摘要
目的建立麻腮风联合减毒活疫苗(Measles,mumps and rubella vaccine,MMR)中新霉素残留量的微生物学检测方法,并进行验证。方法采用管碟法测定新霉素含量,并以新霉素浓度的对数和抑菌圈半径的平方值绘制标准直线。对建立的方法进行同质性、最低检出限、加样回收率及精密度验证。结果建立的方法在新霉素浓度为0.24～4.18 U/ml的范围内线性关系良好,R2=0.997 8;新霉素标准品与供试品的剂量反应直线的回归方程的斜率差异无统计学意义(P>0.05),即标准品与供试品间可满足同质性的要求;该方法的最低检出限为0.05 U/ml;该方法检测新霉素浓度约为0.5和1.0 U/ml的混合溶液,回收率分别为99.22%和99.86%;日内RSD为1.09%,日间RSD为1.42%。结论建立了一种适用于定量测定MMR中新霉素残留量的微生物学检测方法,该方法操作简便,结果可靠,可用于MMR的常规质量控制。
Objective To develop and verify a microbiological method for detection of residual neomycin content in live attenuated measles, mumps and rubella combined vaccine （MMR）. Methods The neomycin content was determined by cylinder plate method, based on which a standard curve was plotted with the log of neomycin concentration against the square of radius of bacteriostatic ring. The developed method was verified for homogeneity, limit of detection （LOD）, re- covery rate and precision. Results The developed method showed good linearity within a neomycin concentration range of 0. 24 - 4. 18 U/ml （R2 = 0. 997 8）. No significant difference was observed between the slopes of dose-response curves of standard neomycin and test samples （P 〉 0. 05）, which met the requirements for homogeneity. The LOD of the developed method was 0. 05 U / ml. By the developed method, the recovery rates of mixed samples at neomycin concen- trations of 0. 5 and 1.0 U/ml were 99. 22% and 99. 86%, while the intra- and inter-RSDs were 1. 09% and 1. 42%, respectively. Conclusion A microbiological method for detection of residual neomycin content in MMR was developed, which was simple, reliable, and might be used for the routine quality control of MMR.
出处
《中国生物制品学杂志》
CAS
CSCD
2013年第3期430-432,共3页
Chinese Journal of Biologicals
关键词
麻腮风联合减毒活疫苗
新霉素
抗生素残留
Live attenuated measles, mumps and rubella vaccine
Neomycin
Residual antibiotic
