Bioequivalence study of domestic recombinant human insulin
10.13699/j.cnki.1001-6821.2015.18.012
- VernacularTitle:国产重组人胰岛素生物等效性研究
- Author:
Yan DONG
1
;
Yong ZENG
;
Xiao-Yan CI
;
Jing GAO
;
Wei-Dang WU
;
Wei LI
;
Ya-Zhuo LI
;
Zi-Hong WEI
;
Xiu-Lin YI
;
Li-Xin JIANG
;
Lei SUN
;
Wei ZHOU
Author Information
1. 天津医科大学药学院
- Keywords:
diabetes mellitus;
insulin;
recombinant human insulin;
pharmacokinetic;
bioequivalence
- From:
The Chinese Journal of Clinical Pharmacology
2015;(18):1837-1839
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the pharmacokinetic and bio-equivalence of domestic and imported recombinant human insulin injec-tion in Beagle dogs.Methods Twelve Beagle dogs were assigned into two groups and the two groups were separately singlely given with test preparation and reference preparation in the same dose in sc injection method according to a randomized two -phase crossover .The plasmas were sampled at different time points after subcutaneous administration and the blood glucose levels were determined by Roche Glucose meter synchronously.The radioimmunoassay ( RIA) method was used to deter-mine the concentration of blood insulin at the different sample points . The pharmacokinetic parameters were calculated by DAS 2.0 software. Results The main pharmacokinetics parameters of test preparation and reference preparation were as follows: t1/2 were ( 1.06 ±0.17 ) and (1.06 ±0.35 ) h; Cmax were ( 97.10 ±45.20 ) and ( 91.30 ±28.20 )μU· mL-1; tmax were ( 0.49 ±0.19 ) and ( 0.49 ±0.18 ) h; area AUC0-t were (168.00 ±40.50) and (168.00 ±41.90) μU· mL-1 · h, respectively. What′s more, Cmin of the test and the referenc were (1.36 ±0.28 ) and (1.37 ±0.34 ) mmol· L-1 separately, and the tmin were ( 1.57 ±0.55 ) and ( 1.74 ±0.65 ) h, respectively. The confidence intervals of Cmax and AUC0-t are 85.5% -117.7% and 97.0%-103.3%.Conclusion The results showed that the test and the reference preparation meet the regulatory cri-teria for the pharmacokinetic equivalence .
