Mucosal cleansing composition
A mucosal cleansing composition using lactic acid and coconut oil fatty acid acylarginine alkylpyrrolidone carboxylate addresses the challenge of paraben alternatives by providing effective antiseptic and antibacterial properties without irritation, suitable for mucosal applications including the vagina.
Patent Information
- Application Number
- JP2020215660
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2020-12-24
- Publication Date
- 2026-03-05
- Estimated Expiration
- 2040-12-24
AI Technical Summary
Existing mucosal cleansers face challenges in achieving effective antiseptic properties without using parabens due to their irritant and allergic effects, making it difficult to find suitable substitutes that maintain antibacterial and preservative properties.
A mucosal cleansing composition containing lactic acid and/or its salts in combination with coconut oil fatty acid acylarginine alkylpyrrolidone carboxylate, optionally with a polyhydric alcohol, to achieve excellent antiseptic properties.
The composition exhibits superior antiseptic properties without parabens, reducing irritation and maintaining effective antibacterial activity, particularly against bacteria associated with bacterial vaginosis while sparing normal vaginal flora.
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Abstract
Description
[Technical Field]
[0001] The present invention relates to a mucosal cleansing composition having excellent antiseptic properties. [Background technology]
[0002] Parabens are substances that exhibit excellent antibacterial and antiseptic properties, and are most widely used in compositions such as cosmetics and quasi-drugs (Patent Document 1).Specific examples of parabens that are used include methylparaben, ethylparaben, propylparaben, and butylparaben.
[0003] It is known that the adhesion of dirt to mucous membranes, such as those of the pharynx, nasal cavity, oral cavity, and vagina, can cause discomfort, and the adhesion of microorganisms can cause inflammation and infection. Removing adhesions from mucous membranes using a mucosal cleanser is considered effective in preventing and alleviating these symptoms. Furthermore, parabens, which have high antibacterial and antiseptic properties, are used in such mucosal cleansers (Patent Document 2).
[0004] On the other hand, parabens are known to have problems such as irritation and allergies (Non-Patent Document 1). For this reason, it is desirable to reduce the amount of paraben used or to refrain from using it at all. However, because parabens themselves have excellent antibacterial and preservative properties, it is still difficult to find a substitute for them in order to minimize the amount of preservatives used or to eliminate their use while ensuring the antibacterial and preservative properties of the composition itself. [Prior art documents] [Patent documents]
[0005] [Patent Document 1] Japanese Patent Application Laid-Open No. 2014-114291 [Patent Document 2] Japanese Patent Application Publication No. 2018-2661 [Non-patent literature]
[0006] [Non-Patent Document 1] Abstracts of the 38th Annual Meeting of the Japanese Society of Toxicology, Session ID: P-67, 2011 Summary of the Invention [Problem to be solved by the invention]
[0007] The present inventors have an object to provide a mucosal cleansing composition that has excellent antiseptic properties without using parabens. [Means for solving the problem]
[0008] As a result of extensive research, the present inventors have found that a mucosal cleansing composition containing lactic acid and / or a salt thereof in combination with a coconut oil fatty acid acylarginine alkylpyrrolidone carboxylate can exhibit excellent antiseptic properties. The present invention was completed through further research based on this finding.
[0009] That is, the present invention provides the following aspects. Item 1. A mucosal cleansing composition containing (A) lactic acid and / or a salt thereof, and (B) a coconut oil fatty acid acylarginine alkylpyrrolidone carboxylate. Item 2. The mucosa cleansing composition according to Item 1, further comprising (C) a polyhydric alcohol. Item 3. The mucosa cleansing composition according to Item 1 or 2, wherein the total content of the component (A) is 0.5 to 2.5% by weight. Item 4. The mucosa cleansing composition according to any one of Items 1 to 3, wherein the total content of lactic acid molecules and lactate ions is 0.4 to 2% by weight. Item 5. The mucosa cleansing composition according to any one of Items 1 to 4, wherein the content of the component (B) is 0.005 to 0.1 wt %. Item 6. The mucosa cleansing composition according to any one of Items 2 to 5, wherein the content of the component (C) is 0.5 to 25 wt %. Item 7. The mucosa cleansing composition according to any one of Items 1 to 6, which has a pH of 3.8 to 8. Item 8. The mucosa cleansing composition according to any one of Items 1 to 7, which is used on the vaginal mucosa. [Effects of the Invention]
[0010] The mucosa cleansing composition of the present invention can exhibit excellent antiseptic properties without containing parabens. DETAILED DESCRIPTION OF THE INVENTION
[0011] The mucosal cleansing composition of the present invention is characterized by containing (A) lactic acid and / or a salt thereof (hereinafter also referred to as "component (A)") and (B) coconut oil fatty acid acyl arginine alkylpyrrolidone carboxylate (hereinafter also referred to as "component (B)"). The mucosal cleansing composition of the present invention will be described in detail below.
