Introduction

The vital role of medicine consists in health care and reaching the upper limit of human longevity. Every day human organism is exposed to miscellaneous adverse factors, among which there are environmental factors, hazardous agents, including ionizing irradiation, toxic substances, malnutrition, etc. All these tell on adaptation and compensatory mechanisms, hence the incidence of occupational diseases and pre-mature aging.

The above stated emphasizes the necessity to develop and integrate with clinical practice new efficient remedies and methods for correction of host functions, improve­ment of resistance to adverse factors, slowing down aging rate and increasing longevity.

The 25-year experience (1971-1996) of research and clinical investigations resulted in a comprehensive method for prevention of age-related pathology, inhibition of aging rate and the increase of life span, based on correction of homeostatic disturbances with the aid of peptide bio regulators.

Bio regulation is a new field of research related to studying molecular and cellular mechanisms responsible for homeostasis, development of substances and methods for restoring physiological functions of the organism with the purpose of prevention and treatment of diseases.

There has been developed a new class of medications capable to restore functional disturbances and prevent pathological processes in those organs and tissues from which they have been obtained.

The program of the Institute set up for the period of 1996-2000 is focused on the development of a comprehensive approach to prevention and correction of involution changes which serve as an indication of pathology and pre-mature aging. This approach is based on the employment of peptide bio regulators, as biologically active food supplements.

A new technology has been worked out for manufacturing biologically active food supplements.

These substances, which are essentially nucleoprotein complexes of organotropic action isolated from animal organs and tissues and including physiological concentra­tions of minerals, microelements and vitamins in assimilable forms got the brand name of cytamins.

Being not drugs per se peptide bio regulators possess powerful healing potential of the latter. Mild physiological regulatory effect of biologically active food supplements — cytamins — on various functional systems of the organism permit to use them as nat­ural adaptogens. Application of cytamins in residual period after stress affections (exposure to hazardous chemical factors, including those of gas, oil, coal industry etc., emotional and physical distress, ionizing radiation, microwave radiation, abnormal acoustic pressure and vibration, climatic, geo- and chronopathogenic factors), appears to be effective.

Very useful cytamins appeared to be in so-called boundary states between health and illness. These arc "physiological" metabolic shifts typical for various age periods of human life, especially pronounced in children and teenagers, as well as during male and female climacteric periods. They may also be related to age-associated decrease of host resistance and connected with it pre-disposition to different diseases and pathologies.

Application of cytamins regulates and restores mechanisms of organism defense. It permits to prevent various diseases and pathologies and accelerate the recovery of patients after illnesses (those of immune, nervous, cardiovascular, respiratory, urinary and other systems, post-surgery and post-injury states, after acute and chronic infections and inflammatory diseases, bums and frostbites, post-radio- and chemotherapy states).

Malnutrition and adverse environmental factors prevent organs and tissues from get­ting necessary quantity and composition of nutritional substances.

The new class of biologically active food supplements is unique, since the latter are con­ductive for optimal functioning and full value nourishment of organs and tissues, they contain no preservatives or other alien to the organism inclusions, they are essentially non-toxic and free of side-effects. In connection with the above said, cytamins are indicated and useful for everyone, while for children, the elderly and old people they are indispensable.For complex restoration of the main functions of the organism, cytamins application is recommended in certain combinations 2-3 times a year. Such courses help to decrease the risk of pathology. Cytamins constitute a class of natural products.

The theory of obtaining and application of tissue specific nucleoprotein complexes – CYTAMINS

Mitotic balance in the functioning organs, i.e. optimal correlation between dividing, functioning and dying cells, is known to be supported by tissue specific proteins associated in the nucleic chromatin. These proteins are specific regulators of both cell division and cell differentiation. However, the use of these endogenous regulators for medical and geronto-logical purposes was ineffective due to short life of these proteins in the blood plasma and cytoplasm, when administered as purified substances.

There is a way of prolonging protein action in the interpolymerase complex. Reliable carriers are linear polyelectrolites, including such strong ones as RNA and DNA, which carry constant negative charge on phosphate groups and form stable complexes with proteins. DNA participation in the structure of interpolymere complex protects it from splitting by cell nucleases, with protein being protected in its turn from hydrolases action.

Judging from X-ray structural investigations, it is such nucleoprotein complexes that exist in the chromatin of the normal (healthy) differentiated cell.

The first principle, put into the basis of the technology for obtaining tissue-specific nucleoprotein complexes, consists in keeping structural elements of chromatin under con­dition of mild alkaline cell hydrolysis, which combines in a natural way endogenous proteins —regulators and complementary sections of DNA. To a certain extent, it is an imitation to nature.

These nucleoprotein complexes were shown by us to include substances with molecular weight 20-40 kDa and 80-100 kDa.

The second principle underlying creation and application of tissue-specific complexes consists in using tablets and capsules with enteric coating for oral application of these endogenous regulators. It has been supposed that assimilation of nucleoprotein complexes within the range of their molecular weight 20-100 kDa takes place on the ciliary surface of the small intestine by endocytosis. Endocytosis - the process typical for the majority of cells — is the absorption of substances on the exterior surface of the membrane with formation of the vial and tearing it off inside the cell. Some cells (e.g. capillary endothelium, intestinal epithelium), grasping the substances by means of endocytosis, transfer them without any transformation to another side of the cell and secret in the out-cell environment, close to another cell or tissue, which in its turn grasps it by means of endocytosis. Such phenomenon has got the name transcytosis. Due to this mechanism, these complexes can reach the organs, for which they are specific, overcoming tissue barriers. In this case, a nucleoprotein complex, reaching the target tissue, can be included into mitochondrion structure or in a cellular nucleus. However, the mechanism of absorption of internalized nucleoprotein com­plexes by host cells needs further investigation. The proteins, responsible for cell cycle con­trol, are known to penetrate through the nuclear membrane inside the nucleus.

