Method of prevention and treatment of diseases associated with vitamin a deficiency

 

(57) Abstract:

The invention relates to medicine. A method for prevention and treatment of diseases associated with vitamin a deficiency, including oral administration of dietary supplements that contain beta-carotene, not less than 2% in the amount of from 0.01 to 0.03 ml/kg body weight, in combination with the antioxidants of the type alpha tocopherolacetate and zinc ascorbate in an amount not less than 1.9% of its mass. The method allows to increase the bioavailability of biologically active additives, so you can use it once a day. table 4.

The invention relates to the field of medicine and veterinary medicine and can be used to improve the immune status and treatment of diseases associated with vitamin a deficiency by filling up biologically necessary standards.

Vitamin a is a multifunctional and essential for the proper functioning of the eyes, skin and mucous membranes. Known methods to improve the immune status based on supplementing the body, either by making pure substance is vitamin a, or use it in combination with other vitamins in the form preparations for oral administration (trivet, tetravit is, in the preventive purposes) to overdose, and signs of toxicosis in the form of embryotoxicity (Patent 20767704, 10.04.97).

Promising was the tendency of supplementation of vitamin a due to the ingestion of beta-carotene, which is converted in the body into vitamin a in the following way: first, micronisation and emulsification in the gastrointestinal tract, then the absorption in the small intestine, partial bioconversion of beta-carotene into retinol, transport of beta-carotene through the lymphatic system and the portal vein to the liver and then into the blood and distribution in organs and tissues (Shashkin b.p. and others, Institute of experimental diagnostics and therapy of tumors cancer center. N. N. Blokhin, M., 2000). In addition to the specified carotene has the ability to capture free radicals, protect cells and tissues from their harmful effects, showing immunomodulatory properties, and its absorption depends on the level of vitamin a in the blood that allows him to avoid overdose.

To prevent beriberi is used as artificial biologically active substances and carotenodermia products. So there is a method of prevention of immunodeficiency, including reception caroteniod the meals of small portions of not less than 0.4 l per day for at least 21 days (Patent 2053786, 10.02.96).

The disadvantage of this method is its focus only on prevention, the complexity of the preservation of carotene in the juice, seasonality and, most importantly, the low bioavailability of beta-carotenoids from juices and vegetables (especially raw), explained by the presence of carotenoids in the complex with the protein.

These drawbacks are eliminated by way of the use of biologically active additives "Between", which is a water-soluble form of beta-carotene food authorized for use in the medical industry (prototype). 1 g of the preparation contains 2% beta-carotene, 0.5% of alpha tocopherolacetate and 0.25% ascorbic acid, which is the active natural antioxidants, normalizing the redox processes in the body. Between appointed as oral nutritional supplements to enhance the body's resistance to adverse environmental influences, for the correction of immunodeficiency States, improve visual acuity, for the prevention of cataracts, cardiovascular, infectious and oncological diseases. The daily requirement of beta-carotene for healthy person 0,005 - 0,006, environmental Degradation and social conditions of the ZMA substances, as vitamins, micro - and macronutrients that expanded the boundaries of risk, and this leads to the need to increase the daily amount of beta-carotene in 5-10 times.

In the preventive purposes of betafite appoint 2-5 drops, which is 0.1-0.5 ml, orally 2-3 times a day for 30 days. (Guidance on the application of "Between - beta-carotene water-soluble food. Approved technical Director belvitamini" A. I. Kirsanov 1998 , agreed the chief state sanitary doctor of MCI - 24 Federal health-biological and experimental problems in the Ministry R. F. C., Lyamin, 1998).

Oral route of administration of the drug chosen due to the fact that the conversion of beta-korotina in vitamin a occurs in the wall of the small intestine. Introduction beta-korotina together with vitamin E contributes to a more economical consumption of the latter, while their joint participation in the protection of membranes from oxidized damage.

The disadvantage of the drug is reducing its effectiveness in the lack of body zinc. Ion zinc is a power function of vitamin a, because the transport of vitamin a through the intestinal mucosa occurs through cincstrike bioavailability and effectiveness of the drug.

