CN1293906C - Chinese medicine preparation for treating rheumatism stagnation-syndrome pain - Google Patents

Chinese medicine preparation for treating rheumatism stagnation-syndrome pain Download PDF

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Publication number
CN1293906C
CN1293906C CNB2004100110987A CN200410011098A CN1293906C CN 1293906 C CN1293906 C CN 1293906C CN B2004100110987 A CNB2004100110987 A CN B2004100110987A CN 200410011098 A CN200410011098 A CN 200410011098A CN 1293906 C CN1293906 C CN 1293906C
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China
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present
chinese medicine
parts
starch
dampness
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CNB2004100110987A
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CN1748763A (en
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周耀群
高陆
白冰
李桂峰
张显涛
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Tongyao Pharmaceutical Group Corp
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修涞贵
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Abstract

The present invention provides a traditional Chinese medicine for treating rheumatism, which belongs to the technical field of traditional Chinese medicines and particularly relates to a traditional Chinese medicine for dispelling wind and dampness, promoting blood circulation for removing obstruction in collaterals, eliminating coldness and relieving pain. The components of the medicine of the present invention have good treatment effect in the range of the following weight portions: 30 to 50 portions of smoothfruit ventilago roots and stems, 30 to 50 portions of dioscorea nipponica and 4 to 10 portions of starch. The preparation method of the present invention comprises the steps that the smoothfruit ventilago roots and stems and the dioscorea nipponica are added with water to be decocted twice; the time of the first decoction is 3 hours, and the time of the second decoction is 2 hours; solutions twice are respectively filtered, and filtrates are combined and concentrated into extract paste of 1.20 to 1.30 (at 25 DEG C) for standby; the starch is added into the extract paste to be uniformly mixed, and the present invention is prepared by granulation, drying, tablet forming and sugar or thin film coating. The present invention has the main functions of dispelling wind and dampness, promoting blood circulation for removing obstruction in collaterals, eliminating coldness and relieving pain, and is used for treating rheumatism. The present invention has exact treatment effect on treating rheumatism patients having rheumarthritis and wind-dampness-coldness arthralgia, has obvious treatment effect on treating rheumarthritis and wind-dampness-coldness arthralgia, and has the advantages of no poison side effect and adverse reactions in the period of medicine utilization.

