CN1088801A - Chinese patent medicine Jinguanpian tablets and the method for making thereof of treatment insensitive impediment, particularly RA and AS - Google Patents

Chinese patent medicine Jinguanpian tablets and the method for making thereof of treatment insensitive impediment, particularly RA and AS Download PDF

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CN1088801A
CN1088801A CN 93100514 CN93100514A CN1088801A CN 1088801 A CN1088801 A CN 1088801A CN 93100514 CN93100514 CN 93100514 CN 93100514 A CN93100514 A CN 93100514A CN 1088801 A CN1088801 A CN 1088801A
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radix
jinguanpian
tablets
grams
tripterygii wilfordii
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严碧玉
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No1 Military Surgeon Univ Pla
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No1 Military Surgeon Univ Pla
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Abstract

A kind of treatment insensitive impediment, feature is Chinese patent medicine Jinguanpian tablets and the method for making thereof of RA and AS, this medicine is based on the compound thunder god vine prescription, and its main component comprises Radix Tripterygii Wilfordii, Herba Asari, Ramulus Mori, Radix Gentianae Macrophyllae, Radix Achyranthis Bidentatae, Radix Dipsaci, Radix Aconiti Lateralis Preparata, Ramulus Cinnamomi, Radix Salviae Miltiorrhizae, Caulis Spatholobi, Herba Epimedii, Semen Coicis, Rhizoma Dioscoreae, Poria, Cornu Cervi Degelatinatum, Fructus Lycii, Rhizoma Polygonati, the Radix Astragali etc.The effect that nourishing the liver and kidney, promoting blood circulation to remove obstruction in the collateral are arranged, to treatment because the arthralgia due to the cohesion of deficiency of the liver and kindey, cold-damp, obstruction of collaterals by blood stasis, joint stuffiness, for a long time pain endlessly, aversion to cold and cold limbs, asthenia, pale tongue or ecchymosis is arranged, insensitive impediment such as stringy and thready pulse or stringy and tense pulse, rheumatoid arthritis, ankylosing spondylitis have above-mentioned disease person rapid-action, good effect, few side effects are current treatment RA, the comparatively ideal new drug of AS.

Description

Chinese patent medicine Jinguanpian tablets and the method for making thereof of treatment insensitive impediment, particularly RA and AS
The invention belongs to the treatment insensitive impediment, especially two wires rheumatism Chinese patent medicine of rheumatoid arthritis (RA) and ankylosing spondylitis (AS) and preparation method thereof.
Rheumatoid arthritis (RA) and ankylosing spondylitis (AS) two diseases because its cause of disease is not bright, up to the present, still do not have the specific medicament of the above-mentioned two kinds of diseases of treatment both at home and abroad, and many patients thereby lose work and self care ability.States such as English in 1932, U.S. begin with aurothioglucose and gold sodium thiomalate treatment RA, because of side effect too disabled greater than 1961, use oral golden Auranofin(Ridaura closely during the last ten years) treatment RA, the control RA state of an illness there is certain effect, but this medicine onset time is slow, to take medicine continuously and just take effect in 3 months, though its side effect is less than the injection gold, but erythra, oral ulcer, alopecia, exfoliative dermatitis can occur after still having 30% patient to take medicine and hematuria occur and albuminuria etc., and cost an arm and a leg, be difficult for being accepted by the patient.More domestic hospital application folk prescription Radix Tripterygii Wilfordii treatment RA and AS in 1963, we also begin with Radix Tripterygii Wilfordii tincture treatment RA and AS in nineteen eighty-two, though find that its curative effect is good, but side effect is bigger, all can have side effects as gastrointestinal tract, reproductive system, blood system, skin etc., it be applied be restricted.
The objective of the invention is at existing treatment insensitive impediment, particularly treat the shortcoming of the medicine of RA, AS, propose a kind of new Chinese patent medicine Jinguanpian tablets and preparation technology thereof, make it both to bring into play the effect of Radix Tripterygii Wilfordii treatment insensitive impediment, significantly reduce its side effect simultaneously based on the compound thunder god vine prescription.
