胃康散质量标准研究  

Quality Standard for Weikang Powder

作　　者：庄伟香 李辉 黄木土 李冬 刘珊 李健 ZHUANG Wei-xiang;LI Hui;HUANG Mu-tu;LI Dong;LIU Shan;LI Jian(Deptartment of Pharmacy,General Hospital of Southern Theatre Command;Guangzhou Key Lab of Rational Drug Use in Senile Chronic Disease Parients,Guangzhou 510010,China)

机构地区：[1]中国人民解放军南部战区总医院药剂科 [2]广州市老年慢病患者合理用药重点实验室,广东广州510010

出　　处：《食品与药品》2019年第3期182-186,共5页Food and Drug

基　　金：广州市科技计划项目(No.201509010012)

摘　　要：目的制定胃康散的质量标准。方法采用TLC对胃康散中的白及、延胡索、甘草进行定性鉴别;采用HPLC法测定胃康散中氯化两面针碱的含量:色谱柱为Agilent 5 TC-C18(250 mm×4.6 mm,5μm),流动相为甲醇-0.1%磷酸(用N,N-二乙基乙胺调pH 6.0)(60:40),检测波长为273 nm,流速为1.0 ml/min,柱温为25℃,进样量为10μl。结果TLC专属性强,分离度较好。氯化两面针碱在7.6~76.1μg/ml范围内浓度与峰面积呈良好的线性关系(r=0.9995),平均加样回收率为98.83%,RSD为2.5%(n=9),精密度、稳定性、重复性试验的RSD均小于3%。结论所建方法简单准确,专属性强,重复性好,可用于胃康散的质量标准控制。Objective To establish the quality standard of Weikang Powder.Methods TLC was used for the qualitative identification of Bletillae rhizoma,Corydalis rhizoma and Clycyrrhizae radix et rhizoma.HPLC was used for the contents determination of nitidine chloride.Diamonsil C18(250 mm×4.6 mm,5μm)was adopted,using methanol-0.1%phoshphoric acid(adjusting pH to 6.0 with N,N-diethylethylamine)(60:40,v/v)at a flow rate of 1 ml/min as mobile phase.The detection wavelength was 273 nm,the column temperature was 25℃,and the injection volume was 10μl.Results TLC analysis was good in separation and strong in specificity.The concentration of nicotine chloride in the range of 7.6-76.1μg/ml had a good linear relationship with the peak area(r=0.9995).The average recovery was 98.83%,with RSD of 2.5%(n=9).RSDs of precision,stability and repeatability tests were less than 3%.Conclusion This method is simple,accurate,specific and reproducible,and can be used for the quality control for Weikang Powder.

关 键 词：胃康散 质量标准 氯化两面针碱 薄层色谱法 高效液相色谱法 

分 类 号：R927.11[医药卫生—药学]