• 中国核心期刊(遴选)数据库收录期刊
  • 中文科技期刊数据库收录期刊
  • 中国期刊全文数据库收录期刊
  • 中国学术期刊综合评价数据库统计源期刊等

• 评价技术与方法 • 上一篇    下一篇

不同厂家小儿氨酚黄那敏片溶出行为的考察

孙婷,苗会娟,张轶华   

  1. 河北省食品药品检验院,河北省食品药品检验院,河北省食品药品检验院
  • 收稿日期:2014-07-09 修回日期:2014-10-06 出版日期:2014-10-25 发布日期:2014-10-25

Research dissolution of Pediatric Paracetamol,Artificial Cow-bezoar and Chlorphenamine Maleate Tablets

  1. Hebei Institute for Food and Drug Control,Shijiazhuang,Hebei,050011,Hebei Institute for Food and Drug Control,Shijiazhuang,Hebei,050011,Hebei Institute for Food and Drug Control,Shijiazhuang,Hebei,050011
  • Received:2014-07-09 Revised:2014-10-06 Online:2014-10-25 Published:2014-10-25

摘要: 目的:建立小儿氨酚黄那敏片溶出行为测定方法,考察制剂中对乙酰氨基酚的溶出行为。方法:采用转蓝法,以水900ml为溶出介质,75转/分。色谱条件为使用Diamonsil C18色谱柱(4.6mm?200 mm,5 μm),流动相:以磷酸盐缓冲液(取磷酸二氢铵11.5g,加水适量使溶解,加磷酸1mL,用水稀释至1000mL)-乙腈(75:25);检测波长:262nm;柱温:30℃;进样量:10μl;流速:1.0ml?min-1。结果:采用此方法考察了17个厂家67批样品的溶出行为,并对AV值进行比较分析。发现药品的溶出行为差异较大,无整体相似。结论:建立的溶出度及HPLC测定方法操作简单,重现性好,可使企业重视药品的溶出行为,提高药品的内在质量。

Abstract: Objective: To establish a test method for the dissolution of Pediatric Paracetamol,and reseach curve of resolution.Methods:The method of dissolution was apparatus 1,the medium was water. And the chromatographic condition of column was Diamonsil C18 (250mm×4.6mm,5μm), the mobile phase was phosphate buffer –acetonile (45:55), the wavelength was 262nm. Results: Research resolution curve of Pediatric Paracetamol of 67 batches in 17 companies, and analysis AV. The result shows that there are obvious difference. Conclusion: The dissolution test method is accurate and widely applicable.