Basis of the present invention is the compound thunder god vine prescription, it is that the inventor is according to traditional Chinese medicine theory, control in conjunction with rash for many years that the clinical experience of arthromyodynia develops, the Main Ingredients and Appearance of this prescription is: Radix Tripterygii Wilfordii, Herba Asari, Ramulus Mori, Radix Gentianae Macrophyllae, Radix Achyranthis Bidentatae, Radix Dipsaci, Radix Aconiti Lateralis Preparata, Ramulus Cinnamomi, Radix Salviae Miltiorrhizae, Caulis Spatholobi, Herba Epimedii, Semen Coicis, Rhizoma Dioscoreae, Poria, Cornu Cervi Degelatinatum, Fructus Lycii, Rhizoma Polygonati, the Radix Astragali etc.
The write out a prescription dosage percentage range (by weight) of each Main Ingredients and Appearance of above-mentioned compound thunder god vine can be: Radix Tripterygii Wilfordii 15-40%, Herba Asari 5-8%, Ramulus Mori 2-15%, Radix Gentianae Macrophyllae 2-15%, cattle rattan 0-10%, Radix Dipsaci 0-10%, Radix Aconiti Lateralis Preparata 3-10%, Ramulus Cinnamomi 3-10%, Radix Salviae Miltiorrhizae 3-10%, Caulis Spatholobi 5-15%, Herba Epimedii 3-6%, Semen Coicis 3-20%, Rhizoma Dioscoreae 5-15%, Poria 5-15%, Cornu Cervi Degelatinatum 0-10%, Fructus Lycii 0-10%, Rhizoma Polygonati 3-10%, Radix Astragali 5-15%.
The write out a prescription dosage percentage ratio of each Main Ingredients and Appearance of preferred compound thunder god vine is (by weight): Radix Tripterygii Wilfordii 20.0%, Herba Asari 6.4%, Ramulus Mori 4.0%, Radix Gentianae Macrophyllae 4.0%, Radix Achyranthis Bidentatae 3.2%, Radix Dipsaci 3.2%, Radix Aconiti Lateralis Preparata 3.2%, Ramulus Cinnamomi 3.2%, Radix Salviae Miltiorrhizae 4.0%, Caulis Spatholobi 6.4%, Herba Epimedii 3.2%, Semen Coicis 4.0%, Rhizoma Dioscoreae 8.0%, Poria 8.0%, Cornu Cervi Degelatinatum 3.2%, Fructus Lycii 4.0%, Rhizoma Polygonati 4.0%, the Radix Astragali 8.0%.
The processing technology of Chinese patent medicine Jinguanpian tablets is earlier according to the write out a prescription dosage weighing of each composition of compound thunder god vine, 17 flavor Chinese medicines that again will be wherein: Herba Asari, Ramulus Mori, Radix Gentianae Macrophyllae, Radix Achyranthis Bidentatae, Radix Dipsaci, Radix Aconiti Lateralis Preparata, Ramulus Cinnamomi, Radix Salviae Miltiorrhizae, Caulis Spatholobi, Herba Epimedii, Semen Coicis, Rhizoma Dioscoreae, Poria, Cornu Cervi Degelatinatum, Fructus Lycii, Rhizoma Polygonati, the Radix Astragali clean respectively, merge after the cutting and concoct, and make thick extractum, its concocting method is undertaken by " national Chinese medicine processing standard "; Radix Tripterygii Wilfordii then cleaned to be dried after handling be ground into fine powder; With mixing, the also drying of granulating in the thick extractum of the preceding 17 flavor Chinese medicines of Radix Tripterygii Wilfordii medicated powder adding, the tabletting sugar coating promptly gets the Jinguanpian tablets product at last then.
For alleviating, remove the toxicity of Radix Tripterygii Wilfordii, the Radix Tripterygii Wilfordii raw material in the prescription must be made peeling and wine earlier usually and wash processing.
