KR20190134260A - A composition comprising Alum for protecting and treating vaginosis disease and the use thereof - Google Patents

Abstract

The present invention relates to a composition which contains alum or salt, sugar, and alum combinations, and exhibits an effect of maintaining vaginal cleanliness of women. More specifically, the alum or salt, sugar, and alum combinations according to the present invention inhibit bacterial growth to maintain vaginal cleanliness of women, and thus can be used as a composition effective and safe for preventing and treating vaginitis.

Description

Composition containing Alum for protecting and treating vaginosis disease and the use

The present invention is to provide an effective and safe composition for the prevention and treatment of intravaginal inflammation containing alum as an active ingredient.

Sujatha Srinivasan and David N. Fredricks, Review Article, The Human Vaginal Bacterial Biota and Bacterial Vaginosis. Interdisciplinary Perspectives on Infectious Diseases, Vol. 2008, Article ID 750479, 22p

Document 2 B. MULVEY, M. L. LANDOLT, and R. A. BUSCH, Effects of potassium aluminum sulphate (alum) used in an Aeromonas salmonicida bacterin on Atlantic salmon, Salmo salar L., Journal of Fish diseases, 1995, Vol. 18, 495-506p

[Document 3] Korean Patent Registration No. 10-0485727

[Document 3] Republic of Korea Patent Application No. 1997-0003404

[Document 4] Republic of Korea Patent Application No. 1997-0067605

[Document 5] Korean Patent Application No. 2001-0106025

[Document 6] Republic of Korea Patent Application No. 2001-0001481

[Document 7] Korean Patent Publication No. 10-2013-0131268

8 Orrhge, K. et al., 2000, Bifidobacteria and lactobacilli in human health, Drugs Exptl. Clin. Res., 26, 95-111

[9] Fuller, K., 1989, Probiotics in man and animals, J. Appl. Bacteriol., 66, 365-378

[Patent 10] Korean Patent Publication No. 10-2015-0075447

[Document 11] Korea Patent Registration No. 10-1133723 B1

Document 12 PCT / WO2011 / 049327 A1

[Document 13] Korean Patent Publication No. 10-2014-0118321

[Document 14] Korean Patent Application No. 10-2016-115716

[Document 15] Korean Patent Publication No. 10-2016-0054915

The present invention relates to a composition containing an effective and safe composition for the prevention and treatment of vaginitis containing alum as an active ingredient, more specifically, the salt, sugar and alum combination composition according to the present invention inhibits the growth of bacteria in the vagina. Therefore, it can be used as an effective and safe detergent composition for the prevention and treatment of vaginitis by maintaining the cleanliness of the vagina of women.

On the other hand, more than 90% of vaginitis in females of childbearing age is bacterial vaginosis, Candida vaginitis, Trichomonas vaginitis, and bacterial vaginosis accounts for 40-50%. These bacteria do not multiply when the vagina inside the woman's vagina is normal, but it is easily invaded when the body is not normal due to overwork, stress, or taking birth control pills, which increases complications such as postoperative infections. Complications such as preterm labor can occur, so care must be taken and effective treatment is required.

Women's vagina is naturally colonized by various bacteria, yeasts and microorganisms. For example, the vagina of a normal woman generally contains about 10 ⁴ or more lactobacillus spp. Per milliliter of vaginal material. Under normal conditions, the vaginal flora provides a weak acidic environment that helps protect against the invasion of pathogenic microorganisms.

However, under these normal conditions, the vaginal flora, or vaginal equilibrium, can be easily overturned by various external factors that ultimately lead to vaginal infection. Vaginal infection is a clinical syndrome, mainly bacterial vaginosis, Candida vaginitis and trichomoniasis vaginitis have been reported, the most common vaginitis is bacterial vaginitis.

The bacterial vaginosis is mainly caused by an increase in the number of anaerobic organisms accompanied by a decrease in lactic acid bacteria in the vagina, and can also be caused by bacterial or viral infections, antibiotics or contraceptives, and excessive vaginal cleansing. Reported to be present. Reducing the number of lactic acid bacteria in the vagina reduces competition for nutrients, reduces the amount of lactic acid present and raises the pH, and proliferation of opportunistic pathogens whose growth is normally inhibited in the vagina This happens because it happens.

Normal vaginal pH is 4.5 ~ 5.1. The inside of the vagina is acidic because the vaginal bacteria and vaginal epithelial cells produce lactic acid using glycogen and glucose. Lactic acid bacteria that live in the vagina play a useful role in producing lactic acid, which maintains pH and inhibits the growth of harmful bacteria.

Bacterial vaginitis is the most common cause of inflammation of the vagina and it is not clear whether it is infected through sexual intercourse. However, there are reports that bacterial vaginosis is associated with sexually transmitted diseases such as gonorrhea and chlamydia. Bacterial vaginitis occurs when anaerobic bacteria of the normal bacteria in the vagina overproliferate due to a decrease in the propagation rate of lactic acid bacteria among the vaginal normal bacteria. Genitourinary pathogens that cause vaginitis include Trichomonas vaginalis, Gardnerella vaginalis, Candida albicans, and Group B Streptococcus agalac. Streptococcus agalactiae, Staphylococcus aureus, Neisseria gonorrore, and E coli. Most of these infections begin with urinary tract infections (Reid, G., Jass, J., Sebulsky, T., and MaCormick, JK 2003. Potential uses of probiotics in clinical practice.Clinical Microbiology Reviews 16: 658-672). Representative symptoms include increased vaginal discharge and the color of the discharge (white or pale yellow, green, gray, etc.) with a fishy smell. The characteristic odor is due to the aromatic amine produced by the overgrown bacteria. (Sujatha Srinivasan and David N. Fredricks, Review Article, The Human Vaginal Bacterial Biota and Bacterial Vaginosis.Interdisciplinary Perspectives on Infectious Diseases, Vol. 2008, Article ID 750479, 22p).

Many vaginitis treatment methods for preventing and treating such vaginitis have been studied. In recent years, as a treatment for vaginal bacterial infections, oral administration of a vaginitis treatment agent such as metronidazole or a cream form is generally used. Such use of a broad spectrum of antibiotics such as metronidazole not only poses the problem of antibiotic resistance, but also the use of such antibiotics is considered undesirable because it can kill a wide range of normal flora in the vagina, including beneficial lactic acid bacteria. It is becoming.

On the other hand, it is reported that the death of normal vaginal flora in the vagina, including lactic acid bacteria, can cause secondary complications. That is, the reduction of lactic acid bacteria that inhibit various opportunistic pathogens in the vagina may increase the pH in the vagina, making it difficult to maintain an acidic environment, thereby accelerating the infection by anaerobic bacterial growth and may cause additional infection. In addition, problems have been reported that prolonged use of antibiotics can cause systemic toxicity due to absorption of antibiotics through the vagina.

Alum, also known as Alunitum, removes wind, lowers heat, swells phlegm, dries moisture, stops itching, quenches thirst, and bones. (骨) was used as a medicine that has the effect of hardening and stopping the hemostasis (살), insecticide (殺蟲), diarrhea. Double salts are salts in which two or more types of salts are combined. The ions in the salts do not form polyatoms such as complex ions, but exist as independent ions.

Alum is also known as alum and has the general formula MIAl (SO4) 2.12H3O or MI2SO4.Al2 (SO4) 3.24H2O. MI refers to a monovalent metal. It is called potassium alum (KAl (SO4) 2.12H2O), ammonium alum ((NH4) Al (SO4) 2.12H2O), etc. according to what monovalent metal ion is contained. In addition, in the broad sense, when other trivalent metal ions such as Ti, V, Cr, Mn, Fe, Co, Rn, Ir, Ga, In are substituted for aluminum, it is also called alum. It is effective for severe wounds, hemorrhoids, acne, improvement (ohg), and lipolysis due to its action, cell regeneration, etc. (Korean Patent Publication No. 10-2014-0118321) Most commonly referred to as alum are potassium alum. Potassium alum is used as a coagulant or mordant, and mordant refers to a material that helps dyeing well by connecting dyes with fibers to be dyed. This is why the use of alum is used to paint balsam nails. Small alum, dehydrated by heating potassium alum, is used as astringent. Astringents are drugs that work to reduce hemostasis or diarrhea.

Colorless to white crystals with no smell and taste slightly pale. The surface is weathered and becomes opaque in air. When heated, it dissolves in crystalline water at 92.5 ℃, and when heated to 100 ℃ or higher, water is generated to become burned alum of white powder. Soluble in water and aqueous solution insoluble in glycerine, not in pH 3.3 ethanol. It is used as a compounding agent that neutralizes sodium bicarbonate to generate carbon dioxide gas. (Korean Patent Laid-Open Publication No. 10-2016-0054915) Alum is a double salt formed by sulfate of aluminum sulfate and monovalent metal. Alkali metals other than lithium, potassium and ammonium are used. Double salts are salts in which two or more types of salts are combined. The ions in the salts do not form polyatoms such as complex ions, but exist as independent ions. Alum is also known as alum and has the general formula MIAl (SO4) 2.12H2O or MI2SO4.Al2 (SO4) 3.24H2O. MI refers to a monovalent metal. It is called potassium alum (KAl (SO4) 2.12H2O), ammonium alum ((NH4) Al (SO4) 2.12H2O), etc. according to what monovalent metal ion is contained. Anti-inflammatory, astringent, hemostatic, cell regeneration is effective. (Korean Patent Publication No. 10-2014-0118321).

