CN1320910C - Medicine for treating osteoarthritis, and its prepn. method - Google Patents
Medicine for treating osteoarthritis, and its prepn. method Download PDFInfo
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- CN1320910C CN1320910C CNB2004100263183A CN200410026318A CN1320910C CN 1320910 C CN1320910 C CN 1320910C CN B2004100263183 A CNB2004100263183 A CN B2004100263183A CN 200410026318 A CN200410026318 A CN 200410026318A CN 1320910 C CN1320910 C CN 1320910C
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Abstract
The present invention discloses a drug for treating cold damp and damp heat syndromes of osteoarthritis (hyperostosis), which is prepared from 5 drugs of fortune's euonymus, lonicera stem, epimedium, pubescent angelica, yam, etc. The present invention has the functions of dispelling wind, eliminating damp, eliminating cold, relieving pains, promoting blood circulation and dredging collaterals, has obvious treatment effect on syndrome aspects of arthralgia, cold pains, ponderosity, limitation of motion, emphasis after fatigue, etc. in the cold damp and damp heat syndromes of osteoarthritis, has no toxic and side effects on a human body, and has good clinical popularization value.
Description
Affiliated technical field
The invention belongs to the preparing technical field of pharmaceuticals, relating to a kind of is the medicine that is used for the treatment of osteoarthritis (bone matrix hyperplasia) syndrome of cold-dampness blocking collaterals of feedstock production and the preparation method of this medicine with the Chinese herbal medicine.
Background technology
Osteoarthritis is one of joint disease common among the crowd, is mainly in the big and movable more joint part that bears a heavy burden, and as big joint such as cervical vertebra, lumbar vertebra, knee joint, hip, sees so that knee osteoarthritis more.Osteoarthritis morbidity is relevant with the age, and the crowd more than 40 years old falls ill more, and prevalence increases with the growth at age.The U.S. is relevant, and the survey showed that, and 38% adult suffers from knee osteoarthritis, and the annual morbidity of the symptomatic knee osteoarthritis of being grown up is 2 ‰.According to China the survey result of certain areas is shown, the knee osteoarthritis prevalence is 25.5% among the adult, then have the people above 50% to suffer from knee osteoarthritis in the crowd of over-65s, visible primary disease is one of major reason that middle-aged and elderly people is disabled and quality of life descends.
Osteoarthritis can be divided into constitutional osteoarthritis and Secondary cases osteoarthritis, and the former is often because of due to articular cartilage degeneration and the joint chronic strain, thus pilosity is born in the middle age (40 years old) afterwards; The latter since often be secondary to congenital or acquired deformity, articular strain (as intra-articular fracture) and other joint disease (as rheumatoid arthritis) afterwards, so also can occur in person between twenty and fifty.No matter constitutional or Secondary cases, the degeneration of articular cartilage is basic pathological change, so treatment means is essentially identical.Modern medicine adopts the means of Drug therapy osteoarthritis mainly to comprise: (1), short-term use sufficient dosage analgesics to be prefered method, as acetyl aminophenol, dextrorotation propoxyphene, codeine etc., but inferior class medicine is because of there being certain addiction, so that unsuitable life-time service, preceding in addition two class medicines occur is nauseating, vomiting, incidence rate dizzy and constipation are higher; (2), anti-inflammatory agent, as non-steroid class and glucocorticoid AIDs such as De Baosong, Limethason such as indomethacin, aspirin, phenylbutazones, but non-steroid class and glucocorticosteroid anti-inflammatory agent have inhibitory action to cartilage matrix synthetic, and life-time service can make the basic lesion of osteoarthritis increase the weight of on the contrary; (3), Chondroprotective agents; matrix metallo-proteinase inhibitor as hyaluronic acid, superoxide dismutase, D-glycosamine, glucosaminoglycan, Cyclomycin family antibiotic, Ado-Met, the heavy absorbent of bis phosphoric acid salt bone and synthetic; the clinical side effects of these medicines is little; but it belongs to the anti-medicine for treating arthritis of chronic effect; and be not extensive use of clinical mostly, curative effect still can not be affirmed.At present the clinical Chinese patent medicine that is used for the treatment of osteoarthritis mainly contains bony spur tablet, GUXIAN PIAN, spur and pain relieving liquid, Dioscorea nipponica bony spur tablet, exempts from the pain sheet, GUTONGNING, sinew soothing and pain relieving are loose etc. all certain curative effect, and non-evident effect, but it is, still undesirable in effect aspect the treatment of clinical osteoarthritis (bone matrix hyperplasia) syndrome of cold-dampness blocking collaterals of seeing because of its effect all is mainly relaxing muscles and tendons and activating QI and blood in the collateral, promoting blood circulation and stopping pain, reinforcing the kidney to strengthen the bone more.
