Patent Description:
Exposed to the external environment, human skin and mucosa are easily contaminated with pathogens, which may lead to pathogen colonization and infection of skin and mucosa, or lead to the carry and spread of pathogens. Cleaning skin and/or mucosa with bacteriostatic products can effectively reduce the pathogen load on skin and/or mucosa and even kill pathogens, thus helping to prevent the infection and spread of pathogens.

To prevent the spoilage of various personal cleaning and care products, such as skin care products, cosmetics, bath products, and shampoo products, as well as various medical products and pharmaceutical products, as a result of microbial contamination during their storage and use, it is essential to inhibit the growth of contaminated microorganisms and even to kill them, such as inhibiting or killing molds, yeast, Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus.

In particular, the surface of the vaginal mucosa is inhabited by a large number of bacteria, fungi, and other microorganisms. As the most abundant bacteria in vagina of a healthy female, lactobacilli metabolize glycogens in vaginal mucosal epithelial cells, produce acids, maintain the vaginal pH in the range between <NUM>-<NUM>, and produce inhibitory substances such as hydrogen peroxide and bacteriocin against pathogens and opportunistic pathogens. They are therefore beneficial and are known as "normal vaginal flora".

The vagina is also inhabited by Gardnerella, Prevotella, Mobiluncus, Escherichia coli, Staphylococcus, Candida, and the like, which are not pathogenic when in small numbers, but may produce harmful metabolites, toxins, etc. when in large numbers thus resulting in pathological changes and diseases in human body. These microorganisms are therefore called "opportunistic pathogens". Among Staphylococcus, the pathogenicity of Staphylococcus aureus is relatively high and representative. Among Candida infections, Candida albicans infection is the most common and representative, accounting for more than <NUM>% of total vaginal and/or vulvar Candida infections.

When the vaginal flora is abnormal and lactobacilli exist in low numbers, the vagina is not only inhabited by a higher number of opportunistic pathogens such as Gardnerella, but also has a decreased resistance to pathogens of high toxicity and pathogenicity. The risk of communicable diseases of the reproductive tract, such as those caused by gonococci, trichomonas, chlamydia, mycoplasmas, and viruses such as HIV and HPV, and the like, then increases.

Currently, the antibacterial therapy remains the primary treatment for vaginal microbial diseases. Although antibacterial therapy can inhibit or kill pathogenic bacteria, it often inhibits or kills beneficial lactobacilli also and results in the reduction of vaginal resistance to infections. Thus, recurrent or persistent vaginal infections occur. It is a hot topic in medical research how to protect the beneficial bacteria in vagina during the course of antibacterial therapy and improve the efficacy of the prevention and treatment.

Therefore, there is a huge practical demand for a safe and effective bacteriostatic product, which is not only suitable for use in cleaning, hygiene, and bacteriostasis of human skin and mucosa, in the antisepsis of personal cleaning and care products such as bath products, skin care products, and cosmetics, and in the antisepsis of medical products, pharmaceutical products, and the like, but also can be used to inhibit abnormal vaginal flora, to restore and/or maintain vaginal lactobacilli, to restore and/or maintain normal vaginal flora, and to restore and/or maintain normal vaginal microecology. Documents <CIT> and <CIT> are related to bacteriostatic compositions directed to female care including a fatty acid or lactic acid, an aromatic alcohol, and sodium benzoate. Documents <CIT> and <CIT> are related to bacteriostatic compositions not directed to female care.

The information in the Background section is intended only to describe the general context of the present invention and shall not be considered as an acknowledgment or in any way as an implication that such information constitutes the prior art known to those of ordinary skill in the art.

The references to the methods of treatments in this description, the in-vivo experiments I to VI and clinical observation I in the examples of the application are to be interpreted as references to compounds, pharmaceutical compositions and medicaments of the present invention for use in those methods.

An objective of the present invention is to provide a bacteriostatic composition.

Another objective of the present invention is to provide a method for inhibiting harmful microorganisms outside the body.

A further objective of the present invention is to provide a composition for use in modulating vaginal flora, referring to inhibiting abnormal vaginal flora, and/or restoring and/or maintaining vaginal lactobacilli.

And a further objective of the present invention is to provide a method for preparing the bacteriostatic composition.

The present invention provides a bacteriostatic composition, wherein the composition comprises the following ingredients:.

The bacteriostatic composition is in one of the following dosage forms: aqueous solutions, water-soluble gels, foams, sprays, ointments, powders, films, capsules, suppositories, tablets, preferably aqueous solutions, water-soluble gels, foams, sprays, or ointments.

In some embodiments, the total content of one or more of the fatty acids and/or salts thereof, calculated as fatty acid, is preferably in the range of <NUM>-<NUM>% (w/w), more preferably in the range of <NUM>-<NUM>% (w/w), and the most preferably in the range of <NUM>%-<NUM>% (w/w); and/or the total content of one or more of the dicarboxylic acids and/or salts thereof, calculated as dicarboxylic acid, is preferably in the range of <NUM>-<NUM>% (w/w), more preferably in the range of <NUM>-<NUM>% (w/w), and the most preferably in the range of <NUM>-<NUM>% (w/w); and/or the total content of one or more of the aromatic alcohols is preferably in the range of <NUM>-<NUM>% (w/w), more preferably in the range of <NUM>-<NUM>% (w/w), and the most preferably in the range of <NUM>-<NUM>% (w/w); and/or the total content of one or more of the aromatic carboxylic acids and/or salts thereof, calculated as aromatic carboxylic acids, is preferably in the range of <NUM>-<NUM>% (w/w), more preferably in the range of <NUM>-<NUM>% (w/w), and the most preferably in the range of <NUM>-<NUM>% (w/w).

In some embodiments, the bacteriostatic composition can further comprise one or more of the dicarboxylic acids, polybasic carboxylic acids, and salts thereof selected from the group consisting of malic acid, citric acid, succinic acid, tartaric acid, maleic acid, isocitric acid, suberic acid, azelaic acid, sebacic acid, and salts thereof, preferably selected from the group consisting of malic acid, citric acid, succinic acid, and salts thereof; the total content of one or more of the dicarboxylic acids, polybasic carboxylic acids, and salts thereof as described is in the range of <NUM>-<NUM>% (w/w). Wherein the acids and/or salts thereof have a buffering effect, which improves the pH stability of the bacteriostatic composition in the present disclosure, and further strengthens the modulating effect of the bacteriostatic composition on the pH of human skin and/or mucosa.

In some embodiments, the bacteriostatic composition can optionally include one or more of the monosaccharides and/or oligosaccharides and/or polysaccharides selected from the group consisting of glucose, fructose, mannose, galactose, maltose, isomaltose, sucrose, isomaltulose, lactose, lactulose, trehalose, cellobiose, melibiose, gentiobiose, <NUM>-kestose, nystose, 1F-fructofuranosylnystose, isomaltotriose, isomaltotetraose, isomaltopentaose, gentiooligosaccharide, raffinose, panose, maltooligosaccharide, palatinose-oligosaccharide, oligofructose, glucomannan, galactooligosaccharide, dextrin, starch, and glycogen; the total content of which is in the range of <NUM>-<NUM>% (w/w). The preferable saccharides are selected from the group consisting of isomaltulose, lactose, lactulose, maltose, isomaltose, trehalose, glycogen, and mixtures thereof; the total content of which is in the range of <NUM>-<NUM>% (w/w). The saccharide-containing bacteriostatic composition in the present disclosure can not only inhibit Candida, Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Gardnerella, Prevotella, Mobiluncus, Aspergillus niger, abnormal flora of skin and/or mucosa, and the like, but also can restore and/or maintain lactic acid bacteria on skin and/or mucosa, and restore and/or maintain the acidity of skin and/or mucosa. Therefore, it is suitable for use in the prevention and/or treatment of the decrease of lactic acid bacteria on skin and/or mucosa and the imbalance of skin and/or mucosa flora, such as the use in the prevention and/or treatment of bacterial vaginosis, aerobic vaginitis, or atrophic vaginitis, or the use in the adjuvant treatment of vaginitis, or the use in the recovery after vaginitis treatment, or the use in the treatment of reproductive tract infections, and the like.

In some embodiments, the bacteriostatic composition can optionally include one or more of the amino acids and/or salts thereof selected from the group consisting of L-glutamic acid, glutamine, L-aspartic acid, asparagine, leucine, isoleucine, phenylalanine, valine, proline, threonine, and salts thereof; the total content of which is in the range of <NUM>-<NUM>% (w/w); the preferable amino acids are glutamic acid, aspartic acid, salts thereof, and mixtures thereof; the total content of which is in the range of <NUM>-<NUM>% (w/w). The bacteriostatic composition in the present disclosure containing amino acids and/or salts thereof can reduce acids production from lactic acid bacteria, thus decreasing the acidity of skin and/or mucosa. It is suitable for use in the modulation of the microenvironment of skin and/or mucosa, such as the use in the treatment or adjuvant treatment of cytolytic vaginosis, vulvovaginal candidiasis, and the like.

In some embodiments, the bacteriostatic composition can optionally include one or more of monoterpene and/or sesquiterpene compounds, including but not limited to citronellol, linalool, geraniol, nerol, eucalyptol, terpineol, carveol, menthol, and lavandulol; the total content of the monoterpene and/or sesquiterpene compounds as described is in the range of <NUM>-<NUM>% (w/w). The monoterpene and/or sesquiterpene compounds may enhance the bacteriostatic effect of the bacteriostatic composition as well as provide a fragrance for the composition.

