人知降糖胶囊质量标准研究  

Study on Quality Standard of RenZhi Glucose-lowering Capsules

作　　者：陈衍斌[1,2] 方欢乐 卢新义[1,2] 刘峰[1,2] 马久太 

机构地区：[1]陕西国际商贸学院,陕西咸阳712000 [2]陕西步长制药有限公司 [3]西安培华学院医学院

出　　处：《西部中医药》2017年第12期13-16,共4页Western Journal of Traditional Chinese Medicine

基　　金：2011年陕西省高新技术产业发展专项资金投资计划项目(编号陕发改资[2011]1666号);陕西省重点研发计划一般项目(编号2017SF-324)

摘　　要：目的:对人知降糖胶囊的质量标准进行研究,建立TLC鉴别方法和菝葜皂苷元的含量测定方法。方法:以甲醇-水(94∶6)为流动相;流速:1.0 m L/min;采用蒸发光散射检测器:漂移管温度80℃,氮气流速每分钟1.7 L。结果:薄层鉴别系统分离度好,专属性强;菝葜皂苷元含量在0.3610~3.610μg范围内呈良好的线性关系,回归方程:Y=1.514 4X+5.088 3(r=0.999 8),平均加样回收率为100.15%,RSD为1.26%。结论:该质量标准分离效果好、专属性强、结果准确可靠,可以有效控制人知降糖胶囊质量。Objective:To study quality standard of RenZhi glucose-lowering capsules, establish TLC identification method and content determination methods for sarsasapogenin. Methods: Methanol-water(94:6) was selected as the mobile phase, flow rate: 1.0 m L/min; HPLC-ELSD was used; the temperature of drift tube was 80℃,nitrogen flow velocity was 1.7 L/min. Results: TLC identification system showed good separation effects and strong specificity, the contents of sarsasapogenin were in the good linear relationship ranged from 0.3610 to 3.610 μg,regression equation: Y=1.514 4 X+5.088 3(r=0.999 8), average recovery rate was 100.15%, RSD was 1.26%.Conclusion: The quality standard, showing good separation effects, strong specificity, accurate and reliable results,could effectively control the quality of RenZhi glucose-lowering capsules.

关 键 词：人知降糖胶囊 菝葜皂苷元 质量标准 

分 类 号：R284.1[医药卫生—中药学]