Traditional Chinese medicine gel for treating stubborn skin stains and preparation method thereof

Abstract

The application provides a traditional Chinese medicine gel for treating stubborn skin color spots and a preparation method thereof, and the traditional Chinese medicine gel is prepared from the following raw materials in mass parts: aloe extract 25-30 parts, opuntia dillenii Haw extract 10-15 parts, safflower 5-10 parts, radix lithospermi 5-8 parts, herba portulacae 5-8 parts, purified water 60-65 parts, carbomer 1-5 parts, fish scale glue 5-8 parts, hydrogenated castor oil 100-110 parts, ethanol 120-140 parts and monoglyceride 4-10 parts. The prepared traditional Chinese medicine gel can clear heat and cool blood, remove blood stasis and remove spots, promote skin metabolism, repair damaged skin cells, and can treat stubborn skin color spots such as chloasma, melasma and age spots, and has no side effects.

Description

Technical Field

[0001] This invention belongs to the field of topical Chinese medicine gels, specifically relating to a Chinese medicine gel for treating stubborn skin pigmentation and its preparation method. Background Technology

[0002] Stubborn skin pigmentation is a type of skin patch or plaque that darkens the skin due to a variety of internal and external factors. The lesions are characterized by butterfly-shaped, round, oval, or irregular shapes, and are commonly found on the face, but can also appear on other parts of the body. They are persistent and difficult to heal.

[0003] Traditional treatments for stubborn skin pigmentation often combine internal and external therapies. However, the internal medications used vary widely due to inconsistent diagnostic classifications, making it difficult to guarantee efficacy. While external medications may have simple compositions, they lack a holistic conditioning effect, resulting in poor efficacy. Physical therapy may provide short-term relief, but the effects are not lasting and the condition is prone to relapse. It also fails to quickly clear heat, cool the blood, remove blood stasis, eliminate pigmentation, and repair damaged skin tissue.

[0004] In view of this, the present invention is hereby proposed. Summary of the Invention

[0005] The primary objective of this invention is to provide a traditional Chinese medicine gel for treating stubborn skin pigmentation. This topical gel can quickly clear heat and cool the blood, remove blood stasis and eliminate spots, repair damaged skin tissue, promote skin metabolism, and has high safety and no irritation to wounds.

[0006] The second objective of this invention is to provide a method for preparing a traditional Chinese medicine gel for treating stubborn skin pigmentation, which is simple to operate and operates under mild conditions.

[0007] In order to achieve the above-mentioned objectives of the present invention, the following technical solution is adopted:

[0008] This invention provides a traditional Chinese medicine gel for treating stubborn skin pigmentation, which is mainly made from the following raw materials by weight: 25-30 parts of aloe vera extract, 10-15 parts of prickly pear cactus extract, 5-10 parts of safflower, 5-8 parts of gromwell root, 5-8 parts of purslane, 60-65 parts of purified water, 1-5 parts of carbomer, 5-8 parts of fish scale glue, 100-110 parts of hydrogenated castor oil, 120-140 parts of ethanol, and 4-10 parts of monoglycerides.

[0009] Preferably, as a further specific embodiment, the mixture comprises 26-29 parts of aloe vera extract, 11-13 parts of prickly pear cactus extract, 6-9 parts of safflower, 6-7 parts of purple gromwell root, 6-7 parts of purslane, 61-64 parts of purified water, 2-3 parts of carbomer, 6-7 parts of fish scale glue, 102-106 parts of hydrogenated castor oil, 125-135 parts of ethanol, and 5-7 parts of monoglyceride.

[0010] Preferably, as a further specific embodiment, the mixture contains 27 parts aloe vera extract, 12 parts prickly pear cactus extract, 7 parts safflower, 6 parts gromwell root, 6 parts purslane, 63 parts purified water, 2 parts carbomer, 6 parts fish scale glue, 105 parts hydrogenated castor oil, 130 parts ethanol, and 6 parts monoglyceride.

