利培酮细菌内毒素检查法可行性研究

Investigation on Feasibility of Bacterial Endotoxin Test for Risperidone

目的研究利培酮原料药的细菌内毒素检测方法,为该品种设立细菌内毒素检查项提供理论基础。方法按《中国药典》2020版1143细菌内毒素检查法进行凝胶法的方法学验证及检查。结果利培酮的细菌内毒素限值定为0.05 EU·mg^(-1),将利培酮稀释至1.25 mg·mL^(-1),使用0.06 EU·mL^(-1)的鲎试剂,对鲎试剂与细菌内毒素反应无明显干扰,可对利培酮进行细菌内毒素检查。结论本文建立的方法可用于利培酮的细菌内毒素检查。

OBJECTIVE To investigate the method of bacterial endotoxin test(BET)for drug substance of risperidone and to provide the theoretical basis for admission bacterial endotoxin test in its specification.METHODS According to bacterial endotoxin test in Chinese Pharmacopoeia 2020 Vol IN general charpters 1143,methodology validation of gel-clot technique in bacterial endotoxin test was conducted and then bacterial endotoxin test of risperidone were carried out.RESULTS The bacterial endotoxin limit of risperidone was set to 0.05 EU·mg^(-1).There was no interference in reaction between tachypleus amebocyte lysate and bacterial endotoxins when risperidone was diluted to 1.25 mg·mL^(-1) and 0.06 EU·mL^(-1) tachypleus amebocyte lysate were used.CONCLUSION The method established in this paper is suitable for bacteria endotoxin test of risperidone.