 On the other hand, as a prior art, alum (Alum) is to remove the toxicity by the law of alum, the chemical composition is potassium aluminum sulfate (KAl (SO 4) 2 · 12H 2 O), antibacterial effect and detoxification, insecticidal, astringent, anti-inflammatory It is known to act, on the other hand, in Korea, a cleanser composition characterized in that it comprises alum, baekbaekpi, haseokgo, talc (Korean Patent Publication No. 10-2004-0071917); , Methyl sulfonymethane, a skin external composition comprising a mixture of alum as an active ingredient (Korean Patent Publication No. 10-2012-0078810); Deodorant using inorganic salt including alum, polyacrylic acid, cyclodextrin, and liquid medium residue (Korean Patent Registration No. 10-1226102); A composition for treating skin diseases comprising sulfur, alum and vinegar as active ingredients (Korean Patent Publication No. 10-2014-0118321); Has been reported.

Therefore, it is urgent to develop safe vaginitis prophylaxis or treatment compositions in which side effects that can more effectively suppress and / or treat vaginal infections are not a problem.

On the other hand, the inventors of the present application confirmed that the composition containing a salt and a sugar composition as an active ingredient shows an excellent inhibitory effect on the antibacterial activity, especially Gardnerella vaginalis (Korean Patent Registration No. 10- 1133723 B1) and PCT application (PCT / WO2011 / 049327 A1); As a follow-up study, there has been a request for a treatment for vaginitis of salt, sugar and lactic acid bacteria combination (Korean Patent Registration No. 10-1784847; Korean Patent Registration No. 10-1833832).

However, none of this document describes or discloses the efficacy of the alum monocomponent or the efficacy of alum and salt, a sugar combination as a vaginitis therapeutic agent.

The inventors of the present invention target the samples of the present invention containing alum, pathogenic microorganisms (E. coli, Staphylococcus aureus), vaginitis agents (Candida albicans , Bacteroides) Fragilis , Gardnerella Barnacles ) and Lactobacillus ( Lactobacillus ) Antimicrobial activity test for ash also loose fill) (Example 2-8); Cytotoxicity experiments using MTT assay method ( Example 9); And the simple clinical experiments by completing the present invention by confirming that the composition of the present invention exhibits the effects of unexpected excellent pH lowering effect, lactic acid concentration increasing activity, inhibiting yeast infection-inducing bacteria and the like.

In order to achieve the above object, the present invention provides a pharmaceutical composition for the prevention and treatment of vaginitis containing alum as an active ingredient.

The present invention also provides a use for the preparation of a composition comprising alum as an active ingredient for the prevention and treatment of vaginitis.

The present invention also provides a method of treating vaginitis in a mammal comprising administering alum to a mammal, including humans.

In another aspect, the present invention provides a health functional food for the prevention and improvement of vaginitis containing alum as an active ingredient.

In another aspect, the present invention provides a health supplement or food additive for the prevention and improvement of vaginitis containing alum as an active ingredient.

The present invention also provides a parenteral composition for the prevention and improvement of vaginitis containing alum as an active ingredient.

The present invention also provides a cleaning composition for the prevention and improvement of vaginitis containing alum as an active ingredient.

In addition, the present invention can be blended lactic acid bacteria in addition to alum.

The present invention provides a pharmaceutical composition for the prevention and treatment of vaginitis containing salt, sugar and alum blend as an active ingredient.

The present invention also provides a use for preparing a composition comprising the salt, sugar and alum blend as an active ingredient for the prevention and treatment of vaginitis.

The present invention also provides a method for treating vaginitis in a mammal comprising administering a salt, sugar and alum combination to a mammal, including humans.

In another aspect, the present invention provides a health functional food for the prevention and improvement of vaginitis containing salt, sugar and alum compound as an active ingredient.

The present invention also provides a health supplement or food additive for the prevention and improvement of vaginitis containing salt, sugar and alum compound as an active ingredient.

The present invention also provides a parenteral composition for the prevention and improvement of vaginitis containing salt, sugar and alum compound as an active ingredient.

The present invention also provides a cleaning composition for the prevention and improvement of vaginitis containing salt, sugar and alum compound as an active ingredient.

In addition, the present invention can be blended with lactic acid bacteria in addition to the salt, sugar and alum blend.

Also referred to herein as alum (also referred to as alum), alum, potassium alum, ammonium alum, golum, alum, small alum, aluminum chlorohydrate, sodium alum, potassium chromium alum And the like, preferably, including alum, potassium alum, ammonium alum, alum, goblin,

Specifically, (a) samples, such as aluminum chlorohydrate, alum, potassium alum, ammonium alum or goblin, are dissolved in distilled water at a composition ratio of 0.2 to 100% by weight, preferably 0.02 to 10% by weight, respectively, about 70 to 200 ºC , Alum, potassium alum, ammonium alum obtained by treatment at 1 to 1 hour, preferably 5 to 40 minutes, preferably at 100 to 150 ºC; (b) 0.2 to 100% by weight of the platen sample, preferably in a composition ratio of 0.02 to 10% by weight in distilled water, 1 minute to 1 hour, preferably at about 70 to 200 ºC, preferably 100 to 150 ºC After the treatment for 5 to 40 minutes to recover the supernatant obtained after centrifugation for 1 minute to 45 minutes, preferably 5 minutes to 30 minutes at a rotation speed of 1000 to 4500 rpm, preferably 2000 to 3000 rpm Obtained high bed; (c) heat the alum at about 50 to 150 ºC, preferably at 80 to 120 ºC for 10 minutes to 1 hour, preferably 15 minutes to 40 minutes, remove the moisture and recover only the remaining powder; Dissolved in distilled water at a composition ratio of from 100 to 100% by weight, preferably 0.02 to 10% by weight, 1 to 1 hour, preferably 5 to 40 minutes at about 70 to 200 ºC, preferably 100 to 150 ºC. After the treatment, the supernatant obtained by recovering the supernatant obtained after centrifugation for 1 minute to 45 minutes, preferably 5 minutes to 30 minutes at a rotation speed of 1000 to 4500 rpm, preferably 2000 to 3000 rpm, is included.

Salts as defined herein include sea salts, processed salts, or purified salts such as sea salt, rock salt; Preferably, processed salt such as molten salt such as refined salt or bamboo salt; More preferably, refined salt or molten salt, most preferably refined salt or domestic sea salt are used for 2 to 7 days at a heating temperature of 200 to 2000 ° C, preferably 800 to 1200 ° C, preferably 12 to 48 hours. Molten salt melted by heating.

Sugars as defined herein are monosaccharides, disaccharides, oligosaccharides, and polysaccharides that can be used as prebiotics well known in the art, and preferably, xylose monosaccharides including pentose sugars such as xylose and arabinose or hexasaccharides such as glucose, mannose, fructose and galactose; Disaccharides such as lactulose, lactitol, sugar, sucrose, lactose, maltose and trehalose; Oligosaccharides such as fructo-oligosaccharides, raffinose, stachyose and maltodextrin; Polysaccharides such as amylose, amylopectin, starch, cellulose and pectin; More preferably, sugar compounds, such as glucose, fructose, galactose, sugar, lactose, fructo-oligosaccharide, and the like, more preferably Preferably, it includes glucose, fructose, lactulose, lactitol, or fructo-oligosaccharides.

In the case of the salt, sugar and alum compounding, the compounding weight part of 1: 100 to 0.01: 100 to 0.01 by weight, preferably 1: 50 to 0.5: 50 to 0.5 of the compounding weight part, more preferably 1: 10 0.1 to 10: 0.1 compounding parts by weight, still more preferably 1: 5 to 1: 5 to 1 compounding parts blended; Compound weight parts of 1: 100 to 0.01: 100 to 0.01: 100 to 0.01, and preferably 1: 50 to 0.5: 50 to 0.5: 50 to 0.5 More preferably, it contains the compounding composition mix | blended with the compounding weight part of 1: 10-0.1: 10-0.1: 10-0.1, and still more preferably 1: 5-1: 5-1: 5-1. .

Vaginosis as defined herein may be any one selected from the group consisting of bacterial vaginosis, fungal vaginitis and trichomonas vaginitis, preferably bacterial vaginitis More preferably, Trichomonas vaginalis, Gardnerella vaginalis, Candida albicans, Group B Streptococcus agalactiae , Streptococcus aureus, Staphylococcus aureus, Neisseria gonorrore, E coli Enterobacter cloacae, Pseudomonas aruginosa (Pseudomonas aeruginosa), Salmonella typhimurium, Bacteroid pragilliris ( Bacteroid vaginitis caused by infection of fragilis ) and Candida albicans, more preferably vaginitis caused by infection of Gardnerella vaginalis or Bacteroid fragilis It will include.

