkali, bianfugenine alkali, N-demethyl-N-formoxyl dehydronuciferine, liriodendrin, Caulis menispermi is appointed alkali, laurifoline, the dehydrogenation discretine, epiberberine, palmatine, acutupyrrocoline.Wherein sinomenine is main active component, and rattan is thicker, and the content of sinomenine is higher.

Caulis Sinomenii bitter in the mouth, suffering, property is flat.Return liver, spleen channel.The modern pharmacological research data shows, Caulis Sinomenii has following pharmacological action: (1) antiinflammatory: sinomenine is external can obviously reduce the mouse peritoneum macrophage synthesis of prostaglandins E that zymosan or Calcium ionophore are induced ₂(PGE ₂) and leukotriene C ₄(LTC ₄); To acute arthritis (AIA) model of rat antigen induction, short-term or mid-term the lumbar injection sinomenine can alleviate arthroncus, the erythrocyte sedimentation rate that slows down (ESR); Observe sinomenine to the lymphocyte effect with external mouse boosting cell core human peripheral blood single nucleus cell, find that sinomenine suppresses lymphocytic propagation and has reversibility, and can increase the generation of interleukin 6 (IL-6), suppress interleukin-22 (IL-2) membrane receptor and express; The external energy of sinomenine produces the resisting rheumatoid arthritis effect by downward human peripheral blood single nucleus cell IL-1 β, IL-8 mrna expression; To collagen Ⅱ induced arthritis (CIA) rat, the sinomenine gavage can be blocked periostitic process by the expression that suppresses periosteum cell malignant proliferation and IL-6 mRNA.Further Anti-inflammatory Mechanism research finds that sinomenine may be by lowering the synthetic performance of Monocytes/Macrophages system inflammation medium and cytokine antiinflammatory action, and be that dose dependent ground significantly reduces T cell within a cell factor TNF-γ, the TNF-alpha molecule is expressed, also may with its inhibition nuclear factor NFkBp ₆₅the degraded of core displacement and inhibitive factor IkB-α thereof is relevant with inhibition nuclear factor NF-kB activity.In addition, vitro enzyme reaction experiment system and the experiment of lipopolysaccharide-induced neurocyte proliferation also find, sinomenine is to Cycloxygenase-2(COX-2) due to PGE ₂synthetic table reveals stronger inhibitory action; Further investigation shows, sinomenine has certain selective inhibitory to the COX-2 activity, and may mainly by the direct effect to the COX enzymatic activity, realize.(2) immunosuppressant: observe after sinomenine is transplanted the ACI-Lewis mouse heart allograft rejection effect produced, find the time-to-live that transplant in lumbar injection sinomenine energy Yancheng.The sinomenine experiment in vitro shows to reduce the combination of thymidine in active T lymphocyte, the synthetic and cell cycle cycle of IL-2; Its mechanism of action may be to suppress the Th1 cell to produce IL-2, and the suppressor T cell subgroup also may be by suppressing peripheral blood cd4 cell propagation, lowers the expression of TNF-α, IFN-γ (IFN-γ) and produces the immunosuppressive action to allograft; In addition, with experimental autoimmune encephalomyelitis rat tail model, find, the immunosuppressive action of sinomenine is with to suppress cerebral tissue NF-kB activity relevant, and this inhibitory action may with increase cortisol secretion, the inhibition prolactin secretion is relevant.(3) on the impact of cardio-cerebrovascular: 1. blood pressure lowering, the isolated rabbit smooth muscle cell proliferation reaction that sinomenine stimulates Endothelin has inhibitory action, also can suppress DNA synthetic, and the hypotensive activity that this may be obvious and lasting with sinomenine is relevant.2. arrhythmia, the single cell of ventricular myocytes of guinea pig film sodium ion electric current (INa) that the research sinomenine separates enzyme, the impact of L-type calcium current (ICa-L) are found, sinomenine is to INa and the effect of ICa-L tool rate dependent block, and this may be its antiarrhythmic important mechanism; Sinomenine also has the concentration dependent retardation to Ventricular Myocytes inward rectification potassium current (IK-L) and Delayed Rectifier Potassium Current (Ik), and its multipole effectiveness that extends myocardial cell may block relevant with potassium channel.3. Cardiac depression; pour into respectively sinomenine and isomers 8 thereof; 14-dihydro Sa Lutali pyridine alkali (DHS) is given normal Isolated Working Rat Hearts; posting a letter, both have direct repression to heart; the contraction power of heart is reduced, and DHS have obvious protective effect to the diastolic function of cerebral ischemic rats heart.4. anti-angiogenic rebirth, the sinomenine in vitro and in vivo all can suppress the vascularization that basic fibroblast growth factor (bFGF) causes, and also can reduce vascular permeability, suppresses the granulocyte migration, thereby plays the effect of rheumatoid arthritis (RA); 5. blood vessel dilating, the external Ca that suppresses of sinomenine ²⁺the activity of passage and Protein kinase C (PKC), increase endothelial cell nitric oxide (NO) and prostacyclin (PGI ₂) activity, there is the vasodilator effect.(4) suppress morphine: with incremental dose method, form the morphine mouse model, and urge and giving up with naloxone after the injection sinomenine, find that the sinomenine lumbar injection can suppress the morphine-dependent mice Inhibits Withdrawal Syndromes, significantly alleviate the weight loss of addiction Mouse and rat, its mechanism may be relevant with the disorder of adjusting monoamine neurotransmitter; Test and also show that the Caulis Sinomenii water extract also can suppress the withdrawal symptom of morphine by isolated guinea pig ileum; Caulis Sinomenii alcohol extract or sinomenine also all can effectively suppress the withdrawal symptom that morphine model naloxone is urged in vivo and in vitro; In addition, continuously gavage also can obviously suppress the formation of the mice Place Preference that morphine causes, and the established conditioned place preference effect of mice is also had to certain inhibitory action.(5) analgesia: sinomenine gavage or subcutaneous injection all have inhibitory action to the reaction of shouting due to the writhing response due to mice acetic acid, electricity irritation afterbody.(6) anxiety: the sinomenine oral administration can increase access times and the time of staying of overhead cross labyrinth small mouse to open arms, increase the time of staying and the activity of shading model small mouse at camera-lucida, increase the population exposed time of mice in the population exposed experiment, there is obvious angst resistance effect.

radix Notoginseng(panax araliaceae plant panax notoginseng(Burk.) dry root of F. H. Chen and rhizome.Excavate before the flowers are in blossom autumn, cleans, and separates main root, supporting root and rhizome, drying) according to documents and materials research, the root and rhizome of Radix Notoginseng contains multiple triterpenoid saponins: arasaponin A, B, C, D, E, G, H, I, J, K, L, M, N, U, R ₁, R ₂, R ₃, R ₄, R ₆, R ₇, ginsenoside Rb ₁, Rb ₂, Rd, Re, Rg ₁, Rg ₂, Rh ₁, Rh ₄, U, 20-O-glucose ginsenoside Rf, Da Ma-20 (22)-alkene-3 β, 12 β, 25-triol-6-O-β-D-pyranglucoside, gypenoside XVII etc.; CYCLIC DIPEPTIDES composition: ring (leucine-threonine), ring (leucine-serine), ring (Ile-Val) etc.; Flavones ingredient: Quercetin etc.; The polysaccharide composition; Sanchinan-A.In addition, also containing the composition such as Radix Notoginseng acid β-sophoroside, dencichine and various trace element etc.

