复方首乌补液质量标准提升研究  

Quality Standard Improvement of Compound Shouwu Fluid Infusion

作　　者：余平 范晓磊 李恒 陆海涛 YU Ping;FAN Xiaolei;LI Heng;LU Haitao(Wuhan Institute for Drug and Medical Device Control,Wuhan,Hubei,China 430075)

机构地区：[1]湖北省武汉药品医疗器械检验所,湖北武汉430075

出　　处：《中国药业》2025年第7期69-72,共4页China Pharmaceuticals

基　　金：2022年度国家药品标准制修订研究课题[2022Z007]。

摘　　要：目的提升复方首乌补液的质量标准。方法采用薄层色谱法对制剂中黄芪、五味子进行定性鉴别;采用高效液相色谱法测定制剂中2,3,5,4'-四羟基二苯乙烯-2-O-β-D-葡萄糖苷的含量,色谱柱为GL Science Inc ODS-C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-水(20︰80,V/V),流速为1.0 mL/min,柱温为30℃,检测波长为320 nm,进样量为10μL。结果黄芪、五味子的薄层色谱斑点显色清晰,且阴性对照无干扰。2,3,5,4'-四羟基二苯乙烯-2-O-β-D-葡萄糖苷的质量浓度在3.428~171.398μg/mL范围内与峰面积积分值线性关系良好(r=1.0000,n=6);精密度、稳定性、重复性试验结果的RSD均低于2.0%;平均加样回收率为99.70%,RSD为1.06%(n=18)。样品中2,3,5,4'-四羟基二苯乙烯-2-O-β-D-葡萄糖苷的含量为0.208~0.642 mg/mL(n=9)。结论该方法操作简便,专属性、重复性均良好,结果准确,可用于复方首乌补液的质量控制。Objective To improve the quality standard of Compound Shouwu Fluid Infusion.Methods Thin-layer chromatography(TLC)method was used for the qualitative identification of Astragali Radix and Schisandrae Chinensis Fructus in the preparation.High-performance liquid chromatography(HPLC)method was used for content determination of 2,3,5,4'-tetrahydroxyl diphenylethylene-2-O-β-D-glucoside in the preparation,the chromatographic column was GL Science Inc ODS-C_(18) column(250 mm×4.6 mm,5µm),the mobile phase was acetonitrile-water(20∶80,V/V),the flow rate was 1 mL/min,the column temperature was 30℃,the detection wavelength was 320 nm,and the injection volume was 10µL.Results The TLC spots of Astragali Radix and Schisandrae Chinensis Fructus were clear and the negative control had no interference.The linear range of 2,3,5,4'-tetrahydroxyl diphenylethylene-2-O-β-D-glucoside was 3.428-171.398µg/mL(r=1.0000,n=6).The RSDs of precision,stability,and repeatability test results were all lower than 2.0%.The average recovery of 2,3,5,4'-tetrahydroxyl diphenylethylene-2-O-β-D-glucoside was 99.70%with an RSD of 1.06%(n=18).The content of 2,3,5,4'-tetrahydroxyl diphenylethylene-2-O-β-D-glucoside in the sample was 0.208-0.642 mg/mL(n=9).Conclusion The method is simple,specific,reproducible,and accurate,which can be used for the quality control of Compound Shouwu Fluid Infusion.

关 键 词：复方首乌补液 薄层色谱法 高效液相色谱法 黄芪 五味子 2 3 5 4'-四羟基二苯乙烯-2-O-β-D-葡萄糖苷 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学] R286.0