Female private part antibacterial nursing gel and preparation method thereof

Abstract

The invention relates to the technical field of nursing hygiene products, and particularly discloses a female private part antibacterial nursing gel and a preparation method thereof.The female private part antibacterial nursing gel is prepared from, by mass, 1%-3% of silver ion albumen glue, 10%-16% of carbomer, 10%-20% of a composite humectant, 0.04%-0.08% of a complexing agent and the balance purified water, and the mass percent of the silver ion albumen glue, the carbomer, the composite humectant, the complexing agent and the balance purified water are 100%. The gel provided by the invention is good in retention property, the antibacterial components without drug resistance risk are adopted to effectively kill various pathogenic bacteria and quickly relieve gynecological inflammation, and the antibacterial components have selectivity, do not indiscriminately kill symbiotic bacteria, and can maintain micro-ecological balance of private parts and keep the private parts healthy.

Description

Technical Field

[0001] The present invention belongs to the technical field of nursing and health products, and particularly relates to a female private part antibacterial nursing gel and a preparation method thereof. Background Art

[0002] The health of the female private part has always been an important issue in the field of gynecology. The skin and mucous membrane structure of the female private part are delicate and communicate with the outside world, making it easy to be invaded by pathogens such as bacteria and fungi, leading to problems such as gynecological inflammation. In addition, the microecological balance of the female private part is also crucial for health.

[0003] Female private part care products are topical preparations designed specifically for maintaining the health of the vagina and external genitalia. Their main functions include antibacterial and anti-inflammatory effects, regulating the microecological balance, and having a daily care role. For example, patent application CN119033678A discloses a female private part care gel and its preparation method and application, which uses tranexamic acid and glutathione in combination to provide antibacterial effects; another example is patent CN109078165B, a composition for female private part care and its preparation method and application, which rationally combines a variety of raw materials with cleaning, sterilizing, and maintenance effects, and can be used for a long time to protect the private part mucous membrane and prevent the invasion of pathogenic bacteria, where chlorhexidine acetate plays the main sterilizing role.

[0004] However, the bactericidal components in some existing care products are mostly chemically synthesized. While killing pathogenic bacteria, they will also kill the resident bacteria and probiotic flora in the vagina, thereby destroying the microecological balance of the local environment, and even causing allergies or irritation. Long-term use will reduce the resistance of the private part to pathogenic bacteria. Therefore, the present invention provides a female private part antibacterial nursing gel that can maintain the microecological balance. Summary of the Invention

[0005] In order to overcome the deficiencies of the above-mentioned prior art, the present invention provides a female private part antibacterial nursing gel. After use, the gel has good retention, can relieve gynecological inflammation, maintain the balance of vaginal flora, keep the private part healthy, effectively kill a variety of pathogenic bacteria with antibacterial components without the risk of drug resistance, and the antibacterial components are selective and will not kill symbiotic bacteria indiscriminately, thus maintaining the microecological balance of the private part.

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

[0007] On the one hand, the present invention provides a female private part antibacterial nursing gel, which, based on 100% by mass percentage, comprises the following components: 1 - 3% silver ion protein glue, 10 - 16% carbomer, 10 - 20% composite humectant, 0.04 - 0.08% complexing agent, and the balance being purified water.

[0008] The nursing gel provided by the present invention can effectively kill a variety of pathogenic bacteria, such as Staphylococcus aureus, Candida albicans, etc., quickly relieve gynecological inflammation, maintain the balance of vaginal flora; and then solve vulvar pruritus, improve abnormal odor, restore the vaginal pH value, and prevent the recurrence of gynecological inflammation.

[0009] In some embodiments, the preparation steps of the silver ion protein gel are as follows: Dissolve chitosan in an acetic acid aqueous solution of 2-4 wt%, add silver nitrate and stir for 1-2 h, then adjust the pH to 3.5-4.5 using lactic acid and sodium hydroxide solution, then add protein and stir evenly, and finally add L-cysteine and stir evenly to obtain the silver ion protein gel.

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

[0011] Preferably, the protein is annexin.