[0011] Among the above-mentioned ingredients, this invention adds the natural medicinal herb aloe vera, which has excellent effects in clearing heat, detoxifying, removing blood stasis, and killing parasites. It can effectively promote skin metabolism, thus clearing heat and cooling blood, removing blood stasis and eliminating spots on stubborn skin pigmentation. Furthermore, the polysaccharides and various vitamins contained in aloe vera have good nourishing, moisturizing, and whitening effects on the skin. It has a good therapeutic effect on melasma, freckles, and pigmented spots. The prickly pear cactus has the effects of clearing heat and detoxifying, strengthening the spleen and stomach, and beautifying the skin. Applying it externally can effectively treat skin pigmentation. Safflower has the effects of promoting blood circulation, relieving menstrual pain, and dispersing blood stasis and relieving pain. Applying it externally through transdermal absorption can improve local microcirculation and further treat skin pigmentation.

[0012] Among the other medicinal herbs, Lithospermum has the effects of clearing heat and cooling blood, promoting blood circulation and detoxifying, and promoting rash eruption and eliminating spots. When used externally, it can improve local microcirculation and further treat skin pigmentation. Purslane is rich in vitamins C and E, which can resist oxidation and inhibit melanin production, while promoting blood circulation and fading spots. It can also soothe and calm the skin and repair damaged skin cells.

[0013] From the perspective of the formulation mechanism of the herbal gel for treating stubborn skin pigmentation of this invention, this invention rationally formulates a herbal gel by combining various components according to the principles of principal, assistant, adjuvant, and guide herbs. In this herbal combination, aloe vera and prickly pear cactus are combined as principal herbs, taking advantage of their effects of clearing heat and cooling blood, removing blood stasis and eliminating spots, and beautifying the skin, effectively clearing stagnation and pigmentation in skin tissues. Safflower and gromwell are combined as assistant herbs, which can play a good role in dispersing blood stasis and improving local microcirculation of the skin. Purslane is used as the left guide herb, which can achieve the effects of clearing heat and detoxifying, anti-oxidation, and inhibiting melanin deposition. Furthermore, through the various effective components contained in purslane, it can effectively promote skin metabolism and repair damaged skin cells. This invention achieves the effects of clearing heat and cooling blood, removing blood stasis and eliminating spots through the interaction of various components, thereby treating pigmentation on the skin surface. This herbal gel has high safety, mild medicinal properties, and no toxic side effects, thus causing no irritation to the affected area.

[0014] This invention also provides a method for preparing the above-mentioned traditional Chinese medicine gel for treating stubborn skin pigmentation, comprising the following steps:

[0015] Carbomer is soaked in pure water to obtain a carbomer aqueous solution;

[0016] Boil fish scale glue in purified water and filter to obtain fish scale glue juice.

[0017] The safflower, gromwell root, and purslane are mixed and soaked, then filtered to obtain medicinal oil;

[0018] Mix aloe vera extract and prickly pear cactus extract evenly and concentrate to obtain a medicinal juice;

[0019] Add the medicinal oil, fish scale glue, medicinal juice, carbomer aqueous solution and monoglyceride in sequence, heat until emulsified, cool down to 25-30℃, stir evenly, and the product is ready.

[0020] Preferably, as a further specific embodiment, the prickly pear cactus extract is prepared by the following method:

[0021] Take fresh prickly pear cactus, crush it, filter it to obtain prickly pear cactus juice, add 60-65wt% ethanol and reflux extract 2-3 times, each time add 2-3 times the total mass of ethanol of prickly pear cactus juice, reflux extract for 2-3 hours, filter and combine the filtrates.

[0022] Adjust the pH of the filtrate to 7.1-7.5, let it stand for 8-10 hours, filter, centrifuge, pass through a macroporous adsorption resin column, rinse with pure water, elute with 30wt% ethanol, collect the eluent, recover the ethanol under reduced pressure, and concentrate to a viscous state to obtain the final product.

[0023] Preferably, as a further specific embodiment, the aloe vera extract is prepared by the following method:

[0024] Take fresh aloe vera, crush it, filter it to obtain aloe vera juice, add 70-75wt% ethanol and reflux extract 2-3 times, each time adding 4-5 times the total mass of ethanol of aloe vera juice, reflux extract for 3-4 hours, filter, and recover the ethanol under reduced pressure to obtain the product.

