Microbiological quality of non-sterile pharmaceutical products.

In microbiological terms, pharmaceutical products can be divided into two groups: sterile and non-sterile. Non-sterile drugs must satisfy the appropriate microbiological purity criteria which are included in pharmacopoeial monographs. Pharmacopoeial studies are prepared specifically with a view to ensuring that the medicinal product is therapeutically effective and safe for the patient. The analysis comprised the results of microbiological purity tests performed before the products are marketed. Total of 1285 samples of non-sterile drugs manufactured by different pharmaceutical plants in Polish were taken into study. The microbiological quality of drugs was assessed in accordance with the criteria included in the European Pharmacopoeia (EP). An analysis of test results demonstrated that the percentage of non-compliant samples was 1.87%. The groups of drugs, which the most often did not satisfy EPs' requirements, were drugs containing raw materials of natural origin (5.7%). The samples of studied drugs that did not meet the criteria contained in EP, exceed the maximum allowable microbiological count limits and contained microbes whose presence is prohibited. The most common non-compliance was the excessive levels of the maximum acceptable fungal count (n = 12) and the excessive the maximum acceptable aerobic microbial count (n = 10).

Effect of oral fructose load on serum uric acid and lipids in kidney transplant recipients treated with cyclosporine or tacrolimus.

Hyperuricemia, frequently observed following kidney transplantation, may adversely affect graft survival. Although hyperuricemia is a well-known adverse effect of cyclosporine (CsA), a similar effect of tacrolimus (Tac) remains debatable. Hyperuricemia is also seen after oral fructose intake in beverages and processed foods. This sugar is blamed for the epidemic of obesity and metabolic syndrome. The aim of our study was to compare the effects of CsA and Tac on an acute oral fructose load in terms of plasma uric acid, serum lipids, and blood pressure in kidney transplant patients. Thirty-two kidney transplant recipients treated with CsA- or Tac-based triple (calcineurin inhibitor + mycophenolate mofetil + prednisone) immunosuppressive therapy displaying stable allograft function (mean glomerular filtration rate = 53 mL/min/1.73m(2)) received an oral challenge with 70 g of fructose. Serum uric acid, lipids, and blood pressure were measured before as well as 60, 120, 180, and 240 minutes after fructose administration. A significant increase in serum uric acid was observed in both groups after oral fructose administration (P < .001). A peak increase in serum uric acid was recorded at 120 minutes after fructose intake. Serum total, LDL, and HDL cholesterol also significantly decreased and serum triglycerides increased to a similar extent in both CsA and Tac groups. No significant changes in blood pressure were observed after fructose consumption. Oral fructose intake induced an acute rise in serum uric acid and triglycerides and decrease in serum cholesterol among kidney transplant recipients. Those changes were similar among patients treated with CsA or Tac.

[Bone marrow cellularity in acute lymphoblastic leukemia of children]. / Komórkowosc szpiku kostnego w ostrej bialaczce limfoblastycznej u dzieci.

The early response to therapy in childhood acute lymphoblastic leukemia (ALL) is typically assessed by bone marrow status. The clearance of blast cells in peripheral blood and bone marrow during induction therapy was analysed in 38 children (27 precursor-B-ALL and 11 precursor T-ALL) treated according to BFM90 or New York 93 protocols. Leukocyte count and peripheral blood smear taken at diagnosis, day 8, day 14 and day 33 as well as bone marrow cellularity and percentage of blasts on days: 0, 14, 33 were analysed. The number of blasts in bone marrow was correlated to bone marrow cellularity (Spearman's rho = 0.72, p = 0.001). Patients with T-ALL were more frequently resistant to steroids in vivo and reached remission later in comparison to precursor-B-ALL children (p = 0.019), however blasts reduction ratio was comparable in both lineages. Bone marrow cellularity on days 14 and 33 of induction therapy was similar.

[Superoxide anion production and adhesiveness of neutrophils in obese patients]. / Wielkosc produkcji anionów ponadtlenkowych oraz adhezja granulocytów obojetnochlonnych u osób z otyloscia.

In 15 subjects with simple obesity and 10 patients with obesity associated with type II diabetes neutrophil adhesiveness and the rate of resting and stimulated production of superoxide anions (O2-) by these cells were assessed. High values were demonstrated of neutrophil adhesiveness suspended in autologous plasma in both groups of patients. The value of O2- production by resting cells was significantly raised, particularly in cases of simple obesity. Stimulated production of superoxides by neutrophils was approaching the value noted in the control group. The obtained results may suggest participation of these cells in the development of atherosclerotic changes.

The loss of sensitization of mouse and rat mast cells by acid pH treatment.

Short incubation of sensitized mouse and rat peritoneal mast cells at 37 degrees C in well defined acid pH (3.5 for mouse and 4.5 for rat mast cells) induces the loss of sensitization, as indicated by antigen-induced histamine release. The acid pH pretreatment of normal mouse and rat mast cells seems to facilitate their subsequent sensitization with mouse IgE antibodies. The possibility, that acid pH treatment removes non-specific IgE from the cells and thus facilitates the binding of specific IgE antibodies is discussed.

Strain and sex dependent sensitivity to skin anaphylactic reactions in the mouse.

The strain-dependent variation in sensitivity of mouse skin to passive cutaneous anaphylaxis (PCA) was observed. The results showed that this variation is not connected either with mast cell number and histamine content in the skin of different mouse strains or with the concentration of non-specific IgE on skin mast cells of these strains. Thus, other factors determining the susceptibility of mouse strains to PCA must exist.

Reaginic sensitization of mice and rats.

The reagin response to hemocyanin (KLH) and egg albumin (EA) was studied in inbred strains (Balb/c, 129, C3H/A, C57BL/6J) and Swiss-Copacabana mice. Both antigens induced apparent and in certain experimental conditions, persistent reagin production, KLH being more effective. Al(OH)3 gel as an adjuvant was more suitable for IgE antibody production, while the Freund's complete adjuvant appeared more appropriate for IgG1 antibody response. The reaginic response to EA and Al(OH)3 in rats Wistar, Sprague-Dawley and F1 hybrids (Wistar x August) was weak and transient. The best sensitization, though relatively low as compared with mouse sensitization, was obtained in Sprague-Dawley and F1 hybrids. The results suggest, that a mouse model of sensitization is quite suitable for studying the persistent reagin response, while a rat model may be useful for investigating the early suppression of reagin response.