Micro-growth factor MGF-containing high-permeability slow-release anti-hair-loss hair-growing functional gel and patch and preparation method thereof

Abstract

The invention relates to a microgrowth factor MGF-containing high-permeability slow-release anti-hair-loss hair-growing functional gel and patch and a preparation method thereof. The microgrowth factor MGF-containing high-permeability slow-release anti-hair-loss hair-growing functional gel and patch comprises the following components in percentage by weight: 0.1-0.5 wt% of microgrowth factor MGF, 0.1-5 wt% of collagen, 1-10 wt% of chitosan, 1-10 wt% of hyaluronic acid, 0.1-1 wt% of acetic acid and the balance of normal saline. Compared with the prior art, the invention utilizes the high permeability and multi-channel regulation effect of the MGF, combines the synergistic effect of the collagen, realizes the deep regulation of hair loss prevention and hair growth through the gel patch technology, and provides an efficient, safe and convenient treatment scheme for alopecia patients.

Description

Technical Field

[0001] The invention relates to the field of cosmetics, in particular to a high-permeability sustained-release hair loss prevention and hair growth gel containing micro growth factor MGF, a patch containing the functional gel and a preparation method thereof. Background Art

[0002] In contemporary society, with the accelerated pace of life and increased work pressure, young people generally face dual challenges to their physical and mental health. Among them, the problem of receding hairline caused by bad living habits and hair care methods is particularly prominent, which not only affects personal image, but also weakens self-confidence and mental state to a certain extent. According to the "2024 China Hair Health Management Industry In-depth Research Report" and the "Chinese Scalp Health White Paper", the number of people with hair loss in my country has exceeded 250 million, and this trend is rapidly spreading to younger groups. Behind this phenomenon, there are both genetic factors and changes in modern lifestyles.

[0003] Specifically, long-term mental stress and high-intensity work pressure lead to endocrine disorders, which in turn affect the normal growth cycle of hair and accelerate the receding hairline.

[0004] At the same time, bad hair care habits, such as frequent use of chemical dyes and perms, improper scalp cleaning methods, excessive combing and pulling of hair, will destroy the microenvironment around the hair follicles, affect the normal physiological functions of hair follicle cells, and lead to thinning hair and a receding hairline.

[0005] In addition, the intensification of environmental pollution and ubiquitous ultraviolet radiation continuously generate a large number of free radicals, which aggravate the oxidative stress response of hair follicle cells, accelerate the atrophy of hair follicles and the pathological process of hair loss, and further aggravate the hairline problem.

[0006] Therefore, the current industry urgently needs a deep regulatory mechanism to effectively address the problem of receding hairline and comprehensively improve the scalp and hair health of people of all ages.

[0007] At present, various anti-hair loss and hair growth products on the market are mostly applied to the hairline by smearing or spraying. During the use of smear-type anti-hair loss and hair growth products, due to the limitations of manual application, it is often difficult to ensure the uniform distribution of the drug on the scalp, resulting in excessive drug concentration in some areas, and insufficient drug in some areas, thus affecting the overall treatment effect. Similarly, although spray-type products seem to be able to evenly cover the scalp, in actual operation, factors such as the particle size of the spray, the spraying angle, and the wind speed may affect the uniformity of the drug distribution. In addition, the smearing and spraying methods may also cause the drug to form residues on the surface of the scalp, hindering further absorption. At the same time, if the hands or tools are not strictly disinfected, the risk of scalp infection may also increase. Moreover, the effect of the anti-hair loss and hair growth technology in the prior art needs to be further improved.

[0008] CN116803404A discloses the use of a water-soluble tomato concentrate in the preparation of products for reducing hair loss and growing hair. The water-soluble tomato concentrate can promote the proliferation of hair papilla cells; inhibit the apoptosis of hair papilla cells; promote the expression of active factor IGF-1, and reduce the expression of TGF-β1, indicating that the water-soluble tomato concentrate has the effect of promoting hair follicles to maintain the growth phase and inhibiting the entry into the regression phase, and thus has a good effect of preventing hair loss and growing hair, but the stability of its active ingredients is not yet known, and factors such as light, temperature, and humidity may have a negative impact on the active ingredients, thereby affecting the final effect of the product. And the permeability is insufficient. Although WSTC has been shown to have the potential to promote the proliferation of hair papilla cells, its ability to penetrate the skin barrier needs to be further improved.

