COMBINATION FOR REDUCING OXIDATIVE STRESS IN THE BODY AND MAINTAINING LIVER FUNCTIONS

Abstract

The invention relates to a composition based on a natural lignocellulose complex, a source of dietary fiber exhibiting antioxidant and adsorption properties and dihydromyrecitin or quercetin, which has hepatoprotective activity when used together due to multidirectional action. This combination can be used to reduce oxidative stress and its inducers in the blood and organs, as well as maintain the detoxification function of the liver and its restoration, contains dihydromyricetin or quercetin in an amount of 5 to 1000 mg and hydrolysed lignin in an amount of 50 mg to 5000 mg. Technical result: the combination has an unexpected synergistic effect aimed at reducing oxidative stress and its inducers, manifested in a decreased level of malondialdehyde and acetaldehyde in the blood and organs, as well as in a beneficial effect on liver function.

Claims

1. The combination for reducing oxidative stress and its inducers in the blood and human organs, which contains dihydromyricetin or quercetin in an amount of 5 to 1000 mg and hydrolytic lignin in an amount of 50 mg to 5000 mg.

2. The combination according to claim 1, wherein the preferred content of dihydromyricetin or quercetin is in an amount from 50 to 1000 mg and hydrolytic lignin in an amount from 500 mg to 5000 mg.

3. The combination according to claim 1, wherein it additionally contains glycine, thiamine.

4. The combination according to claim 3, wherein the glycine is a derivative and/or pharmaceutically acceptable salt of glycine in an amount from 50 mg to 1000 mg.

5. The combination according to claim 3, wherein thiamine is a thiamine derivative, for example benfotiamine, and/or pharmaceutically acceptable salts in an amount of 1 mg to 500 mg.

6. The combination according to claim 1, wherein it is an orally dosage form, namely powder, tablets, capsules, suspensions.

7. The use of the combination according to claim 1 for the comprehensive maintenance of the detoxification function and restoration of the liver.

8. Biologically active food supplement containing the composition according to claim 1 and auxiliary substances.

9. Biologically active food supplement according to claim 8, wherein it is made in the form of a powder, tablet, capsule, bar, and snack.

10. The use of biologically active food supplement according to claim 8 for the comprehensive maintenance of the detoxification function and restoration of the liver.

11. A product for therapeutic and prophylactic dietary food comprising the combination according to claim 1 and auxiliary substances.

12. The product according to claim 11, wherein it is made in the form of a powder, tablet, capsule, bar, snack.

13. The use of the product according to claim 11 for the comprehensive maintenance of the detoxification function and restoration of the liver.

Description

EXEMPLARY EMBODIMENTS

Example 1

[0056] This example illustrates the preparation of a composition containing lignin and DHM or quercetin.

[0057] To obtain the composition, the following procedures were carried out: [0058] 1) lignin grinding using a mill with 0.8 mm mesh size. [0059] 2) sieving of substancesto remove foreign inclusions and lumps, substances were sifted using a vibrating sieve with a 0.32 mm mesh size. Each component was sieved separately. The sifted raw material was re-weighed. The amount of dropout should not exceed 6 wt %. [0060] 3) preparation of compositionsthe amount of active ingredients was calculated, including: hydrolysed lignin in an amount that allows for a dosage of lignin from 50 to 5000 mg/day, DHM in an amount that allows for a dosage of DHM from 5 to 1000 mg/day, quercetin in an amount that allows you to provide a dosage of quercetin from 5 to 1000 mg/day. Raw materials were weighed. The raw material was loaded in portions into the mixer, the resulting mass was mixed for 20 minutes at a mixer rotation speed of 15-20 rpm until the components were evenly distributed. The resulting composition was packaged in a sealed container made of opaque glass or plastic, marking was applied indicating the ratio of active components, the date of production and storage conditions. For further studies, samples weighing 500 g were obtained: 1) composition 1-416.667 g of lignin and 83.333 g of DHM, which is equivalent to a dosage of lignin, 5000 mg+DHM, 1000 mg; 2) composition 2-446.439 g of lignin and 53.571 g of DHM, which is equivalent to a dosage of lignin, 2500 mg+DHM, 300 mg; 3) composition 3-471.698 g of lignin and 28.302 g of DHM, which is equivalent to the dosage of lignin, 500 mg+DHM, 30 mg; 4) composition 4-471.675 g of lignin and 28.325 g of DHM, which is equivalent to the dosage of lignin, 250 mg+DHM, 15 mg; 5) composition 5-454.545 g of lignin and 45.455 g of DHM, which is equivalent to the dosage of lignin, 50 mg+DHM, 5 mg; 6) composition 6-416.667 g of lignin and 83.333 g of quercetin, which is equivalent to the dosage of lignin, 5000 mg+quercetin, 1000 mg; 7) composition 7-446.439 g of lignin and 53.571 g of quercetin, which is equivalent to the dosage of lignin, 2500 mg+quercetin, 300 mg; 8) composition 8-471.698 g of lignin and 28.302 g of quercetin, which is equivalent to the dosage of lignin, 500 mg+quercetin, 30 mg; 9) composition 9-471.675 g of lignin and 28.325 g of quercetin, which is equivalent to the dosage of lignin, 250 mg+quercetin, 15 mg; 10) composition 10-454.545 g of lignin and 45.455 g of quercetin, which is equivalent to the dosage of lignin, 50 mg+quercetin, 5 mg.

