RU2767694C1 - Moisturizing gel for intimate hygiene - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, particularly to gynecology. Moisturizing gel for intimate hygiene contains, wt.%: Cosphaderm x 34-0.5, sodium hyaluronate or hyaluronic acid 1,400–1,800 kDa — 1.0, Cosme-Phytamis Microcirculation — 2.0, Campo Plantservative Wsr — 1.0, low-mineralized mineral water of sulfate-sodium-magnesium-calcium "Moscow" type — up to 100, lactic acid — up to pH of the end product of 7.2.

EFFECT: invention provides regeneration, moistening and improvement of local microcirculation and exchange of genital mucosa.

1 cl, 1 dwg, 2 tbl, 2 ex

Description

The invention relates to medicine, gynecology, pharmacy, relates to a remedy for recovery and can be used for the prevention and correction of genitourinary syndrome in the menopausal period and during surgical menopause, with violations of vaginal secretion in women of reproductive age, as well as in the recovery period after operations on the vulva and vagina.

Menopause is a natural physiological process, accompanied by the extinction of ovarian function and the cessation of menstruation. Due to the physiologically determined deficiency of female sex hormones, this period may be accompanied by varying degrees of climacteric disorders, which also include atrophic processes in the genitourinary system.

With high evidence, the most effective treatment for menopausal syndrome, including atrophic changes in the vulva and vagina, is hormone replacement therapy in the form of local and systemic use of estrogen-containing drugs. But this treatment has many contraindications and often causes side effects. Therefore, the development of new effective methods for the correction of genitourinary syndrome in menopause remains very relevant today.

The causes of dryness of the vagina and vulva in the reproductive period may be:

surgical intervention on the female genital organs (removal of the uterus and ovaries);

operations on the vulva and vagina;

sexually transmitted infections;

violation of the microflora of the vagina, changes in the pH environment, frequent inflammation of the vagina (including vaginal candidiasis);

decreased immunity, frequent stress, depression, nervousness, increased physical and psycho-emotional stress, iron deficiency in the body;

consequences of chemotherapy or radiation therapy in the treatment of cancer;

temporary physiological conditions that affect the production of hormones (pregnancy, the period after childbirth, lactation, and the period before menstruation, when the hormone progestogen is intensively produced, which suppresses estrogen production).

Whatever the cause of dryness of the vaginal mucosa, it is necessary to stop this condition, since if vaginal secretion is disturbed, the vaginal mucosa is at greater risk of trauma, erosion, and the occurrence of chronic inflammatory diseases of the urogenital tract. In this regard, the quality of life of a woman is significantly reduced. Unpleasant painful sensations can make a woman give up intimacy for good, which will subsequently affect her psycho-emotional state.

Known moisturizing gel for intimate hygiene (certificate of state registration No. RU.77.99.29.001.E.010943.11.14 dated 20.11.2014) containing sodium hyaluronate 0.1%; water; propylene glycol; chamomile extract; plant phospholipids (soy and red clover); mallow glycolic extract; carbomer; sodium methyl paraben; cholesterol; imidazolidinyl urea; triethanolamine; disodium editate; sodium propyl paraben; dl-a-tocopherol-acetate.

However, this concentration of hyaluronic acid is not able to provide a long-term moisturizing effect, which is inappropriate for women with atrophic changes in the vulvar and vaginal mucosa.

Known complex for moisturizing intimate areas (state registration certificate No. RU.77.99.37.001.E 006323.08.13 dated 08/01/2013), containing Aqua, Propylene glycol, Hydroxypropylmethylcellulose, Phenoxyethanol, Benzoic acid, Dehydroacetic acid, Ethylhexylglycerin, Polyaminopropyl biguanide, Polysorbate 20, Lactic acid, DMDM hydantoin, Hyaluronic Acid, Activated Glycyrrhizic Acid, Parfum.

The disadvantage of this complex is the lack of a mineralizing effect, i. improvement of tissue trophism and local microcirculation.

Various gels for intimate hygiene based on plant components have also been patented, the action of which is specifically directed either to the antimicrobial effect (for example, RU 2372096 C1, Chubatova S.A. et al., 11/10/2009; RU 2493822 C2, FITOLON-NAUKA LLC ", 09/27/2013; RU 2308951 C2, Vysokov V.I. et al., 10/27/2007), or for moisturizing (RU 2240778 C1, Moscow Pharmaceutical Factory LLC, 11/27/2004), lubricants (RU 2747029 C2, REOXIN, LLS (US), April 23, 2021; RU 2428174 C1, Vysokov V. I. et al., September 10, 2011). However, there is a need for a daily remedy that would have sufficient all of the listed effects, as well as, in addition to those mentioned, the effect of mineralization to improve metabolic processes in the vulva and vagina.

