复方丹参滴丸9种自制对照品纯度定值研究  

Purity assignment study of nine self-made reference substances in compound Danshen dripping pills

作　　者：罗学军 田介峰 阎红 王瑞静 李瑞明[1,2] 宋兆辉 何毅[1,2] Luo Xuejun;Tian Jiefeng;Yan hong;Wang ruijing;Li Ruming;Song Zhaohui;He Yi(Tasly Academy,Tasly Holding Group Co Ltd,Tianjin 300410;State Key Laboratory of Critical Technology in Innovative Chinese Medicine,Tasly Pharmaceutical Group Co Ltd,Tianjin 300410)

机构地区：[1]天士力控股集团有限公司天士力研究院,天津300410 [2]天士力医药集团股份有限公司创新中药关键技术国家重点实验室,天津300410

出　　处：《天津药学》2018年第5期4-6,共3页Tianjin Pharmacy

摘　　要：目的:测定自制对照品的纯度。方法:采用质量守恒法和定量核磁共振两种绝对含量测定方法进行自制对照品纯度的测定。结果:丹参素钠、原儿茶醛、丹酚酸A、丹酚酸B、丹酚酸T/U、三七皂苷R1、人参皂苷Rg1、人参皂苷Re和人参皂苷Rb1采用质量守恒法计算得到的相对纯度分别为:98. 25%、99. 68%、94. 96%、94. 70%、93. 49%、94. 09%、97. 08%、94. 46%和94. 78%,采用核磁共振定量法测定纯度依次为99. 24%、100. 48%、95. 12%、95. 22%、94. 74%、99. 11%、94. 66%、98. 22%和95. 32%。结论:质量守恒法与核磁共振定量法测定的9个自制对照品纯度结果基本一致,2种方法的同时使用能够更好地保证自制对照品纯度赋值的准确性。Objective:To determine the purity of the self-made reference substances of compound danshen dripping pills(DSP).Methods:Two absolute content determination methods,mass balance method and quantitative nuclear magnetic resonance spectroscopy method,were used to determine the purity of the self-made reference substances.Results:By using mass balance method,the relative purity of sodium Danshensu,protocatechuic aldehyde,salvianolic acid A,salvianolic acid B,salvianolic acid T/U,notoginsenoside R 1,ginsenoside Rg 1,ginsenoside Re and ginsenoside Rb 1 are 98.25%,99.68%,94.96%,94.70%,93.49%,94.09%,97.08%,94.46%and 94.78%,respectively;and the relative purity of above self-made reference substances determined by quantitative nuclear magnetic resonance spectroscopy method were 99.24%,100.48%,95.12%,95.22%,94.74%,99.11%,94.66%,98.22%and 95.32%,respectively.Conclusion:The purity evaluation results for the reference substances by mass balance method were basically consistence with those determined by quantitative nuclear magnetic resonance spectroscopy method.Simultaneous determination by both methods can ensure the accuracy of the purity assignment for the self-made reference substances.

关 键 词：自制对照品 纯度赋值 质量守恒法 核磁共振定量法 

分 类 号：R927.1[医药卫生—药学]