澄清度检查法之仪器法的方法学研究

Study on Instrumental Method of Clarity Examination

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。

Objective ： To establish an instrumental method of clarity examination. Methods ： In accordance with European Pharmaco- poeia,the linearity, stability and repeatability of instrumental method were investigated by three turbidimetersdomestic or imported. Meanwhile, whether or not the color solution clarity applied to the instrumental method was also evaluated. Results： The scattering tur- bidimeter was suitable for detection of colorless solution clarity, and the current turbidimeter couldn＇t eliminate the disturbance of color solution. Conclusion： The current turbidimeteris 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.