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目的建立乙型肝炎(简称乙肝)疫苗纯化产物中脂质含量的硫酸-香草醛测定法,并进行验证。方法以三油酸甘油酯为标准品,采用硫酸-香草醛法测定乙肝疫苗纯化产物的脂质含量,并对方法的线性范围、精密性、准确性进行验证,同时分析不同添加物对检测结果的影响。用该方法检测不同厂家乙肝疫苗纯化产物中的脂质含量。结果硫酸-香草醛法的线性范围为50~800μg/ml,回归方程为y=0.001 7 x+0.034 2,r=0.999 1;6次检测同批样品溶液脂质含量的变异系数(coefficient of variation,CV)为0.54%;2名操作人员检测3批样品溶液,重复测定3次的CV值为0.60%~3.26%;9份加标样品溶液的回收率为97.0%~105.4%;加入添加物Tween-20、PEG-6000、葡萄糖、甘油、Tris的样品回收率为92.4%~105.5%。不同厂家疫苗纯化产物每100μg蛋白脂质含量为53.9~309.5μg。结论本实验建立的硫酸-香草醛法具有良好的线性、精密性及准确性,可用于乙型肝炎疫苗纯化产物中脂质含量的测定。
Objective To establish a method for the determination of the lipid content in the purified product of Hepatitis B (HepB) vaccine, and to verify it. Methods The lipid content of purified hepatitis B vaccine was determined with triolein as standard, and the linear range, precision and accuracy of the method were tested. The effects of different additives on the test results Impact. This method was used to test the lipid content in the purified products of hepatitis B vaccine from different manufacturers. Results The linear range of the sulfate-vanillin method was 50 ~ 800μg / ml, the regression equation was y = 0.001 7 x + 0.034 2, r = 0.999 1. The coefficient of variation , CV) was 0.54%. The CV of three batches of samples was detected by two operators and the repeatability was 0.60% -3.26%. The recoveries of nine spiked samples were 97.0% -105.4% The recoveries of Tween-20, PEG-6000, glucose, glycerol and Tris were 92.4% -105.5%. Different manufacturers of vaccine purified products per 100μg protein lipid content of 53.9 ~ 309.5μg. Conclusion The sulfuric acid-vanillin method established in this experiment has good linearity, precision and accuracy and can be used for the determination of lipid content in the purified product of hepatitis B vaccine.