[0012] (A) Lactic acid and / or its salts The mucosa cleansing composition of the present invention contains lactic acid and / or a salt thereof as component (A).
[0013] Lactic acid (2-hydroxypropionic acid) and its salts are ingredients that are incorporated into cosmetics, quasi-drugs, etc. as pH adjusters and / or moisturizing ingredients.
[0014] The salt of lactic acid is not particularly limited as long as it is a cosmetically or pharmaceutically acceptable salt. Specific examples of the salt of lactic acid include alkali metal lactate (sodium lactate, potassium lactate, etc.), alkaline earth metal lactate (calcium lactate, magnesium lactate, etc.), aluminum lactate, zinc lactate, silver lactate, copper lactate, iron lactate, manganese lactate, and ammonium lactate. These lactic acid salts may be used alone or in combination of two or more. In the present invention, the salt of lactic acid is preferably an alkali metal lactate, more preferably sodium lactate.
[0015] In the present invention, any of the L(+), D(-), and DL isomers of component (A) may be used. Specifically, component (A) may be a DL-isomer obtained by chemical synthesis, or an L(+), D(-), or DL isomer obtained by fermentation using lactic acid bacteria. Of these component (A), the L isomer is preferably used in the present invention.
[0016] In the present invention, either lactic acid or a salt of lactic acid may be used as component (A), or a combination of both may be used. In the present invention, a combination of lactic acid and a salt of lactic acid is preferably used as component (A).
[0017] The content of component (A) in the mucosa-cleansing composition of the present invention is, for example, 0.5 to 2.5 wt% in total. From the viewpoint of obtaining better antiseptic properties, the content of component (A) is, for example, 0.8 to 1.5 wt%, and more preferably 1 to 1.2 wt%, in total. Furthermore, the content of component (A) in the mucosa-cleansing composition of the present invention is, for example, an amount such that the total content of lactic acid molecules and lactate ions is 0.4 to 2 wt%. From the viewpoint of obtaining better antiseptic properties, the content of component (A) is, for example, 0.7 to 1.3 wt%, and more preferably 0.9 to 1.1 wt%, in total of lactic acid molecules and lactate ions.
[0018] (B) Coconut oil fatty acid acyl arginine alkylpyrrolidone carboxylate The mucosa cleansing composition of the present invention contains coconut oil fatty acid acyl arginine alkylpyrrolidone carboxylate as component (B).
[0019] Coconut oil fatty acid acylarginine alkylpyrrolidone carboxylate (cocoyl arginine alkylpyrrolidone carboxylate) is a salt of pyrrolidone carboxylic acid and an alkyl ester of a condensation product of arginine and coconut oil fatty acid, and is represented by the following formula: In the present invention, the coconut oil fatty acid acylarginine alkylpyrrolidone carboxylate may be used alone or in combination of two or more.
[0020] [ka]
[0021] In the above formula, R 1 The CO group represents a coconut oil fatty acid acyl group (cocoyl group), and R 2 represents an alkyl group having 1 to 6 carbon atoms, preferably 1 to 3 carbon atoms, and more preferably 2 carbon atoms.
[0022] The content of component (B) in the mucosal cleansing composition of the present invention is, for example, 0.005 to 0.1 wt %. From the viewpoint of obtaining better antiseptic properties, the content of component (B) is preferably 0.007 to 0.1 wt %, and more preferably 0.009 to 0.1 wt %. Furthermore, because the mucosal cleansing composition of the present invention has excellent antiseptic properties, an effective antiseptic effect can be obtained even when the blend amount of component (B) is small. From this viewpoint, suitable examples of the content of component (B) in the mucosal cleansing composition of the present invention include 0.005 to 0.6 wt %, preferably 0.005 to 0.4 wt %, more preferably 0.005 to 0.2 wt %, and even more preferably 0.005 to 0.15 wt %.
