芪蛭皱肺胶囊的质量标准研究

Study on the Quality Control Standard of Qizhizhoufei Capsule

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.