桂枝饮片标准汤剂质量标准研究

发布时间：2019-01-11 14:41

【摘要】：目的制备桂枝饮片标准汤剂,并进行质量标准研究。方法依照标准汤剂的制备要求,制备15批桂枝饮片标准汤剂,以肉桂酸作为定量检测指标,计算转移率与出膏率,并建立其HPLC指纹图谱分析方法。结果通过对15批桂枝标准汤剂进行测定,肉桂酸转移率为56.93%~94.06%,出膏率为3.30%~9.40%;并用中药色谱指纹图谱相似度评价系统(2012A)软件进行指纹图谱分析,标定了9个共有峰,确认4个,分别为原茶儿酸(1号峰)、香豆素(4号峰)、肉桂酸(6号峰)、桂皮醛(7号峰)。对15批桂枝饮片标准汤剂分别进行了相似度评价,其相似度均高于0.95。结论建立了桂枝饮片标准汤剂指纹图谱,该方法精密度、稳定性和重复性良好,具有一定的鉴别意义,可为桂枝配方颗粒的质量控制提供参考。
[Abstract]:Objective to prepare and study the quality standard of Guizhi decoction. Methods according to the requirement of preparation of standard decoction, 15 batches of standard decoction of Guizhi decoction were prepared. The transfer rate and extract rate were calculated with cinnamic acid as the quantitative detection index, and the HPLC fingerprint analysis method was established. Results the results showed that the transfer rate of cinnamic acid was 56.93% and 94.06%, and the ointment rate was 3.30% 9.40%. The chromatographic fingerprint similarity evaluation system (2012A) was used for fingerprint analysis. Nine common peaks were calibrated, and 4 peaks were identified as crude tea acid (peak 1), coumarin (peak 4) and cinnamic acid (peak 6). Cinnamaldehyde (peak 7). The similarity of 15 batches of standard decoction of Cinnamomum Cinnamomi was evaluated, and the similarity was higher than 0.95. Conclusion the fingerprint of Guizhi decoction was established. The method has good precision, stability and reproducibility, and can be used as a reference for the quality control of Guizhi prescription granules.
【作者单位】：广东药科大学国家中医药管理局中药数字化质量评价技术重点研究室广东高校中药质量工程技术研究中心;康美(北京)药物研究院有限公司;广东药科大学中药学院;
【基金】：广东省战略性新兴产业区域集聚发展试点项目——中药经典配方颗粒重点试验平台及中药材全生命周期追溯信息服务平台建设项目(2014793)
【分类号】：R286.0;O657.7

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