Martínez-Bermúdez A, Rodríguez-de Lecea J, Soto-Esteras T, Vázquez-Estévez C, Chena-Cañete C
Departamento de Microbiología I, Facultad de Ciencias Biológicas, Universidad Complutense de Madrid, España.
Rev Latinoam Microbiol. 1991 Apr-Sep;33(2-3):153-7.
In order to analyze the significance of the microbial content of pharmaceutical raw materials contributed to the finished pharmaceutical products, we have carried out a study of contamination taking into account aerobic bacteria, anaerobic bacteria and fungi. None or only low numbers of pathogenic microorganisms was found in most analyzed products but in some materials, specially those of natural origin, we have detected high bacterial and fungal contamination. Microorganisms of the genus Bacillus have been the aerobic bacteria most frequently isolated; Bifidobacterium and Clostridium were the most common anaerobic bacteria and with respect to the fungi, Penicillium and Aspergillus have been found with the highest frequency. These microorganisms can produce problems in pharmaceutical finished products, due to their enzymatic or toxigenic activities.
为了分析原料药微生物含量对成品药的影响，我们开展了一项关于污染情况的研究，研究考虑了需氧菌、厌氧菌和真菌。在大多数分析产品中未发现致病微生物或仅发现少量致病微生物，但在一些原料中，特别是天然来源的原料，我们检测到了较高的细菌和真菌污染。芽孢杆菌属是最常分离出的需氧菌；双歧杆菌和梭菌是最常见的厌氧菌；就真菌而言，青霉和曲霉的检出频率最高。由于这些微生物的酶活性或产毒活性，它们可能会给药品成品带来问题。
