64种注射用药品细菌内毒素检查法的方法学研究.pdfVIP

812 2010 2 8 64 * 蔡 彤, 张国来, 高 华 ( , 100050) : 对 中国药典 2005 年版二部中使用热原检查项的注射剂类药品及临床上通过静脉方 给 药的部分注射用小针剂进行细菌内毒素检查法的方法学研究, 以确定这些品种建立内毒素检查法的可行 性, 以及其检查限值的定值 通过3 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检查法进行检验58 个品种可采用内毒素检查法, 6 个品种需进行进一步研究 : 注射用药品; 细菌内毒素; 方法学研究 : R9 1; R92712 : A : ( 2010) Study of Bacterial Endotoxin Test on 64 Drugs for Injection * Cai T ong, Zhang Guolai, Gao Hua ( National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050) ABSTRACT: Objecti e T o screen the drugs for injection w ith pyrogen test and injections for intravenous in ChP( 2005) Vol !, to evaluate the possibility for the replacement with bacterial endotoxin test, and to investigate the methodology of the bacterial endotoxin test for all kinds of injections required for pyrogen test in ChP( 2005) Vol ! Methods Interference tests w ere done on each sample of injections by using bacterial endotoxin gelmethod T he samples w ere provided by the collaboration of Pharmacology Divisions of Institute for Drug Control in 3 provinces or cities Results Determined the no interference concentration or the minimum no interference dilution of each drug and w hether the drug is valid for bacterial endotoxin test Conclusion 58 drugs for injection are valid for bacterial endotoxin test, and 6 drugs for injection are not suitable for bacterial endotoxin test KEY WORDS: injection; bacterial endotoxin test; methodology study 1 , GMP 2010 , 2 21 2005 205 2005