阅读说明：本技术 抑制阴道炎病原菌的组合物、阴道清洁组合物以及其用途 (Composition for inhibiting pathogenic bacteria of vaginitis, vagina cleaning composition and application thereof ) 是由 谢佩珊 郭仲伟 蔡宜钧 何协勋 郭易纬 黄玉芬 于 2019-10-29 设计创作，主要内容包括：本发明提供了一种抑制阴道炎病原菌的组合物、阴道清洁组合物以及其用途。具体地,本发明提供一种用以抑制阴道炎病原菌的组合物,其包含乳酸菌发酵物,其是于包含牛奶、奶粉及酪蛋白至少其中之一的培养基中以唾液乳酸杆菌AP-32菌株、鼠李糖乳酸杆菌F-1菌株、鼠李糖乳酸杆菌GL-165菌株、动物双歧杆菌乳亚种CP-9菌株、两歧双歧杆菌Bf-688菌株、短双歧杆菌Bv-889菌株或以上乳酸菌菌株的组合与嗜热链球菌共同进行发酵而得。上述乳酸菌菌株发酵物可抑制阴道炎病原菌生长,并以食品组合物、医药及阴道清洁组合物的形式存在。(The invention provides a composition for inhibiting pathogenic bacteria of vaginitis, a vagina cleaning composition and application thereof. Specifically, the invention provides a composition for inhibiting pathogenic bacteria of vaginitis, which comprises a lactobacillus leavening, and is obtained by fermenting streptococcus thermophilus and lactobacillus salivarius AP-32 strain, lactobacillus rhamnosus F-1 strain, lactobacillus rhamnosus GL-165 strain, bifidobacterium animalis subsp lactis CP-9 strain, bifidobacterium bifidum Bf-688 strain, bifidobacterium breve Bv-889 strain or a combination of the lactobacillus strains in a culture medium containing at least one of milk, milk powder and casein. The fermented product of the above lactobacillus strain can inhibit growth of pathogenic bacteria of vaginitis, and is available in the form of food composition, medicine and vaginal cleaning composition.)

1. A composition for inhibiting pathogenic bacteria of vaginitis comprising:

the lactobacillus leavening is obtained by fermenting separated lactobacillus strains and streptococcus thermophilus together by a culture medium containing at least one of milk, milk powder and casein, wherein the lactobacillus strains comprise a lactobacillus strain with a preservation number of CCTCC NO: m2011127 Lactobacillus salivarius subsp.salicinus AP-32 strain, with the preservation number of CCTCC NO: m2011124 Lactobacillus rhamnosus F-1 strain with a preservation number of CCTCC NO: lactobacillus rhamnosus GL-165 strain of M2014591, with preservation number CCTCC NO: m2014588 Bifidobacterium animalis subsp.lactis CP-9 strain, Bifidobacterium bifidum (Bifidobacterium bifidum) Bf-688 strain with the preservation number of CGMCC No.17953, Bifidobacterium breve (Bifidobacterium breve) Bv-889 strain with the preservation number of CGMCC No.16145 or the combination of the above lactobacillus strains, wherein the lactobacillus strains are respectively preserved in China center for type culture collection and China Committee for culture Collection of microorganisms (CCCCCCCCCES) center for general microorganisms; and

an excipient, diluent or carrier.

2. The composition for inhibiting vaginitis recited in claim 1 wherein said fermented product of lactic acid bacteria is a fermented supernatant or whey broth containing inactivated bacterial strains or bacteria or a dried powder thereof.

3. The composition for inhibiting vaginitis recited in claim 1 wherein said lactic acid bacteria fermentation product is contained in an amount of 0.4 to 10%.

4. The composition for inhibiting the onset of vaginitis recited in claim 1 wherein said excipient, diluent or carrier is a food product.

5. The composition for inhibiting pathogenic bacteria of vaginitis claimed in claim 3 wherein said food product comprises fermented milk, yogurt, cheese, powdered milk based drinks and beverages, tea, coffee, functional drinks or combinations thereof.

6. The composition for inhibiting pathogenic bacteria of vaginitis recited in claim 1 wherein said excipient, diluent or carrier is a pharmaceutically acceptable excipient, diluent or carrier.

7. The composition for suppressing vaginitis causing bacteria of claim 6 in the form of an oral preparation or a topical preparation, wherein said oral preparation comprises a lozenge, a capsule, a solution or a powder, and said topical preparation comprises a powder, a cream, a spray, a gel, a solution, a powder or a cream.

8. The composition for inhibiting pathogenic bacteria of vaginitis recited in claim 6 further comprising an anti-inflammatory agent or a preservative.

9. The composition for inhibiting pathogenic bacteria of vaginitis claimed in claim 8 wherein said anti-inflammatory agent or preservative comprises the first combination, the second combination, the third combination, menthol oil, tea tree essential oil, aloe vera extract, Plectranthus amboinicus extract, nano silver or combination thereof and is contained in an amount of 0.1-8%.

10. The composition for inhibiting the pathogenic bacteria of vaginitis recited in claim 6 further comprising a gelling agent.