The compound thunder god vine prescription that Jinguanpian tablets adopted, according to Chinese medical theory, Radix Tripterygii Wilfordii has the effect of expelling wind and removing dampness, relaxing muscles and tendons to promote blood circulation, detoxifcation pain relieving in the side, the Herba Asari acrid in the mouth is warm in nature, can dispel the wind, cold expelling, Hang Shui, have one's ideas straightened out, pain relieving, this two medicine is shared, the male power of medicine is high, follow through people's network, through sick institute, and it is a monarch drug; Ramulus Cinnamomi, Radix Gentianae Macrophyllae, Ramulus Mori, energy expelling wind and removing dampness collateral dredging, the cold and usefulness of three medicine temperature, principal drug assistance is all ministerial drug to pick the heresy by chronic knot altogether; The Radix Astragali, Rhizoma Dioscoreae, Poria, Semen Coicis energy replenishing QI to invigorate the spleen, promoting diuresis to clear away damp pathogen, but Radix Aconiti Lateralis Preparata, Herba Epimedii, Fructus Lycii, Rhizoma Polygonati, Cornu Cervi Degelatinatum, Radix Dipsaci, Radix Achyranthis Bidentatae be liver and kidney tonifying then, bone and muscle strengthening, but recover with above-mentioned 11 flavor tonic strengthening vital QI to eliminate pathogenic factors, promotion, and enhancing is to the toxic tolerance of Radix Tripterygii Wilfordii, Herba Asari, so it is adjuvant drug altogether; We also select for use Caulis Spatholobi and Radix Salviae Miltiorrhizae to turn round and look at gas and blood, promoting blood circulation to remove obstruction in the collateral, promoting tissue regeneration by removing blood stasis, the duty of negative messenger drug.
Therefore, the effect that has nourishing the liver and kidney, promoting blood circulation to remove obstruction in the collateral based on the Jinguanpian tablets of above-mentioned prescription, can be used for treating arthralgia due to deficiency of the liver and kindey, cold-damp cohesion, the obstruction of collaterals by blood stasis, joint stuffiness, pain is endlessly met and is coldly increased the weight of aversion to cold and cold limbs for a long time, soreness of the waist and knees, shortness of breath and lassitude, pale tongue or dark red or ecchymosis is arranged, tongue fur is white, the insensitive impediment of stringy and thready pulse or stringy and tense pulse, all RA, AS are seen has above-mentioned thread disease person to use.
Below be character, pharmacology, toxicity, drug effect and the explanation of clinical trial situation of Jinguanpian tablets of the present invention:
1, character: Jinguanpian tablets is to show sepia, mildly bitter flavor, puckery behind coated tablet, the desaccharide clothing.
2, main pharmacological: Jinguanpian tablets has antiinflammation and significant analgesia role, and the function of microcirculation improvement and adrenal cortex reinforcing is arranged, and can suppress humoral immunization, can adjust again and the function that strengthens cellular immunization.
3, to record LD50 be 26.06g/kg in acute toxicity test.
4, long term toxicity test: the long term toxicity test result of rat and Beagle kind dog (purebred Canis familiaris L.) is not seen toxic reaction and to the infringement of internal organs organ.
5, mutagenicity test: research comprises the Ame's test, the mouse marrow cell chromosome aberration test, mouse bone marrow cells polychromatophilia micronucleus in erythrocytes test, Jinguanpian tablets be to the four kinds of experimentatioies that influence of human body chromosome, and the result shows that Jinguanpian tablets do not induce the human body chromosome distortion.
6, reproductive toxicity test: result of the test does not see that Jinguanpian tablets has harmful effect to rat reproductive performance and the young growth promoter of tire.
Toxicologic study result proves that Jinguanpian tablets clinical treatment dosage is safe.
7, clinical trial:
Official written reply according to new drug evaluation office of central Ministry of Public Health bureau of drug administration, form the clinical verification base by Affiliated Hospital of Guangzhou Traditional Chinese Medicine College, Longhua Hospital of Chinese Midicine Univ. of Shanghai, attached Nanfang Hospital of No.1 Military Medical Univ. and hospital general, the military region, Guangzhou, under strict randomized, double-blind and single blind condition, 446 routine patients are carried out clinical treatment observation.Therapeutic outcome Jinguanpian tablets group is totally 306 examples, clinical remission 45 examples, and produce effects 129 examples, 114 examples that take a turn for the better, invalid 18 examples, total effective rate is 94.1%.Matched group (indometacin) is totally 140 examples, clinical remission 6 examples, produce effects 14 examples, 70 examples that take a turn for the better, invalid 50 examples, total effective rate 64.3%.Clinical test results shows that the curative effect of Jinguanpian tablets obviously is better than matched group.Jinguanpian tablets is to improving arthralgia, joint stuffiness, and symptoms such as soreness of the waist and knees all have extraordinary curative effect.
