摘要
目的制备山萸肉饮片标准汤剂并进行质量研究,为相关研究与药物开发提供参考。方法根据中药饮片标准汤剂制备原则,制备15批不同产地的山萸肉饮片标准汤剂,以莫诺苷、马钱苷和山茱萸新苷作为定量检测指标,计算转移率与出膏率,并建立超高液相色谱(UPLC)特征图谱分析方法。结果 15批山萸肉饮片标准汤剂的出膏率为43.9%~48.2%,莫诺苷转移率为55.8%~90.8%,马钱苷转移率为52.8%~68.3%,山茱萸新苷转移率为47.2%~61.6%。采用《中药色谱指纹图谱相似度评价系统(2012版)》软件进行特征图谱分析,标定了13个共有峰,对15批山萸肉饮片及标准汤剂进行相似度评价,其相似度均大于0.9。结论本研究山萸肉饮片标准汤剂制备规范,测定方法准确可靠,能够反映山萸肉水煎制剂的内在质量,可为山萸肉配方颗粒的质量控制提供参考。
Objective To prepare Corni Fructus standard decoction and conduct research on quality; To provide references for research and development of related medicine. Methods Fifteen batches of Corni Fructus standard decoction were prepared according to the standardization method of TCM decoction pieces. With morroniside, loganin and cornuside as the detection indices, the transfer rate and extraction rate were calculated, and the UPLC characteristic chromatograms analysis method was established. Results According to the measurement of 15 batches of Corni Fructus standard decoctions, the extractum rate was at the range of 43.9%–48.2%, and the transfer rates of morroniside, loganin and cornuside were 55.8%–90.8%, 52.8%–68.3% and 47.2%–61.6%, respectively. Besides, Similarity Evaluation System for Chromatographic Fingerprint of TCM(2012 edition) was used to analyze and compare the characteristic chromatograms, and 13 common peaks were determined. The similarity was over 0.9. Conclusion The preparation of Corni Fructus standard decoction is standard. The determination method is reliable and accurate, which can be used to reflect the quality of Corni Fructus standard decoctions and provide references for the quality control of Corni Fructus formula granules.
引文
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