透明质酸钠注射液细菌内毒素检查法的研究
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[摘要] 目的:建立透明质酸钠注射液的细菌内毒素检查法。方法:按2005版《中国药典》二部中的“细菌内毒素检查法”,用不同厂家的鲎试剂对不同批号的透明质酸钠注射液分别进行干扰试验。结果:透明质酸钠注射液的检测浓度≤5 mg/ml时对细菌内毒素检查法无干扰。结论:透明质酸钠注射液按限值L=0.05 EU/ml进行细菌内毒素检查是可行的。
[关键词] 透明质酸钠注射液;细菌内毒素检查法;鲎试剂;干扰试验
[中图分类号]R927.1 [文献标识码]A [文章编号]1673-7210(2009)07(b)-045-03
Study on the test method of bacterial endotoxin in Sodium Hyaluronate Injection
PAN Weisong1, XIAO Ying2
(1.Institute for Drug Control of Guangzhou, Guangzhou 510610, China; 2.College of Pharmacy, Ji'nan University, Guangzhou 510632, China)
[Abstract] Objective: To establish a bacterial endotoxin test for Sodium Hyaluronate Injection. Methods: According to the Bacterial Endotoxins Test in Chinese Pharmacopoeia edition 2005, different batches of Sodium Hyaluronate Injections from different LAL manufacturers were underwent the interference tests. Results: There was no interference in the bacterial endotoxin test when the concentration of Sodium Hyaluronate Injection is less than or equal to the detection limit 5 mg/ml ......
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