褪黑素缓释片的释放度对比研究  

Comparative study on the releasing properties of Melatonin sustained release tablets

作　　者：多布拉 琼次仁[2] 

机构地区：[1]西藏日喀则市人民医院药剂科,西藏日喀则857000 [2]西藏自治区第二人民医院药剂科,西藏拉萨850000

出　　处：《华西药学杂志》2015年第4期411-413,共3页West China Journal of Pharmaceutical Sciences

摘　　要：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 study the in vitro release rate of Melatonin sustained - release tablets made in lab in comparison to that of the generic products （ Circadin ）. METHODS The in vitro releases of Melatonin was determined by a validated HPLC method. A dissolution test method was developed by investigating effects of the testing apparatus, the stirring speed and the pH of media on the releases of Melatonin. By using the optimized method, the in vitro releases of the sample tablets and Circadin were therefore comparatively investigated. RESULTS Compared to Circadin , the sample tablets exhibited similar releasing properties as Circadin . In water, antifical gastric juice, acetate buffer solution（ pH4.5 ） and artifical intestinal juice, the f2 factor was 64.7,67.1,56.7 and 67.7, respectively. In the pH 6.8 phosphate buffer, the releasing properties of three batches of our products demonstrate the same releasing profiles ,which were best explained by the Weibull model. CONCLUSION Sample has the same release behavior as Circadin ,both of them can release Melatonin sustainedly in 8 h.

关 键 词：褪黑素 缓释制剂 释放度 高效液相色谱法 对比研究 威布尔模型 激素 

分 类 号：R94[医药卫生—药剂学]