Intertissue and intracellular DNA transport occurs in a similar way. The built-in of exogenous DNA into the host cell DNA may occur only in case of breaks in the polynucleotide chain of the host cell, as it happens in injured and aging cells. Such a built-in can be a natural mechanism of DNA repair.

The third principle, underlying the creation and application of tissue-specific nucleoprotein complexes, consists in the fact that DNA-components of these complexes are homologous to the injured DNA of a certain tissue of the human organism, since they have been isolated from the similar, but healthy animal tissue.

The offered concept of obtaining and application of tissue-specific nucleoprotein complexes is based on experimental studies of the mechanisms of endogenous regulation and recovery of the organ and tissue functions.

Cytamins are natural complexes of proteins, nucleic acids, microelements and minerals (copper, zinc, magnesium, manganese, iron, phosphorus, potassium, calcium, sodium and other), vitamins (thiamiri, riboflavin, niacin, retinol, a-tocopherol) in assimilable form. This fact conditions their high nutritional and physiological value for balanced nourishment of all age categories of the population.

Biologically active food supplements Cytamins belong to parapharmaceuticals - food substances, possessing medicinal properties. Being not drugs per se, Cytamins allow to bring cell populations, to which they have affinity, to the optimum level of function.

The phenomenon of normalized perception of nutritious substances by human tissue cells was named "nutriception" (neologism from latin "nutritio — nutrition and "receptio" - perception). The effect of Cytamins is displayed at all stages of cellular metabolism - from trans­portation of nutritious substances through a cellular membrane up to the discharge of intra-cellular metabolism products. Unlike other parapharmaceuticals, they do not stimulate or inhibit cellular metabolism. They contain normal quantity of proteins and fats in their struc­ture and are practically free from carbohydrates. They can be characterized as low caloric products, which moreover permits to use them in dietetics.

The basic mechanism of Cytamin biological action consists in the following: on the one hand, due to their structural similarity with peptide bio regulators, they prepare immature cells of the initial tissue for normal maturation, and one the other hand, they correct cell metabolism in normally developed cells of different tissues. As result, target-tissues develop morphologically normal cell populations revealing optimum level of cell metabolism. This process has physiological character.

The phenomenon of nutriception is observed in all tissues, to which Cytamins have affinity, and, possibly, in this connection, their specialized influence is displayed. These sub­stances support homeostasis in target-organs even in the process of adaptogenic reactions during emotional and physical distress, illness, therapeutic fasting. Therefore, cell requirement in endogenous proteins goes down due to optimization of cell metabolism, the organism resistance to pathogenic agents of any etiology enhances and the immunity comes back to normal. In this way, morphologically and physiologically determined life span of cell population and the organism on the whole is actualized.

Cytamins application brings the mechanisms of the organism protection to the optimum, permitting to prevent the occurrence and development of diseases and pathological states.

The technology of cytamins production provides the obtaining of a product in an easily assimilable form, which guarantees the delivery of active substances directly to the organs and tissues, from which they have been produced: brain, thymus, pancreas, stomach, bronchi, prostate, seminal glands, vessels, cartilage, heart, liver. For this reason, cytamins application conditions normal functioning of corresponding organs and tissues even in case of poor and unbalanced nutrition.

The Cytamins application is recommended:

• to increase organism resistance under the influence of adverse ecological, climatic, occupational and other factors, including psycho-emotional stress;

• to prevent various pathological states and complications; to accelerate the recovery after illness, trauma and surgery;

• in case of malnutrition or dieting, aimed at body weight decrease;

• in case of physical overload (including sports, body-building, etc.);

• to maintain functioning of the main systems of the organism in the elderly and senile persons and to decrease the risk of age-related diseases.

Cytamins are produced as tablets and capsules with enteric coating. Each tablet or capsule contains 10 mg of an active substance.

Complex application of cytamins (no less than 5 brands) 2-3 times a year with an interval 3-6 months seems most effective.

The results of clinical studies and recommendations for application of biologically active food supplements — CYTAMINS

Recommendations for application of biologically active food supplements, cytamins, were developed in the process of clinical studies. Clinical studies were carried out in the Moscow Medical Academy, Institute of the Human Brain of the Russian Academy of Science, Institute of Bioregulation and Gerontology, clinics of the Medical Military Academy, N.N. Petrov Research Institute of Oncology, St. Petersburg Medical University, Research Institute of the Russian Ministry of Defense, the First Clinical Naval Hospital, St. Petersburg Medical Academy for Post-Graduate Education, out­patient department of the Naval clinic and other medical institutions.

The expertise of biologically active food supplements, cytamins, in the Russian Academy of Natural Sciences resulted in the following conclusion: "application of the above food supplements with therapeutic and preventive purposes is not risky either in respect to infec­tious diseases, bearing in mind epizootic and epidemiological safety in this country, or prion diseases (transmissive spongiform encephalopathies)".

The expertise of the method for obtaining and contaminating cytamin prepared raw material with nucleic acids was carried out at the N.N. Petrov Research Institute of Oncology. Here is the conclusion: "The analysis of technology for obtaining prepared raw materials of biologically active food supplements, isolated from various tissues of farm animals, as well as experimentally established rate of nucleic acids degradation in these semi-products rule out any presence of viable viruses or active protooncogens in them".

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