Traditional Chinese medicine composition, itching-relieving repair gel as well as preparation method and application of itching-relieving repair gel

Abstract

The invention discloses a traditional Chinese medicine composition, itching-relieving repair gel and a preparation method and application thereof, the traditional Chinese medicine composition is composed of lithospermum extract, centella asiatica extract, fructus kochiae extract and water chestnut hull extract, so that the traditional Chinese medicine composition is a natural Chinese herbal medicine substance and has the characteristics of being mild and non-irritating; the itching-relieving repairing gel prepared by the preparation method disclosed by the invention has the advantages of mild components, safety, no irritation and good repairing and itching-relieving effects, and the skin wound healing is promoted while the effects of resisting bacteria and relieving itching are exerted, and the obtained itching-relieving repairing gel product has the advantages of mild components, safety, no irritation and good repairing and itching-relieving effects.

Description

Technical Field

[0001] The present invention relates to the technical field of gels, and in particular, to a traditional Chinese medicine composition, an antipruritic repair gel, a preparation method thereof, and an application thereof. Background Art

[0002] Skin wound diseases have now become one of the diseases with the highest incidence in today's society. Whether it is a postoperative wound, a traumatic wound, or a wound caused by ulcers, erosions, burns, etc., in order to improve the repair rate in the existing technology for wound repair, it is easy to cause a decline in the moisturizing and antibacterial properties of the product, and it is difficult to achieve a coordinated improvement in the wound repair rate, moisturizing, and antibacterial properties of the product, which limits the use efficiency of the product.

[0003] A gel preparation refers to a semi-solid or thick liquid preparation with gel properties made from an extract of medicinal materials and a suitable matrix. A traditional Chinese medicine gel preparation is a new type of traditional Chinese medicine external preparation. In recent years, due to its advantages such as good spreading property, easy to clean, high bioavailability, etc., it can reduce the strong subjective feeling of heaviness brought to patients by external preparations and improve the wound moisturizing effect of the product, so it stands out among many dosage forms.

[0004] Among the existing cosmetic ingredients, due to the presence of special additives, heavy metals, hormones, etc., it is easy to cause damage to the skin and allergic poisoning reactions, etc.; ordinary moisturizing products can only act superficially on the skin and cannot deeply moisturize and nourish the skin, and the efficacy components have weak effects. Natural plant extracts are more and more popular and valued by people due to their characteristics of pollution-free, hormone-free, residue-free, and diverse functions, wide application range, safety, etc., so they have quite a high research and development heat in the field of cosmetics research. Therefore, adding traditional Chinese medicine extract components to functional repair products can deeply care for and cultivate the skin on the basis of safety and effectiveness. At the same time, combined with the gel dosage form, the light texture will not cause a burden on the skin, and the fresh texture brings a sense of lightness.

[0005] According to the survey, the number of people with skin problems such as dermatitis and allergies is increasing year by year. Seasonal changes, dust, particles, harmful substances, high-intensity work, and improper use of skin care products in the air and other factors are likely to cause many skin allergy and inflammation problems, manifested as papules, skin flushing, swelling, itching, stinging, burning, itching, desquamation, etc. In particular, cosmetics used on everyone's face every day are the most direct factors affecting the skin condition. Existing repair and antipruritic products designed for skin inflammation have poor effects, and even the products themselves are irritating to the skin. There is an urgent need to seek products with mild, safe, non-irritating ingredients and good repair and antipruritic effects.

[0006] In view of this, the present invention is specifically proposed. Summary of the Invention

[0007] The object of the present invention is to provide a traditional Chinese medicine composition, an antipruritic repair gel, and its preparation method and application. The gel product prepared from the traditional Chinese medicine composition of the present invention has the advantages of mild components, safety, non-irritation, repair, and excellent antipruritic effect.

[0008] The present invention is implemented as follows:

[0009] In the first aspect, the present invention provides a traditional Chinese medicine composition, which is composed of lithospermum extract, centella asiatica extract, Kochia scoparia extract, and water chestnut shell extract; wherein, the mass ratio of lithospermum extract, centella asiatica extract, Kochia scoparia extract, and water chestnut shell extract is 0.2-5:0.2-10:0.1-5:0.1-5.

[0010] In the second aspect, the present invention provides the application of the above traditional Chinese medicine composition in the preparation of a product with antipruritic and repair effects.

[0011] In the third aspect, the present invention provides an antipruritic repair gel, the components of which include the above traditional Chinese medicine composition.

[0012] In the fourth aspect, the present invention provides a preparation method of the above antipruritic repair gel, which includes:

[0013] Mix the gel matrix, moisturizer, antioxidant, and purified water, and after swelling, obtain liquid A; mix the above traditional Chinese medicine composition with purified water, and obtain liquid B after stirring; mix the cosolvent, solubilizer, and penetration enhancer, and obtain liquid C after stirring evenly;

[0014] Mix liquid A, liquid B, and liquid C, add a preservative, and adjust the pH to obtain the antipruritic repair gel.

[0015] The present invention has the following beneficial effects:

[0016] (1) The present invention combines the extracts of lithospermum, centella asiatica, Kochia scoparia, and water chestnut shell, and prepares a traditional Chinese medicine composition at a specific ratio. This composition has good antipruritic and repair effects.

[0017] (2) The traditional Chinese medicine composition of the present invention is a natural Chinese herbal medicine substance, which has the characteristics of mildness and non-irritation. It can play antibacterial and antipruritic effects while promoting the healing of skin wounds. Therefore, it can be prepared into an antipruritic repair gel.