The technical result of the proposed moisturizing gel for intimate hygiene is an improved effect on the genital mucosa in terms of regeneration, moisturizing and improving local microcirculation and metabolism, thereby enhancing its protective properties.

The problem is solved by the fact that the proposed moisturizing gel for intimate hygiene contains xanthan gum (resin), hyaluronic acid, Cosme-Phytamis Microcirculation, Campo Plantservative Wsr, mineral water (well No. 2/69, XIII group, Moscow type), lactic acid in the following ratio of components, wt. %:

Cosphaderm x 34 (xanthan gum) 0.5 Hyaluronic acid or sodium hyaluronate, 1400-1800 kDa 1.0 Cosme-Phytamis Microcirculation, 5% (cypress extracts, witch hazel, butcher's broom, cultural grapes) 2.0 Campo Plantservative Wsr (Japanese honeysuckle extract, fragrant honeysuckle) 1.0 Mineral water (well No. 2/69) up to 100.0 Lactic acid Up to final product pH 7.2

The gel is used as follows: 5 ml of the product is applied to the vulva and vagina - in a ratio of 2:3, using an applicator. The drug is administered at night, or as needed during the daytime, as well as before sexual intercourse.

As part of the proposed gel, commercially available foreign or domestic products are used, shown in table 1 (see, for example, https://www.alexmo-cosmetics.de/Xanthan-CosphadermZ-X-34_1, https://russian.alibaba .com/product-detail/pure-hyaluronic-acid-powder-1400k-1800k-da-sodium-hyaluronate-1600124357740.html, https://www.aromashka.ru/gialuronovaya_kislota08-2.html, https://www .aromashka.ru/gialuronovaya_kislota.html, http://himiya.pro/produkty/gialuronovaya-kislota, https://beurre.ua/cosme-phytamis-mikrocirkulyaciya, http://www.findglocal.com/UA/Odessa /380971698625447/Beurre.-%D0%9A%D1%80%D0%B0%D1%81%D0%BE%D1%82%D0%B0---%D0%B4%D0%B5%D0%BB% D0%BE-%D1%82%D0%B2%D0%BE%D0%B8%D1%85-%D1%80%D1%83%D0%BA, https://docplayer.ru/29137923-Campo- plantsservatives.html, https://cosmetics.specialchem.com/product/i-campo-research-campo-plantservative-wsr), commercially available pharmacopoeial grade lactic acid 90% (https://co2-extract.ru/product_info. php?products_id=49 7), as well as mineral water from well 2/69, located directly on the territory of the National Medical Research Center of the Republic of Kazakhstan of the Ministry of Health of Russia (the proposed name for the mineral water is Kurort on the Arbat, an application for trademark registration No. 2021707555 dated February 15, 2021, published) . Deposit - mineral water "Moskovskaya" (low-mineralized, XIII group, type - Moskovsky) https://mos80.com/m/miller_moskvichka/vims.html, https://sanatoria.ru/text.php?id=351, fig .).

This mineral water in terms of composition and quality is characterized by the following indicators:

- according to the level of general mineralization: M 4.0-4.5 g / dm ³ , belongs to the category of low-mineralized mineral waters,

- hydrochemical group: sulfate-sodium-magnesium-calcium (sodium-calcium-magnesium, magnesium-calcium-sodium), equiv.%:

SO ₄ ^2- > 90

Mg2 ⁺ 25-45

^Ca2+ 25-45

(Na⁺+K⁺) 20-40,

- belongs to the XIII group, type Moscow GOST R 54316-2011.

The reaction of the environment from slightly alkaline to alkaline: pH 7.2-8.9.

Organoleptic properties: opalescent yellowish liquid, taste and smell are characteristic of the complex of substances contained in it.

Biologically active components are found in water in concentrations, in mg/ ^dm3 :

HCO ₃ ^- 100-170 (Na ⁺ +K ⁺ ) 350-550

SO ₄ ^2- 2500-3000 Ca ²⁺ 350-500

Cl ^- >25 Mg ²⁺ 200-300

The content of microcomponents normalized in drinking mineral waters, including heavy metals (lead, mercury, cadmium, arsenic, etc.), compounds of the nitrogen group (nitrites, nitrates), as well as strontium, etc., is significantly lower than the permissible concentrations for drinking mineral waters .

The sanitary and microbiological state of water is within the normal range. Contamination of samples with radionuclides does not exceed the established norms NRB-99/2009.

