BG62593B1 - Dietetic food having cardiotonic, vasoconsolidation, antilipemic and tonization effect - Google Patents

Abstract

The dietetic food is used for the prophylaxy of degenerative and ischemic diseases of the cardiovascular system, as well as for a tonic effect in case of heavy organism loads or for recovery after serious diseases. It improves the pumping function of the myocardium, the blood vessels are expanded, vasomotoric effect is attained and the static and dynamic physical endurance is improved. In certain proportions of the food components there is well expressed antilipenic effect and antioxidant properties. In addition, potential effects of the individual components is observed. The high calory content of the dietetic food contains hawthorn extract from 1 to 8%, protein hydrolysate from 0 to 15% and natural bee honey from 77 to 99%. The hauthorn extract should contain no less thn 18% flavonoids, and the hydrolysate can be of caseine, micro see-weeds or be of animal origin. In diabetics or persons having intolerence to bee honey the latter is excluded and the two components remain in the same proportions. 9 claims

Description

The invention relates to dietary foods with cardiotonic, vasoconstrictive, antilipemic and tonic effects, which improves the function of the heart, strengthens the vascular wall, has a generalising effect and at certain doses reduces the risk of degenerative changes in the blood vessels.

Food may be used in a variety of cardiovascular diseases associated with a decrease in myocardial pump function, vascular spasms of the heart and peripheral vessels, or increased vascular permeability. In the presence of all components at certain doses, it can be used in lipid metabolism disorders and in various degenerative diseases of the vessels. The tonic effect of the food makes it appropriate for physical activity or for the recovery of the body in the postoperative period and convalescence.

BACKGROUND OF THE INVENTION

It is known that with advancing age or in some pathological conditions / stress, toxic damage and post-inflammatory and degenerative diseases / the metabolism and energy processes in the cardiovascular system are impaired. As a result, pathological changes in hemodynamics occur, tissue hypoxia occurs, vascular wall permeability increases, and structural changes in tissues occur. These degenerative changes are the main cause of morbidity, disability and mortality in the world. In most cases, the changes are associated with an increase in the concentration of atherogenic plasma lipids that infiltrate the vascular wall with lipoprotein complexes. This results in loss of wall elasticity, narrowing of vessels, increased risk of blood clots and vascular ruptures, and impaired circulation.

The most commonly used means for the prevention and treatment of these cardiovascular disorders are diet and some drug groups.

The following dietary foods are used.

Hypocaloric diet foods. They reduce body weight at the expense of fat - one of the risk factors for the indicated cardiovascular pathology. The disadvantage of these foods is that they reduce the body's energy reserves, and often the enzyme activity, thereby creating conditions for metabolic disorders.

Pectin-based dietetic foods. They reduce the absorption of substances and improve the excretion of toxic products, but do not strengthen the vessel wall and do not improve metabolism in the heart muscle.

Dietetic foods based on dairy products / as well as soy products /. They are easily digestible, but their protein is not well balanced. They do not have vasoconstrictive properties, and their prolonged administration can lead to disruption of enzymes and mediators.

Natural honey. It is a high calorie tonic food, but it has no vasoconstrictive properties. In addition, it has little effect on protein synthesis.

Dietary foods containing biologically active natural products (garlic, celery and others). They affect only certain parts of the pathological mechanism of these lesions and have little effect. In addition, they are not provided with an energy source.

The most commonly used medicines are the following.

Nitrates. They enhance myocardial perfusion and reduce heart function, but they do not have a vasoconstrictor effect and do not affect degenerative processes.

Calcium antagonists. It also improves myocardial perfusion and dilates the arteries. However, for the most part, they inhibit the heart muscle and do not affect the stability of the vascular wall. They have many side effects such as headache, redness, fatigue and others (Fisher, Grotta, Drugs, 1993, 46 (6), 961).

Beta-blockers reduce heart function and ischemic events, but do not affect vascular tone and permeability. They can also suppress the pumping function of the heart.

Vasodilators dilate both the cardiac and peripheral arteries and improve tissue perfusion. However, they do not have a direct effect on the pumping function of the heart and the stability of the vascular wall. They often cause a sharp decrease in blood pressure (Uzunov, P. Medicines Handbook, S. 1994).

