化瘀生肌膏质量标准研究

目的建立化瘀生肌膏的质量控制方法。方法采用薄层色谱法对方中主要药味当归、紫草、白芷进行定性鉴别,采用高效液相色谱法测定化瘀生肌膏中主要有效成分阿魏酸的含量,流动相为甲醇-5%冰醋酸溶液（30∶70）,检测波长为320 nm。结果薄层色谱定性鉴别的特征斑点清晰,专属性强,阴性对照无干扰。高效液相色谱法测定阿魏酸的线性范围为0.008 6～0.043 2μg（r=0.999 4）,加样回收率为98.79%（RSD=0.96%）。结论该方法简便可靠,专属性强,重复性好,能较全面反映该制剂内在质量,可用于该制剂的质量控制。

Study on Quality Standard of Huayu Shengji Gao

Objective To establish the method to control the quality of Huayu Shengji Gao.Methods Angelica sinensis Radix,Arnebiae Radix and Angelicae dahuricae Radix in the preparation were identified by TLC.The content of ferulaic acid,which is the effective substance in the preparation,was determined by HPLC with methanol-5% acetic acid(30∶70) as the mobile phase,and the detection wavelength was set at 320 nm.Results The spots of TLC were clear without interference in the negative control.The linear relationship of the ferulaic acid was good in the range of 0.008 6-0.043 2 μg(r=0.999 4) and the recovery was 98.79%(RSD=0.96%).Conclusion The methods are simple and feasible with good specialization and reproducibility,and can be applied to control the quality of the preparation.