Example 2

[0061] The example illustrates preparing the combinations of lignin and DHM/quercetin with the addition of auxiliary glycine and thiamine components.

[0062] To obtain compositions of lignin, DHM, glycine and thiamine, as well as compositions of lignin, quercetin, glycine and thiamine, the following procedures were performed: [0063] 1) grinding of lignin and glycine using a mill with a 0.8 mm mesh size. [0064] 2) sieving of substancesto remove foreign inclusions and lumps, substances were sifted using a vibrating sieve with a 0.32 mm mesh size. Each component was sieved separately. The sifted raw material was re-weighed. The amount of dropout should not exceed 6 wt %. [0065] 3) obtaining compositionsthe amount of active ingredients was calculated, including: hydrolysed lignin in an amount that allows for a dosage of lignin from 50 to 5000 mg/day, DHM in an amount that allows a dosage of DHM from 5 to 1000 mg/day, quercetin in an amount that allows to provide a dosage of quercetin from 5 to 1000 mg/day, glycine in an amount that allows a dosage of glycine from 50 to 1000 mg/day, thiamine in an amount that allows a dosage of glycine from 1 to 500 mg/day. Raw materials were weighed. The raw material was loaded in portions into the mixer, the resulting mass was mixed for 20 minutes at a mixer rotation speed of 15-20 rpm until the components were evenly distributed. The resulting composition was packaged in a sealed container made of opaque glass or plastic, marking was applied indicating the ratio of active components, the date of production and storage conditions. For further studies, samples weighing 500 g were obtained: [0066] 1) composition 11-384.615 g of lignin, 76.923 g of DHM and 38.462 g of thiamine, which is equivalent to the dosage of lignin, 5000 mg+DHM, 1000 mg+thiamine, 500 mg; [0067] 2) composition 12-384.615 g of lignin, 76.923 g of quercetin and 38.462 g of thiamine, which is equivalent to the dosage of lignin, 5000 mg+quercetin, 1000 mg+thiamine, 500 mg; [0068] 3) composition 13-438.596 g of lignin, 52.632 g of DHM and 8.772 g of thiamine, which is equivalent to the dosage of lignin, 2500 mg+DHM, 300 mg+thiamine, 50 mg; [0069] 4) composition 14-438.596 g of lignin, 52.632 g of quercetin and 8.772 g of thiamine, which is equivalent to the dosage of lignin, 2500 mg+quercetin, 300 mg+thiamine, 50 mg; [0070] 5) composition 15-467.254 g of lignin, 28.035 g of DHM and 4.673 g of thiamine, which is equivalent to the dosage of lignin, 500 mg+DHM, 30 mg+thiamine, 5 mg; [0071] 6) composition 16-467.254 g of lignin, 28.035 g of quercetin and 4.673 g of thiamine, which is equivalent to the dosage of lignin, 500 mg+quercetin, 30 mg+thiamine, 5 mg; [0072] 7) composition 17-468.150 g of lignin, 28.089 g of DHM and 3.745 g of thiamine, which is equivalent to the dosage of lignin, 250 mg+DHM, 15 mg+thiamine, 2 mg; [0073] 8) composition 18-468.150 g of lignin, 28.089 g of quercetin and 3.745 g of thiamine, which is equivalent to the dosage of lignin, 250 mg+quercetin, 15 mg+thiamine, 2 mg; [0074] 9) composition 19-446.425 g of lignin, 44.643 g of DHM and 8.929 g of thiamine, which is equivalent to the dosage of lignin, 50 mg+DHM, 5 mg+thiamine, 1 mg; [0075] 10) composition 20-446.425 g of lignin, 44.643 g of quercetin