[0009] CN113660947A discloses a composition for promoting hair growth or inhibiting hair loss, which contains growth factors selected from the following groups as active ingredients: VEGF, FGFα, FGFβ, TGF-β, IGF, KGF and SCF, and has the effect of promoting hair growth and preventing hair loss by regulating the hair cycle of patients with hair loss, without causing side effects such as skin irritation. Although this technology lists a variety of growth factors (such as VEGF, FGFα, FGFβ, etc.) as active ingredients, which have the effect of promoting hair follicle cell proliferation and differentiation in mouse models, can promote hair growth and inhibit hair loss, but the specific effects of these growth factors in the patient population are not determined. Moreover, the active factors in different formulations may have different effects on the stability and permeability of the growth factors, thereby affecting their effects. Summary of the invention

[0010] The purpose of the present invention is to overcome the defects of the above-mentioned prior art and to provide a high-permeability sustained-release anti-hair loss and hair growth gel, patch and preparation method thereof containing micro growth factor MGF, which can release micro growth factor MGF and auxiliary ingredients (collagen) having the effect of promoting hair growth to the scalp in a stable and continuous manner, so as to achieve the effect of preventing hair loss and promoting hair growth.

[0011] The purpose of the present invention can be achieved through the following technical scheme: a high-permeability sustained-release anti-hair loss and hair growth gel containing micro growth factor MGF, comprising the following components in weight percentage: micro growth factor MGF 0.1-0.5wt%, collagen 0.1-5wt%, chitosan 1-10wt%, hyaluronic acid 1-10wt%, acetic acid 0.1-1wt%, and the rest is normal saline.

[0012] Further preferably, the functional gel comprises the following components in percentage by weight: micro growth factor MGF 0.1-0.5wt%, collagen 1-5wt%, chitosan 5-10wt%, hyaluronic acid 5-10wt%, acetic acid 0.5-1wt%, and the rest is physiological saline.

[0013] Among them, the role of acetic acid is to dissolve chitosan;

[0014] Among them, the role of normal saline is to dissolve and protect the growth factor MGF and hyaluronic acid;

[0015] Furthermore, the collagen is a recombinant collagen obtained by biological fermentation technology, and its average molecular weight is between 2.5KDa-5KDa, preferably between 2.5KDa-4KDa;

[0016] The present invention also provides a method for preparing a high-permeability sustained-release hair loss prevention and hair growth gel containing micro growth factor MGF, comprising the following steps:

[0017] S1, adding chitosan powder into acetic acid solution, fully dissolving it to form a uniform chitosan solution;

[0018] S2, adding hyaluronic acid powder into physiological saline and fully dissolving it to form a hyaluronic acid solution;

[0019] S3. Under stirring, adding the hyaluronic acid solution to the chitosan solution, and mixing thoroughly to form a mixed gel matrix;

[0020] S4. Adding growth factor MGF and collagen into the mixed gel matrix to evenly disperse the growth factor MGF and collagen to prepare an effective gel.

[0021] Furthermore, the conditions for sufficient dissolution in step S1 are: heating to 45-50° C. and stirring at 200-400 rpm for 2-4 hours.

[0022] Furthermore, the conditions for sufficient dissolution in step S2 are: heating to 45-50° C. and stirring at 200-400 rpm for 5-10 min.

[0023] Furthermore, the conditions for sufficient mixing in step S3 are: heating to 35-40° C. and stirring at 300-600 rpm for 5-10 min.

[0024] Furthermore, in step S4, the conditions for uniformly dispersing the growth factor MGF and collagen are: heating to 35-40° C. and stirring at 300-600 rpm for 10-15 min.

[0025] The present invention also provides a high-permeability sustained-release anti-hair loss and growth gel patch, wherein the patch is a multilayer material in which a patch carrier, a functional gel and an outer film are sequentially arranged and composited.

[0026] Furthermore, the patch carrier is one of non-woven fabric, knitted fabric or woven fabric.

[0027] The present invention also provides a method for preparing a high-permeability sustained-release anti-hair loss and hair growth functional gel patch, which comprises pouring a sterilized, tested bacterial content, toxin and immunogenic qualified functional gel onto a patch carrier, and drying at low temperature for 4-8 hours; the obtained semi-finished product is cut into long strips according to the hairline lines and affixed with a transparent outer film to obtain an anti-hair loss and hair growth gel patch.

