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2种舒他西林片的人体生物等效性
Bioequivalence study of two formulations of domestic sultamicillin in healthy volunteers
【摘要】 目的:比较口服2种舒他西林片的相对生物利用度。方法:20名健康男性受试者采用随机交叉试验设计。反相高效液相色谱法测定单剂量口服2种舒他西林片750 mg后的氨苄西林、舒巴坦血药浓度。DAS程序计算药动学参数,AUC,cmax对数转换后进行分析。结果:口服舒他西林受试制剂和参比制剂氨苄西林的cmax分别是(10.8±s 1.9),(10.4±1.8)mg·L-1;tmax分别是(0.68±0.14),(0.66±0.12)h;AUC0-t分别为(22±4),(22±4)mg·h·L-1;AUC0-∞分别为(24±5),(23±4)mg·h·L-1;t1/2分别是(1.07±0.26),(1.13±0.25)h。口服舒他西林受试制剂和参比制剂舒巴坦的cmax分别是(7.4±1.3),(7.3±1.2)mg·L-1,tmax分别是(0.66±0.12),(0.70±0.10)h,AUC0-t分别为(13.7±2.8),(13.2±2.3)mg·h·L-1;AUC0-∞分别为(14.2±2.9),(13.7±2.5)mg·h·L-1;t1/2分别是(0.97±0.19),(0.87±0.24)h。结论:2种舒他西林片具有生物等效性。
【Abstract】 AIM:To evaluate the bioavailability of sultamicillin tablets from two companies.METHODS: Randomized,cross over designed trial conducted in 20 healthy volunteers.The plasma concentration of ampicillin and sulbactam were tested by reversed-phase high pressure liquid chromatography after a single oral dose of 750 mg tablets of study drug or reference drug.The pharmacokinetic parameters were calculated by pharmaceutic software named DAS.AUC and cmaxwere analyzed after logarithmic transform.RESULTS:The pharmacokinetic parameters of study drug vs reference drug were as follows:ampieillin cmax,(10.8±s 1.9)mg·L-1 and(10.4±1.8)mg·L-1;tmax, (0.68±0.14)h and (0.66±0.12)h;AUC0-t,(22±4)mg·h·L-1 and(22±4)mg·h·L-1;AUC0-∞,(24±5)mg·h·L-1and(23±4)mg·h·L-1;t1/2,(1.07±0.26)h and(1.13±0.25)h;sulbactam cmax,(7.4±1.3)mg·L-1 and (7.3±1.2)mg·L-1;tmax,(0.66±0.12)h and(0.70±0.10)h;AUC0-t,(13.7±2.8)mg·h·L-1 and(13.2±2.3)mg·h·L-1;AUC0-∞,(14.2±2.9)mg·h·L-1and(13.7±2.5)mg·h·L-1;t1/2,(0.97±0.19)h and(0.87±0.24)h. CONCLUSION:The two formulations of sultamicillin tablets are bioequivalent.
【Key words】 anti-infective agents; sultamicillin; tablets; chromatography,high pressure liquid; biological availability;
- 【文献出处】 中国新药与临床杂志 ,Chinese Journal of New Drugs and Clinical Remedies , 编辑部邮箱 ,2006年05期
- 【分类号】R96
- 【被引频次】3
- 【下载频次】73