目的:初步拟定蛇床子搽剂(简称为"搽剂")的质量标准.方法:观察搽剂的性状,采用薄层色谱法对搽剂中蛇床子素进行定性鉴别并对搽剂的相对密度、含醇量和pH值等进行测定,采用高效液相色谱法对搽剂中蛇床子素和欧前胡素进行定量分析.结果:3批样品均为红棕色液体,气香.在供试品薄层色谱中,在与对照品色谱相应位置上显现出相同颜色的荧光斑点.蛇床子素和欧前胡素检测质量浓度的线性范围分别为0.1012~0.9108、0.0062~0.1244 mg/L(r均为0.9996),精密度试验的RSD分别为1.38%、0.79%(n=6),稳定性试验的RSD分别为0.33%、0.41%(n=6),重复性试验的RSD分别为0.83%、1.98%(n=6),平均加样回收率分别为98.73%、99.25%(RSD分别为1.29%、1.22%,n=6);含量测定结果显示,3批样品中蛇床子素含量为2.20~2.35 mg/mL,欧前胡素为0.310~0.340 mg/mL.结论:建立的方法操作简单、快速、准确,可用于蛇床子搽剂的质量控制.%OBJECTIVE:To formulate the quality standard of Cnidium monnieri liniment (called "liniment" for short)preliminarily. METHODS:The property of liniment was observed. TLC was used for qualitative identification of osthole in liniment;relative density,alcohol content and pH value were also determined. The osthole and imperatorin in liniment were analyzed qualitatively by HPLC. RESULTS:3 batch of samples were reddish brown liquid and fragrant smelling. In TLC of test sample,the same color fluorescent spots were found in corresponding position as chromatogram of control sample. The linear range of osthole and imperatorin were 0.101 2-0.910 8(r=0.999 6)and 0.006 2-0.124 4 mg/L(r=0.999 6). RSDs of precision tests were 1.38% and 0.79%(n=6). RSDs of stability tests were 0.33% and 0.41%(n=6). RSDs of reproducibility tests were 0.83% and 1.98%(n=6),respectively. Average recoveries rate were 98.73%(RSD=1.29%,n=6)and 99.25%(RSD=1.22%,n=6).Results of content determination showed that the content of osthole and imperatorin were 2.20-2.35 mg/mL and 0.310-0.340 mg/mL,respectively. CONCLUSIONS:Established method is simple,rapid,accurate and can be used for quality control of C. monnieri liniment.
展开▼
