[关键词]
[摘要]
目的 制备泽泻饮片标准汤剂,并建立其质量评价体系,为泽泻配方颗粒的研制提供参考。方法 收集18批泽泻饮片,按标准工艺制备泽泻饮片标准汤剂,选择23-乙酰泽泻醇B转移率、pH值、出膏率、指纹图谱相似度等参数为评价指标,建立泽泻饮片标准汤剂的质量评价体系。结果 泽泻饮片中23-乙酰泽泻醇B质量分数为0.057%~0.267%,平均值0.156%;水分9.2%~12.8%,平均值10.44%。确定泽泻饮片标准汤剂的检测项目分别为pH值4.11~5.60,出膏率10.25%~17.09%,23-乙酰泽泻醇B的转移率10.49%~17.49%。结论 建立的质量评价方法稳定可行,适用于泽泻标准汤剂的研制与质量评价,可为泽泻配方颗粒及相关经典名方的研制提供参考。
[Key word]
[Abstract]
Objective To prepare standard decoction of Alismatis Rhizoma (AR) and establish its quality evaluation system, and provide reference for the development of dispensing granules of AR. Methods A total of 18 batches of AR decoction pieces were collected to prepare standard decoction of AR according to the standard process. Quality evaluation system of standard decoction of AR was established with pH value, dry extract rate, fingerprint similarity and transfer rate of alisol B 23-acetate as indexes. Results The mass fraction of alisol B 23-acetate in AR decoction pieces was 0.057%-0.267% with the average value of 0.156%, water content was 9.2%-12.8% with the average value of 10.44%; the pH value of standard decoction of AR was 4.11-5.60, dry extract rate was 10.25%-17.09%; transfer rate of alisol B 23-acetate from decoction pieces to standard decoction was 10.49%-17.49%. Conclusion The established quality evaluation method is stable and feasible, which is suitable for the development and quality evaluation of standard decoction of AR, which can provide reference for the development of dispensing granules of AR and related classic formulas.
[中图分类号]
[基金项目]
国家中药标准化项目(ZYBZH-Y-JX-27);中国中医科学院"十三五"重点领域研究专项(ZZ10-007)