Vascular agents (flavonoids or their products) only affect the vascular wall and have no effect on other components of cardiovascular pathology. In addition to flavonoids, hawthorn extract also contains procyanidins and can positively affect the heart's pumping function but has no effect on lipid metabolism. In addition, it does not provide the energy needed for metabolism (Taskov, M. - Acta Physiol.Pharmacol. Bulg., 1977, 3, 4, 53).

All antilipemic preparations (fiber, statins, nicotinic acid derivatives, natural resins) have pronounced antilipemic activity, but some affect only a certain type of dyslipidemia. They have many side effects and affect the permeability of vessels and pumping function of the heart (PEARS, R., Drugs today, 1984, 20, 6, 257).

A biostimulating food (BG 41496) is known based on honey and protein hydrolyzate with a hydrolysis rate exceeding 15%, balanced against the essential amino acids contained therein.

Known for use in the treatment of chronic kidney failure (BG 51068), it contains ultrafiltered, desalinated, water-soluble protein hydrolyzate from fish and honey.

SUMMARY OF THE INVENTION

According to the invention a diet food is created which improves the pumping function of the heart and hemodynamics, strengthens the vascular wall, has a tonic effect on the body and provides easily absorbed energy. At certain component ratios, it reduces the level of atherogenic lipids, thereby antagonizing the degenerative changes in the cardiovascular system and improving circulation.

The dietetic food offered is based on a combination of hawthorn extract up to 8%, protein hydrolyzate of vegetable or animal origin up to 20% and natural bee honey up to 98%. Various variants have been developed in which, due to the specificity of certain diseases or intolerance to some of the components of the composition, one of the ingredients is eliminated, but in any case the food includes at least two of the active components. For example, in diabetics and intolerant to bee honey, the food may be formulated as capsules or tablets containing dry hawthorn extract 0.1-0.3 g and protein hydrolyzate 0.25-1.0 g. There is a possibility where the food contains only hawthorn and bee honey extract, the components being in the following proportions: hawthorn extract from 1 to 8% and bee honey from 92 to 99%.

Hawthorn extract contains at least 18% of flavonoids and procyanidins (both substances that cause the hawthorn to exert its effects on the cardiovascular system). It is obtained by water-alcohol extraction with 40% ethanol on dry leaves and hawthorn. The resulting extract was filtered and air-dried and oven-dried to 70 ° C until solvent was removed.

Protein hydrolyzate of animal origin may be milk, such as casein and blood, meat, fish and mussels. Hydrolysis of vegetable proteins, such as soy, microalgae and others, is also used. It is obtained as follows. Place the protein source in a suitable container and fill with tap water in a ratio of 1: 2.1 to 2.5. Stir well and then 0.05-0.1% calcium hydroxide and 0.2-2% alkaline protease (subtilisin) are added to the suspension. The hydrolysis is carried out at a temperature of 35 to 70 ° C for 90 minutes, after which the suspension is filtered to remove solids and ballast. This is followed by drying of a spray dryer.

Food preparation is as follows. The dosed hawthorn extract is mixed with drinking water on a water mass. The protein hydrolyzate was heated to 70 < 0 > C and mixed with drinking water in a water bath with continuous stirring. The hawthorn and protein hydrolyzate extracts thus treated were combined and the mixture homogenized for 30 to 40 minutes. Bee honey was added to it and the mixture was homogenized again for 30 min. The resulting product was cooled to 30 [deg.] C, then packaged.

The advantages of the food according to the invention are that it improves the functions of the cardiovascular system without impairing the quality of life, widens the blood vessels and enhances the pumping function of the heart, thereby improving tissue perfusion, which leads to a decrease in tissue hypoxia. It also strengthens the cell membranes and reduces the permeability of the vessels, and at certain doses there is a pronounced antilipemic activity superior to that of other diet foods. In contrast to antlipidemic agents, it has hepatoprotective properties.

Another advantage is that it reduces lipid peroxidation and protects the lipid bilayer of membranes from breaking down and provides the body with the necessary readily absorbed energy. It has good taste, is well tolerated and lacks toxic effects at the administered doses, and the food components are water soluble, which facilitates its preparation. The prophylactic and curative effect on lipid abnormalities and the liver is not the result of the summation of the effects of the individual components, because the effect of protein hydrolysates on lipid metabolism is incomparably weaker and hawthorn extract has no such effect. This indicates that the combination of the components results in potentiation of the antilipemic effect.