[0025] Preferably, as a further specific embodiment, the macroporous adsorption resin column is HPD450, and the weight ratio of the macroporous adsorption resin column to aloe vera is (2.1-2.5):1, preferably 2.4:1.

[0026] Preferably, as a further specific embodiment, the volume ratio of the 30wt% ethanol to the macroporous resin is 3-4 ml: 1.1 g;

[0027] The preferred ratio is 3.2 ml: 1 g.

[0028] Preferably, as a further specific embodiment, the safflower, alkanet root and purslane are soaked in hydrogenated castor oil for 3-5 months and then filtered to obtain the filtrate.

[0029] Heat the filtrate to 220-230℃ and stir for 0.5-1 hour. After cooling, filter to obtain the medicinal oil.

[0030] Preferably, the soaking time is 4 months.

[0031] Preferably, as a further specific embodiment, when the gel is stirred under vacuum conditions, the stirring speed is 15-20 rpm and the stirring time is 5-10 min.

[0032] In the above preparation process, this invention employs a soaking and fermentation method on safflower, gromwell root, and purslane to better extract their active ingredients. Hydrogenated castor oil, rather than vegetable oil, is used for soaking and fermentation because it effectively reduces the surface tension of oily substances, allowing for good dispersion through stirring. This results in a stable, transparent, and homogeneous solution formed with the extracted active ingredients. The soaking and fermentation time significantly affects the efficacy of the prepared herbal ointment. Fresh herbs, after drying, shrink due to moisture loss, causing various components to solidify within the cells and disrupting the cell membrane's semi-permeability. This makes the already complex dissolution process more difficult. Therefore, a prolonged oil soaking and fermentation method is used to extract the active ingredients from the herbs. However, the soaking time is crucial; too short a time prevents the extraction of active ingredients, significantly reducing efficacy. When the soaking time is too short, the active ingredients in herbs such as safflower and gromwell root cannot be fully extracted. Therefore, only when the soaking and fermentation time of safflower, gromwell and purslane is within the range provided by this invention can their medicinal components be fully extracted, and the resulting medicinal oil will have the best effect.

[0033] Furthermore, the amount and concentration of ethanol used in the extraction process of prickly pear cactus and aloe vera are also crucial for this invention. This is because the invention involves crushing the aloe vera and prickly pear cactus, and then using ethanol to extract the active ingredients. Compared to the traditional method of using purified water to extract active ingredients, the use of ethanol in this invention allows for the full extraction of active ingredients. When the ethanol concentration is outside the range provided by this invention, excessively high concentrations will deactivate and damage the active ingredients, thus affecting their medicinal properties. Conversely, excessively low concentrations will prevent the active ingredients from being fully extracted, thus affecting the efficacy of the prepared herbal gel. In the extraction process of prickly pear cactus, this invention uses macroporous adsorption resin, which relies on its adsorption properties and large specific surface area for physical adsorption. This allows the active ingredients in the raw materials to be separated by elution with purified water according to their adsorption force and molecular weight, thereby achieving concentration. Therefore, the volume ratio between the macroporous adsorption resin column and the aloe vera and ethanol is also limited. If it is outside the range provided by this invention, the macroporous adsorption resin column will not achieve a good concentration effect.

[0034] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0035] (1) All materials used in this invention are natural ingredients, which are non-irritating and have no unpleasant feel on the affected area.

[0036] (2) This invention adds a variety of mild and non-irritating Chinese herbal ingredients, such as aloe vera extract, prickly pear extract, safflower, gromwell root, purslane and fish scale glue, to achieve the effects of clearing heat and cooling blood, removing blood stasis and eliminating spots through the pharmacology of principal, assistant and adjuvant herbs, and completely cures stubborn skin spots, melasma, freckles, age spots and so on. Detailed Implementation

[0037] The technical solution of the present invention will be clearly and completely described below with reference to specific embodiments. However, those skilled in the art will understand that the embodiments described below are some embodiments of the present invention, but not all embodiments, and are only used to illustrate the present invention, and should not be regarded as limiting the scope 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.

