A female intimate area antibacterial care gel and a method of preparing the same

Abstract

The present application relates to the technical field of nursing sanitary products, and particularly discloses a female private part antibacterial nursing gel and a preparation method thereof, which contains the following components in percentage of 100% by mass: 1-3% of silver ion protein glue, 10-16% of carbomer, 10-20% of composite moisturizing agent, 0.04-0.08% of complexing agent, and the rest of purified water. The gel provided by the present application has good retention, effectively kills various pathogenic bacteria by using the antibacterial component without drug resistance risk, rapidly relieves gynecological inflammation, and the antibacterial component has selectivity and does not indiscriminately kill symbiotic bacteria, so that the microecological balance of the private part can be maintained and the private part can be kept healthy.

Description

Technical Field

[0001] This invention belongs to the field of nursing and hygiene product technology, specifically relating to a female private part antibacterial care gel and its preparation method. Background Technology

[0002] Women's intimate health has always been an important issue in the field of gynecology. The skin and mucous membranes of a woman's intimate area are delicate and open to the outside world, making them susceptible to invasion by pathogens such as bacteria and fungi, leading to gynecological inflammation and other problems. In addition, the microecological balance of a woman's intimate area is also crucial to her health.

[0003] Feminine hygiene products are topical preparations specifically designed to maintain the health of the vagina and external genitalia. Their main functions include antibacterial and anti-inflammatory effects, regulation of the microecological balance, and daily care. For example, patent application CN119033678A discloses a feminine hygiene gel, its preparation method, and its application, which uses tranexamic acid and glutathione in combination to provide antibacterial effects. Another example is patent CN109078165B, which describes a composition for feminine hygiene, its preparation method, and its application. This composition rationally combines multiple raw materials with cleansing, bactericidal, and nourishing effects, and can be used long-term to protect the vaginal mucosa and prevent the invasion of pathogenic bacteria. Chlorhexidine acetate plays the most important bactericidal role.

[0004] However, many existing feminine hygiene products contain chemically synthesized antibacterial ingredients that, while killing pathogens, also kill resident vaginal bacteria and beneficial bacteria, thus disrupting the vaginal microecological balance and potentially causing allergies or irritation. Long-term use can also reduce the vagina's resistance to pathogens. Therefore, this invention provides a feminine hygiene antibacterial care gel that can maintain the vaginal microecological balance. Summary of the Invention

[0005] To overcome the shortcomings of the prior art, the present invention provides a feminine antibacterial care gel. This care gel has good retention after use, can relieve gynecological inflammation, maintain the balance of vaginal flora, and keep the private parts healthy. It uses antibacterial ingredients with no risk of drug resistance to effectively kill a variety of pathogens. Moreover, the antibacterial ingredients are selective and will not indiscriminately kill symbiotic bacteria, thus maintaining the microecological balance of the private parts.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0007] The present invention provides a feminine intimate area antibacterial care gel, which, by weight percentage, contains the following components: 1-3% silver ion protein gel, 10-16% carbomer, 10-20% compound moisturizer, 0.04-0.08% complexing agent, and the balance being purified water.

[0008] The nursing gel provided by this invention can effectively kill a variety of pathogenic bacteria, such as Staphylococcus aureus and Candida albicans, quickly relieve gynecological inflammation, maintain the balance of vaginal flora, and thus solve vulvar itching, improve odor, restore vaginal pH, and prevent recurrent gynecological inflammation.

[0009] In some embodiments, the preparation steps of the silver ion protein gel are as follows: chitosan is dissolved in a 2-4 wt% aqueous acetic acid solution, silver nitrate is added and stirred for 1-2 hours, then the pH is adjusted to 3.5-4.5 using lactic acid and sodium hydroxide solution, followed by the addition of protein and stirring until homogeneous, and finally L-cysteine ​​is added and stirred until homogeneous to obtain the silver ion protein gel.

[0010] In some embodiments, the protein is any one of collagen, annexin, or soy protein.

[0011] Preferably, the protein is an annexin.