Examples of carrying out the invention

Example 1. Dietary food containing 2.0 g of hawthorn extract, 15.0 g of protein hydrolyzate from microalgae and the remaining up to 100 g of honey.

The metered hawthorn extract is mixed with drinking water in a water bath and stirred until a homogeneous semi-liquid mixture is obtained. The hydrolyzate was heated to 70 ° C, mixed with water in a water bath with continuous stirring and added to the hawthorn extract. The resulting mixture was placed in a homogenizer for 30 min. Bee honey is added and the mixture is stirred for 30 minutes. The resulting product was cooled to 30 ° C and packaged.

Example 2. Dietary food in the form of tablets (capsules), wherein the composition of one tablet comprises 0.150 g of hawthorn extract, 0.300 g of protein algae hydrolyzate,

0.040 g of vitamin C, 0.005 g of magnesium stearate and 0.010 g of tabletose.

These substances, dosed in kg, pre-sieved through a 1.5 mm mesh sieve, are placed in a mixer.

Mixing takes 25 to 30 minutes. The resulting mixture was transferred into 20 kg polyethylene bags for storage until tableting. Tableting is performed on a tablet machine. The tablets are then evenly film coated with a film mixture and dried to a moisture content of 3.5-4%.

Example 3. Dietary food containing the following components:

hawthorn dry extract 3.00 g protein hydrolyzate from freshwater microalgae 20.0 g honey 77.0 g

Hawthorn extract is mixed with drinking water in a water bath.

The hydrolyzate was heated to 70 ° C and mixed with drinking water in a water bath, stirring continuously until a homogeneous mass was obtained. The latter is homogenized for 30 to 40 minutes, then mixed with honey and hawthorn extract and homogenized for another 30 minutes. The resulting product is cooled to 30 ° C and then ready for packing and consumption.

Example 4. Dietary food containing the following components:

hawthorn dry extract 2.0 g casein protein hydrolyzate 10.0 g honey 88.0 g

The metered hawthorn extract is mixed with drinking water in a water bath and stirred until a homogeneous semi-liquid mass is obtained. Separately, the pre-heated protein hydrolyzate was homogenized in the same manner, after which the two components were mixed and homogenized for 30 min. The homogenate was mixed with the pre-dosed honey and the mixture was homogenized again for 30 min. The homogenate was mixed with the pre-dosed honey and the mixture was homogenized again for 30 min.

Example 5. Dietary food containing the following components:

hawthorn dry extract 2.0 g protein hydrolyzate from fish 8.0 g honey honey 90.0 g

The composition was prepared in the manner described in Example 5, by dissolving the hydrolysis in water heated to 80 ° C.

Example 6. Dietary food containing the following components:

hawthorn dry extract 2.0 g honey bee 98.0 g y

The hawthorn extract is mixed with drinking water in a water bath and stirred until a homogeneous semi-liquid mass is obtained. The latter is fed into a homogenizer where the honey is dosed. The mixture was homogenized for 30 min at 70 ° C. The resulting product was cooled to 30 ° C and then ready for packing.

Example 7. Dietary food containing the following components:

dry hawthorn extract 0,150g protein hydrolyzate / fish / 0,300 g sorbitol 0,100g tabletose 0,050g

The following substances are pre-screened through a 1.5 mm-diameter sieve in a mixer: hawthorn extract 15 kg, hydrolyzate 30 kg, sorbitol 10 kg and tabletose 5 kg. Mixing is carried out for 25 to 30 minutes, after which the homogenized mixture is transferred into plastic bags for storage until tableting.

The tableting was done in a tablet machine, then filtered and dried to a moisture content of 3.5-4%.

Example 8. Effect on hemodynamic parameters of anesthetized cats

Cats of both sexes anesthetized with urethane are used. Following reparation of the two common carotid arteries and the right jugular vein of the polyphysiograph, the following hemodynamic parameters are recorded: heart rate, systological, mean and diastolic blood pressure, mean right atrial pressure, flow of total carotid artery, and electrocardiography. The effect on the indicated values of 5 mg / kg of hawthorn extract administered intravenously is tested.

The results of the experiments show that the heart rate is not affected by the administered dose. At first, blood pressure increased slightly and briefly, followed by a longer (about 30 min) but mild, hypotensive reaction. The flow of the common carotid artery shows an upward trend / table. 1 /. Right atrial pressure and ECN do not change.

