咳喘定口服液的质量控制

Quality Control of Kechuanding Oral Liquid

目的制订咳喘定口服液的质量控制方法。方法采用薄层色谱法对处方中的金银花、板蓝根、桔梗进行定性鉴别,采用高效液相色谱法测定制剂中绿原酸的含量。结果各品种的薄层色谱特征明显,专属性强;绿原酸进样量在0.201 6～2.016 0μg范围内与峰面积呈现良好的线性关系(r=0.999 9),平均回收率为99.79%,RSD为0.25%(n=6)。结论所建立的方法简便、快捷、准确,能有效地控制该制剂的质量。

Objective To establish the quality control method of Kechuanding Oral Liquid. Methods The thin layer chromatography （TLC） method was used to perform the qualitative identification on honeysuckle, indigowoad root and balloonflower. The HPLC method was adopted to determine the content of chlorogenic acid. Results The TLC features of various medicinal materials were apparent with strong specificity. Chlorogenic acid in sample showed the good linear relationship during the range of 0. 201 6 - 2.016 0 μg （ r = 0. 999 9）, and the average recovery rate was 99.79%, RSD =0.25% （n =6）. Conclusion The established method is simple, rapid, accurate and can effectively control the quality of this praparation.