甲磺酸帕珠沙星眼用即型凝胶的制备及质量控制

Preparation and quality control of the pazufloxacin mesilte in situ forming of eye gel

目的探讨甲磺酸帕珠沙星眼用即型凝胶的制备及含量测定方法。方法以氯化钠为渗透压调节剂,海藻酸钠为基质,制备甲磺酸帕珠沙星眼用即型凝胶,用高效液相色谱法测定含量。结果甲磺酸帕珠沙星检测浓度在6.02-60.20μg/ml范围内与峰面积分值线性关系良好,r=0.99999,平均回收率为101.85%。RSD为1.95%。本品渗透压为280 m0sm/kg,pH值为5.0-7.0。家兔眼刺激性实验表明,该滴眼剂对家兔眼睛无刺激性,符合《中国药典》滴眼剂的要求。结论本滴眼剂处方工艺简单,质量容易控制,稳定性良好。

Objective To establish a method for preparation and measuring the content of the pazufloxaxin mesilate in situ forming of eye gel.Methods In this study,the pazufloxacin mesilate in situ forming of eye gel took sodium chloride as buffer to regulate the pH and osmotic pressure.The sustained-release eye gel using sodium alginate as base material was studied.The ultraviolet spectrophtonetric method was established for the determination of pazufloxacin mesilate.Results There was a good linear relationship within the concentration range of 6.02-60.2 μg/ml.r=0.99999.The average recovery of pazufloxacin mesilate was 101.85%.The RSD was 1.95%.The osmotic pressure and pH of the solution were 280 m0sm/kg and 5.0-7.0 respectively.The result of rabbit-eye irritation test showed that the eye drops had no irritation.Conclusion The pazufloxacin mesilate in situ forming of eye gel is promising with simple formula,preparation process,easy quality and stability.