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目的建立小儿磨积片的质量标准。方法采用薄层色谱法对制剂中甘草、厚朴进行定性鉴别;采用高效液相色谱法对橙皮苷进行定量测定。色谱柱为美国Dikma公司C18柱(250mm×4.6mm,5μm),以乙腈-0.4%磷酸溶液(45∶55)为流动相,体积流量1mL/min,检测波长283nm。结果薄层色谱鉴别斑点清晰,阴性样品无干扰;定量测定中橙皮苷进样量在0.044～0.264μg与峰面积线性关系良好(r=0.9997);平均回收率为98.90%,RSD为1.49%(n=6)。结论建立的方法操作简单,专属性和重现性好,可作为该制剂的质量控制方法。
Objective To establish the quality standard of children’s abrasive films. Methods TLC and HPLC were used to identify licorice and Magnolia officinalis. The content of hesperidin was determined by high performance liquid chromatography. The chromatographic column was a C18 column (250 mm × 4.6 mm, 5 μm) from Dikma Company of America. The mobile phase was acetonitrile-0.4% phosphoric acid solution (45:55). The volume flow rate was 1 mL / min and the detection wavelength was 283 nm. Results The results of TLC showed that the spots were clear and the negative samples had no interference. The quantitative determination of hesperidin showed a good linearity (r = 0.9997) between 0.044 ~ 0.264μg and peak area, the average recovery was 98.90% and the RSD was 1.49% (n = 6). Conclusion The established method is simple, specific and reproducible, and can be used as a quality control method.