In some embodiments, the bacteriostatic composition can optionally include one or more of plant aromatic oils, including but not limited to rose essential oil, clove oil, red thyme oil, lavender oil, peppermint oil, artemisia leaf oil, eucalyptus oil, sassafras oil, litsea cubeba oil, cinnamon essential oil, laurel leaf oil, and thyme oil; the total content of the plant aromatic oils as described is in the range of <NUM>-<NUM>% (w/w). The plant aromatic oils can enhance the bacteriostatic effect of the composition, as well as provide a fragrance for the composition.

In some embodiments, the bacteriostatic composition can optionally include one or more of the vitamins selected from the group consisting of vitamin A, vitamin C, vitamin D, and vitamin E; the total content of which is in the range of <NUM>-<NUM>% (w/w). The vitamins can be highly pure vitamins or the vitamins contained in plant extracts. The vitamins as described have effects of antioxidation, promoting the growth of skin cells, modulating the immune function, or maintaining the integrity of mucosal epithelial cells, etc., and can enhance the stability of the bacteriostatic composition, or protect human skin and/or mucosa.

In some embodiments, the bacteriostatic composition can optionally include one or more of the ingredients selected from the group consisting of dehydroacetic acid, sodium dehydroacetate, sorbic acid, potassium sorbate, sodium sorbate, natamycin, bergenin, tropolone, cinnamaldehyde, pseudolaric acid, chlorogenic acid, <NUM>,<NUM>-pentanediol, <NUM>,<NUM>-hexanediol, <NUM>,<NUM>-hexanediol, <NUM>,<NUM>-octanediol, <NUM>,<NUM>-decanediol, p-hydroxyacetophenone, <NUM>,<NUM>-dihydroxyacetophenone, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate, lysozyme, glycerol monocaprylate, glycerol monodecanoate, and glycerol monolaurate. The ingredients as described are used to further enhance the bacteriostatic or antibacterial effect of the bacteriostatic composition in the present disclosure against Candida, Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Gardnerella, Prevotella, Mobiluncus, Aspergillus niger, abnormal flora of skin and/or mucosa, and the like, and other harmful microorganisms including but not limited to viruses such as HIV and HPV.

In some embodiments, the bacteriostatic composition further comprises one or more of antibacterial drugs, including but not limited to nitroimidazoles such as metronidazole, tinidazole, and ornidazole; aminoglycosides such as gentamicin, tobramycin, amikacin, sisomicin, and netilmicin; quinolones such as ciprofloxacin, ofloxacin, and levofloxacin; furanes such as nifuratel, nifuroxime, furacilin, furazolidone, and furantoin; sulfonamides such as silver sulfadiazine and sodium sulfacetamide; pyrroles such as clotrimazole, fluconazole, miconazole, and ketoconazole; acrylamides such as naftifine and terbinafine; polyenes such as amphotericin B, nystatin, levorin, and natamycin; preferably metronidazole, nifuratel, clotrimazole, or mixtures thereof. The bacteriostatic composition in the present disclosure containing antibacterial drugs is suitable for skin and/or mucosa use, such as for the prevention and/or treatment of bacterial and/or fungal infections of skin, the prevention and/or treatment of bacterial or fungal infections of the oral mucosa, and the prevention and/or treatment of vaginal mucosa infections such as bacterial vaginosis, aerobic vaginitis, and vulvovaginal candidiasis.

In some embodiments, the bacteriostatic composition as described is in one of the following dosage forms: aqueous solutions, water-soluble gels, foams, sprays, or ointments; the pH value of the aqueous solutions, water-soluble gels, foams, sprays, or ointments is in the range of <NUM>-<NUM>, preferably in the range of <NUM>-<NUM>, and more preferably in the range of <NUM>-<NUM>.

In some embodiments, the bacteriostatic composition is a water-soluble gel. The water-soluble gel comprises one or more of non-flowable, viscous, and water-soluble colloidal excipients, including but not limited to xanthan gum, carbomer, polycarbophil, dextran, glucomannan, tragacanth gum, gummitragacanthae, methyl cellulose (MC), carboxymethyl cellulose (CMC), hydroxyethyl cellulose (HEC), hydroxyethyl methyl cellulose (HEMC), and hydroxypropyl methyl cellulose (HPMC), the preferred are xanthan gum and carbomer.

The bacteriostatic composition in the present disclosure has an inhibitory effect on harmful microorganisms, which is referred to but not limited to Candida, Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Gardnerella, Prevotella, Mobiluncus, Aspergillus niger, abnormal flora of skin and/or mucosa, as well as various other pathogenic or opportunistically pathogenic aerobic bacteria, facultative bacteria, anaerobic bacteria, molds, and viruses such as HPV and HIV.

Therefore, the bacteriostatic composition in the present disclosure can be used for the cleaning and/or bacteriostasis and/or disinfection of human skin and/or mucosa such as vaginal mucosa, for the antisepsis of various personal cleaning and care products such as bath products, shampoo products, skin care products and cosmetics, or for the antisepsis of medical products, pharmaceutical products, and the like.

In some embodiments, the bacteriostatic composition in the present disclosure can be a therapeutic product, an active ingredient thereof, and an antiseptic thereof; the therapeutic product form includes but are not limited to drugs, disinfectants, topical microbicides, antibacterial agents, bacteriostatic agents, microecological modulators, flora modulators, microenvironment modulators, microbial modulators, disposable medical supplies, and the like, or the components of medical devices, the components of pharmaceutical devices, the components of disinfection devices, and the components of devices for vagina use.

In some embodiments, the bacteriostatic composition in the present disclosure can be a non-therapeutic product, an active ingredient thereof, and an antiseptic thereof; the non-therapeutic product form is one of the following group: health care products, hygiene products, personal cleaning and care products, cosmetics, disposable hygiene products, cleaning products, daily necessities, microecological care products, deodorants, lubricants, humectants, lotions, cleaning agents, body care products, antipruritic agents, refreshing agents, and the components of sanitary napkins, sanitary pads, and tampons.

In some embodiments, the bacteriostatic composition of the present invention is a vaginal bacteriostatic composition, wherein the vaginal bacteriostatic composition comprises:.

The vaginal bacteriostatic composition as described is in one of the following dosage forms: aqueous solutions, water-soluble gels, foams, sprays, ointments, powders, films, capsules, suppositories, or tablets, preferably aqueous solutions, water-soluble gels, foams, sprays, or ointments.

In some embodiments, the vaginal bacteriostatic composition in the present disclosure further comprises one or more of the estrogens selected from the group consisting of diethylstilbestrol, hexoestrol, estradiol, estrone, estriol, nilestriol, ethinyloestradiol, quinestrol, mestranol, and promestriene, preferably, estriol and promestriene; the total content of which is in the range of <NUM>-<NUM>% (w/w). The vaginal bacteriostatic composition in the present disclosure containing estrogens can promote the glycogen synthesis in vaginal mucosal epithelial cells, and promote the growth of beneficial lactobacilli. It is especially suitable for use in menopause, postmenopausal, and postpartum.

In some embodiments, the vaginal bacteriostatic composition in the present disclosure can further compriseone or more of the phytoestrogens selected from the group consisting of daidzin, daidzein, glycitein, puerarin, coumestrol, genistein, equol, apigenin, genistin, genisteol, biochanin, coumestrol, formononetin, resveratrol, secoisolariciresinol, and lignan; the total content of which is in the range of <NUM>-<NUM>% (w/w). The vaginal bacteriostatic composition in the present disclosure containing phytoestrogens can promote glycogen synthesis in vaginal mucosal epithelial cells, and promote the growth of beneficial lactobacilli. It is especially suitable for use in menopause, postmenopausal, and postpartum.

According to practical needs, the vaginal bacteriostatic composition in the present disclosure can optionally contain different excipients for different dosage forms such as water, xanthan gum, or carbomer. It can also optionally include one or more of the aforementioned ingredients further, such as the dicarboxylic acid(s), polybasic carboxylic acid(s), and salt(s) thereof, e.g., malic acid, citric acid, succinic acid, and salts thereof, in a total content of <NUM>-<NUM>% (w/w); and/or the antibacterial or bacteriostatic agent(s) such as dehydroacetic acid and glycerol monocaprylate; and/or the saccharide(s) such as isomaltulose, lactose, and maltose, in a total content of <NUM>-<NUM>% (w/w); and/or amino acid(s) such as glutamic acid, aspartic acid, and salts thereof, in a total content of <NUM>-<NUM>% (w/w); and/or the monoterpene or sesquiterpene compound(s) such as citronellol and linalool, in a total content of <NUM>-<NUM>% (w/w); and/or the plant aromatic oil(s) such as rose essential oil and clove oil, in a total content of <NUM>-<NUM>% (w/w); and/or the vitamin(s) such as vitamin A, and vitamin C, in a total content of <NUM>-<NUM>% (w/w); and/or antibacterial drug(s) such as metronidazole, nifuratel, and clotrimazole.

Having an inhibitory effect on abnormal vaginal flora but an effect of restoring and/or maintaining and/or promoting vaginal lactobacilli, the vaginal bacteriostatic composition in the present disclosure can be used to restore and/or maintain normal vaginal flora, to restore and/or maintain normal vaginal microecology, and to restore and/or maintain normal vaginal acidity.

