首页|狗仔花饮片标准汤剂的质量标准研究

狗仔花饮片标准汤剂的质量标准研究

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目的:制备狗仔花标准汤剂,建立狗仔花标准汤剂质量标准,为后续狗仔花配方颗粒及其相关制剂质量标准的制定提供参考。方法:制备15批狗仔花标准汤剂,建立狗仔花饮片和标准汤剂特征图谱,确认共有峰,通过共有峰传递数、指标成分转移率和出膏率对标准汤剂进行量值传递规律分析。结果:狗仔花饮片和标准汤剂特征图谱均标定出7个相同的共有峰,说明共有峰均能从饮片传递到标准汤剂中,饮片和标准汤剂特征图谱相似度均>0。9。15批标准汤剂绿原酸的含量为0。25~0。40 mg/g,均值为 0。34 mg/g,转移率为 26。19%~38。52%;咖啡酸的含量为 0。07~0。12 mg/g,转移率为 84。37%~134。93%。15批狗仔花标准汤剂出膏率在11。53%~14。02%,浸出物在6。42%~9。16%。结论:本研究建立的高效液相色谱(HPLC)特征图谱和含量测定方法呈现良好的精密度、重复性和稳定性,为狗仔花饮片及其制剂质量标准的制定提供参考,同时为狗仔花中药配方颗粒产品质量控制奠定基础。
Study on quality standard of Vernonia patula standard decoction
Objective:To prepare the standard decoction of Vernonia patula and establish the quality standard of Vernonia patula standard decoction,so as to provide reference for formulation of the quality standard of Vernonia patula formula granules and its related preparations.Methods:Fifteen batches of Vernonia patula standard decoc-tion were prepared.The fingerprints of decoction pieces and standard decoction were established,and the com-mon peaks in the fingerprints were confirmed.The law of quality value transmitting of Vernonia patula standard decoction was analyzed by the transfer number of common peaks,the transfer rate and extraction ratio of the in-dex components.Results:There were 7 common peaks in the fingerprints of Vernonia patula decoction pieces and standard decoction,indicating that the common peaks could be transferred from the decoction pieces to the standard decoction.The similarity of fingerprints of Vernonia patula and standard decoction was greater than 0.9.The content range of chlorogenic acid in 15 batches of standard decoction was 0.25-0.40 mg/g,with an average of 0.34 mg/g,and the transfer rate range was 26.19%-38.52%.The content range of caffeic acid was 0.07-0.12 mg/g and the transfer rate range was 84.37%-134.93%.The extraction rate of 15 batches of Vernonia patula stan-dard decoction was between 11.53%and 14.02%,and the extracts ranged from 6.42%to 9.16%.Conclusion:The fingerprints and content determination method of high-performance liquid chromatography(HPLC)method demonstrate good precision,repeatability,and stability,which provides reference for the formulation of the quali-ty standards of Vernonia patula and preparations.Additionally,it lays a foundation for the quality control of Ver-nonia patula traditional Chinese medicine formula granule products.

Vernonia patulastandard decoctionhigh-performance liquid chromatography fingerprintsquality evaluation

南惠玲、程艳薇、李秧岭、李芳婵、罗宇东、林宁、钟益宁、陈清

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广西中医药大学中医药壮瑶医药研究院,南宁 530200

广西中医药大学药学院,南宁 530200

广西壮瑶药工程技术研究中心,南宁 530200

广西中医药大学百年乐制药有限公司,南宁 530023

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狗仔花 标准汤剂 高效液相色谱特征图谱 质量评价

广西重点研发计划资助项目

桂科AB21196051

2024

广西医科大学学报
广西医科大学

广西医科大学学报

CSTPCD
影响因子:0.788
ISSN:1005-930X
年,卷(期):2024.41(6)