KR20240146979A - Vaginal health composition containing bacillus coagulans - Google Patents

Abstract

The present invention relates to a vaginal health composition for topical vaginal application in the form of a liquid, gel, cream, ointment, etc. containing 10 to 10 ¹⁰ cfu/mL of spore-forming lactic acid bacteria Bacillus coagulans, and a vaginal health composition which prevents vaginitis and is beneficial to vaginal health by producing lactic acid in the vagina and adjusting the pH of the vagina to 3.5 to 5. Since the spore-forming Bacillus coagulans has high resistance to environmental changes such as high temperature, humidity, and pH, it has very stable characteristics and thus has excellent storage stability compared to vaginal lactic acid bacteria capsules or tablets containing general lactic acid bacteria, and has the effect of improving the burden and foreign body sensation upon vaginal insertion.

Description

{VAGINAL HEALTH COMPOSITION CONTAINING BACILLUS COAGULANS}

The present invention relates to a vaginal health composition containing spore-forming lactic acid bacteria Bacillus coagulans, and more specifically, to a vaginal health composition for vaginal application that prevents vaginitis in women and is beneficial for vaginal health.

The vagina of a woman is located at the entrance of the uterus and is directly affected by the menstrual cycle, and is the most moist and warm place in the female body as it is a passage connecting the vulva and the uterus. In addition, it is located close to the urethra and anus, so it is highly likely to be contaminated by intestinal microorganisms and urinary tract disease microorganisms. Therefore, it is a suitable environment for bacteria or fungi, which are the main causes of vaginitis, to live, and thus there is a high possibility of diseases caused by them.

Under normal conditions, many lactobacilli live inside the vagina, making the inside of the vagina slightly acidic and inhibiting the growth of pathogens or fungi. However, when the balance inside the vagina is disrupted due to long-term use of antibiotics, long-term use of birth control pills, use of tampons or loops, or changes in the balance of female hormones such as pregnancy, childbirth, breastfeeding, or menopause, opportunistic pathogens that are normally suppressed from growing inside the vagina can grow, causing various gynecological diseases.

Among them, vaginitis is a common disease in women and can be caused by various reasons, but one of the most common causes is the disruption of the balance of vaginal bacteria due to the proliferation of harmful bacteria in the vagina.

Typically, more than 95% of the vaginal flora is comprised of beneficial strains of probiotics, including Lactobacillus crispatus, Lactobacillus jensenii, Lactobacillus gasseri, and Lactobacillus iners.

These strains of lactobacillus are important for maintaining a healthy vaginal environment by maintaining the pH level within the vagina at an appropriate level and inhibiting the growth of harmful bacteria.

Harmful bacteria include Gardnerella vaginalis, Staphylococcus aureus, Streptococcus agalactiae, and Enterococcus faecalis. These bacteria increase the pH level in the vagina, which reduces the number of beneficial bacteria, and in the process, causes inflammation in the vagina, which can lead to diseases such as vaginitis, congenital vaginal infections, and cervical cancer.

The pH level in the vagina can vary from woman to woman and is affected by various factors, so the exact value may vary, but it is generally known that the appropriate pH level in the vagina is around 3.8 to 5. It is important to maintain an appropriate pH level in the vagina because it allows the beneficial bacteria in the vagina, lactobacilli, to survive and prevents the growth of harmful bacteria.

There is a way to make the vagina more probiotic (lactic acid bacteria) to lower the pH level and keep the vagina healthy. A representative method is known to be to supply probiotics by consuming fermented foods or health supplements containing probiotics.

It is known that when oral probiotics are taken, some of the probiotics are digested during the digestive process and some are excreted without reaching the vagina.

Of course, some strains of lactic acid bacteria have the ability to reach and reside in the intestines, and some studies have confirmed that some strains exist in the intestines after consuming lactic acid bacteria. However, most of the lactic acid bacteria that are actually ingested do not survive and are digested by gastric acid, digestive enzymes, and sterilization in the small intestine. In order for the ingested lactic acid bacteria to reach the vagina, they must go through digestion in the stomach, small intestine, and large intestine, and the surviving lactic acid bacteria must move from the anus to the vagina. The distance from the anus to the vagina is about 5 cm, and the number of lactic acid bacteria, which are about 0.5 um in size, can decrease rapidly while moving from the anus to the vagina. In addition, it is known that it takes at least two to three months for the surviving lactic acid bacteria to increase in number and form a protective barrier.

