Female vaginal sensitivity regulator based on stem cells and preparation method thereof

Abstract

The invention discloses a female vaginal sensitivity regulator based on stem cells and a preparation method thereof, and belongs to the technical field of biology, the female vaginal sensitivity regulator comprises mesenchymal stem cells, tomaroside A, glycerol, a scutellaria baicalensis extract and a stem cell carrier, and a vaginal injection ointment is obtained by uniformly mixing the mesenchymal stem cells, the tomaroside A, the glycerol, the scutellaria baicalensis extract and the stem cell carrier through a proper amount of deionized water. The mesenchymal stem cells added in the application can be colonized in the vaginal epithelium and vaginal environment to promote differentiation into functional cells and secrete EGF, VEGF and other regenerative factors, collagen synthesis and angiogenesis are further promoted, the thickness of atrophic mucosa is increased, glycogen secretion and lactic acid bacteria microecology are recovered, the pH acid environment is maintained, and the problem of dryness is solved. Through the synergistic effect of the tomato steroid glycoside A and the radix scutellariae extract, the differentiation expression of the mesenchymal stem cells can be promoted while local inflammatory factors are inhibited. The low-molecular-weight lycium barbarum polysaccharide provides osmotic pressure protection, so that the survival rate of stem cells is

Description

Technical Field

[0001] This invention relates to the field of biopharmaceutical technology, specifically to a stem cell-based female vaginal sensitivity modifier and its preparation method. Background Technology

[0002] Low vaginal sensitivity, particularly vaginal dryness, is a common symptom of female reproductive system issues. It primarily manifests as insufficient vaginal mucosal secretion, leading to significantly reduced lubrication. This results in burning pain, itching, difficulty with intercourse, and repeated mucosal damage during intercourse, severely impacting women's quality of life. The main causes of these symptoms include: menopause caused by declining estrogen levels, lactation, or premature ovarian failure, leading to thinning of the vaginal epithelium, reduced glycogen, lactobacillus imbalance, and increased pH; local inflammatory reactions such as atrophic vaginitis and Sjögren's syndrome; and iatrogenic factors caused by long-term use of antidepressants or antihistamines, which seriously affect quality of life and mental health.

[0003] With the development of technology, more and more women are paying attention to this condition and seeking targeted treatment. Currently, the main treatment methods include: using vaginal moisturizers to lubricate and moisturize the vagina, which requires frequent use and can only temporarily relieve dryness, but cannot repair atrophied mucosa, so the treatment effect is not significant; using estrogen suppositories inserted into the vagina, which can effectively thicken the epithelial layer, but there are strict contraindications, such as being contraindicated in people with a history of breast cancer, endometrial cancer, or thrombosis, and long-term use may increase the risk of estrogen-dependent tumors; and new targeted drugs, such as oral selective estrogen receptor modulators, which are expensive and difficult to meet the needs of patients from all walks of life.

[0004] Stem cell therapy is a rapidly developing field. Regarding the improvement of vaginal dryness in women, a vaginal spray containing mesenchymal stem cell factors and its preparation method, published under patent number CN108992662A, utilizes mesenchymal stem cell factors in combination with other components to treat vaginal dryness and provides a method for culturing mesenchymal stem cells. However, it does not directly utilize stem cells, which is a direction that needs further development and exploration.

[0005] Therefore, how to develop a stem cell-based vaginal sensitivity modulator that can provide long-lasting relief from vaginal dryness after injection is a technical problem that urgently needs to be solved by those skilled in the art. Summary of the Invention

[0006] Therefore, this invention provides a stem cell-based female vaginal sensitivity modifier and its preparation method to solve the related technical problems existing in the prior art.

[0007] In order to achieve the above object, the present invention provides the following technical solutions: According to a first aspect of the present invention, a stem cell-based female vaginal sensitivity modulator is provided, comprising the following components in percentage: Mesenchymal stem cells 0.1-1.5% Tomatosteroid A 0.001-0.05% 3-5% glycerin Scutellaria baicalensis extract 0.5-0.8% Stem cell carrier 1-10% The vaginal injection ointment is obtained by mixing an appropriate amount of deionized water evenly.

[0008] Furthermore, the mesenchymal stem cells are 1 x 102 6 -10 7 per mL.

