KR102810558B1 - Vulva care composition and Vulva care products - Google Patents

Abstract

The present invention relates to a vulva care composition containing a natural oil component having a positive effect on the vulva skin environment, and to an invention capable of providing a composition that can be used as a material for a vulva care product that is effective in maintaining and improving the vulva skin environment in a healthy manner, and a product using the same.

Description

{Vulva care composition and Vulva care products containing the same}

The present invention relates to a vulva care composition containing a natural oil component having a positive effect on the vulva skin environment, and to a composition that can be used as a material for a vulva care product that is effective not only in cleansing but also in maintaining and improving the vulva skin environment in a healthy manner, and to a product using the same.

The female urogenital system includes the uterus, vagina, vulva, and urethra, and is easily exposed to external infections due to its anatomical and physiological and functional characteristics. For example, the vagina is rich in nutrients and is located deep inside the body, so the temperature and humidity are high, making it easy for various strains, including bacteria and fungi that are the main causes of vaginitis, to invade, which increases the possibility of various diseases occurring. Therefore, it is advisable to always keep the vagina clean and take care not to expose it to external bacterial infections.

In Korea, external genital cleansing products were reorganized from over-the-counter drugs to cosmetics in 2010, which are more accessible to the general public. The Korean external genital cleansing market grew rapidly until 2019, centered on small and medium-sized enterprises. After that, as pharmaceutical companies and large corporations joined the external genital cleansing market, cosmetics for external genital care became more diverse. This social change was coupled with a cultural change that made external genital care no longer shameful, leading to further growth.

The most common gynecological disease that gynecologists encounter in outpatient clinics is vulvovaginitis. This is an infection or inflammation of the vagina and vulva characterized by symptoms such as abnormal discharge, odor, burning sensation, pain during intercourse, and pain during urination. In particular, the severe itching that accompanies it interferes with daily life.

In Korea, candida vulvovaginitis is a common disease that approximately two-thirds of women experience at least once in their lifetime, and the frequency of infection is high, with 45% of women experiencing it more than twice a year. It is also known that the recurrence rate is high even after complete recovery in most women.

Vulvovaginitis is the most common disease and an infection with a high recurrence rate, but as women became aware of the need for prevention through personal hygiene management, interest in vulvar care products increased, and it is thought that this, along with social and cultural changes, led to the spotlighting of products called 'feminine hygiene products'. However, feminine hygiene products are products used to clean and wash the vulva area, and their use is limited to environments where they can be washed.

In addition, since its main purpose is cleansing, its role in creating a healthy body environment after use is minimal.

The environment of the female vulva provides conditions favorable for the growth of bacteria due to humidity, temperature, and light blocking, and its anatomical structure facilitates the growth of microorganisms due to residues such as urine, feces, and menstrual secretions. C. albicans (Candida albicans), the causative agent of infectious diseases commonly found in the female vulva, is a normal flora of the human body that exists in the mouth, vagina, and intestines of healthy people. However, when the balance of microorganisms is disrupted and overgrowth occurs, it acts as a pathogen, causing an infection called candidiasis. Therefore, the importance of managing the environment around the vulva along with personal hygiene is emphasized in women's vulva care.

Since feminine hygiene products are used on sensitive mucous membrane areas, products that introduce natural plant materials that can improve the vaginal environment inside and outside the female reproductive organs while minimizing the use of chemical synthetic substances have been developed recently. As life becomes more affluent, the demand for women's vulva care products is increasing.

Korean Patent Registration No. 10-4983395 (January 8, 1991) Korean Publication Patent No. 10-2018-0071558 (2018.06.28)

The present invention relates to a composition applicable to an ampoule or serum type vulva care product, rather than a conventional cleansing type vulva care product, and to a vulva care composition containing natural oil compounds and a vulva care product using the same.

