RU2677686C1 - Medicine, pharmaceutical composition, method of treating urogenital diseases of the human body caused by microorganisms of the ureaplasma urealyticum type - Google Patents

Abstract

FIELD: medicine; pharmaceuticals.SUBSTANCE: invention relates to the pharmaceutical industry, in particular to an agent for the treatment of urogenital diseases of the human body caused by microorganisms of the Ureaplasma urealyticum species. Drug for the treatment of urogenital diseases of the human body caused by microorganisms of the species Ureaplasma urealyticum, which is a coniferous chlorophyll-carotene complex, obtained from pine needles based on Pinus Sylvestris and Picea abies (L.) Karst, taken at a ratio of 55:45, coniferous chlorophyll-carotene complex contains water in the amount of 38–42 wt%, the amount of erosive substances 55–61 wt%, the amount of chlorophyll derivatives 0.6–1.2 wt%, moreover, the amount of extractive substances contains: 42–47 wt% of free acids, including pinifilic acid in the amount of 16.5–21.4 wt% of the sum of free acids, 53–58 wt% of neutral components, including in wt% of the sum of neutral components: isoabienol in the amount of 19.3–24.4; the amount of carotenoids selected from lutein, zeaxanthin, β-carotene, 0.3–0.5; waxes 1.7–3.1; essential oils 0.6–0.9. Pharmaceutical composition for the treatment of urogenital diseases of the human body caused by microorganisms of the species Ureaplasma urealyticum. Use of coniferous chlorophyll-carotene complex for the treatment of urogenital diseases of the human body caused by microorganisms of the species Ureaplasma urealyticum. Method for the treatment of urogenital diseases of the human body caused by microorganisms of the species Ureaplasma urealyticum.EFFECT: above remedy is effective for the treatment of urogenital diseases of the human body caused by microorganisms of the species Ureaplasma urealyticum.5 cl, 6 tbl, 8 ex

Description

Technical field

The invention is a group of inventions and relates to the field of medicine, namely to means and methods for treating urogenital diseases of the human body caused by microorganisms of the species Ureaplasma urealyticum.

State of the art

Today, one of the frequently detected conditionally pathogenic microorganisms in the organs of the genitourinary system of the human body is the urogenital microorganisms of the species Ureaplasma urealyticum. The interest of researchers and practitioners in studying their role in the etiology of inflammatory diseases of the genitourinary system is due not only to the wide distribution in the population, but also to the ambiguous attitude towards participating in the development of pathological processes. Ureaplasma urealyticum is present in the urethra, vagina, rectum in 20-75% of healthy people [Nemchenko OI, Uvarova EV Urogenital mycoplasmosis (literature review) // Consilium Medicum. 2007, No. 1, p. 45-51].

It is known that genital mycoplasmas are transmitted and spread during sexual contact, during the passage of the fetus through the genital tract of the mother. In newborns, Ureaplasma urealyticum can be isolated from the mouth, nose, pharynx, genitals, urine, and more often in girls than in boys. Colonization of the genitourinary tract in children is transient and disappears quite quickly, but in 5-20% it persists even at puberty.

The studies confirm the etiological role of Ureaplasma urealyticum in the development of non-gonococcal urethritis and cystitis in both sexes [V. Meshkov. Clinical and microbiological characteristics of the inflammatory process of the lower urinary tract associated with Ureaplasma urealyticum in women: Abstract. dis. Cand. honey. sciences / V.V. Meshkov, M., 2004, 22 pp.]. Ureaplasma urealyticum is thought to cause various genitourinary tract syndromes, such as pyelonephritis or infertility. In women with dysuria, Ureaplasma urealyticum was found to be the predominant infectious agent. [O.V. Lysenko, T.V. Kuznechenkova, V.A. Iglikov, V.P. Deryabin. The prevalence of inflammatory diseases of the genitourinary organs associated with genital mycoplasmas. The effectiveness of the treatment. // Bulletin of Dermatology and Venereology. 2010, No. 2, p. 83-88]. The question of the significance of Ureaplasma urealyticum in the genesis of reproductive dysfunction is discussed; this microorganism was detected in 10.8% of infertile men without signs of urogenital tract damage. With a large concentration of ureaplasma, the sperm is deformed, they attach to the sperm head in the middle part, which reduces their mobility and fertility. Ureaplasma prostatitis, a non-gonococcal type, which takes a chronic course and is difficult to treat, is also described. [Gambini D., Decleva I., Lupica L., Ghislanzoni M., Cusini M., Alessi E. Mycoplasma genitalium in males with nongonococcal urethritis: prevalence and clinical efficacy of eradication // Sex. Transm. Dis. 2000, Vol. 27, P. 226-229].

