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At least 883 records · Page 49Linked to original sources
PubMed2002

Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; final monograph for combination drug products. Final rule.

The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph that establishes conditions under which over-the-counter (OTC) cold, cough, allergy, bronchodilator, and antiasthmatic (cough-cold) combination drug products are generally recognized as safe and effective and not misbranded as part of its ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on the agency's proposed regulation (tentative final monograph) and new data and information on OTC cough- cold combination drug products that have come to the agency's attention.

Analgesics↗
PubMed2003

Production of laccase by Coriolus versicolor and its application in decolorization of dyestuffs: (I). Production of laccase by batch and repeated-batch processes.

The production of laccase by Coriolus versicolor was studied. The effect of cultivation conditions on laccase production by Coriolus versicolor was examined to obtain optimal medium and cultivation conditions. Both batch and repeated-batch processes were performed for laccase production. In repeated-batch fermentation with self-immobilized mycelia, total of 14 cycles were performed with laccase activity in the range between 3.4 and 14.8 U/ml.

Basidiomycota↗
PubMed2003

Progesterone production in bovine luteal cells treated with drugs that modulate nitric oxide production.

The aim of this study was to investigate the influence of nitric oxide (NO) donors (S-nitroso-L-acetyl penicillamine, spermine-NO complex and sodium nitroprusside) and NO synthase inhibitors (N(omega)-nitro-L-arginine methyl ester, N(omega)-nitro-l-arginine, and (+/-)-2-amino-5,6-dihydro-6-methyl-4H-1,3-thiazine) on progesterone production by dispersed bovine luteal cells cultured for 24 h. All NO donors inhibited progesterone production and increased nitrite or nitrate concentration in the medium in a dose-dependent manner. Secretion of progesterone was reduced to 75% (P < 0.01), 56% (P < 0.001) and 37% (P < 0.001) by S-nitroso-L-acetyl penicillamine; to 65% (P < 0.001), 45% (P < 0.001) and 33% (P < 0.001) by spermine-NO complex and to 77% (P < 0.05), 74% (P < 0.01) and 54% (P < 0.001) by sodium nitroprusside treatments at concentrations of 10(-5), 10(-4) and 10(-3) mol l(-1), respectively, compared with the concentration of this hormone measured in cells cultured in medium alone. NO synthase inhibitors decreased significantly (P < 0.05) nitrite or nitrate concentration and increased progesterone secretion with different potency at different doses. Significant increases in progesterone production were observed after N(omega)-nitro-L-arginine methyl ester treatment at a concentration of 10(-5) mol l(-1) and 10(-4) mol l(-1), and after N(omega)-nitro-l-arginine administration at a concentration of 10(-6) mol l(-1) (P < 0.01) and 10(-5) mol l(-1) (P < 0.05), compared with the concentration of this hormone measured in control cells. The results indicate that both NO donors and NO synthase inhibitors regulate steroidogenesis in cultured bovine luteal cells from days 10 to 14 of the oestrous cycle; however, the degree of progesterone inhibition by NO donors and stimulation by NO synthase inhibitors was dependent on the drug used.

Analysis of Variance↗
PubMed1992

[Genetically engineered human insulin. 1. HPLC in analyzing products of basic production stages].

Application of some variants of HPLC for the step-by-step analysis of recombinant human insulin production was studied. Chromatographic columns with commercial and specially developed supports for size-exclusion, ion-exchange and reverse phase HPLC were used. Effective combinations of the chromatographic techniques for analysis of products and intermediates at every technological step were found and used for production of insulin. The authenticity of insulin obtained in the Shemyakin Institute of Bio-organic Chemistry by the scheme described in the present paper was confirmed by means of some physical and chemical methods and biological activity analysis.

Amino Acid Sequence↗
PubMed1992

Activation of cathepsin B involved in enkephalin production by bradykinin and its cleavage products in cultured fibroblasts of the rat dental pulp.