11. The composition for inhibiting pathogenic bacteria of vaginitis recited in claim 10 wherein said gelling agent comprises natural dextran gum, Carbomer (Carbomer) or a combination thereof and is present in an amount of 0.2 to 5%.

12. The composition for inhibiting pathogenic bacteria of vaginitis claimed in claim 6, further comprising an effective ingredient.

13. The composition for inhibiting vaginitis recited in claim 12 wherein said effective ingredient contains sodium hyaluronate (sodium hyaluronate), anti-sensitivity complex (sea hypoturonate), allantoin (lantoin) or combination thereof and the content of said effective ingredient is 0.005-5%, and wherein said anti-sensitivity complex contains deep sea water and Cucurbita pepo seed extract.

14. The composition for inhibiting pathogenic bacteria of vaginitis recited in claim 1 wherein said excipient, diluent or carrier is comprised of sodium hydroxide, triethanolamine, glycerol or combination thereof in an amount of 0.05 to 10% with the balance being made up to 100% with purified water.

15. A vaginal cleaning composition comprising:

the lactobacillus leavening is obtained by fermenting a culture medium containing at least one of milk, milk powder and casein together with separated lactobacillus strains and streptococcus thermophilus, wherein the lactobacillus strains comprise a lactobacillus strain with a preservation number of CCTCC NO: m2011127 Lactobacillus salivarius subsp.salicinus AP-32 strain, with the preservation number of CCTCC NO: m2011124 Lactobacillus rhamnosus F-1 strain with a preservation number of CCTCC NO: lactobacillus rhamnosus GL-165 strain of M2014591, with preservation number CCTCC NO: m2014588 Bifidobacterium animalis subsp.lactis CP-9 strain, Bifidobacterium bifidum (Bifidobacterium bifidum) Bf-688 strain with the preservation number of CGMCC No.17953, Bifidobacterium breve (Bifidobacterium breve) BV-889 strain with the preservation number of CGMCC No.16145 or the combination of the above lactic acid bacteria strains, wherein the lactic acid bacteria strains are respectively preserved in the China center for type culture collection and the China Committee for culture Collection and general microbiological culture center; and

a physiologically acceptable excipient, diluent or carrier.

16. The vaginal cleaning composition of claim 15, wherein the lactic acid bacteria fermented product is a fermentation supernatant, a whey fermentation broth, or a dried powder thereof, comprising a deactivated strain or a removed cell.

17. The vaginal cleaning composition as claimed in claim 15, wherein the excipient, diluent or carrier is a lozenge, capsule, powder, cream, spray, gel, solution, powder, cream or lotion.

18. The vaginal cleaning composition of claim 15, wherein said lactic acid bacteria fermentation is present in an amount of 0.4-10%.

19. Use of a composition comprising a lactic acid bacteria ferment as a medicament for inhibiting a pathogenic bacteria of vaginitis, wherein the composition comprising a lactic acid bacteria ferment comprises:

the lactobacillus leavening is obtained by fermenting a culture medium containing at least one of milk, milk powder and casein together with separated lactobacillus strains and streptococcus thermophilus, wherein the lactobacillus strains comprise a lactobacillus strain with a preservation number of CCTCC NO: m2011127 Lactobacillus salivarius subsp.salicinus AP-32 strain, with the preservation number of CCTCC NO: m2011124 Lactobacillus rhamnosus F-1 strain with a preservation number of CCTCC NO: lactobacillus rhamnosus GL-165 strain of M2014591, with preservation number CCTCC NO: m2014588 Bifidobacterium animalis subsp.lactis CP-9 strain, Bifidobacterium bifidum (Bifidobacterium bifidum) Bf-688 strain with the preservation number of CGMCC No.17953, Bifidobacterium breve (Bifidobacterium breve) BV-889 strain with the preservation number of CGMCC No.16145 or the combination of the above lactic acid bacteria strains, wherein the lactic acid bacteria strains are respectively preserved in the China center for type culture collection and the China Committee for culture Collection and general microbiological culture center; and

an excipient, diluent or carrier.

20. The use of the composition comprising a lactic acid bacteria fermented product according to claim 19 as a vaginal inflammation-inhibiting pathogen, wherein the lactic acid bacteria fermented product is a fermentation supernatant, a whey fermentation broth, or a dried powder thereof, which comprises a deactivated strain or a removed cell.

21. The use of the composition comprising lactic acid bacteria fermented product according to claim 19 as a vaginitis causing pathogen in an amount of 0.4 to 10%.

22. Use of a composition comprising a lactic acid bacteria ferment as claimed in claim 19 for the inhibition of pathogenic bacteria of vaginitis wherein said composition comprising a lactic acid bacteria ferment further comprises an anti-inflammatory agent or preservative.

23. The use of the composition comprising lactic acid bacteria fermented product as claimed in claim 22, wherein the anti-inflammatory agent or preservative comprises a first complex, a second complex, a third complex, menthol oil, tea tree essential oil, aloe vera extract, basil extract, nano silver or a combination thereof, and the content of the anti-inflammatory agent or preservative is 0.1-8%.