[0018] (3) The above traditional Chinese medicine composition in the antipruritic repair gel of the present invention is the main active ingredient. Through reasonable combination with other ingredients, the obtained gel is administered externally, and the drug acts directly on the affected area. The drug acts quickly, which can reduce the pain of patients; at the same time, it has the characteristics of short treatment course, low cost, convenient use, rapid disappearance of clinical symptoms, and significant curative effect. It is convenient and safe to use, and has no toxic and side effects.

[0019] (4) The preparation process of the traditional Chinese medicine composition and the antipruritic and repair gel of the present invention is simple, suitable for large-scale production, and has good industrial practicability. Detailed implementation manners

[0020] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Those not specified in the embodiments are carried out according to conventional conditions or conditions recommended by the manufacturer. Reagents or instruments not indicated by the manufacturer can be obtained as conventional products through commercial purchase.

[0021] The present invention provides a traditional Chinese medicine composition with antipruritic and repair effects. The components of the composition are: Lithospermum erythrorhizon, Centella asiatica, Kochia scoparia, and water chestnut shell. Specifically, the components of the combination are Lithospermum erythrorhizon extract, Centella asiatica extract, Kochia scoparia extract, and water chestnut shell extract.

[0022] Lithospermum erythrorhizon has a long history of medicinal use in China. It was first recorded in "Shennong Ben Cao Jing" and is the dried root of plants such as Lithospermum erythrorhizon and Arnebia euchroma in the family Boraginaceae, with high medicinal value. Lithospermum erythrorhizon is widely used for clearing heat and relieving exterior syndrome, activating blood circulation and detoxifying, and detoxifying and promoting eruption. There is also a Lithospermum erythrorhizon ointment used for treating deep burns. Lithospermum erythrorhizon contains various chemical components such as naphthoquinones, phenolbenzophenones, and phenolic acids, and the lipophilic naphthoquinone compounds are one of the main bioactive components in Lithospermum erythrorhizon. Research shows that shikonin in naphthoquinone compounds can exert anti-inflammatory effects through multiple pathways, such as inhibiting the levels of serum pro-inflammatory cytokines, inhibiting the activities of COX-2 and iNOS in serum and colon, and shikonin can significantly reverse the increased expression of MMP-1, MMP-3, and MMP-13 in chondrocytes induced by IL-1β at the gene and protein levels. And shikonin has a killing effect on a variety of microorganisms, such as affecting the biofilm and transcriptional levels of virulence genes of Listeria monocytogenes, and inhibiting superficial fungi causing foot infections.

[0023] Centella asiatica has a long history of medicinal use. The earliest Chinese herbal medicine work "Shennong Ben Cao Jing" records that it "maintains great heat, evil sores, carbuncles and ulcers spreading, red flushing, red skin, and body heat". Centella asiatica has the effect of promoting wound healing. Tablets and ointments made from asiaticoside have been clinically tested for long-term non-healing lower limb ulcers and trauma cases caused by venous insufficiency, as well as keloids after wound recovery caused by factors such as tendon adhesion and burns caused by surgery or trauma, and all have certain curative effects. Therefore, Centella asiatica is also often used as a beauty medicine. Centella asiatica can treat small wounds, hypertrophic wounds, burns, psoriasis, and scleroderma, etc. Research shows that Centella asiatica can repair aging skin, and its mechanism may be related to the ability of Centella asiatica to promote fibroblast proliferation and increase the intracellular content of collagen and fibronectin. Centella asiatica can also improve the tensile strength of newly formed skin and inhibit the inflammatory reaction of hypertrophic scars or keloids.

[0024] Kochia fruit is the dried ripe fruit of Kochia scoparia (L.) Schrad. of the Chenopodiaceae family. As a commonly used traditional Chinese medicine, it has the effects of clearing heat and promoting diuresis, dispelling wind and relieving itching. Modern chemical composition research shows that Kochia fruit mainly contains saponins, oleanolic acid, β-sitosterol, rutin, isorhamnetin and other components; modern pharmacological research shows that Kochia fruit has anti-inflammatory, hypoglycemic, antibacterial, anti-allergic, diuretic, anti-trichomonas vaginalis and other pharmacological effects, and is commonly used in the treatment of various skin diseases, inflammations and kidney diseases in clinical practice.

[0025] Water chestnut is both a traditional food and a traditional medicine, with health care effects such as anti-tumor and enhancing immunity. As a part of water chestnut, water chestnut shell is rich in effective substances such as polyphenols, polysaccharides, flavonoids and alkaloids, making it have good antioxidant and antibacterial effects.

[0026] Alkanna tinctoria has anti-inflammatory and antibacterial effects and can kill a variety of microorganisms. Centella asiatica can promote the proliferation of fibroblasts and increase the intracellular content of collagen and fibronectin. Kochia fruit has the effects of clearing heat and promoting diuresis, dispelling wind and relieving itching. Water chestnut shell has the effect of clearing heat and detoxifying, and can assist in the treatment of various skin diseases. The existing products, alkanna tinctoria oil and asiaticoside cream, can be used to treat radioactive skin wounds. The present invention combines the extracts of Alkanna tinctoria, Centella asiatica, Kochia fruit and water chestnut shell for the first time. It has been proved by experiments that the combined use of these four can achieve the effects of synergistic antibacterial, anti-inflammatory, itching relief and skin repair.

[0027] For the above traditional Chinese medicine composition, the mass ratio of the extracts of Alkanna tinctoria, Centella asiatica, Kochia fruit and water chestnut shell is 0.2 - 5:0.2 - 10:0.1 - 5:0.1 - 5. Judging from the experimental results, when the ratio of the four substances is within this mass ratio range, its itching relief and repair effect is better.

[0028] Furthermore, when the mass ratio is 0.2 - 3:0.2 - 3:0.2 - 2:0.2 - 2, its itching relief and repair effect is even better.

