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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: At present, two kinds of arbitration test methods are specified in the 2010 edition of the Chinese Pharmacopoeia, and the consistency of the two arbitration methods is analyzed. The scientific and reasonable analysis of the two methods can provide theoretical and experimental support for the revision of the Pharmacopoeia. Methods: The eight arbitration samples collected in their daily work were tested, the results of two kinds of arbitration methods were used to judge the results and the results of each test were judged at the same time to analyze and compare the consistency of the two methods Sex. Results: The 8 batches of test products in this study were judged by two methods of gel test. The two methods showed the same result among the three batches. The results of the five batches were contradictory. The inconsistent rate of the experiment was 62.5%. Arbitration Law in the two kinds of test methods to judge the results of the same sample showed a big difference. Conclusion: There are some discrepancies in the Chinese Pharmacopoeia 2010 edition of the bacterial endotoxin test arbitration methods, it is recommended that the “test for the test, you can use either method to test, when the test results are controversial, unless otherwise specified , The results of the gel method shall prevail. ”Amendment to “ for the test test, you can use either method to test, when the test results are controversial, unless otherwise specified, the gel limit experiment The result is correct. ”