BG3125U1 - Immunotrophic preparation for treatment of adenotonsillar hypertrophy - Google Patents

Abstract

This utility model relates to the pharmaceutical industry, in particular food additives and notably the preparation making in the form of a syrup based on Beta-glucan, arginine, iodine, vitamins selected from the B-group, vitamin D3, vitamin C, vitamin E, vitamin A. These ingredients have been proved to fight adenotonsillar hypertrophy by improving the normal activity of the immune system and supporting the trophism of the lymphoid adenotonsillar tissue.

Description

The present utility model belongs to the field of the pharmaceutical industry, in particular to food supplements and in particular to the preparation of a preparation in the form of a syrup based on Beta-glucan, arginine, iodine, B-group vitamins, vitamin D3. These components have been shown to combat adenotonsillar hypertrophy by improving the normal activity of the immune system and supporting the trophism of lymphoid adenotonsillar tissue. The preparation is especially suitable for children, as the presence of L-arginine improves their growth by helping to produce growth hormone, which is usually lacking in those who often suffer from nocturnal awakenings.

It is known that the symptoms of adenotonsillar hypertrophy are sometimes expressed by a significant decrease in tidal volume, as well as by pathological catarrhal manifestations. The results of these physiological problems can be different, but certainly, sleep disorders and swallowing problems are among the most troubling. In addition, because growth hormone (G.H.) is secreted mainly during sleep stages 3-4, children with adenotonsillar hypertrophy who do not have regular sleep may show growth retardation. The hypertrophic state of lymphoid adenotonsilar tissue can result from several concomitant causes, but two of them are the most important: slow metabolism of the mucosa and imbalance in the balance between immunity and the external causative agent, which is difficult to eliminate.

The ideal thing would be to work for treatment aimed at:

1) reduction of the volume of lympho-reticular tissue, which leads to improved respiration and normalization of sleep,

2) stimulating the reduced secretion of growth hormone (G.H.), thus supporting growth,

3) ensuring good physical health of the patient,

4) reducing the frequency of catarrhal episodes.

The present utility model seeks to provide a preparation in the form of a syrup that allows the aforementioned treatment to be performed. According to the utility model, the preparation is in the form of a syrup in which arginine, Beta-glucan, iodine, B vitamins and vitamin D3 are incorporated in a technological manner, following the rational method described below.

Arginine is an amino acid that is widely distributed in nature and is mainly found in animal proteins. It performs important functions in cellular metabolism and plays a key role in urea biosynthesis in the Krebs cycle.

Arginine itself is not an essential amino acid, but is considered to be one during the growing season. Arginine is indispensable and vital for the construction of protein structures in the body. (Chaitow L .: Aminoacids and their effects to health, Tecniche Nuove 34-38, 1983).

In fact, arginine is involved in the synthesis of creatine and has an important anabolic action that aids metabolism. In addition, it regulates the release of nitric oxide (NO) in the human body. The latter is an important endogenous signaling molecule that regulates vascular tone and microcirculation. It is mainly formed in endothelial cells, neuronal cells and macrophages. For this reason, it has a vasoregulatory, neuro- and immunomodulatory effect. These characteristics, in case arginine is taken in strong doses, are expressed in regenerative activity of tissues, in particular liver and muscle tissues, wound healing and immunostimulatory activity. (Green S. J., Meltzer M. S., Hibbs J. B. Jr., Nacy C. A., J. Immunol. 1990 Jan., 144: 1,278-283).

According to the above characteristics, arginine is able to stimulate the synthesis of growth somatotropic hormone (STH). In fact, arginine is used in therapy against hypopituitarism, which slows down the body's somatic development. (Kiseleva EV, Zarubina N. A., Pankova S. S., Starkova N. T., Probl. Endocrinol. (Mosk) 1991 May; 37 (3): 28-29).

Glucans are natural polysaccharides consisting of monosaccharide units. Found in nature in wheat, barley, oats, in some microorganisms and fungi.

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Glucans, usually derived from cereals, are major components in various diets, but purified beta-glucans, in particular Beta-1,3-glucan and long-chain beta-1,3 / 1,6-glucan derived from yeast, are selectively identified as strong stimulants of the immune system. (Kokashis R. L., Williams D. L., Cook J. A., and Di Luzio N. R., Increased Resistance to Staphylococcus Aureus Infection And Enhancement In Serum Lysozyme Activity By Glucan. Science 199, 1340-1342 (1978)).

Long-chain glucans have the ability to activate and increase the production of macrophages, neutrophils and other cells, as they have specific receptors for these structures. They have been shown to activate macrophages and significantly increase their ability to phagocytose. Activation of such cells by beta-glucan stimulates the body's nonspecific immune response.

Beta-glucan strengthens the body's defense mechanism and strengthens the immune response. (Sherwood E. R., Williams D. J., and Di Luzio N. R., Glucan stimulates the production of antitumor cytolytic, cytostatic factors by macrophages. J. Biol. Resp. Mod-6, 358-381 (1986)).

