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Biomedical subjects

J Aleksandrowicz

Publications and source records attributed to J Aleksandrowicz.

At least 19 recordsLinked to original sources

[Drug resistance of Enterococcus species isolated from the urogenital system].

Despite low virulence of enterococci, they have become important nosocomial pathogens. This has been correlated with the increased use of broad-spectrum antibiotics, particularly cephalosporins. Many strains of enterococci exhibit multiple drug resistance; the most important being high-level resistance (HLR) to penicillin (MIC > 100 mg/l) and gentamicin (MIC > 500 mg/l and 2000 mg/l) and/or streptomycin (MIC > 2000 mg/l). The investigation was performed on 92 strains, isolated from genito-urinary tract and recognised as Enterococcus sp. All strains were obtained from several microbiological laboratories of Gdańsk, Gdynia and Tczew. On biochemical reaction profiles species of enterococci were identified as: E. faecalis (72.8%), E. faecalis varians (9.8%), E. durans (7.6%) and E. faecium (9.8%). The minimal inhibitory concentration (MICs) of penicillin, ampicillin, azlocillin, imipenem, gentamicin, amicacin, ciprofioxacin and vancomycin were determined by the agar dilution method. None of these 92 enterococcal strains was vancomycin resistant. 22.2% of E. faecium and 7.5% of E. faecalis showed high-level resistance to penicillin. None of these strains were produced beta-lactamase. High-level resistance to streptomycin and gentamicin was detected. Both--high-level resistance to streptomycin and gentamicin--were found in 6% E. faecalis; 11.1% E. faecalis varians and 22.2% E. faecium.

Drug Resistance, Microbial↗

[Level of bacterial endotoxins in Haemophilus influenzae type b vaccines conjugated with toxoids (td, Di)].

Quantitative evaluation of bacterial endotoxin was performed in the following vaccines: Act-Hib, Hiberix, Hib-Titer. The aim of this study was to assess the accuracy and precision of chromogenic LAL test with S-2423 substrate for this particular biopreparations and after that to determine the amounts of endotoxin as a factor of vaccine safety. Because of the lack of information concerning the presence of endotoxin in Act-Hib vaccine, we also tried to establish the limits for the presence of endotoxin in this type of vaccine. The estimated level of endotoxin was as follows: 110 EU/ml in Act-Hib, 1.64 EU/ml in Hiberix and 2.4 EU/ml in Hib-Titer. The results of this study showed that the amounts of endotoxin was dependent on the molecular size of polysaccharide PRP and on the presence of protein component. The limit of endotoxin presence in Act-Hib vaccine recommended by us is max. 150 EU/ml.

Endotoxins↗

[Examination of protein MPB 70 properties in BCG substrains used for the production of Polish antituberculosis vaccines].

The aim of the study was examination of MPB70 protein production by different BCG substrains and testing this protein as reagent in allergenic skin test on BCG vaccinated guinea pigs. Three BCG substrains: Danish 1331 (D), Japanese 172 (J) and Polish BCG Moreau (P) were used for the study. The protein MPB70 received from dr Nagai from Osaka University was used as reference preparation. It has been shown that MPB70 protein of molecular weight about 21,500 Da was present only in BCG Moreau (P) and Japanese (J) substrains. In immunoblotting test monoclonal antibodies reacted additionally with 43,000 Da protein in all tested substrains. We suspect that the detected additional molecule was a dimer of MPB70 protein. The development of skin reactions to MPB70 protein was seen in guinea pigs vaccinated with J and P substrains. The peak of alergy to MPB70 protein was observed 9 weeks after vaccination. In sera of vaccinated animals antibodies against MPB70 protein were detected by ELISA method. The possibility of using MPB70 protein for diagnostic purpose is discussed.

Animals↗

The level of endotoxin contamination in biopreparations.

Bacterial endotoxins as contamination of biopreparations have been estimated by chromogenic LAL test. Study on some compounds (aluminium hydroxide, formaldehyde and merthiolate) being components of vaccines showed no effect on the result of LAL test. The level of endotoxins in virus vaccines with the limits defined in producers certificate was adequate, the level of endotoxin was also low in virus vaccines of undefined requirements. The concentration of endotoxin in bacterial vaccines was differentiated. Considering the results of our experiments, as well as the fact, that the requirements for endotoxin contamination of bacterial vaccines are not available it seems necessary to establish the limits for these group of biopreparations.

