RU2486911C1 - Agent for vaginal douche in phase of vaginal microflora recovery following treatment of bacterial vaginosis and vaginal thrush (vaginal yeast) - Google Patents

Abstract

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to pharmaceutical industry, particularly to an agent for vaginal douche. The agent for vaginal douche in the phase of vaginal microflora recovery following the treatment of bacterial vaginosis, vaginal thrush (vaginal yeast) containing acetic acid sodium salt, lactose, dry extract of marigold (Calendula officinalis) in the following proportions.

EFFECT: agent promotes the effective recovery of a normal vaginal flora, provides hygienic cleaning of the vagina from its discharge and vaginal microorganisms during the procedure, eliminates the risk of local allergic reactions.

Description

The invention relates to medicine, in particular to means for douching the vagina.

The state of the barrier properties of the vaginal mucosa is determined by the composition of its microflora, which depends on the acidity of the secretion of the vaginal glands. Normally, the pH of the vagina is 3.9 - 4.4, the environment of the vagina is acidic and inhibits the reproduction of pathogenic microflora. In the vaginal secretion, the Na content is 93.3 mmol / L, Cl - 92.3 mmol / L, which provides physiological indicators of the osmolarity of the vaginal secretion. Normally, in the vagina of an adult woman, lactobacilli dominate, which, by breaking down the glycogen of epithelial cells, produce lactic acid and hydrogen peroxide, which inhibit the growth of pathogenic microflora. In violation of the normal composition of the bacterial flora, vaginal diseases develop.

The main diseases of the vagina:

1. Bacterial vaginosis (vaginal dysbiosis) is a disease that affects 40% to 45% of the adult female population. A disease in which the amount of lactobacillus is reduced, gardnerella begins to develop, the acidic medium “alkalizes” to a pH of 6.0. It manifests itself with abundant secretions with a "fishy smell", itching.

Treatment of bacterial vaginosis is based on the use of topical anti-guards medications, topical anti-inflammatory drugs, immunotherapy, normalization of the vaginal microflora (restoration of the lactobacillus pool), and normalization of pH.

2. Candidiasis colpitis (thrush) is a disease that affects 25% to 40% of the adult female population. Called by fungi of the genus Candida. It manifests itself in the form of itching, "curdled" discharge, pH - 3.0-3.5.

Treatment of candidal colpitis is based on the use of topical antifungal drugs, topical anti-inflammatory drugs, immunotherapy, normalization of the vaginal microflora (restoration of the lactobacillus pool), and normalization of pH (alkalization using soda baths).

Thus, the treatment consists of two phases: the actual treatment of the disease and the restoration of normal vaginal microflora.

The concept of the use of solutions for the treatment of vaginal diseases.

Treatment should be biphasic. 1st phase - anti-inflammatory therapy, 2nd phase - restoration of the vaginal microflora using substances that stimulate its growth.

Known pharmaceutical composition for the treatment of urogenital infections [Pat. RU No. 2401102, A61K 9/02, 10/10/2010]. This pharmaceutical composition contains an antiseptic, a dietary supplement, a component that provides the natural acidity of the vagina, an antifungal agent, anesthetic and a base.

Known pharmaceutical composition for the treatment of candidal vulvovaginitis [Pat. RU No. 2354385 of 2009]. The invention is a pharmaceutical composition made in a dosage form suitable for topical application, which contains at least one antimycotic from the groups: azoles, allylamines, polyenes, nitrofurans, as well as a prebiotic with a degree of polymerization from 2 to 30 or a combination of prebiotics, mixed at a certain content of components in wt.% per unit dosage form.

The disadvantage of the compositions is their implementation in the form of a suppository, which complicates the hygienic cleaning of the vagina from the discharge and microorganisms during the procedure.

Also, when using known compositions, the parameters of its osmolarity are not taken into account. If the parameters of the osmolarity of the syringing solution do not match, undesirable phenomena in the form of transudation of secretion from the vaginal mucosa, increase in the volume of secretions are possible.

The presence of antiseptic components, antimycotics (an antifungal agent) and anesthetics in the composition of the compositions limits the possibility of using these compositions due to the risk of developing a local allergic reaction to these drugs (allergic contact vulvovaginitis).

The objective of the present invention is to develop a means for douching the vagina into the phase of the vaginal microflora after treatment of bacterial vaginosis and candidal colpitis (thrush),

The technical result consists in hygienic cleaning of the vagina from the discharge and microorganisms during the procedure and, in addition, the risk of developing a local allergic reaction is eliminated.

The problem is solved by creating a means for douching the vagina in the recovery phase of the vaginal microflora after treatment of bacterial vaginosis, candidiasis colpitis (thrush) containing sodium salt of acetic acid, lactose, dry extract of calendula (Calendula officinalis) with the following components, wt.%:

acetic acid sodium salt 61.5 lactose 37.5 dry marigold extract (Calendula officinalis) 1,0

For douching, water decoctions and infusions of plant herbs are traditionally used. In this case, the active components of plant materials enter the solution.

Calendula (Calendula officinalis) is effective in gynecological practice in the form of douching with erosion, Trichomonas colpitis, and whites.

