3种头孢克洛制剂在健康人体内的药动学及生物等效性研究
余俊先;史丽敏;王曼丽;杨春秀;王汝龙
【期刊名称】《中国药房》 【年(卷),期】2011(022)002
【摘要】OBJECTIVE: To compare the pharmacokinetics of 3 kinds of cefaclor preparations in healthy volunteers, and to evaluate the bioequivalence of 3 kinds of preparations. METHODS: 18 healthy volunteers received a single dose of 500 mg cefaclor dry suspension (test preparation 1), 500 mg cefaclor dispersible tablets (test preparations 2) or 500 mg cefaclor tablets (reference prepration) respectively. The plasma concentrations of cefaclor were determined by HPLC. The pharmacokinetic parameters and relative bioequivalence of cefaclor were calculated using DAS software. RESULTS: The pharmacokinetic parameters of test preparation 1, test preparation 2 and reference preparation were as follows: cmax( 13.94 ± 3.76) μg· mL-1, (13.54 ± 2.27) μg· mL-1 and (13.86±3.13) μg·mL-1; tmax(0.56 ± 0.13) h, (0.55±0.14) h and (0.51 ±0.13) h; t1/2(0.67± 0.09) h, (0.68±0.15) h and (0.80±0.26) h; AUC0～4(15.16 ± 2.58) μg·h ·mL-1, (14.56± 1.70) μg·h·mL-1 and (14.74±2.07) μg·h ·mL-1. F0～4 of test preparation 1 and test preparation 2 were (103.80 ± 17.80)％ and (100.50 ± 18.40)％. There was no significant difference of cmax、tmax、AUC0～4、AUC0～∞ between 3 kinds of preparations. CONCLUSION: The dry suspension, dispersible
tablets and reference tablets of cefaclor arc bioequivalent.%目的:比较3种头孢克洛制剂在健康志愿者体内的药动学,并评价3种制剂的生物等效性.方法:18名男性健康志愿者,单剂量三交叉分别口服干混悬剂(受试制剂1)、头孢克洛分散片(受试制剂2)和头孢克洛片(参比制剂)500mg后,用高效液相色谱(HPLC)法测定血浆药物浓度,数据经DAS软件处理,计算药动学参数并评价生物等效性.结果:头孢克洛受试制剂1、2与参比制剂的cmax分别为(13.94±3.76)、(13.54±2.27)、(13.86±3.13)μg·mL-1,tmax
分别为(0.56±0.13)、
(0.55±0.14)、(0.51±0.13)h,t1/2分别为(0.67±0.09)、(0.68±0.15)、(0.80±0.26)h,AUC0～4
分别为(15.16±2.58)、(14.56±1.70)、
(14.74±2.07)μg·h·mL-1.受试制剂1、2的F0-4分别为(103.80±17.80)%、(100.50±18.40)%.统计分析表明,2种头孢克洛受试制剂的Cmax、tmax、AUC0～4、AUC0～∞与参比制剂相比均无显著性差异.结论:头孢克洛干混悬剂和分散片与参比制剂生物等效. 【总页数】3页(141-143)
【关键词】头孢克洛;高效液相色谱法;药动学;生物等效性 【作者】余俊先;史丽敏;王曼丽;杨春秀;王汝龙
【作者单位】首都医科大学附属北京友谊医院药剂科,北京市,100050;首都医科大学附属北京友谊医院药剂科,北京市,100050;首都医科大学附属北京友谊医院药剂科,北京市,100050;首都医科大学附属北京友谊医院药剂科,北京市,100050;首都医科大学附属北京友谊医院药剂科,北京市,100050 【正文语种】中文
【中图分类】R944.5;R969.1;R978.1+1
【文献来源】
https://www.zhangqiaokeyan.com/academic-journal-cn_china-pharmacy_thesis/0201242326283.html 【相关文献】
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3种头孢克洛制剂在健康人体内的药动学及生物等效性研究
