Agent for treatment of gynecological and proctological diseases

FIELD: medicine, gynecology, proctology, pharmacy.

SUBSTANCE: invention relates to medicaments made as vaginal and rectal suppository used in treatment of proctological, non-inflammatory and inflammatory diseases of female pelvis organs, among them complicated with suppurative-inflammatory processes. Invention relates to an agent used in treatment of gynecological and proctological diseases it is made as a suppository and comprises 2-ethyl-6-methyl-3-oxypyridine succinate as an active component and a base chosen from group involving polyethylene oxide-1500, polyethylene oxide-400, cacao butter and hydrogenated fats. Invention provides prolonged release of a curative preparation in mucosa and soft tissues and provides its effect for about 12 h. The procedure is suitable and easy in performance and can be carried out by patients independently under ambulatory conditions.

EFFECT: valuable medicinal and pharmaceutical properties of agent.

3 cl, 2 tbl, 2 ex

 

The invention relates to medicine, namely to medicines, made in the form of vaginal suppositories and rectal.

Vaginal suppositories can be used in the treatment of inflammatory diseases of female pelvic organs, including complications of purulent-inflammatory processes:

- salpingitis and oophoritis (acute and chronic);

- an inflammatory disease of the uterus (acute and chronic);

- endo(m & e)metritis); metritis; myometrium; pyometra; abscess of the uterus;

inflammatory disease of cervix uteri; cervicitis, endocervicitis, ectocervical - with or without erosion or ectropion;

- diseases of Bartolomeu gland (cyst, abscess, we have to stop spreading......);

other inflammatory diseases of the vagina and vulva (vaginitis, vulva, vulvovaginitis, vulvar abscess, ulceration of the vagina and vulva;

and non-inflammatory diseases of female genital organs:

- endometriosis;

- prolapse of female genital organs; cystocele, urethrocele, urethrocele, rectocele;

- fistula involving female genital mutilation;

the polyp of female genital organs (uterus, cervix, vagina, vulva......);

- erosion and ectropion of cervix uteri (decapetala (trophic) ulcer);

- cervical dysplasia;

- other non-inflammatory disease of cervix uteri - leukoplasia, stricture and stenosis, insufficiency.....;

- other non-inflammatory diseases of the vagina (dysplasia, leukoplakia, stricture and atresia, Beli, ulcers.......

- Other non-inflammatory disease of the vulva and perineum (dysplasia, leukoplakia), and after surgical interventions on the organs of small pelvis for the prevention of postoperative adhesions, purulent complications, gynecological surgeries, including laparoscopic; postpartum; after instrumental preventive examinations; diagnostic procedures in the vagina; intrauterine manipulation (including abortions).

The known method of prevention of suppuration of wounds of the perineum after its dissection or rupture during childbirth, including a single chip wounds 5% solution of Mexidol in the amount of 2 ml (RF patent 2146523, 2000).

Famous female tampon with prolonged curative action, therapeutic shell which may contain Mexidol with other drugs (RF patent 2178312, 2002).

Known medicines vaginal suppositories, which include antiseptic (povidone-iodine is a complex of PVP iodine, chlorhexidine digluconate), which are used in infectious-inflammatory diseases of female genital organs. However, all of them have adverse reactions: allergies of different types, poorly compatible with friends and drugs, have only a local antiseptic, not promoting epithelization and restore the function of damaged tissues.

Also known vaginal suppositories, which include ketoconazole and butylacetamide used only as antifungal (fungicidal, fungistatic) means, not shown anti-inflammatory and healing effect.

Also known vaginal suppositories, which include antibiotics (nifuratel, nystatin, metronidazole, miconazole nitrate)is used as an antibacterial, antifungal, Antiprotozoal drugs (RLS, M., 2002).

The disadvantage of these tools is their unidirectionality action - antimicrobial or antifungal. They have limitations because of the frequent individual intolerances, as well as the risk of development of side effects with long-term use - reducing the sensitivity of microflora, the emergence of resistant microorganisms and fungi, violation of functions of internal organs when their systemic effects.