[0012] For healthy epidermal skin, preferably, nano silver can achieve higher bactericidal efficiency, and the presence of the stratum corneum reduces the risk of human accumulation. However, under the conditions of mucosal absorption in the female vagina and the presence of beneficial flora, the use of nano silver will cause undifferentiated sterilization and the risk of human residue. The present invention preferably uses silver ions as the antibacterial main body, but there is no pure silver ion sold on the market, and the sold silver ion antibacterial agents are mostly industrial use products, that is, they contain some chemical substances with greater irritation to human mucosa.

[0013] The present invention synthesizes a silver ion protein gel with non-toxic and low-irritating raw materials. The silver ion protein gel is evenly mixed with the gel matrix, and under the intervention of the complexing agent in the formula, it avoids the excessive fixation of silver ions by chitosan, maintains the dynamic release balance of silver ions through competitive binding. In addition, the antibacterial components that take effect have no risk of drug resistance and are suitable for long-term nursing use.

[0014] First, compared with the lack of selectivity of chemical bactericides and the disadvantage of undifferentiated killing of symbiotic bacteria, silver ions have a high killing effect on pathogenic bacteria (such as Staphylococcus aureus, Escherichia coli), while having a weak inhibitory effect on skin symbiotic bacteria (such as Staphylococcus epidermidis). It can reduce the interference with beneficial bacteria and the risk of drug resistance, and the combination of silver ions and chitosan can enhance the penetration of cell membranes and improve the antibacterial efficiency.

[0015] In a second aspect, the annexin used in the protein glue can reduce inflammatory reactions by inhibiting neutrophil extravasation and recruitment, relieve symptoms such as swelling and pain caused by vaginitis, and accelerate the repair of the mucosa. 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 the exposed phospholipids, and the activity of annexin is affected by the vaginal pH (usually 3.8 - 4.5) environment, and the buffering effect of chitosan can effectively relieve the limited activity of annexin.

[0016] In a third aspect, the addition of the protein glue enables the gel to exhibit different fluidities after preparation and after being incorporated into the human body, improving the bactericidal utilization rate of the gel. The reasons are as follows: After being incorporated into the human body, the increase in temperature promotes the movement of molecular segments, and the physical cross-linking between the amino group of chitosan and groups such as silver ions and the carboxyl group of proteins is enhanced, forming a denser polymer network, and the viscosity increases significantly, thereby enhancing the retention. In addition, the sulfhydryl group of L-cysteine can easily reduce the rigid disulfide bond of annexin at body temperature, causing annexin to undergo thermally induced folding, burying the hydrophobic region, and the hydrophilic surface is more likely to form hydrogen bonds with the hydrated layer of the mucosa, enhancing the adhesion, and forming cross-linking points with chitosan through hydrogen bonds or coordination, further solidifying the gel network and capturing solvent molecules, thereby 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 - 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 chitosan is 72 - 85%.

[0021] The degree of deacetylation of chitosan can affect the immune response. Chitosan with a high degree of deacetylation may activate the TLR4 pathway, exacerbate the local immune response, and further aggravate the inflammation.

[0022] In some embodiments, the composite humectant comprises aloe vera extract, chamomile extract, and glycerol.

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

[0024] In the composite humectant, glycerol rapidly absorbs water on the skin surface and forms a film. Meanwhile, aloe polysaccharide and chamomile polysaccharide in aloe vera extract and chamomile extract strengthen the stability of the film structure, reduce evaporation, and form water lock on the surface layer. Further, the hyaluronic acid of aloe and α-bisabolol of chamomile increase the water content of the mucosa. Besides the moisturizing effect, aloe polysaccharide can also promote the synthesis of collagen and complement the mucosal repair function of annexin, enhancing the effect of the nursing 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] In the present invention, sodium gluconate with both moisturizing functions is specifically selected to gently complex Ag⁺, reducing the possible redox reaction of silver ions during storage or use, avoiding the reduction of silver ions into silver elemental particles, and reducing the risks of non-discriminatory sterilization and human residue. At the same time, 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 the disulfide bonds of annexin. In addition, the complex of sodium gluconate and Ag⁺ may compete with the sulfhydryl groups of L-cysteine for binding to Ag⁺ through "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] On the other hand, the present invention provides a preparation method of the above-mentioned nursing gel, and the specific steps are as follows: First, dissolve carbomer in purified water to form a gel-like substance, and then successively add the composite humectant, the complexing agent and silver ion protein glue and stir evenly to obtain the female private part antibacterial nursing gel.

