CAJ | 학술논문

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80 mg，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。
이간병갑기섬유소위완석보료，아극의위장용포의재료，우선괴과감처방공예。채용습법제립압편법제비괴과감완석편，이편제안색、외관형태、중량변화、14 h루적석방도위고찰지표，통과단인소실험화정교실험학정최가공예。결과표명：최가공예위HPMC （ K4M）90 mg，유당130 mg，괴과감80 mg，을순체적분수위95％。채용최가공예제득적괴과감완석편，외관광활평정，구유일정적완석특성급은정성；제고료약물적상대생물이용도。
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 .