复方丹参滴丸9种自制对照品纯度定值研究
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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 R1,ginsenoside Rg1,ginsenoside Re and ginsenoside Rb1 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.
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 R1,ginsenoside Rg1,ginsenoside Re and ginsenoside Rb1 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.
引文
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3 马康,苏福海,王海峰,等.有机纯度标准物质定值技术研究进展[J].分析测试学报,2013,32(7):901-908
4 刘阳,周颖,张才煜,等.核磁共振定量法测定脒基吡唑含量[J].药物分析杂志,2014,34(6):1087-1090
5 刘静,胡晓茹,王明娟,等.金丝桃苷对照品的定值研究[J].药物分析杂志,2015,35(3):524-527
6 孙鹤,郭治昕,李凌艳,等.复方中药国际化开发实例分析[J].世界科学技术—中医药现代化,2017,19(6):914-923
7 中国药典[S]. 2005年版增补本. 2009:103
8 中国药典[S].一部. 2015:11
9 马晓丽,邹萍萍,雷伟,等.定量核磁技术参数的优化及其在中草药定量分析领域的应用[J].药学学报,2014,49(9):1248-1257