CN1301544A - Medicinal composition for curing arthritis and osteoarthropathy and its preparing method - Google Patents

Medicinal composition for curing arthritis and osteoarthropathy and its preparing method Download PDF

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Publication number
CN1301544A
CN1301544A CN99115965A CN99115965A CN1301544A CN 1301544 A CN1301544 A CN 1301544A CN 99115965 A CN99115965 A CN 99115965A CN 99115965 A CN99115965 A CN 99115965A CN 1301544 A CN1301544 A CN 1301544A
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Prior art keywords
water
osteoarthritis
arthritis
treatment
decocts
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CN99115965A
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CN1105570C (en
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陶燕铎
张宝琛
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Qinghai Tanggula Pharmaceutical Co., Ltd.
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Northwest Institute of Plateau Biology of CAS
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Abstract

A medicine composition is prepared with Sailonggu and Saussurea Involucrata and through crushing, water extraction and other conventional technological process. It can expel cold evil and wetness, invigorate liver and kidney so that it is used in treating arthritis and osteoarthropathy, and has high effective rate and no toxic side-effect.

Description

Pharmaceutical composition of treatment of arthritis and osteoarthritis and preparation method thereof
The present invention relates to pharmaceutical composition of a kind of treatment of arthritis and osteoarthritis and preparation method thereof.
Osteoarthritis claims degenerative osteoarthritis again, is one of person in middle and old age's commonly encountered diseases and frequently-occurring disease, often involves positions such as knee joint and lumbar vertebra, cervical vertebra, heel.Primary disease is a principal character with the articular cartilage CCD, can form with the hyperosteogeny at synovitis, hydrarthrosis and knee joint edge.Knee osteoarthritis belongs to the arthromyodynia category in Chinese medicine, the Chinese patent medicine that is exclusively used in treatment osteoarthritis and osteoarthritis at present still belongs to seldom, along with increasing of social old people, its sickness rate is more and more higher, primary disease serious harm old people's health, therefore develop curative effect height, treatment gonarthritis safe in utilization and the Chinese patent medicine of osteoarthritis, healthy significant for the misery guarantee old people who alleviates the old people.
But the total effective rate that the object of the present invention is to provide a kind of dispelling cold and removing dampness, liver and kidney tonifying, treatment osteoarthritis and osteoarthritis reaches more than 90.33%, no side effects, treatment of arthritis safe in utilization and the pharmaceutical composition of osteoarthritis.
Another object of the present invention is to provide the preparation of drug combination method of a kind of treatment of arthritis and osteoarthritis.
Purpose of the present invention can realize by following measure:
The pharmaceutical composition of a kind of treatment of arthritis and osteoarthritis by comprise following raw materials in percentage by weight routinely formulation method make medicament:
Bailey Myospalax Born 1-99% Herba Saussureae Involueratae 1-99%.
Another object of the present invention also can realize by following measure:
1. the preparation of drug combination method of a kind of treatment of arthritis and osteoarthritis comprises the steps: Herba Saussureae Involueratae is pulverized, and decocts with water twice, and the 8-12 that adds water for the first time and be raw material doubly measures, and decocts 2-4 hour; For the second time amount of water be raw material 6-10 doubly, decocted 1-2 hour, merge the water extract twice; 2. Bailey Myospalax Born is pulverized, decocted with water twice, the 8-12 that adds water for the first time and be raw material doubly measures, and decocts 8-10 hour; The 6-10 that adds for the second time water and be raw material doubly measures, and decocts 4-6 hour, merges the water extract twice; 3. after Herba Saussureae Involueratae, Bailey Myospalax Born water extract being mixed routinely preparation make medicament.
The present invention has following advantage compared to existing technology:
