中国药典2010年版细菌内毒素检查法的修订建议

Proposal on revision of the bacterial endotoxin test in the 2010 edition of Chinese Pharmacopoeia

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 give suggestions on revision of the test of bacterial endotoxin in the 2010 edition of Chinese Pharmacopoeia to provide reference for scientific improvement of the method in the new edition of Chi- nese Pharmacopoeia. Methods： The scientific reasonability of the test of bacterial endotoxin in the 2010 edi- tion of Chinese Pharmacopoeia was investigated, and the method was revised with reference to the related part in the pharmacopoeia from other countries in combination with Chinese idiographic practical circumstances. Re- sults ： Suggestions for revisions were made on aspects of standard materials, pH - control on samples, Standard Operating Procedure, and result judgment in limit test of gel - clot method, preparation of solution A in quanti- tative test of gel - clot method, negative controls of the spectrophotometry method, and C series of gel interfering factor test methods. Conclusion ： These suggestions on revision will make the part of the test bacterial endotox- in in the Chinese Pharmacopoeia more precise, scientific, and reasonable, and make a step towards international standard.