| 无细胞百日咳疫苗质量控制方法的建立 |
| |
| 引用本文： | 徐颖华,谭亚军,张庶民,侯启明.无细胞百日咳疫苗质量控制方法的建立[J].粉末涂料与涂装,2009,22(2). |
| |
| 作者姓名： | 徐颖华 谭亚军 张庶民 侯启明 |
| |
| 作者单位： | 中国药品生物制品检定所血清室,北京,100050 |
| |
| 摘 要： | 目的建立我国无细胞百日咳疫苗组分含量和纯度的检测方法。方法应用ELISA方法对生产过程中组分含量(PT和FHA)进行分析,SDS-PAGE和PAGE方法对疫苗原液中PT和FHA的纯度进行测定。结果通过对生产过程中组分含量的测定,绘制出组分动态图,可以实时监控生产过程中有效组分的变化。检测疫苗原液中PT和FHA纯度的SDS-PAGE法的分辨率较高,但PAGE法条带少,易于分析。结论所建立的质量控制方法可用于我国无细胞百日咳疫苗的质量控制。
|
| 关 键 词： | 无细胞百日咳疫苗 质量控制 ELISA SDS-PAGE PAGE |
Quality Control on Acellular Pertussis Vaccine |
| |
| Abstract: | Objective To develop the methods for determination of component content and purity of acellular pertussis vaccine in China.Methods The component content of acellular pertussis during production was determined by ELISA,and the purities of PT and FHA in bulk by SDS-PAGE and PAGE.Results The change of effective components during production can be monitored by determining the component content and plotting a dynamic curve.The resolving power of SDS-PAGE for determination of bulk purity was high,while the bands on PAGE profile were in a small number and easy to be analyzed.Conclusion The developed quality control method was suitable for the acellular pertussis vaccine in China. |
| |
| Keywords: | ELISA SDS-PAGE PAGE |
| 本文献已被 万方数据 等数据库收录！ |
|