Table 1

Effect of 5 mg / kg bw hawthorn extract on hemodynamic parameters of cats in acute trial

No Indicators Output values Change (%) Minute recovery 1. Heartbeat 162 ± 23 -1 / + 1 Mr 2. Arctic pressure 120 ± 16 -6 / + 3 G-20 ' 3. Arctic pressure 82 ± 13 -12 45 ' 4. Medium Right- heart pressure 6 ± 1 0 - 5. Total flow rate carotid 35 ± 10 +11 10 '

Example 9. Effect of extract and hydrolyzate on hemodynamics of anesthetized dogs

Trials were performed on 6 thiopental-ancestry dogs anesthetized, which tested the action of both components. The effect of a combination of 3 mg / kg hawthorn extract and 12 mg / kg hydrolyzate on the following indicators is considered: heart rate, systolic, middle and diastolic blood pressure, systolic and end diastolic left ventricular pressure, average right ventricle pressure and total carotid artery flow rate . Pressure transducers are used for this purpose

Statham P ^ D and Statham SP ₂₂₀₂ electro-flowmeter with suitable flow tests. After recording the baseline data of the indicated indicators on the Biomedica PF _Mb polyphysiograph, the intravenously tested combination is administered. 5 In 5 minutes the values of the indicators are recorded and the changes in percentages relative to the baseline values are calculated.

All experimental data were statistically processed using the Student-Fisher t-curve.

The results of hemodynamic studies are presented in Table. 2, which shows that the composition does not significantly change the heart rate. Systolic blood pressure is reduced by 14% and diastolic blood pressure by 21%. The effect is short-lived and after 15 minutes it is exhausted. Low and extreme diastolic left ventricular pressure decrease. It is noteworthy that the systolic left ventricular pressure not only does not decrease, but exhibits an upward trend due to improvements in the inotropic function of the myocardium. This result, combined with an increase in total carotid artery flow, minute heart volume, and left ventricular function, indicates that myocardial pumping function is enhanced by the combination. In this case, no abnormal changes in the electrocardiographic picture were detected in the administered dose. the composition does not cause cardiotoxic changes. These data together with the decrease in total vascular resistance indicate that the hemodynamics are improved under the influence of the administered dose.

Table 2

Influence on hemodynamic parameters in acute treatment of anesthetized dogs

No Indicators Output values Change (%) Recovery (min) 1. Heart rate / heart rate/ 146 -6 5 2. Systemic blood pressure / mm Hg / 125 -14 30 3. Diastatic blood pressure / mm Hz / 88 -21 45 4. Left ventricular system pressure / mm Hz / 144 +11 50 5. Extremely diast. Left. pressure / mm Hz / 8 -20 30 6. Average right ventricular pressure / mm Hz / 35 -5 10 7. Flow of common carotid artery / ml / min / 52 +12 30 8. Minute blood volume / ml / min / 2240 +19 30 9. Left camera operation / kg / min / m ² / 14,25 +18 15 10. Total vessel resistance / mm Hz / 1 / s / 35654 -10 10

Example 10. Effect on peritoneal permeability of rats

The experiments were performed on 4 groups of 10 male rats using the Teotino method (1963). For 4 groups of 10 rats, 1 ml of 3.8% formalin solution was administered intraperitoneally. In the three test groups, one hour before formalin was administered orally with a probe respectively: hawthorn extract 100 mg / kg bw, protein hydrolyzate 400 mg / kg

ie and diet food containing the two components dissolved in bee honey 500 mg / kg. After 4 h the animals were killed, the abdominal wall was dissected and the amount of peritoneal fluid was measured. The results of the experimental groups are compared with the control group.

From the table. 3 shows that hawthorn extract reduces the amount of peritoneal fluid by about 31% (statistically significant at P <0.05), while the hydrolysis effect is twice as low. The most pronounced is the effect of the food (the agent) - a decrease5 of the amount of the liquid is by 62% and has the highest degree of statistical reliability / P <0,001 /. This result indicates that there are potentiating effects.

Table 3

Impact on peritoneal permeability / by Teotino / / means ± standard deviations /

No The group Number of rats Dose / mg / kg / Peritoneal fluid / ml / Change /% / 1. Control untreated 10 4.8 ± 1.1 2. Experimental extract 10 100 2.9 ± 1.2 -30.7 3. Test hydrolyzate 10 400 4.1 ± 1.5 -15.0 3. Means 10 500 1.8 ± 0.6 ' -62.5

statistical significance for: “- p <0.05, * - p <0.001

Example 11. Effect on capillary permeability of white rats

The experiments were carried out on 40 male Wistar rats weighing 200 to 220 g, divided into 4 groups of 10. After pre-depilation, testing was done using the Borbelli method in Gachnan's modification (1962).