Summary of the invention
The objective of the invention is to the problem at the prior art existence, providing a kind of is the efficient medicine that is used for the treatment of osteoarthritis of feedstock production and the preparation method of this medicine with the Chinese herbal medicine.
The preparation scheme of medicine of the present invention is that the designer obtains by concentrated summary development according to clinical practice for many years and on the modern pharmacology experiment basis, it is according to the Therapeutic Principle of motherland's medical science about wind dispelling collateral dredging, blood circulation promoting and blood stasis dispelling, the strong muscle of bone strengthening, numbness relieving and pain relieving, by science is formulated with five kinds of Chinese medicine raw materials such as Caulis Seu Folium Euonymi Fortunei, Caulis Lonicerae, Herba Epimedii, Radix Angelicae Pubescentis, Rhizoma Dioscoreae Nipponicae in addition.
The weight proportion that constitutes each component raw material of medicine of the present invention is
FUFANGTENG 6～9, Caulis Lonicerae 3～4.5, Herba Epimedii 2～3,
Radix Angelicae Pubescentis 2～3, Rhizoma Dioscoreae Nipponicae 1～1.5.
Medicine of the present invention is a kind of at the clinical effective Chinese medicine preparations of seeing syndrome of cold-dampness blocking collaterals and developing of knee osteoarthritis (bone matrix hyperplasia) more, and its prescription, function and adaptation disease meet the logos of the traditional Chinese medical science to arthromyodynia, rheumatism involving the bone.The side is a monarch drug with the Caulis Seu Folium Euonymi Fortunei, and the kidney invigorating is invigorated blood circulation with repercussive collateral dredging (" Xinhua's book on Chinese herbal medicine outline " meaning Caulis Seu Folium Euonymi Fortunei energy " the strong muscle of the kidney invigorating ", " the temmoku Rhizoma Dioscoreae is planted will in Zhejiang " calls its energy " promoting flow of QI and blood is controlled waist and knee, joint aches ") with the strong muscle of bone strengthening; Minister is with Caulis Lonicerae principal drug assistance a surname blood stasis and smoothing collaterals (" medical science is handed down in a direct line from the master " meaning Caulis Lonicerae " being that a surname is stimulated the menstrual flow the feeling pulse medicine also ", " carrying out Cliff rock book on Chinese herbal medicine " called it and " controlled bones and muscles pain "); Herba Epimedii principal drug assistance invigorating the kidney and strengthening the bones, ventilation promoting the circulation of blood (" Elementary Medicine " meaning Herba Epimedii energy " the kidney invigorating void, supporing yang, hard muscle bone strengthening ", " Bencao Jingshu " calls its " hot with profit kidney, sweet temperature Yiyang gas; the warm QI and blood of passing through ", and " book on Chinese herbal medicine justice " calls its " warm venting QI-blood condenses so can change "); Assistant is driven wet with the Radix Angelicae Pubescentis cold expelling, (" Bencao Jingshu " said: " Radix Angelicae Pubescentis toil temperature can be warded off wind and cold to the principal drug assistance ventilation meridian, and the evil then QI and blood mediation of loosing is so its pain is from ending also again.Bitter can dampness, temperature can ward off cold, suffering and can disperse, cold-damp is gone and the kidney peace, hundred arthralgia." " book on Chinese herbal medicine justice " call its " logical hundred arteries and veins of a surname are in harmonious proportion meridians, logical muscles and bones, sharp joint "); Rhizoma Dioscoreae Nipponicae principal drug assistance promoting blood circulation to remove obstruction in the collateral (" the northeast medicine is planted will " meaning Rhizoma Dioscoreae Nipponicae " relaxing muscles and tendons to promote blood circulation is controlled lumbago and skelalgia, muscles and bones numbness ").Full monarch side one, minister two, assistant two, the merit of