The vulva care composition of the present invention for solving the above-described problems comprises royal jelly and a natural oil mixture component, and the natural oil mixture component comprises olive oil (Olea europaea fruit oil), avocado oil (Persea Gratissima oil), sunflower seed oil (Helianthus Annuus Seed Oil) and soybean oil (Glycine Soja (Soybean) Oil).

In addition, the vulva care product of the present invention is in the form of any one selected from a lotion, a cream, an ampoule, and a serum, and includes a moisturizer, heptyl undecylenate, a fragrance, and the vulva care composition.

The vulva care composition of the present invention and the vulva care product manufactured using the same maintain the environment around the vulva healthier than existing cleansing type products, while being effective in improving soothing, pH recovery, skin hydration and skin elasticity, and improving vulva itching, etc., and are therefore effective in maintaining the cleanliness of the Y zone and preventing gynecological diseases.

The present invention is described in more detail below.

The vulva care composition of the present invention contains royal jelly and a natural oil mixed component, preferably contains 0.10 to 1.50 wt% of royal jelly and the remaining amount of natural oil mixed component among 100 wt%, and more preferably contains 0.20 to 1.20 wt% of royal jelly and the remaining amount of natural oil mixed component among 100 wt%. The royal jelly plays a role in improving skin elasticity and/or providing a skin soothing effect around the vulva, and if the content is less than 0.10 wt%, the content is too low and the skin elasticity and/or soothing effect around the vulva due to its use may be insufficient, and if it exceeds 1.50 wt%, the compatibility and miscibility with the natural oil mixed component may be reduced and the manufacturing cost may increase too much, and therefore it is appropriate to use it within the above range.

The natural oil mixture component in the composition plays a role in improving the environment around the vulva, that is, maintaining or improving soothing, pH recovery, skin hydration and skin elasticity, improving vulvar itching, and improving skin thickness and density.

The above natural oil mixture component includes olive oil (Olea europaea fruit oil), avocado oil (Persea Gratissima oil), sunflower seed oil (Helianthus Annuus (Sunflower) Seed Oil) and soybean oil (Glycine Soja Oil). Preferably, it includes 1.0 to 10 parts by weight of avocado oil, 0.5 to 8.0 parts by weight of sunflower seed oil and 0.5 to 5.0 parts by weight of soybean oil with respect to 100 parts by weight of olive oil, and more preferably, it includes 1.0 to 6.0 parts by weight of avocado oil, 0.8 to 4.0 parts by weight of sunflower seed oil and 0.8 to 4.0 parts by weight of soybean oil with respect to 100 parts by weight of olive oil, which is advantageous in terms of increasing the overall effect of the vulva care composition to be manufactured.

In addition, the present invention provides a vulva care product using the vulva care composition described above, which is a product in the form of any one of a lotion, a cream, an ampoule, and a serum, preferably an ampoule or serum.

A preferred embodiment of the components used in the manufacture of the vulva care product in the form of the above ampoule or serum formulation is as follows: The vulva care product of the present invention comprises a moisturizer, heptyl undecylenate, a fragrance, water as a solvent, and the vulva care composition described above, preferably comprising 8.0 to 12.0 wt% of the moisturizer, 1.0 to 3.0 wt% of the heptyl undecylenate, 0.1 to 1.0 wt% of the fragrance, 15.0 to 20.0 wt% of water and the remaining balance among 100 wt% of the vulva care composition, and more preferably comprising 8.5 to 11.5 wt% of the moisturizer, 1.2 to 2.5 wt% of the heptyl undecylenate, 0.3 to 1.0 wt% of the fragrance, 16.0 to 19.0 wt% of water and the remaining balance among 100 wt% of the vulva care composition. there is.