[0009] Furthermore, the stem cell carrier is composed of 10-15 parts by weight of chitosan and 3-6 parts by weight of wolfberry polysaccharide dissolved and mixed in deionized water.

[0010] Furthermore, the molecular weight of the wolfberry polysaccharide is 20-50 kDa.

[0011] Furthermore, the mesenchymal stem cells are adipose-derived mesenchymal stem cells, bone marrow mesenchymal stem cells, umbilical cord mesenchymal stem cells, or placental mesenchymal stem cells.

[0012] Furthermore, the mesenchymal stem cells are passaged to the P3-P5 generation.

[0013] According to a second aspect of the present invention, a method for preparing a stem cell-based female vaginal sensitivity modifier is provided, comprising the following steps: Weigh out glycerol and stem cell carrier according to the proportions and dissolve them in an appropriate amount of deionized water. Stir and mix until homogeneous to form mixture 1 for later use. Weigh out tomato steroidal A and scutellaria baicalensis extract according to the proportions and add them to the above mixture 1. Stir and mix until uniform to form mixture 2 for later use. Cool the above mixture 2 to 5-10℃, weigh out the mesenchymal stem cells according to the ratio and add them to the above mixture 2, stir and mix until uniform to form a vaginal injection ointment, and store at low temperature.

[0014] Furthermore, the preparation method of the stem cell carrier is as follows: Weigh out chitosan and add it to ultrapure water containing 0.5% acetic acid. Adjust the pH to 5.0-5.5 and stir magnetically in a 60℃ water bath for 2 hours until completely dissolved. Weigh out the wolfberry polysaccharide and add it to sterilized PBS. Shake at 37°C for 30 minutes until completely dissolved. Add the wolfberry polysaccharide solution dropwise to the chitosan solution according to the ratio, stirring while adding. After stirring magnetically at 200 rpm for 1 hour, slowly add NaOH solution to adjust the pH of the mixture to 6.8-7.2, and set aside.

[0015] Furthermore, the preparation method of Scutellaria baicalensis extract is as follows: Select dried Scutellaria baicalensis root, pulverize it with a pulverizer and pass it through a 40-mesh sieve. Weigh the Scutellaria baicalensis root powder that passes through the sieve and add it to 60-70% ethanol for soaking. Reflux it twice in an 80℃ water bath for 2 hours. The extracts were combined and filtered through a 200-mesh filter cloth to obtain a clear filtrate. The filtrate was then rotary evaporated to 1 / 10 of its original volume under a controlled temperature of 50℃ and a pressure of -0.08 MPa to obtain an extract for later use.

[0016] According to a third aspect of the present invention, the use of a stem cell-based female vaginal sensitivity modifier in the preparation of a female vaginal sensitivity modifier is provided.

[0017] The present invention has the following advantages: The mesenchymal stem cells added in this application can colonize the vaginal epithelium. The vaginal environment promotes their differentiation into functional cells and the secretion of regenerative factors such as EGF and VEGF, further promoting collagen synthesis and angiogenesis, increasing the thickness of atrophic mucosa, restoring glycogen secretion and lactic acid bacteria microecology, maintaining an acidic pH environment, and solving the problem of dryness. Through the synergistic effect of lycopene A and Scutellaria baicalensis extract, local inflammatory factors are inhibited while also promoting the differentiation and expression of mesenchymal stem cells. The three-dimensional network of stem cell carriers constructed by chitosan and Lycium barbarum polysaccharides can encapsulate and protect the added mesenchymal stem cells. The cationic chains of chitosan enhance mucosal adhesion, prolonging the retention time of mesenchymal stem cells, while low molecular weight Lycium barbarum polysaccharides provide osmotic pressure protection, significantly improving the survival rate of stem cells. Detailed Implementation

[0018] The following specific embodiments illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0019] According to a first aspect of the present invention, a stem cell-based female vaginal sensitivity modulator is provided, comprising the following components in percentage: Mesenchymal stem cells 0.1-1.5% Tomatosteroid A 0.001-0.05% 3-5% glycerin Scutellaria baicalensis extract 0.5-0.8% Stem cell carrier 1-10% The vaginal injection ointment is obtained by mixing an appropriate amount of deionized water evenly.

[0020] Furthermore, the mesenchymal stem cells were 1 x 102 6 -10 7 per mL.

