妇炎平胶囊质量标准考察  

Research on Quality Standard of Fuyanping Capsule

作　　者：张亚双[1] 

机构地区：[1]苏州药品检验所,江苏苏州215002

出　　处：《抗感染药学》2012年第1期44-46,共3页Anti-infection Pharmacy

摘　　要：目的：建立妇炎平胶囊中苦参、苦参碱、蛇床子、蛇床子素、苦木的薄层色谱（TLC）鉴别方法以及HPLC外标法测定蛇床子素的含量。方法：采用TURNER Kromalil C18柱（200mm×4.6mm;5μm）流动相为乙腈-水（65∶35）,检测波长322nm;经TLC阴性对照和阳性对照试验,确认方中苦参、苦木、蛇床子成分,并经提取后HPLC外标法测定蛇床子素含量。结果：蛇床子素对照品在0.002978~2.978μg/mL范围内呈良好的线性关系,平均加样回收率为97.38%,RSD=2.20%（n=6）;妇炎平胶囊中蛇床子素含量为3.482mg/g。结论：该方法操作简便易行、分离效果好,适用于妇炎平胶囊质量控制。Objective： To establish a method for differentiating Sophorae flavescentis radix, matrine, Cnidii frucrus, osthole and Picrasmae ramulus et folium by TLC and to detect the osthole in Fuyangping capsule by HPLC. Methods： The analysis was performed on TURNER Kromalil C18 column（200 mm×4.6 mm,5 μm） with acetontrile- water（65：35） as mobile phase and the detection wavelength was at 322 nm; TLC was used with positive and negative control to verify the constituents of Sophorae flavescentis radix, Picrasmae ramulus et folium and Cnidii frucrus, Osthole was detected in Fuyangping capsule by HPLC. Results： The osthole had a good linear relationship between 0.002 978 and 2.978 μg/mL, The average recoveries were 97.38% and the RSD was 2.1%（n=6）. The content of osthole in Fuyangping capsule was 3.482 mg/g. Conclusion： This simple and rapid method with good separations can be used to control the quality of Fuyangping capsule.

关 键 词：妇炎平胶囊 高效液相色谱法 蛇床子素 

分 类 号：R927.11[医药卫生—药学]