芪七连胶囊的质量标准研究  

Study on Quality Standard of Qiqilian Capsule

作　　者：陈壮[1] 岳桂华[2] 黄敏[1] 黄小鸥[1] 

机构地区：[1]广西中医学院附属瑞康医院,南宁530011 [2]广西中医学院,南宁530001

出　　处：《中国药房》2013年第27期2551-2553,共3页China Pharmacy

基　　金：广西壮族自治区中医药管理局中医药科技专项资助课题(No.GZYZ1109);广西科学研究与技术开发计划项目(No.桂科攻0993003A-15)

摘　　要：目的:建立芪七连胶囊的质量标准。方法:采用薄层色谱(TLC)法对芪七连胶囊中黄芪和三七进行定性鉴别;采用高效液相色谱-蒸发光散射检测器法测定制剂中黄芪甲苷的含量。结果:TLC定性鉴别方法专属性强,阴性对照无干扰。黄芪甲苷进样量在0.5295～4.2360μg范围内与其峰面积积分值呈良好的线性关系(r=0.9997);精密度、稳定性、重复性试验的RSD均<2%;平均加样回收率为99.34%,RSD=1.10%(n=6)。结论:所建标准可用于芪七连胶囊的质量控制。OBJECTIVE： To establish the quality standard for Qiqilian capsule. METHODS： TLC was used to identify Astragali Radix and Panax notoginseng. A HPLC-ELSD was used to measure the content of astragaloside Ⅳ in Qiqilian capsule. RESULTS： The qualitative identifications with TLC were specific without interference from negative control. The liner range of astragaloside Ⅳ were 0.529 5-4.236 0 μg（r=0.999 7） with average recovery of 99.34%（RSD=1.10%,n=6）. RSDs of precision, stability and reproducibility tests were all lower than 2%. CONCLUSIONS： Established standard can be adopted for the quality control of Qiqilian capsule.

关 键 词：芪七连胶囊 质量标准 薄层色谱法 高效液相色谱-蒸发光散射检测器法 黄芪甲苷 黄芪 三七 

分 类 号：R283.65[医药卫生—中药学] R917[医药卫生—中医学]