Résumé
AbstractIntroduction: In recent years, researchers have paid attention to the biological active products fromraw materials of animal origin. Lyophilized bovine bile and bovine liver hydrolyze and varieties ofplants have been used for increase secretion of bile in traditional systems of medicine of variouscountries. We investigated that beneficial effects of new product particularly its treatment liverdamage, improve regeneration process of damaged liver cell, effects on bile secretion, bile bilirubin,and bile cholesterol and plasma cholesterol levels. Moreover, we investigate physical, chemicalcapacity and drafted a MNS document.Goal: To complete pharmacological, technological and standardization study of Sillichol biologicalactive product.Material and MethodsSeveral biochemical methods were used for determination of chemical compounds in liverhydrolysate and lyophilized bile. The product was formed in combined powder form by dried stirringmethod and it was capsuled by NJP-1200 capsule machine. Litchfield-Wilcoxon’s method was usedto study the acute toxicity effect. The median lethal dose (LD50) value was calculated using themethod of Pearson and toxicity level of was determined according to classification of Sidorov K.K(1973). Human equivalent dose (effective dose) was calculated with according to FDA guidancefor drug-dose conversion. Acute hepatitis – Carbon tetrachloride (CCl4) induced liver damage inrats (Skakun et al, 1984); Bile secretion effect was determined by method of Rozuet Jousse, 1980.All value expressed as mean S.E obtained from n number of experiments. The Student’s t-testfor unpaired observation between control and experimental samples was carried out for statisticalevaluation of a difference; p values of 0.05 or less were considered as statistically significant.ResultsTotal nitrogen, amino nitrogen, fat, ash and solution index were measured in liver hydrolysate.The results were accepted standard requirements of MNS 6484:2014. Bovine bile was dried byLabconco freezone L12 freeze drier in Drug Research Institute. The product named Sillichol wasformed combined powder form and capsuled №0 capsule. From the result of preclinical study, ourinvestigational new product is included in practically non-toxic class according to toxicity classificationby Sidorov (1750 mg/kg). Sillichol biological active product was increase bile level which is producedin liver cells and decreased bile cholesterol levels by 2.3-8.0% in the test group compared with thecontrol and reference groups.Conclusion: The biological active product was improving regeneration process of liver cells,normalize cell structure, effect to the anti-inflammatory in damaged liver cells.
Résumé
BackgroundPreliminary clinical studies indicate that liver extract may be helpful in treating hepatic dysfunction. In addition, liver extract seems to work synergistically with interferon in treating hepatitis C and other viral infections. Laboratory studies indicate that liver extract may have some effects that could be useful in treating certain forms of cancer, such as ability to direct migration of metastasizing cells and inhibition of DNA, RNA and protein formation. More research is needed in these areas to determine liver hydrolysate’s properties.Materials and MethodsSeveral biochemical methods were used for determination of chemical compounds in liver extracts: Total protein and nitrogen content was determined by Kjeldahl method; mineral contents – atomic absorption spectrophotometer; Heme iron content – spectrophotometer; Water soluble vitamins - HPLC method. The pharmacological activities of bovine liver were tested by several pharmacological methods: Acute toxicity – LD50 /Prozorovskii 1978/; Acute hepatitis – Carbon tetrachloride (CCl4) induced liver damage in rats /Skakun et al, 1984/; Biochemical parameters in blood serum – Automatic biochemical analyzer.ResultThe values obtained in determination of the biochemical analysis show that 100 g consumption of studied liver hydrolysate can provide 4.3, 2.1 and 0.3 mg vitamin B1, B3 and B9 respectively. Therefore, present data reveal that liver hydrolysate is a good source of most of the analyzed minerals. The liver hydrolysate contains 56.4% total protein and 4.33% amino nutrient.Conclusions:1. From the results of pharmacological study that involves CCl4 induced acute toxic hepatitis, liver hydrolysate has hepatoprotective effect by protecting the liver cells from injury, improving the regeneration process and by correcting metabolic functions of the liver.2. When tested, hydrolysate’s pharmacological parameters can be analyzed reliably with several liver damage experimental designs, further improvements or the use of new designs such as anemia is needed in further pharmacological study.
Résumé
BackgroundLiver protecting effect of liver hydrolysate is studied on CCl4 induced by acute toxic hepatitis on rats compared with “Raw Liver Glandular” which is similar product of “Swanson”, USA. Result was confirmed with histological study.Materials and MethodsCarbon tetrachloride-CCl4 is considered as a direct hepatotoxin which produces centri-lobular necrosis and steatosis. The mechanism of acute toxic hepatitis induced by CCl4 involves lipid peroxidation of membrane bound fatty acids which result in destructing the cell membrane and the intracellular organells of the hepatocyte.Result:As study result, after 7 days CCL4 exposure, experimental group’s serum ALAT (p<0.01), GGT (p<0.05) and ALP (p<0.05) levels decreased rapidly compared with control groups.ConclusionAlthough, liver hydrolysate is not medicine for treatment liver damage, it might be improved regeneration process in the damaged liver cells. As result, histomorphological study came to the following conclusion: in the seventh day of the model of acute toxic hepatitis of the liver in rats, cytoplasm vacuoles of hepatocytes were decreased sharply, hepatocytes became multilateral, “Kupffer cells” were increased, young hepatocytes were streamlined as columnar-cells, capillaries were became visible and was began regeneration. There were reported that bovine and pork protein hydrolysate contains essential amino acids with antioxidant effect which prevents liver cells from oxidative stress. Besides it, liver hydrolysate containing amino acids, vitamin B1, B6, folic acid and some minerals improves metabolism and regeneration process of damaged liver cells.