Object of the invention is the expansion of the range of drugs that have anti-inflammatory and antibacterial actions used in gynecology for the treatment of inflammation, damage and postoperative of oslojnenny the bodies of female genitals.

This object is achieved in that the proposed remedy for the treatment of gynecological and proctological diseases, made in the form of a suppository containing the active substance 2-ethyl-6-methyl-3-oksipiridina succinate and a base selected from the group of polyethylene oxide 1500, polyethylene oxide 400, cocoa butter, hydrogenated fats, in the following ingredients on one candle:

2-ethyl-6-methyl-3-oksipiridina succinate0,1-1,0
Base1,0-6,0

The tool is intended for the treatment of hemorrhoids, fissures, inflammation and wounds after operations and manipulations in the rectum, as well as for the treatment of non-inflammatory and inflammatory diseases of the pelvic organs in women, including complications of purulent-inflammatory processes, as well as after surgery.

Suppozitornoj bases used in the manufacture of candles:

1) lipophilic - cocoa butter, hydrogenated fats, products of their thermal fractionation is used for the manufacture of suppositories method of pouring;

2) the hydrophilic base and gelatino-glycerol, b) soap-glycerin and polietilenoksidnoy basics, including a mixture of polyethylene oxide 1500 and polyethylene oxide 400.

Using e is the base, you can get suppositories as a method of moulding and pressing. The disadvantage of this framework is that due to the osmotic activity it causes dehydration and irritation of the mucous membrane of the vagina and the rectum.

3) debilnye basics: Lana (Lanolum), witepsol (Witepsolum), labopol (Lasupolum), parkhill, Unilever, harthat and other

Debilnye framework has been used for the preparation of suppositories method of pouring.

Suppositories were mainly prepared by usual method of pouring adopted in the pharmaceutical industry.

The composition for preparation of a vaginal suppository:

2-ethyl-6-methyl-3-oksipiridina succinate - 0,125 1 candle (or 5% by weight); the basis - devilina - paril or harthat, or Unilever or witepsol to obtain suppository weight of 5.0.

Clinical trials were conducted on volunteers:

Example 1:

Patient C., 33 years. Diagnosis: cervical erosion. Conducted cryosurgery. The treatment was carried out with the use of vaginal suppositories containing the active substance is 5% and the basis - witepsol, which was administered 2 times a day (morning and evening) for 5 days.

During treatment the process of regeneration of the mucous was successful, mucous on the wound surface was fully restored.

Pain to palpation in the surgical wound disappeared on the 2nd day of th is operation. Postoperative complications were not.

Example 2. Patient K., aged 60. The diagnosis of prolapse of the anterior wall of the vagina.

Surgery plastic of the front wall of the vagina. Treatment sutured wounds were conducted with the use of vaginal suppositories (same composition), which was administered 2 times a day for 5 days.

After 5 days the wound healed completely without scars, restore the structure and functioning of the microcirculatory system and the mucous membrane of the vagina; pain on palpation of the postoperative wounds disappeared on the 2nd day of treatment. Temperature response in the postoperative period was absent.

Bacteriological examination of vaginal contents the patient IgKOE Enterococcus fecalis was 5.2 per 1 ml; IgKOE Escherichia coli - 5,4; Candida sp.- 5,2; St. epidermidis and 4.4; Pseudomonas aeruginosa - 4,2; Streptococcus sp.- 4,7.

Colonization resistance of microorganisms of the vagina (lgKOE/ml) before surgery and on the 5th day after treatment (see table 1).

