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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。结果甲磺酸帕珠沙星检测浓度在4~40μg/m l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320 mOsm/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 investigate the preparation and content determination of pazufloxacin mesylate instant gel (0.3%). Methods Boric acid as osmotic regulator and sodium alginate as thickening agent were used to prepare pazufloxacin mesylate or gel eye drops (0.3%). The content was determined by high performance liquid chromatography. Results Pazufloxacin mesylate showed a good linear relationship with the peak area in the range of 4 ~ 40μg / ml. The average recovery was (99.985 ± 0.205)%. RSD is 0.322%. The osmotic pressure of this product is 320 mOsm / kg, pH value is 4.87. Rabbit eye irritation experiments show that the eye drops on rabbits eye irritation, in line with the requirements of the Chinese Pharmacopoeia eye drops. Conclusion This eye drops prescription process is simple, easy to control the quality, good stability.