RU2626673C1 - Means for treatment of skin and mucosa diseases, for local use, which is anti-inflammatory, anti-bacterial, antiviral, wound-healung, anti-fungal - Google Patents

Abstract

FIELD: pharmacology.

SUBSTANCE: means for skin and mucosa diseases treatment, which has anti-inflammatory, anti-bacterial, antiviral, wound-healing, anti-fungal activity, is a Gynura Procumbens leaf hydrolyte obtained by steam or water distillation of fresh or dry leaves of Gynura Procumbens at a fresh leaves and water ratio of 1:3-6 or at a dry leaves and water ratio of 1:30-60.

EFFECT: means has a high efficiency for treatment of skin and mucosa diseases due to pronounced anti-inflammatory, anti-bacterial, antiviral, wound-healing, anti-fungal action.

1 tbl, 13 ex

Description

The invention relates to the pharmaceutical industry, namely, a medicinal product based on plant materials - Gynura Procumbens for topical use, intended for the treatment of diseases of the skin and mucous membranes, which has anti-inflammatory, antibacterial, antiviral, wound healing, antifungal effects.

Currently, bacterial infections of the skin, mucous membranes and subcutaneous tissue account for more than 30% of all skin diseases, fungal infections of the skin are detected in 2% of all patients seeking medical help (any), and in the structure of inflammatory diseases at different age periods make up 68 -93%.

Of the greatest importance in the treatment of all of the above diseases are antibacterial, antiviral, anti-inflammatory, antifungal and wound healing drugs of local action.

The wound process is complex and multi-stage, and the drugs used to treat wounds act on various mechanisms depending on the stage of the disease.

From the prior art, preparations for the treatment of skin diseases based on plant components are widely known.

So, from the document [1], an ointment for external use with biostimulating properties for the treatment of burns, skin diseases and wound healing is known, which can also be used in cosmetology. The ointment for the treatment of burns, skin diseases and wound healing contains gum, beeswax, sea buckthorn oil, cow oil, pork fat and a biologically active substance selected from the group: aloe extract, plantain extract, succession extract, rosehip extract, hypericum oil, linseed oil , marigold oil, burdock oil, chamomile oil or propolis. The use of the ointment showed its stimulating effect on the regenerative processes of connective tissue and epithelium, which indicates the biostimulating effect of the ointment and is confirmed by a reduction in the healing time of wounds with good fixation and even distribution on the skin surface and ease of use. However, the lack of ointment is a multicomponent composition and insufficiently high pharmacological effect.

From the document [2], a tool based on natural components is known that has anti-inflammatory and wound healing effects. The tool is made in the form of an ointment and, in addition to natural vegetable oils, may contain bear fat, bear bile, propolis, lanolin, honey, mummy. The ointment can be used to treat hemorrhoids, burns, sinusitis, post-stroke conditions, gunshot and stab wounds, trophic ulcers, postoperative fistula, inflammation of the appendages, diabetic microangiopathy of the lower extremities, as well as papillomas, birthmarks, seborrhea and psoriasis. This composition is multicomponent, has low antibacterial activity and does not have antifungal activity.

The authors of the present invention have developed a new tool from plant materials - leaves of Gynura Procumbens.

Gynura Procumbens from the family of asters was born many centuries ago on the African continent, then the plant successfully migrated to Asia, where it was appreciated by the healers of China and Southeast Asia. It was used simply as food and at the same time as a cure for disease.

In Southeast Asia, Jinura (Ginura) is part of a balanced diet and a healthy lifestyle. Phytochemical studies confirm that extract from ginura leaves is an excellent natural source of many potent biologically active components, including flavonoids, carotenoids, alkaloids and essential oils. An active effect on metabolic processes puts Ginuru in a number of other medicinal plants, which are actively used as primary protection for cancer patients before chemotherapy and radiotherapy. The results of clinical studies confirm the therapeutic effect of ginura in diabetes, kidney disease, gastroenterological and cardiovascular diseases. The plant has pronounced antioxidant properties, inhibits the growth of cancer cells in the body, has an anti-inflammatory effect and helps to increase reproductive function.

A document [3] discloses the use of Gynura Procumbens alcohol extract for the treatment of various skin diseases. In particular, the anti-inflammatory, antioxidant effect of the Gynura Procumbens alcohol extract is disclosed.

