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目的研制乳酸环丙沙星眼用即型凝胶。方法以泊洛沙姆407为温敏型材料制备乳酸环丙沙星眼用即型凝胶,通过对胶凝温度的考察确定处方,考察了乳酸环丙沙星眼用即型凝胶的黏度,采用无膜溶出模型对药物的体外释放机制进行研究,对制剂的眼刺激性进行评价。结果确定18%的泊洛沙姆407作为乳酸环丙沙星眼用即型凝胶的基质。药物的体外释放呈零级动力学特征,释放量取决于凝胶溶蚀量。该制剂对兔眼无刺激。结论该制剂制备方法简单,剂量易于控制,展现出良好的眼部应用前景。
Objective To develop ciprofloxacin lactate eye gel. Methods Poloxamer 407 was used as a thermosensitive material to prepare ciprofloxacin ophthalmic gels. The prescription of gelatinization temperature was determined and the viscosity of ciprofloxacin lactate gelatin , The membrane-free dissolution model was used to study the mechanism of drug release in vitro and the eye irritation of the preparation was evaluated. As a result, 18% of poloxamer 407 was identified as a matrix for ciprofloxacin lactate gels. Drug release in vitro showed zero-order kinetic characteristics, the amount of release depends on the amount of gel dissolution. The preparation is non-irritating to rabbit eyes. Conclusion The preparation method of the preparation is simple, the dosage is easy to control, and the application prospect of the eye is good.