六神软膏质量控制标准研究

Study on the quality control standard of Liushen ointment

目的:建立六神软膏的质量标准。方法:采用薄层色谱法对制剂中的麝香、牛黄、蟾酥进行定性鉴别;采用HPLC-ELSD法测定制剂中胆酸的含量,色谱条件:Alltima C18柱(4.6mm×250mm,5μm),以乙腈-0.3%醋酸水溶液(45∶55)为流动相,流速1.0mL·min-1,柱温35℃,ELSD漂移管温度95℃,载气流量2.5L·min-1,进样量20μL,以外标两点对数方程计算样品的含量。结果:TLC色谱中能检出麝香、牛黄、蟾酥;HPLC含量测定中,胆酸在1.022～40.880μg之间呈良好的线性关系,r=0.9994,平均回收率为98.8%,RSD(n=6)为1.6%。结论:本方法可准确地进行定性、定量,可用于控制六神软膏的质量。

Objective：To establish the quality standard of Liushen ointment composed of Moschus,Calculus Bovis,Venenum Bufonis.Methods：The quality of each raw material was identified by TLC.The quantity of the preparation was conducted by HPLC-ELSD and the method was developed with the condition as follows：Alltima C18（4.6 mm×250 mm,5 μm）,mobile phase acetonitrile-0.3% acetic acid（45∶55）,flow rate of 1.0 mL·min-1,the temperature of column 35 ℃,the temperature of evaporator tube 95 ℃,carrier gas flow of 2.5 L·min-1,the injection volume was 20 μL,calculating the content with logarithmic equation of external standard.Result：Moschus,Calculus Bovis and Venenum Bufonis could be detected by TLC.Cholic acid showed a good linear relationship in a range of 1.022-40.880 μg（r=0.9994）.The average recovery was 98.8%,and RSD（n=6）was 1.6%.Conclusion：This method is simple,reliable,accurate,and can be used to control the quality of Liushen ointment.