Description

A kind of Chinese medicine preparation for the treatment of rheumatic arthralgia
Technical field
The invention belongs to technical field of Chinese medicines, be specifically related to expelling wind and removing dampness, promoting blood circulation to remove obstruction in the collateral, dispersing cold for relieving pain Chinese medicine preparation, international Patent classificating number: A61K35/78, A61P29/00.
Background technology
Rheumatic arthritis and cold rheumatoid joint pain belong to the cold-damp arthromyodynia, are a kind of commonly encountered diseases, frequently-occurring disease, because human righteousness's deficiency, and exopathogen invasion and attack such as wind, cold, wet, heat, or interior living phlegm-damp, pyretic toxicity, congestion cause the passages through which vital energy circulates retardance, QI and blood is not smooth; Numbness person closes also, for bitterly meaning is closed not in resistance, and the pain that arthromyodynia is located with limbs, joint, muscle, muscles and bones etc., miserable, weight person's numbness, scorching hot, even arthroncus, joint stuffiness is so that be deformed into characteristics; The medicine of treatment rheumatic arthritis and cold rheumatoid joint pain is many now, for example: and pill for treating rheumatism and alleviating pain, rheumatic arthralgia cream, treating rheumatism disease pellet etc., but up to the present, still do not have the specific medicament of treatment rheumatic arthralgia.
Summary of the invention
The purpose of this invention is to provide a kind of a kind of Chinese medicine preparation for the treatment of rheumatic arthralgia with expelling wind and removing dampness, promoting blood circulation to remove obstruction in the collateral, dispersing cold for relieving pain function.
Each component of medicine of the present invention has better curative effect in the following weight parts scope:
Radix seu Caulis Verntilaginis Leiocarpae 30-50 part, Dioscorea nipponica bone 30-50 part, starch 4-10 part;
Be preferably: 35 parts of Radix seu Caulis Verntilaginis Leiocarpae, 35 parts in Dioscorea nipponica bone, 5 parts of starch;
The best is; 45 parts of Radix seu Caulis Verntilaginis Leiocarpae, 45 parts in Dioscorea nipponica bone, 6 parts of starch.
Preparation method of the present invention:
Get Radix seu Caulis Verntilaginis Leiocarpae, the Dioscorea nipponica bone decocts with water secondary, the 1st time 3 hours, the 2nd time 2 hours, gradation filtered, merging filtrate also is concentrated into the extractum of 1.20-1.30 (25 ℃), and is standby; Add starch, mixing is granulated, drying, and tabletting, sugar coating or film-coat promptly get the present invention.
Function of the present invention cures mainly: expelling wind and removing dampness, promoting blood circulation to remove obstruction in the collateral, dispersing cold for relieving pain are used for rheumatic arthralgia.
Usage and dosage of the present invention: oral, a 4-5 sheet, 3 times on the one.
Side of the present invention separates:
Radix seu Caulis Verntilaginis Leiocarpae is the dry rattan of leguminous plant spatholobus suberectus,
Meridian distribution of property and flavor: bitter, little sweet, warm, return Liver Channel;
Function: activating blood circulation, channels sootheing and network vessel quickening;
Cure mainly: menoxenia, blood deficiency and yellow complexion, paralysis and numbness, rheumatic arthralgia;
Composition: contain the pure and mild ferrum matter of Radix seu Caulis Verntilaginis Leiocarpae;
Pharmacology: promoting the circulation of blood is promoted blood circulation, warm waist knee joint, and the effect of bringing high blood pressure down is found in modern experiment; Isolated uterine there is inhibitory action, there is excitation in uterus on the throne, can strengthen the uterus rhythmicity and shrink; Total phosphorus metabolism in 24 hours has facilitation to Mouse Uterus.
Dioscorea nipponica bone another name dioscorea japonica, CHUANDILONG, Os Draconis, dragon grass, be Dioscoreaceae plant Dioscorea nipponica Mak. Ningpo Yam Rhizome rhizome;
Gather and process: spring, autumn excavate, and uproot and get stem, remove root hair, and crust (cork) dries;
Character: rhizome is cylindrical, class is cylindrical, and is crooked slightly, and the finger-like branch is arranged, different in size, diameter 0.3-1.5 centimetre, the surface is brown or yellow, both sides scattered palpus shape radicula or radicula mark of break, and matter is hard, and section is smooth, white or off-white color, mealiness, feeble QI, bitter and puckery flavor;
Chemical constituent: mainly contain dioscin multiple steroid saponins such as (dioscin);
Nature and flavor are warm in nature, sweet in the mouth, hardship;
Function cures mainly: relaxing muscles and tendons to promote blood circulation, cough-relieving pain relieving, wind-expelling pain-stopping cure mainly the ruined pain of waist, muscles and bones numbness, anemofrigid-damp arthralgia, traumatic injury, sprain one's back, cough and pant.
Pharmacodynamic test of active extract of the present invention:
One, test objective is observed antiinflammatory of the present invention, pain relieving and cold-resistant function by animal experiment.
Two, test material
1, medicine: the present invention, QUFENG ZHITONG JIAONANG (Xianyang Buchang Pharmaceutical Co., Ltd's production);
2, animal: Kunming kind white mice, body weight 18-25 gram, male and female dual-purpose; The Wistar rat, body weight 150-200 gram, male and female dual-purpose.White mice, the equal Shenyang Medical College of rat animal housing provide.
Three, test and result
1, the present invention is to the influence of 0.6% acetic acid induced mice writhing response
Get 50 of mices, male and female half and half, body weight 18-22 gram is divided into 5 groups at random by body weight, and water gastric infusion after 14 hours is can't help in fasting, and three dosage groups of the present invention are by 12.0 gram/kilograms, 8.0 gram/kilograms, 4.0 gram/kilograms (being equivalent to the crude drug amount) gastric infusion; Blank group is irritated the distilled water of capacity such as stomach, after the administration 45 minutes, inject 0.2 milliliter of 0.6% acetum for every mouse peritoneal, after 5 minutes in the record 10 minutes every mice body (abdominal part indent, stretch hind leg, buttocks is raised) number of times appears turning round.The results are shown in following table:
