气雾剂辅助取样装置作为取样替代方法的验证

Validation of Alternative Sampling Device Method for Aerosols

试验制备了人工污染气雾剂样品,按照中国药典2015年版(ChP 2015)通则9201"药品微生物检验替代方法验证指导原则"的有关规定,分别采用辅助取样装置的方法和药典方法对定量检验中的主要验证参数进行研究比较。取样装置法的准确度、精密度、定量限、线性和重现性指标均不低于药典方法,且本法具有简便、引入污染风险小等特点,可作为中国药典中气雾剂微生物取样的替代方法。

Artificial contamination aerosols were prepared firstly so as to compare the main indexes of sampling device method established in our study with the pharmacopoeia method according to the alternative method validation guidelines for microbial tests recorded in Chinese Pharmacopoeia 2015 edition. Quantitative parameters such as accuracy, precision, limit of quantification, linearity and repeatability were tested. The results showed that the sampling device method was as effective as the pharmacopoeia method, moreover, the sampling device method is simpler and has less pollution risks, suggesting that the sampling device method could be used as an alternative sampling method for the microbial test of aerosols.