RU2519226C1 - Medication for prevention and treatment of andrological diseases and method of obtaining thereof - Google Patents

Abstract

FIELD: chemistry, pharmacology.

SUBSTANCE: medication for prevention and treatment of andrological diseases represents dried alcohol extract of gonads of sea urchin Strongylocentrotus droebachiensis, obtained by successive processing of gonads with two-phase extractant chloroform-ethanol, then with 95% ethyl alcohol, keeping with periodical mixing, solid residue after separation of liquid extract is poured with 70% ethyl alcohol and kept with mixing, separated and dried under specified conditions.

EFFECT: medication is efficient for prevention and treatment of andrological diseases.

3 cl, 4 tbl, 6 ex

Description

The invention relates to the pharmaceutical industry, and in particular to a tool for the prevention and treatment of andrological diseases.

Sexual life is one of the most important components of human relationships and largely determines the quality of human life as a whole. Problems associated with the ability to achieve and maintain an erection, can cause serious neuropsychic disorders in men, as well as lead to a violation of family relationships [O. Khlyakina An integrated approach to the problem of male infertility in an industrial region // Bulletin of regenerative medicine. - 2010. - N 6. - S. 73-74].

Erectile dysfunction (ED) - the inability to achieve and (or) maintain an erection sufficient to have a full sexual intercourse, which limits or makes satisfactory sexual intercourse impossible. ED is a common medical problem. According to the results of statistical studies, the prevalence of erectile dysfunction among men of all ages is 10%, and it is estimated that over 100 million men currently suffer from erectile dysfunction worldwide. More than 30% of men aged 18 to 59 years have varying degrees of severity of sexual dysfunction, 15% have severe ED. Almost 50% of men over 40 have ED of varying severity, and with age their number increases and reaches 70% by 70 years. Studies conducted in the early 90s of the XX century, invariably note the effect of age on the prevalence of ED, as well as the close relationship of ED with cardiovascular diseases [Vertkin A.L., Morgunov L.Yu., Budylev S.A., Krivtsova E.V. Erectile dysfunction: recurrence and notes // Medical Council, 2011, No. 1-2: 30-40]. According to the forecast I.A. Ayta [Ayta I.A., McKinlay J.B., Krane R.J. The likely worldwide increase in erectile dysfunction between 1995 and 2025 and some possible policy consequences // BJU Int. 1999, 84 (1): 50-56], the number of patients with ED in the world will increase from 152 million people in 1995 to 322 million by 2025 and will be more than 11.9 million people in Europe, in North America - more than 9.1 million, in Africa - more than 19.3 million, in Asia - more than 113 million.

These indicators make the treatment of ED one of the important social tasks. For doctors, this task is primarily associated with the development of drug treatment, since its results over the past decade have shown high efficiency.

In recent years, drugs have appeared that have a pronounced clinical effect and allow high-efficiency non-invasive treatment of ED. Experience has been gained with the use of selective type 5 phosphodiesterase inhibitors, which are currently accepted first-line therapy. At the same time, a significant risk of developing unwanted effects and a short-term effect limit their widespread use in these patients.

Known drug Viagra based on the medicinal substance sildenafil citrate with a therapeutic dose of 25 mg. The following side effects are on the part of the cardiovascular system: headache, flushing, vasodilation; from the central nervous system: dizziness, increased muscle tone, insomnia; from the digestive tract: dyspepsia, diarrhea, nausea; from the musculoskeletal system: pain in the muscles and joints; on the part of the respiratory system: nasal congestion, pharyngitis, rhinitis, sinusitis, respiratory tract infection, respiratory distress; from the sensory organs: a slight change in vision (color perception, clarity), conjunctivitis; on the part of the skin: rash; from the genitourinary system: urinary tract infections, disorders of the function of the prostate gland; others: asthenia, pain (including in the abdomen, back), flu symptoms, rarely - cases of priapism. The action of this drug is based on the physiological mechanism of erection, which involves the release of nitric oxide in the cavernous bodies of the penis during sexual stimulation.

