广州化工
廣州化工
엄주화공
GUANGZHOU CHEMICAL INDUSTRY AND TECHNOLOGY
2014年
13期
47-51
,共5页
何广卫%苏峰%许国琴%许慧雷
何廣衛%囌峰%許國琴%許慧雷
하엄위%소봉%허국금%허혜뢰
富马酸喹硫平%骨架缓释片%羟丙甲纤维素%f2 相似因子%累积释放度
富馬痠喹硫平%骨架緩釋片%羥丙甲纖維素%f2 相似因子%纍積釋放度
부마산규류평%골가완석편%간병갑섬유소%f2 상사인자%루적석방도
Quetiapine fumarate%Matrix sustained-release%HPMC%f2 similarity factor%cumulate release rate
以HPMC为骨架缓释材料，乳糖为填充剂，枸橼酸钠为pH调节剂，硬脂酸镁为润滑剂，采用单因素试验和正交实验设计方法，通过f2相似因子和累积释放度综合评分进行评价，最终确定富马酸喹硫平缓释片的处方组成为：富马酸喹硫平230 g， HPMC K100Lv 180 g， HPMC K4M 60 g，乳糖50 g，柠檬酸钠75 g，硬脂酸镁6 g。自研缓释片释放行为与原研制剂一致（ f2≥50），且符合Higuchi模型和Ritger-Peppas方程，表明药物释放机制是扩散与溶蚀并存的双重机制。
以HPMC為骨架緩釋材料，乳糖為填充劑，枸櫞痠鈉為pH調節劑，硬脂痠鎂為潤滑劑，採用單因素試驗和正交實驗設計方法，通過f2相似因子和纍積釋放度綜閤評分進行評價，最終確定富馬痠喹硫平緩釋片的處方組成為：富馬痠喹硫平230 g， HPMC K100Lv 180 g， HPMC K4M 60 g，乳糖50 g，檸檬痠鈉75 g，硬脂痠鎂6 g。自研緩釋片釋放行為與原研製劑一緻（ f2≥50），且符閤Higuchi模型和Ritger-Peppas方程，錶明藥物釋放機製是擴散與溶蝕併存的雙重機製。
이HPMC위골가완석재료，유당위전충제，구연산납위pH조절제，경지산미위윤활제，채용단인소시험화정교실험설계방법，통과f2상사인자화루적석방도종합평분진행평개，최종학정부마산규류평완석편적처방조성위：부마산규류평230 g， HPMC K100Lv 180 g， HPMC K4M 60 g，유당50 g，저몽산납75 g，경지산미6 g。자연완석편석방행위여원연제제일치（ f2≥50），차부합Higuchi모형화Ritger-Peppas방정，표명약물석방궤제시확산여용식병존적쌍중궤제。
Using f2 similarity factor and comprehensive score of the cumulate release rate as response value , single factor test and orthogonal experimental design were used to determine the viscosity and dosage of HPMC as matrix materials and dosage of lactose as diluents and sodium citrate as pH regulators and magnesium stearate as lubricants .The optimal formulation (1 000 units) was quetiapine fumarate 230 g, HPMC K100Lv 180 g, HPMC K4M 60 g, lactose 50 g, sodium citrate 75 g and magnesium stearate 6 g.The dissolution profile in difference pH media was consistent with reference listed drug ( f2≥50 ) , and the sustained -release tablets in vitro release fitted to the Higuchi model and Ritger -Peppas equation , the release mechanism in vitro was diffusion combined with corrosion.