[0028] Compared with the prior art, the present invention has the following beneficial effects:

[0029] 1. The present invention utilizes the high permeability and multi-pathway regulation of MGF to activate the MAPK / ERK signaling pathway and the PI3K / Akt / mTOR signaling pathway, thereby accelerating the generation of hair. At the same time, MGF affects a series of transcription factors and angiogenesis-promoting factors, as well as the expression and activity of genes related to the hair follicle cycle, accelerates the generation of hair, provides sufficient nutrition and oxygen support for hair follicle cells, regulates the conversion of hair follicles from the growth phase to the regression phase and the resting phase, prolongs the growth phase, shortens the resting phase, thereby increasing the growth time and density of hair. Furthermore, the synergistic effect of MGF combined with collagen provides favorable conditions for hair growth, improves the hair follicle microenvironment, and provides favorable conditions for hair growth. The addition of collagen can enhance the toughness of hair follicles and reduce hair follicle damage and hair loss caused by external forces.

[0030] 2. The gel patch of the present invention uses controlled release technology to release the micro growth factor MGF and auxiliary components (collagen) that promote hair growth to the scalp in a stable and continuous manner, ensuring that the scalp is continuously nourished for a period of time, prolonging the drug action time, and achieving the effect of preventing hair loss and promoting hair growth. Through the gel patch technology, deep regulation of hair loss prevention and hair growth is achieved, providing an efficient, safe and convenient treatment plan for patients with hair loss.

[0031] 3. Compared with smearing or spraying methods, gel patch technology can more accurately control the amount and speed of drug release, reduce drug residue and waste on the scalp surface, and thus reduce the risk of side effects caused by drug overdose or improper use.

[0032] 4. The gel patch is easy and quick to use, does not require complicated application or spraying process, and is almost imperceptible when worn, and does not affect the user's daily activities.

[0033] 5. The present invention uses degradable materials to reduce environmental pollution. At the same time, due to its long-term mechanism of action, the frequency and total amount of drug use are reduced. DETAILED DESCRIPTION

[0034] The present invention is described in detail below with reference to specific embodiments.

[0035] The present invention uses controlled release technology to release the micro growth factor MGF and auxiliary components (collagen) that have the effect of promoting hair growth to the scalp in a stable and continuous manner, so as to achieve the effect of preventing hair loss and promoting hair growth.

[0036] in:

[0037] MGF (Mechano Growth Factor) is produced by gene splicing variation, with a molecular weight of about 200 and a specific E functional domain located at its C-terminus. It can quickly penetrate the cell membrane and exert its effects, with high permeability, and its penetration depth is ten times that of traditional growth factors. MGF activates the intracellular signal transduction pathway by binding to specific cell membrane receptors, thereby exerting the above-mentioned biological functions. These signal transduction pathways include PI3K / Akt, MAPK, etc., which jointly regulate processes such as cell growth, proliferation and differentiation.

[0038] In the existing technology, MGF generally plays an important role in muscle growth and repair and is widely used in sports science, medicine and rehabilitation. It can promote the repair and growth of waste tissue by activating muscle stem cells and increase protein synthesis, thereby accelerating muscle hypertrophy and injury repair.

[0039] The present invention discloses the new function of micro growth factor MGF (Mechano Growth Factor) in promoting scalp health and preventing hair loss and growing hair.

[0040] During hair growth, MGF can stimulate the proliferation and differentiation of hair follicle stem cells (a part of the hair papilla cells), thereby increasing the activity of hair follicles.

[0041] After binding to its receptor, MGF can activate the MAPK / ERK signaling pathway. This pathway plays an important role in cell proliferation, differentiation, survival, and cell cycle regulation. In hair follicle cells, the activation of the MAPK / ERK pathway can promote cells from a dormant state to a proliferative state, accelerate DNA replication and cell division, and thus promote hair growth.

[0042] In addition to the MAPK / ERK pathway, MGF can also play a role through the PI3K / Akt / mTOR signaling pathway. This pathway is closely related to cell metabolism, growth, survival, and protein synthesis. In hair follicle cells, the activation of the PI3K / Akt / mTOR pathway can increase the cell's uptake and utilization of nutrients, promote cell growth and proliferation, and thus promote hair growth. At the same time, MGF can affect the expression and activity of a series of transcription factors, especially through factors such as β-catenin and Lef / Tcf in the Wnt signaling pathway, promoting the proliferation and differentiation of hair follicle stem cells to transform into hair matrix cells, thereby accelerating hair production.

[0043] In addition, MGF promotes the expression of angiogenic factors (VEGF, Ang-1, etc.), enhances the construction and expansion of the vascular network around the hair follicles, increases local blood flow and oxygen supply, and provides sufficient nutrition and oxygen support for hair follicle cells.

[0044] Not only that, MGF also regulates the transition of hair follicles from the growth phase to the regression phase and the resting phase by affecting the expression of genes related to the hair follicle cycle, prolonging the growth phase and shortening the resting phase, thereby increasing the growth time and density of hair.