The literature data indicate a limited choice of agents with aphrodiatic activity, the effectiveness of which is very limited [Seifulla R.D., Ankudinova I.A., Kim E.K. Sexual behavior of men. - M .: Jaguar, 89 p.]. Modern pharmacology examines a variety of products of natural origin (mainly on a plant, but also animal basis) based on the guidelines obtained in traditional medicine, in order to evaluate the scientific basis of their empirical application. Many drugs of natural (animal and plant) origin are also used to treat ED. Interest in the methods of so-called biological medicine is great throughout the world. This is due to the fact that these drugs have significantly fewer side effects compared to chemotherapy drugs, do not cause addiction and withdrawal syndrome.

Known complex drug from plant materials Tentex forte (Himalaya Drug Co, India), approved for use in Russia with a decrease in libido and functional disorders of sexual function [Reference Vidal. Medicines in Russia. - M .: AstraPharmService. - 2012. - 1664 p.]. This drug is produced by a foreign company and is expensive due to the complex composition of medicinal herbs that grow in different countries of the world and have limited raw materials, the minimum course of treatment is 3-4 weeks. In addition, the drug is contraindicated in hypertension, atherosclerosis, heart failure.

Known fortifying agents obtained from raw materials of animal origin. Pantocrine and Rantorine - extracts from antlers of sika deer, red deer, red deer or extract from antlers of reindeer [Mashkovsky M.D. Medicines, t. 1. - M .: Medicine, 1993, S. 165-166].

It is known to use sea urchin caviar as a means to stimulate erythropoiesis. The stimulating effect is to increase the production of progenitor cells, red blood cells and hemoglobin [RU 2195944 C1, 01/10/2003].

A means for maintenance therapy is known, which is a peptide complex obtained by treating the frozen caviar of sea urchins with a 5% solution of acetic acid. This tool supports the male reproductive system (RU 2414914 C1, 03/27/2011). In the patent RU 2420212 C1, 06/10/2011 a similar tool is disclosed. The disadvantage of these funds is the incomplete complex of biologically active substances that enter into them, which affect the male reproductive system.

Closest to the proposed is the use of caviar of sea urchins in frozen or lyophilized form in an amount of 0.3-0.6 or 0.08-0.21 g / kg of weight as a means to increase sexual activity [RU 2197253 C2, 01.27.2003 ]. The disadvantage of the claimed use of sea urchin caviar is the insufficient effect on the male reproductive system, the use of native animal raw materials with great variability, the possibility of introducing foreign substances, and a short shelf life due to autolytic processes taking place in untreated caviar.

The objective of the invention is the creation of a drug in which the contraindications available to the medicines indicated above are eliminated, and also taking into account known preventive agents, the creation of a drug that does not have the disadvantages of the known prototypes

- the duration of the development of the therapeutic effect,

- possible overdose,

- the impossibility of preparing this product in the form of tablets or capsules due to the large weight of the mixture.

The drug should include a minimum amount of ingredients with the most pronounced therapeutic properties in relation to erectile dysfunction with a minimum of contraindications and side effects.

The drug should provide, when ingested, the maximum preservation of the amount of biologically active substances, have a convenient consumer form for use and storage, and have high manufacturability in mass production.

The problem is solved by creating a means for the prevention and treatment of andrological diseases, characterized in that it is a dry alcoholic extract of gonads of sea urchins Strongylocentrotus droebachiensis, obtained by sequential treatment of gonads, for purification from ballast substances, with a two-phase extractant chloroform-ethanol (2: 1) and ethyl alcohol 95%, extraction with a 70% aqueous solution of ethyl alcohol, separation and drying, the obtained extract of sea urchin gonads contains 15-40% peptides, 0.15-4% amino acids, 0.15-1.0% poly aharidov, we trace elements and has the following characteristics: in the amino acid composition analyzed by gas chromatography massdetektirovaniem, dominant amino acids are glycine, alanine, glutamic acid, histidine; moreover, the relative content of glycine exceeds the content of other dominant amino acids by 2 times and the ratio of essential / non-essential amino acids is about 0.22.

