银杏提取物缓释片的制备及其体外释放度的研究

目的:制备银杏提取物缓释片并考察其体外释放度.方法:以溶胀性材料羧甲基纤维素钠和羟丙甲基纤维素为骨架材料,直接粉末压片制备银杏提取物缓释片.根据单因素试验中各因素对银杏提取物体外释放度影响结果,进行正交设计,优化处方和工艺,以f_2相似因子法评价释放的差异.结果:羟丙甲基纤维素与羧甲基纤维素钠的用量比、羟丙甲基纤维素的黏度、不同的稀释剂均对药物释放有一定的影响,而缓释片的硬度、片重等对药物的释放没有显著的影响.结论:以羟丙甲基纤维素和羧甲基纤维素钠为骨架材料,制得持续释药12 h的银杏提取物缓释片.

Preparation and in vitro release of ginkgo biloba extract sustained-release tablets

Objective: To prepare ginkgo biloba extract (GBE) sustained-release tablets and observe its in vitro release profile. Method: GBE sustained-release tablets were prepared by direct compression method using sodium carboxymethylcellulose (CMC-Na) and hydroxypropyl methylcellulose HPMC) as matrix excipients. Based on the result of single-factor selecting experiment, the formulations and preparation process were optimized through orthogonal design, and release difference of tablets was evaluated with similarity factor (f₂). Result: The ratio of HPMC and CMC-Na, the viscosity of HPMC and the different types of the diluents had pronounced effect on the release of GBE sustained release tablets, although the hardness and weight difference of tablets did not show notable influences. Conclusion: GBE sustained-release tablets that prepared by using the mixture of HPMC and CMC-Na display constant release profile in 12 h.