预灌封注射器玻璃针管内表面化学稳定性研究

摘要

目的：通过测试评价预灌封注射器玻璃针管内表面化学稳定性。方法测试模拟试验提取液中不溶性微粒、可见异物、 pH值，并通过亚甲蓝染色实验和扫描电镜对预灌封注射器玻璃针管内表面耐受性进行考察。结果模拟试验中提高提取溶液的pH值，延长灭菌时间，模拟试验提取液中可见柱状异物，玻璃针管内表面染色明显，扫描电镜观察到浸蚀区域。结论预灌封注射器接触的液体碱性越强、接触时间越长，玻璃针管内表面将越容易受到浸蚀，存在脱片风险。%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.