[0029] It has been proved by experiments that the above traditional Chinese medicine composition has the effect of itching relief and repair, so it can be prepared into related products, such as drugs, foods or cosmetics.

[0030] When the above product is a drug, its ingredients include the above traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0031] When the above product is a food, its ingredients include the above traditional Chinese medicine composition and food-acceptable excipients.

[0032] When the above product is a cosmetic, its ingredients include the above traditional Chinese medicine composition and cosmetic-acceptable excipients.

[0033] The dosage forms of the related products can be pills, capsules, granules, tablets, external ointments, external gels or patches.

[0034] In order to convert the above traditional Chinese medicine composition into related products, the present invention also provides an antipruritic and repair gel and its preparation method. The antipruritic and repair gel includes the above traditional Chinese medicine composition, as well as a gel matrix, a humectant, a solubilizer, a penetration enhancer, an antioxidant, a cosolvent and a preservative.

[0035] In this gel product, the mass percentage of the traditional Chinese medicine composition is: 0.5 - 10%.

[0036] Specifically, in this antipruritic and repair gel, the mass percentage of the lithospermum extract is 0.2 - 5%, the mass percentage of the centella asiatica extract is 0.2 - 10%, the mass percentage of the Kochia scoparia extract is 0.1 - 5%, and the mass percentage of the water chestnut shell extract is 0.1 - 5%;

[0037] Preferably, the mass percentage of the lithospermum extract in this antipruritic and repair gel is 0.2 - 3%, the mass percentage of the centella asiatica extract is 0.2 - 3%, the mass percentage of the Kochia scoparia extract is 0.2 - 2%, and the mass percentage of the water chestnut shell extract is 0.2 - 2%.

[0038] The extracts in the present invention are all alcohol extracts. The above extracts can be obtained by purchasing commercially, or can also be obtained by using conventional extraction methods in the art. The present invention does not make any limitations in this regard.

[0039] In some embodiments, the gel matrix includes any one or more of poloxamer, carbomer, celluloses, gelatin, sodium alginate and chitosan.

[0040] More preferably, the gel matrix is carbomer 940, and the mass percentage of carbomer is 0.2 - 1.5%.

[0041] The present invention selects carbomer 940 as the gel matrix because it has short rheology, high viscosity, high clarity, low ion tolerance and shear tolerance, and is suitable for gels and creams. It has an obvious protective effect on human skin and has a certain affinity for human skin. After adding it to cosmetics and using it, it can protect the skin and reduce the irritation and damage of irritating substances to human skin and skin mucosa, and can prevent various allergic symptoms from occurring.

[0042] In some embodiments, the humectant includes any one or more of glycerin, propylene glycol, panthenol, fructose, butylene glycol, 1,2 - hexanediol, pullulan, tamarind seed polysaccharide and squalane.

[0043] More preferably, the humectant is glycerin, and the mass percentage of glycerin is 5 - 15%.

[0044] Glycerol is selected as the humectant because when it acts on the skin, it not only simply absorbs moisture and moisturizes, but also plasticizes and softens the stratum corneum, maintains the lipid-soluble property of the lamellar lipids, thus promoting the enzyme-regulated hydrolysis of corneal desmosomes in the extracellular matrix, thereby improving dry and chapped skin. Adding glycerol to the gel can effectively increase the moisturizing performance of the gel.

[0045] In some embodiments, the solubilizer includes any one or more of polysorbate-20, PPG-26-buteth-26, PEG-40 hydrogenated castor oil, PPG-5-ceteth-5, and steareth-21.

[0046] More preferably, the solubilizer is PEG-40 hydrogenated castor oil, and the mass percentage of PEG-40 hydrogenated castor oil is 3-15%.

[0047] PEG-40 hydrogenated castor oil has good emulsifying properties, which can help mix water and oil and evenly apply the cosmetics on the skin; secondly, it can improve the stability and ductility of the cosmetics, making the cosmetics last longer; in addition, PEG-40 hydrogenated castor oil also has moisturizing and antioxidant effects, and has a certain moisturizing and nursing effect on the skin.

[0048] In some embodiments, the penetration enhancer includes any one or more of azone, diethylene glycol monoethyl ether, menthol, and isopropyl myristate.

[0049] More preferably, the penetration enhancer is azone and / or menthol, the mass percentage of azone is 0.5-3%, and the mass percentage of menthol is 0.05-1%.

[0050] Azone can change the structure of the lipid bilayer of the skin, making it loose and the lipid molecules easier to flow, thus promoting the absorption of drugs.

[0051] Menthol belongs to the extracts of traditional Chinese medicine, has a long clinical application history and high safety, so it is a penetration enhancer with great application value. It mainly disrupts the interstitial substance of keratinocytes, causing an increase in the intercellular space of epidermal cells, thereby reducing the skin's hindrance to drugs and making it easier for drugs to penetrate and absorb. Some studies have shown that menthol has the strongest effect among the penetration enhancers of traditional Chinese medicine, and even some studies have reported that its effect on certain drugs is slightly stronger than that of azone. In addition, menthol is often added to topical preparations such as skin, and can play roles such as local antipruritic, analgesic, cooling, and mild local anesthesia.

[0052] In some embodiments, the antioxidant includes any one or more of sodium sulfite, sodium bisulfite, sodium metabisulfite, sodium thiosulfate, thiourea, cysteine, dibutylhydroxytoluene, and potassium sorbate.

[0053] More preferably, the antioxidant is sodium bisulfite, and the mass percentage of sodium bisulfite is 0.01-1%.

[0054] For the cosolvent and preservative, the present invention does not make any limitation, and those skilled in the art can select according to needs or actual situations.

