摘要
目的:建立固本丹胶囊的质量控制标准。方法:采用TLC法对方中黄芪进行定性鉴别;采用HPLC法测定该药中毛蕊异黄酮葡萄糖苷(毛蕊异黄酮-Glc)、橙皮苷和淫羊藿苷的含量。结果:黄芪的TLC色谱图斑点较为清晰,阴性对照无干扰,专属性良好。HPLC法中毛蕊异黄酮-Glc、橙皮苷与淫羊藿苷分别在1.974~39.480μg·ml^-1(r=0.999 9)、5.226~104.520μg·ml^-1(r=0.999 9)和2.684~53.680μg·ml^-1(r=0.999 9)范围内与峰面积呈良好线性关系;平均回收率分别为98.6%(RSD=1.3%)、99.2%(RSD=1.0%)和97.8%(RSD=1.8%)(n=6)。结论:此方法专属性强、精密度高、重复性好,可为建立固本丹胶囊药品的质量控制提供依据。
Objective:To establish the quality control standard for Gubendan capsules.Methods:Radix Astragali in the formulation was identified by TLC.Calycosin-7-O-β-D-glucoside,hesperidin and icariin in Gubendan capsules were determined by HPLC.Results:The spots in TLC were clear and could be well separated,and the negative samples showed no interference;the HPLC method showed that the linear range of calycosin-7-O-β-D-glucoside,hesperidin and icariin was 1.974-39.480,5.226-104.520 and 2.684-53.680μg·ml^-1(r=0.999 9),respectively;the average recovery was 98.6%(RSD=1.3%),99.2%(RSD=1.0%)and 97.8%(RSD=1.8%)(n=6),respectively.Conclusion:The methods are good in repeatability and reliable in the results,which provide reference for establishing the quality control method for Gubendan capsules.
作者
程伟
赵群涛
赵万隆
Cheng Wei;Zhao Quntao;Zhao Wanlong(Xinyang Institute for Food and Drug Control,Henan Xinyang 464000,China;Shanghai Qingpu Institute for Food and Drug Control)
出处
《中国药师》
CAS
2019年第6期1174-1176,共3页
China Pharmacist