24. The use of a composition comprising a lactic acid bacteria ferment as claimed in claim 19 for the inhibition of pathogenic bacteria of vaginitis wherein said composition comprising a lactic acid bacteria ferment further comprises a gelling agent.

25. The use of the composition comprising lactic acid bacteria fermented product according to claim 24, wherein the gelling agent comprises natural dextran gum, Carbomer (Carbomer) or a combination thereof, and the content of the gelling agent is 0.2-5%.

26. The use of the composition comprising a lactic acid bacteria fermented product according to claim 19 as a vaginal inflammation-inhibiting pathogen, wherein the composition comprising a lactic acid bacteria fermented product further comprises an active ingredient.

27. The use of the composition comprising lactobacillus ferments as a vaginitis-inhibiting agent according to claim 26, wherein said active principle comprises sodium hyaluronate (sodium hyaluronate), anti-allergy complex (sea deep water) comprising sea deep water and cucurbita pepo seed extract, allantoin (lantoin) or a combination thereof, and the content of the active principle is 0.005-5%.

28. The use of a composition comprising a lactic acid bacteria fermented product as claimed in claim 19, wherein the excipient, diluent or carrier comprises sodium hydroxide, triethanolamine, glycerol or a combination thereof in an amount of 0.05-10% and the balance to 100% pure water.

29. The use of the composition comprising lactic acid bacteria fermented product according to claim 19 as a vaginal inflammation pathogenic bacteria inhibiting composition, wherein the composition comprising lactic acid bacteria fermented product is a food composition, a pharmaceutical composition or a vaginal cleaning composition.

Technical Field

The invention relates to a composition, a vagina cleaning composition and application thereof, in particular to a composition for inhibiting pathogenic bacteria of vaginitis, a vagina cleaning composition and application thereof.

Background

The study of probiotics on human health is extensive, and in general, strains with special efficacy on human health are called functional probiotics (microorganisms for the evaluation of probiotics in food; Report of joint FAO/WHO working group on drawing probiotics for the evaluation of probiotics in food; London Ontario, Canada April 30and May 1,2002: 1-7). The special effects of common functional probiotics comprise the regulation of gastrointestinal tract functions, the regulation of immunity, even anti-inflammatory reaction and the like. It is noted that the specific efficacy of the functional probiotic is the specificity of the strain (strains) rather than the species (species), i.e. even the same species, if different strains, may have different efficacies, even the opposite.

Some studies have indicated that modern women have a probability of more than 50% of developing urinary or vaginal infections. Lower genital tract symptoms such as dysuria, pruritus and secretions are common in women at an outpatient visit. The most common causes are vulvar tract infections, which are common in women of childbearing age for three reasons: candidiasis, bacterial vaginal disease, and trichomoniasis, both of which are caused by microorganisms. The vagina is communicated with the outside and is close to the anus with a plurality of potential pathogenic bacteria, so that a plurality of chances are provided for the invasion of the pathogenic bacteria, and a human body has a set of defense systems to avoid the excessive proliferation of the pathogenic bacteria.

The main basis of the vaginal defense system is an acidic environment with a pH below 4.5. The acidic environment is not beneficial to the proliferation of potential pathogenic bacteria, and the acidophilic bacillus is an ideal environment, so that the acidophilic bacillus can continuously produce acid and maintain a healthy state. However, if the activity of acidic bacteria is lowered, for example, if a broad-spectrum antibiotic is used, the pH of the vagina is increased, which causes proliferation of pathogenic bacteria and infection.

In view of the above, the development of products having the effect of inhibiting vaginal pathogenic bacteria is the objective of the present efforts.

Disclosure of Invention

The invention provides a composition for inhibiting pathogenic bacteria of vaginitis, which comprises a fermentation product obtained by fermenting lactic acid bacteria strains and streptococcus thermophilus together in a culture medium containing at least one of milk, milk powder and casein. The fermented product of the above lactobacillus strain can inhibit growth of pathogenic bacteria of vaginitis, and is available in the form of food composition, medicine and vaginal cleaning composition.