Radix Notoginseng sweet in the mouth, micro-hardship, warm in nature.Return liver, stomach warp.There is the dissipating blood stasis hemostasis, subduing swelling and relieving pain.For spitting of blood, to spit blood, epistaxis, have blood in stool, metrorrhagia, traumatic hemorrhage, breast ventral spine pain, tumbling and swelling.The modern pharmacological research data shows, Radix Notoginseng has following pharmacological action: (1) hemostasis, antithrombotic, promotion hemopoietic: dencichine Rockwell solution lumbar injection can shorten the bleeding time of mice docking.Cooked Radix Notoginseng powder ethanol extract is oral, and mice is had gentle promotion blood coagulation and promotes Fibrinolytic effect.Panax Notoginseng saponin R ₁the microcirculation of auricular microcirculation obstacle mice due to normal mouse and norepinephrine be can significantly promote or improve with ginsenoside Rd's subcutaneous injection, blood plasma recalcification time and clotting time extended.The external propagation that can promote people's bone marrow granulocyte (CFU-GM), red system (CFU-E) hemopoietic progenitor cell of Radix Notoginseng total arasaponins, induce the increase of the transcription factor NF-E2 of hematopoietic cell AP-1 family, c-jun, c-fos, with specific DNA, promote son to increase in conjunction with activity, regulate and control the gene expression relevant to the human hematopoietic cell proliferation and differentiation; (2) on the impact of cardiovascular system: arasaponin is external to the open endochylema Ca caused with the calcium channel opening associated with beta receptor of voltage-dependent Ca channel in cardiac myocytes ²⁺rising has inhibitory action; Radix Notoginseng total arasaponins is external suppresses the propagation of people's fetal blood pipe that hyclone, Hyperlipidemic Serum bring out, rabbit aorta, rat smooth muscle cells (VSMC), suppressing Hyperlipidemic Serum promotes [3H] thymidine to infiltrate the process of cell, reduce Hyperlipidemic Serum and suppress NO release, the retardance cell is in G ₀/ G ₁phase, reduce the NF-kB activity, thus the performance study of anti-atherogenic effect.The external apoptosis of cardiac muscle that AngiotensionⅡ (AngII) is induced of Radix Notoginseng total arasaponins has remarkable inhibitory action; Gavage can be improved the Acute Myocardial Ischemia Rats cardiac function, and the intravenous injection pretreatment can suppress tumor necrosis factor α (TNF-α) and discharge, and increases the bcl-2 protein expression, reduces the Bax protein expression simultaneously; Compound components of panax notoginseng can strengthen the isolated rat myocardial contraction, decreased heart rate, reduce lipid peroxide (LPO) generation and lactic acid dehydrogenase (LDH), creatine phosphokinase (CPK) release, reduce blood vessel endothelium active factors vaso-excitor material (TXB2) and discharge and the myocardial cell energy expenditure, increase blood vessel endothelium and expand angiogenic substance (PGF ₁) discharge, alleviate the rat myocardial cell damage that ischemia-reperfusion causes; (3) protection brain and nervous system: the saponin triol lumbar injection of Radix Notoginseng can raise HSP ₇₀albumen, lower expression of transferrin, reduces brain water content, and the protection blood brain barrier, have protective effect to middle cerebral artery occlusion type rat (MCAO) focal cerebral ischemia, promotes MCAO rat cerebral cell propagation; The expansible cerebrovascular smooth muscle of Radix Notoginseng total arasaponins intravenous injection, reduce cerebral vascular resistance (CVR), lumbar injection can suppress after Focal Ischemia-Reperfusion in Rats the ischemic region cerebral cortex and tail shell core myeloperoxidase (MPO) (MPO) is active, ICAM-1 (ICAM-1) is expressed, neutrophil infiltration, alleviate the inflammatory reaction of cerebral infarction dead band, suppressing matrix metalloproteinase (MMP-9) expresses, alleviate cerebral infarction dead space volume and blood-brain barrier disruption degree, reduce Caudate Nucleus of Rat injectable collagen enzyme induction cerebral hemorrhage hindbrain iron concentration.The thick saponin of Radix Notoginseng, ginsenoside Rd can promote the astrocyte differentiation of culture of neural stem cells neural, the Radix Notoginseng total arasaponins lumbar injection T that can raise ₁₃-L ₁prostacyclin (the PGI of joint spinal cord Allen`s injury rats ₂), reduce platelet thrombus element A ₂(TXA ₂), regulate the relation between vasodilation and contraction, increase SCBF, reduce malonaldehyde (MDA) and generate and superoxide dismutase (SOD) activity decreased, alleviate the grey matter district and necrosis occurs, myelin separates and the mitochondrion edema, improve microcirculation disturbance, alleviate Secondary injury, (4) slow down aging: the arasaponin subcutaneous injection can reduce the D-galactose and cause cerebral hippocampal district interleukin-11 β, the increase of interleukin 6 (IL-1 β, IL-6) content that Oxidative Injury causes, and reduces neurocyte Ca ²⁺overload and apoptosis, improve the aging rats ability of learning and memory and descend, Radix Notoginseng total arasaponins rat oral gavage drug serum, the toxicity of external energy antagonism beta amyloid peptide 25-35 fragment to the NG108-15 neurocyte, promote its growth, gavage can alleviate the D-galactose and merge the minimizing of brain cholinergic neuron quantity and the decline of CAT (ChAT) level that amino-(3-hydroxy-5-isoxazolyl)acetic acid. (IBA) damage causes, but due to intravenous injection antagonism IBA, the dementia rats learning and memory reduces, improve acetylcholine (Ach) in hippocampus, norepinephrine (NE) and dopamine (DA) in cerebral cortex, the neurotransmitter content such as 5-hydroxy tryptamine (5-HT), lumbar injection can improve SOD in the rat body, catalase (CAT), glutathion (GSH) content, (5) protect the liver: the Radix Notoginseng powder gavage can reduce the TNF-α of alcoholic fatty liver in rats, and leptin (Leptin) level alleviates hepatic tissue fat and becomes, Radix Notoginseng total arasaponins is external can significantly suppress cultured rat hepatic stellate cells (HSC) propagation, induces the HSC apoptosis, may be one of mechanism of action of its anti-hepatic fibrosis, (6) anti-hepatic ischemia-reperfusion injury: the Radix Notoginseng total arasaponins specific inhibition is cultivated receptor dependency Ca on rat liver cell membrane ²⁺passage (ROC), suppress hepatocellular Ca ²⁺interior stream, blocking-up endogenous InsP3 (IP3) approach, prevent Ca ²⁺overload, Radix Notoginseng total arasaponins pretreatment Rat Donor Liver, can effectively alleviate the ischemical reperfusion injury that suppresses liver, suppress hepatocellular apoptosis, suppress TNF-α, the expression of caspase-3, suppress oxygen-derived free radicals and generate, raise the expression of controlling gene bcl-2 albumen, and can be by suppressing calcium overload, antioxidant radical damage, promote the multiple mechanism such as metabolism of energy substances to alleviate the damage of rat liver when cryopreservation, (7) anti-kidney region fibrosis: rat renal tubular epithelial cells (NRK52E) transdifferentiation that the external IL-1 of the inhibition α of Radix Notoginseng total arasaponins induces, reduce Extracellular Matrix Secretion, suppress people's renal cells HK-2 propagation and total collagen secretion that Uremic serum is induced, delay the renal tubulointerstitial fibrotic processes, (8) immunoloregulation function: the xylanase extracted in Radix Notoginseng has the activity that suppresses I type HIV (human immunodeficiency virus) (HIV-1) reverse transcriptase, arasaponin gavage energy obvious stimulation mice spleen lymphocytes proliferation, conversion, the effect of promotion Delayed onset allergy, improve mouse antibodies production cell number, serum hemolysin, promote the monocytes/macrophages carbon granule to clean up effect, improve NKT (NK) cytoactive, the arasaponin subcutaneous administration can significantly promote the mouse boosting cell propagation that concanavalin A, Con A (ConA), phytolacca american albumen (PWM), ovalbumin (OVA) are induced, and improves OVA specific IgG, IgG in serum ₁, IgG _2bantibody horizontal, lumbar injection can significantly improve burned mouse abdominal cavity Phagocytic Function, reduces NO and produces, and improves the proliferative function of lymphocyte, Radix Notoginseng total glycosides can improve rat polyarthritis due to Freund adjuvant, and this effect may be relevant with the secretion that suppresses serum levels of inflammatory cytokines TNF, IL-1 β.In addition, Radix Notoginseng total glycosides in therapeutic process to rat growthing development unrestraint effect.(9) other: Radix Notoginseng extract also reaches contained ginsenoside Rg ₁anti-tumor activity is arranged; Radix Notoginseng total arasaponins can promote the regeneration of adult rat pattern of retinal ganglion cells; Saponin contained in leaf is fed, and can significantly reduce serum cholesterol, the triacylglycerol content of hyperlipidemia rabbit, improves the ratio of high density lipoprotein and cholesterol.In addition, arasaponin also has the effects such as blood sugar lowering, adjusting body substance metabolism.

