基于一测多评法同时测定脑心舒通胶囊中6种成分的含量
Simultaneous Determination of Six Components in Naoxinshutong Capsule by QAMS Method
蔡琨 1李文强 2苏嘉烨 3梁帆 3严志明 3张毅3
作者信息
- 1. 山东达因海洋生物制药股份有限公司,山东荣成 264300
- 2. 陕西步长制药有限公司,陕西咸阳 712000;陕西省创新药物研究中心,陕西咸阳 712000
- 3. 陕西步长制药有限公司,陕西咸阳 712000
- 折叠
摘要
目的:建立HPLC一测多评法同时测定脑心舒通胶囊中6种成分(丹参素、原儿茶醛、羟基红花黄色素 A、迷迭香酸、天麻素、丹酚酸 B),使用外标法验证此方法在脑心舒通胶囊中质量控制应用的可行性及适应性.方法:以丹参素为内标物,建立其与其他 5 种成分间的相对校正因子,并计算脑心舒通胶囊各成分含量,实现一测多评.结果:丹参素与其他五种成分的相对校正因子分别为 1.025、2.157、0.760、1.820、6.224;9 批脑心舒通胶囊中用一测多评法测定 6 种成分的含量与外标法测定结果无显著差异(相对误差＜5%).结论:该方法准确可靠,可用于脑心舒通胶囊的质量控制.
Abstract
Objective:To establish HPLC quantitative analysis of multi-components by single marker method(QAMS)for the simultaneous determination of 6 components(Danshensu,protocatechualdehyde,hydroxylsafflower yellow pigment A,rosmarinic acid,gastrodin and salviolic acid B)in Naoxinshutong capsule,and using external standard method(ESM)verify the feasibility and adaptability of this method for quality control in Naoxinshutong capsules.Methods:Using Danshensu as internal reference,the relative correction factors between salvianol and other 5 ingredients are established,and the contents of each component of Naoxinshutong capsule are calculated to achieve one measurement and multiple evaluation.Results:The relative correction factors of Danshensu are 1.025,2.157,0.760,1.820 and 6.224 with other 5 ingredients.There is no significant difference in the content of 6 components in 9 batches of Naoxinshutong capsules by QMAS and ESM(relative error lower than 5%).Conclusion:With Danshensu as the internal standard,the content of 6 components in Naoxinshutong capsule is determined by QMAS.The method is reliable and accurate,and can be used for the quality control of Naoxinshutong capsule.
关键词
一测多评/相对校正因子/脑心舒通胶囊/高效液相色谱/外标法Key words
quantitative analysis of multi-components by single marker/relative correction factors/Naoxinshutong capsule/HPLC/external standard method引用本文复制引用
基金项目
陕西省重点研发计划(2022ZDLSF05-13)
出版年
2024
NETL
NSTL
万方数据