摘要
目的提升藏药材唐古特铁线莲的质量标准。方法参照2020年版《中国药典》第四部通则,以19批自西藏、青海各不同地区采收集的唐古特铁线莲药材为研究对象,对其进行外观性状鉴别,药材组织切片及粉末显微鉴别;以常春藤皂苷元为对照物质,对药材进行薄层色谱(TLC)鉴别及高效液相色谱(HPLC)含量测定研究;对藏药材唐古特铁线莲的各检查项及浸出物进行测定。结果唐古特铁线莲药材在性状、显微和TLC鉴别方面均具有专属性特征;水分含量为7.51%~12.55%,总灰分含量为4.54%~7.68%,酸不溶性灰分含量为0.10%~1.06%,热浸法水溶性浸出物含量为21.16%~40.32%,建议暂定药材中水分、总灰分、酸不溶性灰分含量分别不得过13.0%、8.0%、1.00%,热浸法水溶性浸出物含量不得少于20.0%;常春藤皂苷元在2.5137~1005.5μg·mL^(-1)(r=0.9999)内与色谱峰面积线性关系良好,其定量限为25.14 ng,检测限为7.54 ng;唐古特铁线莲中常春藤皂苷元含量为0.074%~1.667%,平均加样回收率98.02%~99.25%,方法准确度良好。建议暂定唐古特铁线莲药材中常春藤皂苷元含量不得少于0.10%。结论该研究结果可为唐古特铁线莲药材的质量控制和标准提高提供参考。
Objective To improve the quality standard of Tibetan medicinal material Clematis tangutica(Maxim.)Korsh..Methods According to the 2020 Chinese Pharmacopoeia(VolumeⅣ),19 batches of Clematis tangutica(Maxim.)Korsh.from different areas of Tibet and Qinghai were used as the research object.The appearance characteristics were identified,and the tissue sections and powder were identified by microscopy.As a control substance,Hederagenin was identified by TLC and determined by HPLC.The inspection items and extract items of Clematis tangutica(Maxim.)Korsh.was determined.Results Clematis tangutica(Maxim.)Korsh.was specific in character,under microscope and in TLC identification.The content ranges of water,total ash,acid insoluble ash and the water-soluble extract of hot leaching were 7.51%-12.55%,4.54%-7.68%,0.10%-1.06%,and 21.16%-40.32% respectively.The contents of moisture,total ash and acid insoluble ash should be no more than 13.0%,8.0% and 1.00% respectively,and the water-soluble extract of hot leaching should be no less than 20.0%.Hederagenin had a good linearity with the chromatographic peak area at 2.5137-1005.5μg·mL^(-1)(r=0.9999).The limits of quantitation and detection were 25.14 ng and 7.54 ng.The content of hederagenin in Clematis tangutica(Maxim.)Korsh.ranged from 0.074% to 1.667%.The average recovery was 98.02%-99.25%,with good method accuracy.The content of hederagenin in the Clematis tangutica(Maxim.)Korsh.should be no less than 0.10%.Conclusion The study provides a scientific basis for the quality control and standard improvement of Clematis tangutica(Maxim.)Korsh..
作者
万玉莹
陈晓奇
王喜锟
邓顺艳
邹海飞
周燕
达娃卓玛
WAN Yu-ying;CHEN Xiao-qi;WANG Xi-kun;DENG Shun-yan;ZOU Hai-fei;ZHOU Yan;DAWA Zhuo-ma(Tibet University,Lhasa 850012;National Medical Products Administration Key Laboratory for Quality Control of Traditional Chinese Medicine,Institute of Food and Drug Control of Tibet Autonomous Region,Lhasa 850005;Chengdu Institute of Organic Chemistry,Chinese Academy of Sciences,Chengdu 610041;Chengdu Institute of Biology,Chinese Academy of Sciences,Chengdu 610042)
出处
《中南药学》
CAS
2022年第8期1895-1902,共8页
Central South Pharmacy
基金
西藏自治区自然科学基金项目(No.XZ2019ZRG-168)。
关键词
藏药材
唐古特铁线莲
质量标准
常春藤皂苷元
Cubic插值法
统计学原理
Tibetan medicine
Clematis tangutica(Maxim.)Korsh.
quality standard
hederagenin
Cubic interpolation method
principle of statistics