rhizoma Curcumae Longae(this product is zingiberaceous plant curcuma longal. dry rhizome.Excavate when stem and leaf is withered winter, clean, boil or steam to the saturating heart, dry, go out fibrous root) according to documents and materials research, the rhizome chemical composition of Rhizoma Curcumae Longae mainly contains: the curcumin material, its mother nucleus structure is diphenyl hydro carbons in heptan, arranged dividing of phenol and non-phenol, also comprise demethoxycurcumin and de-1,7-bis(3,4-dimethoxyphenyl)-1,6-heptadiene-3,5-dione.Diphenylheptane constituents: curcumin, demethoxycurcumin, bisdemethoxycurcumin, letestuianin C, dihydro curcumin, tetrahydrocurcumin; Terpenoid: the main component in Rhizoma Curcumae Longae volatile oil is sesquiterpene and monoterpenes compound, and its structure type mainly contains: germacrane, guainane type, carane type, eudesmane-type, Bisabolane, elemane type, xanthane type etc.Sesquiterpenoids composition: the new ketone of Rhizoma Curcumae Longae, Rhizoma Curcumae Longae keto-alcohol A, B, Germacrone-13-aldehyde, Rhizoma Curcumae dicyclo ketenes, α-turmerone, Bisabolol curcumol, Bisabolol turmerone, curcumenol, procurcumenol, different procurcumenol, table procurcumenol, deoxidation curdione, (+)-germacrone-4,5-epoxide, Rhizoma Curcumae azulene ketone glycol; Alkaloids: isolated quinoline alkaloid 2-(2'-methyl-1'-propenyl)-4,6-dimethyl-7-hydroxyquinoline; Polysaccharide composition: Rhizoma Curcumae Longae Polysaccharide A, B, C, D and trace element.

Rhizoma Curcumae Longae acrid in the mouth, hardship, warm in nature.Return spleen, Liver Channel.There is the removing blood stasis circulation of qi promoting, inducing menstruation to relieve menalgia.For the twinge of the breast side of body, obstruction of qi in the chest and cardialgia, dysmenorrhea amenorrhea, lump in the abdomen, rheumatism shoulder arm pain, tumbling and swelling.Miao ethnic group's medicine think " nest Kazakhstan " (Rhizoma Curcumae Longae) flavor numb, peppery, micro-hardship, hot in nature.Enter cold warp.The modern pharmacology research data shows: Rhizoma Curcumae Longae has following pharmacological action: (1) antiinflammatory, analgesia: the various extract gavages of Rhizoma Curcumae Longae volatile oil and Rhizoma Curcumae Longae can reduce acetic acid induced mice writhing response number of times, and rat toes swelling due to Ovum Gallus domesticus album is had to obvious inhibitory action; In two kinds of rat pancreatic adenitis models that Magainin and ethanol cause in conjunction with the low dosage cholecystokinin, curcumin can obviously improve the indexs such as serum amylase, trypsin and neutrophil cell infiltration; In the curcumin body and external all can be by Janus kinases-STAT(JAK-STAT in blocking-up T lymphocyte) interleukin 12 (IL-12) signal conduction on path, suppress the inflammatory reaction of experimental allergic encephalomyelitis mice; Curcumin is oral to the chronic colitis mice, can increase the activity of myeloperoxidase (MPO) (MPO) and tumor necrosis factor α (TNF-α); (2) anticoagulant: the external Platelet Aggregation in Rabbits that can suppress collagen protein and arachidonic acid-induction in the cyclohexane extraction position of Rhizoma Curcumae Longae rhizome methanolic extract, aryl turmerone is main active; (3) antitumor: curcumin can suppress the growth of human liver cancer cell; Can also, by regulating cellular immune function, prevent the formation of mice intestinal mucosa adenocarcinoma; (4) antibiotic: experiment in vitro shows, Rhizoma Curcumae Longae volatile oil has inhibitory action in various degree to funguses such as the antibacterials such as staphylococcus aureus, bacillus subtilis, diphtheria corynebacterium, escherichia coli, bacillus cereus, Salmonella typhimurium and ANs; The methanolic extract of Rhizoma Curcumae Longae has strong inhibitory action to bacillus aerogenes capsulatus, escherichia coli; The ethyl acetate of Rhizoma Curcumae Longae rhizome, methanol and water extract all can suppress methicillin-resistant Staphylococcus aureus, and ethyl acetate extract can also suppress methicillin-resistant Staphylococcus aureus invasion human mucosa fibroblast effectively.Curcumin is one of bacteriostatic active ingredients; (5) the external antioxidation that can improve rat liver cell membrane of Turmeric Root, eliminate APAP to hepatocellular prooxidant effect; Oral administration can reduce CCl ₄the Rat Hepatocyte Injury caused, oxidative stress and the serum transaminase that can also reduce hepatic injury mice due to lumbar injection chlorination pot cadmium raise.The turmeric ethanol extraction can suppress hepatic injury rat blood serum alanine aminotransferase (ALT) due to acetyl aminophenol, aspartate transaminase (AST) and alkali phosphatase (ALP) and raise; Oral administration can suppress Schistosoma mansoni and infect the Mouse Liver dysfunction caused, and can also reduce the level of pyruvate kinase.The curcumin gastric infusion is to CCl ₄, the hepatic injury that adds lipopolysaccharide-induced mice of D-galactosamine and bacillus calmette-guerin vaccine all has protective effect; Externally can suppress the Mouse Liver sternzellen-expression of T6I Collagen Type VI and the phosphorylation of extracellular signal-regulated kinase, thereby suppress the hypertrophy of hepatic stellate cell; (6) protect kidney: the curcumin vivo medicine-feeding can raise the expression of antioxidase in mitochondrial matrix, and the injury of kidney that rat ureteral obstruction or ischemia-reperfusion are caused has protective effect; (7) antioxidation: the lumbar injection curcumin can suppress the generation of ischemia-reperfusion rat cerebral tissue malonaldehyde (MDA) and nitrite, improves superoxide dismutase (SOD) activity; (8) fibrosis: oral curcumin can obviously suppress Pulmonary Fibrosis in Rats due to bleomycin, reduces rat liver collagen deposition and spider cell DNA synthetic.In agarose gel, the extract of Rhizoma Curcumae Longae has protective effect to the oxidative damage of DNA; (9) relieving psychological pressure: oral Rhizoma Curcumae Longae ethanol extraction can reduce the pressure that the mandatory swimming of mice produces, and comprises levels such as reducing serotonin, 5-HIAA, norepinephrine, dopamine.The Oral Administration in Rats Rhizoma Curcumae Longae ethanol extraction of long-term slight pressurized, can increase interleukin 6 (IL-6), the tumor necrosis factor α (TNF-α) of serum, lowers the activity of the natural killer cell (NKC) of splenocyte, reaches the effect of decompression; (10) blood sugar lowering: oral blood glucose and the plasma glycoprotein that can reduce the type 2 diabetes mellitus mice of tetrahydrocurcumin.The oral blood glucose that can suppress type 2 diabetes mellitus mice KK-A (y) of curcuminoid in the turmeric ethanol extraction and the sesquiterpenoids composition in hexane extract rises.Curcumin is oral to diabetic nephropathy rats due to streptozotocin, can improve oxidative stress, produces the kidney protective effect; (11) on the impact of cardiovascular system: oral curcuma powder can reduce the myocardial cell apoptosis of myocardial ischaemia reperfusion injury rat, the myocardial infarction that minimizing is caused by ischemia-reperfusion, recover myocardium antioxidant status and the hemodynamic parameter of change, obviously reduce lipid peroxidation; (12) other: Rhizoma Curcumae Longae also has effects such as regulating immunity, anti-gastric-ulcer, antifertility; Curcumin also has anti-skin oxidative damage, kills the effects such as leishmania.

the Radix Paeoniae Alba(ranunculaceae plant Radix Paeoniae paeonia lactiflorapall. dry root.Summer, Qiu Erji excavate, clean, remove end to end and radicula, put in boiling water after boiling after removing crust or peeling and boil again, dry) according to documents and materials, Radix Paeoniae Alba root contains the monoterpene glycosides composition: peoniflorin, benzoylpaeoniflorin, galloylpaeoniflorin, Hydroxy peoniflorin, albiflorin _r1, oxypaeoniflorin, Radix Paeoniae aglycon ketone, (Z)-(1S, 5R)-β-pinen-10-yl-

β-vicianoside, paeonilactones A, B, C, 6-O-β-D-glucnoxqanosyl-lactinolide; Three ter penoids: 11 α, 12 α-epoxy-3 β, 23-dihydroxyolean-28,13 beta-ol ide, 3 β-hydroxy-11-

Oxo-olean-12-en-28-oic acid, 3 β, 23-dihydroxy-olean-11,13 (18)-dien-28-oic acid, 11 α, 12 α-epoxy-3 β, 23-dihydroxy-30-norolean-20 (29)-en-28,13 beta-ol ide; Also contain canhydrolyzable tannin: 1,2,3,4,6-five galloyl glucoses, cachou extract [(+)-catechin], 1,2,3,4-tetragalloyl

-6-digalloyl-β-D-glucose etc.; Volatile oil is mainly containing benzoic acid, paeonol etc.

