抗粘灵气雾剂质量控制方法研究

Study on the Qaulity Standard of Anti-adhesion Aerosol

目的：建立抗粘灵气雾剂的质量标准。方法：采用薄层色谱鉴别（TLC）对制剂中的当归、赤芍、黄芪进行鉴别，采用高效液相色谱法同时定量测定阿魏酸、芍药苷的含量。结果：阿魏酸在2．04—20．4μg／ml范围内线性关系良好，相关系数为0．9992，平均回收率为96．2％，RSD为1．5％；芍药苷在32—400μg／ml范围内线性关系良好，相关系数为0．9993，平均回收率为97．3％，RSD为1．0％。结论：TLC鉴别专属性强，重现性好。建立的定性定量方法简便、可行，可用于抗粘灵气雾剂的质量控制。

Objective： To establish the quality standards of anti-adhesion aerosol. Methods： TLC was used to identify angelica, red peony root, astragalus in the preparations and HPLC was used to simultaneous quantitativly determinate the cowtent of ferulie acid and paeoniflorin. Results ： The linear of ferulic acid was 2. 04 - 20. 4 μg/ml （ r = 0. 9992）, the average recoveries was 96. 2% with RSD of 1.5%. The linear of paeoniflorin was 32 - 400 μg/ ·ml （ r = 0. 9993 ） , the average recoveries was 97. 3% with RSD of 1.0%. Conclusion： The TLC identification had specificity and reproducibility. Establish qualitative and quantitative methods are simple and feasible, and can be used for quality control of the anti-adhesion aerosol.