复方磺胺甲唑片溶出曲线研究

目的: 了解目前国内复方磺胺甲 唑片在溶出行为方面与标准制剂之间的差异。 方法: 参照日本橙皮书中方法规定的4种不同pH的溶出介质来模拟消化道内的体液,对国内不同区域的13个生产企业的样品进行溶出曲线考察,并使用AV值方法计算溶出曲线相似度并进行评价。 结果: 共绘制了104条溶出曲线,表明13个企业的复方磺胺甲 唑片溶出行为与标准曲线存在较大差异,仅有6条样品的溶出曲线与标准曲线相似,并且在4种介质中各生产企业间样品间溶出行为也存在较大差异。 结论: 目前国内该品种生产工艺差异较大,溶出行为与标准制剂存在差异。

Objective: To study the difference in dissloution behavior of compoud sulfamethoxazole tablets between domestic preparations and foreign standard agents. Methods: Refer to methods of the japanese Orange Book,studied samples’ dissloution curve of thirteen pharmaceutical enterprises by using four kind of dissolution medium in defferent pH value to simulate digestive tract. Results: 104 samples’ dissloution curves were geted,and only six of which resembled with standard dissloution curves of the Orange Book,the others showed great difference with standard dissloution curves,there was great difference in domestic thirteen pharmaceutical enterprises. Conclusion: It showed great difference in compoud sulfamethoxazole tablets’ production process of domestic pharmaceutical enterprises,and there is great difference in dissloution behavior contrasted to foreign standard agents.

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