Mechanisms of cathepsin B activation involved in methionine-enkephalin (ME) production induced by bradykinin (BK), des-Arg9-BK or L-arginine (L-Arg) were studied using cultured fibroblasts of the rat dental pulp, especially from a viewpoint of intracellular signal transduction. BK, des-Arg9-BK, L-Arg or cysteine enhanced the release of ME-like peptides from the cells, and the release of ME-like peptides induced by des-Arg9-BK was inhibited by des-Arg9-[Leu8]-BK (BK B1-receptor antagonist) and E-64 (a specific inhibitor of cysteine proteinases). The activation of cathepsin B by BK or des-Arg9-BK was inhibited by des-Arg9-[Leu8]-BK or islet-activating protein (IAP), and the activation of cathepsin B by L-Arg was inhibited by Leu-Arg (kyotorphin-receptor antagonist) or Botulinum C3-enzyme. The activation of cathepsin B by those stimulants was dependent on calcium ion. These results suggest that the ME production by BK or des-Arg9-BK may be mediated by Ca(2+)-dependent cathepsin B activation through B1-receptors and IAP-sensitive G-proteins, whereas the production by L-Arg may be mediated by Ca(2+)-dependent cathepsin B activation through kyotorphin-receptor and Botulinum C3-enzyme-sensitive G-proteins. On the other hand, the activation of cathepsin B was inhibited by neomycin B (phospholipase C inhibitor) and various serine/threonine kinase inhibitors. These results indicate that phospholipase C and serine/threonine kinases are involved in the activation of cathepsin B by BK, des-Arg9-BK or L-Arg. Genistein inhibited the activation of cathepsin B by des-Arg9-BK or L-Arg in a different fashion, suggesting that tyrosine kinase(s) is also involved in the activation. Cathepsin B activation by BK or L-Arg but not des-Arg9-BK was inhibited by L-NMMA (inhibitor of NO synthesis), and the activation by L-Arg was enhanced by beta-glycerophosphate (beta-GP: inhibitor of phosphatases), while the activation by BK or des-Arg9-BK was inhibited by beta-GP. These results suggest that BK-induced cathepsin B activation in the fibroblasts may be due to a combined effect of des-Arg9-BK and L-Arg.

Animals↗
PubMed1992

Cytokine regulation of colony-stimulating factor (CSF) production in cultured human synovial fibroblasts. II. Similarities and differences in the control of interleukin-1 induction of granulocyte-macrophage CSF and granulocyte-CSF production.

Synovial fibroblasts are likely to be a significant source of granulocyte-macrophage colony-stimulating factor (GM-CSF) and granulocyte-CSF (G-CSF), which could be crucial to the pathogenesis of rheumatoid arthritis. Using specific enzyme-linked immunosorbent assays (ELISAs) and Northern analysis, GM-CSF and G-CSF expression were followed in human synovial fibroblast-like cells in response to a number of agents, either alone or in the presence of an optimal stimulatory concentration of interleukin-1 (IL-1). For both CSFs, interferon-gamma (100 U/mL) did not increase their levels but dramatically suppressed the stimulatory action of IL-1, while basic fibroblast growth factor (10(-8) mol/L), although nonstimulatory by itself, potentiated IL-1 action. The glucocorticoid, dexamethasone (10(-7) mol/L), inhibited IL-1-stimulated CSF production. However, evidence was obtained for noncoordinated CSF regulation. Cyclooxygenase inhibitors potentiated the action of IL-1 on GM-CSF synthesis but suppressed G-CSF synthesis, suggesting that endogenous cyclooxygenase products can have opposite effects in modulating the levels of each CSF. Also, the lymphokine, IL-4 (250 pmol/L), slightly inhibited GM-CSF formation in the presence of IL-1 but elevated the G-CSF levels in these cultures without having an effect by itself. Transforming growth factor beta (less than or equal to 20 ng/mL) did not modulate levels of either CSF. Mesenchymal cell production of both GM-CSF and G-CSF is generally viewed as being under coordinate control; our findings suggest that their synthesis in IL-1-stimulated human synoviocytes can be modulated by a number of agents, in some cases with divergent actions depending on which CSF is examined.

Cells, Cultured↗
PubMed2003

Demonstration of apoptosis-associated cleavage products of DNA, complement activation products SC5b-9 and C3d/dg, and immune complexes CIC-C3d, CIC-IgA, and CIC-IgG in the urine of patients with membranous glomerulonephritis.

