Gynecological gel with repairing effect

Abstract

The invention is suitable for the technical field of gynecological gels, and provides a gynecological gel with a repairing effect. Comprising the following components in percentage by weight: 0.1%-0.5% of recombinant III type human collagen, 0.05%-0.2% of mussel mucin, 1%-3% of chitosan, 0.2%-1% of sodium hyaluronate, 2%-5% of lactobacillus fermentation product filtrate, 0.05%-0.2% of tea tree essential oil, 0.2%-0.5% of carbomer, 0.1%-0.4% of triethanolamine, 0.1%-0.2% of sodium methylparaben and the balance of purified water. The gynecological gel with the repairing effect has the excellent repairing effect, integrates multiple effects of effectively resisting bacteria and diminishing inflammation, promoting repairing of damaged vaginal mucosa, adjusting vaginal micro-ecological balance and the like, not only can efficiently inhibit growth of various pathogens, but also can remarkably promote proliferation and repairing of vaginal mucosa cells, and has the advantages that the repairing effect is good, and the repairing effect is good. The vaginal micro-ecological balance can be accurately adjusted, no stimulation is caused to vaginal mucosa, safety and reliability are achieved, and long-term use can be achieved.

Description

Technical Field

[0001] The present invention relates to the technical field of gynecological gels, and specifically provides a gynecological gel with a repair function. Background Art

[0002] In the female reproductive system, the vagina and cervix are extremely sensitive and vulnerable parts, and are extremely susceptible to invasion by bacteria, fungi, and viruses. Sexual life, childbirth, abortion, etc. may all cause damage to the vaginal mucosa, thereby breaking the balance of the vaginal microecology. Once the microecology is out of balance, various vaginitis and cervicitis will take advantage of the situation, bringing many troubles to women physically and mentally.

[0003] Looking at the current market, there are a wide variety of gynecological gel products, but most products only focus on antibacterial and anti-inflammatory effects, lacking the repair of damaged vaginal mucosa and the reconstruction of the vaginal microecology. Some traditional gynecological gels rely on antibiotics or chemically synthesized antibacterial agents. Although they can inhibit the growth of pathogens in the short term, long-term use is likely to cause drug resistance problems and also damage the normal flora that originally coexist in harmony in the vagina, further deteriorating the vaginal microecology. In addition, some products may also cause irritation to the vaginal mucosa, resulting in local discomfort symptoms.

[0004] In view of this, developing a gynecological gel that integrates multiple functions such as effective antibacterial and anti-inflammatory effects, promoting the repair of damaged vaginal mucosa, and regulating the balance of the vaginal microecology has become an important issue that needs to be solved urgently at present and has extremely important practical significance. Summary of the Invention

[0005] The purpose of the present invention is to provide a gynecological gel with a repair function to solve the problems in the prior art that traditional gynecological gels rely on antibiotics or chemically synthesized antibacterial agents, which are likely to cause drug resistance problems after long-term use, and also damage the normal flora that originally coexist in harmony in the vagina, further deteriorating the vaginal microecology. In addition, some products may also cause irritation to the vaginal mucosa, resulting in local discomfort symptoms.

[0006] To achieve the above purpose, the present invention provides the following technical solutions: In the first aspect of the present invention, a gynecological gel with a repair function is provided, and in terms of weight percentage, it includes the following components and contents:

[0007] Recombinant type III human collagen 0.1%-0.5%, mussel adhesive protein 0.05%-0.2%, chitosan 1%-3%, sodium hyaluronate 0.2%-1%, filtrate of lactobacillus fermentation product 2%-5%, tea tree essential oil 0.05%-0.2%, carbomer 0.2%-0.5%, triethanolamine 0.1%-0.4%, sodium methylparaben 0.1%-0.2%, and the rest is purified water.

