Traditional Chinese medicine composition for repairing skin barrier as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for improving a skin barrier function, which is prepared from angelica sinensis, radix rehmanniae, radix polygonati officinalis, rhizoma bletillae and astragalus membranaceus in specific parts by weight, and has a remarkable treatment effect on dry skin and psoriasis. The traditional Chinese medicine has no adverse reaction in the treatment process, is safe in components, remarkable in effect and worthy of clinical popularization and application.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine compositions, in particular to a traditional Chinese medicine composition for repairing skin barrier function. Background Art

[0002] The skin barrier function is one of the important physiological functions of the skin, which can effectively prevent the invasion of external harmful substances and maintain the water balance in the skin. The occurrence and aggravation of many skin diseases are closely related to the damage of the barrier function, such as atopic dermatitis, psoriasis, ichthyosis, acne, hormone-dependent dermatitis, etc., manifested as increased trans epidermal water loss (TEWL), reduced stratum corneum hydration (SCH), changes in the sebum components of the intercellular lipid membrane of stratum corneum cells, reduced synthesis of filaggrin, and changes in the activity of certain enzymes. Rational use of moisturizing emollients can be used as the basic treatment for such diseases. Existing studies have shown that choosing a suitable topical emollient can strengthen the skin barrier function, break the inflammatory cycle established and enhanced due to barrier damage, and reduce the skin sensitivity to stimuli, relieve the symptoms of dryness and itching, and delay the recurrence of the disease. Therefore, topical emollients are not only an important adjuvant treatment means for skin disease patients, but also an important measure for maintaining skin barrier function and preventing damage.

[0003] At present, the common active ingredients in moisturizing emollient products include ceramides, urea, butylene glycol, hyaluronic acid, animal and vegetable oils, and mineral oils. Each ingredient plays an important role in skin moisturizing and repair, but there are many defects in their use effects and safety. For example, the feel of mineral oil is poor, and long-term use may cause pore blockage. In addition, mineral oil that does not meet safety standards may contain harmful substances such as aromatic hydrocarbon compounds. Long-term exposure to these ingredients will increase the risk of skin cancer. Urea should be used with caution for pregnant women because it may pose certain risks to the fetus or the mother. Hygroscopic ingredients such as hyaluronic acid, glycerol, and butylene glycol keep the skin moist by absorbing water from the external environment, but they can also drive the water in the deep epidermis and dermis into the stratum corneum to maintain the water content of the stratum corneum. Therefore, when the air humidity is low and insufficient water can be absorbed from the air, they may absorb water from the skin interior, resulting in dermal water loss, and further aggravating dryness, tightness, or dehydration. Vegetable oils with high oleic acid content and low or lacking linoleic acid content may cause destructive changes in the inflammatory skin stratum corneum structure. In addition, the ecological pollution generated during the production and processing of ingredients such as urea and mineral oil cannot be ignored.

[0004] Existing scientific research has confirmed that some traditional Chinese medicines have anti-inflammatory, soothing, and skin barrier repair effects. For example, the external use of extracts such as licorice, purslane, salvia miltiorrhiza, and bletilla striata can protect the skin and reduce damage. Various traditional Chinese medicine compound external preparations with the effects of clearing heat and cooling blood to detoxify, nourishing yin and blood to moisten dryness, and clearing heat and promoting diuresis can also safely and effectively treat various skin diseases with damaged skin barriers, such as acne, psoriasis, and chronic eczema, improve the skin barrier function of patients, and improve the quality of life of patients. As the effects of traditional Chinese medicine ingredients in skin barrier repair have been scientifically verified, more and more skin care products have begun to incorporate traditional Chinese medicine ingredients to enhance the moisturizing and repair effects of the products. Common traditional Chinese medicine ingredients such as purslane, lithospermum erythrorhizon, scutellaria baicalensis, and ginseng are widely used in different dosage forms such as ointments, aqueous solutions, and oils. These traditional Chinese medicine skin care products show good repair effects in the treatment of skin allergies, eczema, and hormone-dependent dermatitis and other diseases.

