复方溴莫尼定倍他洛尔滴眼剂的制备及药效学研究

Preparation and Initial Pharmacodynamic Study on Betaxolol Hydrochloride and Brimonidine Tartrate Compound Eye Drops

目的:制备复方溴莫尼定倍他洛尔滴眼剂,并研究其对家兔眼压的影响。方法:按照处方制备滴眼剂,采用冰点降低法测定等渗性,用高效液相色谱法对其进行含量测定。药效学考察:将10只家兔随机分为实验组和对照组,对照组给予处方量的辅料制成的滴眼剂,实验组给予按照处方组成制备的滴眼剂,用眼压计测量给药前和给药后1h、2h、3h、4h、5h、6h后的眼压,观察该复方制剂对家兔眼压的影响。结果:经测定该复方制剂等渗,实验组用药后眼压出现明显下降。结论:该滴眼剂制备工艺可行,复方制剂具有良好的降眼压效果。

Objective： To prepare betaxolol hydrochloride and brimonidine tartrate compound eye drops,study its quality,and invest their quality stability.To study the pharmacodynamic action of effects on intraocular pressure in rabbits.Methods：To prepare eye drops in accordance with prescription,the isotonic of compound eye drops is measured by freezing point depression,the content of compound eye drops is determined with HPLC.Pharmacodynamic study：The 10 rabbits were randomly divided into experimental group and control group.The control group received the eye drops made of pharmaceutical necessities in prescription,and the experimental group was given the compound eye drops that be prepared according to prescription.The changes of intraocular pressure were observed before,and 1h,2h,3h,and 4h after treatment.IOP is measured with tonometer,and record them.Results：Data shows that the compound preparation is isotonic,and the intraocular pressure is significantly decreased after treatment in the experimental group,while no significant changes of intraocular pressure are observed in the control group.Conclusion：The preparation method is reasonabl,and the IOP decline was significant.