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

[0030] 1. The present invention provides a female private part antibacterial nursing gel, which uses antibacterial components without the risk of drug resistance to effectively kill a variety of pathogenic bacteria, thereby eliminating gynecological inflammation, maintaining the balance of vaginal flora, keeping the private part healthy. At the same time, the composite humectant is used to increase and maintain the mucosal moisture, and sodium gluconate with both moisturizing functions is specifically selected to gently complex Ag⁺, reducing the possible redox reaction of silver ions during storage or use, avoiding the formation of silver oxide, and maintaining the antibacterial effect.

[0031] 2. The silver ion protein glue provided by the present invention mainly consists of silver ions, chitosan, annexin, and L-cysteine. Among them, silver ions have a highly efficient killing effect on pathogenic bacteria, can also reduce the interference with beneficial bacteria and the risk of drug resistance, and the combination of silver ions and chitosan can enhance the penetration of cell membranes and improve the antibacterial efficiency; annexin can reduce inflammatory reactions, relieve symptoms such as swelling and pain caused by vaginitis, and accelerate the repair of mucous membranes. 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 the gel of the present invention is incorporated into the human body, by enhancing the physical cross-linking effect and the heat-induced folding of L-cysteine on annexin, the gel network is further solidified to capture solvent molecules, thereby improving the retention of the gel and the bactericidal utilization rate of the gel. On this basis, gluconic acid sodium is used to complex Ag+, avoiding the reduction of silver ions into silver single particles, reducing the risk of non-discriminatory sterilization and human residue. At the same time, the reducing hydroxyl group of gluconic acid sodium protects the sulfhydryl group of L-cysteine from being prematurely oxidized, maintaining its reducing activity on the disulfide bond of annexin. Detailed implementation manners

[0033] The following will illustrate the present invention in combination with specific implementation examples. It should be noted that the following examples are examples of the present invention, only used to illustrate the present invention, and not used to limit the present invention. Without departing from the gist or scope of the present invention, other combinations and various improvements within the concept of the present invention can be made.

[0034] It is worth noting that the raw materials used in the following preparation examples and examples, if not specifically stated, are from any commercially available manufacturer: the deacetylation degree of chitosan is 80%, 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 60 g of chitosan in 1800 mL of acetic acid aqueous solution with a concentration of 3 wt%, add 10 g of silver nitrate and stir for 2 h, then use lactic acid and 0.1 mol / L sodium hydroxide solution to adjust the pH to 4 ± 0.1, then add 12 g of annexin and stir evenly, and finally add 4.1 g of L-cysteine and stir evenly to obtain silver ion protein glue A.

[0038] Preparation Example 2

[0039] The difference in the preparation steps of silver ion protein glue B from Preparation Example 1 is that the dosage of silver nitrate is 12 g.

[0040] Preparation Example 3

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

[0042] Preparation Example 4

[0043] The preparation steps of silver ion protein glue D are different from those of Preparation Example 1 in that the amount of annexin used is 6 g.

[0044] Preparation Example 5

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

[0046] Preparation Example 6

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

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

[0049] Preparation Example 7

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

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

[0052] Example 1

[0053] A female private part antibacterial care gel, calculated by 100% by mass percentage, comprises the following components: 2% silver ion protein glue A, 13% carbomer, 15% compound moisturizer, 0.06% sodium gluconate, and the balance is purified water;

[0054] The compound moisturizer comprises 2.5% aloe vera extract, 1.5% chamomile extract and 11% glycerol.

[0055] The preparation steps of the female private part antibacterial care gel in this example are as follows: first dissolve carbomer in purified water to form a gel-like substance, and then sequentially add the compound moisturizer, sodium gluconate and silver ion protein glue A and stir evenly to obtain the female private part antibacterial care gel.

[0056] Example 2

[0057] A female private part antibacterial care gel, calculated by 100% of the mass percentage, contains the following components: 1% silver ion protein glue A, 10% carbomer, 10% compound moisturizer, 0.04% sodium gluconate, and the balance is purified water;

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

[0059] In this embodiment, the preparation steps of the female private part antibacterial care gel are the same as those in Embodiment 1.

[0060] Example 3

[0061] A female private part antibacterial care gel, calculated by 100% of the mass percentage, contains the following components: 3% silver ion protein glue A, 16% carbomer, 20% compound moisturizer, 0.08% sodium gluconate, and the balance is purified water;

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

[0063] In this embodiment, the preparation steps of the female private part antibacterial care gel are the same as those in Embodiment 1.

