定量伤寒Vi多糖疫苗O-乙酰基含量的药典方法的改良及其验证  

Modificaton of pharmacopoeia method for quantitative detection of O-acetyl group content in typhoid Vi polysaccharide vaccine and its validation

作　　者：李占辉 马玉倩[2] 何亚丽 陈国明 刘静 闫春 Li Zhanhui Ma Yuqian He Yali Chen Guoming Liu Jing Yan Chun(Quality Inspection Department, Beijing Tiantan Biological Products Co., Ltd., Beijing 100176, China)

机构地区：[1]北京天坛生物制品股份有限公司质量检定室,100176 [2]北京和睦家医院检验科,100016

出　　处：《国际生物制品学杂志》2017年第1期13-17,共5页International Journal of Biologicals

摘　　要：目的 通过应用低浓度对照品,对定量伤寒Vi多糖疫苗O-乙酰基含量的药典方法（O-乙酰基测定法）进行改良,并验证该法的可行性.方法 以含0.05、0.10、0.20、0.30、0.40、0.50 μmol溴化乙酰胆碱的对照品溶液制作改良O-乙酰基测定法的标准曲线,并对该法的标准曲线线性、准确度、精密度、专属性和耐用性进行验证.结果 改良O-乙酰基测定法的标准曲线线性良好,决定系数＞0.998.该法的准确度、精密度和专属性良好,O-乙酰基回收率为99.8％～101.3％,实验间和实验内相对标准偏差均＜4％,O-乙酰基加样回收率均＞96％.该法测定O-乙酰基的定量限为0.070 mmol/L.结论 应用低浓度对照品的改良O-乙酰基测定法可用于定量伤寒Vi多糖疫苗O-乙酰基含量.Objective To modify pharmacopoeia method （O-acetyl group assay） for quantitative detection of O-acetyl group content in typhoid Vi polysaccharide vaccine using low concentration control,and validate the feasibility of the modified method.Methods The standard curve of the modified method was established using control solution containing 0.05,0.10,0.20,0.30,0.40,0.50 μmol of acetylcholine bromide,and the standard curve linearity,accuracy,precision,specificity and durability of the modified method were validated.Results The standard curve linearity was good,with coefficient of determination 〉 0.998.The accuracy,precision and specificity were all good,the recoveries of O-acetyl group were 99.8%-101.3%,the relative standard deviations of intra-and inter-assay were both 〈 4%,and the recoveries of added O-acetyl group were all 〉 96%.The limit of quantitation of O-acetyl group was 0.070 mmol/L.Conclusion The modified method using low concentration control can be used for quantitative detection of O-acetyl group content in typhoid Vi polysaccharide vaccine.

关 键 词：分光光度法 紫外线 细菌菌苗 O-乙酰基 

分 类 号：R392-33[医药卫生—免疫学]