Group Dosage (gram/kilogram) Number of animals (only) Turn round the body number of times
The present invention 12.0 10 18.2±5.9 *
The present invention 8.0 10 20.1±4.6
The present invention 4.0 10 22.9±4.9
QUFENG ZHITONG JIAONANG 8.0 10 17.3±6.1 *
Blank 10 26.8±7.2
The T check is compared with the blank group, *P<0.05.
2, the influence of xylol induced mice ear swelling of the present invention
Get 50 of mices, male and female half and half, body weight 20-25 gram is divided into 5 groups at random by body weight, 10 every group; Three dosage groups of the present invention are by 12.0 gram/kilograms, 8.0 gram/kilograms, 4.0 gram/kilograms (being equivalent to the crude drug amount) gastric infusion; QUFENG ZHITONG JIAONANG is by 8.0 gram/kilograms (being equivalent to the crude drug amount) gastric infusion, the distilled water of capacity such as blank group filling stomach, after the administration 45 minutes, with 5 seconds of dimethylbenzene cotton balls contact mice left side ear, draw neck to put to death animal after 15 minutes, with diameter 7mm card punch mice ears same area homalographic being downcut, is the swelling degree with left and right sides auricle weight difference, the results are shown in following table:
Group Dosage (gram/kilogram) Number of animals (only) Turn round the body number of times
The present invention 12.0 10 6.45±1.36 **
The present invention 8.0 10 8.35±1.77
The present invention 4.0 10 7.52±1.68 *
QUFENG ZHITONG JIAONANG 8.0 10 7.64±1.71
Blank 10 9.60±1.74
The T check is compared with the blank group, *P<0.05, *P<0.01.
3, cold-resistant function of the present invention
Get 50 of mices, male and female half and half, body weight 18-22 gram is divided into 5 groups at random by body weight; Three dosage groups of the present invention are irritated stomach by 12.0 gram/kilograms, 8.0 gram/kilograms, 4.0 gram/kilograms and are given aqueous suspension of the present invention; Positive controls is irritated stomach QUFENG ZHITONG JIAONANG aqueous suspension 8.0 gram/kilograms, the distilled water of capacity such as blank group filling stomach; After the administration 30 minutes, mice is put into-5 ± 1 ℃ of refrigerators, (one in a cage, refrigerator stays passage) took out after 2 hours, and statistics is respectively organized mice survival number, calculates and respectively organizes the mice survival rate, the results are shown in following table:
Group Number of animals (only) Dosage (gram/kilogram) The survival number of elements Survival rate (%)
Blank 10 3 30
The present invention 10 12 8 Δ 80
The present invention 10 8 6 60
The present invention 10 4 4 40
QUFENG ZHITONG JIAONANG 10 8 6 60
The T check is compared Δ<0.05 with the blank group.
Conclusion: the present invention can suppress the mice ear due to the dimethylbenzene; That reduces by 0.6% acetic acid induced mice turns round the body number of times; Improve the tolerance to cold of mice.Illustrate that the present invention has certain antiinflammatory, pain relieving and cold-resistant function.
Acute toxicity test of the present invention:
Test method is got fasting and be can't help 20 of 12 hours healthy mices of water, male and female half and half, and body weight 18-22 gram is irritated stomach respectively and is given aqueous suspension of the present invention (0.35 grams per milliliter is equivalent to the crude drug amount) 0.4 milliliter/10 grams, and one day twice, 6 hours at interval; Observe 1 every day after the administration, observed continuously 7 days; Movable minimizing on the same day after the mice administration as a result, indivedual mice lassitudes recovered normal in second day, and the mice general state is good in 7 days, and body weight gain is normal, none death.
The result: it is 28.0 gram/kilograms (suitable crude drug amounts) that the present invention gives the maximum tolerated dose of mouse stomach administration, is 133.3 times of the clinical daily dose of being grown up.
Long term toxicity test of the present invention:
Test method is got 80 of the healthy istar rat of W in normal one week of raising, measure routine blood test and biochemical indicator, be divided into 4 groups at random by body weight, every group 20, male and female half and half, large, medium and small three the dosage groups of the present invention are respectively by 8.0 gram/kilograms, 6.0 gram/kilograms, 4.0 gram/kilograms (quite crude drug amount) gastric infusion, the distilled water of capacity such as blank group filling stomach, be administered once every day, 12 weeks of successive administration, per 4 weeks are surveyed a body weight, general state, behavioral activity, diet drinking-water, defecation and other poisoning manifestations of observing a rat every day; After the last administration 24 hours, routine blood test and biochemical indicator were measured in blood sampling, sacrifice of animal 50%, dissect core, liver, spleen, stomach, kidney main organs weigh, and do histopathologic examination; Remaining 50% animal is put to death after normally raising for 2 weeks, carries out above-mentioned inspection equally, the recovery situation after the observation drug withdrawal.
Rat continuous irrigation stomach gives the present invention's 8.0 gram/kilograms, 6.0 gram/kilograms, 4.0 gram/kilograms (quite crude drug amount) as a result, be administered once every day, 12 weeks of successive administration, be respectively adult 38.1,28.6 and 19.0 times of a clinical daily dose, rat growth as a result is normal, routine blood test and biochemical investigation no abnormality seen change, and main organs coefficient and histological examination there is no toxic pathology and change; Illustrate that the clinical using dosage of the present invention is safe and reliable, maximal non-toxic effect dosage is 8.0 gram/kilograms.
Clinical trial of the present invention:
This group of physical data case 400 examples are divided into test group 300 examples at random, matched group 100 examples;
Age The state of an illness The course of disease The symptom scores accumulated
Maximum Minimum On average Slight person Moderate person Severe person The shortest The longest On average Minimum At most On average
Experimental group 300 examples 65 18 3915± 10.74 75 179 46 3 months 6 years 2.19 ±1.38 9 26 14.39 ±3.79
