期刊文献+

气雾剂辅助取样装置作为取样替代方法的验证 被引量:1

Validation of Alternative Sampling Device Method for Aerosols
原文传递
导出
摘要 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.
作者 蒋波 范一灵 钟玮 刘浩 杨美成 JIANG Bo;FAN Yiling;ZHONG Wei;LIU Hao;YANG Meicheng(Shanghai lnstitute for Food and Drug Control, Shanghai 201203)
出处 《中国医药工业杂志》 CAS CSCD 北大核心 2018年第6期835-838,共4页 Chinese Journal of Pharmaceuticals
基金 2015中国药典标准提高研究项目
关键词 气雾剂 取样装置 微生物检验 替代方法 验证 aerosol sampling device microbiological test alternative method validation
  • 相关文献

同被引文献3

引证文献1

二级引证文献8

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部