Therefore, the vaginal bacteriostatic composition in the present disclosure can be used to clean and take care of vagina and/or vulva, and/or to reduce and/or eliminate vaginal pruritus, and/or soreness, and/or dryness, and/or irritation, and/or dyspareunia, and/or to reduce and/or eliminate abnormal vaginal discharge, and/or unpleasant odor of vaginal discharge. It can also be used for the prevention and/or treatment and/or adjuvant treatment of the imbalance of vaginal flora, and/or bacterial vaginosis, and/or aerobic vaginitis, and/or cytolytic vaginosis, and/or vulvovaginal Candidiasis, and/or atrophic vaginitis, etc..

The present invention also provides a method for inhibiting harmful microorganisms outside the body, wherein the method includes the steps of using a bacteriostatic composition according to the invention. Therefore, the bacteriostatic composition as described in the method for inhibiting harmful microorganisms outside the body in the present disclosure can be used for the antisepsis of various personal cleaning and care products such as bath products, shampoo products, skin care products, and cosmetics, or for the antisepsis of medical products, pharmaceutical products, and the like.

In some embodiments, the bacteriostatic composition as described in the method for inhibiting harmful microorganisms outside the body in the present disclosure can be a non-therapeutic product, an active ingredient thereof, or an antiseptic thereof; wherein the non-therapeutic product form includes but are not limited to health care products, personal cleaning and care products, cosmetics, hygiene products, disposable hygiene products, cleaning products, daily necessities, microecological care products, deodorants, lubricants, humectants, lotions, cleaning agents, body care products, antipruritic agents, refreshing agents, or can be the components of hygiene products or cleaning care products such as sanitary napkins, sanitary pads, or tampons.

When the bacteriostatic composition as described in the present disclosure for inhibiting harmful microorganisms outside the body is used for antisepsis, the content of each ingredient of the bacteriostatic composition in the present disclosure contained in bath products, shampoo products, skin care products, cosmetics, pharmaceutical products, and other medical products, and the like, i.e. the total content of one or more of the fatty acids and/or salts thereof calculated as fatty acid, the total content of one or more of the dicarboxylic acids and/or salts thereof calculated as dicarboxylic acid, the total content of one or more of the aromatic alcohols, the total content of one or more of the aromatic carboxylic acids and/or salts thereof calculated as aromatic carboxylic acid, shall be within the total content ranges of the four ingredients in the bacteriostatic composition in the present disclosure.

The present invention also provides a vaginal bacterial composition for use in modulating vaginal flora, wherein the modulating vaginal flora refers to at least one of the following: inhibiting abnormal vaginal flora, restoring and/or maintaining vaginal lactobacilli. Wherein the vaginal bacteriostatic composition comprises one or more of the fatty acids and/or salts thereof selected from the group consisting of butyric acid, valeric acid, hexanoic acid, heptanoic acid, caprylic acid, nonanoic acid, capric acid, undecylic acid, undecylenic acid, lauric acid, and salts thereof; the total content of which, calculated as fatty acid, is in the range of <NUM>-<NUM>% (w/w), preferably in the range of <NUM>-<NUM>% (w/w). The more preferable fatty acids and/or salts thereof are selected from the group consisting of butyric acid, hexanoic acid, caprylic acid, capric acid, undecylic acid, salts thereof, and mixtures thereof; the total content of which is in the range of <NUM>-<NUM>% (w/w);.

Wherein the vaginal bacteriostatic composition is in one of the following dosage forms: aqueous solutions, water-soluble gels, foams, sprays, ointments, powders, films, capsules, suppositories, or tablets, preferably aqueous solutions, water-soluble gels, foams, sprays, or ointments.

In some embodiments, the vaginal bacteriostatic composition as described for use in modulating vaginal flora in the present invention also comprises one or more of the dicarboxylic acids and/or salts thereof selected from the group consisting of glutaric acid, adipic acid, pimelic acid, and salts thereof; the total content of which, calculated as dicarboxylic acid, is in the range of <NUM>-<NUM>% (w/w). The preferabe dicarboxylic acid and/or salt thereof is adipic acid and/or salt thereof, the total content of which is in the range of <NUM>-<NUM>% (w/w). The combination of dicarboxylic acids such as adipic acid, salts thereof as described and fatty acids such as butyric acid, salts thereof in the present disclosure can enhance the bacteriostatic effect of the fatty acids and/or salts thereof as described against Candida albicans.

In some embodiments, the vaginal bacteriostatic composition as described for use in modulating vaginal flora in the present invention may also comprise one or more of the aromatic alcohols selected from the group consisting of benzyl alcohol, phenethyl alcohol, phenoxyethanol, and cinnamyl alcohol; the total content of which is in the range of <NUM>-<NUM>% (w/w). The preferable aromatic alcohols are phenethyl alcohol, cinnamyl alcohol, or mixtures thereof; the total content of which is in the range of <NUM>-<NUM>% (w/w). The combination of aromatic alcohols such as phenethyl alcohol as described and fatty acids such as butyric acid, and salts thereof in the present disclosure can enhance the bacteriostatic effect of the fatty acids and/or salts thereof as described against Candida albicans, Staphylococcus aureus, Escherichia coli, abnormal vaginal flora, and the like.

In some embodiments, the vaginal bacteriostatic composition for use in modulating vaginal flora in the present invention may also comprise one or more of the aromatic carboxylic acids and/or salts thereof selected from the group consisting of benzoic acid, p-hydroxybenzoic acid, p-methoxybenzoic acid, salicylic acid, cinnamic acid, gentianic acid, caffeic acid, and salts thereof; the total content of which, calculated as aromatic carboxylic acid, is in the range of <NUM>-<NUM>% (w/w). The preferable aromatic carboxylic acids and/or salts thereof are selected from the group consisting of benzoic acid, cinnamic acid, p-hydroxybenzoic acid, salts thereof, and mixtures thereof; the total content of which is in the range of <NUM>-<NUM>% (w/w). The combination of aromatic carboxylic acids such as benzoic acid, salts thereof as described and fatty acids such as butyric acid, salts thereof in the present disclosure can enhance the bacteriostatic effect of the fatty acids and/or salts thereof as described against Candida albicans, Staphylococcus aureus, Escherichia coli, abnormal vaginal flora, and the like.

In some embodiments, the vaginal bacteriostatic composition for use in modulating vaginal flora in the present invention comprises: (<NUM>) one or more of the fatty acids and/or salts thereof selected from the group consisting of butyric acid, valeric acid, hexanoic acid, heptanoic acid, caprylic acid, nonanoic acid, capric acid, undecylic acid, undecylenic acid, lauric acid, and salts thereof; the total content of which, calculated as fatty acid, is in the range of <NUM>-<NUM>% (w/w), preferably in the range of <NUM>-<NUM>% (w/w). The preferable fatty acids and salts thereof are selected from the group consisting of butyric acid, hexanoic acid, caprylic acid, capric acid, undecylic acid, salts thereof, and mixtures thereof; the total content of which is in the range of <NUM>-<NUM>% (w/w); (<NUM>) one or more of the dicarboxylic acids and/or salts thereof selected from the group consisting of glutaric acid, adipic acid, pimelic acid, and salts thereof; the total content of which, calculated as dicarboxylic acid, is in the range of <NUM>-<NUM>% (w/w); preferably adipic acid and/or salt thereof, the total content of which is in the range of <NUM>-<NUM>% (w/w); (<NUM>) one or more of the aromatic alcohols selected from the group consisting of benzyl alcohol, phenethyl alcohol, phenoxyethanol, and cinnamyl alcohol; the total content of which is in the range of <NUM>-<NUM>% (w/w); the preferable aromatic alcohols are phenethyl alcohol, cinnamyl alcohol, or mixtures thereof; the total content of which is in the range of <NUM>-<NUM>% (w/w).

The combination of dicarboxylic acids such as adipic acid and/or salts thereof, aromatic alcohols such as phenethyl alcohol, and fatty acids such as butyric acid and/or salts thereof in the present disclosure has a synergetic bacteriostatic effect against Candida albicans, Staphylococcus aureus, and Escherichia coli, and has an inhibitory effect on abnormal vaginal flora.

In some embodiments, the vaginal bacteriostatic composition for use in modulating vaginal flora in the present disclosure comprises: (<NUM>) one or more of the fatty acids and/or salts thereof selected from the group consisting of butyric acid, valeric acid, hexanoic acid, heptanoic acid, caprylic acid, nonanoic acid, capric acid, undecylic acid, undecylenic acid, lauric acid, and salts thereof; the total content of which, calculated as fatty acid, is in the range of <NUM>-<NUM>% (w/w), preferably in the range of <NUM>-<NUM>% (w/w). The preferable fatty acids and/or salts thereof are selected from the group consisting of butyric acid, hexanoic acid, caprylic acid, capric acid, undecylic acid, salts thereof, and mixtures thereof; the total content of which is in the range of <NUM>-<NUM>% (w/w); (<NUM>) one or more of the dicarboxylic acids and/or salts thereof selected from the group consisting of glutaric acid, adipic acid, pimelic acid, and salts thereof; the total content of which, calculated as dicarboxylic acid, is in the range of <NUM>-<NUM>% (w/w); preferably adipic acid and/or salt thereof in the total content of <NUM>-<NUM>% (w/w); (<NUM>) one or more of the aromatic carboxylic acids and/or salts thereof selected from the group consisting of benzoic acid, p-hydroxybenzoic acid, p-methoxybenzoic acid, salicylic acid, cinnamic acid, gentianic acid, caffeic acid, and salts thereof; the total content of which, calculated as aromatic carboxylic acid, is in the range of <NUM>-<NUM>% (w/w). The preferable aromatic carboxylic acids and/or salts thereof are benzoic acid, cinnamic acid, p-hydroxybenzoic acid, salts thereof, and mixtures thereof; the total content of which is in the range of <NUM>-<NUM>% (w/w).