Radix Paeoniae Alba bitter in the mouth, acid, cold nature.Return liver, spleen channel.There is nourishing blood for regulating menstruation, astringing YIN to stop sweating, easing the affected liver to relieve pain, suppressing liver-YANG.For blood deficiency and yellow complexion, menoxenia, spontaneous perspiration, night sweat, hypochondriac pain, stomachache, limb pain twin, have a headache dizzy.The modern pharmacological research data shows, the Radix Paeoniae Alba has following pharmacological action: (1) spasmolytic: Radix Paeoniae Alba water extraction liquid has obvious inhibitory action to rabbit intestinal tube smooth muscle movement.To the next day stomach electricity arhythmicity rat of fasting due to feeding, Radix Paeoniae Alba decoct can be by neurally reducing nitrogen and cholinergic nerve increases and make its stomach electricity rhythm and pace of moving things recover normally.Radix Paeoniae Alba water extraction liquid has obvious inhibitory action to the contraction frequency in isolated mouse uterus due to oxytocin; (2) analgesia: confirm that with hot plate method in mice, writhing method Radix Paeoniae Alba total glucosides has analgesic activity, can obviously extend mice and shout incubation period, suppress writhing response; Its analgesic activity is not overturn by naloxone; (3) immunoloregulation function: with Radix Paeoniae Alba water decoction, to mice, feed, phagocytic percentage and the phagocytic index of Turnover of Mouse Peritoneal Macrophages all are significantly improved than matched group.Radix Paeoniae Alba total glucosides produces leukotriene B to rat peritoneal macrophages ₄inhibitory action with suitable with the NSAID (non-steroidal anti-inflammatory drug) flufenamic acid of dosage, and be dosage correlation, the antiinflammatory of prompting Radix Paeoniae Alba total glucosides and immunoregulation effect may with the leukotriene B of its impact ₄generation relevant.All to adjuvant arthritis rats, low splenic lymphocytes has potentiation for Radix Paeoniae Alba total glucosides, peoniflorin and Radix Paeoniae Alba total glucosides removal peoniflorin, prevents that peritoneal macrophage from producing excessive interleukin-11 (IL-1); (4) protect the liver: D-Gal (D-Gal-N), bacillus calmette-guerin vaccine (BCG) are added to lipopolysaccharide (LPS), titanium tetrachloride and the various hepatic injury of albumin induced mice to Radix Paeoniae Alba total glucosides and Liver Fibrosis Model all has protective effect, can obviously reduce serum alanine transaminase (ALT) and aspartate transaminase (AST) level, alleviate pathological lesion and the fibrosis of liver; (5) antibiotic: the Radix Paeoniae Alba all has inhibitory action in various degree to staphylococcus aureus, Hemolytic streptococcus, Streptococcus viridans, streptococcus pneumoniae, Bacillus typhi, Bacillus paratyphosus B, escherichia coli, bacillus pyocyaneus; (6) on the impact of cardio-cerebrovascular: the rat platelet coagulation that Radix Paeoniae Alba total glucosides is induced adenosine diphosphate (ADP) (ADP) has inhibitory action; Can obviously improve the function of the rabbit ischemic myocardial that pituitrin causes, extend the time that asphyxiating hypoxia mice electrocardio disappears; Also can extend panting the time after the disconnected cranium of mice, improve the brain electrical acti of rat, reduce brain calcium, sodium and water content, cerebral infarction is plugged with to protective effect, the mechanism of action may and reduce apoptosis-related with free radical resisting; (7) other: the Radix Paeoniae Alba also has the effects such as antitumor, blood fat reducing, defying age, anti-stress and promotion learning and memory.

radix Glycyrrhizae(glycyrrhizic legume glycyrrhiza uralensisfisch., Glycyrrhiza inflata Bat. glycyrrhiza inflatabat. or Glycyrrhiza glabra L. glycyrrhiza glabral. dry root and rhizome) according to documents and materials, Radix Glycyrrhizae root and rhizome master, containing take the triterpene saponin that pentacyclic triterpene is aglycon,, containing glycyrrhizin, is mainly potassium, the calcium salt of glycyrrhizic acid, is the sweet ingredient of Radix Glycyrrhizae; Preparing glycyrrhetinic acid after the glycyrrhizic acid hydrolysis, have another name called 18 β-glycyrrhizic acid; Other triterpene saponin has: Glycyrrhiza uralensis Fisch. saponin A, B, glyuranolide, uralenolide, glycyrrhizin A ₃, B ₂, C ₂, D ₃, E ₂, F ₃, G ₂, H ₂, J ₂, K ₂; Flavone compound has: 4',7-Dihydroxyflavanone, liquirtin, isoliquiritin unit, isoliquiritin, Neoliquiritin, Neoisoliquiritin, licoricidin (+)-Licoricidin., Licoricone, formononetin, different ononin, Licurazid, 5-O-methyl licoricidin (+)-Licoricidin., glycyrrhizin-4`-celery glycosyl (1 → 2) glucoside, glycyrrhizin-7,4`-diglucoside.

The Radix Glycyrrhizae sweet in the mouth, property is flat.GUIXIN, lung, spleen, stomach warp.There is invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, alleviate pain relieving, coordinating the actions of various ingredients in a prescription.For weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, gastral cavity abdomen, the anxious pain of extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.The modern pharmacological research data shows, Radix Glycyrrhizae has following pharmacological action: the effect of (1) adrenocortical hormone sample: the glycyrrhizic acid in Radix Glycyrrhizae and preparation thereof and enoxolone can suppress kidney 11-β hydroxyl steroid dehydrogenase (11-OHSD) activity, make the local hydrocortisone of kidney or Corticosterone Level increase and then act on aldosterone receptor and produce the effect of mineralocorticoid sample over the aldosterone level.Also has in addition the effect of glucocorticoid sample; (2) on the impact of digestive system: bismuth glycyrrhetate potassium gavage Dichlorodiphenyl Acetate, water logging stress reach the rat gastric ulcer that pylorus ligation causes all good inhibitory action, but gastric acid secretion inhibiting also reduces pepsic activity.The Licorice root gavage has inhibitory action to rat stomach power, with it, causes that 5-hydroxy tryptamine (5-HT), P-material (SP) are relevant with vasoactive intestinal peptide (VIP) dyssecretosis; (3) antiinflammatory: the acute inflammation of oozing out inflammation and chronic granulation tissue hyperplasia that the mice auricle swelling that the Licorice root subcutaneous injection brings out Oleum Tiglii, acetic acid bring out all has obvious inhibitory action.Where main officer of Tibet is calculated may, owing to strengthening the Pituitary Adrenal s function, increase and the generation antiinflammatory action thereby adrenal hormone is secreted; Prostaglandin E in the effect of enoxolone and inflammation-inhibiting tissue ₂(PGE ₂) generation, antagonism inflammatory mediator histamine, 5-hydroxy tryptamine etc. relevant; (4) antibiotic, antiviral: experiment in vitro shows, Licorice root is to staphylococcus aureus, escherichia coli, Staphylococcus albus, group B streptococcus, Pseudomonas aeruginosa etc.; Licoflavone is to the staphylococcus aureus of methicillin-sensitivity, methicillin-resistant staphylococcus aureus, micrococcus luteus, pneumobacillus etc.; Monosodium glycyrrhetin all has significant inhibitory action to staphylococcus aureus, group B streptococcus, Streptococcus mutans etc.Glycyrrhizin has significant inhibitory action to I type herpes simplex virus (HSV-1), Severe acute respiratory syndrome (SARS) virus, cytomegalovirus and HIV (human immunodeficiency virus) (HIV); Licoflavone is 25 times of glycyrrhizin to the inhibitory action of HIV virus multiplication; Licorice root is to respiratory syncytial virus also inhibitory action; (5) on the impact of cardiovascular system: glycyrrhizin can make rat artery wall solvent body phospholipase A ₂active obviously decline, also can suppress the inflammatory reaction of body and blood vessel wall, prevents arteriosclerotic generation and development.Quiver in the mice chamber that the anti-chloroform of this sour sodium lumbar injection energy of 18 β-Radix Glycyrrhizae brings out, chloroform-epinephrine caused rabbit ventricular arrhythmia, rat ventricular arrhythmia time of occurrence due to prolongation calcium chloride, rat and the Cor Leporis rule that slows down, the heart rate acceleration that part is resisted isoproterenol.In addition, licorice water extract, Radix Glycyrrhizae total flavones and isoliquiritigenin etc. also have antiarrhythmic effect; (6) relieving cough and expelling phlegm: licoflavone, enoxolone and Radix Glycyrrhizae extractum gavage mice ammonia is drawn cough, sulfur dioxide draws to cough that significant antitussive effect is all arranged, what wherein effect was the strongest is enoxolone.The antitussive of liquorice flavonoids compound is all relevant with maincenter and peripheral action.In addition, can also promote throat and bronchial analysis, present the effect of relieving cough and expelling phlegm; (7) removing toxic substances: Radix Glycyrrhizae and preparation thereof are poisoning to some drugs, alimentary toxicosis, interior metabolism product are poisoning certain Detoxication.Mechanism and the glycyrrhizic acid of removing toxic substances with poisonous substance in conjunction be converted into minuent or innocuous substance, glycyrrhizin absorption poisonous substance and epinephrine effect, with and hydrolysis after the enoxolone of generation and glucuronic acid to protect the liver function relevant; (8) antitumor: glycyrrhizin, glycyrrhizic acid, enoxolone etc. have antitumor action in various degree, and its mechanism is relevant with inducing apoptosis of tumour cell, antioxidation, anti-promoting, anti-mutation and immunoregulation effect; (9) other: Radix Glycyrrhizae also has the effects such as antioxidation, antiallergic, raising internal ear auditory function, anti-cerebral ischemia.