As defined herein, the lactic acid bacteria are representative bacteria widely used as probiotic, which are well known in the art, preferably any lactic acid bacteria that are widely used as probiotics, specifically, the genus Lactobacillus (Lactobacillus), Bifidobacterium strain (Bifidobacterium), Bacillus (Bacillus), Streptococcus (Streptococcus), Enterococcus microorganisms (Enterococcus); Preferably the genus Bifidobacterium genus, Lactobacillus genus or Streptococcus strains, more preferably the genus Bifidobacterium genus or Streptococcus strains; More preferably, Bifidobacterium longum, Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium animalis subspecies lactis (Bifidobacterium animalis ssp. lactis, Bifidobacterium adolescentis, Bifidobacterium pseudocatenulatum, Bifidobacterium catenulatum or Bifidobacterium catenulatum or Bifidobacterium infantis Bifidobacteria, such as Bifidobacterium thermophilum strains; Bifidobacterium sp. Strains such as; Lactobacillus plantarum, Lactobacillus pentosus, Lactobacillus casei, Lactobacillus casei ssp. Paracasei, Lactobacillus rhamnosus Lactobacillus delophic, Lactobacillus delbrueckii, Lactobacillus delbrueckii ssp.bulgaricus, Lactobacillus delbruki subspecies delbruus del delbrueckii), Lactobacillus fermentum, Lactobacillus gasseri, Lactobacillus reuteri, Lactobacillus reuteri, Lb. brevis, Lactobacillus cellobiusus (Lb. cellobius). , Lactobacillus crispatus, Lb.GG, Lactoba Loose zone soniyi (Lb. johnsonii), Lactobacillus lactis (Lb. lactis), Lactobacillus flow Terry (Lb. reuteri), Lactobacillus spp, including Lactobacillus salivarius (Lb. salivarius) species; Bacillus genus strains such as Bacillus cereus toyoi or Bacillus cereus strains; Leuconostoc species, such as Leuconostoc citreum and Leuconostoc mesenteroides; Pediococcus species, such as Pediococcus acidilactici and Pediococcus pentosaceus; Propionibacterium species, such as Propionibacterium acidifaciens and Propionibacterium acidipropionici; Streptococcus thermophilus, S. S. cremoris, S. Infantarius (S. infantarius) S. intermedius, S. S. lactis, S. Streptococcus species, such as the S. salivarius subsp. Thermophilus strain; Enterococcus species, such as Enterococcus faecalis and Enterococcus faecaium; Saccharomyces species, such as Saccharomyces cerevisiae, Saccharomyces boulardii, preferably, Bifidobacterium strains or Bifidobacterium strains, most preferably, Lactobacillus ash FIG filler's (Lactobacillus acidophilus, KCTC No.3164), Bacillus cereus (Bacillus cereus, KCTC No.13123), Bifidobacterium ronggum (Bifidobacterium and a sub sp .longum longum, KCTC No.3128) or Streptococcus species (Streptococcus sp, KCTC No.5644).

Hereinafter, the present invention will be described in detail.

For example, the domestic and foreign processed salt, sun salt, or refined salt of the present invention may be used for 2 to 7 days, preferably 12 to 48 hours at a heating temperature of 200 to 2000 ° C, preferably refined salt or 800 to 1200 ° C. A first step of obtaining molten molten salt by heating; Sugar compounds such as glucose, fructose, or sugar commercially available for the salt, preferably glucose, alum and / or Bifidobacterium species; Lactobacillus species; Bacillus species; Leukonostoc species; Pediococcus species; Propionibacterium species; Streptococcus species; Enterococcus strains Saccharomyces species (Saccharomyces species) strains, such as salt, sugar and alum in the blending weight ratio of 1: 100 to 0.01: 100 to 0.01 of the weight, preferably 1: 50 to 0.5: 50 to 0.5 compounding weight parts, more preferably 1: 10 to 0.1: 10 to 0.1 compounding weight parts, still more preferably 1: 5 to 1: 5 to 1 compounding weight parts of the formulation; salt, sugar , Alum and lactic acid bacteria blending weight ratio of 1: 100 ~ 0.01: 100 ~ 0.01: 100 ~ 0.01 of the blending weight parts, preferably 1: 50 ~ 0.5: 50 ~ 0.5: 50 ~ 0.5 blending weight parts, more preferably Is 1: 10 to 0.1: 10 to 0.1: 10 to 0.1 of the blending weight parts, even more preferably 1: 5 to 1: 5 to 1: Second step to obtain; the blend composition at a culture temperature of 0 to 100 ° C., preferably 10 to 80 ° C .; 50 to 90% relative humidity, preferably 60 to 80% relative humidity for 1 hour to 7 days, preferably Preferably, a third step of preparing a culture by incubating for 6 hours to 3 days, more preferably 12 hours to 24 hours; the culture is at a drying temperature of 20 to 100 ℃, preferably 50 to 80 ℃ The third step of drying; The composition of the present invention can be prepared by a manufacturing process comprising a fourth step of adding an appropriate amount of purified water, buffer or other isotonic solution applicable to the skin other than the active ingredient to the dried formulation composition Do.

In addition, the present invention may additionally add one or more additives selected from a suitable amount of pigments, fragrances, etc. in the range of about 0 to 10% by weight based on the total weight of the composition.

Accordingly, the present invention melts by heating domestic and foreign salts, preferably domestic salts at a heating temperature of 200 to 2000 ° C, preferably 800 to 1200 ° C for 2 to 7 days, preferably 12 to 48 hours. A first step of obtaining molten salt; Sugar compounds such as glucose, fructose, or sugar commercially available for the salt, preferably glucose, alum and / or Bifidobacterium species; Lactobacillus species; Bacillus species; Leukonostoc species; Pediococcus species; Propionibacterium species; Streptococcus species; Enterococcus strains Saccharomyces species (Saccharomyces species) strains, such as salt, sugar and alum in the blending weight ratio of 1: 100 to 0.01: 100 to 0.01 of the weight, preferably 1: 50 to 0.5: 50 to 0.5 compounding weight parts, more preferably 1: 10 to 0.1: 10 to 0.1 compounding weight parts, still more preferably 1: 5 to 1: 5 to 1 compounding weight parts of the formulation; salt, sugar , Alum and lactic acid bacteria blending weight ratio of 1: 100 ~ 0.01: 100 ~ 0.01: 100 ~ 0.01 of the blending weight parts, preferably 1: 50 ~ 0.5: 50 ~ 0.5: 50 ~ 0.5 blending weight parts, more preferably Is 1: 10 to 0.1: 10 to 0.1: 10 to 0.1 of the blending weight parts, even more preferably 1: 5 to 1: 5 to 1: Second step to obtain; the blend composition at a culture temperature of 0 to 100 ° C., preferably 10 to 80 ° C .; 50 to 90% relative humidity, preferably 60 to 80% relative humidity for 1 hour to 7 days, preferably Preferably, a third step of preparing a culture by incubating for 6 hours to 3 days, more preferably 12 hours to 24 hours; the culture is at a drying temperature of 20 to 100 ℃, preferably 50 to 80 ℃ A third step of drying a method of preparing a composition of the present invention comprising a fourth step of adding an appropriate amount of purified water, a buffer, or other isotonic solution applicable to the skin to the dried blended composition to provide.

Therefore, the present invention provides a composition containing an alum or salt, sugar and alum combination as an effective ingredient effective for preventing and treating intravaginal inflammation prepared by the preparation method.

In addition, the composition of the present invention is a medicine that has been used for a long time as an edible or herbal, the composition of the present invention also has no problems such as toxicity and side effects.

The pharmaceutical composition of the present invention comprises 0.1 to 50% by weight of the above components relative to the total weight of the composition.

Pharmaceutical compositions comprising the components of the present invention may further comprise suitable carriers, excipients and diluents commonly used in the manufacture of pharmaceutical compositions.

Carriers, excipients and diluents that may be included in the compositions of the present invention include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, gelatin, calcium phosphate, calcium silicate, Cellulose, methyl cellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil.

Compositions comprising the components of the invention are each formulated in the form of oral formulations, external preparations, suppositories, and sterile injectable solutions, such as powders, granules, tablets, capsules, suspensions, emulsions, syrups and aerosols, according to conventional methods Can be used.

Specifically, when formulated, it may be prepared using diluents or excipients such as commonly used fillers, extenders, binders, wetting agents, disintegrating agents, surfactants, and the like. Solid form preparations for oral administration include tablets, pills, powders, granules and capsules, and the like form at least one excipient such as starch, calcium carbonate, sucrose in the compound. ), Lactose, gelatin and the like can be mixed.  

In addition to the simple excipients, lubricants such as magnesium stearate and talc may also be used. Liquid preparations for oral use include suspensions, solvents, emulsions and syrups, and may include various excipients, such as wetting agents, sweeteners, fragrances and preservatives, in addition to the commonly used simple diluents, water and liquid paraffin. have. Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, lyophilized preparations and suppositories. As the non-aqueous solvent and suspending agent, vegetable oils such as propylene glycol, polyethylene glycol and olive oil, and injectable esters such as ethyloleate may be used. As the base of the suppository, witepsol, macrogol, tween 61, cacao butter, laurin butter and glycerogelatin may be used.

