盐酸二甲双胍缓释片的生物等效性评价

吴琳华;刘红梅;赵红光;纪宏宇;王智勇;杜霞

中国药学杂志 ›› 2006, Vol. 41 ›› Issue (03) : 214-216.

中国药学杂志 ›› 2006, Vol. 41 ›› Issue (03) : 214-216.
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盐酸二甲双胍缓释片的生物等效性评价

  • 吴琳华;刘红梅;赵红光;纪宏宇;王智勇;杜霞
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Studies on Bioequivalence of Metformin Hydrochloride Sustained Release Tablets

  • WU Lin-hua, LIU Hong-mei,ZHAO Hong-guang,JI Hong-yu,WANG Zhi-yong ,DU Xia
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摘要

目的对国产两种盐酸二甲双胍缓释片制剂进行生物等效性评价。方法单剂量(1 000 mg)、多剂量(1 000 mg·d-1×7d)试验各选20例受试者,受试者随机分组、自身对照口服药物,采用反相HPLC测定血浆中盐酸二甲双胍的浓度,并计算相关药动学参数判定两制剂是否生物等效。结果单剂量时,受试制剂与参比制剂主要药动学参数ρmax分别为(2.329±0.486)及(2.308±0.502)mg·L-1;tmax分别为(3.700±0.571)及(3.600±0.940)h;t1/2分别为(7.484±2.612)及(7.724±2.799)h;AUC0~t分别为(13.387±3.394)及(13.589±2.917)mg·h·L-1;AUC0~∞分别为(18.575±3.841)及(19.069±3.792)mg·h·L-1;受试制剂相对于参比制剂的生物利用度F为(98.10±8.90)%。多剂量时,受试制剂与参比制剂主要药动学参数ρmax分别为(1.876±0.545)及(2.111±0.630)mg·L-1;ρmin分别为(0.212±0.047)及(0.227±0.054)mg·L-1;tmax分别为(4.100±0.912)及(3.750±0.716)h;t1/2分别为(11.477±3.851)及(13.529±4.067)h;AUCss分别为(15.137±2.749)及(15.855±3.322)mg·h·L-1;ρav分别为(0.631±0.114)及(0.661±0.138)mg·L-1;DF分别为(2.609±0.644)%及(2.812±0.645)%;受试制剂相对于参比制剂的生物利用度F为(98.00±22.7)%。结论统计分析结果显示,受试制剂与参比制剂生物等效。

Abstract

OBJECTIVE To study the bioequivalence of metformin hydrochloride tablets in healthy volunteers.METHODS A single oral dose(1 000 mg) and multiple oral doses(1 000 mg·d-1×7 d) of reference or test metformin hydrochloride preparations were given to 20 healthy male volunteers according to an open randomized crossover study.The plasma concentrations of metformin hydrochloride were determined by RP-HPLC method.The pharmacokinetic parameters and bioavailability of test preparation were compared with reference preparation.RESULTS The main pharmacokinetic parameters of the test preparation and the reference preparation were as follows,single dose(SD): ρmax(2.329±0.486) and(2.308±0.502) mg·L-1;tmax(3.700±0.571) and(3.600±0.940)h;t1/2(7.484±2.612) and(7.724±2.799)h;AUC0~t(13.387±3.394) and(13.589±2.917) mg·h·L-1;AUC0~∞(18.575±3.841) and(19.069±3.792) mg·h·L-1.The relative bioavailability of the test to reference preparation was(98.10±8.90)%.Multiple doses(MD): ρmax(1.876±0.545) and(2.111±0.630) mg·L-1;ρmin(0.212±0.047) and(0.227±0.054)mg·L-1;tmax(4.100±0.912) and(3.750±0.716)h;t1/2((11.477±3.851))and(13.529±4.067) h;AUCss(15.137±2.749) and(15.855±3.322) mg·h·L-1;ρav(0.631±0.114) and((0.661±0.138)) mg·L-1;DF(2.609±0.644)% and(2.812±0.645)%,respectively.The relative bioavailability of test to reference preparation was(98.00±22.7)%.CONCLUSION The results of statistic analysis show that the reference preparation and the test preparation are bioequivalent.

关键词

盐酸二甲双胍 / 反相高效液相色谱法 / 药动学 / 生物等效性

Key words

metformin hydrochloride / RP-HPLC / pharmacokinetics

引用本文

导出引用
吴琳华;刘红梅;赵红光;纪宏宇;王智勇;杜霞. 盐酸二甲双胍缓释片的生物等效性评价[J]. 中国药学杂志, 2006, 41(03): 214-216
WU Lin-hu;LIU Hong-mei;ZHO Hong-gung;JI Hong-yu;WNG Zhi-yong;DU Xi. Studies on Bioequivalence of Metformin Hydrochloride Sustained Release Tablets [J]. Chinese Pharmaceutical Journal, 2006, 41(03): 214-216

参考文献

[1] WANG P,DING L H,GUO Z B.Relative bioavailability and pharmacokinetics of metformin htdrochloride enteric dissolving tablets by HPLC[J] .Chin Hosp Pharm J(中国医院药学杂志)),2002,22(11):664. [2] CHEN W L,LI X N,XU H R,et al.Bioequivalence of domestic metformin tablets in healthy male volunteers[J] .Chin J Clin Pharm(中国临床药学杂志),2003,12(1):19. [3] HE H X,HAN M,HUANG P,et al.Study on bioequivalence of domestic metformin hydrochloride tablets[J] .J China Pharm(中国药房),2002,13(11):669.

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