注意缺陷多動(dòng)障礙（ADHD）是多發(fā)病于童年期的臨床常見慢性神經(jīng)發(fā)育性障礙，哌甲酯類藥品治療該病應(yīng)用較為廣泛。結(jié)合相關(guān)文獻(xiàn)，概述國內(nèi)外上市的治療ADHD的哌甲酯類藥品及其藥學(xué)研究的影響因素，從藥學(xué)審評角度分析此類藥品的藥學(xué)研究關(guān)注點(diǎn)，提出結(jié)合藥品釋藥機(jī)制等特性進(jìn)一步加強(qiáng)制劑的溶出度控制、乙醇劑量傾瀉和撒拌給藥等研究的建議，以期為兒童用藥的研發(fā)和技術(shù)評價(jià)提供一定的參考。

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.

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