Agent having antianemic, immunomodulating and adaptogenic actions (variants)

FIELD: chemical-and pharmaceutical industry.

SUBSTANCE: claimed agent contains DNA sodium salt isolated from bovine testis and is useful in peroral application in form of powder, tablets, pellets, and capsules for treatment and prophylaxis of anemia, secondary immunodeficit conditions and as bracing agent. Agent may additionally contains biologically active components and filler.

EFFECT: effective and convenient agent having antianemic, immunomodulating and adaptogenic actions.

3 cl, 3 ex, 6 tbl

 

The invention relates to pharmaceutical industry and can be used for the treatment and prevention of anemia, secondary immunodeficiency States and as a fortifying agent.

It is known tool - polidan (sodium nukleospermata) - 1.5% solution for injection, (registration number 95/292/8), stimulating leucopoiesis, containing a mixture of sodium salts polihlorgidratov derivatives of DNA and RNA extracted from sturgeon milk. (RLS, M., 2002, s)

Polidan - injectable drug that restores reduced as a result of cancer chemotherapy cytotoxic means indicators of the white blood cells (leukopenia).

The disadvantage of this tool is the fact that the drug is used insufficiently purified components of the nucleic acid fragments isolated from tissues of organisms, evolutionary distant from the person class (fish), which are administered by injection. At their introduction, there are a few negative points: significant pain, pyrogenic action; injection route of administration carries a potential risk of infection, the need for the participation of staff and establishment of aseptic conditions the injection.

The closest analogue to the present invention is a tool that has leukopoiesis and immunomodulatory property - Derinat.(RLS, M., 2002, s)

Derinat - sodium salt of DNA with a molecular mass of 270 to 500 KD with a small impurity content of less than 1%, is allocated from sturgeon milk. Derinat also normalizes the reduced hematopoiesis, but additionally shows immunomodulatory effects, is used in the form of a 1.5% solution for intramuscular injection.

The disadvantage of this tool is that when parenteral significant pain, pyrogenic action potential risk of infection, the need for the participation of staff and establishment of aseptic conditions the injection.

The technical result is to expand the range of action of the drug, creating a new drug with anti-anemic, adaptogenic and immunomodulatory activity, reduce the risk of infection and ease of use of the possibility of oral administration, without the participation of the medical staff.

The invention consists in that the product contains sodium salt of DNA isolated from mammalian tissue is bovine testes, which is intended for oral administration in the form of tablets, coated tablets and capsules for the treatment and prevention of anemia, secondary immunodeficiency and improve efficiency.

The proposed group of inventions, United is isobretatelsky plan.

The proposed tool with Antianemic, immunomodulatory, adaptogenic action, containing the sodium salt of DNA from tissues of animal origin, microcrystalline cellulose and excipients in the following ratio of ingredients in grams per 1 tablet weighing 0.2 g:

sodium salt of DNA0,05
microcrystalline cellulose0,149
excipientsthe rest of it.

Medicine as excipients contains starch, calcium stearate or magnesium stearate.

The proposed tool with Antianemic, immunomodulatory, adaptogenic action, containing the sodium salt of DNA from tissues of animal origin, cyanocobalamin (vitamin B12), folic acid and excipients in the following ratio of ingredients in grams per 1 tablet weighing 0.5 g:

sodium salt of DNA0,025
cyanocobalamin (vitamin B12)0,00002
folic acid0,0001
excipientsthe rest of it.

Medicine as excipients contains sakh the RNA powder, the starch syrup and sugar nibs.

Also proposed a means of having Antianemic, immunomodulatory, adaptogenic action, containing the sodium salt of DNA from tissues of animal origin, glucose and excipients in the following ratio of ingredients in grams per 1 capsule:

sodium salt of DNA0,3
glucose0,3

The use of biologically active components extends the range of therapeutic action of the drug. For example, vitamin b12and folic acid increased Antianemic properties, glucose enhances adaptogenic activity. Vegetable cellulose, such as MCC, performs the role of sorbent media, prolonging and intensifying the action of the tool. The use of different dosage forms (tablets, pills, capsules, powders, and others) influence the ease of preparation.

Example 1. Getting tablets.

The composition tabletsThe content of components in one pill
The component containing the sodium salt of DNA0.05 g25
biologically active component: microcrystallin cellulose0,149 g75
Excipients: starch, calcium stearate or magnesium stearateenough to get pills weight 0,2

Every day during the month of 22 women with anemia and asteno vegetative syndrome received 1 tablet 2 times a day. Other drugs in this period was not prescribed.

The number of erythrocytes, leukocytes, hemoglobin concentration increased significantly and reached the level of norms (table 1, 2)

Table 1

Change indicators hemogram tablets admission
IndicatorsInitial levelAfter 4 weeks
Hemoglobin, g/l115,3±2,6of 124.8±3,0*
Erythrocytes, ×1012/l3,98±0,14,22±0,08*
* - p<0,05 - t-criterion of student relative to the initial level.