The combination of dicarboxylic acids such as adipic acid and/or salts thereof, aromatic carboxylic acids such as benzoic acid and/or salts thereof, and fatty acids such as butyric acid and/or salts thereof in the present disclosure has a synergetic bacteriostatic effect against Candida albicans, Staphylococcus aureus, and Escherichia coli, and has an inhibitory effect on abnormal vaginal flora.

In some embodiments, the vaginal bacteriostatic composition for use in modulating vaginal flora in the present disclosure may comprise: (<NUM>) one or more of the fatty acids and/or salts thereof selected from the group consisting of butyric acid, valeric acid, hexanoic acid, heptanoic acid, caprylic acid, nonanoic acid, capric acid, undecylic acid, undecylenic acid, lauric acid, and salts thereof; the total content of which, calculated as fatty acid, is in the range of <NUM>-<NUM>% (w/w), preferably in the range of <NUM>-<NUM>% (w/w). The preferable fatty acids and/or salts thereof are selected from the group consisting of butyric acid, hexanoic acid, caprylic acid, capric acid, undecylic acid, salts thereof, and mixtures thereof; the total content of which is in the range of <NUM>-<NUM>% (w/w); (<NUM>) one or more of the aromatic alcohols selected from the group consisting of benzyl alcohol, phenethyl alcohol, phenoxyethanol, and cinnamyl alcohol; the total content of which is in the range of <NUM>-<NUM>% (w/w). The preferable aromatic alcohols are phenethyl alcohol, cinnamyl alcohol, or mixtures thereof; the total content of which is in the range of0. <NUM>-<NUM>% (w/w); (<NUM>) one or more of the aromatic carboxylic acids and/or salts thereof selected from the group consisting of benzoic acid, p-hydroxybenzoic acid, p-methoxybenzoic acid, salicylic acid, cinnamic acid, gentianic acid, caffeic acid, salts thereof; the total content of which, calculated as aromatic carboxylic acid, is in the range of <NUM>-<NUM>% (w/w). The preferable aromatic carboxylic acids and/or salts thereof are selected from the group consisting of benzoic acid, cinnamic acid, p-hydroxybenzoic acid, salts thereof, and mixtures thereof; the total content of which is in the range of <NUM>-<NUM>% (w/w).

The combination of aromatic alcohols such as phenethyl alcohol, aromatic carboxylic acids such as benzoic acid and/or salts thereof, and fatty acids such as butyric acid and/or salts thereof in the present disclosure has a synergetic bacteriostatic effect against Candida albicans, Staphylococcus aureus, and Escherichia coli, and has an inhibitory effect on abnormal vaginal flora.

In some embodiments, the vaginal bacteriostatic composition for use in modulating vaginal flora in the present disclosure may comprise: (<NUM>) one or more of the fatty acids and/or salts thereof selected from the group consisting of butyric acid, valeric acid, hexanoic acid, heptanoic acid, caprylic acid, nonanoic acid, capric acid, undecylic acid, undecylenic acid, lauric acid, and salts thereof; the total content of which, calculated as fatty acid, is in the range of <NUM>-<NUM>% (w/w), preferably in the range of <NUM>-<NUM>% (w/w). The preferable fatty acids and/or salts thereof are selected from the group consisting of butyric acid, hexanoic acid, caprylic acid, capric acid, undecylic acid, salts thereof, and mixtures thereof; the total content of which is in the range of <NUM>-<NUM>% (w/w); (<NUM>) one or more of the dicarboxylic acids and/or salts thereof selected from the group consisting of glutaric acid, adipic acid, pimelic acid, and salts thereof; the total content of which, calculated as dicarboxylic acid, is in the range of <NUM>-<NUM>% (w/w); preferably adipic acid and/or salt thereof in the total content of <NUM>-<NUM>% (w/w); (<NUM>) one or more of the aromatic alcohols selected from the group consisting of benzyl alcohol, phenethyl alcohol, phenoxyethanol, and cinnamyl alcohol; the total content of which is in the range of <NUM>-<NUM>% (w/w). The preferable aromatic alcohols are phenethyl alcohol, cinnamyl alcohol, or mixtures thereof; the total content of which is in the range of <NUM>-<NUM>% (w/w); (<NUM>) one or more of the aromatic carboxylic acids and/or salts thereof selected from the group consisting of benzoic acid, p-hydroxybenzoic acid, p-methoxybenzoic acid, salicylic acid, cinnamic acid, gentianic acid, caffeic acid, salts thereof; the total content of which, calculated as aromatic carboxylic acid, is in the range of <NUM>-<NUM>% (w/w). The preferable aromatic carboxylic acids and/or salts thereof are selected from the group consisting of benzoic acid, cinnamic acid, p-hydroxybenzoic acid, salts thereof, and mixtures thereof; the total content of which is in the range of <NUM>-<NUM>% (w/w).

The combination of dicarboxylic acids such as adipic acid and/or salts thereof, aromatic alcohols such as phenethyl alcohol, aromatic carboxylic acids such as benzoic acid and/or salts thereof, and fatty acids such as butyric acid and/or salts thereof in the present disclosure has a synergetic bacteriostatic effect against Candida albicans, Staphylococcus aureus, and Escherichia coli, and has an inhibitory effect on abnormal vaginal flora. After vaginal application of the bacteriostatic composition, there was a significant decrease in abnormal vaginal flora and a significant increase in lactobacilli. Therefore, the bacteriostatic composition as described has the effects of inhibiting abnormal vaginal flora, restoring and/or maintaining and/or promoting vaginal lactobacilli, and restoring and/or maintaining normal vaginal acidity.

In some embodiments, the vaginal bacteriostatic composition as described for use in modulating vaginal flora in the present disclosure may further comprise one or more of the estrogens selected from the group consisting of diethylstilbestrol, hexoestrol, estradiol, estrone, estriol, nilestriol, ethinyloestradiol, quinestrol, mestranol, and promestriene; the total content of which is in the range of <NUM>-<NUM>% (w/w), preferably estriol and promestriene. As estrogens can promote the glycogen synthesis of vaginal mucosal epithelial cells and promote the growth of beneficial lactobacilli, the bacteriostatic composition in the present disclosure containing estrogens is especially suitable for use in menopause, postmenopausal, or postpartum.

In some embodiments, the vaginal bacteriostatic composition for use in modulating vaginal flora in the present disclosure may further comprises one or more of the phytoestrogens selected from the group consisting of daidzin, daidzein, glycitein, puerarin, coumestrol, genistein, equol, apigenin, genistin, genisteol, biochanin, coumestrol, formononetin, resveratrol, secoisolariciresinol, and lignan; the total content of which is in the range of <NUM>-<NUM>% (w/w). As phytoestrogens can promote the glycogen synthesis of vaginal mucosal epithelial cells and promote the growth of beneficial lactobacilli, the bacteriostatic composition in the present disclosure containing phytoestrogens is especially suitable for use in menopause, postmenopausal, or postpartum.

The vaginal bacteriostatic composition of the invention may be used to restore and/or maintain normal vaginal flora, and/or to restore and/or maintain normal vaginal microecology, and/or to restore and/or maintain normal vaginal acidity, and/or to clean and take care of the vagina and/or vulva, and/or to reduce and/or eliminate vaginal pruritus, soreness, dryness, irritation, and dyspareunia, and/or to reduce and/or eliminate abnormal vaginal discharge and unpleasant odor of vaginal discharge.

The vaginal bacteriostatic composition of the invention may be used to prevent and/or treat the imbalance of vaginal flora, bacterial vaginosis, aerobic vaginitis, cytolytic vaginosis, vulvovaginal Candidiasis, and/or atrophic vaginitis.

The bacteriostatic composition of the invention can be prepared by the following method, wherein the preparation method comprises the following steps: to add the following ingredients to an excipient, wherein the excipient is used for aqueous solutions, water-soluble gels, foams, suppositories, or tablets:.

The composition as described is in one of the following dosage forms: aqueous solutions, water-soluble gels, foams, sprays, ointments, powders, films, capsules, suppositories, or tablets, preferably, aqueous solutions, or water-soluble gels, or foams, or sprays, or ointments.

In some embodiments, the preparation method comprises the addition of one or more of the fatty acids and/or salts thereof as described, the total content of which, calculated as fatty acid, is preferably in the range of <NUM>-<NUM>% (w/w), more preferably in the range of <NUM>-<NUM>% (w/w), and the most preferably in the range of <NUM>%-<NUM>% (w/w); and/or the addition of one or more of the dicarboxylic acids and/or salts thereof as described, the total content of which, calculated as dicarboxylic acid, is preferably in the range of <NUM>-<NUM>% (w/w), more preferably in the range of <NUM>-<NUM>% (w/w), and the most preferably in the range of <NUM>-<NUM>% (w/w); and/or the addition of one or more of the aromatic alcohols, the total content of which is preferably in the range of <NUM>-<NUM>% (w/w), more preferably in the range of <NUM>-<NUM>% (w/w), and the most preferably in the range of <NUM>-<NUM>% (w/w); and/or the addition of one or more of the aromatic carboxylic acids, the total content of which is preferably in the range of <NUM>-<NUM>% (w/w), more preferably in the range of <NUM>-<NUM>% (w/w), and the most preferably in the range of <NUM>-<NUM>% (w/w).

