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目的比较褪黑素缓释片(Circadin)与自制缓释片的释放度。方法采用HPLC法测定褪黑素的含量,考察释放度检查装置、转速、pH对释放度的影响,并比较进口药物与自制样品的释放度。结果自制样品与进口药物比较,在水、人工胃液、pH4.5乙酸盐缓冲液和人工肠液中释放的f2因子分别为64.7、67.1、56.7、67.7,表明两者释放行为相似;3批样品的释放曲线拟合符合威布尔模型。结论自制缓释片与进口药物的释放行为一致,均能在8 h内缓慢释放褪黑素。
Objective To compare the release of melatonin and homemade sustained release tablets. Methods The content of melatonin was determined by HPLC. The effects of device, rotation speed and pH on the release of melatonin were investigated. The release of imported drugs and homemade samples were compared. Results Compared with the imported drugs, the f2 factors released in water, artificial gastric juice, pH4.5 acetate buffer and artificial intestinal juice were 64.7, 67.1, 56.7 and 67.7 respectively, indicating that the release behavior of the two samples was similar. Three batches of samples The fit of the release curve fits the Weibull model. Conclusion The self-made sustained-release tablets showed the same release behavior as the imported drugs, both of which released melatonin slowly within 8 hours.