ABSTRACT
OBJECTIVE:To investigate the quality differences of Betamethasone tablet from different enterprises,and provide reference for the eventual establishment of the drug relative quality evaluation system. METHODS:According to the principle and steps of the ideal point method,a mathematical model was established. And the perfect point of the 3 inspection parameters (content,content uniformity and dissolution)of Betamethasone tablet was regarded as the upper limit theoretically,and the permis-sible point as the prescribed minimum in the model. After homogenizing the initial data or ones to be quantifiable were translated in-to evaluation parameters;and the evaluation parameters were calculated by ideal point method to receive comprehensive evaluation results. RESULTS:According to variance analysis,there was no significant difference in the comprehensive evaluation results of Betamethasone tablet from different enterprises(P=0.54>0.05),indicating that the overall quality of Betamehasone tablet was good. CONCLUSIONS:The mathematical model of quality evaluation with different drug has certain feasibility and operability.
ABSTRACT
Objective: To investigate the application of microemulsion TLC in separation and identification of various effective compositions in traditional Chinese patent medicines. Methods: The various compositions in Kangganmao Granules and Fangfeng Tongsheng Pills were separated and identified simultaneously on polyamide film with six kinds of SDS/n C 4H 9OH/n C 7H 16 /H 2O microemulsions as the mobile phases. Affections of kinds and acidity on separationg results of microemulsions were investigated. Results: The baicalin, chlorogenic acid, Saposhnikovia and glycyrrhiza in Kangganmao Gronules and the emodin, chrysophanol, baicalin, Saposhnikovia and Glycyrrhizae in Fangfeng Tongsheng Pills may be separated and identified simultaneously with microemulsion (containing 75% water) formic acid (9∶1) as mobile phase. Conclusion: Microemulsion TLC is an efficient, simple new method for the separation and identification of various compositions in traditional Chinese patent medicines.