AIM: To investigate the involvement of complement activation and apoptosis in the pathogenesis of membranous glomerulonephritis by determining the concentrations of apoptosis-associated 180 bp nucleosomes and complement activation products SC5b-9 and C3d/dg in the urine of patients with membranous glomerulonephritis. METHODS: Morning urine was taken from 15 patients with immunohistologically established membranous glomerulonephritis. Apoptosis-associated 180 bp nucleosomes, complement activation products SC5b-9, C3d/dg, and immune complexes CIC-C3d, CIC-IgA, and CIC-IgG were detected in the urine samples by using antigen-specific enzyme-linked immunosorbent assay. RESULTS: Concentrations of measured parameters were expressed in units of standard deviation, ie, relatively to the average concentrations measured in healthy subjects. We found drastically increased concentrations of apoptosis-associated 180 bp nucleosomes (13.71+/-14.97; p=0.047), complement activation products SC5b-9 (197.07+/-134.88; p=0.003) and C3d/dg (38.70+/-43.35; p=0.048), and immune complexes CIC-C3d (11.01+/-13.39; p=0.74), CIC-IgA (7.93+/-4.38; p=0.001), and CIC-IgG (20.56+/-10.87; p=0.001) in the urine of patients with an active form of membranous glomerulonephritis. All studied molecules were absent, or present in very low concentrations, in healthy subjects and patients with membranous glomerulonephritis in remission. The mean differences between healthy controls and patients with the active disease were statistically significant in all parameters, except CIC-C3d. CONCLUSIONS: There is an association of complement activation and apoptosis with membranous glomerulonephritis. Correlation analysis suggests that the excretion of apoptosis-associated 180 bp nucleosomes, SC5b-9, C3d/dg, and immune complexes containing IgA and IgG in the urine of patients with active membranous glomerulonephritis does not depend solely on the passive transport together with other proteins, but is probably an independent active process.

Adult↗
PubMed1978

Activation of human B lymphocytes. IX. Modulation of antibody production by products of activated macrophages.

Human monocytes, after in vitro activation by mixed lymphocyte culture (MLC) supernatants produce a monokine (MK) that enhances the plaque-forming cell (PFC) response of pokeweed mitogen (PWM)-stimulated human B lymphocytes. Technical conditions and kinetics of MK production were established. Irradiation of monocytes (5000 rads) does not abolish MK production but heat-killed cells are unable to release the factor. Highly T cell-depleted monocyte populations still produced the PFC-enhancing factor. The same MK has an inconsistent enhancing effect on the PFC responses of lipopolysaccharide (LPS) and nocardia water-soluble mitogen (NWSM)-stimulated B cells. Other macrophage activators such as LPS, phytohemagglutinin (PHA), and latex particles failed to induce consistently the liberation of the PFC-enhancing MK. The target cell for the MK activity on PWM-stimulated B cells appears to be the B lymphocyte itself. These studies demonstrate that soluble monocyte products can have substantial modulatory effects on human B cell function.

Antibody Formation↗
PubMed2003

The use of dried bakery products in a free-choice feeding method for small-scale broiler production.

Waste material from bakeries is an unconventional energy feed source which is available in sufficient quantities for use in small-scale broiler production in South Africa. Small-scale broiler producers do not have access to the computer programs required to balance home-mixed rations. This investigation confirms that the use of dried bakery products (DBP) in a 2-stage, free-choice method can be used to compensate for this lack. A total of 570 day-old male broiler chickens was assigned to 3 feeding treatments: the control group was fed a 2-stage feeding programme using standard commercial starter and grower rations. The 2nd group received a commercial starter ration up to Day 7 and was thereafter given a choice of a commercial starter ration with normal salt content (0.35%) and DBP. The 3rd group was fed a commercial starter ration up to Day 7, then offered a choice of commercial starter ration with a lower salt content (0.1%) and DBP. The low salt alternative was used to test whether the higher salt percentage in DBP influenced the choice of feed by the birds. It was found that the control group consumed significantly more feed (P < 0.05) and was significantly heavier (P < 0.05) than the experimental groups. However, there was no significant difference between the 2 experimental groups, which indicated that salt content did not play a role in the choice of ration. Feed consumption by both experimental groups was about one-third less than the control group, but the profit margin, as calculated using gross margin analysis, was approximately 15 % higher. It was therefore concluded that dried bakery products can be profitably incorporated as an energy feed source, using the free-choice feeding method, in small-scale broiler enterprises.

Animal Feed↗
PubMed2004

Back pain and productivity: measuring worker productivity from an employer's perspective.

Most non-elderly Americans receive their health insurance coverage through their workplace. Employers, who historically saw the provision of this benefit as only an incentive for recruitment and retention, are now beginning to appreciate the value of health coverage and its effect on organizational performance and productivity. Back pain is a major contributor to reduced worker productivity and management of back pain is a major driver for prescribing of analgesic pharmacotherapy. This article examines various methods to assess productivity gains or losses, from an employer's perspective.

Absenteeism↗
PubMedDate not supplied

Effects of ribavirin on cytokine production of recall antigens and phytohemaglutinin-stimulated peripheral blood mononuclear cells. (Inhibitory effects of ribavirin on cytokine production).