[0005] However, although some skin care products add Chinese herbal ingredients to enhance the moisturizing effect, there are several problems. First, the effective ingredients of traditional Chinese medicine in some products are relatively few, and chemical components dominate. Second, the compound preparation is only formulated based on the pharmacological effects of modern medicine, ignoring the harmony and effectiveness of the overall formula; or it is not rationally formulated according to the theory of monarch, minister, assistant, and envoy in traditional Chinese medicine, resulting in the efficacy of traditional Chinese medicine ingredients may not achieve the best synergistic effect, and even the overall effect may be reduced due to the mismatch or conflict between ingredients; there are also problems such as the lack of a complete and systematic theoretical system to guide the selection of prescriptions and medicines, resulting in the limited effects of products. Finally, in clinical practice, traditional Chinese medicine is often applied in a roughly processed form, and the effective ingredients are not fully extracted and utilized, affecting its bioavailability and efficacy.

[0006] Based on the above technical problems, it is necessary to develop a skin care product that is natural, effective, and mild in repairing the skin barrier under the guidance of traditional Chinese medicine theory. Summary of the Invention

[0007] In order to solve one of the above technical problems existing in the prior art, the present invention provides a traditional Chinese medicine prescription with improved skin barrier function. An external composition prepared with this prescription, specifically a cream, has important clinical significance and market prospects. Further, the present invention provides a preparation method of this composition.

[0008] According to one aspect of the present invention, a traditional Chinese medicine formula for improving skin barrier function is provided, which is made from the following Chinese medicinal materials in parts by weight: 3 - 12 parts of angelica sinensis, 2 - 6 parts of rehmannia glutinosa, 2 - 6 parts of polygonatum odoratum, 2 - 6 parts of bletilla striata, and 1 - 3 parts of astragalus membranaceus.

[0009] According to a preferred embodiment of the present invention, in the traditional Chinese medicine composition of the present invention, there are 3 parts of angelica sinensis, 2 parts of rehmannia glutinosa, 2 parts of polygonatum odoratum, 2 parts of bletilla striata, and 1 part of astragalus membranaceus.

[0010] According to a further preferred embodiment of the present invention, in the traditional Chinese medicine composition of the present invention, there are 6 parts of Angelica sinensis, 4 parts of Rehmannia glutinosa, 4 parts of Polygonatum odoratum, 4 parts of Bletilla striata, and 2 parts of Astragalus membranaceus.

[0011] According to a further preferred embodiment of the present invention, in the traditional Chinese medicine composition of the present invention, there are 12 parts of Angelica sinensis, 6 parts of Rehmannia glutinosa, 6 parts of Polygonatum odoratum, 6 parts of Bletilla striata, and 3 parts of Astragalus membranaceus.

[0012] The present invention selects five traditional Chinese medicines, namely Angelica sinensis, Rehmannia glutinosa, Polygonatum odoratum, Astragalus membranaceus, and Bletilla striata, and formulates them according to the monarch, minister, assistant, and courier theory. The theoretical basis of traditional Chinese medicine is as follows:

[0013] Angelica sinensis is sweet and warm. It is recorded in "Shennong Ben Cao Jing": "It is mainly used for women with uterine bleeding and infertility, various malignant sores, and metal wounds." It is recorded in "Compendium of Materia Medica": "It breaks stasis and nourishes new blood... moistens the intestines, muscles, bones, and skin, treats carbuncles and sores, discharges pus and relieves pain, and harmonizes blood and nourishes blood." It is used heavily for nourishing blood and promoting granulation, and is the monarch drug. Modern pharmacology believes that it has beauty effects such as moisturizing, cleansing, promoting skin metabolism, and adjusting natural skin secretions.

[0014] Rehmannia glutinosa is sweet and cold. It is recorded in "Shennong Ben Cao Jing": "It fills the bone marrow and grows muscles... taking it for a long time can make the body light and prevent aging, and the fresh one is especially good." It is recorded in "Ben Jing Feng Yuan": "Dried Rehmannia glutinosa is specifically for cooling blood and nourishing yin, and externally moistens the skin and makes it shiny." Modern pharmacological research believes that Rehmannia glutinosa can have anti-inflammatory, anti-allergic, and anti-aging effects. One clinical trial believes that skin care products containing Rehmannia glutinosa and other ingredients have good effects on improving skin dryness symptoms.

[0015] Polygonatum odoratum is sweet and slightly cold. It is recorded in "Shennong Ben Cao Jing": "It can remove dark spots on the face, make the complexion good and shiny, and make the body light and prevent aging." Polygonatum odoratum is moist in nature and has a mild medicinal property, and has a good moisturizing effect on the skin. Modern pharmacological research shows that one of the main active ingredients in Polygonatum odoratum is Polygonatum odoratum polysaccharide, which can effectively slow down the loss of skin moisture, and its moisturizing property is more obvious than that of propylene glycol.

