中国药典2010年版细菌内毒素检查法仲裁方法研究

Study on Chinese Pharmacopoeia 2010 arbitration test for bacterial endotoxin test

目的:目前中国药典2010年版细菌内毒素检查法中规定了2种仲裁试验方法,研究2种仲裁方法判定的一致性,分析其科学性与合理性,为药典修订提供理论与实验支持。方法:通过对在日常工作中收集的8批需进行仲裁的供试品进行检验,用2种仲裁方法的结果判断标准同时对每一试验结果进行判断,以分析比较2种方法结果判断的一致性。结果:本次研究的8批供试品用凝胶法的2种试验判断方法进行判定,2种判断方法表现出3批结果一致,5批结果矛盾,实验结果不一致率达62.5%。仲裁法中2种试验方法对同一样品的结果判断表现出了较大差异。结论:中国药典2010年版细菌内毒素检查法仲裁方法存在不够严谨之处,建议将"供试品检测时,可使用其中任何一种方法进行试验,当测定结果有争议时,除另有规定外,以凝胶法结果为准。"修订为"供试品检测时,可使用其中任何一种方法进行试验,当测定结果有争议时,除另有规定外,以凝胶限度实验结果为准。"

Objective：To investigate the consistency between the two arbitration test methods described in the bac- terial endotoxin test section of Chinese Pharmacopoeia 2010 edition ,to analyze the scientific nature and rationality of these two arbitration test methods, and to provide a theoretical and experimental support for the revision of the Chi- nese Pharmacopoeia. Methods： Eight sets of samples collected in the routine work were tested simultaneously by both of the two arbitration test methods. Each set of samples was judged by both of the two different judgment stand- ards of the two different arbitration test, respectively, in order to analyze the consistency of the results by two differ- ent judgment standards. Results：Eight sets of samples were tested by the gel - clot method. Three sets of samples showed the agreement between two judgment methods, and the other five sets of samples presented controversy be- tween the two judgment methods. Based on these results, the inconsistent rate of the two different judgment methods was tested as 62.5%. There were relatively significant differences between the two different arbitration methods. Conclusion ：The arbitration method of bacterial endotoxin test in the Chinese Pharmacopoeia 2010 edition is not rig- orous enough. It is suggested that the expression in the Chinese Pharmacopoeia 2010 edition：＂ Either of these meth- ods can be used for the assay of the test samples;if the determination results are controversial, the results by the gel - clot method should prevail, unless otherwise specified. ＂ be amended to ＂Either of these methods can be used for the assay of the test samples ; if the determination results are controversial, the results by the gel - clot limit test should prevail, unless otherwise specified. ＂