摘要目的:建立准确快速检测灭活疫苗中β-丙内酯(β-propiolactone, BPL)含量的分析方法。方法:采用气相色谱法进行BPL含量检测，用外标法计算BPL含量。对分析方法的专属性、系统适应性、线性和范围、准确度、精密度、检测限、定量限、耐用性进行验证。结果:BPL溶液和供试品溶液在相应保留时间内可见BPL峰，阴性对照溶液未出峰。BPL峰5次进样峰面积相对标准偏差小于2%且与其他峰分离度大于1.5。BPL的浓度在1.11～35.52 μg/ml范围内与峰面积成线性关系。浓度分别为2.22、4.44和8.88 μg/ml的供试品溶液回收率在97.3%～106.9%之间，相对标准偏差均小于3%。检测限为0.30 μg/ml，定量限为0.49 μg/ml。结论:建立的BPL检测方法具有良好的专属性、系统适应性、线性和范围、准确度、精密度、耐用性，符合定量检测的需求。

abstractsObjective:To establish an accurate and rapid analytical method to detect the content of β-propiolactone (BPL) in inactivated vaccines.Methods:The content of BPL was determined by gas chromatography and calculated by external standard method. The specificity, system adaptability, linearity and range, accuracy, precision, detection limit, quantitative limit and durability of the analytical method were verified.Results:The peak of BPL in BPL solution and sample solution was observed during the corresponding retention time, and there was no BPL peak observed in reference solution. The relative standard deviation (RSD) of BPL peak area was less than 2% and the degree of separation from other peaks was greater than 1.5. The concentration of BPL in the range of 1.11-35.52 μg/ml was linearly related to the peak area. The recovery rates of 2.22, 4.44, and 8.88 μg/ml solution samples were between 97.3% and 106.9%, and the RSDs were all less than 3%. The detection limit was 0.30 μg/ml and the quantitative limit was 0.49 μg/ml.Conclusion:The established method has good specificity, system adaptability, linearity and range, accuracy, precision and durability, and is accord with requirements of quantitative measurement.