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 injected, 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 determined 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, absolute bioavailability of ig Recombinant hirudin enteric-coated capsule was (14.908±1.868)%; the pharmacokinetic parameters in single 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, AUC0-1 440 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.