小儿健脾口服液的质量标准

Quality Standard for Xiaoer jianpi Oral Liquid

目的建立小儿健脾口服液的质量标准。方法采用TLC法鉴别白术、山楂,以HPLC测定橙皮苷的含量。结果TLC法可明显鉴别白术、山楂,橙皮苷在0.288～1.440μg内线性关系良好(r=0.9995),平均回收率为98.6%(RSD=1.03%,n=5)。结论方法简便、准确、稳定、重复性好,可用于该制剂的质量控制。

OBJECTIVE To establish a quality standard for Xiaoer jianpi oral liquid. METHODS The rhizoma atractylodix macrocephalae and fructus crataegi in Xiaoer jianpi oral liquid were identified by TLC, the content of aurantiamarin in Xiaoer jianpi oral liquid was determined by HPLC. RESULTS The rhizoma atractylodix macrocephalae and fructus crataegi could be identified by TLC, within the range of 0. 288 ～ 1. 440 μg, aurantiamarin assumed fine linear relation （ r = 0. 999 5 ）, the average recovery rate was 98.6%, RSD = 1.03%. CONCLUSION The method is simple, accurate and stable with fine reproducibility,it can be used in the quality control of the product.