Abstract:
Objective
To investigate the pharmacokinetics of loteprednol etabonate in beagle dogs through different routes of administration，and to provide reference for clinical medication safety.
Methods
Beagle dogs were given loteprednol etabonate eye drops(test preparation) or oral administration of loteprednol etabonate capsules(reference preparation). Concentration of PJ90 and PJ91, which were non active metabolite of loteprednol etabonate, was determined by HPLC method.
Results
PJ90 and PJ91 were not detected after administration of eye drops. After oral administration，the main pharmcokinetic parameters of PJ90 and PJ91 in the plasma were as follows: Tmax was (1.38±0.89)h and (1.17±0.90)h，ρmax was (0.35±0.05) mg/L and (0.24±0.13) mg/L，t1/2 was (7.11±3.76)h and (14.95±9.30)h，AUC0-t was (2.12±1.42) mg/(h·L) and (2.02±1.29)mg/(h·L)，and AUC0-∞  was (2.81±1.83)mg/(h·L) and (3.97±3.23)mg/(h·L).
Conclusion
Loteprednol etabonate eye drops are safe.

Key words: Loteprednol etabonate, HPLC, Pharmacokinetics