| 魏慧慧,刘艳,殷剑峰,苏丽红,王玉梅.游离DNA保存管中咪唑烷基脲的定量检测方法[J].中国药事,2022,36(9):1034-1039 |
| 游离DNA保存管中咪唑烷基脲的定量检测方法 |
| Quantitative Detection Method of Imidazolidinyl Urea in Cell-free DNA Collection Tubes |
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| DOI：10.16153/j.1002-7777.2022.09.009 |
| 中文关键词: 游离DNA保存管 咪唑烷基脲 线性 定量限 精密度 准确度 特异性 |
| 英文关键词: cell-free DNA collection tubes imidazolidinyl urea linearity limit of quantitation precision accuracy specificity |
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| 中文摘要: |
| 目的：建立游离DNA保存管中咪唑烷基脲的定量检测方法。方法：利用咪唑烷基脲水溶液中含有的尿囊素和甲醛的缩合片段，可以与Nash's试剂反应生成黄色的产物[3,5-二乙酰基-1,4-二氢二甲基吡啶(DDL)]，以其吸光度与咪唑烷基脲浓度成正相关的特性来测定咪唑烷基脲的含量。优化使用本方法检测该类产品的线性范围，考察其定量限、精密度及准确度、特异性指标，并以所建立的方法初步用于游离DNA保存管检测。结果：本方法检测的线性范围确定为0.025~1.6 mg·mL-1，定量限为0.057 mg·mL-1，以高、中、低浓度样品评估方法精密度，其标准偏差均不大于10%。检测咪唑烷基脲国际标准品配制的模拟样品，其回收率在85%~115%范围内，且其结果不受常见添加剂的干扰；用所建立的方法检测了两批两种规格的细胞游离DNA保存管，结果均符合产品的技术要求。结论：所建立的方法可以用于游离DNA保存管中咪唑烷基脲的定量检测。 |
| 英文摘要: |
| Objective: To develop a quantitative detection method of imidazolidinyl urea in cell-free DNA collection tubes. Methods: The condensation fragment of allantoin and formaldehyde contained in imidazolidinyl urea aqueous solution could react with Nash's reagent to produce yellow products [3,5-diacetyl-1,4-dihydrodimethylpyridine (DDL)]. The absorbance was directly correlated with the concentration of imidazolidinyl urea, which could be adopted for assay of imidazolidinyl urea. The linear range of the method was optimized in this type of products, and its limit of quantitation, precision, accuracy and specificity performance were studied. The developed method was preliminarily applied to the detection of cell-free DNA collection tubes. Results: The linear range of this method was determined to be 0.025-1.6 mg·mL-1, and the limit of quantification was 0.057 mg·mL-1. The precision of the method was evaluated with high, medium and low concentration samples, and the standard deviation was not more than 10%. The recoveries of simulated samples prepared with imidazolidinyl urea of international standard were in the range of 85%-115%, and the results were not disturbed by common additives. Two specifications from two batches of cell-free DNA collection tubes were tested with the developed method, and the results were all in line with the technical requirements of the products. Conclusion: The developed method could be used for quantitative detection of imidazolidinyl urea in cell-free DNA collection tubes. |
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