The paper [4] studied the antioxidant activity of Gynura Procumbens. Gynura Procumbens methanol extract was fractionated in chloroform, ethyl acetate, butanol, water. Among all the extracts, the ethyl acetate fraction showed a more pronounced antioxidant activity.

The patent [5] discloses a composition for the prophylaxis and treatment of inflammatory and allergic disorders, containing as an active component an extract (selected from aqueous, methanol, ethanol and / or butanol) Gynura Procumbens.

The patents [6], [7], [8] disclose the use of Gynura Procumbens extracts in compositions for preventing anti-inflammatory, allergic, bacterial disorders, as well as aging.

The disadvantage of the above funds is not sufficiently high anti-inflammatory, antibacterial, antiviral, wound healing, antifungal properties for the treatment of diseases of the skin and mucous membranes.

The authors of the present invention unexpectedly found that the hydrolyte from the leaves of Gynura Procumbens has a high activity - anti-inflammatory, antimicrobial, antiviral, wound healing, antifungal, does not cause irritation and allergies, can be used to prevent and treat various diseases of the skin and mucous membranes due to the unique composition of biologically active substances that make up its composition.

Hydrolates (hydrosols) - water obtained by steam or water distillation of water through plant material. When water vapor passes through plant material, they are saturated with valuable components contained in plants: essential oils, acids, bioflavonoids, vitamins and other valuable substances. Steam extracts more valuable substances from the plant than water, therefore, the content of extracted substances in the hydrolyte is much higher than in ordinary broth, while various “ballast” substances — salts, dyes, etc., do not get into the hydrolyte, so the effect of the hydrolyte is much more effective and harmless than the effects of a decoction. Hydrolates contain about 0.2-0.5% (sometimes more) of water-soluble components of plants distributed in water in ionized form.

Hydrolates differ in properties from essential oils, as they consist of an aqueous phase and a water-soluble plant extract. Essential oils are contained in ordinary hydrolyte in a concentration optimal for use in a pure, undiluted form [9].

Hydrolates retain all the beneficial qualities of essential oils, but unlike the latter, they act very gently without causing burns or allergic reactions, they are safe for use on delicate areas of the body, as well as on skin prone to inflammation. The main advantage of using hydrolytes in comparison with concentrated essential oils is their more gentle effect on the skin and mucous membranes.

The document [10] discloses the use of hydrolytes of various plants for the treatment and prevention of skin diseases.

The prototype of the proposed invention is a document [11], which presents a report on the study of Gynura Procumbens and tools based on it. This document discloses that Gynura Procumbens has great therapeutic potential, a variety of pharmacological activities: antihypertensive, cardioprotective, antihyperglycemic, anti-cancer, antibacterial, antioxidant, general protective, anti-inflammatory. Gynura Procumbens is characterized by a high content of biologically active substances: flavonoids, glycosides, etc. This document describes the use of the aqueous and alcoholic extract of Gynura Procumbens leaves. The disadvantage of the agents from Gynura Procumbens described in the document [11] is that the agents have less pronounced pharmacological activity for treating the skin and are characterized by a low content of biologically active substances. The result is insufficient clinical results in the treatment of various skin diseases.

The objective of the proposed invention was to develop a tool based on the unique plant Gynura Procumbens, the use of which will lead to high clinical results in the treatment of various diseases of the skin and mucous membranes due to the high anti-inflammatory, antibacterial, antiviral, wound healing, antifungal effects.

The technical result consists in the fact that the proposed topical agent, which is a hydrolyte of leaves of Gynura Procumbens, is highly effective in the treatment of diseases of the skin and mucous membranes due to its high anti-inflammatory, antibacterial, antiviral, wound healing, antifungal effects.

The technical result is achieved by the fact that the proposed tool for the treatment of diseases of the skin and mucous membranes for topical application has anti-inflammatory, antibacterial, antiviral, wound healing, antifungal effects, is a hydrolyte of leaves Gynura Procumbens obtained using the method of steam or water distillation of fresh leaves in the ratio of fresh leaves and water 1: 3-6 or dry leaves with a ratio of dry leaves and water 1: 30-60.

During clinical trials, it was found that the optimal ratio of feedstock and water for steam or water distillation is: for fresh leaves 1: 3-6, for dry leaves 1: 30-60, respectively.

