滋阴扶阳丸质量标准的研究  

Quality Standards for Ziyinfuyang Pills

作　　者：刘娟[1,2] 胡春晓[1,2] 庞建云[1,2] 刘肖[1,2] 沈成英[1] 钟芮娜 李仙义[3] 袁海龙 LIU Juan;HU Chun-xiao;PANG Jian-yun;LIU Xiao;SHEN Cheng-ying;ZHONG Rui-na;LI Xian-yi;YUAN Hai-long(Air Force General Hospital,Beijing Traditional Chinese Medicine,Chengdu 100142,China;College of Pharmacy,C 611137,China;Institute for Drug and hengdu University of Instrument Control of Directorate of Medical Services, Logistics Support Department, Central Military Commission of PRC,Beijing 100166,China)

机构地区：[1]空军总医院药学部,北京100142 [2]成都中医药大学,四川成都611137 [3]中央军委后勤保障部卫生局药品仪器检验所,北京100166

出　　处：《解放军药学学报》2018年第2期137-139,共3页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：军队医疗机构制剂标准研究科研课题;No.2014ZX09J14106-01A

摘　　要：目的建立滋阴扶阳丸的质量标准。方法采用显微鉴别法对滋阴扶阳丸中茯苓、甘草进行显微鉴别;TLC法对白术定性鉴别;HPLC-ELSD法测定制剂中黄芪含量。采用Inertsil ODS-3色谱柱(250 mm×4.6 mm,5μm),流动相为甲醇-水(71∶29),流速:1.0ml·min^(-1)。结果茯苓、甘草的显微鉴别方法简捷、快速;白术TLC鉴别阴性无干扰;黄芪甲苷在0.5~2.0μg(r=0.9985)范围内线性关系良好,平均加样回收率为101.31%,RSD为2.88%(n=6)。结论本研究建立的方法结果准确,重复性好,专属性强,可用于该制剂的质量控制。Objective To establish a quality standard for Ziyinfuyangpills.Methods Poria cocos and Glycyrrhizae Radix et rhizome were identified by microscopy.TLC was used to qualitatively identify Atractylodis Macrocephalae Rhizoma,and the content of astragaloside IV in Astragali Radix was determined by HPLC-ELSD.The chromatographic conditions of astragaloside IV involved Inertsil ODS-3（250 mm×4.6 mm,5μm）column with methanol-water acid solution（71∶29）as the mobile phase at a flow rate of 1.0 ml·min^-1.Results The microscopic identification method was simple and fast.There was no negative interference in TLC.Astragaloside Ⅳ showed a good linear relationship in the range of 0.5-2.0μg（r =0.9985）,with an average recovery of 101.31%（RSD=2.88,n =6）.Conclusion This method is accurate,reliable and stable,which can be applied to quality control of Ziyinfuyangpills.

关 键 词：滋阴扶阳丸 质量标准 显微鉴别 黄芪甲苷 

分 类 号：R927.2[医药卫生—药学]