香菇多糖原料药热原检查法和细菌内毒素检查法的建立与比较

Establishment and comparison of pyrogen test and bacterial endotoxin test for lentinan API

目的:建立热原检查方法和细菌内毒素检查方法,为难溶性样品香菇多糖无菌原料提供安全性检验方法。方法:热原检查法参照《中华人民共和国药典》(ChP) 2015年版四部通则1142建立;细菌内毒素检查法参照《中华人民共和国药典》(ChP) 2015年版四部通则1143方法 1(凝胶法)建立。结果:香菇多糖无菌原料在稀释至0. 2 mg·m L-1时,对热原升温没有干扰作用;在稀释至2. 5μg·m L-1时,对鲎试剂凝集反应无干扰作用。结论:物理研磨不影响细菌内毒素的生物活性,可采用研磨法建立难溶样品香菇多糖的热原和细菌内毒素检查方法,2种方法检测结果一致,细菌内毒素检查法更加经济、方便、快捷。

Objective:To establish pyrogen test and bacterial endotoxin test for insoluble APIs of aseptic lentinan,thus to provide safety test method for it.Methods:Pyrogen test was carried out according to ChP 2015 volume IV general principles 1142.Bacterial endotoxin test was carried out according to Ch P 2015 volume IV general principles 1143-1(gel-clot technique).Results:There was no interference on pyrogen warming effect when lentinan was diluted to 0.2 mg·mL-1,and there was no interference on the bacterial endotoxin test when the concentration of lentinan was diluted to 2.5μg·mL-1.Conclusion:Physical grinding does not affect the bioactivity of bacterial endotoxin.The pyrogen test and bacterial endotoxin test of insoluble aseptic lentinan APIs can be established by physical grinding.The results of the two methods are consistent.The bacterial endotoxin test is more economical,convenient and quick.