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目的为药品生产企业完善儿童非处方说明书提供参考,同时为我国药品监管部门管理和规范我国儿童非处方药说明书提供建议。方法依据美国现行的《联邦食品、药品和化妆品法案》等法律法规分析美国儿童常用的非处方药布洛芬混悬液说明书的结构,归纳总结出美国儿童非处方药说明书规范的一般特点。结果美国儿童非处方药说明书有利于不具备医药知识的普通大众阅读理解;对药品安全使用给予充足的强调和警告,突出了药品的安全性;设置了独立的非活性成分条目,突出药用辅料的安全性,有利于药品监管部门对药用辅料的管理。结论借鉴美国儿童非处方药说明书的相关法律法规,严格规范非处方药说明书规范细则,加大监管力度,同时向普通大众宣传医药知识,切实保障儿童用药安全合理。
The purpose is to provide a reference for pharmaceutical manufacturers to perfect the children’s over-the-counter prescriptions, and to provide suggestions for our country’s pharmaceutical regulatory authorities to regulate and standardize our children’s non-prescription drugs. Methods According to the current “Federal Food, Drug and Cosmetic Act” and other laws and regulations in the United States, this paper analyzes the structure of the instructions of the commonly used over-the-counter drug ibuprofen suspension for children in the United States and summarizes the general characteristics of the specifications of the American children over-the-counter drug specification. As a result, the instructions for non-prescription drugs for children in the United States are beneficial to the general public for reading comprehension without medical knowledge, adequate emphasis and warning on the safe use of medicines are given, and the safety of medicines is highlighted. Independent non-active ingredients are set to highlight the safety of pharmaceutical excipients Sex, is conducive to pharmaceutical regulatory authorities on the management of pharmaceutical excipients. Conclusions Drawing on the relevant laws and regulations of the American children’s OTC prescriptions, we strictly regulate the rules and regulations of non-prescription drug manuals and intensify supervision. At the same time, we publicize the medical knowledge to the general public and ensure the safety and rational use of medicines for children.