Preferred dosages of the components of the present invention vary depending on the condition and weight of the patient, the extent of the disease, the form of the drug, the route of administration and the duration, and may be appropriately selected by those skilled in the art. However, for the desired effect, the component of the present invention can be administered in (0.0001 ~ 100) mg / kg, preferably (0.001 ~ 100) mg / kg divided into once or several times daily. The components of the present invention in the composition may be formulated in an amount of (0.0001 to 50) wt% based on the total weight of the total composition.

The pharmaceutical composition of the present invention can be administered to mammals such as mice, mice, livestock, humans, etc. by various routes. All modes of administration can be expected, for example by oral, rectal or intravenous, intramuscular, subcutaneous, intrauterine dural and intracere broventricular injections.

The present invention also provides a dietary supplement for the prevention and improvement of vaginitis comprising alum or salt, sugar and alum blend as an active ingredient.

As defined herein, "health functional food" means a food manufactured and processed using raw materials or ingredients having functional properties useful for the human body according to the Health Functional Food Act No. 6767, and "functional" means It means ingestion for the purpose of obtaining useful effects on health use such as nutrient control or physiological action on structure and function.

The health functional food of the present invention comprises the ingredient in an amount of 0.01 to 95%, preferably 1% to 80% by weight, based on the total weight of the composition.

In addition, a health functional food in the form of a pharmaceutical dosage form such as powders, granules, tablets, capsules, pills, suspensions, emulsions, syrups or tea bags, leaching tea, health drinks, etc. for the purpose of preventing or improving the disease of the present invention. Can be manufactured and processed.

In addition, the present invention provides a dietary supplement or food additives for the prevention and improvement of vaginitis comprising alum or salt, sugar and alum blend as an active ingredient.

In addition, the health functional food may further include food additives, and the suitability as a "food additive" is in accordance with the General Regulations and the General Test Act of the Food Additives Agency approved by the Ministry of Food and Drug Safety unless otherwise specified. Determined by the relevant standards and standards.

Examples of items listed in the "Food Additives Code" include, for example, chemical synthetic products such as ketones, glycine, potassium citrate, nicotinic acid, and cinnamon acid, natural additives such as navy, licorice extract, crystalline cellulose, guar gum, and sodium L-glutamate. Mixed preparations, such as a preparation, an alkali addition agent, a preservative preparation, and a tar pigment preparation, are mentioned.

Functional foods containing the components of the present invention include bread, rice cakes, dried fruit, candy, chocolate, chewing gum, confectionery such as ice cream, ice cream products such as ice cream, ice cream powder, milk, low fat milk, lactose milk Processed milk, Goat milk, Fermented milk, Buttered milk, Concentrated milk, Milk cream, Butter oil, Natural cheese, Processed cheese, Milk powder, Dairy products such as whey, Meat products, Egg products, Meat products such as hamburger Fish products such as processed meat products such as sausage, sausage and bacon Ramen noodles, Dried noodles, Raw noodles, Milk noodles, Luxurious dried noodles, Improved noodles, Frozen noodles, Pasta noodles, Fruit drinks, Vegetable drinks, Carbonated drinks, Two Lactobacillus beverages such as oil and yogurt, beverages such as mixed drinks, soy sauce, miso, red pepper paste, seasoning, cheonggukjang, mixed soy sauce, vinegar, sauces, tomato ketchup, curry, dressing , It is not but be a shortening and pizza, limited.

The health functional beverage composition of the present invention is not particularly limited to other ingredients except for containing the above ingredients as essential ingredients in the indicated ratios, and may contain various flavors or natural carbohydrates as additional ingredients, such as ordinary drinks. Examples of the aforementioned natural carbohydrates include monosaccharides (eg, glucose, fructose, and the like); Disaccharides (eg maltose, sucrose and the like); And conventional sugars such as polysaccharides (eg dextrin, cyclodextrin, etc.), and sugar alcohols such as xylitol, sorbitol, erythritol. As flavoring agents other than those described above, natural flavoring agents (tauumatin, stevia extract (e.g., Rebaudioside A, glycyrrhizin, etc.) and synthetic flavoring agents (saccharin, aspartame, etc.) can be advantageously used. have. The proportion of said natural carbohydrates is generally about (1-20) g, preferably about (5-12) g per 100 mL of the composition of the present invention.

In addition to the above, the composition of the present invention includes various nutrients, vitamins, minerals (electrolytes), synthetic flavors and natural flavoring agents, colorants, pectic acid and salts thereof, alginic acid and salts thereof, organic acids, protective colloidal thickeners, pH adjusters, stabilizers, preservatives, glycerin, alcohols, carbonation agents used in carbonated drinks, and the like. The compositions of the present invention may also contain pulp for the production of natural fruit juices and fruit juice beverages and vegetable beverages. These components can be used independently or in combination. The proportion of such additives is not so critical but is generally selected from the range of 0 to about 20 parts by weight per 100 parts by weight of the composition of the present invention.

In addition, the components of the present invention can be added to food or beverages for the purpose of preventing the desired disease. At this time, the amount of the ingredient in the food or beverage may be added at 0.01 to 15% by weight of the total food weight, the health beverage composition is added at a ratio of 0.02 to 5 g, preferably 0.3 to 1 g based on 100 mL Can be.

Ingredients according to the present invention added to foods, including beverages in the process of manufacturing the health functional food can be appropriately added or reduced the content as needed.

The present invention also provides a cleaning composition for preventing and improving vaginitis comprising alum or salt, sugar and alum blend as an active ingredient.

In addition, the cleaning composition proposed by the present invention may further add one or more additives selected from other antimicrobial agents, pigments, fragrances, etc. in addition to the active ingredient in the range of 0.1 to 20 parts by weight per 100 parts by weight of the composition. It is also possible to select different usage amounts as needed.

Since the cleaning composition according to the present invention is made of a material having the above-mentioned action and effect, it is judged that the effect of inhibiting bacterial propagation by the action of the mixed combination is excellent.

Pathogenic microorganisms (E. coli, Staphylococcus aureus), causative agents (Candida albicans , Bacteroides ) for alum or a combination composition of salt, sugar and alum combination according to the present invention Fragilis , Gardnerella Antimicrobial activity tests on day pants-less) and Lactobacillus (Lactobacillus ash also loose fill) (Example 2-8); Cytotoxicity experiments using the MTT assay (room heomye 9); And it was confirmed through the simple clinical experiments that the composition of the present invention exhibits the effect of the unexpected excellent pH lowering effect, lactic acid concentration increasing activity, inhibiting yeast infection-inducing bacteria and the like.

Therefore, the present invention provides a composition for the prevention and treatment of vaginitis, which contains alum or salt, sugar and alum blend obtained as the active ingredient as an active ingredient. The formulation may be a preparation for parenteral administration, for example, topical administration such as liquids, gels, cleaning compositions, intravaginal tablets, suppositories, creams, ointments, dressing solutions, sprays, and other coatings. It may be a liquid formulation, such as a solution, suspension, emulsion type, sterile aqueous solution, non-aqueous solvent, suspension, emulsion, lyophilized formulation, suppository, cream, ointment, jelly, foam, cleaning agent or vaginal insert, preferably The external preparations for skin such as liquids, gels, cleaning compositions, intravaginal tablets, more preferably liquids, gels for application or direct skin application of hygiene products such as tampons, sanitary napkins, diapers, panties, etc. external skin preparations such as gels), cleaning compositions, and intravaginal tablets. The formulation may be prepared by, for example, adding a dissolution aid, emulsifier, buffer for pH adjustment, and the like in sterile water.

As the non-aqueous solvent or suspending solvent, propylene glycol, polyethylene glycol, vegetable oil such as olive oil, injectable ester such as ethyl oleate, and the like may be used.

As the suppository, witepsol, macrogol, tween 61, cacao butter, laurin butter, glycero gelatin and the like may be used.

In more detail, the vaginal cleaning composition may include a carrier for formulating it in addition to the antimicrobial composition. The carrier may be a binder, a suspending agent, a suspending agent, a solubilizer, a buffer, a preservative, a lubricant, an isotonic agent, an excipient, a stabilizer, a dispersant, a suspending agent, a coloring agent, a fragrance, and the like.

Furthermore, the compositions for the prevention or treatment of vaginitis of the present invention can be prepared by using appropriate methods known in the art or by methods disclosed in Remington's Pharmaceutical Science (Recent Edition, Mack Publishing Company, Easton PA). And preferably formulated.

The composition of the present invention comprises 0.001 to 99.99% by weight, preferably 0.1 to 99% by weight, more preferably 1 to 30% by weight, even more preferably 5 to 10, based on the total weight of the composition. It may be included in the weight%, it can be appropriately adjusted the content of the active ingredient according to the method of use and purpose of use of the composition.

Preferred dosages of the combinations of the present invention vary depending on the condition and weight of the patient, the extent of the disease, the form of the drug, the route of administration and the duration, and may be appropriately selected by those skilled in the art.

The dosage of the composition for preventing or treating vaginitis according to the present invention may be appropriately selected by those skilled in the art in consideration of the method of administration, the age, sex and weight of the recipient, and the severity of the disease. For example, the composition for preventing or treating vaginitis of the present invention may be administered at 0.0001 mg / kg to 1000 mg / kg, more preferably 0.01 mg / kg to 100 mg / kg, based on the composition. Administration may be administered once a day or may be divided several times. The dosage does not limit the scope of the invention in any aspect.

