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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 of QN Capsule. Methods: The pangolin was identified by TLC qualitatively. The content of tetrahydropalmatine and rosmarinic acid was determined by HPLC. Phenomenex C18 column (4.6 mm × 250 mm, 5 μm); mobile phase A was a 0.1% phosphoric acid solution (pH = 6.0 with triethylamine) -methanol Methanol (55:45), gradient elution. The flow rate was 0.8 m L · min-1 and the column temperature was 28 ℃. The detection wavelength was 282 nm (0-25 min) and 330 nm (25.01-60 min). Results: There was a clear spot in the TLC and no interference with the negative control. The injection volumes of tetrahydropalmatine and rosmarinic acid showed good linearity (r = 0.999 8) between 0.015 0 ~ 0.751 0,0.060 3 ~ 3.016 μg and peak area, respectively ), The average recovery was 98.86% (RSD 0.9%) and 99.96% (RSD 1.0%), respectively. Conclusion: The method is simple, reliable and accurate and can be used for the quality control of the preparation.