Study on the Pharmacokinetics of Recombinant Hirudin Enteric-coated Capsule by Single and Multiple Ad-ministration in Beagle Dogs
10.6039/j.issn.1001-0408.2017.07.15
- VernacularTitle:重组水蛭素肠溶胶囊单次和多次给药在Beagle犬体内的药动学研究
- Author:
Hui YANG
;
Yuanda ZHOU
;
Haixia HE
;
Kai FAN
- Keywords:
Recombinant hirudin;
Enteric-coated capsule;
Injection;
Single administration;
Multiple administration;
Pharmaco-kinetics;
Beagle dogs
- From:
China Pharmacy
2017;28(7):916-918
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To study the pharmacokinetic characteristics of Recombinant hirudin enteric-coated capsule by single and multiple administration in Beagle dogs. METHODS:12 Beagle dogs were divided into single ig group and single iv group by random control method,6 in each group. Recombinant hirudin 0.2 mg/kg was intragastrically administrated or intravenously inject-ed,blood sample was collected;after 2 weeks of cleaning,12 dogs were intragastrically administrated recombinant hirudin 0.2 mg/kg,for 7 d. Sample blood was collected,referred to multiple ig group. Recombinant hirudin concentration in plasma was deter-mined by enzyme-linked immunosorbent assay,and pharmacokinetic parameters were calculated by DAS 2.0 software. RESULTS:The results showed that pharmacokinetics by ig and iv recombinant hirudin in Beagle dogs fitted to two-compartment model,abso-lute bioavailability of ig Recombinant hirudin enteric-coated capsule was(14.908±1.868)%;the pharmacokinetic parameters in sin-gle ig group and multiple ig group were tpeak of(2.105±0.243),(3.000±0.000)h,t1/2β of(8.660±2.965),(14.870±2.710)h, cmax of(10.700±0.872),(12.05±1.587)ng/mL,AUC0-1440 min of(55.250±4.386),(58.978±6.002)ng·h/mL,without statistical significances in two groups(P>0.05). CONCLUSIONS:The ig Recombinant hirudin enteric-coated capsule can be absorbed into the blood to a certain extent. There is no accumulation for ig Recombinant hirudin enteric-coated capsule for several days,and it dose not change the pharmacokinetic characteristics.
