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[二十种植物源药物的微生物污染情况]

[Microbial contamination of twenty drugs of plant origin].

作者信息

Favet J

机构信息

Laboratoire de microbiologie générale, Université de Genève, Bastions.

出版信息

Pharm Acta Helv. 1992;67(9-10):250-8.

PMID:1438458
Abstract

Twenty drugs of plant origin were analysed in order to determine the microbial contamination level. A light homogenizing method was used to avoid an increase in the antimicrobial capacity of certain drugs, which would falsify the analytical results. The total viable aerobic count (TVC) varied from 10(1) to 10(7) CFU/g and in 11 samples out of 21 was equal to or higher than 10(5) CFU/g. The number of fungi varied from one drug to another, but was generally lower than the aerobic TVC to the power of 10. No cases containing Aspergillus flavus were found. The total viable anaerobic count consisted mainly of facultative anaerobic germs. Aerobic spores and facultative anaerobic bacteria were abundant. They often represented more than 50% of the aerobic TVC and among them, Bacillus cereus was found. Concerning specified micro-organisms, Escherichia coli was found 3 times, Staphylococcus aureus 2 times and Pseudomonas (not aeruginosa) a few times. Salmonella was never found. The Enterobacteriaceae, on the other hand, were often found and in some cases their number can be greater than 10(4) CFU/g. The typed bacteria corresponded to Enterobacter spp. Some drug samples in bags were analysed. The level of contamination was identical to that found in the bulk drugs. The analysis in parallel of a black tea sample showed an aerobic TVC of 4.10(3) CFU/g. Specified micro-organisms were not found in the infusions. In comparison with non-boiled drugs, the survivors can represent up to 30% of the aerobic TVC.

摘要

为确定微生物污染水平,对20种植物源药物进行了分析。采用轻度匀浆法以避免某些药物抗菌能力增强,否则会使分析结果失真。需氧菌总数(TVC)在10¹至10⁷CFU/g之间变化,21个样品中有11个等于或高于10⁵CFU/g。真菌数量因药物而异,但通常低于需氧TVC的10次方。未发现含有黄曲霉的情况。总厌氧活菌数主要由兼性厌氧菌组成。需氧芽孢和兼性厌氧细菌数量丰富。它们通常占需氧TVC的50%以上,其中发现了蜡样芽孢杆菌。关于特定微生物,发现大肠杆菌3次,金黄色葡萄球菌2次,假单胞菌(非铜绿假单胞菌)若干次。从未发现沙门氏菌。另一方面,肠杆菌科经常被发现,在某些情况下其数量可大于10⁴CFU/g。分型细菌对应于肠杆菌属。对袋装药物样品进行了分析。污染水平与散装药物中的污染水平相同。对一个红茶样品的平行分析显示需氧TVC为4×10³CFU/g。输液中未发现特定微生物。与未煮过的药物相比,存活菌可占需氧TVC的30%。

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