肾炎Ⅱ号颗粒质量标准的提高  

Improvement of Quality Standard for Shenyan Ⅱ Granules

作　　者：马善波[1,2] 曹金一[2] 赵锐帆 王晶[1] 石小鹏[2] 杨志福[2] 文爱东[2] 胡本祥[1] 

机构地区：[1]陕西中医药大学药学院,陕西咸阳712083 [2]第四军医大学西京医院药剂科

出　　处：《中国药师》2016年第5期1008-1011,共4页China Pharmacist

基　　金：军队医疗制剂标准提高专项课题(编号:14ZJZ15-1)

摘　　要：目的:建立肾炎Ⅱ号颗粒的质量标准。方法:采用显微镜对石韦进行显微特征性鉴别;采用TLC法对主要成分地黄、茜草、小蓟等进行定性鉴别;采用HPLC法测定西洋参中人参皂苷的含量,色谱柱:WONDER CRACT ODS-2(150 mm×46mm,5μm),流动相:乙腈-0.1%磷酸溶液(28∶72),流速:1.1 ml·min^(-1),检测波长:203 nm,柱温:40℃,进样量:10μl。结果:薄层色谱斑点清晰,在与对照药材或对照品色谱相应的位置上,显相同颜色的荧光主斑点,阴性样品无干扰;西洋参中人参皂苷的线性浓度38.9~194.5μg·ml^(-1)(r=0.999 3),平均回收率为98.3%,RSD为1.9%(n=6)。结论:本方法操作简便,专属性高、重复性好,可作为肾炎Ⅱ号颗粒的质量控制方法。Objective：To establish the quality standard for Shenyan Ⅱ granules.Methods：The characteristics of Folium Pyrrosiae were identified by microscopy.The three herbs in the preparation,rehmannia,madder and thistle were identified by TLC qualitatively.The content of ginsenoside in American ginseng was determined by HPLC.Chromatographic separation was carried out by using a WONDER CRACT ODS-2（150 mm × 46 mm,5 μm） column.The mobile phase consisted of acetonitrile-0.1% phosphoric acid（28 ∶72） with gradient elution at a flow rate of 1.0 ml·min^-1,and the injection volume was 10 μl.The detection wavelength and the column temperature was 203 nm and 40 ℃,respectively.Results：The spots in TLC were clear without any interference.The linear range of ginsenoside was 38.9^-194.5 μg·ml^-1（r = 0.999 3）.The average recovery was98.3% and RSD was 1.9%（n = 6）.Conclusion：The method is simple and highly specific with good repeatability,which can be used as the quality control method for Shenyan Ⅱ granules.

关 键 词：肾炎Ⅱ号颗粒 质量标准 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]