CN100333758C - Gout resisting Chinese medicine composition and its prepn process - Google Patents
Gout resisting Chinese medicine composition and its prepn process Download PDFInfo
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Abstract
The present invention discloses a traditional Chinese medicine composition for resisting gout and a preparation method thereof. The composition is prepared from 90 shares of rhubarb, 30 shares of ethanol extract of tetrandria root, 60 shares of plantain seed, 60 shares of oriental waterplantain rhizome, 60 shares of water extract of medicinal cyathula root and general supplementary materials with appropriate quantity. In the preparation method, a. weighing is carried out to the weight proportion; b. tetrandria root is pulverized into crude powder and is heated and is extracted fro two times through backflow with 95% of ethanol, and dry extract 1 is obtained by vacuum dryness after filtrate is concentrated; c. rhubarb is heated and is extracted for two times through backflow with 70% of ethanol, and filtrate 2 is obtained through filtration; d. plantain seed, oriental waterplantain rhizome and medicinal cyathula root are decocted for two times with water, and filtrate 3 is obtained through filtration; e. the filtrate 2 and the filtrate 3 are merged, and dry extract 4 is obtained by drying after pressure reduction and concentration; f. the dry extract 1 and the dry extract 4 are mixed, supplementary materials with appropriate quantity are added, and granules are prepared and are pressed into tablets or encapsulated. The present invention has the advantages of high bioavailability of medicinal materials, good medicine effect and small dose.
Description
Technical field
The present invention relates to a kind of medicine of gout, be meant a kind of Chinese medicine composition of gout especially, the invention still further relates to the preparation method of this Chinese medicine composition.
Background technology
Uric acid is deposited on connective tissue and forms tophus, and average time of occurrence is 10 years; Involve the many joints of upper and lower extremities through 10～20 years, false rheumatoid arthritis can occur.Because arthritis is frequently shown effect, urate increases in the intraarticular calmness, and arthroncus continues and can not disappear, joint deformity or stiff, and joint motion is restricted.Simultaneously in the sclerotin in joint, synovial membrane, toughness and the subcutaneous of ear-lobe have tophus to form, and through the direct touch of skin tangible tenderness can be arranged, the urate crystal of adularescent is discharged behind the ulceration.The patient who has also can have renal function to go down and complication such as crown arteriosclerosis, hypertension.Along with the great variety of people's dietary structure, the sickness rate of gout is raising year by year.Male more than 40 years old gets gout often, and wherein the overwhelming majority all is that dinner party at ordinary times is many, motion is few, and many people with obesity.A lot of people began to get fat in the middle age, and in daily life, and feed too much consumes very fewly, causes excess fat at subcutaneous, abdominal part or internal organs repertory.When tired, hungry, health can be employed the fat that stockpiles and produce heat for the body activity, and the ketoboidies that fat this moment " burning " produces has hindered the drainage of blood uric acid, serum uric acid level is increased, and bring out gout.
Gout system is by the resistance of the turbid damp stasis of blood, and the joint meridians of being detained are due to QI and blood is not smooth.Clinical anti-gout drugs commonly used has colchicine, probenecid, allopurinol etc. at present, but its side effect is bigger, and according to Chinese medical discrimination, China patient's medication custom etc., the patient more presses for the Chinese patent medicine of determined curative effect.Gout relieving capsule determined curative effect, taking convenience, be the exclusive product of the green pharmaceutcal corporation, Ltd in Qinghai, the gout relieving capsule has effect, its monarch drug monarch wood of promoting blood circulation to restore menstrual flow, promoting diuresis to eliminate damp pathogen, reducing swelling and alleviating pain and pricks (Radix Et Rhizoma Rhei) stasis removing, purging fire and cooling blood, blood circulation promoting and blood stasis dispelling, is applicable to various Baconic's diseases of catharsis, grand disease; The ministerial drug tower is appointed wood (Semen Plantaginis), Rhizoma Alismatis promoting diuresis to eliminate damp pathogen, and treating stranguria purging heat cures mainly swollen, the arthralgia of grand foot sick, that the sick guiding of Baconic rises; Expelling wind and removing dampness, pain relieving diuretic such as adjuvant drug Radix Stephaniae Tetrandrae; Blood circulation promoting and blood stasis dispelling such as messenger drug Radix Cyathulae, priming is descending, invigorating the liver and kidney, treating stranguria puckery.All medicines share, and can control goat.The prescription and the method for making of gout relieving capsule are as follows: [prescription] Radix Et Rhizoma Rhei 90g, Semen Plantaginis 60g, Rhizoma Alismatis 60g, Radix Cyathulae 60g, Radix Stephaniae Tetrandrae 30g; [method for making] above five tastes are ground into fine powder, and mixing incapsulates, promptly.[usage and dosage] is oral, one time 2～4,3 times on the one, one after each meal.
