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According to the European Directive 2001/83/EC, medicinal products, contrary to foodstuffs, require a pre-marketing authorisation by competent authorities. Quality has to be proven in accordance with the European directives and guidelines, while safety and efficacy through pharmacological- toxicological and clinical studies and/or bibliographic application (Art. 10.1 (a) (ii)). Apart from these options, some European countries have established a simplified proof of efficacy, e.g. for traditional herbal medicinal products. The study of AESGP (European Medicines Manufacturers’ Association), “Herbal Medicinal Products in the European Union”, which was performed in 1998 on behalf of the European Commission, elucidates the regulatory situation in member states of the European Union, in particular the implementation of the option of bibliographic application. ESCOP, the European Scientific Cooperative on Phytotherapy, has published 80 monographs on the medicinal use of herbal drugs in order to provide harmonised criteria of assessment on a European level. A similar project has been initiated by the World Health Organisation (WHO). The Herbal Medicinal Products Working Party (HMPWP) at the European Agency for the Evaluation of Medicines (EMEA) has published various guidelines on the quality, safety and efficacy of herbal medicinal products, e.g. the so-called core-data on herbal drugs based on monographs.Apart from the area of the ‘well-established medicinal use’ products suitable for bibliographic applications, a further category of traditionally used herbal medicinal products is being established on a European level. The European directive on traditional herbal medicinal products amending Directive 2001/83/EC provides the option of a simplified registration procedure under certainconditions, e.g. established safety, plausible efficacy on the basis of long-term use and experience as well as proven quality. A new Committee for Herbal Medicinal Products is being founded which is to be responsible for the preparation of Community herbal monographs on products with well- established medicinal use and on traditional herbal medicinal products. The parties involved hope that further discussion in ESCOP/ WHO monographs and the preparation of new core-data takes place as a basis for well-established medicinal use in order to facilitate mutual recognition and to achieve a European-wide rational assessment for all kinds of herbal medicinal products.
Background. The copaiba oil is a common natural product used in cosmetic industry and as a nutraceutical product. However, lack of quality control and scarce knowledge about its antimicrobial activity is a point of concern. The proposal of this study was to investigate the physicochemical properties and the antimicrobial activity of five commercial brands of copaiba oil. Material and methods. Acidity and ester index, refractory index, solubility in alcohol, and thin layer chromatography were performed to verify the physicochemical properties of five commercial copaiba oils sold in local pharmacies. Ultra performance liquid chromatography coupled with diode-array detection and electrospray ionization quadrupole time-of-flight mass spectrometry (UPLC-DAD/ESI-Q-TOF-MS) was used to investigate diterpene acids while the volatile compounds were analysed by gas chromatography-mass spectrometry (GC-MS). Antibacterial and antifungal activities were also evaluated by agar diffusion technique; and minimal inhibitory concentration and maximal bactericidal concentration were defined for each sample and bacteria. Results. The physical-chemical analysis revealed heterogeneity between all samples analysed. The A1 sample showed characteristics of copaiba oil and was mainly composed by hydrocarbon sesquiterpenes (29.95% β-bisabolene, 25.65% Z-a-bergamotene and 10.27% β-cariophyllene). Among diterpene acids, the UPLC- DAD/ESI-Q-TOF-MS data are compatible with presence of copalic and/or kolavenic acid (m/z 305 [M + H]+). Candida albicans was sensitive to almost all samples at high concentration and Saccaromyces. cere- visiae showed sensitivity to A1 sample at 100 mg/mL. Although variable, all samples showed antibacterial activity. Significant activity was seen for A3 (19.0 ±0 and 15.6 ±0.5 mm), A4 (16.6 ±0.5 and 15.6 ±0 mm), and A5 (17.1 ±0 and 17.1 ±0 mm) on Staphylococcus saprophyticus and S. aureus, respectively. All samples were active against Klebsiella pneumoniae showing >15 mm diameter halo inhibition; and only A2 was active against Eschirichia coli. Phytopatogens tested revealed resistance of Ralstonia solanacearum CGH12 to all samples and susceptibility of Xcv 112 strain of Xanthomonas campestris pv campestris to almost all samples. MIC and MMC showed bacteriostatic effect against clinical interest bacteria and bactericidal effect against phytopatogens. Conclusion. The results from physicochemical analysis reinforce the fact that it is imperative to include simple conventional methods in the analysis of oil products. The analysis of copaiba oil gives safe products and purity which ensure products with quality. Also, since copaiba oil is an over-the-counter product the results indicate that pharmacosurveillance must be improved by the governmental regulation agency to avoid microorganism resistance selection and to achieve better international quality products.
