高效液相色谱法测定心脑康胶囊中芍药苷的不确定度评定  

Uncertainty evaluation for determination of paeoniflorin in Xinnaokang capsules by high performance liquid chromatography

作　　者：刘小燕 张建林 倪琳 宋平顺 LIU Xiaoyan;ZHANG Jianlin;NI Lin;SONG Pingshun(Gansu Institute for Drug Control,National Key Laboratory for Quality Control of Chinese Medicinal Materials and Pieces,Lanzhou 730030,China)

机构地区：[1]甘肃省药品检验研究院,国家中药材及饮片质量控制重点实验室,兰州730070

出　　处：《化学分析计量》2024年第4期115-119,125,共6页Chemical Analysis And Meterage

基　　金：国家药监局中药材及饮片质量控制重点实验室项目(2023GSMPA-KL07)。

摘　　要：建立心脑康胶囊中芍药苷含量的不确定度评定方法,考察《中华人民共和国药典》(2020年版)一部心脑康胶囊中芍药苷含量测定的影响因素。利用建立的数学模型,可知芍药苷含量测定的不确定度来源包括芍药苷对照品的纯度、称取质量、对照品溶液的体积、样品的称取质量、样品溶液体积、平均装量、样品的重复性测定及液相色谱仪测量偏差,评估并量化各不确定度分量,合成得到心脑康胶囊中芍药苷含量的不确定度。结果表明,心脑康胶囊中芍药苷含量为0.68 mg时,扩展不确定度为0.018 mg(k=2)。不确定度来源主要为对照品溶液体积、样品溶液体积、样品重复性测定及液相色谱仪。测量过程中可选择经过校准且精度较高的玻璃量器,控制环境温度接近20℃,并加强液相色谱仪的定期维护保养,以提高测定结果的准确性。Through the evaluation of the uncertainty of paeoniflorin content in Xinnaokang capsules,the influencing factors of paeoniflorin content in Xinnaokang capsules in Chinese Pharmacopoeia(2020 edition)were investigated.According to the mathematical model established,the sources of uncertainty in the determination of paeoniflorin content included the purity,the weight and the volume of paeoniflorin reference substance,the weight and the volume of the sample solution,the average loading volume,the repeatability of the sample and the measurement deviation of the liquid chromatograph.The uncertainty components of each factor were evaluated,the uncertainty of paeoniflorin content in Xinnaokang capsules was synthesized.The results indicated that the expanded uncertainty was 0.018 mg(k=2)when the content of paeoniflorin in Xinnaokang capsule was 0.68 mg.The main sources of uncertainty were the constant volume of standard solution,the constant volume of the testing solution,the repeatability of the sample and the liquid chromatograph.In order to improve the accuracy and reliability of the testing results,a calibrated and high-precision glass gauge should be selected in the measurement process,and the ambient temperature should be controlled close to 20℃.

关 键 词：心脑康胶囊 芍药苷 高效液相色谱法 不确定度评定 

分 类 号：O657.7[理学—分析化学]