Table 1

The microorganismBefore surgeryAfter the treatment
Candida sp.5,22,9
Enterococcus fekalis5,22,7
Escherichia coliof 5.43,0
St. Epidermidis4,43,2
Streptococcus sp.the 4.72,6
Pseudomonas aeruginosa4,24,0

In all diseases where as a required component is present in an inflammatory reaction, leading role in the damage of cells and tissues of the body perform reactive oxygen species (ROS)produced by leukocytes, mainly neutrophils. Although the most destructive forms of ROS generated by myeloperoxidase, act phagolysosome leukocyte, however, in inflammation neutrophils can secrete this enzyme in the extracellular space. The destruction of the infectious agent in the development of the inflammatory process may be provided and the cost associated damage to the body's own tissue in inflammation, while oxygendependent tissue damage is as a direct and indirect nature. The last is when the effects of ROS on regulatory and effector molecules, for example, proteases and inhibitors of proteases.

A source of reactive oxygen species in inflammation and are faguoqitirute cells with powerful specialized systems generate ROS. Upon contact of phagocytes with alien particles leads to the activation of the cells with the formation of superoxidedismutase. This phenomenon is called "peroxide" or "respiratory burst. Bactericidal effect of phagocytes is the action of ROS inside phagolysosome, and cytotoxic - action on objects located outside of phagocyte, and through the release of ROS from the cell in its microenvironment. Activation of phagocytes associated not only with bacterial aggression, but also other kinds of influences (xenobiotics, allergens, pollutants).

Thus, the influence of different factors inflammation caused including infectious agents, leading to increased concentrations of reactive oxygen species and the initiation of the FLOOR, which in turn is accompanied by activation of antioxidant, inhibiting lipid peroxidation at an optimal level. Depletion of AOS leads to a significant and uncontrolled increase in the FLOOR, the accumulation of peroxidation products (Vladimirov, Y.A., 1998), damage to biomembranes (Mokhnatkin NS et al., 1986), modification of proteins, lipids, nucleic acids (E.S. Reynolds, Mosien M.T., 1980).

Modification of proteins leads to the emergence of their antigenic properties and lipid peroxidation leads to increased production of factors of chemotaxis (thromboxanes, leukotrienes), which increases the migration of phagocytes to the site of their formation (Y. Fujimoto et al., 1983). Therefore, activation of phagocytes in inflammation has the ability to Samoilovs that helps to maintain vospalitelno the process and can lead to the formation of a vicious circle of inflammation.

Free-radical oxidation of unsaturated fatty acids (EFA) of the phospholipids of cell membranes of tissue cells and blood plasma lipoproteins (LPO) result in peroxide degradation of molecules of phospholipids, which entails a violation of the structure of cell membranes and lipoproteins. With regard to membrane peroxidation NLC leads to disruption of the barrier and matrix functions, increasing the ion permeability, the fall of transmembrane potentials, reduction of ATP synthesis in mitochondria and eventually to cell death.

Free-radical damage mechanism cytoplasmic, mitochondrial and nuclear membranes, nuclear and mitochondrial genome, lipoproteins of blood leads to damage of blood vessels and blood-tissue interfaces barriers, impaired delivery of oxygen to the tissues, which plays an important, often decisive role in the pathogenesis of the most common diseases inflammatory, toxic, or autoimmune nature.

Previously known positive effect of antioxidants on the prevention of infection and healing of purulent and gunshot wounds, burns, trophic ulcers (Mframe. 1975; Acknolage et al., 1979; Hinder, 1991; Haniwell, 1994).

Among synthetic analogues of vitamins, aromatic and heteroaromatic phenols most promising antioxidants are made in the derivative 3-oksipiridina, are structural analogues of vitamin B6 (pyridoxol, pyridoxal, pyridoxamine), which play an important role in the life of the organism and executes the role of non-specific physiological antioxidants.

The most promising and well-studied antioxidant from the group 3-oksipiridina is 2-ethyl-6-methyl-3-oksipiridina succinate.

A wide range of pharmacological activity of 2-ethyl-6-methyl-3-oksipiridina succinate due to the antioxidant and antiradical properties characteristic of aromatic phenols, structural similarity with compounds of vitamin B6, as well as the presence of succinate, exhibiting the properties of antihypoxic drug.