The technical result of the invention is increased efficiency in the prevention and treatment of andrological diseases due to the combined action of biologically active substances in the extracted extract from the gonads of the sea urchin Strongylocentrotus droebachiensis. The technical result is to obtain a safe product based on the extract of gonad of sea urchins in the form of a finished dosage form for oral administration with a pronounced therapeutic effect, containing, according to the invention, an alcoholic extract of gonad of sea urchins (EGME), as well as pharmaceutically acceptable excipients in the following ratio ingredients, in wt.%:

- alcoholic extract of gonads of sea urchins 5-50 - Excipients up to 100

The claimed drug is made in powder, tablet or capsule form.

The result achieved by using the invention is to obtain a metered dose preparation consisting of a minimum amount of highly effective ingredients, the combined effect of which, on the one hand, ensures the effectiveness of action against andrological diseases, and on the other hand, has an expanded spectrum of preventive and healing effects on the body. Technological features of the production of the drug do not create difficulties in its mass production, and the consumer form provides the body with the perception of the entire amount of biologically active substances and ease of administration and storage.

Experimental studies conducted by the authors allowed us to establish that in order to obtain an extract fresh or freshly frozen, stored for no more than 3 months, the gonads of sea urchins Strongylocentrotus droebachiensis should be sequentially cleaned of ballast substances by extraction with chloroform-ethanol (2: 1) biphasic extractant in a ratio of 1 :( 5-7) and ethyl alcohol 95%, with a ratio of 1: (5-10), incubated with periodic stirring for 17-24 hours in a dark place at room temperature, then extract the solid residue with a 70% aqueous solution ethyl alcohol in a ratio of 1: (4-7), withstand with stirring at room temperature for 19-24 hours, separate the alcohol extract and dry. The output of EGME is about 6.5% of the mass of gonads.

The complex of biologically active substances isolated from the gonads of sea urchins contains natural biologically active substances in the following amounts (wt.%): 15-40% peptides, 0.15-4% amino acids, 0.15-1.0% polysaccharides, trace elements.

EGME exhibits the declared properties at the indicated ratio of peptides, amino acids, polysaccharides. Isolation of a single peptide fraction or individual amino acids from a product, followed by determination of their pharmacological activity, indicated a decrease in the severity of effects and failure to achieve the total stimulating effect stated in the present invention.

The amino acid composition of EGME was studied using gas chromatography with mass detection. EGME identified 16 amino acids, including 9 essential ones. The dominant amino acids are glycine, alanine, glutamic acid, histidine, and the relative content of glycine exceeds the content of other dominant amino acids by 2 times and the ratio of essential / non-essential amino acids is about 0.22.

As excipients, pharmaceutically acceptable excipients are used, which are used in encapsulation and tabletting of drugs from the groups of binders, disintegrants, and antifriction agents that promote tabletting.

Experimental studies have been conducted to evaluate the stimulatory effect of a drug containing EHME. The activity of sexual behavior was determined by the method of Buresh et al. (Buresh Y., Bureshova O., Houston J.P. Methods and basic experiments on the study of the brain and behavior. - M.: Higher School. - 1991. - 300 p.).

To confirm the stimulating effect of the new drug, a comparative study was conducted with analogues - Viagra and Tentex forte preparations.

The experiments were performed on sexually mature male Wistar rats, which were divided into groups of 10 animals each. 1st group - control. The preparations containing EGME and comparison preparations animals received intragastrically through a probe once and for 60 days. Viagra was administered once.

A comparison of the claimed means with the known ones shows that for the first time a single application of the extract of gonadal sea urchins to increase sexual activity and repeated use to improve the quality of spermatogenesis is proposed.

Thus, the claimed invention meets the criteria of the invention of "Novelty" and "Inventive step", as it clearly does not follow for a specialist from the prior art. The proposed solution meets the criteria of the invention "industrially applicable", as it can be effectively used in practical health care.

The invention is illustrated, but not limited to the following examples of specific performance.

