双氯芬酸钠脉冲控释片的制备及释药机制的研究

Study on Diclofenac Sodium pulsatile release tablets prepatation and its release mechanism in vitro

目的选用高分子材料制备双氯芬酸钠(Diclofenac Sodium,DS)脉冲控释片,进行体外释放度考察并解析其释药机制。方法采用压制包衣技术制备DS脉冲控释片;用RP-HPLC法测定制剂含量;并应用紫外分光光度法进行体外释放度研究。结果HPMC用量或黏度增大,释药时滞延长;稀释剂用量增大,释药时滞缩短;在一定范围内,EC黏度对释药行为无影响。结论DS脉冲控释片能实现体外定时脉冲释药,并可通过调整处方实现不同时滞的控释效果。

Objective Use the high polymer material to prepare the pulsatile release tablets d Diclofenac Sodium （DS） and study the release mechanism in vitro. Methods The pulsatile tablets of DS was prepared with the press - coated technics. The effect of the core and the fdm on pulsataile release of DS was investigated under release rate test by UV. To develop a method for the quantitative determination of DS in DS pulsatile release tables. Results With the increase of HPMC amount or HPMC viscosity,the lag -time was prolonged;With the increase of additives amount, the lag -time was shortened;EC viscosity above certain degree showed no effect on DS. Conlusion The press -coated tablets of DS can be re- lease at the predetermined time and the controlled - release purpose can be reached by adjusting formulation and technic factors.