[0012] For healthy epidermal skin, nano-silver is preferred for its higher bactericidal efficiency, and the presence of the stratum corneum reduces the risk of accumulation in the body. However, under conditions of absorption by the vaginal mucosa and the presence of beneficial bacteria, the use of nano-silver may result in indiscriminate sterilization and the risk of residue in the human body. This invention preferably uses silver ions as the antibacterial agent, but pure silver ions are not commercially available. Most commercially available silver ion antibacterial agents are industrial products, which contain some chemicals that are highly irritating to human mucous membranes.

[0013] This invention synthesizes silver ion protein glue using non-toxic and low-irritant raw materials. The silver ion protein glue is uniformly mixed with the gel matrix, and with the intervention of the complexing agent in the formula, excessive fixation of silver ions by chitosan is avoided. The dynamic release balance of silver ions is maintained through competitive binding. In addition, the effective antibacterial components have no risk of drug resistance and are suitable for long-term care.

[0014] Firstly, compared to the lack of selectivity and indiscriminate killing of symbiotic bacteria by chemical bactericides, silver ions have a highly effective killing effect on pathogenic bacteria (such as Staphylococcus aureus and Escherichia coli), while having a weaker inhibitory effect on skin symbiotic bacteria (such as Staphylococcus epidermidis). This can reduce interference with beneficial bacteria and the risk of drug resistance. Furthermore, the combination of silver ions and chitosan can enhance the penetration of cell membranes and improve antibacterial efficiency.

[0015] Secondly, the annexin used in this protein glue can reduce inflammatory responses by inhibiting neutrophil extravasation and recruitment, relieving symptoms such as redness, swelling, and pain caused by vaginitis, and accelerating mucosal repair. In addition, annexin can not only form a synergistic antibacterial effect with chitosan, that is, after chitosan destroys the bacterial membrane structure, annexin will further interfere with microbial metabolism by binding to exposed phospholipids, but also the activity of annexin is affected by the vaginal pH environment (usually 3.8-4.5). The buffering effect of chitosan can effectively alleviate the limited activity of annexin.

[0016] Thirdly, the addition of this protein gel causes the gel to exhibit different fluidity after preparation and after being introduced into the human body, improving the sterilization utilization rate of the gel. This is because: after being introduced into the human body, the increase in temperature promotes the movement of molecular chain segments, and the physical cross-linking between the amino groups of chitosan and silver ions, carboxyl groups of proteins, etc., is enhanced, forming a tighter polymer network, and the viscosity increases significantly, thereby enhancing retention. In addition, the thiol groups of L-cysteine ​​easily reduce the rigid disulfide bonds of annexin at body temperature, causing annexin to undergo thermally induced folding, embedding in the hydrophobic region, and making it easier for the hydrophilic surface and the hydration layer of the mucosa to form hydrogen bonds, enhancing adhesion, and forming cross-linking points with chitosan through hydrogen bonds or coordination, further solidifying the gel network, capturing solvent molecules, and thus improving the retention of the gel.

[0017] In some embodiments, the mass ratio of chitosan to silver nitrate is (5.5–7.5):1.

[0018] In some embodiments, the mass ratio of chitosan to protein is 1:(0.15 to 0.25).

[0019] In some embodiments, the mass ratio of L-cysteine ​​to protein is (0.3-0.4):1.

[0020] In some embodiments, the degree of deacetylation of the chitosan is 72-85%.

[0021] The degree of deacetylation of chitosan can affect the immune response. High degree of deacetylation of chitosan may activate the TLR4 pathway, aggravate the local immune response, and thus aggravate inflammation.

[0022] In some embodiments, the compound moisturizer comprises aloe vera extract, chamomile extract, and glycerin.

[0023] In some embodiments, the mass ratio of the aloe vera extract, chamomile extract, and glycerin is (0.1–0.3):(0.1–0.2):1.

