Abstract: AIM: To characterize the pharmacokinetic proper ties of a Bacillus subtilis fibrinoly tic enzyme (BSFE) following intravenous infusion in rhesus monkeys.METHODS: Six mon-keys received sing leintraveno us infusion doses of BSFE at 2.5 mg/kg.Serum concentration of BSFE was measured at various time-point s after dosing by ELISA.Pharmacokinetic parameters were calculated with DAS 2.0 software.RESULTS: The concentration-timepro file of BSFE in monkey s was described by a two-compartment model.The mean time to reach peak concentration (tmax) was 0.5 h.The mean peak concentration (Cmax) was(592.3 ±150.9) μg/L.The mean elimination half-life (t1/2β) was (5.78 ±1.19) h. The mean drug clearance from the serum (CL) was (4.42 ±1.19) L·h-1·kg -1.The mean area under the serum concentration-time curve (A UC0 -24.5 h) was (557.1 ±211.1) μg·L-1·h. CONCLUSION: A sandwich ELISA method is sensitive, high specificity and convenient, sui table for the determination of BSFE in serum and its pharmacokinetics studies.

Key words: Bacillus subtilis fibrino lytic enzyme, ELISA, Pharmacokinetics, Monkey