吴远波　刘宇政　吴靓　吴克勤　冷红文　焦涛　张鸿

【摘要】目的：制备覆盆子饮片标准汤剂，并建立质量评价方法。方法：按技术要求制备12批覆盆子标准汤剂，测定鞣花酸成分含量并计算其转移率，测定出膏率，并建立标准汤剂HPLC指纹图谱分析方法。结果：通过对12 批覆盆子标准汤剂进行测定，鞣花酸转移率为49.9%～82.8%，出膏率为13.2%～15.5%;指纹图谱中标定了9 个共有峰，指认了其中3 个峰，12 批覆盆子标准汤剂相似度均>0.9。结论：本研究可为覆盆子配方颗粒制备提供标准参考。

【关键词】覆盆子;标准汤剂;质量评价;指纹图谱

【中图分类号】R283 【文献标志码】 A【文章编号】1007-8517（2021）23-0039-06

Preparation and Quality Evaluation of Rubi Fructus Standard Decotion

WU Yuanbo¹LIU Yuzheng¹WU Jing¹WU Keqin¹LENG Hongwen¹JIAO Tao²ZHANG Hong^1*

1. Jiangxi Academy of Medical Science， Nanchang 330006， China;

2.Drug Detection Department， Dandong Market Supervision Service Center， Dandong 118002， China

Abstract：Objective To prepare Rubi Fructus standard decotion， and to establish the method for the quality evaluation. Methods 12 batches of Rubi Fructus standard decotion were prepared according to technical requirement. Ellagic acid was determined and the transfer rate was calculated. The extraction rate was determined. The HPLC fingerprint chromatogram analysis method of the standard decotion were established. Results According to the detection of 12 batches of Rubi Fructus standard decotion， the transfer rate ranged from 49.9% to 82.8% and the extraction rate ranged from 13.2% to 15.5%. 9 common peaks were determined and 3 of them were identified in the fingerprint chromatogram. Moreover， the similarities of 12 batches of Rubi Fructus standard decotion were all over 0.9. Conclusion This study can provide a standard reference for the preparation of Rubi Fructus formula granules.

Key words：Rubi Fructus; Standard Decotion; Quality Evaluation; Fingerprint Chromatogram

中药配方颗粒既继承了传统汤剂的优点，又具有服用方便、易于贮藏、质量稳定、便于调剂等优势^[1]，被广泛关注，也越来越多地被医生和患者接受。然而，中药配方颗粒与传统中药饮片汤剂在临床应用中是否等效备受争议^[2-3]，且尚无统一的制备工艺和质量标准^[4-5]，仍需进一步规范和完善。为解决中药配方颗粒发展面临的问题，2021年1月，国家药品监督管理局在征求意见稿的基础上正式发布《中药配方颗粒质量控制与标准制定技术要求》 （以下简称《技术要求》），提出标准汤剂为衡量单味中药配方颗粒是否与其相对应的单味中药饮片临床汤剂基本一致的物质基准，并提出中药配方颗粒的所有药学研究均须与标准汤剂进行对比^[6-7]。

覆盆子为蔷薇科植物华东覆盆子Rubus chingii Hu的干燥果实，夏初果实由绿变绿黄时采收，为常用中药，具有益肾固精缩尿、养肝明目的功效，用于遗精滑精，遗尿尿频，阳痿早泄，目暗昏花^[8]。覆……