基于数学模型的非洛地平缓释片检验指标综合评价的探讨

目的为客观评价合格药品的生产质量状况,有效区分其存在的差异程度,通过建立一定的数学模型,对特定药品每一项可定量的检验指标进行综合评价。方法本数学模型将药品的检验指标参数以理论最佳点做理想值,以药品合格标准做下限值,转化成各指标的评价指数,并使各评价指数同量齐次;各检验指标的评价指数经过带权重的理想点法计算,得到综合评价结果;其中,运用专家经验评定法确定各检验指标的权重。结果数学模型确立后,尝试以非洛地平缓释片各项检验数据为例进行试评价,获得了较为符合客观实际的结果,说明了用数学模型评价药品检验的各项指标的可行性和可操作性,该方法也可以推广至其他药品检验指标的综合结果判断。结论利用数学模型对药品检验结果进行评价的方法,可以成为药品质量监督管理的新思路,也可以为药品按质定价提供参考性依据。

Comprehensive Evaluation of Results from Drug Examination in View of Mathematical Model and Its Application

Objective The especial mathematical model was established,in order to assess the eligible drugs complying with national standards quantitatively,distinguish the discrepancy in the qualified drugs significantly and judge the examined results of drug comprehensively.Methods On the basis of items examining drug in China Pharmacopoeia the perfect point was regarded as the upper limit theoretically,and the permissible point as the prescribed minimum in the model.After homogenizing the initial data or ones to be quantifiable in drug test were translated into commensurate parameters and then calculated by ideal point method with weight which was identified by experience.The integrated value can indicate the diversity of drug quality finally.Results As an attempt,the given data from Felodipine Sustained-release Tablets were calculated and evaluated.It showed feasible,operative,and suitable to other drugs if only readjust the model slightly that the method could made the reliable outcome of evaluating drug quality.Conclusions The thoughts and suggestion of supervising the quality pharmaceutically,and pricing according to the quality should be provided for government through the way of mathematical analyzing and evaluating the results of drug checkout in China.