在最大使用条件下,评估Ethiqa XR无菌度超出"废弃日期"
Heather Vorwerk1, LaTisha Moody1, Bhupinder Singh1
1Rutgers University Animal Care, Rutgers University, Piscataway, New Jersey.
概括
埃蒂卡XR是一种延长释放的布普伦诺啡,在入侵后180天内保持不孕. 这一发现支持延长使用超过90天的丢弃日期,提高了研究人员使用小动物模型的成本效益.
科学领域:
- 药理学 药理学是指药理学的学科.
- 药物的配方 药物的配方
- 无菌性测试 无菌性测试
背景情况:
- 埃蒂卡XR是一种FDA指数,延长释放,与脂质结合的布普伦诺芬配方,提供72小时的止痛效果.
- 由于药物的数量,90天后的丢弃日期对小动物研究来说可能是成本高昂的.
- 延长使用Ethiqa XR可能会提高研究人员的成本效益.
研究的目的:
- 为了评估Ethiqa XR在标记的90天后丢弃日期之后的无菌性.
- 为了确定是否可以保持不育的额外90天 (总共180天).
- 评估长期储存对细菌,真菌和内毒素污染的影响.
主要方法:
- 在每周两次注射针之前,用70%的异醇消毒小瓶.
- 样本从瓶子中收集到180天后的时间.
- 每月对细菌,真菌和内毒素污染进行测试.
主要成果:
- 在整个180天的研究期间,所有Ethiqa XR瓶都没有细菌污染.
- 在发酵后180天内,在瓶子中没有检测到真菌污染.
- 内毒素水平仍然低于可接受的限度,证实了长达180天的无菌性.
结论:
- 埃蒂卡XR保持无菌性长达180天后入侵.
- 延长使用Ethiqa XR超过90天是可行的.
- 这为在小动物研究中使用Ethiqa XR的研究人员提供了更好的成本效益.
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