In addition, to the experimental observation result of Jinguanpian tablets and single Radix Tripterygii Wilfordii clinical efficacy and side effect: the Jinguanpian tablets group is totally 177 examples, clinical remission 14 examples, produce effects 72 examples, effective 86 examples, invalid 5 examples, total effective rate 97.2%; Matched group (single Radix Tripterygii Wilfordii) 165 examples, clinical remission 18 examples, produce effects 95 examples, effective 46 examples, invalid 6 examples, total effective rate 96.4%.Two groups of situation such as following tables that side effect occurs in the treatment:
Jinguanpian tablets group single Radix Tripterygii Wilfordii group
Side effect example number side effect example number side effect example number
Epigastric discomfort 3 loss of appetite 8 SGPT raise 2
Upper abdominal pain 6 dizziness headaches 2 in the dry mouth with bitter taste 2
1 amenorrhea, 5 hyper-menorrheas 2 of suffering from abdominal pain
1 facial pigmentation, the 5 armpit hair pubes of suffering from diarrhoea come off 2
Leukopenia 4 vomitings 1
Alopecia 3 oral ulcer 1
Nervous 3 hyperhidrosis 1
Diarrhoea 3 heatings 1
Nauseating 2 erythra 1
Fingernail attenuation and soft 2 skin pruritus 1
Above-mentioned clinical comparison test explanation, Jinguanpian tablets and single Radix Tripterygii Wilfordii all have better therapeutic effect to rheumatoid arthritis and ankylosing spondylitis, but the side effect of single Radix Tripterygii Wilfordii group is more, in early days based on gastrointestinal reaction, clothes back endocrine reaction for a long time engenders, and there are alopecia, armpit hair, pubes to come off and skin is taupe, oral ulcer, erythra and leukopenia appear in a few patients, and have serious feel sick, vomiting, stomachache and diarrhoea so that a few patients can't adhere to taking medicine and drug withdrawal.The side effect of Jinguanpian tablets group is starkly lower than single Radix Tripterygii Wilfordii group.In follow-up observation, the relapse rate of single Radix Tripterygii Wilfordii group is higher simultaneously, and Jinguanpian tablets group state of an illness alleviation back recurrence is less.New drug Jinguanpian tablets of the present invention is used compound of Chinese medicine insensitive impediment, particularly RA and AS, its prescription monarch, minister, help, make clear and definite, reasonable recipe, has rapid-action, good effect, the characteristics of few side effects, reliable and stable through hospital clinical evidences such as Longhua, Shanghai hospital, Affiliated Hospital of Guangzhou Traditional Chinese Medicine College, be current treatment RA, the comparatively ideal new drug of AS.
Embodiment one
The Jinguanpian tablets prescribed dose:
Radix Tripterygii Wilfordii 156 grams, Herba Asari 50 grams, Ramulus Mori 31 grams, Radix Gentianae Macrophyllae 31 grams, Radix Achyranthis Bidentatae 25 grams, Radix Dipsaci 25 grams, Radix Aconiti Lateralis Preparata 25 grams, Ramulus Cinnamomi 25 grams, Radix Salviae Miltiorrhizae 31 grams, Caulis Spatholobi 50 grams, Herba Epimedii 25 grams, Semen Coicis 31 grams, Rhizoma Dioscoreae 62 grams, Poria 62 grams, Cornu Cervi Degelatinatum 25 grams, Fructus Lycii 31 grams, Rhizoma Polygonati 31 grams, the Radix Astragali 62 grams.
Above-mentioned Radix Tripterygii Wilfordii raw material is removed the peel, wine is washed processing.
