从药品说明书谈配方信息挖掘

Explore of Recipe Information from Drug Package Inserts

本文比较了中、美、欧三地对于药品说明书中关于辅料的相关规定,总结了各地药品说明书对于辅料披露程度的特点,给出了药剂领域专利从业者检索药品说明书的建议。专利工作者在剂型类专利申请的检索过程中,应当重视药品说明书的检索,充分利用上市药品在不同地区的说明书信息,更好地了解现有技术,避免漏检。

This paper compares the relevant regulations on excipients in the drug package inserts of China,US and Europe,summarizes the characteristics of the disclosure of drug excipients in drug package inserts,and gives suggestions for patent practitioners of pharmacy about search skills on drug package inserts.During the process of searching on dosage form patent application,patent workers should pay attention to the retrieval of the drug package inserts,make full use of the information of drug package inserts in different regions,understand the existing technology better,and avoid missed inspection.