The inventors have unexpectedly found that the hydrolyte obtained from the leaves of Gynura Procumbens is characterized by a high content of biologically active substances that are not found in the known hydrolytes of other plants.

The composition of the proposed tool - leaf hydrolyte Gynura - includes:

1. Amino acids:

- serine;

- lysine;

- threonine;

- alanine;

- glutamine;

- citrulline;

- cystine;

- cysteine.

2. Organic acids:

- succinic acid;

- isovaleric acid.

3. Microelements:

- palladium;

- lithium;

- platinum;

- cobalt;

- bromine;

- gold;

- iron;

- zinc.

The presence of amino acids with antibacterial, immunomodulating and regenerating properties, in combination with the most important trace elements in organic form (associated with amino acids), provides high penetration into the cells and high antimicrobial properties.

This fact is one of the distinguishing features of the hydrolyte from the leaves of Gynura Procumbens from other hydrolytes.

The proposed tool can be effectively used to treat skin diseases such as contact dermatitis, atopic dermatitis, eczema, psoriasis, seborrheic dermatitis, seborrheic alopecia with seborrheic dermatitis, perioral dermatitis, bacterial infections, viral infections such as warts, papillomas, herpes simplex, fungal infections, insect bites, as well as in the treatment of inflammatory, bacterial, fungal diseases of the mucous membranes.

Obtaining Hydrolate from Gynura Procumbens Leaves

To obtain leaf hydrolyte Gynura Procumbens used the standard method for producing plant hydrolytes using a distillation unit that operates in steam and water distillation mode.

Fresh or dry leaves of Gynura Procumbens were taken to obtain the hydrolyte. The ratio of plant materials and water for fresh leaves is 1: 3-6, for dry leaves 1: 30-60, respectively.

To obtain the hydrolyte by steam distillation, fresh or dry leaves of Gynura Procumbens are placed on the grill of a distillation unit located at least 5 cm above the upper water level.

To obtain hydrolyte by water distillation, fresh or dry leaves of Gynura Procumbens are placed directly in a vessel with water.

The vessel with water is heated to a high temperature, and the steam begins to break the glands of the plant, thereby releasing the essence of the plant in the form of steam. The steam is collected in a pipe passing through the cooling units, after which it again takes on a liquid form and is discharged into a sump. The resulting hydrolyte and the fraction of essential oils are separated.

The composition of the resulting hydrolyte from the leaves of Gynura Procumbens was studied using a spectral-dynamic complex (certified in the EU as KME, Medicial Expert Complex).

According to the results of the study, the following groups of biologically active substances were isolated in the hydrolyte from the leaves of Gynura Procumbens.

Amino acids: serine, lysine, threonine, alanine, glutamine, citrulin, cystine, cysteine; organic acids: succinic acid, isovaleric acid; macro- and microelements: palladium, lithium, platinum, cobalt, bromine, gold, iron, zinc.

It was established experimentally that the maximum content of biologically active substances in the hydrolyte is achieved using the ratio of plant materials and water for fresh leaves 1: 3-6, for dry leaves 1: 30-60, respectively.

The following are examples of a clinical trial of the proposed hydrolyte from the leaves of Gynura procumbens and a comparison of its pharmacological activity with known prototype agents and hydrolytes of other plants.

Example 1

A study of the pharmacological activity of the proposed hydrolyte from the leaves of Gynura procumbens was carried out on a burn wound model [12].

To do this, under ketamine-droperidol-atropine anesthesia in Wistar rats weighing 220-250 g, a thermal burn was reproduced in the back region (the depilated surface was exposed to a 300 W halogen lamp at a distance of 1 cm for 10 s). The experiments were carried out in accordance with the rules for the humane treatment of animals, which are regulated by the "Rules for the Use of Experimental Animals" [13], according to the protocol approved by the Committee on Biomedical Ethics of the NRCRC SB RAMS.

The animals were divided into an experimental group and a control group.

The animals of the experimental groups immediately after the manipulation and then throughout the experiment were applied the studied hydrolyte of Gynura procumbens leaves, and the rats of the control group were treated with water, or alcohol, or ethyl acetate extract of Gynura procumbens leaves.

