基于色差计新技术的溶液颜色测定仪在注射液检查中的应用

The application of drug solution colorimeter based on new technology in injection examination

溶液颜色检查法是《中华人民共和国药典》规定的一项重要内容,常用比色液目视法,本文详细介绍了新一代色差仪的原理和特点,对仪器技术指标进行了考察和分析,提出了色差计法在注射液检查中的优势,详细列举了色差仪新技术在各类注射剂溶液颜色检查中的应用,包括采用比色液目视法检查的注射剂、中药注射剂、《中华人民共和国药典》二部中收载的颜色超出标准比色液范围需另配对照液的17个品种注射剂以及一致性评价中要求与参比制剂比对的注射剂,认为仪器法可以更多地用于注射液颜色检查。

Test of colour of solution is an important content in ChP,and visual method is commonly used.In this paper,the principle and characteristics of a new generation of colorimeter are introduced in detail,and technical specifications of the colorimeter are measured and analyzed.The advantages of colorimeter in injection examination are put forward.The application of colorimeter as a new technology in tests of color for injections and traditional Chinese medicine injections compared with reference solution,17 kinds of injections beyond the range of reference solution,and injections required to be compared with reference preparation in conformity evaluation was detailed.It is considered that the instrumental method can be commonly used in the color test of injections.