化学药品标准分析模型研究

Research on Analysis Model for Chemical Drug Standards

目的:建立化学药品标准分析模型,为标准工作提供参考。方法:通过对同品种各版本的标准内容进行比较与分析,研究其变化规律。结果:同品种的标准按照颁布时间排序,其质控项目在指标数量、方法与限度方面有一定变化规律,可通过设定特定的变化指标,绘制质控项目的衍变图,描述其发展趋势。结论:通过运用标准分析模型,可对同品种同一项目的内容进行比较,为专家进行资料收集提供依据;同时可推算出一个拟定标准,作为没有样品时标准提高等工作的参考,具有一定的实践意义。

Objective： To research and establish an analysis model for chemical drug standards to provide the reference for the standard exploration jobs. Methods： The standard variation was studied by comparing and analyzing every version standard for the same drug to look for the change rule. Results： The standard items of the drug had some change rules in indicator numbers,testing methods and limits according to the order of issue time. The standard development trends could be described by making specific indicators and drawing evolution figures of the items. Conclusion： By the standard analysis model,the same item of the same drug can be compared to provide the reference for data collecting of experts. Meanwhile,formulate standard can be calculated to provide the reference for the standard improvement without drug standards.