Composition and Method for Modulating and Maintaining Vaginal Bacterial Flora and Vaginal Acidity

Abstract

The present invention relates to the use of benzoic acid and/or its sodium salt in combination with saccharide(s) as active components in the manufacture of a vaginal composition for modulating vaginal flora and vaginal acidity, thereby maintaining the pH value of vaginal secretion within a range from 3.5 to 4.5; and the present invention further relates to a vaginal composition and a method for modulating and maintaining normal vaginal flora and vaginal acidity.

1 - 15 . (canceled) 
     
     
         16 . A method for modulating vaginal flora and vaginal acidity thereby always maintaining the pH value of vaginal secretion within a range from 3.5 to 4.5, wherein the said method comprises administrating an effective amount of a vaginal composition comprising benzoic acid and/or its sodium salt in combination with saccharide(s) as active components. 
     
     
         17 . The method according to  claim 16 , it is for promoting the Gram-positive bacilli to multiply and produce acids in vagina when the Gram-positive bacilli in vagina are rare and the vaginal acidity is over-weak, and for inhibiting the production of acids in vagina when the Gram-positive bacilli in vagina are abundant and the vaginal acidity is over-strong. 
     
     
         18 . The method according to  claim 16 , it is for cleaning-nursing vagina, eliminating or alleviating unpleasant odor of vaginal secretion, and eliminating or alleviating discomforts such as pruritus vulvae, vulvodynia, algopareunia, etc. 
     
     
         19 . The method according to  claim 16 , it is for treating Lactobacillosis, Cytolytic vaginosis, Candidal vaginitis, Bacterial vaginosis, or vaginal dysbacteriosis. 
     
     
         20 . The method according to  claim 16 , wherein the vaginal composition includes, but is not limited to the following vaginal dosage forms: water-soluble gels, solutions, aerosols, creams, ointments, capsules, microcapsules, suppositories, or tablets, preferably water-soluble gels, capsules or tablets. 
     
     
         21 . The method according to  claim 16 , wherein the saccharide(s) is glucose, fructose, mannose, or oligosaccharides or polysaccharides that can be hydrolyzed in vivo or in vitro to produce glucose, fructose and/or mannose, or any mixture of these saccharides, wherein the said oligosaccharides or polysaccharides include but are not limited to the following: sucrose, maltose, lactose, lactulose, trehalose, cellobiose, melibiose, raffinose, malto-oligosaccharide, isomalto-oligosaccharide, fructo-oligosaccharide, dextrin, starch and glycogen; preferably the said saccharide is glucose, fructose, mannose, sucrose, maltose, trehalose, cellobiose, melibiose, malto-oligosaccharide, fructo-oligosaccharide, dextrin, starch or a mixture thereof; more preferably the said saccharide is glucose, fructose, sucrose, maltose or a mixture thereof. 
     
     
         22 . The method according to  claim 16 , wherein the said composition further optionally comprises one or more antibacterial agents and/or bactericides, antibacterial drugs or antibiotics, which are effective to bacteria and/or fungi, include but are not limited to the following: sorbic acid and salts thereof, vitamin B 1 , vitamin K 3 , vitamin K 4 , propionic acid and salts thereof, acetic acid, dehydroacetic acid, phydroxybenzoates, hydrogen peroxide, fluconazol, itraconazole, butoconazole, miconazole, clotrimazole, nystatin, metronidazole, lincomycin, amoxicillin and/or various defensins and antibacterial peptides, wherein the said antibacterial drugs are preferably metronidazole, fluconazole, clotrimazole. 
     
     
         23 . The method according to  claim 16 , wherein the said composition further optionally comprises an estrogen, which includes but is not limited to stilbestrol, estradiol and/or estriol. 
     
     
         24 . The method according to  claim 16 , wherein the said composition further optionally comprises live lactobacilli and/or other live lactic-acid-producing bacteria. 
     
     
         25 . A vaginal composition, wherein:
 (1) comprising benzoic acid and/or its sodium salt, and saccharide(s) as active ingredients;   (2) comprising one or more inactive excipient(s) suitable for human vagina;   wherein the said saccharide is glucose, fructose, mannose, or oligosaccharides or polysaccharides that can be hydrolyzed in vivo or in vitro to produce glucose, fructose and/or mannose, or any mixture of these saccharides, wherein the said oligosaccharides or polysaccharides include but are not limited to the following: sucrose, maltose, lactose, lactulose, trehalose, cellobiose, melibiose, raffinose, malto-oligosaccharide, isomalto-oligosaccharide, fructo-oligosaccharide, dextrin, starch and glycogen; preferably the said saccharide is glucose, fructose, mannose, sucrose, maltose, trehalose, cellobiose, melibiose, malto-oligosaccharide, fructo-oligosaccharide, dextrin, starch or a mixture thereof; more preferably the said saccharide is glucose, fructose, sucrose, maltose or a mixture thereof.   The said vaginal composition is a cleaning-nursing product, a deodorizing agent, a cosmetic, a disinfectant composition or a pharmaceutical composition, which includes but is not limited to the following vaginal dosage forms: water-soluble gels, solutions, aerosols, creams, ointments, capsules, microcapsules, suppositories or tablets, preferably water-soluble gels, capsules or tablets   
     
     
         26 . The composition according to  claim 25 , wherein the said composition is a non-flowable, viscous, water-soluble gel, wherein:
 (1) wherein the total amount of benzoic acid and/or its sodium salt, calculated based on sodium benzoate, is 0.01-5.0% (w/v), preferably 0.1-1.0% (w/v), more preferably 0.2-0.5% (w/v);   (2) wherein the total amount of the said saccharide(s) in the water-soluble gel composition is 0.1-20% (w/v), preferably 0.5-12%(w/v);   (3) wherein the said inactive excipient is a non-flowable, viscous, water-soluble gel matrix, wherein the said gel matrix is preferably Xanthan gum, polycarbophil;   (4) the said composition does not comprise live bacteria, fungi or other microorganisms; the said gel is preferably a single dose packaged in a sterilizing and sealing manner.   
     
     
         27 . The composition according to  claim 25 , wherein the said composition further optionally comprises one or more antibacterial agents and/or bactericides, antibacterial drugs or antibiotics, which are effective to bacteria and/or fungi, include but are not limited to the following: sorbic acid and salts thereof, vitamin B 1 , vitamin K 3 , vitamin K 4 , propionic acid and salts thereof, acetic acid, dehydroacetic acid, phydroxybenzoates, hydrogen peroxide, fluconazol, itraconazole, butoconazole, miconazole, clotrimazole, nystatin, metronidazole, lincomycin, amoxicillin and/or various defensins and antibacterial peptides, wherein the said antibacterial drugs are preferably metronidazole, fluconazole, clotrimazole. 
     
     
         28 . The composition according to  claim 25 , wherein the said composition further optionally comprises an estrogen, which includes but is not limited to stilbestrol, estradiol and/or estriol. 
     
     
         29 . The composition according to  claim 25 , wherein the said composition further optionally comprises live lactobacilli and/or other live lactic-acid-producing bacteria.