Antibacterial drugs are known that are prescribed for urogenital infections caused by microorganisms of the Ureaplasma urealyticum species, these are antibiotics: tetracyclines, macrolides, azalides, fluoroquinolones. The sensitivity of mycoplasmas to antibiotics is very wide (Review of articles in the journal Antimicrob. Agents Chemother, 1992-2003). All mycoplasmas are resistant to cephalosporins, penicillins, rifampicin, nalidixic acid. Currently, in obstetric and gynecological practice, especially in the treatment of pregnant women, the most commonly used is josamycin (Vilprafen), which is prescribed to pregnant women with a burdened obstetric history if they have massive mycoplasma colonization of the vagina. In this case, Vilprafen is prescribed orally at a dose of 500 mg 3 times a day for 10 days. Nonpregnant women, as well as men, are prescribed tetracyclines, including doxycycline (Unidox Solutab) inside at a dose of 100 mg 2 times a day for 10 days, azithromycin, prescribed at a dose of 1 g once, is the drug of choice.

However, all antibiotics have side effects that often cause significant harm to the human body, especially their use is undesirable during pregnancy and lactation. In addition, a number of specialists note a higher elimination ability of doxycycline against Ureaplasma urealyticum compared to macrolides. One of the significant problems with the use of tetracycline drugs is its poor tolerance: toxic effects on the liver, blood, decreased absorption of such important trace elements as iron, calcium, magnesium.

The closest analogue of the claimed invention is an antibiotic - doxycycline, which is most often used in relation to these microorganisms for the treatment of urogenital infections. [Makarov O.V. Infections in obstetrics and gynecology, O.V. Makarov, V.A. Aleshkin, T.N. Savchenko. M.: MEDpress-inform, 2007, 464 p.]

Doxycycline is a semi-synthetic antibiotic of the broad-spectrum tetracycline group. It has a bacteriostatic effect due to the suppression of protein synthesis of pathogens. After oral administration, it is rapidly and almost completely absorbed from the gastrointestinal tract. Despite the marked increase in the resistance of Ureaplasma urealyticum to tetracyclines in several countries, the above treatment regimens demonstrate comparable efficacy. Some studies indicate that treatment with tetracyclines does not produce the desired effect. [Falk L., Fredlund N., Jensen J.S. Tetracycline treatment does not eradicate Mycoplasma genitalium // Sex. Transm. Infect, 2003, Vol. 79, P. 318-319].

However, doxycycline, like other antibiotics, has hepatotoxicity and can have a negative effect on the blood, causing thrombocytopenia and neuropenia. It causes allergic reactions, potentiates the effect of indirect anticoagulants. Doxycycline is contraindicated in pregnancy and lactation, because it crosses the placental barrier. It can cause irreversible discoloration of the teeth, enamel hypoplasia, suppression of bone growth and the fragility of the skeleton of the fetus, as well as the development of fatty liver. Due to the suppression of intestinal microflora, doxycycline reduces the prothrombin index, which requires dose adjustment of indirect anticoagulants. Reception of doxycycline reduces the reliability of contraception and increases the frequency of bleeding while taking estrogen-containing oral contraceptives. The simultaneous use of doxycycline and retinol increases intracranial pressure. With cerebral lesions of the ureaplasma etiology in premature infants, the use of doxycycline does not have a clinically pronounced effect.