In the preparation of water-soluble gels, a non-flowable, viscous, and water-soluble colloidal excipient is needed, which enables the composition to homogeneously contact with the vaginal mucosa and to stay for a longer time to take effect. In some embodiments, wherein the excipient is xanthan gum, carbomer, polycarbophil, dextran, glucomannan, tragacanth gum, gummitragacanthae, methyl cellulose (MC), carboxymethyl cellulose (CMC), hydroxyethyl cellulose (HEC), hydroxyethyl methyl cellulose (HEMC), and hydroxypropyl methyl cellulose (HPMC), preferably xanthan gum, and carbomer.

In some embodiments, wherein the composition can be prepared according to the following technological process: weigh and take (<NUM>) one or more of the fatty acids and/or salts thereof such as propionic acid and/or sodium salt thereof, (<NUM>) one or more of the dicarboxylic acids and/or salts thereof such as adipic acid and/or salts thereof, (<NUM>) one or more of the aromatic alcohols such as phenethyl alcohol, (<NUM>) one or more of the aromatic carboxylic acids and/or salts thereof such as benzoic acid and/or sodium salts thereof, (<NUM>) one or more of the colloidal substrates such as xanthan gum, and other ingredients, mix well, add purified water quantitatively, stir and mix well, so that each ingredient is dissolved and the colloidal substrate swells into homogeneous colloid; adjust the pH value of the composition with acid and/or alkali to the range of <NUM>-<NUM>, preferably <NUM>-<NUM>, and more preferably <NUM>-<NUM>. In some embodiments, sterilization can be further carried out, wherein the sterilization technology may be selected from the following: radiation sterilization, high-temperature sterilization (for example, sterilizing at <NUM> for <NUM>-<NUM> minutes; or sterilizing at <NUM> for > <NUM> minutes), intermittent sterilization (for example, sterilizing at <NUM> for <NUM> minutes, then placing at <NUM> for <NUM>-<NUM> hours, then once again at <NUM> for <NUM> minutes, then at <NUM> for <NUM>-<NUM> hours, and finally at <NUM> for <NUM> minutes). Alternatively, in some embodiments, wherein ingredients such as benzoic acid and/or sodium salt thereof are dissolved separately into solutions, sterilized by filtration, and then added into a sterilized water-soluble gel.

In some embodiments, when a solution is prepared, all of the above ingredients except xanthan gum can be mixed well, dissolved with water, sterilized, and packaged; or dissolved, filtered, and packaged.

In some embodiments, when an emulsion-type ointment is prepared, the selection of excipient and the specific preparation process can be referred to methods known to those skilled in the art, such as the method introduced in Pharmacy (see Reference <NUM>) edited by Fang Liang.

In some embodiments, a tablet can be prepared by referring to methods known to those skilled in the art, such as the method introduced in Pharmacy (see Reference <NUM>) edited by Fang Liang, where quantified fatty acid and/or salt thereof, dicarboxylic acid and/or salt thereof, aromatic alcohol, aromatic carboxylic acid and/or salt thereof, and other ingredients are thoroughly mixed with excipients, then directly tableting. Optionally, excipients can be added, e.g., lubricants such as magnesium stearate or disintegrants such as sodium carboxymethyl starch can be added, homogeneously mixed, then tableting. In some embodiments, the prepared tablets can also be packaged into administration apparatus, disinfection devices, medical devices, or pharmaceutical devices.

In some embodiments, a film or suppository can be prepared by referring to methods known to those skilled in the art, such as the method introduced in Pharmacy (see References <NUM> and <NUM>) edited by Fang Liang.

In some embodiments, when sanitary napkins, sanitary pads, or tampons containing the bacteriostatic composition in the present disclosure are prepared, ingredients such as fatty acid and/or salt thereof, dicarboxylic acid and/or salt thereof, aromatic alcohol, aromatic carboxylic acid and/or salt thereof in the present disclosure, e.g., sodium benzoate, sodium propionate, hexanoic acid, phenethyl alcohol, adipic acid, and other ingredients, can be weighed and taken, then added with corresponding excipients, and prepared into powders, films, tablets, or capsules, which are then placed inside the sanitary napkins, sanitary pads, or tampons through an appropriate method or process. Optionally, ingredients such as fatty acid and/or salt thereof, dicarboxylic acid and/or salt thereof, aromatic alcohol, aromatic carboxylic acid and/or salt thereof in the present disclosure, such as sodium propionate, hexanoic acid, phenethyl alcohol, sodium benzoate, adipic acid, and other ingredients, and appropriate excipients, are attached to the inner-layer materials of sanitary napkins, sanitary pads, or tampons via an appropriate process.

In some embodiments, when the dosage forms such as capsules, suppositories, or tablets are prepared, each unit dosage form comprises a specific content range of the ingredients of the composition in the present disclosure. For example, each unit dosage form comprises one or more of the fatty acids and/or salts thereof, the total content of which, calculated as fatty acid, is in the range of <NUM>-<NUM>; one or more of the dicarboxylic acids and/or salts thereof, the total content of which, calculated as dicarboxylic acid and/or polybasic carboxylic acid, is in the range of <NUM>-<NUM>; one or more of the aromatic alcohols, the total content of which is in the range of <NUM>-<NUM>; and one or more of the aromatic carboxylic acids and/or salts thereof, the total content of which, calculated as aromatic carboxylic acid, is in the range of <NUM>-<NUM>. Preferably, each unit dosage form comprises one or more of the fatty acids and/or salts thereof, the total content of which, calculated as fatty acid, is in the range of <NUM>-<NUM>; one or more of the dicarboxylic acids and/or salts thereof, the total content of which, calculated as dicarboxylic acid and/or polybasic carboxylic acid, is in the range of <NUM>-<NUM>; one or more of the aromatic alcohols, the total content of which is in the range of <NUM>-<NUM>; and one or more of the aromatic carboxylic acids and/or salts thereof, the total content of which, calculated as aromatic carboxylic acid, is in the range of <NUM>-<NUM>.

Various organic acids and/or salts thereof used in the preparation method in the present disclosure, such as fatty acid and/or salt thereof, dicarboxylic acid and/or salt thereof, or aromatic carboxylic acid and/or salt thereof, are dissolved in water into non-ionized molecules and ionized ions. The ratio of the non-ionized molecules to the ionized ions depends on the pH value of the solutions and the ionization constant (pKa) of the organic acid. Evidently, both organic acids and salts thereof are organic acid molecules or organic acid radical ions after dissolution in water. From this perspective, there is no substantive difference between the two.

Multiple exemplary embodiments of the present invention and of examples having permitted to validate the invention are described in detail below. Furthermore, wherein a range of values is provided in this invention, it should be understood that the upper and lower limits of that range, and each intermediate value between them, are also specifically disclosed. Each smaller range between any stated value or intermediate value in a stated range and any other stated value or intermediate value in that stated range is included in the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which this invention belongs. In case of conflict with any incorporated literature, this Specification shall prevail. Unless otherwise stated, "%" is a percentage by weight.

Bacteriostatic agents, commonly used for the cleaning, bacteriostasis, or disinfection of skin and/or mucosa such as povidone iodine and chlorhexidine, are mostly broad-spectrum bacteriostatic agents that inhibit not only Escherichia coli, Staphylococcus aureus, and fungi, but also lactic acid bacteria such as lactobacilli. Antiseptics, commonly used in skin care products, cosmetics, bath products, as well as medical products and pharmaceutical products such as chlorobutanol and benzalkonium chloride, usually also have an inhibitory effect on lactic acid bacteria such as lactobacilli. There is a lack of highly selective bacteriostatic agents or bacteriostatic compositions that strongly inhibit harmful bacteria, but weakly inhibit beneficial bacteria such as lactobacilli.

The prior art (e.g., <CIT>, <CIT>, and <CIT>) discloses compositions formulated with the combination of low-concentration bacteriostatic agents, such as the low-concentration of phenethyl alcohol, propionic acid and/or salt thereof, and/or benzoic acid and/or salt thereof, which can inhibit Escherichia coli and Staphylococcus aureus, with an inhibition rate against Escherichia coli and Staphylococcus aureus of up to more than <NUM>% and a low inhibition rate against Candida albicans of <<NUM>% according to the test methods and judgment criteria of results in the National Standards of the People's Republic of China Hygienic Standard for Disposable Sanitary Products (GB15979-<NUM>).

Increasing the concentration of the bacteriostatic agent can enhance the bacteriostatic effect against Candida albicans. Studies have shown that an appropriate increase in the concentration of each ingredient in the bacteriostatic combination of "propionic acid and/or salt thereof + benzoic acid and/or salt thereof + phenethyl alcohol" can not only enhance the bacteriostatic effect of the combination of bacteriostatic agents, therefor more effectively inhibit Escherichia coli, Staphylococcus aureus, and the like, but also inhibit Candida albicans by an inhibition rate of more than <NUM>%. However, the higher the concentration of the bacteriostatic agent is, the stronger the inhibition against lactobacilli and other lactic acid bacteria becomes. The experimental example I disclosed in <CIT> showed that when the concentration of sodium propionate was <NUM>% (w/v) or <NUM>% (w/v), the growth of lactobacilli was not significantly inhibited; when the concentration of sodium propionate was <NUM>% (w/v), the growth of lactobacilli was inhibited. When the concentration of phenethyl alcohol was <NUM>% (w/v), the growth of lactobacilli was not significantly inhibited; when the concentration of phenethyl alcohol was <NUM>% (w/v), the growth of lactobacilli and acid production was inhibited.

