猪源纤维蛋白贴配方的优化

Optimization of the formulation of a porcine fibrin patch

目的优化猪源纤维蛋白贴(简称“DBT”)的配方。方法在单因素实验的基础上,以冻干前的纤维蛋白原、凝血酶和胶原蛋白含量为考察因素,以黏合强度、持黏力和吸水力的总评归一化(OD)值为响应值,采用Box-Behnken-响应面法优化DBT的配方,并进行验证。结果根据单因素实验和Box-Behnken-响应面法优化结果,结合实际生产,得DBT的最优配方为纤维蛋白原含量6.5 mg/cm^(2)、凝血酶含量8.0 IU/cm^(2)、胶原蛋白含量5.6 mg/mL;3次验证实验的平均OD值为0.7266(RSD=0.58%,n=3),与预测OD值(0.7330)的相对误差为-0.87%。结论所得DBT的最优配方稳定、可行。

OBJECTIVE To optimize the formulation of a porcine fibrin patch(abbreviated as“DBT”).METHODS Based on single-factor tests,with the contents of fibrinogen,thrombin and collagen before freeze-drying as the factors,with the overall desirability(OD)value of adhesion strength,holding viscosity and water absorption as response value,the formulation of DBT was optimized by Box-Behnken-response surface methodology,and the verification tests were conducted.RESULTS According to the results of the single factor tests and Box-Behnken-response surface methodology,combined with the actual production,the optimal formulation of DBT was 6.5 mg/cm^(2)of fibrinogen,8.0 IU/cm^(2)of thrombin and 5.6 mg/mL of collagen.The average OD value of 3 validation tests was 0.7266(RSD=0.58%,n=3),and the relative error of which with the predicted value(0.7330)was-0.87%.CONCLUSIONS The optimal formulation of DBT is stable and feasible.