[0055] In some embodiments, by mass percentage, the components of the antipruritic repair gel of the present invention are: gel matrix 0.2-1.5%, humectant 5%-15%, solubilizer 3-15%, penetration enhancer 0.2-10%, antioxidant 0.01-1%, traditional Chinese medicine composition 0.5-10%, cosolvent 0.5-8%, preservative 0.01-1%, and the balance is purified water.

[0056] The present invention adds a traditional Chinese medicine composition to the gel, and uses this traditional Chinese medicine composition to achieve the purpose of antipruritic, and at the same time can further improve the repair effect of skin cells, and can also play an antibacterial and anti-inflammatory role on the damaged part, providing a good growth environment for the regeneration and repair of skin cells, and the added promoting factors can also further improve the vitality of cell regeneration, thereby improving the efficiency of skin repair and reducing the recovery period.

[0057] For the preparation method of the above antipruritic repair gel, it includes the following steps:

[0058] S1. Mix the gel matrix, humectant, antioxidant and purified water, and after swelling, obtain liquid A;

[0059] S2. Mix the above traditional Chinese medicine composition with purified water, and obtain liquid B after stirring;

[0060] S3. Mix the cosolvent, solubilizer and penetration enhancer, and obtain liquid C after stirring evenly;

[0061] S4. Mix liquid A, liquid B and liquid C, add a preservative, and adjust the pH to obtain the antipruritic repair gel.

[0062] The gel obtained by the above preparation method has good uniformity and stability, can adhere well to the skin surface, penetrate the skin quickly, has a high safety coefficient and good treatment effect.

[0063] The features and properties of the present invention will be further described in detail below in conjunction with examples.

[0064] The lithospermum extract, centella asiatica extract, and Kochia scoparia extract used in the present invention are purchased from Xi'an Jinheng Chemical Co., Ltd., and the product numbers are: JH20240620, JH20240626, and JH20240702 respectively; the water chestnut shell extract is purchased from Shaanxi Zhou Shi Digital Industry Development Group Co., Ltd., and the product number is: SXZS240518-2.

[0065] Example 1

[0066] This example is an antipruritic and repair gel, which is prepared by the following steps:

[0067] (a) Weigh 1 kg of gel matrix, 16 kg of humectant, 0.1 kg of antioxidant and 50 kg of purified water, mix them, and let them swell for 1 h to obtain Solution A;

[0068] (b) Weigh 8 kg of traditional Chinese medicine composition and 10 kg of purified water, mix them, and stir at 30 °C for 10 min to obtain Solution B;

[0069] (c) Weigh 8 kg of solubilizer, 2.2 kg of penetration enhancer, 2 kg of cosolvent and 2.7 kg of purified water, mix them, and stir at 30 °C for 10 min to obtain Solution C;

[0070] (d) Mix Solution A, Solution B and Solution C, add an appropriate amount of preservative, stir for 30 min, and finally add a pH regulator, mix evenly to obtain the antipruritic and repair gel.

[0071] Among them, the gel matrix uses Carbomer 940, the humectant uses glycerol, the antioxidant uses sodium bisulfite, the traditional Chinese medicine composition is a mixture of lithospermum extract, centella asiatica extract, Kochia scoparia extract, and water chestnut shell extract, and the mass ratio of lithospermum extract, centella asiatica extract, Kochia scoparia extract, and water chestnut shell extract is: 4:4:3:2. The solubilizer uses PEG-40 hydrogenated castor oil, the penetration enhancer uses azone, the cosolvent uses absolute ethanol, the preservative uses KF-88, and the pH regulator uses triethanolamine.

[0072] Example 2

[0073] This example is an antipruritic and repair gel, which is prepared by the following steps:

[0074] (a) Weigh 0.6 kg of gel matrix, 12 kg of humectant, 0.05 kg of antioxidant and 50 kg of purified water, mix them, and let them swell for 1 h to obtain Solution A;

[0075] (b) Weigh 1 kg of traditional Chinese medicine composition and 10 kg of purified water, mix them, and stir at 40 °C for 10 min to obtain Solution B;

[0076] (c) Weigh 12 kg of solubilizer, 4 kg of penetration enhancer, 2 kg of cosolvent and 8.35 kg of purified water, mix them, and stir at 40 °C for 10 min to obtain Solution C;

[0077] (d) Mix Solution A, Solution B and Solution C, add an appropriate amount of preservative, stir for 30 min, and finally add a pH regulator, mix evenly to obtain the antipruritic and repair gel.

[0078] Among them, the gel matrix uses carbomer 940, the humectant uses glycerin, the antioxidant uses sodium bisulfite, the traditional Chinese medicine composition is a mixture of lithospermum extract, centella asiatica extract, fructuskochiae extract, and water chestnut shell extract, and the mass ratio of lithospermum extract, centella asiatica extract, fructuskochiae extract, and water chestnut shell extract is: 3:3:3:2. The solubilizer uses PEG-40 hydrogenated castor oil, the penetration enhancer uses laurocapram, the cosolvent uses absolute ethanol, the preservative uses KF-88, and the pH regulator uses triethanolamine.

[0079] Example 3

[0080] This example is an antipruritic and repair gel, prepared by the following steps:

[0081] (a) Weigh 1.4 kg of gel matrix, 20 kg of humectant, 2 kg of antioxidant and 50 kg of purified water, mix them, and soak for 1 h to obtain liquid A;

[0082] (b) Weigh 10 kg of traditional Chinese medicine composition and 10 kg of purified water, mix them, and stir at 50 °C for 10 min to obtain liquid B;

[0083] (c) Weigh 4 kg of solubilizer, 0.4 kg of penetration enhancer, 2 kg of cosolvent and 0.2 kg of purified water, mix them, and stir at 50 °C for 10 min to obtain liquid C;

[0084] (d) Mix liquid A, liquid B and liquid C, add an appropriate amount of preservative, stir for 30 min, and finally add the pH regulator and mix evenly to obtain the antipruritic and repair gel.

