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目的:建立定量检测利巴韦林注射液细菌内毒素的实验方法。方法:采用《中国药典》2005年版二部附录中细菌内毒素的动态浊度法。结果:将利巴韦林注射液配制成5 mg·ml~(-1)的溶液,用细菌内毒素定量法检测无干扰因素影响,内毒素回收率在50%～200%之间。结论:使用动态浊度法定量检测利巴韦林注射液中细菌内毒素可行。动态浊度定量法以其快捷、准确、灵敏,可以动态观察反应过程,帮助分析干扰情况等优势,更应得到应用和推广。
Objective: To establish a method for the quantitative detection of bacterial endotoxin in ribavirin injection. Methods: The dynamic turbidity method of bacterial endotoxin in the appendix of 2005 edition of Chinese Pharmacopoeia was used. Results: Ribavirin injection was formulated into a solution of 5 mg · ml ~ (-1). The bacterial endotoxin assay was used to detect the effect of non-interfering factors. The recovery rate of endotoxin was between 50% and 200%. Conclusion: It is feasible to use dynamic turbidity method to quantitatively detect bacterial endotoxin in ribavirin injection. Dynamic turbidimetric method for its fast, accurate and sensitive, you can dynamically observe the reaction process to help analyze the interference and other advantages, but should be applied and promotion.