CAJ | 학술논문

目的验证乙酰丙酮比色法测定流感病毒裂解疫苗游离甲醛含量的可行性,并确认该法测定游离甲醛含量优于品红亚硫酸法. 方法对乙酰丙酮比色法进行准确度、精密度、专属性、线性、耐用性验证,并将该法与品红亚硫酸法进行比较.结果乙酰丙酮比色法的标准曲线具有可靠性,甲醛回收率为100.3％～100.9％,相对标准偏差(relative standard deviation,RSD)为0.49％.该法的精密度和专属性良好,实验间和实验内RSD均＜5.0％,甲醛加样回收率均＞99.0％.与品红亚硫酸法相比,该法的线性更好,偏差更小.结论乙酰丙酮比色法可用于流感病毒裂解疫苗游离甲醛含量测定.
목적 험증을선병동비색법측정류감병독렬해역묘유리갑철함량적가행성,병학인해법측정유리갑철함량우우품홍아류산법. 방법 대을선병동비색법진행준학도、정밀도、전속성、선성、내용성험증,병장해법여품홍아류산법진행비교.결과 을선병동비색법적표준곡선구유가고성,갑철회수솔위100.3％～100.9％,상대표준편차(relative standard deviation,RSD)위0.49％.해법적정밀도화전속성량호,실험간화실험내RSD균＜5.0％,갑철가양회수솔균＞99.0％.여품홍아류산법상비,해법적선성경호,편차경소.결론 을선병동비색법가용우류감병독렬해역묘유리갑철함량측정.
Objective To validate feasibility of using acetylacetone colorimetric method for determination of free formaldehyde content in influenza vaccine (split virion),and to confirm the acetylacetone colorimetric method was better than the magenta sulphurous acid colorimetric method.Methods The accuracy,precision,specificity,linearity and durability of the acetylacetone colorimetric method were validated.The acetylacetone colorimetric method was compared with the magenta sulphurous acid colorimetric method.Results The standard curve of the acetylacetone colorimetric method was reliable,recoveries of formaldehyde were 100.3％-100.9％ and relative standard deviation (RSD) was 0.49％.The precision and specificity of the acetylacetone colorimetric method were good,RSDs of intra-assay and inter-assay were both ＜5.0％ and recoveries of formaldehyde were ＞99.0％.The acetylacetone method had better linearity and lower deviation as compared with the magenta sulphurous acid colorimetric method.Conclusion The acetylacetone colorimetric method for the determination of free formaldehyde content in influenza vaccine (split virion) is feasible.