Bacterial Vaccines↗

[LAL (Limulus Amoebocyte Lysate) test as applied to the safety evaluation of biological preparations].

In the paper some problems concerning of pyrogen testing were described. The risk of reactions after administration parenteral preparations contaminated pyrogenic substances give the cause for searching sensitive, repeated methods of their designation. The paper is review of the adaptation Limulus Amoebocyte Lysate (LAL) test for the estimation of endotoxin in biological preparations. The paper overview, chemical structure of endotoxin the characteristic of Limulus polyphemus, principle basis of the LAL test and general remarks of application. The LAL test according to the opinion of many authors is more sensitive in comparing with the pyrogen rabbit test.

Biological Assay↗

[Use of the LAL test for quantitative determination of Bacteroids fragilis endotoxin].

The aim of this study was the evaluation of LAL test with chromogenic substrate usefulness for the quantitative detection of B. fragilis endotoxin and the determination of the amount of endotoxin in culture filtrates of the strains of this species. Also, the trial was undertaken to determine the influence of clindamycin on endotoxin release from B. fragilis rods to the culture medium. Four B. fragilis strains were examined: one nonenterotoxigenic (NTBF) and three enterotoxigenic (ETBF). The growth of cultures was determined and endotoxin liberated to the culture medium during growth of strains was detected. BHI broth and BHI broth with addition of sub inhibitory doses (sub-MIC) of clindamycin were applied. Bacterial cultures were incubated for 48 hours at 37 degrees C. Samples of bacterial cultures were collected after 4, 8, 16, 24 and 48 hours of cultivation, and the optical density was measured. Then the samples were centrifuged, supernatants were filtered through 0.45 micron filters and concentrated three times with 5000 D ultrafilters. Prepared samples were kept frozen at -70 degrees C until used. The amount of endotoxin in samples was determined using quantitative LAL test with chromogenic substrate S-2423. The results of the experiments indicate that LAL test is the useful method for determination of B. fragilis endotoxin concentration. This endotoxin activates the enzymatic system present in Limulus polyphemus amebocyte lysate. Endotoxin is shed spontaneously by B. fragilis rods to the culture medium during growth. Clindamycin at subinhibitory concentrations (sub-MIC) inhibits the growth of cultures of examined strains. The antibiotic caused increase in endotoxin amount in culture medium.

Bacteroides fragilis↗

[The immunochemical characteristics of adult sera after Td vaccination].

The results of immunochemical test of 29 adults sera before and after Td vaccination were presented. The level of 12 protein fractions was in normal range value in 26 of examined sera. There was IgA deficiency in one serum, in two others haptoglobin deficiency and high levels of transferrin and IgM were observed.

Adult↗

[LAL test used for detection of undesirable biologically active substances in biopreparations].

Detection of bacterial endotoxin was performed in four groups of biopreparations: IVIG, virus and bacterial vaccines and antibiotics. The 44 samples of biopreparations were tested by the qualitative LAL-test (gel-clot) and some of them (22 samples) by the quantitative, LAL-test (chromogenic end-point). The concentration of endotoxin in 10 samples of IVIG was in the range from 0.457 EU/ml to 19.46 EU/ml. Only 4 of them did not exceed the limit recommended by FDA for human globulins (5 EU/ml). In the 9 samples out of 10 samples of virus vaccines the presence of endotoxin was in the range from 0.06 to 0.15 EU/ml. The concentration of endotoxin in 10 samples of bacterial vaccines determined by gel- clot method was below sensitivity of test (2 EU/ml). In antibiotics we did not find the presence of endotoxin in the range recommended by Ph. Eur. 1995 limits (0.1-0.2 EU/ml). The presented data show the necessity for requirements elaboration for each type of biopreparations.

Anti-Bacterial Agents↗

[Evaluation of contamination of serum derived intravenous preparations].

The concentration of Al in 4 lots of 5% Albumina and in 14 lots of 5% immunoglobulins were estimated by adsorptive stripping voltammetric method. Mean Al concentrations amounted to 142.6 micrograms/l in 5% Albumina and to 202 micrograms/l in IVIG preparations produced in Poland. Al concentrations in foreign IVIG preparations ranged from 14 to 54 micrograms/l. These data show the need to consider setting an upper limit of microgram Al/l in i.v. drug products produced or registered in Poland.