To date, there is no reliable antibiotic for the treatment of infections of the urogenital tract, chronic prostatitis and other diseases associated with mycoplasmas. In recent years, the treatment of mycoplasmosis and its associates has become more complicated due to the emergence of strains that are resistant to antibiotics and multi-drug resistance. The position that a chronic urogenital infection (urethritis, cervitis, bacterial vulvovaginitis) proceeds as a mixed invasion of mycoplasmas and serves as an indicator of a violation of human immunoresistance is justified, therefore, one has to resort to the appointment of antioxidants, immunostimulants and drugs that restore the normal microflora of the vagina and intestines ( and probiotics).

Methods of treating diseases of the urogenital tract caused by mycoplasmas in these cases are complex, phased and include treatment with drugs that not only inhibit the growth of mycoplasmas, but also restore the microflora and the body's immune resistance. In etiotropic therapy include a lot of drugs and methods. Treatment that complements antibiotic therapy includes immunotherapy, restorative drugs, physiotherapy, and bacterial preparations that restore microflora (lactic acid bacteria, lactobacterin, colibacterin). Also used are prebiotics containing lactulose, such as Lactusan, Dufalac, Normase, and the prebiotic inulin, which enhance the reproduction of the physiologically normal microflora of the vagina and intestines. Currently existing generally accepted treatment regimens do not always give the proper effect due to the fact that the individual characteristics of the patient’s body are not taken into account: the presence of concomitant diseases, changes in the immune system, as well as the characteristics of the pathogen (state of its biological activity, resistance to antibiotics).

The disadvantages of the above described methods of treatment are: an insignificant result, the inability to completely suppress the growth of microorganisms and cope with the infection, since many multiresistant strains of antibiotics have appeared. Also, the specificity of "membrane parasites", which penetrate into the cells, do not find obstacles from the human immune system and contribute to the spread of infection.

Disclosure of invention

The aim of the present invention is the creation of a new herbal medicine, a new pharmaceutical composition of herbal origin, with antibacterial and antioxidant activity, capable of suppressing foci of infection, the growth of concomitant pathogenic microflora, with minimal side effect and enhancing the body’s immune response, as well as a new method for treating urogenital diseases of the human body caused by microorganisms of the species Ureaplasma urealyticum.

To achieve this goal, the authors proposed:

A medicine for the treatment of urogenital diseases of the human body caused by microorganisms of the species Ureaplasma urealyticum, which is a coniferous chlorophyll-carotene complex obtained from needles based on Pinus Sylvestris and Picea abies (L.) Karst, taken in a ratio of 55:45. The coniferous chlorophyll-carotene complex contains water in an amount of 38-42 mass%, the amount of extractive substances 55-61 mass%, the sum of chlorophyll derivatives 0.6-1.2 mass%, and the sum of extractive substances contains: 42-47 mass% of free acids including pinifilic acid in the amount of 16.5-21.4 wt% of the total free acids, 53-58 mass% of neutral components, including in mass% of the sum of neutral components: isoabienol in the amount of 19.3-24.4; the amount of carotenoids selected from lutein, zeaxanthin, β-carotene, 0.3-0.5; waxes 1.7-3.1; essential oils 0.6-0.9.

The pharmaceutical composition for treating urogenital diseases of the human body caused by microorganisms of the Ureaplasma urealyticum species contains the aforementioned coniferous chlorophyll-carotene complex in a therapeutically effective amount and pharmaceutically acceptable carriers and / or solvents, the pharmaceutical composition being in the form of a solution, suspension, capsule, tablet, granules, suppositories.

The use of the aforementioned coniferous chlorophyll-carotene complex for the treatment of urogenital diseases of the human body caused by microorganisms of the species Ureaplasma urealyticum.

