甘草浸膏胶囊质量标准的建立  

Establishment of Quality Standard for Extractum Glycyrrhizae Capsules

作　　者：马宏达[1] 吴琼[1] 王常丽[1] 胡北[1] 贾辉[1] Ma Hongda Wu Qiong Wang Changli Hu Bei Jia Hui(Department of Pharmacy, General Hospital of Shenyang Military Command Area, Shenyang 110016, China)

机构地区：[1]沈阳军区总医院药学部,沈阳110016

出　　处：《中国药师》2017年第9期1651-1653,共3页China Pharmacist

基　　金：军队医疗机构制剂标准提高科研专项课题(编号:13ZJZ02)

摘　　要：目的:建立甘草浸膏胶囊中两种有效成分质量控制标准。方法:采用TLC法对方中甘草进行鉴别;测定样品中甘草苷和甘草酸铵的含量。色谱条件:色谱柱为Inertsil C_(18)柱(150 mm×4.6 mm,5μm);流动相:乙腈(A)-0.2%磷酸(B)(0~8min:20%A^20%A;8~34 min:20%A^50%A;34~35 min:50%A^100%A;35~40 min:100%A^20%A);流速为1.0 ml·min^(-1);检测波长:237 nm;柱温:25℃。结果:薄层定性鉴别的斑点清晰,分离效果良好;甘草苷在0.002 0~0.100 0 mg·ml^(-1)浓度范围内线性关系良好(r=0.999 5),平均加样回收率为100.29%,RSD为2.94%(n=6);甘草酸铵在0.002 0~0.100 0 mg·ml^(-1)浓度范围内线性关系良好(r=0.999 8),平均加样回收率为101.46%,RSD为2.33%(n=6)。结论:所建立方法快速简便,重复性好,专属性强,可作为该制剂的质量控制方法。Objective ： To establish the quality standard for two effective components in extractum glycyrrhizae capsules. Methods ： Radix glycyrrhizae was identified by a TLC method. The contents of liquiritin and ammonium glycyrrhizinate in extractum glycyrrhizae capsules were determined by HPLC. An Inertsil C18 （ 150 mm×4.6 mm,5μm） column was used. The mobile phase consisted of acetonitrile （A）-0.2% phosphoric acid （B） （0-8 min： 20% A-20% A;8-34 min： 20% A-50% A;34-35 min： 50% A-100% A;35-40 min： 100% A-20% A） at a flow rate of 1.0 ml · min^-1. The detection wavelength was at 237 nm under 25℃. Results： The spots in TLC were clear. Liquiritin showed a good linear relationship within the range of 0. 002 0-0. 100 0 mg· ml^-1（ r = 0.999 5 ）. The aver- age recovery was 100.29% , and the RSD was 2.94% （n = 6）. Ammonium glycyrrhizinate showed a good linear relationship within the range of 0.002 0-0. 100 0 mg · ml^ -1 （ r = 0. 999 8）. The average recovery was 101.46%, and the RSD was 2.33% （ n = 6）. Conclusion： The method is simple, reliable and reproducible, which can be used for the quality control of the preparation.

关 键 词：甘草浸膏胶囊 质量标准 甘草苷 甘草酸铵 高效液相色谱法 薄层色谱法 

分 类 号：TQ460.72[医药卫生—药物分析学]