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| 整体法评估药品中需氧菌计数检验结果的不确定度 |
| Uncertainty Estimation for Total Aerobic Microbial Determination of Drugs by Global Approach |
| 投稿时间：2020-05-27 修订日期：2020-09-17 |
| DOI： |
| 中文关键词: 需氧菌计数，不确定度评估，整体法，正交试验，重复测量 |
| 英文关键词: Total aerobic microbial determination, Uncertainty estimation, Global approach, Orthogonal design, Repeated measurement |
| 基金项目: |
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| 摘要点击次数: 341 |
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| 中文摘要: |
| 目的：建立药品中需氧菌计数检验结果的不确定度评估方法。方法：本研究是以咽炎片为例，用整体法分析不确定度来源，参照正交试验方法依据《中华人民共和国药典》2015年版进行需氧菌总数计数，对检验过程中的不确定度进行量化。结果：需氧菌计数结果对数值符合正态分布，计算可得扩展不确定度和需氧菌总数的取值范围。结论：用整体法评估检测结果的不确定度操作简便,结果客观可靠，可用于药品微生物实验室内部质量控制。 |
| 英文摘要: |
| Objective: To establish method for uncertainty estimation of total aerobic microbial test of drugs. Method: The main sources of uncertainty in the process of test were analyzed by global approach. Taking Yanyan Tablet for example, measurement uncertainty of total aerobic microbial amounts were detected according to orthogonal design and Chinese Pharmacopoeia 2015. Results: Logarithm of total aerobic amounts conform to normal distribution. The expanded uncertainty and distribution range of test results were calculated. Conclusion: Estimation of measurement uncertainty by global approach was simple enough to operate with reliable result and could be used for internal quality control in pharmaceutical microbiology laboratories. |
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