A method of treating urogenital diseases of the human body caused by microorganisms of the species Ureaplasma urealyticum involves administering an effective amount of the above-mentioned coniferous chlorophyll-carotene complex in a daily dose for a person from 100 to 1280 mg.

The implementation of the invention

The authors conducted studies of the inventive herbal medicines with antibacterial activity against microorganisms of the species Ureaplasma urealyticum. The product is a coniferous chlorophyll-carotene complex of plant origin (CGNC - Conifer Green Needle Complex), which contains biologically active natural compounds. This is a thick dark green paste with the smell of needles.

The coniferous chlorophyll-carotene complex CGNC can be used both as an independent agent and as part of pharmaceutical compositions in combination with pharmaceutically acceptable carriers, solvents and excipients.

The coniferous complex CGNC contains sodium salts of higher fatty and resin acids, chlorophyll and its derivatives, carotenoids, terpenoids and their derivatives (salts, esters, di- and tricyclic terpenic acids, as well as their salts and esters, including labdanum type - pinifolic acid), terpenoid alcohols, including isoabienol, polyprenols and their acetates. In addition, the CGNC coniferous complex contains pinifolic acid in an amount of at least 16-23% of the total amount of acids and isoabienol in an amount of at least 11-18% of the neutral fraction, polyprenols and their acetates in an amount of 1.5-2.5%.

Get coniferous complex CGNC from strictly regulated raw materials - needles, consisting of 55% Pinus Sylvestris and 45% Picea abies (L.) Karst.

The authors conducted studies and studied the antibacterial activity of CGNC on microorganisms of the species Ureaplasma urealyticum.

Studies have been conducted on the antibacterial action of CGNC in various concentrations - 100, 200, 300 mg / ml. CGNC was dissolved in hot (56 ° C) sterile distilled water, the initial solution was prepared at a concentration of 1000 mg / ml and then used to obtain solutions with desired concentrations. The research results were carried out in several stages, which are shown in the examples.

At the NIEM them. Pasteur (St. Petersburg), in the immunology laboratory, patients with diseases of the urogenital tract were examined, from which viable strains of the species Ureaplasma urealyticum were isolated, which were tested for sensitivity to the coniferous chlorophyll-carotene complex CGNC and doxycycline. The work was carried out during the examination of 180 patients aged 23 to 51 years with diseases of the urogenital tract, from which 20 viable strains were isolated. Patients were examined on an outpatient basis: some patients first went to the doctor about pregnancy, infertility, chronic cystitis, others came back for a second with a diagnosis of chronic vaginal candidiasis (CVB), trichomoniasis, mycoplasmosis, chronic prostatitis. Some had a history of concomitant infections, such as gardenenosis, chlamydia, and some had no complaints. Microorganism strains of the species Ureaplasma urealyticum were found in these patients (Appendix 1 Table 1).

For Ureaplasma urealyticum, doxycycline was chosen as the reference drug. Sensitivity to doxycycline was determined on S.I.R. MYCOPLASMA (BIO-RAD Laboratories) in accordance with the instructions for the test system. For the antibiotic resistance test, the pathogen concentration was not lower than 104 CFU / ml, microorganisms were tested in the logarithmic growth phase. Doxycycline was present in the nutrient medium at concentrations of 4 mg / L and 8 mg / L. The color change in the samples with both concentrations of doxycycline made it possible to evaluate the strain as resistant, the color change in the sample containing 8 mg / l of antibiotic as moderately resistant. No color change in both samples, as a sensitive strain.

Example 1. Suppression of the growth and reproduction of microorganisms of the species Ureaplasma spp. On clinical strains taken from patients with diseases of the urogenital tract in comparison with the drug - doxycycline. Testing of coniferous chlorophyll-carotene complex in relation to clinical strains of microorganisms of the species Ureaplasma spp. given in table 2.

