107 resultados para Microbiological quality control


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Considering the quality of the phytotherapic agents, it is important to point out that it includes rigorous attendance of the different steps of the development and production of these products, from the collection of the vegetable to the availability of the final product. In this work the quality control of the Operculina macrocarpa (Linn) Urb. roots, popularly known as 'batata-de-purga', was carried out. Pharmacopoeic and no pharmacopoeic methodologies were employed to physico-chemical and microbiological quality control. The obtained results showed that the roots presents a content of resin of 9,85%, The microbiological analysis did not present pathogenic growth among the other accomplished tests. The work stands out the importance of the establishment of norms for the quality control for the plants, so that they are found able to be used for phytotherapic reasons.

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

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The microbiological control of moisturizing mask formulation added of hibiscus flowers, assai palm, black mulberry and papaw glycolic extracts, determining the number of viable microorganisms and possible presence of pathogenic. The moisturizing mask formulation was composed of zinc oxide (5. 0%) and moisturizing cream constituted of triceteareth-4 phosphate (and) cetyl alcohol (and) stearyl alcohol (and) sodium cetearyl sulfate (and) oleth-10 (qs 50g). To this formulation was added hibiscus flowers glycolic extract (2. 5%), assai palm glycolic extract (1. 5%), black mulberry glycolic extract (1. 5%) and papaw glycolic extract (2. 0%). The formulation was stored in aseptically clean recipients, away from humidity and light, in fresh and airy places. The results of the microbiological analysis on the counting of aerobic mesophilic microorganisms (bacteria and fungi), of the above mentioned formulation, revealed a bioburden < 10 CFU/mL in all samples. Such data indicate adequate microbiological quality of the tested products, according to official recommendations. Furthermore, it was not detected the presence of pathogenic microorganisms, assuring the harmlessness of the formulation. The results lead us to conclude that the formulation and raw materials analyzed did not present microbial contamination, evidenced for estimating the number of viable microorganisms (<10 UFC/g) and for researching pathogens.

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A simple, sensitive and specific agar diffusion bioassay for the antibacterial gatifloxacin was developed using a strain of Bacillus subtilis ATCC 9372 as the test organism. Gatifloxacin could be measured in tablets and raw material at concentration ranging 4-16 mu g ml(-1). The calibration graph for gatifloxacin was linear from 4.0 to 16.0 mu g ml(-1). A prospective validation of the method demonstrated that the method was linear (r(2) = 0.9993), precise (R.S.D. = 1.14%) and accurate. The results confirmed its precision and did not differ significantly from others methods described in the literature. The validated method yielded good results in terms of the range, linearity, precision, accuracy, specificity and recovery. We concluded that the microbiological assay is satisfactory for in vitro quantification of the antibacterial activity of gatifloxacin. (c) 2005 Elsevier B.V. All rights reserved.

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The validation of a simple, sensitive and specific agar diffusion bioassay, applying cylinder-plate method, for the determination of the antibiotic azithromycin in ophthalmic solutions is described. Using a strain of Bacillus subtilis ATCC 9372 as the test organism, azithromycin at concentrations ranging from 50.0 to 200.0 μg·mL-1 could be measured in 1.666 7 mg·mL-1 ophthalmic solutions. A prospective validation of the method showed that the method was linear (r = 0.999 9) and precise (RSD = 0.70) and accurate (it measured the added quantities). The results obtained by bioassay method could be statistically calculated by linear parallel model and by means of regression analysis and verified using analysis of variance (ANOVA). We conclude that the microbiological assay is satisfactory for quantification of azithromycin in ophthalmic solutions.

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Isotope screening is a simple test for determining the photosynthetic pathway used by plants. The scope of this work was to classify the photosynthetic type of some herbs and medicinal plants through studies of the carbon isotope composition (δ13C). Also, we propose the use of carbon isotope composition as a tool to control the quality of herbs and medicinal plants. For studies of δ13C, δ 13C‰ = [R (sample)/R (standard) - 1] × 10-3, dry leaves powdered in cryogenic mill were analyzed in a mass spectrometer coupled with an elemental analyzer for determining the ratio R = 13CO2/12CO2. In investigation of δ13C of 55 species, 23 botanical families, and 44 species possessed a C3 photosynthetic type. Six species found among the botanical families Euphorbiaceae and Poaceae were C4 plants, and 5 species found among the botanical families Agavaceae, Euphorbiaceae, and Liliaceae possessed CAM-type photosynthesis. Carbon isotope composition of plants can be used as quality control of herbs and medicinal plants, allowing the identification of frauds or contaminations. Also, the information about the photosynthetic type found for these plants can help in introducing and cultivating exotic and wild herbs and medicinal plants.

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Orbifloxacin is a fluoroquinolone with broad-spectrum antimicrobial activity, and belongs to the third generation of quinolones. Regarding the quality control of medicines, a validated microbiological assay for determination of orbifloxacin in pharmaceutical formulations has not as yet been reported. For this purpose, this paper reports the development and validation of a simple, sensitive, accurate and reproducible agar diffusion method to quantify orbifloxacin in tablet formulations. The assay is based on the inhibitory effect of orbifloxacin upon the strain of Staphylococcus aureus ATCC 25923 used as test microorganism. The results were treated statistically by analysis of variance and were found to be linear (r = 0.9992) in the selected range of 16.0-64.0 μg/mL, precise with relative standard deviation (RSD) of repeatability intraday = 2.88%, intermediate precision RSD = 3.33%, and accurate (100.31%). The results demonstrated the validity of the proposed bioassay, which allows reliable orbifloxacin quantitation in pharmaceutical samples and therefore can be used as a useful alternative methodology for the routine quality control of this medicine. © 2011 by the authors; licensee MDPI, Basel, Switzerland.

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The validation of a microbiological assay, applying agar diffusion method for determination of the active of cefuroxime in power for injection, is described. Using a strain of Micrococcus luteus ATCC 9341 as the test organism, cefuroxime was measured in concentrations ranging from 30.0 to 120.0 μg/mL. The method validation showed that it is linear (r = 0.9999), precise (relative standard deviation = 0.37%) and accurate (it measured the added quantities). Microbiological assay is satisfactory for quantitation of cefuroxime in powder for injection and the validity of the proposed bioassay, which is a simple and a useful alternative methodology for cefuroxime determination in routine quality control.

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Ceftriaxone sodium is a cephalosporin with broad-spectrum antimicrobial activity and belongs to the third generation of cephalosporins. Regarding the quality control of medicines, a validated microbiological assay for the determination of ceftriaxone sodium in powder for injectable solution has not been reported yet. This paper reports the development and validation of a simple, accurate and reproducible agar diffusion method to quantify ceftriaxone sodium in powder for injectable solution. The assay is based on the inhibitory effect of ceftriaxone sodium on the strain of Bacillus subtilis ATCC 9371 IAL 1027 used as test microorganism. The results were treated statistically by analysis of variance and were found to be linear (r = 0.999) in the selected range of 15.0-60.0 μg/mL, precise with a relative standard deviation (RSD) of repeatability intraday = 1.40%, accurate (100.46%) and robust with a RSD lower than 1.28%. The results demonstrated the validity of the proposed bioassay, which allows reliable ceftriaxone sodium quantitation in pharmaceutical samples and therefore can be used as a useful alternative methodology for the routine quality control of this medicine. © 2012 by the authors; licensee MDPI, Basel, Switzerland.

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Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

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Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)