Quality Evaluate of Betamethasone Tablet by Establishing a Mathematical Model
10.6039/j.issn.1001-0408.2016.03.46
- VernacularTitle:建立数学模型综合评价倍他米松片的质量
- Author:
Jingyi ZHU
;
Li XU
;
Qi LI
;
Liyu WEN
- Publication Type:Journal Article
- Keywords:
Mathematical model;
Ideal point method;
Betamehasone tablet;
Quality of drug;
Quality evaluation
- From:
China Pharmacy
2016;27(3):417-420
- CountryChina
- Language:Chinese
-
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.