[0023] In the mucosal cleansing composition of the present invention, the ratio of component (A) to component (B) is determined by the above-mentioned content of each component. For example, the content of component (B) relative to 100 parts by weight of the total amount of component (A) is 0.4 to 9 parts by weight. From the viewpoint of obtaining superior antiseptic properties, the content of component (B) relative to 100 parts by weight of the total amount of component (A) is preferably 0.6 to 9 parts by weight, more preferably 0.7 to 9 parts by weight, even more preferably 0.8 to 9 parts by weight, and even more preferably 0.85 to 9 parts by weight. Furthermore, because the mucosal cleansing composition of the present invention has excellent antiseptic properties, effective antiseptic effects can be achieved even when the blending ratio of component (B) is low. From this viewpoint, suitable examples of the content of component (B) relative to 100 parts by weight of the total amount of component (A) in the mucosal cleansing composition of the present invention include 0.4 to 6 parts by weight, preferably 0.4 to 3 parts by weight, more preferably 0.4 to 1.5 parts by weight, and even more preferably 0.4 to 0.9 parts by weight.
[0024] The content of component (B) relative to 100 parts by weight of the total content of lactic acid molecules and lactate ions is, for example, 0.5 to 11 parts by weight. From the viewpoint of obtaining better antiseptic properties, the content of component (B) relative to 100 parts by weight of the total content of lactic acid molecules and lactate ions is preferably 0.7 to 11 parts by weight, more preferably 0.8 to 11 parts by weight, even more preferably 0.9 to 11 parts by weight, and even more preferably 0.95 to 11 parts by weight. Furthermore, because the mucosal cleansing composition of the present invention has excellent antiseptic properties, it can effectively achieve antiseptic effects even when the blending ratio of component (B) is low. From this viewpoint, suitable examples of the content of component (B) relative to 100 parts by weight of the total content of lactic acid molecules and lactate ions in the mucosal cleansing composition of the present invention include 0.5 to 7 parts by weight, preferably 0.5 to 4 parts by weight, more preferably 0.5 to 2 parts by weight, and even more preferably 0.5 to 1.2 parts by weight.
[0025] (C) Polyhydric alcohol The mucosal cleansing composition of the present invention may further contain a polyhydric alcohol to further reduce irritation. Examples of polyhydric alcohols include dihydric alcohols such as 1,3-butylene glycol and propylene glycol, and trihydric alcohols such as glycerin. These polyhydric alcohols may be used alone or in combination.
[0026] Among these polyhydric alcohols, it is preferable to include at least a trihydric alcohol as component (C) from the viewpoint of further reducing irritation and further improving the antiseptic effect.
[0027] The content of component (C) in the mucosa cleansing composition of the present invention is, for example, 0.5 to 25% by weight in total. From the viewpoint of further reducing irritation and / or further improving antiseptic effect, the content of component (C) is preferably 1 to 20% by weight in total, more preferably 3 to 15% by weight, even more preferably 4.5 to 11% by weight, and even more preferably 5.8 to 10.5% by weight.
[0028] In the mucosal cleansing composition of the present invention, the ratio of component (A) to component (C) is determined by the above-mentioned content of each component, and the content of component (C) per 1 part by weight of the total amount of component (A) is, for example, 0.4 to 22 parts by weight. From the viewpoint of further reducing irritation and / or further improving antiseptic effect, the content of component (C) per 1 part by weight of the total amount of component (A) is preferably 1 to 18 parts by weight, more preferably 2 to 12 parts by weight, even more preferably 4 to 9 parts by weight, and even more preferably 5 to 9 parts by weight. Furthermore, the content of component (C) per 1 part by weight of the total amount of lactic acid molecules and lactate ions is, for example, 0.5 to 26 parts by weight. From the viewpoint of further reducing irritation and / or further improving antiseptic effect, the content of component (C) per 1 part by weight of the total amount of lactic acid molecules and lactate ions is preferably 1 to 21 parts by weight, more preferably 3 to 16 parts by weight, even more preferably 5 to 11 parts by weight, and even more preferably 6 to 11 parts by weight.