Though extensive patients is good to gout relieving capsule reflection, because of capsule is that pulverizing medicinal materials is directly adorned capsule, medical material does not pass through any leaching process, and bioavailability is relatively poor, and dose is bigger, is 6～12/day, fails to bring into play best the effectiveness of this prescription.The present inventor is a curative effect of improving this kind, improves the bioavailability of medical material, and former technology is made amendment, and works out rational technical process by the experimental study screening, and the effective ingredient in the medical material is carried out purification, makes medicine bring into play drug effect better.
Summary of the invention
One of them purpose of the present invention is to provide the Chinese medicine composition of the less a kind of gout of a kind of bioavailability height, good drug efficacy, dose of medical material.
Another object of the present invention is to provide a kind of preparation method of this Chinese medicine composition.
Last purpose of the present invention is achieved in that a kind of Chinese medicine composition of gout, be that water extract by the alcohol extract of 90 parts of Radix Et Rhizoma Rhei, 30 parts of Radixs Stephaniae Tetrandrae and 60 fens Semen Plantaginiss, 60 portions of Rhizoma Alismatis, 60 portions of Radix Cyathulaes adds an amount of adjuvant commonly used and makes, the deal of above-mentioned each crude drug is a weight portion.
Medicine described in the Chinese medicine composition of above-mentioned a kind of gout is tablet or capsule.
Back of the present invention one purpose is achieved in that a kind of preparation method of Chinese medicine composition of gout, comprises the steps:
A) take by weighing Radix Et Rhizoma Rhei, Semen Plantaginis, Rhizoma Alismatis, Radix Cyathulae, Radix Stephaniae Tetrandrae by weight proportion, standby;
B) Radix Stephaniae Tetrandrae is ground into coarse powder, extracts secondary with 90～95% alcohol heating reflux, merge extracted twice liquid, filter, filtrate is concentrated into the extractum of 1.20～1.30/60 ℃ of relative densities, and the dry dry extract 1 that gets is standby;
C) Radix Et Rhizoma Rhei is extracted secondary with 65～75% alcohol heating reflux, merge extracted twice liquid, filter to get filtrate 2, standby;
D) with Semen Plantaginis, Rhizoma Alismatis, Radix Cyathulae three flavor Chinese crude drugs, decoct with water secondary, merge decocting liquid twice, filter to get filtrate 3, standby;
E) above-mentioned filtrate 2 and filtrate 3 are merged, be concentrated into relative density and be 1.20/60 ℃ extractum, dry dry extract 4, standby;
F) above-mentioned dry extract 1, dry extract 4 are mixed, add appropriate amount of auxiliary materials, make granule, suppress in flakes or load into capsule.
Add for the first time 6 times of amount ethanol in the preparation method of the Chinese medicine composition of above-mentioned a kind of gout in the step b), add 5 times of amount ethanol for the second time, each heating and refluxing extraction 1.5 hours.
Add for the first time 6 times of amount ethanol in the preparation method of the Chinese medicine composition of above-mentioned a kind of gout in the step c), heating and refluxing extraction 1.5 hours adds 5 times of amount ethanol for the second time, heating and refluxing extraction 1 hour.
For the first time add 8 times of water gagings in the step d) in the preparation method of the Chinese medicine composition of above-mentioned a kind of gout, decocted 2 hours, add 6 times of water gagings for the second time, decocted 1.5 hours.
The present invention by adopting different extracting method to extract its effective ingredient to raw medicinal material, can better bring into play drug effect after refining the purification, has improved the bioavailability of raw medicinal material, easier being absorbed by the body according to the character of the effective ingredient of each medical material; Simultaneously, because the extraction of effective ingredient and concentrated makes the content of dispersion of every of Chinese medicine composition of the present invention (grain) be equivalent to former capsular twice, dose reduces by one times, reduces to 1～2 from take 2～4 at every turn, has made things convenient for taking of patient.From the drug effect that Chinese medicine preparation of the present invention is correlated with, the experimental study of toxicity, the result shows that this product is compared with former gout relieving capsule, and drug effect is stronger, and does not see toxic reaction; For extensive patients provides a kind of more fine gout medication.
