摘要
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 for Xiao’er Moji Tablets （XMTs）. Methods Glycyrrhizae Radix and Magnoliae Officinalis Cortex were identified by TLC. Hesperidin was determined by HPLC. The chromatographic column was a Dikma-C18 column （250 mm × 4.6 mm, 5 μm） with a mobile phase of acetonitrile-0.1% phosphoric acid solution （45：55）. The flow rate was 1.0 mL/min; The detective wavelength was set at 283 nm. Results TLC spots developed were fairly clear and the negative sample showed no interference. The calibration curve was linear within range of 0.044-0.264 μg （r = 0.999 7）. The average recovery was 98.90%, RSD was 1.49% （n = 6）. Conclusion The method is accurate, sensitive, and specific. It could be used for the quality control of XMTs.
出处
《药物评价研究》
CAS
2011年第6期439-441,共3页
Drug Evaluation Research