[0045] In addition to the key role of MGF growth factor in regulating the hair growth cycle, collagen, as the main component of the extracellular matrix, is also crucial for the stability and support of the hair follicle microenvironment.

[0046] Collagen is a protein widely found in animal connective tissues and is the main component of skin, bones, hair and other tissues. It has good biocompatibility, degradability and the function of promoting cell growth. In skin and hair follicle tissues, collagen can form a fiber network to provide support for cells and regulate the interaction between cells.

[0047] Collagen can promote the proliferation of cells around hair follicles, thereby accelerating hair growth.

[0048] Through its unique fiber network structure, collagen can regulate the microenvironment such as osmotic pressure and pH around the hair follicles, providing favorable conditions for hair growth.

[0049] The addition of collagen can enhance the toughness of hair follicles and reduce hair follicle damage and hair loss caused by external forces.

[0050] Collagen is an important component of the extracellular matrix, which can promote the synthesis and deposition of other matrix components (such as hyaluronic acid, elastic fibers, etc.), and further improve the hair follicle microenvironment.

[0051] The present invention utilizes the high permeability and multi-pathway regulatory effects of MGF, combined with the synergistic effect of collagen, and achieves deep regulation of anti-hair loss and hair growth through gel patch technology, providing patients with hair loss with an efficient, safe and convenient treatment plan.

[0052] The following is a detailed description through specific examples. The raw materials and detection methods involved in the present invention are all commonly used raw materials and detection methods in the art unless otherwise specified. For example, the growth factor MGF used in the following examples is a commercially available product.

[0053] Example 1

[0054] A patch of a high-permeability sustained-release anti-hair loss and hair growth gel containing micro growth factor MGF is prepared by the following method:

[0055] (1) Preparation of gel matrix

[0056] a. Add chitosan powder to acetic acid solution, heat to 45-50°C, and stir at 200 rpm for 2-4 hours until fully dissolved to form a uniform chitosan solution;

[0057] b. Add hyaluronic acid powder to physiological saline, heat to 45-50°C, and stir at 200 rpm for 5-10 minutes until fully dissolved to form a hyaluronic acid solution;

[0058] (2) Mixing of active ingredients and gel matrix

[0059] a. While stirring, add the hyaluronic acid solution to the chitosan solution, heat to 35-40°C, and stir at 400 rpm for 5-10 minutes to form a mixed gel matrix;

[0060] b. Add the growth factor MGF and collagen to the mixed gel matrix, heat to 35-40°C, and stir at 400rpm for 10-15min to evenly disperse the growth factor MGF and collagen to prepare an effective gel;

[0061] Wherein, the mass fraction of micro growth factor MGF is 0.1wt%, the mass fraction of collagen is 1wt%, the mass fraction of chitosan is 5wt%, the mass fraction of hyaluronic acid is 5wt%, and the mass percentage of acetic acid is 1%;

[0062] c. Sterilization is carried out before coating and molding, and the bacterial content, toxins, immunogenicity, etc. are tested for quality control.

[0063] (3) Coating and molding of functional gel

[0064] a. Pour the efficacy gel onto the patch carrier and dry at low temperature for 4-8 hours;

[0065] b. Cut the functional gel into long strips along the hairline and stick a transparent outer film on it to obtain the anti-hair loss and hair growth gel patch.

[0066] Example 2

[0067] A patch of a high-permeability sustained-release anti-hair loss and hair growth gel containing micro growth factor MGF is prepared by the following method:

[0068] (1) Preparation of gel matrix

[0069] a. Add chitosan powder to acetic acid solution, heat to 45-50°C, and stir at 200 rpm for 2-4 hours until fully dissolved to form a uniform chitosan solution;

[0070] b. Add hyaluronic acid powder to physiological saline, heat to 45-50°C, and stir at 200 rpm for 5-10 minutes until fully dissolved to form a hyaluronic acid solution;

[0071] (2) Mixing of active ingredients and gel matrix

[0072] a. While stirring, add the hyaluronic acid solution to the chitosan solution, heat to 35-40°C, and stir at 400 rpm for 5-10 minutes to form a mixed gel matrix;

[0073] b. Add the growth factor MGF and collagen to the mixed gel matrix, heat to 35-40°C, and stir at 400rpm for 10-15min to evenly disperse the growth factor MGF and collagen to prepare an effective gel;

[0074] Wherein, the mass fraction of micro growth factor MGF is 0.3wt%, the mass fraction of collagen is 3wt%, the mass fraction of chitosan is 5wt%, the mass fraction of hyaluronic acid is 8wt%, and the mass percentage of acetic acid is 1%;

[0075] c. Sterilization is carried out before coating and molding, and the bacterial content, toxins, immunogenicity, etc. are tested for quality control.

