妇宁康片的质量标准研究

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目的:建立妇宁康片的质量控制方法。方法:薄层色谱法对人参、赤芍、蛇床子、当归、黄柏进行定性鉴别;高效液相色谱法对淫羊藿苷进行含量测定,以Diamonsil~(TM) C_(18)(200 mm×4.6 mm,5μm)为分析柱,乙腈-水(26:74)为流动相;流速:1.0ml·min~(-1);检测波长:270 nm。结果:薄层色谱中均能明显地检出人参、赤芍、蛇床子、当归、黄柏,淫羊藿苷在0.043~0.517μg·ml~(-1)范围内,浓度与峰面积呈良好的线性关系,r=0.999 9,平均回收率为99.4%,RSD=1.8%(n=6)。结论:本法简便,准确,专属性强,可以作为该制剂的质量控制方法。 Objective: To establish the method of quality control of Fu-ning Kang tablets. Methods: The contents of Icariin were determined by thin-layer chromatography (HPLC) with Diamonsil ™ C 18 (200 mm × 4.6 mm, 5 μm) as the analytical column and acetonitrile-water (26:74) as the mobile phase. The flow rate was 1.0 ml · min -1 and the detection wavelength was 270 nm. Results: The contents of ginseng, radix paeoniae rubra, Cnidium monnieri, Angelica sinensis, cortex phellodendri, icariin in the range of 0.043 ~ 0.517μg · ml ~ (-1) were clearly detected by TLC. The linear relationship, r = 0.999 9, the average recovery was 99.4%, RSD = 1.8% (n = 6). Conclusion: This method is simple, accurate and specific and can be used as the quality control method of this preparation.
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