and 8.929 g of thiamine, which is equivalent to the dosage of lignin, 50 mg+quercetin, 15 mg+thiamine, 1 mg; [0076] 11) composition 21-357.143 g of lignin, 71.429 g of DHM and 71.429 g of glycine, which is equivalent to the dosage of lignin, 5000 mg+DHM, 1000 mg+glycine, 1000 mg; [0077] 12) composition 22-357.143 g of lignin, 71.429 g of quercetin and 71.429 g of glycine, which is equivalent to the dosage of lignin, 5000 mg+quercetin, 1000 mg+glycine, 1000 mg; [0078] 13) composition 23-378.788 g of lignin, 45.455 g of DHM and 75.757 g of glycine, which is equivalent to the dosage of lignin, 2500 mg+DHM, 300 mg+glycine, 500 mg; [0079] 14) composition 24-378.788 g of lignin, 45.455 g of quercetin and 75.757 g of glycine, which is equivalent to the dosage of lignin, 2500 mg+quercetin, 300 mg+glycine, 500 mg; [0080] 15) composition 25-320.500 g of lignin, 19.231 g of DHM and 160.259 g of glycine, which is equivalent to the dosage of lignin, 500 mg+DHM, 30 mg+glycine, 250 mg; [0081] 16) composition 26-320.500 g of lignin, 19.231 g of quercetin and 160.250 g of glycine, which is equivalent to the dosage of lignin, 500 mg+quercetin, 30 mg+glycine, 259 mg; [0082] 17) composition 27-333.333 g of lignin, 66.667 g of DHM, 33.333 g of thiamine and 66.667 g of glycine, which is equivalent to the dosage of lignin, 5000 mg+DHM, 1000 mg+thiamine, 500 mg+glycine, 1000 mg; [0083] 18) composition 28-333.333 g of lignin, 66.667 g of quercetin, 33.333 g of thiamine and 66.667 g of glycine, which is equivalent to the dosage of lignin, 5000 mg+quercetin, 1000 mg+thiamine, 500 mg+glycine, 1000 mg; [0084] 19) composition 29-373.134 g of lignin, 44.776 g of DHM, 7.463 g of thiamine and 74.627 g of glycine, which is equivalent to the dosage of lignin, 2500 mg+DHM, 300 mg+thiamine, mg+glycine, 500 mg; [0085] 20) composition 30-373.134 g of lignin, 44.776 g of quercetin, 7.463 g of thiamine and 74.627 g of glycine, which is equivalent to the dosage of lignin, 2500 mg+quercetin, 300 mg+thiamine, 50 mg+glycine, 500 mg; [0086] 21) composition 31-318.450 g of lignin, 19.107 g of DHM, 3.185 g of thiamine and 159.225 g of glycine, which is equivalent to the dosage of lignin, 500 mg+DHM, 30 mg+thiamine, 5 mg+glycine, 250 mg; [0087] 22) composition 32-318.450 g of lignin, 19.107 g of quercetin, 3.185 g of thiamine and 159.225 g of glycine, which is equivalent to the dosage of lignin, 500 mg+quercetin, 30 mg+thiamine, 5 mg+glycine, 250 mg; [0088] 23) composition 33-340.575 g of lignin, 20.435 g of DHM, 2.725 g of thiamine and 136.230 g of glycine, which is equivalent to the dosage of lignin, 250 mg+DHM, 15 mg+thiamine, 2 mg+glycine, 100 mg; [0089] 24) composition 34-340.575 g of lignin, 20.435 g of quercetin, 2.725 g of thiamine and 136.230 g of glycine, which is equivalent to the dosage of lignin, 250 mg+quercetin, 15 mg+thiamine, 2 mg+glycine, 100 mg; [0090] 25) composition 35-235.845 g of lignin, 23.585 g of DHM, 4.717 g of thiamine and 235.845 g of glycine, which is equivalent to the dosage of lignin, 50 mg+DHM, 5 mg+thiamine, 1 mg+glycine, 50 mg; [0091] 26) composition 36-235.845 g of lignin, 23.585 g of quercetin, 4.717 g of thiamine and 235.845 g of glycine, which is equivalent to the dosage of lignin, 50 mg+quercetin, 5 mg+thiamine, 1 mg+glycine, 50 mg.