The objective of the invention is to develop a method for the prevention and treatment of diseases associated with lack of vitamin a in the conditions of zinc deficiency.

Technical results that may be obtained by using the proposed method are:

-increased bioavailability;

-improving the immune status of the body;

-correction of immune disorders.

The solution of the above problem and achieve the above results became possible due to the fact that in the known method of prevention and treatment of diseases associated with vitamin a deficiency, comprising oral administration of an additive in a pharmacologically acceptable carrier in an amount of 0.01 and 0.03 ml/kg body weight, which represents the beta-carotene in the amount of not less than 2% in combination with the antioxidants of the type alpha tocopherolacetate and ascorbate-insideradio connection, alternating courses, including the cottage of the drug for at least 10 days, followed by breaks, oral administration of biologically active additives is carried out every day; as the ascorbate-insideradio compounds in the composition of the additive is injected ascorbate zinc in an amount not less than 1.9% of the accounts for the full absorption of vitamin a in the body mode, close to the natural processes that allows you to fully compensate for the vitamin a deficiency and prevent its occurrence or to facilitate treatment of diseases associated with the deficit at a significantly reduced dose compared to the prototype.

The use of the proposed combination of essential features is not known in the prior art. Creative step is to achieve positive dynamics of the process of absorption of vitamin a due to the correction of metabolic disorders and drug use in the required dose by ensuring conditions of high bioavailability of the carotenoid ideally, expressed as the ratio of the amount absorbed by the body, which gives a biological or pharmacological response to standard dose. The method allows to achieve remission of the disease faster in comparison with treatment of the prototype, the drug is more efficient in cases of zinc deficiency and manifests in the inventive combination is such a valuable specific properties as photoprotection, antioxidant, anti-stress, increased immunocompetence, and promotes conservation of antioxidant vitamins.

The method is simple to execute and Moresque the method proves examples of specific performance, the results of which, for clarity, are summarized in four tables on the principle: control group - the way the prototype (ascorbate-instalada additive in the form of ascorbic acid in the "Between") - the inventive method similar to the experimental group (ascorbate-instalada additive in the form of zinc ascorbate in the "Betulinol")

Control experiments without adding in the process of feeding carotenodermia drug taken for clarity, the values of positive dynamics of the absorption of vitamin A. as a feed in the examples used food from areas with low levels of zinc (of 0.878-1,093 mg/kg soil). Grown in regions such grains are also deficient in this essential trace element that causes disturbances in metabolism, reducing the resistance of the organism of animals. The flow of feed of many micronutrients provides only 30-70% of the demand of the body.

The bioavailability of the drug was determined by the concentration of vitamin a in the serum.

Example 1

Form a control group of laying hens, thus take into account gender, age, breed, body weight, conditions of feeding and housing. A group of 3,000 birds at the age of 210 days. 30 days (ensenaste of oviposition during the period of experiment, % - 60,1

The average weight of the eggs in the beginning of the experiment, g - 55,80,7

The average weight of the eggs at the end of the experience, Mr. 59,50,9

Blood levels of vitamin a, g/ml 0,350,03

Indicators of natural resistance was:

Bactericidal activity of blood serum, % - 21,850,51

The authors estimated the effect activity of blood serum, % - 13,180,55

Phagocytic activity of pseudosinella, % - 36,022,49

Example 2

In example 1 to form a pilot group of laying hens. Once a day the bird in the drinking water, add between (prototype) at the rate of 30 ml per 1000 head of cattle (of 0.015 ml/kg). The amount of ascorbic acid in the product is 0.25%. Between feeding for 10 days, then do a ten-day break and re-feeding for 10 days.

30 days (monitor period) indicators of the experimental group the following:

Livestock safety, % - 96,9

The intensity of oviposition during the period of experiment, % - 61,72

The average weight of the eggs in the beginning of the experiment, g - 55,70,6

The average weight of the eggs at the end of the experience, Mr. 59,70,7

Blood levels of vitamin a, g/ml 0,370,02

Indicators of natural resistance was:

Bactericidal activity of blood serum, % - 44,764,54

The authors estimated the effect activity of serum shelter the experience in this group increased compared with the control 1.62%, as blood levels of vitamin a - 5.7%.