AIM: To evaluate the effects of ribavirin on cytokine production of recall antigen and PHA-stimulated PBMC obtained from healthy individuals. MATERIALS AND METHODS: PBMC were challenged with tetanus toxoid (5 microg/mL) and PHA (10 microg/mL) in absence or presence of ribavirin at different concentrations (1, 10 and 100 (microM). Parallel sets of wells containing PBMC exposed to medium alone were used as negative controls. On day 3 after initiation of the cultures, IL-2, IFN-gamma, IL-4, IL-10, TNF-alpha content were determined in supernatants of PBMC from the different individuals. RESULTS: The effects of ribavirin on cytokine released by human PBMC in response to PHA and TT showed a great variation among individuals. No significant changes were observed between 1-10 microM concentrations in the production of TNF-alpha, IFN-gamma and IL-10 by both PHA and TT-stimulated PBMC. Ribavirin inhibited TNF-alpha, IFN-gamma, and IL-10 in both PHA and TT-stimulated PBMC at 100 microM (p <0.05). At this concentration, ribavirin induced an increase of 124% in the production of IL-2 by PHA-stimulated PBMC (p <0.05). CONCLUSIONS: The present data suggest that ribavirin may cause diverse effects on immunoregulatory cytokine secretion with changes in the Th1/Th2 balance.

Antigens↗
PubMed2005

Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; amendment of final monograph for over-the-counter nasal decongestant drug products. Final rule.

The Food and Drug Administration (FDA) is amending the final monograph (FM) for over-the-counter (OTC) nasal decongestant drug products (drug products used to relieve nasal congestion due to a cold, hay fever, or other upper respiratory allergies) to remove the indication "for the temporary relief of nasal congestion associated with sinusitis" and to prohibit use of the terms "sinusitis" and "associated with sinusitis" elsewhere on the labeling. This final rule is part of FDA's ongoing review of OTC drug products.

Drug Labeling↗
PubMed2006

Improving preanalytic processes using the principles of lean production (Toyota Production System).

The basic technologies used in preanalytic processes for chemistry tests have been mature for a long time, and improvements in preanalytic processes have lagged behind improvements in analytic and postanalytic processes. We describe our successful efforts to improve chemistry test turnaround time from a central laboratory by improving preanalytic processes, using existing resources and the principles of lean production. Our goal is to report 80% of chemistry tests in less than 1 hour and to no longer recognize a distinction between expedited and routine testing. We used principles of lean production (the Toyota Production System) to redesign preanalytic processes. The redesigned preanalytic process has fewer steps and uses 1-piece flow to move blood samples through the accessioning, centrifugation, and aliquoting processes. Median preanalytic processing time was reduced from 29 to 19 minutes, and the laboratory met the goal of reporting 80% of chemistry results in less than 1 hour for 11 consecutive months.

Autoanalysis↗
PubMed2006

[Product quality and genome analysis in pig production--a review].

Product quality in the pig is defined by the choice of lean meat including a reasonable intramuscular fat content and good water binding capacity, which can be produced and marketed at a reasonable price, based on good fattening performance and disease resistance. Traits of product quality are mostly of polygenic character, while some of these genes show larger effects. Genome analysis intends to identify the genetic basis of phenotypic trait variation and to complement conventional phenotypic selection criteria by direct regarding of the nucleotide level, thus marker assisted selection. The present paper describes the most important markers in use to improve product quality in swine, and shows perspectives of genome analysis in this regard, including positional and functional strategies.

Animals↗
PubMed1991

Monokine production by human T cells; IL-1 alpha production restricted to memory T cells.

The production of cytokines is a key event of inflammation. In this report we demonstrate that normal human T cells are capable to produce IL-1 alpha, IL-6, and TNF-alpha, cytokines formerly considered to be monokines. This production was optimal after stimulation with a combination of anti-CD2, PMA, and anti-CD28. All three cytokines were produced in a bioactive form. Both naive (CD4+CD45RA+) and memory (CD4+CD45RO+) subsets of T cells were shown to produce similar amounts of IL-6 and TNF-alpha. In contrast the production of IL-1 alpha was found to be completely restricted to the CD4+CD45RO+ subset. The finding that T cells are such potent producers of these important mediators of the inflammatory response might be a key observation in the appreciation of the role of T cells in chronic inflammation.

CD4 Antigens↗
PubMed1991

Regulation of murine mononuclear phagocyte inflammatory products by macrophage colony-stimulating factor. Lack of IL-1 and prostaglandin E2 production and generation of a specific IL-1 inhibitor.