[0076] (3) Coating and molding of functional gel

[0077] a. Pour the efficacy gel onto the patch carrier and dry at low temperature for 4-8 hours;

[0078] b. Cut the functional gel into long strips along the hairline and stick a transparent outer film on it to obtain the anti-hair loss and hair growth gel patch.

[0079] Example 3

[0080] A patch of a high-permeability sustained-release anti-hair loss and hair growth gel containing micro growth factor MGF is prepared by the following method:

[0081] (1) Preparation of gel matrix

[0082] a. Add chitosan powder to acetic acid solution, heat to 45-50°C, and stir at 200 rpm for 2-4 hours until fully dissolved to form a uniform chitosan solution;

[0083] b. Add hyaluronic acid powder to physiological saline, heat to 45-50°C, and stir at 200 rpm for 5-10 minutes until fully dissolved to form a hyaluronic acid solution;

[0084] (2) Mixing of active ingredients and gel matrix

[0085] a. While stirring, add the hyaluronic acid solution to the chitosan solution, heat to 35-40°C, and stir at 400 rpm for 5-10 minutes to form a mixed gel matrix;

[0086] b. Add the growth factor MGF and collagen to the mixed gel matrix, heat to 35-40°C, and stir at 400rpm for 10-15min to evenly disperse the growth factor MGF and collagen to prepare an effective gel;

[0087] Wherein, the mass fraction of micro growth factor MGF is 0.5wt%, the mass fraction of collagen is 5wt%, the mass fraction of chitosan is 10wt%, the mass fraction of hyaluronic acid is 10wt%, and the mass percentage of acetic acid is 1%;

[0088] c. Sterilization is carried out before coating and molding, and the bacterial content, toxins, immunogenicity, etc. are tested for quality control.

[0089] (3) Gel coating and molding

[0090] a. Pour the efficacy gel onto the patch carrier and dry at low temperature for 4-8 hours;

[0091] b. Cut the functional gel into long strips along the hairline and stick a transparent outer film on it to obtain the anti-hair loss and hair growth gel patch.

[0092] Comparative Example 1

[0093] The mass fraction of micro growth factor MGF is 0wt%, the mass fraction of collagen is 1.1wt%, and the rest is the same as in Example 1.

[0094] Comparative Example 2

[0095] The mass fraction of micro growth factor MGF is 1.1wt%, the mass fraction of collagen is 0wt%, and the rest is the same as in Example 1.

[0096] Comparative Example 3

[0097] IGF was used to replace the micro growth factor MGF, and the rest was the same as in Example 1.

[0098] Characterization data and effect data of the products of the embodiments and comparative examples

[0099] 1. Security Testing

[0100] 1) Test sample: the efficacy gel in Examples 1-3.

[0101] 2) Number of participants: 120 participants, half male and half female, aged between 20 and 55 years old, all meeting the criteria for subjects.

[0102] 3) Test method: 120 subjects who meet the test criteria were randomly divided into 4 groups, corresponding to the test subjects using the efficacy gel in Examples 1-3 and the blank group not applying any sample, with 30 subjects in each group; a third-party testing agency was used to test safety. The selected area should not exceed 50mm 2 , a suitable patch with a depth of about 1mm, add about 0.02-0.025ml (g) of the test substance into the patch tester by the closed patch test method. The patch tester is attached to the curved side of the subject's forearm, and the test substance is removed after 24 hours. The skin reaction is observed at 0.5h, 24h, and 48h after removal: the results are recorded according to the skin reaction grading standards in the "Cosmetic Safety Technical Regulations 2015".

[0103] Table 1 Patch test results

[0104]

[0105] Note: Skin reaction grading standards:

[0106] Grade 0: negative reaction;

[0107] Grade 1: Suspicious reaction; only slight erythema;

[0108] Grade 2: weak positive reaction (erythema reaction); erythema, infiltration, edema, and papules may be present;

[0109] Grade 3: Strong positive reaction (herpes reaction); erythema, infiltration, edema, papules, herpes: the reaction may extend beyond the test area;

[0110] Grade 4: Extremely strong reaction (confluent herpes reaction): obvious erythema, severe infiltration, edema, confluent herpes, and the reaction exceeds the test area.

[0111] 4) Test results: The results in Table 1 show no irritation and pass the safety test.

