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目的:建立痔科消炎止痛洗剂的质量标准。方法:采用TLC法对痔科消炎止痛洗剂中黄柏、当归、黄芪进行定性鉴别;采用HPLC法测定黄柏中盐酸小檗碱含量,色谱条件为Agilent 5 TC-C18色谱柱(250 mm×4.6 mm,5μm),流动相:乙腈-0.05 mol·L~-1磷酸二氢钾溶液(30∶70),流速:1.0 ml·min~-1,检测波长:265 nm,柱温:30℃。结果:痔科消炎止痛洗剂中黄柏、当归、黄芪的薄层色谱斑点清晰,专属性强,阴性对照无干扰;盐酸小檗碱在0.029~3.628μg范围内,呈良好的线性关系(r=0.999 9),平均回收率为97.83%,RSD=2.05%(n=6)。结论:定性、定量方法准确可靠、重复性好,能有效控制痔科消炎止痛洗剂的内在质量。
Objective: To establish the quality standard of hemorrhoid medicine anti-inflammatory and analgesic lotion. Methods: The contents of berberine hydrochloride in Phellodendron chinense were determined by TLC. The chromatographic conditions were as follows: Agilent 5 TC-C18 column (250 mm × 4.6 mm , 5μm). The mobile phase was acetonitrile-0.05mol·L -1 potassium dihydrogen phosphate solution (30:70), the flow rate was 1.0 ml · min -1, the detection wavelength was 265 nm and the column temperature was 30 ℃. Results: TLC spots of Phellodendri, Angelica and Astragalus in Hemorrhoida Anti-inflammatory Analgesic Lotion were clear, specific and non-interfering with negative control. Berberine hydrochloride showed a good linear relationship in the range of 0.029 ~ 3.628μg (r = 0.999 9). The average recovery was 97.83% with RSD = 2.05% (n = 6). Conclusion: The qualitative and quantitative methods are accurate and reliable, and the repeatability is good. It can effectively control the internal quality of hemorrhoid and anti-inflammatory analgesic lotion.