CAJ | 학술논문

目的：研究并优化盐酸帕洛诺司琼口腔崩解片的制备工艺。方法采用粉末直接压片法制备盐酸帕洛诺司琼口腔崩解片,采用 HPLC 法测定其含量,以崩解时限为指标优化处方。结果以12%低取代羟丙甲基纤维素,甘露醇∶优化微晶纤维素为2∶1,2%硬脂酸镁,3%甜菊苷制备的盐酸帕洛诺司琼口腔崩解片(60 mg/片)外观圆整光洁,口感良好,崩解时限为12 s,硬度为3 kg,4 min 溶出度为99%。结论该制剂制备简单,处方合理,崩解较快。
목적：연구병우화염산파락낙사경구강붕해편적제비공예。방법채용분말직접압편법제비염산파락낙사경구강붕해편,채용 HPLC 법측정기함량,이붕해시한위지표우화처방。결과이12%저취대간병갑기섬유소,감로순∶우화미정섬유소위2∶1,2%경지산미,3%첨국감제비적염산파락낙사경구강붕해편(60 mg/편)외관원정광길,구감량호,붕해시한위12 s,경도위3 kg,4 min 용출도위99%。결론해제제제비간단,처방합리,붕해교쾌。
Objective To prepare optimization of palonosetron hydrochloride oral disintegrating tablets by orthogonal test. Methods Palonosetron hydrochloride oral disintegrating tablets were prepared with direct compression process.The content of pal-onosetron hydrochloride was determined by HPLC.The formulation was optimized with disintegration time as evaluation indices. Results The optimal formulation(60 mg/tablet)was as follows:L-HPC 12%,mannitol∶SMCC= 2∶1,magnesium stearate 2%, stevia glycosides 3%.The oral disintegrating tablets showed dine appearance and tested better;the disintegration time was 12 sec-onds;the tablets featured a hardness of 3 kg;4 min dissolution rate was 99%.Conclusion The preparation method is simple and reasonable,and the tablets can disintegrate rapidly.