[0085] Among them, the gel matrix uses carbomer 940, the humectant uses glycerin, the antioxidant uses sodium bisulfite, the traditional Chinese medicine composition is a mixture of lithospermum extract, centella asiatica extract, fructuskochiae extract, and water chestnut shell extract, and the mass ratio of lithospermum extract, centella asiatica extract, fructuskochiae extract, and water chestnut shell extract is: 5:4:3:2. The solubilizer uses PEG-40 hydrogenated castor oil, the penetration enhancer uses laurocapram, the cosolvent uses absolute ethanol, the preservative uses KF-88, and the pH regulator uses triethanolamine.

[0086] Example 4

[0087] This example is an antipruritic and repair gel, which is different from Example 1 in that carbomer 940 is replaced with an equal amount of gelatin.

[0088] Example 5

[0089] This example is an antipruritic and repair gel, which is different from Example 1 in that carbomer 940 is replaced with an equal amount of carbomer U20.

[0090] Example 6

[0091] This example is an antipruritic and repair gel, which is different from Example 1 in that glycerol is replaced by an equal amount of propylene glycol.

[0092] Example 7

[0093] This example is an antipruritic and repair gel, which is different from Example 1 in that the solubilizer is replaced by an equal amount of purified water.

[0094] Example 8

[0095] This example is an antipruritic and repair gel, which is different from Example 1 in that laurocapram is replaced by an equal amount of menthol.

[0096] Example 9

[0097] This example is an antipruritic and repair gel, which is different from Example 1 in that the penetration enhancer is laurocapram and menthol, and the mass ratio of laurocapram to menthol is 5:1.

[0098] Example 10

[0099] This example is an antipruritic and repair gel, which is different from Example 1 in that the penetration enhancer is laurocapram and menthol, and the mass ratio of laurocapram to menthol is 1:5.

[0100] Example 11

[0101] This example is an antipruritic and repair gel, which is different from Example 1 in that sodium bisulfite is replaced by an equal amount of VE oil.

[0102] Example 12

[0103] This example is an antipruritic and repair gel, which is different from Example 1 in that liquid b is prepared by the following steps: (b) Weigh 8 kg of traditional Chinese medicine and 10 kg of purified water and mix them, and stir at 30 °C for 15 min to obtain liquid b.

[0104] Among them, the traditional Chinese medicine is the extract of lithospermum erythrorhizon, the extract of centella asiatica, the extract of Kochia scoparia, and the extract of water chestnut shell, and the mass ratio of the extract of lithospermum erythrorhizon, the extract of centella asiatica, the extract of Kochia scoparia, and the extract of water chestnut shell is 1:1:1:1.

[0105] Example 13

[0106] This example is an antipruritic and repair gel, which is different from Example 12 in that the traditional Chinese medicine is the extract of lithospermum erythrorhizon, the extract of centella asiatica, the extract of Kochia scoparia, and the extract of water chestnut shell, and the mass ratio of the extract of lithospermum erythrorhizon, the extract of centella asiatica, the extract of Kochia scoparia, and the extract of water chestnut shell is 2:3:4:4.

[0107] Example 14

[0108] This embodiment is an antipruritic and repair gel. The difference from Embodiment 12 is that the traditional Chinese medicine is composed of lithospermum extract, centella asiatica extract, Kochia scoparia extract, and water chestnut shell extract, and the mass ratio of lithospermum extract, centella asiatica extract, Kochia scoparia extract, and water chestnut shell extract is 3:2:4:4.

[0109] Comparative Example 1

[0110] This comparative example is an antipruritic and repair gel. The difference from Embodiment 1 is that the traditional Chinese medicine composition is replaced with an equal amount of lithospermum extract.

[0111] Comparative Example 2

[0112] This comparative example is an antipruritic and repair gel. The difference from Embodiment 1 is that the traditional Chinese medicine composition is replaced with an equal amount of centella asiatica extract.

[0113] Comparative Example 3

[0114] This comparative example is an antipruritic and repair gel. The difference from Embodiment 1 is that the traditional Chinese medicine composition is replaced with an equal amount of Kochia scoparia extract.

[0115] Comparative Example 4

[0116] This comparative example is an antipruritic and repair gel. The difference from Embodiment 1 is that the traditional Chinese medicine composition is replaced with an equal amount of water chestnut shell extract.

[0117] Comparative Example 5

[0118] This comparative example is an antipruritic and repair gel. The difference from Embodiment 1 is that the traditional Chinese medicine composition is lithospermum extract and centella asiatica extract, and the mass ratio of lithospermum extract to centella asiatica extract is 1:1.

[0119] Comparative Example 6

[0120] This comparative example is an antipruritic and repair gel. The difference from Embodiment 1 is that the traditional Chinese medicine composition is lithospermum extract and Kochia scoparia extract, and the mass ratio of lithospermum extract to Kochia scoparia extract is 4:3.

[0121] Comparative Example 7

[0122] This comparative example is an antipruritic and repair gel. The difference from Embodiment 1 is that the traditional Chinese medicine composition is lithospermum extract and water chestnut shell extract, and the mass ratio of lithospermum extract to water chestnut shell extract is 2:1.

[0123] Comparative Example 8

[0124] This comparative example is an antipruritic and repair gel, which is different from Example 1 in that the traditional Chinese medicine composition is Centella asiatica extract and Kochia scoparia extract, and the mass ratio of Centella asiatica extract to Kochia scoparia extract is 4:3.