The inventor has continuously carried out an in-depth study to further develop bacteriostatic compositions that effectively inhibit harmful microorganisms but not beneficial bacteria such as lactobacilli, and that can be used for the cleaning, bacteriostasis, or disinfection of skin and/or mucosa, and can be used as antiseptics for skin care products, cosmetics, and bath products, as well as medical products and pharmaceutical products. The inventor has found that the selective combination of appropriate fatty acids and/or salts thereof with dicarboxylic acids, aromatic alcohols, and aromatic carboxylic acids has a synergetic bacteriostatic effect against not only Staphylococcus aureus and Escherichia coli, but also Candida albicans, as well as significantly inhibits the growth of Pseudomonas aeruginosa and Aspergillus niger. The vaginal use of bacteriostatic composition prepared accordingly can result in a significant decrease in abnormal vaginal flora and a significant increase in lactobacilli, thus effectively modulate vaginal flora and vaginal acidity. Therefore, the bacteriostatic composition in the present disclosure can be used for the cleaning, bacteriostasis, or disinfection of skin and/or mucosa, and for antisepsis of bath products, skin care products, and cosmetics, as well as medical products, and pharmaceutical products.

In order to facilitate the accurate understanding of relevant nouns or phrases or expressions or standards mentioned herein, the meanings thereof are hereby clarified and defined as follows:
"Lactobacillus" refers to the bacteria of the genus Lactobacillus, a kind of gram-positive, rod-shaped, non-spore-forming bacteria capable of producing a large amount of lactic acid as a byproduct of glucose metabolism, comprising hundreds of species and subspecies.

"Lactic acid bacteria" is a general term of bacteria capable of metabolizing fermentable carbohydrates to produce a large amount of lactic acid, and refer to bacteria of more than <NUM> species of <NUM> genera. Lactobacillus is also a kind of lactic acid bacteria.

"Normal vaginal flora" refers to a Nugent score of <NUM>-<NUM>. The vaginal bacteria are dominated by Lactobacillus species and with a small number of other bacteria. Wherein the "other bacteria" refer to gram-positive cocci such as Staphylococcus and Streptococcus, gram-negative bacilli such as Gardnerella and Escherichia coli, gram-negative cocci such as Veillonella parvula, and obligate anaerobes such as Prevotella and Mobiluncus.

"Abnormal vaginal flora" refers to a Nugent score of <NUM>-<NUM>. The vaginal bacteria are dominated by other bacteria and with a small number of Lactobacillus species. Wherein the "other bacteria" refer to gram-positive cocci such as Staphylococcus and Streptococcus, gram-negative bacilli such as Gardnerella and Escherichia coli, gram-negative cocci such as Veillonella parvula, and obligate anaerobes such as Prevotella and Mobiluncus.

"Harmful microorganisms" generally refer to various highly pathogenic microorganisms, or various opportunistically pathogenic microorganisms that cause disease when human immunity is weakened, or microorganisms that cause the spoilage of food, pharmaceutical products, cosmetics, and hygiene products, including but not limited to the following group of microorganisms: Candida, Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Gardnerella, Prevotella, Mobiluncus, Aspergillus niger, the abnormal flora of skin and/or mucosa, as well as viruses such as HPV and HIV.

"Ingredient" refers to various ingredients in the composition, including bacteriostatic agents and other ingredients without bacteriostatic activity.

"Bacteriostatic agent" refers to various ingredients with bacteriostatic effects, or combinations thereof, not limited to conventional bacteriostatic agents or combinations thereof recognized by those skilled in the art.

"Inhibition rate" is the inhibition rate of bacteriostatic agents against Escherichia coli, Staphylococcus aureus, Candida albicans, or other microorganisms obtained by referring to the test methods and judgment criteria in Appendix C of GB <NUM>-<NUM> Hygienic Standard for Disposable Sanitary Products.

"Bacteriostatic effect" refers to the inhibition of bacteria, fungi, or other microorganisms by bacteriostatic agents. The strength of inhibition is judged herein based on the inhibition rate, specifically as follows: inhibition rate ><NUM>%, indicating "possessing bacteriostatic effect "; inhibition rate ><NUM>%, indicating "strong bacteriostatic effect".

"Low-concentration bacteriostatic agent" is a relatively low concentration bacteriostatic agent with an inhibition rate of <<NUM>% against Candida albicans.

"High-concentration bacteriostatic agent" is a relatively high concentration bacteriostatic agent with an inhibition rate of ><NUM>% against Candida albicans.

"No difference in inhibition rates" or "no influence on bacteriostatic effect" indicates that the difference between two inhibition rates is <<NUM>%.

"A difference in inhibition rates" or "influence on bacteriostatic effect" indicates that the difference between two inhibition rates is <NUM>-<NUM>%.

"A significant difference in inhibition rates" or "significant influence on bacteriostatic effect" indicates that the difference between two inhibition rates is ><NUM>%.

"Synergistic bacteriostatic effect" refers to the combination of two or more bacteriostatic agents acting against Escherichia coli, Staphylococcus aureus, or Candida albicans, which has an inhibition rate that is more than <NUM>% higher than the sum of the inhibition rates of each bacteriostatic agent acting alone.

This embodiment provides a plurality of exemplary ingredients of the bacteriostatic composition. Unless specifically stated otherwise, exemplary ingredients of the composition, described hereunder, are the following substances:
Propionic acid <NPL>, adipic acid <NPL>, phenethyl alcohol (<NUM>-phenylethanol) <NPL>, butyric acid (n-butyric acid) <NPL>, hexanoic acid (n-hexanoic acid) <NPL>, pimelic acid <NPL>, malic acid (L-hydroxysuccinic acid) <NPL>, cinnamic acid (trans-cinnamic acid) <NPL>, salicylic acid (<NUM>-hydroxybenzoic acid) <NPL>, lauric acid (dodecanoic acid) <NPL>, valeric acid (n-valeric acid) <NPL>, heptanoic acid (enanthic acid)<NPL>, caprylic acid (n-caprylic acid) <NPL>, nonanoic acid (n-nonanoic acid) <NPL>, capric acid (n-capric acid) <NPL>, undecylic acid (undecanoic acid) <NPL>, cinnamyl alcohol (<NUM>-phenyl-<NUM>-propen-<NUM>-ol) <NPL>, succinic acid (butanedioic acid) <NPL>, tartaric acid (L-tartaric acid) <NPL>, maleic acid (cis-butenedioic acid) <NPL>, citric acid <NPL>, fumaric acid (trans-butenedioic acid) <NPL>, undecylenic acid (<NUM>-undecylenic acid) <NPL>, glutaric acid <NPL>.

Add <NUM> of adipic acid, <NUM> of propionic acid, <NUM> of phenethyl alcohol, <NUM> of citric acid, and <NUM> of maltose to <NUM> of purified water and stir to dissolve them, then add <NUM> of xanthan gum, and complement purified water to render a total weight of <NUM>. Stir for the xanthan gum to swell into a homogeneous viscous gel, then adjust pH to <NUM> with <NUM> mol/L of sodium hydroxide solution, and sterilize at <NUM> for <NUM> minutes, to obtain the water-soluble gel composition in the present disclosure.

Raw materials were weighed and taken according to the following formula, to prepare <NUM> of composition by basically following the method in example <NUM>.

Raw materials were weighed and taken according to the following formula, to prepare <NUM> of the composition by basically following the method in example <NUM>.

A tablet containing <NUM> of adipic acid, <NUM> of sodium benzoate, <NUM> of propionic acid, and <NUM> of sucrose was prepared basically following the method described in Reference <NUM>.

A vaginal suppository containing <NUM> of adipic acid, <NUM> of sodium benzoate, <NUM> of propionic acid, and <NUM> of maltose was prepared basically following the method described in Reference <NUM>.

This embodiment is used to validate the efficacy of the composition. The examples were designed to study the effect of each ingredient and combination of ingredients for illustrative purposes. Only the compositions comprising the at least four ingredients as defined in independent claim <NUM>, or comprising the at least two ingredients as defined for the vaginal bacteriostatic composition of independent claim <NUM>, are to be considered compositions according to the invention.

According to the method described in Appendix C of GB <NUM>-<NUM> Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their inhibition rates of <NUM> minutes of action against Candida albicans ATCC <NUM>. The percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was <NUM>. The experimental results are shown in Table <NUM>.

In summary, it could be seen from the comparison of experimental results of Groups <NUM>-<NUM> and Group <NUM> that, when the pH value was <NUM>, <NUM>% and <NUM>% benzyl alcohol respectively affected the bacteriostatic effect of the solution containing "<NUM>% propionic acid, <NUM>% adipic acid, and <NUM>% sodium benzoate" against Candida albicans, and could enhance the bacteriostatic effect.

According to the method described in Appendix C of GB <NUM>-<NUM> Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their inhibition rates of <NUM> minutes of action against Candida albicans ATCC <NUM>, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was <NUM>. The experimental results are shown in Table <NUM>.

