Schwarb F P, Gabard B, Bieli E, Schwab S, Surber C
Institute of Hospital Pharmacy, University Hospital, Basel, Switzerland.
Dermatology. 2001;203(3):248-55. doi: 10.1159/000051759.
Microbiological quality of topical products comprises both, the microbiological purity of the unopened product and the efficacy of the antimicrobial preservation system.
Subsequent to an outbreak of invasive Paecilomyces lilacinus mycosis among patients of an isolation ward, probably caused by a contaminated skin care product, the microbiological quality of different skin care products from the market was investigated.
The different products were investigated for their efficacy of antimicrobial preservation in general and especially against P. lilacinus according to a pharmacopoeial routine method slightly adopted for the purpose of this investigation.
The products did partially not comply with the British Pharmacopoeia 1993 test for efficacy of antimicrobial preservation. The antimicrobial preservation systems were less effective against P. lilacinus than against the pharmacopoeial reference germs. The antimicrobial preservation efficacy decreased towards the end of the shelf-life of the product. A decreased P. lilacinus inoculum dose was related to an increased growth of the micro-organisms.
Topical products are, unless not labelled otherwise, non-sterile preparations and their preservation systems are only tested against pharmacopoeial key micro-organisms. The microbiological behaviour following contamination with other germs remains unknown.
局部用产品的微生物质量包括未开封产品的微生物纯度和抗菌保存系统的效能。
在一个隔离病房的患者中爆发了可能由受污染的护肤品引起的侵袭性淡紫拟青霉病后，对市场上不同护肤品的微生物质量进行了调查。
根据为本研究目的稍作调整的药典常规方法，对不同产品的抗菌保存效能进行了总体研究，特别是针对淡紫拟青霉的效能。
部分产品不符合英国药典1993年抗菌保存效能测试标准。抗菌保存系统对淡紫拟青霉的效果比对药典参考菌株的效果差。产品保质期快结束时，抗菌保存效能降低。淡紫拟青霉接种剂量降低与微生物生长增加有关。
除非另有标注，局部用产品为非无菌制剂，其保存系统仅针对药典关键微生物进行测试。被其他病菌污染后的微生物行为仍不清楚。
