妇舒康洗液质量标准研究

Study on quality standard of Fushukang Lotion(妇舒康洗液)

目的建立妇舒康洗液的质量标准。方法采用薄层色谱(TLC)法定性鉴别妇舒康洗液中的百部、苍术、冰片、蒲公英;采用高效液相色谱(HPLC)法测定妇舒康洗液中蛇床子素、盐酸小檗碱的含量,色谱柱为Thermo C_(18)(250.0 mm×4.6 mm,5.0μm),流动相为乙腈-0.02 moL/L KH2PO4溶液,柱温40℃,流速1.0 mL/min,梯度洗脱,检测波长323 nm,进样量10μL。结果百部、冰片、苍术、蒲公英的TLC鉴别专属性强,且阴性无干扰。盐酸小檗碱、蛇床子素的回归方程分别为Y=0.0614X-0.6009(r=0.9997),Y=0.0623X-1.2717(r=0.9996),线性范围分别为20.52~205.20,34.84~348.40 ng;平均加样回收率分别为99.41%,99.37%(n=9),RSD分别为1.16%,1.02%。结论该方法简便易操作,重复性好,可用于妇舒康洗液的质量控制。

Objective To establish the quality control standard of Fushukang Lotion(妇舒康洗液).Methods Thin layer chromatography(TLC)method was used to qualitatively identify Radix Stemonae,Atractylodes Lancea,Borneolum Syntheticum,Taraxacum Mongolicum in Fu shukang Lotion.High performance liquid chromatography(HPLC)method was used to determine the content of Fructus Cnidii and Berberine hydrochloride.The chromatography column was Thermo C_(18)(250.0 mm×4.6 mm,5.0μm).The mobile phase is acetonitrile-0.02 mol/L KH2PO4 solution,with a column temperature of 40℃,a flow rate of 1.0 mL/min,gradient elution,detection wavelength of 323 nm,and injetion vulume of 10μL.Results The TLC spots of Radix Stemonae,Atractylodes Lancea,Borneolum Syntheticum,Taraxacum Mongolicum have good specificity and no interference.The regression equations of Berberine hydrochloride and Fructus Cnidii were Y=0.0614X-0.6009(r=0.9997),Y=0.0623X-1.2717(r=0.9996),respectively,The average recoveries were 99.41%and 99.37%(n=9),with RSD were 1.16%and 1.02%,respectively.The linear relationship were good in 20.52 to 205.20,34.84 to 348.40 ng,respectively,with RSD of 1.16%,1.02%.Conclusion The method is simple,easy to operate and repeatable,and can be used for the quality control of Fushukang Lotion.