当热击时:研究二碳酸注射中的意外颗粒
Narasimha Swamy Kollu1, Ravikiran Allada1
1Department of Analytical Research & Development, Steriscience Specialties Private Limited, 154/11, Krishnaraju Layout, Panduranga Nagar, Bengaluru, Karnataka, 560076, India.
Journal of pharmaceutical sciences
|December 13, 2025
概括
可注射二碳酸注射中的可见颗粒,由于高温灭菌与玻璃瓶相互作用,造成了风险. 识别陶松石晶体可以防止监管问题,并确保患者的安全.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 分析化学 分析化学
背景情况:
- 注射剂中的颗粒物会导致严重的不良事件,如栓塞和.
- 药品中的可见颗粒违反了药典标准,冒着监管行动的风险.
- 在玻璃瓶中注射的二碳酸容易在杀菌过程中形成颗粒.
研究的目的:
- 为了研究高温杀菌后,二碳酸注射中的颗粒物意外形成.
- 为了确定观察到的粒子的组成和来源.
- 为了告知防止父体配方中的颗粒形成的策略.
主要方法:
- 在121°C处绝育二碳酸注射剂.
- 使用分析技术的组合分析颗粒物的分析.
- 在热处理过程中研究药物容器相互作用.
主要成果:
- 在121°C的灭菌后,二碳酸注射中形成的颗粒物.
- 这些颗粒被确定为陶矿晶体.
- 形成归因于药物与在高温下从玻璃瓶中出的之间的相互作用.
结论:
- 在玻璃瓶中注射二碳酸的高温灭菌可以导致陶颗粒的形成.
- 这一发现凸显了评估药物容器相互作用和优化绝育条件的关键需求.
- 为了确保可注射产品的安全性和有效性,全面的颗粒识别是必不可少的.
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