Chemical composition. Flower baskets contain carotene C40H56, lycopene C40H56, violaxanthin C40H56O4 and rubixanthin C40H56O, neolikopin A, citraxanthin C40H56O, flavochrom C40H56O, flavoxanthin C40H56O3 and chrysantemaxanthin. The total amount of these carotenoids in the marginal flowers is about 3%. In addition, in flower baskets, essential oil (0.02%), resins, mucus, albumin, malic acid (6.8%), pentadecyl C15H30O2 and traces of salicylic acid, as well as a small amount of alkaloids, were found. In the aerial part of the plant, the bitter substance calendene C23H3807, saponins were found, during the hydrolysis of which oleanolic and glycuronic acids were obtained, as well as the presence of two unsaturated triterpendiols - arindiol, faradiol C30H50O2. The seeds contain a fatty oil, represented by glycerides, acids, phytosterol. Calendula flowers have an antiseptic, anti-inflammatory effect.

The composition of the product is designed so that when preparing an aqueous solution for douching, an aqueous solution is obtained that corresponds to the osmolarity of the vaginal secretion, the use of which allows normalizing the pH of the vaginal secretion during douching, and helps to restore the normal microflora of the vagina, provides hygienic cleaning of the vagina from the discharge and microorganisms during time of the procedure, creates optimal conditions for the action of medicinal herbs, eliminates the risk of development local allergic reaction.

In order to optimize the composition of the solution for douching the vagina in the phase of restoration of the vaginal microflora and bring its osmolarity parameters closer to optimal, to restore the natural pool of lactobacillus (Doderlein sticks), the composition of the product includes sodium salt of acetic acid, lactose, and calendula dry extract.

When preparing an aqueous solution of the indicated product, the sodium salt of acetic acid provides a solution for douching, which has an optimal osmolarity (in 120 ml of a solution - up to 300 mosmol / l) of the solution and has buffering properties. Sodium salt of acetic acid (sodium acetate) is traditionally used in the nutrient medium for growing lactobacilli, it does not interfere with the growth and reproduction of lactobacillus. Acetic acid sodium salt inhibits the growth of streptococci, molds and many other microorganisms. The presence in the solution of the sodium salt of acetic acid creates the most favorable conditions for the development of lactobacilli against the background of suppression of the pathogenic microflora of the vagina.

Lactose is a breeding ground for the development of lactobacilli, the main component of normal microflora. Lactobacilli produce lactic acid, which helps maintain a normal pH of vaginal secretion. At the same time, the antiseptic, anti-inflammatory effects of calendula extract are preserved.

The use of this tool in the form of an aqueous solution provides the possibility of uniform distribution of the solution of the drug in the full volume of the vagina and allows for hygienic cleaning of the vagina from the discharge and microorganisms during the procedure.

An aqueous solution is prepared on the basis of these components - 4 grams of the drug are dissolved in 120 ml of pure water (solution temperature 34-36 degrees) and douching is carried out using a modified device with a volume of 120 ml.

In the period from January 30, 2012 to March 16, 2012, the claimed drug was tested in the Gynecological Department of the Novosibirsk City Perinatal Center.

In addition to patients with a diagnosis of bacterial vaginosis, for the indicated period, 63 patients with a diagnosis of acute candidal colpitis, confirmed by smear microscopy, were treated in the department. Of the total number of 63 patients, depending on the duration and severity of the symptoms of the disease, 34 patients were prescribed specific systemic antimycotic therapy in combination with immunomodulators in combination with douching of the claimed drug.

In the phase of the disease recovery in the groups, douching was performed twice a day for 7 days by the claimed agent.

On the 4th day of treatment, all patients noted the absence of complaints and the absence of signs of yeast infection with smear microscopy, in contrast to the standard 7-day period for normalizing these parameters when using traditional candidiasis colpitis therapy using systemic antimycotic and immunocorrective therapy. In the group, by the 4th day of treatment, symptoms stopped and the microscopic picture of smears normalized. One patient of the group (3%) required additional administration of systemic antimycotics and immunomodulators in connection with the progression of symptoms. No side effects of douching were noted.

On the 14th day of douching (on the 7th day of using the means to restore the vaginal flora), all 63 patients showed a complete absence of complaints. According to microscopic examination, all patients showed an I-II degree of purity of the vaginal flora.

The use of an aqueous solution of this product provides hygienic cleaning of the vagina from the discharge and microorganisms during the procedure, creates optimal conditions for the action of medicinal herbs, eliminates the risk of developing a local allergic reaction. The inclusion of the douching procedure of the claimed agent in the complex of therapeutic measures reduces the treatment time for bacterial vaginosis and candidal colpitis, contributes to the normalization of the natural vaginal flora.

Claims (1)

A means for douching the vagina in the recovery phase of the vaginal microflora after treatment of bacterial vaginosis, candidiasis colpitis (thrush), characterized in that it is a powder containing sodium salt of acetic acid, lactose and dry extract of calendula (Calendula officinalis) with the following components, wt .%:
acetic acid sodium salt 61.5 lactose 37.5 dry marigold extract (Calendula officinalis) 1,0