药用蔗糖细菌内毒素检查法建立及方法学研究

Study on Bacterial Endotoxin Test Establishment and Methodology of Pharmaceutical Grade Sucrose

目的建立药用蔗糖细菌内毒素检查法。方法参照中国药典2015年版四部通则1143细菌内毒素检查法进行实验^([1])。结果当药用蔗糖配制成2.0mg·mL^(-1)浓度时进行细菌内毒素检查无干扰作用。结论药用蔗糖建立细菌内毒素检查法是可行的。

OBJECTIVE To establish a method for testing bacterial endotoxin of Pharmaceutical Grade Sucrose.METHODS According to the Becterial Endotoxin Test approved by the general rule 1143 of Chinese Pharmacopoeia 2015 edition vol Ⅳ.RESULTS Pharmaceutical Grade Sucrose did not interfere with bacterial endotoxin test when it was diluted to the concentration of 0.0625mg·mL（-1）.CONCLUSION It is suitable for bacterial endotoxin test of Pharmaceutical Grade Sucrose.