【摘要】 目的:建立乙酰半胱氨酸细菌内毒素检查方法。方法:按照《中国药典》2020年版四部通则1143细菌内毒素凝胶检查法进行方法学验证和细菌内毒素检查。结果:最大不干扰浓度为3.125 mg·mL^-1,使用0.06 EU·mL^-1的鲎试剂，对鲎试剂与内毒素反应无干扰影响，三批乙酰半胱氨酸细菌内毒素检查均符合规定。结论:本法可用于乙酰半胱氨酸的质量控制。更多还原

【Abstract】 Objective: Toestablisha method for determining bacterial endotoxin of acetylcysteine. Methods: According to the bacterial endotoxin test gel method in the general chapter 1143, Chinese Pharmacopoeia 2020 Vol Ⅳ, validation test was performedto verify the bacterial endotoxin test of acetylcysteine. Results: There was no reaction interference between tachypleus amebocyte lysate and bacterial endotoxins when the maximal non-interference concentration was 3.125 mg·mL^-1 and 0.06 EU·mL^-1 tachypleus amebocyte lysate were used. Three batches of bacterial endotoxin test of acetylcysteine all met the requirements.Conclusion: The bacterial endotoxin test established can be used for the quality control of acetylcysteine.更多还原