Among the compositions of external genital care products, the above-mentioned moisturizers serve to increase the moisturizing power of the product and include sodium lactate, glycolic acid, urea, hydrolyzed proteins, hyaluronic acid, salicylic acid, phospholipids, propylene glycol, butylene glycol, pentylene glycol, caprylyl glycol, ethoxylatedpropylene glycol, glycerol, collagen, pyrrolidone carboxylic acid (PCA), sodium PCA, betaine, glucose, sucrose, xylitol, fructose, sorbitol, It may include at least one selected from mannitol, hydrolyzed starch, sodium levulinate, caprylic/capric triglyceride, hydrogenated lecithin, and ceramide NP, preferably at least one selected from hyaluronic acid, propylene glycol, butylene glycol, pentylene glycol, caprylyl glycol, ethoxylated propylene glycol, sodium levulinate, caprylic/capric triglyceride, hydrogenated lecithin, and ceramide NP glycerol, and more preferably at least one selected from butylene glycol, pentylene glycol, caprylic/capric triglyceride, hydrogenated lecithin, and ceramide NP glycerol. In addition, if the content of this in the product is less than 8.0 wt%, the moisturizing effect due to its use may be insufficient, and if it is used in excess of 12.0 wt%, there may be a problem of the viscosity of the product becoming too high, so it is appropriate to use it within the above range.

Among the compositions of the vulvar care product, the heptyl undecylenate plays a role in assisting in the formation of a moisturizing film, increasing skin soothing and maintaining or improving skin elasticity. If the content is less than 1.0 wt%, the amount used may be too little and the effect of its use may be minimal. If it exceeds 3.0 wt%, the excessive use may actually increase the stickiness of the vulvar care product, thereby reducing the feeling of use. Therefore, it is appropriate to use it within the above range.

The above fragrance, when used in the composition of external genital care products, increases the marketability of the product, and general fragrances used in skin care products can be used without limitation.

The content of the solvent, water, in the composition of the vulva care product is appropriately about 15 to 20 wt%, and the amount of the solvent, water, can be adjusted depending on the formulation of the vulva care product to be manufactured. In the case of an ampoule or serum formulation, it is appropriate to use it within the above range.

The vulva care product of the present invention described above may be manufactured by adding at least one selected from natural extracts and commercialized agents in addition to the ingredients described above to provide additional functionality.

The above natural extract is a natural material having antibacterial and anti-inflammatory effects on vaginitis-causing bacteria and for preventing and improving itching in the vagina and the Y zone, and may include at least one selected from an extract of Aster japonica, an extract of Aster japonica root, and an extract of Coptis chinensis. Preferably, the extract of Aster japonica, an extract of Aster japonica root, and an extract of Coptis chinensis may be mixed in a weight ratio of 1:0.5 to 1.5:0.1 to 1.0, and more preferably, the extract of Aster japonica, an extract of Aster japonica root, and an extract of Coptis chinensis may be mixed in a weight ratio of 1:1.0 to 1.5:0.1 to 0.5. And, when using a natural extract as an ingredient of a vulva care product, it is appropriate to use the content of the natural extract in an amount of 1.0 to 10.0 wt%, preferably 3.0 to 10.0 wt%, and more preferably 5.0 to 8.0 wt% of the total weight of the vulva care product. Using it in this content range is advantageous in terms of securing appropriate antibacterial properties of the vulva care product and not interfering with the effect of the vulva care product to be manufactured.

The above-mentioned extract ingredient, Leonurus japonicus Houtt ., is also called Yukmocho, and as it is not picky about growing conditions, it grows well anywhere, and the leaves grow opposite each other with long petioles. Leonurus japonicus Houtt. is harvested before the flowers bloom, and in the Donguibogam, it is known as a medicinal herb that reduces swelling and helps cure various diseases after childbirth.

The above extract of the plant is obtained by extracting the plant from the dried plant of the plant before it blooms and extracting it with hot water. It can provide the function of making the skin around the vulva elastic and reducing the occurrence of odor.