In summary, it could be seen from the comparison of experimental results of Groups <NUM>-<NUM> and Group <NUM> that, when the pH value was <NUM>, propionic acid affected or significantly affected the bacteriostatic effect of the solution containing "<NUM>% adipic acid, <NUM>% benzyl alcohol, and <NUM>% sodium benzoate" against Candida albicans, and enhanced the bacteriostatic effect. The higher the concentration of propionic acid was, the stronger the bacteriostatic effect against Candida albicans became.

In summary, when the pH value was <NUM>, <NUM>% and <NUM>% benzoic acid significantly affected the bacteriostatic effect of the solution containing "<NUM>% propionic acid, <NUM>% adipic acid, and <NUM>% phenethyl alcohol" against Candida albicans, and enhanced the bacteriostatic effect. The higher the concentration of benzoic acid was, the stronger the bacteriostatic effect against Candida albicans became.

In summary, it could be seen from the comparison of experimental results of Group <NUM> and Group <NUM> that, when the pH value was <NUM>, <NUM>% propionic acid affected the bacteriostatic effect of the solution containing "<NUM>% adipic acid, <NUM>% phenethyl alcohol, and <NUM>% sodium benzoate" against Candida albicans, and enhanced the bacteriostatic effect.

In summary, it could be seen from the comparison of experimental results of Groups <NUM> and <NUM>, and Groups <NUM> and <NUM> that, when the pH value was <NUM>, <NUM>% pimelic acid significantly affected the bacteriostatic effect of the solution containing "<NUM>% p-hydroxybenzoic acid, <NUM>% phenethyl alcohol, and <NUM>% propionic acid" against Candida albicans, and enhanced the bacteriostatic effect, while <NUM>% malic acid did not affect the bacteriostatic effect of the solution containing "<NUM>% p-hydroxybenzoic acid, <NUM>% phenethyl alcohol, and <NUM>% propionic acid" against Candida albicans.

According to the method described in Appendix C of GB <NUM>-<NUM> Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their bacteriostatic effects of <NUM> minutes of action against Candida albicans ATCC <NUM>, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was <NUM>. The experimental results are shown in Table <NUM>.

In summary, it could be seen that when the pH value was <NUM>, the inhibition rate of the combination of <NUM>% adipic acid, <NUM>% butyric acid, <NUM>% sodium benzoate, and <NUM>% phenethyl alcohol against Candida albicans was much higher than that of each of the ingredients or the combination of any two or three of these ingredients, indicating the combination of these four ingredients had a synergistic bacteriostatic effect against Candida albicans.

In summary, it could be seen that the inhibition rate of the combination of <NUM>% adipic acid, <NUM>% sodium benzoate, <NUM>% hexanoic acid, and <NUM>% phenethyl alcohol, against Candida albicans was significantly higher than that of the combination of any three of these four ingredients, and also significantly higher than the sum of the inhibition rate of each ingredient, indicating that the combination of these four ingredients had a synergistic bacteriostatic effect against Candida albicans.

In summary, it could be seen that <NUM>-<NUM>% cinnamic acid and <NUM>-<NUM>% salicylic acid affected or significantly affected the bacteriostatic effect of the solution containing "<NUM>% adipic acid, <NUM>% phenethyl alcohol, and <NUM>% propionic acid", against Candida albicans. The higher the concentration of cinnamic acid or salicylic acid was, the further enhanced the bacteriostatic effect became.

In summary, it could be seen that <NUM>-<NUM>% undecylic acid, <NUM>% undecylenic acid, and <NUM>-<NUM>% lauric acid significantly affected the bacteriostatic effect of the solution containing "<NUM>% sodium benzoate, <NUM>% phenethyl alcohol, and <NUM>% adipic acid" against Candida albicans respectively, and enhanced the bacteriostatic effect.

According to the method described in Appendix C of GB <NUM>-<NUM> Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their bacteriostatic effects of <NUM> minutes of action against Candida albicans ATCC <NUM>, and the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w). The experimental results are shown in Tables <NUM>-<NUM>.

In summary, it could be seen that the solution containing <NUM>% butyric acid, <NUM>% pimelic acid, and <NUM>% phenethyl alcohol had a synergistic bacteriostatic effect against Candida albicans, and enhanced the bacteriostatic effect.

According to the method described in Appendix C of GB <NUM>-<NUM> Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing sodium propionate and dicarboxylic acid or tricarboxylic acid were studied for their bacteriostatic effects of <NUM> minutes of action against Candida albicans ATCC <NUM>, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was <NUM>. The experimental results are shown in Table <NUM>.

In summary, it could be seen that the combination of adipic acid and sodium propionate had a synergistic bacteriostatic effect against Candida albicans.

According to the method described in Appendix C of GB <NUM>-<NUM> Hygienic Standard for Disposable Sanitary Products, the combination of citric acid, malic acid, or succinic acid respectively with a basic bacteriostatic solution containing "<NUM>% (w/w) adipic acid + <NUM>% (w/w) sodium benzoate + <NUM>% (w/w) propionic acid + <NUM>% (w/w) phenethyl alcohol" was studied for the bacteriostatic effect of <NUM> minutes of action against Candida albicans ATCC <NUM>, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of the basic bacteriostatic solution was <NUM>. The experimental results are shown in Table <NUM>.

In summary, it could be seen that citric acid, malic acid, or succinic acid did not affect the bacteriostatic effect of the basic bacteriostatic solution containing "<NUM>% (w/w) adipic acid + <NUM>% (w/w) sodium benzoate + <NUM>% (w/w) propionic acid + <NUM>% (w/w) phenethyl alcohol" against Candida albicans.

In summary, it could be seen that, when the pH value was <NUM>, the combinations of each one of the seven fatty acids of different concentrations (<NUM>% butyric acid, <NUM>% valeric acid, <NUM>% hexanoic acid, <NUM>% heptanoic acid, <NUM>% caprylic acid, <NUM>% nonanoic acid, <NUM>% capric acid) respectively and <NUM>% adipic acid or <NUM>% pimelic acid respectively had a synergistic bacteriostatic effect against Candida albicans, and enhanced the bacteriostatic effect.

According to the method described in Appendix C of GB <NUM>-<NUM> Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their inhibition rates of <NUM> minutes of action against Escherichia coli ATCC <NUM>, Staphylococcus aureus ATCC <NUM>, and Candida albicans ATCC <NUM>, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was <NUM>. The experimental results are shown in Table <NUM>.

It was evident in the results in Table <NUM> that, when the pH value was <NUM>, each one of the nine fatty acids of different concentrations (<NUM>% butyric acid, <NUM>% hexanoic acid, <NUM>% heptanoic acid, <NUM>% caprylic acid, <NUM>% nonanoic acid, <NUM>% capric acid, <NUM>% undecylic acid, <NUM>% undecylenic acid, <NUM>% lauric acid) respectively and <NUM>% pimelic acid had a bacteriostatic effect or a strong bacteriostatic effect against Candida albicans, and the inhibition rates were <NUM>%-<NUM>% or ><NUM>%, and had a strong bacteriostatic effect against Escherichia coli and Staphylococcus aureus, and the inhibition rates were <NUM>%.

In summary, it could be seen that each one of the cinnamyl alcohol of <NUM>, <NUM>%, or <NUM>% significantly affected the bacteriostatic effect of the solution containing "<NUM>% pimelic acid, <NUM>% sodium benzoate, and <NUM>% propionic acid" against Candida albicans respectively, and enhanced the bacteriostatic effect.

In summary, it could be seen that, when the pH value was <NUM>, the solution containing <NUM>% pimelic acid, <NUM>% sodium benzoate, and <NUM>% propionic acid had a synergistic bacteriostatic effect against Candida albicans, and enhanced the bacteriostatic effect.

According to the method described in Appendix C of GB <NUM>-<NUM> Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their inhibition rates of <NUM> minutes of action against Escherichia coli ATCC <NUM> and Staphylococcus aureus ATCC <NUM>, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was <NUM>. The experimental results are shown in Table <NUM>.

According to the method described in Appendix C of GB <NUM>-<NUM> Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their bacteriostatic effects of <NUM> minutes of action against Candida albicans ATCC <NUM>, and the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w). The experimental results are shown in Table <NUM>.

It was evident in the results of Groups <NUM>-<NUM> in Table <NUM> that, when the pH value was <NUM> and <NUM> respectively, the solution containing "<NUM>% citric acid, <NUM>% adipic acid, <NUM>% propionic acid, <NUM>% butyric acid, <NUM>% sodium benzoate, and <NUM>% phenethyl alcohol" had a bacteriostatic effect against Candida albicans, and the inhibition rates were <NUM>% and <NUM>% respectively. When the pH value was <NUM>, the solution containing these ingredients had an inhibition rate of <NUM>% against Candida albicans.

In summary, it could be seen that the lower the pH value of the solution containing "<NUM>% citric acid, <NUM>% adipic acid, <NUM>. <NUM>% propionic acid, <NUM>% butyric acid, <NUM>% sodium benzoate, and <NUM>% phenethyl alcohol" was, the stronger the bacteriostatic effect of the solution against Candida albicans became.

In summary, it could be seen that when the pH value of the solution was <NUM>, the <NUM>% and <NUM>% puerarin contained in the solution respectively did not affect the inhibitory effect of the solution against Candida albicans, and did not weaken the bacteriostatic effect.

Understandably, other estrogens such as diethylstilbestrol, hexoestrol, estradiol, estrone, estriol, nilestriol, ethinyloestradiol, quinestrol, mestranol, and promestriene, and other phytoestrogens such as daidzin, daidzein, glycitein, puerarin, coumestrol, genistein, equol, apigenin, genistin, genisteol, biochanin, coumestrol, formononetin, resveratrol, secoisolariciresinol, and lignan are similar to puerarin in property and action principle. Therefore, it can be inferred that said estrogens and phytoestrogens will not significantly weaken the inhibitory effect of the compositions against Candida albicans.