(2) the basic technology route determines

We are Chinese medicine compound, with hard capsule, are applied to clinical.According to traditional medication custom, adopt the concentrated method of water boiling and extraction to prepare capsule, beat powder because gained water extraction immersion cream is dry after hygroscopicity strong, be difficult for long preservation, screen by moulding process, add microcrystalline Cellulose can improve powder fluidity as adjuvant, and reduce the extractum hygroscopicity.Said preparation basic technology route is: it is concentrated that above nine flavor medical materials (Radix Notoginseng beats except powder) decoct with water extractions → water extraction liquid, dry must extract powder → add Radix Notoginseng powder and appropriate amount of auxiliary materials, mix homogeneously → filled capsules → polishing → bottling, finished product.

two, medical material pre-treating technology research

Scald Rhizoma Cibotii, Zaocys, Rhizoma Homalomenae, Rhizoma Curcumae Longae, the Radix Paeoniae Alba, Caulis Sinomenii, Radix Glycyrrhizae, Radix Notoginseng for " 2010 editions one one of Chinese pharmacopoeia is recorded product; Heiguteng exract is " Guizhou Province's Chinese crude drug, ethnic drug quality standard (version in 2003) ", and the prescription Chinese crude drug is identified by Korea Spro of No. 2 Affiliated Hospital of Guiyang College of Traditional Chinese Medicine rosy clouds associate professor of pharmacy.

scald Rhizoma Cibotiithis product is Dicksoniaceae plant Rhizoma Cibotii cibotium barometz(L.) dry rhizome of J. Sm., remove silt, removes hard root, petiole and golden yellow fine hair, cuts sheet, and drying is scalded method according to appendix II D of Chinese Pharmacopoeia version in 2010 again, with stir-baking in sand, to heaving, removes remaining fine hair after cooling.

zaocysthis product is Colubridae animal Zaocys zaocys dhumnades(Cantor) dry body.

rhizoma Homalomenaethis product is the aroid Rhizoma Homalomenae homalomena occulta(Lour.) dry rhizome of Schoot, two seasons of spring and autumn excavate, and clean, and remove crust, dry.

heiguteng exractthis product is asclepiadaceae plant Caulis et Radix Periplocae Forrestii periploca forrestii Schltr.dry root.

caulis Sinomeniithis product is the menispermaceous plants Sinomenium acutum sinomenium acutum(Thunb.) Rehd. et Wils. and hair Sinomenium acutum s. acutum(Thunb.) Rehd. et Wils. var. cinereumrehd. the dry rattan of et Wils..Time of the year when autumn changes into winter taps, and binding or cut long section is dried.

radix Notoginsengthis product is panax araliaceae plant panax notoginseng(Burk.) dry root of F. H. Chen and rhizome.Excavate before the flowers are in blossom autumn, cleans, and separates main root, supporting root and rhizome, drying.

rhizoma Curcumae Longaethis product is zingiberaceous plant curcuma longal. dry rhizome.Excavate when stem and leaf is withered winter, cleans, and boils or steam to the saturating heart, dries, and goes out fibrous root.

the Radix Paeoniae Albathis product is the ranunculaceae plant Radix Paeoniae paeonia lactiflorapall. dry root.Summer, Qiu Erji excavate, and clean, and remove end to end and radicula, put in boiling water after boiling after removing crust or peeling and boil, dry.

radix Glycyrrhizaethis product is glycyrrhizic legume glycyrrhiza uralensisfisch., Glycyrrhiza inflata Bat. g. in-

flatabat. or Glycyrrhiza glabra L. g. glabral. dry root and rhizome.

three, the screening of process conditions

(1) Study on extraction

The mensuration of 1 medical material water absorption rate

Take 1/5 recipe quantity medical material (except Radix Notoginseng powder) and amount to 27g, add 10 times of water gagings and soak, soak different time, filter, claim wet medicine weight (till no longer increasing to medical material weight), measure the medical material water absorption rate, formula following (the results are shown in Table 1-1).

mbquality (g) under-medical material water suction saturation

mgthe quality (g) of-medical material under drying regime

From table 1-1, the medical material water absorption rate is 128.15%, for convenience of operation, take water absorption rate as 130% calculating, and the medical material water absorption is heavy 1.3 times of medical material.Therefore should add first the water of 1.3 times of amounts during water extraction.

The quadrature factor of 2 decocting processes

Under the condition that meets the medical material water absorption rate, soak 1h, investigate the principal element of amount of water, decocting time, three impact decoction effects of decoction number of times, by each factor 3 level, use L ₉(3 ⁴) orthogonal table arrangement test (table 2-1).Boiled process adopts orthogonal test to be screened (table 2-2), take the total solid matters yield as investigating index, and extraction process is inquired into.Quadrature variance analysis as a result and factor level analysis in table 2-3, table 2-4.

2.1 test method and result

2.1.1 sample preparation

Take 1/5 recipe quantity medical material (except Radix Notoginseng powder) 27g, by orthogonal test table, tested (table 2-2) (soaking for the first time 1h), medicinal liquid filters, the concentrated 100ml that is settled to.Standby.

2.1.2 the total solid matters yield is measured

From above-mentioned filtrate, each precision is got two parts of 10ml, and to the evaporating dish of constant weight, water bath method, measure according to dry weightless mensuration (" appendix IX G of Chinese pharmacopoeia version in 2010), calculates the total solid matters yield, and formula is as follows.

wfor the weight of solids in 10ml filtrate, vfor constant volume, wtfor the sample weight that feeds intake.

2.2 interpretation of result

Take the total solid matters yield as index, and analyze and can obtain from table 2-3, table 2-4: factor B has statistical significance, is principal element, and factor A, C affect without significance, is secondary cause.With reference to the mean estimated value of B factor level, this test index total solid matters yield height is better, therefore selects B factor level 3; For secondary cause A, B, select A level 1 according to cost-saving and need of production, C level 1, this prescription extraction optimum process condition is: A ₁b ₃c ₁, medical material soaks 1 h, and 8 times of water gagings decoct 3 times (adding for the first time 1.3 times of water gagings), each 0.5 hour.

2.3 the process certification of three batch samples experiment

Get the medical materials such as boiling hot Rhizoma Cibotii, Zaocys, Rhizoma Homalomenae, Heiguteng exract, press optimal extract process A ₁b ₃c ₁extract, measure the total solid matters yield, result shows (in Table 2-5): total solid matters yield meansigma methods is 14.43%, RSD=1.37%, illustrates that process stabilizing is feasible.