1, the present invention is with the cooperation of complementing each other of Herba Saussureae Involueratae, Bailey Myospalax Born, make full use of the function of its dispelling cold and removing dampness and liver and kidney tonifying, can be used for treating osteoarthritis, cold-damp resistance network, deficiency of the liver and kindey, arthralgia, swelling, joint stuffiness, meet coldly increase the weight of, disease such as soreness of the waist and knees.
2, the present invention observes through clinical 300 example treatments, and its treatment knee osteoarthritis obvious effective rate reaches more than 35.67%, and total effective rate reaches more than 90.33%; Confirm that through acute, long term toxicity test the present invention is nontoxic, have no side effect.
Toxicity test of the present invention:
1, its maximum tolerated dose is surveyed in acute toxicity test of the present invention, and the result is greater than the 100g/kg body weight, is 833 times of adult's daily dose.
2, long term toxicity test: according to 90 days long term toxicity test results of rat, the capsule in high dose group (7.5g/kg body weight) that proof the present invention makes, be equivalent to 6.25 times of clinical consumptions, do not see any toxicity, comprise general signs, outward appearance, behavior, body weight, routine blood test, hepatic and renal function, electrocardiogram, organ coefficient mensuration, pathologic finding etc. all belong to normal range.
Pharmacodynamic study of the present invention:
(1) antiinflammatory experiment
1, to the prevention experiment of rat albumen arthritis, the result shows: have and prevent arthritic effect preferably;
2, to the arthritic treatment experiment of rat formaldehyde, the result shows: PARA FORMALDEHYDE PRILLS(91,95) arthritis has the obvious treatment effect;
3, medicine separation chemistry position is to the arthritic treatment experiment of rat formaldehyde, and the result shows: the Herba Saussureae Involueratae total alkaloids has significant antiinflammatory action;
4, to the swollen outgrowth influence experiment of rat granuloma, the result shows: the granuloma hypertrophy is had certain inhibitory action;
5, to the influence experiment of mouse ear capillary permeability, the result shows: mice ear is had the obvious suppression effect.
(2) inhibitory action of adjuvant-induced arthritis
Experiment shows: the capsule that the present invention makes is to the rat assist agent arthritis primary affection, and the change of supervention sexually transmitted disease (STD) has significant inhibitory effect.
1, to the preventive effect of constitutional pathological changes: the result has significant preventive effect;
2, to the preventive effect of Secondary cases pathological changes: the result has significant preventive effect;
3, to the therapeutical effect of secondary affection: the result has the obvious treatment effect.
(3) analgesic experiment
1, to white mice electricity irritation reaction influence experiment: the result has significant analgesia role;
2, the inhibition of white mice writhing response is tested: the result has significant analgesia role.
(4) the effect experiment that mouse antibodies is generated
The special humoral immunoresponse(HI) of mice experiment showed, the be significantly improved effect of immunity of organisms of these product.
Clinical trial result of the present invention:
According to " new Chinese medicine clinical research guideline " functional characteristics, formulate clinical trial protocol, (synopsis is as follows) in conjunction with this product
(1) case is selected:
1, tcm diagnosis standard:
2, Chinese medical discrimination standard: be applicable to cold-damp resistance network, deficiency of the liver and kindey disease.
3, Western medicine diagnose standard: be applicable to that osteoarthritis is the object of observation.
4, include exclusion standard in:
(2) test method: adopt double blinding dual analog grouping contrast method and contrast method at random.
1, treatment group: 300 examples
2, matched group: 150 examples, use ZHUANGGU GUANJIE WAN.
3, the course of treatment: be 1 month, can carry out 1-2 the course of treatment.
(3) efficacy determination:
1, clinical disease changes (sxemiquantitative scoring method)
2, curative effect determinate standard: be divided into the level Four standard.
Clinical recovery: produce effects, effective, invalid.
Clinical research is summed up:
