注射用甘氨双唑钠细菌内毒素检查的方法学研究  

Study on the Method of Detecting Bacterial Endotoxins in Sodium Glycididazole for Injection

作　　者：郭咸希[1] 宋金春[1] 

机构地区：[1]武汉大学人民医院药学部,武汉430060

出　　处：《中国药师》2012年第7期997-999,共3页China Pharmacist

摘　　要：目的:建立注射用甘氨双唑钠的细菌内毒素检查法,以确保其临床使用的安全性。方法:依照《中国药典》2010年版二部附录ⅪE细菌内毒素检查法,使用两个厂家生产的鲎试剂对3个厂家生产的9个批号注射用甘氨双唑钠进行干扰试验。结果:供试品对细菌内毒素检查的最大不干扰浓度为20.0 mg·ml^(-1)。结论:建立的注射用甘氨双唑钠注射液细菌内毒素检查法可行,具有简便、快捷、可靠等优点。Objective： To establish an examination method for the bacterial endotoxins in sodium glycididazole ior injection to ensure the clinical safety. Method： Interference experiments of 9 batches of the samples from three manufactures were carried out according to the bacterial endotoxins test described in Appendix XI E, Volume two, Chinese Pharmacopoeia 2010 edition using tachypleus amebocyte lysates （TAL） produced by two factories. Result： The samples in the concentration below 20.0 mg · ml -1showed no interference in the bacterial endotoxins test. Conclusion： The established method of bacterial endotoxins test for sodium glycididazole for injection is feasible, simple, rapid and reliable.

关 键 词：细菌内毒素 注射用甘氨双唑钠 干扰试验 

分 类 号：R927.12[医药卫生—药学]