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目的研制盐酸莫西沙星温度敏感眼用凝胶,并考察其体外释放行为。方法采用冷溶法制备温敏凝胶;以泊洛沙姆407(P407)和泊洛沙姆188(P188)为温敏凝胶材料,模拟泪液稀释前后的胶凝温度为评价指标,采用均匀设计法对盐酸莫西沙星温度敏感眼用凝胶处方进行优化;采用无膜溶出法研究盐酸莫西沙星眼用凝胶的释药特性。结果盐酸莫西沙星温度敏感眼用凝胶的胶凝温度随P407浓度增大而降低,随P188浓度增加先升高后降低;模拟泪液的稀释可使胶凝温度升高;均匀设计法筛选出温度敏感眼用凝胶的最佳处方为230 mg·mL-1P407和80 mg·mL-1P188;凝胶溶蚀与药物的释放呈良好的相关性,说明眼用凝胶中药物的释放由凝胶的溶蚀所决定。结论均匀设计法可用于筛选眼用凝胶的处方,处方中含230 mg·mL-1P407和80 mg·mL-1P188的盐酸莫西沙星温度敏感眼用凝胶的性质满足眼部用药的设计要求,体现出良好的应用前景,可进一步研究开发。
Objective To develop a temperature-sensitive ophthalmic gel for moxifloxacin hydrochloride and investigate its in vitro release behavior. Methods The thermosensitive gels were prepared by cold-solution method. The gelation temperature before and after tear dilution was simulated by using poloxamer 407 (P407) and poloxamer 188 (P188) as the thermosensitive gels. Xisha Star temperature-sensitive ophthalmic gel prescription was optimized; the release characteristics of moxifloxacin hydrochloride ophthalmic gel were studied by membrane-free dissolution method. Results The gelation temperature of moxifloxacin hydrochloride temperature-sensitive ophthalmic gel decreased with the increase of P407 concentration and then increased with the increase of P188 concentration and then decreased. Simulated tear fluid dilution increased gelation temperature. The uniform design method screened The best prescription of temperature-sensitive ophthalmic gel was 230 mg · mL-1P407 and 80 mg · mL-1P188. The gel dissolution showed a good correlation with the drug release, indicating that the release of the drug in the ophthalmic gel consisted of gel The dissolution of the decision. Conclusion The uniform design method can be used to screen the prescription of ophthalmic gel. The prescription of moxifloxacin hydrochloride temperature-sensitive ophthalmic gel containing 230 mg · mL-1 P407 and 80 mg · mL-1 P188 meets the design requirements of eye medication , Showing a good application prospects, further research and development.