艾滋病DNA疫苗细菌内毒素检查法的方法建立  

Validation of Bacterial Endotoxin Test in Human Immunodeficiency Virus DNA Vaccine

作　　者：李婷 邱家新 杨丽菲 吴创豪 文了 孔雯雯 陈志伟[2] 杜严华 LI Ting;QIU Jia-xin;YANG Li-fei;WU Chuang-hao;WEN Liao;KONG Wen-wen;CHEN Zhi-wei;DU Yan-hua(Guangzhou Baiyunshan Baidi Bio-Technology Co.,Ltd,Guangzhou 511495,China;Shenzhen the Third People′s Hospital,Shenzhen 518000,China;Shenzhen Immuno Cure Biomedicine Co.,Ltd.Shenzhen 518000,China)

机构地区：[1]广州白云山拜迪生物医药有限公司,广东广州511495 [2]深圳市第三人民医院,中国深圳518000 [3]深圳医克生物医药有限公司,广东深圳518000

出　　处：《海峡药学》2022年第9期38-41,共4页Strait Pharmaceutical Journal

摘　　要：目的建立艾滋病DNA疫苗细菌内毒素的检查法。方法根据《中国药典》(2020年版)四部通则1143凝胶法进行细菌内毒素检查和方法学验证,验证该方法的灵敏度、干扰试验、中间精密度以及耐用性。结果经过灵敏度复核,鲎试剂(0.5 EU·mL^(-1))的λC在0.5λ~2.0λ,干扰试验显示供试品在最大稀释倍数下对结果无干扰,中间精密度符合要求,不同厂家、供试品阳性对照的配制方法结果显示该方法耐用性好。结论建立的方法有较好的灵敏度、专属性、中间精密度和耐用性,可用于艾滋病DNA疫苗细菌内毒素的检测。OBJECTIVE To establish a bacterial endotoxin test for HIV DNA vaccine.METHODS The bacterial endotoxin test and methodology validation were carried out according to China General Pharmacopoeia(2020 Edition)four general principles 1143 bacterial endotoxin gel method,to verify the sensitivity,interference test),intermediate precision and durability of the method.RESULTS The sensitivity of tachypleus amebocyte lysate(0.5 eu·mL^(-1))was verifiedλC at 0.5λ-2.0λ,The interference test shows that the test article has no interference with the results under the maximum valid dilution.The intermediate precision could meet the requirements.The different manufacturers and the preparation method of positive control shows that the method has good durability.CONCLUSION the established method is sensitive,specific and durable,and can be used for the detection of bacterial endotoxin in HIV DNA vaccine.

关 键 词：细菌内毒素 艾滋病DNA疫苗 鲎试剂 干扰试验 验证 

分 类 号：R927[医药卫生—药学]