摘要
目的探讨甲磺酸帕珠沙星即型凝胶滴眼剂（0．3％）的制备及含量测定方法。方法以硼酸为渗透压调节剂，海藻酸钠为增稠剂，制备甲磺酸帕珠沙星即型凝胶滴眼剂（0．3％）。用高效液相色谱法测定含量。结果甲磺酸帕殊沙星检测浓度在4—40μg/ml范围内与峰面积分值线性关系良好，t=0．0005，平均回收率为（99．985±0．205）％。RSD为0．322％。本品渗透压为320m0sm／kg，pH值为4．87。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 fbr preparation and measuring the content of pazufloxaxin mesilate in the in - situ gelling of eye drops（0.3% ）. Methods In this study, in - situ gelling of pazufloxacin mesilate eye drops took boric acid as buffer to regulate the pH and osmotic pressure. The sustained - release eye drops using sodium alginate as viscosity - promoting agent was studied. The uhraviolet speetrophtonetric method was established for the determination of pazufloxacin mesilate. Results There was a good linear relationship within the concentration range of 4 -40 μg/ml. The average recovery of pazuloxacin mesilate was 99. 85 ＋-0. 205. The RSD was 0.322%. The osmotic pressure and pH of the solution were 320 mOsm/kg and 4.87 respeetively. The result of rabbit - eye irritation test showed that the eye drops had no irritation. Conclusison The pazufloxacin mesilate in - situ gelling of eye drops is promising with simple fnrmula, preparation process, easy quality and stability.
出处
《临床医学》
CAS
2008年第8期108-110,共3页
Clinical Medicine
关键词
甲磺酸帕珠沙星
即型凝胶
滴眼剂
Pazufloxacin mesilatc
In - situ gelling
Eye drops