[0038] To more clearly illustrate the technical solutions in this invention, specific embodiments are described below.

[0039] Example 1

[0040] Take 25g of aloe vera extract, 10g of prickly pear cactus, 5g of safflower, 5g of purple gromwell root, 5g of purslane, 60g of purified water, 1g of carbomer, 5g of fish scale glue, 100g of hydrogenated castor oil, 120g of ethanol and 4g of monoglyceride.

[0041] Place 1g of carbomer in a glass container, pour in purified water and soak until the carbomer is completely dissolved to obtain a carbomer aqueous solution.

[0042] Place 5g of fish scale glue in another glass container, pour in purified water and simmer until the fish scale glue is completely dissolved. Filter to obtain a fish scale glue solution.

[0043] Mix 5g of safflower, 5g of gromwell root and 5g of purslane in a clay pot, pour in 100g of hydrogenated castor oil and soak for 3 months. Filter with a filter cloth, squeeze out the liquid on the filter cloth, and then pour the filtrate into a pot and heat it to 220℃ and stir for 0.5h. After cooling, filter to obtain medicinal oil.

[0044] Take 10g of fresh prickly pear cactus, place it in a mortar and crush it, filter it with a filter cloth, squeeze out the liquid on the filter cloth, then add 60wt% ethanol to the filtrate and reflux extract twice, each time adding 2 times the total mass of ethanol of the prickly pear cactus juice, reflux extract for 2 hours, filter and combine the filtrates.

[0045] The pH of the filtrate was adjusted to 7.1, and after standing for 8 hours, it was filtered, centrifuged, and then passed through a macroporous adsorption resin column, wherein the weight ratio of the macroporous adsorption resin column to the prickly cactus was 2.1:1. After rinsing with purified water, it was eluted with 30wt% ethanol, wherein the volume ratio of 30wt% ethanol to the mass ratio of macroporous resin was 3ml:1.1g. The eluent was collected, the ethanol was recovered under reduced pressure, and then concentrated to a viscous state to obtain the final product.

[0046] Take 25g of fresh aloe vera and crush it in another mortar. Filter it with a filter cloth and squeeze out the filtrate on the filter cloth. Then add 70wt% ethanol to the aloe vera juice and reflux extract twice. Each time, add 4 times the total mass of ethanol to the aloe vera juice and reflux extract for 3 hours. Filter and recover the ethanol under reduced pressure to obtain the product.

[0047] Aloe vera extract and prickly pear cactus extract were mixed and stirred with a stirring rod. After being mixed evenly, the mixture was concentrated to obtain a medicinal juice.

[0048] Add the medicinal oil, fish scale glue, medicinal juice, carbomer aqueous solution and monoglyceride in sequence, heat until emulsified, cool down to 25°C, and stir in a vacuum system at a speed of 15 rpm for 5 minutes to obtain the final product.

[0049] Example 2

[0050] Take 30g of aloe vera extract, 15g of prickly pear cactus, 10g of safflower, 8g of purple gromwell root, 8g of purslane, 65g of purified water, 5g of carbomer, 8g of fish scale glue, 110g of hydrogenated castor oil, 140g of ethanol and 10g of monoglyceride.

[0051] Place 5g of carbomer in a glass container, pour in purified water and soak until the carbomer is completely dissolved to obtain a carbomer aqueous solution.

[0052] Place 8g of fish scale glue in another glass container, pour in purified water and simmer until the fish scale glue is completely dissolved. Filter to obtain a fish scale glue solution.

[0053] Mix 10g of safflower, 8g of gromwell root and 8g of purslane in a clay pot, pour in 110g of hydrogenated castor oil and soak for 5 months, filter with a filter cloth, squeeze out the liquid on the filter cloth, then pour the filtrate into a pot and heat it to 230℃ and stir for 1 hour. After cooling, filter to obtain medicinal oil.