According to the method described in Appendix C of GB <NUM>-<NUM> Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their bacteriostatic effects of <NUM> minutes of action against Candida albicans ATCC <NUM>, the percentage concentration of each ingredient therein was the weight percentage concentration %.

(w/w), and the pH value of each group was <NUM>. The experimental results are shown in Table <NUM>.

It was evident in the comparison of experimental results of Group <NUM> to Group <NUM> in Table <NUM> that, when the pH value was <NUM>, <NUM>% glutamic acid did not affect the bacteriostatic effect of the solution containing "<NUM>% malic acid, <NUM>% adipic acid, <NUM>% sodium benzoate, <NUM>% propionic acid, and <NUM>% phenethyl alcohol" against Candida albicans.

Understandably, other appropriate amino acids such as glutamine, L-aspartic acid, asparagine, leucine, isoleucine, phenylalanine, valine, proline, and threonine are similar to glutamic acid in property and action principle. Therefore, it can be inferred that said amino acids will not affect the inhibitory effect of the compositions against Candida albicans.

According to the method described in Appendix C of GB <NUM>-<NUM> Hygienic Standard for Disposable Sanitary Products, aqueous solutions containing different ingredients were studied for their bacteriostatic effects of <NUM> minutes of action against Escherichia coli ATCC <NUM> and Staphylococcus aureus ATCC <NUM>, the percentage concentration of each ingredient therein was the weight percentage concentration % (w/w), and the pH value of each group was <NUM>. The experimental results are shown in Table <NUM>.

Basically by referring to the methods and results determination criteria in Volume IV <NUM> Bacteriostatic Effectiveness Testing of the Pharmacopoeia of the People's Republic of China <NUM>, the bacteriostatic composition was studied for their bacteriostatic effects against Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, and Aspergillus niger. The experimental results are shown in Table <NUM>.

It was evident in the results in Table <NUM> that, when the pH value was <NUM>, the reduced logarithm of the bacterial concentration was <NUM> on day <NUM> relative to day <NUM>, and did not increase on day <NUM> relative to day <NUM> for all test bacteria, which met the requirements. It could be seen that the composition with a pH value of <NUM> in the test had an antiseptic effect.

It should be noted that even if the experimental conditions and methods are identical, the results of the in vitro bacteriostatic experiments, such as inhibition rate, may still differ due to the existence of experimental errors when the experiments are repeated, but such differences are reasonable and are understandable to those skilled in the art. Therefore, if there is any inconsistency between the in vitro experimental data in this disclosure and the data in the previous application documents, the data in this disclosure shall prevail.

Three groups of gels containing different ingredients respectively were vaginally administered to Cynomolgus Monkeys, <NUM> once a day, for five consecutive days. Vaginal swabs were collected for the test of pH value and for smear staining and microscopic examination to observe the effects of the gels on the pH value of vaginal secretions and on the vaginal flora of Cynomolgus Monkeys. The experimental results are shown in Table <NUM>:.

In summary, it could be seen that all the three groups of gels, which had a pH value of <NUM>, had the efficacies of inhibiting abnormal vaginal flora, restoring vaginal acidity, and restoring vaginal lactobacilli. Between the gels of Groups B and C, which both contained adipic acid, and contained either citric acid or succinic acid respectively, Group B had better efficacy than Group C and Group <NUM>, the latter did not contain adipic acid. The gel of Group <NUM> containing no adipic acid had the weakest efficacy in inhibiting abnormal vaginal flora, in restoring vaginal acidity, and in restoring vaginal lactobacilli among the three groups of gels.

Three groups of gels containing different ingredients respectively were vaginally administered to Rhesus Monkeys, <NUM> once a day, for five consecutive days. Vaginal secretions were collected for the test of pH value and for smear staining and microscopic examination, to observe the effects of the gels on the pH values of vaginal secretions and on the vaginal flora of Rhesus Monkeys. The experimental results are shown in Table <NUM>:.

In summary, it could be seen that the three groups of gels containing <NUM>% (w/w) butyric acid, <NUM>% (w/w) capric acid, or <NUM>% (w/w) capric acid respectively in the experiment had the effect of inhibiting abnormal vaginal flora, modulating vaginal flora, restoring vaginal lactobacilli, and restoring vaginal acidity to normal.

Five groups of gels containing different ingredients respectively were vaginally administered to Cynomolgus Monkeys, <NUM> once a day, for five consecutive days. Vaginal swabs were collected for the test of pH value and for smear staining and microscopic examination to observe the effects of the gels on the pH values of vaginal secretions and on the vaginal flora of Cynomolgus Monkeys. The experimental results are shown in Table <NUM>:.

Three groups of gels that contained different ingredients were vaginally administered to Cynomolgus Monkeys, <NUM> once a day, for five consecutive days. Vaginal swabs were collected for the test of pH value, and for smear staining and microscopic examination to observe the effects of the gels on the pH values of vaginal secretions and on the vaginal flora of Cynomolgus Monkeys. The experimental results are shown in Table <NUM>:.

In summary, it could be seen that the three groups of gels, which had a pH value of <NUM> and contained "<NUM>% (w/w) isomaltulose, <NUM>% (w/w) sodium benzoate, <NUM>% (w/w) propionic acid, <NUM>% (w/w) adipic acid, <NUM>% (w/w) phenethyl alcohol, <NUM>% (w/w) malic acid, and <NUM>% (w/w) xanthan gum ", as well as <NUM>% (w/w) heptanoic acid, <NUM>% (w/w) hexanoic acid, or <NUM>% (w/w) valeric acid respectively had the efficacy of inhibiting abnormal vaginal flora and restoring vaginal lactobacilli. The two groups of gels containing <NUM>% (w/w) heptanoic acid or <NUM>% (w/w) hexanoic acid respectively also had the efficacy of restoring vaginal acidity.

Six groups of gels containing different ingredients were vaginally administered to Cynomolgus Monkeys, <NUM> once a day, for five consecutive days. The vaginal swabs were collected for the test of pH values and for smear staining and microscopic examination to observe the effects of the gels on the pH values of vaginal secretions and on the vaginal flora of Cynomolgus Monkeys. The experimental results are shown in Table <NUM>:.

In summary, it could be seen that these <NUM> gel compositions had the effect of inhibiting abnormal vaginal flora, restoring vaginal acidity, and restoring vaginal lactobacilli.

The gels containing adipic acid or fumaric acid were vaginally administered to Cynomolgus Monkeys, <NUM> once a day, for five consecutive days, and vaginal swabs were collected for the test of pH value and for smear staining and microscopic examination to observe the effects of the gels on the pH values of vaginal secretions and on the vaginal flora of Cynomolgus Monkeys. The experimental results are shown in Table <NUM>:.

In summary, it could be seen that the gel containing <NUM>% (w/w) adipic acid had the effect of inhibiting abnormal vaginal flora, restoring vaginal lactobacilli, and restoring vaginal acidity.

The gel A was vaginally administered in <NUM> patients with bacterial vaginosis (BV) and <NUM> healthy volunteers, <NUM> once a day, for <NUM> consecutive days, and vaginal swabs were collected on the third day of administration (V1) and <NUM> days after drug discontinuance (V2) for the test of pH value and for smear staining and microscopic examination to observe the effects of the gel on the pH values of vaginal secretions and on the vaginal flora. The experimental results are shown in Table <NUM>:.

After five administrations and an interval of <NUM> days after drug discontinuance, the results showed that the administrations did not affect the pH value of vaginal secretions or the vaginal flora in healthy volunteers.

Claim 1:
A bacteriostatic composition, characterized in that it comprises:
(<NUM>) one or more of the fatty acids and/or salts thereof selected from the group consisting of acetic acid, propionic acid, butyric acid, isobutyric acid, valeric acid, hexanoic acid, heptanoic acid, caprylic acid, nonanoic acid, capric acid, undecylic acid, undecylenic acid, lauric acid, and salts thereof; the total content of the ingredients (<NUM>) as described, calculated as fatty acid, is in the range of <NUM>-<NUM>% (w/w);
(<NUM>) one or more of the dicarboxylic acids and/or salts thereof selected from the group consisting of glutaric acid, adipic acid, pimelic acid, and salts thereof; the total content of the ingredients (<NUM>) as described, calculated as dicarboxylic acid, is in the range of <NUM>-<NUM>% (w/w);
(<NUM>) one or more of the aromatic alcohols selected from the group consisting of benzyl alcohol, phenethyl alcohol, phenoxyethanol, and cinnamyl alcohol; the total content of the ingredients (<NUM>) as described is in the range of <NUM>-<NUM>% (w/w);
(<NUM>) one or more of the aromatic carboxylic acids and/or salts thereof selected from the group consisting of benzoic acid, p-hydroxybenzoic acid, p-methoxybenzoic acid, salicylic acid, cinnamic acid, gentianic acid, caffeic acid, and salts thereof; the total content of the ingredients (<NUM>) as described, calculated as aromatic carboxylic acid, is in the range of <NUM>-<NUM>% (w/w);
the bacteriostatic composition is in a dosage form selected from the group consisting of aqueous solutions, water-soluble gels, foams, sprays, ointments, powders, films, capsules, suppositories, and tablets.