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目的对2000年版《中国药典》二部中有热原检查项的注射剂类药品进行细菌内毒素检查法的方法学研究,以确定热原检查法改为内毒素检查法的可行性,以及其检查限值的定值。方法通过28个省市药检所药理室的协作研究,采用细菌内毒素凝胶法,对每个品种抽取的样品进行干扰实验。结果确定了每个品种的不干扰浓度或稀释倍数,并以此判断该品种能否使用细菌内毒素法进行检验。结论84个品种可采用内毒素检查法,16个品种暂不能采用内毒素检查法。
Objective To study the method of bacterial endotoxin test for injectable drugs with pyrogen test items in the 2000 edition of “Chinese Pharmacopoeia” to determine the feasibility of converting pyrogen test to endotoxin test and its examination The value of the limit. Methods Collaborative research was conducted in pharmacological laboratories of 28 provincial and municipal drug testing institutes. Bacterial endotoxin gel method was used to interfere with the samples taken from each variety. The results confirmed that each species does not interfere with the concentration or dilution factor, and to determine whether the species can be tested using bacterial endotoxin method. Conclusion 84 endotoxin test methods can be used for 84 varieties, and endotoxin test method can not be used for 16 varieties.