知母药材及生饮片质量标准提升研究  

Improvement researches on quality standard of Anemarrhenae Rhizoma and its raw processed products

作　　者：黄琪 邵志愿 吴德玲 彭代银 金传山 张启岭 马凯 HUANG Qi;SHAO Zhi-yuan;WU De-ling;PENG Dai-yin;JIN Chuan-shan;ZHANG Qi-ling;MA Kai(College of Pharmacy,Anhui University of Chinese Medicine,Hefei 230012,China;Anhui Province Key Laboratory of Traditional Chinese Medicine Decoction Pieces of New Manufacturing Technology,Heifei 230012,China;Anhui Guangyintang Traditional Chinese Medicine Company,Bozhou 236800,China;Bozhou Yonggang Traditional Chinese Medicine Company,Bozhou 236800,China)

机构地区：[1]安徽中医药大学药学院,安徽合肥230012 [2]中药饮片制造新技术安徽省重点实验室,安徽合肥230012 [3]安徽广印堂中药股份有限公司,安徽亳州236800 [4]亳州市永刚饮片厂有限公司,安徽亳州236800

出　　处：《中国中药杂志》2020年第23期5701-5711,共11页China Journal of Chinese Materia Medica

基　　金：国家重点研发计划项目(2018YFC1707004);国家中药标准化建设项目(ZYBZH-Y-AH-02);安徽省高校科研创新平台团队建设项目(2015TD035);2015年度中医药行业科研专项(201507002-18);2019年度安徽省自然科学基金项目(1908085QH372)。

摘　　要：完善知母药材和生饮片质量标准,为其质量标准的修订提供科学依据。以知母皂苷BⅡ、知母皂苷AⅢ为指标性成分,采用硅胶G薄层色谱法进行检识;以新芒果苷和芒果苷为指标性成分,采用聚酰胺薄层色谱法进行检识。以HPLC-ELSD对知母皂苷BⅡ、知母皂苷AⅢ进行含量测定,以HPLC-UV对新芒果苷、芒果苷、异芒果苷进行含量测定。根据2015年版《中国药典》对知母药材和生饮片的水分、总灰分、酸不溶性灰分进行测定;以80%乙醇为溶剂进行浸出物含量测定,以HPLC-ELSD和HPLC-UV建立指纹图谱。结果表明,所建立的薄层色谱法、HPLC-ELSD、HPLC-UV含量测定法稳定可行,HPLC-ELSD指纹图谱指认2个色谱峰、HPLC-UV指纹图谱指认3个色谱峰,该方法专属性强,可从整体上对知母药材和生饮片进行鉴别和质量控制。与2015年版《中国药典》相比,该文修订了知母薄层鉴别和含量测定项,增加了浸出物及HPLC指纹图谱项,可为知母药材和生饮片的质量控制提供科学依据。This study is to improve the quality standard and supply the scientific basis for Anemarrhenae Rhizoma and its raw processed products.Steroidal saponin including timosaponin BⅡ,timosaponin AⅢ and flavonoids including neomangiferin and mangiferin were selected as the indicative components.Silica gel G thin layer chromatography(TLC)and polyamide TLC were used to detect the two types of compounds,respectively.The contents of timosaponin BⅡ and timosaponin AⅢ were determined by HPLC-ELSD and the content of neomangiferin,mangiferin and isomangiferin were determined by HPLC-UV.Moisture,total ash and acid insoluble ash were determined according to Chinese Pharmacopoeia(2015 edition).And 80% ethanol was selected as the solvent and the content determination of total extract were determined.The fingerprints of Anemarrhenae Rhizoma and its raw processed products were established by HPLC-UV and HPLC-ELSD.The results showed that the methods of TLC and HPLC have been successfully stablished.There are 2 and 3 peaks which have been identified by HPLC-ELSD and HPLC-UV,respectively.The HPLC fingerprint methods are specific and can be used to identify and quality control for Anemarrhenae Rhizoma and its raw processed products in the mass.Comparing to Chinese Pharmacopoeia(2015 edition),the TLC identification and content determination were revised and the total extract determination and HPLC fingerprints were added in the present study.Our results can be used as the scientific basis of quqlity control for Anemarrhenae Rhizoma and its raw processed products.

关 键 词：知母 薄层鉴别 含量测定 指纹图谱 质量标准 

分 类 号：R284.1[医药卫生—中药学]