Chemical Potency and Degradation Products of Medications Stored Over 550 Earth Days at the International Space Station
Chemical Potency and Degradation Products of Medications Stored Over 550 Earth Days at the International Space Station
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DOI：
10.1208/s12248-015-9834-5
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发表时间：
2016-01-01
期刊：
影响因子：
4.5
通讯作者：
Wotring, Virginia E.
中科院分区：
文献类型：
--
作者：
Wotring, Virginia E.
药物会随着时间的推移而降解，而极端的储存条件会加速降解。目前的程序确保国际空间站（ISS）上的药物在到期前得到补充，但在未来的长期探索任务中，再补给可能是不可能的。因此，储存在国际空间站上的药物被送回地球进行分析。这是一次机会性的、观察性的小规模调查，目的是检验iss老化不会导致异常退化的假设。分析9种药物的活性药物成分（API）含量及降解量；结果与2012年美国药典（USP）要求进行了比较。这些药物包括两种助眠药、两种抗组胺药/减充血药、三种止痛药、一种止泻药和一种警觉性药物。由于样品是偶然地从未使用的医疗用品中获得的，每种药物仅在1个时间点可用，并且没有对照样品（地球上类似时期的样品）可用。一种药物在过期5个月后达到了USP要求。9种药物中有4种（44%）在过期后8个月符合USP要求。另外三种药物（33%）在到期前2-3个月符合USP指南。一种化合物，一种用作助眠的膳食补充剂，在过期后11个月未能达到USP的要求。未发现异常降解产物。有限的、以证据为基础的延长药物保质期是可能的，这将有助于为长期的勘探任务做准备。只有将飞行老化样品与适当匹配的地面对照进行分析，才能确定航天环境对药物稳定性的影响。
Medications degrade over time, and degradation is hastened by extreme storage conditions. Current procedures ensure that medications aboard the International Space Station (ISS) are restocked before their expiration dates, but resupply may not be possible on future long-duration exploration missions. For this reason, medications stored on the ISS were returned to Earth for analysis. This was an opportunistic, observational pilot-scale investigation to test the hypothesis that ISS-aging does not cause unusual degradation. Nine medications were analyzed for active pharmaceutical ingredient (API) content and degradant amounts; results were compared to 2012 United States Pharmacopeia (USP) requirements. The medications were two sleep aids, two antihistamines/decongestants, three pain relievers, an antidiarrheal, and an alertness medication. Because the samples were obtained opportunistically from unused medical supplies, each medication was available at only 1 time point and no control samples (samples aged for a similar period on Earth) were available. One medication met USP requirements 5 months after its expiration date. Four of the nine (44% of those tested) medications tested met USP requirements 8 months post expiration. Another three medications (33%) met USP guidelines 2-3 months before expiration. One compound, a dietary supplement used as a sleep aid, failed to meet USP requirements at 11 months post expiration. No unusual degradation products were identified. Limited, evidence-based extension of medication shelf-lives may be possible and would be useful in preparation for lengthy exploration missions. Only analysis of flight-aged samples compared to appropriately matched ground controls will permit determination of the spaceflight environment on medication stability.