| 李文东,王成刚,刘海涛,王俊秋.澄清度检查法之仪器法的方法学研究[J].中国药品标准,2016,17(4):271-275 |
| 澄清度检查法之仪器法的方法学研究 |
| Study of the Instrumental Method of Clarity Examination |
| 投稿时间：2016-03-25 修订日期：2016-06-23 |
| DOI： |
| 中文关键词: 澄清度检查法 仪器法 散射光式浊度计 |
| 英文关键词: Study on Instrumental Method of Clarity Examination |
| 基金项目: |
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| 摘要点击次数: 731 |
| 全文下载次数: 318 |
| 中文摘要: |
| 目的：建立澄清度检查法之仪器法。方法：参照《欧洲药典》溶液澄清度和浊度级别中的仪器法，采用三台国内外生产的浊度计进行方法学研究，对线性，稳定性和重复性进行考察，同时对有色溶液的澄清度检查是否适用于仪器法也进行考察。结果：散射光式浊度仪适用于对无色溶液进行浊度测定，线性、稳定性和重复性均符合要求；现有浊度计无法消除有色溶液中的颜色对浊度值测定的干扰。结论：现有散射光式浊度计适用于无色溶液的浊度值测定，对目视法无法有效判断的样品提供了补充检测方法。 |
| 英文摘要: |
| Objective: To establish an instrumental method of clarity examination. Methods: In accordance with European Pharmacopoeia,the linearity, stability and repeatability of instrumental method were investigated by three turbidimeters domestic or imported . Meanwhile, whether or not the color solution clarity applied to the instrumental method was also evaluated. Results: The scattering turbidimeter was suitable for detection of colorless solution clarity, and the current turbidimeter couldn’t eliminate the disturbance of color solution. Conclusion: The current turbidimeter is suitable for detection of colorless solution clarity. The instrumental method will be an additional clarity detection method for the samples not suitable for visual method. |
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