To improve the above-mentioned aspects and effectively deliver lactic acid bacteria into the vagina, products in the form of lactic acid bacteria capsules, tablets, suppositories, and insertable applicators that can be inserted into the vagina have been released and are being sold on the market. However, there are inconveniences in use, such as the burden of inserting them into the vagina or the foreign body sensation.

In addition, vaginal topical preparations containing general lactic acid bacteria may cause storage stability problems such as proliferation and death of lactic acid bacteria.

Therefore, there is a need for the development of a composition for vaginal application that can maintain the vaginal pH at a normal level, effectively prevent diseases related to the vagina, improve itchiness caused by various diseases, and is easy to use due to its low irritation and minimal skin irritation.

The spore-forming lactic acid bacteria Bacillus coagulans are lactic acid bacteria that have been proven to be safe for the human body and generally exist in a spore state, but some also exist in a bacilli state. Since spores increase the ability to survive environmental changes, Bacillus coagulans that exist in a spore state can easily survive under various temperatures and pH conditions.

The inventor of the present invention completed the present invention by manufacturing a vaginal application agent containing the spore lactic acid bacteria Bacillus coagulans and confirming the effect of reducing vaginal pH through experiments to confirm the decrease in vaginal pH before and after use (Experimental Example 1) and simple clinical experiments.

1. Publication patent 10-2021-0128429 2. Registered patent 10-1833832

The present invention relates to a vaginal health composition containing spore-forming lactic acid bacteria Bacillus coagulans. Since oral lactic acid bacteria have difficulty surviving and reaching the vagina and thus have insufficient effects on vaginal health, the purpose of the present invention is to provide a composition for vaginal application that can effectively apply lactic acid bacteria into the vagina.

In addition, the present invention provides a vaginal application containing Bacillus coagulans, a spore-type lactic acid bacteria proven to be safe for the human body, since vaginal application containing general lactic acid bacteria causes storage stability problems due to proliferation and death of lactic acid bacteria, thereby providing a vaginal application composition having excellent storage stability and ease of use.

In one embodiment of the present invention, a vaginal health composition containing 10 to 10 ¹⁰ cfu/mL of spore-forming lactic acid bacteria Bacillus coagulans, wherein the spore-forming lactic acid bacteria produce lactic acid in a woman's vagina to adjust the pH of the vagina to 3.5 to 5, thereby preventing vaginitis and being a vaginal health composition beneficial to vaginal health.

In another embodiment of the present invention, the spore lactic acid bacteria, Bacillus coagulans, may be a health composition existing in the form of spores or viable bacilli.

In another embodiment of the present invention, the composition may be a vaginal health composition for vaginal application, which is formulated with at least one selected from oil, water, a surfactant, a moisturizer, lower alcohol, a thickener, a chelating agent, a pigment, a preservative, or a fragrance so that it can be applied intravaginally, and is topically administered in the form of any one of a lotion, a cream, an ointment, a serum, an essence, a gel, a spray, a liquid, an emulsion, an emulsion, and a suspension.

In another embodiment of the present invention, the composition may be a health composition in which the weight ratio of the spore lactic acid bacteria, Bacillus coagulans, is 1 to 10 wt%.

In another embodiment of the present invention, the vaginitis may be a vaginal health composition that is one of bacterial vaginitis, fungal vaginitis, and trichomoniasis vaginitis.

In another embodiment of the present invention, the composition may be a quality health composition used as a cosmetic or over-the-counter drug.

Bacillus coagulans is a lactic acid bacterium proven to be safe for the human body. Since it forms spores, it has high resistance to environmental changes such as high temperature, humidity, and pH, and has very stable characteristics. Therefore, it has excellent storage stability compared to vaginal insertion lactic acid bacteria capsules or tablets containing general lactic acid bacteria, and it has the effect of improving the burden or foreign body sensation when inserted into the vagina as a formulation for vaginal application.

The present invention relates to a vaginal health composition for vaginal application containing Bacillus coagulans in the form of spores or rods, wherein Bacillus coagulans is a lactic acid bacterium proven to be safe for the human body. In addition, it is known to be an anaerobic bacterium that forms spores and is positive for Gram stain and catalase and produces lactic acid.

