舒胸脉冲控释滴丸的体外释药特性考察

Investigation of in vitro Release Characteristics of Shuxiong Pulsatile Controlled-Release Dropping Pills

摘要:

目的：探讨舒胸脉冲控释滴丸的体外释药特性。方法：采用小杯法测定体外释放度，考察不同释放介质、转速对舒胸脉冲控释滴丸体外释药行为的影响，阐述脉冲控释滴丸的释药机制及释药特点。结果：释放介质的pH对脉冲控释滴丸释药的影响最明显。前2 h介质为0.1 mol·L^-1的盐酸溶液，2 h后采用磷酸钠溶液将介质调pH 6.8，转速100 r·min^-1，恒温（37±0.5） ℃，脉冲控释滴丸释药良好。结论：舒胸脉冲控释滴丸时滞后符合一级释药动力学模型，具备优良控释制剂的特征。

Abstract:

Objective: To investigate in vitro release characteristics of Shuxiong pulsatile controlled-release dropping pills (SPCDP). Method: Determination of dissolution was taken by small glass method, effects of dissolution medium and stirring rate on in vitro release behavior were investigated, then release mechanism and characteristics of pulsatile controlled-release dropping pills were explained. Result: Release behavior of SPCDP was influenced most greatly by pH value of dissolution medium.Release behavior of pulsatile controlled-release dropping pills was good in 0.1 mol·L^-1 HCl solution at the first 2 h and in phosphate buffer solution (pH 6.8) after 2 h with stirring rate of 100 r·min^-1 by small glass method at (37±0.5) ℃. Conclusion: Description of dissolution profiles suggested that first order equation was the most appropriate model to describe release kinetics of SPCDP, this preparation had excellent characteristics of controlled-release formulation.