Example 3

In example 1 to form a pilot group of laying hens. Once a day the bird in the drinking water, add Bettina at the rate of 30 ml per 1000 head of cattle (of 0.015 ml/kg). The number of ascorbate zinc drug is 1.9%, which corresponds to the minimum present value. Bettina feeding the bird in example 2.

30 days (monitor period) indicators of the experimental group the following:

Livestock safety, % - 97,0

The intensity of oviposition during the period of experiment, % - 64,98

The average weight of the eggs in the beginning of the experiment, g - 55,60,7

The average weight of the eggs at the end of the experience, Mr. 60,30,6

Blood levels of vitamin a, g/ml 0,440,02

Indicators of natural resistance was:

Bactericidal activity of blood serum, % - 51,25,71

The authors estimated the effect activity of blood serum, % - 23,413,40

Phagocytic activity of pseudosinella, % - 50,834,08

The intensity of oviposition during the period of experience in this group increased compared with the control 4,88%, as compared with the prototype by 3.26% with a minimum content of ascorbate zinc in the product. The content of vitamin a in the serum increased in comparison with the control and prototype by 25.7% and 18.9% with the.

Observation of the animals was performed during 30 days. Indicators of microclimate throughout the monitored period were within the established norms. In the beginning of the experiment, 85% of newborn calves marked with simple dyspepsia, accompanied by indigestion no significant changes in the General condition of the animals. By the end of the reporting period, the clinical condition of the calves did not change.

Indicators of safety, productivity, and natural resistance calves of the control group were:

Safety, % - 100

The live weight of calves at the beginning of the experience, kg - 39,80,59

The live weight of calves at the end of the experience, kg - 53,91,60

Average daily gain, g - 486,236,8

Costs f.u 1 g increase to 6.5

Blood levels of vitamin a, g/ml 2,550,07

Indicators of natural resistance:

Bactericidal activity, % - 17,951,06

Phagocytic activity, % - 42,001,81

The authors estimated the effect activity, % - 4,71,31

Example 5

Form a group of calves in example 4. The animal is feeding between the prototype with his mother's milk two ten-day cycles with an interval of 10 days. The amount of ascorbic acid in the preparation of 0.25%.

Conditions experienced rootmenuitem standards.

In the beginning of the experiment, 85% of newborn calves marked with simple dyspepsia, accompanied by indigestion no significant changes in the General condition of the animals. At the end of the monitored period, the phenomenon of dyspepsia decreased by 50%.

At the end of the experiment the results of the prototype were:

Safety, % - 100

The live weight of calves at the beginning of the experience, kg - 40,50,36

The live weight of calves at the end of the experience, kg - 55,01,38

Average daily gain, g - 500,440,4

Costs f.u 1 g increase of 6.3

Blood levels of vitamin a, g/ml 2,610,02

Indicators of natural resistance:

Bactericidal activity, % - 30,951,11

Phagocytic activity, % - 63,332,20

The authors estimated the effect activity, % - 6,371,45

Example 6

Form a group according to example 4. Calves give Bettina by the present method at a dose of 1 ml/bird. (of 0.03 ml/kg). The number of ascorbate zinc in the preparation of 1.4%, which corresponds to its extremely high minimum value. The drug is feeding with milk two ten-day cycles. Conditions of experimental animals similar to example 4.

In the beginning of the experiment, 85% of newborn calves marked with simple dyspepsia, accompanied by digestive disorders without significant avanyu control and was 5% lower compared to the prototype. At the end of the reporting period the performance of the group by the present method with the lowest exorbitant amount of ascorbate-insideradio component in Bettinelli was:

Safety, % - 100

The live weight of calves at the beginning of the experience, kg - 40,20,36

The live weight of calves at the end of the experience, kg - 55,11,22

Average daily gain, g - 500,539,3

Costs f.u 1 g increase to 6.2

Blood levels of vitamin a, g/ml 2,6180,02

Indicators of natural resistance:

Bactericidal activity, % - 31,351,10

Phagocytic activity, % - 63,222,10

The authors estimated the effect activity, % - 8,311,34

Example 7

Form a group according to example 4. Calves give Bettina by the present method at a dose of 1 ml/bird. (of 0.03 ml/kg). The number of ascorbate zinc in the preparation of 1.9%, which corresponds to the minimum present value ascorbate-insideradio component. The drug is feeding with milk two ten-day cycles, the interval between which is 10 days. Conditions of experimental animals similar to example 4.

