冻干人用狂犬病疫苗（Vero细胞）半成品SEC-HPLC左侧肩峰蛋白鉴定

Identification of left shoulder protein from SEC-HPLC of final bulk of freeze-dried rabies vaccine (Vero cells) for human use

目的对冻干人用狂犬病疫苗(Vero细胞)半成品SEC-HPLC左侧肩峰蛋白进行鉴定。方法将人血白蛋白(human serum albumin,HSA)和疫苗半成品分别进行SEC-HPLC分析,收集左侧肩峰后进行烷基化,并用胰酶酶解,产物进行nanoLC-MS/MS分析。结果HSA SEC-HPLC左侧肩峰成功鉴定6个蛋白,包括1个HSA和5个非HSA蛋白;疫苗半成品SEC-HPLC左侧肩峰成功鉴定3个蛋白,包括1个HSA和2个非HSA蛋白,它们均在HSA SEC左侧肩峰中被鉴定。结论冻干人用狂犬病疫苗(Vero细胞)半成品SEC-HPLC左侧肩峰蛋白来源于HSA。

Objective To identify the left shoulder protein from SEC-HPLC of final bulk of freeze-dried rabies vaccine(Vero cells)for human use.Methods HSA and final bulk of vaccine were subjected to SEC-HPLC respectively,of which the left shoulder proteins were collected,alkylagted,digested with trypsin,and analyzed by nanoLC-MS/MS.Results Six kinds of protein,including one kind of HSA and five kinds of non-HSA,were identified from the left shoulder of HSA.However,three kinds of protein,including one kind of HSA and two kinds of non-HSA,were identified from the left shoulder of final bulk of vaccine.Conclusion The left shoulder protein from SEC-HPLC of final bulk of freeze-dried rabies vaccine(Vero cells)for human use were derived from HSA.