DE202018101105U1 - Hygienic agent with active ingredient for lowering the pH of the vagina and / or the external genitals - Google Patents

Abstract

The hygienic agent (1) having an active substance for lowering the pH of the vagina and / or the external genitalia, where the active substance contains the crystalline lactic acid or its salts and on the surface layer (2) of the hygienic agent (1), for the contact with the body is determined, and / or placed in the internal structure of the hygienic agent (1), characterized in that the lactic acid and / or its salt in the active ingredient in the form of monogestered monoglycerol monoesters for the gradual release of lactic acid from the hygienic means (1) are.

Description

Range of technology

The technical solution relates to the field of intimate hygiene, specifically a hygienic agent with active ingredient for lowering the pH of the vagina and / or the external genitalia.

Previous state of the art

The female genitourinary tract is colonized with a holistic microbial ecosystem that includes more than 50 different bacterial species, while being characterized by the specific low pH that restricts the growth of unwanted microorganisms. In fertile years, microorganisms that produce lactic acid and belong to the genus Lactobacillus predominate. The acidic pH is important for maintaining a healthy microbial flora throughout the vagina in which these pHs are antagonistic to pathogenic microorganisms such as Candida yeast and undesirable bacterial species. The physiological pH of the vaginal mucosa and external genitalia is significantly lower, which effectively restricts the colonization of the vaginal mucosa with pathogenic microorganisms. For intimate feminine hygiene, never use ordinary base bar soap and intimate products that are totally unsuitable for the external genitalia, as the pH of the vagina is very acidic and this protective barrier is disturbed when using an alkaline soap. Perfumed soaps, sanitary napkins and other means of intimate hygiene can additionally irritate the sensitive skin and mucous membranes. Conversely, such intimate care agents that have a pH of 5.5 are suitable.

The microbial ecosystem and the physiological pH of the external genitalia and vaginal mucosa of a healthy woman can be improved by taking antibiotics, chemotherapeutic agents, antimycotics, hormone changes of the organism, such. During pregnancy, after menopause or when taking birth control pills, by wearing an unsuitable underwear, in menstruation, in women suffering from diabetes, etc. are disturbed. The risk of spreading unwanted microorganisms from the rectum into the genitourinary tract must also be considered. All of these changes can cause infections, resulting in the disruption of a normal microbial flora, changes in the physiological pH of the vaginal mucosa and external genitalia, and subsequent development of microbial infections involving vaginal, urinary tract, and common primary inflammation, particularly skin wolf, cause. The following types of microorganisms are most frequently associated with the mentioned infections: Escherichia, Enterococcus, Psedomonas, Proteus, Klebsiella, Streptococcus, Staphylococcus, Gardnerella, Ureplasma, Bacteriodes, Peptococcus, Neisseria, Serratia, Corynebacterium, Clostridium and Candida. The cited specification of microorganisms closely correlates with the fact that there is an increased risk of migration of these microorganisms from the rectum into the vagina and the external genitalia in women in view of a shorter distance between the rectum and the genitourinary tract. Particularly at risk are young women who do not yet have a well-developed microflora in the genitourinary area, and older women who, due to hormone changes, are no longer adequately protected by the vaginal microflora, which at the same time influences the stability of the physiological pH. Increasing the pH can lead to the development of bacterial vaginosis or aerobic vaginitis, as well as being a significant indicator of an abnormal vaginal microflora. The disturbance of the microbial balance may also be negatively related to the reproductive ability of the woman.

Today, there are a number of known products on the market designed to regulate or lower the pH of the vaginal milieu and external genitalia. The products mentioned are based on a simple application of creams, gels and intimate soaps with the lactic acid, which is the most important natural factor how to ensure the acid pH of the vaginal mucous membrane and the external genitalia. Under normal circumstances, lactic acid is produced in a healthy woman, especially by bacteria of the genus Lactobacillus. However, when the stability of the vaginal microbial flora is disturbed, the production of lactic acid decreases mainly due to the decline of Lactobacillus, and then the pH of the mucosa increases. This increase in pH then brings about a radical increase in the risk of inflammatory spread. Particularly in this situation, it is suitable to regulate the elevated pH with a natural component, ie with the lactic acid, in combination with probiotic bacteria by external application in the form of a gel, a soap for intimate hygiene or other means. When the probiotic culture is combined with a prebiotic component, the so-called symbiotic component is created, in which, thanks to the lowering of the pH value, the lactic acid creates the optimal environment for the propagation of the probiotic culture and the prebiotic component as a source of selective nutrients is used for the probiotic culture, which increases the proliferation of probiotic Bacteria especially supported on and in the sanitary napkin.

