Summary of the invention
The technical problem that the present invention will solve provides a kind of pharmaceutical composition of treating rheumatoid arthritis; Can dispel the wind dispelling toxins and dredging collaterals, benefiting QI and nourishing blood set upright, and is used to treat pain of joint muscle that rheumatoid arthritis, ankylosing spondylitis and other rheumatism immune diseases cause, swelling, limitation of activity etc.; For this reason, the present invention provides this preparation of drug combination method simultaneously.
For solving the problems of the technologies described above, the technical scheme that the present invention taked is following.
A kind of pharmaceutical composition of treating rheumatoid arthritis, the main pharmacodynamics raw material of processing this pharmaceutical composition by ratio of weight and the number of copies is: Caulis Sinomenii 50~150, Radix Tripterygii Wilfordii 50~150, Herba Epimedii 50~150; Radix Gentianae Macrophyllae 50~150, Caulis Spatholobi 100~200, Radix Salviae Miltiorrhizae 100~200, Rhizoma Corydalis 50~150; The Radix Astragali 100~200, Radix Rehmanniae 100~200, the Radix Paeoniae Alba 50~150; Radix Et Rhizoma Rhei 50~150, Radix Scutellariae 50~150, Radix Glycyrrhizae 10~150.
As a kind of optimal technical scheme of the present invention, the main pharmacodynamics raw material of processing this pharmaceutical composition by ratio of weight and the number of copies is: Caulis Sinomenii 82~86, Radix Tripterygii Wilfordii 82~86, Herba Epimedii 82~86; Radix Gentianae Macrophyllae 82~86, Caulis Spatholobi 160~175, Radix Salviae Miltiorrhizae 160~175, Rhizoma Corydalis 108~116; The Radix Astragali 160~175, Radix Rehmanniae 160~175, the Radix Paeoniae Alba 82~86; Radix Et Rhizoma Rhei 54~58, Radix Scutellariae 54~58, Radix Glycyrrhizae 54~58.
As a kind of optimal technical scheme of the present invention, the main pharmacodynamics raw material of processing this pharmaceutical composition by ratio of weight and the number of copies is: Caulis Sinomenii 84, Radix Tripterygii Wilfordii 84, Herba Epimedii 84; Radix Gentianae Macrophyllae 84, Caulis Spatholobi 168, Radix Salviae Miltiorrhizae 168, Rhizoma Corydalis 112; The Radix Astragali 168, Radix Rehmanniae 168, the Radix Paeoniae Alba 84; Radix Et Rhizoma Rhei 56, Radix Scutellariae 56, Radix Glycyrrhizae 56.
As a kind of optimal technical scheme of the present invention, the main pharmacodynamics raw material of processing this pharmaceutical composition by ratio of weight and the number of copies is: Caulis Sinomenii 85, Radix Tripterygii Wilfordii 85, Herba Epimedii 82; Radix Gentianae Macrophyllae 86, Caulis Spatholobi 170, Radix Salviae Miltiorrhizae 162, Rhizoma Corydalis 110; The Radix Astragali 173, Radix Rehmanniae 174, the Radix Paeoniae Alba 82; Radix Et Rhizoma Rhei 54, Radix Scutellariae 58, Radix Glycyrrhizae 54.
The preparation of drug combination method of above-mentioned treatment rheumatoid arthritis: take by weighing each pharmacodynamic raw materials according to above-mentioned prescription, through pulverize, the water concentration contracts or the two bonded mode with each pharmacodynamic raw materials mixing, promptly get.
As a kind of optimal technical scheme of above-mentioned method for preparing, its step comprises:
A, take by weighing each pharmacodynamic raw materials according to above-mentioned prescription, wherein Radix Gentianae Macrophyllae, Radix Salviae Miltiorrhizae, Rhizoma Corydalis, the Radix Astragali, the Radix Paeoniae Alba, Radix Glycyrrhizae, Radix Et Rhizoma Rhei, Radix Scutellariae eight flavor medicated powder are broken into fine powder;
B, Caulis Sinomenii, Radix Tripterygii Wilfordii, Radix Rehmanniae, Caulis Spatholobi, Herba Epimedii five kinds of Chinese medicine add 6~10 times of water gagings and decoct, and decocting liquid filters, and filtrating is concentrated into the clear paste that relative density is 1.10g/ml~1.20g/ml;
C, steps A gained fine powder is joined in the clear paste of step B, mixing, drying is ground into fine powder, sieves, and promptly gets.
