青皮饮片标准煎液质量评价研究

Study on quality evaluation of standard decoction of Qingpi

目的:制备青皮饮片标准煎液,并建立其质量控制方法。方法:按照标准煎液制备要求制备10批青皮饮片标准煎液,建立UPLC特征图谱分析方法,以橙皮苷为定量指标,计算出膏率、含量和转移率。结果:10批青皮标准煎液的出膏率范围为19.9%~29.4%,橙皮苷含量范围为25.5~33.0 mg﹒g^-1,转移率范围为8.9%~11.1%。采用《中药色谱指纹图谱相似度评价系统(2012 版)》软件进行分析和相似度评价,标定了8个共有特征峰,并指认橙皮苷、川陈皮素共2个色谱峰。通过与对照图谱比对,相似度均在0.99以上。结论:本研究建立的青皮饮片标准煎液的质量评价方法准确可靠、稳定性、重复性良好,可为青皮配方颗粒及其他源于青皮水煎液的制剂的质量控制提供参考。

Objective:To prepare standard decoction of Qingpi and establish quality control method.Method:Ten batches of standard decoction of Qingpi were prepared according to the standardization method.The UPLC characteristic chromatogram was established and hesperidin was selected as the detection indices for quantitation.Result:The extract rate of standard decoction was within the range of 19.94%–29.43%.The content of hesperidin was 25.5~33.0 mg﹒g-1 with the transfer rate ranged from 8.9% to 11.1%.Besides,Similarity Evaluation System for Chromatographic Fingerprint of TCM (2012 edition) was used to analyze and compare the characteristic chromatograms.Eight common peaks were detected and two chromatographic peaks of hesperidin,nobiletin were identified.The similarity was over 0.99 by comparing with the control chromatogram.Conclusion:This study establishes the quality control method of standard decoction of Qingpi,which can provide references for the quality control of Qingpi formula granules and preparations derived from decoction pieces.