0~96 h分別為(2.85±0.64)和(2.79±0.48)μg/mL·h,Tmax分別為(4.33±0.65)和(4.16±0.71)h,Cmax分別為(0.091±0.017)和(0.086±0.021)μg/mL,t1/2分別為(26.08±3.64)和(26.94±4.21)h,兩者的lnAUC和lnCmax經(jīng)雙單側(cè)t檢驗(yàn)證明差異無(wú)統(tǒng)計(jì)意義。結(jié)論 測(cè)試片劑與國(guó)外上市的參比片劑具有生物等效性,其平均相對(duì)生物利用度為(98.0±9.76)%。;Objective To investigate in vivo pharmacokinetics and bioequivalence of Meloxicam Chewable Tablets in healthy Beagle's dogs. Method Twelve healthy adult Beagle's dogs were randomized into two groups. Using the double-preparation, double-cycle, cross-over method and administering orally of testing and reference tablet (2 mg) respectively. The plasma concentration of meloxicam was determinated by RP-HPLC. The 3P97 software was adopted to calculate the pharmacokinetic parameters and evaluate the bioequivalence of two preparations. Results The area under the curves (AUC0-96 h) of the testing tablets and innovator tablets were (2.85±0.64) and (2.79±0.48) μg/mL·h. The peak time (Tmax) was (4.33±0.65) and (4.16±0.71) h. The peak concentration (Cmax) was (0.091±0.017) and (0.086±0.021) μg/mL. The half time (t1/2) was (26.08±3.64) and (26.94±4.21) h. After the double unilateral t test, there was no statistical significance in the difference of lnAUC and lnCmax between the testing tablets and innovator tablets. Conclusion The testing tablets and innovator tablets are bioequivalent. The relative bioavailability of generic tablet is (98.0±9.76)%."/>

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首頁(yè) > 過(guò)刊瀏覽>2017年第40卷第9期 >2017,40(9):1254-1258. DOI:10.7501/j.issn.1674-6376.2017.09.011
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美洛昔康咀嚼片的生物等效性研究

Study on bioequivalence of Meloxicam Chewable Tablets

發(fā)布日期:2017-09-07
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