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2种舒他西林片的人体生物等效性 被引量:4

Bioequivalence study of two formulations of domestic sultamicillin in healthy volunteers
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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,c_(max)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c_(max)分别是(10.8±s 1.9),(10.4±1.8)mg·L^(-1);t_(max)分别是(0.68±0.14),(0.66±0.12)h;AUC_(0-t)分别为(22±4),(22±4)mg·h·L^(-1);AUC_(0-∞)分别为(24±5),(23±4)mg·h·L^(-1);t_(1/2)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c_(max)分别是(7.4±1.3),(7.3±1.2)mg·L^(-1),t_(max)分别是(0.66±0.12),(0.70±0.10)h,AUC_(0-t)分别为(13.7±2.8),(13.2±2.3)mg·h·L^(-1);AUC_(0-∞)分别为(14.2±2.9),(13.7±2.5)mg·h·L^(-1);t_(1/2)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。 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. A UC and cmax were analyzed after logarithmic transform. RESULTS: The pharmacokinetic parameters of study drug vs reference drug were as follows :ampicillin 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^-1 and (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^-1 and (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 suhamicillin tablets are bioequivalent.
出处 《中国新药与临床杂志》 CAS CSCD 北大核心 2006年第5期346-349,共4页 Chinese Journal of New Drugs and Clinical Remedies
关键词 抗感染药 舒他西林 片剂 色谱法 高压液相 生物利用度 anti-infective agents sultamicillin tablets chromatography,high pressure liquid biological availability
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