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作 者:王金淼[1,2] 池军 江雪 刘勇 李振国 许二平[1,2,3] 代丽萍[1,2,3] 王智民 WANG Jin-miao;CHI Jun;JIANG Xue;LIU Yong;LIU Zhen-guo;XU Er-ping;DAI Li-ping;WANG Zhi-min(Henan University of Chinese Medicine,Zhengzhou 450046,China;Engineering Technology Research Center for Comprehensive Development and Utilization of Authentic Medicinal Materials in Henan Province,Zhengzhou 450046,China;Henan Key Laboratory for Modern Research on Zhongjing's Herbal Formulae,Zhengzhou 450046,China;Henan Institute for Food and Drug Control,Zhengzhou 450012,China;Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China)
机构地区:[1]河南中医药大学,河南郑州450046 [2]河南省豫产道地药材综合开发利用工程技术研究中心,河南郑州450046 [3]河南省仲景方药重点实验室,河南郑州450046 [4]河南省食品药品检验所,河南郑州450012 [5]中国中医科学院中药研究所,北京100700
出 处:《中国中药杂志》2021年第17期4417-4423,共7页China Journal of Chinese Materia Medica
基 金:国家药典委员会国家药品标准提高项目(2019Z098)。
摘 要:针对皂角刺现行药典标准缺项问题,对皂角刺药材和饮片进行质量标准研究。采用薄层色谱法,建立以花旗松素对照品及皂角刺对照药材为对照的薄层鉴别方法;参照2020年版《中国药典》四部通则,对皂角刺药材和饮片的水分、总灰分、醇溶性浸出物进行测定;采用高效液相色谱法,以花旗松素为质控指标,建立皂角刺药材和饮片的含量测定方法。基于不同产地皂角刺药材及饮片各30批次样品的测定结果,撰写了皂角刺的质量标准草案,为《中国药典》皂角刺质量标准的修订提出建议。In view of the current inadequate standards for Gleditsiae Spina in the Chinese Pharmacopoeia,this study put forward some new items of the quality standards of Gleditsiae Spina.Thin-layer chromatography(TLC)was performed for identification with the reference substance of taxifolin and the reference material of Gleditsiae Spina as the control.According to the general principles of the Chinese Pharmacopoeia(2020 edition,Vol.4),the moisture,total ash content,and alcohol-soluble extract of medicinal materials and decoction pieces of Gleditsiae Spina were determined.The content determination method for medicinal materials and decoction pieces of Gleditsiae Spina was established using high-performance liquid chromatography(HPLC),with taxifolin as the quality control index.Based on the determination results of 30 batches of samples of Gleditsiae Spina from different habitats,the draft quality standards of Gleditsiae Spina were developed,which provided suggestions for the revision of the quality standards of Gleditsiae Spina in the Chinese Pharmacopoeia.
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