Microorganisms such as bacteria naturally die over time, but some microorganisms can use spore-type defense mechanisms to increase their survival and respond to environmental changes. Spores are internal structures that are usually formed inside the strain, and when released outside the cell, they have the characteristic of developing into strains again when appropriate environmental conditions are met. Microorganisms that exist in spore form are also included in living (viable) microorganisms.

Since spores increase the ability to survive environmental changes, Bacillus coagulans, which generally exists in the form of spores, has high survival ability and resistance to environmental changes even under extreme stress, temperature and aeration, and a wide range of pH conditions, making it easy to survive.

Bacillus coagulans generally exists in a spore state, but when appropriate nutrients and environmental factors are met, the spores develop into a bacilli state. An appropriate environment in which Bacillus coagulans can develop into a bacilli state is generally an environment with high temperature and high humidity, and it is known to develop at a temperature of about 30 to 50℃. Therefore, since the vaginal environment of a woman is 37℃ and has high humidity, Bacillus coagulans is suitable for developing into a bacilli when applied to the vagina, producing lactic acid and lowering the pH inside the vagina to acidify it.

The vaginal health composition containing the Bacillus coagulans of the present invention is formulated as a lotion, cream, ointment, serum, essence, gel, spray, solution, emulsion, emulsion, and suspension for intravaginal application and is used as a cosmetic or over-the-counter drug.

When the formulation of the present invention is a lotion, cream, ointment, serum, essence or gel, animal oil, vegetable oil, wax, paraffin, starch, tragacanth, cellulose derivatives, polyethylene glycol, silicone, bentonite, silica, talc or zinc oxide may be used as a carrier component.

If the formulation of the present invention is a spray, it may contain a propellant such as chlorofluorohydrocarbon, propane/butane or dimethyl ether as a carrier component.

When the formulation of the present invention is a liquid, emulsion or emulsion, a solvent, a solubilizer or an emulsifier is used as a carrier component, and specific examples thereof include water, ethanol, isopropanol, ethyl carbonate, ethyl acetate, benzyl alcohol, benzyl benzoate, propylene glycol, 1,3-butyl glycol oil, glycerol aliphatic ester, polyethylene glycol or sorbitan fatty acid ester.

When the formulation of the present invention is a suspension, liquid diluents such as water, ethanol or propylene glycol, suspending agents such as ethoxylated isostearyl alcohol, polyoxyethylene sorbitol ester and polyoxyethylene sorbitan ester, microcrystalline cellulose, aluminum metahydroxide, bentonite, agar or tragacanth can be used as carrier components.

In addition, the vaginal health composition containing the Bacillus coagulans of the present invention can be used by appropriately blending oil, water, surfactants, moisturizers, lower alcohols, thickeners, chelating agents, pigments, preservatives, or fragrances, in addition to the ingredients described above in each formulation, as needed.

For example, a lotion, cream, ointment or gel formulation manufactured with a vaginal health composition containing Bacillus coagulans can be manufactured to contain, in addition to the Bacillus coagulans strain according to the present invention, 5 to 20 wt% of an oil (squalane, petrolatum, octyldodecanol, etc.), 3 to 15 wt% of a wax component (cetanol, stearyl alcohol, lead, etc.), and 0.05 to 2 wt% of a surfactant (polyethylene oleyl ether, polyoxyethylene, hydrogenated castor oil, etc.). Serums and essences can be manufactured to contain, in addition to the Bacillus coagulans strain according to the present invention, 5 to 30 wt% of a polyhydric alcohol such as glycerin or propylene glycol.

The solution, emulsion or emulsion can be prepared to contain, in addition to the Bacillus coagulans strain according to the present invention, 1 to 10 wt% of a polyhydric alcohol (propylene glycol, glycerin, etc.) and 0.05 to 2 wt% of a surfactant (polyethylene oleyl ether, polyoxyethylene, hydrogenated castor oil, etc.).

The Bacillus coagulans according to the present invention may be contained in an amount of 0.1 to 50 wt%, preferably 0.5 to 20 wt%, and more preferably 1 to 10 wt%.