[0125] Comparative Example 9

[0126] This comparative example is an antipruritic and repair gel, which is different from Example 1 in that the traditional Chinese medicine composition is Centella asiatica extract and water chestnut shell extract, and the mass ratio of Centella asiatica extract to water chestnut shell extract is 2:1.

[0127] Comparative Example 10

[0128] This comparative example is an antipruritic and repair gel, which is different from Example 1 in that the traditional Chinese medicine composition is Kochia scoparia extract and water chestnut shell extract, and the mass ratio of Kochia scoparia extract to water chestnut shell extract is 3:2.

[0129] Comparative Example 11

[0130] This comparative example is an antipruritic and repair gel, which is different from Example 1 in that the traditional Chinese medicine composition is Lithospermum erythrorhizon extract, Centella asiatica extract and Kochia scoparia extract, and the mass ratio of Lithospermum erythrorhizon extract, Centella asiatica extract to Kochia scoparia extract is 4:4:3.

[0131] Comparative Example 12

[0132] This comparative example is an antipruritic and repair gel, which is different from Example 1 in that the traditional Chinese medicine composition is Lithospermum erythrorhizon extract, Centella asiatica extract and water chestnut shell extract, and the mass ratio of Lithospermum erythrorhizon extract, Centella asiatica extract to water chestnut shell extract is 2:2:1.

[0133] Comparative Example 13

[0134] This comparative example is an antipruritic and repair gel, which is different from Example 1 in that the traditional Chinese medicine composition is Lithospermum erythrorhizon extract, Kochia scoparia extract and water chestnut shell extract, and the mass ratio of Lithospermum erythrorhizon extract, Kochia scoparia extract to water chestnut shell extract is 4:3:2.

[0135] Comparative Example 14

[0136] This comparative example is an antipruritic and repair gel, which is different from Example 1 in that the traditional Chinese medicine composition is Centella asiatica extract, Kochia scoparia extract and water chestnut shell extract, and the mass ratio of Centella asiatica extract, Kochia scoparia extract to water chestnut shell extract is 4:3:2.

[0137] Comparative Example 15

[0138] This comparative example is an antipruritic and repair gel, which is different from Example 1 in that the mass ratio of lithospermum extract, centella asiatica extract, Kochia scoparia extract and water chestnut shell extract in the traditional Chinese medicine composition is 4:4:3:1.

[0139] Comparative Example 16

[0140] This comparative example is an antipruritic and repair gel, which is different from Example 1 in that the mass ratio of lithospermum extract, centella asiatica extract, Kochia scoparia extract and water chestnut shell extract in the traditional Chinese medicine composition is 4:4:3:3.

[0141] Comparative Example 17

[0142] This comparative example is an antipruritic and repair gel, which is different from Example 1 in that the mass ratio of lithospermum extract, centella asiatica extract, Kochia scoparia extract and water chestnut shell extract in the traditional Chinese medicine composition is 4:4:1:1.

[0143] Comparative Example 18

[0144] This comparative example is an antipruritic and repair gel, which is different from Example 1 in that the lithospermum extract in the traditional Chinese medicine composition is replaced with an equal amount of aloe extract.

[0145] Comparative Example 19

[0146] This comparative example is an antipruritic and repair gel, which is different from Example 1 in that the centella asiatica extract in the traditional Chinese medicine composition is replaced with an equal amount of aloe extract.

[0147] Comparative Example 20

[0148] This comparative example is an antipruritic and repair gel, which is different from Example 1 in that the Kochia scoparia extract in the traditional Chinese medicine composition is replaced with an equal amount of aloe extract.

[0149] Comparative Example 21

[0150] This comparative example is an antipruritic and repair gel, which is different from Example 1 in that the water chestnut shell extract in the traditional Chinese medicine composition is replaced with an equal amount of aloe extract.

[0151] Comparative Example 22

[0152] This comparative example is an antipruritic and repair gel, which is different from Example 1 in that the lithospermum extract in the traditional Chinese medicine composition is replaced with an equal amount of dictamnus dasycarpus extract.

[0153] Comparative Example 23

[0154] This comparative example is an antipruritic and repair gel, which is different from Example 1 in that the centella asiatica extract in the traditional Chinese medicine composition is replaced with an equal amount of dictamnus dasycarpus extract.

[0155] Comparative Example 24

[0156] This comparative example is an antipruritic and repair gel, which is different from Example 1 in that the Kochia scoparia extract in the traditional Chinese medicine composition is replaced with an equal amount of Dictamnus dasycarpus extract.

[0157] Comparative Example 25

[0158] This comparative example is an antipruritic and repair gel, which is different from Example 1 in that the water chestnut shell extract in the traditional Chinese medicine composition is replaced with an equal amount of Dictamnus dasycarpus extract.

[0159] Experimental Example 1

[0160] This experiment is a performance detection test for the antipruritic and repair gels of Examples 1-14 and Comparative Examples 1-25.

[0161] 1) Antipruritic efficacy

[0162] Animal experiment: Refer to (Guidelines for the Research of New Traditional Chinese Medicines). The experimental temperature is 20-25°C, and the relative humidity is 60-70%. Compound dexamethasone acetate cream is used in the positive control group.

[0163] The mice are randomly divided into 3 groups, with 10 mice in each group, namely the blank control group, the sample group (applying Examples 1-14, Comparative Examples 1-25), and the positive control group. One day before the experiment, the right hind foot dorsum of each group of mice is shaved, and the sample (Examples 1-14, Comparative Examples 1-25) is applied once. On the day of the experiment, the shaved area of the right hind foot dorsum of the animals is abraded with coarse sandpaper, about 1 cm 2 range or so, and then the sample is applied once again at this site. The blank control group is given an equal amount of normal saline. After 10 minutes, start to drop 0.05 mL / animal of 0.01% histamine phosphate on the wound surface. Thereafter, the concentration is increased at intervals of 0.01%, 0.02%, 0.03%, 0.04%... Each time, it is 0.05 mL / animal until the mice turn back to lick their right hind feet. The total amount of histamine phosphate given when the mice finally turn back to lick their right hind feet is the itching threshold. The test results are shown in Table 1.

