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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。
Objective To prepare bovine serum albumin (BSA) sustained-release tablets and investigate its in vitro release. Methods BSA as model drug and alkyl pectin as matrix material were used to prepare BSA sustained-release tablets and investigate the influencing factors of in vitro release. The stability experiment and the determination of the precision were studied. The effects of release media pH value (1.0, 6.86, 7.8), basket rotation speed (50,100,150r · min-1), tabletting pressure (6,8,10kg · mm-2 ), The degree of substitution of pectin (DS = 0.136 0,0.141 2,0.156 3) on the in vitro release of BSA sustained-release tablets. Results The average recovery of the stability test was (99.99 ± 0.45)% and the RSD was 0.45%. The average recovery of the precision test was (100.31 ± 0.037)% and the RSD was 0.036 7%. All of them met the experimental requirements. BSA sustained-release tablets have pH-sensitive properties, almost no drug release within 24h in pH <6.8 medium, and sustained release in phosphate buffer solution of pH7.8 for 24h, with a cumulative release of more than 96%. Conclusion When using pH7.8 buffer as the releasing medium, the different tabletting pressure and spinning speed have significant effects on drug release. The prepared sustained-release tablets as a drug carrier has a good application prospect.