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预灌封注射器玻璃针管内表面化学稳定性研究

张广湘 林杨 陈晓媛 吴漪 雷秀峰

临床医学工程2016,Vol.23Issue(3):270-271,2.
临床医学工程2016,Vol.23Issue(3):270-271,2.DOI:10.3969/j.issn.1674-4659.2016.03.0270

预灌封注射器玻璃针管内表面化学稳定性研究

Research on Chemical Stability of Glass Needle Tube Inner Surface of Prefilled Syringe

张广湘 1林杨 1陈晓媛 1吴漪 1雷秀峰1

作者信息

  • 1. 广东省医疗器械质量监督检验所,广东广州510663
  • 折叠

摘要

Abstract

Objective To evaluate the chemical stability of glass needle tube inner surface of prefilled syringe by simulation testing. Methods Insoluble particles, visible foreign matte and pH value in the liquid of simulated extraction were tested. The glass prefilled syringe needle tube surface tolerance was evaluated by methylene blue staining and scanning electron microscope (SEM). Results When improving pH value of extraction solution or prolonging sterilization time in the simulation test, columnar foreign body was visible in extraction solution, staining was obvious on glass tube inner surface, and erosion area was observed with SEM. Conclusion With stronger alkaline liquid or longer contact time, prefilled syringe will make its glass needle tube inner surface erosed more easily.

关键词

预灌封注射器/玻璃内表面/模拟试验/浸蚀

Key words

Prefilled syringe/Glass inner surface/Simulation test/Erosion

分类

预防医学

引用本文复制引用

张广湘,林杨,陈晓媛,吴漪,雷秀峰..预灌封注射器玻璃针管内表面化学稳定性研究[J].临床医学工程,2016,23(3):270-271,2.

基金项目

广州市科研条件建设项目“广州市生物医用血液净化材料研究与开发重点实验室”(项目编号:穗科信字[2013]163-5号) (项目编号:穗科信字[2013]163-5号)

临床医学工程

1674-4659

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