复方氨酚烷胺片质量标准改进  

Improvement on Quality Standards for Compound Paracetamol and Amantadine Hydrochloride Tablets

作　　者：孙莉[1] 

机构地区：[1]安徽省芜湖市药品检验所,安徽芜湖241001

出　　处：《中国药业》2008年第17期26-27,共2页China Pharmaceuticals

摘　　要：目的修订提高复方氨酚烷胺片的质量标准。方法采用薄层色谱法对人工牛黄中的胆红素、贝斯素、胆酸、猪去氧胆酸进行定性鉴别;采用高效液相色谱法对复方氨酚烷胺片中的对乙酰胺基酚、咖啡因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;对乙酰胺基酚、咖啡因和马来酸氯苯那敏的质量浓度分别在50.10～500.60μg/mL,3.2～30.6μg/mL,0.525～5.20μg/mL范围内与峰面积线性关系良好,平均回收率分别为99.72%,99.60%,98.96%,RSD分别为0.24%,0.75%,0.78%(n=6)。结论所用方法准确、快速,可用于该制剂的质量控制。Objective To improve the quality standards of compound paracetamol and amantadine hydrochloride tablets. Methods Bilirubin, beisisu, cholic acid and hyodeoxycholic acid in artificial bezoar were qualitatively identified by TLC. The contents of paracetamol, caffeine and chlorphenamine maleate in compound paracetamol and amantadine hydrochloride tablets were determined by HPLC. Results The identification method was exclusive. The calibration curves of paracetamol, caffeine, chlorphenalnine meleate were linear in the range of 50. 10- 500. 60 ug/mL, 3.2 - 30. 6 ug/mL, 0. 525 - 5.20 ug/mL, respectively. The average recover was 99.72% , 99.60% , 98.96% , respectively. RSD was 0. 24% ,0. 75% ,0. 78%. respectively. Conclusion This method is accurate and quick. It can be applied to the quality control of the tablets.

关 键 词：复方氨酚烷胺片 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R927[医药卫生—药学] R971.1