The specific embodiment
The capsule preparation of embodiment 1 Chinese medicine composition of the present invention
A) take by weighing Radix Et Rhizoma Rhei 180g, Semen Plantaginis 120g, Rhizoma Alismatis 120g, Radix Cyathulae 120g, Radix Stephaniae Tetrandrae 60g by weight proportion, standby;
B) Radix Stephaniae Tetrandrae is ground into coarse powder, extract secondary with 95% alcohol heating reflux, add for the first time 6 times of amount ethanol, add for the second time 5 times of amount ethanol, each heating and refluxing extraction 1.5 hours merges extracted twice liquid, filter, filtrate is through being evaporated to the extractum of 1.20～1.30/60 ℃ of relative densities, and vacuum drying gets dry extract 1, and is standby;
C) Radix Et Rhizoma Rhei is extracted secondary with 70% alcohol heating reflux, add 6 times of amount ethanol for the first time, extracted 1.5 hours, add 5 times of amount ethanol for the second time, each heating and refluxing extraction 1 hour merges extracted twice liquid, filters to get filtrate 2, and is standby;
D) with Semen Plantaginis, Rhizoma Alismatis, the Radix Cyathulae three flavor Chinese crude drugs of above-mentioned weight, decoct with water secondary, add 8 times of water gagings for the first time, decocted 2 hours, add 6 times of water gagings for the second time, decocted 1.5 hours, merge decocting liquid twice, filter to get filtrate 3, standby;
E) above-mentioned filtrate 2 and filtrate 3 are merged, be evaporated to relative density and be 1.20/60 ℃ extractum, vacuum drying gets dry extract 4, and is standby;
F) above-mentioned dry extract 1, dry extract 4 are mixed, add appropriate amount of auxiliary materials, make granule, load into 1000 capsules.
The preparation tablets of embodiment 2 Chinese medicine compositions of the present invention
Substantially the same manner as Example 1, not existing together is f) above-mentioned dry extract 1, dry extract 4 are mixed, add appropriate amount of auxiliary materials, make granule, be pressed into 1000 tablets of tablets.
The instructions of taking of above-mentioned capsule or tablet and consumption: oral, one time 1～2 (sheet), three times on the one.
Experimental example 1 effect experiment
Chinese medicine composition of the present invention all has significant analgesia role to glacial acetic acid lumbar injection and thermostimulation induced mice pain.Glacial acetic acid induced mice abdominal cavity capillary permeability is increased and acute inflammation model such as the swelling of rat carrageenan toes, dimethylbenzene induced mice auricle edema all has obvious inhibitory action.The bullate subacute inflammation model of rat granuloma also there is certain inhibitory action.Employing micro-crystal type uric acid sodium brings out rabbit acute arthritis model, micro-crystal type uric acid sodium causes the naked arthroncus method of rat and hypoxanthine causes the mice hyperuricemia model, observe the gout effect of Chinese medicine composition of the present invention, the result shows: Chinese medicine composition of the present invention can obviously reduce leukocytic quantity in the rabbit synovial membrane liquid, alleviates synovial tissue's edema degree, reduce the infiltration of inflammatory cell, suppress micro-crystal type uric acid sodium and induce the swelling of rat toes, and can obviously reduce hyperuricemia mice serum uric acid level.The above pharmacological testing of Chinese medicine composition of the present invention shows that this medical instrument has the effect of analgesia, antiinflammatory, gout, for the clinical goat that is used for due to the dampness and heat stasis provides experimental basis.
Experimental example 2 acute toxicity testings
The application mice carries out acute toxicity testing and shows: mice oral administration gavage Chinese medicine composition of the present invention (tablet) is under 57.2g crude drug/kg dosage, the light activity minimizing appears in the 30min mice after the administration, recover normal about 2 hours, observed 7 days continuously after the administration, none animal dead, its overall health of patients, diet, to take the photograph water, defecation and body weight gain all normal, and experimental result shows: mice oral administration gavage Chinese medicine composition of the present invention (tablet) maximum dosage-feeding is 57.2g crude drug/kg/d (LD
50＞57.2g crude drug/kg).Chinese medicine composition of the present invention (tablet) the clinical application total amount of being grown up every day is 0.06g crude drug/kg/d; Press weighing machine, mouse stomach Chinese medicine composition of the present invention (tablet) dosis tolerata is 953 times of clinical adult's consumption.Point out this medicine acute toxicity low, clinical drug safety.