Defend the requirement that medicine is examined No. 62 file of word (1997) according to Ministry of Public Health bureau of drug administration (97) ZL-51 file and Hebei province Department of Public Health Ji, by Guang-amen Hospital, China Traditional Chinese Medicine Instl is that group leader unit, the hospital of traditional Chinese hospital, Beijing, Institute of orthopedics and traumatology, Chinese Academy for Traditional Chine, No.2 Hospital, Hebei Medical Univ. and the 3rd hospital of Hebei Medical University participate in, and from year April in October, 1997 to 1998 capsule that the present invention prepares has been carried out the clinical research work of II phase.300 examples have been finished in the clinical trial treatment, and matched group is finished 150 examples.Clinical test results: capsule for treating knee osteoarthritis obvious effective rate of the present invention is 35.67%, and total effective rate is 90.33%; Matched group obvious effective rate 22.67%, total effective rate are 76.00%; Treatment group curative effect is better than matched group, and learning by statistics to handle has significant difference.Clinical use capsule of the present invention is not seen untoward reaction, and menses, urine, the just detection of routine and the heart, liver, renal function have no adverse effects, and be safe in utilization.
The present invention also will be described in further detail in conjunction with the embodiments:
Embodiment one:
The pharmaceutical composition of a kind of treatment of arthritis and osteoarthritis by comprise following raw materials in percentage by weight routinely formulation method make medicament: Bailey Myospalax Born 50%, Herba Saussureae Involueratae 50%.
The preparation of drug combination method of described treatment of arthritis and osteoarthritis comprises the steps: 1. Herba Saussureae Involueratae to be pulverized, and decocts with water twice, adds 10 times of amounts that water is raw material for the first time, decocts 3 hours; For the second time amount of water is 8 times of raw material, decocts 2 hours, merges the water extract twice; 2. Bailey Myospalax Born is pulverized, decocted with water twice, add 10 times of amounts that water is raw material for the first time, decocted 9 hours; For the second time add 8 times of amounts that water is raw material, decocted 5 hours, merge the water extract twice; 3. after Herba Saussureae Involueratae, Bailey Myospalax Born water extract being mixed routinely preparation make medicament.
Embodiment two:
The pharmaceutical composition of a kind of treatment of arthritis and osteoarthritis by comprise following raw materials in percentage by weight routinely formulation method make medicament: Bailey Myospalax Born 2%, Herba Saussureae Involueratae 98%.
Its preparation technology and example are together.
Embodiment three:
The pharmaceutical composition of a kind of treatment of arthritis and osteoarthritis by comprise following raw materials in percentage by weight routinely formulation method make medicament: Bailey Myospalax Born 98%, Herba Saussureae Involueratae 2%.
Its preparation technology and example are together.
Embodiment four:
The pharmaceutical composition of a kind of treatment of arthritis and osteoarthritis by comprise following raw materials in percentage by weight routinely formulation method make medicament: Bailey Myospalax Born 30%, Herba Saussureae Involueratae 70%.
Its preparation technology and example are together.
Embodiment five:
The pharmaceutical composition of a kind of treatment of arthritis and osteoarthritis by comprise following raw materials in percentage by weight routinely formulation method make medicament: Bailey Myospalax Born 40%, Herba Saussureae Involueratae 60%.
Its preparation technology and example are together.
Embodiment six:
The pharmaceutical composition of a kind of treatment of arthritis and osteoarthritis by comprise following raw materials in percentage by weight routinely formulation method make medicament: Bailey Myospalax Born 70%, Herba Saussureae Involueratae 30%.
Its preparation technology and example are together.
Embodiment seven:
The pharmaceutical composition of a kind of treatment of arthritis and osteoarthritis by comprise following raw materials in percentage by weight routinely formulation method make medicament: Bailey Myospalax Born 60%, Herba Saussureae Involueratae 40%.
Its preparation technology and example are together.
Embodiment eight:
The pharmaceutical composition of a kind of treatment of arthritis and osteoarthritis by comprise following raw materials in percentage by weight routinely formulation method make medicament: Bailey Myospalax Born 80%, Herba Saussureae Involueratae 20%.
Its preparation technology and example are together.