Example 3

[0092] This example illustrates the study of the claimed composition in relation to drug hepatotoxicity.

[0093] Many commonly used drugs, including paracetomol, the well-known analgesic and antipyretic drug, exhibit liver toxicity. An overdose of paracetomol causes acute hepatotoxicity, including the formation of necrosis foci.

[0094] Procedure: Outbred male rats weighing 250-270 g were studied. The study involved 11 groups of animals, 6 animals in each group: group 1pathology control, group 2lignin, 5000 mg+DHM, 1000 mg, group 3lignin, 2500 mg+DHM, 300 mg, group 4lignin, 500 mg+DHM, 30 mg, group 5 lignin, 5000 mg+DHM, 1000 mg+glycine, 1000 mg, group 6-lignin, 5000 mg+DHM, 1000 mg+thiamine, 500 mg, group 7lignin, 5000 mg+DHM, 1000 mg+thiamine, 500 mg+glycine, 1000 mg, group 8lignin, 250 mg+DHM, 15 mg+thiamine, 2 mg+glycine, 100 mg, group 9lignin, 50 mg+DHM, 5 mg, group 10lignin, mg+DHM, 5 mg+thiamine, 1 mg+glycine, 50 mg, group 11lignin, 5000 mg+quercetin, 1000 mg. The dosages are indicated according to the human normal values; when calculating the doses, a recalculation was made taking into account the weight and metabolic coefficient for experimental animals. Before the start of the experiment, the animals were deprived of access to food for 12 hours. Paracetamol as a suspension in 1% starch solution was administered intragastrically using a probe. The paracetomol dosage was 2 g/kg body weight. One hour after the introduction of paracetamol, the studied combinations were also introduced in the form of suspensions in a starch solution. Two hours after the introduction of the studied substances, the animals received a standard food. The observation was continued for 24 hours, after which the animals were euthanized. During the study, ALT, AST, bilirubin, MDA and TNF blood levels were determined in animals, and the liver was subjected to histological examination at the end of the study. The degree of liver damage was assessed by summing the number and size of necrotic foci and inflammation foci during microscopic analysis using a scoring system.

[0095] Results: Paracetomol overdose led to significant functional changes in the liver: increased ALT, AST and bilirubin levels, significant oxidative stress, which led to an increased blood MDA, increased proinflammatory cytokine TNF level, as well as the appearance of necrosis foci in the liver tissues (Table. 1, mean valuestandard deviation). All combinations studied contributed to preserving liver functions, which was expressed in a decreased severity of pathological changes in liver tissues (calculated in points), as well as a decreased level of liver enzymes (ALT and AST) and bilirubin. Against the background of using the studied combinations, a decreased intensity of oxidative stress caused by paracetomol overdose was observed, which was manifested in a decreased malondialdehyde level. A significant decrease in the pro-inflammatory cytokine TNF level, which was observed against the background of using the mentioned combinations, allows concluding on their anti-inflammatory activity, which is also of great importance for maintaining the normal liver functioning and the body's resistance against oxidative stress. The most pronounced beneficial effect was shown by a combination of lignin, 5000 mg+DHM, 1000 mg and a combination of lignin, 5000 mg+quercetin, 1000 mg. Glycine and/or thiamine introduced into the LH and DHM combination, and, in particular, their mixtures, enhanced the protective effect of the combination. The data obtained indicate that using a combination of lignin at a dose of 5000 mg and DHM (quercetin) at a dose of 1000 mg allowed achieving the most pronounced anti-toxic effect of paracetomol in relation to the liver, which makes it possible to preserve liver function.

