| Tripterygium total terpenoids tablets, a kind of effective drugs for the treatment of rheumatoid arthritis, are prepared the dried root extract of Tripterygium, it has the expelling wind-evil and elimination of the wet disease, opening the eollateral channels and relieving pain and other effects. The triptolide is a diterpenoid epoxide and trace active ingredients, with a variety of clinical efficacy, but also is a major ingredient the caused toxicity. Therefore, accurate control over their content in the tablets in clinical efficacy and safety of medication is necessary.In recent years, Tripterygium wilfordii and triptolide have become a hot spot Modernization of Traditional Chinese Medicine, has considerable potential value and broad market prospects, reported more about tripterygium wilfordii and triptolide on the pharmacological effects and methods for the determinationof triptolide in various formulations.but the stability of triptolide in the preparation are few reports, the subject study on triptolide of Tripterygium total terpenoids tablets quality standards and stability.In the quality standard research, we determine the method of HPLC for triptolide of Tripterygium total terpenoids tablets, this study investigated liquid chromatography conditions for the test materials and preparation method, established the method is simple, separation and high reproducibility content method.In the strong degradation trial, we investigated the contengts of triptolide and Tripterygium total terpenoids tablets from the pH and oxidation. Concluded: Acidic conditions, triptolide content gradually decreased with time increased, no obvious peaks of impurities; alkaline conditions, triptolide content was significantly decreased, and impurity peak; oxidation conditions, the reference substance content of triptolide gradually decreased with time increased, there is no obvious peaks of impurities, preparation of triptolide content decreased significantly within 1 h, placed 8h detected Triptolide peaks, analysis may be under oxidative conditions generated the reversible response of triptolide and triptonide. Tripterygium total terpenoids tablets acceleration test, study on the impact of Tripterygium total terpenoids tablets from temperature, rehumidity, light intensity and other aspects. Triptolide content decreased under the high temperature and high humidity conditions; the content of triptolide little effect by light intensity, but a downward trend, should be kept sealed in cool and dark; the use of chemical kinetics study of different temperature on Tripterygium total terpenoids tablets by triptolide degradation rate express,temperature significant effect on the degradation rate, and predict its validity. |