The composition for inhibiting the pathogenic bacteria of vaginitis in one embodiment of the invention comprises the lactobacillus leavening and an excipient, a diluent or a carrier. The lactobacillus leavening is obtained by fermenting separated lactobacillus strains and streptococcus thermophilus together by a culture medium containing at least one of milk, milk powder and casein, wherein the lactobacillus strains comprise a strain with a preservation number of CCTCC NO: m2011127 Lactobacillus salivarius subsp.salicinus AP-32 strain (preservation date: 2011, 4/10 days; preservation unit: China Center for Type Culture Collection (CCTCC); preservation unit address: university of Wuhan, Zip code 430072; classification name: Lactobacillus salivarius subsp.salicinus), preservation number is CCTCC NO: m2011124 Lactobacillus rhamnosus F-1 strain (preservation date: 2011, 4 and 10 months; preservation unit: China Center for Type Culture Collection (CCTCC); preservation unit address: Wuhan university, Wuhan, China, zip code 430072; classification name: Lactobacillus rhamnosus (Lactobacillus rhamnosus)), and the preservation number is CCTCC NO: m2014591 (Lactobacillus rhamnosus) GL-165 strain (preservation date: 2014, 11, 24 days; preservation unit: China Center for Type Culture Collection (CCTCC); preservation unit address: Wuhan university, Wuhan, China, postal code 430072; classification name: Lactobacillus rhamnosus), preservation number CCTCC NO: m2014588 Bifidobacterium animalis subsp.lactis CP-9 strain (preservation date: 24.11.2014; preservation unit: China typical culture collection center (CCTCC)), preservation unit address: university of Wuhan, postal code 430072; classification name: Bifidobacterium animalis subsp.lactis), Bifidobacterium bifidum (Bifidobacterium bifidum) Bf-688 strain (preservation date: 18.06.18.2019; unit: China microbial culture Collection center (CGMCC), preservation unit address: Beijing Yang district North Cheng No.1 institute of Bifidobacterium 3, institute of Microbiologics, postal code 100101; classification name: Bifidobacterium bifidum (Bifidobacterium animalis subsp.collection), and Bifidobacterium strain preservation unit address: 2019. CGMCC), Bifidobacterium bifidum (CGMCC), and Bifidobacterium longum culture collection unit address: 2019. CGMCC), and Bifidobacterium breve culture collection unit address: CGMCC # 1618 Center of mass (CGMCC); the address of the depository: the microbial research institute of the national academy of sciences, No. 3, west road, north west of the area facing the sun, beijing, zip code 100101; and (3) classification and naming: bifidobacterium breve (Bifidobacterium breve)) or a combination of the above lactobacillus strains. The lactobacillus strains are respectively preserved in China center for type culture Collection and China Committee for culture Collection of microorganisms, general microbiological center.

Another embodiment of the vaginal cleaning composition of the present invention comprises a lactic acid bacteria ferment together with a physiologically acceptable excipient, diluent or carrier. The lactobacillus leavening is obtained by fermenting a culture medium containing at least one of milk, milk powder and casein together with separated lactobacillus strains and streptococcus thermophilus, wherein the lactobacillus strains comprise a strain with a preservation number of CCTCC NO: m2011127 Lactobacillus salivarius AP-32 strain, with the preservation number of CCTCC NO: m2011124 Lactobacillus rhamnosus F-1 strain with a preservation number of CCTCC NO: the lactobacillus rhamnosus GL-165 strain of M2014591 has a preservation number of CCTCC NO: m2014588 Bifidobacterium animalis subsp.lactis CP-9 strain, Bifidobacterium bifidum Bf-688 strain with the preservation number of CGMCC No.17953, Bifidobacterium breve Bv-889 strain with the preservation number of CGMCC No.16145 or the combination of the lactobacillus strains. The lactobacillus strains are respectively preserved in China center for type culture Collection and China Committee for culture Collection of microorganisms, general microbiological center.

In another embodiment of the present invention, the use of the composition comprising lactobacillus leavening as a drug for inhibiting pathogenic bacteria of vaginitis, wherein the composition comprising lactobacillus leavening comprises lactobacillus leavening and an excipient, diluent or carrier. The lactobacillus leavening is obtained by fermenting a culture medium containing at least one of milk, milk powder and casein together with separated lactobacillus strains and streptococcus thermophilus, wherein the lactobacillus strains comprise a strain with a preservation number of CCTCC NO: m2011127 Lactobacillus salivarius AP-32 strain, with the preservation number of CCTCC NO: m2011124 Lactobacillus rhamnosus F-1 strain with a preservation number of CCTCC NO: the lactobacillus rhamnosus GL-165 strain of M2014591 has a preservation number of CCTCC NO: m2014588 Bifidobacterium animalis subsp.lactis CP-9 strain, Bifidobacterium bifidum Bf-688 strain with the preservation number of CGMCC No.17953, Bifidobacterium breve Bv-889 strain with the preservation number of CGMCC No.16145 or the combination of the lactobacillus strains. The lactobacillus strains are respectively preserved in China center for type culture Collection and China Committee for culture Collection of microorganisms, general microbiological center.

The purpose, technical content, features and effects of the present invention will be more readily understood by the following detailed description of the embodiments taken in conjunction with the accompanying drawings.

Drawings

FIG. 1 shows the results of the inhibition of pathogenic bacteria of vaginitis by the metabolites of the respective lactic acid bacteria of the present invention.

Fig. 2 shows the results of the inhibition of pathogenic bacteria of vaginitis by the metabolites of the respective lactic acid bacteria of the present invention.

FIG. 3 shows the results of the mixed lactic acid bacteria strain fermentate inhibiting the pathogenic bacteria of vaginitis.

FIG. 4 shows a histogram showing the results of the mixed fermentate of the lactic acid bacteria strain of the present invention against the pathogenic bacteria of vaginitis.

FIG. 5 shows a histogram showing the results of different concentrations of the starter gel of the invention for the inhibition of the pathogenic bacteria of vaginitis.

