亮菌甲素氯化钠注射液细菌内毒素的鲎试验研究

LLA of Bacterial Endotoxins in Armillarisin A and Sodium Chloride Injection

目的:探讨亮菌甲素氯化钠注射液进行细菌内毒素检查的可行性。方法:采用凝胶法鲎试验对样品中的细菌内毒素进行检测。结果:6批亮菌甲素氯化钠注射液及其2倍稀释液对细菌内毒素检查均没有干扰作用;所测样品的细菌内毒素含量均小于0.5EU·ml-1。结论:可建立亮菌甲素氯化钠注射液的细菌内毒素检查法,日常细菌内毒素检查时可将样品稀释2倍以排除其干扰作用。

Objective: To explore the feasibility of bacterial endotoxins in Armillarisin A and sodium chloride for injection ( ASCI). Method: Gel-clot LLA was applied to detect the bacterial endotoxins in ASCI. Result: The samples and their 2-fold dilution from six batches of ASCI didnt interfere with the test of bacterial endotoxins; the content of bacterial endotoxins in all tested samples were not more than 0.5 EU·ml-1. Conclusion: LLA can TAL provide a new way to detect the bacterial endotoxins in ASCI, samples can be diluted to two times to avoid their interference effects.