[0054] Take 15g of fresh prickly pear cactus, place it in a mortar and crush it, filter it with a filter cloth, squeeze out the liquid on the filter cloth, then add 65wt% ethanol to the filtrate and reflux extract 3 times, each time adding 3 times the total mass of ethanol of prickly pear cactus juice, reflux extract for 3 hours, filter and combine the filtrates.

[0055] Adjust the pH of the filtrate to 7.5, let it stand for 10 hours, filter, centrifuge, and then pass it through a macroporous adsorption resin column, wherein the weight ratio of the macroporous adsorption resin column to the prickly cactus is 2.5:1. After rinsing with purified water, elute with 30wt% ethanol, wherein the volume ratio of 30wt% ethanol to the mass ratio of macroporous resin is 4ml:1.1g. Collect the eluent, recover the ethanol under reduced pressure, and concentrate it to a viscous state to obtain the final product.

[0056] Take fresh aloe vera and crush it in another mortar. Filter it with a filter cloth and squeeze out the filtrate on the filter cloth. Then add 75wt% ethanol to the aloe vera juice and reflux extract it 3 times. Each time, add 5 times the total mass of ethanol to the aloe vera juice and reflux extract for 4 hours. Filter and recover the ethanol under reduced pressure to obtain the product.

[0057] Aloe vera extract and prickly pear cactus extract were mixed and stirred with a stirring rod. After being mixed evenly, the mixture was concentrated to obtain a medicinal juice.

[0058] Add the medicinal oil, fish scale glue, medicinal juice, carbomer aqueous solution and monoglyceride in sequence, heat until emulsified, cool down to 30°C, and stir in a vacuum system at a speed of 20 rpm for 10 minutes to obtain the final product.

[0059] Example 3

[0060] Take 27g of aloe vera extract, 12g of prickly pear cactus, 7g of safflower, 6g of purple gromwell root, 6g of purslane, 63g of purified water, 2g of carbomer, 6g of fish scale glue, 105g of hydrogenated castor oil, 130g of ethanol and 6g of monoglyceride.

[0061] Place 2g of carbomer in a glass container, pour in purified water and soak until the carbomer is completely dissolved to obtain a carbomer aqueous solution.

[0062] Place 6g of fish scale glue in another glass container, pour in purified water and simmer until the fish scale glue is completely dissolved. Filter to obtain a fish scale glue solution.

[0063] Mix 7g of safflower, 6g of gromwell root and 6g of purslane in a clay pot, pour in 105g of hydrogenated castor oil and soak for 4 months. Filter with a filter cloth, squeeze out the liquid on the filter cloth, and then pour the filtrate into a pot and heat it to 225℃ and stir for 0.7h. After cooling, filter to obtain medicinal oil.

[0064] Take 12g of fresh prickly pear cactus, crush it in a mortar, filter it with a filter cloth, squeeze out the liquid on the filter cloth, then add 62wt% ethanol to the filtrate and reflux extract 3 times, each time adding 2 times the total mass of ethanol of prickly pear cactus juice, reflux extract for 2.5h, filter and combine the filtrates.

[0065] The pH of the filtrate was adjusted to 7.2, and after standing for 9 hours, it was filtered, centrifuged, and then passed through a macroporous adsorption resin column, wherein the weight ratio of the macroporous adsorption resin column to the prickly cactus was 2.4:1. After rinsing with purified water, it was eluted with 30wt% ethanol, wherein the volume ratio of 30wt% ethanol to the mass ratio of macroporous resin was 3.2ml:1.1g. The eluent was collected, the ethanol was recovered under reduced pressure, and then concentrated to a viscous state to obtain the final product.

[0066] Take 27g of fresh aloe vera and crush it in another mortar. Filter it with a filter cloth and squeeze out the filtrate on the filter cloth. Then add 73wt% ethanol to the aloe vera juice and reflux extract it 3 times. Each time, add 4 times the total mass of ethanol to the aloe vera juice and reflux extract for 4 hours. Filter and recover the ethanol under reduced pressure to obtain the product.