Microbial deposits for patent procedures:

(one) AP-32 Strain

The preservation number is: CCTCC NO: m2011127;

the preservation date is as follows: 2011, 4 months and 10 days;

the preservation unit: china Center for Type Culture Collection (CCTCC);

the address of the depository: wuhan university, Wuhan, China, zip code 430072;

and (3) classification and naming: lactobacillus salivarius (Lactobacillus salivarius subsp. solicinius);

(II) F-1 Strain

The preservation number is: CCTCC NO: m2011124;

the preservation date is as follows: 2011, 4 months and 10 days;

the preservation unit: china Center for Type Culture Collection (CCTCC);

the address of the depository: wuhan university, Wuhan, China, zip code 430072;

and (3) classification and naming: lactobacillus rhamnosus (Lactobacillus rhamnosus);

(III) GL-165 Strain

The preservation number is: CCTCC NO: m2014591;

the preservation date is as follows: 11/24/2014;

the preservation unit: china Center for Type Culture Collection (CCTCC);

the address of the depository: wuhan university, Wuhan, China, zip code 430072;

and (3) classification and naming: lactobacillus rhamnosus (Lactobacillus rhamnosus);

(tetra) CP-9 Strain

The preservation number is: CCTCC NO: m2014588;

the preservation date is as follows: 11/24/2014;

the preservation unit: china Center for Type Culture Collection (CCTCC);

the address of the depository: wuhan university, Wuhan, China, zip code 430072;

and (3) classification and naming: bifidobacterium animalis subsp. lactis;

(V) Bf-688 bacterial strain

The preservation number is: CGMCC No. 17953;

the preservation date is as follows: 18 months 06 in 2019;

the preservation unit: china general microbiological culture Collection center (CGMCC);

the address of the depository: the microbial research institute of the national academy of sciences, No. 3, west road, north west of the area facing the sun, beijing, zip code 100101;

and (3) classification and naming: bifidobacterium bifidum (Bifidobacterium bifidum);

(six) Bv-889 Strain

The preservation number is: CGMCC No. 16145;

the preservation date is as follows: year 2018, month 07, 23;

the preservation unit: china general microbiological culture Collection center (CGMCC);

the address of the depository: the microbial research institute of the national academy of sciences, No. 3, west road, north west of the area facing the sun, beijing, zip code 100101;

and (3) classification and naming: bifidobacterium breve (Bifidobacterium breve).

Detailed Description

The following detailed description of the various embodiments of the invention, taken in conjunction with the accompanying drawings, is provided by way of illustration. Aside from the detailed description, this invention is capable of broad application in other embodiments and many variations and modifications of the invention will be apparent to those skilled in the art upon reading the specification and understanding the present invention. In the description of the specification, numerous specific details are set forth in order to provide a more thorough understanding of the invention; however, the present invention may be practiced without some or all of these specific details. In other instances, well-known steps or elements have not been described in detail so as not to unnecessarily obscure the present invention. The same or similar components in the drawings will be denoted by the same or similar symbols. It is specifically noted that the drawings are merely schematic and do not represent actual sizes or quantities of elements, and that some of the details may not be fully depicted in order to simplify the drawings.

The freeze-dried culture of the lactobacillus strain is respectively preserved in China center for type culture Collection (CCTCC, address of Wuhan university of Wuhan, China 430072) and China general microbiological culture Collection center (CGMCC, address of Beijing university of Chaoyang, North Cheng Xilu No.1 institute of microbiology, China academy of sciences). The details of the deposit are shown in table 1:

TABLE 1 deposited data of Lactobacillus strains

The fermentates of the deposited lactobacillus strains as listed in table 1 were found to have an inhibitory effect on the activity of the pathogenic bacteria of vaginitis. Thus, the fermentates of the deposited strains of lactic acid bacteria listed in Table 1 may be used as a means of inhibiting the pathogenic bacteria of vaginitis.

In one embodiment, the composition for inhibiting vaginitis causing bacteria of the present invention comprises the fermented lactic acid bacteria and an excipient, diluent or carrier. The lactobacillus leavening is obtained by fermenting separated lactobacillus strain and streptococcus thermophilus together with culture medium containing milk, milk powder, casein or combination thereof as substrate. The lactobacillus strain can be a lactobacillus strain with a preservation number of CCTCC NO: m2011127 Lactobacillus salivarius subsp.salicinus AP-32 strain, with the preservation number of CCTCC NO: m2011124 Lactobacillus rhamnosus F-1 strain with a preservation number of CCTCC NO: lactobacillus rhamnosus GL-165 strain of M2014591, with preservation number CCTCC NO: m2014588 Bifidobacterium animalis subsp.lactis CP-9 strain, Bifidobacterium bifidum (Bifidobacterium bifidum) Bf-688 strain with the preservation number of CGMCC No.17953, Bifidobacterium breve (Bifidobacterium breve) Bv-889 strain with the preservation number of CGMCC No.16145 or the combination of the above lactobacillus strains, wherein the lactobacillus strains are respectively preserved in China center for type culture collection and China Committee for culture Collection of microorganisms (CCCCCCCCCES) common microorganism center.

In one embodiment, the excipient, diluent or carrier may be a physiologically acceptable excipient, diluent or carrier, such that the composition of the present invention is useful as a food composition or vaginal cleansing composition. In one embodiment, the excipient, diluent or carrier can be a pharmaceutically acceptable excipient, diluent or carrier, such that the composition of the present invention can be used as a pharmaceutical composition.