In addition, the composition for preventing or treating vaginitis of the present invention may further include a compound or plant extract having a known vaginitis inhibitory activity in addition to the antimicrobial composition, and each of 5 parts by weight to 20 parts by weight based on 100 parts by weight of the antimicrobial composition. Can be.

The composition for preventing or treating vaginitis of the present invention can be directly applied to animals including humans. The animal is a biological group corresponding to a plant, and mainly eats organic matter as nutrients, and means that digestion, excretion, and respiratory organs are differentiated, and preferably, vertebrates, more preferably mammals. The mammal may preferably be a human.

The present invention also provides a vaginal cleaning composition comprising the alum or salt, sugar and alum blend as an active ingredient.

Alum or salt, sugar and alum combination composition according to the present invention is a pathogenic microorganism (E. coli, Staphylococcus aureus), causative agent (Candida albicans, Bacteroides pragilis), lactic acid bacteria (Lactobacillus ashdophyll) Antimicrobial activity test against Ruth) (Experimental Example 2-8); Cytotoxicity experiment using MTT assay method (Experimental Example 9); And it can be used as an effective and safe composition for the prevention and treatment of vaginitis by confirming that the composition of the present invention through the simple clinical experiments show the effect of those skilled in the art unexpectedly excellent pH lowering effect, lactic acid concentration increasing activity, inhibiting yeast infection-inducing bacteria, etc. have.

Hereinafter, the present invention will be described in detail by the following Examples and Experimental Examples.

However, the following Examples and Experimental Examples are only illustrative of the present invention, and the content of the present invention is not limited by the following Examples and Experimental Examples.

Example  1. Alum Sample Preparation

1-1. Alum  Sample manufacturing

First, alum (Anjin Pharmaceutical, 200g), potassium alum (Cas No. 7784-24-9, sigma), ammonium alum (Cas No. 7784-26-1, sigma), aluminum chlorohydrate (Cas No. 7784-13- 6, J. Blanco) was dissolved in distilled water at a composition ratio of 0.02 to 10% by weight, respectively, and treated for 20 minutes at 120 ºC. Thereafter, stored at room temperature (25 ºC) and alum sample (hereinafter referred to as MP), potassium alum (hereinafter referred to as KMP), ammonium alum (hereinafter referred to as AMP), aluminum chlorohydrate (hereinafter referred to as CMP) Used.

1-2. Govan  Sample manufacturing

1-2-1. Govan (1) Sample Preparation

Goban 1 (Human Herb, 500g) was dissolved in distilled water at a composition ratio of 0.02 to 10% by weight, and treated at 120 ºC for 20 minutes. Then, after centrifugation with a 2500 rpm centrifugal separator (LABOGENE, 1730R) for 15 minutes, the supernatant was stored at room temperature (25 ºC) and used as a high plate sample 1 (hereinafter referred to as KP1).

1-2-2. High Class (2) Sample Preparation

Goban 2 (Anjin Chemical, 200g) heated alum at 100 ºC for 30 minutes. Water was removed and only the powder was recovered, and the powder was dissolved in distilled water at a composition ratio of 0.02 to 10% by weight, and treated at 120 ºC for 20 minutes. Then, after centrifugation at 2500 rpm for 15 minutes with a centrifuge (LABOGENE, 1730R), the supernatant is stored at room temperature (25 ºC) and used as a high plate sample 2 (hereinafter referred to as KP2).

Example 2. Preparation of Formulations

1-1. Preparation of salt

1-1-1. Manufacture of Molten Salt

Molten salt 400 mg (Cheonsan Light Salt Co., Ltd.) obtained by heating a domestic salt (Shinan Sunil Salt) at a heating temperature of 850 to 1000 ° C. for 24 hours was obtained.

1-1-2. Preparation of Refined Salt

400 mg of purified salt (Duksan Chemical NaCl F.W.58.44) was obtained.

1-1-3. Preparation of sun salt

400 mg of sun salt (salt as mineral salt = sea salt as sun salt) were obtained.

One- 2.saccharides  Ready

1-2-1. Production of glucose

Glucose was purchased from 800 mg from D (+)-Glucose, Cat no. Jb01, JT Baker.

1-2-2. Preparation of fructooligosaccharides

Fructooligosaccharide was purchased from 800 mg from the company (derived from chicory, Cat no. F8052050 g, sigma).

1-2-3. Preparation of Lactulose

Lactulose was used by purchasing 800 mg from the company (Lactulose, wako, 126-03732).

1-2-4. Preparation of Fructose

Fructose was used by purchasing 800 mg from the company (Fructose, junsei, 64505-0410).

1-2-5. Preparation of Fructose

Lactitol was purchased from 800 mg (Lactitol, Cat no. Sc488686, santa cruz) was used.

1-3. Formulation of Formulations

The salts, sugars, and alums were dried and blended in the composition shown in Table 1, and used as a blend sample in the following experiment.

Alum Blend denomination A salt sugars Alum PC1 Sodium chloride 5mg Glucose 5mg MP 5mg PCL1 Sodium chloride 5mg Glucose 5mg KMP 5mg PL2 Molten Salt 5mg Fructooligosaccharide 10mg AMP 10mg PLL2 Molten Salt 5mg Fructooligosaccharide 10mg KP1 10mg PL3 Natural Salt 5mg Lactulose 25mg KP2 25mg PLL3 Natural Salt 5mg Lactulose 25mg MP 25mg PL4 Sodium chloride 5mg Fructose 2.5mg KMP 2.5mg PLL4 Sodium chloride 5mg Fructose 2.5mg KP1 2.5mg PL5 Molten Salt 5mg Lactitol 1mg KP2 1 mg PLL5 Molten Salt 5mg Lactitol 1mg MP 1 mg PB1 Sodium chloride 5mg Glucose 5mg KMP 5 mg PBL1 Sodium chloride 5mg Glucose 5mg AMP 5 mg PB2 Molten Salt 5mg Fructooligosaccharide 10mg KP1 10 mg PBL2 Molten Salt 5mg Fructooligosaccharide 10mg KP2 10 mg PB3 Natural Salt 5mg Lactulose 25mg MP 25 mg PBL3 Natural Salt 5mg Lactulose 25mg KMP 25 mg PB4 Sodium chloride 5mg Fructose 2.5mg AMP 2.5 mg PBL4 5 mg sodium chloride Fructose 2.5mg KP1 2.5 mg PB5 Molten Salt 5mg Lactitol 1mg KP2 1 mg PBL5 Molten Salt 5mg Lactitol 1mg MP 1 mg PF1 Sodium chloride 5mg Glucose 5mg KMP 5 mg PFL1 Sodium chloride 5mg Glucose 5mg AMP 5 mg PF2 Molten Salt 5mg Fructooligosaccharide 10mg KP1 10 mg PFL2 Molten Salt 5mg Fructooligosaccharide 10mg KP2 10 mg PF3 Natural Salt 5mg Lactulose 25mg MP 25 mg PFL3 Natural Salt 5mg Lactulose 25mg KMP 25 mg PF4 Sodium chloride 5mg Fructose 2.5mg AMP 2.5 mg PFL4 Sodium chloride 5mg Fructose 2.5mg KP1 2.5 mg PF5 Molten Salt 5mg Lactitol 1mg KP2 1 mg PFL5 Molten Salt 5mg Lactitol 1mg MP 1 mg PS1 Sodium chloride 5mg Glucose 5mg KMP 5 mg PSL1 Sodium chloride 5mg Glucose 5mg AMP 5 mg PS2 Molten Salt 5mg Fructooligosaccharide 10mg KP1 10 mg PSL2 Molten Salt 5mg Fructooligosaccharide 10mg KP2 10 mg PS3 Natural Salt 5mg Lactulose 25mg MP 25 mg PSL3 Natural Salt 5mg Lactulose 25mg KMP 25 mg PS4 Sodium chloride 5mg Fructose 2.5mg AMP 2.5 mg PSL4 Sodium chloride 5mg Fructose 2.5mg KP1 2.5 mg PS5 Molten Salt 5mg Lactitol 1mg KP2 1 mg PSL5 Molten Salt 5mg Lactitol 1mg MP1 mg

Experimental Example 1. Titration pH Measurement Experiment

In order to check the proper pH in the human body of the above example samples, 100 healthy volunteers (42 patients with vaginitis, 58 normal patients, Korean women living in Jeonbuk, 20 to 50 years old) were used after washing, and the effects Investigate.

The alum composition prepared in Example prepared as described above was used for 100 women for 5 days (once a day, once used amount 200 ml), and the vaginal acidity was measured before the experiment was conducted (pH meter / MP-103, www.yuyuinst.co.kr) and intravaginal acidity after the experiment.

