注射用药用辅料甘露醇细菌内毒素检查方法研究

为了建立注射用药用辅料甘露醇的细菌内毒素检查方法，根据《中华人民共和国药典二部（2010年版）》中的“细菌内毒素检查法及指导原则”进行试验。将甘露醇溶解稀释至100mg·mL-1，用标示灵敏度A为0．125EU·mL-1的鲎试剂检测其细菌内毒素。结果表明，100mg·mL-1的甘露醇及稀释液对细菌内毒素检查无干扰。说明鲎试剂方法用于甘露醇的细菌内毒素检查是可行、有效的。

Study on Bacterial Endotoxins Test for the Injectable Auxiliary Material Mannitol

In order to establish a method for detecting bacterial endotoxins in the injectable auxil- iary material mannitol, experiment was implemented according to the bacterial endotoxins test procedures and the guiding principles in Chinese Pharmacopeia 2010 edition Vol. II. Bacterial endotoxins in mannitol that had been dissolved and diluted to the concentration of 100 mg ~ mL-1 was tested by tachypleus amebocyte lysate with sensitivity of 0. 125 EU mL-1. Results showed that the solution containing 100 mg mL-1 mannitol and its dilute solution do not interfere with the bacterial endotoxins test. Therefore, the bacterial endotoxin test is feasible and effective to detect bacterial endotoxins in mannitol.