首页|基于滇丹参标准汤剂的量值传递规律研究

基于滇丹参标准汤剂的量值传递规律研究

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目的:建立滇丹参标准汤剂的超高效液相色谱法(UPLC)含量测定和特征图谱方法,对滇丹参饮片、标准汤剂及配方颗粒的量值传递规律进行研究.方法:制备 15 批滇丹参标准汤剂,建立其指标成分迷迭香酸UPLC含量测定方法,并测定各批标准汤剂中迷迭香酸的含量,计算其转移率;建立标准汤剂UPLC特征图谱并进行聚类分析及主成分分析.基于标准汤剂出膏率、指标成分含量、特征图谱的一致性,制备 3 批滇丹参配方颗粒,研究滇丹参饮片-标准汤剂-配方颗粒指标性成分迷迭香酸的量值传递情况及特征图谱中特征峰的变化趋势.结果:15 批滇丹参标准汤剂中迷迭香酸质量分数为 0.36%~0.83%,转移率为 31.72%~60.57%.标准汤剂的UPLC特征图谱中共有 5 个特征峰,相似度均大于 0.9,聚类分析可将其分为 2 类;2 个主成分累积方差贡献率为 98.005 2%;饮片中的5 个特征峰全部转移至标准汤剂中.指认出峰 1、峰 2 分别为迷迭香酸、咖啡酸.3 批滇丹参配方颗粒的迷迭香酸含量及转移率、特征图谱均与同批饮片制备的标准汤剂接近,且均在质量标准规定范围内.结论:建立的基于滇丹参标准汤剂的饮片-标准汤剂-配方颗粒的UPLC含量测定方法和特征图谱,全面反映了三者量值传递规律,可对滇丹参配方颗粒制备工艺的全过程进行质量控制.
Quantity Transfer Law of Diandanshen Standard Decoction
Objective:This paper aims to establish ultra-performance liquid chromatography(UPLC)content determination and characteristic spectrum method for Diandanshen standard decoction and study the quantity transfer law of Diandanshen decoction pieces,standard decoction,and formula granules.Methods:15 batches of Diandanshen standard decoction were prepared.A method for determining the UPLC content of rosmarinic acid as an indicator component was established,and the content of rosmarinic acid in each batch of standard decoction was determined to calculate its transfer rate.UPLC characteristic spectrums of standard decoction were built,and cluster analysis and principal component analysis were performed.Based on the consistency of the standard decoction extract rate,indicator component content,and characteristic spectrum,three batches of Diandanshen formula granules were prepared to study the quantity transfer of the indicator component,namely rosmarinic acid in Diandanshen decoction slices,standard decoction,and formula granules,as well as the variation of characteristic peaks in the characteristic spectrum.Results:The content of rosmarinic acid in 15 batches of Diandanshen standard decoction is 0.36%-0.83%,and the transfer rate is 31.72%-60.57%.The UPLC characteristic spectrum of the standard decoction has a total of five characteristic peaks,with a similarity being greater than 0.9.Cluster analysis is divided into two categories.The cumulative variance contribution rate of the two principal components is 98.005 2%.All five characteristic peaks in the decoction pieces are transferred to the standard decoction,and peaks 1 and 2 are identified as rosmarinic acid and caffeic acid,respectively.The rosmarinic acid content,transfer rate,and characteristic spectrum of the three batches of Diandanshen formula granules are close to the standard decoction prepared from the same batch of decoction pieces,and all are within the quality standard range.Conclusion:The UPLC content determination and characteristic spectrum of decoction pieces,standard decoction,and formula granules based on Diandanshen standard decoction established in this study comprehensively reflect the transfer law of the three values,and quality control can be carried out throughout the entire process of preparing Diandanshen formula granules.

Diandanshen formula Granulesstandard decoctionrosmarinic acidUPLCcharacteristic spectrumcluster analysisprincipal component analysis

娄涛涛、王艳芳、孙宜春、向家俊、安加文、李慧馨

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国药集团 同济堂贵州制药有限公司,贵州 贵阳 550009

滇丹参配方颗粒 标准汤剂 迷迭香酸 超高效液相色谱法 特征图谱 聚类分析 主成分分析

2024

中国现代中药
中国中药协会,中国医药集团总公司,中国药材公司

中国现代中药

CSTPCD
影响因子:0.65
ISSN:1673-4890
年,卷(期):2024.26(12)