As a kind of optimal technical scheme of above-mentioned method for preparing, every 100g step C gained powder adds water with refined honey 31g~39g and processes water-honeyed pill 1000g, and drying gets finished product.
As a kind of optimal technical scheme of above-mentioned method for preparing, among the step B, Caulis Sinomenii, Radix Tripterygii Wilfordii, Radix Rehmanniae, Caulis Spatholobi, Herba Epimedii five kinds of Chinese medicine add 8 times of water gagings and decoct 2~4 times, decoct collecting decoction continued subsequent step altogether 2 hours~4 hours.
A kind of optimal technical scheme as above-mentioned method for preparing takes by weighing each pharmacodynamic raw materials according to above-mentioned prescription, is ground into fine powder, sieves, and every 100g gained powder adds water with refined honey 31g~39g and processes water-honeyed pill 1000g, and drying gets finished product.
A kind of optimal technical scheme as above-mentioned method for preparing takes by weighing each pharmacodynamic raw materials according to above-mentioned prescription, and the decocting that adds 7~9 times of amounts boils 2 times, 2 hours for the first time; 1.5 hours for the second time, collecting decoction filtered, and is condensed into thick paste; Add the cane sugar powder mixed pelletization, drying gets finished product.
Adopt the beneficial effect that technique scheme produced to be:
Function of the present invention cures mainly: the dispelling toxins and dredging collaterals that dispels the wind, benefiting QI and nourishing blood are set upright, and are used for pain of joint muscle that rheumatoid arthritis, ankylosing spondylitis and other rheumatism immune diseases cause, swelling, limitation of activity etc.
Pharmaceutical composition of the present invention is through repeated screening, adopts the medicine and the Radix Tripterygii Wilfordii of existing heat-clearing and toxic substances removing, removing heat from blood collateral dredging to share, and has synergistic therapeutic action, again can benefiting QI and nourishing blood, the hepatoprotective kidney tonifying, and to alleviate the toxic and side effects of Radix Tripterygii Wilfordii.Caulis Sinomenii is searched wind prevailing over dampness, arthralgia relieving by relaxing muscles and tendons in the side, and Radix Tripterygii Wilfordii dispelling toxins and dredging collaterals, anti-inflammation detumescence are monarch drug altogether; Herba Epimedii expelling wind and removing dampness, the Radix Gentianae Macrophyllae eliminating impediment that dispels the wind, Caulis Spatholobi, Radix Salviae Miltiorrhizae, Rhizoma Corydalis activating blood circulation and unblocking obstruction, strengthening the principal agent curative effect is ministerial drug altogether; Assistant is with the Radix Astragali, Radix Rehmanniae, Herba Epimedii, Radix Paeoniae Alba qi and blood tonifying, and negative and positive are taken into account setting upright, the Radix Et Rhizoma Rhei clearing away heat and purging, and the Radix Scutellariae heat clearing and damp drying is getting rid of evils, and the bias of system principal agent of can holding concurrently, the Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription.Have no adverse reaction through clinical this preparation of reference validation, toxicity is less, and is safe and reliable.
Following Test Example further illustrates beneficial effect of the present invention.Wherein employed outturn sample of the present invention is the pill product of following embodiment 1 preparation.Usage and dosage of the present invention is during human trial: oral, and one time 0.5 bag (4g), 2 times on the one; One month is a course of treatment.
Test Example (1), acute toxicity test in mice
The college of traditional Chinese medicine of Hebei Medical University is studied the acute toxicity test in mice of these article; The result shows: 20 of Kunming strain mices; When twice on the one gastric infusion of per os, dosage are 24g/kg/ day (be equivalent to clinical consumption 120 times), observe a week continuously; Mice does not have death, does not find untoward reaction.According to " study of tcm new drug guide " (94~0198) chapter 2 The acute toxicity tests evaluation criterion, these article oral administration acute toxicity is nontoxic for basically.
