阿片类药物防滥用药学技术研究进展

Advances in studies on opioids with abuse-deterrent formulations

阿片类药物在治疗中重度疼痛的药物中占有重要地位,但在其应用过程中出现了大量药品滥用与成瘾的现象,引发了严重的社会问题。美国作为药品滥用程度最严重的国家之一,2011年前后,FDA先后发布了一系列有关阿片类药物开发的指导原则和评价通则,加快并促进了药品防滥用方面技术的革新。本文根据《Abuse-Deterrent Opioids—Evaluation and Labeling Guidance for Industry》中提出的几种药品防滥用技术对近年来国外各种阿片类上市药物进行分析,期望对国内相关领域的研究提供帮助。

Opioids have played an important role in the treatment of moderate and severe pain.But a large number of drug abuse and addiction have emerged in their application,which has caused serious social problems.The United States is one of the countries with the most serious drug abuse.Around 2011,FDA successively issued a series of guidelines and evaluation rules on the development of opioids,speeding up and promoting the innovation of drug abuse prevention technology.We analyzes various opioids on the market abroad in recent years according to several drug abuse prevention technologies proposed in the"Abuse-Deterrent Opioids—Evaluation and Labeling Guidance for Industry".It is expected to be helpful to domestic research in related fields.