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双白片质量标准研究
引用本文:杨婉花,郝晓静,李娟,姚英,施惠娟,陈冰.双白片质量标准研究[J].中国药房,2010(27):2549-2551.
作者姓名:杨婉花  郝晓静  李娟  姚英  施惠娟  陈冰
作者单位:[1]上海交通大学医学院附属瑞金医院药剂科,上海市200025 [2]上海中医药大学,上海市200032 [3]上海上联药业有限公司,上海市201703
基金项目:上海市科研计划项目课题(08ZR141400)
摘    要:目的:建立双白片的质量标准。方法:采用薄层色谱(TLC)法鉴别双白片中黄芪、刺五加和芍药;采用高效液相色谱(HPLC)法测定双白片中芍药苷的含量。结果:双白片中黄芪、刺五加及芍药的TLC分别在与对照品色谱对应的位置上显相同颜色的斑点,专属性好。芍药苷进样浓度在3.20~64.00μg·mL-1范围内与峰面积积分值呈良好的线性关系(r=0.9993);平均回收率为99.12%,RSD=1.18%(n=6)。结论:所建标准可用于双白片的质量控制。

关 键 词:双白片  薄层色谱法  高效液相色谱法  质量标准

Study on Quality Standard of Shuangbai Tablets
YANG Wan-hua,LI Juan,CHEN Bing.Study on Quality Standard of Shuangbai Tablets[J].China Pharmacy,2010(27):2549-2551.
Authors:YANG Wan-hua  LI Juan  CHEN Bing
Institution:(Dept.of Pharmacy,Ruijin Hospital of Shanghai Jiaotong University Sch-ool of Medicine,Shanghai 200025,China)HAO Xiao-jing(Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China)YAO Ying,SHI Hui-juan(Shanghai Shanglian Pharmaceutical Co.,Ltd.,Shanghai 201703,China)
Abstract:OBJECTIVE:To establish quality standards of Shuangbai tablet.METHODS:Identification of Astragalus membranaceus,Acanthopanax senticosus and Paeoniae lactiflora was carried out by TLC.The content of paeoniflorin in Shuangbai tablet was determined by HPLC.RESULTS:The TLC spots of A.membranaceus,A.senticosus and P.lactiflora were same to some TLC spots of reference substance.TLC spots were specific.The linear range of paeoniflorin were 3.20-64.00 μg·mL^-1(r=0.999 3) with an average recovery of 99.12%(RSD=1.18%,n=6).CONCLUSION:Established standard can be used for the quality control of Shuangbai tablets.
Keywords:Shuangbai tablet  TLC  HPLC  Quality standard
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