[0164] Table 1 Influence of the antipruritic and repair gel of the present invention on the itching reaction induced by histamine phosphate

[0165]

[0166]

[0167]

[0168] Note: P value: All are compared with the blank control.

[0169] It is obvious from the test results that, compared with Comparative Examples 1-25, the antipruritic repair gel prepared in the Examples has a better antipruritic effect. Example 1 has a significant effect of increasing the itching threshold of mice compared with the blank control sample, and the effect is the best. Especially for the traditional Chinese medicine composition, it can be seen from the results of the Examples and Comparative Examples that the combination of Lithospermum erythrorhizon, Centella asiatica, Kochia scoparia and Trapa bispinosa at a specific ratio can play a synergistic role. For example, compared with Comparative Examples 11, 21 and 25, the itching threshold of mice using Example 1 is significantly higher than that of mice using Comparative Examples 11, 21 and 25, indicating that the addition of Trapa bispinosa can improve the antipruritic effect of the antipruritic gel, and the effect is better than that of aloe and Dictamnus dasycarpus Turcz.

[0170] 2) Moisturizing and repairing effects

[0171] Thirty-five subjects aged 21-57 were continuously used the antipruritic repair gel prepared by the present invention for 28 days. Through the tests of the water content of the stratum corneum and the trans-epidermal water loss (TEWL) value, the changes of the tested parts before and 4 weeks after the product use were tested. The test conditions were 20-22 °C and the relative humidity was 40%-60%. The test site was the inner side of the forearm.

[0172] ① Moisturizing effect: The moisture content (MMV) value of the stratum corneum of human skin was measured by the capacitance method, and the skin moisture content was detected by a skin moisture content tester (Cormeter CM825, CK, Germany) (the larger the MMV value, the higher the water content of the stratum corneum).

[0173] ② Skin barrier protection effect: The trans-epidermal water loss (TEWL) value was detected by a transdermal water loss tester (Tewameter TM300, CK, Germany); the smaller the TEWL value, the better the skin barrier and the better the repair. The test results are shown in Tables 2, 3 and 4.

[0174] Table 2 Skin reaction record table

[0175]

[0176] Table 3 Test results of the water content of the stratum corneum before and after using the antipruritic repair gel

[0177]

[0178]

[0179]

[0180] Table 4 Test results of the trans-epidermal water loss (TEWL) value before and after using the antipruritic repair gel

[0181]

[0182]

[0183] It can be clearly seen from the test results that the antipruritic and repair gel prepared by the present invention has high safety, and no abnormal reactions occurred in the subjects after 4 weeks of use. By comparing the changes in the water content of the stratum corneum and the trans-epidermal water loss value of the skin before and after 4 weeks of using each example and comparative example, it can be known that the water content of the stratum corneum of the skin increased in each group after 4 weeks of use, and the trans-epidermal water loss value decreased. Among them, the water content of the stratum corneum in Example 1 increased the most, and the trans-epidermal water loss value decreased the most, followed by Example 9. It is proved that the gel of the present invention can better relieve skin water loss and at the same time increase skin water content. Especially for the traditional Chinese medicine composition, it can be seen from the results of the examples and comparative examples that the combination of lithospermum, centella asiatica, Kochia scoparia and water chestnut shell at a specific ratio can play a synergistic role. Taking Example 1 and Comparative Examples 21 and 25 as examples, compared with Example 1, the increase in the water content of the stratum corneum of the skin in Comparative Example 21 and Comparative Example 25 was less, and the reduction in the trans-epidermal water loss value was less, indicating that the performance of Example 1 in increasing the water content of the stratum corneum of the skin and reducing the trans-epidermal water loss value is better than that of Comparative Example 21 and Comparative Example 25, suggesting that the effect of compounding the extract of water chestnut shell with the other three traditional Chinese medicines is better than that of compounding the extract of aloe or dictamnus dasycarpus with the other three traditional Chinese medicines.

[0184] In order to further verify that the antipruritic and repair gel of the present invention has the effects of relieving itching and soothing skin discomfort, the soothing ability tests of skin pain and itching were carried out on Example 1, Example 9 and Comparative Examples 1-25.

[0185] Experimental method: 60 female volunteers aged 21-57 were selected and divided into 12 groups for testing. The skin of the 60 volunteers was in a healthy state. Before the experiment, the subjects were informed of the risks and signed an informed consent form. When the skin on the flexor side of the forearm of each group of subjects was stimulated with yam peel until itching occurred, the yam peel was removed, and the antipruritic and repair gels of Example 1, Example 9 and Comparative Examples 1-25 were used on the corresponding parts of the forearm respectively, and then a comparative score was made. The degree of itching was recorded and scored at the 5th, 10th, 15th, 20th and 25th minutes.

[0186] Among them, the degree of itching was distinguished and evaluated by the feelings of the subjects, and the score was recorded as 0-10 points. The stronger the itching feeling, the higher the score, and the initial itching degree was recorded as 10 points; the scores of 5 volunteers in each group were averaged and rounded to obtain the final score and recorded. The test results are shown in Table 5.

