羌活胜湿汤物质基准多指标成分含量测定及量值传递分析

Analysis on the determination and quantity transfer of multi index components in Qianghuo Shengshi Decoction

关键词:  经典名方  羌活胜湿汤  物质基准  量值传递

Key words:  classical prescription  Qianghuo Shengshi Decoction  substance benchmark  quantity transfer

摘要:

[目的] 建立经典名方羌活胜湿汤（QSD）物质基准的高效液相（HPLC）含量测定方法，进行量值传递分析。[方法] 制备15批QSD物质基准冻干粉，以羌活醇、二氢欧山芹醇当归酸酯、5-O-甲基维斯阿米醇苷、蔓荆子黄素、异欧前胡素、甘草酸铵为专属性指标成分，建立含量测定的检测方法，明确指标成分的含量范围、转移率范围及出膏率，对饮片到物质基准对应实物间的量值传递进行分析。[结果] 15批物质基准指标成分含量（转移率）分别为：羌活醇1.09~1.70 mg/g（10.17%~32.62%），二氢欧山芹醇当归酸酯0.06~0.20 mg/g（7.30%~10.85%），5-O-甲基维斯阿米醇苷1.27~2.81 mg/g（66.13%~92.13%），蔓荆子黄素0.09~0.59 mg/g（5.24%~13.37%），异欧前胡素0.03~0.28 mg/g（0.94%~1.92%），甘草酸铵12.74~33.78 mg/g（48.96%~62.56%）；出膏率为30.09%~34.35%。[结论] 采用HPLC法初步建立了经典名方QSD物质基准多指标成分含量测定方法，为经典名方QSD后续的研究及相关制剂研发的质量控制提供依据。

Abstract:

[Objective] Establish the High Performance Liquid Chromatography(HPLC) content determination method of multi-index components in Qianghuo Shengshi Decoction(QSD) substance benchmarks, to analysis the quantity transfer of multi-index components. [Methods] Preparing 15 batches of substance benchmarks freeze-drying powder(lyophilized powder) samples of QSD. The specific components, including Notopterol, Columbianadin, 5-O-methylvisammioside, Vitexicarpin, Isoimperatorin, and Ammonium Glycyrrhizinate were used as indexes to establish the HPLC method for quantitative evaluation, and define the contents and the transfer rate range of multi-index components and the paste-forming rate range to analysis on the quantity transfer of multi index components in decoction pieces to substance benchmarks. [Results] The contents and transfer rates of the 15 batches of substance benchmarks were 1.09~1.70 mg/g and 10.17%~32.62% of Notopterol;Columbianadin were 0.06~0.20 mg/g and 7.30%~10.85%;5-O-methylvisammioside were 1.27~2.81 mg/g and 66.13%~92.13%;Vitexicarpin were 0.09~0.59 mg/g and 5.24%~13.37%;Isoimperatorin were 0.03~0.28 mg/g and 0.94%~1.92%;Ammonium Glycyrrhizinate were 12.74~33.78 mg/g and 48.96%~62.56%, respectively. The paste-forming rate ranged from 30.09% to 34.35%. [Conclusion] The content determination method of standard multi-index components of classical famous prescription QSD was preliminarily established by HPLC, which provided a basis for the quality control of the follow-up research and the development of related preparations of QSD.