麻黄标准汤剂质量评价体系的建立.docVIP

麻黄标准汤剂质量评价体系的建立 　　[摘要]建立麻黄标准汤剂质量控制方法，为所有中药饮片标准汤剂质量评价方法的制定提供参考。制备麻黄标准汤剂，建立UPLC-UV指纹图谱并测定其麻黄碱和伪麻黄碱总含量；采用UPLC-QTOF/MS对主要色谱峰进行结构确认，明确汤剂中的主要化学成分；计算出膏率、指标成分转移率、pH，评价工艺的稳定性。结果麻黄汤剂中麻黄碱与伪麻黄碱的平均总浓度为（2.11±0.70） g?L-1；所有麻黄水煎液指纹图谱相似度均大于0.85；麻黄标准汤剂对照指纹图谱主要共有峰有10个，包括生物碱、有机酸类和黄酮；麻黄标准汤剂出膏率为（17±3.2）%、麻黄碱与伪麻黄碱的整体转移率为（32.4±8.1）%。该文建立了系统评价麻黄标准汤剂的质量评价方法，为所有源于麻黄水煎液的制剂的质量控制标准的制定提供参考。 　　[关键词] 麻黄； 标准汤剂/标准煎液； 指纹图谱； 含量测定； 出膏率； 转移率 　　[Abstract] To establish the quality control methods for the standard decoction of Ephedrae Herba， and provide the reference for quality evaluation method of all Chinese herbal medicine decoction.Standard decoction of Ephedrae Herba was prepared， and UPLC-UV fingerprint was established to determine the total contents of ephedrine and pseudoephedrine. Then UPLC-QTOF/MS was used to confirm the major common peaks in the fingerprint to clarify the main chemical constituents in the decoction. In addition， the stability of the process was evaluated by calculating the parameters such as the extraction ratio， transfer rate of the index components and the pH values.In the decoction of Ephedrae Herba， the total average concentration of ephedrine and pseudoephedrine was （2.11±0.70） g?L-1； the similarities of all the fingerprints were more than 0.85； there were 10 major common peaks in the fingerprint， including alkaloids， flavonoids and organic acids； the extraction ratio was （17±3.2）%， and the overall transfer rate of ephedrine and pseudoephedrine was （32.4±8.1）%.The method for evaluating the quality of standard decoction of Ephedrae Herba was established in this article， providing reference for the quality control of products which were stemmed from the water extract of Ephedrae Herba. 　　[Key words] Ephedrae Herba； standard decoction； fingerprint； content determination； extraction ratio； transfer rate 　　??剂作为中药传统的用药形式，至今仍被广泛使用，但由于其携带不便，煎煮耗时长和质量不均一等缺点给患者用药带来极大不便。为了解决以上问题，以汤剂为基础进行浓缩加工的中药配方颗粒等现代中药剂型不断出现。但由于缺乏统一的质量标准以及合理的中间监管过程造成了市场上现代剂型间剂量不统一、质量不稳定等问题[1]。2016年，陈士林研究员首次提出采用