一测多评法在注射用丹参多酚酸质量控制中的研究

Quantitative analysis of multi-components by single marker method for quality control of salvianolic acids for injection

目的建立一测多评法测定注射用丹参多酚酸中4种酚酸类成分的含量。方法以丹酚酸B为内参物,建立迷迭香酸、紫草酸、丹酚酸Y相对于丹酚酸B的相对校正因子(RCF),比较一测多评法与外标法含量测定结果的差异,评价一测多评方法的可行性和准确性。结果注射用丹参多酚酸中各指标成分的相对校正因子耐用性良好,一测多评法和外标法测定结果无明显差异。结论本研究建立的注射用丹参多酚酸一测多评含量测定方法准确、简单,可以用于该产品的质量评价。

Objective To establish a quantitative analysis of multi-components by single marker(QAMS) to determine 4 phenolic acid compounds in salvianolic acids for injection. Methods The relative correction factors of rosmarinic acid, lithospermic acid, and salvianolic acid Y were established with salvianolic acid B as the internal standard. We compared the content difference determined by QAMS and external standard methods, and evaluated the feasibility and the accuracy of QAMS. Results Durability of relative correction factors of every compound in salvianolic acids for injection was good. The result showed no significant difference by QAMS and external standard methods. Conclusion QAMS is accurate and simple for the quality control of salvianolic acids for injection.