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| 哌甲酯类药品治疗注意缺陷多动障碍药学研究的一般考虑 | |
| 引用本文： | 司晓菲,孙昱,李艳杰,葛妍秀,姜典卓. 哌甲酯类药品治疗注意缺陷多动障碍药学研究的一般考虑[J]. 现代药物与临床, 2022, 45(4): 611-617 |
| 作者姓名： | 司晓菲 孙昱 李艳杰 葛妍秀 姜典卓 |
| 作者单位： | 国家药品监督管理局 药品审评中心, 北京 100022 |
| 摘 要： | 注意缺陷多动障碍（ADHD）是多发病于童年期的临床常见慢性神经发育性障碍，哌甲酯类药品治疗该病应用较为广泛。结合相关文献，概述国内外上市的治疗ADHD的哌甲酯类药品及其药学研究的影响因素，从药学审评角度分析此类药品的药学研究关注点，提出结合药品释药机制等特性进一步加强制剂的溶出度控制、乙醇剂量倾泻和撒拌给药等研究的建议，以期为儿童用药的研发和技术评价提供一定的参考。 |
| 关 键 词： | 注意缺陷多动障碍 哌甲酯类药品 释药机制 乙醇剂量倾泻 儿童用药 |
| 收稿时间： | 2021-12-02 |
Pharmaceutical considerations on development of methylphenidate drugs for treatment of attention deficit hyperactivity disorder |
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| SI Xiaofei,SUN Yu,LI Yanjie,GE Yanxiu,JIANG Dianzhuo. Pharmaceutical considerations on development of methylphenidate drugs for treatment of attention deficit hyperactivity disorder[J]. Drugs & Clinic, 2022, 45(4): 611-617 | |
| Authors: | SI Xiaofei SUN Yu LI Yanjie GE Yanxiu JIANG Dianzhuo |
| Affiliation: | Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China |
| Abstract: | Attention deficit hyperactivity disorder (ADHD) is the most common neurobehavioral disorders in child, methylphenidate drugs are widely used for treatment of ADHD. This article mainly refers to relevant literature of representative methylphenidate drugs from domestic and foreign market, based on the understanding of CMC review experience, briefly discussed the general consideration on the development of methylphenidate drugs, and proposed some suggestion about dissolution control, alcoholinduced dose-dumplings and sprinkle in combination with drug release mechanisms, in order to provide some reference for pediatric drug research and development units and the technical evaluation. |
| Keywords: | attention deficit hyperactivity disorder methylphenidate drugs drug release mechanisms alcohol-induced dosedumplings pediatric drugs |
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