对《中国药典》2010年版第二增补本收载的阿法骨化醇软胶囊含量均匀度检测项目和方法的商榷

Suggestion on Content Uniformity Test Method for Alfacalcidol Soft Capsules in Pharmcopiea

目的:建议《中国药典》对阿法骨化醇软胶囊以装量差异替代含量均匀度检测。方法:根据《中国药典》《美国药典》《欧洲药典》及《日本药局方》对含量均匀度检测项目的规定和方法,分析局颁标准和《中国药典》2010年版第二增补本对阿法骨化醇软胶囊含量均匀度检查项目的合理性问题。结果与结论:局颁标准和《中国药典》2010年版第二增补本收载的阿法骨化醇软胶囊含量均匀度检查方法不合理。阿法骨化醇软胶囊是由均匀的油溶液压制而成,应该采用装量差异检查,而不是进行含量均匀度检查。其含量均匀度检查方法不仅不易操作,而且引入了错误的概念和实验误差。

Objective： To suggest that content uniformity detection bereplaced by weight variation for alfacalcidol soft capsules in chinese pharmacopoeia. Methods： Reasonable questions of alfacalcidol soft capsules content uniformity in the National Drug Standard and the second supplement of Chinese Pharmacopoeia 2010 edition were discussed according to content uniformity testing program requirements and test methods of Chinese Pharmacopoeia, USP, European Pharmacopoeia and Japanese Pharmacopoeia. Results and Conclution： Alfacalcidol soft capsules content uniformity testing methods were inappropriate in the National Standard and the second supplement of Chinese Pharmacopoeia 2010 edition. Alfacalcidol soft capsules were pressed together by a homogeneous oil solution, which needs to check the weight variation, rather than content uniformity checks. Its content uniformity testing methods not only were difficult to operate and wrong concepts and experimental error were introduced as well.