避免疫苗中有色物质干扰的甲醛残留量测定法

Detection of Free Formaldehyde in Vaccines Avoiding Interference from Colored-Substances

建立了一种能有效避免疫苗中有色物质干扰的甲醛残留量测定法。采用乙酰丙酮分光光度法,利用"本底扣除"的方式,在410 nm波长处对疫苗中甲醛的残留量进行测定。结果显示,酚红、中性红等有色物质均不会对测定结果产生干扰;在0.002~0.2 mg/m L范围内,吸光度与浓度呈良好的线性关系(r=0.9999,n=7);在0.005、0.05、0.15 mg/m L三种添加浓度下,该方法的平均回收率分别为110.5%、97.5%和101.3%;对24批含有有色物质的疫苗进行测定,所得结果与专属性较强的HPLC法一致。该方法专属性强、准确度好、适用范围宽,可以作为疫苗中甲醛残留量的检测方法。

To establish a method for the detection of free formaldehyde in vaccines that can avoid the interference from colored substances, the analysis was performed by of ＂ deducting background＂ at 410 nm. Phenol red and acetyl acetone spectrophotometric method with the means neutral red did not interfere with the result; the linearity range was 0.002- 0.2 mg/mL （ r = 0.9999, n = 7） , and under 0.005, 0.05, 0.15 mg/mL levels of accession, the average recoveries were respectively 108.6%, 97.5% and 101.3% ; 24 batches of sample were detected by the new established method, and the results were in agreement with HPLC. The method is characterized by good specificity and accuracy with wide adaptive range. It can be used for the formaldehyde detection in vaccines.