[0067] Aloe vera extract and prickly pear cactus extract were mixed and stirred with a stirring rod. After being mixed evenly, the mixture was concentrated to obtain a medicinal juice.

[0068] Add the medicinal oil, fish scale glue, medicinal juice, carbomer aqueous solution and monoglyceride in sequence, heat until emulsified, cool down to 29°C, and stir in a vacuum system at a speed of 17 rpm for 8 minutes to obtain the final product.

[0069] Example 4

[0070] The specific preparation steps of the traditional Chinese medicine gel are the same as in Example 3, except that the components are adjusted to 20g of aloe vera extract, 5g of prickly pear cactus, 2g of safflower, 2g of purple gromwell root, 2g of purslane, 50g of purified water, 1g of carbomer, 4g of fish scale glue, 80g of hydrogenated castor oil, 100g of ethanol and 2g of monoglyceride.

[0071] Example 5

[0072] The specific preparation steps of the traditional Chinese medicine gel are the same as in Example 3, except that the hydrogenated castor oil component is adjusted to 80g.

[0073] Example 6

[0074] The specific preparation steps of the traditional Chinese medicine gel are the same as in Example 3, except that the hydrogenated castor oil component is adjusted to 130g.

[0075] Example 7

[0076] The specific preparation steps of the traditional Chinese medicine gel are the same as in Example 3, except that the ethanol in the prickly pear cactus extract is adjusted to 70 wt%.

[0077] Example 8

[0078] The specific preparation steps of the traditional Chinese medicine gel are the same as in Example 3, except that the ethanol in the prickly pear cactus extract is adjusted to 30wt%.

[0079] Example 9

[0080] The specific preparation steps of the traditional Chinese medicine gel are the same as in Example 3, except that the weight ratio of macroporous adsorption resin column to prickly pear cactus is adjusted to 1.5:1.

[0081] Example 10

[0082] The specific preparation steps of the traditional Chinese medicine gel are the same as in Example 3, except that the volume ratio of 30wt% ethanol to macroporous resin is adjusted to 2:1.

[0083] Example 11

[0084] The specific preparation steps of the traditional Chinese medicine gel are the same as in Example 3, except that 2 times the total mass of ethanol of aloe vera juice is added to the prickly pear cactus each time.

[0085] Example 12

[0086] The specific preparation steps of the traditional Chinese medicine gel are the same as in Example 3, except that the number of reflux extractions is adjusted to 1.

[0087] Example 13

[0088] The specific preparation steps of the traditional Chinese medicine gel are the same as in Example 3, except that the number of times the prickly pear cactus is refluxed and extracted is adjusted to 5 times.

[0089] Comparative Example 1

[0090] The specific preparation steps of the traditional Chinese medicine gel are the same as in Example 3, except that safflower, gromwell and purslane are soaked in purified water.

[0091] Comparative Example 2

[0092] The specific preparation steps of the traditional Chinese medicine gel are the same as in Example 3, except that the prickly prickly cactus is not used.

[0093] Comparative Example 3

[0094] The specific preparation steps of the traditional Chinese medicine gel are the same as in Example 3, except that aloe vera is not used.

[0095] Experimental Example 1

[0096] Experiments were conducted on the products obtained in Examples 1-13 and Comparative Examples 1-3 of the present invention and commercially available common drugs for treating pigmentation. The test results are shown in Table 1.

[0097]

[0098]

[0099] Experimental Example 2

[0100] The efficacy of this invention in treating stubborn pigmentation will be verified through clinical cases.

[0101] Patient ①: Zhu Moumou, male, age: 60 years old.

[0102] The patient has had pigmented patches under his left armpit for over 10 years, and has sought medical attention multiple times, including using over-the-counter ointments, without significant improvement. Currently, the skin is smooth without any raised areas, and the patches cover an area of ​​10 cm². 2 It is brown in color.

[0103] After one week of treatment with the herbal gel of this invention, the color of the patches on the skin under the left armpit significantly faded. After another week of treatment, the patches had essentially disappeared, becoming indistinguishable from the rest of the skin, and their color matched the surrounding areas. Two more weeks of consolidation treatment resulted in complete fading of the pigmentation without recurrence.