At present, there are on the market means of intimate hygiene, such as sanitary napkins, day or night hindlimbs, panty liners, tampons enriched with lactic acid. The solution UV 23192 is known, which describes the enrichment of the absorbent core with a crystalline form of lactic acid with the aim of lowering the pH, in particular in the case of ladies' care. However, this solution is based on micronization of the lactic acid and its rapid dissolution, resulting in an uncontrolled and rapid lowering of the pH of the sanitary napkin with a short-term effect. The solution is also loud WO 2008/060200 , which describes a hygienic agent containing the mixture for the suppression of microbial spread in the urogenital area. The mixture contains an extracellular product of at least one genus of probiotic bacteria and at least one additive in the form of an organic acid, the pH of which then does not exceed 5.5, and / or salts thereof, wherein the extracellular product is e.g. As are antimicrobial peptides, not actual probiotic bacteria. The acid can then be the lactic, acetic, ascorbic, citric acid among others. The said hygienic agent does not solve the independent application of lactic acid and is only bound to Lactobacillus species that produce said acid. It is also the solution loud DE 2309575 known, which relates to the execution of menstrual tampons, where the tampon is impregnated with an impregnation of lactic acid, glycogen or sugar or bacteria Lactobacillus vaginalis. All other known patents are linked to the use of probiotic bacteria that produce the lactic acid. However, to date there is no hygienic agent on the market which would contain the applied lactic acid either in the actual absorbent core of the sanitary agent or directly on a nonwoven or the actual toilet paper that comes into contact with the skin and external genitalia and their Release would be gradual and corrected by the autopsy of the crystallized lactic acid or its salt monoglycerol monoester would thus very quickly reduce the pH of the hygienic agent used to the required physiological pH of the external genitalia, ie ideally 5 to 5.5.

The object of the technical solution is to provide a hygienic agent with an active ingredient for lowering the pH of the vagina and / or the external genitalia, which contains the lactic acid or its salts, which would be effectively stabilized in the hygienic agent, whereby their healing and preventive effects and would maintain the optimum pH for propagation of probiotic bacteria. The hygienic agent according to this technical solution should represent a new hygienic product, which, with its composition, will naturally contribute to the stabilization of the pH and microflora of the external genitals, the rectum and the skin in the genital area.

Basis of the technical solution

The hygienic agent with the active ingredient for lowering the pH of the vagina and / or the external genital eliminates the above-mentioned defects according to this technical solution. The active ingredient contains the crystalline lactic acid or its salts and is placed on the surface layer of the sanitary agent intended for contact with the body and / or in the internal structure of the sanitary product. The basis of the technical solution is that the lactic acid and / or its salts are present in the active ingredient in the form of the autologous monoglyceryl monoester for the gradual release of lactic acid from the hygienic agent. The autopsy of the lactic acid or its salts ensures the encapsulated form of the active ingredient which is effectively stabilized in the sanitary agent, thereby ensuring a gradual and controlled release of the lactic acid which regulates the pH of the hygienic agent.

The active ingredient in a favorable embodiment further includes the probiotic culture of the genus Lactobacillus, Bifidobacterium or Streptococcus. The presence of these cultures, i. Bacteria of the fermentation of milk, ensures the production of lactic acid and thus the optimal environment of the hygienic agent.

The active ingredient advantageously further contains the prebiotic component from the group of inulin or fructooligosaccharides. The prebiotic component provides support for the proper growth and proliferation of the probiotic culture of the bacteria of the milk fermentation, thereby adjusting the balance in the hygienic agent.

In the active ingredient, the lactic acid and / or its salts, the probiotic culture and prebiotic component are homogenized in a suitable manner. Advantageously, the lactic acid and / or its salts are in micronized form.

