中国临床药理学杂志
中國臨床藥理學雜誌
중국림상약이학잡지
THE CHINESE JOURNAL OF CLINICAL PHARMACOLOGY
2010年
3期
201-204
,共4页
陆益红%文红梅%李伟%池玉梅%张银娣%沈建平%张正行
陸益紅%文紅梅%李偉%池玉梅%張銀娣%瀋建平%張正行
륙익홍%문홍매%리위%지옥매%장은제%침건평%장정행
盐酸多奈哌齐片%药代动力学%生物等效性%高效液相飞行时间质谱
鹽痠多奈哌齊片%藥代動力學%生物等效性%高效液相飛行時間質譜
염산다내고제편%약대동역학%생물등효성%고효액상비행시간질보
donepezil hydrochloride tablets%pharmacokinetics%bio-equivalence%high pressure liquid chromatography time-of-flight mass spectrometry
目的 研究国产与进口盐酸多奈哌齐片在健康人体的生物等效性.方法 20名男性健康志愿者随机交叉给药,分别单剂量口服国产(受试制剂)与进口盐酸多奈哌齐片(参比制剂),用高效液相飞行时间质谱(HPLC/TOF/MS)联用技术,测定人血浆中多奈哌齐的浓度,计算2者的药代动力学参数及相对生物利用度,并评价2制剂的生物等效性.结果 口服国产及进口盐酸多奈哌齐片5mg的主要药代动力学参数:t_(1/2)分别为(62.56±9.76),(65.70±12.80)h;t_(max)分别为(3.15±0.67),(3.10±0.55)h;C_(max)分别为(10.42±2.52),(10.06±2.02)ng·mL~(-1);AUC_(0-192)分别为(489.37±154.32),(484.76±150.13)ng·h·mL<-1>;AUC_(0-∞)分别为(566.52±193.84),(564.38±176.10)ng·h·mL~(-1).用AUC_(0-192)、AUC_(0-∞)估算多奈哌齐供试片的相对生物利用度分别为(100.7±9.2)%,(99.2 ±11.9)%.结论 2种盐酸多奈哌齐片为生物等效制剂.
目的 研究國產與進口鹽痠多奈哌齊片在健康人體的生物等效性.方法 20名男性健康誌願者隨機交扠給藥,分彆單劑量口服國產(受試製劑)與進口鹽痠多奈哌齊片(參比製劑),用高效液相飛行時間質譜(HPLC/TOF/MS)聯用技術,測定人血漿中多奈哌齊的濃度,計算2者的藥代動力學參數及相對生物利用度,併評價2製劑的生物等效性.結果 口服國產及進口鹽痠多奈哌齊片5mg的主要藥代動力學參數:t_(1/2)分彆為(62.56±9.76),(65.70±12.80)h;t_(max)分彆為(3.15±0.67),(3.10±0.55)h;C_(max)分彆為(10.42±2.52),(10.06±2.02)ng·mL~(-1);AUC_(0-192)分彆為(489.37±154.32),(484.76±150.13)ng·h·mL<-1>;AUC_(0-∞)分彆為(566.52±193.84),(564.38±176.10)ng·h·mL~(-1).用AUC_(0-192)、AUC_(0-∞)估算多奈哌齊供試片的相對生物利用度分彆為(100.7±9.2)%,(99.2 ±11.9)%.結論 2種鹽痠多奈哌齊片為生物等效製劑.
목적 연구국산여진구염산다내고제편재건강인체적생물등효성.방법 20명남성건강지원자수궤교차급약,분별단제량구복국산(수시제제)여진구염산다내고제편(삼비제제),용고효액상비행시간질보(HPLC/TOF/MS)련용기술,측정인혈장중다내고제적농도,계산2자적약대동역학삼수급상대생물이용도,병평개2제제적생물등효성.결과 구복국산급진구염산다내고제편5mg적주요약대동역학삼수:t_(1/2)분별위(62.56±9.76),(65.70±12.80)h;t_(max)분별위(3.15±0.67),(3.10±0.55)h;C_(max)분별위(10.42±2.52),(10.06±2.02)ng·mL~(-1);AUC_(0-192)분별위(489.37±154.32),(484.76±150.13)ng·h·mL<-1>;AUC_(0-∞)분별위(566.52±193.84),(564.38±176.10)ng·h·mL~(-1).용AUC_(0-192)、AUC_(0-∞)고산다내고제공시편적상대생물이용도분별위(100.7±9.2)%,(99.2 ±11.9)%.결론 2충염산다내고제편위생물등효제제.
Objective To study the bioequivalence of domestic and im-ported donepezil hydrochloride tablets in healthy volunteers. Methods Twenty healthy males volunteers were orally administered with a random-ized and single crossover dose of domestic and imported donepezil hydro-chloride tablets 5 mg. The plasma concentration of donepezil was deter-mined by high pressure liquid chromatography time-of-flight mass spectrometry. The pharmacokinetic parameters and relative bioavalibility were calculated to evaluate the bioequivalence of two preparations. Re-sults The main pharmacokinetic parameters of test (domestic)and refer-ence(imported) sample were as follows: t_(1/2) were (62. 56 ± 9. 76) h and (65. 70 ±12. 80)h;t_(max) were (3.15±0.67) h and (3. 10±0.55) h;C_(max)were(10. 42±2. 52) ng· mL~(-1) and (10. 06±2. 02) ng· mL~(-1) ;AUC_(0-192) were (489. 37 ±154. 32) ng·h · mL~(-1) and (484. 76 ±150. 13) ng ·h · mL~(-1);AUC_(0-∞) were (566.52±193.84) ng · h· mL~(-1) and (564.38 ±176. 10) ng ·h ·mL~(-1). The mean bioavalibility values of AUC_(0-192) and AUC_(0-∞) were (100.7±9.2)% and (99.2±11.9)%. Conclusion The two kinds of donepezil hydrochloride tablets were bioequivalent.