[0104] Patient ②: Xie, female, age: 40.

[0105] Four years ago, the patient developed light brown patches of varying sizes on both cheeks. She consulted a dermatologist and was diagnosed with melasma. She used over-the-counter ointments for treatment, but the effects were minimal. Currently, the patches are symmetrically distributed on both cheeks and the outer edges of the eyes. The patches vary in size and are light brown. She also experiences poor sleep and appetite, and anxiety.

[0106] Treatment with the herbal gel prepared according to this invention resulted in a significant lightening of the color of the patches on both sides of the skin after one week of treatment. After another week of treatment, the patches on both cheeks essentially disappeared. Two more weeks of consolidation treatment resulted in the complete disappearance of the patches on the face without recurrence.

[0107] Patient ③: Wang Moumou, female, age: 30 years old.

[0108] The patient developed brown spots of varying sizes on both cheeks, bridge of the nose, and nostrils. He tried to treat them by applying over-the-counter ointments, but the effect was not obvious.

[0109] After one week of treatment with the herbal gel prepared according to this invention, the color of the skin spots significantly lightened, changing from brown to light brown. After another week of treatment, the spots essentially disappeared. Two more weeks of consolidation treatment resulted in the complete disappearance of the facial spots without recurrence.

[0110] Based on the above data, the following conclusions can be drawn:

[0111] Comparative examples 1-4 show that the dosage of each component is crucial for this invention. This is because the invention utilizes the synergistic effects of each component, adhering to the principles of principal, assistant, adjuvant, and guide, to rationally formulate a traditional Chinese medicine gel for treating stubborn pigmentation. Through the interaction of the components, the prepared traditional Chinese medicine gel can achieve the effects of clearing heat and cooling blood, removing blood stasis and eliminating spots, promoting skin metabolism, and repairing damaged skin cells. It can effectively treat stubborn skin pigmentation such as melasma, dark spots, and age spots with significant efficacy and no side effects.

[0112] By comparing Examples 3 and 5-6, it can be seen that the amount of hydrogenated castor oil affects the soaking effect of safflower, gromwell root, and purslane. If too much hydrogenated castor oil is used, the active ingredients in the raw materials will be over-dissolved in the hydrogenated castor oil, leading to drug denaturation and affecting the medicinal effect. If too little hydrogenated castor oil is used, the active ingredients will not be completely extracted, resulting in a low content of active ingredients and poor medicinal effect of the prepared Chinese medicine gel.

[0113] By comparing Examples 3 and 7-13, it can be seen that the present invention, in extracting the effective components contained in *Opuntia ficus-indica* and *Aloe vera*, also limits the ethanol concentration, the weight ratio of macroporous adsorption resin to *Opuntia ficus-indica*, the number of reflux extractions, the amount of ethanol used, and the mass ratio between the volume of the macroporous adsorption resin column and 30wt% ethanol. This is because the present invention uses ethanol to extract the effective components contained in *Opuntia ficus-indica* and *Aloe vera*. Compared with the traditional method of extracting effective components using purified water, the use of ethanol in the present invention allows for the full extraction of effective components. When the ethanol concentration is outside the range provided by the present invention... Excessive ethanol concentration can deactivate and damage the active ingredients, thus affecting their medicinal properties. Conversely, insufficient ethanol concentration can prevent the complete precipitation of active ingredients, thereby affecting the efficacy of the prepared herbal gel. In the extraction process of Opuntia ficus-indica, this invention employs macroporous adsorption resin, which relies on its adsorption capacity and physical adsorption through its large specific surface area. This allows the active ingredients in the raw material to be separated by elution with pure water according to their adsorption force and molecular weight, thereby achieving concentration. Therefore, the volume ratio between the macroporous adsorption resin column and aloe vera and ethanol is also limited. If it is outside the range provided by this invention, the macroporous adsorption resin column cannot achieve a good concentration effect.