Vacuum installation templates are used. The evacuation was carried out for 2 min at -0.5 atm. pressure. Only animals that showed at least five petechial haemorrhages in 7 fields were included in the experiment. After 24 h, a second test was performed, dividing the animals into the following groups: control (evacuation only) and 3 experimental treated with hawthorn 100 mg / kg bw, hydrolyzate 400 mg / kg bw, and treated a food group containing the indicated amounts of the two components. Substances were administered 2 h before testing.

As can be seen from the table. 4 is the highest number of capillary hemorrhages in the control group. Hawthorn extract reduces capillary permeability and reduces the number of bleeding by 33%, while the action of hydrolyzate is low. Particularly is the reduction in permeability from food, in which the number of bleeding is reduced by 52%, ie. much more than the sum of the two components combined.

Table 4

Effect on capillary permeability of white rats

No. Substance Number of petechin Change /% / before the substance after the substance 1. Control 9,1 9,4 - 2. Hawthorn extract 9.5 6,3 33 3. Hydrolyzate 8.9 8.0 10 4. Means 9,8 4.6 * 52

* - statistical significance at p <0.05

Note:% calculations were made against the results of the second control group test.

Example 12. Impact on the physical endurance of white rats

The experiments were performed on 5 groups of 10 male rats, breed Wistar, weighing 180 to 200 g. The first group is a control roll, to which 1 ml / 100 g bw is administered 6 days a week. saline. The other groups are experimental and are administered orally, respectively: hawthorn extract 100 mg / kg bw, honey 1 g / 100 g bw, protein hydrochloride 400 mg / kg bw. and diet food containing the components at the indicated doses. Concurrent with the treatment, a physical stamina training is performed daily / Taskov, M.Sb. Tr. NIHFI, 1984 /. Experiment 15 lasted for 4 weeks, taking into account the following indicators: static physical endurance / time in s spent on a wooden stick above the electrified floor /, dynamic physical endurance / number of sub-20 wheels during the experiment and bounce strength / and resistance to stress / the duration of the experiment to obtain a seizure in s /. Animals with approximately the same baseline data were selected and 25 compared to baseline data.

The results of the experiments performed are different in Table. 5, showing that, at the end of the experiment, the values of the physiological parameters studied differ sharply from the baseline. In the experimental group treated with hawthorn, static physical endurance increased by 11% compared to the control group, and for the other experimental groups the changes were as follows: in the honey treated group, static endurance increased by 15%, in protein hydrolyzate the increase in the value of this indicator is about 20%, and for food - about 48%. Statistical significance was observed only in the diet-treated group, indicating that effects were potentiating. In the same way, the dynamic endurance changes, which increases in the group treated with food by about 100%. The weakest is the stimulating effect of hawthorn extract. Resistance to irritation with electricity increases less. Of these, the increase was most pronounced in the protein hydrolyzate group (14%). Statistically significant increase in this value was only in the dietary food group (64%).

Table 5

Effect on the physical endurance of rats at one month treatment - comparative study

#Group Indicators Static withstood. (S) Dynamic endurance (number) Resistance to stress (s) Before After 1 m Before After 1 m Before After 1 m 1. Controlled 432 ± 85 585 ± 96 62 ± 18 84 ± 23 654 ± 103 858 ± 134 2. Experimental extract 422 ± 95 644 ± 142 68 ± 21 96 ± 30 635 ± 126 905 ± 140 3. Test honey 398 ± 78 662 ± 108 58 ± 16 104 ± 20 650 ± 110 944 ± 168 4. Pilot test. hydrolyzate 440 ± 80 695 ± 122x 64 ± 20 124 ± 32x 616 ± 135 979 ± 156 5. Means 428 ± 96 868 ± 144 * 66 ± 22 168 ± 43 ** 642 ± 134 1404 ± 185 *

