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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 study the preparation and determination of pazufloxacin mesylate as gels. Methods sodium chloride as osmotic regulator, sodium alginate as matrix, preparation Pazufloxacin mesylate eye gel, determination of content by high performance liquid chromatography. Results Pazufloxacin mesylate concentration in the range of 6.02 ~ 60.20μg / ml range of peak area score was good, r = 0.99999, the average recovery was 101.85%. RSD is 1.95%. This product osmotic pressure 280 m0sm / kg, pH value of 5.0 to 7.0. Rabbit eye irritation experiments show that the eye drops on rabbits eye irritation, in line with the “Chinese Pharmacopoeia” eye drops requirements. Conclusion This eye drops prescription process is simple, easy to control the quality, good stability.