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药物(如卡洛芬)原液及其稀释液随时间推移的稳定性和无菌性。

Strength and Sterility of Stock and Diluted Carprofen Over Time.

机构信息

Unit for Laboratory Animal Medicine, University of Michigan, Ann Arbor, Michigan; Division of Animal Resources, University of Illinois at Urbana-Champaign, Champaign, Illinois.

Unit for Laboratory Animal Medicine, University of Michigan, Ann Arbor, Michigan.

出版信息

J Am Assoc Lab Anim Sci. 2021 Jul 1;60(4):470-474. doi: 10.30802/AALAS-JAALAS-20-000102. Epub 2021 May 10.

Abstract

Carprofen, a nonsteroidal antiinflammatory drug, is a commonly used analgesic for laboratory animals. The manufacturer labeling indicates the stock bottle may be stored and used for up to 28 d under refrigeration. However, institutional guidelines may vary in how long diluted carprofen solutions can be stored before they must be discarded. When administered to laboratory rodents, small volumes of the stock solution are diluted to provide accurate dosing and ease of administration. Because carprofen is formulated for use in companion animals (for example, dogs) and comes in larger volume multidose vials, the majority of carprofen at our institution is discarded before it can be used. In this study, we evaluated the amount of target ingredient present (strength), sterility, and endotoxin levels of both stock and diluted carprofen when stored in a variety of containers and at multiple temperature settings for up to 180 d, mimicking facets of typical use in laboratory animal research and medicine. We demonstrated that when refrigerated and stored in sterile vials, stock and diluted carprofen can be kept and used for up to 180 d while retaining strength and sterility. For short-term use, diluted carprofen can also be stored for up to 60 d at room temperature in conical tubes. These results will help establish scientifically justified storage conditions for carprofen to ensure that these agents remain appropriately potent and sterile for therapeutic use in laboratory animals.

摘要

卡洛芬是一种非甾体类抗炎药,是实验室动物常用的镇痛药物。制造商标签表明,冷藏条件下,原药瓶可保存和使用长达 28 天。然而,机构指南可能因稀释后的卡洛芬溶液在必须丢弃之前可以保存多长时间而有所不同。当给实验啮齿动物给药时,将小体积的原液稀释以提供准确的剂量和便于给药。由于卡洛芬是为伴侣动物(例如狗)配制的,并且装在更大体积的多剂量小瓶中,因此我们机构的大部分卡洛芬在使用之前就被丢弃了。在这项研究中,我们评估了在长达 180 天的时间内,在各种容器和多个温度设置下储存的原液和稀释液的目标成分含量(效力)、无菌性和内毒素水平,模拟了实验室动物研究和医学中药物的典型使用情况。我们证明,在冷藏并保存在无菌小瓶中时,原液和稀释液的卡洛芬可保存和使用长达 180 天,同时保持效力和无菌性。对于短期使用,稀释后的卡洛芬也可以在室温下锥形管中储存长达 60 天。这些结果将有助于确定卡洛芬的科学合理储存条件,以确保这些药物在实验室动物的治疗应用中保持适当的效力和无菌性。

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Strength and Sterility of Stock and Diluted Carprofen Over Time.药物(如卡洛芬)原液及其稀释液随时间推移的稳定性和无菌性。
J Am Assoc Lab Anim Sci. 2021 Jul 1;60(4):470-474. doi: 10.30802/AALAS-JAALAS-20-000102. Epub 2021 May 10.

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