论文部分内容阅读
目的比较《中华人民共和国药典》(ChP)、《美国药典》(USP)和《欧洲药典》(EP)所收载的生物检定统计方法的差异,探索更优的分析方法。方法通过查阅中、美、欧药典的现行版(ChP2010、USP 35、EP 7.0)关于生物检定统计的相关内容,特别是它们之间的算法差异,用专业知识进行分析和阐述,比较各自的优缺点。结果各国药典的生物检定统计方法各有优缺点。其中:《中华人民共和国药典》仅有量反应的分析方法,且对异常值的检验仅给出Dixon法,但所用的可信限率相对简便易行;《美国药典》在异常值判断给出了较为全面的分析,提供适用不同情况下的统计方法;《欧洲药典》的内容相对全面,包括量反应、质反应的常规统计方法和四参数方法等。结论中、美、欧药典均需进一步完善,以适应越来越多的新分析方法。建议性地提出了生物检定统计法的三个重要方向。
Objective To compare the difference of the bioassay statistical methods contained in the “Chinese Pharmacopoeia” (ChP), “USP” and “European Pharmacopoeia” (EP) to explore better analytical methods. Methods By referring to the relevant contents of bioassay statistics (ChP2010, USP 35, EP 7.0), especially the differences between the algorithms, and using the professional knowledge to analyze and expound the current advantages of the Chinese, American and European pharmacopoeias Disadvantages. Results Pharmacopoeia of various countries have different advantages and disadvantages of bioassay methods. Among them, the “Pharmacopoeia of the People’s Republic of China” is only a quantitative analysis of the reaction method, and the test for outliers only gives Dixon method, but the confidence limits used are relatively simple and easy; “American Pharmacopoeia” is given in the judgment of outliers A more comprehensive analysis provides statistical methods for different situations. The “European Pharmacopoeia” is relatively comprehensive in contents, including the conventional statistical methods of quantitative reaction and qualitative reaction and the four-parameter method. Conclusions Chinese, American and European pharmacopoeia need to be further improved to adapt to more and more new analytical methods. Proposed to put forward biometric test of the three important directions.