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Objective:To investigate the pharmacokinetics of clindamycin phosphate vaginal gel in healthy Chinese female volunteers.Methods:Ten healthy Chinese female volunteers were intravaginally given with 5.0g of clindamycin phosphate vaginal gel (equivalent to 100mg of clindamycin) once for single dose treatment,and 5.0g,once a day for 3 days,for multiple dose treatment.The serum concentration of clindamycin were determined by HPLC-MS method and its pharmacokinetic parameters of clindamycin were calculated by DAS 1.0 software.Results:The main pharmacokinetic parameters of clindamycin for single dose and multiple doses were as follows:t1/2 were (15.30±2.62) hours and (14.78±2.49) hours,Tmax were (4.88±0.94) hours and (4.70±0.59) hours,Cmax were (38.30±22.77) ng/ml and (44.87±26.71) ng/ml,AUC0-∞ were (783.45±351.19)ng·ml-1·h-1 and (1015.68±456.95) ng·ml-1·h-1,respectively.Conclusion:The Cmax of clindamycin phosphate vaginal gel after a single dose and multiple doses are obviously lower and t1/2 are longer than that of clindamycin phosphate oral preparations,which suggests that clindamycin phosphate vaginal gel acts locally and can be slowly absorbed to circulation for systemic actions.
