国际检验医学杂志
國際檢驗醫學雜誌
국제검험의학잡지
INTERNATIONAL JOURNAL OF LABORATORY MEDICINE
2014年
16期
2214-2215
,共2页
头孢呋辛酯片%溶出曲线%f2因子
頭孢呋辛酯片%溶齣麯線%f2因子
두포부신지편%용출곡선%f2인자
cefuroxime axetil tablets%stripping curve%f2 factor
目的:评价自制制剂与原研药的溶出行为相似性。方法基于药典中的溶出度测定方法,分别考察自制制剂与原研药品在纯水,0.1、0.05 mol/L 盐酸,pH4.5、pH6.8的介质,以及在25、50、75 r/min 转速时的溶出行为,并用 f2因子法比较溶出曲线。结果当转速为50 r/min 在5种介质中,f2因子分别为57.65,79.17,73.56,66.83和62.33;介质为0.1 mol/L 的盐酸,转速为25 r/min 和75 r/min 时,f2值分别为65.35、78.48。结论自制制剂与原研药各条件下的溶出曲线相似。
目的:評價自製製劑與原研藥的溶齣行為相似性。方法基于藥典中的溶齣度測定方法,分彆攷察自製製劑與原研藥品在純水,0.1、0.05 mol/L 鹽痠,pH4.5、pH6.8的介質,以及在25、50、75 r/min 轉速時的溶齣行為,併用 f2因子法比較溶齣麯線。結果噹轉速為50 r/min 在5種介質中,f2因子分彆為57.65,79.17,73.56,66.83和62.33;介質為0.1 mol/L 的鹽痠,轉速為25 r/min 和75 r/min 時,f2值分彆為65.35、78.48。結論自製製劑與原研藥各條件下的溶齣麯線相似。
목적:평개자제제제여원연약적용출행위상사성。방법기우약전중적용출도측정방법,분별고찰자제제제여원연약품재순수,0.1、0.05 mol/L 염산,pH4.5、pH6.8적개질,이급재25、50、75 r/min 전속시적용출행위,병용 f2인자법비교용출곡선。결과당전속위50 r/min 재5충개질중,f2인자분별위57.65,79.17,73.56,66.83화62.33;개질위0.1 mol/L 적염산,전속위25 r/min 화75 r/min 시,f2치분별위65.35、78.48。결론자제제제여원연약각조건하적용출곡선상사。
Objective To evaluate the similarity of dissolution profiles of self-produced and original drug cefuroxime axetil tab-lets.Methods Based on the dissolution detection method in the Chinese Pharmacopoeia,the dissolution behaviors of the self-pro-duced preparation and original drug were investigated in pure water,0.1 mol/L hydrochloric acid,0.05 mol/L hydrochloric acid, pH4.5 and pH6.8 medium and the rotation speed of 50,25,75 r/mim.The stripping curves were evaluated by the f2 factor method. Results In the rotation speed of 50 r/min,the f2 factors in different mediums were 57.65,79.17,73.56,66.83 and 62.33 respec-tively;the medium was 0.1 mol/L hydrochloric acid with the rotation speed of 25,75 r/min,the f2 factors were 65.35 and 78.48 re-spectively.Conclusion The stripping curves of self-produced preparation and original drug are similar under various conditions.