天麻蜜环菌质量标准的建立  

Establishment of Quality Standard for Armillariella mellea

作　　者：贺敬霞 党艳妮[1,2] 张笑笑 黄壮壮 王益民[2] 张鑫 陈衍斌 HE Jing-xia;DANG Yan-ni;ZHANG Xiao-xiao;HUANG Zhuang-zhuang;WANG Yi-min;ZHANG Xin;CHEN Yan-bin(Shaanxi Institute of International Trade&Commerce,Xianyang 712042,China;Shaanxi Buchang Pharmaceuticals Limited Company,Xi'an 710075,China)

机构地区：[1]陕西国际商贸学院,陕西咸阳712042 [2]陕西步长制药有限公司,陕西西安710075

出　　处：《中国现代中药》2022年第2期327-331,共5页Modern Chinese Medicine

基　　金：陕西省重点研发计划项目(2017ZDXM-SF-003)。

摘　　要：目的:建立天麻蜜环菌的质量标准。方法:采用薄层色谱法(TLC)建立天麻蜜环菌鉴别方法,按照《中华人民共和国药典》2020年版(四部)通则2331测定天麻蜜环菌中二氧化硫的残留量,并建立天麻蜜环菌中染料木素、麦角甾醇高效液相色谱法(HPLC)测定方法。结果:建立的TLC色谱图中,天麻蜜环菌样品与天麻蜜环菌对照药材在相同位置上显示相同颜色的斑点。3批天麻蜜环菌样品中二氧化硫残留量为9.477~15.905 mg·kg^(-1),均低于《日本药局方》第17版与《美国药典》43版要求。建立的天麻蜜环菌HPLC测定方法,染料木素、麦角甾醇线性关系良好(r分别为0.9995、0.9998),平均加样回收率分别为102.90%、101.29%,RSD均小于2%。结论:建立的天麻蜜环菌测定法具有方法简单、稳定性好、专属性强的优点,能够用于天麻蜜环菌质量评价。Objective:To establish the quality standard for Armillariella mellea.Methods:Thin-layer chromatography(TLC) was used to establish the identification method for A.mellea.According to the general rule 2331 of Chinese Pharmacopoeia(2020 edition),the sulfur dioxide in A.mellea was measured,and the high-performance liquid chromatography(HPLC) method for the determination of genistein and ergosterol was established.Results:In the TLC profile,A.mellea sample and the reference crude drug showed the same color spots at the same positions.The sulfur dioxide residue in three batches of A.mellea was 9.477-15.905 mg·kg^(-1),which was lower than the requirements in Japanese Pharmacopoeia 17^(th) edition and United States Pharmacopoeia 43^(th) edition.The established HPLC method for the determination of genistein and ergosterol in A.mellea showed a good linear relationship(r=0.999 5,0.999 8).The average recoveries were 102.90% and 101.29%,respectively,with RSDs<2%.Conclusion:The established method is simple,stable,and specific,which can be used for quality evaluation of A.mellea.

关 键 词：天麻蜜环菌 薄层色谱法 二氧化硫 染料木素 麦角甾醇 质量标准 

分 类 号：R282.71[医药卫生—中药学]