[0114] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine gel for treating stubborn skin pigmentation, characterized in that, By weight, it is mainly made from the following raw materials: 25-30 parts aloe vera extract, 10-15 parts prickly pear cactus extract, 5-10 parts safflower, 5-8 parts gromwell root, 5-8 parts purslane, 60-65 parts purified water, 1-5 parts carbomer, 5-8 parts fish scale glue, 100-110 parts hydrogenated castor oil, 120-140 parts ethanol, and 4-10 parts monoglycerides.

2. The traditional Chinese medicine gel according to claim 1, characterized in that, Aloe vera extract 26-29 parts, prickly pear cactus extract 11-13 parts, safflower 6-9 parts, gromwell root 6-7 parts, purslane 6-7 parts, purified water 61-64 parts, carbomer 2-3 parts, fish scale glue 6-7 parts, hydrogenated castor oil 102-106 parts, ethanol 125-135 parts, and monoglycerides 5-7 parts.

3. The traditional Chinese medicine gel according to claim 1, characterized in that, 27 parts of aloe vera extract, 12 parts of prickly pear cactus extract, 7 parts of safflower, 6 parts of purple gromwell root, 6 parts of purslane, 63 parts of purified water, 2 parts of carbomer, 6 parts of fish scale glue, 105 parts of hydrogenated castor oil, 130 parts of ethanol and 6 parts of monoglycerides.

4. A method for preparing a traditional Chinese medicine gel as described in any one of claims 1-3, characterized in that, Includes the following steps: Carbomer is soaked in pure water to obtain a carbomer aqueous solution; Boil fish scale glue in purified water and filter to obtain fish scale glue juice. The safflower, gromwell root, and purslane are mixed and soaked, then filtered to obtain medicinal oil; Mix aloe vera extract and prickly pear cactus extract evenly and concentrate to obtain a medicinal juice; Add the medicinal oil, fish scale glue, medicinal juice, carbomer aqueous solution and monoglyceride in sequence, heat until emulsified, cool down to 25-30℃, stir evenly, and the product is ready.

5. The preparation method according to claim 4, characterized in that, The prickly pear cactus extract was prepared by the following method: Take fresh prickly pear cactus, crush it, filter it to obtain prickly pear cactus juice, add 60-65wt% ethanol and reflux extract 2-3 times, each time add 2-3 times the total mass of ethanol of prickly pear cactus juice, reflux extract for 2-3 hours, filter and combine the filtrates. Adjust the pH of the filtrate to 7.1-7.5, let it stand for 8-10 hours, filter, centrifuge, pass through a macroporous adsorption resin column, rinse with pure water, elute with 30wt% ethanol, collect the eluent, recover the ethanol under reduced pressure, and concentrate to a viscous state to obtain the final product.

6. The preparation method according to claim 4, characterized in that, The aloe vera extract is prepared by the following method: Take fresh aloe vera, crush it, filter it to obtain aloe vera juice, add 70-75wt% ethanol and reflux extract 2-3 times, each time adding 4-5 times the total mass of ethanol of aloe vera juice, reflux extract for 3-4 hours, filter, and recover the ethanol under reduced pressure to obtain the product.

7. The preparation method according to claim 5, characterized in that, The macroporous adsorption resin column is HPD450, and the weight ratio of the macroporous adsorption resin column to aloe vera is (2.1-2.5):1, preferably 2.4:

1.

8. The preparation method according to claim 5, characterized in that, The volume ratio of the 30wt% ethanol to the macroporous resin is 3-4 ml: 1.1 g; The preferred ratio is 3.2 ml: 1 g.

9. The preparation method according to claim 4, characterized in that, The safflower, alkanet root, and purslane were soaked in hydrogenated castor oil for 3-5 months, and then the filtrate was collected by filtration. Heat the filtrate to 220-230℃ and stir for 0.5-1 hour. After cooling, filter to obtain the medicinal oil. Preferably, the soaking time is 4 months.

10. The preparation method according to claim 4, characterized in that, When the gel is stirred under vacuum, the stirring speed is 15-20 rpm and the stirring time is 5-10 min.

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