经典名方“竹茹汤”的物质基准量值传递分析

Quality value transmitting of substance benchmarks of Zhuru Decoction

为阐明竹茹汤物质基准的关键质量属性,制备18批物质基准对应实物,建立竹茹汤物质基准指纹图谱及其含量测定的检测方法,明确其指纹图谱共有峰的色谱峰归属,相似度范围,浸出物范围,指标性成分葛根素、甘草苷和甘草酸的含量以及转移率范围。结果表明,18批竹茹汤物质基准对应实物共标定25个共有峰,指纹图谱相似度均大于0.95。汇总特征峰信息可知,葛根、甘草、生姜分别贡献21、3、1个色谱峰;18批物质基准对应实物的浸出物18.45%~25.29%;不同批次物质基准对应实物的指标性成分含量和转移率:葛根素质量分数2.20%~3.07%,转移率38.5%~45.9%;甘草苷质量分数0.24%~0.85%,转移率15.9%~37.5%;甘草酸质量分数0.39%~1.87%,转移率16.2%~32.8%。该实验采用浸出物、指纹图谱及指标性成分含量测定相结合的模式,对经典名方竹茹汤物质基准的量值传递过程进行分析,初步建立了科学稳定的物质基准质量评价方法,为经典名方竹茹汤的后续开发及相关制剂的质量控制提供依据。

A total of 18 batches of Zhuru Decoction samples were prepared.Chromatographic fingerprints were established for Zhuru Decoction and single decoction pieces,the content of which was then determined.The extraction rate ranges,content,and transfer rate ranges of puerarin,liquiritin,and glycyrrhizic acid,together with the common peaks and the similarity range of the fingerprints,were determined to clarify key quality attributes of Zhuru Decoction.The 18 batches of Zhuru Decoction samples had 25 common peaks and the fingerprint similarity higher than 0.95.Puerariae Lobatae Radix,Glycyrrhizae Radix et Rhizoma,and Zingiberis Rhizoma Recens had 21,3,and 1 characteristic peaks,respectively.The 18 batches of samples showed the extraction rates within the range of 18.45%-25.29%.Puerarin had the content of 2.20%-3.07%and the transfer rate of 38.5%-45.9%;liquiritin had the content of 0.24%-0.85%and the transfer rate of 15.9%-37.5%;glycyrrhizic acid had the content of 0.39%-1.87%and the transfer rate of 16.2%-32.8%.In this paper,the quality value transmitting of substance benchmarks of Zhuru Decoction was analyzed based on chromatographic fingerprints,extraction rate,and the content of index components.A scientific and stable method was preliminarily established,which provided a scientific basis for the quality control and formulation development of Zhuru Decoction.