Matched group 100 examples 64 18 39.13 ±11.37 30 60 10 3 months 5 years 2.04 ±1.33 8 25 14.27 ±4.15
Diagnostic criteria is according to the unified combination of Chinese and Western medicine diagnostic criteria of " rheumatism tremble with fear sick academic forum " specified " rheumatic four diseases " in 1985 and specified standard of standard of in April, 1988 whole nation combination of Chinese and Western medicine rheumatism academic conference revision.
Traditional Chinese medical science typing standard
Syndrome of cold-dampness blocking collaterals: the limbs joint cold type of pain is heavy, or swelling, and local fear of cold, color of the leather are not red, and that touches is not hot, meets the cold pain that increases, hotly then subtract, enlarged tongue, matter is light dark, tongue is greasy in vain or sliding white, stringy and tense pulse or string are slow.
Mild symptoms weight classification and integration method
Symptom Heavy (3 minutes) In (2 minutes) Gently (1 minute) Do not have (0 minute)
*Arthralgia Severe pain is difficult because of bearing Pain still can be stood Pain slightly No pain
*Limbs are heavy Heavy obvious, influence activity Heavyly obviously influence activity slightly The heavy activity that do not influence is arranged slightly No sense of heaviness
Local cool Obviously there is cool sense the part, very then is in a cold sweat There are cool sense, no cold sweat in the part The part has cool sense slightly There is not cool sense
Swelling Swelling is obvious Swelling Swelling slightly No swelling
Local fear of cold Local fear of cold is obvious Local fear of cold Local milli fear of cold No fear of cold
Meet the cold pain that increases Meeting cold pain obviously increases Meeting cold pain increases Meeting cold pain increases slightly Meeting cold pain does not increase
Picture of the tongue (counting 1 fen) arranged Do not have (counting 0 fen)
Pulse condition (counting 1 fen) arranged Do not have (counting 0 fen)
Annotate: 1. *On former score basis superior 2; 2. state of an illness severe 〉=19 minute, moderate 11-18, slight≤10 minutes.
Clinical indexes:
One, safety detects index
1, general health check-up project; 2, blood, urine, just routine examination; 3, the heart, liver, kidney function test.
Two, health giving quality observation index
1, observe muscle arthralgia, heavy, swelling, there are cool sense or fear of cold in the part, meets the cold situation of change that increases symptom such as pain and tongue, arteries and veins treatment front and back;
2, erythrocyte sedimentation rate, anti-chain physics and chemistry such as " O " detect the situation of change of index treatment front and back.
Observe and administrated method
To meet the rheumatic arthritis and cold rheumatoid joint pain patient 400 examples of diagnostic criteria, be divided into test group 300 examples, matched group 100 examples; Test group is taken the present invention's (every contains crude drug 1.00 grams), and is every day 3 times, each 5, oral; Matched group is taken the FENGSHI GUANJIEYAN PIAN that Baicheng Wanda pharmaceutcal corporation, Ltd produces, and every day 2 times, each 4, oral, one month is a course of treatment, all observes a course of treatment, and stopping using the observation period, other has the medicine of associated treatment effect.
Curative effect determinate standard
1, clinic control; Clinical symptoms all disappears, and it is normal that the tongue arteries and veins recovers, and integration is zero;
2, produce effects: clinical symptoms obviously disappears, and the treatment back preceding integration of treatment descends 〉=2/3;
3, effective: clinical symptom relief, integration descended<2/3, 〉=1/3 before treated the treatment back;
4, invalid: clinical symptoms does not have obvious improvement, and the treatment back preceding integration of treatment descends<1/3.
Test group and matched group general curative effect are relatively
Group The example number Clinic control Produce effects Effectively Invalid Show control rate % Total effective rate %
Example (%) Example (%) Example (%) Example (%)
Test group 300 47(15.67) 123(41) 98(32.67) 32(10.67) 56.67 89.33
Matched group 100 13(13) 26(26) 38(38) 23(23) 39 77
U=2.98 P<0.01
Last table is analyzed through Ridit, U=2.98, and there is significant difference P<0.01, and prompting investigational agent curative effect obviously is better than matched group.
The different sick curative effects of planting of test group compare
The sick kind The example number Clinic control Produce effects Effectively Invalid Show control rate % Total effective rate %
Example (%) Example (%) Example (%) Example (%)
Arthritis 56 6(10.71) 15(26.79) 22(39.29) 13(23.21) 37.5 76.79
Arthralgia 244 41(16.80) 108(44.26) 76(31.15) 19(7.79) 61.06 92.21
U=2.98 P<0.01
Last table is analyzed through Ridit, U=2.98, and there is significant difference P<0.01, and the prompting investigational agent is better than rheumatic arthritis to the curative effect of cold rheumatoid joint pain.
In sum, the present invention treats rheumatic arthritis and cold rheumatoid joint pain belongs to cold-damp arthromyodynia person determined curative effect, still is that cold rheumatoid joint pain all has obvious curative effects to rheumatic arthritis no matter, and the curative effect of cold rheumatoid joint pain is better than rheumatic arthritis; Patient to different sexes, all ages and classes section, the different state of an illness and the different courses of disease all is suitable for, and does not find toxic and side effects and untoward reaction during medication; Determined curative effect of the present invention, safety in utilization.
The specific embodiment
Embodiment 1:
It is standby to get 35 parts of Radix seu Caulis Verntilaginis Leiocarpae, 35 parts in Dioscorea nipponica bone, 5 parts of starch;
Preparation method of the present invention:
Get Radix seu Caulis Verntilaginis Leiocarpae, the Dioscorea nipponica bone decocts with water secondary, the 1st time 3 hours, the 2nd time 2 hours, gradation filtered, merging filtrate also is concentrated into the extractum of 1.20-1.30 (25 ℃), and is standby; Add starch, mixing is granulated, drying, and tabletting, sugar coating or film-coat promptly get the present invention.
Embodiment 2:
It is standby to get 45 parts of Radix seu Caulis Verntilaginis Leiocarpae, 45 parts in Dioscorea nipponica bone, 6 parts of starch;
Preparation method is with embodiment 1.