[0064] Example 4

[0065] This embodiment provides a female private part antibacterial care gel and its preparation method. The specific implementation manner 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 B.

[0066] Example 5

[0067] This embodiment provides a female private part antibacterial care gel and its preparation method. The specific implementation manner 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 part antibacterial care gel and its preparation method. The specific implementation manner 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 D.

[0070] Example 7

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

[0074] Example 9

[0075] This embodiment provides a female private part antibacterial care gel and a preparation method thereof. The specific implementation manner is the same as that of Embodiment 1, except that: the composite moisturizer contains 4% chamomile extract and 11% glycerol.

[0076] Comparative Example 1

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

[0078] Comparative Example 2

[0079] A female private part antibacterial care gel, calculated by 100% by mass percentage, contains the following components: 2% silver ion protein glue A, 13% carbomer, 15% composite moisturizer, and the balance is purified water;

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

[0081] The preparation steps of the female private part antibacterial care gel in this comparative example are the same as those of Embodiment 1.

[0082] Performance test:

[0083] 1. Vaginal Mucosa Irritation Test: Thirty-six ordinary-grade female New Zealand rabbits weighing 2 - 2.5 kg were selected and randomly divided into 12 groups, corresponding to Examples 1 - 9, Comparative Examples 1 - 2, and the control group, with 3 rabbits in each group. The test was conducted according to 2.3.5 in the "Disinfection Technical Specifications" (2002 Edition). The rabbits were fixed on their backs, the vaginal orifice was exposed, a syringe was inserted 4 cm into the vaginal orifice, and 2 mL of the antibacterial gel sample was slowly injected. The injection was repeated every 24 h for 5 consecutive days. The control group was treated with normal saline in the same way. After the last injection and 2 h of placement, the animals were sacrificed, the intact vagina was longitudinally incised, and the vagina was fixed in 10% formalin solution for 24 h. Tissues from 3 parts at both ends and the center of the vagina were selected for making slides, and after HE staining, histopathological examination was carried out. The histopathological examination results were scored according to the vaginal mucosa irritation reaction scoring standard, with the maximum score being 16 points. The results are shown in Table 1.

[0084] 2. Antibacterial Test: This test conducted a 24-hour antibacterial test on the gels provided in Examples 1 - 9, Comparative Examples 1 - 2, and the control group to characterize the antibacterial effects against the private part pathogenic bacteria Staphylococcus aureus ATCC 6538, Candida albicans ATCC 10231, and Escherichia coli ATCC 25922. The specific operation was referred to the "Disinfection Technical Specifications" (2002 Edition). The results are shown in Table 1.

[0085] 3. Selective Antibacterial Experiment: Candida albicans ATCC 10231 and Lactobacillus acidophilus ATCC 4356 were inoculated into an agar nutrient medium (the formula is referred to the "Disinfection Technical Specifications" (2002 Edition)) at a live bacteria count ratio of 1:1. The medium contained 5 wt% of the gels provided in Examples 1 - 9 and Comparative Examples 1 - 2. After culturing for 24 hours according to the standard method, the colony numbers of each bacterial population were counted. The results are shown in Table 2.

[0086] 4. Temperature Change Fluidity Test: Using a Hakker rheometer, the shear rate was γ = 500 (1 / s), and the temperatures were 20°C and 37°C respectively. The results are shown in Table 2.

[0087] Table 1

[0088]

[0089]

[0090] Table 2

[0091]

[0092] As can be seen from the data in Table 1, compared with the control group, the gel provided by the present invention has good inhibitory ability against pathogenic bacteria and low irritation to vaginal mucosa. Among Examples 1-3, due to the change in the dosage of silver ion protein glue, the concentration of antibacterial components changes, and then the antibacterial rate changes. At the same time, the irritation to vaginal mucosa also changes. Combining the data in Table 2, it can be known that the present invention co-cultures the resident bacteria in the private parts and the pathogenic bacteria that cause the disruption of the microecological balance in the same environment. Among them, the colony number of Candida albicans decreases after cultivation, while Lactobacillus acidophilus increases. This simulated drug administration data shows that the antibacterial gel provided by the present invention has certain bactericidal selectivity; at the same time, the change in fluidity at different temperatures also indicates that the gel of the present invention has good retention after use.

