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药品和化妆品的微生物稳定性。

Microbial Stability of Pharmaceutical and Cosmetic Products.

机构信息

Department of Pharmaceutics and Drug Delivery, University of Mississippi School of Pharmacy, University, MS, 38677, USA.

Institute for Drug Delivery and Biomedical Research, Bangalore, Karnataka, India.

出版信息

AAPS PharmSciTech. 2018 Jan;19(1):60-78. doi: 10.1208/s12249-017-0875-1. Epub 2017 Oct 10.

Abstract

This review gives a brief overview about microbial contamination in pharmaceutical products. We discuss the distribution and potential sources of microorganisms in different areas, ranging from manufacturing sites, pharmacy stores, hospitals, to the post-market phase. We also discuss the factors that affect microbial contamination in popular dosage forms (e.g., tablets, sterile products, cosmetics). When these products are contaminated, the microorganisms can cause changes. The effects range from mild changes (e.g., discoloration, texture alteration) to severe effects (e.g., changes in activities, toxicity). The most common method for countering microbial contamination is the use of preservatives. We review some frequently used preservatives, and we describe the mechanisms by which microorganisms develop resistance to these preservatives. Finally, because preservatives are inherently toxic, we review the efforts of researchers to utilize water activity and other non-preservative approaches to combat microbial contamination.

摘要

本文简要概述了药品中的微生物污染问题。我们讨论了微生物在不同领域(包括制药厂、药店、医院以及上市后阶段)的分布和潜在来源。我们还讨论了影响常见剂型(如片剂、无菌产品、化妆品)中微生物污染的因素。当这些产品受到污染时,微生物可能会引起变化。这些影响的范围从轻微变化(例如变色、质地改变)到严重影响(例如活性、毒性改变)。对抗微生物污染最常见的方法是使用防腐剂。我们回顾了一些常用的防腐剂,并描述了微生物对这些防腐剂产生抗性的机制。最后,由于防腐剂本质上是有毒的,我们还回顾了研究人员利用水活度和其他非防腐剂方法来对抗微生物污染的努力。

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