Table 1

Recipe for intimate hygiene gel

No. p / p Names of components (trade names) wt% content Russian names of components Phases one Cosphaderm x 34 0.5 Xanthan gum (gum) A 2 Hyaluronic acid (sodium hyaluronate) 1.0 Hyaluronic acid (sodium hyaluronate)
1400-1800 kDa D 3 Cosme-Phytamis Microcirculation 5% 2.0 Glycerine extract of cypress, witch hazel, butcher's broom, cultural grapes B 4 Campo Plantservative Wsr 1.0 Aqueous extract of Japanese honeysuckle and fragrant honeysuckle E five Lactic acid 0.4 Pharmacopeia grade lactic acid 90% F 6 Mineral water type "Moscow" Up to 100.0 Mineral water type "Moscow" wells 2/69 FROM

Get this tool as follows.

In the reactor with a stirrer (60 rpm) load the prescription amount of phase A, add the prescription amount (table 1) of phase B, mix until smooth. Phase C is added to the resulting mass and stirred for 5-10 minutes. Then add the prescription amount of phase D, continuing to mix until a thick homogeneous mass is obtained. The mixing time is 2 hours + 30 minutes. The prescription amount of phase E is added to the resulting homogeneous mass and mixed for another 5-10 minutes. Then add prescription amount of phase F (lactic acid) and mix for another 30-40 minutes.

After mixing, a sample of the resulting mixture is taken, and the pH is measured. In the finished product, the pH should be 7.2. If it is necessary to adjust the pH, this can be done by adding an additional appropriate amount of lactic acid or the mineral water used (up to 100.0 wt%). Then the finished mass is unloaded from the reactor and packaged in sterile, glass or plastic, hermetically sealed vials for subsequent use as intended. The production itself is sterile, and therefore additional sterilization of the product is not required.

Table 2 shows the effects of the active ingredients of the moisturizing gel for intimate hygiene.

table 2

The action of the active ingredients of the gel for intimate hygiene

Name of the active component effects Hyaluronic acid Has moisturizing
regenerating effect; restores and maintains tissue elasticity; exhibits moderate antibacterial and antiviral properties; has an anti-inflammatory effect. Cypress extract Increases tissue elasticity; has antiseptic properties, due to the presence of camphene; contributes to the rapid healing of tissues. witch hazel extract Due to the presence of flavonoids, it improves microcirculation, strengthening the walls of blood vessels and increasing their elasticity. Due to bioactive substances, it has a wound healing effect, accelerates the processes of tissue regeneration. The presence of organic acids, vitamins and tannins determines the anti-inflammatory, antiseptic and analgesic effects. The extract also has antimicrobial, antifungal properties. Ruscus extract Butcher's broom extract helps to improve metabolic processes in tissues and increases their elasticity. The extract contains a group of saponins, primarily ruscogenins, whose biological action helps to strengthen the vascular wall, reduce permeability and increase capillary resistance. Also, this extract has an anti-inflammatory effect. Cultural grape extract It is a powerful antioxidant, improves blood circulation. It has regenerating and anti-inflammatory effects. Japanese honeysuckle, fragrant honeysuckle They have anti-inflammatory and antioxidant, as well as antiviral and antibacterial effects. Lactic acid By adjusting the pH of the product, it helps to increase the natural protection of the vagina from genital infections, improving the living conditions of the normal microflora of the vagina. Mineral water (well No. 2/69) It has a mineralizing effect, improving local blood circulation and tissue trophism. xanthan gum Gels the water phase and retains microscopic oil droplets in it, thickens the liquid oil phase. High level of viscosity and stabilization of emulsions. Dissolution is fast, at room temperature, without heating. Acid-, thermally and salt-resistant. Improves the tactile properties of cosmetics.

Thus, to obtain a moisturizing gel for intimate hygiene, according to the recipe, an aqueous phase with dissolved active ingredients is introduced into its composition and lactic acid is added to create the optimal pH of the product. The resulting gel has a completely natural composition and is produced without the addition of fragrances. The gel has a pleasant appearance and delicate texture. Its components are quickly absorbed, leaving no stains on clothes.

The tool is suitable for daily care of intimate parts of the body or skin in the intimate area. The composition used makes it possible to compensate for the lack of macro- and microelements in these areas, restore the natural level of humidity, increase protective functions and immunity.

