尿毒营养合剂质量标准研究

Quality Standard of Niaodu Yingyang Mixture

目的建立尿毒营养合剂的质量标准。方法采用薄层色谱(TLC)法对制剂中的黄芪、茯苓、白术、山药进行定性鉴别;采用高效液相色谱(HPLC)法测定黄芪甲苷含量,色谱柱为Waters Symmetry C_(18)柱(150 mm×4.6 mm,5μm),流动相为乙腈-水(34∶66,V/V),流速为1 m L/min,检测器为蒸发光散射检测器(ELSD),柱温为30℃,漂移管温度为60℃。结果黄芪、茯苓、白术、山药的TLC图斑点清晰,分离度好,阴性对照无干扰。黄芪甲苷进样量在0.87~17.31μg范围内的自然对数值与峰面积自然对数值线性关系良好;精密度、稳定性、重复性试验的RSD均小于3.0%;平均加样回收率为105.28%,RSD为2.20%(n=6)。结论所建立的方法可用于尿毒营养合剂的质量控制。

Objective To establish the quality standard of Niaodu Yingyang Mixture.Methods Thin-layer chromatography(TLC)method was adopted for the qualitative identification of Radix Astragalus membranaceus,Poria cocos,Rhizoma Atractylodis macrocephalae and Rhizoma Dioscorea oppositifolia in Niaodu Yingyang Mixture.High-performance liquid chromatography(HPLC)method was adopted for the content determination of astragalosideⅣ,the chromatographic column was Waters Symmetry C18 column(150 mm×4.6 mm,5μm),the mobile phase was acetonitrile-water(34∶66,V/V),the flow rate was 1 m L/min,the detector was evaporative light scattering detector(ELSD),the column temperature was 30℃,and the drift tube temperature was 60℃.Results The TLC spots of Radix Astragalus membranaceus,Poria cocos,Rhizoma Atractylodis macrocephalae and Rhizoma Dioscorea oppositifolia were clear and well separated without negative interference.The linear range of astragelosideⅣwas 0.87-17.31μg.The RSDs of precision,stability and repeatability tests were less than 3.0%.The average recovery of astragalosideⅣwas 105.28%with RSD of 2.20%(n=6).Conclusion The established method can be used for the quality control of Niaodu Yingyang Mixture.