《德国药品法典》规定下的南葶苈子质量标准体系制定研究  

Study on the establishment of the quality standard system of Descurainiae Semen under the requirements of German Pharmaceutical Codex

作　　者：卢晨娜 向定华 谢胡敏 许海玉[1] 王梅 孙朋悦 李皓月 刘晓谦[1] 李春[1] 宋坪 Lu Chenna;Xiang Dinghua;Xie Humin;Xu Haiyu;Wang Mei;Sun Pengyue;Li Haoyue;Liu Xiaoqian;Li Chun;Song Ping(National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines,Research Center of Chemistry for Chinese Materia Medica,Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China;European Center for Chinese Medicine and Natural Compounds,Institute of Biology,Leiden University,2333BE Leiden,the Netherlands;SU BioMedicine,Leiden Bio Science Park,2333BD Leiden,The Netherlands;Department of Dermatology,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China)

机构地区：[1]中国中医科学院中药研究所中药化学研究中心中药质量控制技术国家工程实验室,北京100700 [2]莱顿大学欧洲天然产物与中医药研究所莱顿大学生物学研究所,莱顿2333BE [3]SU生物医学莱顿生物科学园,莱顿2333BD [4]中国中医科学院西苑医院皮肤科,北京100091

出　　处：《国际中医中药杂志》2025年第1期88-95,共8页International Journal of Traditional Chinese Medicine

基　　金：中国-荷兰中医药防治重大感染性疾病“一带一路”联合实验室建设项目(Z211100007921004);中国-奥地利中医药防治重大感染性疾病“一带一路”联合实验室建设与联合研究项目(2020YFE0205100)。

摘　　要：目的建立符合《德国药品法典》(DPC)要求的南葶苈子质量标准体系,并比较DPC与《中华人民共和国药典》关于中药材质量标准体系建立规定的异同点。方法依据DPC相关要求,并借鉴《中华人民共和国药典》方法,观察30批南葶苈子药材的外观性状和显微特征,测定其干燥失重、总灰分和酸不溶性灰分,以硅胶G薄层板为固定相,乙酸乙酯-甲酸-水(7∶1.5∶2.5,V/V/V)为展开剂,女贞苷和芦丁为系统适应性试验(SST)指标,槲皮素-3-O-β-D-葡萄糖-7-O-β-D-龙胆双糖苷和异鼠李素-3-O-β-D-葡萄糖-7-O-β-D-龙胆双糖苷为检测指标,建立南葶苈子的薄层色谱鉴别方法。以槲皮素-3-O-β-D-葡萄糖-7-O-β-D-龙胆双糖苷为检测指标,参考2020年版《中华人民共和国药典》建立南葶苈子药材含量测定方法。结果30批样品干燥失重为6.15%~12.0%,总灰分为3.17%~9.44%,酸不溶性灰分为0.14%~4.82%。女贞苷、芦丁分离度符合DPC关于薄层鉴别中SST指标的要求,所有批次样品中指标成分均获得了良好分离,该方法可有效区分南、北葶苈子。通过现代色谱和光谱技术,明确HPLC图上与待测成分(槲皮素-3-O-β-D-葡萄糖-7-O-β-D-龙胆双糖苷)相邻的色谱峰的结构为葶苈子酸酐B,所有批次样品中二者的分离度均>3.1,符合DPC关于含量测定SST指标的要求。方法学考察结果均符合含量测定要求,30批南葶苈子药材中槲皮素-3-O-β-D-葡萄糖-7-O-β-D-龙胆双糖苷含量为0.062%~0.125%。结论本文建立的南葶苈子质量标准体系完善,符合DPC要求,可用于南葶苈子的质量控制。Objective To establish a quality standard system for Descurainiae Semen under the requirements of German Pharmaceutical Codex(DPC);To compare the similarities and differences between DPC and the Pharmacopoeia of the People's Republic of China regarding the establishment of a quality standard system for TCM medicinal materials.Methods Based on the requirements of DPC,and referring to the relevant methods of Pharmacopoeia of the People's Republic of China,the quality of 30 batches of Descurainiae Semen samples were assessed by observing the appearance and microscopic characteristics and determining their loss on drying,total ash content,and ash insoluble in hydrochloric acid.A TLC identification method was established based on a silica gel G TLC plate,using a developing agent composed of ethyl acetate,formic acid,and water in the ratio of 7:1.5:2.5(V/V/V).The method utilized rutin and quercetin as indicators for the System Suitability Test(SST),and took quercetin-3-O-β-D-glucose-7-O-β-D-gentiobioside and isorhamnetin 3-O-β-D-glucose-7-O-β-D-gentiobioside as the index.Based on the content determination method for Descurainiae Semen in the Pharmacopoeia of the People's Republic of China,a content determination method was established with quercetin-3-O-β-D-glucose-7-O-β-D-gentiobioside as the index.Results The loss on drying for the 30 batches of samples ranged from 6.15%to 12.0%,with the total ash content ranged from 3.17%to 9.44%,and the ash insoluble in hydrochloric acid content ranged from 0.14%to 4.82%.The resolution of rutin and quercetin met the DPC's requirements for the SST criteria in TLC identification,and all batches of samples showed good separation of the index components.This method could effectively distinguish Descurainiae Semen from Lepidii Semen.Using modern chromatographic and spectroscopic techniques,the structure of the chromatographic peak adjacent to the component of the index(quercetin-3-O-β-D-glucoside-7-O-β-D-gentiobioside)was identified as descuraic anhydride B.The resolution betwee

关 键 词：含量测定(中药) 南葶苈子 《德国药品法典》 质量标准体系 薄层色谱鉴别 含量测定 

分 类 号：R28[医药卫生—中药学]