For the work, 10 clinical, well reproducible strains, Ureaplasma urealyticum, were selected. After selection of strains based on testing of patient profiles and typing of isolates by PCR-RT, all selected cultures were tested for sensitivity to the coniferous chlorophyll-carotene complex (Table 2).

The following are data on the study of the antibacterial activity of the coniferous chlorophyll-carotene complex in relation to the clinical strains of Ureaplasma urealyticum in table 2.

Designations: I - relatively resistant, R - resistant, S - sensitive. * - concentration of doxycycline 8 mg / l.

Five strains (155-2910, 150-2910. 146-2910, 144-2910, 10-2610) died in the presence of coniferous complex in concentrations from 100 mg / ml. Strain 132-2610 was sensitive to the coniferous complex at concentrations of 200 and 300 mg / ml. Strain 128-2910, relatively resistant to doxycycline, was resistant to the coniferous complex in all three concentrations. Strain 125-2110 showed moderate sensitivity to the coniferous complex: its concentrations of 200 and 300 mg / ml significantly reduced the amount of Ureaplasma urealyticum, but no absolute destruction of microorganisms was observed.

Thus, the strain Ureaplasma urealyticum showed good sensitivity to the coniferous complex, comparable with sensitivity to doxycycline (Table 3).

In relation to microorganisms of the species Ureaplasma urealyticum, it was found that the sensitivity of the drug and the antibiotic doxycycline lie in the same range of 86.6-90.0%. But, the fact that Ureaplasma urealyticum, resistant to doxycycline, turned out to be sensitive to the coniferous chlorophyll-carotene complex prompted the authors to continue research in this direction.

Example 2. Suppression of the growth and reproduction of microorganisms of the species Ureaplasma urealyticum resistant to doxycycline.

Research was continued on clinical strains of Ureaplasma urealyticum to determine whether the coniferous chlorophyll-carotene complex would inhibit the growth of doxycycline-resistant microorganisms. This was done by selecting from a group of patients aged 17 to 49 years with urogenital infection clinical strains of the species Ureaplasma spp. Who underwent several courses of antibiotic therapy (including doxycycline), but did not achieve treatment success (Appendix 2 Table 4 ) 220 patients (95 men and 125 women) with chronic inflammatory diseases of the urogenital tract and examined by contact were examined. At the same time, 60% of patients presented various complaints in the genital area for discomfort, discharge, burning, itching, and 40% of patients did not complain and were examined.

A total of 10 viable strains of Ureaplasma spp., Resistant to the antibiotic doxycycline, were isolated. Strains of Ureaplasma spp., Resistant to doxycycline, were isolated from patients, of which women make up 50% with a diagnosis of cervicitis, cystitis, bacterial vaginosis and 50% of men with a diagnosis of urethritis, chronic prostatitis, chlamydia, as well as examined by contact with sexual partners infected microorganisms of the genus Ureaplasma spp. All patients indicated a multiple (2-3 courses) and long-term treatment (up to 5 courses) with a history of antibiotics, which did not bring a positive effect in the treatment of the underlying disease associated with an infection of the urogenital tract. (Appendix 2 Table 4).

Legend: R - Resistant

As can be seen from table 5, a study of the antibacterial activity of the drug in respect of 10 strains of Ureaplasma spp., Resistant to doxycycline, found that the coniferous complex inhibited the growth and reproduction of these microorganisms. Only one strain 1461603, isolated from a patient with a diagnosis of cystitis, repeatedly and ineffectively treated with antibiotics, was resistant to the coniferous complex. Strain 1242203 remained viable in the presence of coniferous complex at a concentration of 100 mg / ml, but was destroyed at higher concentrations of this drug.

Thus, in this case, when isolating the clinical strains of Ureaplasma spp. Resistant to doxycycline, the coniferous chlorophyll-carotene complex was highly effective at all concentrations from 100 to 300 mg / ml and suppressed growth in 80-90% of cases, while the drug comparisons doxycycline was not active.