2-ethyl-6-methyl-3-oksipiridina succinate has the ability to inhibit excessive free-radical oxidation of lipids, resulting in decreased viscosity of the plasma membrane, increases the content of polar lipid fractions (phosphatidylserine and phosphatidylinositol and others) in the membrane, decreasing the ratio of cholesterol/phospholipid decreases the viscosity of the lipid layer and increases membrane fluidity. Initially, when its effect on the plasma membrane of cells changes the microenvironment of the membrane receptors located mainly on the cell surface and are in most cases lipidzavisimy. In is the result of changing the conformation and the ability of membrane receptors to bind biologically active substances.

At the second stage in the diffuse distribution of the antioxidant in the cell is its direct effect on membrane structure, allowing inhibited lipid peroxidation and slows their release from the membrane.

Protective effect of 2-ethyl-6-methyl-3-oksipiridina succinate blood cells, identified by hypotonic and oxygen hemolysis, plays an important role in the human microcirculation.

2-ethyl-6-methyl-3-oksipiridina succinate inhibits free-radical stage of prostaglandin synthesis catalyzed by cyclooxygenase and lipoxygenase, and thereby increases the ratio prostacyclin/thromboxane A2. Increase antiaggregatory activity of the vascular wall leads to the improvement of microcirculation.

Found that 2-ethyl-6-methyl-3-oksipiridina succinate has also antiglucocorticoid activity, blocks the glucocorticoid receptor, inhibiting effect of glucocorticoids, and, therefore, limits the implementation of the stress response, thereby reducing the activity processes the FLOOR.

Studies have shown that 2-ethyl-6-methyl-3-oksipiridina succinate inhibits both enzymatic and nonenzymatic FLOOR, and their antioxidant activity in both cases about the same.

Anti-inflammatory and antioxidative 2-ethyl-6-methyl-3-oksipiridina succinate is achieved by reducing the level of free radicals, sorption effects on the primary source of inflammatory endotoxemia by binding of endo - and exotoxins, enhance drainage functions of the lymphatic system.

To the stabilization of cell membranes and blood vessels, which provides the active substance, it prevents the penetration of pathogenic microorganisms, toxins and degradation products in the blood.

High therapeutic activity of 2-ethyl-6-methyl-3-oksipiridina succinate due to the presence of immunomodulatory and immunostimulatory properties. Restoring the activity of nonspecific humoral protection, boosting local immunity by increasing phagocytic activity of leukocytes, it leads to rapid elimination of the inflammatory process in the damaged tissues, destruction of pathogenic organisms, contributes to a significant improvement of treatment results.

During conservative treatment during the reparative process following changes occur in the microcirculation in the area of inflammation:

decreases swelling and improves the rheology of blood flow in microvessels, there are opportunities for the normal outflow of blood, reduced vascular resistance, restores tone of smooth muscle cells of intact arterioles and precapillaries, there is increased growth of the capillary network in the area damaged microvessels and Bess is sadistic sections of tissue.

The results of experimental and clinical observations allowed us to conclude that the anti-inflammatory effect of Mexidol is mediated through its ability to stabilize the redox potential of the body by engaging homeostatic reactions of different levels of integration: the drug increases the energy efficiency of redox processes, stabilize hormonal and immune status, stabilizes the biological mechanisms of protection, and also has antibacterial activity. Study of antimicrobial activity of 2-ethyl-6-methyl-3-oksipiridina succinate against gram-positive and gram-negative strains of microorganisms, and fungi (6 strains of each species of microorganisms) allows to reliably estimate the results of the study of antimicrobial activity. As can be seen from table 2, 2-ethyl-6-methyl-3-oksipiridina succinate possesses antimicrobial activity against gram-positive and gram-negative flora and fungi Candida.

The results of the study of antimicrobial activity of 2-ethyl-6-methyl-3-oksipiridina succinate are given in table 2.