[0029] When the mucosa cleansing composition of the present invention contains a dihydric alcohol as component (C), the content of the dihydric alcohol is, for example, 0.5 to 20% by weight. From the viewpoint of further reducing irritation, the content of the dihydric alcohol is preferably 0.7 to 10% by weight, more preferably 0.9 to 6% by weight, 0.9 to 2% by weight, or 2 to 6% by weight.
[0030] When the mucosal cleansing composition of the present invention contains a dihydric alcohol as component (C), the ratio of component (A) to dihydric alcohol is determined by the above-mentioned contents, and the content of dihydric alcohol per part by weight of the total amount of component (A) is, for example, 0.4 to 18 parts by weight. From the viewpoint of further reducing irritation, the content of dihydric alcohol per part by weight of the total amount of component (A) is preferably 0.6 to 12 parts by weight, more preferably 0.7 to 8 parts by weight, and even more preferably 0.8 to 5 parts by weight, 0.8 to 2 parts by weight, or 2 to 5 parts by weight. Furthermore, the content of dihydric alcohol per part by weight of the total amount of lactic acid molecules and lactate ions is, for example, 0.5 to 21 parts by weight. From the viewpoint of further reducing irritation, the content of the dihydric alcohol per 1 part by weight of the total content of lactic acid molecules and lactate ions is preferably 0.7 to 16 parts by weight, more preferably 0.9 to 13 parts by weight, and even more preferably 1 to 5.5 parts by weight, 1 to 2 parts by weight, or 2 to 5.5 parts by weight.
[0031] When the mucosa cleansing composition of the present invention contains a trihydric alcohol as component (C), the content of the trihydric alcohol is, for example, 0.5 to 20% by weight. From the viewpoint of further reducing irritation and further improving the antiseptic effect, the content of the trihydric alcohol is preferably 2 to 10% by weight, more preferably 3 to 8% by weight, and even more preferably 4 to 6% by weight.
[0032] When the mucosal cleansing composition of the present invention contains a trihydric alcohol as component (C), the ratio of component (A) to trihydric alcohol is determined by the above-mentioned contents, and the content of trihydric alcohol per part by weight of the total amount of component (A) is, for example, 0.4 to 18 parts by weight. From the viewpoint of further reducing irritation and further improving antiseptic effect, the content of trihydric alcohol per part by weight of the total amount of component (A) is preferably 1 to 12 parts by weight, more preferably 2 to 10 parts by weight, even more preferably 3 to 7 parts by weight, and even more preferably 4 to 5 parts by weight. Furthermore, the content of trihydric alcohol per part by weight of the total amount of lactic acid molecules and lactate ions is, for example, 0.5 to 21 parts by weight. From the viewpoint of further reducing irritation and further improving antiseptic effect, the content of trihydric alcohol per part by weight of the total amount of lactic acid molecules and lactate ions is preferably 1 to 16 parts by weight, more preferably 2 to 11 parts by weight, even more preferably 3 to 8 parts by weight, and even more preferably 4.8 to 6 parts by weight.
[0033] Other ingredients In addition to the above-mentioned components, the mucosal cleansing composition of the present invention may contain other bases and additives required for formulation, etc., as long as they do not impair the effects of the present invention. Such bases and additives are not particularly limited as long as they are pharmaceutically acceptable. Examples of such bases and additives include aqueous bases such as water and lower alcohols having 1 to 5 carbon atoms, and additives such as surfactants, preservatives, flavoring agents, colorants, thickeners, pH adjusters, humectants, stabilizers, antioxidants, UV absorbers, chelating agents, adhesives, buffers, solubilizers, solubilizers, and preservatives. These bases and additives may be used alone or in combination of two or more. The content of these bases and additives can be appropriately determined depending on the formulation, etc.
[0034] Of the above bases and additives, the mucosa cleansing composition of the present invention preferably contains substantially no preservatives. "Substantially free of preservatives" means that the preservatives are not contained at a concentration that produces a preservative effect, and specifically, the preservative content is 0.01 wt% or less, preferably 0.001 wt% or less, more preferably 0.0001 wt%, and most preferably 0 wt%.
