关于修订阿法骨化醇软胶囊含量均匀度检测方法建议.PDFVIP

826 中国药事 2015 年 8 月 第 29 卷 第 8 期 关于修订阿法骨化醇软胶囊含量均匀度检测方法 的建议 * 郭丹，张叶，陈阳，乐健 （上海市食品药品检验所，上海 201203） 摘要 目的：比较阿法骨化醇软胶囊含量均匀度不同测定方法的结果，提出阿法骨化醇软胶囊含量均 匀度检查新方法。方法：对 2 批不同规格的阿法骨化醇软胶囊，按《中国药典》2010 年版的色谱条件 进行实验，再按《中国药典》2010 年版附录方法和国家药品标准及《中国药典》2015 版征求意见稿方 法，计算其含量均匀度，并且对 2 种方法的结果进行了比较，分析其不足之处，提出采用测定内容物 主药浓度和单位制剂的装量来计算单位制剂的含量，进而计算含量均匀度的新方法。结果：新方法简 单、易行、更易于理解，能更加准确直观地反映制剂含量均匀度的优劣，同时也减少了实验的工作量。 结论：本文提出的新方法更适于阿法骨化醇软胶囊含量均匀度的检测。 关键词： 阿法骨化醇；软胶囊；含量均匀度；标准修订；国家药品标准；《中国药典》 中图分类号：R921 文献标识码：A 文章编号： 1002-7777(2015)08-0826-05 doi:10.16153/j.1002-7777.2015.08.009 Suggestion on Revision of the Content Uniformity Test Method for Alfacalcidol Soft Capsules Guo Dan, Zhang Ye, Chen Yang, Le Jian* (Shanghai Institute of Food and Drug Control, Shanghai 201203, China) Abstract Objective: To compare the results of the content uniformity test for alfacalcidol soft capsules obtained by two methods and suggest a new method for the uniformity test. Methods: Two batches of alfacalcidol soft capsules of different specifications were tested based on the chromatographic conditions in Pharmacopoeia of Peoples Republic of China (2010 edition). The content uniformity of the two batches of alfacalcidol soft capsules were calculated respectively by using the method in the appendix of Pharmacopoeia of Peoples Republic of China (2010 edition) and the National Drug Standards and the method in draft version of Pharmacopoeia of Peoples Republic of China (2015 edition), and the results by the two methods were compared to analyze their shortcomings. At the same time, a new method for the content uniformity test was suggested where the main drug concentration of the inclusions and the dosing of the unit preparation were determined to calculate the content of the unit preparation thus to calculate the content uniformity. Results: The new method is simple to conduct and easy to understand