[0112] 2. Stability test

[0113] 1) Test sample: the functional gel in Examples 1-3.

[0114] 2) Test method: Internal control standard, observe the appearance color, viscosity and pH for three months.

[0115] Table 2 Stability test results

[0116] time 45℃ 40℃ 37℃ 25℃ 5℃ -15℃ CYCLE illumination 1W √ √ √ √ √ √ √ √ 2W √ √ √ √ √ √ √ √ 3W √ √ √ √ √ √ √ √ 4W √ √ √ √ √ √ √ √ 2M √ √ √ √ √ √ √ √ 3M √ √ √ √ √ √ √ √

[0117] Among them, "CYCLE" refers to the cycle, and the cycle setting is: heating from -15℃ to 45℃, cooling from 45℃ to -15℃ for five times.

[0118] 4) Test results: The results in Table 2 show that the performance gels in Examples 1-3 are stable in properties within 3 months.

[0119] 3. Cell proliferation effect test

[0120] Test method:

[0121] 1) Human Hair Follicle Outer Root Sheath Cells (HFORS) were cultured at 10 3 -10 4 The cells were seeded in a 96-well plate at a density of 10 cells / well, 100 μL of culture medium was added, and the cells were cultured in a CO2 incubator at 37°C for 24 hours.

[0122] 2) The efficacy gels of Examples 1-3 and Comparative Examples 1-3 were added to the plate and incubated in an incubator for 48 hours.

[0123] 3) Use a repeating pipette to add 10 μL of CCK8 solution to each well of the culture plate and incubate the culture plate in an incubator for 1-4 hours.

[0124] 4) Use an ELISA reader to measure the absorbance at 450 nm and create a standard curve for data analysis.

[0125] 5) Calculation of cell proliferation change rate: Taking the blank sample without adding the functional gel as a reference, the cell proliferation change rate of each example group was calculated. The specific calculation formula is: Cell proliferation change rate (%) = (absorbance of the test group - absorbance of the blank sample) / absorbance of the blank sample * 100%.

[0126] Table 3 Cell proliferation rate change

[0127]

[0128]

[0129] From the experimental results in Table 3, it can be seen that the functional gels in Examples 1-3 all show a significant proliferation promoting effect on human hair follicle outer root sheath cells (HFORS), and with the gradual increase in the content of micro-growth factor MGF and collagen in the gel formula, the effect of promoting cell proliferation shows a significant increasing trend. Specifically, in Example 1, the functional gel containing a relatively low concentration of MGF (0.1wt%) and collagen (1wt%) has a cell proliferation change rate of 45.23%; in Example 2, the concentrations of MGF and collagen are increased to 0.3wt% and 3wt%, respectively, and the cell proliferation change rate increases to 52.68% accordingly; in Example 3, the concentrations of MGF and collagen reach the highest, 0.5wt% and 5wt%, respectively, and the cell proliferation change rate also climbs to 58.16%. This result fully shows that the functional gel of the present invention can significantly enhance the vitality of hair follicle cells by scientifically matching MGF and collagen, thereby promoting hair growth.

[0130] In contrast, the cell proliferation effect of the gels in Comparative Examples 1-3 is much lower than that of the examples due to deficiencies in the formula design. In Comparative Example 1, MGF was not added, and only a higher proportion of collagen (1.1wt%) was contained. The cell proliferation change rate was only 13.05%, which highlights the key role of MGF in promoting hair follicle cell proliferation. Comparative Example 2, on the contrary, only added a high proportion of MGF (1.1wt%), but no collagen was added. The cell proliferation change rate was 27.58%, which was an improvement over Comparative Example 1, but still significantly lower than Example 1. This illustrates the important role of collagen in promoting hair follicle cell proliferation in coordination with MGF. Comparative Example 3 uses IGF to replace MGF. Although IGF is also a growth factor, its cell proliferation change rate is only 18.52%, which is much lower than that of the examples. This further verifies the unique advantages and irreplaceability of MGF in promoting hair follicle cell proliferation.

[0131] 4. Anti-hair loss efficacy test

[0132] 1) Test sample: the anti-hair loss and hair growth gel patch in Examples 1-3 and Comparative Examples 1-3

[0133] 2) Test subjects: 120 healthy test subjects (20-55 years old, average age 38.1 years old) were randomly divided into 5 groups, each with 20 people, regardless of gender, and each group used the same formula product. Written informed consent was signed.