[0035] In addition to the above-mentioned components, the mucosal cleansing composition of the present invention may contain other pharmacological ingredients as needed, provided that the effects of the present invention are not impaired. Examples of such pharmacological ingredients include vitamins, antihistamines, local anesthetics, anti-inflammatory agents, skin protectants, blood circulation promoters, cooling agents, mucopolysaccharides, etc. These pharmacological ingredients may be used alone or in combination of two or more. When these pharmacological ingredients are contained, the content thereof may be appropriately determined depending on the type of pharmacological ingredient used, the desired effect, etc.
[0036] form The pH (25°C) of the mucosal cleansing composition of the present invention is not particularly limited as long as it does not damage the mucosa, but may be, for example, 3.8 to 8, preferably 3.9 to 6, more preferably 4 to 5, even more preferably 4 to 4.5, and even more preferably 4 to 4.2. The mucosal cleansing composition of the present invention can be adjusted to such a pH by conventional methods, for example, by adding a buffer such as hydrochloric acid, acetic acid, citric acid, gluconic acid, succinic acid, tartaric acid, maleic acid, sulfuric acid, phosphoric acid, malic acid, arginine, aqueous ammonia, diisopropanolamine, diethanolamine, triisopropanolamine, triethanolamine, monoethanolamine, potassium hydroxide, calcium hydroxide, sodium hydroxide, or a salt thereof. The pH can also be adjusted by adjusting the amount of lactic acid and / or a salt thereof in component (A).
[0037] The dosage form of the mucosal cleansing composition of the present invention is not particularly limited, and examples thereof include liquid, paste, ointment, powder, granules, tablets, cream, etc. Among these, a preferred example of the dosage form of the mucosal cleansing composition of the present invention is a liquid.
[0038] Furthermore, the mucosal cleansing composition of the present invention may be provided as a product containing each component at the above-mentioned concentrations, or may be provided as a concentrate that is prepared so that the concentration of each component becomes the above-mentioned concentration by diluting it with water or the like as appropriate when used.
[0039] Purpose The mucosal cleansing composition of the present invention has excellent antiseptic properties even without the addition of parabens, and is therefore used for cleansing mucous membranes. The mucous membrane to which the mucosal cleansing composition of the present invention is applied is not particularly limited, and can be applied to, for example, the mucous membranes of the nasal cavity, pharynx, oral cavity, ear, vagina, bladder, rectum, etc., and is preferably applied to the vaginal mucosa. In particular, when the mucosal cleansing composition of the present invention is applied to the vagina, it can be used for selective antibacterial purposes, exhibiting antibacterial activity against bacteria associated with bacterial vaginosis (BV) but not against lactobacilli, which are normal vaginal bacteria.
[0040] The method of using the mucosal cleansing composition of the present invention is not particularly limited as long as it has a cleansing effect, and examples thereof include dripping onto the mucosa, spraying onto the mucosa with a spray or the like, injecting using a catheter or the like, in the case of the nasal cavity, pouring the cleansing solution into the nasal cavity and spitting it out from the opening, or pouring the cleansing solution into one nostril and spitting it out from the other nasal cavity, in the case of the oral cavity, holding it in the mouth and using it for mouthwashing, and brushing with a brush, and in the case of the vagina, injecting it into the vaginal cavity and allowing it to flow out from the vaginal opening, etc.
[0041] Furthermore, the amount of the mucosal cleansing composition of the present invention to be applied during cleansing is not particularly limited and can be set appropriately taking into consideration the size of the application site, the degree of adhesion of foreign matter to the mucosa, etc., but examples include 10 to 30 mL, preferably 15 to 25 mL, when cleansing the nasal mucosa; 0.2 to 1 mL, preferably 0.2 to 0.7 mL, when cleansing the ear mucosa; 5 to 30 mL, preferably 10 to 20 mL, when cleansing the oral mucosa; and 50 to 200 mL, preferably 100 to 140 mL, when cleansing the vaginal mucosa. [Example]
[0042] The present invention will be explained in more detail below by showing examples, but the present invention is not limited to these examples.
