Investigation of Pharmacokinetics and Bioequivalence of Mecobalamin in Healthy Volunteers by Chemilu-minescent Microparticle Immunoassay
- VernacularTitle:化学发光微粒子免疫法研究甲钴胺在健康人体内的药动学和生物等效性
- Author:
Cuixia YU
;
Hongwei FAN
;
Yunfang HU
;
Jianjun ZOU
- Publication Type:Journal Article
- Keywords:
Mecobalamin;
Bioequivalence;
CMIA
- From:
China Pharmacist
2014;(10):1619-1621,1622
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To develop a chemiluminescent microparticle immunoassay ( CMIA) method for the determination of meco-balamin in human serum to investigate the pharmacokinetics and bioequivalence of mecobalamin. Methods:A single oral dose of two kinds of mecobalamin was given to 19 healthy volunteers in a randomized three-period crossover study. The concentrations of mecobal-amin in serum were assayed by CMIA, the main pharmacokinetic parameters were analyzed by DAS 3. 0 software, and the bioequiva-lence was evaluated. Results: The main pharmacokinetic parameters of test and reference mecobalamin tablets were as follows: tmax were (4.2 ±1.9)h and (4.4 ±2.4)h,Cmax were (322.0 ±145.4) ng·L-1 and (282.2 ±108.1) ng·L-1,t1/2 were (19.2 ±5.3) h and (20.0 ±6.3)h,AUC0-72 were (6 769.1 ±2 169.4) ng·h·L-1 and (6 400.6 ±1 921.5) ng·h·L-1. F(0-72) and F(0-∞) of the test tablets was 105. 9% ± 13. 2% and 104. 9% ± 12. 6%,respectively. Conclusion:The method is simple and precise. The two tablets are bioequivalent.
