阿莫西林胶囊特征指纹溶出过程图谱研究

Study on Dissolution Fingerprint Chromatograms of Amoxicillin Capsules

分别以pH 1.2,4.5及6.8的溶液为溶出介质,在温度37℃,转速为100 r/min条件下,对5个厂家,0.25 g及0.5 g两种规格的阿莫西林胶囊进行溶出度检测。建立不同厂家产品的特征指纹溶出过程图谱。对指纹图谱差异相对较小的两种0.5 g规格阿莫西林胶囊,进一步考察了其在pH 1.2,45℃条件下的溶出曲线。结果显示,两种规格的5个厂家的阿莫西林胶囊各自呈现的三条溶出曲线所构成的特征图谱均存在明显差异。pH 1.2及45℃溶出条件下,后两厂家溶出曲线相对于pH 1.2及37℃溶出条件的溶出过程曲线,差异加大,有利于产品的进一步区分。在检测设备及人员低配备条件下,该法可实现阿莫西林胶囊来源的有效筛选及质量鉴定。

Dissolution tests were proceeded at 100 rpm/min and 37℃,using pH 1.2,4.5,6.8 solution as the dissolution medium respectively.Three 0.25 g and 0.5 g amoxicillin capsules from five factories were tested in order to establish fingerprint chromatograms of different factories.To further distinguish two 0.5 g amoxicillin capsules which had relatively small differences,the dissolution behaviors of these products were evaluated at 45℃in pH 1.2.The results showed that the fingerprint chromatograms of amoxicillin capsules from five factories had obvious differences.The dissolution differences between later two factory were expanded at 45℃in pH 1.2.The method can provide effect screening for the source of amoxicillin and detecting of quality in low-resource settings.