Beta-glucans have also been shown to be specific for the C3 complement receptor membrane. (Ross G. D., Cain J. A., Myones B. L. et al. "Specificity of membrane complement receptor type three (CR3) for beta-glucans", Complement 4: 61-74, 1987).

In order to assess the role of immunity, it must be remembered that according to its origins, it is divided into innate and acquired.

Innate immunity is non-specific immunity - it includes skin, gastric juices, lysosomes, the complement system, macrophages and neutrophils.

Acquired immunity is the specific immunity of the immune memory in the body, which is formed and represented by T and B lymphocytes.

In an attempt to fight the invader, a reduced or delayed biological response of our immune system leads to an increase in the volume of the lympho-reticular tissue of the tonsils, which can generate hyperplasia and cause hypertrophy.

Changing by accelerating the response of macrophages means helping the first line of defense of our body by improving the response against "external invaders". Stimulating the lymphocyte response means activating the immune memory against a "specific invader" and initiating protection directed directly against that invader and not against others.

However, the two systems - innate and acquired immunity, work in sync and balance each other to suppress the "invader".

The complement system is an important part of innate immunity. It plays an important role in protecting the body against infectious external agents. The S3 factor of the complement system is undoubtedly the focal point, as it plays the role of a link between acquired and innate immunity. In fact, it is responsible for activating macrophages and neutrophils. Activation of macrophages results in the expression and release of the cytokine Interleukin 1 (IL-1). Being a major factor in the inflammatory process, it stimulates the production and growth of lymphocytes. They in turn induce the production of cytokines from Interleukin 2 to Interleukin 6 (IL-2; IL-6) inclusive, as well as a factor that stimulates colonies of granulocytes and monocytes and then neutrophils and macrophages. It is clear that factor S3 of the complement system is able to activate all innate and acquired immune functions, which makes it very important for the body's defenses. Therefore, beta-glucan, which is able to react with factors B and D of the complement system and activate factor C3 of this system, is also able to support the overall functioning of the immune system.

Iodine is a therapeutic and prophylactic agent with proven antiseptic activity against bacterial, viral and fungal infections. It is the most effective broad-spectrum and non-toxic antiseptic.

Iodine performs an active function in the metabolism of lymph nodes, improving the trophism of lympho-reticular tissue, increases blood flow in it and improves lymphatic drainage.

Iodine contributes to the normal functioning of the thyroid gland and stimulates the production of its hormones. Thyroid hormones are extremely important for metabolism, growth and development of the body. The amount of iodine absorbed through the digestive system, circulating in the form of iodide, is captured by up to 90% of the thyroid gland in

2155 Descriptions to certificates for registration of utility models № 04.1 / 15.04.2019 organism. As a result of the oxidation process, it is converted into metallic iodide, which is part of the thyroid hormones (T3-triiodothyronine and T4-thyroxine). Receptors for the hormones T3 and T4 of the thyroid gland are present in all tissues. Due to this, these hormones have an effect on the whole body. The hormones T3 and T4 increase the volume of circulating blood, increase oxygen consumption and respectively affect the metabolism of tissues. Thyroid hormones stimulate protein, carbohydrate and lipid metabolism. Up to 1% of these hormones reach the mammary glands, gastric mucosa and lympho-reticular tissue daily, thus being considered to be actively involved in the trophism of these structures. Therefore, when it comes to tonsillar lymphoreticular tissue, it can be concluded that in cases of hypertrophy, the increase in iodine supply can lead to a marked improvement in the trophism of this tissue and a positive effect in the normalization of its activity and functionality.

The B vitamins used are: B5, B6 and B12.

The metabolic consequences of vitamin B5 deficiency, also known as pantothenic acid, have been described by RS Fry and his team since 1976. Vitamin B5 is used in otorhinolaryngology in cases of chronic inflammation of the upper respiratory tract. Contributes to the protection and rapid recovery of the mucosa.

Vitamin B6, also known as pyridoxine, is known to contribute to the normal functioning of the immune system. Studies have been performed to evaluate the effect after further administration.

In fact, the lack of vitamin B6 leads to changes in the cells of the immune system and their activity, ie. there is a decrease in the number of lymphocytes, the level of interleukin and slows down the response to mitogens in the body.

Vitamin B12 is known as a hematopoietic factor, is involved in stimulating growth and enhancing appetite. The therapeutic effect of vitamin B12 on anemia, especially on malignant anemia, is based on sound biochemical and clinical documentation. Obviously, the supply is vitamin B12, provides good physical health.

Vitamin D3 affects almost all cells in the body. Vitamin D3 has a huge impact on immunity because it plays an important role in the regulation of the cells of the immune system and contributes to its effectiveness. Vitamin D3 is needed for the immune system to function normally. If there is a sufficient amount of vitamin D3, a person suffers 4-5 times less often from seasonal viral infections, such as flu, colds and others. This is proven. All this defines it as an important factor for the normal functioning of the child's body.