The above-mentioned Koraiensis root extract component, Koraiensis , is a perennial herb of the Asteraceae family in the Campanulate order, which grows in wetlands, and the main stem grows straight from the sideways spreading rhizome, and has grooves and lines. The leaves on the root fall when the flower blooms. The leaves on the stem are opposite, lanceolate, 12–19 cm long, 1.5–3 cm wide, hard, and pointed at both ends.

The above extract of the root of the common dandelion is obtained by extracting the dried root of the common dandelion with an ethanol solution at 15 to 35°C, preferably 20 to 30°C, for 1 to 2 hours, and has an antibacterial effect against bacteria that cause vaginitis around the vulva.

The above coptis extract component, Coptis chinensis , is an evergreen perennial herb of the Ranunculaceae family in the Ranunculal order of the dicotyledonous plant, native to China and also cultivated in Korea, Japan, and China for herbal medicine. It grows in moist soil in the shade of mountain forests. This coptis is called coptis in oriental medicine when the root is collected and dried in the sun. It is known to be effective in treating gastritis by regulating gastric acid secretion, enteritis, and pneumonia, and has an anti-inflammatory effect.

The above-mentioned coptis extract uses an extract obtained by performing an extraction process on dried coptis root with an ethanol solution at 15 to 35°C, preferably 20 to 30°C, for 2 to 3 hours, and together with the extract of the root of Aster japonica, has an antibacterial effect against bacteria that cause vaginitis around the vulva.

The above compatibilizer serves to increase the compatibility and miscibility of the vulva care composition and other ingredients in the vulva care product, and may include at least one selected from galactolipid, perlecan, and iridoid glycosides, and preferably may include at least one selected from galactolipid and iridoid glycosides. In addition, when the compatibilizer is used as an ingredient of the vulva care product, the content thereof is 0.2 to 1.5 wt%, preferably 0.2 to 0.5 wt%, and more preferably 0.20 to 0.35 wt% based on the total weight of the vulva care product, which is suitable for preventing a decline in the function of the vulva care product and manufacturing a vulva care product with excellent marketability.

The vulva care product of the present invention may be manufactured by further applying additives including a skin elasticity improving agent, a skin whitening agent, a pH adjusting agent, a viscosity adjusting agent, etc., in addition to the vulva care composition, moisturizer, heptyl undecylate, fragrance, solvent, natural extract, and commercializing agent described above.

As a preferred example, in order to soothe the skin, strengthen the skin barrier, and increase the antibacterial activity against harmful bacteria, exosomes derived from Asimina triloba leaves may be further included as an additive in an amount of 0.01 to 0.5 wt%, preferably 0.05 to 0.20 wt%, and more preferably 0.05 to 0.15 wt%.

The vulva care product of the present invention described above has excellent effects in maintaining or improving skin soothing, pH recovery, skin hydration, and skin elasticity.

In addition, the vulvar care product of the present invention has excellent antibacterial properties against vaginitis-causing bacteria such as Neisseria gonorrhoeae, Chlamydia trachomatis, Gardnerella Vaginalis, Candida and/or Trichomonas.

In addition, the vulva care product of the present invention is effective in improving vulva itching, etc., and is effective in maintaining the cleanliness of the Y zone and preventing female diseases.

Hereinafter, the present invention will be described more specifically through examples; however, the following examples do not limit the scope of the present invention, and should be interpreted as helping to understand the present invention.

[Example]

Example 1: Preparation of a vulvar care product

(1) Manufacturing of external genital care composition

Olive oil (Olea europaea fruit oil), avocado oil (Persea Gratissima oil), sunflower seed oil (Helianthus Annuus Seed Oil), and soybean oil (Glycine Soja Oil) were slowly stirred and mixed at 30 to 32°C in a reactor equipped with a stirrer to prepare a natural oil mixture. Royal jelly was then added thereto, and the mixture was slowly stirred and mixed at 30 to 32°C for 30 minutes to prepare a vulva care composition. The composition ratios within the composition are as shown in Table 1 below.

