文献类型：期刊文献

中文题名：芪蛭皱肺胶囊的质量标准研究

英文题名：Study on the Quality Control Standard of Qizhizhoufei Capsule

作者：魏舒畅[1];黄燕[1];李金田[1];刘永琦[1];武晓玉[1]

第一作者：魏舒畅

机构：[1]甘肃中医学院

第一机构：甘肃中医药大学

年份：2012

卷号：18

期号：3

起止页码：72

中文期刊名：中国实验方剂学杂志

外文期刊名：Chinese Journal of Experimental Traditional Medical Formulae

收录：CSTPCD;;北大核心:【北大核心2011】；

基金：甘肃省科技攻关科研项目(2GS035-A43-067);甘肃省教育厅产学研对接科研项目(03zd-04)

语种：中文

中文关键词：芪蛭皱肺胶囊;质量标准;薄层色谱;高效液相色谱;黄芪甲苷

外文关键词：Qizhizhoufei capsule;quality standard;TLC;HPLC;astragaloside

摘要：目的:建立芪蛭皱肺胶囊的质量控制方法。方法:采用TLC方法对制剂中黄芪、水蛭、赤芍、丹参、枳实进行定性鉴别;采用HPLC对制剂主药黄芪中黄芪甲苷进行含量测定。采用Hypersil ODS-C18(4.6 mm×250 mm,5μm),以甲醇-水(75∶25)为流动相,流速1.0 mL.min-1,柱温40℃,蒸发光散射检测器:漂移管温度75℃,载气流速2.1 L.min-1。结果:黄芪、水蛭、赤芍、丹参、枳实的定性鉴别方法专属性强,阴性无干扰;黄芪甲苷加样回收率(n=6)97.97%,RSD 2.21%;黄芪甲苷进样量在0.28～1.68μg与峰面积自然对数呈良好线性关系。结论:方法简便可行,重复性好,可用于该制剂的质量控制。
Objective:To establish the quality control standard of qizhizhoufei capsule.Method:Radix Astragali,Hirudo,Radix Paeoniae Rubra,Radix et Rhizoma Salviae Miltiorrhizae and Fructus Aurantii Immaturus were identified by TLC.The content of Astragaloside in qizhizhoufei capsule was determined by HPLC.Hypersil ODS-C18(4.6 mm×250 mm,5 μm) was used,with methanol-water(75∶25) as mobile phase,the flow rate was 1.0 mL·min-1,the column temperature was at 40 ℃.Evaporative Light Scattering Detector(ELSD): the temperature of drift tube was 75 ℃,the flow rate of carrier gas was 2.1 L·min-1.Result: The TLC identification methods for the Radix Astragali,Hirudo,Radix Paeoniae Rubra,Radix et Rhizoma Salviae Miltiorrhizae and Fructus Aurantii Immaturus was highly specificity,the negative sample didn't interfere the identification of TLC.The average recoveries(n=6) of astragaloside was 97.97%,RSD was 2.21%.The linear range of astragaloside was 0.28-1.68 μg.Conclusion: The method is simple,repeatable and may be used for the quality control of qizhizhoufei capsule.