TABLE-US-00001 TABLE 1 Data of biochemical and histological analysis before the start of the study (using the example of the control group) and after loading with paracetamol (2 g/kg) ALT, AST, Bilirubin, MDA, Liver damage, TNF level, Groups: u/l u/l mg/dl nmol/mg points pg/ml Control (prior to the beginning 53.18 6.36* .sup.87.82 7.81* 0.194 0.009*.sup. 1.46 0.23*.sup. 0*** 34.60 2.60* of the study) Control (at the end of the study) 193.98 12.25.sup.# 265.43 12.73.sup.# 0.246 0.005.sup.# 3.33 0.23.sup.# 17.33 3.39.sup.# 170.42 10.33.sup.# lignin, 5000 mg + DHM, .sup.66.47 4.12*.sup.# 105.28 5.09*.sup.# 0.170 0.006*.sup.# 1.79 0.17*.sup.# 8.67 2.07*.sup.# 65.29 17.23* 1000 mg lignin, 2500 mg + DHM, .sup.92.12 5.27*.sup.# 152.92 6.13*.sup.# 0.228 0.003*.sup.# 2.35 0.08*.sup.# 11.33 3.01*.sup.# 95.87 7.03* 300 mg lignin, 500 mg + DHM, 30 mg 112.65 6.03*.sup.# 186.70 8.08*.sup.# 0.215 0.004*.sup.# 2.78 0.16*.sup.# 14.17 4.58.sup.# 113.33 6.07* lignin, 5000 mg + DHM, 1000 61.65 3.33* 101.05 9.75*.sup. 0.164 0.004*.sup.# 1.63 0.12*.sup. 8.83 1.94*.sup.# 62.61 4.82* mg + glycine, 1000 mg lignin, 5000 mg + DHM, 1000 61.85 5.51* .sup.99.93 6.02* 0.161 0.006*.sup.# 1.62 0.16*.sup. 8.33 1.37*.sup.# 60.53 6.92* mg + thiamine, 500 mg lignin, 5000 mg + DHM, 1000 59.98 4.37* .sup.94.27 5.21* 0.154 0.004*.sup.# 1.57 0.14*.sup. 7.68 12.01*.sup.# 57.16 14.36* mg + thiamine, 500 mg + glycine, 1000 mg lignin, 250 mg + DHM, 15 mg + .sup.146.17 12.25*.sup.# 209.47 9.95*.sup.# 0.231 0.005*.sup.# 2.94 0.18*.sup.# 14.92 3.71.sup.# 124.56 6.20* thiamine, 2 mg + glycine, 100 mg lignin, 50 mg + DHM, 5 mg 186.11 8.13.sup.# 247.02 10.24.sup.# 0.234 0.006.sup.# 3.20 0.13.sup.# 16.72 2.30.sup.# 159.34 6.23* lignin, 50 mg + DHM, 5 mg + 183.54 10.18.sup.# 241.93 14.87.sup.# 0.239 0.008.sup.# 3.15 0.21.sup.# 16.09 2.98.sup.# 157.12 5.36* thiamine, 1 mg + glycine, 50 mg lignin, 5000 mg + quercetin, .sup.67.32 3.25*.sup.# 107.27 5.11*.sup.# 0.178 0.007*.sup.# 1.92 0.16*.sup.# 9.17 1.94*.sup.# 65.52 7.80* 1000 mg *p < 0.05 versus the control group at the end of the study .sup.#p < 0.05 versus the control group before the start of the study

Example 4

[0096] This example illustrates the study of the claimed composition in relation to alcohol intoxication of the human body.

