【摘要】 目的制备牛血清蛋白(BSA)缓释片并对其体外释放进行考察。方法以BSA为模型药物,烷基果胶为骨架材料制备BSA缓释片并考察其体外释放的影响因素。研究了稳定性实验,并进行精密度测定,考察释放介质pH值(1.0,6.86,7.8)、转篮转速(50,100,150r·min-1)、压片压力(6,8,10kg·mm-2)、果胶取代度(DS=0.136 0,0.141 2,0.156 3)等对BSA缓释片体外释放实验的影响。结果稳定性实验的平均回收率为(99.99±0.45)%,RSD为0.45%,精密度实验平均回收率为(100.31±0.037)%,RSD为0.036 7%,均符合实验要求。BSA缓释片具有pH敏感性,在pH<6.8的介质中24h内几乎不释放药物,而在pH7.8的磷酸盐缓冲液中可持续释药24h,累积释放量达96%以上。结论以pH7.8的缓冲液为释放介质时,不同的压片压力、转篮转速对药物释放有明显影响。制得的缓释片作为药物载体具有较好的应用前景。更多还原

【Abstract】 OBJECTIVE To prepare bovine serum albumin(BSA) tablets and investigate the drug release in vitro.METHODS BSA tablet was prepared with alkyl-pectin as skeleton materials for colon-specific delivery(BSA-CSD),and the releasing property in vitro was evaluated.The stability and precision of the tablets were also tested.The effects of different pH(1.0,6.86,7.8) of different dissolution media,rotational speeds(50,100,150 r·min-1),compaction pressures(6,8,10 kg·mm-2) and degree of substitution(DS=0.136 0,0.141 2,0.156 3) of pectin on dissolution rates were studied.The releasing property of the preparation was evaluated by the dissolution tests in vitro by measuring the content of BSA.RESULTS The stability testing of the average recovery was(99.99±0.45)%,and the RSD was 0.45%;the average recovery of precision was(100.31±0.0367)%,and the RSD was 0.037%,which conformed to the requirements of experiments.The results showed the BSA sustained-releasing tablet kept releasing for 24 h in phosphate buffer solution at pH 7.8,while hardly released in the environment at pH<6.8.The accumulating releasing rate was above 96%.CONCLUSION The different rotational speeds and compaction pressures made significant difference on the releasing rate in phosphate buffer solution at pH 7.8.Therefore,the tablets has a good prospect of application in drug delivery system.更多还原