In the beginning of the experiment, 85% of newborn calves marked with simple dyspepsia, accompanied by indigestion no significant changes in the General condition of the animals. At the end of controlpro fewer ascorbate-insideradio connection. At the end of the reporting period the performance of the group by the present method with the minimum limit number of ascorbate-insideradio component in Bettinelli was:

Safety, % - 100

The live weight of calves at the beginning of the experience, kg - 40,80,62

The live weight of calves at the end of the experience, kg - 55,91,72

Average daily gain, g - 520,742,2

Costs f.u 1 g gain - 6,0

Blood levels of vitamin a, g/ml 2,840,08

Indicators of natural resistance:

Bactericidal activity, % - 36,730,41

Phagocytic activity, % - 63,671,18

The authors estimated the effect activity, % - 9,871,32

Example 8

Form a group according to example 4. Calves give Bettina by the present method at a dose of 1 ml/bird. (of 0.03 ml/kg). The number of ascorbate zinc in the preparation of 2.5%, which corresponds to a value exceeding the lower the minimum claimed. The drug is feeding with milk two ten-day cycles with desyatietazhny break. Conditions of experimental animals similar to example 4.

In the beginning of the experiment, 85% of newborn calves marked with simple dyspepsia, accompanied by indigestion no significant changes in the General condition of the animals. At the end of the monitored period, the phenomenon of dyspepsia soderzhaschego connection. At the end of the reporting period the performance of the group by the present method with a high content of zinc ascorbate in Bettinelli was:

Safety, % - 100

The live weight of calves at the beginning of the experience, kg - 41,30,61

The live weight of calves at the end of the experience, kg - 56,011,42

Average daily gain, g - 522,641,3

Costs f.u 1 g gain - 6,0

Blood levels of vitamin a, g/ml 2,840,08

Indicators of natural resistance:

Bactericidal activity, % - 37,830,31

Phagocytic activity, % - 65,541,19

The authors estimated the effect activity, % - 9,951,42

Example 9

Form a control group of sows Estonian bacon breed 16 goals with regard to age, body weight and physiological state of animals. Sows receive feed from the calculation of 32 kg/bird per day. Observation of the animals is carried out for two months: unmarried, pregnant and lactating periods.

The parameters of the control group were:

Inseminated sows - 16

He oporosis, heads - 9

Fertility, % - 56,3

Born piglets in the group goal. - 87

The safety of the young, % - 72,4

Number of patients (hypotrophic) piglets to weaning period, % - 12,6

Increase 1 hoeru 9 form a group - analogues of sows Estonian bacon rocks. Animals used between at the rate of 0.01 ml/kg body weight (1.5 ml on goal.) in day. The content of ascorbic acid in the preparation of 2.5%. Between give wet mechancal desyatiletnimi cycles with intervals of 8-10 days for two months.

Accounting is carried out in a single, pregnant and lactating periods. The performance of the experimental group was:

Inseminated sows - 16

He oporosis, heads - 11

Fertility, % - 68,8

Born piglets in the group goal. - 116

The safety of the young, % - 74,1

Number of patients (hypotrophic) piglets to weaning period, % - 6,9

Increase 1 head during lactation, kg - 5,06

Blood levels of vitamin a, g/ml 0,660,02

The number of sick piglets to weaning period decreased by 5.7% compared with the control, and the increase of 1 head per lactation increased by 4.5%.

Example 11

In example 9 form a group - analogues of sows Estonian bacon rocks. Animals used Bettina at the rate of 0.01 ml/kg body weight (1.5 ml on goal. ) a day. The content of ascorbate zinc drug is 2.2%. Bettina used in example 10.