[0016] Astragalus membranaceus is sweet and slightly warm. It is recorded in "Ben Cao Zheng Yao": "It tonifies the lung qi, strengthens the skin and hair, astringes sweating and supports sores, quenches thirst and relieves asthma. It benefits the stomach qi, removes skin heat, stops diarrhea and promotes granulation, and tonifies deficiency and treats consumption." Modern pharmacological research believes that the main component of traditional Chinese medicine Astragalus membranaceus, astragaloside, can balance the formation and reconstruction of collagen and promote the formation of new blood vessels. Astragalus polysaccharide components can promote the proliferation and collagen synthesis of fibroblasts at appropriate concentrations.

[0017] Bletilla striata is bitter, sweet, astringent, and slightly cold. "Shennong Ben Cao Jing" records: "It is mainly used to treat carbuncles, malignant sores, gangrene, yin injury, and necrotic muscles." "Ben Cao Yi Du" records that "it can remove freckles on the head and face, make the skin turn from black to white, heal chapped hands and feet, and make the rough muscles become smooth. It can quickly remove corruption and disperse stasis, and has a good effect on promoting granulation and relieving pain." Kong Lingshan et al. measured Bletilla striata polysaccharide. The infrared spectrum showed that Bletilla striata polysaccharide is a pyranose polysaccharide and contains mannose. The results of the moisture retention experiment showed that the moisture absorption and retention of Bletilla striata polysaccharide were better than those of glycerol and hyaluronic acid at 81% relative humidity (RH). The results of skin moisture testing showed that the cream containing Bletilla striata polysaccharide had a good moisturizing effect.

[0018] This invention is modified from the empirical formula "Yangxue Runfu Decoction" of Professor Zhao Bingnan, the founder of traditional Chinese medicine dermatology and surgery. Angelica sinensis is used in large doses to nourish blood and promote granulation, providing the "blood" in the skin barrier as the nutritional basis, and serving as the monarch drug. Rehmannia glutinosa and Polygonatum odoratum nourish yin and moisten dryness, and together they are the ministerial drugs, providing "essence" and "body fluid" as the structural basis of the barrier. When combined with Angelica sinensis, the effect of nourishing yin and blood is more prominent. Astragalus membranaceus replenishes qi and consolidates the exterior. Visible blood is generated from invisible qi, realizing the exterior-defending and protective functions of the skin barrier. Qi and blood depend on each other and generate each other. Qi needs to rely on the flow of blood to have a foundation and will not disperse, and blood can also nourish qi. Bletilla striata heals sores and promotes granulation. The above two drugs are used as assistant drugs together. The whole formula has the effects of nourishing blood and promoting blood circulation, moistening dryness and promoting granulation, effectively playing the roles of repairing the skin barrier and moisturizing.

[0019] According to another aspect of the present invention, the traditional Chinese medicine formula for improving skin barrier function can be prepared into various traditional Chinese medicine preparations by methods and excipients well known in the art, such as decoctions, pills, decoctions, granules, ointments, pills, tablets, wet compresses, medicinal wines, and so on.

[0020] According to one aspect of the present invention, the traditional Chinese medicine composition preparation can be a cream, including the following composition in weight percentage:

[0021] 3 - 12 parts of a traditional Chinese medicine extract prepared by decocting Angelica sinensis, Rehmannia glutinosa, Polygonatum odoratum, Bletilla striata, and Astragalus membranaceus, 8 - 10 parts of an emulsifier, 23 - 28 parts of an emollient, 13 - 16 parts of a humectant, 1 - 2 parts of a preservative, and an appropriate solvent.

[0022] According to the embodiment of the present invention, the traditional Chinese medicine extract is prepared in the following manner: Take the corresponding weight parts of Angelica sinensis, Rehmannia glutinosa, Polygonatum odoratum, Bletilla striata, and Astragalus membranaceus, add twice the amount of water, heat and decoct for extraction once or multiple times, combine the extraction solutions, and concentrate to obtain.

[0023] According to the embodiment of the present invention, the emulsifier is selected from one or a combination of more than one of PEG - 10 polydimethylsiloxane, dimethyldistearylammonium lithium montmorillonite, and cyclopentasiloxane.

[0024] According to the embodiment of the present invention, the emollient is selected from one or a combination of more than one of polydimethylsiloxane, polydimethylsiloxanol, and caprylic / capric triglyceride.