Claims (3)

1, the pharmaceutical composition of a kind of treatment of arthritis and osteoarthritis, it is characterized in that by comprise following raw materials in percentage by weight routinely formulation method make medicament:
Bailey Myospalax Born 1-99% Herba Saussureae Involueratae 1-99%.
2, the pharmaceutical composition of treatment of arthritis as claimed in claim 1 and osteoarthritis is characterized in that described medicament is meant medically any dosage form of indication.
3,1. the preparation of drug combination method of described treatment of arthritis of a kind of claim 1 and osteoarthritis is characterized in that comprising the steps: Herba Saussureae Involueratae is pulverized, and decocts with water twice, and the 8-12 that adds water for the first time and be raw material doubly measures, and decocts 2-4 hour; For the second time amount of water be raw material 6-10 doubly, decocted 1-2 hour, merge the water extract twice; 2. Bailey Myospalax Born is pulverized, decocted with water twice, the 3-12 that adds water for the first time and be raw material doubly measures, and decocts 8-10 hour; The 6-10 that adds for the second time water and be raw material doubly measures, and decocts 4-6 hour, merges the water extract twice; 3. after Herba Saussureae Involueratae, Bailey Myospalax Born water extract being mixed routinely preparation make medicament.
CN99115965A 1999-12-30 1999-12-30 Medicinal composition for curing arthritis and osteoarthropathy and its preparing method Expired - Lifetime CN1105570C (en)

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CN1105570C CN1105570C (en) 2003-04-16

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101028325A (en) * 2007-04-24 2007-09-05 杨文龙 Medicinal composition containing sailonggu, and its preparation and quality control
CN101716217B (en) * 2009-12-02 2012-05-23 中国科学院西北高原生物研究所 Medical composition containing rhododendron anthopogonoide oil and application thereof
CN104277091A (en) * 2014-09-17 2015-01-14 正源堂(天津滨海新区)生物科技有限公司 Method for extracting 7-beta-hydroxyl cholesterol from osteon myospalacem baileyi
CN104857089A (en) * 2015-05-21 2015-08-26 河南黑马动物药业有限公司 Liquid medicine for treating rheumatism and rheumatoid arthritis and preparation method of liquid medicine
CN105055449A (en) * 2015-07-27 2015-11-18 中国科学院西北高原生物研究所 Sailong bone extract with activities of resisting inflammation and easing pain as well as preparation method and Chinese herbal preparation
CN115300539A (en) * 2022-08-16 2022-11-08 西安今正制药有限公司 Compound sialon capsule, its preparation method and application in rheumatism bone disease

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101028325A (en) * 2007-04-24 2007-09-05 杨文龙 Medicinal composition containing sailonggu, and its preparation and quality control
CN101028325B (en) * 2007-04-24 2013-05-29 杨文龙 Medicinal composition containing sailonggu, and its preparation and quality detection method
CN101716217B (en) * 2009-12-02 2012-05-23 中国科学院西北高原生物研究所 Medical composition containing rhododendron anthopogonoide oil and application thereof
CN104277091A (en) * 2014-09-17 2015-01-14 正源堂(天津滨海新区)生物科技有限公司 Method for extracting 7-beta-hydroxyl cholesterol from osteon myospalacem baileyi
CN104857089A (en) * 2015-05-21 2015-08-26 河南黑马动物药业有限公司 Liquid medicine for treating rheumatism and rheumatoid arthritis and preparation method of liquid medicine
CN104857089B (en) * 2015-05-21 2018-04-06 许昌市天源生物科技股份有限公司 A kind of decoction for treating rheumatism and rheumatoid arthritis and preparation method thereof
CN105055449A (en) * 2015-07-27 2015-11-18 中国科学院西北高原生物研究所 Sailong bone extract with activities of resisting inflammation and easing pain as well as preparation method and Chinese herbal preparation
CN105055449B (en) * 2015-07-27 2019-08-09 中国科学院西北高原生物研究所 A kind of Sailongbone extracts with anti-inflammatory and antalgic activity, preparation method and Chinese materia medica preparation
CN115300539A (en) * 2022-08-16 2022-11-08 西安今正制药有限公司 Compound sialon capsule, its preparation method and application in rheumatism bone disease

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