论文部分内容阅读
目的 制备一种由溶蚀塞控制时滞的新型脉冲给药系统并对其体外释药行为进行评价。方法 用灌注法制备非渗透性胶囊体 ,用湿法制粒压片法制备含药片和溶蚀塞 ,将填充剂和含药片用溶蚀塞密封在非渗透性胶囊体中制备磷酸川芎嗪 (TMPP)脉冲塞胶囊 ,用释放度测定法研究溶蚀塞的制剂学特征及溶出条件对释药时滞的影响。结果 溶蚀塞的处方组成和重量能显著影响磷酸川芎嗪脉冲塞胶囊的释药时滞 ,释药时滞随溶蚀塞中凝胶形成赋形剂羟丙甲基纤维素 (HPMC)含量和溶蚀塞重量的增加而增加 ,而溶蚀塞的硬度对时滞无显著影响。此外 ,释药时滞还随搅拌桨转速的增加而缩短。溶出介质的pH则对时滞无显著影响。结论 通过调节溶蚀塞的处方组成和重量可获得具有适当时滞的脉冲给药系统 ,满足时辰治疗的要求
OBJECTIVE: To prepare a new pulsed drug delivery system controlled by dissolution plugs and to evaluate its in vitro drug release. Methods Permeable capsule was prepared by perfusion method. The tablet and dissolution plug were prepared by wet granulation method. The filler and tablet were sealed with impermeable capsule in a non-permeable capsule to prepare a pulse of tetramethylpyrazine phosphate (TMPP) Capsule, the release of determination of dissolution of the dissolution of the pharmaceutical characteristics and dissolution conditions on the release of drug delay. Results The composition and weight of the dissolving plugs could significantly affect the release delay of Ligustrazine Phosphate Capsules. The drug release time lags with the content of hydroxypropyl methylcellulose (HPMC) and dissolution plugs The increase of weight increases, while the hardness of the dissolution plug has no significant effect on the time lag. In addition, the release delay is also shortened as the propeller speed increases. The pH of the dissolution medium had no significant effect on the time lag. Conclusion Pulsed drug delivery system with appropriate time delay can be obtained by adjusting the composition and weight of the dissolution plug prescription to meet the requirements of the hour treatment