Excretion of animals from the experiment was carried out in terms: 3, 7 and 14 days.

For histological evaluation of pharmacological activity, burn wound fragments were fixed with FineFix solution. The resulting material was poured into paraffin, sections were prepared with a thickness of 5 μm, which were stained according to the Van Gieson method [14].

It was shown that when using the proposed tool, the area of the burn wound decreased by 53% on day 3, while the extracts from the experimental group showed a decrease in area to only 26-30% on day 3. On the 7th day, the area of the burn wound in the experimental group decreased by 73%, on the 14th day the wounds completely healed.

Also, in the experimental groups, the content of gram (-) bacteria (CFU / g) and gram (+) bacteria (CFU / g) decreased by 74% already on the 3rd day, while in the control group the number of bacteria decreased by 3 days only by 32-41%.

Example 2. Wound healing activity

The wound healing activity of the studied leaf hydrolyte Gynura procumbens was evaluated planimetrically by A.V. Cherkasov [15]. So, by 3 days of the experiment, the burn area decreased by 2-2.5 times in all groups of animals compared with the initial value (4 cm ² ).

By the end of the experiment (14 days) in the experimental groups, almost complete healing of the thermal burn was observed - from 0.4 to 1.0% of the initial area of the burn remained compared to 22.4% in the control group.

Evaluation of the dynamics of the processes of epithelization of a wound defect consisting in the formation of an epithelium at the site of skin damage is an important characteristic of the rate of regeneration.

It was established that when applying the test composition, complete epithelization of the burn wound was achieved by the 14th day of the experiment in the experimental groups. At the same time, epithelization in the control group does not occur by 14 days of the experiment. On histological sections, maturation of granulation tissue in a burn wound without epithelization is observed.

Thus, as a result of the studies, pronounced wound healing activity of the studied composition was revealed, which manifests itself in the early epithelization of the burn wound compared to the control group of animals.

Example 3. Anti-inflammatory activity

When assessing the anti-inflammatory activity of the studied composition - leaf hydrolyte Gynura procumbens - it was shown that in the control group of animals, the healing process of the burn wound morphologically corresponds to the canons of the development of the inflammatory response, while even for 3 days the peak of the severity of neutrophilic leukocyte infiltration remains in the form of a wide band through all layers wounds with swelling of adjacent tissues.

The use of the test composition by 3 days of the experiment significantly reduced edema and the severity of neutrophilic infiltration - the exudative phase of inflammation in the wound area. In this case, the studied composition helps to reduce the area of necrosis and reduce edema in the tissues of the burn wound.

Example 4. Antibacterial activity

The study of the antibacterial activity of the proposed leaf hydrolyte Gynura procumbens was carried out by agar diffusion on solid nutrient media by analyzing growth inhibition zones of test microorganisms used to determine the antimicrobial effect of drugs. Studies were carried out for the following standard strains of microorganisms: Staphylococcus aureus ATCC 653 8-P, Staphylococcus aureus 209-P, Escherichia coli ATCC 25922, Bacillus subtillis ATCC 6633, Candida albicans ATCC 865-653, Pseudomonas aeruginosa ATCCus vulgaris, 8585 Pr. It was established that a pronounced antimicrobial effect is actively manifested in relation to all of the above test cultures.

The local anesthetic activity of the developed composition was studied in experiments in vivo by the Rainier-Valet method, which is based on the change in the sensitivity of the rabbit’s cornea when a test sample is applied to it, which is expressed in response to an irritant in the form of closing of the eyelid.

0.1 g of the test composition was injected into the conjunctival sac of a rabbit's eye using a syringe. Using calibrated hairs, rhythmic irritations were applied to the cornea at a frequency of 100 beats per minute after 1, 2, 5, 8, 10, 12, 15 minutes and then every 5 minutes until the eyelids closed. The time between the introduction of a sample of the composition and the onset of the manifestation of a pharmacological action was taken as the rate of onset of local anesthesia. The relative strength of the anesthetic effect was calculated according to the Rainier index, summing up the amount of irritation in 13 measurements, starting from the 8th minute, within an hour.

The indicator of complete anesthesia was considered the absence of a blinking reflex for 1 min at 100 contacts of calibrated hairs with the cornea of the eye.

