党参标准汤剂质量评价的建立

目的:建立党参标准汤剂的质量控制方法,评价其质量的稳定性和主要影响因素。方法:收集有代表性的党参药材及饮片,制备党参标准汤剂;建立UPLC指纹图谱及党参炔苷的含量测定方法,采用UPLC-Q-TOF/MS对主要色谱峰进行结构确认,明确标准汤剂中的主要化学成分;计算出膏率、指标成分转移率和溶液p H等参数,评价工艺的稳定性。结果:党参标准汤剂中党参炔苷平均质量分数0.02%,指纹图谱相似度均0.9;党参标准汤剂对照指纹图谱主要共有峰有12个,出膏率45.4%,转移率58.1%。结论:建立的系统评价党参标准汤剂的质量评价方法稳定可行,党参饮片厚度是影响其标准汤剂出膏率的主要因素。

Quality Evaluation of Standard Decoction of Codonopsis Radix

Objective: To establish quality control methods for standard decoction of Codonopsis Radix and evaluate its stability and main influencing factors. Method: Standard decoction of Codonopsis Radix was prepared,its quality control method containing the determination of lobetyolin and UPLC fingerprint was established.The main common peaks in fingerprint were identified to clarify the main chemical constituents in the standard decoction and evaluate the stability of process by calculating the parameters,such as dry extract rate,transfer rate of index components and pH of the standard decoction. Result: The concentration of lobetyolin in the standard decoction was 0.02%,the similarities of its fingerprints were >0.9;there were 12 major common peaks in the fingerprint.Dry extract rate of standard decoction of Codonopsis Radix was 45.4%,the transfer rate of lobetyolin was 58.1%. Conclusion: Methods for evaluating the quality of standard decoction of Codonopsis Radix is presented,and thickness of decoction pieces of Codonopsis Radix is the main factor affecting dry extract rate of the standard decoction.