咳速停口服液质量标准研究

目的:建立咳速停口服液的质量标准。方法:采用薄层色谱法对麻黄、桑叶、甘草进行定性鉴别;采用高效液相色谱法对黄芩苷进行含量测定:色谱柱为Spherigel ODS C18(250mm×4.6mm,5μm),流动相为甲醇-0.4%磷酸(52∶48),检测波长为280nm,流速为1.0mL·min-1。结果:麻黄、桑叶、甘草的特征斑点明显,可用于定性鉴别;黄芪苷的进样量在0.24~1.20μg范围内与峰面积积分值呈良好的线性关系(r=0.9998),平均回收率为98.72%,RSD=1.02%(n=6)。结论:所建标准可用于咳速停口服液的质量控制。

Quality Criteria of Kesuting Oral Liquid

OBJECTIVE： To establish the quality criteria of Kesuting oral liquid. METHODS： Qualitative identification of Herba Ephedrae, Folium Mori and Radix Et Rhizoma Glycyrrhizae was conducted using TLC method, The content of Baicalin was determined by HPLC in which the chromatographic separation was performed on Spherigel ODS C18（250mm × 4.6mm, 5μm） column with mobile phase consisted of methanol- 0.4%phosphate solvent（52 ： 48） at a flow rate of 1.0 mL . min^-1. The UV wavelength was set at 280 nm. RESULTS： The TLC spots of Herba Ephedrae, Folium Mori and Radix Et Rhizoma Glycyrrhizae were characteristic and obvious, and which can be used for qualitative identification. The linear range of Baicalin was 0.24- 1.20 μg （ r = 0.999 8） with a mean recovery rate of 98.72% （RSD = 1.02%, n = 6） . CONCLUSION ： The establish criteria are suitable for the quality control of Kesuting oral liquid.