房蕴歌;朱厚达;刘晓谦;陈两绵;孟辰笑凝;张东;高慧敏;王智民;
FANG Yun-ge;ZHU Hou-da;LIU Xiao-qian;CHEN Liang-mian;MENG Chen-xiao-ning;ZHANG Dong;GAO Hui-min;WANG Zhi-min;Tianjin University of Traditional Chinese Medicine;National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicine, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences;College of Pharmacy, Henan University of Chinese Medicine;

• 1:天津中医药大学
• 2:中国中医科学院中药研究所中药质量控制技术国家工程实验室
• 3:河南中医药大学药学院

摘要(Abstract)：

苦参为豆科植物苦参Sophora flavescens的干燥根。苦参药效物质基础的深入研究使其质量标准的完善和提高成为可能。该研究采用硅胶GF_(254)薄层板,三氯甲烷-甲醇-水-甲酸(4∶2∶1∶0.6)的下层溶液为展开剂以及不同的检视方法,建立了以苦参对照药材为对照的主要黄酮和生物碱共薄层的定性鉴别方法。修订【含量测定】分析方法,包括简化供试品溶液的制备方法,更改氨基柱为十八烷基硅烷键合硅胶柱;并将该方法与《中国药典》2015年版方法进行对比分析;在此基础上,测定了32批苦参饮片中4种生物碱的含量,结果表明32批样品全部符合《中国药典》2015年版苦参饮片标准,不同样品中含氧化苦参碱和苦参碱之和在1.08%～2.55%,氧化槐果碱和槐果碱之和在0.369%～0.860%,4种成分总量在1.67%～3.40%;统计学表明氧化苦参碱与氧化槐果碱、氧化苦参碱和苦参碱总量与氧化槐果碱+槐果碱总量分别呈显著性正相关。参照《中国药典》2015年版四部通则相关方法测定了32批样品的水分和浸出物,12批样品中13种有机氯类农药残留量,结果表明所有测试样品水分和浸出物合格,未检出测定的13种农药。该研究为修订《中国药典》2020年版苦参药材和饮片的质量标准提供了参考。
Sophorae Flavescentis Radix is prepared from the root of Sophora flavescens. The comprehensive knowledge of the effective components in S. flavescens makes its quality standard improvement more possible. TLC identification method for main flavonoids and alkaloids in one test was established using GF_(254) thin layer plate and the lower solution of chloroform-methanol-water-formic acid(4∶2∶1∶0.6) as developing solvent. The quantitative method of marker alkaloids was revised including the simplified sample preparation procedure and the chromatographic conditions. The determination of four alkaloids in the samples indicated that 32 batches of tested samples were qualified ones. The total oxymatrine and matrine, total oxysophocarpine and sophocarpine, as well as total amount of four tested components in the different samples were 1.08%-2.55%, 0.369%-0.860%, 1.67%-3.40%, respectively. There was a significantly positive correlation between oxymatrine and oxysophocarpine. Total oxymatrine and matrine had same correlation with total oxysophocarpine and sophocarpine. The moisture content and extractive in 32 batches of samples fulfilled the require of not more than 11.0% and not less than 20.0%, respectively. Thirteen tested pesticides were not detected in 12 batches of samples. The present study provided the evidence for the revision of quality standard of Sophora Flavescentis Radix.

关键词(KeyWords)： 苦参;生物碱;黄酮;薄层鉴别;含量测定;质量标准
Sophorae Flavescentis Radix;alkaloids;flavonoids;TLC identification;content determination;quality standard

Abstract:

Keywords:

基金项目(Foundation): 国家重点研发计划“中医药现代化研究”项目(2017YFC1701900);; 国家中药标准化项目(ZYBZH-Y-JIN-34);; 国家药典委员会2018年度药品标准提高项目(2018Z064)

作者(Author): 房蕴歌;朱厚达;刘晓谦;陈两绵;孟辰笑凝;张东;高慧敏;王智民;
FANG Yun-ge;ZHU Hou-da;LIU Xiao-qian;CHEN Liang-mian;MENG Chen-xiao-ning;ZHANG Dong;GAO Hui-min;WANG Zhi-min;Tianjin University of Traditional Chinese Medicine;National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicine, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences;College of Pharmacy, Henan University of Chinese Medicine;

Email:

DOI: 10.19540/j.cnki.cjcmm.20200314.201

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