Claims (4)

1, a kind of Chinese medicine preparation for the treatment of rheumatic arthralgia, make by the following weight parts crude drug:
Radix seu Caulis Verntilaginis Leiocarpae 30-50 part, Dioscorea nipponica bone 30-50 part, starch 4-10 part.
2, a kind of Chinese medicine preparation for the treatment of rheumatic arthralgia according to claim 1, wherein the consumption of each crude drug is: 35 parts of Radix seu Caulis Verntilaginis Leiocarpae, 35 parts in Dioscorea nipponica bone, 5 parts of starch.
3, a kind of Chinese medicine preparation for the treatment of rheumatic arthralgia according to claim 1, wherein the consumption of each crude drug is: 45 parts of Radix seu Caulis Verntilaginis Leiocarpae, 45 parts in Dioscorea nipponica bone, 6 parts of starch.
4, the method for the Chinese medicine preparation of the described treatment rheumatic arthralgia of preparation claim 1:
Get Radix seu Caulis Verntilaginis Leiocarpae, the Dioscorea nipponica bone decocts with water secondary, the 1st time 3 hours, the 2nd time 2 hours, gradation filtered, and is at 25 ℃ of merging filtrates and be concentrated into the extractum of 1.20-1.30, standby; Add starch, mixing is granulated drying, tabletting, sugar coating or film-coat.
CNB2004100110987A 2004-09-17 2004-09-17 Chinese medicine preparation for treating rheumatism stagnation-syndrome pain Expired - Lifetime CN1293906C (en)

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CNB2004100110987A CN1293906C (en) 2004-09-17 2004-09-17 Chinese medicine preparation for treating rheumatism stagnation-syndrome pain

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1073870A (en) * 1992-10-26 1993-07-07 常民 The preparation method of neck-building medicine
CN1490017A (en) * 2002-10-14 2004-04-21 何廷银 Medicines against rheunatoid and rheumatic diseases

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1073870A (en) * 1992-10-26 1993-07-07 常民 The preparation method of neck-building medicine
CN1490017A (en) * 2002-10-14 2004-04-21 何廷银 Medicines against rheunatoid and rheumatic diseases

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