[0021] Furthermore, the stem cell carrier is composed of 10-15 parts by weight of chitosan and 3-6 parts by weight of wolfberry polysaccharide dissolved and mixed in deionized water.

[0022] Furthermore, the molecular weight of wolfberry polysaccharides is 20-50 kDa.

[0023] Furthermore, mesenchymal stem cells can be adipose-derived mesenchymal stem cells, bone marrow mesenchymal stem cells, umbilical cord mesenchymal stem cells, or placental mesenchymal stem cells.

[0024] Furthermore, the mesenchymal stem cells were passaged to the P3-P5 generation.

[0025] According to a second aspect of the present invention, a method for preparing a stem cell-based female vaginal sensitivity modifier is provided, comprising the following steps: Weigh out glycerol and stem cell carrier according to the proportions and dissolve them in an appropriate amount of deionized water. Stir and mix until homogeneous to form mixture 1 for later use. Weigh out tomato steroidal A and scutellaria baicalensis extract according to the proportions and add them to the above mixture 1. Stir and mix until uniform to form mixture 2 for later use. Cool the above mixture 2 to 5-10℃, weigh out the mesenchymal stem cells according to the ratio and add them to the above mixture 2, stir and mix until uniform to form a vaginal injection ointment, and store at low temperature.

[0026] Furthermore, the preparation method of the stem cell carrier is as follows: Weigh out chitosan and add it to ultrapure water containing 0.5% acetic acid. Adjust the pH to 5.0-5.5 and stir magnetically in a 60℃ water bath for 2 hours until completely dissolved. Weigh out the wolfberry polysaccharide and add it to sterilized PBS. Shake at 37°C for 30 minutes until completely dissolved. Add the wolfberry polysaccharide solution dropwise to the chitosan solution according to the ratio, stirring while adding. After stirring magnetically at 200 rpm for 1 hour, slowly add NaOH solution to adjust the pH of the mixture to 6.8-7.2, and set aside.

[0027] Furthermore, the preparation method of Scutellaria baicalensis extract is as follows: Select dried Scutellaria baicalensis root, pulverize it with a pulverizer and pass it through a 40-mesh sieve. Weigh the Scutellaria baicalensis root powder that passes through the sieve and add it to 60-70% ethanol for soaking. Reflux it twice in an 80℃ water bath for 2 hours. The extracts were combined and filtered through a 200-mesh filter cloth to obtain a clear filtrate. The filtrate was then rotary evaporated to 1 / 10 of its original volume under a controlled temperature of 50℃ and a pressure of -0.08 MPa to obtain an extract for later use.

[0028] According to a third aspect of the present invention, the use of a stem cell-based female vaginal sensitivity modifier in the preparation of a female vaginal sensitivity modifier is provided.

[0029] To better illustrate the technical effects of the present invention, specific embodiments are provided below.

[0030] Preparation Example 1 The preparation method of stem cell vectors is as follows: Take 12g of chitosan (purchased from Shanghai Aladdin Biochemical Technology Co., Ltd.) and add it to 500mL of ultrapure water containing 0.5% acetic acid. The pH is 5.0-5.5. Stir the mixture magnetically in a water bath at 200rpm and 60℃ for 2 hours until it is completely dissolved and free of particles. Set aside for later use.

[0031] Add 4g of Lycium barbarum polysaccharide (purchased from Beijing Solarbio Science & Technology Co., Ltd.) to 500mL of sterile PBS, and gently shake at 37℃ for 30min until completely dissolved. Be careful to avoid foaming during the shaking process.

[0032] Add the wolfberry polysaccharide solution dropwise to the chitosan solution while stirring. After stirring magnetically at 200 rpm for 1 hour, slowly add a 1M NaOH solution to adjust the pH of the mixture to 6.8-7.2. Set aside for later use.

[0033] The above-mentioned dropwise addition process is best performed at room temperature in the dark, and the pH adjusted above should be close to the physiological pH to avoid damaging stem cells after preparation.

[0034] Next, the cells were pre-frozen at -80℃ for 6 hours and then freeze-dried for another 24 hours to obtain freeze-dried stem cell carriers. These carriers were then irradiated with gamma rays at a dose of 15-25 kGy and sterilized for later use.

