中国药房2012，Vol.23Issue(26)：2434-2436,3.DOI:10.6039/j.issn.1001-0408.2012.26.12
2种替米沙坦制剂的人体生物等效性研究
Study on the Bioequivalence of 2 Kinds of Domestic Telmisartan Preparations in Human
摘要
Abstract
OBJECTIVE: To study the bioequivalence of Telmisartan capsule and Telmisartan tablet. METHODS: A randomized crossover design was performed in 20 healthy volunteers. A single oral dose of either domestic Telmisartan capsules (test preparation) or imported Telmisartan tablets (reference preparation) 80 mg were administered Plasma concentration of telmisartan was measured by HPLC. The pharmacokinetic parameters were measured by 3p97 software. RESULTS: Blood concentration-time curves of test preparation or reference preparation fitted to one-compartment open model. Pharmacokinetic parameters were as follows: tv2ke were(74.23 ±25.11 )h and (79.18 ± 23.27)h, tmax(2.08 ± 1.64) h and (2.02 ±0.86) h,Cmax(2.10 ± 1.36)μg·mL-1 and (1.95±1.08)μg·mL-1, AUG0-144h( 116.25 ±55.97) μg·h·mL-1 and (123.94 + 65.66) μg·h·mL-1, respectively. The relative bio-availability of domestic capsules was (93.80 ± 12.24)% , compared with imported tablet. There was no significant difference in pharmaceutical parameters through variance analysis, t-test and 1 —2α confidence interval method. CONCLUSION: Domestic Telmisartan capsule and imported Telmisartan tablet are bioequivalent.关键词
替米沙坦/药动学/生物等效性/高效液相色谱法Key words
Telmisartan/ Pharmacokinetics/ Bioequivalence/ HPLC分类
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穆晓涛,徐明,成小蔓..2种替米沙坦制剂的人体生物等效性研究[J].中国药房,2012,23(26):2434-2436,3.
