双氯芬酸胆碱滴眼剂的稳定性和刺激性

Study on the trill and stability of diclofenac acid-choline eyedrops

目的 :观察双氯芬酸胆碱滴眼剂的刺激性及稳定性。方法 :双氯芬酸胆碱 1.30g ,硼砂 5 .73g ,硼酸8.6 8g ,氯化钠 3.0 0g ,吐温 80 80 1.5ml,聚乙烯吡咯烷酮 (PVP) 2 0 .0 0g ,注射用水加至 10 0 0ml,配制成双氯芬酸胆碱滴眼剂。测定该滴眼剂的标准曲线、回收率及精密度。取健康家兔 12只 ,用长期刺激实验和持续性刺激实验观察该滴眼剂的刺激性。恒温加速实验及留样观察 2 8个月 ,评价该滴眼剂的稳定性。结果与结论 :标准曲线Y =0 .0 2 4 3X +0 .0 10 4 ,r=0 .9999,于 2 76nm处有最大吸收。平均回收率为 10 0 .0 5 % ,日内RSD 0 .14 % ,日间 0 .4 8%。恒温加速实验结果显示该滴眼剂中双氯芬酸胆碱降解反应属于一级反应 ,且不同温度下降解反应机制相同 ,推算其室温有效期为 2 .96a ,与留样观察结果一致。长期及持续性刺激实验均显示家兔角膜无异常 ,分泌物未增加 ,提示该滴眼剂对黏膜基本无刺激。

Aim:To investigate the trill and stability of diclofenac acid-choline eyedrops.[WT5”FZ]Methods: The diclofenac acid-choline eyedrops was made, and its standard curve,recycle ratio,and accuracy were detected. The trill was detected by long stimulating experiment and constant stimulating accelerating experiment.The stability was detected by constant temperature UV-spectrophotometry. Results and Conclusion:The equation of standard curve was Y=0.024 3X+0.010 4,r= 0.999 9. The recycle ratio was 100.05%. The degradation reaction of diclifenac acid-choline in eyedrops belongs to first-order reation,and its machanim may be same under different temperatures. The period of validity of diclofenanc acid-choline eyedrops in room temperature is 2.96 years.The results of stimulating experiment suggest that the eyedrops are safety to mucous embrance.