[0035] Preparation Example 2 The preparation method of Scutellaria baicalensis extract is as follows: Select 200g of dried Scutellaria baicalensis root (purchased commercially), pulverize it using a pulverizer and pass it through a 40-mesh sieve. Weigh 100g of the sieved Scutellaria baicalensis root powder and add it to 1.5L of 60-70% ethanol for soaking. Reflux it twice in an 80℃ water bath for 2 hours.

[0036] The extracts were combined and filtered through a 200-mesh filter cloth to obtain a clear filtrate. The filtrate was then filtered through a 0.22 μm filter membrane for sterilization. The temperature was controlled at 50℃ and the pressure at -0.08 MPa. The filtrate was then rotary evaporated to 1 / 10 of its original volume to obtain an extract for later use.

[0037] Preparation Example 3 Preparation of stem cells The mesenchymal stem cells used in this embodiment are umbilical cord mesenchymal stem cells, purchased from Shanghai Xinyu Biotechnology Co., Ltd.

[0038] Cell resuscitation: Thaw cryovials containing 1 mL of cell suspension rapidly by shaking in a 37°C water bath. Add 5 mL of 10% fetal bovine serum and penicillin-streptomycin-containing complete umbilical cord mesenchymal stem cell culture medium, and mix thoroughly. Centrifuge at 800 rpm for 5 min, discard the supernatant, and add 4-6 mL of the above complete culture medium, then rehydrate. Add the cell suspension to a culture flask and incubate overnight in a 5% CO2 incubator at 37°C. Change the medium the next day and check the cell density. When the cell density reaches 80%-90%, passage culture can be performed.

[0039] Cell passage: Discard the culture supernatant and wash the cells 1-2 times with calcium- and magnesium-free PBS. Add 1-2 mL of cell digestion solution containing 0.25% trypsin to the culture flask and incubate at 37°C for 1-2 min. Observe the cell digestion under a microscope. After complete digestion, add 5 mL of complete culture medium containing 10% fetal bovine serum to stop the digestion. Gently pipette the cells until they are completely detached, then aspirate and centrifuge at 800 rpm for 10 min. Discard the supernatant and add 1-2 mL of culture medium, then mix well. Prepare the above culture medium at a ratio of 5 mL / flask. Seed the cell suspension at a 1:5 ratio into new culture flasks for passage. Collect the cells at P4 for later use.

[0040] Example 1 This embodiment provides a method for preparing a stem cell-based female vaginal sensitivity modifier, including the following steps: Weigh out 3g of glycerol and 1g of the stem cell carrier from Preparation Example 1 according to the proportion and dissolve them in 96mL of deionized water. Stir and mix until homogeneous to form Mixture 1 for later use. Weigh out 0.001g of tomato steroidal glycoside A and 0.5g of Scutellaria baicalensis extract from Preparation Example 2 according to the proportions, add them to the above mixture 1, and stir until uniform to form mixture 2 for later use; Cool the above mixture 2 to 5-10℃, and weigh 0.1 mL of mesenchymal stem cells from Preparation Example 3 (cell concentration 1X10) according to the ratio. 7 Add the product (1) to the above mixture 2, stir and mix until uniform to form a vaginal injection ointment, and store at low temperature.

[0041] Example 2 This embodiment provides a method for preparing a stem cell-based female vaginal sensitivity modifier, including the following steps: Weigh out 5g of glycerol and 10g of the stem cell carrier from Preparation Example 1 according to the proportion and dissolve them in 83mL of deionized water. Stir and mix until uniform to form Mixture 1 for later use. Weigh out 0.05g of tomato steroidal glycoside A and 0.8g of Scutellaria baicalensis extract from Preparation Example 2 according to the proportions, add them to the above mixture 1, and stir until uniform to form mixture 2 for later use; Cool the above mixture 2 to 5-10℃, and weigh 1.5 mL of mesenchymal stem cells from Preparation Example 3 (cell concentration 1X10) according to the ratio. 7 Add the contents of the above mixture 2 to the mixture and stir until homogeneous to form a vaginal injection ointment. Store at low temperature.