[0093] Combining the data in Table 1 and Table 2, it can be known that compared with Example 1, the silver ion concentration in Example 4 increases. Although the ability to resist pathogenic bacteria has improved, too high a concentration has a higher irritation to vaginal mucosa, and at the same time, it also increases the killing rate of beneficial bacteria; the silver ion concentration in Example 5 decreases, resulting in a decrease in the ability to inhibit pathogenic bacteria, and further limiting the growth of beneficial bacteria. Further combining the increased irritation and the decrease in the colony number of beneficial bacteria in Comparative Example 2 without adding sodium gluconate, it can be seen that sodium gluconate can reduce non-discriminatory sterilization and irritation to the human body. The possible reason is that it avoids the reduction of silver ions into silver single particles.

[0094] Compared with Example 1, Examples 6-7 changed the dosage of annexin in the silver ion protein glue, which did not affect the bactericidal selectivity, but the change in its dosage would affect the fluidity of the gel. Further combining Comparative Example 1 without adding annexin, it can be seen from the irritation score of the mucosa that annexin effectively alleviates the congestion and swelling of the mucosa, but too high a concentration may also cause rejection reactions; at the same time, the absence of annexin in Comparative Example 1 will also affect its synergistic antibacterial effect with chitosan, resulting in a decrease in the antibacterial rate. Compared with Example 1, Example 8 lacks the addition of L-cysteine in the silver ion protein glue, which is not conducive to the improvement of retention after the temperature rises, but has little effect on the bactericidal effect. Combining Example 1 and Example 9, it can be seen that the addition of Aloe vera extract in the composite moisturizer can reduce the irritation to vaginal mucosa.

[0095] The above-mentioned examples and comparative examples do not impose any formal restrictions on the present invention. Although the present invention has been disclosed above with preferred examples, it is not intended to limit the present invention. Any person skilled in the art, without departing from the scope of the technical solution of the present invention, can make some changes or modifications to equivalent embodiments by using the above-disclosed technical content. However, as long as it does not depart from the content of the technical solution of the present invention, any simple modification, equivalent change and modification made to the above examples based on the technical essence of the present invention still belong to the scope of the technical solution of the present invention.

Claims

1. A female private part antibacterial care gel, characterized in that, By mass percentage of 100%, it contains the following components: 1-3% silver ion protein glue, 10-16% carbomer, 10-20% compound moisturizer, 0.04-0.08% complexing agent, and the balance is purified water.

2. The female private part antibacterial care gel according to claim 1, characterized in that, The preparation steps of the silver ion protein glue are as follows: Dissolve chitosan in 2-4 wt% acetic acid aqueous solution, add silver nitrate and stir for 1-2 h, then adjust the pH to 3.5-4.5 using lactic acid and sodium hydroxide solution, then add protein and stir evenly, and finally add L-cysteine and stir evenly to obtain silver ion protein glue.

3. The female private part antibacterial care gel according to claim 2, characterized in that, The protein is any one of collagen, annexin, and soy protein.

4. The female private part antibacterial care gel according to claim 2, characterized in that The mass ratio of chitosan to silver nitrate is (5.5-7.5):

1.

5. The female private part antibacterial care gel according to claim 2, characterized in that, The mass ratio of chitosan to protein is 1:(0.15-0.25).

6. The female private part antibacterial care gel according to claim 2, characterized in that The deacetylation degree of the chitosan is 72-85%.

7. The female private part antibacterial care gel according to claim 1, wherein The compound moisturizer contains Aloe vera extract, chamomile extract, and glycerol.

8. The female private part antibacterial care gel according to claim 7, characterized in that, The mass ratio of the Aloe vera extract, chamomile extract, and glycerol is (0.1-0.3):(0.1-0.2):

1.

9. The female private part antibacterial care gel according to claim 1, characterized in that, The complexing agent is any one of disodium EDTA, sodium citrate, or sodium gluconate.

10. A method for preparing the female private part antibacterial care gel according to any one of claims 1-9, characterized in that, The specific steps are as follows: First, dissolve carbomer in purified water to form a gel, then sequentially add the compound moisturizer, complexing agent, and silver ion protein glue and stir evenly to obtain the female private part antibacterial care gel.

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