Establish the method of bacterial endotoxins test for human papillomavirus bivalent(types 16,18)vaccine(pichia pastoris)
10.12173/j.issn.1005-0698.202410105
- VernacularTitle: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
- Author:
Li WANG
1
,
2
;
Chongyi YANG
;
Hongyan WANG
;
Jiansheng LU
;
Bin CHENG
Author Information
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)
- Keywords:
Human papillomavirus bivalent(types16,18)vaccine(pichia pastoris);
Bacterial endotoxins test;
Gel-clot technique;
Photometric technique;
Kinetic-turbidimetric assay;
Kinetic-chromogenic assay
- From:
Chinese Journal of Pharmacoepidemiology
2024;33(11):1239-1246
- CountryChina
- Language:Chinese
-
Abstract:
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).