As a result of the above experiment, the alum, govan 1, govan 2, potassium alum, ammonium alum according to the present invention were used as 0.02 to 10% by weight of pH according to the weight ratio of vaginal acidity (pH3.2 to 4.5) in healthy women. When confirmed, it was confirmed that the proper pH. (Table 2)

PH test results for each sample Sample PH 10% Govan 1 3.42 Govan 2 2.67 alum 2.78 Potassium alum 3.14 Ammonium alum 3.19 Aluminum Chlorohydrate 4.25 0.02% Govan 1 4.32 Govan 2 4.16 alum 4.27 Potassium alum 4.35 Ammonium Alum 4.39 Aluminum Chlorohydrate 4.9

Experimental Example  2. Microbial Culture and Experimental Preparation

In order to confirm the inhibitory activity against the yeast infection-inducing bacteria of the example samples, an experiment was performed as follows using a method described in the literature (Hygienic standard for disposable sanitary products GB 15979-2002, National Standard of the People's). Republic of China; Cosmetic Microbial Limit Test, Ministry of Food and Drug Safety)

2-1. Yeast Infection Preparation

Vaginitis in Table 3 to confirm the bactericidal activity against pathogenic microorganisms (E. coli, Staphylococcus), vaginal agents (Candida albicans, Bacteroides prazilis, Gardella vaginalis) and lactic acid bacteria (Lactobacillus ashdophilus) Experiments were conducted based on the hygienic standard for disposable sanitary products GB 15979-2002, National Standard of the People's Republic of China.

Experimental fungus Fungus Nomenclature Scientific name Sales Number or Cat. No. Where to buy or buy No. One Escherichia coli E. coli ; DH5alpa Cat. No. RH617 RBC No. 2 Staphylococcus Staphylococcus aureus KCTC No.1621 Korea Research Institute of Bioscience and Biotechnology No. 3 Candida albicans Candida  albicans KCTC No.7122 Korea Research Institute of Bioscience and Biotechnology No. 4 Lactobacillus ashdophyllus Lactobacillus acidophilus KCTC No.3164 Korea Research Institute of Bioscience and Biotechnology No. 5 Bacteroides fragilis Bacteridees  fragilis KCTC No.5013 Korea Research Institute of Bioscience and Biotechnology No. 6 Gardnerella Barnalis Gardnerella  vaginalis KCTC No.5097 Korea Research Institute of Bioscience and Biotechnology

Experimental Example  3. Experiment of inhibitory activity against pathogenic microorganisms (E. coli)

In order to confirm the inhibitory activity against the pathogenic microorganisms (E. coli) of the sample of the above example, the experiment was performed as follows using the method described in the literature as follows. (Hygienic standard for disposable sanitary products GB 15979-2002, National Standard of the People's Republic of China)

3-1. Experiment process

In order to confirm the bactericidal activity against Escherichia coli, the following experiment was carried out by measuring the growth inhibition index (Hygienic standard for disposable sanitary products GB 15979-2002, National Standard of the People's Republic of China) using LB medium.

E. coli of Table 2 incubated overnight in LB (Yeast extract 5g, NaCl 10g, Tryptone 10g) medium at 1: 100, and then incubated at 37 ° C for 18 hours. The cultured Escherichia coli was diluted 1/100 in LB liquid medium, and the sample of the example (high plate 1, high plate 2, alum, potassium alum, ammonium alum, aluminum chlorohydrate; 10%, 0.02% (w / v)) Was treated with 2/100 and incubated in an incubator (Korean Science, HB-R) for 20 minutes at 25 ℃. The culture solution was diluted 1/10 in PBS (NaCl 8g, KCl 0.2g, Na ₂ HPO ₄ 1.44g KH ₂ PO ₄ 0.24g, pH 7.4), and 200ml of the diluent was diluted with LB solid medium (Yeast extract 5g, NaCl 10g, Tryptone 10g, Agar 15g) was dispensed and smeared and incubated at 37 ° C. for 24 hours and then the number of colonies was measured to compare the growth rate.

3-2. Experiment result

Samples of the present invention was confirmed to exhibit a strong inhibitory activity against E. coli growth (Table 4).

Antimicrobial Activity Test Results (E. Coli) Escherichia coli sample Growth rate (%) Control 100 10% Govan 1 2 Govan 2 5 alum 6 Potassium Alum 5 Ammonium Alum 9 Aluminum Chlorohydrate 3 0.02% Govan 1 45 Govan 2 47 alum 40 Potassium Alum 48 Ammonium Alum 40 Aluminum Chlorohydrate One

Experimental Example 4. Inhibitory activity test against pathogenic microorganisms ( Staphylococcus aureus )

In order to confirm the inhibitory activity against the pathogenic microorganisms (S. aureus) of the sample of the above example, the experiment was performed as follows using the method described in the literature as follows. Was performed. (Hygienic standard for disposable sanitary products GB 15979-2002, National Standard of the People's Republic of China)

4-1. Experiment process

In order to confirm the bactericidal activity against Staphylococcus aureus, the following experiment was carried out by measuring the growth inhibitory index (Hygienic standard for disposable sanitary products GB 15979-2002, National Standard of the People's Republic of China) using Nutrient medium.

Inoculated at 1: 100 with Staphylococcus aureus cultured overnight in Nutrient (Beef extract 3g, Peptone 5g, pH 6.8) medium and incubated at 37 ℃ for 18 hours. The cultured Staphylococcus aureus was diluted to 2/1000 in nutrient medium, and the sample of Examples (high 1, high 2, alum, potassium alum, ammonium alum, aluminum chlorohydrate; 10%, 0.02% (w / v)) was added. Treated with 2/100 and incubated in an incubator (Korean Science, HB-R) for 20 minutes at 25 ℃. The culture solution was diluted 1/10 in PBS (NaCl 8g, KCl 0.2g, Na ₂ HPO ₄ 1.44g KH ₂ PO ₄ 0.24g, pH 7.4), and 150ml of the diluted solution was dispensed and plated in nutrient solid medium, and then 37 ° C. After culturing for 24 hours at, the number of colonies was measured to compare growth rates.

4-2. Experiment result

Samples of the present invention was confirmed to exhibit a strong inhibitory activity against staphylococcus growth (Table 5).

Antimicrobial Activity Test Results (Staphylococcus) Staphylococcus sample Growth rate (%) Control 100 10% Govan 1 24 Govan 2 20 alum 9 Potassium Alum 9 Ammonium Alum 3 Aluminum Chlorohydrate 0 0.02% Govan 1 38 Govan 2 47 alum 27 Potassium Alum 37 Ammonium Alum 39 Aluminum Chlorohydrate 0

Experimental Example 5. Inhibitory activity test against vaginitis-inducing bacteria ( Candida albicans )

In order to confirm the inhibitory activity against the vaginitis-inducing bacteria (Candida albicans) of the sample of the Examples, the experiment was performed as follows by using the method described in the literature as follows. (Hygienic standard for disposable sanitary products GB 15979-2002, National Standard of the People's Republic of China)

5-1. Experiment process

In order to confirm the bactericidal activity against Candida albicans, the following experiment was performed using a hygienic standard for disposable sanitary products GB 15979-2002, National Standard of the People's Republic of China.

Candida albicans incubated overnight in Malt (MB cell, Cat. No. MB-M1069) medium at 1:10 and then incubated at 37 ° C. for 18 hours. The cultured Candida albicans was diluted 3/10 in malt liquid medium, and the sample of the example (high plate 1, high plate 2, alum, potassium alum, ammonium alum, aluminum chlorohydrate; 10%, 0.02% (w / v)) ) Was treated with 2/100 and incubated in an incubator (Korean Science, HB-R) for 20 minutes at 25 ℃. The culture solution was diluted 1/10 with PBS (NaCl 8g, KCl 0.2g, Na ₂ HPO ₄ 1.44g KH ₂ PO ₄ 0.24g, pH 7.4), and 150 ml of the diluted solution was dispensed into a malt solid medium and plated. After time incubation, the number of colonies was measured to compare growth rates.

5-2. Experiment result

Samples of the present invention was confirmed to exhibit a strong inhibitory activity against Candida albicans growth (Table 6).

Antimicrobial Activity Test Results (Candida albicans) Candida albicans sample Growth rate (%) Control 100 10% Govan 1 77 Govan 2 83 alum 49 Potassium Alum 48 Ammonium Alum 65 Aluminum Chlorohydrate 0 0.02% Govan 1 68 Govan 2 88 alum 83 Potassium alum 60 Ammonium Alum 62 Aluminum Chlorohydrate 100

Experimental Example  6. Lactobacillus ( Lactobacillus Ashdophyllus Inhibitory activity experiment for

In order to confirm the inhibitory activity against the lactic acid bacteria (Lactobacillus ashidophyllus) of the sample of the Example was carried out as follows using the method described in the literature as follows. (HHygienic standard for disposable sanitary products GB 15979-2002, National Standard of the People's Republic of China)

6-1. Experiment process

Hygienic standard for disposable sanitary in anaerobic conditions using MRS medium (Gibco, Cat. No. 288130) and GasPak (BD, Cat. No. 260683) to determine the bactericidal activity against Lactobacillus ashdophyllus products GB 15979-2002, National Standard of the People's Republic of China).