When developing a moisturizing gel formulation, the selection of components was carried out by studying the interaction of active components with each other. So, in order to improve local microcirculation, the following were used as the main assets: cypress extract, witch hazel extract, butcher's broom extract, cultivated grape extract, mineral water (well No. 2/69). To provide anti-inflammatory, antibacterial and antiviral effects, extracts of Japanese honeysuckle and fragrant honeysuckle were used. The main moisturizing and regenerating component is hyaluronic acid. Lactic acid in the composition of the gel adjusts the pH of the product, improving the vital activity of the vaginal microflora.

With regular consistent use, the moisturizing gel maintains the optimal water balance of the skin and mucous membranes of the genital organs, reduces the feeling of discomfort and dryness throughout the day, and minimizes side effects after traumatic procedures.

The method of application includes applying the product to the skin of the intimate area or intimate parts of the body, it is recommended to use it at least 2 times a day. Means is quickly absorbed, without leaving marks on clothes.

The application is carried out as follows: 5 ml of the product is applied to the vulva area and to the vaginal mucosa (in a ratio of 2:3), using an applicator. A woman can do it herself. Perhaps the introduction at night, or as needed during the daytime, as well as before sexual intercourse.

The use of a moisturizing gel for intimate hygiene allows you to effectively act on the genital mucosa, regenerating, moisturizing and improving local microcirculation and metabolism, thereby enhancing its protective properties.

The form of the gel allows both to create a concentration of useful substances on the mucous membrane of the genital organs, and to ensure the absorption through the mucous membrane of the ions contained in it due to the presence of low-mineralized mineral water in the composition of the ingredients, improving the metabolic processes of tissues.

To test the Moisturizing Intimate Hygiene Gel, a group of 20 female volunteers aged 30-60 suffering from permanent or temporary dryness of the vulva and vagina was created.

The procedures were performed as follows.

Every day in the evening before going to bed and, as necessary, during the daytime, as well as before sexual intercourse, it was applied to the vulva area and, with the help of an applicator, 5 ml of the drug was injected into the vagina, in a ratio of 2:3 (on the vulva / in the vagina).

During the study, it was forbidden to change the dosage of the daily used intimate hygiene gel. The use of local and systemic hormone-containing agents was also excluded.

Before and at the end of the study, each woman was assessed by the index of vaginal health. The pH, moisture and elasticity of the vagina, the amount of secretions and the characteristics of the epithelium were determined. And also evaluated the index of female sexual function (IFSf) in terms of: sexual desire, sensitivity and excitability, lubrication (moistening of the vagina), orgasticity, satisfaction with sexual life, coital and / or postcoital discomfort / pain, in women who are sexually active.

Example 1. Patient A., 36 years old.

Vaginal health index = 19 points. IHSf on the scales "lubrication" and "pain" was 2.1 and 2, respectively. After a month of using a moisturizing gel for intimate hygiene:

- the index of vaginal health has increased to 22 points, in particular, due to indicators of moisture and elasticity;

-indicators "lubrication" and "pain" IZHSf improved to the corresponding values: 4.8 and 4.

Example 2. Patient S., 55 years old.

Vaginal health index=14 points. IHSf on the scales of "lubrication" and "pain" was 1.2 and 4, respectively. Condition after a month of using a moisturizing gel for intimate hygiene:

- the index of vaginal health increased to 22 points, in particular, due to the indicators of elasticity and characteristics of the epithelium of the vulva and vagina;

- indicators "lubrication" and "pain" IZHSf improved to the corresponding values: 2.4 and 4.8.

After 1 month of daily use of the study gel, all patients noted that immediately after applying the product, there is a feeling of comfort in the vulva and vagina. The feeling of moisture after using the gel for intimate hygiene occurred in 100% of the subjects. The index of female sexual function on the "lubrication" scale improved in 80% of the subjects living sexually, on the "pain" scale - in 70% of patients.

Thus, compared with analogues, the claimed moisturizing gel for intimate hygiene allows you to effectively moisturize the mucosa of the vulva and vagina, while having a pronounced regenerating and anti-inflammatory effect, thereby enhancing the protective properties of tissues.

Claims (2)

Moisturizing gel for intimate hygiene containing xanthan gum, hyaluronic acid, Cosme-Phytamix Microcirculative, Campo Plantservative Wsr, mineral sulfate-sodium-magnesium-calcium low-mineralized water of the Moscow type, lactic acid in the following ratio, wt. %: Cosphaderm x 34 0.5 Sodium hyaluronate or hyaluronic acid acid 1400-1800 kDa 1.0 Cosme-Phytamis Microcirculation 2.0 Campo Plantservative Wsr 1.0 Mineralized low-mineralized water sulfate-sodium-magnesium-calcium Moscow type up to 100.0 Lactic acid up to final product pH 7.2

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