云南重楼果壳中重楼皂苷VII化学对照品的制备纯化及其质量控制研究  

Preparation,Purification and Quality Control of PolyphyllinⅦfrom the Fruit Shell of Paris polyphylla Smith var.yunnanensis(Franch.)Hand.-Mazz.

作　　者：柴玲 陈明生 饶伟文 袁健童 冯军 刘布鸣 CHAI Ling;CHEN Mingsheng;RAO Weiwen;YUAN Jiantong;FENG Jun;LIU Buming(Guangxi Key Laboratory of Traditional Chinese Medicine Quality Standards,Guangxi Institute of Chinese Medicine&Pharmaceutical Science,Nanning 530022,China;Guilin Food and Drug Inspection Institute,Guilin 541002,China)

机构地区：[1]广西壮族自治区中医药研究院广西中药质量标准研究重点实验室,广西南宁530022 [2]桂林市食品药品检验所,广西桂林541002

出　　处：《现代中药研究与实践》2025年第1期55-59,共5页Research and Practice on Chinese Medicines

基　　金：广西中药质量标准研究重点实验室开放课题(桂中重开201701)。

摘　　要：目的研究云南重楼果壳中重楼皂苷Ⅶ化学对照品的制备方法及其质量标准,为含重楼皂苷Ⅶ的药材及其相关产品的质量控制提供物质基础。方法云南重楼果壳粗粉经乙醇回流提取,采用硅胶柱色谱和高效制备液相色谱分离纯化得到高纯度的重楼皂苷Ⅶ,通过红外光谱、质谱、核磁共振谱等手段进行结构确证,采用薄层色谱法及高效液相色谱法测定样品的纯度,炽灼残渣法测定灰分,以质量平衡法计算重楼皂苷Ⅶ的含量。结果重楼皂苷Ⅶ用高效液相色谱面积归一化法测得含量均值为98.98%,炽灼残渣法测定灰分值为0.02%,以质量平衡法计算得含量为98.96%。结论制备所得的重楼皂苷Ⅶ对照品符合中药化学对照品技术要求,且建立的分析方法可靠、准确,可为含重楼皂苷Ⅶ的中药材或中药复方制剂的质量控制以及中药对照品的质量标准研究提供依据。Objective To investigate the preparation method and quality standard of polyphyllinⅦ,providing a material basis for the quality control of medicines and related products containing polyphyllinⅦ.Methods Fruit shell powders of Paris polyphylla Smith were extracted with ethanol.The extract was then purified using silica gel column chromatography and high-performance preparative liquid chromatography successively to obtain high-purity polyphyllinⅦ.The structure of polyphyllinⅦwas confirmed through infrared spectrum(IR),mass spectrometry(MS)and nuclear magnetic resonance spectrum(NMR).The purity of polyphyllinⅦwas detected using HPLC and TLC methods.The ash content was measured by the ignition residue method,and the polyphyllinⅦcontent was calculated using the mass balance method.Results The mean content of polyphyllinⅦdetermined by HPLC was 98.98%.The ash content measured by the ignition residue method was 0.02%.The content calculated by calculated by the mass balance method was 98.96%.Conclusion The prepared polyphyllinⅦreference standard meets the technical requirements for chemical reference substances in traditional Chinese medicine.The established analytical methods are reliable and accurate,providing a scientific basis for the quality control of medicinal herbs and Chinese medicine preparation containing polyphyllinⅦ,as well as the study of quality standard for chemical reference substance.

关 键 词：云南重楼 果壳 重楼皂苷Ⅶ 化学对照品 制备纯化 质量控制 

分 类 号：R284.1[医药卫生—中药学]