The influence of macrophage (M)-CSF on the production of inflammatory mediators has been examined in murine peritoneal macrophages. Cultures of macrophages treated with up to 30,000 U/ml of human rM-CSF or with 10,000 U/ml of L929-derived M-CSF did not reveal either PGE2, IL-1, or IL-6 secretion. In contrast, LPS, which served as a positive control, stimulated production of significant levels of PGE2, IL-1, and IL-6. Furthermore, Northern blot analysis of macrophage RNA revealed a strong induction of IL-1 alpha and IL-6 mRNA by LPS but not by M-CSF. Conditioned medium from macrophage cultures treated with purified L929 or human rM-CSF in combination with LPS exhibited a significant reduction of IL-1 bioactivity as compared with an LPS challenge alone. To investigate the mechanism involved in this M-CSF-dependent reduction of IL-1 bioactivity, we measured IL-1 alpha gene expression. The addition of M-CSF to LPS-treated macrophages did not affect IL-1 alpha mRNA levels suggesting that M-CSF may regulate production of an IL-1 inhibitor. This hypothesis was shown to be valid because removal of IL-1 alpha from conditioned medium of LPS plus M-CSF-treated cells allowed the detection of a nondialyzable factor that blocked IL-1-dependent thymocyte proliferation. The inhibitor appeared to be specific because it did not inhibit IL-2 and TNF bioactivities. Furthermore, this IL-1 inhibitor, which binds to cells and not to IL-1, competed with the binding of radioactive IL-1 alpha or beta to EL-4.6.1 cells. The results demonstrate that M-CSF alone does not induce proinflammatory mediators and PGE2 as was previously published. The data also suggest that M-CSF may play a role in the down-regulation of inflammatory responses.

Animals↗
PubMed1990

[Presence of nitrates and nitrites in baker's products and in certain other flour products].

The results of the study demonstrated that the content of nitrates and nitrites in various baker's products varied from 0.96 (in wheat rolls and baguettes) to 44.07 mg KO3/kg in pumpernickel bread. In wholemeal bread, village bread, tourist bread, rye brown bread and Graham bread the content of these compounds was from 1.46 to 27.10 mg KNO3/kg. The mean content of nitrites in these bread sorts was 1.76 mg NaNo2/kg, range 0.10-4.40 mg NaNo2/kg. In white wheat flours (Wrocław flour, cake flour and Poznań flour) the content of nitrates ranged from 1.10 to 19.08 mg KNO3/kg, and in the dishes produced from them in household was from 0.50 to 16.33 mg KNO3/kg. The content of nitrites in these flours was in the range from 0.00 to 4.16 mg NaNo2/kg, and in the products prepared from them it was from 0.00 to 1.60 mg NaNO2/kg. Eleven types were tested also of popular biscuits, wafers, gingerbread and hard cakes in which the content of nitrates was from 3.66 to 17.72 mg/kg, and that of nitrites was from 0.00 to 8.80 mg NaNo2/kg. Considering the average consumption of these products per one person in the seashore region and the mean values of nitrates and nitrites it was calculated that they provided daily about 3.9 mg KNO3 and 0.4 NaNo2, that is about 1.8% of nitrates and 7.7% of nitrites consumed by adults in daily food ration.

Bread↗
PubMed1986

Hydroxyurea induction of hemoglobin F production in sickle cell disease: relationship between cytotoxicity and F cell production.

Initial alterations in fetal hemoglobin (HbF) production among eight sickle cell anemia subjects treated with hydroxyurea (Hu) are summarized. Four of these subjects had been previously treated with 5-azacytidine (5-aza). All subjects treated with Hu (50 mg/kg/d for three to five days) had suppression of their total reticulocyte counts by seven days, whereas the four subjects previously treated with 5-aza (2 mg/kg/d for three to five days) had increased reticulocyte counts at day 7. The effect of Hu on increasing the number of HbF-containing reticulocytes (F reticulocytes) is extremely variable, ranging from ten-to less than onefold differences in maximal posttherapy v pretherapy levels. Recovery from marrow suppression did not result in greater than twofold increases in F reticulocyte counts. Mean day 7 F reticulocyte levels in the four subjects treated with both Hu and 5-aza were 4.1 X 10/microL and 15.4 X 10(4)/microL, respectively. Among Hu-treated subjects, increased F reticulocyte production was correlated with low serum creatinine levels and rapid removal of Hu from the plasma. Furthermore, suppression of CFU-E colony formation on day 2 of therapy with Hu was inversely correlated with maximal F reticulocyte response. We conclude that where Hu treatment results in marrow toxicity (decreased reticulocyte counts, decreased CFU-E colony formation) HbF production is less likely to increase. Those sickle cell anemia subjects with minimal renal dysfunction (serum creatinine level, greater than 1.0 mg/dL) exhibit the most cytotoxicity and least F reticulocyte response to Hu.

Anemia, Sickle Cell↗