3 is concentrated and dry

3.1 the impact of extractum relative density on the extract dry time

Get medical material (except Radix Notoginseng) 1/5 recipe quantity 27 g such as boiling hot Rhizoma Cibotii, Zaocys, Rhizoma Homalomenae, Heiguteng exract, press optimal extract process A ₁b ₃c ₁extract (soaking for the first time 1 h), collecting decoction, decocting liquid is statically placed in ambient temperature overnight, filters, the concentrated 100ml that is settled to.Standby.Precision measures the equivalent extracting solution, and, to different relative densities, in 80 ℃ of constant pressure and dries, time length sees drying concentrated (traditional handicraft is concentrated).The results are shown in Table 3-1.

Result of the test shows: when extractum is concentrated into relative density and is 1.35-1.40, dry shortest time used, and also easy operating, be 1.35-1.40 therefore select extractum is concentrated into to relative density.

3.2 the impact of baking temperature on the extract dry time

Get medical material (except Radix Notoginseng) 1/5 recipe quantity 27 g such as boiling hot Rhizoma Cibotii, Zaocys, Rhizoma Homalomenae, Heiguteng exract, press optimal extract process A ₁b ₃c ₁extract (soaking for the first time 1 h), collecting decoction, decocting liquid is statically placed in ambient temperature overnight, filters, the concentrated 100ml that is settled to.Standby.Precision measures the equivalent extracting solution, and being concentrated into relative density is 1.35-1.40, with different temperatures, different drying mode (constant pressure and dry, drying under reduced pressure), is dried to constant weight, sees drying the time.In Table 3-2.

From table 4-2,80 ℃ of drying under reduced pressure (0.06 MPa) are consuming time few, and extractum is easy to pulverize; 80 ℃ of dryings of normal pressure are consuming time consuming time slightly long than 80 ℃ of drying under reduced pressure.When baking temperature is 90 ℃, because its excess Temperature likely causes the change of its effective ingredient, therefore do not adopt.Consider, select 80 ℃ of constant pressure and dry extractum.

(2) preparations shaping technical study

The preparation of 4 extract powders

Get the medical material of recipe quantity, according to the preferred technique of Golden Crow Jiangu capsule for strengthening bone Study on extraction extracted, concentrated, drying under reduced pressure processes to obtain dry extract.Dry extract is pulverized, and crosses 65 mesh sieves, gets dry extract and soaks powder, moistureproof standby.Different batches Golden Crow Jiangu capsule for strengthening bone Chinese crude drug (except Radix Notoginseng) paste-forming rate experimental data, in Table 4.

Result: by the experiment of 8 batches, its average paste-forming rate is 11.50%.

The selection of 5 adjuvants

5.1 prescription day dose is determined

According to former clinical prescription medical material amount (except Radix Notoginseng), being 135 g, is the dose on the three of being grown up, and the paste-forming rate by 11.50% calculates, it is 6.175 g that the adult takes extractum total amount (containing Radix Notoginseng) every day, draft day taking three to four times, each serving with 4 0# hard capsules, every fills 0.45 g.Substantially meet and former clinical prescription day take the crude drug amount.

5.2 the preparation of the former powder of medicine

According to clinical prescription dosage, this product paste-forming rate and finished product day taking dosage, the ratio of calculating preparation extract powder used and adjuvant is 3.38:1, press pertinent literature, it is adjuvant that seminar selects microcrystalline Cellulose, soluble starch, design 4 different prescriptions, study they and the moisture absorption situation (design is write out a prescription in Table 5-1) of the mixed medicated powder of extract powder and full extract powder.

5.2 the percentile mensuration of medicated powder moisture absorption

Weighing botle is dried to constant weight, and cooling accurately weigh afterwards, add respectively the fine drug powder after above-mentioned mixing, at about 2 mm of even stand, weighing botle bottom thickness, precise weighing.The exsiccator that separately bottom is filled to the NaCl supersaturated solution is put into 25 ℃ of incubator constant temperature 24 h, now, relative humidity in exsiccator is about 75%, powdered medicine bottle after weighing is put into to exsiccator (the weighing bottle cap is opened), respectively at 24,48,72,96h weighs, and is calculated as follows medicated powder moisture absorption percentage rate.

The 2 medicated powder moisture absorption percentage rate reductions of writing out a prescription show at most microcrystalline Cellulose anti humility performance optimum, therefore determine its adjuvant as this capsule.

5.3 the former powder physical characteristic of medicine is investigated

Prepare 1 batch of former powder of Golden Crow Jiangu capsule for strengthening bone by technique, measure critical relative humidity, stop than angle and bulk density, to investigate production process, to the ambient humidity requirement, the mobility of medicated powder and capsule loading amount.

5.3.1 the critical relative humidity of the former powder of medicine is measured

Hard capsule filling environment humidity is very large on hard capsule fill impact, is necessary to measure the critical relative humidity of the former powder of Golden Crow Jiangu capsule for strengthening bone.At the about former powder of 2 mm of the weighing botle bottom tiling thickness of constant weight, at P ₂o ₅in exsiccator, be placed to constant weight, prepare altogether 7 duplicate samples, be placed in respectively in the drying receptacle that fills variable concentrations sulphuric acid and different salt supersaturated solutions (the weighing bottle cap is opened), in 25 ℃ of constant incubators, keep weighing after 7 d, calculate former powder hydroscopicity, in Table 5-2.

6 packings

The sealing in medicinal high density polyethylene packaging bottle of packing into of populated capsule is preserved, investigate through preliminarily stabilised, room temperature (relative humidity is controlled at 62%) is lower preserves 13 months, and capsule still keeps neatly, without adhesion, is out of shape hardening, the phenomenon such as break.Content is without the moisture absorption, air slaking, stiff, the phenomenon such as spoiled of luming.

7 pilot scales

Carry out 10 times of productions of three batches of amplifications by working out preparation process condition, the production technology index is carried out to comprehensive assessment, medical material and finished product are carried out to performance rating, investigate this product preparation technology's reasonability.By data show in table 7, should produce 10000 finished products by fed intake theory, capsule finished product net yield is not less than 85%.The explained hereafter condition meets the large production requirement of factory, and operability is stronger, and finished product, medical material, semi-manufactured goods quality are controlled, and end product quality is stable.Pilot scale processing parameter and pilot product Quality Checkout Data, in Table 7.

table 7 pilot scale processing parameter and pilot product quality testing data

experiment two: clinical drug efficacy study

1 clinical data

1.1 the routine RA patient of physical data 90 is my institute's Rheumatism Dept. outpatient service and inpatient, by table of random number, carries out Unified number, is divided into two groups, treatment group 90 example and matched group 30 examples.Male 18 examples in treatment group 90 examples, female's 42 examples, 16～70 years old age, average 51.78 ± 14.67 years old; The course of disease is the longest 21 years, the shortest 6 months, and average 4.83 ± 5.14; The function of joint classification is formulated standard with reference to ACR ^[1]: I level 22 examples, II level 14 examples, III level 10 examples, IV level 14 examples.Male 11 examples in matched group 30 examples, female's 19 examples, 16～69 years old age, average 50.71 ± 15.13 years old; The course of disease is the longest 19 years, the shortest 6 months, and average 5.44 ± 3.91; Function of joint classification I level 11 examples, II level 8 examples, III level 7 examples, IV level 4 examples.The clinical datas such as two groups of patient ages, sex, the state of an illness, function of joint distribute without significant difference ( p>0.05).

1.2 diagnostic criteria

The Western medicine diagnose standard, the RA criteria for classification of promulgating in 1987 by American Rheumatism Association ^[2];

morning, deadlock was at least 1 hour, continued at least 6 weeks.

3 or 3 above swollen joints, continued at least 6 weeks.

wrist, metacarpophalangeal joints or proximal interphalangeal joint are swollen, continue at least 6 weeks.

the symmetry swollen joint, continued at least 6 weeks.

subcutaneous nodule.

the change of x-ray.

the rheumatoid factor positive, titer>1:32.

Possess more than 4 or 4 and can make a definite diagnosis rheumatoid arthritis in above 7.

The Syndrome Classification standard is pressed Ministry of Public Health " new Chinese medicine treatment rheumatoid arthritis guideline of clinical investigations ", and card belongs to the kidney qi asthenic cold type ^[3].

Primary symptom: joint cold type of pain and swelling, pain increase in intensity under coldness, pain alleviated while getting warmth, the joint joint stuffiness, morning deadlock, joint deformity.