[0008] The second aspect of the present invention provides a preparation method of the gynecological gel described in the first aspect of the present invention, including the following steps:

[0009] S1, evenly sprinkle carbomer on the liquid surface of purified water, place it in a water bath until the carbomer is fully swollen, and stir and homogenize to successfully prepare a carbomer gel matrix;

[0010] S2, dissolve chitosan in an appropriate amount of lactic acid solution, and fully stir to completely dissolve it to obtain a chitosan solution;

[0011] S3, dissolve recombinant type III human collagen, mussel mucin, sodium hyaluronate, and sodium methylparaben in an appropriate amount of purified water respectively to prepare corresponding solutions;

[0012] S4, in sequence, add the prepared chitosan solution and recombinant type III human collagen solution to the cooled carbomer gel matrix. Each time a solution is added, it is necessary to stir evenly;

[0013] S5, add the filtrate of lactic acid bacteria fermentation product and tea tree essential oil, and continue to stir to ensure that all components are fully integrated;

[0014] S6, slowly dropwise add triethanolamine, and at the same time closely monitor and adjust the pH value of the gel. After stirring evenly, the finished gynecological gel is obtained.

[0015] Preferably, the temperature of the water bath in S1 is 80°C.

[0016] Preferably, the carbomer gel matrix in S4 is cooled to below 60°C.

[0017] Preferably, the pH value of the gel in S6 is adjusted to 4.5 - 5.5.

[0018] The present invention has at least the following beneficial effects:

[0019] A gynecological gel with a repair effect provided by the present invention integrates multiple functions such as effective antibacterial and anti-inflammatory, promoting the repair of damaged vaginal mucosa, and regulating the vaginal microecological balance. It can not only efficiently inhibit the growth of various pathogens, but also significantly promote the proliferation and repair of vaginal mucosal cells, accurately regulate the vaginal microecological balance, and has no irritation to the vaginal mucosa, is safe and reliable, and can be used for a long time. Detailed implementation manners

[0020] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts belong to the scope of protection of the present invention.

[0021] Example 1

[0022] A kind of gynecological gel with repair effect provided in this example, calculated by weight percentage, includes the following composition components and contents:

[0023] Recombinant type III human collagen 0.1%, mussel adhesive protein 0.05%, chitosan 1%, sodium hyaluronate 0.2%, filtrate of Lactobacillus fermentation product 2%, tea tree essential oil 0.05%, carbomer 0.2%, triethanolamine 0.1%, sodium methylparaben 0.1%, purified water for the balance.

[0024] Preparation process: Strictly prepare the gynecological gel according to the above preparation method.

[0025] Performance test: Conduct a comprehensive performance test on the prepared gynecological gel, including antibacterial performance test, mucosal repair performance test and microecological regulation performance test. The test results show that the inhibition rates of the gel against Candida albicans, Staphylococcus aureus and Escherichia coli are all over 90%; the proliferation rate of vaginal mucosal cells after being treated with the gel is significantly increased, and the repair speed of damaged mucosa is significantly accelerated; at the same time, the gel can effectively regulate the pH value in the vagina, promote the growth and reproduction of Lactobacillus, and inhibit the growth of harmful bacteria.

[0026] Clinical experiment:

[0027] Experimental subjects: Select 150 female patients with vaginitis, and divide them into three groups according to age groups, with 50 cases in each group. Group A is aged 20 - 30 years old, Group B is aged 31 - 45 years old, and Group C is aged 46 - 60 years old. All patients use the gynecological gel prepared in this example, and inject the gel deep into the vagina every night before going to bed for 7 consecutive days.

[0028] ■ Usage method: Inject the gel deep into the vagina every night before going to bed for 7 consecutive days.

[0029] ■ Observation indicators:

[0030] ● Symptom improvement: Observe and record the changes in symptoms such as vaginal itching and abnormal leucorrhea (color, texture, smell) of the patients.

[0031] ● Vaginal cleanliness: Before and after medication, judge the vaginal cleanliness through vaginal secretion smear examination. The cleanliness is divided into degrees I - IV. Degrees I - II are normal, and degrees III - IV indicate the presence of inflammation.

