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目的:建立复方卡力孜然酊的质量标准。方法:采用TLC对处方中补骨脂、驱虫斑鸠菊、当归、蛇床子和丁香进行定性鉴别;并用HPLC对处方中补骨脂素进行含量测定,采用Kromasil C18(4.6 mm×250 mm,5μm)色谱柱,以甲醇-水(50∶50)为流动相,流速1.0 mL·min-1,柱温35℃,检测波长246 nm,进样量为10μL。结果:薄层色谱斑点清晰,易于识别,专属性强;补骨脂素在0.050 04～0.350 28μg呈良好的线性关系(r=0.999 9),平均回收率为98.4%,RSD 0.9%(n=9)。结论:方法准确灵敏,重复性好,提高后的质量标准更有效的控制制剂质量。
Objective: To establish the quality standard of compound kali cumin tincture. Methods: The prescriptions of psoralen, Vernonia lutea, Angelica sinensis, Cnidium monnieri and clove were identified qualitatively by TLC. The content of psoralen in the prescription was determined by HPLC and determined by Kromasil C18 (4.6 mm × 250 mm, 5 μm ) Column with methanol-water (50:50) as mobile phase at a flow rate of 1.0 mL · min-1 and a column temperature of 35 ℃ with a detection wavelength of 246 nm. The injection volume was 10 μL. Results: The TLC spots were clear, easily identifiable and specific. Psoralen showed good linearity (r = 0.999 9) at 0.050 04 ~ 0.350 28 μg with an average recovery of 98.4% and RSD 0.9% (n = 9). Conclusion: The method is accurate, sensitive and reproducible. The improved quality standard is more effective in controlling the quality of preparation.