左卡尼汀注射液细菌内毒素检查方法的研究(1)
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[摘要] 目的:建立左卡尼汀注射液细菌内毒素的检查方法。方法:按《中国药典》2005年版二部“细菌内毒素检查法”,用不同厂家的鲎试剂对不同批号的左卡尼汀注射液分别进行干扰试验。结果:左卡尼汀注射液稀释至浓度5 mg/ml或以下的溶液对细菌内毒素检查法无干扰作用。结论:本方法对左卡尼汀注射液进行细菌内毒素检查是可行的。
[关键词] 左卡尼汀注射液;细菌内毒素检查法;鲎试剂;干扰试验
[中图分类号] R927.2[文献标识码] B[文章编号] 1673-7210(2010)04(c)-072-03
Study on the method of bacterial endotoxin test in L-carnitine Injection
ZHOU Yongbiao, WANG Wenjia, LI Wei
(Institute for Drug Control of Guangzhou, Guangzhou 510160, China)
[Abstract] Objetive: To establish the bacterial endotoxin test method in L-carnitine Injection. Methods: According to the bacterial endotoxins test in Chinese Pharmacopoeia 2005 version (Ⅱ) appendix, different batches of L-carnitine Injection from different TAL manufacturers were underwent the interference tests ......
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