中国健康志愿者头孢地尼干混悬剂生物等效性研究

丁肖梁, 袁静, 张霞, 董吉, 王子腾, 缪丽燕

中国药学杂志 ›› 2016, Vol. 51 ›› Issue (2) : 127-130.

PDF(724 KB)
PDF(724 KB)
中国药学杂志 ›› 2016, Vol. 51 ›› Issue (2) : 127-130. DOI: 10.11669/cpj.2016.02.011
论著

中国健康志愿者头孢地尼干混悬剂生物等效性研究

  • 丁肖梁1, 袁静2, 张霞2, 董吉1, 王子腾1, 缪丽燕1
作者信息 +

Bioequivalence of Cefdinir Suspension in Chinese Healthy Volunteers

  • DING Xiao-liang1, YUAN Jing2, ZHANG Xia2, DONG Ji1, WANG Zi-teng1, MIAO Li-yan1
Author information +
文章历史 +

摘要

目的 评价国产头孢地尼干混悬剂与参比头孢地尼胶囊的生物等效性,评价其临床疗效。方法 24名健康男性志愿者交叉口服100 mg的头孢地尼干混悬剂(试验制剂)和头孢地尼胶囊(参比制剂,全泽复),采用UPLC-MS/MS测定血浆中头孢地尼药物浓度。采用WinNonlin 6.3软件处理得到药动学参数并进行统计学分析。结果 头孢地尼干混悬剂及参比胶囊的主要药动学参数分别为:ρmax分别为(1 034.78±358.17),(969.71±297.38) ng·mL-1;tmax分别为(2.98±0.60),(3.44±0.70) h;AUC0-12分别为(4 911.24±1 675.30),(4 522.35±1 600.13) h·ng·mL-1;AUC0-∞分别为(5 026.24±1 735.32),(4 680.69±1 699.93) h·ng·mL-1;t1/2分别为(1.71±0.23),(1.79±0.39) h。ρmax,AUC0-12,AUC0-∞的90%置信区间分别为95.6%~115.3%,99.9%~117.2%,99.0%~116.0%。结论 头孢地尼干混悬剂与参比头孢地尼胶囊具有生物等效性。

Abstract

OBJECTIVE To evaluate the bioequivalence of cefdinir suspension and reference cefdinir capsule in Chinese healthy male subjects.METHODS A single oral dose of 100 mg cefdinir suspension or cefdinir capsule was given to 24 subjects according to a 2-way crossover design. The plasma concentrations of cefdinir were determined by UPLC-MS/MS. The pharmacokinetic parameters were calculated and bioequivalence was compared by WinNonlin 6.3 program. RESULTS The main pharmacokinetic parameters of cefdinir suspension and cefdinir capsule were as follow: ρmax were (1 034.78±358.17), (969.71±297.38) ng·mL-1;tmax were (2.98±0.60), (3.44±0.70) h; AUC0-12 were (4 911.24±1 675.30), (4 522.35±1 600.13) ng·h·mL-1; AUC0-∞ were (5 026.24±1 735.32),(4 680.69±1 699.93) ng·h·mL-1;t1/2 were (1.71±0.23), (1.79±0.39) h. The 90% confidential interval of ρmax, AUC0-12, AUC0-∞ of tested formulation were 95.6%-115.3%, 99.9%-117.2%, 99.0%-116.0%. CONCLUSION The two formulations are bioequivalent.

关键词

头孢地尼 / 药动学 / 生物等效性 / 超高效液相-串联质谱法

Key words

cefdinir / pharmacokinetics / bioequivalence / UPLC-MS/MS

引用本文

导出引用
丁肖梁, 袁静, 张霞, 董吉, 王子腾, 缪丽燕. 中国健康志愿者头孢地尼干混悬剂生物等效性研究[J]. 中国药学杂志, 2016, 51(2): 127-130 https://doi.org/10.11669/cpj.2016.02.011
DING Xiao-liang, YUAN Jing, ZHANG Xia, DONG Ji, WANG Zi-teng, MIAO Li-yan. Bioequivalence of Cefdinir Suspension in Chinese Healthy Volunteers[J]. Chinese Pharmaceutical Journal, 2016, 51(2): 127-130 https://doi.org/10.11669/cpj.2016.02.011
中图分类号: R969.2   

参考文献

[1] GU X Z, MAO Y Y. Clinical application of cefdinir . Chin J New Drugs Clin Rem(中国新药与临床杂志),2003, 22(12):754-756.
[2] CHEN Z J, ZHANG J, YU J C, et al. Selective method for the determination of cefdinir in human plasma using liquid chromatography electrospray ionization tandam mass spectrometry . J Chromatogr B Analyt Technol Biomed Life Sci, 2006, 834(1-2): 163-169.
[3] MA R R, ZHANG H L, HOU J. Bioequivalence of cefdinir granule and capsule in healthy volunteers. Chin J Antibiotics(中国抗生素杂志),2002,11(27):677-680.
[4] ZHANG X P, ZHAO L P, LEI G M, et al. Bioequivalence of cefdinir dispersible tablets in healthy volunteers. J China Pharm(中国药房), 2007, 18(32):2514-2516.
[5] REN P, ZHAO G, XU K, et al. Pharmacokinetics and bioequivalence of cefdinir dispersible tablet in healthy volunteers. Her Med(医药导报),2009, 28(2):168-170.
[6] HUANG M, ZHANG Q Y, ZHOU W J, et al. Pharmacokinetics and bioequivalence study of cefdinir suspension in healthy volunteers. Her Med(医药导报), 2013,32(7): 851-855.
PDF(724 KB)

Accesses

Citation

Detail

段落导航
相关文章

/