Conveniently, the sanitary agent is formed with the lower impermeable layer, the absorbent core, and the upper surface layer of textile fabric or nonwoven fabric. The lactic acid and / or its salts, the probiotic culture and prebiotic component, ie the Complex active ingredient is in powder form and forms a functional layer on the back of the upper surface layer.

The functional layer is advantageously covered with a sticky layer for connection to the absorbent core. Advantageously, the tacky layer is formed with a hot melt adhesive layer. Thereby, the active ingredient is fixed in the internal structure of the sanitary agent, and the sanitary agent is formed with a comprehensive structure having the above-mentioned functional properties.

The sanitary agent is created in a suitable form in the form of a sanitary napkin or day or night intimates or panty liner or child or incontinence diaper or a tampon. The use of the hygienic agent is therefore very diverse.

The advantages of the active ingredient for the lowering of the pH of the vagina and / or the external sexual organs according to this technical solution consist mainly in that the active ingredient is effectively stabilized in the hygienic agent, whereby the healing and preventive effects of the hygienic agent increases which will maintain the optimum pH for the propagation of probiotic bacteria. The hygienic product according to this technical solution represents a new hygienic product, which with its composition contributes to the stabilization of the pH value and the microflora of the external genitals, the rectum and the skin in the genital area.

list of figures

• Schnitt durch das hygienische Mittel von Seite beim Auftragen des Wirkstoffs auf die Textilfasern,
• Ansicht des hygienischen Mittels in Form einer Damenbinde,
• Schnitt durch das hygienische Mittel auf ,
• Ansicht des hygienischen Mittels in Form einer Kinderwindel,
• Schnitt durch das hygienische Mittel auf .

The technical solution mentioned is explained in the following figures:

• Cut by the hygienic agent from the side when applying the active substance to the textile fibers,
• View of the sanitary product in the form of a sanitary napkin,
• Cut through the hygienic means .
• View of the hygienic agent in the form of a child's diaper
• Cut through the hygienic means ,

Example of the realization of the technical solution

It is understandable that the concrete examples of the realization of the technical solution described and illustrated below are illustrative and do not represent a restriction of the technical solution to the examples mentioned. Those skilled in the art will or will be able to ascertain higher or lower number of equivalents to the specific implementations of the technical solutions described herein using routine experimentation. These equivalents are also included within the scope of the following claims.

example 1

On is the hygienic agent 1 with active ingredient for lowering the pH of the vagina, where 70% by weight of crystalline lactic acid with the distilled monoglyceride DIMODAN (Danisco) by gentle grinding of the mixed mixture in the fragment mill at room temperature without heating, in 3 mass ratios 1 : 2 is being autopsied. On the back of the upper surface layer 2 , Topsheet, the sanitary napkin is 0.1 g of the powder mixture of the autopsied lactic acid, the probiotic culture Lactobacillus acidophilus in final concentration 1 × 10 ⁸ CFU / g homogenized with 0.05 g prebiotic inulin applied with dried and purified compressed air, specifically atomized , For fixing the powder mixture on the back of the upper surface layer 2 the sanitary napkin is the objective surface layer 2 with a homogeneous micro-application of the sticky layer, ie with a layer 7 of the hot-melt adhesive of 3.5 to 5 g / m ² provided by means of a fixing roller 5 is applied. When connecting the upper surface layer 2 made of nonwoven fabric with the remaining components of the sanitary napkin, it comes on the fixing rollers for a firm pressing of the homogeneous powder mixture to the lower impermeable layer 3 ,

Example 2

The autopsy of the crystalline lactic acid and its calcium salt, ie calcium lactate pentahydrate, in proportion 60 : 40, is performed using monoglyceride alginate in an industrial extruder. The absorbent, which is part of the absorbent core 4 of the hygienic agent 1 Forms into the absorbent core before application 4 in the ratio of 80 parts of the absorbent and 19 parts of the autopsied lactic acid with the probiotic culture L. acidophilus in the final concentration 1 × 10 ⁹ CFU and 1 part 95 % By weight of the fructo-oligosaccharide as a prebiotic. The mixture prepared in this way is used for the production of the absorbent core 4 of the hygienic agent 1 in the form of the sanitary napkin, either between two cellulose cores or on the surface of the absorbent core 4 before stacking, where the sanitary napkin described in this example on is shown. On is the section through the sanitary napkin shown. The Calcium lactate pentahydrate and the lactic acid are micronised prior to application.