playing expelling wind and removing dampness, blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, the strong muscle of the kidney invigorating altogether.The prescription of this medicine has following characteristics: the Chinese patent medicine of 1, making a general survey of many treatment osteoarthritis, be difficult Caulis Seu Folium Euonymi Fortunei, Caulis Lonicerae, the Radix Angelicae Pubescentis person of being used as medicine, and this side is monarch with the Caulis Seu Folium Euonymi Fortunei, Caulis Lonicerae is a minister, it is its distinctive feature, and the side is five kinds of Chinese medicine only, and can and control " empty, evil, the stasis of blood ", is the prescription refine; 2, this side is with supporing yang Herba Epimedii the kidney invigorating, its be intended to " the strong kidney of temperature is superintended and directed yang-energy, and the excess of YANG then the moon is filled, and goes out from getting rid of evils, and also can drive evil unlikelyly to invade again ...." 3, in the virtue Radix Angelicae Pubescentis its with there being three: one, get its " product that dispel the wind ... mostly be hot and loose, can manage it and to moisten, the wet cold expelling of victory is arranged, make the heresy of cold-damp saturating, send out the inducing vomiting merit from the inside and outside." the 2nd, Radix Angelicae Pubescentis is " the profit product in the wind medicine, the fraud of the diffusing blood impairment of YIN of the nothing of using "; The 3rd, " the abnormal smells from the patient hero is listed as Radix Angelicae Pubescentis, sweet perfumes are diffused all around, and the evil numbness of wind and cold in the joint person in muscle, and the flavor of non-these male row can not reach between the passages through which vital energy circulates joint." so it has the usefulness of the through sick institute of priming again.
The above-mentioned medicine that is used for the treatment of osteoarthritis (bone matrix hyperplasia) syndrome of cold-dampness blocking collaterals can be made said multiple dosage form on the pharmaceutics, as capsule, tablet etc.The preparation method of its Tabules is as described below: after each medical material is made only, cut into slices in the prescription, gets 1/3rd amount Radix Angelicae Pubescentiss and is ground into fine powder, and standby; The Radix Angelicae Pubescentis of getting surplus is ground into coarse powder, the Radix Angelicae Pubescentis coarse powder is put in the reflux, extract, jar, the alcohol reflux of adding 85% three times adds 3 times for the first time and measures 85% ethanol, and second and third time respectively adds the ethanol of 2 times of amounts 85%, each reflux, extract, 3 hours, merge extractive liquid, filters filtrate decompression (0.07MPa, 50 ℃) reclaim ethanol after, it is standby to collect extracting solution; Other gets the FUFANGTENG of prescription amount, Caulis Lonicerae, Herba Epimedii, Rhizoma Dioscoreae Nipponicae four Chinese medicine raw material decocts with water twice, adds 12 times of water gagings for the first time, decocts 2 hours, for the second time add 8 times of water gagings, decocted 1 hour, filter, filtrate and above-mentioned Radix Angelicae Pubescentis extracting solution merge, decompression (0.08MPa, 60 ℃) is concentrated into the thick paste that relative density is 1.35～1.40 (60 ℃ of surveys), adds above-mentioned Radix Angelicae Pubescentis fine powder, mixing, decompression (0.08MPa, 65 ℃) drying is ground into fine powder, an amount of with 80% ethanol, 14 mesh sieves are granulated, 65 ℃ of dryings, 12 mesh sieve granulate, add 3% magnesium stearate, mixing with the dark arc punch die of 10mm tabletting, promptly makes this medicinal tablet.
In development process of the present invention, be therapeutic effect and the safety that proves this medicine, the designer has carried out the experimental study of pharmacodynamics, toxicology and clinicing aspect to the tablet that obtains according to above-mentioned preparation method, and the result is as follows in its experimental study.
