清开灵注射液热原替代检查法对比研究  

Alternative Pyrogen Tests for Qingkailing Injection

作　　者：盖雅婷 王赟 洪颖 吴尚毅 吴海苹 李彩霞[3] GAI Ya-ting;WANG Yun;HONG Ying;WU Shang-yi;WU Hai-ping;LI Cai-xia(Xiamen Institute for Food and Drug Quality Control,Xiamen 361012,China;Xiamen Bioendo Technology Co.,Ltd.Xiamen 361022,China;The First Affiliated Hospital of Xiamen University,Xiamen 361005,China)

机构地区：[1]厦门市食品药品质量检验研究院,福建厦门361012 [2]厦门鲎试剂生物科技股份有限公司,福建厦门361022 [3]厦门大学附属第一医院,福建厦门361005

出　　处：《解放军药学学报》2025年第1期48-52,共5页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：2023年度福建省药品监督管理局科技计划项目,No.2023-4。

摘　　要：目的考察建立清开灵注射液热原替代检查法的可行性。方法采用热原检查法(家兔法)、细菌内毒素检查法(微量动态显色法)、体外热原检查法(单核细胞活化反应检查法)对4批次清开灵注射液进行对比研究。结果使用家兔法对清开灵注射液进行热原检查,结果存在假阴性,单核细胞活化反应检查法不存在假阴性;微量动态显色法用于清开灵注射液细菌内毒素检查不存在假阴性反应。结论微量动态显色法与单核细胞活化反应检查法分别可替代家兔法用于细菌内毒素和热原检查,并均可实现定量检测,增强清开灵注射液药品质量控制。建议采用微量动态显色法作为热原检查法(家兔法)的替代方法。Objective To investigate the feasibility of alternative pyrogen tests being established for Qingkailing injection.Methods Pyrogen test(rabbit pyrogen test,RPT),bacterial endotoxin test(micro kinetic chromogenic assay,mKCA)and in vitro pyrogen test(monocyte-activation test,MAT)were used to compare and contrast four batches of Qingkailing injection.Results There was false negative reaction in the pyrogen test of Qingkailing injection by RPT,but no in the bacterial endotoxin test by mKCA or in the pyrogen test by MAT.Conclusion mKCA and MAT can be used to replace RPT for bacterial endotoxin or pyrogen test respectively,and both can ensure quantitative detection and strengthen the quality control over Qingkailing injection.mKCA is recommended as an alternative method for RPT.

关 键 词：清开灵注射液 热原检查法 微量动态显色法 单核细胞活化反应检查法 

分 类 号：R927.12[医药卫生—药学]