无防腐剂复方托吡卡胺滴眼液的兔散瞳效果实验

Experimental Study on Mydriatic Effect of Tropicamide Phenylephrine Eye Drops Without Preservative on Rabbits

目的探讨无防腐剂复方托吡卡胺滴眼液对实验兔的散瞳效果。方法取实验兔30只,按体质量随机分为空白对照组(等体积0.9%氯化钠注射液),参比制剂组[参比制剂(规格为每瓶10 mL),50μL],受试制剂组[受试制剂(无防腐剂,规格为每瓶0.4 mL),50μL],各10只。各组实验兔双眼均分别给予相应药物或0.9%氯化钠注射液1次。分别于给药前及给药后0.25,0.5,1,2,4,8,12,24 h检测实验兔的双眼瞳孔最大直径,计算给药前后的最大直径差。测量双眼正向(0°、90°)及斜向(45°、135°)的轴线直径,计算瞳孔面积。结果与空白对照组比较,受试制剂组与参比制剂组实验兔给药后除24 h外其余时间点的瞳孔最大直径差均显著增大,且参比制剂组给药后各时间点、受试制剂组除给药后24 h外其余各时间点实验兔的瞳孔面积均显著增大(P<0.05或P<0.01);受试制剂组实验兔给药后各时间点的瞳孔最大直径差和瞳孔面积与参比制剂组比较均无显著差异(P>0.05)。结论复方托吡卡胺滴眼液受试制剂与参比制剂对实验兔的散瞳效果基本一致。

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),50μL],the test preparation group[commercial test preparation(without preservative,specification:0.4 mL per bottle),50μL],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.