| 顾珉,许丹,顾炳仁.荧光染色计数法在制药用水微生物限度检查替代方法可行性探讨[J].中国药品标准,2017,18(4):298-303 |
| 荧光染色计数法在制药用水微生物限度检查替代方法可行性探讨 |
| Validation of alternative Detection of Microorganism in Pharmaceutical Water with Fluorescent staining Method |
| 投稿时间：2017-04-25 修订日期：2017-08-03 |
| DOI： |
| 中文关键词: 制药用水 微生物限度检查 替代方法 荧光染色计数法 |
| 英文关键词: Keywords：pharmaceutical water microbial limit test alternative method fluorescent staining method |
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| 中文摘要: |
| 摘要 目的：考察荧光染色法在测定制药用水中微生物的方法适用性，评价荧光染色法在制药用水进行微生物限度检查的可行性。方法：按药品微生物检验替代方法验证指导原则的要求，从准确度、精密度、线性、定量限、范围等方面来进行定量检验的替代方法验证,并取实验室不同取样点纯化水样进行测试比较。结果：荧光染色法的各项验证参数均与药典方法相当，且不同取样点纯化水样的两种方法检测结果无显著差异。结论：本文的试验为荧光染色计数法后续在制药用水微生物检测中实际应用提供了参考。 |
| 英文摘要: |
| Abstract Objective: To investigate the applicability and the feasibility of fluorescent staining method for microbial limit test of pharmaceutical water. Methods: According to the requirements of the guidelines for the validation of alternative methods for microbiological testing of pharmaceuticals, an alternative method for quantitative test pharmaceutical water was evaluated from the aspects of accuracy, precision, linearity, limit of quantification and range. And purified water samples from different sampling points in the laboratory were tested and compared. Results: The verification parameters of the fluorescence staining method were the same as those of the Pharmacopoeia method. There were no significant differences between the two methods for the purified water samples at different sampling points. Conclusion: The test in this paper provides a reference for the practical application of fluorescence staining method in microbiological detection of pharmaceutical water. |
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