小儿氨酚黄那敏颗粒质量标准的研究
Study on quality standard for Xiao'er Anfenhuangnamin granules
分类号：
出版年·卷·期（页码）：2009,29 (8):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
目的：建立小儿氨酚黄那敏颗粒中胆酸、猪去氧胆酸及胆红素测定方法。方法：用薄层色谱法对胆酸、猪去氧胆酸进行定性鉴别；高效液相色谱法对胆红素进行含量测定, 以DiamonsilTM C18（4.6mm×250 mm,5μm）为分析柱，四氢呋喃-乙腈-0.1%醋酸铵（pH4.7）（42﹕22﹕36）为流动相；流速：1.0 mL·min-1；检测波长：452nm；进样量20μL。结果：薄层色谱中均能明显地检出胆酸和猪去氧胆酸,胆红素对照品在0.6555～13.11μg·mL-1范围内，浓度与峰面积呈良好的线性关系，r=0.999 5，平均回收率为98.6%,RSD = 1.0% ( n = 9)。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。
-----英文摘要：---------------------------------------------------------------------------------------
Objective: To establish a method for the determination ofcholic acid ,hyodexycholic acid and bilirubin in Xiao'er Anfenhuangnamin granules.Cholic acid and hyodexycholic acid could be identified by TLC；The HPLC for determination ofbilirubin was conducted on a DiamonsilTM C18（4.6mm×250 mm,5μm） with tetrahydrofuran- acetonitrile- 0.1%ammonium acetate（pH4.7）（42﹕22﹕36）as mobile phase at the flow rate of 1.0 mL·min-1, detection wavelength was set at 452nm. The calibration curve of bilirubin was linear range of 0.6555 ～13.11μg·mL-1，(r=0.999 5),The average recovery of bilirubin was 98.6% with RSD=1.0%（n=9）. Conclution:The method is simple,accurate ， and suitable for the determination ofcholic acid ,hyodexycholic acid and bilirubin in Xiao'er Anfenhuangnamin granules.
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