Vulva care composition Content (weight%) Royal Jelly 0.75 Natural oil blend 99.25 wt% Natural oil blend Olive oil (Olea europaea fruit oil) 100 weight parts Avocado Oil (Persea Gratissima Oil) 1.95 weight parts Sunflower Seed Oil (Helianthus Annuus (Sunflower) Seed Oil) 1.55 weight parts Glycine Soja Oil 1.55 weight parts

(2) Manufacturing of external genital care products in serum form

Next, the vulva care composition prepared in advance was added to a reactor equipped with a stirrer, and then the moisturizers butylene glycol, heptyl undecylenate, and fragrance were added, and then slowly stirred and mixed at 25 to 27°C.

After sufficient mixing, water as a solvent was added thereto, and slowly stirred and mixed at 25 to 27°C for 1 hour to manufacture a serum-type external genital care product. The contents of the ingredients used in the manufacture of the product are as shown in Table 2 below.

Examples 2-3: Manufacturing of external genital care products

(1) Production of natural extracts

A natural extract was prepared by mixing the extract of Atractylodes japonica, the extract of the root of Atractylodes rhizome, and the extract of Coptis chinensis in a weight ratio of 1:1.35:0.37.

The above extract of the plant was prepared by drying the whole plant of the plant, which was collected before the flower blooms, and subjecting it to a hot water extraction process with water at 100 to 110°C for about 5 hours, then drying the filtered filtrate to obtain a powder.

The above extract of the root of the plant was prepared by subjecting the dried root of the plant to an alcohol extraction process using a 70% by volume ethanol aqueous solution at 25 to 27°C for 1 hour, filtering the resulting filtrate, and drying the resulting powder.

The above Coptis chinensis extract was prepared by performing an alcohol extraction process on dried Coptis chinensis roots using a 60% volume concentration ethanol aqueous solution at 25 to 27°C for 2 hours, then drying the filtered filtrate to obtain a powder.

(2) Manufacturing of external genital care products in serum form

The vulva care composition manufactured in Example 1 was placed in a reactor equipped with a stirrer, and then the moisturizers butylene glycol, heptyl undecylenate, and fragrance were added, and then slowly stirred and mixed at 25 to 27°C.

After sufficient mixing, the previously manufactured natural extract, the commercializing agent iridoid glycoside, and the solvent water were added, and slowly stirred and mixed at 25 to 27°C for 1 hour to manufacture a serum-type vulvar care product. The contents of the ingredients used in the manufacture of the product are as shown in Table 2 below.

Example 4: Preparation of external genital care product

Same composition as in Example 2 A vulvar care product in the form of a serum was manufactured, and exosomes derived from Asimina triloba leaves were further used in an amount as shown in Table 2 below to manufacture a vulvar care product. The Asimina triloba-derived exosomes are exosomes obtained by segmenting Asimina triloba leaves, squeezing the juice to obtain the juice, filtering the same, performing equilibrium density centrifugation on the filtered juice, and then performing gel filtration.

Comparative Example 1 (Control Group)

As comparative example 1 (control group), Vaseline (baseliene) was prepared.

Comparative Example 2

A vulvar care product was manufactured in the same manner as in Example 1, but a vulvar care composition was used, manufactured by mixing 0.75 wt% of royal jelly and 99.25 wt% of olive oil alone.

Comparative Example 3

A vulvar care product was manufactured in the same manner as in Example 1, but a vulvar care composition was used, which was manufactured by mixing 0.75 wt% of lotus jelly and 99.25 wt% of avocado oil alone.

