药学研究
藥學研究
약학연구
JOURNAL OF PHARMACEUTICAL RESEARCH
2015年
5期
249-253,308
,共6页
查静%王铁杰%王思明%涂家生
查靜%王鐵傑%王思明%塗傢生
사정%왕철걸%왕사명%도가생
预混辅料%口腔崩解片%拉莫三嗪
預混輔料%口腔崩解片%拉莫三嗪
예혼보료%구강붕해편%랍막삼진
Co-processed exicipient%Orally disintegrating tablets%Lamotrigine
目的：由预混辅料入手，制备拉莫三嗪口腔崩解片。方法以异麦芽酮糖醇、微晶纤维素和交联聚维酮为主要辅料，使用湿法制粒的方法制备预混辅料，并测定了预混辅料产品的粉体学性质。选用拉莫三嗪为主药，与预混辅料及少量崩解剂、润滑剂和矫味剂，通过粉末直压的方法制备拉莫三嗪口腔崩解片，并对拉莫三嗪口腔崩解片进行基本的体外评价。结果通过单因素考察和正交试验，预混辅料的最终处方组成为：异麦芽酮糖醇与微晶纤维素的比例为3：4，加入8%交联聚维酮。拉莫三嗪口腔崩解片的最优处方组成（按1000片计）为：25 g 拉莫三嗪，137 g预混辅料，14.4 g低取代羟丙基纤维素，1.8 g硬脂酸镁，1.8 g矫味剂。拉莫三嗪口腔崩解片的崩解时限为35 s，且在5 min内溶出完全。结论根据试验，制备的预混辅料的性质优良，口腔崩解片的崩解时限、口感和溶出度等均符合规定。
目的：由預混輔料入手，製備拉莫三嗪口腔崩解片。方法以異麥芽酮糖醇、微晶纖維素和交聯聚維酮為主要輔料，使用濕法製粒的方法製備預混輔料，併測定瞭預混輔料產品的粉體學性質。選用拉莫三嗪為主藥，與預混輔料及少量崩解劑、潤滑劑和矯味劑，通過粉末直壓的方法製備拉莫三嗪口腔崩解片，併對拉莫三嗪口腔崩解片進行基本的體外評價。結果通過單因素攷察和正交試驗，預混輔料的最終處方組成為：異麥芽酮糖醇與微晶纖維素的比例為3：4，加入8%交聯聚維酮。拉莫三嗪口腔崩解片的最優處方組成（按1000片計）為：25 g 拉莫三嗪，137 g預混輔料，14.4 g低取代羥丙基纖維素，1.8 g硬脂痠鎂，1.8 g矯味劑。拉莫三嗪口腔崩解片的崩解時限為35 s，且在5 min內溶齣完全。結論根據試驗，製備的預混輔料的性質優良，口腔崩解片的崩解時限、口感和溶齣度等均符閤規定。
목적：유예혼보료입수，제비랍막삼진구강붕해편。방법이이맥아동당순、미정섬유소화교련취유동위주요보료，사용습법제립적방법제비예혼보료，병측정료예혼보료산품적분체학성질。선용랍막삼진위주약，여예혼보료급소량붕해제、윤활제화교미제，통과분말직압적방법제비랍막삼진구강붕해편，병대랍막삼진구강붕해편진행기본적체외평개。결과통과단인소고찰화정교시험，예혼보료적최종처방조성위：이맥아동당순여미정섬유소적비례위3：4，가입8%교련취유동。랍막삼진구강붕해편적최우처방조성（안1000편계）위：25 g 랍막삼진，137 g예혼보료，14.4 g저취대간병기섬유소，1.8 g경지산미，1.8 g교미제。랍막삼진구강붕해편적붕해시한위35 s，차재5 min내용출완전。결론근거시험，제비적예혼보료적성질우량，구강붕해편적붕해시한、구감화용출도등균부합규정。
Objective To prepare Lamotrigine Orally Disintegrating Tablets( ODTs)based on the co-processed ex-cipients. Methods Firstly,to prepare the co - processed excipient consisting of isomalt,microcrystalline cellulose and crospovidone by wet granulation method. Afterwards,Lamotrigine ODTs was directly compressed after mixing the co-pro-cessed excipient with a small amount of disintegrant,taste-masked agents and magnesium stearate,and the formula optimi-zation was conducted. Finally,the micromeritic properties of co-processed excipient and the disintegration time of Lam-otrigine ODTs with the optimal formula were investigated. Results The desirable co-processed excipient composed of iso-malt/microcrystalline cellulose at a ratio of 3:4 and 8% crospovidone. And the components of the optimal formula of Lam-otrigine ODTs(in 1 000)included 25 g lamotrigine,137 g co-processed excipient,14. 4 g low-substituted hydroxypropyl cellulose,1. 8 g magnesium stearate,1. 8 g taste-masked agents. From the in-vitro study,the disintegration and dissolu-tion time of Lmotrigine ODTs were within 35 seconds and 5 minutes,respectively. Conclusion According to the experi-ments,the micromeritic properties of co-processed excipients was good and the disintegration time,the dissolution time and the taste of ODTs were eligible.
