小儿氨酚黄那敏片质量标准的完善

Improvement of the Quality Standard for Pediatric Paracetamol,Artificial Cow-bezoar and Chlorphenamine Maleate Tablets

目的:完善小儿氨酚黄那敏片质量标准。方法:采用薄层色谱法对人工牛黄中的胆红素、贝斯素、胆酸、猪去氧胆酸进行鉴别;采用高效液相色谱法对小儿氨酚黄那敏片中对乙酰胺基酚和马来酸氯苯那敏进行含量测定。结果:薄层色谱鉴别方法专属性强;含量测定方法简便。重复性好。结论:建立的方法可准确、快速地进行定性、定量测定,可用于该制剂的质量控制。

Objective： To improve the quality standard for pediatric paracetamol, artificial cow-bezoar and chlorphenamine maleate tablets. Method： The bilirubin, beisisu, cholic acid and hyodeoxycholic acid were identified by TLC. The contents of paracetamol and chlorphenamine maleate in pediatric paracetamol, artificial cow-bezoar and chlorphenamine maleate tablets were determined by HPLC. Result： The TLC methods was specific. The content determination of method was simple, accurate and repeatable. Conclusion： This method is accurate and quick, it can be applied to quality control of this preparation.