中、美、欧药典关于生物检定统计法的比较  

A comparison of the bioassay statistical method in ChP with those in USP and EP

作　　者：项荣武[1] 梁露花[1] 党丹[1] 谭德讲[2] 

机构地区：[1]沈阳药科大学医疗器械学院,辽宁沈阳110016 [2]中国食品药品检定研究院,北京100050

出　　处：《沈阳药科大学学报》2014年第10期819-824,共6页Journal of Shenyang Pharmaceutical University

基　　金：辽宁‘百千万人才工程’培养经费资助项目(2011921045)

摘　　要：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 This paper aims to explore a better analytical method above the biological statistics re- corded in ChP, USP, and EP. Methods The current version of various pharmacopeia, namely ChP 2010, USP35 and EPT, varies in algorithm. By analyzing and elaborating different approaches in a professional way, advantages and drawbacks of each approach were shown. Results ChP analyzes graded response and u- ses Dixon on the test of outliers, its FL is comparatively simple and easy. By contrast, USP gives general a- nalysis of outliers and provides circumstantial statistical approaches. Comparatively, EP stands out in its com- prehensive use of different approaches, including conventional statistical approach on graded response and quantal response and four-parameter approach. Conclusions Every pharmacopeia is to be improved as the statistical approach develops. Therefore, three important directions for the development of biological statistics are proposed in the paper.

关 键 词：生物检定统计法 中华人民共和国药典 美国药典 欧洲药典 

分 类 号：R917[医药卫生—药物分析学] R95[医药卫生—药学]