无防腐剂复方托吡卡胺滴眼液的兔散瞳效果实验OACSTPCD

Objective To investigate the mydriatic effect of Tropicamide Phenylephrine Eye Drops without preservative on experimental rabbits.Methods Thirty experimental rabbits were selected and randomly divided into the blank control group(equal volume of 0.9%Sodium Chloride Injection),the reference preparation group[reference preparation(specification:10 mL per bottle),50 μL],the test preparation group[commercial test preparation(without preservative,specification:0.4 mL per bottle),50 μL],with 10 rabbits in each group.The experimental rabbits in each group were given corresponding drug or 0.9%Sodium Chloride Injection once.Before and after administration of 0.25,0.5,1,2,4,8,12,24 h,the maximum diameter of the pupils in both eyes of the experimental rabbits was measured,the difference in maximum diameter before and after administration was calculated;the positive(0°,90°)and oblique(45°,135°)axial diameters of both eyes were measured,and the pupil area of the experimental rabbits was calculated.Results Compared with those in the blank control group,the difference in maximum pupil diameter in the test and the reference preparation groups at all time points except 24 h after administration significantly increased,the pupil area in the reference preparation group at all time points and in the test preparation group at all time points except 24 h after administration significantly increased(P<0.05 or P<0.01).The difference in the maximum pupil diameter and pupil area in the test preparation group at all time points after administration were similar to those in the reference preparation group(P>0.05).Conclusion The test and reference Tropicamide Phenylephrine Eye Drops have similar mydriatic effects on experimental rabbits.