Table 2 Changes in physiological parameters during the pill

Blood pressure, mm HgHeart rate, beats/minRespiratory rate, dehat. movement/min
And the move. 1 month.Outcome.1 month.Outcome.1 month.
118,4±3,9/70,7±2,4to 113.4±2,4 /69,3±1,481,8±1,975,7±1,2*17,7±0,514,2±0,5**
* - p<0,05; ** - p<0,01 by t-criterion of student relative to the initial level.

Example 2. Obtaining bean.

CompositionThe content of the pellet components
A preparation containing the sodium salt of DNA0.025 g5%
Biologically active components:

Cyanocobalamin (vitamin B12)

Folic acid
0,00012 g

0,00002 g

0,0001
0,02%
Filling:

Powdered sugar

Starch syrup

Sugar globules
a quantity sufficient to obtain tablets weighing 0.5 g

Daily for 18 months women with signs of anemia and asteno vegetative syndrome received 2 tablets 2 times a day. Other drugs in this period were not applied.

The test results presented in table 3, 4.

Table is 3

The effects of taking pills at the indicators hemogram
IndicatorsInitial levelAfter 4 weeks
Hemoglobin, g/l113,3±5,5122,9±4,29*
Erythrocytes, ×1012/l3,91±0,174,29±0,09*
* - p<0.05 by t-criterion of student relative to the initial level.
Table 4

Change index of phagocytic activity of neutrophils when taking pills
IndicatorsInitial levelAfter 1 month
The percentage of phagocytosis38,83±2,4350,83±of 3.77**
Phagocytic index1,48±0,071,59±0,05
Phagocytic number0,57±0,040,83±0,08**
Abs. the number of captured objects phagocytosis1786±1722070±245
** - p<0,01 by t-criterion of student relative to the initial level.

Example 3. Getting the capsules.

CompositionThe ratio of the components in one capsule weight 0.6 g
Among the STV, containing the sodium salt of DNA0.3 g50%
Glucose0.3 g50%

The tablets, pills, powder from capsules significantly improve the health of the animals (table 5, 6).

Table 5

The effect of the drug on the physical endurance of mice
Forms of medicationThe number of animalsRetention time on the horizontal rod, s
Control912,22±2,31
Powder1033,10±of 5.82**
Tablets1036,50±5,22***
Pills929.67 per±6,93*
* - p<0,05; ** - p<0,01; *** p<0,001 t-criterion of student relative to control.
Table 6

The effect of the drug on the power stability and muscle endurance of mice
Options experienceMass is held weights, gThe sailing time, sec
Control 36,18±3,32465,67±73,91
(n=11)(n=6)
Powder44,50±1,62*778,20±158,77*
(n=12)(n=5)
• - p<0.05 by t-criterion of student relative to control.

A comprehensive study of the biological properties showed that the tool has no toxicity, mutagenicity, embryotoxicity, teratogenicity, does not show allergenic properties, i.e. it is a harmless tool and can be recommended for long-term, daily use.

The tool stimulates all the elements of the immune system: increases the phagocytic activity of macrophages and neutrophils; enhances antibody production; increases the number of T-lymphocytes; protects the immune system by inhibiting the action of immunosuppressants and stress; when the secondary immunodeficiencies use oral increases to normal titers of hemagglutinin, the number of antibody productive cells and indicators phagocytic activity of neutrophils. Derinat with intramuscular injection of the same dose of these indicators to a normal level does not recover.

An important property of the tool is its ability in oral in the introduction to provide Antianemic action. In animals shows that the drug has the ability to increase to normal reduced number of erythrocytes and hemoglobin concentration, increases the cellularity of the bone marrow, eliminates lymphopenia.

When administered orally, the drug significantly increase muscle strength and endurance animals.

With the participation of a group of volunteers confirmed immunomodulatory, retrobestiality and adaptogenic activity of the drug used in the form of tablets and pills. The drug significantly increases mental and physical performance.

1. A means of having Antianemic, immunomodulatory, adaptogenic action, characterized in that it contains the sodium salt of DICK isolated from bovine testes, microcrystalline cellulose and excipients in the following ratio of ingredients in grams per 1 tablet weighing 0.2 g:

sodium salt of DNA0,05
microcrystalline cellulose0,149
excipientsrest

2. The tool according to claim 1, where the auxiliary substances contains starch, calcium stearate or magnesium stearate.

3. A means of having Antianemic, immunomodulatory, adapt the military action, characterized in that it comprises a sodium salt of DNA isolated from bovine testes, cyanocobalamin (vitamin B12), folic acid and excipients in the following ratio of ingredients in grams per 1 tablet weighing 0.5 g:

sodium salt of DNA0,025
cyanocobalamin (vitamin B12)0,00002
folic acid0,0001
excipientsrest

4. The tool according to claim 3, where as excipients contains sugar, starch syrup and sugar nibs.

5. A means of having Antianemic, immunomodulatory, adaptogenic action, characterized in that it comprises a sodium salt of DNA isolated from bovine testes and glucose in the following ratio of ingredients in grams per 1 capsule:

sodium salt of DNA0,3
glucose0,3



 

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