The Pharmaceutical Research Of Tougu Analgesic Liniment

Objective:Developed of traditional Chinese medicine compound medicine "Tou Gu analgesic liniment" for the treatment of a series of arthralgia caused by wind co ld dampness,and research of the preparation process,quality standard and preliminary stability and safety.Method:With the test result of main efficacy components and pharmacodynamics as an index, screening of preliminary preparation route; With mul tiple efficacy composition as an index, screening of preparation technology paramet ers by orthogonal test method. The corydalis rhizoma, gentianae macrophyllae radix, angelicae pubescentis radix, cinnamomi cortex and resina draconis has carried on the qualitative identification by using thin layer chromatography(TLC);Using high p erformance liquid chromatography(HPLC) method for the content determination of tetrahydropalmatine in corydalis rhizoma and the ferulic acid in chuanxiong rhizoma.To take a preliminary study on the stability of the preparation by using long-term r etention samples observation and heating speed observation.This article respectively examined irritating and allergic on rates.Results:Raw materials extraction technology of Tougu analgesic liniment identified as:Phryma leptostachya L?Common clubmoss her b Latin?gentianae macrophyllae radix?carthami flos were decocted with 2 times am ount of 10 and 8 times of water for 90 minutes,next decoction fluid was concentra ted on stress to the relative proportion of 1.08 to 1.10 under 60 degree centigrade and added ethanol to alcohol content up to 60 for 12 hours,then the solid particles were filtered from the solution.The twice sieve powder of corydalis rhizoma and any other 8 traditional Chinese medicines were reflux extracted with 2 times amount of 4 and 3 times of 60% ethanol for 2 hours,then extracting solution was added to decoction fluid in 4 degree centigrade overnight,and the add 60% ethanol to filtr ate until 1000 ml.The corydalis rhizoma, gentianae macrophyllae radix, angelicae pub escentis radix, cinnamomi cortex and resina draconis, in the chromatogram of the test, had the same color spots with reference material on the corresponding position, negative without interference. In the preparation determined by quantitative analysis, tetrahydropalmatine content shall not be less than 1.0 mg/bottle, ferulicacid content shall not be less than 1.0 mg/bottle.Preliminary stability study for 12 months at room temperature sample inspecting and 6 months of heating speed, the results showed that the product quality is stable and controllable and safety testing showed that this product has no irritability and excitement. Conclusion: The pharmaceutical technology of Tougu analgesic liniment is stable, the quality control method is accurate with a good reproducibility and the preparation quality is stable.