statistical significance: at x - p <0.05; * - p <0.01; ♦ * - p <0.001

Example 13. Effect on a Triton-Induced Model of Hyperlipoproteinemia in Rats

4 groups of male Wistar rats were used. Three of the groups were treated for 7 days with Triton - 300 mg / kg bw, subcutaneously. The fourth group is control and treated with saline. After day eight, two of the Triton-treated groups received 500 mg / kg of the combination and 100 mg / kg, respectively. fenofibrate. The experiment continued until day 15, when the three Triton-treated groups were killed by decapitation and blood was collected in dry tubes. After 1 h the blood was centrifuged at 2000 rpm and the secreted serum was stored in a minus cooler until testing. The values of the following lipid indices are determined in serum-5 strains: total cholesterol, cholesterol and high, low and very low density lipoproteins (HDL, LDL and LDL), triglycerides, total fat, β-lipoproteins and acetylcholinesterase. In addition, gains and weights of the following parenchymal organs are determined: spleen, kidney, adrenal glands, heart and testes. The size of adipocytes in imic is also determined.

From the table. 6 shows that the values of the investigated lipid parameters under the influence of Triton increase many times: total cholesterol is increased 7 times, triglycerides - 25 times and total fats 9 times. The serum of animals in this group is a kind of dessert milk, which makes it impossible to separate the two lipoprotein fractions (LDL and HDL). In the two experimental groups, to which, in addition to Triton, one of the test substances is administered, the serum is clear and clear, and the values of the lipid parameters are reduced many times over. No significant differences were observed in the effect of the two test substances.

The results of studies show that food has a pronounced prophylactic effect in a model of Triton-induced hyperlipidemia.

Pathohistological examinations of parenchymatous organs show that in the experimental animals there are less ultrastructural changes in the mitochondria, especially in the 10 zozomes, compared to controls treated with Triton alone. In addition, lipid deposition in the liver was decreased in experimental animals and glycogen levels were retained, unlike the Triton controls, in which 15 there was a decrease in glycogen.

A significant advantage in experimental food-treated animals is that the rate of lipid peroxidation in the liver is slowed down and the level of malone dialdehyde dehydrate is reduced. Compared to fenofibre, the action of the composition is more pronounced, i. it has an auxiliary antioxidant effect, which is of great importance in the prevention and treatment of many processes: tissue hypoxia, chronic inflammatory and degenerative processes, malignant neoplasms and others.

In the experimental animals, the change in the weights of the test organs is also smaller.

Table 6

Comparative study of the therapeutic effect of the agent in a model of hypertipoproteinemia in rats induced with Triton

No. Indicators Control Experienced untreated -Ngriton newt + remedy Triton + fenofibrate 1. Cholesterol (mmol / 1) 1.49 ± 0.49 12.72 ± 1.87 1.79 ± 0.30 2.04 ± 0.24 2. Hall-HDL (mmol / 1) 1.03 ± 0.20 - 1.30 ± 0.24 1.35 ± 0.18 3. Triglycerol (mmol / 1) 1.24 ± 0.90 16.43 ± 3.2 0.50 ± 0.08 0.67 ± 0.28 4. Common grease (g / 1) 3.36 ± 0.54 32.73 ± 8.73 2.80 ± 0.88 2.48 ± 0.44 5. Beta-lipoprote. (g / l) 0.60 ± 0.32 0.71 ± 0.30 0.41 ± 0.11 0.36 ± 0.05 6. Acetylcholines- terrace (mmol / 1) 9.23 ± 3.99 12.67 ± 5.47 9.22 ± 3.86 8.43 ± 2.25 7. Adipocytes (t) 9.16 ± 1.21 20.60 ± 0.39 11.60 ± 2.74 17.60 ± 2.70 8. Gain (g) 60.0 ± 15.8 22.00 ± 18.9 52.00 ± 23.6 43.00 ± 21.7 9. Spleen (g) 1.13 ± 0.22 0.80 ± 0.17 1.08 ± 0.15 1.17 ± 0.29 10. Kidney (g) 1.33 ± 0.20 0.78 ± 0.12 1.15 ± 0.13 1.05 ± 0.05 11. Adrenal glands (g) 0.063 ± 0.03 0.033 ± 0.02 0.049 ± 0.01 0.063 ± 0.01 12. Heart (g) 0.66 ± 0.07 0.28 ± 0.05 1.59 ± 0.12 0.26 ± 0.08 13.Testis (g) 2.11 ± 0.48 1.35 ± 0.40 1.59 ± 0.12 1.94 ± 0.35

Example 14. Toxicological studies

A. Acute toxicity of hawthorn extract and combination is studied. The experiments were performed on white mice and rats. The test substances are administered orally once, observing the general condition and behavior of the animals. Group mortality was reported within 2 weeks of application.