Table 2

GramThe zone of growth inhibition in mm (M±m)GramSonsidering growth in mm (M± m)
Candida1,29+1,36Pseudomonas eureginosa7,25+1,87
Streptococcus spp.4,85±2,64Escherichia coli6,68±1,25
Staphylococcus epidermidis2,64+0,95
Proteus spp.3,95±1,34
Staphylococcus aureus2,38±1,18

The effectiveness of conservative treatment of inflammation and prevention of postoperative complications using 2-ethyl-6-methyl-3-oksipiridina succinate due to its antibacterial effect, restore the activity of the vasomotor oscillations, antioxidant and antihypoxic effect on capillary and postcapillary links microvasculature. The use of 2-ethyl-6-methyl-3-oksipiridina succinate in the postoperative treatment of aseptic wounds may facilitate the removal of post-traumatic changes, prevent the development of septic complications will stimulate the reparative process and to contribute to the restoration of the structure and performance of the microcirculatory system of soft tissue.

Thus, the obtained data indicate a pronounced anti-inflammatory, antibacterial and immunostimuliruyushhim step 2-ethyl-6-methyl-3-is Sipiagin succinate.

The technical result from the use of the proposed framework leads to a reduction of the period of liquidation and post-traumatic local inflammatory disorders, prevents the development of suppurative complications, and helps restore the structure and performance of the microcirculatory system of soft tissue and mucosa, destruction of pathogenic organisms and the restoration of normal microflora of the vagina.

The use of the dosage form in the form of suppositories provides a prolonged release of therapeutic drug in the mucous membranes and soft tissues, and provides the action for about 12 hours, in contrast to washing and irrigation, the duration of which lasts less than 1 hour; however, the procedure is convenient and easy to perform and can be done by patients themselves in the outpatient setting.

1. The treatment for gynecological and proctological diseases characterized by the fact that it is made in the form of a suppository and contains the active substance 2-ethyl-6-methyl-3-oksipiridina succinate and a base selected from the group of polyethylene oxide 1500, polyethylene oxide 400, cocoa butter, hydrogenated fats in the following ingredients on one candle:

2-ethyl-6-methyl-3-oksipiridina with ccinet 0,1-1,0
Base1,0-6,0

2. The tool according to claim 1, which is intended for the treatment of hemorrhoids, fissures, inflammation and wounds after operations and manipulations in the rectum.

3. The tool according to claim 1, which is intended for the treatment of non-inflammatory and inflammatory diseases of the pelvic organs in women, including complications of purulent-inflammatory processes, as well as after surgery.



 

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EFFECT: reduced treatment time, lowered recurrence of diseases, lack of adverse effects, and lowered cost.

FIELD: medicine, cardiology, chemical-pharmaceutical industry.

SUBSTANCE: invention relates to development of a complex from vegetable raw, vitamins, amino acids, trace elements and macroelements used in treatment of cardiovascular system diseases in carrying out the supporting therapy. Agent used in treatment of cardiovascular system in carrying out the supporting therapy contains as active components vitamins, bioflavonoids, trace elements, macroelements, extracts from medicinal plants, red grape polyphenol complex, broccoli concentrate, borage oil, L-cysteine, L-glutathione, D,L-methionine, and special supplements as cellulose, silicon dioxide, stearic acid, magnesium stearate and hydroxypropylcellulose, and this agent is made as a tablet formulation in the definite content of components per one tablet, in mg. Agent is designated in carrying out the supporting therapy in hypertensive disease of I-II degree, ischemic heart disease I-II of the functional class , neurocirculatory dystonia of different types. Agent is prescribed in the dose one tablet 1-2 times before eating or with food by course for one month. "AngioTonik" is agent able to provide body by all nutrient substances that are necessary for normal function of cardiovascular system.

EFFECT: valuable medicinal properties of agent.

5 cl, 5 tbl, 3 dwg

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