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目的建立小儿退热镇惊口服液的质量标准。方法采用TLC对方中知母、金银花、板蓝根进行定性鉴别;用HPLC法对绿原酸进行含量测定:色谱柱:Welchrom C_(18)(4.6 mm×250 mm,5μm),流动相:乙腈-0.4%磷酸溶液(10:90),流速为1.0 ml.min~(-1),检测波长为327 nm。结果薄层鉴别斑点清晰、分离较好,阴性对照无干扰;绿原酸的浓度在2~135μg·ml~(-1)范围内与峰面积呈良好的线性关系(r=0.9998),平均加样回收率为99.03%,RSD为2.81%(n=6)。结论所用定性与定量方法简便、专属性强,结果准确、可靠;所建标准可用于小儿退热镇惊口服液的质量控制。
Objective To establish the quality standard of oral antipyretic and anticonvulsant solution in children. Methods The contents of chlorogenic acid were determined by HPLC. The chromatographic column was Welchrom C_ (18) (4.6 mm × 250 mm, 5 μm). The mobile phase was acetonitrile-0.4 % Phosphoric acid solution (10:90) at a flow rate of 1.0 ml.min ~ (-1) at a detection wavelength of 327 nm. Results The TLC spots were clear, the separation was good and the negative control had no interference. The concentration of chlorogenic acid showed a good linear relationship with the peak area in the range of 2 ~ 135μg · ml ~ (-1) (r = 0.9998) The sample recovery was 99.03% with a RSD of 2.81% (n = 6). Conclusion The qualitative and quantitative methods used are simple, specific, accurate and reliable. The standards can be used for the quality control of antipyretic and oral liquid in children.