Method for making: fine powder is cleaned, is ground into to Radix Tripterygii Wilfordii, sieve, all the other 17 flavor Chinese medicines are cleaned, every flavor decocts with water three times after the cutting, and each 2 hours, collecting decoction, filtration, it is 1.33(80-85 ℃ that filtrate is concentrated into relative density) thick extractum, the Radix Tripterygii Wilfordii fine powder is added mixing in the above-mentioned thick extractum, granulation, drying, compacting (wherein can add appropriate amount of starch and filler) in blocks, sugar coating promptly makes the patent medicine Jinguanpian tablets again.Above-mentioned dosage can make 1000 of Jinguanpian tablets approximately.
Embodiment two
The Jinguanpian tablets prescribed dose:
Radix Tripterygii Wilfordii 140 grams, Herba Asari 47 grams, Ramulus Mori 39 grams, Radix Gentianae Macrophyllae 50 grams, Radix Achyranthis Bidentatae 25 grams, Radix Dipsaci 25 grams, Radix Aconiti Lateralis Preparata 25 grams, Ramulus Cinnamomi 25 grams, Radix Salviae Miltiorrhizae 31 grams, Caulis Spatholobi 50 grams, Herba Epimedii 25 grams, Semen Coicis 31 grams, Rhizoma Dioscoreae 54 grams, Poria 54 grams, Cornu Cervi Degelatinatum 25 grams, Fructus Lycii 31 grams, Rhizoma Polygonati 39 grams, the Radix Astragali 62 grams.
Method for making and requirement are with embodiment one.
Embodiment three
The Jinguanpian tablets prescribed dose:
Radix Tripterygii Wilfordii 273 grams, Herba Asari 54 grams, Ramulus Mori 23 grams, Radix Gentianae Macrophyllae 31 grams, Radix Achyranthis Bidentatae 25 grams, Radix Dipsaci 25 grams, Radix Aconiti Lateralis Preparata 25 grams, Ramulus Cinnamomi 25 grams, Radix Salviae Miltiorrhizae 23 grams, Caulis Spatholobi 31 grams, Herba Epimedii 17 grams, Semen Coicis 23 grams, Rhizoma Dioscoreae 54 grams, Poria 47 grams, Cornu Cervi Degelatinatum 23 grams, Fructus Lycii 23 grams, Rhizoma Polygonati 23 grams, the Radix Astragali 54 grams.
Method for making and requirement are with embodiment one.
Embodiment four
The Jinguanpian tablets prescribed dose:
Radix Tripterygii Wilfordii 181 grams, Herba Asari 50 grams, Ramulus Mori 31 grams, Radix Gentianae Macrophyllae 31 grams, Radix Achyranthis Bidentatae 25 grams, Radix Dipsaci 25 grams, Radix Aconiti Lateralis Preparata 25 grams, Ramulus Cinnamomi 25 grams, Radix Salviae Miltiorrhizae 31 grams, Caulis Spatholobi 50 grams, Herba Epimedii 25 grams, Semen Coicis 31 grams, Rhizoma Dioscoreae 62 grams, Poria 62 grams, Fructus Lycii 31 grams, Rhizoma Polygonati 31 grams, the Radix Astragali 62 grams.
Method for making and requirement are with embodiment one.

Claims (5)

1, the Chinese patent medicine Jinguanpian tablets of a kind of treatment insensitive impediment, particularly rheumatoid arthritis (RA) and ankylosing spondylitis (AS), it is characterized in that this medicine based on the compound thunder god vine prescription, the Main Ingredients and Appearance of said prescription comprises Radix Tripterygii Wilfordii, Herba Asari, Ramulus Mori, Radix Gentianae Macrophyllae, Radix Achyranthis Bidentatae, Radix Dipsaci, Radix Aconiti Lateralis Preparata, Ramulus Cinnamomi, Radix Salviae Miltiorrhizae, Caulis Spatholobi, Herba Epimedii, Semen Coicis, Rhizoma Dioscoreae, Poria, Cornu Cervi Degelatinatum, Fructus Lycii, Rhizoma Polygonati, the Radix Astragali.