Inferior disease: tastelessness and no thirst, aversion to wind and cold, overcast and rainy increasing the weight of, limbs are heavy.

The tongue arteries and veins: pale tongue, tongue is white, a little less than deep-thready pulse.

1.3 inclusive criteria is the masculinity and femininity patient in age 16-70 year (1); (2) the criteria for classification and the tcm diagnosis standard that meet RA, card belongs to the kidney qi asthenic cold type; (3) with other impact, do not treat and detect the disease of index; (4) be willing to the therapist of being checked.(5) participated in the Informed Consent Form of this test by the agreement of patient or its family members (guardian) signature.

1.4 exclusion standard ?(1) except the regulation medication, long-term taking is treated Western medicine or the other drug person of not withdrawing of primary disease; (2) merge intentionally, the serious disease persons such as brain, liver, renal insufficiency and hemopoietic system; (3) the age is person below 16 years old or more than 70 years old; (4) gestation or women breast-feeding their children; (5) allergic constitution, or those who are allergic to this drug; (6) according to the judgement of researcher, think and should not those selected.

1.5 reject and the case rejecting case that comes off: (1) do not meet inclusive criteria and the person of being included into; (2) not medication in accordance with regulations, can't judge curative effect, or data not umbra ring curative effect or safety judgement person.The judgement come off: screen the qualified patient who enters test, all have the right to exit at any time clinical trial, no matter when what is because exiting, and as long as no completing, clinical trial is omnidistance to be observed, and is the case that comes off.Case management comes off: after the patient comes off, contact with the patient as far as possible, complete the evaluation item that can complete, record as far as possible last medicine time.To because untoward reaction comes off, whether relevant with trial drug through following up a case by regular visits to last judgement.

research method

2.1 Therapeutic Method treatment group: oral Golden Crow Jiangu capsule for strengthening bone (Drug Manufacturing Room of the court produce, lot number: 050203,051223), each 4, every day 3 times; Matched group: oral rheumatoid arthritis sheet [the good nurse's Pharmaceutical in Liaoning (group) Co., Ltd produces, lot number: 050306,060103], each 4, every day 3 times.Two groups for the treatment of times are 2 months.

2.2 observation item

(1) tcm symptom sign (in Table 1), clinical symptoms and function of joint: arthralgia or tenderness number, arthroncus number, stiff time in morning, the average grip of both hands; (2) lab testing: rheumatoid factor (RF), erythrocyte sedimentation rate (ESR), C reactive protein (CRP); (3) safety detects: blood, urine, stool routine examination, hepatic and renal function, rabat, electrocardiogram etc.; (4)) x-ray is taken the photograph sheet: the positive bit slice in both hands joint, read sheet by the blind method of radiologist.

2.3 curative effect determinate standard is clinic control (1): cardinal symptom, the whole improvement rate of sign >=75%, erythrocyte sedimentation rate and c reactive protein normally or obviously improve or approach normal; (2) produce effects: cardinal symptom, the whole improvement rate of sign >=50%, erythrocyte sedimentation rate and c reactive protein are improved; (3) effective: the whole improvement rate of cardinal symptom, sign >=30%, erythrocyte sedimentation rate and c reactive protein are improved or without improvement; (4) invalid: cardinal symptom, the whole improvement rate of sign<30%, erythrocyte sedimentation rate and c reactive protein are without improvement.

Cardinal symptom, sign refer to the stiff time of arthralgia number, arthroncus number, morning (minute), 5 of pain level and function of joint classifications etc.Whole improvement rate refers to the percentage rate that improves of above 5 indexs: (before treatment-treatment is rear)/the front value for the treatment of * 100%, ask its meansigma methods after addition.

The tcm syndrome curative effect is concluded standard:

Clinic control: tcm clinical practice symptom, sign disappear, and the syndrome integration reduces >=95%.

Produce effects: tcm clinical practice symptom, sign are obviously improved, and the syndrome integration reduces >=70%.

Effectively: tcm clinical practice symptom, sign all are improved, and the syndrome integration reduces >=30%.

Invalid: tcm clinical practice symptom, sign all are not improved, even increase the weight of, the syndrome integration reduces not enough >=30%.

Computing formula (nimodipine method): [integration before integration after integration before treatment-treatment/treatment] * 100%.

2.4 statistical method adopt the SPSS17.0 software analysis, the measurement data data are used

± S means, between two groups measurement data relatively with the t check, the enumeration data rate relatively use χ ²check, ranked data adopt Ridit to analyze.

2.5 effectiveness and safety evaluatio (1) efficiency evaluation: detect respectively the curative effect index such as ESR, CRP, RF before treatment and after treatment, and carry out the semiotics scoring.(2) safety evaluatio: detect the safety indexes such as routine blood test, routine urinalysis, stool routine examination, hepatic and renal function before treatment and after treatment, carry out safety evaluation.

result

Statistics after 3.1 the treatment of case dropping situations case dropping situations finishes, treatment group, matched group are all without the case that comes off.

3.2 Clinical efficacy comparison treatment group clinic control 15 examples, produce effects 17 examples, effective 14 examples, invalid 14 examples, total effective rate is 76.7%; Matched group clinic control 4 examples, produce effects 7 examples, effective 8 examples, invalid 11 examples, total effective rate is 63.3%, two group relatively statistical significance (P<0.05).

3.3 before and after two groups of patient treatments traditional Chinese medical science disease integral contrast in Table 1, table 2, primary symptom, inferior disease all have clear improvement (P<0.05 or P<0.01) after two groups of patient treatments, except arthralgia and joint, do cold two diseases, all the other indices treatment groups all are better than matched group (P<0.05).

3.6 untoward reaction do not occur in the routine patient treatment process of safety evaluatio treatment group 60.In the routine patient treatment process of matched group 30, untoward reaction 4 examples (13.33%) appear, gastrointestinal reaction 2 examples wherein, transaminase's 1 example that slightly raises, menolipsis 1 example.Two groups of patients recover normally after anti symptom treatment, not impact treatment.

conclusion

RA belongs to motherland's medical science " arthromyodynia " category, "Nei Jing" has proposed the earliest wind-cold damp pathogen and body and " in outer, has been harmonious " and causes the viewpoint of numbness, think in " wet three gas of wind and cold mix to combined into numbness also ", point out that it occurs except the invasion and attack of the wet exopathogen of wind and cold, also relevant with the positive QI-insufficiency of body.Chinese medicine is treated the history that more than one thousand years is arranged to RA, remarkable because of clinical efficacy, toxic and side effects is little, day by day is subject to people's attention.Golden Crow Jiangu capsule for strengthening bone is that the Miao in Guizhou compatriot is used for the treatment of for a long time arthromyodynia one of experience side is arranged, and as inventor's prescription of reaching an agreement on, my institute's Rheumatism Dept. is used for the treatment of RA and has shown better clinical efficacy.Medicine scalds the compositions such as Rhizoma Cibotii, Caulis Sinomenii, Heiguteng exract, Rhizoma Homalomenae, Zaocys, Radix Notoginseng, the Radix Paeoniae Alba, Rhizoma Curcumae Longae, Radix Glycyrrhizae.The invigorating the liver and kidney of monarch drug Rhizoma Cibotii, strong spinal column, wind-damp dispelling, the Zaocys wind-damp dispelling, restore menstrual flow and invigorate blood circulation; Ministerial drug Rhizoma Homalomenae, Heiguteng exract, little cyanine Radix seu Caulis fici Martinii wind-expelling pain-stopping, strengthening the tendons and bones; Adjuvant drug Radix Notoginseng, Rhizoma Curcumae Longae promoting blood circulation and stopping pain; Make the medicine Radix Paeoniae Alba, the Radix Glycyrrhizae stomach function regulating that nourishes blood, relieving spasm to stop pain.Full side has the effect of reinforcing the kidney to strengthen the bone, promoting blood circulation, dredging meridian and relieving pain, make that muscles and bones is strong, loose through ruton, strongly fragrant heresy, blood stasis, heresy is moved back and is not just being hindered, from the kidney invigorating, strong muscle, strong bone, invigorate blood circulation, nourish blood, dispel the wind, the multi-angle prescriptions such as dredging collateral, analgesic therapy, shape is loose and power is special, coordinates precise and appropriate.In the strong bone side of the clinical research confirmation Golden Crow in early stage, the treatment to RA has good efficacy for we, especially alleviate RA patient clinical symptom, reduce antirheumatic and shown clinical efficacy preferably as the toxic and side effects aspect of methotrexate etc., it is furtherd investigate, inquire into its treatment mechanism, improve treatment, the quality of making the life better of RA, there is wide potential applicability in clinical practice.Show that by this group data Golden Crow Jiangu capsule for strengthening bone is evident in efficacy to the RA patient clinical, can alleviate RA patient clinical sings and symptoms, reduce the inflammatory parameters such as erythrocyte sedimentation rate, c reactive protein, clinical efficacy is better than the rheumatoid arthritis sheet.

