消核灵胶囊的质量标准

Quality Standard of Xiaohelin Capules

目的：建立消核灵胶囊的质量标准。方法：采用TLC对穿山甲进行定性鉴别;采用HPLC测定延胡索乙素和迷迭香酸的含量。Phenomenex C18色谱柱（4.6 mm×250 mm,5μm）;流动相A为0.1%磷酸溶液（以三乙胺调节p H至6.0）-甲醇（45∶55）,流动相B为0.1%磷酸溶液-甲醇（55∶45）,梯度洗脱;流速0.8 m L·min-1,柱温28℃,检测波长282 nm（0~25 min）,330 nm（25.01~60 min）。结果：薄层色谱图斑点清晰,阴性对照无干扰;延胡索乙素和迷迭香酸进样量分别在0.015 0~0.751 0,0.060 3~3.016μg与峰面积呈良好线性关系（r=0.999 8）,平均加样回收率分别为98.86%（RSD 0.9%）和99.96%（RSD 1.0%）。结论：该方法简便、可靠、准确,可用于该制剂的质量控制。

Objective： To establish the quality standard for Xiaohelin capsules. Method： Pangolin in Xiaohelin capsules was indentified by TLC. The content of tetrahydropalmatine and rosmarinic acid were determined by HPLC. Phenomenex C18（ 4. 6 mm × 250 mm,5 μm） column was adopted and eluted with the mobile phase A of 0. 1% phosphoric acid（ adjusted p H to 6. 0 with triethylamine）-methanol（ 45∶ 55） and the mobile phase B of0. 1% phosphoric acid-methanol（ 55 ∶ 45） in a gradient mode at a flow rate of 0. 8 m L·min-1. The column temperature was set at 28 ℃. The detection wavelength was 282 nm（ 0-25 min,for tetrahydropalmatine） and330nm（ 25. 01-60 min, for rosmarinic acid）. Result： The developed TLC spots were fairly clear without interference. Tetrahydropalmatine and rosmarinic acid showed a good linear relationship in the ranges between0. 015 0-0. 751 0,0. 060 3-3. 016 μg（ r = 0. 999 8）,the average recovery rates were 98. 86%（ RSD 0. 9%） and99. 96%（ RSD 1. 0%） respectively. Conclusion： The method is simple,reliable and accurate,and can be used in the quality control of Xiaohelin capsules.