[0025] According to an embodiment of the present invention, the humectant is selected from one or more combinations of butylene glycol and glycerol.

[0026] According to an embodiment of the present invention, the preservative is selected from one or more combinations of hydroxyacetophenone and 1,2 - hexanediol.

[0027] According to one of the preferred embodiments of the present invention, the preparation further contains essential oil. More preferably, the essential oil is plum blossom essential oil, for example, 0.1 part can be added.

[0028] According to one of the preferred embodiments of the present invention, the solvent in the preparation is water. More preferably, it is deionized water, for example, it can contain 37.9 - 46.9 parts.

[0029] The cream provided by the present invention is a skin - care cream based on herbal traditional Chinese medicine, and has the technical effect of repairing the skin barrier.

[0030] According to another aspect of the present invention, a method for preparing the above - mentioned cream is provided, which includes the following steps:

[0031] (1) Prepare the traditional Chinese medicine extract: Take the corresponding weight parts of Angelica sinensis, Rehmannia glutinosa, Polygonatum odoratum, Bletilla striata and Astragalus membranaceus, add twice the amount of water, heat and decoct for extraction once or multiple times, combine the extraction solutions, concentrate and then add the preservative;

[0032] (2) Prepare phase A: Take the emulsifier and emollient and stir at room temperature until uniformly emulsified;

[0033] (3) Prepare phase B: Take the humectant and preservative and heat and stir evenly;

[0034] (4) Prepare phase C: Take glycerol, the solvent and the traditional Chinese medicine extract, and stir evenly at room temperature;

[0035] (5) Emulsify: Slowly drop the said phase B and phase C into phase A, stir slowly to uniformly emulsify. After the dropping is completed, stir evenly at medium speed and then homogenize to uniformly emulsify to obtain a delicate paste, cool down to room temperature, and then it is ready.

[0036] Preferably, in the above - mentioned preparation process, in step (5), when adding phase B and phase C, the essential oil component of phase D, such as plum blossom essential oil, can also be added, then stir and homogenize to obtain a delicate paste, and then cool down to room temperature.

[0037] The present invention aims to provide a traditional Chinese medicine composition, its preparation, method of preparation and application that can repair the skin barrier under the guidance of the qi - blood - body - fluid dialectical system. The products provided by the present invention have the following characteristics:

[0038] 1. It is developed by modifying the empirical formula of famous veteran Chinese doctors, with the effects of nourishing blood and promoting blood circulation, moistening dryness and promoting granulation, effectively playing a role in repairing the skin barrier and moisturizing.

[0039] 2. The cream is a skin care cream based on herbal Chinese medicine. After decocting and concentrating Angelica sinensis, Rehmannia glutinosa, Polygonatum odoratum, Bletilla striata, and Astragalus membranaceus in a specific proportion, specific preservatives are added to ensure the activity and stability of the ingredients.

[0040] 3. The emulsification formula and preparation process of the cream: Adopt a four-phase compound emulsification system of A, B, C, and D, and reasonably control the stirring speed and homogenization conditions to ensure that the texture of the cream is delicate and stable.

[0041] This traditional Chinese medicine composition is guided by the dermatological qi, blood, body fluid dialectical system and is modified from Yangxue Runfu Decoction. The research results show that it can significantly improve the skin barrier function of patients with xerosis cutis in clinical trials, improve skin roughness, cracks, and flushing caused by dryness, reduce dandruff shedding, improve the quality of life of patients, and have no obvious adverse reactions; in animal experiments, it can significantly improve the skin lesions of psoriasis mice induced by imiquimod cream, improve the skin barrier function, and have no irritation to intact skin. All effective components of the present invention are derived from natural products, with the advantages of stable and lasting efficacy, safety and no irritation, and environmental friendliness. Therefore, it is very suitable for preparing external skin care preparations for various diseases with damaged skin barriers. Description of the Drawings

[0042] Figure 1 Shows the skin lesion conditions of each group of psoriasis-like mouse models after drug administration. From ① to ⑥ are the blank control group, the model group, the calcipotriol group, the low-concentration ointment group, the medium-concentration ointment group, and the high-concentration ointment group respectively.