2, by the described Chinese patent medicine Jinguanpian tablets of claim 1, it is characterized in that the dosage percentage ratio (by weight) of said each Main Ingredients and Appearance of prescription is: Radix Tripterygii Wilfordii 15-40%, Herba Asari 5-8%, Ramulus Mori 2-15%, Radix Gentianae Macrophyllae 2-15%, cattle rattan 0-10%, Radix Dipsaci 0-10%, Radix Aconiti Lateralis Preparata 3-10%, Ramulus Cinnamomi 3-10%, Caulis Spatholobi 5-15%, Herba Epimedii 3-6%, Semen Coicis 3-20%, Rhizoma Dioscoreae 5-15%, Poria 5-15%, Cornu Cervi Degelatinatum 0-10%, Fructus Lycii 0-10%, Rhizoma Polygonati 3-10%, Radix Astragali 5-15%, Radix Salviae Miltiorrhizae 3-10%.
3, by the described Chinese patent medicine Jinguanpian tablets of claim 1, it is characterized in that the dosage percentage ratio (by weight) of said each Main Ingredients and Appearance of prescription is: Radix Tripterygii Wilfordii 20.0%, Herba Asari 6.4%, Ramulus Mori 4.0%, Radix Gentianae Macrophyllae 4.0%, cattle rattan 3.2%, Radix Dipsaci 3.2%, Radix Aconiti Lateralis Preparata 3.2%, Ramulus Cinnamomi 3.2%, Radix Salviae Miltiorrhizae 4.0%, Caulis Spatholobi 6.4%, Herba Epimedii 3.2%, Semen Coicis 4.0%, Rhizoma Dioscoreae 8.0%, Poria 8.0%, Cornu Cervi Degelatinatum 3.2%, Fructus Lycii 4.0%, Rhizoma Polygonati 4.0%, the Radix Astragali 8.0%.
4, the method for making of the described Chinese patent medicine golden light of claim 1 sheet, it is characterized in that Herba Asari, Ramulus Mori, Radix Gentianae Macrophyllae, cattle rattan, Radix Dipsaci, Radix Aconiti Lateralis Preparata, Ramulus Cinnamomi, Radix Salviae Miltiorrhizae, Caulis Spatholobi, Herba Epimedii, Semen Coicis, Rhizoma Dioscoreae, Poria, Cornu Cervi Degelatinatum, structure Fructus Lycii, Rhizoma Polygonati, the Radix Astragali 17 flavor Chinese medicines are cleaned respectively, merge after the cutting and concoct, make thick extractum, again Radix Tripterygii Wilfordii is cleaned the processing after drying and be ground into fine powder, then Radix Tripterygii Wilfordii medicated powder is added mixing in the thick extractum, granulate and drying, last tabletting sugar coating promptly gets the Jinguanpian tablets product.
5,, it is characterized in that the peeling of process crude drug, wine be washed processing to described Radix Tripterygii Wilfordii raw material earlier by the method for making of the described Chinese patent medicine Jinguanpian tablets of claim 4.
CN 93100514 1993-01-01 1993-01-01 Chinese patent medicine Jinguanpian tablets and the method for making thereof of treatment insensitive impediment, particularly RA and AS Pending CN1088801A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1087949C (en) * 1999-10-14 2002-07-24 周沛 Medicine for treating rigid spine inflammation and prepn. method thereof
CN1119156C (en) * 2000-01-27 2003-08-27 辛耀禄 Xiancaoteng capsule made of korean epimedium herb, liquorice root and common threewingnut root and its preparation
CN100502911C (en) * 2002-04-09 2009-06-24 四川省中药研究所 An anti-rheumatism medicament and preparation method thereof

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1087949C (en) * 1999-10-14 2002-07-24 周沛 Medicine for treating rigid spine inflammation and prepn. method thereof
CN1119156C (en) * 2000-01-27 2003-08-27 辛耀禄 Xiancaoteng capsule made of korean epimedium herb, liquorice root and common threewingnut root and its preparation
CN100502911C (en) * 2002-04-09 2009-06-24 四川省中药研究所 An anti-rheumatism medicament and preparation method thereof

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