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一项关于药品和化妆品防腐剂功效快速检测方法应用的研究。

A study of the use of rapid methods for preservative efficacy testing of pharmaceuticals and cosmetics.

作者信息

Connolly P, Bloomfield S F, Denyer S P

机构信息

Department of Pharmacy, King's College London, UK.

出版信息

J Appl Bacteriol. 1993 Nov;75(5):456-62. doi: 10.1111/j.1365-2672.1993.tb02802.x.

DOI:10.1111/j.1365-2672.1993.tb02802.x
PMID:8300446
Abstract

Three rapid microbiological methods, impedance, the direct epifluorescence technique (DEFT-MEM) and ATP bioluminescence (ATP-B) were evaluated for their applicability to preservative efficacy testing (PET) of pharmaceuticals and cosmetics. A good correlation between rapid method response and total colony counts was obtained for untreated suspensions of Staphylococcus aureus, Pseudomonas aeruginosa and Candida albicans with all three methods but, for Aspergillus niger, with impedance only. For chlorhexidine-treated suspensions of Staph. Aureus and C. albicans, a good dose-response curve was obtained with impedance, but ATP-B and DEFT-MEM methods underestimated the kill by the order of 1-6 logs. From the results of this study it is concluded that impedance offers an alternative method to colony counting methods for PET but, at their present level of method development, neither DEFT-MEM nor ATP-B can be considered as satisfactory.

摘要

评估了三种快速微生物学方法,即阻抗法、直接表面荧光技术(DEFT-MEM)和ATP生物发光法(ATP-B)在药品和化妆品防腐剂效能测试(PET)中的适用性。对于金黄色葡萄球菌、铜绿假单胞菌和白色念珠菌的未处理悬浮液,使用这三种方法均能得到快速方法响应与总菌落计数之间的良好相关性,但对于黑曲霉,仅阻抗法能得到良好相关性。对于洗必泰处理过的金黄色葡萄球菌和白色念珠菌悬浮液,阻抗法得到了良好的剂量-反应曲线,但ATP-B法和DEFT-MEM法将杀菌效果低估了1至6个对数级。从本研究结果得出结论,阻抗法为PET的菌落计数法提供了一种替代方法,但就目前的方法发展水平而言,DEFT-MEM法和ATP-B法都不能被认为是令人满意的。

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