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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 establish a standard analytical model for chemical products and provide reference for standard work. Methods: By comparing and analyzing the standard content of different editions of the same breed, the variation rules were studied. Results: The standard of the same breed was sorted according to the promulgation time. The quality control items of the breed had some regularities in the number of indicators, methods and limits. By setting specific indicators of change, the quality control project could be drawn and the development trend was described. Conclusion: Through the use of standard analysis model, the content of the same item in the same breed can be compared to provide a basis for experts to collect data; at the same time, a proposed standard can be deduced as reference for raising standards without samples, significance.