基于标准汤剂的马兰草配方颗粒质量评价研究
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贵州省科合计划项目 (黔科合支撑 \[2022\]一般186)


Study on quality evaluation of Kalimeris indica(L.)Sch .-Bip.formula granules based on standard decoction
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    摘要:

    为实现马兰草配方颗粒生产全过程的质量控制,建立了基于标准汤剂的马兰草配方颗粒质量评价方法。依据中药饮片标准汤剂的制备要求,制备了15批马兰草标准汤剂及3批配方颗粒,定量计算隐绿原酸、咖啡酸、阿魏酸、3,5-O-二-咖啡酰奎宁酸和4,5-O-二-咖啡酰奎宁酸的含量,并采用超高效液相色谱法(ultra performance liquid chromatography,UPLC)建立马兰草的特征图谱并进行分析。结果表明:15批马兰草标准汤剂(S1—S15)和3批配方颗粒(KL1—KL3)的UPLC 指纹图谱有23个共有峰,相似度评价、层次聚类分析( hierarchical clustering analysis,HCA)、主成分分析表明,马兰草配方颗粒和标准汤剂成分相似;15 批马兰草标准汤剂(S1—S15)的出膏率为18.84%~32.52%,隐绿原酸、咖啡酸、阿魏酸、3,5-O-二-咖啡酰奎宁酸和4,5-O-二-咖啡酰奎宁酸的质量分数分别为 0.42~0.83、 0.37~0.95、 0.29~0.61、 0.08~0.18和0.19~0.44 mg/g,5种成分从饮片到标准汤剂的转移率分别为33.77%~82.62%、28.44%~65.96%、30.98%~71.08%、26.29%~77.87%和25.91%~60.79%;3 批马兰草配方颗粒(KL1—KL3)中5种成分从饮片到配方颗粒的转移率分别为47.96%~50.82%、32.89%~39.45%、42.48%~43.89%、26.94%~33.96%和33.32%~35.57%,与饮片到标准汤剂的转移率基本一致。所提出的马兰草标准汤剂的制备工艺可行,建立的标准汤剂特征图谱及含量测定方法稳定,可为马兰草配方颗粒的质量标准研究提供依据。

    Abstract:

    To achieve quality control throughout the entire production process of Kalimeris indica(L.)Sch .-Bip. formula granules, a quality evaluation method based on standard decoction was established for Kalimeris indica(L.)Sch .-Bip. formula granules. According to the preparation requirements of standard decoction for traditional Chinese medicine, 15 batches of Kalimeris indica(L.)Sch .-Bip. standard decoction and three batches of formula granules were prepared. The contents of cryptochlorogenic acid, caffeic acid, ferulic acid,3 ,5-O-di-caffeoylquinic acid, and 4 ,5-O-di-caffeoylquinic acid were quantitatively calculated, and the characteristic chromatogram of Kalimeris indica(L.)Sch .-Bip. was established and analyzed using ultra-high performance liquid chromatography. The results show that there were 23 common peaks in the UPLC fingerprint spectra of 15 batches of Kalimeris indica(L.)Sch .-Bip. standard decoction (S1-S15) and three batches of formula granules (KL1-KL3). Similarity evaluation, HCA, and PCA indicate that the components of Kalimeris indica(L.)Sch .-Bip. formula granules are similar to those of the standard decoction. The extract yield of 15 batches of Kalimeris indica(L.)Sch .-Bip. standard decoction (S1-S15) range from 18.84% to 32.52%. The mass fractions of cryptochlorogenic acid, caffeic acid, ferulic acid, 3 ,5-O-di-caffeoylquinic acid, and 4 ,5-O-di-caffeoylquinic acid are 0.42~0.83, 0.37~0.95, 0.29~061, 0.08~0.18, and 0.19~0.44 mg/g, respectively. The transfer rates of the five components from the decoction pieces to the standard decoction are 33.77%~82.62%, 28.44%~65.96%, 30.98%~71.08%, 26.29%~77.87%, and 25.91%~60.79%, respectively. The transfer rates of the five components from the decoction pieces to the formula granules in the three batches of Kalimeris indica(L.)Sch .-Bip. formula granules (KL1-KL3) are 47.96%~50.82%, 32.89%~39.45%, 42.48%~43.89%, 26.94%~33.96%, and 33.32%~35.57%, respectively, which are basically consistent with the transfer rates from the decoction pieces to the standard decoction. The proposed preparation process of Kalimeris indica(L.)Sch .-Bip. standard decoction is feasible, and the established characteristic fingerprint spectrum and content determination methods of the standard decoction are stable, providing a basis for the quality standard research of Kalimeris indica(L.)Sch .-Bip. formula granules.

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何燕玲,向家俊,安加文,梁玉婷,刘珈羽,陈 浩,李慧馨.基于标准汤剂的马兰草配方颗粒质量评价研究[J].河北工业科技,2026,43(4):289-299

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  • 收稿日期:2026-01-30
  • 最后修改日期:2026-07-13
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  • 在线发布日期: 2026-08-09
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