[0042] Example 3 This embodiment provides a method for preparing a stem cell-based female vaginal sensitivity modifier, including the following steps: Weigh out 4g of glycerol and 6g of the stem cell carrier from Preparation Example 1 according to the proportion and dissolve them in 89mL of deionized water. Stir and mix until uniform to form Mixture 1 for later use. Weigh out 0.03g of tomato steroidal glycoside A and 0.65g of Scutellaria baicalensis extract from Preparation Example 2 according to the proportions, add them to the above mixture 1, and stir until uniform to form mixture 2 for later use; Cool the above mixture 2 to 5-10℃, and weigh 0.8 mL of mesenchymal stem cells from Preparation Example 3 (cell concentration 1X10) according to the specified ratio. 7 Add the contents of the above mixture 2 to the mixture and stir until homogeneous to form a vaginal injection ointment. Store at low temperature.

[0043] Example 4 This embodiment provides a method for preparing a stem cell-based female vaginal sensitivity modifier, including the following steps: Weigh 4.5g of glycerol and 8g of the stem cell carrier from Preparation Example 1 according to the proportion and dissolve them in 86mL of deionized water. Stir and mix until homogeneous to form Mixture 1 for later use. Weigh out 0.025g of tomato steroidal glycoside A and 0.7g of Scutellaria baicalensis extract from Preparation Example 2 according to the proportions, add them to the above mixture 1, and stir until uniform to form mixture 2 for later use; Cool the above mixture 2 to 5-10℃, and weigh 1.2 mL of mesenchymal stem cells from Preparation Example 3 (cell concentration 1X10) according to the ratio. 7 Add the contents of the above mixture 2 to the mixture and stir until homogeneous to form a vaginal injection ointment. Store at low temperature.

[0044] Example 5 This embodiment provides a method for preparing a stem cell-based female vaginal sensitivity modifier, including the following steps: Weigh 3.5g of glycerol and 2g of the stem cell carrier from Preparation Example 1 according to the proportion and dissolve them in 94mL of deionized water. Stir and mix until homogeneous to form Mixture 1 for later use. Weigh out 0.01g of tomato steroidal glycoside A and 0.6g of Scutellaria baicalensis extract from Preparation Example 2 according to the proportions, add them to the above mixture 1, and stir until uniform to form mixture 2 for later use; Cool the above mixture 2 to 5-10℃, and weigh 0.5 mL of mesenchymal stem cells from Preparation Example 3 (cell concentration 1X10) according to the specified ratio. 7 Add the contents of the above mixture 2 to the mixture and stir until homogeneous to form a vaginal injection ointment. Store at low temperature.

[0045] Comparative Example 1 The method used in this comparative example is the same as that in Example 4, except that the mesenchymal stem cells used in Preparation Example 3 were not added and were replaced with deionized water.

[0046] Comparative Example 2 The method used in this comparative example is the same as that in Example 4, except that tomatine A was not added and deionized water was used instead.

[0047] Comparative Example 3 The comparative example follows the same method as Example 4, except that the Scutellaria baicalensis extract from Preparation Example 2 was not added; instead, deionized water was used.

[0048] Comparative Example 4 The method used in this comparative example is the same as that in Example 4, except that the stem cell carrier used in Preparation Example 1 was not added and deionized water was used instead.

[0049] Comparative Example 5 The method used in this comparative example is the same as that in Example 4, except that the added stem cell carrier does not contain wolfberry polysaccharide and is replaced with deionized water.

[0050] Test Example 1 The survival rates of stem cells in the vaginal sensitivity modulators prepared in Examples 1-5 and Comparative Examples 1-5 were detected at 12 h and 24 h using the CCK-8 assay. The results are shown in Table 1 below:

[0051] In summary, the regulator in Example 4 of this application achieved the best survival rate at 24 hours, indicating that adding the complete stem cell carrier provides optimal protection for stem cells, thereby improving survival rate, and the amount of stem cells added and the stem cell carrier are well-matched. In contrast, Comparative Example 4, without the stem cell carrier, showed poor stem cell survival rates at both 12 and 24 hours, with a survival rate below 50% after 24 hours. Furthermore, while Comparative Example 5, without the addition of Lycium barbarum polysaccharide, showed some improvement in 24-hour stem cell survival rate, the improvement efficiency did not reach the level of Example 4. This demonstrates that the synergistic effect of Lycium barbarum polysaccharide and chitosan products achieved a relatively ideal protective effect on stem cells. It should also be noted that the cell survival rates of Comparative Examples 2 and 3 were lower than those of Example 4. This indicates that tomatine A and Scutellaria baicalensis extract also had a positive effect on cell survival. Through the synergistic effect of tomatine A and Scutellaria baicalensis extract, they can not only exert their original inhibitory effect on local inflammatory factors, but also promote the differentiation and expression of mesenchymal stem cells, thereby improving their survival rate. This is something that has not been discovered before.