Background. Osmotic dehydration (OD) is a technology that allows the concentration mainly of fruits and vegetables, without change of phase, through partial water removal, when immersed in a hypertonic solution of sugar, salt or others. It can be successfully applied to some products whose production is not fully marketed in fresh form. However, an additional process is necessary to stabilize the product. The process leads to the achievement of high quality alternative products, with an extended shelf-life, economy in storage and transport. The aim of this work was to study, at a pilot scale, the behaviour evaluation of a sucrose dehydration solution, during twelve OD reuses, and the quality of processed mandarins. Material and methods. The process was carried out using mandarins (Citrus reticulata Blanco) cv Clementina Nova, from Algarve, Portugal, manually peeled and segments chemically skinned. In assays a 60°Brix sucrose solution was used, conducted in thermo-stabilized baths, at 45°C, 16 h, 40 oscillations per minute and a fruit:solution ratio of 1:2 (m/m). After each OD cycle, the solution was filtered and reconcentred to 60°Brix by sucrose addition, and adjusted to original volume. The osmodehydrated mandarins were stabilized by pasteurization. The drying solution behaviour and mandarins‟ quality were assessed through different physical, chemical and microbiological analysis. Results. The factorial discriminate analysis allowed to distinguish a different behaviour between the original and final dehydration sucrose solution during OD processes, but did not affect its desiccant power, only a high pollutant load development explained by BOD5 values. The results of osmodehydrated mandarins showed that stability was achieved by “combined process” with pasteurization. Conclusions. The results lead to conclude that osmotic dehydration process is a good op-tion to improve mandarin‟s stabilization, after pasteurization, increasing added value. Its viability is connected to the management of the drying solution and the number of uses depends on the type of product being dehydrated and their processing sequence. Though the negative microbial load, it must be given attention to dilute the solution before its release as effluent
The objective of the research study was to determine the effect of phosphate preparations added in the form of 1 % aqueous solutions of various pH values on the quality of emulsion-type sausages. Four variants of sausages were manufactured: control variant with no phosphate preparations added (V1) and three variants with the phosphate preparations added: V2: 7.3; V3: 8.3; and V4: 9.7. The pH values of the meat batter and finished product were determined and the yield of the finished product was estimated. In the sausages studied, the total heme pigments and nitrosylhemochroms were determined and the heme pigment conversion degree was calculated. The texture parameters were measured and the sensory analysis of the emulsion-type sausages was performed. It was found that the addition of phosphate preparations impacted the pH value of the finished product, its yield, the total heme pigments and nitrosylhemochroms, as well as the heme pigment conversion degree. Moreover, a positive effect was reported of the added phosphate preparations on the texture of finished products (their hardness and chewiness) compared to the sausages with no phosphate preparations added. It was confirmed that it was advantageous to add, during the production process, phosphate preparations in the form of 1 % aqueous solutions of higher pH values to the emulsion-type sausages made from mechanically separated poultry meat; a proof thereof was, among other things, the increased yield of the finished product (from 117.9 % as for V1 to 122.8 % as for V4). The best results were obtained when the pH value of 1 % aqueous solutions of phosphate preparations was 9.7.
This paper presents the effects of mixing non-homogeneous bicomponent granular structures by the flow method with the use of an inverted cone insert as a supporting element. The analysis of homogeneity of mixtures after 10 consecutive flows was carried out based on computer image analysis. Based on these tests, the use of a nonlinear regression for the mo-delling of two selected parameters of the process was proposed. Spatial dependence was described by the relation between the va-riance of the tracer distribution (dependent variable) and density ratio of the mixed components, and the diameter of the cone insert used (independent variables). The mathematical description was made with the use of a ‘nonlinear regression’ module. The results obtained in these tests proved that the use of supporting insert improves the degree of mixability of granular materials. The two-dimensional model in the form of a quadratic function may be a for-mula for describing the influence of selected parameters on the homogeneity of a granulate mixture before the beginning of the mixing process.
The aim of this study was to determine which method of hygienic behaviour assessment is more reliable: the evaluation of the pierced brood removal rate or the evaluation of the freeze-killed brood removal rate. Additionally, we aimed to determine whether freeze-killed brood should be placed in colonies when defrosted or still frozen. Defrosted freeze-killed brood was removed faster within a 24 h period. The removal rates for pierced brood and frozen freeze-killed brood were similar in hygienic colonies. In non-hygienic colonies, pierced brood was removed at a significantly slower rate than frozen or defrosted freeze-killed brood. The mechanisms of removing frozen and defrosted freeze-killed brood were similar to each other and different from those observed in the case of pierced brood. The defrosting of brood prior to its introduction into colonies seems inadvisable, as it accelerates brood removal. Our results confirm the hypotheses of those researchers who believe that the frozen freeze-killed brood removal test is not always appropriate. A good solution is, therefore, to perform the frozen freeze-killed brood and pin-killed brood removal tests simultaneously. The time from the beginning of the tests to the moment 50% and 75% of dead-brood cells have been cleaned up should be assumed as the appropriate duration of the hygienic behavior evaluation tests.
The paper presents factors affecting the pressure agglomeration process of plant material and the quality of the received product as well as the test results of selected apparatus and process parameters on the density and kinetic durability of the received pellets. The tests were conducted in a technical scale on a SS-2 test stand whose basic component is a pellet mill with a ring working system.
The effect of addition of wheat cellulose preparation on the quality and structure of finely ground model products was tested. Apart from potassium tripolyphosphate, the wheat cellulose preparation WF-400 was added to the stuffing, at different levels of addition of technological water: 30, 50 and 80%. The testing of the model processed meat products covered: determination of heat leakage, evaluation of the basic composition in the preserved product block according to the relevant PN ISO standards, quality and profile sensory evaluation, analysis of texture profile and tensile strength of slices with the universal machine Zwick model 1445. The values of the evaluated parameters of texture profile and quality and sensorial profile of model products were substantially affected by the level of addition of technological water. The higher level of water addition substantially lowered the values of the tested parameters. The preparation of tripolyphosphate as well as tripolyphosphate and cellulose effectively reduced cooking losses and they had a structure-creating action, the cellulose preparation “strengthened” the action of phosphates. In result of the trial the use of cellulose preparation as a functional additive and/or with potassium tripolyphosphate to finely ground meat products was found reasonable and, in particular, to the products of different level of addition of technological water.
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