有关鱼腥草素钠与合成鱼腥草素质量标准的探析

Analysis and Discussion on the Quality Standards of Sodium Houttuyfonate and Natrii Houttuyfonas

目的:通过红外分光光度法和高效液相色谱法证明鱼腥草素钠与合成鱼腥草素为同一物质,并建立高效液相色谱测定其片剂含量的方法。方法:采用C8(4.6 mm×250 mm,5μm)色谱柱,以甲醇-水-10%四丁基氢氧化铵溶液(55∶45∶0.3)为流动相,流量1 m L·min^(-1),柱温45℃,检测波长为286 nm。结果:鱼腥草素钠与合成鱼腥草素在2.1~42μg·m L^(-1)浓度范围内线性关系良好(r=1),平均加样回收率为99.0%(n=9)。结论:鱼腥草素钠与合成鱼腥草素质量标准应合并统一,所建立的方法简单,专属性好,辅料无干扰,适用于片剂的含量测定。

Objective： To prove Sodium Houttuyfonate and Natrii Houttuyfonas for the same substance by IR and HPLC,and establish an HPLC method for the determination of Sodium Houttuyfonate Tablets. Methods： HPLC was carried out on a Cs （4. 6 mm ×250mm,5μm）column with a mixture of methanol-water-10% tetrabutylammonium hydroxide solution（55： 45： 0. 3 ） as the mobile phase at a flow rate of 1 mL · min^-1 . The detection wavelength was 286 nm and the column temperature was set at 45 ℃. Results： The calibra- tion curves of Sodium Houttuyfonate and Natrii Houttuyfonas were linear in the range of 2. 1 - 42 μg · mL ^- 1 （ r = 1 ）. The average recov- ery were 99. 0% （n = 9）. Conclusion： The quality standards of Sodium Houttuyfonate and Natrii Houttuyfonas should be united and unified. The method is simple and specific. It＇s suitable for the determination of Sodium Houttuyfonate Tablets.