双价人乳头瘤病毒疫苗(毕赤酵母)细菌内毒素检查方法的建立  

Establish the method of bacterial endotoxins test for human papillomavirus bivalent(types 16,18)vaccine(pichia pastoris)

作　　者：王莉 杨崇仪 王红艳 卢建升 程宾 WANG Li;YANG Chongyi;WANG Hongyan;LU Jiansheng;CHENG Bin(Yunnan Institute for Food And Drug Control,Kunming 650106,China;MITT Public Province Platform for Industrial Technology Foundation,Kunming 650106,China)

机构地区：[1]云南省食品药品监督检验研究院,昆明650106 [2]工业和信息化部产业技术基础公共服务平台,昆明650106

出　　处：《药物流行病学杂志》2024年第11期1239-1246,共8页Chinese Journal of Pharmacoepidemiology

基　　金：云南省科技厅重大科技专项计划(202002AA100008)。

摘　　要：目的建立双价人乳头瘤病毒疫苗(毕赤酵母)的细菌内毒素检查方法。方法按《中国药典》2020年版三部通则1143细菌内毒素检查法及四部指导原则9251“细菌内毒素检查法应用指导原则”中的相关规定进行凝胶法、光度法(动态浊度法和动态显色法)测定细菌内毒素方法学研究。结果双价人乳头瘤病毒疫苗(毕赤酵母)经40倍及以上稀释,对凝胶法反应无干扰,同时动态浊度法及动态显色法回收率也可达到要求。结论建立双价人乳头瘤病毒疫苗(毕赤酵母)的凝胶法、动态浊度法及动态显色法进行细菌内毒素检查可行。Objective Establish the method of bacterial endotoxins test for human papillomavirus bivalent(types 16,18)vaccine(pichia pastoris).Methods The method of gel-clot technique and photometric technique(kinetic-turbidimetric assay and kineticchromogenic assay)for the determination of bacterial endotoxins was carried out according to the Appendix of China Pharmacopoeia in 2020 VolⅢ1143“bacterial endotoxins test”and VolⅣ9251“guidelines for bacterial endotoxin test”.Results There is no interference after more than forty times dilution for gel-clot technique,the recovery rates of kineticturbidimetric assay and kinetic-chromogenic assay can also meet the requirements.Conclusion It is feasible to establish gel-clot technique,kinetic-turbidimetric assay and kinetic-chromogenic assay for bacterial endotoxin test of human papillomavirus bivalent(types 16,18)vaccine(pichia pastoris).

关 键 词：双价人乳头瘤病毒疫苗(毕赤酵母) 细菌内毒素检查 凝胶法 光度法 动态浊度法 动态显色法 

分 类 号：R927.1[医药卫生—药学]