Experimental example 3 long term toxicity tests
Select the SD rat for use, give variable concentrations (0.9,2.7, the Chinese medicine composition of the present invention (tablet) of 8.1g crude drug/kg), every day gastric infusion once, continuous 90 days, respectively organized 10 animals (male and female half and half) extremely that live in 24 hours after the last administration, all the other 10 animals continuation observation 2 all backs are extremely alive.Duration of test is observed outward appearance, general behavior, the body weight change of animal, after the administration 90 days and carry out hematology's (RBC, HCT, MCV, MCH, MCHC, HB, PLT, CT, WBC and classification, reticulocyte, clotting time) in 2 weeks of drug withdrawal and index inspections such as serum biochemistry (AST, ALT, ALP, Glu, BUN, Crea, TP, T.BIL, ALB, GLOB, A/G, CHOL), urine biochemistry, organ coefficient, histopathology.Result of the test shows: each treated animal general state is good, all no abnormal variation of outward appearance sign, behavioral activity, body weight gain; Three dosage groups and matched group hematological examination, blood biochemical are learned, the urine biochemical analysis is all in normal range, do not have significant difference between group; Each is organized main organs and organizes and do not see that pathology relevant with medicine change.The These parameters drug withdrawal is not seen change after 2 weeks yet.This test dosage is respectively 15,45,135 times of clinical medicine dose, show according to result of the test: basic, normal, high three dosage of Chinese medicine composition of the present invention (0.9,2.7, the 8.1g crude drug/kg) administration in continuous 90 days does not have obvious influence to rat, no clear and definite toxicity target organ and sensitive indicator, convalescent period observes and does not also see the retardance toxic reaction, and the dosage safety of prompting this product clinical practice is higher.
Claims (6)
1. the Chinese medicine composition of a gout is that water extract by the alcohol extract of 90 parts of Radix Et Rhizoma Rhei, 30 parts of Radix Stephaniae Tetrandrae and 60 fens Semen Plantaginiss, 60 portions of Rhizoma Alismatis, 60 portions of Radix Cyathulaes adds an amount of adjuvant commonly used and makes, and the deal of above-mentioned each crude drug is a weight portion.
2. Chinese medicine composition according to claim 1 is characterized in that described medicine is tablet or capsule.
3. the preparation method of the Chinese medicine composition of the described gout of claim 2, its feature comprises the steps:
A) take by weighing Radix Et Rhizoma Rhei, Semen Plantaginis, Rhizoma Alismatis, Radix Cyathulae, Radix Stephaniae Tetrandrae by weight proportion, standby;
B) Radix Stephaniae Tetrandrae is ground into coarse powder, extracts secondary with 90～95% alcohol heating reflux, merge extracted twice liquid, filter, concentrating filter liquor is to the extractum of 1.20～1.30/60 ℃ of relative densities, and dry dry extract 1 is standby;
C) Radix Et Rhizoma Rhei is extracted secondary with 65～75% alcohol heating reflux, merge extracted twice liquid, filter to get filtrate 2, standby;
D) with Semen Plantaginis, Rhizoma Alismatis, Radix Cyathulae three flavor Chinese crude drugs, decoct with water secondary, merge decocting liquid twice, filter to get filtrate 3, standby;
E) above-mentioned filtrate 2 and filtrate 3 are merged, be concentrated into relative density and be 1.20/60 ℃ extractum, dry dry extract 4, standby;
F) above-mentioned dry extract 1, dry extract 4 are mixed, add appropriate amount of auxiliary materials, make granule, suppress in flakes or load into capsule.
4. preparation method according to claim 3 is characterized in that adding for the first time in the step b) 6 times of amount ethanol, adds 5 times of amount ethanol for the second time, each heating and refluxing extraction 1.5 hours.
5. preparation method according to claim 3 is characterized in that adding for the first time in the step c) 6 times of amount ethanol, and heating and refluxing extraction 1.5 hours adds 5 times of amount ethanol for the second time, heating and refluxing extraction 1 hour.
6. preparation method according to claim 3 is characterized in that adding 8 times of water gagings for the first time in the step d), decocts 2 hours, adds 6 times of water gagings for the second time, decocts 1.5 hours.
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| CN104644911A (en) * | 2013-11-18 | 2015-05-27 | 沈阳绿洲制药有限责任公司 | Compound traditional Chinese medicinal preparation for treating gout |
| CN106214880A (en) * | 2016-10-20 | 2016-12-14 | 广西田林县林子蚂蜂养殖科技有限公司 | A kind of wasp wine treating gout |
| CN108186825A (en) * | 2018-03-07 | 2018-06-22 | 黄振忠 | A kind of drug for treating gout |
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