用概率模型评价倍他米松片的质量

Quality evaluation of betamethasone tablets by probabilistic model

目的:运用概率模型考察不同企业生产的倍他米松片的质量,为建立药品质量等级评价体系提供参考。方法:依据理想点法原理和正态分布概念建立数学模型,将倍他米松片的3个测量指标(含量、含量均匀度和溶出度)转换成空间坐标。以理论最佳参数作为理想空间点,以药品合格标准参数作为下限空间点,通过多维空间向量夹角隶属度转化成各指标的评价指数。各测量指标的评价指数经过方差分析后进行综合评价,运用概率论与数理统计中的正态分布模型,对各测量指标评价指数分布进行概率分析,得出不同企业生产的倍他米松片质量综合评价结果。结果:3家企业生产的倍他米松片的质量综合评价结果经方差分析,P>0.05,即评价差异无统计学意义,表明各企业生产的药品整体质量良好。对评价指数进行概率分析,发现A企业获得质量优良的片剂可能性较大。结论:数学模型对药品的质量等级评价以及企业等级评定有重要作用。本研究建立的方法具有一定的实用性,值得推广。

Objective ：To investigate the quality of betamethasone tablets produced by different manufacturers by probabi-listic model , so as to provide reference for the establishment of the drug quality grading evaluation system . Methods： A mathe-matical model was established based on the principle of ideal point method and the concept of normal distribution .The 3 detec-tion parameters （drug content, content uniformity and dissolution ） of betamethasone tablets as the measurement results were converted to space coordinates . The perfect ideal parameter was regarded as an ideal space point theoretically , and the standard qualified parameter of the drug was regarded as the lower limit space point . After translating the subordination of angle includ - ed in the multi-dimensional space vector into evaluation parameters the evaluation grade was appraised by variance analysis and calculated by using the normal distribution model of probability theory and mathematical statistics to obtain further comprehen - sive evaluation results .Results ： According to the result of ANOV A analysis , t here were no significant differences in the compre-hensive evaluation results of betamethasone tablets produced by different manufacturers （ P〉0 .05）,indicating that the overall quality of betamethasone tablets was good .Analysis of evaluation parameters distribution indicated that manufacturer A could offer greater potential to get better betamethasone tablets .Conclusion： The mathematical model could play an important role in the evaluation of the quality grade of the drugs and the grade of the drug manufacturers . The method is practical and worth further spreading .