抗氧化口服液质量标准研究

Study on the Quality Control Standard for Antioxidation Oral Liquid

目的:建立抗氧化口服液的质量标准.方法:采用TLC对处方中黄芪、淫羊藿进行定性鉴别;用RP-HPLC法对处方中淫羊藿中淫羊藿苷进行含量测定.结果:在TLC色谱中,能检出黄芪、淫羊藿;高效液相色谱(HPLC)法中,淫羊藿苷在0.614～1.842 μg与峰面积呈良好的线性关系,r=0.9997,平均回收率为100.45%,RSD=2.12%.结论:所建立的方法对方中黄芪、淫羊藿能进行定性鉴别,并能准确、快速地对淫羊藿苷进行定量检测,可作为抗氧化口服液的质量控制方法.

Objective: To develop the quality control standard for Antioxidation Oral Liquid. Methods: Applying TLC to identify Radix Astragali,Herba Epirnedii,and HPLC to determine the content of Icariin of Herba Epimedii. Results:Radix Astragali and Herba Epimedii could be indentified by TLC. Icariin showed a good linear relationship at the range of 0. 614-1. 842μg,r=0. 999 7. The average recovery was 100. 45% ,and RSD was 2. 12%. Conclusion:The method is accurate and quick,and can be used for the quality control for Antioxidation Oral Liquid.