三康胶囊质量标准的提高  

Studies on Quality Standards of Sankang Capsules

作　　者：涂宏海[1] 贾正平[2] 兰建国[1] 盛杰[2] 耿东升[1] 李茂星[2] 王超[1] 

机构地区：[1]新疆军区药品仪器检验所,新疆乌鲁木齐830063 [2]兰州军区总医院药材科,甘肃兰州730050

出　　处：《解放军药学学报》2010年第5期430-433,共4页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：全军医学科学技术研究"十一五"计划重大专项课题项目;No.06D005-5

摘　　要：目的建立三康胶囊的质量标准。方法采用显微鉴别法对鹿茸、鸡内金、白术、人参鉴别;采用薄层色谱鉴别法对黄芪、当归、枸杞子、黄连、淫羊藿、人参、三七、女贞子等进行鉴别;采用高效液相色谱法测定黄芪中黄芪甲苷含量,以十八烷基硅烷键合硅胶为填充剂;以乙腈-水(36:64)为流动相;蒸发光散射检测器检测。结果显微鉴别法和薄层色谱鉴别法定性鉴别方法专属性强。黄芪甲苷在0.4455～4.455μg范围内呈良好的线性关系(r=0.9996)。平均回收率为95.76%,RSD为2.2%,三康胶囊中黄芪甲苷平均含量为0.1524mg/粒。结论方法精密度好、专属性、重复性较强,结果可靠,能够有效控制三康胶囊质量标准。Objective To establish a quality control standard for Sankang Capsules.Methods Cornu Cervi pantotrichum,corium stomachium galli,Atractylodes macrocephala,ginseng were identified by Micro-distinguish;Radix Astragali,Radix Angelicae Sinensis,Lycium chinense Mill.,Rhizoma Coptidis,Herba Epimedii,Radix Ginseng,Radix Notoginseng,Fructus Ligustri Lucidi were identified by thin layer chromatography and Astragaloside was determined by high performance liquid chromatography.C18 column was used as the chromatographic column and acetonitrile-water（36：64） was used as the mobile phase.The evaporation light scattering detector was used for detection.Results The qualitative identifications with Micro-distinguish and thin layer chromatography were specific.The linear range of astragaloside Ⅳ was 0.4455-4.455 μg（r=0.9996）.The average recovery was 95.76%,RSD was 2.2%.The content of astragaloside Ⅳ in Sankang Capsules was 0.1524 mg/pill.Conclusion This method is precise,accuracy,specific and reproducible.The result is reliable and could be used to control the quality of Sankang Capsules.

关 键 词：三康胶囊 黄芪甲苷 高效液相色谱法 显微鉴别 薄层色谱鉴别 含量测定 

分 类 号：R917[医药卫生—药物分析学]