Example 3

The absorbent core 4 of the hygienic agent 1 forming absorbent in the form of a child's diaper is in the absorbent core before application 4 the child's diaper is homogenized with the autopsied lactic acid. The autopsy takes place dry in the fragment mill at 70 revolutions per minute. The mixture for the preparation of the autoxidized lactic acid is 40 parts 60 % Of crystalline lactic acid and 60 parts of glyceryl stearate having the pH controlled at 5.5. The final superabsorbent mixture was prepared by homogenization in the barrel homogenizer in the ratio of 99 parts of the absorbent and 1 part of the autoxidized lactic acid. The mixture prepared in this way is used for the application of the superabsorbent 6 enriched by the acidified lactic acid produced in defibrated cellulose containing the absorbent core 4 the child diaper makes as on is imaged, or it is applied to the upper surface layer 2 of the nonwoven fabric, the so-called topsheet, directly applied when the absorbent core 4 only with the superabsorbent 6 and the distribution strip 8th is formed. On is the section through the child diaper shown.

Example 4

The absorbent core 4 the incontinence diaper 1 forming absorbent is in the absorbent core before application 4 homogenized with the glyceryl lactate -activated crystalline lactic acid. The mixture prepared in this way is used for the production of the absorbent core 4 used, wherein the lactic acid is micronized before application.

Industrial applicability

The hygienic agent with active ingredient for lowering the pH of the vagina and / or the external genitals according to this technical solution can be used especially in feminine hygiene in the form of sanitary napkins, day and night timpani, panty liners and tampons, both in time Menstruation, as well as in the meantime, can be used for the assurance of high quality feminine hygiene with the aim of renewing the physiological pH with a gradual and gentle release of lactic acid and renewing the natural microflora of the vagina and external genitals To stabilize or support the skin and rectum thanks to the addition of the probiotic culture with a prebiotic, which serves as a selective source of energy. The sanitary product can be further used in routine infant hygiene in the form of baby diapers and incontinence products, where lowering the pH eliminates the proliferation of pathogenic microorganisms and reduces the risk of surface inflammation and dermal wolfing.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• WO 2008/060200 [0005]
• DE 2309575 [0005]

Claims (9)

The hygienic agent (1) having an active substance for lowering the pH of the vagina and / or the external genitalia, where the active substance contains the crystalline lactic acid or its salts and on the surface layer (2) of the hygienic agent (1), for the contact with the body is determined, and / or placed in the internal structure of the hygienic agent (1), characterized in that the lactic acid and / or its salt in the active ingredient in the form of monogestered monoglycerol monoesters for the gradual release of lactic acid from the hygienic means (1) are. The sanitary means after Claim 1 , characterized in that the active substance further contains the probiotic culture of the genus Lactobacillus, Bifidobacterium or Streptococcus. The sanitary means after Claim 1 or 2 , characterized in that the active substance further contains the prebiotic component from the group inulin or fructo-oligosaccharides. The hygienic remedy for one of the Claims 1 to 3 , characterized in that the lactic acid and / or its salts, the probiotic culture and the prebiotic component in the active ingredient are homogenized. The hygienic remedy for one of the Claims 1 to 4 , characterized in that the lactic acid and / or its salts are in micronized form. The sanitary composition according to claims 1 to 5, characterized in that it is formed with the lower impermeable layer (3), the absorbent core (4) and the upper surface layer (2) of textile fabric or nonwoven fabric, wherein the active ingredient is in powder form and forms a functional layer on the back of the upper surface layer (2). The sanitary means after Claim 6 , characterized in that the functional layer is covered with a tacky layer for connection to the absorbent core (4). The sanitary means after Claim 7 , characterized in that the sticky layer is formed with a layer (7) of the hot melt adhesive. The hygienic remedy for one of the Claims 1 to 8th , characterized in that it is provided in the form of a sanitary napkin or daytime or Nachtintimbinde or panty liner or child diaper or incontinence diaper or a tampon.

Images