药品包装用玻璃容器内表面耐受性检测技术研究进展

Research Progress of Inner Surface Tolerance Testing Technology of Glass Containers for Pharmaceutical Packaging

关键词:  药用玻璃  内表面耐受性  玻璃脱片  影响因素  检测技术

Key words:  pharmaceutical glass  inner surface durability  glass flake  influence factor  detection technology

摘要:

目的 探讨药用玻璃的侵蚀机制及影响因素，及在玻璃类药包材内表面耐受性研究中常见的检测方法，为评估药用玻璃内表面的侵蚀状况提供参考。方法 通过对药用玻璃侵蚀机制的分析着手，明确了化学组成、生产工艺、内表面处理方法和药品性质等因素对内表面耐受性的影响。同时，系统介绍了多种检测药用玻璃内表面耐受性的方法，包括目视检查法、亚甲基蓝染色法、光学显微镜法、电子显微镜法、原子力显微镜（AFM）法、二次离子质谱（SIMS）法、X射线光电子能谱（XPS）法和电感耦合等离子体（ICP）法等。结果 阐述了这些方法的原理和特点及在内表面耐受性研究中的应用。结论 药用玻璃的内表面耐受性是药品包装安全性的重要因素。多种检测方法各有优势，可根据研究需求和实验条件选择合适的方法。未来需要进一步优化检测技术，开发更高效、灵敏的检测手段，以更好地评估药用玻璃的侵蚀状况，提高药品包装的安全性和可靠性。

Abstract:

OBJECTIVE Exploring the erosion mechanism and influencing factors of medicinal glass, as well as common detection methods in the study of the inner surface durability of glass drug packaging materials, to provide reference for evaluating the erosion status of the inner surface of medicinal glass. METHODS Starting from the analysis of the erosion mechanism of medicinal glass, the influence of factors such as chemical composition, production process, internal surface treatment method, and drug properties on the inner surface durability has been clarified. At the same time, the system introduces various methods for detecting the inner surface durability of medicinal glass, including visual inspection, methylene blue staining, optical microscopy, electron microscopy, atomic force microscopy (AFM), secondary ion mass spectrometry (SIMS), X-ray photoelectron spectroscopy (XPS), and inductively coupled plasma (ICP) , etc. RESULTS Explained the principles and characteristics of these methods, as well as their applications in the study of inner surface durability. CONCLUSION The inner surface durability of medicinal glass is an important factor in the safety of drug packaging. Multiple detection methods have their own advantages, and suitable methods can be selected according to research needs and experimental conditions. In the future, it is necessary to further optimize detection technology and develop more efficient and sensitive detection methods to better evaluate the erosion status of medicinal glass and improve the safety and reliability of drug packaging.