The duration of general anesthesia was characterized by the time from the start of anesthesia to the complete restoration of sensitivity. The results obtained were processed by the method of variation statistics [16]. The development time of the anesthetic effect is 1-5 minutes, the time of complete anesthesia is 55-70 minutes, the Rainier index is 1100-1400 conv. units, recovery time sensitivity 70-80 minutes.

High values of the Rainier index, the duration of general anesthesia for the proposed pharmacological composition (compared with agents from the control group) indicate not only an increased antibacterial effect of the agent from the experimental group, but also a prolongation of the anesthetic effect.

Example 5. Antifungal activity

In three groups of guinea pigs of 8 animals, each was plucked in the caudal region of the back in a 4 × 4 cm area, after which a dense standard suspension of a virulent laboratory strain of the fungus, gypsum trichophyton, was applied to the exposed area.

The test results were as follows. In the first group untreated, by the tenth day from the moment of infection, all the signs of experimental mycosis (peeling, hyperemia, infiltrate, crust formation) developed. In the second group of pigs (control) treated with the aqueous, or alcohol, or ethyl acetate extract of Gynura Procumbens, by the tenth day from two to three animals only peeling was observed and from five to six peeling with mild hyperemia (depending on the extract used) . In the third group of pigs treated with the proposed tool, three animals had smooth skin without all signs of mycosis by the 8th day. Two pigs have smooth skin without signs of mycosis - by the 10th day, three pigs - peeling, but without hyperemia by the tenth day. In no case of the use of the claimed funds was there any signs of a skin-irritating effect.

Thus, the use of the proposed composition has reduced the treatment time for patients with fungal skin diseases.

Example 6. Antiviral activity

Patient S., 27 years old. Ds: Multiple warts.

Concomitant diseases have not been identified.

The proposed tool was applied topically to the wart from 1 to 4 times a day, preferably from 1 to 2 times a day. After application, the product was rubbed and allowed to be absorbed. This treatment was repeated until the warts at least visually disappear.

The treatment indicates a positive treatment, removal of warts. Removal occurs in a short time, after the procedure, the skin is restored without visible pigmentation at the site of the wart, as well as the absence of a scar.

The use of means of the control group showed low antiviral activity.

The proposed tool also showed high efficiency in the treatment of papillomatosis.

The proposed tool was investigated in 98 patients with various skin diseases, namely contact dermatitis, atopic dermatitis, eczema, psoriasis, seborrheic dermatitis, seborrheic alopecia with seborrheic dermatitis, perioral dermatitis, bacterial infections, viral infections such as warts, herpes simplex, papillomas , fungal infections, insect bites, as well as inflammatory, bacterial, fungal diseases of the mucous membranes.

The following are examples of the use of the proposed tool for the treatment of some of the listed diseases.

Example 7

Patient K., 21 years old.

Ds: Atopic dermatitis, moderate severity, exacerbation phase.

Concomitant diseases have not been identified.

From the anamnesis it is known that blood pressure suffers from birth. I contacted a dermatologist at my place of residence, treatment was prescribed: antihistamines, topical glucocorticoids with a temporary positive effect. Marks an exacerbation of the skin process in the autumn-winter time, after contact with household chemicals. Last exacerbation after contact with phosphate detergent. On examination, the rashes are localized on the palmar surfaces, knee, elbow bends, are represented by multiple papules, fissures, lichenification, subjectively pronounced itching. SCORAD index 7.0 points.

The patient was prescribed the proposed tool 3 times a day to apply in the area of rashes. The use of a new external agent was carried out for 14 days, after which there was a remission. The patient noted the excellent tolerance of the product, was satisfied with the properties of the skin after treatment, since dryness and tightness of the skin were completely absent; its use is continued prophylactically after each water treatment; clinical remission of blood pressure remains.

The proposed external agent was used to treat patients with mild atopic dermatitis (n = 13), while the standardized SCORAD disease severity index before treatment was 8.1 ± 1.3 points. The comparison group (control group) consisted of patients (m = 13) with mild atopic dermatitis, before the start of therapy, the average group index SCORAD was 8.3 ± 0.9 points, that is, it did not statistically differ from the index of the main group. After the completion of the 4-week course of therapy in both groups, the residual symptoms of atopic dermatitis (BP) were evaluated by the attending physician and the subjective attitude of the patients to the external treatment (therapy compliance factors) was studied.

