经典名方温经汤物质基准关键质量成分群的量值传递研究

Study on the Value Transmission of the Key Quality Component Groups of the Material Standard of the Classical Famous Prescription Wenjing Decoction

目的建立温经汤物质基准的特征指纹图谱,阐明温经汤中桂皮醛和甘草酸等7种药效成分在饮片-水煎液-冻干粉(物质基准对应实物)的量值传递规律,评价温经汤物质基准的可靠性和科学性。方法依据古代医籍记载的方法制备15批温经汤物质基准,采用HPLC法测定温经汤中芍药苷、阿魏酸、甘草酸、甘草苷以及三种挥发性药效成分(桂皮醛、丹皮酚和藁本内酯)的含量并建立其特征指纹图谱。以上述7种成分的转移率为主要评价指标,分析各成分从饮片到标准煎液(中间体)、以及从标准煎液到冻干粉(物质基准)的转移率。结果(1)15批温经汤物质基准的特征图谱相似度良好(>0.9),共指认出9个特征峰,其中两个特征峰同时来源于白芍和牡丹皮,两个特征峰同时来源于酒当归和川芎,四个特征峰来源于炒甘草,一个特征峰来源于肉桂。(2)15批温经汤水煎液到物质基准的量值传递结果表明,芍药苷、甘草酸、甘草苷、阿魏酸、桂皮醛、丹皮酚、藁本内酯的转移率范围分别为:90.28%~156.84%;85.04%~106.25%;76.95%~119.30%;84.07%~119.51%;58.07%~89.82%;71.20%~102.19%;52.35%~104.20%。结论15批温经汤物质基准对应实物(冻干粉)与标准煎液(按古籍记载制备)具有质量一致性,具有可靠性和科学性,可作为温经汤复方制剂(颗粒)研发的质量基准物质。

Objective To establish the characteristic fingerprint of Wenjing Decoction material standard,clarify the quantity transfer law of seven effective components in Wenjing decoction,such as cinnamaldehyde and glycyrrhizic acid,in the decoction pieces,water decoction and freeze-dried powder(material standard corresponding to the real object),and evaluate the reliability and scientificity of Wenjing Decoction material standard.Methods Fifteen batches of Wenjing Decoction were prepared according to the method recorded in ancient medical books.The contents of paeoniflorin,ferulic acid,glycyrrhizic acid,liquiritin and three volatile components(cinnamaldehyde,Paeonol and ligustilide)in Wenjing Decoction were determined by HPLC,and the characteristic fingerprint was established.Taking the transfer rate of the above seven components as the main evaluation index,the transfer rates of each component from decoction pieces to standard decoction(intermediate)and from standard decoction to lyophilized powder(material standard)were analyzed.Results(1)The similarity of 15 batches of Wenjing decoction was good(>0.9),and a total of 9 characteristic peaks were identified,including two characteristic peaks from Paeonia lactiflora and Cortex Moutan,two from Jiudanggui and Chuanxiong,four from Chaogancao and one from cinnamon.(2)The results showed that the transfer rates of paeoniflorin,glycyrrhizic acid,liquiritin,ferulic acid,cinnamaldehyde,Paeonol and ligustilide ranged from 90.28%to 156.84%,respectively;85.04%~106.25%;76.95%~119.30%;84.07%~119.51%;58.07%~89.82%;71.20%~102.19%;52.35%~104.20%.Conclusion The quality of the 15 batches of Wenjing Decoction(lyophilized powder)is consistent with that of the standard decoction(prepared according to the records of Ancient Books),which is reliable and scientific,and can be used as the quality reference material for the research and development of Wenjing Decoction compound preparation(granules).