基于标准汤剂的马兰草配方颗粒质量评价研究OA
Study on quality evaluation of Kalimeris indica(L.)Sch.-Bip.formula granules based on standard decoction
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.
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 0.42～0.83,0.37～0.95,0.29～0.61,0.08～0.18,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.
何燕玲;向家俊;安加文;梁玉婷;刘珈羽;陈浩;李慧馨
国药集团同济堂(贵州)制药有限公司,贵州 贵阳 550009国药集团同济堂(贵州)制药有限公司,贵州 贵阳 550009国药集团同济堂(贵州)制药有限公司,贵州 贵阳 550009国药集团同济堂(贵州)制药有限公司,贵州 贵阳 550009国药集团同济堂(贵州)制药有限公司,贵州 贵阳 550009国药集团同济堂(贵州)制药有限公司,贵州 贵阳 550009国药集团同济堂(贵州)制药有限公司,贵州 贵阳 550009
医药卫生
中药化学马兰草标准汤剂配方颗粒指纹图谱层次聚类分析主成分分析质量评价
chemistry of traditional Chinese medicineKalimeris indica(L.)Sch.-Bip.standard decoctionformula granulesfingerprint spectrumhierarchical clustering analysis(HCA)principal component analysisquality evaluation
《河北工业科技》 2026 (4)
289-299,11
贵州省科合计划项目(黔科合支撑[2022]一般186)
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