Comparative studies revealed a significant superiority of the new external agent, when used in patients with blood pressure 1.5 times less than in the treatment of drugs from the control group, peeling of the skin was noted, residual dry skin and redness were recorded 2 times less, about 3 times skin contraction was less frequently observed; itching, burning and swelling of the skin were completely absent.

According to patients, the new external agent was characterized by excellent and good tolerance (93.8%), high satisfaction with the use of the drug and overall satisfaction of the patient with skin properties after treatment (100% and 93.8%, respectively).

Example 8

Patient S., 36 years old.

Ds: Vulgar psoriasis, progressive stage.

Concomitant diseases: metabolic syndrome.

From the anamnesis it is known that he considers himself ill for 12 years, when, after suffering stress, he noted the appearance of rashes in the elbow joints. I did not go to doctors, I was not treated on my own. In 2016, he noted an exacerbation of the skin process for no apparent reason. On examination, the skin process of a chronic inflammatory nature, is localized on the elbow joints, is represented by single papules, plaques up to 5 cm in diameter, with severe hyperkeratosis, without subjective sensations. In this connection, treatment was prescribed as an external therapy according to example 1, the agent should be applied after water procedures and during the day. As a result of the treatment, it was noted: on day 3, a decrease in rashes, on day 10 on the site of plaques foci of hyperpigmentation. There are no new rashes.

Example 9

On examination and treatment, 20 patients with various forms of eczema were observed. The proposed agent was prescribed, which was applied to the affected areas 2 times a day. The group included patients with chronic eczema.

Patients noted good tolerance to the drug. Side effects and complications were not identified. Analysis of the results of the study showed that, against the background of therapy, all patients recovered. As a rule, itching decreased immediately after application of the drug, and epithelialization of foci and resolution of rashes was noted by the end of the second week.

Example 10

Patient B., 38 years old, complained of vesicle rashes that appear on normal or slightly reddened edematous skin of the genital organs and perianal region, preceding rashes itching, burning, tingling, pain in the inguinal-scrotal region. After 6 days, the bubbles burst, forming surface erosion. From the anamnesis of the disease, it was found that it suffers from genital herpes for about 5 years, relapses 2-3 times a year. The diagnosis is confirmed by the results of immunological blood tests by determining antibodies to the herpes type II antigen (HSV-2) by enzyme immunoassay. In the study of immune status reduced number of T-lymphocytes (0,92⋅10 ⁹ / l), T-helper (0,37⋅10 ⁹ / L), the reduction index Th / Tc (3.08), increased B- lymphocytes (0.35⋅10 ⁹ / l), IgG (9.5 g / l), decreased IgM (0.78 g / l) and IgA (0.88 g / l) as well as slgA in the urethra to be separated - 0 , 28 g / l (indicators were compared with the results of studies of healthy donors).

The patient underwent a course of treatment with the proposed agent, which was applied 2 times a day in the morning and evening for 3 weeks.

After the first week of the course, the patient noted the complete disappearance of pain, burning, itching. By the end of the course of treatment, lymphadenopathy disappeared, and a clear regression of herpetic eruptions was observed. In the study of immune status: increased number of T-lymphocytes (1,22⋅10 ⁹ / l), T-helper (0,55⋅10 ⁹ / L) increased the index of Th / Tc (4.33), decreased the number of B- lymphocytes (0.28⋅10 ⁹ / l), IgG (8.81 g / l), the content of IgM (0.82 g / l) and IgA (1.18 g / l), as well as slgA (0, 42 mg / ml), that is, these indicators are much closer to the level of healthy individuals.

Thus, the proposed tool has an antiviral effect, gives a high therapeutic effect.

Example 11

A patient, 45 years old, was observed for: bronchial asthma, mixed form, moderate severity, DN 1, concomitant diseases: chronic purulent sinusitis, recurrent polyposis rhinosinusitis, allergic rhinitis, hay fever, allergic rhinoconjunctivitis. Sensitization to household, epidermal allergens.

Complaints: constant nasal congestion, nasal discharge of a mucopurulent nature, attacks of shortness of breath, cough.

For ten years - chronic purulent rhinosinusitis, since 2003 - recurrent polypous rhinosinusitis, about which six surgical interventions were performed.