Serum formulation vulvar care product Example 1 Example 2 Example 3 Example 4 Comparative Example 2 Comparative Example 3 Moisturizer (butylene glycol) 9.8 9.0 8.8 9.0 9.8 9.8 Heptyl undecylenate 1.8 1.5 1.3 1.5 1.8 1.8 spices 0.5 0.4 0.4 0.4 0.5 0.5 water 17.9 18.0 18.4 18.0 17.9 17.9 Natural extracts - 5.9 8.0 5.9 - - Exosomes from Papaya leaves - - - 0.1 Commercialization agent (iridoid glycoside) - 0.28 0.30 0.28 - - Vulva care composition Remaining amount out of 100% by weight

Experimental Example 1: Measuring the effectiveness of external genital care products

(1) In order to confirm the effect of the control group, Comparative Example 1 (Vaseline), and the vulva care products manufactured in Examples 1 to 4 and Comparative Examples 2 to 3, skin hydration distribution, pH change, skin thickness and density, skin elasticity, skin pigmentation, and vulva itching (VAS) were measured.

The subjects of the experiment were 22 healthy adult women aged 20 to 60 (mean age 45.55±7.81 years).

Measurements were performed on the armpit (underarm), which has a similar environment and histological structure to the vulva and where the measurement equipment can be applied, and the forearm was used for other skin measurement sites. However, the VAS evaluation used a research sample directly on the vulva.

(2) Measuring tool

Skin measurement tools included Moisture Map MM200 (Courage Khazaka electronic GmbH, Germany) for skin moisture distribution, Skin pH meter PH905 (Courage+Khazaka electronic GmbH, Germany) for pH change, Ultrascan UC22 (Courage Khazaka electronic GmbH, Germany) for skin thickness and density, Cutometer® MPA580 (Courage+Khazaka electronic GmbH, Germany) for skin elasticity, and Antera 3D (Antera 3D CS, Miravex Limited, Ireland) for skin pigmentation. In addition, VAS (Visual analogue scale) was used to evaluate vulvar itching.

(3) Data analysis method

Data analysis was performed using SPSS 28.0 for Windows. Normality was verified through Shapiro-Wik test, and if the p value was 0.05 or higher, it was judged to satisfy normal distribution. For the pre-post comparison, if normality was satisfied, the repeated measures ANOVA was applied to verify the utility, and if it was not satisfied, the Wilcoxon signed-ranks test was applied to verify the utility.

The prior homogeneity of the experimental group and the control group was verified through the Independent t-test, and the post hoc comparison between groups was applied with the Repeated Measures ANOVA or Repeated Measures ANCOVA. The statistical significance level of all data was set to p < 0.05, and the skin prior homogeneity test is as shown in Table 3 below.

division Group p -value Skin moisture distribution chart Examples 1-3 vs. control 0.590 Redness 0.914 Skin pH balance 0.831 Skin thickness 0.971 Skin Density 0.137 Skin elasticity 0.700 Skin pigmentation too 0.872

(4) Measurement of skin moisture distribution

The results of analyzing the hydration distribution of the skin before and after application to the forearms of the study subjects are shown in Table 4 below.

(5) Skin soothing to physical stimulation

A 2.5 cm wide cotton bandage (Daeil Band, Daeil Pharmaceutical) was applied to the forearms of the subjects 20 times with a constant pressure to induce physical stimulation. The a ^* value of the left and right forearms where the physical stimulation was induced was measured. The a ^* value was measured immediately after applying the research sample and the control sample, respectively, and the pre- and post-test results were analyzed. The results are shown in Table 4 below.

(5) Skin pH changes

The results of analyzing the skin pH before and after the application of the sample to the subjects' underarms on both sides are shown in Table 4 below.

(6) Measurement of skin thickness and density

After inducing the same physical stimulation as in the above-mentioned authenticity measurement experiment on both forearms of the research subjects, the skin thickness and density of the left and right forearms where the physical stimulation was induced were measured. The sample and control groups were applied to both forearms for 14 days, and the post-test values were measured. The results are shown in Table 4 below.

(7) Measurement of skin elasticity and skin pigmentation

After using the sample on both armpits (underarm) of the research subjects for 14 days, skin elasticity and skin pigmentation were measured and analyzed compared to before use, and the results are shown in Table 4 below.

