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目的:对中国药典2010年版附录中的细菌内毒素检查法提出修订建议,为新版药典该方法的科学完善提供参考。方法:研究中国药典2010年版细菌内毒素检查法的科学合理性,参照国外药典相关部分、结合国内实际情况进行修订。结果:针对标准物质、供试品pH调节、凝胶法实验稀释倍数要求和结果判断、凝胶半定量试验A溶液的制备、光度测定法1阴性对照以及凝胶法干扰试验C系列平行管数等部分提出了修订意见和建议。结论:修订后的细菌内毒素检查法叙述更加严谨、科学、合理,且与国际接轨。
OBJECTIVE: To propose amendments to the bacterial endotoxin test in the appendix of the 2010 edition of the Chinese Pharmacopoeia to provide a reference for the scientific perfection of the new Pharmacopoeia. Methods: To study the scientific rationality of the Chinese Pharmacopoeia 2010 edition bacterial endotoxin test, with reference to the relevant parts of the foreign Pharmacopoeia, combined with the actual situation in the country to be revised. Results: For the standard substances, for the test sample pH adjustment, the gel method to determine the dilution factor requirements and results to determine the semi-quantitative gel A solution preparation, photometric method 1 negative control and gel interference test C series of parallel tubes And other parts of the proposed amendments and suggestions. Conclusion: The revised bacterial endotoxin test narrates more rigorously, scientifically and reasonably, and is in line with international standards.