Albumins↗

[Aluminum as an adjuvant in vaccines and post-vaccine reactions].

Aluminium compounds have been widely used as adjuvants in prophylactic and therapeutic vaccines. Adjuvants are able to stimulate the immune system in a nonspecific manner, i.e. high antibody level can be obtained with minimal dose of the antigen and with reduced number of inoculations. Adjuvants use has been mostly empirically determined by such factors as efficacy and safety. The mechanism of action of the aluminium adjuvants is not completely understood and is very complex. The basic factors of the mode of action: 1) the complex of antigen and aluminium gel is more immunogenic in structure than free antigen, 2) effect "depot"--The antigen stimulus last longer, 3) the production of local granulomas. Vaccines adsorbed onto aluminium salts are a more frequent cause of local post-vaccinal reactions than plain vaccines. 5-10% those vaccinated can develop a nodule lasting several weeks at the injection site. In some rare cases the nodules may become inflammatory and even turn into an aseptic abscess. The nodules persisting more than 6 weeks may indicate development of aluminium hypersensitivity. Finally aluminium adjuvant immunogens induce the production of IgE antibodies.

Adjuvants, Immunologic↗

Dissolution and relative bioavailability of two carbamazepine preparations for children with epilepsy.

The in-vitro dissolution profiles of two carbamazepine formulations (Tegretol and a generic carbamazepine) have been assessed and the bioavailability of carbamazepine compared in 12 epileptic children at steady-state. Dissolution from the generic formulation (100 and 200 mg tablets) tended to be greater than for the proprietary tablets. However, the bioavailability and pharmacokinetics of carbamazepine when assessed at steady-state were similar for the two formulations. It appears, therefore, that the breakthrough seizures and higher incidence of neurological side-effects observed when children were given generic carbamazepine in place of the proprietary formulation cannot be accounted for by differences in bioavailability or pharmacokinetics.

Adolescent↗

[A rapid method of measuring the level of aluminum in biological preparations using aluminon].

The aim of this study was to adapt aluminon for determination of Al3+ content in biopreparations adsorbed on Al(OH)3. Aluminum + aluminon complex was identified by spectrophotometry at A535. It was found that the method applied allows to obtain reproducible results. Its sensitivity for Al3+ contains between 85 to 680 micrograms. This method is less laborious in comparison with so far used versenian method.

Allergens↗

[Physico-chemical studies of aluminum hydroxide in biological preparations preserved in different conditions].

An observation of physico-chemical properties of 0.5% Al(OH)3 and vaccines adsorbed to it (Di, Te, Di-Te, Di-Te-Per) stored for 3-24 months in various pH (5, 7, 8) and temperatures -18 degrees, +37 degrees, +45 degrees and +65 degrees was carried out. For this purpose an analysis of sedimentation rate, microscopic observation and ++roentgenographic analysis were performed. It was found that a decrease of storage temperature of Al(OH)3 gel and vaccines down to -18 degrees C resulted in some changes in structure and morphology of this absorbent (big precipitates) and it led to a significant increase of sedimentation rate.

Adjuvants, Immunologic↗

[Various immunochemical properties of nonspecific bacterial vaccines].

After critical evaluation of the composition and technology of preparation of nonspecific bacterial vaccines (nsb) some of them were withdrawn from the production (Neoflaminum, Neurovaccinum) and replaced with a new one (Polyvaccinum submite). Part of them were modified (media) and modernised (Panodinum, vaccine according to Delbet). Panodine produced at the present is free from bovine bile, which according to the results of the studies is strongly haemolytic for human and animal red blood cells. Thus it was justified to withdraw this component from Neoflaminum and Panodinum preparations. Purity and degree of lysis of these preparations were evaluated on the basis of ratio between nucleic acid absorbance and protein absorbance A260/A280. This allowed to determine if nsb tested are partially lysed and if their production process is reproducible. Our pilot studies on five patients suffering from infectious asthma indicate that a restoration of phagocytic activity of granulocytes and an increase of leukocytes migration after subsequent Panodine injections take place.

Animals↗