中国现代中药2018，Vol.20Issue(5)：616-621,6.DOI:10.13313/j.issn.1673-4890.20170918005
艾附暖宫软胶囊的质量标准研究
Study on Quality Standard of Aifu Nuangong Soft Capsules
摘要
Abstract
Objective:To establish a simple quality control method to ensure the safety,efficacy and stability of Aifu Nuangong soft Capsule.Methods:TLC was used to analyze qualitatively 6 kinds of Chinese herbs(Radix Angelicae Sinensis, Rhizome Chuanxiong,Fructus Evodiae,Radix Astragali,Radix Dipsaci and Radix Paeoniae Alba)in the prescription.A HPLC method was used to study quantitatively paeoniflorin and asperosaponin VI in the preparation.The determination of paeon-iflorin was carried out by using Venusil XBP C18(250 mm×4.6 mm,5 μm)as an analytical column and acetonitrile-0.1%phosphoric acid(14:86,V/V)as a mobile phase at a flow rate of 1.0 mL·min-1,and the detection wavelength was set at 230 nm.The determination of asperosaponin VI was carried out by using ZORBAX SB-C18(250 mm×4.6 mm,5 μm)as an analyt-ic column and acetonitrile-water(28:72,V/V)as a mobile phase at a flow rate of 1.0 mL·min-1,and the detection wave-length was set at 212 nm.Results:Characteristic spots of TLC were clear with strong specificity and the negative test showed no interference.There was a good linear relationship for paeoniflorin in the range of 0.141 1-2.822 7 μg and the recovery was 99.19%(RSD=1.91%).There was a good linear relationship for asperosaponin VI in the range of 0.304 6-6.092 5μg and the recovery was 99.65%(RSD=1.00%).Conclusion:The quality standard is reasonable and can be used for the quality control of Aifu Nuangong soft Capsule.关键词
艾附暖宫软胶囊/薄层色谱法/高效液相色谱法/质量标准Key words
Aifu Nuangong soft Capsule/TLC/HPLC/quality standard引用本文复制引用
王健,蒋亚南,李逢春,杨海燕,宋汉敏,李振国..艾附暖宫软胶囊的质量标准研究[J].中国现代中药,2018,20(5):616-621,6.基金项目
河南省科技攻关项目(152102310131) （152102310131）