[0052] In Examples 1-5, the stem cells in Example 4 achieved the best survival rate. There were slight differences in the stem cell survival rates among the examples. Therefore, Example 4 was selected as the experimental example for the following test cases, and the other examples 1-3 and 5 were not tested.

[0053] Test Example 2 To verify the effectiveness of the vaginal sensitivity modifier in improving vaginal dryness and enhancing sensitivity, the following tests were conducted: Sixty postmenopausal women aged 45-65 years with a vaginal health index (VHI) of less than 15, experiencing dyspareunia due to vaginal dryness, and not having used hormone replacement therapy for at least 3 months, and excluding those with a history of breast cancer, acute vaginal infection, or serious chronic diseases, were recruited. These 60 subjects were randomly divided into 6 groups: Experimental Group 1 used the formulation of Example 4, Experimental Group 2 used the formulation of Comparative Example 1, Experimental Group 3 used the formulation of Comparative Example 2, Experimental Group 4 used the formulation of Comparative Example 3, the control group used 0.01% estriol cream, and the blank group used a gel without active ingredients. The administration method was: vaginal administration twice weekly, 5 mL each time, for 4 weeks, and the user experience was recorded. The following indicators were measured: (1) Indicator 1 Vaginal Health Index (VHI): Assessment dimensions: elasticity, secretions, pH, mucosal integrity, and moisture (0-5 points each).

[0054] Testing timeframes: baseline, week 2, and week 4.

[0055] Sexual Function Index (FSFI): The questionnaire consists of 19 items (desire, arousal, lubrication, orgasm, satisfaction, and pain), with a total score of 2-36.

[0056] (2) Indicator 2 Vaginal mucosal thickness: Ultrasound examination (high-frequency probe, measuring the thickness of the anterior vaginal wall medial layer, mm).

[0057] Inflammatory markers: IL-6 and TNF-α (pg / mL) were detected in vaginal douche fluid using ELISA.

[0058] Patient self-reported improvement rate: Post-treatment satisfaction questionnaire ("significant improvement" / "partial improvement" / "no improvement").

[0059] The experimental data are shown in Table 2 below:

[0060] Note: * indicates p < 0.01 compared to the control group; # indicates a significant difference between the experimental group and the control group.

[0061] Summary and Analysis (1) Mucosal repair and lubrication function VHI Total Score: The experimental group 1 (22.3 points) was significantly higher than the control group (17.6 points, p<0.01), indicating that stem cells combined with tomato steroid A and Scutellaria baicalensis extract are superior to traditional hormone therapy in restoring vaginal elasticity, secretions and moisture.

[0062] Experimental group 2 (without stem cells) scored only 13.2 on the VHI test, proving that stem cells are the core driving force for mucosal regeneration.

[0063] Experimental group 3 (without tomato steroid A) and experimental group 4 (without Scutellaria baicalensis extract) decreased by 15.7% and 25.1% respectively, showing that the two have a synergistic enhancing effect on stem cell function. In the absence of these two components, the synergistic function is reduced.

[0064] Mucosal thickness: The experimental group 1 (1.91 mm) was close to the normal reproductive age level (2.0 mm), which was 24.8% higher than the control group (1.53 mm) (p<0.01), confirming the ability of stem cells to directly differentiate into epithelial cells.

[0065] (2) Sexual function and inflammation control FSFI Total Score: Experimental group 1 (28.4 points) was superior to the control group (25.1 points, p<0.05) in terms of libido, lubrication and pain relief.

[0066] TNF-α levels: The level in experimental group 1 (8.7 pg / mL) was only 53.7% of that in the control group (p<0.001), highlighting the potent anti-inflammatory effect of Scutellaria baicalensis extract. Meanwhile, experimental group 4 (without Scutellaria baicalensis extract) showed a 65.5% increase in TNF-α, further validating its necessity.