[0187] Table 5 Test of the soothing ability of skin itching of Example 1, 9 and Comparative Examples 1-25

[0188]

[0189]

[0190]

[0191] It can be seen from the test results in Table 5 above that the antipruritic and repair gels prepared in Example 1, Example 9 and Comparative Examples 15 to 17 have obvious soothing effects on skin itching, and among them, the antipruritic and repair gels prepared in Example 1 and Example 9 have the best soothing effects. When the antipruritic and repair gel contains Lithospermum erythrorhizon, Centella asiatica, Kochia scoparia, and water chestnut shell, and only contains one or several of Lithospermum erythrorhizon, Centella asiatica, Kochia scoparia, and water chestnut shell (Comparative Examples 1 to 6), the antipruritic and soothing effects of the prepared antipruritic and repair gel are significantly weaker than those of Example 1 and Example 9; when aloe is used to replace any one of the traditional Chinese medicines (Comparative Examples 18 to 21), its antipruritic and soothing effects are weaker than those of Example 1; when Dictamnus dasycarpus Turcz. is used to replace any one of the traditional Chinese medicines (Comparative Examples 22 to 25), its antipruritic and soothing effects are weaker than those of Example 1; it shows that the combined use of Lithospermum erythrorhizon, Centella asiatica, Kochia scoparia, and water chestnut shell can enhance its antipruritic and soothing effects, indicating that the antipruritic gel has a good antipruritic and soothing effect.

[0192] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. For those skilled in the art, the present invention can have various changes and modifications. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, The traditional Chinese medicine composition is composed of lithospermum extract, centella asiatica extract, fructuskochiae extract and water chestnut shell extract; Among them, the mass ratio of lithospermum extract, centella asiatica extract, fructuskochiae extract and water chestnut shell extract is 0.2-5:0.2-10:0.1-5:0.1-5.

2. The traditional Chinese medicine composition according to claim 1, characterized in that In the traditional Chinese medicine composition, the mass ratio of lithospermum extract, centella asiatica extract, fructuskochiae extract and water chestnut shell extract is 0.2-3:0.2-3:0.2-2:0.2-2.

3. Use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a product with antipruritic and repair effects.

4. The application according to claim 3, characterized in that The dosage form of the product includes pills, capsules, granules, tablets, external ointments, external gels or patches; Preferably, the dosage form of the product is an external gel.

5. A kind of antipruritic repair gel, characterized in that, Its components include the traditional Chinese medicine composition according to claim 1 or 2.

6. The antipruritic repair gel according to claim 5, characterized in that, The mass percentage of the traditional Chinese medicine composition in the antipruritic and repair gel is: 0.5-10%; Preferably, in the antipruritic and repair gel, the mass percentage of lithospermum extract is 0.2-5%, the mass percentage of centella asiatica extract is 0.2-10%, the mass percentage of fructuskochiae extract is 0.1-5%, and the mass percentage of water chestnut shell extract is 0.1-5%; Preferably, in the antipruritic and repair gel, the mass percentage of lithospermum extract is 0.2-3%, the mass percentage of centella asiatica extract is 0.2-3%, the mass percentage of fructuskochiae extract is 0.2-2%, and the mass percentage of water chestnut shell extract is 0.2-2%.

7. The antipruritic repair gel according to claim 6, wherein The components of the antipruritic and repair gel further include a gel matrix, a humectant, a solubilizer, a penetration enhancer and an antioxidant; Preferably, the gel matrix in the antipruritic and repair gel includes any one or more of poloxamer, carbomer, celluloses, gelatin, sodium alginate and chitosan; Preferably, the humectant includes any one or more of glycerol, propylene glycol, panthenol, fructose, butylene glycol, 1,2-hexanediol, pullulan, tamarind seed polysaccharide and squalane; Preferably, the solubilizer includes any one or more of polysorbate-20, PPG-26-buteth-26, PEG-40 hydrogenated castor oil, PPG-5-ceteth-5 and steareth-21; Preferably, the penetration enhancer includes any one or more of azone, diethylene glycol monoethyl ether, menthol and isopropyl myristate; Preferably, the antioxidant includes any one or more of sodium sulfite, sodium bisulfite, sodium metabisulfite, sodium thiosulfate, thiourea, cysteine, dibutylhydroxytoluene and potassium sorbate.

8. The antipruritic repair gel according to claim 7, wherein The gel matrix is carbomer 940, and the mass percentage of the carbomer is 0.2-1.5%; Preferably, the humectant is glycerol, and the mass percentage of the glycerol is 5-15%; Preferably, the solubilizer is PEG-40 hydrogenated castor oil, and the mass percentage of the PEG-40 hydrogenated castor oil is 3-15%; Preferably, the penetration enhancer is azone and / or menthol, the mass percentage of azone is 0.5-3%, and the mass percentage of menthol is 0.05-1%; Preferably, the antioxidant is sodium bisulfite, and the mass percentage of sodium bisulfite is 0.01-1%.

9. The antipruritic repair gel according to any one of claims 6-8, characterized in that, By mass percentage, the components of the antipruritic repair gel are: 0.5-10% of the traditional Chinese medicine composition, 0.2-1.5% of the gel matrix, 5%-15% of the humectant, 3-15% of the solubilizer, 0.2-10% of the penetration enhancer, 0.01-1% of the antioxidant, 0.5-8% of the cosolvent, 0.01-1% of the preservative, and the balance is purified water.

10. The preparation method of the antipruritic repair gel according to claim 9, characterized in that, Comprising: Mix the gel matrix, humectant, antioxidant and purified water, and after swelling, obtain solution A; Mix the traditional Chinese medicine composition with purified water and stir to obtain solution B; Mix the cosolvent, solubilizer and penetration enhancer and stir evenly to obtain solution C; Mix solution A, solution B and solution C, add the preservative, and adjust the pH to obtain the antipruritic repair gel.

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