Thus, in 90% of cases, the coniferous chlorophyll-carotene complex in the maximum concentration suppressed the growth and reproduction of the microorganism of the species Ureaplasma spp., While the antibiotic doxycycline did not act on these strains. The data obtained demonstrate new properties and the specific effect of the drug against this microorganism, which is not affected by the antibiotic, and shows the possibility of using the coniferous chlorophyll-carotene complex even in cases where antibiotic therapy has no effect.

The coniferous chlorophyll-carotene complex can be used both as an independent agent and as part of pharmaceutical compositions in combination with pharmaceutically acceptable carriers, solvents and excipients.

An effective amount is in the range from 1.0 to 1500 mg per day and can be administered as a single dose or in multiple doses. More specific amounts depend on the type of pathology, the condition of the patient, the presence of isolated strains of microorganisms, since the choice of doses and the duration of treatment are strictly individual.

Examples of pharmaceutical compositions include any solid (capsules, tablets, granules, powders, etc.) or liquid (solutions, suspensions, emulsions) oral forms, semi-solid forms for external use (creams, gels, ointments) or traditional forms for rectal and vaginal administration (suppositories).

Compositions for oral administration may contain traditional excipients / ingredients, they can be made in solid or liquid form: in the form of capsules, tablets, solution, suspension or syrup. They may contain any suitable excipients, such as binders (e.g. sugar, gelatin, sorbitol, carrageenan or polyvinylpyrrolidone), excipients (lactose, soybean oil, starch, calcium phosphate, sorbitol), tabletting lubricants (e.g. magnesium stearate, silicon dioxide ), disintegrants (e.g. hydroxypropyl starch, glycerin, polyvinylpyrrolidone (PVP), microcrystalline cellulose, carboxymethyl cellulose), fluidity improvers (e.g. colloidal silicon dioxide; talc), moisturizers (e.g. sodium l uril sulfate), surface-active or dispersing agent.

Liquid forms for oral administration may include solvents (water, vegetable or animal oils, mineral oil), dextrose, other saccharide solutions, glycols and surfactants or dispersants (surfactants), colorants and flavorings.

These compositions are prepared by known conventional methods, including mixing the active ingredient with a carrier, which may contain one or more auxiliary ingredients, using a wet or dry process for preparing a ready-to-sell product from a mixture.

Tablets can be obtained by compression using appropriate equipment, and the active ingredient in the form of a paste, powder or granules, if necessary, is mixed with excipients (e.g. lactose, calcium phosphate, sugars, sorbitol, microcrystalline cellulose), binders (e.g. povidone, starch , gelatin, hydroxypropyl methylcellulose), lubricants (e.g. stearic acid, magnesium stearate), fluidity improvers (e.g. colloidal silicon dioxide; talc), inert solution telyami, disintegrants (such as cellulose derivatives, starch, cross-linked povidone, sodium carboxymethyl cellulose) surface-active or dispersing agents. Tablets obtained by molding on appropriate equipment contain a mixture of moistened powder of coniferous complex with inert liquid solvents.

The pharmaceutical composition can be produced in the form of dry granules or powder, either in the form of raw materials for the tabletting process, or in the form of granules formed during the tablet manufacturing process using a granulation process in which the CGNC coniferous complex and carriers are granulated using a solution of suitable binders ( for example, an aqueous solution of PVP, starch pastes, etc.).

If necessary, tablets can be obtained with a different shell: to mask the taste or for better preservation, or for delayed or controlled release of the active ingredient.

The tablet shell typically includes a film former, such as methyl cellulose, hydroxypropyl methyl cellulose, PVP, and plasticizers such as triacetin, polyethylene glycol, or glycerol, emulsifiers (e.g., talc), colorants, and sometimes gloss, such as beeswax or carnauba wax. Enteral coatings include enteric polymers such as acrylates (Eudragits), phthalate esters (e.g., cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate).