One, cures mainly relevant pharmacodynamic study with function
Through tablet result of the test of the present invention is shown, two dosage groups of this medicine 4.2g/kg and 8.4g/kg cause the pedal swelling that scorching mice causes to bright egg remarkable inhibitory action (P＜0.01), rat agar is caused that ankle swelling has tangible antagonism (P＜0.05 or P＜0.01), to rat granuloma is swollen significant inhibitory effect (P＜0.01) is arranged, show that tablet of the present invention has significant antiinflammatory action.The 4.2g/kg of this medicine and 8.4g/kg dosage cause the effect (P＜0.01) that pain is reacted the threshold of pain that increases significantly to mice electrostimulation, hot plate method "; rat formaldehyde is caused the pain reaction certain analgesic activity (P＜0.05 or P＜0.01); show that tablet of the present invention has certain analgesic activity, and analgesic activity strengthens with dosage.Three dosage groups of this medicine large, medium and small (4.5g/kg, 9g/kg, 18g/kg) have significant inhibitory effect (P＜0.05 or P＜0.01) to rat assist agent arthritis, illustrate that tablet of the present invention has certain inhibitory action to the rat assist agent arthritis secondary disease.Though this medicine does not have obviously influence to mice, rat body weight, thymus, spleen weight, but can significantly promote the peritoneal macrophage phagocytic function, can increase mononuclear phagocyte system again and clean up function, show that tablet antiinflammatory action of the present invention may be relevant with the adjusting non-specific immunity.This medicine is formed with inhibitory action to platelet thrombus simultaneously, and the hemorheology of rat index is improved, and blood viscosity reduces, and erythrocyte electrophoresis speed is accelerated, and Fibrinogen reduces, and shows that tablet of the present invention has multiple pharmacological effect.
Two, toxicological study
The acute toxicity test of tablet of the present invention being done by the institute of Chinese materia medica, Shaanxi shows: the maximum dosage-feeding that Kunming mouse and the administration of SD strain rat oral gavage must this medicines is 60g crude drug/kg, converts this dosage with body weight and is about clinical 111 times of drafting the Coming-of-Age Day consumption.
The long term toxicity test of tablet of the present invention being done by institute of Chinese materia medica, Shaanxi etc. shows: maximal dose that must this medicine to three months gastric infusions of SD rat is a 4.8g/kg (37.8g crude drug/kg), be equivalent to 70 times of clinical adult's consumption every day approximately.The general situation of animal, hematology, blood biochemical are learned, electrocardiogram is all no abnormal, the also no abnormal pathological change of system's dissection, organ coefficient and histopathological examination.Drug withdrawal 30 days is no abnormality seen also.
Three, clinical research
Drug main of the present invention will be used for the treatment of knee osteoarthritis (knee joint OA) syndrome of cold-dampness blocking collaterals.According to Ministry of Public Health bureau of drug administration (94) ZL-22 file, observe the curative effect and the safety of tablet in treatment knee osteoarthritis of the present invention.This clinical experimental study work is respectively in Guang-amen Hospital, China Traditional Chinese Medicine Instl, Hospital Attached to Shandong Chinese Medical Univ., Traditional Chinese Medicine Research Institute, Shanxi Province Affiliated Hospital, the second clinical hospital of Xian Medical Univ (existing Shanghai Communications University, Xi'an second hospital), five tame units of The People's Hospital carry out, this clinical experimental study is according to the diagnostic criteria of the knee osteoarthritis of " new Chinese medicine clinical research guideline " formulation, the dialectical standard of syndrome of cold-dampness blocking collaterals, curative effect detects index and efficacy assessment standard, around test is the course of treatment, adopt the random-blind method to divide treatment group and matched group, treatment group 3 clothes capsules of the present invention every day, each 6 (every heavy 0.25g is heavy), the treatment group uses tablet of the present invention to observe 300 examples, above 137 examples of