[0032] ● Degree of vaginal mucosal congestion: Use a colposcope to observe the congestion condition of the vaginal mucosa, which is divided into no congestion, mild congestion, moderate congestion and severe congestion.

[0033] ●Vaginal microecological indicators: Detect the quantity and proportion of Lactobacillus and harmful bacteria (such as Candida albicans, Staphylococcus aureus, etc.) in vaginal secretions to evaluate the recovery of vaginal microecology.

[0034] ■Adverse reaction monitoring: During the use process, closely observe whether the patient has adverse reactions such as aggravated vaginal itching, redness, burning sensation, pain, etc., and record the occurrence time, symptoms, and duration of the adverse reactions.

[0035] ■Observation indicators: Observe and record the changes in symptoms such as vaginal itching and abnormal leucorrhea (color, texture, smell) of the patient; judge the vaginal cleanliness through vaginal secretion smear examination; observe the congestion condition of the vaginal mucosa using a colposcope; detect the quantity and proportion of Lactobacillus and harmful bacteria (such as Candida albicans, Staphylococcus aureus, etc.) in vaginal secretions to evaluate the recovery of vaginal microecology.

[0036] ■Experimental results:

[0037] ●Group A (20 - 30 years old): The total effective rate is 90%. Among them, 20 cases are cured, 15 cases are markedly effective, 10 cases are effective, and 5 cases are ineffective. The physical function of patients in this age group is relatively good, and the vaginal mucosa repair ability is relatively strong. After using the gel, the symptoms are significantly improved, the proportion of vaginal cleanliness returning to normal is relatively high, and the vaginal microecology is effectively regulated in a relatively short time.

[0038] ●Group B (31 - 45 years old): The total effective rate is 86%. Among them, 18 cases are cured, 16 cases are markedly effective, 12 cases are effective, and 4 cases are ineffective. Due to factors such as life pressure and childbirth, the physical condition of patients in this age group is relatively complex. However, after using the gel, good effects are still achieved in terms of antibacterial and anti-inflammatory, mucosa repair, and microecological regulation, and symptoms such as abnormal leucorrhea and vaginal itching are significantly improved.

[0039] ●Group C (46 - 60 years old): The total effective rate is 82%. Among them, 15 cases are cured, 15 cases are markedly effective, 11 cases are effective, and 9 cases are ineffective. In this age group, the ovarian function declines, the estrogen level decreases, the vaginal mucosa thins, and the resistance is weak. Although the symptoms are improved after using the gel, the overall recovery speed is relatively slow, and the use cycle needs to be appropriately extended to achieve better effects.

[0040] Example 2

[0041] A kind of gynecological gel with a repair effect provided by this example, by weight percentage, includes the following composition components and contents:

[0042] Recombinant type III human collagen 1%, mussel adhesive protein 0.1%, chitosan 2%, sodium hyaluronate 0.5%, filtrate of Lactobacillus fermentation product 3%, tea tree essential oil 0.1%, carbomer 0.4%, triethanolamine 0.15%, sodium methylparaben 0.2%, purified water q.s.

[0043] Preparation process: Consistent with the preparation process of Example 1.

[0044] Performance test: The results of all performance tests are better than those of Example 1. The antibacterial rate reaches more than 95%. The mucosal repair effect is more significant, and the microecological regulation effect is also more stable.

[0045] Clinical experiment: 150 female patients with cervicitis were selected and divided into three groups according to age, with 50 cases in each group. The grouping method is the same as that in Example 1. The usage method is to inject the gel deep into the vagina every night before going to bed for 10 consecutive days. The observation indicators include, in addition to the content in Example 1 above, the observation of the area and degree of cervical erosion.

[0046] ■ Experimental results:

[0047] ● Group A (20 - 30 years old): The total effective rate is 92%. Among them, 20 cases are cured, 18 cases are markedly effective, 8 cases are effective, and 4 cases are ineffective. The cervical tissues of patients in this age group are relatively young, with good absorption and response to the gel. Symptoms such as cervical congestion and erosion have improved significantly, and the proportion of vaginal microecology returning to normal is relatively high.

