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Toxicological evaluation of xanthan gum based hydrogel formulation in Wistar rats using single dose study

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Malik N. S., Ahmad M., Minhas M. U., Tulain R., Khalid I., Barkat K., Rashid A.
Acta Poloniae Pharmaceutica - Drug Research
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2020
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vol. 77
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issue 2
353-360
EN
Xanthan gum-based hydrogel formulation FXG3 was prepared by a free radical polymerization technique. To assess safety of FXG3 hydrogel for potential application as new drug delivery system, a single oral dose toxicity study was conducted according to OECD guidelines. Female adult rats of Wistar strain were divided into group A and group B. Group A served as the control and was given 1mL/100 g body weight 0.9% saline. Group B received a dose of 5g/kg body weight of FXG3 hydrogel. Rats were observed continuously for 14 days for clinical signs, and prior to terminal sacrifice, blood samples were taken to assess for haematology and biochemical parameters. Selected organs (heart, liver, lung, kidneys, spleen, and stomach) were removed and examined macroscopically, washed, sliced and stained with haematoxylin-eosin for histopathological investigation. No mortality or any signs of acute toxicity was observed during the observation period. No macroscopic alteration was found in the selected organs. Histopathological examination did not show any pathological changes. Thus, the maximal tolerated dose of FXG3 was calculated to be higher than 5g/kg body weight. It can be concluded that FXG3, a xanthan gum-based hydrogel formulation, was non-toxic after acute oral administration at 5g/kg body weight, and thus may be a promising candidate in controlled drug delivery system.
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The value of histological changes and immunohistochemical markers Ki67 and p53 in the assessment of ulcerative colitis related dysplasia

86%
Fratila O., Ilias T., Puscasiu D.
Open Medicine
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2010
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vol. 5
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issue 4
417-425
EN
The risk of carcinoma increases in patients with a 10-year or longer duration of ulcerative colitis (UC). To search for a more objective parameter to assess epithelial dysplasia. The study comprised 25 cases of longstanding UC: 7 cases with regenerative atypia, 7 with low grade dysplasia, 7 with high grade dysplasia, and 4 cases indefinite for dysplasia. The colonic biopsies obtained during endoscopy were stained with H&E to identify the aforementioned categories. Seventy-five sections from biopsy specimens were stained immunohistochemically to detect differences in the frequency and pattern of nuclei positive for the proliferation marker Ki67 and p53. In high grade dysplasia, the distribution of Ki67 positive cells was diffuse throughout the full length of the crypt, whereas low grade dysplasia and epithelium indefinite for dysplasia, as well as regenerative epithelium, showed an expanded basal zone. None of the regenerative atypia cases showed strong intensity p53 staining compared to dysplasia cases. None of the high grade dysplasia cases showed restricted p53 staining to the lower two thirds of the crypt. All the cases of HGD showed extension of Ki67 and p53 staining above the basal two thirds of the crypt. Ki67 and p53 immunostained cell assessment combined with routine histological evaluation of colorectal mucosa can improve the diagnostic accuracy, as well as the assessment of malignant transformation risk.
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