应用高效体积排阻色谱法测定市场抽检口蹄疫灭活疫苗中的抗原（146S）含量

Using high performance size exclusion chromatography to determine antigen (146S) content in foot-and-mouth disease inactivated vaccine of quality supervision

关键词:  高效体积排阻色谱  口蹄疫  灭活疫苗  146S

Key words:  high performance size exclusion chromatography(HPSEC)  foot-and-mouth disease(FMD)  inactivated vaccine  146S

摘要:

应用高效体积排阻色谱法对5批市场抽检口蹄疫灭活疫苗中有效抗原(146S)含量进行检测,并使用口蹄疫O型、A型和亚洲1型抗原测试卡对5批疫苗中的抗原进行鉴别。结果显示高效体积排阻色谱法测定146S标准品浓度与峰面积线性关系良好 (R₂ = 0.9937, n = 7),5批疫苗均检测到146S特征吸收峰,经计算得到灭活疫苗中有效抗原含量分别为2.05μg/mL、3.73μg/mL、2.03μg/mL、4.87μg/mL、3.41μg/mL；使用抗原测试卡鉴别了5批疫苗中的抗原类型。结果表明高效体积排阻色谱法简便、高效,准确度较高,有望在口蹄疫灭活疫苗的质量控制中发挥重要作用。

Abstract:

The effective antigen (146S) in 5 batches of foot-and-mouth disease inactivated vaccine of quality supervision was detected by high performance size exclusion chromatography and the antigen serotype was identified by foot-and-mouth disease antigen test cards of O, A and Asia 1 serotype. The results showed a good linearity between peak area and concentration of 146S standard (R₂ = 0.9937, n = 7). There were 146S absorption peaks in all 5 vaccines, and calculated the 146S concentration were 2.05 μg/mL, 3.73 μg/mL, 2.03 μg/mL, 4.87 μg/mL and 3.41 μg/mL, respectively. The foot-and-mouth disease antigen test cards were used to identify the antigen serotype. The results indicated high performance size exclusion chromatography is simple, efficient and accurate in detecting the concentration of 146S, which could shed light on the quality control of foot-and-mouth disease inactivated vaccine.