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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 a bacterial endotoxin test for sodium glycididazole injection for safety in clinical use. Methods: According to the bacterial endotoxin test method of appendix ⅪE of Chinese Pharmacopoeia, 2010 edition, the interference test of 9 batches of glycopyrrolate sodium for injection produced by 3 manufacturers was conducted using the 鲎 reagents produced by two manufacturers. Results: The maximum concentration of test sample for bacterial endotoxin test was 20.0 mg · ml ~ (-1). Conclusion: The established bacterial endotoxin test for injectable sodium glycididazole injection is feasible, simple, quick and reliable.