Test Example (2), the mice test of pesticide effectiveness
The college of traditional Chinese medicine of Hebei Medical University herbal pharmacology research department has carried out experimental study to the drug effect of these article; Result of study shows: pharmaceutical composition of the present invention (0.7g/kg, 1.4g/kg, 2.8g/kg) can suppress to intersect rat paw edema due to the dish glue, suppresses the swollen hypertrophy of rat granuloma; Pharmaceutical composition of the present invention (0.9g/kg, 1.8g/kg, 3.6g/kg) can obviously suppress the swelling of xylol induced mice auricular concha, improves mice hot plate method pain threshold, and 0.6% acetic acid induced mice pain is had significant analgesia role.
Test Example (3), rat long term toxicity test
Herbal pharmacology teaching and research room of the college of traditional Chinese medicine of Hebei Medical University has carried out the rat long term toxicity test to these article.The result shows: the oral suspension administration; Dosage is 6g/kg, 3g/kg, 1.5g/kg (be equivalent to clinical consumption 30 times, 15 times, 7.5 times); 90 days long term tests of SD rat oral gavage administration are shown by the reagent thing; The general situation no abnormality seen of animal; Blood parameters such as hematological indices such as the body weight of each administration group, erythrocyte number, hemoglobin, platelet count, numeration of leukocyte and classification, clotting time and aspartate aminotransferase, alanine aminotransferase, alkali phosphatase, blood urea nitrogen, total protein, albumin, blood glucose, STB, creatinine, T-CHOL are with the relatively equal no significant difference of blank group.The main organs weight coefficient of each administration treated animal and matched group compare, also no significant difference.The pathological examination no abnormality seen.After the drug withdrawal 14 days, the hematological indices of administration treated animal, blood parameters, main organs weight coefficient and matched group be zero difference relatively all, and pathological examination is respectively organized also no abnormality seen of internal organs.The medication under experimental condition of these article of explanation is a basic security.These article of prompting use under prescribed dose maybe be safe and reliable.
Test Example (4), clinical observation on the therapeutic effect
Pharmaceutical composition of the present invention is that Shijiazhuang safety hospital is through research for many years; Heat-clearing and toxic substances removing, removing heat from blood collateral dredging medicine and Radix Tripterygii Wilfordii are share; The therapeutical effect of not only have tonify deficiency, blood stasis dispelling, getting rid of evils; And the synergistic therapeutic action of benefiting QI and nourishing blood, hepatoprotective kidney tonifying is arranged, can alleviate the toxic and side effects of Radix Tripterygii Wilfordii.For clinical efficacy property and the safety of verifying medicine composite for curing rheumatoid arthritis of the present invention; Shijiazhuang City, Hebei Province safety hospital; Adopt the observational technique of contrast at random; Carry out the clinical contrast observation with positive control drug tripterygium glycosides sheet, being tried case, to be the diagnostic criteria, the Chinese medical discrimination that meet rheumatoid arthritis be retention of damp-heat in the interior, deficiency of qi and blood, congestion resistance network card person and the case of signing Informed Consent Form.Accomplish clinical observation 120 examples altogether; Being in January, 2006 ~ 2007 my gate of year December examines and inpatient; Abide by district's group randomization and be divided into pharmaceutical composition group of the present invention (being the treatment group) and tripterygium glycosides sheet group (being matched group), each 60 example.Result of the test shows, treat 3 courses of treatment after, the treatment group is slow, and to show rate be 78.3%, matched group is slow, and to show rate be 43.33%, the treatment group is higher than matched group, compares that there were significant differences (P<0.05); Two groups of patient's traditional Chinese medical science disease clinical efficacies compare, and treatment group total effective rate is 98.33%, and the matched group total effective rate is 95.00%, and the treatment group is higher than matched group, and relatively there were significant differences (P<0.05).It is thus clear that pharmaceutical composition of the present invention is rheumatoid arthritis patient's clinical symptoms preferably, obviously improve arthralgia, the swelling degree of patient with rheumatoid arthritis.It is evident in efficacy to use medicine composite for curing rheumatoid arthritis of the present invention.
The specific embodiment
Following examples have specified the present invention.Various raw material used in the present invention and items of equipment are conventional commercially available prod, all can buy directly through market to obtain.
The instructions of taking of pharmaceutical composition of the present invention is: oral, and once half bag to one bag, every packed 8g, 2 times on the one, sooner or later respectively once; Anemia of pregnant woman, liver function injury, renal insufficiency person forbidding are given up alcohol, strong tea, make regular check on routine blood test, hepatic and renal function.
