中国中药杂志

2021, v.46(19) 5005-5014

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温经汤物质基准多指标成分含量测定及量值传递研究
Study on determination and quantity transfer of multi index components in Wenjing Decoction

吴革林;滕菲;李祥溦;刘博男;杜玉苹;朱晶晶;冯伟红;
WU Ge-lin;TENG Fei;LI Xiang-wei;LIU Bo-nan;DU Yu-ping;ZHU Jing-jing;FENG Wei-hong;Chinese Medicine Research Institute of Yangtze River Pharmaceutical Group;Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences;

摘要(Abstract):

该文在经典名方温经汤文献考证的基础上,确定药材基原、炮制方法,并制备了15批温经汤物质基准冻干粉样品,以专属性成分芍药苷和甘草苷、人参皂苷Rg_1、Re、Rb_1甘草酸和丹皮酚为指标,建立温经汤物质基准冻干粉HPLC定量评价方法,明确指标性成分的含量范围以及在人参、芍药、牡丹皮、甘草等药材中的转移率。研究结果表明,15批物质基准中芍药苷和甘草苷的质量分数分别为0.62%~0.86%、0.25%~0.76%,从饮片到物质基准的转移率分别为14.99%~19.42%、28.11%~40.93%,人参皂苷Rg_1+Re和Rb_1质量分数分别为0.14%~0.30%、0.07%~0.21%,从饮片到物质基准的转移率分别为25.92%~61.88%、25.03%~64.06%,甘草酸和丹皮酚的质量分数分别为0.63%~1.16%、0.09%~0.25%,从饮片到物质基准的转移率分别为23.43%~35.53%、5.34%~10.44%,转移率批间一致性好,表明制备工艺稳定。建议温经汤物质基准冻干粉中含芍药苷和甘草苷分别不得少于0.52%和0.35%,人参皂苷Rg_1和Re之和不得少于0.15%,人参皂苷Rb_1不得少于0.10%,甘草酸和丹皮酚分别不得少于0.63%和0.12%。该研究通过指标成分定量,对经典名方温经汤的量值传递过程进行分析,为温经汤后续的开发及相关制剂的质量控制提供依据。
Based on the textual research on literature, the key information of Wenjing Decoction were tested and identified, and 15 batches of lyophilized powder samples of Wenjing Decoction were prepared. The specific components, including paeoniflorin, glycyrrhizin, ginsenosides(Rg_1, Re and Rb_1), glycyrrhizic acid, and paeonol, were used as indexes to establish the HPLC method for quantitative evaluation, and the content ranges and transfer rates of these components were determined. The results showed that the contents of paeoniflorin, glycyrrhizin, ginsenosides Rg_1 + Re, ginsenoside Rb_1, glycyrrhizic acid, and paeonol in the 15 batches of samples were 0.62%-0.86%, 0.25%-0.76%, 0.14%-0.30%, 0.07%-0.21%, 0.63%-1.16%, and 0.09%-0.25%, respectively, and their transfer rates from the decoction pieces to the reference materials were 14.99%-19.42%, 28.11%-40.93%, 25.92%-61.88%, 25.03%-64.06%, 23.43%-35.53%, and 5.34%-10.44%, respectively. The consistency of the transfer rates between batches indicated that the preparation process was stable. It is suggested that the contents of paeoniflorin, glycyrrhizin, ginsenosides Rg_1 + Re, ginsenoside Rb_1, glycyrrhizic acid, and paeonol in Wenjing Decoction should not be less than 0.52%, 0.35%, 0.15%, 0.10%, 0.63%, and 0.12%, respectively. In this study, we determined the contents and analyzed the quantity transfer process of the index components in Wenjing Decoction, which can provide a basis for the follow-up development of Wenjing Decoction and the quality control of related preparations.

关键词(KeyWords): 经典名方;温经汤;物质基准;量值传递
classic prescription;Wenjing Decoction;benchmark;quantity transfer

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基金项目(Foundation): 国家重点研发计划项目(2018YFC1707002)

作者(Author): 吴革林;滕菲;李祥溦;刘博男;杜玉苹;朱晶晶;冯伟红;
WU Ge-lin;TENG Fei;LI Xiang-wei;LIU Bo-nan;DU Yu-ping;ZHU Jing-jing;FENG Wei-hong;Chinese Medicine Research Institute of Yangtze River Pharmaceutical Group;Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences;

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