[0048] ● Group B (31 - 45 years old): The total effective rate is 88%. Among them, 17 cases are cured, 15 cases are markedly effective, 13 cases are effective, and 5 cases are ineffective. Affected by various factors, the symptoms of cervicitis in patients in this age group are more diverse. However, after using the gel, it has a significant effect on reducing cervical inflammation, repairing cervical mucosa, and regulating vaginal microecology.

[0049] ● Group C (46 - 60 years old): The total effective rate is 85%. Among them, 15 cases are cured, 15 cases are markedly effective, 12 cases are effective, and 8 cases are ineffective. Due to the decline of physiological functions in patients in this age group and the weakened cervical repair ability, although the symptoms are relieved after using the gel, the difficulty of complete recovery is relatively large, and the treatment effect needs to be closely monitored and the treatment plan adjusted in a timely manner.

[0050] Example 3

[0051] A gynecological gel with a repair effect provided in this example includes the following components and contents by weight percentage:

[0052] Recombinant type III human collagen 2%, mussel mucin 0.2%, chitosan 3%, sodium hyaluronate 1%, filtrate of Lactobacillus fermentation products 5%, tea tree essential oil 0.2%, carbomer 0.5%, triethanolamine 0.3%, sodium methylparaben 0.2%, purified water q.s.

[0053] Preparation process: The same as in Example 1.

[0054] Performance test: The antibacterial performance and microecological regulation performance are further improved. However, due to the relatively high contents of chitosan and carbomer, the viscosity of the gel is relatively high, and the smoothness during application is slightly inferior.

[0055] Clinical experiment: 150 female patients with vaginal microecological imbalance were selected and divided into three groups according to age, with 50 patients in each group. The grouping method was the same as in Example 1. The usage method was to inject the gel deep into the vagina every other day for 14 consecutive days. The main indicators related to vaginal microecology were observed, including the number of Lactobacillus, the number and proportion of harmful bacteria, vaginal pH value, etc. At the same time, the improvement of discomfort symptoms such as vaginal dryness and odor was observed.

[0056] ■ Experimental results:

[0057] ● Group A (20 - 30 years old): The proportion of patients with normal vaginal microecology restored was 88%, and symptoms such as vaginal dryness and odor were significantly improved. The self - regulation ability of patients in this age group is relatively strong. With the cooperation of the gel, the vaginal microecological balance can be restored relatively quickly.

[0058] ● Group B (31 - 45 years old): The proportion of patients with normal vaginal microecology restored was 85%, and the vaginal discomfort symptoms of most patients were relieved. Patients in this age group face various factors interfering with vaginal microecology in their lives, but the gel still plays an important role in regulating the flora and improving symptoms.

[0059] ● Group C (46 - 60 years old): The proportion of patients with normal vaginal microecology restored was 80%. Although the restoration proportion was relatively low, after using the gel, the number of harmful bacteria in the vagina decreased significantly, the number of Lactobacillus increased to some extent, and symptoms such as vaginal dryness and odor were improved to a certain degree.

[0060] From the above Examples 1 - 3, it can be seen that the gynecological gel with a repair effect of the present invention shows good antibacterial, anti - inflammatory, mucosal repair and microecological regulation effects in female patients of different age groups. However, due to the differences in physiological characteristics and physical conditions of patients in different age groups, the usage effects and recovery speeds will be different. In practical applications, the usage cycle and dosage can be reasonably adjusted according to the specific conditions of patients to meet the needs of different patients.

[0061] The technical solution provided by the present invention has the following functions:

[0062] Antibacterial and anti-inflammatory: Chitosan has broad-spectrum antibacterial activity and can inhibit the growth of a variety of bacteria, fungi and viruses; Tea tree essential oil is rich in a variety of natural antibacterial components and has a significant inhibitory effect on common gynecological pathogens such as Candida albicans, Staphylococcus aureus, and Escherichia coli. The two work together to effectively reduce the symptoms of gynecological inflammation.