[0024] In this compound moisturizer, glycerin rapidly absorbs water on the skin surface and forms a film. Meanwhile, aloe polysaccharides from aloe vera extract and chamomile extract enhance film stability, reduce evaporation, and create a surface-locking moisture barrier. Furthermore, hyaluronic acid from aloe vera and α-bisabolol from chamomile increase mucosal moisture content. In addition to moisturizing effects, aloe polysaccharides also promote collagen synthesis and complement the mucosal repair function of annexin, enhancing the effectiveness of the moisturizing gel.

[0025] In some embodiments, the complexing agent is any one of disodium EDTA, sodium citrate, or sodium gluconate.

[0026] Preferably, the complexing agent is sodium gluconate.

[0027] This invention specifically selects sodium gluconate, which also has moisturizing properties, to gently chelate Ag+, reducing the redox reactions that silver ions may undergo during storage or use. This prevents silver ions from being reduced to elemental silver particles, reducing the risk of indiscriminate sterilization and human residue. Simultaneously, the reducing hydroxyl groups of sodium gluconate can indirectly protect the sulfhydryl groups of L-cysteine ​​from premature oxidation during storage, maintaining its reducing activity on annexin disulfide bonds. Furthermore, the complex of sodium gluconate and Ag+ may compete with the sulfhydryl groups of L-cysteine ​​for Ag+ binding through a "soft acid-soft base" interaction, reducing the oxidative damage of Ag+ to the thiol groups of annexin, thereby protecting the conformational integrity of annexin.

[0028] Another aspect of the present invention provides a method for preparing the above-mentioned nursing gel, the specific steps of which are as follows: first, carbomer is dissolved in purified water to form a gel, and then a composite moisturizer, a complexing agent and silver ion protein gel are added in sequence and stirred evenly to obtain the female private antibacterial nursing gel.

[0029] Compared with the prior art, the present invention has the following beneficial effects:

[0030] 1. This invention provides a feminine intimate area antibacterial care gel that uses antibacterial ingredients with no risk of drug resistance to effectively kill a variety of pathogens, thereby eliminating gynecological inflammation, maintaining the balance of vaginal flora, and keeping the intimate area healthy. At the same time, it improves and maintains the moisture of the mucosa through a compound moisturizer, and also gently chelates Ag+ with specially selected sodium gluconate with moisturizing function to reduce the possible oxidation-reduction reaction of silver ions during storage or use, avoid the formation of silver oxide, and maintain the antibacterial effect.

[0031] 2. The silver ion protein adhesive provided by this invention has silver ions, chitosan, annexin, and L-cysteine ​​as its main components. Among them, silver ions have a highly effective killing effect on pathogens and can reduce interference with beneficial bacteria and the risk of drug resistance. Furthermore, the combination of silver ions and chitosan can enhance the penetration of cell membranes and improve antibacterial efficiency. Annexin can reduce inflammatory response, relieve symptoms such as redness, swelling, and pain caused by vaginitis, and accelerate the repair of mucosa. It also forms a synergistic antibacterial effect with chitosan, and the buffering effect of chitosan effectively alleviates the limited activity of annexin in the vaginal pH environment.

[0032] 3. After being introduced into the human body, the gel of this invention further solidifies the gel network by enhancing physical cross-linking and the thermally induced folding of annexin by L-cysteine, thereby capturing solvent molecules and improving the gel's retention and bactericidal utilization rate. Furthermore, by using sodium gluconate to complex Ag+, the reduction of silver ions to silver elemental particles is prevented, reducing the risk of indiscriminate sterilization and human residue. Simultaneously, the reducing hydroxyl groups of sodium gluconate protect the sulfhydryl groups of L-cysteine ​​from premature oxidation, maintaining its reducing activity on annexin disulfide bonds. Detailed Implementation

[0033] The present invention will be described below with reference to specific embodiments. It should be noted that the following embodiments are examples of the present invention and are used only to illustrate the invention, not to limit it. Other combinations and various modifications within the scope of the present invention can be made without departing from its spirit or scope.

[0034] It is worth noting that, unless otherwise specified, the raw materials used in the following preparation examples and embodiments are all from any commercially available manufacturer: the degree of deacetylation of chitosan is 80%, and it was purchased from Shanghai Maokang Biotechnology Co., Ltd.

