Assessment of the Quality of the Simvastatin Commercialized by Pharmacies of Manipulation from the City of Belo Horizonte/Brazil

被引:1
|
作者
Leal, Alexandre Soares [1 ]
Sepe Melo, Fernanda Peixoto [1 ]
Bomfim Gomes, Tatiana Cristina [1 ]
Santana, Amalia Soares [2 ]
da Cunha, Luzia Helena [2 ]
Saiki, Mitiko [3 ]
机构
[1] Ctr Desenvolvimento Tecnol Nucl CDTN, Belo Horizonte, MG, Brazil
[2] Fundacao Ezequiel Dias FUNED, Belo Horizonte, MG, Brazil
[3] Inst Pesquisas Energet & Nucl IPEN, Sao Paulo, SP, Brazil
关键词
Quality Control; Simvastatin; Good Practice of Manipulation; Health Surveillance;
D O I
10.3395/vd.v2i1.113
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
The growing expansion of the magistral sector associated with reports of deviations from quality of compounded drugs, with serious cases, has generated a series of efforts by the Health Surveillance in the search for an efficient monitoring of pharmacies and products offered to the population. Thus, the aim of this study was to evaluate the quality of preparations containing simvastatin, manipulated in some pharmacies of Belo Horizonte/MG, after reviewing the health legislation occurred in 2007, through the realization of pharmacopoeic physicochemical analyzes of determination weight, identity and content of active ingredient and uniformity of dosage units. Further, research by neutron activation analysis, the presence and concentration of inorganic impurities in the samples of simvastatin manipulated. The results expressed an index of satisfactoriness of only 30%. This fact confirms the need for fast and efficient acts by public health authorities, and improving processes used in the manipulation within the establishments, to ensure the quality of compounded drugs.
引用
收藏
页码:69 / 74
页数:6
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