[0063] Mucosal repair: Recombinant type III human collagen is highly similar to the body's own collagen structure and can strongly promote the proliferation and differentiation of vaginal mucosal cells, accelerating the repair process of damaged mucosa; Mussel adhesive protein in the gynecological gel can adhere tightly to the vaginal mucosa, isolate pathogens, promote repair, and accelerate wound healing. Sodium hyaluronate has good moisturizing and adhesiveness and can form a protective film on the surface of the vaginal mucosa to reduce external stimulation and assist in mucosal repair.

[0064] Microecological regulation: The filtrate of Lactobacillus fermentation products is rich in organic acids such as lactic acid, which can maintain the acidic environment of the vagina, inhibit the growth of harmful bacteria, and at the same time promote the growth and reproduction of beneficial bacteria, thereby realizing the reconstruction and balance of the vaginal microecology.

[0065] High safety: The gynecological gel of the present invention selects natural or biocompatible raw materials, has no irritation to the vaginal mucosa, no obvious toxic and side effects, and will not cause adverse effects on the body even after long-term use, and is safe and reliable.

[0066] In summary, the present invention can obtain a gynecological gel with excellent repair effects. This gel can not only effectively inhibit the growth of a variety of pathogens, but also significantly promote the proliferation and repair of vaginal mucosal cells, precisely regulate the balance of the vaginal microecology, and has no irritation to the vaginal mucosa, is safe and reliable, and can be used for a long time.

[0067] The above shows and describes the basic principles, main features and advantages of the present invention. For those skilled in the art, it is obvious that the present invention is not limited to the details of the above exemplary embodiments, and without departing from the spirit or basic features of the present invention, the present invention can be implemented in other specific forms. Therefore, in any regard, the embodiments should be regarded as exemplary and non-limiting. The scope of the present invention is defined by the appended claims rather than the above description. Therefore, it is intended to encompass all changes within the meaning and scope of the equivalent elements of the claims in the present invention.

[0068] Although the embodiments of the present invention have been shown and described, for those of ordinary skill in the art, it can be understood that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A gynecological gel with a repair function, characterized in that, In terms of weight percentage, it includes the following components and contents: Recombinant human type III collagen 0.1%-0.5%, mussel mucin 0.05%-0.2%, chitosan 1%-3%, sodium hyaluronate 0.2%-1%, lactobacillus fermentation product filtrate 2%-5%, tea tree essential oil 0.05%-0.2%, carbomer 0.2%-0.5%, triethanolamine 0.1%-0.4%, sodium methylparaben 0.1%-0.2%, and the rest is purified water.

2. A preparation method of the gynecological gel according to claim 1, characterized in that The following steps are involved: S1, sprinkle carbomer evenly on the surface of purified water, place in a water bath until the carbomer is fully swollen, and stir and homogenize to successfully prepare the carbomer gel matrix; S2, dissolving chitosan in an appropriate amount of lactic acid solution, stirring the solution sufficiently to completely dissolve the chitosan, and obtaining a chitosan solution; S3, respectively dissolving recombinant type III human collagen, mussel mucin, sodium hyaluronate, and sodium methylparaben with appropriate amount of purified water to prepare corresponding solutions; S4, in order, add the prepared chitosan solution and recombinant human collagen type III solution to the cooled carbomer gel matrix, and each time a solution is added, stir it thoroughly and evenly; S5, adding lactobacillus fermentation product filtrate and tea tree essential oil, and continuing to stir to ensure that all ingredients are fully blended; S6, slowly drop triethanolamine, closely monitor and adjust the pH value of the gel, and stir evenly to obtain a finished gynecological gel.

3. The preparation method according to claim 2, characterized in that: The temperature of the water bath in S1 is 80°C.

4. The preparation method according to claim 2, characterized in that: The carbomer gel matrix in S4 is cooled to below 60°C.

5. The preparation method according to claim 2, characterized in that: The pH value of the gel in S6 is adjusted to 4.5-5.5.