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 kinetic-chromogenic assay)for the determination of bacterial endotoxins was carried out according to the Appendix of China Pharmacopoeia in 2020 Vol Ⅲ 1143"bacterial endotoxins test"and Vol IV 9251"guidelines for bacterial endotoxin test".Results There is no interference after more than forty times dilution for gel-clot technique,the recovery rates of kinetic-turbidimetric 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
Key words
Human papillomavirus bivalent(types16,18)vaccine(pichia pastoris)/Bacterial endotoxins test/Gel-clot technique/Photometric technique/Kinetic-turbidimetric assay/Kinetic-chromogenic assay
维普
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