灌注法制备脉冲给药装置的新型非渗透性胶囊体

Preparation of novel impermeable capsule bodies for pulsatile drug delivery device

目的制备一种用于脉冲给药装置的新型非渗透性胶囊体,优化制备工艺并考察处方对其渗透行为的影响,研究其药剂学性质。方法灌注法制备非渗透性胶囊体,通过HPLC法测定渗透介质中药物磷酸川芎嗪的浓度,考察影响药物通过胶囊体渗出量的影响因素。结果用11%的45 cps乙基纤维素(EC)溶液制备的胶囊体可在24 h内保持非渗透能力。随着制备胶囊体的EC粘度级别的增加和EC溶液浓度的增大,制得的EC胶囊体的非渗透能力逐渐增大。结论调整EC黏度级别和EC浓度,用灌注法可制备在一定时间内保持非渗透的合适胶囊体,为进一步制备用于时辰治疗的脉冲释药装置奠定基础。

OBJECTIVE To prepare novel impermeable capsule bodies for pulsatile drug delivery device, to optimize the preparing technique and evaluate the effects of the formulation on their permeable behavior, and to investigate their pharmaceutical properties. METHODS Impermeable capsule bodies were prepared by filling method. Tetramethylpyrazine phosphate concentration in infitration media was determined by HPLC and influential factors on drug permeability through capsule bodies were studied. RESULTS Capsule bodies prepared with 11% of ethyl cellulose （EC） solution could keep impermeable within 24 h. The impermeable ability of EC capsule bodies was gradually enhanced with the increase of viscosity grade of EC and concentration of EC solution. CONCLUSION By adjusting viscosity grade of EC and concentration of EC solution, capsule bodies may be impermeable within a certain period of time obtained using filling method, which provider foundation for further preparation of pulsatile drug delivery device for chronotherapy,