Example 1. Obtaining EGME

100 g of fresh gonads of sea urchins Strongylocentrotus droebachiensis are cleaned of ballast substances by extraction with 500 ml of a two-phase extractant chloroform-ethanol (2: 1), drained, dried in air and again filled with 500 ml of ethyl alcohol 95%, incubated with periodic stirring for 20 hours in in a dark place at room temperature, the solid residue after separation of the liquid extract is poured with 70% ethyl alcohol in a ratio of 1: 5 and kept under stirring at room temperature for 22 hours. The resulting alcoholic extract of sea urchin gonads is separated and dried. The yield of dry product is 6.5% by weight of the gonads.

Example 2. Obtaining EGME

100 g of fresh gonads of sea urchins Strongylocentrotus droebachiensis are purified from ballast substances by extraction with 650 ml of a two-phase extractant chloroform-ethanol (2: 1), drained, dried in air and again poured into 800 ml of ethyl alcohol 95%, incubated with periodic stirring for 24 hours in in a dark place at room temperature, the solid residue after separation of the liquid extract is poured with 70% ethyl alcohol in a ratio of 1: 6 and kept under stirring at room temperature for 24 hours.

The resulting alcoholic extract of sea urchin gonads is separated and dried. The yield of dry product is 6.5% by weight of the gonads.

Example 3. Hard gelatin capsules for oral administration (in g per 100 g).

EGME - 8

Microcrystalline cellulose, silicon dioxide, magnesium stearate - up to 100.

The calculated amount of EGME, 1/3 of the total amount of microcrystalline cellulose, is introduced into the mortar, carefully rubbed with a pestle until a uniform concentrate is obtained. Then, the remaining amount of microcrystalline cellulose, the required amount of silicon dioxide and magnesium stearate are added in portions, mixed and then encapsulated in hard gelatin capsules with a filling mass of 0.19 g.

EGME used in this embodiment is obtained from gonads of sea urchins and contains 33% of peptides, 0.9% of amino acids, 0.6% of polysaccharides, trace elements.

Example 4. Tablets for oral administration (in g per 100 g).

EGME-10

Microcrystalline cellulose, lactose, silicon dioxide, polyvinylpyrrolidone, calcium stearate - up to 100.

The calculated amount of EGME, 1/3 of the total amount of microcrystalline cellulose, is introduced into the mortar, carefully rubbed with a pestle until a uniform concentrate is obtained. Then the remaining amount of microcrystalline cellulose, the required amount of lactose and a solution of polyvinylpyrrolidone are added in portions. The wet mass is wiped through a sieve with a hole diameter of 2 mm, dried at a temperature of 55 ± 5 ° C, sieved through a sieve with a hole diameter of 1 mm, a dusting mixture of calcium stearate and silicon dioxide is added, mixed and then tabletted. Get tablets with a diameter of 8 mm and a mass of 0.3 g.

EGME used in this embodiment is derived from gonads of sea urchins and contains 38% peptides, 1.0% amino acids, 0.4% polysaccharides, trace elements.

Example 5. The effect on sexual behavior of male rats

The level of sexual activity of males during the experiment was studied in three stages: before the administration of the studied drugs - stage 0, after a single injection - stage 1, and after repeated (60 days) administration - stage 2. Registration of indicators was carried out individually for each male, in the first half the dark phase of the light mode (from 11 to 15 hours). Induction of the sexual behavior of males was carried out by placing a female in a cage to a male in a state of artificially stimulated estrus. Registration of indicators began immediately after placing the female to the male and lasted 20 minutes. The experimental results are presented in tables 1 and 2.

The tool according to example 3 increased the libido of male rats in terms of latency of the cage (LPS) and latent period of intromission (LPI) after a single use (table 1), and these differences were the same after a single or after 60 days of administration the drug. Similar changes were observed against the background of the use of Viagra comparison drug; against the background of the use of the Tentex forte drug, there was no change in this indicator (Table 1).

