非无菌水性基质药品中洋葱伯克霍尔德菌群控制的一般考虑

Control considerations of Burkholderia cepacia complex in non-sterile aqueous drugs

洋葱伯克霍尔德菌群(Burkholderia cepacia complex,BCC)在营养有限的水性环境中有较强的生存能力,对一些治疗用抗菌药和常用抑菌剂具有耐药性,可引起囊性纤维化、慢性肉芽肿患者或低免疫力易感人群的严重感染。BCC已被美国食品药品监督管理局(FDA)明确归为不可接受微生物,因此,非无菌水性基质药品中BCC的预防及控制对药品安全至关重要。主要对BCC的特性、检测方法及风险评估和控制策略进行阐述,为非无菌水性基质药品中BCC的研究和控制提供参考。

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.