[0134] Hair loss condition requirements:

[0135] Male: Shows obvious hairline receding, including but not limited to any one or more of the following: receding temporal corners, receding forehead hairline, and sparse hairline on the top of the head;

[0136] Women: Show obvious hairline changes, such as receding hairline, irregular hairline, sparse hair, etc.

[0137] Before enrollment, subjects were asked a series of questions about their medical history, health status, etc. according to the inclusion and exclusion criteria. At the same time, the compliance of the test site was evaluated and recorded.

[0138] 3) Test method: Use the gel patch every night. Apply the anti-hair loss and hair growth gel patch of Examples 1-3 and Comparative Examples 1-3 to the hairline or areas with sparse hair. Tear off the anti-hair loss and hair growth gel patch after 30 minutes without washing. The trial lasts for 8 weeks.

[0139] During the test, all testers used no other anti-hair loss products except the anti-hair loss and hair growth gel patches of test examples 1-3 and comparative examples 1-3.

[0140] A 4 cm × 3 cm detection area was selected at the hair loss area of ​​the tester's head, and the hair follicle analyzer was used to photograph the tester's detection area before using the sample (D0), 28 days after using the sample (D28), and 56 days after using the sample (D56). The data was analyzed using the software SPSS to obtain the effective hair follicle density change data, and the results are shown in Table 4.

[0141] Table 4 Changes in effective hair follicle density

[0142] sample <![CDATA[Day 0 (pcs / cm 2 )]]> <![CDATA[After the 28th day (pcs / cm 2 )]]> <![CDATA[After the 56th day (pcs / cm 2 )]]> Example 1 51.23±11.26 98.74±12.37 123.52±10.86 Example 2 50.18±10.44 107.25±11.18 135.49±12.31 Example 3 52.57±10.38 114.62±12.05 141.73±11.88 Comparative Example 1 51.64±11.03 57.58±11.63 59.27±10.26 Comparative Example 2 52.01±10.75 68.13±11.48 82.59±10.74 Comparative Example 3 51.08±10.42 46.52±10.79 65.93±11.48

[0143] 4) Test results: From the results in Table 4, it can be seen that after 8 weeks of anti-hair loss and hair growth gel patch testing, Example-3 showed significant anti-hair loss and hair growth effects. Specifically:

[0144] On the 28th day, the effective hair follicle density of all Example groups increased significantly compared with the baseline (day 0). The effective hair follicle density of Example 1 increased from an average of 51.23±11.26 / cm 2Increased to 98.74±12.37 / cm 2 , nearly doubled; the effective hair follicle density of Example 2 increased to 107.25±11.18 / cm 2 , the growth rate is 111.2%; while the growth rate of Example 3 is more significant, reaching 114.62±12.05 pieces / cm 2 , the growth rate was as high as 123.7%, showing a stronger ability to promote hair follicle growth.

[0145] At the end of the 56th day of testing, the effective hair follicle density of each example group continued to increase steadily, further consolidating the effect of preventing hair loss and promoting hair growth. The effective hair follicle density of Example 1 increased to 123.52±10.86 / cm 2 , an increase of 140.7% compared to the baseline; the effective hair follicle density of Example 2 climbed to 135.49±12.31 / cm 2 , the growth rate is 167.5%; while Example 3 reaches 141.73±11.88 / cm 2 The growth rate is as high as 172.3%, which shows that the anti-hair loss and hair growth effect of the product becomes more significant with the extension of the use time.

[0146] In contrast, the performance of Comparative Examples 1-3 in terms of hair follicle density growth is significantly inferior. Due to deficiencies in the formula design (such as the lack of key ingredients MGF or collagen, or the replacement of MGF with other growth factors), the effective hair follicle density growth of these comparative examples during the test period was limited. Specifically, the effective hair follicle density growth rate of Comparative Example 1 was only 11.5%, that of Comparative Example 2 was 32.4%, and that of Comparative Example 3 was 29.1%, all of which were far lower than the performance of the Example group.

[0147] The test results show that the anti-hair loss and hair growth gel patch can effectively reduce hair loss and significantly promote the growth of new hair follicles, thereby increasing hair density and has a clear anti-hair loss and hair growth effect.

[0148] 5. Permeability Test

[0149] 1) Test samples: Example 1 and Comparative Example 3.

