左归浓缩丸稳定性评价

Evaluation of stability of Zuogui Concentrated Pills

目的评价左归浓缩丸的稳定性。方法 HPLC法测定毛蕊花糖苷、马钱苷、金丝桃苷含有量,经典恒温加速试验检测其相对含有量,拟合动力学方程。经典恒温法和多元线性模型预测有效期,高温、高湿、强光照、加速、长期试验考察稳定性。结果毛蕊花糖苷、马钱苷、金丝桃苷的降解均符合一级动力学过程,2种方法所测左归浓缩丸的有效期分别为25.6个月和23.9个月。在各试验下,3种成分含有量、外观性状、溶散时限、水分、重量差异均无明显变化。结论左归浓缩丸稳定性较好,有效期暂定为2年。

AIM To evaluate the stability of Zuogui Concentrated Pills.METHODS HPLC was applied to determining the contents of acteoside,loganin and hyperoside,whose relative contents were detected by classical constant temperature accelerated test,after which the fitting of kinetic equation was conducted.The period of validity was predicted by classical constant temperature method and multivariate linear model,and the stability was investigated by high temperature,high humidity,strong light,accelerated and long-term tests.RESULTS The degradation of acteoside,loganin and hyperoside accorded with the first-order kinetic process.The periods of validity were found to be 25.6 months and 23.9 months by two methods,respectively.No obvious changes were observed on three constituents’ contents,appearance and character,disintegration time limit,moisture content and weight variation under various tests.CONCLUSION A tentatively scheduled two-year validity period is suitable for Zuogui Concentrated Pills due to its good stability.