洋蔥伯克霍爾德菌群（Burkholderia cepacia complex，BCC）在營養(yǎng)有限的水性環(huán)境中有較強(qiáng)的生存能力，對(duì)一些治療用抗菌藥和常用抑菌劑具有耐藥性，可引起囊性纖維化、慢性肉芽腫患者或低免疫力易感人群的嚴(yán)重感染。BCC已被美國食品藥品監(jiān)督管理局（FDA）明確歸為不可接受微生物，因此，非無菌水性基質(zhì)藥品中BCC的預(yù)防及控制對(duì)藥品安全至關(guān)重要。主要對(duì)BCC的特性、檢測(cè)方法及風(fēng)險(xiǎn)評(píng)估和控制策略進(jìn)行闡述，為非無菌水性基質(zhì)藥品中BCC的研究和控制提供參考。

Burkholderia cepacia complex (BCC) have a well-documented ability to utilize nutrient-limited aquatic sources as energy, and it present an inherent resistance to antibiotics and antiseptics effectiveness, which causing a serious threat to susceptible patients, particularly those with cystic fibrosis and chronic granulomatous or who are immunocompromised. BCC were defined as objectionable microorganisms by FDA. This review to provide control strategies and discuss characteristic considerations, analytical method and risk assessments that are relevant to BCC control in non-sterile aqueous drugs.

R951