[0035] Preparation Example 1

[0036] The preparation steps of silver ion protein glue A are as follows:

[0037] Dissolve 60g of chitosan in 1800mL of 3wt% acetic acid aqueous solution, add 10g of silver nitrate and stir for 2h. Then adjust the pH to 4±0.1 using lactic acid and 0.1mol / L sodium hydroxide solution. Next, add 12g of annexin and stir until homogeneous. Finally, add 4.1g of L-cysteine ​​and stir until homogeneous to obtain silver ion protein glue A.

[0038] Preparation Example 2

[0039] The preparation steps of silver ion protein glue B differ from those in preparation example 1 in that the amount of silver nitrate used is 12g.

[0040] Preparation Example 3

[0041] The preparation steps of silver ion protein glue C differ from those in Preparation Example 1 in that the amount of silver nitrate used is 7.5g.

[0042] Preparation Example 4

[0043] The preparation steps of silver ion protein gel D differ from those in preparation example 1 in that the amount of annexin used is 6g.

[0044] Preparation Example 5

[0045] The preparation steps for silver ion protein gel E differ from those in Preparation Example 1 in that the amount of annexin used is 18g.

[0046] Preparation Example 6

[0047] The preparation steps of silver ion adhesive are as follows:

[0048] Dissolve 60g of chitosan in 1800mL of 3wt% acetic acid aqueous solution, add 10g of silver nitrate and stir for 2h, then adjust the pH to 6±0.2 with 0.1mol / L sodium hydroxide solution to obtain silver ion gel.

[0049] Preparation Example 7

[0050] The preparation steps of silver ion protein glue F are as follows:

[0051] Dissolve 60g of chitosan in 1800mL of 3wt% acetic acid aqueous solution, add 10g of silver nitrate and stir for 2h. Then adjust the pH to 4±0.1 using lactic acid and 0.1mol / L sodium hydroxide solution. Next, add 12g of annexin and stir until homogeneous to obtain silver ion protein glue F.

[0052] Example 1

[0053] A feminine intimate antibacterial care gel, by weight percentage, contains the following components: 2% silver ion protein gel A, 13% carbomer, 15% complex moisturizer, 0.06% sodium gluconate, and the balance being purified water;

[0054] The complex moisturizer contains 2.5% aloe vera extract, 1.5% chamomile extract, and 11% glycerin.

[0055] In this embodiment, the preparation steps of the antibacterial care gel for the female private parts are as follows: first, carbomer is dissolved in purified water to form a gel, and then a compound moisturizer, sodium gluconate and silver ion protein glue A are added in sequence and stirred evenly to obtain the antibacterial care gel for the female private parts.

[0056] Example 2

[0057] A feminine intimate antibacterial care gel, by weight percentage, contains the following components: 1% silver ion protein gel A, 10% carbomer, 10% complex moisturizer, 0.04% sodium gluconate, and the balance being purified water;

[0058] The complex moisturizer contains 0.9% aloe vera extract, 0.9% chamomile extract, and 8.2% glycerin.

[0059] The preparation steps of the antibacterial care gel for the female private parts in this embodiment are the same as in Embodiment 1.

[0060] Example 3

[0061] A feminine intimate antibacterial care gel, by weight percentage, contains the following components: 3% silver ion protein gel A, 16% carbomer, 20% complex moisturizer, 0.08% sodium gluconate, and the balance being purified water;

[0062] The complex moisturizer contains 4% aloe vera extract, 2.5% chamomile extract, and 13.5% glycerin.

[0063] The preparation steps of the antibacterial care gel for the female private parts in this embodiment are the same as in Embodiment 1.

[0064] Example 4

[0065] This embodiment provides a female private antibacterial care gel and its preparation method. The specific implementation method is the same as that in Embodiment 1, except that: silver ion protein gel A is replaced by an equal amount of silver ion protein gel B.