 Allergic history: in contact with pets, physical exertion - asthma attacks, cough, rhinoconjunctivitis.

Objectively: the condition is satisfactory. The skin is clean, normal color, rashes, no swelling. Nasal breathing is free. In the lungs, vesicular breathing, no wheezing. Heart sounds are clear, rhythmic. Heart rate = 78 per minute. HELL = 110/70 mm RT. Art.

On examination:

Complete blood count: hemoglobin 11.7 g / dl (norm 12-16), red blood cells - 4.07-10 ⁶ / μl (norm 3.9-5), white blood cells 8.7⋅10 ³ / μl, lymphocytes 27% (norm 20-37), monocytes 6% (norm 2-8), eosinophils 2% (norm 1-4), basophils 0 (norm 0-1), fifth neutron. 3% (norm 1-4), neutral. 62% (norm 52-72), platelets 327⋅10 ³ / μl (norm 130-400), ESR 7 mm / h (norm 0-20).

Biochemical blood test: total bilirubin 10.3 μmol / l; direct bilirubin 1.8 μmol / L (norm 0-3.4), ALT 15 IU / L (0-34), ACT 16 IU / L (norm 0-34), alkaline phosphatase 44 IU / L (norm 47- 119 IU / L), gamma-GT 14 IU / L (norm 0-38), glucose 5 mmol / L (norm 4.1-5.9), urea 2.2 mmol / L (norm 2.8-7 , 2), creatinine 69 µmol / L (norm 58-96), uric acid 178.7 (norm 154.7-357), iron 15.6 µmol / L (norm 10.7-32.2), triglycerides 0 96 mmol / L (norm less than 1.7), total cholesterol 5.7 mmol / L (norm less than 5.2).

General analysis of urine: color - salt. yellow, rel. density 1020, reaction 7, protein - traces, epit. flat - single in the field of view, white blood cells 0-3 in the field of view, erythrocytes. - absent., bilirubin - absent., nitrites - negative., cylinders - absent., glucose - absent., ketone bodies - absent., salts - absent., bacteria - absent.

In the inoculation from the nasal mucosa, isolated: Streptococcus viridans 10 ⁶ (norm 10 ⁶ ).

Sputum cytology: epithelium - in a moderate amount in the field of view; leukocyte reaction - in a single amount in the field of view, the composition of the microflora is gram (+) cocci in a moderate amount.

FVD (02/12/08): Moderate obstructive respiratory dysfunction. The test with ventolin is positive (+ 32%).

Blood test for AT cytomegalovirus IgG 13.4 (more than 1.1 - positive.)

Positive skin scarification tests with household allergens.

Primary ENT consultation:

The mucous membrane of the oropharynx is pink, tonsils are normal, the gaps are clear, the back of the pharynx is unchanged, the mucous membrane of the larynx is pink, the vocal cords are gray, mobile, close.

The mucous membrane of the nose is swollen, mucopurulent discharge in the nasal passages, polypous growth of the nasal mucosa on both sides, paranasal sinuses are filled with a thickened polypous mucosa.

Conclusion: chronic purulent sinusitis, recurrent polypous rhinosinusitis.

The treatment was carried out by spraying the hydrolyte of the leaves of Gynura Procumbens in the paranasal sinuses.

Using the proposed tool 3-6 times a day effectively reduces swelling of the nasal mucosa during the day.

A month after the treatment, the patient fully recovered nasal breathing and smell (the patient did not smell for more than ten years).

A repeated examination of the otolaryngologist revealed a significant decrease in polypous growths of the nasal mucosa and sinuses. Mucosal edema was practically absent.

Example 12

A patient, 21 years old, was observed for chronic purulent rhinosinusitis.

Upon treatment, he complained of an almost constant nasal congestion and mucopurulent discharge from the nose, frequent headaches, and worsening during the year. After surgery for the curvature of the septum, from then on, nasal congestion began to be permanent, noted frequent mucopurulent discharge from the nose and headaches. Over the course of the year, sanitation of the paranasal sinuses and local and general antibacterial therapy in combination with antihistamines and vasoconstrictive endonasal sprays were repeatedly performed.

