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罗红霉素片溶出度测定方法研究

Methodological study on the dissolution of roxithromycin tablets
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摘要 目的研究罗红霉素片溶出度。方法以硫酸溶液(75/100)为显色剂,比色法测定罗红霉素片的溶出度。溶出条件为中国药典2005年版溶出度测定法第一法,溶出介质为盐酸溶液(0.1 mol.L-1)。结果绘制的溶出曲线表明45 min内罗红霉素片可溶出80%以上,确定的溶出时间为45 min,限度为80%。结论测定3批样品的溶出量均符合规定。 Aim To study the dissolution of roxithromycin tablets.Methods Sulfuricacid(75/100) being used as the color-developing agent,the colorimetric method was employed in the determination of the dissolution of roxithromycin tablets.The method was simple and dependable,following the paddle method of ChP 2005.The mediator was hydrochloric acid solution(0.1 mol·L-1).Results The curve showed that roxithromycin tablets can dissolve 80% and upwards within 45 minutes.It is confimed that the time of dissolution was 45 minutes and the limit was 80%.Conclusion 3 batches of samples were tested and the results met the qualification.
出处 《安徽医药》 CAS 2009年第4期391-393,共3页 Anhui Medical and Pharmaceutical Journal
关键词 比色法 罗红霉素 溶出度 calorinetric method roxithromycin dissolution
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