Tests have shown that at a dose of 2 g / kg bw. the extract does not cause toxic changes and mortality in the treated animals. This result puts him in the low-toxicity group.

The composition of the extract and hydrolyzate in the given ratios, administered at doses up to 2 g / kg, also did not cause mortality. This indicates that, according to Hodg and Sterner's classification, the composition is classified as a low-toxic substance.

B. Subacute / one-month / toxicity of hawthorn extract

At a dose of 1 g / kg bw, administered orally daily to rats for 1 month, the extract did not induce toxic changes in the main clinical laboratory parameters and in the parenchymal organs of the animals tested.

The above examples show that dietary food in both variants has a pronounced effect, improving the pumping function of the myocardium, reducing the permeability of vessels and strengthening the vascular wall. With the addition of 10% protein hydrolyzate, these effects are exacerbated, and new effects such as pronounced antilipemic action and antioxidant properties are also emerging. There is also a potentiation of some of the effects observed in the individual components, such as potentiation of membrane and vasoconstrictor action, tonic action and myocardial pump function. Apart from the already mentioned cardiovascular diseases / ischemic heart disease, chronic inflammatory and degenerative diseases of the myocardium and vessels, etc. "Elderly heart" and others / food can be used to restore the body after severe physical and mental stress, in the postoperative period and in convalescent patients. It is especially suitable for chronic hepatitis due to its established antioxidant properties. The use of active therapeutic factors of natural origin as food not only avoids the psycho-barrier inherent in the use of medicines, especially synthetic origin, but also reduces the risk of toxic effects in prolonged courses of administration. In addition, food can be taken from an early age, which makes it a promising prophylactic for these diseases.

Application of the invention

Foods prepared with honey are administered in a daily dose of 30 to 60 g, divided into 1 to 4 intakes depending on age, body weight and needs of the body. In the form of capsules or tablets (without honey), it can be taken orally daily at a dose of 2-3 times up to 2-3 single doses (tablets). Dietary foods can be used for a long time (months and years) without the risk of cumulation. It can also be used by children over 1 year of age if necessary to strengthen the blood vessels and to tone them after various toxic infectious diseases. In adults, food is suitable for chronic myocarditis and myocardiopathy, chronic inflammatory and degenerative diseases of the vessels, ischemic heart disease, various forms of dyslipidemia, arteritis, thrombophlebitis and other disorders of the vascular wall. Food improves the efficiency of the cardiovascular system and has a pronounced tonic effect. It is especially suitable for people who are under heavy physical and mental stress and so on. "Old man's heart".

Claims

Claims (9)

1. Dietetic food with cardiotonic, vasoconstrictive, antilipemic and tonic action based on protein hydrolyzate and bee honey, characterized in that it also contains hawthorn extract from 1 to 8%, in which case protein hydrolyzate is up to 20%, and in this case natural honey is up to 99%. Diet food according to claim 1, characterized in that it contains from 1 to 8% hawthorn extract, from 5 to 20% protein 10 hydrolyzate and from 77 to 99% natural bee honey. Diet food according to claim 1, characterized in that it is in the form of tablets or capsules containing 5 dry hawthorn extract 0.1-0.3 g and protein hydrolyzate 0.25-1.0 g. 4. Diet food according to claim 1, characterized in that it contains dry hawthorn extract from 1 to 8% and honey from 92 to 99%. 5. Dietetic food according to claims 1 to 4, characterized in that the hawthorn extract contains at least 18% flavonoids. 6. Dietetic food according to claims 1 to 4, characterized in that the protein hydrolyzate is of animal or vegetable origin. Diet food according to claim 6, characterized in that the protein hydrolyzate is hydrolyzed casein. Dietary food according to claim 10 6, characterized in that the protein hydrolyzate is from meat, blood, fish or mussels. Diet food according to claim 6, characterized in that the protein hydrolyzate is from soy or microalgae. Expert: M. Mineva Publication of the Patent Office of the Republic of Bulgaria 1113 Sofia, 52-B Dr. GM Dimitrov Blvd. Editor: N. Bozhinova Cf. № 4000 Circulation: 40 MB