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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

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

classical prescriptionQianghuo Shengshi Decoctionsubstance benchmarkquantity transfer

王敏、薛志峰、孙新茹、李丹丹、王志娟、惠玉玉、刘志东

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天津中医药大学,现代中药发现与制剂技术教育部工程中心,天津 301617

天津中医药大学,组分中药国家重点实验室,天津 301617

哈尔滨珍宝制药有限公司,哈尔滨 150040

经典名方 羌活胜湿汤 物质基准 量值传递

天津市科技计划项目

21ZYJDJC00020

2024

天津中医药大学学报
天津中医药大学

天津中医药大学学报

CSTPCD
影响因子:1.324
ISSN:1673-9043
年,卷(期):2024.43(1)
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