摘要
目的:建立3个品种中药注射剂的细菌内毒素检查方法,比较基因重组鲎试剂(rLAL)与传统鲎试剂(TAL/LAL)检查结果的差异,确定rLAL的适用性。方法:依据《中国药典》2020年版四部<1143细菌内毒素检查法>、<9251细菌内毒素检查法应用指导原则>,采用rLAL、LAL、TAL3种鲎试剂对丹红注射液、痰热清注射液、血必净注射液3种中药注射剂进行细菌内毒素检查。结果:3种鲎试剂均可用于3种中药注射剂细菌内毒素检查,检测结果均符合规定。其中rLAL检测灵敏度更高,可达0.001 EU·mL^(-1),且具有更大的MVD值。结论:基因重组鲎试剂可取代传统鲎试剂用于3种中药注射剂细菌内毒素检查。
Objective:To establish bacterial endotoxin test methods for 3 kinds of traditional Chinese medicine injection and confirm the suitability of recombinant LAL reagent(rLAL)by comparing the difference of test results of rLAL and TAL/LAL.Methods:Bacterial endotoxins in Danghong injection,Tanreqing injection and Xuebijing injection were tested by rLAL,LAL and TAL,according to the Chinese Pharmacopoeia 2020 volume Ⅳ<1143 Test for Bacterial Endotoxin>and<9251 The Guidelines of the Bacterial Endotoxin Test>.Results:All the 3 lysate reagents can be used in the bacterial endotoxin test for 3 traditional Chinese medicine injections,test results met the requirements.rLAL has a higher sensitivity,up to 0.001 EU·mL^(-1),and a higher MVD.Conclusion:The rLAL can be used in the bacterial endotoxin test for three traditional Chinese medicine injections to replace TAL/LAL.
作者
刘枕
马帅
冯宇
高新贞
LIU Zhen;MA Shuai;FENG Yu;GAO Xinzhen(Zibo Institute for Food and Drug Control,Zibo 255086,China;Coastal-Times International Bio Medical Technologies(Beijing)Co.,Ltd.,Beijing 102600,China)
出处
《中国药品标准》
CAS
2022年第4期430-434,共5页
Drug Standards of China
关键词
基因重组鲎试剂
中药注射剂
细菌内毒素
动态显色法
定量检测
recombinant LAL Reagent(rLAL)
traditional Chinese medicine injection
bacterial endotoxin
kinetic chromogenic method
quantitative determination
