中国当代医药2025，Vol.32Issue(4)：9-13,5.DOI:10.3969/j.issn.1674-4721.2025.04.02
自身对照法和对照品法测定维生素C片溶出度的比较
Comparison of self-control method and control article method of deter-mining the dissolution of Vitamin C Tablets
邓丰 1陈佳林2
作者信息
- 1. 福建省食品药品质量检验研究院,福建 福州 350012
- 2. 福建省福抗药业股份有限公司,福建 福州 350309
- 折叠
摘要
Abstract
Objective To establish a discriminative method for the dissolution curve of Vitamin C Tablets.Methods The self-control method and the control article method with ultraviolet-visible spectrophotometry were verified separately.The comparation of the two methods was carried on,and the single batch consistency and the batch-to-batch consistence of quality of A-E batches were evaluated.Results When the self-control method and control article method were used respec-tively,the mass concentration of Vitamin C Tablets of batch E showed bothly a good linear relationship with the absorbance A within the range of 2-12 mg/L,the regression equation were A=0.006 4C+0.006 9(r=0.999 9,n=6)and A=0.008 1C+0.010 1(r=0.999 9,n=6)respectively;the RSD of precision were 0.73％and 0.55％respectively;the RSD of repeatability were 0.94％and 0.79％respectively;the RSD of stability(6 h)were only 1.88％and 1.72％respectively;the recoveries of the three dosing levels were all less than 100.50％,and the RSD were all less than 1.00％.There were no statistically significant differences in the accumulated dissolution rates of each detection time based in Tukey and Levene(P＞0.05).Single batch consistencies of five batches were all good,but the self-control method could easily and effectively distinguish the dissolution behavior of Vitamin C Tablets from various batches.Conclusion The self-control method could not only provide a basis for developing a method and a standard of the dissolution of Vitamin C Tablets,but also provide a reference for quality control and quality inspection.关键词
紫外-可见分光光度法/维生素C片/自身对照法/对照品法Key words
Ultra violet-visible spectrophotometry/Vitamin C Tablets/Self-control method/Control article method分类
医药卫生引用本文复制引用
邓丰,陈佳林..自身对照法和对照品法测定维生素C片溶出度的比较[J].中国当代医药,2025,32(4):9-13,5.