produce effects wherein, obvious effective rate is 45.67%, effective 132 examples, effective percentage is 44%, and total effective rate is 89.67%; Matched group uses the Dioscorea nipponica bony spur tablet to observe 150 routine patients, above 59 examples of produce effects wherein, obvious effective rate is 39.33%, effective 58 examples, effective percentage are 38.67%, and total effective rate is 75%, two groups of curative effects are learned by statistics and are handled P＜0.05, significant difference is arranged, illustrate that tablet of the present invention has the effect of dispelling cold and removing dampness, removing obstruction in the collateral to relieve pain, the curative effect of treatment knee osteoarthritis is better than the matched group medicine.Tablet in treatment knee osteoarthritis of the present invention clinical symptoms such as arthralgia (not suffer from night pain, when walking pain), morning deadlock, joint cold type of pain, heavy etc. curative effect preferably arranged all, can obviously improve these symptoms, particularly the curative effect for kneed cold type of pain obviously is better than matched group, has statistical significance.Because pain is the main clinical manifestation of knee osteoarthritis, so this clinical trial has adopted the scale method of continuing to use in the world to measure the variation of the treatment front and back gonalgia.The result shows that treatment back scale method score value has tangible reduction before the treatment, learns by statistics and handles P＜0.01, and the difference of highly significant is also arranged, and illustrates that tablet of the present invention has analgesic effect preferably.This clinical trial also uses behind the tablet of the present invention the variation of clinical sign to sum up to the knee osteoarthritis patient, the result shows that tablet of the present invention can improve the clinical sign of knee osteoarthritis, and it presses the disappearance rate of kneecap test, floating patella test and tenderness to be respectively 41.77%, 40.9% and 46%.During this clinical trial is carried out, use tablet of the present invention to have 5 routine patients the symptom of stomach discomfort to occur, occurrence rate is 1.67%, and this has stimulation relevant with a certain composition of this medicine to gastric mucosa, and changing one after each meal into does not promptly have this untoward reaction.Yu Wei sees other clinical adverse.Menses, urine, just routine and electrocardiogram, liver function, renal function detect explanation tablet of the present invention to blood, urine, just routine and the heart, liver, renal function all have no adverse effects, and be safe and reliable.
Claims (2)
1, a kind of medicine for the treatment of osteoarthritis, the Chinese medicine medicine material that it is characterized in that making medicament is pressed column weight amount proportioning and is consisted of:
Caulis Seu Folium Euonymi Fortunei 6～9, Caulis Lonicerae 3～4.5, Herba Epimedii 2～3,
Radix Angelicae Pubescentis 2～3, Rhizoma Dioscoreae Nipponicae 1～1.5.
2, the medicine of treatment osteoarthritis according to claim 1 is characterized in that described medicament is capsule or tablet.
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| CN102441088B (en) * | 2011-11-30 | 2014-04-02 | 宋爱民 | Traditional Chinese medicinal liquor used for treating lumbar muscle fiber inflammation |
| CN104524190A (en) * | 2015-01-06 | 2015-04-22 | 王国徽 | Medicament for treating rheumatic lumbar disease and preparation method thereof |
| CN104547581A (en) * | 2015-01-06 | 2015-04-29 | 王国徽 | Medicinal liquor for treating rheumatic lumbar spondylosis, dispelling wind and expelling cold and preparation method thereof |
| CN108210682A (en) * | 2018-02-27 | 2018-06-29 | 黄建民 | A kind of promoting blood circulation medicine puree and preparation method for treating Osteoarthritis |
| CN114949098A (en) * | 2022-03-28 | 2022-08-30 | 江苏莹华生物制药有限公司 | Traditional Chinese medicine sustained-release gel for treating osteoarthritis and preparation method thereof |
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| 扶芳藤及其制剂药理与临床研究概况 刘华钢 梁秋云，广西中医药，第26卷第3期 2003 * |
| 扶芳藤风湿片中卫矛醇的薄层扫描分析法 杨群英，中成药，第18卷第3期 1996 * |
| 扶芳藤风湿片中卫矛醇的薄层扫描分析法 杨群英，中成药，第18卷第3期 1996;扶芳藤及其制剂药理与临床研究概况 刘华钢 梁秋云，广西中医药，第26卷第3期 2003 * |
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