山茶苷A对照品的制备研究-中国药品标准杂志.DOCVIP

水黄皮素化学对照品制备及分析研究( 刘布鸣1，黄瑞松2，黄艳1，邱宏聪1，冯军1，1，苏青2 广西中药质量标准研究重点实验室，广西中医药研究院，南宁 530022；2. 广西民族医药研究院，南宁 530022) Study on the Preparation and Analysis of Candidate Reference Substance of Karanjin Liu Buming1，H Ruisong 2，H Yan1， Q Hongcong1，F Jun1，1，S Qing2 （1.Guangxi Key Laboratory of Traditonal Chinese Medicine Quality Standards, Guangxi Institute of Traditional Medical and Pharmaceutical Sciences, Nanning 530022；2. Guangxi Research Institute of ational Medicine, Nanning530022） 摘要目的研究水黄皮素干花豆。方法采用有机溶剂取快速硅胶柱、重结晶和反相制备高效液相色谱对水黄皮素进行分离纯化，通过波谱等确证化学结构，结果水黄皮素候选化学对照品高效液相色谱纯度测定均值为98.33%，炽灼残渣测定均值为0.01%；以质量平衡法计算其含量为98.32%。结论制备的水黄皮素对照品符合中药化学对照品技术要求，可作为药材或制剂质量控制的标准；建立的分析方法准确、可靠，为对照品质量控制提供科学依据。 关键词：水黄皮素化学对照品制备干花豆 中图分类号: R284.2 文献标识码: A 文章编号: Abstract ObjectiveTo prepare high purity candidate reference substance of Karanjin and establish an analysis method.Methods： Ethanol-extract of the rhizome of Fordia cauliflora Hemsl was isolated and purified by RP-HPLC combining with column chromatography and recrystallization. The structure of Karanjin was identified by UV，IR，MS1HNMR.Its purity was determined by HPLC, the ash content was determined by residue on ignition methodand the content of Karanjin was calculated by mass balance method.Results：The average tested contents of chromatographic purity and ash was 98.33% and 0.01%, respectively. The content of Karanjin was 98.32% by mass balance method.Conclusion：The candidate reference substance of Karanjin can be used for the quality control of herbal medicine. The analysis method is accurate and reliable , and the scientific basis of quality control of the reference substance was provided. Key words: Karanjin; candidate reference substance; preparation; mass balance method; Fordia cauliflora Hems1． 安全、有效、质量可控是药品研发与生产的基本原则，而标准物质则是实现质量可控原则的技术保障，在药品质量评价与控制中起到作用。目前中药化学对照品种类，且 缺乏质量控制，不能满足现代中药发展的需求，高纯度中药化学对照品的制备与分析方法研究的。水黄皮素（Karanjin）为呋喃黄酮类化合物，化学名3-甲氧基-2-苯基-4H-呋喃[2,3-H]-1-苯并呋喃-4-酮（3-methoxy-2-phenyl-4H-furo[2,3-H]-1-benzopyran-4-one