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Updated: Jul 11, 2025

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Measuring Enzymatic Stability by Isothermal Titration Calorimetry
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人类胰岛素的热稳定性和储存
Bernd Richter1, Brenda Bongaerts1, Maria-Inti Metzendorf1
1Cochrane Metabolic and Endocrine Disorders Group, Institute of General Practice, Medical Faculty of the Heinrich-Heine-University, Düsseldorf, Germany.
The Cochrane database of systematic reviews
|November 6, 2023
概括
人类胰岛素可以在高达37°C的温度下长时间保持功效,即使在波动的条件下,为没有冷藏的患者提供了可行的选择. 这项研究为在具有挑战性的环境中管理胰岛素储存提供了关键的见解.
科学领域:
- 糖尿病管理 糖尿病管理
- 药物稳定性 药物稳定性
- 治疗药物监测 治疗药物监测
背景情况:
- 人类胰岛素的温度敏感性需要谨慎储存,制造商建议冷藏完整的瓶子和室温打开的瓶子 (4-6周).
- 关于胰岛素在使用中的保质期 (10-45天) 和最高温度 (25-37°C) 的建议各不相同.
- 气候危机和有限的制冷供应给糖尿病患者带来了极端高温的挑战.
研究的目的:
- 为了分析储存人体胰岛素在制造商推的温度范围或使用时间之外的影响.
- 评估在各种存储条件下与现实世界相关的胰岛素稳定性.
主要方法:
- 使用柯克伦搜索方法进行系统的文献综述,包括临床和体外研究.
- 对制药公司关于人体胰岛素热稳定性的数据的分析.
- 用GRADE方法来评估临床研究证据的确定性.
主要成果:
- 实验室内研究表明,在4-23°C保存长达28天的预填注射器中,胰岛素活性没有临床相关的损失.
- 未打开的瓶子和子在28.9-37°C下保持有效期长达四个月,一些研究显示损失最小 (在37°C下28天后<18%).
- 打开的瓶子和弹在高达37°C的温度下在12周内没有显示出临床相关的活性损失;在高达12周的振荡温度 (25-37°C) 中也没有显示出任何损失.
结论:
- 制药数据表明,未打开的胰岛素可以在高达25°C的温度下存储六个月或在37°C的温度下存储两个月,而不会显著失去功效.
- 在25-37°C之间波动的温度在长达三个月内不会影响胰岛素活性.
- 像土这样的简单冷却装置可以帮助降低储存胰岛素的环境温度,但需要对各种储存条件和胰岛素类型进行进一步的临床研究.
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