Initial consultation of ENT: the mucous membrane of the oropharynx is pink, the tonsils are ordinary, the back wall of the pharynx is hypertrophied, the mucous membrane of the larynx is pink, the vocal cords are gray, mobile, close. Nasal mucosa - hypertrophic, congestive, edematous. In the nasal passages - mucopurulent discharge. Auditory passages, eardrums are not changed.

Conclusion: chronic purulent rhinosinusitis.

During the examination: skin allergological tests with household, epidermal, pollen allergens are negative. IgE total 90 cells / E (within normal limits), cytological examination of a smear from the nasal mucosa - cells of squamous and cylindrical epithelium, leukocytes up to 40 in the field of vision were detected. Cytological picture of the inflammatory process of the nasal mucosa.

When sowing a nasal swab, polyvalent microflora was found.

When examining the immune status, there is an increase in the relative and absolute number of T-lymphocytes, T-cytotoxic lymphocytes, B-lymphocytes. The decrease in the relative absolute number of NK cells. Decreased leukocyte. / T-lymph. index.

A course of treatment was carried out by introducing hydrolyte of the leaves of Gynura Procumbens in the paranasal sinuses 3-4 times a day for a month.

After the treatment, normal nasal breathing was restored for a month, the mucopurulent discharge from the nose stopped.

Repeated consultation with an otolaryngologist: no complaints, oropharyngeal mucosa pink, tonsils normal, pink back of the larynx, vocal cords gray, mobile, close, nasal mucosa normal. Auditory passages and eardrums are not changed. With a repeated cytological examination of the smear of the nasal mucosa, there are no signs of an inflammatory process. No pathogenic flora was found in the culture of the smear from the nasal mucosa.

Example 13

Patients with non-infected postoperative wounds, patients with purulent lesions of the female genital mucous membranes, over 18 years old, were selected for the study, regardless of concomitant diseases. The total number of patients was 45 people.

Clinical trials were conducted in two parallel groups. The main group of 30 patients with diagnoses: cervical erosion - 9 people, cervicitis - 7 people, colpitis - 6 and 8 women - postoperative wounds. The control group consisted of 15 patients. Patients of the main group for local treatment used the proposed tool. Patients in the control group received conventional traditional topical treatment using well-known antiseptics, ointment preparations and vaginal tablets.

In patients with the use of the proposed agent, normalization of leukocytes in the discharge from the cervical canal and vagina, a decrease of 1-2 days of mucopurulent and purulent discharge from the genital tract, local tissue edema, hyperemia, hyperthermia, normalization of the function of the cervix and vagina, decrease were observed general and local signs of inflammation, accelerated wound healing time 2.5 times.

With colpitis, 3-4 days there was a complete disappearance of signs of inflammation; in patients with postoperative wounds with Gynura Procumbens leaf hydrolyte, wound healing occurred on the 2nd – 3rd day, granulation tissue growth and healing was observed from the 4th to 5th day, scarring occurred on the 5th – 7th day. In general, the duration of treatment was reduced by 2-3 times compared with traditional treatment.

Thus, the claimed tool has a pronounced antiseptic, antibacterial effect against gram-positive and gram-negative bacteria, as well as wound healing effect.

All this indicates the advisability of using the drug for the treatment of patients with inflammatory processes of the cervix and vagina, as well as with postoperative wounds.

The treatment with the proposed agent has shown high efficiency, rapid removal of inflammation, suppression of viruses, rapid reduction of bacterial contamination, effective healing of wounds, cleansing of wounds from necrotic plaque, acceleration of epithelization and maturation of granulation tissue, removal of edema, hyperemia, rapid restoration of skin and mucous membranes, elimination of mycoses , itching, burning, swelling, normalization of the sebaceous glands, restoration of hair growth, reduction of skin pores were quickly removed.

Thus, the proposed tool is effective for the treatment of various skin diseases and mucous membranes for topical application, has a pronounced anti-inflammatory, antibacterial, antiviral, wound healing, antifungal effect.

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Claims (1)

An agent for treating diseases of the skin and mucous membranes, for topical use, which has anti-inflammatory, antibacterial, antiviral, wound healing, antifungal effects, which is Gynura Procumbens leaf hydrolyte, obtained by steam or water distillation of fresh or dry Gynura Procumbens leaves in a ratio of fresh leaves to water 1: 3-6 or with a ratio of dry leaves and water 1: 30-60.