摘 要 目的：考察盐酸布比卡因注射液与给药器具的相容性。方法：根据盐酸布比卡因注射液临床使用中可能接触到的不同类型及不同材质的给药器具，开展相容性研究。结果：经过可提取物试验和浸出物试验，各元素及有机物均未超过其每日允许暴露量，玻璃材质给药器具未观察到侵蚀脱片现象。结论：盐酸布比卡因注射液在不同类型及不同材质给药器具中均稳定。

    关键词 盐酸布比卡因注射液 给药器具 相容性

    中图分类号：R943； R971.2 文献标志码：A 文章编号：1006-1533(2024)19-0081-04

    引用本文 施建国， 蒋宇丹. 盐酸布比卡因注射液与给药器具相容性研究[J]. 上海医药， 2024， 45(19)： 81-84； 89.

    Study on the compatibility of bupivacaine hydrochloride injection with drug delivery devices

    SHI Jianguo， JIANG Yudan

    (Shanghai Harvest Pharmaceutical Co.， Ltd.， Shanghai 201206， China)

    ABSTRACT Objective： To investigate the compatibility of bupivacaine hydrochloride injection with drug delivery devices. Methods： The compatibility study was carried out according to the drug delivery devices of the different types and materials that may be exposed to bupivacaine hydrochloride injection in clinical use. Results： The results met the requirements after extraction and leaching test. Conclusion： Bupivacaine hydrochloride injection is stable in different types and materials of drug delivery devices. ......