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目的研究盐酸索他洛尔脉冲微丸的体外释放特性,根据本类脉冲释放曲线的关键点的比较指导处方优化。方法采用多种数学模型拟合释放曲线,并对各曲线回归方程进行拟合优度测验;同时利用曲线的载荷信息,通过曲线的生长速度函数的一阶和二阶导数得到曲线变化的数学突变点。结果Logistic拟合释放曲线的拟合优度x2及AIC最小,r2最接近于1,说明Logistic拟合效果最好;同时得到比较本类型释放曲线的3个关键点t1=-(lnc2+1.317)/c3,tm=(lnc2)/c3,t2=(1.317-lnc2)/c3,将曲线分为迟释期(0～t1)、突释期(t1～t2)以及减速释放期(t2～∞)。结论通过本类型的曲线拟合及推导,提出可以用模拟曲线的关键点评价不同处方的释放特性,从而指导及优化处方并作进一步研究。
Objective To study the in vitro release characteristics of sotalol hydrochloride pellets and to optimize the prescription according to the comparison of the key points of this type of pulse release curve. Methods A variety of mathematical models were used to fit the release curve and goodness-of-fit tests were performed on the regression equations of each curve. At the same time, the mathematical mutation of the curve was obtained by using the load information of the curve and the first and second derivatives of the growth rate function of the curve point. Results The goodness-of-fit and logarithmic AIC of Logistic fitted release curve were the best, and r2 was the closest to 1, which indicated that Logistic fit was the best. At the same time, we obtained three key points t1 = - (lnc2 + 1.317) /c3,tm=(lnc2)/c3,t2=(1.317-lnc2)/c3, the curve is divided into the period of delayed release (0 ~ t1), burst release (t1 ~ t2) and deceleration release period (t2 ~ ∞ ). Conclusion Through the curve fitting and derivation of this type, it is proposed that the release characteristics of different prescriptions can be evaluated by using the key points of the simulated curve so as to guide and optimize the prescription and further study.