Bacillus coagulans strains are generally cultured in MRS medium, centrifuged, and lyophilized to obtain lactic acid bacteria strains, which are then suspended and dissolved in phosphate buffered solution (PBS) to be used as lactic acid bacteria strain lysates.

First, dissolve the oil component in the Bacillus coagulans strain and the appropriate carrier described above, and slowly add the surfactant and water and mix. The ratio of oil and water may vary depending on the formulation. Stabilizers and preservatives may be added to increase durability. In addition, moisturizers, low-grade alcohols, thickeners, chelating agents, pigments, preservatives, or fragrances may be additionally mixed, and in the process of mixing each component, the mixing process is generally performed at a temperature of 60 to 80℃ using an emulsifier (homomixer) to mix to form a homogeneous formulation. After the emulsification process, it is cooled after degassing and filtration. The cooling process lowers the temperature of the viscous mixture emulsified at a high temperature to increase the viscosity, and since phase separation may occur when the temperature changes rapidly, the temperature should be lowered gradually. After the cooling process is complete, it is filled into a container and commercialized.

Hereinafter, embodiments of the present invention will be described in detail so that those skilled in the art can easily implement the present invention. However, the present invention may be implemented in various different forms and is not limited to the embodiments described herein.

Hereinafter, the present invention will be described in detail through the following experimental examples.

However, the following experimental examples are only intended to illustrate the present invention, and the content of the present invention is not limited by the following experimental examples.

Manufacturing Example 1: Manufacturing of a sample (lotion manufactured with a vaginal health composition containing Bacillus coagulans)

Bacillus coagulans MTCC 5856 10 ⁸ cfu (spores) was mixed with 20 wt% of squalane and 2 wt% of polyethylene oleyl ether in an amount corresponding to 10 wt%. At 70°C, 15 wt% of cetanol was further added and mixed to obtain a homogeneous formulation, and the temperature was gradually lowered to 20°C to prepare a vaginal lotion containing Bacillus coagulans.

Experimental Example 1: pH reduction effect experiment

Ten women aged 20 to 40 suffering from vaginitis were selected, numbered from experimenter 1 to 10, and used a lotion (Preparation Example 1) manufactured with a vaginal health composition for vaginal application containing Bacillus coagulans of the present invention for 7 days. The pH reduction effect was evaluated, and the results are shown in Table 1 below. The vaginal pH was measured using pH paper, and the vaginal pH measurement values before using the lotion containing Bacillus coagulans are also shown in Table 1 below.

Vaginal pH before use Vaginal pH after use Degree of pH reduction Experimenter 1 5 5 0 Experimenter 2 6 4 2 Experimenter 3 6 4 2 Experimenter 4 6 5 1 Experimenter 5 6 5 1 Experimenter 6 4 4 0 Experimenter 7 5 4 1 Experimenter 8 5 5 0 Experimenter 9 6 5 1 Experimenter 10 6 4 2

As described in Table 1 above, when the vaginal pH of 10 subjects was measured before conducting this experiment, 1 subject had a pH of 4, 3 subjects had a pH of 5, and 6 subjects had a pH of 6, representing a value of 60%.

In addition, when the vaginal pH was measured after using the lotion manufactured as a vaginal health composition for vaginal application containing Bacillus coagulans for 7 days, it was confirmed that the vaginal pH of all subjects fell below 5, with 5 subjects having a pH of 4 and 5 subjects having a pH of 5.

When examining the degree of decrease in the pH measurement value inside the vagina, it was confirmed that 70%, or 7 subjects, had a decreased pH level of 0 for 3 subjects with no change, 1 for 4 subjects, and 2 for 3 subjects, as shown in the table below, and that vaginal acidification progressed. However, the subjects whose pH decrease level was 0 already had a vaginal pH level that is generally considered to be within the normal range before the experiment, with the measured pH values being pH 5, pH 4, and pH 5, respectively. Therefore, although the pH did not decrease due to the lotion manufactured with the vaginal health composition for vaginal application of the present invention, it was confirmed that there was an effect of adjusting it to pH 3.5 to 5.

Therefore, it was confirmed that the lotion manufactured with the vaginal health composition for vaginal application containing the Bacillus coagulans of the present invention is effective in improving vaginal acidification, although there may be individual differences or differences in physical constitution.