The capsule shell usually includes a film former (gelatin, carrageenin, etc.), a plasticizer (glycerin, triacetin, water) and other excipients such as buffering systems, preservatives, dyes. Shells can be obtained, for example, from hydroxypropyl starch, 2-basic sodium phosphate, glycerol, or hydroxypropyl methylcellulose or a mixture thereof with gelling agents (carrageenin, gelatin, waxes) in different ratios to provide the desired release profile.

Compositions for parenteral administration can be prepared both by traditional methods in pharmacy (solutions, suspensions), and in the form of aqueous microemulsions according to patent RU 2189231 based on Hanks solution with 10% ethanol solution or other methods. These may include water, pharmaceutically acceptable fats or oils, alcohols or other organic solvents, surfactants and / or antioxidants, preservatives. Typical coniferous complex concentrations range from 0.01% to 80%. Finished formulations may contain a single dose or in the form of vials containing several single doses. Finished dosage forms, if necessary, may contain stabilizers, buffer systems, and other auxiliary agents.

Rectal or vaginal suppositories may include industry-known traditional ingredients such as hydrophobic or hydrophilic bases (e.g., solid fats, cocoa butter and / or derivatives thereof, semi-synthetic glycerides (Novata, Wittespol, Suppocire or Ovucire series), polyethylene glycols, glycerin, gelatin ), viscosity enhancers (stearic acid, colloidal silicon dioxide), mechanical enhancers (castor oil, glycerin, polysorbates), emulsifiers (lecithin, polysorbates, cetostearyl alcohol), and other substances such as preservatives and buffer systems. Vaginal suppositories can also be formed in the form of tablets, and even with some degree of blistering. They are usually produced by a granulation process and often use a water-soluble diluent such as lactose.

Compositions for external use are prepared by traditional methods in pharmacy, mixing the fat base with an emulsifier and an aqueous base into which the coniferous complex is introduced.

Examples of pharmaceutical compositions:

Example No. 1. Liquid water-soluble oral suspension form.

Coniferous chlorophyll-carotene complex 1-15 mass. % Tween80 2-10 mass. % Ethanol 1-10 mass. % Purified (pyrogen-free) water the rest is up to 100 mass. %

CGNC is mixed with Tween-80 and ethanol until a homogeneous mass is obtained with stirring and a temperature of 50-80 ° C, then purified (pyrogen-free water) is gradually added in small portions until a colloidal solution is obtained, poured into vials, sterilized.

Example No. 2. Liquid fat-soluble oral form.

Coniferous chlorophyll-carotene complex 5-60 mass. % Lecithin 5-10 mass. % Deodorized Vegetable Oil (sunflower and / or olive and / or coconut, and / or peanut and / or castor oil) the rest is up to 100 mass. %

CGNC, lecithin and vegetable oil are mixed in the specified proportion, the mixture is heated to 50-60 ° C, mixed and poured into vials with a dispenser, sterilized.

Example No. 3. Oral form in the form of tablets.

Coniferous chlorophyll-carotene complex 5-45 mass. % Lactose 5-40 mass. % Starch 20-30 mass. % MCC 5-40 mass. % PVP 2-5 mass. % Calcium stearate 0.5-2.0 mass. %

Example No. 4. Soft food capsules.

The contents of the capsule.

Coniferous chlorophyll-carotene complex 5-40 mass. % Vegetable oil deodorized and / or soybean oil, coconut oil, and / or hydroxypropyl starch up to 100 mass. %

Capsule shell.

Film-forming substance 10-25 mass. % (gelatin, carrageenin) Glycerol 5-20 mass. % Buffer 0-1 mass. % Dye on demand Preservative 0.1-2 mass. % Water the rest is up to 100 mass. %

These ingredients are mixed, placed in capsules, which are packaged in blisters.

Example No. 5. Rectal or Vaginal Suppositories

Coniferous chlorophyll-carotene complex 100-500 mg (4-20 wt.%) Lecithin 25-250 mg (1-10 wt.%) Castor oil 50-250 mg (2-10 wt.%) Preservative 0.001-0.2 mass. % Cacao butter up to 2,500 mg.

