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 determining the dissolution of Vitamin C Tablets

作　　者：邓丰 陈佳林 DENG Feng;CHEN Jialin(Fujian Institute for Food and Drug Quality Control,Fujian Province,Fuzhou 350012,China;Fujian Fukang Pharmaceutical Co.,Ltd.,Fujian Province,Fuzhou 350309,China)

机构地区：[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

出　　处：《中国当代医药》2025年第4期9-13,共5页China Modern Medicine

摘　　要：目的为了建立维生素C片有区分力的溶出曲线测定法。方法分别对紫外可见分光光度自身对照法和对照品法作方法学验证,并对A~E批次的维生素C片的批内均一性和批间一致性进行对比分析、评价。结果分别采用自身对照法和对照品法时,E批次维生素C片质量浓度在2~12 mg/L范围内,与吸光度A的线性关系良好,回归方程分别为A=0.0064C+0.0069(r=0.9999,n=6)和A=0.0081C+0.0101(r=0.9999,n=6);精密度试验的RSD分别为0.73%和0.55%;重复性试验的RSD分别为0.94%和0.79%;稳定性试验(6 h)时RSD分别仅为1.88%和1.72%;3个加标水平的平均回收率均<100.50%,RSD均<1.00%;采用Tukey均值法与Levene方差齐性检验法,各检测时间测得的累积溶出率比较,差异无统计学意义(P>0.05)。5个批次的批内均一性较好,但自身对照法能更简便、有效地区分不同批次的维生素C片的溶出行为。结论紫外-可见分光光度自身对照法不仅能为制订维生素C片溶出度测定方法与标准提供依据,也能为质量控制与质量检查提供参考。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 respectively,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=0.0064C+0.0069(r=0.9999,n=6)and A=0.0081C+0.0101(r=0.9999,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 

分 类 号：R927.2[医药卫生—药学]