[0067] In summary, stem cells form the foundation of the therapeutic effect, while lycopene A and Scutellaria baicalensis extract enhance the overall efficacy by promoting mucin secretion and inhibiting inflammation, respectively. This study is the first to demonstrate that a triple regimen of stem cells, lycopene A, and Scutellaria baicalensis extract can simultaneously achieve mucosal regeneration, lubrication, and anti-inflammatory functions.

[0068] Although the present invention has been described in detail above with general descriptions and specific embodiments, modifications or improvements can be made to it, which will be obvious to those skilled in the art. Therefore, all such modifications or improvements made without departing from the spirit of the present invention fall within the scope of protection claimed by the present invention.

Claims

1. A stem cell-based vaginal sensitivity modifier, characterized in that, The components include the following percentages: Mesenchymal stem cells 0.1-1.5% Tomatosteroid A 0.001-0.05% 3-5% glycerin Scutellaria baicalensis extract 0.5-0.8% Stem cell carrier 1-10% The vaginal injection ointment is obtained by mixing an appropriate amount of deionized water evenly.

2. The stem cell-based female vaginal sensitivity modifier as described in claim 1, characterized in that, The mesenchymal stem cells were 1 x 102 6 -10 7 per mL.

3. The stem cell-based female vaginal sensitivity modifier as described in claim 1, characterized in that, The stem cell carrier is made by dissolving and mixing 10-15 parts by weight of chitosan and 3-6 parts by weight of wolfberry polysaccharide in deionized water.

4. The stem cell-based female vaginal sensitivity modifier as described in claim 3, characterized in that, The molecular weight of the wolfberry polysaccharide is 20-50 kDa.

5. The stem cell-based female vaginal sensitivity modifier as described in claim 1, characterized in that, The mesenchymal stem cells mentioned are adipose-derived mesenchymal stem cells, bone marrow mesenchymal stem cells, umbilical cord mesenchymal stem cells, or placental mesenchymal stem cells.

6. The stem cell-based female vaginal sensitivity modifier as described in claim 2, characterized in that, The mesenchymal stem cells mentioned are cells passaged to the P3-P5 generation.

7. A method for preparing a stem cell-based female vaginal sensitivity modifier, characterized in that, Includes the following steps: Weigh out glycerol and stem cell carrier according to the proportions and dissolve them in an appropriate amount of deionized water. Stir and mix until homogeneous to form mixture 1 for later use. Weigh out tomato steroidal A and scutellaria baicalensis extract according to the proportions and add them to the above mixture 1. Stir and mix until uniform to form mixture 2 for later use. Cool the above mixture 2 to 5-10℃, weigh out the mesenchymal stem cells according to the ratio and add them to the above mixture 2, stir and mix until uniform to form a vaginal injection ointment, and store at low temperature.

8. The method for preparing the stem cell-based female vaginal sensitivity modifier as described in claim 7, characterized in that, in, The preparation method of stem cell vectors is as follows: Weigh out chitosan and add it to ultrapure water containing 0.5% acetic acid. Adjust the pH to 5.0-5.5 and stir magnetically in a 60℃ water bath for 2 hours until completely dissolved. Weigh out the wolfberry polysaccharide and add it to sterilized PBS. Shake at 37°C for 30 minutes until completely dissolved. Add the wolfberry polysaccharide solution dropwise to the chitosan solution according to the ratio, stirring while adding. After stirring magnetically at 200 rpm for 1 hour, slowly add NaOH solution to adjust the pH of the mixture to 6.8-7.2, and set aside.

9. The method for preparing a stem cell-based female vaginal sensitivity modifier as described in claim 7, characterized in that, in, The preparation method of Scutellaria baicalensis extract is as follows: Select dried Scutellaria baicalensis root, pulverize it with a pulverizer and pass it through a 40-mesh sieve. Weigh the Scutellaria baicalensis root powder that passes through the sieve and add it to 60-70% ethanol for soaking. Reflux it twice in an 80℃ water bath for 2 hours. The extracts were combined and filtered through a 200-mesh filter cloth to obtain a clear filtrate. The filtrate was then rotary evaporated to 1 / 10 of its original volume under a controlled temperature of 50℃ and a pressure of -0.08 MPa to obtain an extract for later use.

10. The use of the stem cell-based female vaginal sensitivity modifier as described in any one of claims 1-6 in the preparation of a female vaginal sensitivity modifier.

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