摘要
建立以一测多评法测定香丹注射液中丹参素钠、原儿茶醛、迷迭香酸、丹酚酸B含量的方法,并验证该方法在香丹注射液中应用的准确性和科学性。以原儿茶醛为指标,采用高效液相色谱法建立丹参素钠、迷迭香酸、丹酚酸B与原儿茶醛的相对校正因子,并用该校正因子计算相应成分的含量;同时采用外标法测定香丹注射液中4种成分的含量,并比较计算值与实测值的差异,以验证一测多评法的准确性和可行性。30批香丹注射液一测多评的计算结果与外标法的实测值之间无显著性差异,实验所得的相对校正因子可信赖。一测多评法用于香丹注射液中丹参素钠、原儿茶醛、迷迭香酸、丹酚酸B的含量测定是可行的、准确的。
The method,quantitative analysis of multi-components assay by single marker（QAMS）,was established for the content determination of sodium danshensu,protocatechuic aldehyde,rosmarinic acid,salvianolic acid B in Xiangdan Injection.and the accuracy and science of the method was verified. Using protocatechuic aldehyde as index,the relative correlation factors（RCF）of sodium danshensu,rosmarinic acid,salvianolic acid B were established by HPLC and it was used to calculate the content of them.The results of QAMS method were compared with those external standard method to evaluate the quality. The results of 30 batches of samples by 2 methods didn＇t show significant difference.Obtained RCFs were reliable. It is feasible and suitable to evaluate the quality of sodium danshensu,protocatechuic aldehyde,rosmarinic acid,salvianolic acid B in Xiangdan Injection by QAMS.
出处
《辽宁中医药大学学报》
CAS
2015年第9期50-53,共4页
Journal of Liaoning University of Traditional Chinese Medicine
基金
国家关于香丹注射液标准的探索性研究项目
