解肌宁嗽口服液质量标准提升研究

Study on the improvement of quality standard of Jiejingningsou Oral Liquid

目的为提升解肌宁嗽口服液质量标准,建立高效液相色谱法测定解肌宁嗽口服液中葛根素含量的方法。方法采用高效液相色谱法。色谱柱为Agilent Zorbax Eclipse plus C 18(4.6 mm×250 mm,5μm),流动相为甲醇-0.1%柠檬酸溶液(25∶75,V/V),流速为1.0 mL·min^-1,检测波长为250 nm,柱温为30℃,进样量为10μL。结果葛根素的进样量在0.036 8~0.368 4μg范围内与相应峰面积呈良好的线性关系;精密度、稳定性、重复性试验的RSD均≤2.0%;平均加样回收率为100.0%,RSD为0.8%(n=6)。结论本法简便、快速、结果准确、重复性好,可用于解肌宁嗽口服液的质量控制。

Objective To improve the quality standard of Jiejingningsou Oral Liquid,and establish an HPLC method for the determination of puerarin in Jiejiningsou Oral Liquid.Methods The analysis was performed on Agilent Zorbax Eclipse plus C 18(4.6 mm×250 mm,5μm)with column temperature 30℃.The mobile phase was composed of methanol and 0.1%citric acid solution(25∶75,V/V)with a rate of 1 mL·min^-1.The detection wavelength was 250 nm.The injection volume was 10μL.Results The linear range of puerarin was 0.036 8~0.368 4μg(R^2=1)and the average recovery of puerarin was 100.0%(RSD=0.8%).Conclusion The method was simple,fast and accurate with good repeatability.It was suitable for the determination of puerarin in Jiejiningsou Oral Liquids.