(8) Evaluation of vulvar itching

Among the research subjects, 12 patients with vulvar itching were selected, and among them, 6 patients were divided into groups and used the sample of Comparative Example 1 or Example 1 for 14 days. The results of the VAS (Visual analogue scale) measurement are shown in Table 4 below.

division Example 1 Example 2 Example 3 Example 4 Comparative example
1 Comparative Example 2 Comparative Example 3 Skin moisture
Distribution map jeon 43.51 43.23 43.62 44.01 44.02 43.56 43.83 after 106.88 108.98 109.17 110.53 88.12 90.36 92.08 Authenticity jeon 13.12 13.21 13.18 13.13 13.07 13.10 13.08 after 7.26 7.02 6.98 6.74 12.23 11.03 10.55 skin
pH jeon 6.65 6.67 6.70 6.65 6.69 6.68 6.64 after 5.87 5.88 5.76 5.77 6.54 6.45 6.43 skin
thickness jeon 940.86 941.02 940.76 940.83 941.21 940.95 941.07 after 1030.19 1030.65 1031.23 1031.62 967.34 970.92 972.04 skin
density jeon 19.38 19.40 19.52 20.37 21.03 19.98 20.34 after 24.81 25.03 25.41 25.92 22.72 22.96 23.23 skin
Elasticity jeon 65.47 65.38 65.29 65.58 65.26 65.19 65.34 after 71.18 71.87 72.51 72.84 65.85 67.82 67.72 skin
Pigment too jeon 0.54 0.53 0.54 0.55 0.52 0.53 0.54 after 0.50 0.48 0.49 0.48 0.51 0.51 0.52 VAS
evaluation jeon 5.62 - - - 5.71 - - after 1.50 - - - 4.93 - -

Looking at the experimental results in Table 4 above, it was confirmed that the external genital care serums of Examples 1 to 4 were superior in terms of skin moisture distribution, soothing effect, pH reduction, skin thickness and density improvement, skin elasticity improvement, and skin pigmentation reduction compared to the control group, Comparative Example 1.

Specifically comparing Comparative Example 1 and Example 1, Example 1 showed an increase in skin moisture distribution by about 145.6%, an improvement in soothingness by about 44.6%, a decrease in skin pH by about 11.73%, and also an improvement in skin thickness by about 9.5%, skin density by 28.0%, and skin elasticity by 1.9%. Furthermore, skin pigmentation was improved by about 7.4%, and vulvar itching was improved by about 73.3%. In contrast, Comparative Example 1, which is the control group, showed lower effects of improving skin moisture distribution, soothingness, skin thickness, density and elasticity, and skin pigmentation compared to Example 1, and showed almost no improvement in vulvar itching.

Furthermore, in Comparative Example 2, where olive oil was used alone, and Comparative Example 3, where avocado oil was used alone, overall skin improvement effects were superior to those of the control group, Comparative Example 1, but relatively poor skin improvement effects were observed compared to Example 1, where the natural oil mixture components of the examples were used.

Experimental Example 2: Cytotoxicity Test

(1) Cell culture

Murine macrophage cell line RAW264.7 cells were obtained from KCLB (Korean Cell Line Bank) and cultured in DMEM medium containing 100 units/㎖ penicillin-streptomycin and 10% FBS (fetal bovine serum) at 37℃ in an incubator with 5% _CO2 , and subcultured once every 3 to 4 days. Lipopolysaccharide (E. coli serotype 0111:B4) was purchased from Sigma and used.