Example No. 6. Vaginal suppositories.

They usually weigh 2-4 g, and examples indicate that the content of active substances (solids) is usually about 10-25%.

Coniferous chlorophyll-carotene complex 100-500 mg (4-20 wt.%) Castor oil 50-250 mg (2-10 wt.%) Colloidal silicon 50-500 mg (2-20 wt.%) Peg 4000 up to 2,500 mg.

Example No. 7. Ointment for external use 10%.

1 g of ointment contains 300 mg of CGNC coniferous complex and excipients: sodium bicarbonate, macrogol 400, macrogol 4000, macrogol 1000, purified water; ointment is packaged in aluminum tubes of 20 g and placed in a cardboard box.

Example No. 8. Vaginal gel.

Coniferous chlorophyll-carotene complex 3-15 mass. % Carbapol 0.5-3.0 mass. % Triethanolamine (TEA) or 15% solution sodium alkali 0.2-2.0 mass. % Polysorbate 0.001-5 mass. % Preservative 0.001-0.2 mass. % Glycerol 10-30 mass. % Water the rest is up to 100 mass. %

Industrial applicability

Studies and tests have shown that the use of the coniferous chlorophyll-carotene complex (both as an independent agent and as part of pharmaceutical compositions in combination with pharmaceutically acceptable carriers, solvents and auxiliaries) in the treatment of urogenital infections associated with microorganisms of the species Ureaplasma urealyticum, including doxycycline resistant strains, it is a gentle method of treatment and will be widely used in medicine. The data obtained demonstrate new properties and the specific effect of the drug against strains of these microorganisms, including those resistant to doxycycline.

So today, drugs with coniferous chlorophyll-carotene complex have established themselves as drugs with minimal side effects (individual intolerance) compared to antibiotics. The manufacturing technology of drugs includes well-known generally accepted methods and does not require expensive equipment.

Annex 1

Designations: NMC - menstrual irregularities, AB-antibiotic therapy, HBV-chronic bacterial vaginosis

Appendix 2

Claims (5)

1. A drug for the treatment of urogenital diseases of the human body caused by microorganisms of the species Ureaplasma urealyticum, characterized in that it is a coniferous chlorophyll-carotene complex obtained from needles based on Pinus Sylvestris and Picea abies (L.) Karst, taken in the ratio 55 : 45, coniferous chlorophyll-carotene complex contains water in an amount of 38-42 mass%, the amount of extractive substances 55-61 mass%, the sum of chlorophyll derivatives 0.6-1.2 mass%, and the sum of extractive substances contains: 42-47 mass % free acids, including pinifilo th acid of 16,5-21,4% by weight of the sum of the free acids, 53-58% by weight of neutral components, including the mass% of the neutral components: izoabienol in an amount of 19,3-24,4; the amount of carotenoids selected from lutein, zeaxanthin, β-carotene, 0.3-0.5; waxes 1.7-3.1; essential oils 0.6-0.9. 2. A pharmaceutical composition for the treatment of urogenital diseases of the human body caused by microorganisms of the species Ureaplasma urealyticum, characterized in that it contains a coniferous chlorophyll-carotene complex according to claim 1 in a therapeutically effective amount and pharmaceutically acceptable carriers and / or solvents. 3. The pharmaceutical composition according to claim 2, characterized in that it is made in the form of a solution, suspension, capsule, tablet, granule, suppository. 4. The use of the coniferous chlorophyll-carotene complex according to claim 1 for the treatment of urogenital diseases of the human body caused by microorganisms of the species Ureaplasma urealyticum. 5. A method of treating urogenital diseases of the human body caused by microorganisms of the species Ureaplasma urealyticum, characterized in that an effective amount of the coniferous chlorophyll-carotene complex according to claim 1 is administered in a daily dose for a person from 100 to 1280 mg.