藿芪灌注液中淫羊藿苷和黄芪甲苷稳定性试验研究

Study on Stability of Icariin and Astragaloside in Huoqi Perfusion

关键词:  藿芪灌注液  稳定性试验  高效液相色谱法  淫羊藿苷  黄芪甲苷

Key words:  huoqi perfusion  stability test  HPLC  icariin  astragaloside  

摘要:

目的 研究藿芪灌注液的稳定性。方法 采用HPLC法测定藿芪灌注液中淫羊藿苷与黄芪甲苷含量,使用WondaSil C18柱(4.6mm×250mm,5μm),流动相：乙腈-水28:72,柱温40℃,检测波长270nm,进样量10μl,流速1.0 ml /min测定淫羊藿苷的含量；使用ZORBAX SB-C18柱(4.6mm×150mm,5μm),漂移管温度为90℃,载气流速为2.5L/min,流动相：甲醇-水65:35,柱温：40℃,流速：1ml/分钟,用蒸发光散射检测器检测测定黄芪甲苷的含量。藿芪灌注液于高温60℃放置10 d,高湿度90％±5％放置10 d,经强光照射4500±500LX放置10 d,加速试验在温度40℃±2℃、相对湿度75％±5％的条件下放置6个月,长期试验在温度25℃±2℃、相对湿度60％±10％的条件下放置12个月,考察藿芪灌注液在不同条件存放后的性状、鉴别、pH、淫羊藿苷含量、黄芪甲苷含量以及无菌检查等项目的变化。结果 藿芪灌注液在不同条件存放后所有指标均未有明显变化,符合质量标准要求。结论 藿芪灌注液性质稳定可靠。

Abstract:

Objective To investigate the stability of Huoqi Perfusion.Methods The contents of icariin and astragaloside were determined by HPLC, The separation of the icariin was achieved by a WondaSil-C18(4.6mm×250mm,5μm) and mobile phase composed of acetonitrile-water( 28:72) ,the detection wavelength was 270 nm,the column temperature was 40℃,the injection volume of 10μl,the flow rate was 1.0 mL/min；The separation of the astragaloside was achieved by a ZORBAX SB-C18(4.6mm×150mm,5μm),The drift tube temperature is 90℃,The carrier gas flow rate is 2.5L/min and mobile phase composed of methanol-water( 65:35) , the flow rate was 1.0 mL/min；the column temperature was 40℃,with evaporative light scattering detector. Huoqi Perfusion was treated respectively with high temperature(60℃)for 10 days, high wet(RH95?Ee5%)for 10 days,high light(4500±500LX )for 10 days,accelerating testing (40℃±2℃,RH75?Ee5%)for six months,and a long-term testing (25℃±2℃,RH60?Ee10%) for twelve months, and then the changes of characters, identification, pH, Icariin,Astragaloside and sterility test under different storage conditions were observed.Results All of the tested indexes of Huoqi Perfusion were consistent with the quality standards. Conclusion The tested of Huoqi Perfusion is stable and reliable.