枸橼酸西地那非速崩舌下片的制备及质量评价

目的制备枸橼酸西地那非速崩舌下片,并评价其质量。方法采用升华剂为致孔剂,采用外加致孔刺法压制舌下片,并以真空干燥除去升华剂获得快速崩解的舌下片,对速崩舌下片以崩解时间、润湿时间、吸水比、体外溶出度等指标评价处方。结果以升华剂为致孔剂制备的枸橼酸西地那非速崩舌下片,均在30 s内崩解,且各样品均在6 min内即可达到全部溶出,其他各检测指标均符合速崩舌下片的指标。结论采用升华剂为致孔剂制备枸橼酸西地那非速崩舌下片工艺可行,制备的速崩舌下片崩解时间短,溶出速率快。

Preparation and Evaluation of Sildenafil Citrate Rapidly Disintegrating Sublingual Tablets

Objective To prepare Sildenafil Citrate Rapidly Disintegrating Sublingual Tablets and to evaluate its quality. Methods The sublimation agent was adopted as the pore- forming agent. The sublingual tablets were prepared by adding pore- forming agent and the vacuum drying was conducted for removing the sublimation agent and obtaining the rapidly disintegrating sublingual tablets. The formula- tion was evaluated by the indexes of the disintegrating time, wetting time, water absorption ratio and in vitro dissolution rate. Results Sildenafil Citrate Rapidly Disintegrating Sublingual Tablets prepared by using the sublimation agent as the pore- forming agent was dis- integrated within 30 s. The each sample was completely dissolved within 6 s. The other detection indexes all accorded with the standard of rapidly integrating sublingual tablets. Conclusion Preparing Sildenafil Citrate Rapidly Disintegrating Sublingual Tablets by using the sublimation agent as the pore-forming agent is feasible in technology, the prepared rapidly disintegrated sublingual tablets have the short disintegrating time and rapid dissolution.