In the case of a food composition, the physiologically acceptable excipient, diluent or carrier may be a food product. For example, the food product may include, but is not limited to, a milk drink, tea, coffee, a functional drink, or a combination thereof, wherein the milk drink may include fermented milk, yogurt, cheese, or milk drink milk powder, and the like.

In the embodiment of the pharmaceutical composition, the pharmaceutical composition can be an oral dosage form or an external dosage form. For example, oral dosage forms can be tablets, capsules, solutions, powders, or the like; the topical dosage form can be powder, cream, spray, gel, solution, powder or cream.

In the embodiment of the vaginal cleansing composition, the vaginal cleansing composition can be a lozenge, capsule, powder, cream, spray, gel, solution, powder, cream, or lotion.

In one embodiment, the fermentation product produced by fermentation of the lactic acid bacteria strain of the present invention may comprise a deactivated strain or a thallus-removed fermentation broth or a dried powder thereof. For example, the fermentation broth may be a fermentation supernatant, a whey fermentation broth, or the like. In one embodiment, the powder content of the lactobacillus fermentation product in the composition for inhibiting the pathogenic bacteria of vaginitis of the present invention is more than 0.4%; alternatively, the content of the solution of the lactic acid bacteria fermented product is 2% or more.

In one embodiment, the composition for inhibiting vaginitis pathogens of the present invention further comprises an anti-inflammatory agent or a preservative. For example, the anti-inflammatory agent or preservative may be the first complex, the second complex, the third complex, menthol oil, tea tree essential oil, aloe vera extract, basil extract, nano-silver, or a combination thereof. The first complex comprises dipropylene glycol (dipropylene glycol), hydroxyacetophenone (hydroxy acetophenone), octyl glycol (caprylyl glycol), and dipotassium glycyrrhizinate (dipotassium glycyrrhizinate), known in the industry as activinol-M. The second complex comprises a soybean Seed Extract (Glycine Soja Seed Extract), a Houttuynia Cordata Extract (Houttuynia Cordata Extract), a Scutellaria Baicalensis Root Extract (Scutellaria Baicalensis Baicales Root Extract), a neem Leaf Extract (Melia Azadirachta Leaf Extract), a chinese Rehmannia Root Extract (Rehmannia Chinensis Root Extract), a white willow Bark Extract (Salix Alba Bark Extract), a yellow tiller Extract Bark (phelloderon alcohol Bark Extract), o-cymene-5-Ol (o-Cymen-5-Ol), lactobacillus, Pear Juice fermentation Filtrate (Pear Juice nutrient), glycerol Caprylate (glycerol Caprylate), ethylhexylglycerol (ethylhexylglycerol), PEG-60Hydrogenated Castor Oil (Castor Oil-60 Hydrogenated Castor Oil), butyl Glycol (Butylene Glycol), and water (known in the industry as hydroxyl acetate). The third complex comprises Zanthoxylum Piperitum Extract (Zanthoxylum Piperitum Extract), Pulsatilla Koreana Root Extract (Pulsatilla Koreana Root Extract) and moss Extract (Usnea Barbata Extract), known in the industry as EURO-NApre. In one embodiment, the anti-inflammatory agent or preservative is present in an amount of 0.1 to 8%.

In one embodiment, the composition for inhibiting vaginitis pathogenic bacteria of the invention further comprises a gel. For example, the gelling agent may be natural dextran, Carbomer (Carbomer), or a combination thereof. In one embodiment, the gelling agent is present in an amount of 0.2 to 5%.

In one embodiment, the composition for inhibiting pathogenic bacteria of vaginitis further comprises an active ingredient. For example, the active ingredient may be sodium hyaluronate (sodium hyaluronate), anti-allergy complex (anti-allergy complex) comprising deep ocean water and Cucurbita pepo seed extract, known in the industry as ocaline XP, allantoin (llantoin), or a combination thereof. In one embodiment, the content of the effective component is 0.005-5%.

In one embodiment, the excipient, diluent or carrier comprises sodium hydroxide, triethanolamine, glycerol or a combination thereof in an amount of 0.05-10%, and pure water as a solvent to make up to 100%.

Example 1: morphological and general Properties of the lactic acid bacteria strains of the invention

The taxonomical characteristics of the strain were confirmed based on the results of 16S rDNA sequence analysis and analysis by the API bacterial identification system. The morphological and general qualitative characteristics of the lactic acid bacterial strains according to the invention are detailed in table 2:

table 2 morphological and general characterization of the lactic acid bacteria strains of the invention

Example 2: collection of lactic acid bacteria fermentation product of the present invention

The lactobacillus leavening is prepared by fermenting a culture medium which contains milk, milk powder and casein or the combination of the milk, the milk powder and the casein as substrates with separated lactobacillus salivarius AP-32 strain, lactobacillus rhamnosus F-1 strain, lactobacillus rhamnosus GL-165 strain, bifidobacterium animalis subsp lactis CP-9 strain, bifidobacterium bifidum Bf-688 strain, bifidobacterium breve Bv-889 strain or the combination of the lactobacillus strains and streptococcus thermophilus together, and then obtaining fermentation liquor by centrifugation. Since streptococcus thermophilus is used for fermentation assistance, the specific strain is not further limited. According to the requirement, the lactobacillus fermentation liquor can be further dried into lactobacillus fermentation product powder.