Records re the s was:

Inseminated sows - 16

He oporosis, heads - 14

Fertility, % - 87,5

Born piglets in the group goal. - 133

The safety of the young, % - 80,0

Number of patients (hypotrophic) piglets to weaning period, % - 2,8

Increase 1 head during lactation, kg - 6,12

Blood levels of vitamin a, g/ml 0,910,05

The number of sick piglets to weaning period decreased by 4.1% compared to the prototype, and gains 1 head per lactation was higher by 20.9% compared with the prototype and 26.4% compared to control.

Example 12

Form a control group of piglets at weaning, four months of age number 17 goals. Animals matched with regard to age, body weight, sex and physiological state. The basic diet is animal feed, milk and milk products.

Observation of the animals is carried out in two months.

After monitoring the performance of the control group were:

Blood levels of vitamin a, g/ml 0,550,021

Indicators of natural resistance, %:

Bactericidal activity of serum - 31,121,88

The authors estimated the effect activity of blood serum - 10,211,11

Phagocytic aktivnog">

Animals give the basic diet is based 1.2 kg of feed, 0.2 kg whole milk and 1 litre of skim milk per head per day.

Pigs plus oral use between (prototype) desyatiletnimi cycles with intervals of 8-10 days for two months at a dose of 0.01 ml/kg. Content of ascorbic acid in the product of 0.25%.

After two months (controlled period) indicators of this group was:

Blood levels of vitamin a, g/ml 0,670,011

Indicators of natural resistance, %:

Bactericidal activity of serum - 50,431,69

The authors estimated the effect activity of blood serum - 18,611,43

Phagocytic activity of leukocytes - 41,981,89

After 2 months of daily growth exceeded the control by 10.9%.

Example 14

Form a similar group of piglets at weaning in example 12.

Animals give the basic diet is based 1.2 kg of feed, 0.2 kg whole milk and 1 litre of skim milk per head per day.

Pigs plus oral use Bettina (the inventive method) desyatiletnimi cycles with intervals of 8-10 days for two months at a dose of 0.01 ml/kg Content of ascorbate zinc in the preparation of 2.5%, which exceeds minimalvery:

Blood levels of vitamin a, g/ml 0,910,011

Indicators of natural resistance, %:

Bactericidal activity of serum - 57,021,19

The authors estimated the effect activity of blood serum - 17,2411,49

Phagocytic activity of leukocytes - 50,772,01

After two months, the average increase has exceeded the control by 13.9%, and in comparison with the prototype (with equal content of ascorbate-insideradio connection in the prototype and the preparation by the present method) average daily gain was higher by 2.6%.

Example 15

Form experienced group of piglets at weaning in example 12.

Animals give the basic diet is based 1.2 kg of feed, 0.2 kg whole milk and 1 litre of skim milk per head per day.

Pigs plus oral use Bettina (the inventive method) desyatiletnimi cycles with intervals of 8-10 days for two months at a dose of 0.01 ml/kg Content of ascorbate zinc in the preparation of 1.9%.

After two months (controlled period) indicators of this group was:

Blood levels of vitamin a, g/ml 0,820,021

Indicators of natural resistance, %:

Bactericidal activity of serum - 56,221,24

The authors estimated the effect activity of the th growth exceeded the control by 12.4%, but in comparison with the prototype (with less content of ascorbate-insideradio connection) average daily gain was higher by 1.3%.

As can be seen from the presented examples, the use of the proposed method for the prevention and treatment of diseases associated with vitamin a deficiency, using as ascorbate-insideradio connection ascorbate zinc in a complex with beta-carotene and alpha-tocopherolacetate in the inventive mode with a slight zinc deficiency in feed, allowed us to obtain a significant increase compared with the prototype, even if the amount of ascorbate-insideradio component is less than in the prototype.

Examples 7 and 8 show the feasibility and the high efficiency of the proposed method in the treatment of dyspepsia in calves, as the primary presence in 85% of the animals of dyspepsia after application of the drug phenomenon of dyspepsia in the group decreased compared with control at 65%, with the prototype by 15% (example 7).

The positive effect of the introduced ascorbate-insideradio compounds in the additive "Bettina" on the physiological condition of the calves contributes to a more optimal feed conversion kg growth and re-weighing operations calves.

