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在给药前处理治疗性蛋白时,请勿弹拨或丢弃非标签使用的塑料注射器。

Do not flick or drop off-label use plastic syringes in handling therapeutic proteins before administration.

机构信息

College of Pharmacy, Dongguk University-Seoul, Gyeonggi 10326, Republic of Korea.

出版信息

Int J Pharm. 2020 Sep 25;587:119704. doi: 10.1016/j.ijpharm.2020.119704. Epub 2020 Jul 31.

Abstract

This study investigates the formation of subvisible particles formed by external stresses produced such as flicking and dropping syringes. Flow imaging was used to visualize and quantify microparticles from 1 μm to over 25 μm as a result of mishandling. Microparticles increased in the presence of silicone oil that was present in syringes. Thus, silicone oil in syringes may affect the activity of therapeutic proteins being injected. Present data showed detailed and differentiated morphologies of proteinaceous particles, silicone oil, air bubbles, and plastic debris in mishandled syringes. In some cases, the presence of bisphenol A in syringes was detected by FT-IR. Disposable plastic syringes were evaluated and showed differences in their content of silicone oil. Syringes that contain 0.45 μm filters inside the needle cap as well as silicone oil-free syringes release proteinaceous subvisible particles after mechanical stress. These stress-generated particles can be delivered to patients, compromising patient care.

摘要

本研究调查了由弹丸和掉落注射器等外力产生的亚可见颗粒的形成。流动成像技术用于可视化和量化由于处理不当而产生的 1μm 至 25μm 以上的微粒。在注射器中存在硅油的情况下,微粒会增加。因此,注射器中的硅油可能会影响正在注射的治疗性蛋白质的活性。目前的数据显示了在处理不当的注射器中蛋白质颗粒、硅油、气泡和塑料碎片的详细和差异化形态。在某些情况下,通过傅里叶变换红外光谱法(FT-IR)检测到注射器中存在双酚 A。对一次性塑料注射器进行了评估,结果显示它们的硅油含量存在差异。含有针帽内 0.45μm 过滤器以及无硅油的注射器在机械应力后会释放出蛋白质亚可见颗粒。这些由应力产生的颗粒可能会被输送给患者,从而影响患者护理。

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