[0066] Example 5

[0067] This embodiment provides a female private antibacterial care gel and its preparation method. The specific implementation method is the same as that in embodiment 1, except that silver ion protein glue A is replaced by an equal amount of silver ion protein glue C.

[0068] Example 6

[0069] This embodiment provides a female private antibacterial care gel and its preparation method. The specific implementation method is the same as that in Embodiment 1, except that: silver ion protein gel A is replaced by an equal amount of silver ion protein gel D.

[0070] Example 7

[0071] This embodiment provides a female private antibacterial care gel and its preparation method. The specific implementation method is the same as that in Embodiment 1, except that: silver ion protein glue A is replaced by an equal amount of silver ion protein glue E.

[0072] Example 8

[0073] This embodiment provides a female private antibacterial care gel and its preparation method. The specific implementation method is the same as that in Embodiment 1, except that: silver ion protein gel A is replaced by an equal amount of silver ion protein gel F.

[0074] Example 9

[0075] This embodiment provides a feminine intimate antibacterial care gel and its preparation method. The specific implementation method is the same as that in Embodiment 1, except that the compound moisturizer contains 4% chamomile extract and 11% glycerin.

[0076] Comparative Example 1

[0077] This comparative example provides a female private antibacterial care gel and its preparation method. The specific implementation method is the same as that in Example 1, except that the silver ion protein glue A is replaced by an equal amount of silver ion glue.

[0078] Comparative Example 2

[0079] A feminine intimate antibacterial care gel, by weight percentage, contains the following components: 2% silver ion protein gel A, 13% carbomer, 15% complex moisturizer, and the balance being purified water;

[0080] The complex moisturizer contains 2.5% aloe vera extract, 1.5% chamomile extract, and 11% glycerin.

[0081] The preparation steps of the antibacterial care gel for the female private parts in this comparative example are the same as in Example 1.

[0082] Performance testing:

[0083] 1. Vaginal mucosal irritation test: Thirty-six ordinary female New Zealand rabbits, weighing 2–2.5 kg, were randomly divided into 12 groups, corresponding to Examples 1–9, Comparative Examples 1–2, and a control group, with 3 rabbits in each group. The experiment was conducted according to section 2.3.5 of the 2002 edition of the "Disinfection Technical Specifications". The rabbits were fixed supine, exposing the vaginal opening. A syringe was inserted 4 cm into the vaginal opening, and 2 mL of antibacterial gel sample was slowly injected. This injection was repeated every 24 hours for 5 consecutive days. The control group was treated with physiological saline in the same way. Two hours after the last injection, the animals were sacrificed, and the intact vagina was longitudinally cut open. The vagina was fixed in 10% formalin solution for 24 hours. Tissue sections were prepared from three locations: both ends and the center of the vagina. After HE staining, histopathological examination was performed. The histopathological examination results were scored according to the vaginal mucosal irritation reaction scoring standard, with a maximum score of 16 points. The results are shown in Table 1.

[0084] 2. Antibacterial test: This test was conducted on the gels provided in Examples 1-9, Comparative Examples 1-2, and the control group for 24 hours to characterize the antibacterial effect against Staphylococcus aureus ATCC 6538, Candida albicans ATCC 10231, and Escherichia coli ATCC 25922, which are pathogenic bacteria of the private parts. The specific operation was carried out in accordance with the "Disinfection Technical Specifications" (2002 edition). The results are shown in Table 1.

[0085] 3. Selective antibacterial test: Candida albicans ATCC 10231 and Lactobacillus acidophilus ATCC 4356 were inoculated into agar nutrient medium (the formula of which can be found in "Disinfection Technical Specifications" (2002 edition)) at a 1:1 ratio of live bacteria. The medium contained 5 wt% of the gel provided in Examples 1-9 and Comparative Examples 1-2. After culturing for 24 hours according to the standard method, the number of colonies of each bacterial population was counted. The results are shown in Table 2.

[0086] 4. Temperature-dependent flowability test: A Hakker rheometer was used with a shear rate of γ = 500 (1 / s) and temperatures of 20℃ and 37℃. The results are shown in Table 2.