Example 8 shows that when the content of ascorbate zinc in the product in quantities of 2.5%, which corresponds to a value higher than the minimum of the proposed limit of 0.6%, the productivity of calves is approximately in the same range, when its content in Bettinelli amounts to 1.9%, in this regard, it is irrational to overstate the value of the ascorbate-insideradio connections in the proposed method, which has a positive effect on the economic side of the proposed method.

Similarly, it should be noted that the use of the proposed method had a positive effect on the fertility of sows, which compared with the prototype is 1.5%. Sows experimental group the number of piglets in the litter exceeds the control, they are bigger, better grow and develop, which is confirmed by data presented in table for their safety and the average live weight per head at birth and at weaning. Recent data indirectly characterize positive effect on milk yield of sows. The number of piglets lipotropics sows which the drug is administered orally for the prototype, 5.7% was less than the control and the treated Bettina - 9.8%. And, most importantly, the concentration of vitamin a in sivaram is;0,001), that is, compared with the prototype increased by 37.8%.

Thus, even with a slight zinc deficiency in almost all considered indicators the method comprising the introduction Betulinol, shows great efficiency in comparison with the prototype. Application of the proposed method contributes to the optimization of metabolism due to more intense saturation of the body with beta-carotene, vitamins a, E and zinc ascorbate, and also allows you to increase the fertility of sows, to increase the number of piglets in the litter, increase their natural resistance, safety, growth rate with a smaller number ascorbinatoxydase compounds in the additive. Side effects when using Betulinol claimed method was not found.

The results of laboratory studies of blood shows that the highest bioavailability wn Bettina, as to all controlled indicators significant difference with the control group. The content of vitamin a in the serum of calves fed Bettina, 11.3% (p<0,05) was higher than in the control and treated between, only 2.3% (p>0,05). In addition, both carolinablue increase in the bactericidal activity of serum from 72.5% (p<0,001) compared with control, and use Betulinol increases this figure twice. Phagocytic activity of leukocytes from calves experimental groups with a high degree of confidence exceeds the control 50.8% and 51.5%, respectively. Differences in lysozyme activity of serum proved to be reliable only in calves treated Bettina by the present method.

Use as ascorbate-insideradio compounds zinc ascorbate in the claimed amount of the additive "Bettina" calves contributes to the enrichment of the body, beta-carotene, vitamin a and zinc ascorbate; improves the clinical condition of the animals, has a therapeutic effect in the treatment of gastrointestinal diseases, increases the natural resistance of the body, stimulates their growth and development. Technical results of the proposed method for calves compared to the way the prototype is much larger.

The results of these studies show the positive impact Betulinol by the present method on the productivity of poultry, with the introduction Betulinol provides more effective than the method on the prototype with fewer ascorbate-insideria the Nol helps to improve the natural resistance in poultry. Influence Betulinol on indicators of bactericidal activity of blood serum and phagocytic activity of pseudosinella (judging by a higher degree of reliability of differences between control and experimental groups) in comparison with the method of the prototype much more.

Maintaining a constant concentration of vitamin a in the blood throughout the period giving the drug and during his break allows you to properly treat and don't spend more amount of the drug on the achievement of specified concentrations. Thus, these examples show that the inventive method includes the introduction as ascorbate-insideradio connection ascorbate zinc in additive "Bettina", gives more significant results in the treatment and prevention of hypovitaminosis. In addition, it helps to increase animal productivity, increase natural resistance of the body and is the most effective of all known methods based on supplementation And deficiency States by introducing known carotenodermia drugs.

Method of prevention and treatment of diseases associated with vitamin a deficiency,IOM carrier in an amount of 0.01 and 0.03 ml/kg body weight, representing the beta-carotene in the amount of not less than 2% in combination with the antioxidants of the type alpha tocopherolacetate and ascorbate-insideradio connection, alternating courses, including the cottage of the drug for at least 10 days subsequent intervals, wherein the oral administration is carried out every day, as the ascorbate-insideradio compounds enter in the composition of this Supplement zinc ascorbate in an amount not less than 1.9% of its mass.

 

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