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.
ABSTRACT
<p><b>OBJECTIVE</b>To develop self-microemulsifying preparations of total flavones of Hippophae Rhamnoides L. (TFH) and the determination method of dissolution.</p><p><b>METHOD</b>The equilibrium solubility of TFH in different compositions of oils, emulsifier and assistant emulsifier was investigated. The self-microemulsion formula was optimized by constructing the pseudo-ternary phase diagrams of blank SMEDDS determining the self-microemulsifying efficiency and the stability of the SMEDDS. The 2 hours dissolution curve of TFH self-microemulsifying preparations was established. The optimal self-microemulsion formula was composed of MIGLYOL 812 N, Cremophor EL and 1,2-Propylene glycol.</p><p><b>RESULT</b>The ratio of them was 0.5:5.7:3.8. The average particle size was 12.1 nm. The dissolution rate at 10 minutes of TFH self-microemulsifying preparation was 131% higher than that of Xinda kang tablets.</p><p><b>CONCLUSION</b>The acquired microemulsion with small particle size is stable. The dissolution rate is evidently improved compared with market dosage forms.</p>