Oldham G B, Andrews V
Moorfields Eye Hospital, London.
Br J Ophthalmol. 1996 Jul;80(7):588-91. doi: 10.1136/bjo.80.7.588.
AIMS/BACKGROUND: Preservatives are added to multidose eyedrop containers to ensure that the eyedrops do not become heavily contaminated during patient use. This enables eyedrops to be used for up to 1 month after opening. However, patients are frequently required to use unpreserved eyedrops as their eyes are unable to tolerate these preservatives. Some commercial unpreserved unit dose eyedrops are available, but the range is limited, and they cannot be used in all cases. Twenty one different unpreserved eyedrop formulations in multidose bottles were tested to establish their inherent efficacy in antimicrobial preservation, and to help determine a suitable in use storage life.
The eyedrops were inoculated with a known quantity of four different micro-organisms according to the method of the European Pharmacopoeia 'Test for the efficacy of antimicrobial preservation'. After set periods of time, samples were taken to determine the number of viable organisms remaining.
Antibiotics and alkaloids were generally shown to have higher kill rates than other eyedrops such as artificial tears and steroids.
In general, once opened by individual patients in a domiciliary situation, a 7 day in use storage life is confirmed for eyedrops containing alkaloids or antibiotics, if they are stored in the refrigerator after opening.
目的/背景:多剂量滴眼剂容器中添加了防腐剂,以确保滴眼剂在患者使用期间不会受到严重污染。这使得滴眼剂在开封后最多可使用1个月。然而,由于患者的眼睛无法耐受这些防腐剂,他们经常需要使用无防腐剂的滴眼剂。市面上有一些商用的无防腐剂单位剂量滴眼剂,但种类有限,并非在所有情况下都适用。对21种不同的多剂量瓶装无防腐剂滴眼剂配方进行了测试,以确定它们在抗菌保存方面的固有功效,并帮助确定合适的使用期储存期限。
根据欧洲药典“抗菌防腐剂效力试验”的方法,用已知数量的四种不同微生物接种滴眼剂。在设定的时间段后,取样以确定剩余的活菌数量。
抗生素和生物碱类滴眼剂的杀菌率通常高于其他滴眼剂,如人工泪液和类固醇滴眼剂。
一般来说,含生物碱或抗生素的滴眼剂在家庭环境中被个体患者开封后,若开封后储存在冰箱中,其使用期储存期限确认为7天。