Zhang Lin-Lin, An Ya-Ling, Yang Rui-Hua, Sun Ren-di, Zhang Yue-Li, Zhang Yuan-Yuan, Hou Jin-Jun, Wu Wan-Ying, Guo De-An
Shanghai Institute of Materia Medica, Chinese Academy of Sciences Shanghai 201203, China.
Shanghai Green Valley Pharmaceutical Co., Ltd. Shanghai 201000, China.
Zhongguo Zhong Yao Za Zhi. 2020 Apr;45(7):1670-1675. doi: 10.19540/j.cnki.cjcmm.20200207.303.
Developing high-quality standard is useful for promoting the quality of traditional Chinese medicine injections, which could be evaluated by establishing the comprehensive quality control method. A method for simultaneous determination of salvianolic acid B, rosmarinic acid and lithospermic acid in Salvianolate for Injection was developed for quantitative analysis of multi-components with single-marker(QAMS). ZORBAX Eclipse Plus C_(18) chromatographic column was adopted, with 0.1% phosphoric acid and acetonitrile as mobile phase. The flow rate was set at 1 mL·min~(-1). The column temperature was set at 20 ℃, and the detection wavelength was 286 nm. Salvianolic acid B was used as internal reference. The relative correction factors of rosmarinic acid and lithospermic acid(f_(s/i)) were 0.58 and 0.94, respectively. About 85% of substances in Salvianolate for Injection were quantified by the established QAMS method. The analysis of different batches of intermediates and preparations during four years showed that the contents of salvianolic acid B were 77.1%-81.5% in intermediates and 70.5%-80.1% in preparations; The total content of rosmarinic acid and lithospermic acid was about 6%. The ratio of rosmarinic acid to lithospermic acid was(3.4∶1-10∶1) and(2.5∶1-5∶1), respectively, which showed that the ratio was more stable in preparation. The QAMS method established is feasible for comprehensive quality control of multiple components of in Salvianolate for Injection.
制定高质量标准有助于提高中药注射剂的质量，这可以通过建立综合质量控制方法来进行评估。建立了一种同时测定注射用丹参酚酸中丹酚酸B、迷迭香酸和紫草酸的方法，用于单指标多成分定量分析（QAMS）。采用ZORBAX Eclipse Plus C18色谱柱，以0.1%磷酸和乙腈为流动相。流速设定为1 mL·min-1。柱温设定为20℃，检测波长为286 nm。以丹酚酸B为内参物。迷迭香酸和紫草酸的相对校正因子（f s/i）分别为0.58和0.94。所建立的QAMS方法可对注射用丹参酚酸中约85%的成分进行定量。对四年内不同批次中间体和制剂的分析表明，中间体中丹酚酸B的含量为77.1%-81.5%，制剂中为70.5%-80.1%；迷迭香酸和紫草酸的总含量约为6%。迷迭香酸与紫草酸的比例分别为（3.4∶1-10∶1）和（2.5∶1-5∶1），表明制剂中的比例更稳定。所建立的QAMS方法可用于注射用丹参酚酸多成分的综合质量控制。