[0043] Test Example Mucosal cleansing compositions were prepared according to the compositions shown in Table 1. Details of component (A) shown in Table 1 are as follows. The mucosal cleansing compositions shown in Table 1 were liquid. Lactic acid (fermented product containing 90% lactic acid by weight; trade name Musashino Lactic Acid 90F; manufactured by Musashino Chemical Laboratory Co., Ltd.) The values in the table indicate the amount of lactic acid contained in the lactic acid material. Fermented product containing sodium lactate (50% sodium lactate by weight); product name: Lactic Acid Sodium F; manufactured by Musashino Chemical Laboratory Co., Ltd. The values in the table indicate the amount of sodium lactate contained in the sodium lactate material. Coconut oil fatty acid acyl arginine PCA salt; Ajinomoto Co., Inc., product name CAE, N-coconut oil fatty acid acyl L-arginine ethyl DL-pyrrolidone carboxylate
[0044] <Anti-corrosion efficacy test> The preservative efficacy test was carried out by the Asaga method shown below. (1) Aspergillus brasiliensis (KPB1042) was spread onto SCD medium, and Candida albicans (KPB1039) onto PDA medium using a platinum loop, and they were pre-cultured at 35°C for 18 to 24 hours. (2) A 10 μL plastic loopful of the pre-cultured bacteria was taken and suspended in 10 mL of physiological saline to prepare an A. brasiliensis spore suspension and a C. albicans bacteria suspension. (3) 0.1 mL of the spore solution or bacterial solution was inoculated into 20 g of the mucosal cleansing composition that had been dispensed in advance, stirred, and the initial bacterial count was measured. (4) After storage at 25°C, the bacterial counts were measured after 1 week (1w), 2 weeks (2w), and 4 weeks (4w). The measured bacterial counts were expressed as a relative value (%), with the initial bacterial count taken as 100%. The results are shown in Table 1.
[0045] <Irritation evaluation test> (1) Preparation of the cultured corneal model LabCyte CORNE-MODEL24 The assay medium was warmed and added in 0.5 mL portions to row 1 of a 24-well assay plate. A cultured corneal model, LabCyte CORNEA-MODEL24 (Lot No. LCC24-191014-A), was transferred to row 1 of the 24-well assay plate. The 24-well assay plate was placed in a CO2 incubator and left undisturbed overnight.
[0046] (2) Application of test substance and washing PBS was warmed and added in 0.5 mL portions to the third row of a 24-well assay plate. 50 μL of the test substance (mucosal cleansing composition) was placed on the cultured epidermis in the culture cup and allowed to spread throughout. After 7 minutes of exposure, the cultured corneal model was washed 20 times, wiped dry with a sterile cotton swab, and transferred to the third row of a 24-well assay plate.
[0047] In the above (1) and (2), exposure and washing were performed for one plate (using 6 wells). The test in (3) described below was performed for two plates (total of 12 wells). In (1) to (3), the samples and PBS for washing were warmed to 37°C before use. The plates were placed on a hot plate at 32°C.
[0048] (3) WST-8 Study EBSS was warmed to 37°C and diluted to a Cell Counting Kit-8:EBSS ratio of 1:10 (volume ratio) to prepare a WST-8 diluted solution, which was then added in 0.3 mL aliquots to row 4 of a 24-well assay plate. The cultured corneal models were wiped dry with a sterile cotton swab and transferred to row 4 of the 24-well assay plate. A blank well was filled with WST-8-supplemented medium. The plate was placed in a CO2 incubator and incubated for 3.5 hours. After the reaction was complete, the culture cup was removed and 200 μL of WST-8 reaction solution was transferred to a 96-well plate. 200 μL of blank medium was added to column A1. Absorbance at 450 nm and 650 nm was measured using a microplate reader.
[0049] (4) Calculation of human corneal cell viability The absorbance at 450 nm was subtracted from the absorbance at 650 nm to obtain the measured value, and the reproductive cell rate for the test substance was calculated using the following formula. The results are shown in Table 2.
[0050]
number
[0051] <Bactericidal Efficacy Test> The following bacterial vaginosis (BV)-associated bacteria and lactobacillus (a normal vaginal flora) were used as test bacteria to test the selective bactericidal activity of the mucosal cleansing composition, assuming application to the vaginal mucosa. The details of the bacterial species, growth medium, and agar medium for measuring viable cell count for each bacterium are as follows:
[0052] ·BV bacteria Test strain: Fusobacterium nucleatum subsp. Nucleatum ATCC 25586 Growth medium: F. nucleatum → Modified GAM liquid medium Agar medium for measuring viable bacterial count: Modified GAM agar medium to which fetal bovine serum has been added to a final concentration of 10% by weight
[0053] ·Lactobacillus Test strain: Lactobacillus crispatus ATCC 33820 Growth medium: MRS liquid medium supplemented with fetal bovine serum to a final concentration of 10% by weight Agar medium for measuring viable bacteria count: MRS agar medium
[0054] The two types of test bacteria were subjected to a test at 37°C for 24 hours in an environment of 93% by volume of nitrogen, 5% by volume of carbon dioxide, and 2% by volume of oxygen. Specifically, the following procedure was carried out.
