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目的对不同厂家盐酸多奈哌齐片的体外溶出情况进行考察,评价其内在质量。方法采用光纤溶出度实时测定仪(浆法)绘制盐酸多奈哌齐片在不同pH溶出介质中的溶出曲线,转速50 r·min~(-1)、测定波长为271 nm,溶出介质500 ml。结果在水、pH 1.2盐酸、pH 4.0醋酸盐缓冲液和pH 6.8磷酸盐缓冲液中,各厂家盐酸多奈哌齐片的溶出曲线有显著性差异。结论不同厂家生产的盐酸多奈哌齐片的溶出曲线明显不一致,通过进行溶出度检查有助于控制药物质量。
Objective To investigate the in vitro dissolution of donepezil hydrochloride tablets from different manufacturers and evaluate its intrinsic quality. Methods Dissolution curves of donepezil hydrochloride tablets in different pH dissolution media were drawn by using optical fiber dissolution real-time analyzer (slurry method) at a rotational speed of 50 r · min -1 with a wavelength of 271 nm and a dissolution medium of 500 ml. Results The dissolution profiles of donepezil hydrochloride tablets in water, pH 1.2 HCl, pH 4.0 acetate buffer and pH 6.8 phosphate buffer were significantly different. Conclusion The dissolution curves of donepezil hydrochloride tablets produced by different manufacturers are obviously inconsistent. The dissolution test can help control the quality of the drug.