摘要
目的:制备奥氮平口溶膜处方并评价其质量。方法:采用溶剂浇铸法制备奥氮平口溶膜,分别以羟丙甲基纤维素(HPMC)和聚乙二醇400(PEG400)用量作为考察因素,以口溶膜的拉伸强度、延展率、10 min药物溶出度作为评价指标,通过Box-Behnken效应面法优化了奥氮平口溶膜的处方;评价口溶膜的拉伸强度、延展率、耐折度、崩解时限和药物溶出度,并与市售奥氮平口崩片进行体外溶出度对比研究。结果:当HPMC和PEG400用量分别为11.0%和2.3%,制得的奥氮平口溶膜成膜性能较强,具有较高的硬度和柔韧性,50 s内可迅速溶解,药物溶出速度较快,与市售奥氮平口崩片体外溶出相似。结论:奥氮平口溶膜处方设计合理,工艺可行,质量稳定可控,值得进一步开发研究。
Objective： To prepare olanzapine oral disintegrating films and evaluate its quality. Methods： The formula of olanzap- ine oral disintegrating films was optimized by Box-Behnken response surface methodology, the effects of the amount of HPMC and PEG400 were selected as the independent variables, and the tensile strength , the elongation rate and the drug dissolution at 10 min were used as the dependent variables. The tensile strength, elongation rate, folding endurance, disintegration time and drug dissolution of olanzapine oral disintegrating films were evaluated and the in vitro dissolution was compared with that of the marketed olanzapine oral disintegrating tablets. Results： The optimal formula of olanzapine oral disintegrating films was as follows： the amount of HPMC was 11.0% and the amount of PEG400 was 2.3%. The oral disintegrating films had good film-forming performance, high hardness and flexibility, and could quickly disintegrate in 50 s with fast drug dissolution, and the in vitro dissolution was similar to the marketed olanzapine oral disintegrating tablets. Conclusion： The formula of olanzapine oral disintegrating films is reasonable, the preparation process is feasible, and the quality is stable and controlled, which is worthy of further development.
出处
《中国药师》
CAS
2018年第1期104-108,共5页
China Pharmacist
关键词
奥氮平
口溶膜
溶剂浇铸法
BOX-BEHNKEN效应面法
Olanzapine
Oral disintegrating films
Solvent casting method
Box-Behnken response surface methodology
