槐果碱缓释片的制备及工艺优选

Optimization of formulation technology for sustained- release tablets of sophocarpine

以羟丙甲基纤维素为缓释辅料,雅克宜为肠溶包衣材料,优选槐果碱处方工艺.采用湿法制粒压片法制备槐果碱缓释片,以片剂颜色、外观形态、重量变化、14 h累积释放度为考察指标,通过单因素实验和正交实验确定最佳工艺.结果表明:最佳工艺为HPMC(K4M)90 mg,乳糖130 mg,槐果碱80mg,乙醇体积分数为95%.采用最佳工艺制得的槐果碱缓释片,外观光滑平整,具有一定的缓释特性及稳定性;提高了药物的相对生物利用度.

To optimize the prescription process , sophocarpine oral release tablets were pre-pared using HPMC as hydrophilic gel matrix sustained -release materials and Acry-EZE as enteric coating material .Sophocarpine sustained -release tablets were prepared using wet granulation method .Single factor and orthogonal experiments was conducted to determine the optimum process with tablet color , morphology , weight change and 14 h cumulative release as evaluation indexes .Results indicated that the optimum prescription is HPMC （ K4M） 90 mg, lactose 130 mg, sophocarpine 80 mg; ethanol purity of 95%.Sophocarpine oral sus-tained-release tablet prepared by optimum prescription has smooth appearance , certain slow-release characteristics and good stability .The well designed formulation can improve the relative bioavailability of the drugs .