Table 1 The latent period of cage and intromission after a single and 60-day administration of drugs% from 0 point (before drug administration) (n = 10) Group dose 1st stage 2nd stage LPS LPI LPS LPI The control 120 ± 12 107 ± 8 124 ± 8 105 ± 11 The tool according to example 3, 13 mg / kg 52 ± 6 * 59 ± 8 * 53 ± 6 * 62 ± 9 * Viagra, 9 mg / kg 24 ± 3 * 42 ± 6 * - - Tentex forte, 18 mg / kg 110 ± 9 104 ± 8 104 ± 8 99 ± 6 Notes: * - differences are statistically significant compared with the control group of animals, student t-test at p <0.05

A decrease in the latent period of the cage by 2.3 times and intromission by 1.8 times with the use of the agent of Example 3 indicates a decrease in the threshold of sexual arousal, which, in turn, indicates a positive effect of the drug on the libido of males.

The number of intromissions against the background of the administration of the studied drug according to example 3 increased statistically significantly after 60 days of drug administration by 59%, and the number of ejaculations - by 56% compared with the control (table 2). Against the background of the use of the drug Viagra, the number of intromissions increased after a single application. Against the background of the use of the drug Tentex forte, there were no changes in both indicators.

table 2 The number of intromissions and ejaculations after a single and 60-day administration of drugs% from 0 point (before drug administration) (n = 10) Group dose 1st stage 2nd stage Number of intromissions Ejaculation count Number of intromissions Ejaculation count The control 104 ± 5 111 ± 16 96 ± 7 93 ± 11 The tool according to example 3, 13 mg / kg 128 ± 10 115 ± 15 153 ± 14 * 145 ± 17 * Viagra, 9 mg / kg 172 ± 14 * 161 ± 16 * - - Tentex forte, 18 mg / kg 116 ± 15 93 ± 19 110 ± 9 77 ± 16 Notes: * - differences are statistically significant compared with the control group of animals, student t-test at p <0.05

Indicators of the number of intromissions and ejaculations characterize the erectile component of sexual behavior, the level of potency of males. And an increase in this indicator, coupled with an increase in libido, determines the lengthening of the copulatory act.

Example 5. The effect on the generative function of male rats. The experiment was conducted on 50 male rats and 100 female rats, which were divided into 10 groups: 2 control groups — intact females and males, which were injected with 1% methylcellulose solution; 3 groups of males who received, for 60 days, the product of example 4 in 3 doses of 1.3, 6.5 and 13 mg / kg, which corresponded to 3 groups of intact females; 1 group of males who received Tentex forte at a dose of 18 mg / kg for 60 days, which corresponded to a group of intact females. At the end of drug administration, experimental animals were mated.

During the experiment, the number of live and dead fetuses, pre- and post-implantation mortality was estimated for each female rat.

The males evaluated their ability to fertilize and conceive, calculated the pregnancy index, and the functional state of the sperm. The number of baby rats, weight gain, sex distribution, and physical development were evaluated in the offspring.

Under the influence of the means of example 3 in doses of 1.3, 6.5 and 13 mg / kg, an increase in the total number of sperm cells was observed by 19-21%. Sperm motility varied statistically significantly with the use of the agent of Example 3 at doses of 1.3, 6.5 and 13 mg / kg by 9, 12 and 16%, respectively. Under the influence of the drug Tentex forte, such changes were absent (Table 3).

Table 3 Functional state of sperm in rats (M ± m n = 10) Group dose Sperm count, million in 1 ml of ejaculate Mobile% Fixed% The control 12.9 ± 0.5 24.9 ± 0.9 75.1 ± 1.1 The agent according to example 3, 1.3 mg / kg 15.6 ± 0.6 * 27.2 ± 0.8 * 72.8 ± 1.3 * The tool according to example 3, 6.5 mg / kg 15.4 ± 0.5 * 28.0 ± 0.7 * 72.0 ± 1.2 * The tool according to example 3, 13 mg / kg 15.3 ± 0.7 * 28.8 ± 1.1 * 71.2 ± 1.1 * Tentex forte, 18 mg / kg 13.2 ± 0.6 22.1 ± 0.9 77.9 ± 1.0 Note: * - the differences are statistically significant compared with the control group by t-student test at p <0.05.

