细菌内毒素光度法检测能力验证研究  

Proficiency testing for determination of photometric method of bacterial endotoxin

作　　者：杜颖 陈晨 蔡彤 谭德讲 高华 DU Ying;CHEN Chen;CAI Tong;TAN De-jiang;GAO Hua(Division of Pharmacology,Institute for Chemical Drug Control,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院化学药品检定所药理室,北京102629

出　　处：《中国药理学通报》2022年第11期1717-1722,共6页Chinese Pharmacological Bulletin

基　　金：国家药典委员会国家药品标准制修订研究(No.2022Y09)。

摘　　要：目的设计并实施细菌内毒素光度法检测能力验证计划,以评价实验室使用光度法测定细菌内毒素的能力和水平。方法按照《中国药典》2015年版四部(通则1143)细菌内毒素检查法-方法2光度测定法,各实验室使用其中任一种方法,测定待测样品内毒素含量。对参加实验室的反馈结果,使用统计软件JMP13进行统计分析,采用参加者的公议值,即本次所有参加实验室的有效检测结果的稳健平均值作为该轮次能力验证待测样品内毒素含量的指定值X。根据以下准则评价参加实验室的结果:(1)实验室检测结果在样品指定值的50%~200%范围内,为满意结果;(2)实验室检测结果不在样品指定值的50%~200%范围内,为不满意结果。结果49个实验室参加了本次能力验证计划,获“满意”结果的实验室有45家,满意度为91.8%;获“不满意”结果的实验室4家,均为检测结果不在样品指定值的50%~200%范围内,不满意率为8.2%。结论本轮能力验证参加实验室大部分可以准确检测出待测样品中的细菌内毒素含量,表明目前我国的实验室细菌内毒素检测水平总体较好。Aim To design and implement the bacterial endotoxin test proficiency testing plan to evaluate the laboratory′s ability and level to determine bacterial endotoxin.Methods According to the Chinese Pharmacopoeia(2015 edition,Vol IV)-1143 Bacterial Endotoxin Test-Photometric Method(Method 2),each laboratory used any of these methods to determine the endotoxin content of the sample to be tested.The statistical software JMP13 was used for statistical analysis of the feedback results of the participating laboratories.The consensus value of the participants,namely the robust average value of the effective test results of all the participating laboratories,was used as the assigned value X of the endotoxin content of the samples to be tested in the proficiency testing of the round.The results of participating laboratories were evaluated according to the following criteria:(1)the laboratory test results were within 50%to 200%of the assigned value of the sample,which was evaluated satisfactory;(2)the laboratory test results were not within the 50-200%range of the assigned value of the sample,which was evaluated dissatisfactory.Results A total of 49 laboratories participated in this capacity verification plan,with 45 in the laboratory with satisfactory results,with a satisfaction of 91.8%;There were 4 laboratories that received“dissatisfaction”results,all of which were not within the range of 50%-200%of the assigned value of samples,and the dissatisfaction of 8.2%.Conclusions Most of the participating laboratories can accurately detect the bacterial endotoxin content in the sample to be tested,indicating that the level of bacterial endotoxin detection in our country is generally good at present.

关 键 词：能力验证 细菌内毒素 光度测定法 浊度法 显色基质法 稳健平均值 

分 类 号：R378[医药卫生—病原生物学] R392.11[医药卫生—基础医学] R927.1R996