After inoculating 1: 100 of Lactobacillus ashdophyllus incubated overnight in MRS (Gibco, Cat. No. 288130) medium under anaerobic conditions in GasPak, and incubated at 37 ° C for 18 hours. The cultured Lactobacillus ashdophyllus was diluted 2/1000 in MRS liquid medium, and the example samples (Govan 1, Govan 2, Alum, Potassium Alum, Ammonium Alum, Aluminum Chlorohydrate; 10%, 0.02% (w) / v)) was treated with 2/100 and incubated in an incubator (Korean Science, HB-R) for 20 minutes at 25 ℃. The culture solution was diluted 1/10 with PBS (NaCl 8g, KCl 0.2g, Na ₂ HPO ₄ 1.44g KH ₂ PO ₄ 0.24g, pH 7.4), and 150ml of the diluted solution was dispensed into MRS solid medium and plated. After 24 hours of incubation at a ℃ colony number was measured to compare the growth rate.

6-2. Experiment result

Samples of the present invention was confirmed to exhibit a strong inhibitory activity against Lactobacillus ashidophyllus growth (Table 7).

Antimicrobial Activity Test Results (Lactobacillus ashdophyllus) Lactobacillus ashdophyllus sample Growth rate (%) Control 100 10% Govan 1 87 Govan 2 75 alum 74 Potassium alum 80 Ammonium Alum 61 Aluminum Chlorohydrate 0 0.02% Govan 1 80 Govan 2 73 alum 78 Potassium alum 82 Ammonium Alum 81 Aluminum Chlorohydrate 0

Experimental Example 7 Inhibitory Activity Test against Yeast Infection Bacteria ( Bacteroides pragilis )

In order to confirm the inhibitory activity against the yeast infection-inducing bacteria (Bacteroides prasilis) of the sample of the Example was carried out as follows using the method described in the literature as follows. (Hygienic standard for disposable sanitary products GB 15979-2002, National Standard of the People's Republic of China)

7-1. Experiment process

Hygienic standard for disposable sanitary products using Casman medium (Hymedia, Cat. No. M766) and GasPak (BD, Cat. No. 260683) to determine the bactericidal activity against anaerobic bacteroides pragilis GB 15979-2002, National Standard of the People's Republic of China).

Bacteroides pragilis, which was incubated overnight in Casman (Hymedia, Cat. No. M766) medium under anaerobic conditions in GasPak (BD, Cat. No. 260683) at 1: 100, was incubated at 37 ° C for 18 hours. The cultured Bacteroides pragilis was diluted to 2/1000 in casman medium, and the example samples (high 1, high 2, alum, potassium alum, ammonium alum, aluminum chlorohydrate; 10%, 0.02% (w / v) )) Was treated with 2/100 and incubated at 25 ° C. for 20 minutes in an incubator (Korean Science, HB-R). The culture solution was diluted 1/10 with PBS (NaCl 8g, KCl 0.2g, Na ₂ HPO ₄ 1.44g KH ₂ PO ₄ 0.24g, pH 7.4), and 150ml of the dilution was dispensed into casman solid medium and plated. After 48 hours of incubation, the number of colonies was measured and growth rates were compared.

7-2. Experiment result

Samples of the present invention was confirmed to exhibit a strong inhibitory activity against Bacteroides pragilis growth (Table 8).

Antimicrobial Activity Test Results (Bacteroides pragilis) Bacteroides fragilis sample Growth rate (%) Control 100 10% Govan 1 0 Govan 2 0 alum 0 Potassium alum 0 Ammonium Alum 0 Aluminum Chlorohydrate 5 0.02% Govan 1 54 Govan 2 17 alum 76 Potassium alum 62 Ammonium Alum 75 Aluminum Chlorohydrate 93

Experimental Example  8. Yeast infection-causing bacteria Gardnerella Trousers Inhibitory activity experiment for

In order to confirm the inhibitory activity against the yeast infection-causing bacteria (Gardnerella vaginalis) of the example samples, the following experiment was performed using the method described in the literature as follows (Hygienic standard for disposable sanitary products GB 15979- 2002, National Standard of the People's Republic of China

8-1. Experiment process

Hygienic standard for disposable sanitary products using Casman medium (Hymedia, Cat. No. M766) and GasPak (BD, Cat. No. 260683) to determine the bactericidal activity of the anaerobic microorganism Gardella pannaris GB 15979-2002, National Standard of the People's Republic of China).

Inoculated at 1: 100 in Gardella pannaris incubated overnight in Casman medium (Hymedia, Cat. No. M766) under anaerobic conditions in GasPak, and incubated at 37 ° C. for 18 hours. The cultured Gardella pannalis was diluted 4/1000 in casman liquid medium, and the example samples (high plate 1, high plate 2, alum, potassium alum, ammonium alum, aluminum chlorohydrate; 10%, 0.02% (w / v)) was treated with 2/100 and incubated in an incubator (Korean Science, HB-R) for 20 minutes at 25 ℃. The culture solution was diluted 1/10 with PBS (NaCl 8g, KCl 0.2g, Na ₂ HPO ₄ 1.44g KH ₂ PO ₄ 0.24g, pH 7.4), and 150ml of the dilution was dispensed into casman solid medium and plated in GasPak 37 After 48 hours of incubation, the number of colonies was measured and growth rates were compared.

8-2. Experiment result

It was confirmed that the samples of the present invention show a strong inhibitory activity against the growth of Gardnerella varnalis (Table 9).

Antimicrobial Activity Test Results (Gardnerella Barnalis) Gardnerella Barnalis sample Growth rate (%) Control 100 10% Govan 1 0 Govan 2 0 alum 0 Potassium alum 0 Ammonium Alum 0 Aluminum Chlorohydrate One 0.02% Govan 1 68 Govan 2 72 alum 78 Potassium alum 85 Ammonium Alum 95 Aluminum Chlorohydrate 5

As a result of the above experiments, it was confirmed that the samples of the present invention showed a strong inhibitory activity against the growth of various vaginitis causing bacteria except lactic acid bacteria (Table 10).

Experimental Example  9. Cytotoxicity Experiment

In order to confirm the cytotoxicity of the sample of the Example was carried out as follows by referring to the MTT analysis method described in the literature as follows (cosmetic toxicity test animal replacement test method, skin irritation test, Food and Drug Safety Evaluation Institute)

9-1. Experiment process

Example samples for human keratinocyte (HaCaT) cells, ie, alveolar 1, alum, potassium alum, ammonium alum, aluminum chlorohydrate (0.1%, 0.01% (w / v)). Same progress.

Human keratinocyte (HaCaT) cells (CLS, No. 300493) were inoculated by 1 × 10 ⁴ , and then cultured in an incubator (BB15, Thermo scientific) under conditions of 5 hours CO 2, 37 ° C. for 18 hours. After confirming that the cells were completely attached to the bottom, 0.1%, 0.01% (w / v) Example Samples were treated for 15 minutes at 5% CO 2, 37 ° C. conditions. After removing the samples from each well, the cells were changed to the cell culture medium and incubated in an incubator (BB15, Thermo scientific) for 42 hours under conditions of 5% CO2 and 37 ° C. Thereafter, the number of living cells was measured by MTT assay, and the degree of toxicity of the cells was measured in the experimental group compared to the control group.

9-2. Experiment result

As a result of the experiment, it was confirmed that the samples of the present invention have a weak cytotoxicity on the cell growth rate (Table 11).

Cytotoxicity Test Results 24h 48h Control 100.0 100.0 Alum 0.1% 79.9 104.6 Alum 0.01% 88.8 97.2 Govan 1 0.1% 74.4 61.8 Govan 1 0.01% 95.3 92.8 Ammonium Alum 0.1% 82.5 85.0 Ammonium Alum 0.01% 92.9 102.4 Potassium Alum 0.1% 87.4 109.2 Potassium Alum 0.01% 98.3 88.3 Aluminum Chlorohydrate 0.1% Aluminum Chlorohydrate 0.01%

Clinical Example 1. Simple Clinical Experiment (1)

PB2 prepared in the above embodiment The tablet composition for intravaginal injection was used for 100 women (35 infected patients, 65 normal people, Korean women living in Jeonbuk, 20 to 50 years old), and then the effect was investigated.

Intravaginal intravenous tablet composition prepared in Example prepared as described above was used for 100 women for 5 days (once a day, once daily use 1200mg), to suppress the unpleasant odor, the degree of freshness, itching the skin itching According to the questionnaire, the results were classified into four stages, that is, (1) very satisfied, (2) satisfied, (3) moderate and (4) dissatisfied according to satisfaction, and the results are shown in Table 12 below.

Survey Content Survey Content very good satisfied usually dissatisfaction system Unpleasant odor suppression 80 19 One 0 100 Refreshing degree 79 16 5 0 100 Skin pruritus soothing effect 79 17 4 0 100

As can be seen from Table 12, 99% replied that the unpleasant odor suppression effect, and particularly 80% replied that they are very satisfied (selected mainly those who have an unpleasant odor before the questionnaire. In consideration of individual differences, differences in constitution, etc., it was confirmed that the present invention has an excellent effect on suppressing unpleasant odors.

In addition, 95% of the respondents who surveyed the feeling after using the present invention were satisfied that 79% answered that they are very satisfied. In particular, considering the individual differences or differences in constitution, the present invention is clean and refreshing to the user. It was confirmed that the effect is to maintain the mood for a long time.

