Composition comprising benzoic acid in combination with organic acid preservatives as active ingredients and the use thereof
View Patent ↗The present invention relates to the use of low content of benzoic acid and/or sodium salt thereof in combination with one or more organic acid preservatives as active ingredients in the manufacture of a vaginal composition, wherein the composition has weak inhibition effect on normal vaginal lactobacilli while has strong inhibition effect on vaginal fungi and/or pathogenic vaginal lactobacilli, the organic acid preservatives are selected from the group consisting of dehydroacetic acid and/or sodium salt thereof, propionic acid and/or a salt thereof, sorbic acid and/or a salt thereof. The composition of the present invention is particularly useful in inhibiting vaginal fungi, and/or inhibiting pathogenic vaginal lactobacilli, and/or promoting normal vaginal lactobacilli, and/or maintaining normal vaginal acidity, and/or modulating vaginal microecosystem, and/or modulating vaginal microbials, and/or selectively decontaminating vagina.
1. A vaginal composition for inhibiting vaginal fungi, comprising the following:
(1) benzoic acid and/or sodium salt thereof, the total concentration of which, calculated based on sodium benzoate, is 0.025-0.2% (w/v);
(2) dehydroacetic acid and/or sodium salt thereof, wherein the total concentration of the dehydroacetic acid and/or sodium salt thereof, calculated based on sodium dehydroacetate, is 0.005-0.025% (w/v);
(3) an ointment matrix or water;
(4) the pH value of the composition is from 3.5 to 6.5;
wherein the composition is packaged in the form of one of a sterilized and sealed single dose package, a vagina use device, or a disposable vagina use device.
2. The composition according to claim 1 , further comprising 0.001˜0.5 mg metronidazole or tinidazole per unit dosage form.
3. The composition according to claim 1 , further comprising one or more estrogens, selected from the group consisting of stilbestrol, estradiol and/or estriol, at a total amount of 0.01˜3 mg per unit-dosage form.
4. A method for inhibiting vaginal fungi, comprising intravaginal administration of an effective amount of the composition of claim 1 to a female in need thereof.
5. The composition according to claim 1 , the composition further comprising 0.01˜0.25 mg metronidazole or tinidazole per unit dosage form.
6. The composition according to claim 1 , wherein the composition further comprises estriol.
7. The vaginal composition according to claim 1 , wherein the total concentration of benzoic acid and/or sodium salt thereof is 0.05˜0.125% (w/v) calculated based on sodium benzoate.
8. The vaginal composition according to claim 1 , wherein the ointment matrix is non-flowable, viscous, water-soluble gel matrix.
9. The vaginal composition according to claim 1 , wherein the ointment matrix comprises Xanthan gum.
10. The vaginal composition according to claim 1 , wherein the pH value of the composition is from 3.5 to 6.5.
11. The vaginal composition according to claim 1 , wherein the composition is in the form of a sterilized and sealed single dose package.
12. The vaginal composition according to claim 1 , wherein the pH value of the composition is from 4.0 to 5.5.
13. The vaginal composition according to claim 1 , further comprising propionic acid and/or a salt thereof, and the total concentration of propionic acid and/or a salt thereof, calculated based on sodium propionate is 0.05˜1.0% (w/v).
14. The vaginal composition according to claim 13 , wherein the total concentration of propionic acid and/or a salt thereof is 0.1˜0.5% (w/v) calculated based on sodium propionate.