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目的:建立斑秃搽剂的质量控制方法。方法:采用TLC法对斑秃搽剂中当归、红花进行定性鉴别;采用HPLC测定方中阿魏酸的含量,色谱柱为Cosmosil C_(18)(250 mm×4.6 mm,5μm),以乙腈-0.05%磷酸溶液(17:83)为流动相,流速为1.0ml·min~(-1),检测波长为316 nm,柱温为30℃。结果:当归、红花的TLC特征斑点清晰,分离度好,阴性对照无干扰。阿魏酸在4.04～20.20μg·ml~(-1)的浓度范围内呈良好线性关系,回归方程为Y=0.864X+0.280,r=0.999 7。平均加样回收率为101.1%,RSD=1.0%(n=6)。结论:所建标准可用于癍秃搽剂的质量控制。
Objective: To establish a quality control method of alopecia areata. Methods: The content of ferulic acid in Radix Angelicae Sinensis and Radix was determined by TLC method. The content of ferulic acid was determined by HPLC. The chromatographic column was Cosmosil C 18 (250 mm × 4.6 mm, 5 μm) The mobile phase was 0.05% phosphoric acid solution (17:83), the flow rate was 1.0 ml · min -1, the detection wavelength was 316 nm and the column temperature was 30 ℃. Results: The TLC features of Angelica sinensis and Safflower were clear, the resolution was good, and the negative control had no interference. Ferulic acid showed a good linearity in the range of 4.04-20.20μg · ml -1, the regression equation was Y = 0.864X + 0.280, r = 0.999 7. The average recovery was 101.1% with RSD = 1.0% (n = 6). Conclusion: The proposed standard can be used for the quality control of baldness liniment.