透明质酸钠注射液细菌内毒素检查法的研究  

Study on the test method of bacterial endotoxin in Sodium Hyaluronate Injection

作　　者：潘卫松[1] 肖瑛[2] 

机构地区：[1]广州市药品检验所,广东广州510610 [2]暨南大学药学院,广东广州510632

出　　处：《中国医药导报》2009年第20期45-47,共3页China Medical Herald

基　　金：广州市科技计划项目(2007Z3-D0031);暨南大学引进人才科研启动项目(51205070)

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≤5mg/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=0.05EU/ml进行细菌内毒素检查是可行的。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. Conclusion： Carrying out the bacterial endotoxin test by the limit L of 0.05 EU/ml is feasible for Sodium Hyaluronate Injection.

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 

分 类 号：R927.1[医药卫生—药学]