Example 3: analysis of the bacteria of the present invention for inhibiting pathogenic bacteria of vaginitis

The ability of lactic acid bacteria to inhibit pathogenic bacteria of vaginitis was tested by the antibacterial method described in Candida, Infectious Diseases in Obstotrics and Gynecology,13(2),69-75, Strus et al, 2005. Firstly, lactobacillus strains of Lactobacillus salivarius AP-32, Lactobacillus reuteri GL-104, Lactobacillus paracasei GL-156, Lactobacillus rhamnosus F-1, Lactobacillus rhamnosus GL-165, Bifidobacterium animalis subsp lactis CP-9, Bifidobacterium bifidum Bf-688 and Bifidobacterium breve Bv-889, which are activated to the 3 rd generation of lactic acid bacteria, are respectively smeared on corresponding solid culture media and the smearing width is maintained to be 2 cm. The SY-66 strain of Streptococcus thermophilus (Streptococcus thermophilus) is used as a negative control group, and the lactobacillus is not smeared on the control group (control). Culturing for 2 days under the corresponding culture condition of lactobacillus, injecting 14mL of culture medium for culturing pathogenic bacteria of vaginitis, and respectively and uniformly coating the bacterial liquid of the pathogenic bacteria of vaginitis on the culture medium after the culture medium is solidified. The pathogenic bacteria of vaginitis tested included Candida albicans (Candida albicans), Staphylococcus aureus (Staphylococcus aureus), Escherichia coli (Escherichia coli), Staphylococcus aureus-resistant strains (MRSA), Streptococcus B (GBS), and Escherichia coli-resistant strains (Escherichia coli-ESBL). Culturing the culture medium coated with the pathogenic bacteria of vaginitis under the corresponding culture conditions of the pathogenic bacteria. When the corresponding culture time is reached, the bacterium disc is taken out, and the bacteriostasis width is measured by a ruler so as to evaluate the bacteriostasis capability of the lactobacillus strain fermentation product. The higher the score, the better the bacteriostatic ability, and the evaluation criteria are shown in table 3.

TABLE 3 evaluation criteria

Representing symbol	Width of bacteriostasis (cm)	Scoring
			(-)	0	0
(+/-)	<2	1
			(++)	<3	2
(+++)	<4	3
			(++++)	<5	4
(+++++)	<9	5
			(++++++)	9	6

The results of the inhibition of vaginal pathogenic bacteria by the metabolites of the lactic acid bacteria strain of the present invention are shown in fig. 1 and 2. As is clear from the results shown in fig. 1 and 2, the metabolites of the lactic acid bacteria strain of the present invention have an activity of inhibiting pathogenic bacteria of vaginitis.

Example 4: analysis of the lactic acid bacterium fermented product of the present invention for inhibiting pathogenic bacteria of vaginitis

The method for detecting the capability of the lactobacillus leavening for inhibiting the pathogenic bacteria of the vaginitis is as follows. In one embodiment, a culture medium based on milk, milk powder or casein is prepared by fermenting Lactobacillus salivarius AP-32 strain, Lactobacillus rhamnosus F-1 strain, GL-165 strain, Bifidobacterium animalis subsp lactis CP-9 strain, Bifidobacterium bifidum Bf-688 strain, Bifidobacterium breve Bv-889 strain and Streptococcus thermophilus together, centrifuging, and collecting the upper layer fermentation liquid.

The lactobacillus fermentation liquor is used as the solution of the vaginitis pathogen culture medium powder, and the supernatant prepared culture medium without lactobacillus fermentation is used as the control group. After preparation, the culture dish was sterilized and half a culture dish was cast with gel. After the gel solidified, the gel containing the control group was poured into the other half of the petri dish. Then, the culture medium was uniformly coated with bacterial solutions of pathogenic bacteria of vaginitis (candida albicans, staphylococcus aureus, escherichia coli). Culturing under the culture conditions corresponding to pathogenic bacteria of vaginitis. After the incubation time was reached, the plate was removed and the bacteriostatic performance of the lactobacillus fermentation broth of the present invention was compared with the control group, and the results are shown in fig. 3. As can be seen from the results of fig. 3, the lactic acid bacteria fermented solution of the present invention has an excellent effect of inhibiting pathogenic bacteria of vaginitis, compared to the control group.