Experimental Example 2: Experiment on the effect of reducing itchiness

Ten women aged 20 to 40 who felt itching were selected and numbered from experimenter 1 to 10. After using a lotion manufactured as a vaginal health composition for vaginal application containing Bacillus coagulans for 7 days, the itching reduction effect was evaluated and the results are shown in Table 2 below. The scores range from 1 to 10, and a score closer to 10 was given as the better the effect was felt to be.

Itching reduction effect (1:lowest, 10:highest) Experimenter 1 6 Experimenter 2 7 Experimenter 3 6 Experimenter 4 8 Experimenter 5 5 Experimenter 6 7 Experimenter 7 4 Experimenter 8 7 Experimenter 9 7 Experimenter 10 8

As described in Table 2 above, the lotion manufactured with the vaginal health composition for vaginal application containing the Bacillus coagulans of the present invention was used for 7 days to evaluate the effect of reducing itching, and the highest score was 8 out of 10. Out of a total of 10 people, 2 people scored 8 points, 4 people scored 7 points, 2 people scored 6 points, 1 person scored 5 points, and 1 person scored 4 points, so 8 people, corresponding to 80%, gave a score of 6 points or higher and evaluated that the lotion was effective in reducing itching.

Therefore, it was confirmed that the lotion manufactured with the vaginal health composition for vaginal application containing the Bacillus coagulans of the present invention is effective in reducing itching, although there may be individual differences or differences in physical constitution.

Experimental Example 3: Skin irritation occurrence test

In addition to the itching reduction effect, an additional evaluation was conducted on the same 10 test subjects as in Experimental Example 2 to determine whether skin irritation occurred, and the results are shown in Table 3 below. The scores range from 1 to 10, with scores closer to 10 indicating no irritation.

Degree of skin irritation
(1: Severe irritation, 10: No irritation) Experimenter 1 7 Experimenter 2 8 Experimenter 3 6 Experimenter 4 7 Experimenter 5 6 Experimenter 6 6 Experimenter 7 5 Experimenter 8 6 Experimenter 9 8 Experimenter 10 7

As described in Table 3 above, when a lotion manufactured with a vaginal health composition for vaginal application containing the Bacillus coagulans of the present invention was used for 7 days, in addition to the effect of reducing itching, the occurrence of skin irritation was additionally evaluated. When a score of 10 is considered to be no irritation at all, the highest score is 8 out of 10. Out of a total of 10 people, 2 people scored 8 points, 3 people scored 7 points, 4 people scored 6 points, and 1 person scored 5 points. In other words, 9 people, corresponding to 90%, gave a score of 6 points or higher and evaluated that there was no skin irritation.

Therefore, it was confirmed that the lotion manufactured with the vaginal health composition for vaginal application containing the Bacillus coagulans of the present invention was generally free of skin irritation and thus had no problems in use, although there may be individual differences or differences in physical constitution.

Claims (6)

A vaginal health composition containing 10 to 10 ¹⁰ cfu/mL of spore-forming lactic acid bacteria Bacillus coagulans,
The above spore lactic acid bacteria produce lactic acid in the vagina of a woman, adjust the pH of the vagina to 3.5 to 5, prevent vaginitis, and are a vaginal health composition beneficial to vaginal health. In paragraph 1,
The above-mentioned lactic acid bacterium, Bacillus coagulans, is a health composition that exists in the form of spores or viable bacilli. In paragraph 1,
The composition is a vaginal health composition for vaginal application, which is formulated with at least one selected from oil, water, a surfactant, a moisturizer, lower alcohol, a thickener, a chelating agent, a pigment, a preservative, or a fragrance so that it can be applied intravaginally, and is administered topically in the form of any one of a lotion, a cream, an ointment, a serum, an essence, a gel, a spray, a liquid, an emulsion, an emulsion, and a suspension. In paragraph 1,
A composition for vaginal health, wherein the weight ratio of the above-mentioned lactic acid bacterium, Bacillus coagulans, is 1 to 10% by weight. In paragraph 1,
A vaginal health composition wherein the above vaginitis is one vaginitis selected from bacterial vaginitis, fungal vaginitis, and trichomoniasis vaginitis. In paragraph 1,
The above composition is a quality health composition used for cosmetics or non-medicinal products.