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片剂配方中一些常用辅料中微生物的存在情况。

The presence of microorganisms in some common excipients used in tablet formulation.

作者信息

Obuekwe Ifeyinwa F, Eichie Florence

机构信息

Department of Pharmaceutical Microbiology, Faculty of Pharmacy, University of Benin, Benin City, Nigeria.

出版信息

Acta Pol Pharm. 2006 Mar-Apr;63(2):121-5.

Abstract

Strict measure on the need to control microbial contamination in the formulation of solid dosage forms such as tablets and capsules are not usually in place as is done in other pharmaceutical preparations. The presence of microorganisms in some common excipients such as starch and lactose powders, and distilled water used in tablet formulation was investigated in this study. Organisms isolated were Geotrichuim and Aspergillus spp as well as two strains of Staphylococcus aureus. Lactose tablets were further formulated using 5% starch as binder. Some of the isolated organisms were, in turn, inoculated into these tablets and stored over a period of several weeks. The physical properties of these tablets were determined at various time intervals. Marked increases in the disintegration times of these tablets were observed, while there was a decrease in the hardness property for both the fungi and bacteria. These observed effects have serious implications in the overall bioavailability of drugs such as tablets formulated from contaminated excipients.

摘要

与其他药物制剂不同,对于片剂和胶囊等固体剂型的配方,通常没有严格措施来控制微生物污染。本研究调查了一些常见辅料(如淀粉和乳糖粉)以及片剂配方中使用的蒸馏水中微生物的存在情况。分离出的微生物有地霉属和曲霉属,以及两株金黄色葡萄球菌。进一步用5%淀粉作为粘合剂配制乳糖片。然后将一些分离出的微生物接种到这些片剂中,并储存数周。在不同时间间隔测定这些片剂的物理性质。观察到这些片剂的崩解时间显著增加,而真菌和细菌处理的片剂硬度均有所下降。这些观察到的影响对由受污染辅料制成的片剂等药物的整体生物利用度有严重影响。

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