冷藏制药的防腐剂有效性测试:选择具有挑战性的隔离物和储存温度
Seyed Sadeq Mousavi Ghahfarrokhi1,2,3, Zeinab Zarei1, Khadijeh Hamidian1
1Department of Drug and Food Control, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
PDA journal of pharmaceutical science and technology
|April 29, 2025
概括
对胰岛素产品的抗微生物防腐剂有效性测试显示,根据储存温度,结果各不相同. 在室内和冷藏条件下进行测试,可以更准确地评估无菌多剂量瓶中的防腐剂有效性.
科学领域:
- 制药科学 制药科学
- 微生物学 微生物学
- 药物产品的稳定性 药物产品的稳定性
背景情况:
- 对于多用途制药产品来说,抗微生物有效性测试至关重要.
- 防腐剂保护剂型免受微生物污染.
- 胰岛素产品需要严格的测试来确保安全性和有效性.
研究的目的:
- 为了评估胰岛素配方的抗微生物防腐剂的有效性.
- 为了比较室温和冷藏温度的综合测试结果.
- 评估心理耐受性微生物对防腐剂有效性的影响.
主要方法:
- 胰岛素产品 (中性蛋白质和常规胰岛素) 经过了欧洲药典和美国药典的抗微生物防腐剂有效性测试.
- 在室温和冷藏温度下进行了测试.
- 心理耐受性菌株Serratia marcescens被纳入了挑战测试中.
主要成果:
- 在室温下使用的胰岛素产品符合欧洲药典A和美国药典标准.
- 冷藏的胰岛素产品符合美国药典的标准,但在接触时间小于7天时未能达到欧洲药典A标准.
- 在两种测试温度中,Serratia marcescens数量减少是一致的.
结论:
- 目前的综合抗微生物有效性测试可能无法完全捕捉冷藏下防腐剂的性能.
- 在室温和冷藏温度下进行测试,可以更全面地评估无菌多剂量瓶的防腐剂有效性.
- 储存温度显著影响对胰岛素产品抗微生物防腐剂有效性的解释.
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