[0097] The description presents various diseases and conditions characterized by elevated blood MDA and AA levels. The most well-developed models for restoring such conditions are the models with a single or multiple administration of alcohol to laboratory animals, mainly rats. Given the reliability of alcoholic models, a model of this kind was chosen to confirm the studied combinations' ability to reduce blood MDA and AA levels when they increase due to various reasons. Wistar rats weighing 200-220 g were studied. The study involved 11 groups of animals, 10 rats in each group: group 1pathology control, group 2lignin, 5000 mg+DHM, 1000 mg, group 3lignin, 2500 mg+DHM, 300 mg, group 4lignin, 500 mg+DHM, 30 mg, group 5lignin, 5000 mg+DHM, 1000 mg+glycine, 1000 mg, group 6lignin, 5000 mg+DHM, 1000 mg+thiamine, 500 mg, group 7group 7lignin, 5000 mg+DHM, 1000 mg+thiamine, 500 mg+glycine, 1000 mg, group 8lignin, 250 mg+DHM, 15 mg+thiamine, 2 mg+glycine, 100 mg, group 9lignin, 50 mg+DHM, 5 mg, group 10lignin, 50 mg+DHM, 5 mg+thiamine, 1 mg+glycine, 50 mg, group 11lignin, 5000 mg+quercetin, 1000 mg. The dosages are indicated according to the human normal values; when calculating the doses, a recalculation was made taking into account the weight and metabolic coefficient for experimental animals. The investigated substances and their mixtures were injected intragastrically using a probe in the form of suspensions prepared in 1% starch solution, 30 minutes before the introduction of ethanol. Ethanol solution was introduced to rats intragastrically using a probe, based on a dosage of 12 ml of 40% ethanol solution per 1 kg of body weight. The ethanol solution was administered fractionally in 4 doses with an interval of 1 hour between the injections. The individual volume of the injected solution was calculated in accordance with the body weight of the animal, measured immediately before administration. Blood sampling for studying the analyzed parameters (the level of ethanol, AA and MDA, as well as the level of the antioxidant enzyme superoxide dismutase (SOD) in the blood) was performed before the start of the study, then 1 hour after the last injection of ethanol and 8 hours after the last injection of ethanol. The experimental results are presented in Table 2.