Vitamin D3 contributes to the normal absorption of calcium and phosphorus in the body, helps the proper functioning of muscles and maintain muscle tone. Vitamin D3 supports bone growth and keeps them in good health.

The preferred composition of the immunotrophic preparation in the form of a syrup, according to the present utility model, is presented in Table 1.

2156 Descriptions to certificates for registration of utility models № 04.1 / 15.04.2019

TABLE

Arginine

Vitamin B5

I

For ΙΟΟτηΙ

I | \ 5ϋ e

I______ mg

Vitamin B6 7 mg --- - Vitamin B12 and no, Vitamin D3 25 ЦЙ Iodine __ 2,000 I 1

I Bsga-glijan 1800 jng [Distilled water '60, 00 g

The amounts of the individual components may vary within the following ranges - described in Table 2 - to maintain the efficacy of the product therapy.

The data in the table refer to 100 ml of solution.

[Arginine

Vitamin B5

TABLE I '4 *] 0s _J___

14 «1-120 m _S

Ji 1-21} nig

Vitamin B6

| Nntamip H12 | * - S5 hg 1 [Vitamin D3 1 15 -] 00 μβ .1 1__________________ _ _ 'Iodine ______ _ __ 11600 * 4000 pg Beta-gluedn IjO + 2000 mg;

The addition of iodine to the body is preferably provided in the form of potassium iodide.

Other components used can be: flavorings (vanilla flavor, pineapple, citric acid), stabilizers (xanthan gum), sweeteners (fructose and caramel from sucrose), preservatives (sodium benzoate, methyl hydroxy benzoate, potassium sorbate), colorants.

Possible implementations of the utility model are with the participation of components such as:

Vitamins: vitamin B1; vitamin B2; vitamin B3; vitamin B9; Vitamin C; vitamin E; vitamin A, etc.

Chemical elements and microelements: zinc; iron; sodium; calcium; phosphorus, etc.

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Various extracts of: echinacea; elderberry; shipka; camomile; cinquefoil; astragan; Ginseng; green tea; raspberry; pelargonium; turmeric; verbena; mallow, etc.

Other active substances: biotin; niacin; lysine; bioflavonoids; folic acid; propolis; honey; colostrum and its derivatives, etc.

There is ample evidence of the benefits of these components on children's healthy growth. To varying degrees, the above ingredients contribute to and help strengthen the body's natural defenses.

Generally, the formulation prepared according to the present utility model may be prescribed to a patient in daily doses of 5 ml or 10 ml to stimulate the immune system response. However, it is for those skilled in the art to determine the duration and periods of therapy, as well as the doses of the drug, in relation to the general physical condition of the patient and the extent and condition of the hypertrophied tissue to be treated.

Table III shows the nutritional value of the components in the described utility model, relative to a daily dose of 10 ml.

TABLE III

P "^ rangkel stays' Daily dose of 10 ml Ί R _d D), A. (%)

I___________________________ '' Arginine

Vitamin B5

0.55 y | ___________________ ____ н ___ ΰ, ο mg г 1 ϋϋ%

1— “1 Вητεώληκ Vb OJ mg 50%! .. ______________________j Vitamin 1312 1 - .. 100% ^; 1 'Vitamin U3 1 2.5 pg 50% 1 [Iodine! 200 μβ B3 ^u / o I (Glunin 80 nig G ___ ..

In the light of the above, the preparation of the preparation according to the utility model allows us to:

• ensuring good physical health for the patient, protection of the mucosa through vitamins B5, B6, B12 and L-arginine;

• stimulating growth by supporting the production of growth hormone, thanks to the action of L-arginine;

• supporting the trophism of the adenoid lympho-reticular tissue, thanks to the action of iodine;

• improving the normal activity of the immune system through Beta-glucan.

Claims (4)

Claims Immunotrophic preparation for the treatment of adenotonsillar hypertrophy in the form of a syrup, characterized in that it includes as active ingredients beta-glucan, arginine and iodine and added vitamins selected from B-group and vitamin D, as well as vitamin C and / or vitamin E, and / or vitamin A, and / or vitamin D3. 2158 Descriptions to certificates for registration of utility models № 04.1 / 15.04.2019 Immunotrophic preparation according to Claim 1, characterized in that per 100 ml of product arginine44-10g, beta-glucan6 30 ^ -2000mg, iodine6 1600 ^ -4000, Vitamin D3 is 5 100 pg, vitamin B-group is Vitamin B12 of 8 4- 35 mcg, Vitamin B6 of 3 4- 20 mg and Vitamin B5 of 48 4-120 mg. Immunotrophic preparation according to claim 2, characterized in that per 100 ml of syrup arginine is 5.50 g, beta-glucan is 800 mg, iodine is 2000 pg, Vitamin D3 is 25 pg, Vitamin B12 is 25 pg, Vitamin B6 is 7 mg and Vitamin B5 60 mg, the rest up to 100 ml is distilled water. Immunotrophic preparation according to any one of the preceding claims, characterized in that it is for administration to a patient at a daily dose of 5 or 10 ml.