Relate to notions such as " coarse powder ", " fine powder ", " fine powder " among the following embodiment, its concrete implication is following:
1. powder grades:
Coarse powder refers to and can be no more than 20% powder through No. three sieves but be mixed with all through a sieve;
Coarse powder refers to and can be no more than 40% powder through No. four sieves but be mixed with all through No. two sieves;
Middle powder refers to and can be no more than 60% powder through No. five sieves but be mixed with all through No. four sieves;
Fine powder refers to and can all sieve through No. five, and contains and can be no less than 95% powder through No. six sieves;
Fine powder refers to can be all through No. six sieves, and contain and can be no less than 95% powder through No. seven sieves;
Impalpable powder refers to and can all sieve through No. eight, and contains and can be no less than 95% powder through No. nine sieves;
2. medicine screening etc.:
Embodiment 1
A kind of pharmaceutical composition of treating rheumatoid arthritis, the main pharmacodynamics raw material of processing this pharmaceutical composition by ratio of weight and the number of copies is: Caulis Sinomenii 84, Radix Tripterygii Wilfordii 84, Herba Epimedii 84; Radix Gentianae Macrophyllae 84, Caulis Spatholobi 168, Radix Salviae Miltiorrhizae 168, Rhizoma Corydalis 112; The Radix Astragali 168, Radix Rehmanniae 168, the Radix Paeoniae Alba 84; Radix Et Rhizoma Rhei 56, Radix Scutellariae 56, Radix Glycyrrhizae 56.Its preparation process comprises:
A, take by weighing each pharmacodynamic raw materials according to above-mentioned prescription, wherein Radix Gentianae Macrophyllae, Radix Salviae Miltiorrhizae, Rhizoma Corydalis, the Radix Astragali, the Radix Paeoniae Alba, Radix Glycyrrhizae, Radix Et Rhizoma Rhei, Radix Scutellariae eight flavor medicated powder are broken into fine powder;
B, Caulis Sinomenii, Radix Tripterygii Wilfordii, Radix Rehmanniae, Caulis Spatholobi, Herba Epimedii five kinds of Chinese medicine add 8 times of water gagings and decoct three times, and each 1 hour, collecting decoction filtered, and filtrating is concentrated into the clear paste that relative density is 1.10g/ml~1.20g/ml (50 ℃~60 ℃);
C, steps A gained fine powder is joined in the clear paste of step B, mixing, drying is ground into fine powder, sieves;
D, every 100g step C gained powder add water with refined honey 31g~39g and process water-honeyed pill 1000g, and drying gets finished product.
Embodiment 2
A kind of pharmaceutical composition of treating rheumatoid arthritis, the main pharmacodynamics raw material of processing this pharmaceutical composition by ratio of weight and the number of copies is: Caulis Sinomenii 85, Radix Tripterygii Wilfordii 85, Herba Epimedii 82; Radix Gentianae Macrophyllae 86, Caulis Spatholobi 170, Radix Salviae Miltiorrhizae 162, Rhizoma Corydalis 110; The Radix Astragali 173, Radix Rehmanniae 174, the Radix Paeoniae Alba 82; Radix Et Rhizoma Rhei 54, Radix Scutellariae 58, Radix Glycyrrhizae 54.
Its preparation method is: take by weighing each pharmacodynamic raw materials according to above-mentioned prescription, be ground into fine powder, sieve, every 100g gained powder adds water with refined honey 31g~39g and processes water-honeyed pill 1000g, and drying gets finished product.
Embodiment 3
The drug regimen composition formula of present embodiment is identical with embodiment 1.
Its preparation method is: take by weighing each pharmacodynamic raw materials according to above-mentioned prescription, the decocting that adds 8 times of amounts boils 2 times, 2 hours for the first time; 1.5 hours for the second time, collecting decoction filtered; Be condensed into thick paste; Add cane sugar powder (consumption of cane sugar powder is: make every 15g raw medicinal herbs make the 10g product particle) mixed pelletization, drying gets finished product.
In addition; Dried cream, thick paste or the mixture of powders of the above embodiment of the present invention preparation can add Mel or other pharmaceutically acceptable excipient, process pill or other acceptable clinically granules, drop pill, tablet, capsule, suspensoid, oral liquid etc.
Foregoing description only proposes as the enforceable technical scheme of the present invention, not as the single restrictive condition to its technical scheme itself.