| 乙酰丙酮比色法在流感病毒裂解疫苗游离甲醛含量测定中的应用 |
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| 引用本文： | 方曼莉,马雷钧,郁佳俊,封向明,沈坚,程鹏飞. 乙酰丙酮比色法在流感病毒裂解疫苗游离甲醛含量测定中的应用[J]. 国际生物制品学杂志, 2014, 37(6): 281-284. DOI: 10.3760/cma.j.issn.1673-4211.2014.06.006 |
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| 作者姓名： | 方曼莉 马雷钧 郁佳俊 封向明 沈坚 程鹏飞 |
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| 作者单位： | 200051 上海生物制品有限责任公司质量检定室（方曼莉、马雷钧、郁佳俊、封向明、程鹏飞），质量保证部（沈坚） |
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| 摘 要： | 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，甲醛回收率均为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。
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| 关 键 词： | 比色法 甲醛 流感疫苗 |
The application of acetylacetone colorimetric method for determination of free formaldehyde content in influenza vaccine (split virion) |
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| Fang Manli,Ma Leijun,Yu Jiajun,Feng Xiangming,Shen Jian,Cheng Pengfei. The application of acetylacetone colorimetric method for determination of free formaldehyde content in influenza vaccine (split virion)[J]. International Journal of Biologicals, 2014, 37(6): 281-284. DOI: 10.3760/cma.j.issn.1673-4211.2014.06.006 |
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| Authors: | Fang Manli Ma Leijun Yu Jiajun Feng Xiangming Shen Jian Cheng Pengfei |
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| Affiliation: | *Department of Quality Control, Shanghai Institute of Biological Products Co., Ltd., Shanghai 200051, China |
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| Abstract: | 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. |
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| Keywords: | Colorimetry Formaldehyde Influenza vaccines |
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