花黄合剂制备工艺及质量控制研究  

Research on Preparation Process and Quality Standard of Huahuang Mixture

作　　者：谢嘉驰 杨宁 罗纯清 罗黎霞 XIE Jiachi;YANG Ning;LUO Chunqing;LUO Lixia(Department of Pharmacy,Xiangtan Hospital of Traditional Chinese Medicine,Hunan Province,Xiangtan 411100,China)

机构地区：[1]湘潭市中医医院药学部,湖南湘潭411100

出　　处：《中国中医药现代远程教育》2023年第1期137-139,150,共4页Chinese Medicine Modern Distance Education of China

摘　　要：目的 筛选花黄合剂的最佳制备工艺,并建立其质量控制标准。方法 采用单因素方法考察花黄合剂加水量、煎煮时间及煎煮次数,以浸膏所获得率作为综合评价的指标;以口感为考查指标,优选成型工艺的辅料配方。采用显微鉴别法和薄层色谱法对花黄合剂中大黄、山银花、知母、黄连、连翘、黄芩进行定性鉴别。结果 优选的提取工艺为提取2次,分别加8倍和6倍量水,煎煮2 h和1 h。成型工艺:100 g清膏量,选择16 g蔗糖,0.6 g甜菊糖,加入0.2%山梨酸钾作为抑菌剂。显微鉴定法可观察到主要显微特征;薄层色谱斑点清晰,专属性强,阴性对照无干扰。结论 此研究方法简单可行、科学合理,适用于花黄合剂的制备及质量控制,并为下一步临床前实验奠定基础,为科学合理用药提供可靠依据。Objective To optimize the preparation procedure and to establish the quality standard of Huahuang mixture. Methods The single factor method was used to investigate the amount of water, boiling time and boiling times of Huahuang mixture, and the rate of extract was taken as the index of comprehensive evaluation. The excipient formula of molding process was optimized with taste as the index. Rheum palmatum L, Lonicera macranthoides Hand-Mazz, Anemarrhena asphodeloides Bge, Coptis chinensis Franch, Forsythia suspense(Thunb.)Vahl and Scutell aria baicalensis Georgi in Huahuang mixture were identified by microscopic and thin layer chromatography. Results The preferred extraction process is to extract twice, add 8 times and 6 times the amount of water respectively, and decoct for 2 hours and 1 hour. Molding process: 100g clear cream, 16g sucrose, 0.6g stevia, and 0.2% potassium sorbate as a bacteriostatic agent. Microscopic identification method can be used to observe the main microscopic features;TLC spots are clear, specificity is strong, and the negative control has no interference. Conclusion This research method is simple, feasible, scientific and reasonable,suitable for the preparation and quality control of Huahuang mixture, and lays the foundation for the next step of preclinical trials and provides a reliable basis for scientific and rational drug use.

关 键 词：花黄合剂 制备工艺 单因素考察 浸膏得率 成型工艺 质量控制 

分 类 号：R283.6[医药卫生—中药学]