When using the product according to example 3, in doses of 1.3, 6.5 and 13 mg / kg in males and their further use to cover female rats, the pregnancy index was 97-99%, while the Tentex-forte pregnancy index was used. accounted for 90%.

When using the tool according to example 3, as well as when using the comparison drug Tentex forte, there was no negative effect on the generative function of the testes of experimental male rats and impaired prenatal development of offspring.

There was no increase in the levels of pre- and post-implantation mortality in the experimental groups compared with the control group.

The resulting offspring did not change the survival rate and weight gain when using the test tool according to example 3 and the comparison drug Tentex forte male rats. The use of drugs did not affect the number of born rat pups, as well as the level of death of newborns during feeding. The ratio of males and females in litters did not differ in the studied groups.

The parameters of the physical development of the rat pups (timing of the detachment of the auricle, appearance of the primary hairline, teething, opening of the eyes, lowering of the testes and opening of the vagina) were synchronous in the litters of the experimental and control groups. The zoopsychological development of rat pups from fathers who did not receive drugs and fathers who received the test agent of Example 3 and the Tentex forte comparison drug during spermatogenesis did not differ significantly. This fact indicates that the agent in doses of 1.3, 6.5 and 13 mg / kg does not have a negative effect on the morphological and functional state of sperm, which manifests itself in the postnatal period.

The observed improvement in sperm quality under the action of the agent of Example 3, primarily sperm motility, is especially important when using reproductive technologies such as intrauterine insemination and in vitro fertilization.

Example 6. The object of the study were extracts obtained from the gonads of a sea urchin, having a different set of biologically active compounds and considered as possible candidates for drugs for the prevention and treatment of andrological diseases.

The goal is to study the effect of new drug candidates from gonads (caviar) of sea urchin on ED in old rats with a single administration.

1. Extract from the gonads of the sea urchin "IE1"

Obtained by extraction of chloroform / ethanol (2/1). It is a viscous, thick, sticky mass of orange-brown color, soluble in hydrophobic solvents. To obtain the IE1 solution, corn oil was used (Refined, deodorized corn oil, grade P, GOST 8808-2000). Storage at a temperature not exceeding + 4 ° C.

2. Extract from the gonads of the sea urchin "IE2"

Obtained by cleaning eggs with a mixture of chloroform and ethanol (2: 1) and subsequent extraction with ethanol 95%. It is a viscous, thick, sticky mass of orange-brown color, soluble in hydrophobic solvents. To obtain a solution of IE2 extracts, corn oil was used (Refined, deodorized corn oil, grade P, GOST 8808-2000).

The extracts were stored at a temperature not exceeding + 4 ° C.

3. Extract from the gonads of the sea urchin "EEZ"

Obtained by purification of gonads with a mixture of chloroform and ethanol (2: 1) and subsequent extraction with ethanol 70% (the proposed tool). It is a yellow powder. To obtain the emulsion of the IEZ extracts, a solution of 70% ethanol and corn oil (refined, deodorized corn oil, grade P, GOST 8808-2000) was used.

Storage at a temperature not exceeding + 4 ° C.

4. Extract from the gonads of the sea urchin "IE4"

Obtained by purification of gonad with a mixture of chloroform and ethanol (2: 1) and subsequent extraction with ethanol 50%. It is a sticky powder of yellow-orange color. To obtain the emulsion of IE4 extracts, a 50% ethanol solution and corn oil were used (refined, deodorized corn oil, grade P, GOST 8808-2000).

Storage at a temperature not exceeding + 4 ° C.

5. Extract from the gonads of the sea urchin "IE5"

Obtained by purification of gonad with a mixture of chloroform and ethanol (2: 1) and subsequent extraction with ethanol 20%. It is a light brown powder. Distilled water was used to obtain a solution of IE5 extracts.

Storage at a temperature not exceeding + 4 ° C.

From the data given in table 4 it is seen that the use of old male rats as a model ofrectile dysfunction was justified. Old males receiving a placebo showed a lack of cages and intromissions, as well as low interest in females. Statistically significant differences in the behavioral reactions in experimental animals between the groups receiving the test extracts were revealed, and statistically significant differences in the studied parameters between the groups of animals receiving the preparations and the control animals were revealed.

