豆豉溶栓酶肠溶片剂的制备及体外释放度

Preparation and in vitro Drug-release of Douchi Fibrinolytic Enzyme Enteric-coated Tablets

采用均匀设计优化豆豉溶栓酶肠溶片片芯的制备工艺。结果表明,按优化处方经工艺过程制得的片芯酶活性损失仅6%。包肠溶衣后的制品在0.1mol/L盐酸中2h平均累积释放率为2.1%;在0.2mol/L磷酸钠缓冲液(pH6.8)中,23.4min累积释药50%,45min释药86.3%,释药规律符合Weibull分布模型。

The preparation of douchi （fermented soybean） fibfinolytic enzyme tablets was optimized by uniform design. The results showed that the loss of enzyme activity of the tablets in the procedure prepared by the optimized formulation was about 6 %. The 2h accumulative amount of the enteric layer coated product in 0. lmol/L HCl was 2.1%. The time of release 50 % amount of the enzyme was 23.4min and the 45min accumulative amount was 86.3 % in 0.2mol/L sodium phosphate buffer solution （pH 6.8） and could be simulated by Weibull model.