| 头孢克洛缓释胶囊的药动学及生物等效性研究 |
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| 引用本文： | 宋祥珍,;李芹,;曹斌,;姚静,;张自强. 头孢克洛缓释胶囊的药动学及生物等效性研究[J]. 中国药房, 2009, 0(35): 2744-2747 |
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| 作者姓名： | 宋祥珍, 李芹, 曹斌, 姚静, 张自强 |
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| 作者单位： | [1]南京长澳制药有限公司,南京市211500; [2]青海省中医院,西宁市810000; [3]中国药科大学,南京市210009; [4]南京长澳医药科技有限公司,南京市210038 |
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| 摘 要： | 目的:研究头孢克洛缓释胶囊的药动学及生物等效性。方法:采用随机交叉-自身对照试验设计,20名健康志愿者单剂量(375mg)及多剂量(每日2次,连续5d)口服头孢克洛缓释胶囊受试制剂与参比制剂后,以高效液相色谱-电喷雾串联质谱(LC-MS/MS)法测定人血浆中头孢克洛的浓度,并以BAPP软件求算药动学参数,以方差分析法和双单侧t检验对主要药动学参数及两制剂生物等效性进行判定。结果:受试者单剂量口服受试制剂与参比制剂后主要药动学参数:tmax分别为(1.050±0.390)、(1.450±1.120)h,Cmax分别为(4.391±1.146)、(4.331±1.081)μg.mL-1,t1/2分别为(0.835±0.078)、(0.836±0.114)h,AUC0～12分别为(12.696±1.620)、(12.651±2.199)μg.h.mL-1,AUC0～∞分别为(12.699±1.621)、(12.654±2.199)μg.h.mL-1;多剂量口服受试制剂与参比制剂后主要药动学参数:Cav分别为(1.353±0.214)、(1.398±0.344)μg.mL-1,AUCss0～τ分别为(16.240±2.567)、(16.780±4.129)μg.h.mL-1。结论:受试制剂与参比制剂为生物等效制剂。
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| 关 键 词： | 头孢克洛 缓释胶囊 生物等效性 药动学 高效液相色谱-电喷雾串联质谱法 |
Bioequivalence and Pharmacokinetics of Cefaclor Sustained - release Capsules |
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| Affiliation: | SONG Xiang-zhen,CAO Bin(Nanjing Chang＇ ao Pharmaceutical Co., Ltd., Nanjing 211500, China) LI Qin(Qinghai Provincial Hospital of TCM, Xining 810000, China) YAO Jing(China Pharmaceutical University, Nanjing 210009, China) ZHANG Ziqiang(Nanjing Chang＇ao Pharmaceutical Science and Technology Limited Company, Nanjing 210038, China) |
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| Abstract: | OBJECTIVE： To study the pharmacokinetics and the bioequivalence of cefaclor sustained - release capsules. METHODS： A cross- over randomized self- control study was performed in which 20 healthy volunteers were assigned to re- ceive single dose （375 mg） and multi- doses（bid for 5 consecutive days） of cefaclor sustained release capsules（test and refer- ence preparations） . Then plasma concentrations of cefaclor were determined by LC- MS/MS. The pharmacokinetic parame- ters were analyzed with the aid of BAPP software. The main pharmacokinetic parameters and the bioequiavailability of the two preparations were assessed by F - test and two - one side t test. RESULTS： The main pharmacokinetics parameters of test preparation vs. reference preparation of cefaclor sustained- release capsules （single dose） were as follows： tmax（ 1.050± 0.390） vs. （1.450_1.120） h, Cmax（4.391）± 1.146） vs.（4.331± 1.081）μg·mL-1; t 1/2（0.835±0.078） vs.（0.836±0.114） h; AUC0-2 （12.696±1.620） vs.（12.651±_2.199） μg·mL-1, AUC0-∞（12.699±1.621） vs.（12.654±2.199） μg·mL-1.Themain pharmacokinetics parameters of test preparation vs. reference preparation of cefaclor sustained - release capsules（multi - doses） were as follows： Cmax（1.353±0.214） vs.（1.398±0.344）μg·mL-1, and AUC%-t（16.240± 2.567） vs.（16.78024.129）μg·mL-1 CONCLUSION： The test preparation and the reference preparation of ce{aclor are bioequivalent. |
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| Keywords: | Cefaclor Sustained - release capsule Bioequivalence Pharmacokinetics HPLC - MS/MS |
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