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。
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 oJ People＇s 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 People＇s Republic of China （2010 edition） and the National Drug Standards and the method in draft version of Pharmacopoeia oJ People＇s 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 dosi.ng 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, which can reflect the quality of the content uniformity and reduce workload in the experiment. Conclusion： The new method proposed in this study is more suitable for the content uniformity test for alfacalcidol soft capsules.
出处
《中国药事》
CAS
2015年第8期826-830,共5页
Chinese Pharmaceutical Affairs
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》
alfacalcidol
soft capsules
content uniformity
standard revision
the national drug standards
Pharmacopoeia of People＇s Republic of China
