Evaluation of stability of Zuogui Concentrated Pills / 中成药

ABSTRACT

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.