摘要
目的应用吖啶橙分光光度法来检测HBVDNA疫苗双质粒制剂中的十二烷基硫酸(sodium dodecyl sulfate,SDS)残留量。方法将SDS标准品按不同浓度与吖啶橙混合作用后,经甲苯萃取,再测定A499值,制定出相应的标准曲线。根据待测样品的A499值,求出其SDS浓度。结果SDS浓度在0～0.0032%的范围内,线性关系良好,相关系数r>0.99,而SDS浓度在0～0.0064%的范围,曲线的相关系数r仅为0.96。因此,应采用在0～0.0032%的范围的标准曲线。待测样品三批制剂的SDS残留量均小于0.002%,表明制剂的SDS残留合格,检测结果稳定可靠。结论建立了检测HBVDNA疫苗双质粒制剂中SDS残留量的实验方法,为进一步的终产品质量控制及后续的实验研究奠定了基础。
Objective To determine concentration of sodium dodecyl sulfate （SDS） in therapeuatic double plasmid HBV DNA vaccine by using Acridine Orange-spetrophotometer.Methods Standard SDS in different concentrations was mixed with Acridine Orange dye.By toluene extracting,absorbency of 499nm （A499） was checked.Criterional curve was established according to SDS concentration and A499. SDS concentration could be determined by A499 in the tested sample.Results When SDS concention was 0~0.0032%,r 0.99 and the linear relationship was good.When SDS concention was 0~0.0064%,r 0.96.Curve in 0~0.0032% concentration was better.The concentrations of remnant SDS were 0.002% or less in three groups of tested samples and were eligible.The test results were stable and reliable.Conclusion The experimental method to quantitate the SDS concentration in therapeuatic double plasmid HBV DNA vaccine was established to lay the foundation of final product quality control and the following research.
出处
《华南国防医学杂志》
CAS
2010年第1期1-2,16,共3页
Military Medical Journal of South China
基金
国家"863"课题基金资助项目(2002AA2Z3317)
关键词
治疗性双质粒
HBV
DNA疫苗
吖啶橙
SDS
Therapeuatic double plasmid
HBV
DNA vaccine
Acridine Orange
Sodium dodecyl sulfate
