摘要
低浓度阿托品滴眼剂作为延缓青少年近视的眼用制剂,临床疗效已得到广泛认可,但已上市的硫酸阿托品水溶液型滴眼剂存在因pH值低而导致的眼刺激性、制剂稳定性差和患者依从性差等问题.该文对目前在研和在售的硫酸阿托品眼用制剂的处方和制备工艺进行了文献调研和总结,分析了各种改善硫酸阿托品眼用制剂稳定性和依从性的技术方案特点和优劣势,以期为阿托品眼用制剂的优化提供一定的参考.
Abstract
Low-concentration atropine eyedrops,an ophthalmic formulation for delaying myopia of adolescents,has been widely recognized due to its clinical therapeutic effects.However,the commercialized atropine sulfate eyedrops,ophthalmic aqueous solution,have many problems,such as eye irritation caused by low pH value of the aqueous solution,poor stability of the preparations and poor patient compliance.In this review,the formulations and preparation processes of atropine sulfate ophthalmic preparations currently under development and on the market are summarized,the characteristics,advantages and disadvantages of various technical approaches for improving stability and compliance of atropine sulfate ophthalmic products are analyzed,hoping to provide some references for the optimization of atropine ophthalmic formulations.
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