小儿参术健脾丸质量标准提升研究

Improvement of Quality Standard for Xiaoer Shenzhu Jianpi Pills

目的提升小儿参术健脾丸的质量标准。方法对制剂中茯苓、党参、山楂、白扁豆、甘草药材进行显微鉴别;采用薄层色谱(TLC)法对制剂中的白术、陈皮、山楂、甘草药材进行定性鉴别;采用高效液相色谱法测定制剂中橙皮苷的含量,色谱柱为Agilent Zor⁃bax SB-C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.2%磷酸水溶液(18∶82,V/V),流速为1.0 mL/min,检测波长为283 nm,柱温为30℃,进样量为10μL。结果茯苓、党参、山楂、白扁豆、甘草药材显微特征明显。白术、陈皮、山楂、甘草药材的TLC图斑点清晰,分离度高,阴性对照无干扰。橙皮苷质量浓度在4.8984~48.9842μg/mL范围内与峰面积线性关系良好(r=0.9999);精密度、稳定性、重复性试验结果的RSD均小于3.0%;平均加样回收率为99.69%,RSD为2.94%(n=9)。结论建立的质量标准可用于小儿参术健脾丸的质量控制。

Objective To improve the quality standard of Xiaoer Shenzhu Jianpi Pills.Methods Poria,Codonopsis Radix,Crataegi Fructus,Lablab Semen Album and Glycyrrhizae Radix et Rhizoma in the preparation were identified by the microscopic identification method.Atractylodis Macrocephalae Rhizoma,Citri Reticulatae Pericarpium,Crataegi Fructus and Glycyrrhizae Radix et Rhizoma in the preparation were qualitatively identified by the thin-layer chromatography(TLC)method.The content of hesperidin in the preparation was determined by the high-performance liquid chromatography(HPLC)method.The chromatographic column was Agilent Zorbax SB-C_(18) column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.2%phosphoric acid aqueous solution(18∶82,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 283 nm,the column temperature was 30℃,and the injection volume was 10μL.Results The microscopic characteristics of Poria,Codonopsis Radix,Crataegi Fructus,Lablab Semen Album and Glycyrrhizae Radix et Rhizoma were obvious.The TLC chromatograms of Atractylodis Macrocephalae Rhizoma,Citri Reticulatae Pericarpium,Crataegi Fructus and Glycyrrhizae Radix et Rhizoma had clear spots and good separation,with no interference from the negative reference.The linear range of hesperidin was 4.8984-48.9842μg/mL(r=0.9999).The RSDs of precision,stability and repeatability tests were all less than 3.0%.The average recovery rate of hesperidin was 99.69%,with an RSD of 2.94%(n=9).Conclusion The established quality standard can be used for the quality control of Xiaoer Shenzhu Jianpi Pills.