目的 建立UHPLC法同时测定不同厂家、不同剂型益心舒制剂中阿魏酸、迷迭香酸、紫草酸、洋川芎内酯I、丹酚酸B、隐丹参酮和丹参酮II_A 7种成分的含量，为进一步提升益心舒制剂的质量控制水平奠定基础。方法 采用Waters Acquity HSS T3色谱柱（100 mm×2.1 mm，1.8 μm），以0.5%甲酸水溶液-乙腈为流动相，梯度洗脱，体积流量0.4 mL/min，柱温37℃，检测波长：阿魏酸为322 nm，迷迭香酸、紫草酸、洋川芎内酯I和丹酚酸B为280 nm，隐丹参酮和丹参酮II_A为265 nm。采用所建立的含量测定方法测定不同批次、不同厂家、不同剂型的益心舒制剂中7种化学成分的含量，并进一步比较分析。结果 所检测的7种成分在15 min内全部出峰，且在各自线性范围内线性关系良好，相关系数均大于0.999 5，精密度、稳定性和重复性的RSD小于2.46%，平均加样回收率为97.56%~104.44%，RSD值均小于3.72%。不同厂家生产的益心舒制剂中7种成分含量差异显著；成分中，来自丹参药材的成分含量差异相对较小，而来自川芎药材的阿魏酸和洋川芎内酯I含量差异较大。结论 该方法简便快捷、稳定，测定结果准确可靠，不仅实现了从成分含量上对川芎的质量评价，同时通过对多个成分的测定完善了对丹参的质量评价，一方面为进一步提升益心舒制剂的整体质量控制水平奠定基础，另一方面也为不同厂家、不同剂型的益心舒制剂的质量对比研究提供参考。

Objective To establish a UHPLC method for simultaneous determination of seven components including ferulic acid, rosmarinic acid, lithospermic acid, senkyunolide I, salvianolic acid B, cryptotanshinone, and tanshinone II_A in Yixinshu preparations (益心舒制剂) with different dosage forms conducted by different manufacturers, laying a foundation for its further quality control promotion. Methods Chromatographic separation was performed on a Waters Acquity HSS T3 column (100 mm×2.1 mm, 1.8 μm) at 37℃ of column temperature with 0.5% aqueous formic acid-acetonitrile as mobile phase for gradient elution. The flow rate was set at 0.4 mL/min, and the detection wavelength were set at 322 nm for ferulic acid, 280 nm for rosmarinic acid, lithospermic acid, senkyunolide I, salvianolic acid B, and 265 nm for cryptotanshinone, tanshinone II_A. Different batches, different manufacturers and different dosage forms of Yixinshu preparations were determined by the established method, then the results were compared and analyzed. Results The seven components were separated clearly within 15 min. They presented good linear relationship in their linear ranges respectively, and all of the correlation coefficients were higher than 0.999 5. The RSD of precision, stability and repeatability were less than 2.46%. The average recoveries varied between 97.56% and 104.44% with RSD less than 3.72%. The contents of seven components in Yixinshu preparations produced by different manufacturers were different remarkably. Components which were originated from Salviae Miltiorrhizae Radix et Rhizoma (SMRR) presented a smaller difference relatively, but the other components that come from Chuanxiong Rhizoma (CR) exhibited significant difference. Conclusion The established multi-component determination method is proved to be convenient, accurate and reliable enough. The quality of CR was estimated by quantitative data of chemical components, and the evaluation measurements of SMRR were well improved. On one hand it serves as a basis for the further promotion of overall quality control of Yixinshu preparations, on the other hand it provides a reference for the quality comparation of Yixinshu preparations conducted by different manufacturers or different dosage forms.

R286.02

国家重大新药创制专项（2014ZX09201021）