In addition, 96% replied that the skin sedation effect of the present invention was satisfactory. In particular, 79% answered that they were very satisfied, so that the present invention was effective in calming the skin itch due to individual differences or constitution differences. It became.

Clinical Example 2. Simple Clinical Experiment (2)

The PC1 combination cleaning composition prepared in the above example was washed with 100 women (42 patients with diseases, 58 normal persons, and Korean women living in Jeonbuk, 20 to 50 years old), and then the effects were investigated.

100 women were used for 5 days (once a day, once daily use 200ml), and the vaginal acidity was measured before performing the experiment (pH meter / MP-103). , www.yuyuinst.co.kr) and the intravaginal acidity after the experiments are shown in Table 13 below.

Vaginal acidity measurement result division Mountain road system <3.5 4 4.5 5 5.5 6 > 6.5 Before implementation One 7 8 17 49 19 100 After implementation One 23 50 22 4 0 0 100

Before the experiment, the experimental group had an acidity of 5.5 or more and 85%, and 68% of those who had an acidity of 6.0 or more were found to be considerably advanced in alkalinization.

As shown in Table 13, the acidity was measured after the experiment, and it was found that acidification in the vagina proceeded rapidly. In the experimental group, 90% belonged to the normal acidity, and the group belonging to the normal acidity 4.5 in the vagina reached 50%.

Therefore, when the cleaning composition of the present invention considers individual differences, differences in constitution, and the like, it was confirmed that the present invention is very helpful for vaginal acidification.

Although formulation examples of the composition comprising the combination of the present invention will be described, the present invention is not intended to be limiting but merely illustrative.

Formulation Example 1 Preparation of Powder

PC1 ------------------------------------------------- 20 mg

Lactose ----------------------------------------------- 100 mg

Talc ------------------------------------------------ 10 mg

The above ingredients are mixed and filled in an airtight cloth to prepare a powder.

Formulation Example 2 Preparation of Tablet

PLL3 ------------------------------------------------ 10 mg

Corn Starch ----------------------------------------- 100 mg

Lactose ----------------------------------------------- 100 mg

Magnesium Stearate ---------------------------------- 2 mg

After mixing the above components, tablets are prepared by tableting according to a conventional method for preparing tablets.

Formulation Example 3 Preparation of Capsule

PB1 ------------------------------------------------- -10 mg

Crystalline Cellulose ------------------------------------- 3 mg

Lactose ------------------------------------------- 14.8 mg

Magnesium Stearate ------------------------------- 0.2 mg

According to a conventional capsule preparation method, the above ingredients are mixed and filled into gelatin capsules to prepare capsules.

Formulation Example 4 Preparation of Injection

PF4 ------------------------------------------------ 10 mg

Mannitol -------------------------------------------- 180 mg

Sterile Distilled Water for Injection ------------------------------- 2974 mg

Na ₂ HPO ₄ 12H ₂ O ---------------------------------------- 26 mg

According to the conventional method for preparing an injection, it is prepared in the amount of the above ingredient (2) per ampoule.

Formulation Example 5 Preparation of Liquid

PSL1 ------------------------------------------------ 10 mg

Isomerized sugar --------------------------------------------- 10 g

Mannitol ------------------------------------------------ 5 g

Purified Water ----------------------------------------------- Proper

According to the conventional method of preparing a liquid solution, each component is added to the purified water to dissolve it, and lemon flavor is added thereto, the above components are mixed, and then purified water is added to adjust the whole to 100, and then filled into a brown bottle and sterilized to prepare a liquid solution. do.

Formulation Example 6 Preparation of Healthy Food

PS5 ---------------------------------------------- 1000 mg

Vitamin Mixture --------------------------------------- Proper

Vitamin A Acetate ------------------------------- 70 μg

Vitamin E ------------------------------------------ 1.0 mg

Vitamin B1 ---------------------------------------- 0.13 mg

Vitamin B2 ---------------------------------------- 0.15 mg

Vitamin B6 ----------------------------------------- 0.5 mg

Vitamin B12 ---------------------------------------- 0.2 μg

Vitamin C ------------------------------------------- 10 mg

Biotin --------------------------------------------- 10 μg

Nicotinamide ------------------------------------ 1.7 mg

Folic Acid ----------------------------------------------- 50 μg

Calcium Pantothenate ------------------------------------- 0.5 mg

Mineral mixture --------------------------------------- Correct

Ferrous Sulfate ---------------------------------------- 1.75 mg

Zinc Oxide ----------------------------------------- 0.82 mg

Magnesium Carbonate ------------------------------------- 25.3 mg

Potassium monophosphate ---------------------------------------- 15 mg

Dicalcium Phosphate ---------------------------------------- 55 mg

Potassium Citrate ----------------------------------------- 90 mg

Calcium Carbonate ------------------------------------------ 100 mg

Magnesium Chloride ------------------------------------- 24.8 mg

Although the composition ratio of the vitamin and mineral mixture is a composition suitable for a relatively healthy food in a preferred embodiment, the compounding ratio may be arbitrarily modified, and the above ingredients are mixed according to a conventional health food manufacturing method. The granules may be prepared and used for preparing a health food composition according to a conventional method.

Formulation example  7. Manufacture of health drinks

PC1 --------------------------------------------- 1000 mg

Citric Acid ------------------------------------------ 1000 mg

Oligosaccharide ------------------------------------------ 100 g

Plum concentrate ------------------------------------------ 2 g

Taurine ---------------------------------------------- 1 g

Add purified water ----------------------------- 900 mL total

After mixing the above components in accordance with a conventional healthy beverage manufacturing method, and then stirred and heated at 85 ℃ for about 1 hour, the resulting solution is filtered and obtained in a sterilized container, sealed sterilization and refrigerated and then stored in the present invention Used to prepare healthy beverage compositions.

Claims (20)

Pharmaceutical composition for the prevention and treatment of vaginitis containing alum as an active ingredient. Pharmaceutical composition for the prevention and treatment of vaginitis containing salt, sugar and alum compound as an active ingredient. The method according to claim 1 or 2,
The alum is alum, potassium alum, ammonium alum, goban, small alum, aluminum chlorohydrate, sodium alum, or potassium chromium a pharmaceutical composition, characterized in that alum. The method according to claim 1 or 2,
The salt is a parenteral, processed salt, or parenteral pharmaceutical composition. The method according to claim 1 or 2,
The sugar is a pharmaceutical composition, characterized in that the sugar selected from the group consisting of monosaccharides (diosaccharides), disaccharides (disaccharides), oligosaccharides (oligosaccharides), and polysaccharides (polysaccharides). The method of claim 5,
The sugar is xylose, arabinose, glucose, glucose, mannose, fructose, galactose, lactulose, lactitol, lactitol, sugar sucrose, lactose, maltose, trehalose, fructo-oligosaccharides, raffinose, stachyose, maltodextrin, amylose Pharmaceutical composition, characterized in that the sugar selected from the group consisting of amylopectin (amylopectin), starch (starch), cellulose (cellulose), and pectin (pectin). The method of claim 2,
When the salt, sugar and alum formulation is a pharmaceutical composition, characterized in that the formulation is formulated in a blending part by weight of 1: 100 ~ 0.01: 100 ~ 0.01 by weight. The method according to claim 1 or 2,
The vaginitis is a pharmaceutical composition of any one selected from the group consisting of bacterial vaginitis, fungal vaginitis and trichomonas vaginitis. Health functional food for the prevention and improvement of vaginitis containing alum as an active ingredient. Health functional food for prevention and improvement of vaginitis containing salt, sugar and alum compound as an active ingredient. The method according to claim 9 or 10,
The health functional food is a health functional food in the form of powders, granules, tablets, capsules, pills, suspensions, emulsions, syrups, tea bags, leach teas, or health drinks. Health functional food for the prevention and improvement of vaginitis containing alum as an active ingredient. Health supplement for prevention and improvement of vaginitis containing salt, sugar and alum compound as an active ingredient. A parenteral composition for the prevention and improvement of vaginitis containing alum as an active ingredient. A parenteral composition for the prevention and improvement of vaginitis containing salt, sugar and alum compound as an active ingredient. The method according to claim 14 or 15,
The composition may be a liquid, gel, cleaning composition, intravaginal tablet, suppository form, cream, ointment, dressing solution, spray, coating agent, solution type, suspension type, emulsion type, sterilized aqueous solution, non-aqueous solvent, suspension A parenteral composition which is an agent, emulsion, lyophilized preparation, suppository, cream, ointment, jelly, foam, cleanser or vaginal insert. The method of claim 16,
The composition is a parenteral composition for the application or direct skin application of hygiene products such as tampons, sanitary napkins, diapers, panties and the like. Cleaning composition for the prevention and improvement of vaginitis containing alum as an active ingredient. Cleaning composition for the prevention and improvement of vaginitis containing salt, sugar and alum compound as an active ingredient. The method of claim 18 or 19,
The composition may be a liquid, gel, cleaning composition, intravaginal tablet, suppository form, cream, ointment, dressing solution, spray, coating agent, solution type, suspension type, emulsion type, sterilized aqueous solution, non-aqueous solvent, suspension Detergent composition which is an agent, emulsion, lyophilized formulation, suppository, cream, ointment, jelly, foam, detergent or vaginal insert.