[0055] (1) Preparation of test bacterial solution 1. The stock strain was transferred to MRS agar medium and pre-cultured anaerobically using Anaeropack Kenki at 37°C for 24 hours. 2. After pre-culture, the test bacteria were diluted to approximately 1.0 x 10 using a 3x concentrated growth medium. 7 The test bacterial solution was prepared so that the concentration was CFU ml / L.
[0056] (2) Adjusting the working environment 1. A container filled with a predetermined amount of liquid nitrogen was placed in a glove box. In addition, a sealed container to be used for the reaction of the test sample and the test bacterial solution was placed in the glove box with the lid open. 2. The liquid nitrogen was left for a predetermined time, and the air in the glove box was replaced with nitrogen. 3. The oxygen concentration in the glove box was adjusted to 2% using air from the test room. 4. Using experimental gas (carbon dioxide), the carbon dioxide concentration in the glove box was adjusted to 5%.
[0057] (3) 1. In a safety cabinet, the test sample (mucosal cleansing composition) and the test bacteria solution were mixed in a 2:1 ratio and dispensed into petri dishes. The petri dish containing the dispensed solution was placed in the glove box prepared in 2.(2), and the petri dish was placed in a sealed container that had been set up beforehand, and the container was then sealed with a lid inside the glove box. 3. The sealed container with the lid was taken out of the glove box and allowed to react at 37°C for a predetermined time. 4. After leaving the suspension for a specified time in a safety cabinet, 0.5 mL of the test bacteria suspension was added to 4.5 mL of SCDLP and mixed. 5. Using Anaeropack Kenki, viable bacterial counts were measured by the pour plate culture method. The results are shown in Table 3.
[0058] [Table 1]
[0059] [Table 2]
[0060] [Table 3]
[0061] As shown in Tables 1 and 2, mucosal cleansing compositions containing lactic acid, sodium lactate, and coconut oil fatty acid acylarginine PCA salt were found to have excellent antiseptic properties while being low in irritation. Furthermore, as shown in Table 3, when applied to the vaginal mucosa, mucosal cleansing compositions containing lactic acid, sodium lactate, and coconut oil fatty acid acylarginine PCA salt exhibited antibacterial activity against bacteria associated with bacterial vaginosis (BV), but not against lactobacilli, a normal vaginal flora, and also possessed selective antibacterial activity.
[0062] Prescription example Liquid mucosal cleansing compositions were prepared according to the formulations shown in Table 4. The lactic acid material, sodium lactate material, and coconut oil fatty acid acylarginine PCA salt used in each mucosal cleansing composition were the same as those used in the test examples, and the values in the table indicate the amount of lactic acid contained in the lactic acid material and the amount of sodium lactate contained in the sodium lactate material. All mucosal cleansing compositions had excellent antiseptic properties, low irritation, and selective antibacterial properties.
[0063] [Table 4]
Claims
1. A mucosal cleansing composition for use on the vaginal mucosa, comprising (A) lactic acid and / or a salt thereof, (B) a coconut oil fatty acid acylarginine alkylpyrrolidone carboxylate, and (C) glycerin, and having a pH of 4 to 4.
5.
2. 2. The mucosa cleansing composition according to claim 1, wherein the total content of component (A) is 0.5 to 2.5% by weight.
3. 3. The mucosa cleansing composition according to claim 1, wherein the total content of lactic acid molecules and lactate ions is 0.4 to 2% by weight.
4. The mucosa cleansing composition according to any one of claims 1 to 3, wherein the content of the component (B) is 0.005 to 0.1 wt%.
5. The mucosa cleansing composition according to any one of claims 1 to 4, wherein the content of the component (C) is 0.5 to 25 wt%.
Citation Information
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