(2) Cytotoxicity evaluation-MTT assay

RAW 264.7 cells were seeded at 1.0× ¹⁰⁶ cells/㎖ in a 24-well plate and cultured for 18 hours under 37℃, 5% _CO2 conditions. Then, the samples (100㎍/㎖, 300㎍/㎖) and LPS (1㎍/㎖) were treated simultaneously and cultured for 24 hours. After culture, MTT was added at a concentration of 500㎍/㎖ and reacted at 37℃ for 3 hours and the supernatant was removed. DMSO (dimethyl sulfoxide) was added to dissolve the formazan precipitate formed by the reaction with living cells, and then transferred to a 96-well plate and the absorbance was measured at 540 nm.

The cytotoxicity results of the serums manufactured in Examples 1 to 4 are shown in Table 5 below. The control group was not treated with the sample composition.

Cell Viability (%) Composition (sample) concentration 0㎍/㎖ 100㎍/㎖ 300㎍/㎖ Control group (blank) 115.3% - - Example 1 - 101.8 100.4 Example 2 - 102.3 99.7 Example 3 - 100.6 99.2 Example 4 - 100.8 99.8

Looking at the results of the cytotoxicity experiment in Table 5 above, all of Examples 2 to 4 showed almost no cytotoxicity or very low cytotoxicity overall.

Experimental Example 3: Antibacterial Experiment

The antibacterial activity of each serum manufactured in Examples 1 to 4 against Candida albicans ATCC 10231 was confirmed by the Korea Conformity Laboratories, and the results are shown in Table 6 below. The test method was measured according to KCL-FIR-1002:2018.

Test items Initial concentration
(CFU/mL) Concentration after 24 hours
(CFU/mL) Decrease rate
(%) Candida Example 1 2.4×10 ⁴ 7.8×10 ³ 67.70 Example 2 2.4×10 ⁴ 9.8×10 ² 95.91 Example 3 2.4×10 ⁴ 2.6×10 ² 98.92 Example 4 2.4×10 ⁴ < 10 99.99

Looking at the experimental results in Table 6 above, it was confirmed that all of Examples 1 to 4 had antibacterial properties against Candida, a bacterium that causes vaginitis. However, compared to Example 1 that did not use natural extracts, Examples 2 to 4 that used natural extracts had much better antibacterial properties, and in particular, Example 4 that used more exosomes derived from the poplar tree showed the best antibacterial properties.

Through the above examples and experimental examples, it was confirmed that the vulva care composition of the present invention and the vulva care product manufactured using the same are effective in maintaining a healthier environment around the vulva, while also improving the soothing, pH recovery, skin hydration and skin elasticity around the vulva, and improving vulva itching, and are effective in maintaining the cleanliness of the Y zone and preventing gynecological diseases.

Claims (4)

Contains 0.10 to 1.50 wt% of royal jelly and the remaining 100 wt% of natural oil mixture.
A vulva care composition characterized in that the above natural oil mixture ingredients include olive oil (Olea europaea fruit oil), avocado oil (Persea Gratissima oil), sunflower seed oil (Helianthus Annuus Seed Oil) and soybean oil (Glycine Soja Oil).
A vulvar care composition according to claim 1, characterized in that the natural oil mixture component comprises 1.0 to 10 parts by weight of avocado oil, 0.5 to 8.0 parts by weight of sunflower seed oil, and 0.5 to 5.0 parts by weight of soybean oil, per 100 parts by weight of olive oil.
One formulation selected from lotion, cream, ampoule, and serum.
A vulvar care product characterized by comprising 8.0 to 12.0 wt% of a moisturizer, 1.0 to 3.0 wt% of heptyl undecylenate, 0.1 to 1.0 wt% of a fragrance, 15.0 to 20.0 wt% of water, and the remaining balance of 100 wt% of the vulvar care composition of claim 1 or 2.
In the third paragraph, at least one selected from natural extracts and commercialized agents is further included,
The above natural extracts include at least one selected from among an extract of Atractylodes japonica, an extract of the root of Atractylodes rhizome, and an extract of Coptis chinensis.
A vulvar care product, characterized in that the commercializing agent comprises at least one selected from galactolipid, perlecan, and iridoid glycosides.