[0150] 2) Test method: Add the test samples to the human skin 3D model (the model can be a commonly used 3D skin model in the art, such as any one of the models mentioned in "Li Xiao, Zhang Xiao'e, Lu Yongbo, et al. Cosmetic efficacy evaluation (VIII) - Application of 3D skin model in cosmetic efficacy evaluation [J]. Surfactant Chemical Industry, 2018, 48(09): 489-494+510. DOI: 10.13218 / j.cnki.csdc.2018.09.002.") and leave for 24 hours. Remove the stratum corneum and basement membrane of the human skin 3D model. Collect the content of MGF or IGF, the active ingredient of the test sample, from the epidermis, and calculate the penetration amount of the active ingredient in the stratum corneum and epidermis (mg / 100mL).

[0151] Table 5 Permeability effect test

[0152] Group The effective ingredients MGF or IGF penetrate into the stratum corneum and epidermis Example 1 10.25 Comparative Example 3 3.18

[0153] The experimental results show that compared with the traditional growth factor IGF used in Comparative Example 3, the specific micro growth factor MGF in Example 1 has a significantly higher retention rate inside the epidermis, confirming the advantage of MGF over traditional growth factors in skin permeability.

[0154] The invention can be understood and used by a person skilled in the art. It is obvious that a person skilled in the art can easily make various modifications to these embodiments and apply the general principles described herein to other embodiments without creative work. Therefore, the present invention is not limited to the above embodiments, and improvements and modifications made by a person skilled in the art based on the disclosure of the present invention without departing from the scope of the present invention should be within the scope of protection of the present invention.

Claims

1. A high permeability sustained-release hair loss prevention and hair growth gel containing micro growth factor MGF, characterized in that: The invention comprises the following components in percentage by weight: micro growth factor MGF 0.1-0.5wt%, collagen 0.1-5wt%, chitosan 1-10wt%, hyaluronic acid 1-10wt%, acetic acid 0.1-1wt%, and the rest is physiological saline.

2. The high-permeability sustained-release hair loss prevention and hair growth gel containing micro-growth factor MGF according to claim 1, characterized in that: The collagen is a recombinant collagen obtained through biological fermentation technology, and its average molecular weight is between 2.5KDa and 5KDa.

3. A method for preparing a high-permeability sustained-release anti-hair loss and hair growth gel containing micro growth factor MGF as claimed in claim 1 or 2, characterized in that: The following steps are involved: S1, adding chitosan powder into acetic acid solution, fully dissolving it to form a uniform chitosan solution; S2, adding hyaluronic acid powder into physiological saline and fully dissolving it to form a hyaluronic acid solution; S3. Under stirring, adding the hyaluronic acid solution to the chitosan solution, and mixing them thoroughly to form a mixed gel matrix; S4. Adding growth factor MGF and collagen into the mixed gel matrix to evenly disperse the growth factor MGF and collagen to prepare a functional gel.

4. The method for preparing a high-permeability sustained-release hair loss prevention and hair growth gel containing micro growth factor MGF according to claim 3, characterized in that: The conditions for sufficient dissolution in step S1 are: heating to 45-50° C. and stirring at 200-400 rpm for 2-4 hours.

5. The method for preparing a high-permeability sustained-release anti-hair loss and hair growth gel containing micro growth factor MGF according to claim 3, characterized in that: The conditions for sufficient dissolution in step S2 are: heating to 45-50° C. and stirring at 200-400 rpm for 5-10 min.

6. The method for preparing a high-permeability sustained-release anti-hair loss and hair growth gel containing micro growth factor MGF according to claim 3, characterized in that: The conditions for sufficient mixing in step S3 are: heating to 35-40° C. and stirring at 300-600 rpm for 5-10 min.

7. The method for preparing a high-permeability sustained-release hair loss prevention and hair growth gel containing micro growth factor MGF according to claim 3, characterized in that: Step S4: The conditions for uniformly dispersing the growth factor MGF and collagen are: heating to 35-40° C. and stirring at 300-600 rpm for 10-15 min.

8. A high permeability sustained-release anti-hair loss and hair growth gel patch containing the high permeability sustained-release hair loss prevention and hair growth gel patch according to claim 1 or 2, characterized in that: The patch is a multi-layer material formed by sequentially arranging a patch carrier, a functional gel and an outer film.

9. The high permeability sustained-release hair loss prevention and hair growth gel patch according to claim 8, characterized in that: The patch carrier is one of non-woven fabric, knitted fabric or woven fabric.

10. A method for preparing the high permeability sustained-release anti-hair loss and hair growth gel patch as claimed in claim 8, characterized in that: The sterilized and tested functional gel with qualified bacterial content, toxin and immunogenicity is poured onto the patch carrier and dried at low temperature for 4-8 hours; the obtained semi-finished product is cut into long strips according to the hairline lines and affixed with a transparent outer film to obtain an anti-hair loss and hair growth gel patch.

Images