Relative bioavalability of hydrochloride eperisone granule in healthy volunteers
- VernacularTitle:盐酸乙哌立松颗粒剂人体生物利用度研究
- Author:
Rui-Chen GUO
;
Ben-Jie WANG
;
Wen-Dong ZHANG
;
Chao-Wu LI
;
Zhi-Li LI
;
- Publication Type:Journal Article
- Keywords:
eperisone hydrochloride;
myonal;
bioavalability;
bioequivalence;
GC-MS;
tolperisong
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2000;0(02):-
- CountryChina
- Language:Chinese
-
Abstract:
Aim The relative bioavalability of hydrochloride eperisone granule in 10 healthy volunteers was studied. Methods The time-plasma concentrations of hydrochloride eperisone granule, as test drug, and myonal, as reference drug, were determined by GC-MS, with tolperisone senuing as internal standard.The pharmacokinetic parameters of both reference and test drug were calculated and analyzed with two-one side test and confidential interval test. Results The results showed that the AUC0-8, AUC0-∞, Cmax, Tpeak, t1/2(?) and t1/2(?) were (17.9?1.3)ng?h?ml-1 and(18.6?1.6)ng?h?ml-1, (19.1?1.2)ng?h?ml-1 and (20.2?1.6)ng?h?ml-1, (5.2?0.5)ng?ml-1 and (5.4?0.5) ng?ml-1, (1.05?0.18)h and (1.08?0.23)h, (0.78? 0.13)h and ( 0.82?0.14)h,( 1.8?0.3)h and (1.8?0.3)h, respectively. The relative bioavalability of test drug was (105? 5)%. Conclusion It can be concluded that the test and reference are bioequivalented between individuals, preparations and periods.
