過氧化氫酶脂質(zhì)體的藥代動(dòng)力學(xué)和生物等效性初步研究
發(fā)布時(shí)間：2019-03-06 09:28
【摘要】：目的:研究過氧化氫酶脂質(zhì)體(catalase liposomes,CALP)在SD大鼠體內(nèi)的藥代動(dòng)力學(xué)和生物等效性。方法:采用逆向蒸發(fā)法制備了CALP,并測定其粒徑、Zeta電位及包封率。將12只雄性SD大鼠隨機(jī)分為2組,分別靜脈注射CALP和游離過氧化氫酶(catalase,CAT),測定給藥后不同時(shí)間點(diǎn)大鼠血漿中過氧化氫酶的活性。采用DAS 2.1.1軟件計(jì)算藥物代謝動(dòng)力學(xué)參數(shù),并對CALP和CAT進(jìn)行生物等效性評價(jià)。結(jié)果:CALP的包封率為(53.72±1.67)%,粒徑和Zeta電位分別為(405.40±21.89)nm和(-15.70±3.22)m V。CALP和CAT的主要藥物代謝動(dòng)力學(xué)參數(shù)AUC0-t分別為(203.22±11.75)U(ml·h)和(50.92±3.51)U(ml·h),Cmax分別為(70.79±1.33)U/ml和(51.48±2.78)U/ml,Tmax分別為(0.58±0.14)h和(0.17±0.00)h。ln AUC、ln Cmax經(jīng)方差分析和雙單側(cè)檢驗(yàn)證明差異具有統(tǒng)計(jì)學(xué)意義(P0.05)。AUC0-t、AUC0-∞和Cmax的90%可置信區(qū)間分別為133.8%~140.1%,132.3%~146.7%,104.7%~107.5%。CALP和CAT的Tmax經(jīng)非參數(shù)法檢驗(yàn)差異無統(tǒng)計(jì)學(xué)意義(P0.05)。CALP的相對生物利用度為(399.1±23.1)%。結(jié)論:CALP提高了過氧化氫酶的生物利用度,CALP與CAT不具有生物等效性。
[Abstract]:Aim: to study the pharmacokinetics and bioequivalence of catalase liposomes (catalase liposomes,CALP) in SD rats. Methods: CALP, was prepared by reverse evaporation and its particle size, Zeta potential and entrapment efficiency were determined. Twelve male SD rats were randomly divided into two groups. CALP and free catalase (catalase,CAT) were injected intravenously. The activities of catalase in plasma of rats were measured at different time points after administration. The pharmacokinetic parameters were calculated by DAS 2.1.1 software, and the bioequivalence of CALP and CAT was evaluated. Results: the encapsulation efficiency of CALP was (53.72 鹵1.67)%. The main pharmacokinetic parameters of (405.40 鹵21.89) nm and (- 15.70 鹵3.22) m V.CALP and CAT were (203.22 鹵11.75) U (ml 路h and (50.92 鹵3.51) U (ml 路h, respectively. The main pharmacokinetic parameters were (405.40 鹵21.89) nm and (- 15.70 鹵3.22) m V.CALP, respectively. ) U (ml 路h), The Cmax values were (70.79 鹵1.33) U/ml and (51.48 鹵2.78) U / ml, (0.58 鹵0.14) h and (0.17 鹵0.00) h.ln AUC, respectively. Ln Cmax was statistically significant by variance analysis and bilateral one-sided test (P0.05). The 90% confidence intervals of AUC0-t,AUC0- 鈭，
本文編號：2435406
[Abstract]:Aim: to study the pharmacokinetics and bioequivalence of catalase liposomes (catalase liposomes,CALP) in SD rats. Methods: CALP, was prepared by reverse evaporation and its particle size, Zeta potential and entrapment efficiency were determined. Twelve male SD rats were randomly divided into two groups. CALP and free catalase (catalase,CAT) were injected intravenously. The activities of catalase in plasma of rats were measured at different time points after administration. The pharmacokinetic parameters were calculated by DAS 2.1.1 software, and the bioequivalence of CALP and CAT was evaluated. Results: the encapsulation efficiency of CALP was (53.72 鹵1.67)%. The main pharmacokinetic parameters of (405.40 鹵21.89) nm and (- 15.70 鹵3.22) m V.CALP and CAT were (203.22 鹵11.75) U (ml 路h and (50.92 鹵3.51) U (ml 路h, respectively. The main pharmacokinetic parameters were (405.40 鹵21.89) nm and (- 15.70 鹵3.22) m V.CALP, respectively. ) U (ml 路h), The Cmax values were (70.79 鹵1.33) U/ml and (51.48 鹵2.78) U / ml, (0.58 鹵0.14) h and (0.17 鹵0.00) h.ln AUC, respectively. Ln Cmax was statistically significant by variance analysis and bilateral one-sided test (P0.05). The 90% confidence intervals of AUC0-t,AUC0- 鈭，
本文編號：2435406
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