CAJ | 학술논문

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。
목적：비교아법골화순연효낭함량균균도불동측정방법적결과，제출아법골화순연효낭함량균균도검사신방법。방법：대2비불동규격적아법골화순연효낭，안《중국약전》2010년판적색보조건진행실험，재안《중국약전》2010년판부록방법화국가약품표준급《중국약전》2015판정구의견고방법，계산기함량균균도，병차대2충방법적결과진행료비교，분석기불족지처，제출채용측정내용물주약농도화단위제제적장량래계산단위제제적함량，진이계산함량균균도적신방법。결과：신방법간단、역행、경역우리해，능경가준학직관지반영제제함량균균도적우렬，동시야감소료실험적공작량。결론：본문제출적신방법경괄우아법골화순연효낭함량균균도적검측。
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 speciifcations were tested based on the chromatographic conditions inPharmacopoeia of 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 ofPharmacopoeia of 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 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, which can relfect 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.