Table 4 Rat libido ratios against the background of the use of the studied substances (M ± m n = 5) Group Nose sniffing Genital sniffing Auto-grooming Partner grooming Attempted Abstraction Intromission Control (starch solution) 2.4 ± 0.5 3.6 ± 1.1 13.2 ± 2.8 1.7 ± 0.7 0 0 IE1, 7 mg / kg 1.2 ± 0.2 * 7.0 ± 2.1 * 12.1 ± 4.5 12.7 ± 8.8 * 2.1 ± 1.1 * 0 IE2, 7 mg / kg 2.1 ± 0.4 * 5.6 ± 1.7 10.2 ± 4.2 4.0 ± 1.1 * 0 0 IE3, 7 mg / kg 3.8 ± 2.3 * 23.4 ± 10.5 * 17.8 ± 3.3 * 8.0 ± 3.0 * 6.7 ± 2.6 * 2.1 ± 0.7 * IE4, 7 ".g / kg 3.4 ± 1.1 * 10.4 ± 4.2 * 8.4 ± 2.9 3.7 ± 2.2 4.1 ± 1.7 * 1.7 ± 0.7 * IE5, 7 mg / kg 4.1 ± 1.5 * 8.4 ± 3.3 * 12.6 ± 2.8 9.0 ± 5.4 * 0 0 Note: * - the differences are statistically significant compared with the control group by t-student test at p <0.05

Extract IE 1 at a dose of 7 mg / kg showed no effect with respect to the effect on rat libido upon oral administration. This was expressed in the absence of intromission throughout the observation period after administration.

Extract IE 2 at a dose of 7 mg / kg also had no effect on intromission and attempted shrinking.

IE 3 extract at a dose of 7 mg / kg showed the most pronounced effect on libido, which was expressed in a significant increase in genital sniffing by 550% (from 3.6 ± 1.1 to 23.4 ± 10.5, p <0.05 ) and grooming by 370% (from 1.7 ± 0.7 to 8.0 ± 3.0, p <0.05) compared with the control, as well as the appearance of cage and intromission.

Extract IE 4 at a dose of 7 mg / kg had less pronounced effectiveness on sexual behavior when administered orally.

Extract IE 5 at a dose of 7 mg / kg did not show effectiveness, which was manifested in the absence of cages and intromission while maintaining interest in females.

It was found that when administered orally at a dose of 7 mg / kg, extracts were found to be effective for sexual behavior: IE 3> IE 4> IE 1. The extracts IE 2 and IE 5 did not affect erectile function in old Wis-tar rats.

Thus, the agent from the gonads of sea urchins has the entire spectrum of biological activity necessary for the formation and maintenance of androgenic functions (spermatogenesis, erectile function). It can be used in men with:

- oligospermia;

- infertility (impaired spermatogenesis);

- Erectile dysfunction (erectile dysfunction) of various origin;

- to restore and enhance sexual function, stimulate sexual desire, as well as the prevention of their disorders.

Claims (3)

1. A tool for the prevention and treatment of andrological diseases, characterized in that it is a dried alcoholic extract of the gonads of sea urchins Strongylocentrotus droebachiensis obtained by sequential treatment of gonads, to cleanse the ballast substances, with a two-phase extractant chloroform-ethanol (2: 1) in a ratio of 1: 1 : (5-7), then 95% ethyl alcohol at a ratio of 1: (5-10), keeping under periodic stirring for 17-24 hours in a dark place at room temperature, the solid residue after separation of the liquid extract for pour 70% ethyl alcohol in a ratio of 1: (4-7) and incubated with stirring and room temperature for 19-24 hours, separated and dried, while the resulting extract contains 15-40% peptides, 0.15-4% amino acids , 0.15-1.0% polysaccharides. 2. The tool according to claim 1, where the gonads of sea urchins are used fresh, frozen or dry. 3. The tool according to claim 1, characterized in that it can be made in the form of tablets or gelatin capsules.