TABLE-US-00002 TABLE 2 Content of ethanol, malondialdehyde (MDA), acetaldehyde (AA) and superoxide dismutase (SOD) in the blood of rats that received the selected substances 30 minutes before the introduction of 40% ethanol solution Ethanol level, mg/ml MDA level, nM AA level, M SOD level, u/mg Groups: 0 h 1 h 8 h 0 h 1 h 8 h 0 h 1 h 8 h 0 h 8 h Control 0 6.79 0.03 7.36 12.08 9.33 71.37 120.52 79.49 25.55 8.52 0.25.sup.# 0.00 0.41 0.37.sup.# 0.26 2.21 5.05 2.26 2.70 0.84.sup.# lignin, 5000 mg + 0 4.68 0.02 7.22 3.74 5.12 72.53 83.93 69.67 24.91 22.62 DHM, 1000 mg 0.25.sup.#* 0.00 0.38 0.09.sup.#* 0.13.sup.#* 2.21 3.30* 2.73 3.01 1.59* lignin, 2500 mg + 0 5.37 0.03 6.95 4.31 6.02 71.23 102.36 68.30 25.01 17.18 DHM, 300 mg 0.19.sup.#* 0.00 0.24 0.11.sup.#* 0.25* 2.58 2.63*.sup.# 2.91 3.10 0.94* lignin, 500 mg + 0 5.83 0.03 7.03 8.96 6.23 78.15 116.89 80.5 25.26 12.49 DHM, 30 mg 0.34.sup.#* 0.00 0.15 0.68.sup.#* 0.55 2.43 5.52.sup.# 3.37 3.18 0.87* lignin, 5000 mg + 0 4.44 0.02 7.40 3.95 4.75 73.23 80.79 69.24 25.68 23.17 DHM, 1000 mg + 0.24.sup.# 0.00 0.22 0.28.sup.#* 0.28.sup.#* 1.35 1.71* 1.46 3.32 1.19* glycine, 1000 mg lignin, 5000 mg + 0 4.47 0.02 7.07 3.99 4.60 72.30 79.07 69.63 25.02 24.00 DHM, 1000 mg + 0.20.sup.# 0.00 0.34 0.30.sup.#* 0.27.sup.#* 2.43 1.58* 2.23 3.11 1.16* thiamine, 500 mg lignin, 5000 mg + 0 4.17 0.02 7.28 3.65 4.60 74.62 75.89 70.51 25.32 25.62 DHM, 1000 mg + 0.19.sup.# 0.00 0.27 0.23.sup.#* 0.27.sup.#* 2.07 2.36* 1.94 3.17 2.04* thiamine, 500 mg + glycine, 1000 mg lignin, 250 mg + 0 6.02 0.02 6.96 9.34 6.86 71.89 118.07 78.45 25.07 15.87 DHM, 15 mg + 0.21.sup.#* 0.00 0.22 0.42.sup.#* 0.39* 2.17 4.36.sup.# 3.08 3.44 1.14* thiamine, 2 mg + glycine, 100 mg lignin, 50 mg + 0 6.53 0.03 7.20 11.02 8.43 74.67 119.63 79.91 24.95 9.93 DHM, 5 mg 0.12.sup.# 0.00 0.25 0.38.sup.#* 0.26.sup.#* 2.71 4.56.sup.# 2.09 3.15 0.78.sup.# lignin, 50 mg + 0 6.49 0.03 7.21 10.68 8.21 75.11 119.45 79.92 24.89 10.54 DHM, 5 mg + 0.17.sup.# 0.00 0.30 0.54.sup.#* 0.30.sup.#* 3.01 4.97.sup.# 2.19 3.26 0.92.sup.# thiamine, 1 mg + glycine, 50 mg lignin, 5000 mg + 0 4.80 0.02 7.14 4.45 5.44 74.72 87.66 71.95 24.97 21.92 quercetin, 1000 mg 0.15.sup.#* 0.00 0.24 0.15.sup.#* 0.16.sup.#* 1.73 1.64* 2.31 3.09 1.30* *p < 0.05 in relation to the Control group at the same time point (nonparametric Mann-Whitney test), .sup.#p0.05 relative to the value before ethanol administration in the same group (Wilcoxon nonparametric test).

[0098] As shown in Table 2, all the combinations studied have an effect on the ethanol blood level 1 hour after the last administration, and also contribute to a decrease in oxidative stress and lipid peroxidation after the administration of ethanol (1 and 8 hours after the last administration). The studied combinations contributed to a decrease in the MDA level in all groups. The SOD level significantly decreased against the background of introducing ethanol in the control group. However, the enzyme level in the groups receiving the studied combinations was significantly higher than in the control group, which indicates a more active antioxidant defense in the animals' organism. The use of combinations made it possible to achieve a significant decrease in the acetaldehyde levelone of the key inducers of oxidative stress and liver damage while taking ethanol. The most pronounced effect was observed with the introduction of a combination of lignin, 5000 mg+DHM, 1000 mg, when using thiamine and/or glycine as additional components, as well as with the introduction of a combination of lignin, 5000 mg+quercetin, 1000 mg. The results obtained indicate a comparable efficacy of the combinations of lignin, 5000 mg+DHM, 1000 mg and lignin, 5000 mg+quercetin, 1000 mg.

[0099] The beneficial effect of thiamine is associated with its ability to activate various branches of the body's antioxidant system, as well as activate many biochemical processes, thereby contributing to the accelerated elimination of ethanol and its decay products from the body. The beneficial effect of glycine is associated with its ability to interact with gamma-aminobutyric acid receptors in the nervous system, which reduces the central nervous system's sensitivity to the effects of ethanol. In addition, glycine has antihypoxic and antioxidant effects, reduces the hepatocytes and Kupffer cells' sensitivity to the effects of endotoxins, and also reduces their ability to synthesize pro-inflammatory cytokines.

Example 5

[0100] Obtaining finished forms of food additives and food products.

