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[药物制剂所用原材料的微生物含量研究]

[Studies of the microbial content of raw materials used in pharmaceutical preparations].

作者信息

Bonomi E, Negretti F

出版信息

Ann Ist Super Sanita. 1977;13(4):805-32.

PMID:616195
Abstract

The microbiological controls (determination of the total and mycetic bacterial count; isolation of enterococci, Clostridium, Pseudomonas aeruginosa, Staph. aureus, E. coli, Salmonella and other Enterobacteriaceae) executed on 1517 samples of 100 varous raw materials, have ascertained the presence of a microbial contamination varying to matters, with presence also of pathogenic or hygienically undesirable microrganisms. The more contaminated substances have resulted to be those organic either of vegetable or animal origin. Sensible differences have been noted between the various lots and according to the various suppliers. The conservation trials under various conditions of temperature (15-22-37 degrees C) and humidity (30 degrees - 60 degrees - 90 degrees of relative humidity) with opened or closed recipients, have demonstrated the possibility of remarkable increases of the number of the microrganisms in the raw materials with increase of temperature and humitidy, especially in the non hermatically closed recipients.

摘要

对100种不同原材料的1517个样本进行了微生物控制(测定细菌总数和霉菌数量;分离肠球菌、梭菌、铜绿假单胞菌、金黄色葡萄球菌、大肠杆菌、沙门氏菌和其他肠杆菌科细菌),已确定微生物污染因物质而异,还存在致病或卫生方面不良的微生物。污染更严重的物质是植物或动物来源的有机物质。不同批次之间以及根据不同供应商已注意到明显差异。在温度(15 - 22 - 37摄氏度)和湿度(相对湿度30% - 60% - 90%)的各种条件下,对打开或封闭容器中的原材料进行的保存试验表明,随着温度和湿度升高,原材料中的微生物数量可能会显著增加,尤其是在未密封的容器中。

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