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

    • 摘要:
      目的  探讨药用玻璃的侵蚀机制与影响因素,以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 通过分析药用玻璃侵蚀机制,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、原子力显微镜法、二次离子质谱法、X射线光电子能谱法和电感耦合等离子体法等。
      结果 药用玻璃在特定条件下可能发生内表面侵蚀甚至脱片,微小玻璃脱片进入药液后难以察觉,构成潜在用药风险。不同检测方法在观察玻璃内表面侵蚀方面各具优势,涵盖从宏观观察到微观形貌分析、表面元素组成及离子迁移检测等多个层面。
      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。综合运用多种检测方法,有助于全面评估玻璃内表面的侵蚀程度,为药用玻璃的选用与质量评价提供科学依据。

       

      Abstract:
      OBJECTIVE  To explore 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 was clarified. At the same time, the system introduced various methods for detecting the inner surface durability of medicinal glass, including visual inspection, methylene blue staining, optical microscopy, electron microscopy, atomic force microscopy, secondary ion mass spectrometry, X-ray photoelectron spectroscopy, and inductively coupled plasma, etc.
      RESULTS  Pharmaceutical glass might undergo internal surface erosion and even flaking under specific conditions. Tiny glass flakes that entered the drug solution were hard to detect and posed a potential risk to medication use. Different detection methods had their own advantages in observing the internal surface erosion of glass, covering multiple aspects from macroscopic observation to microscopic morphology analysis, surface element composition, and ion migration detection.
      CONCLUSION  The inner surface durability of medicinal glass is an important factor in the safety of drug packaging. The comprehensive application of multiple detection methods is conducive to a comprehensive assessment of the erosion degree of the inner surface of the glass, providing a scientific basis for the selection and quality evaluation of pharmaceutical glass.

       

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