三氯甲烷-水振荡萃取法建立药用辅料氢化大豆卵磷脂细菌内毒素检查方法  

Establishment of the bacterial endotoxin test method of hydrogenated soybean lecithin through trichloromethane vibration extraction method

作　　者：刘雪莉 袁坤[2] 赵冬 王铁战 崔晓燕 甄晓兰 施麟 李挥 LIU Xueli;YUAN Kun;ZHAO Dong(Hebei Institute For Drug and Medical Device Control,Hebei,Shijiazhuang 050200,China;不详)

机构地区：[1]河北省药品医疗器械检验研究院,石家庄市050200 [2]河北省石家庄市中医院 [3]河北省药品职业化检查员总队

出　　处：《河北医药》2021年第5期780-783,共4页Hebei Medical Journal

基　　金：河北省市场监督管理局科研计划项目(编号:2020ZD19)。

摘　　要：目的建立药用辅料氢化大豆卵磷脂的细菌内毒素检查方法。方法氢化大豆卵磷脂用三氯甲烷溶解后再用BET水振荡、萃取、稀释,按《中国药典》2020年版通则1143以及美国药典USP42-<85>,建立细菌内毒素方法学。结果上层萃取液稀释至12.5 mg/ml时,对鲎试剂凝集反应无干扰作用,氢化大豆卵磷脂细菌内毒素检查限值可定为0.006 EU/mg。结论药用辅料氢化大豆卵磷脂可采用三氯甲烷-水振荡萃取法建立其细菌内毒素检查方法。Objective To establish the bacterial endotoxin test(BET)method of hydrogenated soybean lecithin through trichloromethane vibration extraction method.Methods The hydrogenated soybean lecithin was dissolved,then was oscillated in BET water,mixed,extracted and diluted,and the supernatant was taken.The BET method was established according to the bacterial endotoxin test approved by Chinese pharmacopeia(2020,General Principle1143)and American pharmacopeia(USP42-<85>).Results No interference was found in BET after the supernatant was diluted to 12.5mg/ml.The limit value of the bacterial endotoxin detection of hydrogenated soybean lecithin could be set at 0.006 EU/mg.Conclusion The BET can be used to control the quality of medicinal excipient of hydrogenated soybean lecithin through trichloromethane vibration extraction method.

关 键 词：氢化大豆卵磷脂 细菌内毒素 鲎试剂 

分 类 号：R927[医药卫生—药学]