静脉炎合剂的制备及质量控制

Preparation and quality control for phlebitis mixture

目的完善静脉炎合剂的质量控制标准。方法采用TLC法对静脉炎合剂方中红花、当归、绵萆薢、伸筋草进行定性鉴别;采用HPLC法测定防己中粉防己碱的含量,色谱柱：Agilent Zorbax Extend-C18柱（4.6mm×150mm,5μm）;流动相：甲醇-0.3%二乙胺（75∶25）;检测波长：282nm,柱温：27℃,流速：1.0mL/min。结果薄层色谱图清晰,阴性对照无干扰;粉防己碱在5.18~259.00μg/mL浓度范围内与峰面积呈良好线性关系,r=0.999 9（n=8）,平均加样回收率为99.8%（RSD=1.91%,n=9）。结论本实验建立的质量控制方法简便、准确、重现性好,可用于静脉炎合剂的质量控制。

Objective To improve the quality control standards for phlebitis mixture.Methods TLC was applied to identify flowers carthami,Angelica sinensis,Rhizoma Dioscoreae Septemlobae,and Herba Lycopodii.HPLC analysis was carried out by using Agilent Zorbax Extend-C18column with methanol-0.3% diethylamine（75∶25）as mobile phase.The detection wavelength was 282mm,the column temperature was 27℃and the flow rate 1.0mL/min.Results The thin-layer chromatogram was distinct and the negative control had no interference.The linear relation between peak area and concentration of tetrandrine（5.18-259.00μg/mL）were good（r=0.999 9,n=8）.The average recovery rate was 99.8%（RSD= 1.91%,n=9）.Conclusion This method based on the experiment was proved to be simple,accurate and highly reproducible.It could be used for quality control in the production of phlebitis mixture.