Example 5: analysis of the lactic acid bacterium fermented product of the present invention for inhibiting vaginitis pathogenic bacteria

Another method for detecting the capability of lactobacillus leavening to inhibit pathogenic bacteria of vaginitis is as follows. The culture medium containing 10% of the lactic acid bacteria fermentation broth of the present invention was quantified to 4.9mL of a culture tube, and a liquid medium that was not fermented by lactic acid bacteria was used as a control group. Then, respectively adding 0.1mL of activated colpitis pathogenic bacteria (candida albicans, staphylococcus aureus, escherichia coli, staphylococcus aureus with drug-resistant strains (MRSA), streptococcus type B (GBS) and escherichia coli with drug-resistant strains (ESBL) into a bacteria culture tube, culturing according to the culture conditions of the corresponding colpitis pathogenic bacteria, diluting according to a proper sequence after culturing, diluting and coating a common culture group and a control group sequence on a solid culture medium corresponding to the colpitis pathogenic bacteria, culturing the bacterial disks in an incubator according to the culture conditions of the corresponding colpitis pathogenic bacteria, taking out the bacterial disks and counting the number of bacterial colony pathogenic bacteria to compare the bacteriostatic rate after reaching the corresponding culture time, and calculating the bacteriostatic rate as follows:

the bacteriostatic rate (%) was (1-experimental/control group) × 100%.

The results of the detection of the pathogenic bacteria inhibiting vaginitis with the lactic acid bacteria fermented product of the present invention are shown in fig. 4, wherein the symbol x indicates a p value <0.001, i.e., there was a statistically significant difference. The results shown in fig. 4 show that the lactobacillus fermentation broth of the present invention has significant inhibitory effect on vaginitis pathogens, and the bacteriostatic rate on various vaginitis pathogens is above 80%.

Example 6: analysis of vaginitis-inhibiting pathogenic bacteria of lactic acid bacteria fermented product gel of the present invention

The method for detecting the capability of the lactobacillus leavening gel for inhibiting the pathogenic bacteria of the vaginitis is as follows. First, a gel (e.g., natural dextran, carbomer), an active ingredient (e.g., sodium hyaluronate, Ocaline XP, allantoin) are weighed in an appropriate ratio and stirred with 50% water until completely dissolved. Then adding the lactobacillus fermentation liquor (2%, 5% and 10%), anti-inflammatory agent or antiseptic (such as activivonol-M, acnebusters, EURO-Napre, menthol oil, tea tree essential oil, aloe extract, Plectranthus Amboinicus extract, and nano silver), stirring and mixing uniformly. Then adding excipient (such as sodium hydroxide, triethanolamine, and glycerol), adjusting pH to 4.5-6.5, adding pure water to 100%, and stirring. The control group only contains gel without the lactobacillus fermentation liquor, the effective components and the anti-inflammatory agent/preservative; the other control group contained only gelling agent and anti-inflammatory/preservative agent but not the lactic acid bacteria fermentation broth of the present invention. 0.1ml of activated vaginitis pathogens (concentration 1X 10) were each taken⁵～9×10⁵CFU/ml candida albicans, staphylococcus aureus, escherichia coli) was added to 2.5g each of the experimental gels, mixed well and allowed to stand for 20 minutes. Then, 22.5ml of purified water was added thereto and diluted 10-fold, and 0.1ml was diluted in an appropriate sequence, and plated and cultured at 37 ℃. And finally, obtaining the bacteriostasis rate according to the bacteriostasis rate calculation method.

The analysis results of the pathogenic bacteria inhibiting vaginitis of the lactic acid bacteria fermented gel of the present invention are shown in fig. 5, wherein the symbol indicates a p value <0.001 and the symbol indicates a p value <0.01, i.e., statistically, very significant differences are observed; the symbol indicates a p value <0.05, i.e. statistically significant differences. As can be seen from the results in fig. 5, the control group containing only the anti-inflammatory agent/preservative had a statistical significance compared to the control group, but had a bacteriostatic rate of less than 75% against vaginal pathogens. The gel containing 2%, 5% and 10% of lactobacillus fermentation liquor has obvious inhibition effect on vaginitis pathogenic bacteria, and the bacteriostasis rate is over 90%, wherein the bacteriostasis rate of the gel containing 5% and 10% of lactobacillus fermentation liquor on various vaginitis pathogenic bacteria is 100%.

In summary, the composition for inhibiting vaginitis causing bacteria of the present invention comprises a lactic acid bacteria fermented product obtained by fermenting streptococcus thermophilus with lactobacillus salivarius AP-32 strain, lactobacillus rhamnosus F-1 strain, lactobacillus rhamnosus GL-165 strain, bifidobacterium animalis subsp lactis CP-9 strain, bifidobacterium bifidum Bf-688 strain, bifidobacterium breve Bv-889 strain or a combination of the above lactobacillus strains in a culture medium comprising at least one of milk, milk powder and casein. The fermented product of the lactic acid bacteria strain can inhibit the growth of pathogenic bacteria of vaginitis, so that the fermented product can be used for inhibiting the pathogenic bacteria of vaginitis, and exists in the forms of food compositions, pharmaceutical compositions or vagina cleaning compositions. Preferably, the composition for inhibiting vaginitis pathogens of the present invention further comprises an anti-inflammatory agent/preservative or other effective ingredients to further enhance the ability to inhibit vaginitis pathogens.

The above-described embodiments are merely illustrative of the technical spirit and features of the present invention, and the object of the present invention is to enable those skilled in the art to understand the content of the present invention and to implement the same, and the scope of the present invention should not be limited by the above-described embodiments, i.e., all equivalent changes and modifications made in the spirit of the present invention should be covered by the scope of the present invention.