不同厂家阿莫西林胶囊体外溶出度考察

Investigation on in vitro dissolution of Amoxicillin Capsules from four different manufactures

目的考察4个厂家阿莫西林胶囊的体外溶出度,为临床用药提供参考。方法分别以水、pH 1.2盐酸溶液、pH 4.0醋酸盐缓冲液及pH 6.8磷酸盐缓冲液为介质,测定样品累积溶出度,并选择非模型依赖法判定溶出曲线的相似性。结果 4个厂家阿莫西林胶囊在各介质条件下的溶出曲线均具有相似性,且30 min内的溶出度均超过90%。结论 4个厂家阿莫西林胶囊剂的溶出参数无显著性差异,溶出质量具有一致性。

Objective To investigate the in vitro dissolutions of Amoxicillin Capsules from four manufacturers and to provide reference for its clinical application. Methods Various dissolution media of water, pH 1.2 hydrochlorothiazide buffer solution, pH 4.0 acetate buffer solution and pH 6.8 phosphate buffer solution were used to determine the accumulative dissolution of the samples. A model - independent approach was applied to evaluate the comparability of dissolution curve. Results The dissolution profiles of Amoxicillin Capsules from the four manufacturers showed similarity and their dissolution quantity were more than 90% in 30 rain under four different pH condition. Conclusion There was no significant difference in the dissolution of Amoxicillin Capsules from the four manufacturers, and they all had uniform dissolution performance.