, model case

Left so-and-so, female, 42 years old, the grade teacher, (outpatient service number: 1180873) of going to a doctor in April, 2006.The patient extremity multi-joint symmetry pain occurred without obvious inducement before 3 years, being carrying out property increases the weight of, look into the RF positive in outer court, the anti-CCP positive, diagnosis RA, give the intravenous injection methotrexate, oral English is the treatments such as green grass or young crops, leflunomide, Glucosidorum Tripterygll Totorum too, it is not obvious that arthralgia is alleviated, and erythrocyte sedimentation rate, c reactive protein continue to raise, and turns to control that many hospital's curative effects are not good enough inside and outside the province.Both hands carpal joint and metacarpophalangeal joints are out of shape gradually, and doctor advised adds uses biological preparation, and the patient, because of the application of economic cause refusal, introduces by friend my section of going to a doctor.Look into: both hands metacarpophalangeal joints, proximal interphalangeal joint, carpal joint and double knee joint swelling, sharp ache, meet cold increasing the weight of, soreness of the waist and knees, the part joint deformity, moving obstacle, can't take care of oneself, and the X sheet shows both hands interphalangeal joint narrow gaps, the bone destruction of part joint, routine blood test shows HGB:81g/L, PLT:372 * 10 ⁹/ L, ESR:102mm/h, CRP:86mg/L, RF:320IU/L.Pale tongue, tongue is greasy in vain, a little less than deep-thready pulse.Tcm diagnosis: arthromyodynia belongs to the kidney qi deficiency and coldness.Western medicine diagnose: rheumatoid arthritis.Reinforcing the kidney to strengthen the bone is given in Chinese traditional treatment, promoting blood circulation to remove obstruction in the collateral, oral Golden Crow Jiangu capsule for strengthening bone (medicine is comprised of boiling hot Rhizoma Cibotii, Zaocys, Rhizoma Homalomenae, Heiguteng exract, Caulis Sinomenii, Radix Notoginseng, Rhizoma Curcumae Longae, the Radix Paeoniae Alba, Radix Glycyrrhizae etc.), each 4, every day 3 times, arthralgia slightly subtracts, after taking January, the diet multiplication, arthralgia obviously alleviates.Continue and take 2 months, arthroncus disappears, and pain is not obvious, improving action, and the check routine blood test is normal, ESR:21mm/h, CRP:2.7mg/L.After continuing conditioning after treatment half a year, all diseases are eliminated substantially, and physical recovery is good.

The specific embodiment

embodiment 1:raw material: scald Rhizoma Cibotii 312.5g Zaocys 208.3g Rhizoma Homalomenae 312.5g

Heiguteng exract 187.5g Caulis Sinomenii 625.0g Radix Notoginseng 62.5g Rhizoma Curcumae Longae 416.7g Radix Paeoniae Alba 625.0g Radix Glycyrrhizae 125.0g microcrystalline Cellulose 85g

Preparation method: it is standby that Radix Notoginseng breaks into fine powder, the water soaking that all the other 8 flavor medicines add 9.3 times of amounts for the first time decocted 0.5 hour after 1 hour, the decocting that second and third time respectively adds 8 times of amounts boils, and each 0.5 hour, merges decocting liquid 3 times, filter, it is 1.35～1.40(60 ℃ that the filtrate normal pressure is concentrated into relative density) thick extractum, be placed in 80 ℃ of constant pressure and dries, broken mistake 65 mesh sieves of dried cream powder are mixed homogeneously with Radix Notoginseng powder, microcrystalline Cellulose, the 0# hard capsule of packing into makes 1000 of hard capsules, obtains Golden Crow Jiangu capsule for strengthening bone.

Usage and dosage: oral, 3 times on the one, each 4.

embodiment 2:raw material: scald Rhizoma Cibotii 200g Zaocys 100g Rhizoma Homalomenae 200g Heiguteng exract 150g Caulis Sinomenii 500g Radix Notoginseng 40g Rhizoma Curcumae Longae 300g Radix Paeoniae Alba 500g Radix Glycyrrhizae 80g microcrystalline Cellulose 60g

Preparation method: it is standby that Radix Notoginseng breaks into fine powder, the water soaking that all the other 8 flavor medicines add 9.3 times of amounts for the first time decocted 0.5 hour after 1 hour, the decocting that second and third time respectively adds 8 times of amounts boils, and each 0.5 hour, merges decocting liquid 3 times, filter, it is 1.35～1.40(60 ℃ that the filtrate normal pressure is concentrated into relative density) thick extractum, be placed in 80 ℃ of constant pressure and dries, broken mistake 65 mesh sieves of dried cream powder are mixed homogeneously with Radix Notoginseng powder, microcrystalline Cellulose, the 0# hard capsule of packing into makes hard capsule, obtains Golden Crow Jiangu capsule for strengthening bone.

Usage and dosage: oral, 3 times on the one, each 4.

embodiment 3:raw material: scald the Rhizoma Cibotii 400g Zaocys 300g Rhizoma Homalomenae 400g Heiguteng exract 350g Caulis Sinomenii 700g Radix Notoginseng 100g Rhizoma Curcumae Longae 500g Radix Paeoniae Alba 700 g Radix Glycyrrhizae 160g microcrystalline Cellulose 110g

Preparation method: it is standby that Radix Notoginseng breaks into fine powder, the water soaking that all the other 8 flavor medicines add 9.3 times of amounts for the first time decocted 0.5 hour after 1 hour, the decocting that second and third time respectively adds 8 times of amounts boils, and each 0.5 hour, merges decocting liquid 3 times, filter, it is 1.35～1.40(60 ℃ that the filtrate normal pressure is concentrated into relative density) thick extractum, be placed in 80 ℃ of constant pressure and dries, broken mistake 65 mesh sieves of dried cream powder are mixed homogeneously with Radix Notoginseng powder, microcrystalline Cellulose, the 0# hard capsule of packing into makes hard capsule, obtains Golden Crow Jiangu capsule for strengthening bone.

Usage and dosage: oral, 3 times on the one, each 4.

Claims (3)

1. a Chinese medicinal capsule for the treatment of rheumatoid arthritis, it is characterized in that: according to listed as parts by weight, it is to be prepared from by boiling hot Rhizoma Cibotii 200～400g, Zaocys 100～300g, Rhizoma Homalomenae 200～400g, Heiguteng exract 150～350g, Caulis Sinomenii 500～700g, Radix Notoginseng 40～100g, Rhizoma Curcumae Longae 300～500g, the Radix Paeoniae Alba 500～700g, Radix Glycyrrhizae 80～160g, microcrystalline Cellulose 60～110g.

2. treat according to claim 1 the Chinese medicinal capsule of rheumatoid arthritis, it is characterized in that: according to listed as parts by weight, it is to be prepared from by boiling hot Rhizoma Cibotii 312.5g, Zaocys 208.3g, Rhizoma Homalomenae 312.5g, Heiguteng exract 187.5g, Caulis Sinomenii 625.0g, Radix Notoginseng 62.5g, Rhizoma Curcumae Longae 416.7g, Radix Paeoniae Alba 625.0g, Radix Glycyrrhizae 125.0g, microcrystalline Cellulose 85g.

3. the preparation method of the Chinese medicinal capsule of the described treatment rheumatoid arthritis of claim 1 or 2, it is characterized in that: it is standby that Radix Notoginseng breaks into fine powder, the water soaking that all the other 8 flavor medicines add 9.3 times of amounts for the first time decocted 0.5 hour after 1 hour, the decocting that second and third time respectively adds 8 times of amounts boils, each 0.5 hour, merge 3 times decocting liquid, filter, the filtrate normal pressure is concentrated into the thick extractum that relative density is 1.35～1.40, be placed in 80 ℃ of constant pressure and dries, broken mistake 65 mesh sieves of dried cream powder are mixed homogeneously with Radix Notoginseng powder, microcrystalline Cellulose, the hard capsule and get final product of packing into.