红花标准汤剂的质量评价

目的:建立红花标准汤剂的质量控制方法。方法:收集有代表性的14批红花,制备红花标准汤剂,计算出膏率、指标成分转移率和溶液pH等参数,评价工艺的稳定性;建立指标成分含量测定和指纹图谱方法,采用UPLC-Q-TOF/MS对主要色谱峰进行结构确认,明确红花标准汤剂中的主要化学成分。结果:标准汤剂出膏率32.6%,羟基红花黄色素A的转移率61.2%,pH 4.1;标准汤剂中羟基红花黄色素A平均质量浓度3.6 g·L~(-1),指纹图谱相似度均0.9,标准汤剂的主要成分为黄酮类。结论:建立了系统评价红花标准汤剂的质量评价方法,为所有源于红花水煎液的制剂的质量标准制定提供参考,所得红花标准汤剂的指标成分转移率高、质量均一性良好。

Quality Evaluation of Standard Decoction of Carthami Flos

Objective: To establish quality control methods for standard decoction of Carthami Flos. Method: Standard decoction of Carthami Flos was prepared,its dry extract rate,transfer rate of index components and pH were calculated to evaluate the stability of the process.A quality control method containing determination of hydroxysafflor yellow A and UPLC-UV fingerprint was established,the main common peaks in fingerprint were identified to clarify the main chemical constituents in standard decoction of Carthami Flos. Result: The concentration of hydroxysafflor yellow A in the standard decoction was 3.6 g·L^-1.The similarities of fingerprints of samples were >0.9.The dry extract rate of the standard decoction was 32.6%,the transfer rate of hydroxysafflor yellow A was 61.2%,pH was 4.1. Conclusion: Methods for evaluating the quality of standard decoction of Carthami Flos is presented,they can provide reference for the quality control of products which are stemmed from the water extract of Carthami Flos.