[0087] Table 1

[0088]

[0089]

[0090] Table 2

[0091]

[0092] As shown in Table 1, compared to the control group, the gel provided by this invention has good inhibitory ability against pathogenic bacteria and low irritation to the vaginal mucosa. In Examples 1-3, variations in the amount of silver ion protein gel altered the concentration of the antibacterial component, thus changing the antibacterial rate and the irritation to the vaginal mucosa. Combined with the data in Table 2, this invention co-cultures resident bacteria of the private parts and pathogenic bacteria that disrupt the microecological balance in the same environment. The number of *Candida albicans* colonies decreased after culturing, while the number of *Lactobacillus acidophilus* increased. This simulated drug administration data indicates that the antibacterial gel provided by this invention has a certain degree of bactericidal selectivity. Simultaneously, changes in fluidity at different temperatures also indicate that the gel of this invention has good retention after use.

[0093] Combining the data in Tables 1 and 2, it can be seen that compared to Example 1, the increased silver ion concentration in Example 4, while improving the ability to resist pathogenic bacteria, also resulted in higher irritation to the vaginal mucosa due to the excessively high concentration, and also increased the kill rate of beneficial bacteria. In Example 5, the decreased silver ion concentration led to a decrease in the ability to inhibit pathogenic bacteria, which in turn limited the growth of beneficial bacteria. Further analysis of the increased irritation and decreased beneficial bacteria colony count in Comparative Example 2 (without sodium gluconate) suggests that sodium gluconate can reduce indiscriminate sterilization and irritation to the human body, possibly because it prevents silver ions from being reduced to elemental silver particles.

[0094] Compared to Example 1, Examples 6-7 changed the amount of annexin in the silver ion protein gel. This did not affect the bactericidal selectivity, but the change in amount affected the gel's fluidity. Further analysis of Comparative Example 1, which did not contain annexin, showed that annexin effectively alleviated mucosal congestion and swelling, but excessively high concentrations could cause rejection reactions. Simultaneously, the absence of annexin in Comparative Example 1 also affected its synergistic antibacterial effect with chitosan, leading to a decrease in the antibacterial rate. Compared to Example 1, the silver ion protein gel in Example 8 lacked the addition of L-cysteine, which is detrimental to improved retention after temperature increases, but has minimal impact on the bactericidal effect. Combining Examples 1 and 9, it is evident that the addition of aloe vera extract to the compound moisturizer can reduce irritation to the vaginal mucosa.

[0095] The embodiments and comparative examples described above do not limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A feminine intimate antibacterial care gel, characterized in that, The silver ion protein glue is prepared by the following steps: dissolving chitosan in 2-4 wt% acetic acid aqueous solution, adding silver nitrate and stirring for 1-2 h, then adjusting pH to 3.5-4.5 using lactic acid and sodium hydroxide solution, then adding protein and stirring until uniform, and finally adding L-cysteine and stirring until uniform. The protein is annexin. The mass ratio of chitosan to silver nitrate is (5.5-7.5):

1. The mass ratio of chitosan to protein is 1:(0.15-0.25). The degree of deacetylation of the chitosan is 72-85%.

2. The female intimate area antibacterial care gel of claim 1, wherein, The composite moisturizer comprises aloe barbadensis extract, chamomile extract and glycerol.

3. The female intimate area antibacterial care gel of claim 1, wherein, The mass ratio of the aloe barbadensis extract, chamomile extract and glycerol is (0.1-0.3):(0.1-0.2):

1.

4. The female intimate area antibacterial care gel of claim 3, wherein, The complexing agent is any one of disodium EDTA, sodium citrate or sodium gluconate.

5. The female intimate area antibacterial care gel of claim 1, wherein, The specific steps are as follows: first, dissolve the carbomer in purified water to form a gel, then add the composite moisturizer, the complexing agent and the silver ion protein glue in sequence and stir until uniform, thereby obtaining the female private part antibacterial care gel.

6. A process for the preparation of the gel for the aseptic care of the intimate parts of the female according to any one of claims 1-5, characterized in that, ​

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