亚单位流感疫苗中裂解剂检测方法的改进  

Improvement of Detection Method for Lysis Substance in Sub-unit Influenza Vaccine

作　　者：田文莉 杨江山 杨桂华 李小强 

机构地区：[1]天士力金纳生物技术[天津]有限公司,天津300410

出　　处：《中国药事》2012年第1期35-37,共3页Chinese Pharmaceutical Affairs

摘　　要：目的改进检测亚单位流感疫苗中裂解剂(壬苯醇醚-9)含量的HPLC方法。方法以C4柱(Thermo BioBasic-4)代替药典使用的C18柱(Thermo BDS Hypersil C18),改变相应流动相比例。结果 C4柱保留时间仅3.27～3.34min,杂峰少,易积分,在5～2500μg.mL-1范围内线性关系良好,回收率约为100%,日内精密度和日间精密度均小于3%。结论 C4柱与C18柱相比更快速准确,更适用于实验室对裂解剂含量的常规检测。Objective To improve the HPLC method for determination of lysis substance（nonoxynol-9） in sub-unit influenza vaccine.Methods Using C4 column（Thermo BioBasic-4） instead of C18 column（Thermo BDS Hypersil C18） provided by CH.P.Results The retention time of C4 column was only 3.27~3.34 min.Few miscellaneous peaks made integrate easy.The linear range was 5~2500μg·mL-1.The recovery rate was about 100%.The relative standard deviations of intra and inter-day assay were lower than 3% respectively.Conclusion C4 column is more rapid,accurate and suitable for the routine detection of lysis substance（nonoxynol-9） than C18 column.

关 键 词：壬苯醇醚-9 HPLC 亚单位流感 疫苗 

分 类 号：R927.2[医药卫生—药学] R511.7