百年康口服液的质量控制标准

Standard of Quality Controlof Bainiankang Oral Liquid

目的制定百年康口服液的质量控制标准。方法采用薄层色谱(TLC)法对处方中的橙皮苷和酸枣仁皂苷进行定性鉴别。采用高效液相色谱(HPLC)法测定橙皮苷的含量,色谱柱为YMCC18(150mm×4.6mm,5μm),流动相为甲醇-乙酸-水(35:4:61),流速为1.0mL.min-1,检测波长为285nm。结果在TLC色谱中能检出橙皮苷和酸枣仁皂苷,橙皮苷在10～100μg.mL-1浓围内线性关系良好(r=0.9993),平均回收率为101.49%,RSD为1.81%。结论本方法可以快速、准确、简便地对百年康口服液进行定性、定量检测,可以用于该制剂的质量控制。

OBJECTIVE To establish the quality standard of Bainiankang oral liquid.METHODS TLC was used for the identification of hesperidin and jujuboside.HPLC was conducted with a YMC C18(150 mm×4.6 mm,5 μm)column,methanol-acetic acid-water(35:4:61) as mobile phase,flow rate was 1.0 mL·min-1,a detecting wavelength was at 285 nm.RESULTS Hesperidin and jujuboside could be detected by TLC.Hesperidin had a good linear relationship within the concentration range of 10～100 μg·mL-1,r=0.999 3,the average recovery was 101.49%,and the RSD was 1.81%.CONCLUSION This method is simple,the result is accurate,reliable with a good reproducibility.So this method can be used for quality control of Bainiankang oral liquid.