镇痫片质量标准研究(英文)

Qualitative and Quantitative Evaluation of Zhenxian Tablets

目的建立镇痫片的质量标准。方法采用薄层色谱法对其处方中石菖蒲、广郁金和远志进行定性鉴别；用反相高效液相色谱法测定人工牛黄中胆红素的含量。结果在所使用的色谱条件下，胆红素出峰位置未见干扰，胆红素在0．0439-0．3073μg范围内线性关系良好（r=0．9998）。镇痫片中胆红素的平均加样回收率为98．62％，相对标准偏差为1.09％（n=6）。结论该方法操作简单、稳定、专属性和重现性良好，可作为镇痛片的质量控制方法。

Objective To establish the test methods for the quality of Zhenxian Tablets. Methods The thin layer chromatography had been adopted for the quality identification of Rhizoma Acori Tatarinowii, Radix Curcumae and Radix Polygalae in the products of Zhenxian Tablets. The content of Bilirubin in Calculus Bovis in the Tablets was determined by RP - HPLC. Results Under the chro- matographic conditions used, there was no interference found in the position of Bilirubin peak. bilirubin had fine linear response（ r = 0.9998） in the content range of 0. 0439 - 0.3073 μg, the average recovery of Bilirubin in Zhenxian Tablets was 98.62% with the relative standard deviation of 1.09% （n =6）. Conclusion The method is simple, recurrent well, stable and accurate, so it can be used as a reliable tool for quality standard in the production of Zhenxian Tablets.