[0101] It should be noted that the above studies on a composition containing lignin, dihydromyricetin or quercetin were carried out using ready-made forms containing auxiliary components, which in turn were used to reduce oxidative stress and the level of oxidative stress inducers in the blood and organs, as well as for the complex maintenance of detoxification function and restoration of the liver.

[0102] Based on the disclosed composition of lignin and dihydromyricetin or quercetin, the invention can be embodied as a biologically active food additive or product for therapeutic and prophylactic dietary nutrition in the form of tablets, for the creation of which auxiliary substances were used from the following range: stabilizers, fillers, anti-caking and binding agents: hemicellulose, guar gum, acacia gum, gum arabic, locust bean gum, starches, including starch esters and modified starches, dextrins, pectins, lecithins, polydextroses, cellulose, including modified celluloses, croscarmellose dihydroxide, polyviniroses, polyviniroses magnesium aluminum silicates, calcium carbonate, lactose monohydrate; leavening agents: povidone and its modifications, starches, including modified, cellulose, including modified; acidity regulators: acetic acid and its salts, ascorbic acid and its salts, citric acid and its salts, lactic acid and its salts, malic acid and its salts, tartaric acid and its salts; glidants: talc, starch, including modified starch, silicon dioxide, macrogol, stearic acid and its salts; dyes: curcumin, anthocyanins, carmine, betanin, capsorubin; sweeteners: aspartame, acesulfame potassium, polyols, stevia components, sucralose, glycyrrhizic acid and its salts; antioxidants: ascorbic acid and its salts, citric acid and its salts, tocopherols, tartaric acid and its salts; preservatives: sorbic acid and its salts, benzoic acid and its salts, acetic acid and its salts, propionic acid and its salts; glazers: wax (beeswax, candle wax, microcrystalline, polyethylene) and shellac. The selected auxiliary substances were used in quantities that ensure their technological properties and characteristics required for the finished form.

[0103] Based on the disclosed composition of lignin and dihydromyricetin or quercetin, the invention can be embodied as a biologically active food additive or food product in the form of a powder, for the creation of which the following auxiliary substances were used: stabilizers, fillers, anticaking agents: hemicellulose, starches, including starch esters and modified starches, dextrins, pectins, lecithins, polydextroses, cellulose, including modified cellulose, croscarmellose, polyvinylpyrrolidone, silicon dioxide, magnesium silicates, calcium carbonate, lactose monohydrate; acidity regulators: acetic acid and its salts, ascorbic acid and its salts, citric acid and its salts, lactic acid and its salts, malic acid and its salts, tartaric acid and its salts, hydrochloric acid, hydrogen peroxide; colorants: curcumin, anthocyanins, carmine, betanin, tannins, capsorubin; sweeteners: aspartame, acesulfame potassium, polyols, stevia components, sucralose, glycyrrhizic acid and its salts; glidants: talc, starch, including modified starch, silicon dioxide, macrogol, stearic acid and its salts; antioxidants: ascorbic acid and its salts, citric acid and its salts, tocopherols, tartaric acid and its salts; preservatives: sorbic acid and its salts, benzoic acid and its salts, acetic acid and its salts, propionic acid and its salts; commercially available flavors. The selected auxiliary substances were used in quantities that ensure their technological properties and characteristics required for the finished form.

[0104] Based on the disclosed composition of lignin and dihydromyricetin or quercetin, the invention can be embodied as a biologically active food supplement or food product in the form of a bar, candy or snack, which was created using auxiliary substances from the following range: fillers (base)puree from fresh or dried fruits and vegetables, fresh or dried fruit and vegetable paste, muesli, corn, rice and cereal flakes, corn, rice and cereal extruded balls, soy protein isolate, milk protein concentrate, sugar syrups, including glucose-fructose syrup, sugar-milk syrup, fruit and berry syrup, animal and vegetable fat; flavors: flavors permitted for use in food, fresh and dried berries, fruits and vegetables, coconut, nuts and seeds, honey, cocoa powder, chocolate, salt, spices, citric acid and its salts; antioxidants: ascorbic acid and its salts, citric acid and its salts, tocopherols, tartaric acid and its salts. The selected auxiliary substances were used in quantities that ensure their technological properties and characteristics required for the finished form.