[0043] Figure 2 Shows the comparison of skin lesion conditions of a certain subject before and after drug administration. From top to bottom are the initial skin lesions of the subject, the initial dermoscopy of the subject, the skin lesions of the subject after 2 weeks of drug administration, the dermoscopy of the subject after 2 weeks of drug administration, the skin lesions of the subject after 4 weeks of drug administration, and the dermoscopy of the subject after 4 weeks of drug administration.

[0044] Figure 3 Shows the comparison of skin lesion conditions of another subject before and after drug administration. ① is the skin lesion (upper figure) and dermoscopy (lower figure) conditions of the subject at the initial diagnosis, ② is the skin lesion (upper figure) and dermoscopy (lower figure) conditions of the subject after 2 weeks of drug administration, and ③ is the skin lesion (upper figure) and dermoscopy (lower figure) conditions of the subject after 4 weeks of drug administration. Detailed Description of the Invention

[0045] To make the objectives, technical solutions and advantages of the present invention more clear and understandable, the present invention will be further described in detail below in conjunction with embodiments. The specific embodiments described herein are only used to explain the present invention and do not constitute any limitation to the present invention. In addition, in the following description, the descriptions of well-known structures and technologies are omitted to avoid unnecessarily confusing the concepts of the present disclosure. Such structures and technologies have also been described in many publications.

[0046] Definition

[0047] Unless otherwise defined, all technical terms and scientific terms used in the present invention have the same meanings as those commonly used in the field to which the present invention belongs. For the purpose of interpreting this specification, the following definitions will be applied, and where appropriate, terms used in the singular form will also include the plural form and vice versa.

[0048] Unless the context clearly indicates otherwise, the expressions "a" and "an" used herein include plural referents. For example, referring to "a cell" includes multiple such cells and equivalents known to those skilled in the art and so on.

[0049] The term "about" used herein means a range of ±20% of the value thereafter. In some embodiments, the term "about" means a range of ±10% of the value thereafter. In some embodiments, the term "about" means a range of ±5% of the value thereafter.

[0050] Embodiments and drawings are provided below to assist in understanding the present invention. However, it should be understood that these embodiments and drawings are only used to illustrate the present invention but do not constitute any limitation. The actual protection scope of the present invention is set forth in the claims. It should be understood that any modifications and changes can be made without departing from the spirit of the present invention. The reagents and / or reagent kits used in the following embodiments are all commercially available or can be synthesized by known methods.

[0051] It should be noted that for those not specified with specific conditions in the embodiments, they are carried out according to conventional conditions, manufacturer's suggestions or experimental conditions reported in the public. For those reagents or instruments without indicating the manufacturer, they are all conventional products that can be purchased commercially. For those reagents with the manufacturer indicated, similar products of other manufacturers are substitutable.

[0052] The preparation process of the traditional Chinese medicine cream preparation of the present invention is described in detail as follows:

[0053] Step S1: Preparation of traditional Chinese medicine extract:

[0054] Ratio of medicinal materials: Take 6 parts of Angelica sinensis, 4 parts of Rehmannia glutinosa, 4 parts of Polygonatum odoratum, 4 parts of Bletilla striata, and 2 parts of Astragalus membranaceus.

[0055] Extraction process: Add 10 times the amount of water and decoct for extraction 3 times at 90 - 100 °C for 60 minutes each time, then combine the extraction solutions. Concentrate to 100 parts using vacuum concentration technology and add 1 part of preservative (1,2 - hexanediol, p - hydroxyacetophenone).

[0056] Step S2: Preparation of Phase A (oil phase) raw materials

[0057] Ingredients: 9 parts of emulsifier, 10 parts of emollient polydimethylsiloxane, 10 parts of emollient polydimethylsiloxanol, 5 parts of emollient caprylic / capric triglyceride.

[0058] Process: At room temperature, add the above - mentioned components to a stirring pot and stir at a stirring speed of 60 rpm until uniformly emulsified to form fine particles. After defoaming, set aside.

[0059] Step S3: Preparation of Phase B (water - soluble active substance) raw materials

[0060] Ingredients: 5 parts of butanediol, 0.5 part of p - hydroxyacetophenone, 0.5 part of 1,2 - hexanediol.

[0061] Process: Heat to 45 - 50 °C and stir evenly at 60 rpm.

[0062] Step S4: Preparation of Phase C (aqueous phase and traditional Chinese medicine liquid) raw materials

[0063] Ingredients: 10 parts of glycerol, 43.9 parts of deionized water, 6 parts of traditional Chinese medicine extraction solution.

[0064] Process: Stir evenly at room temperature and set aside.

[0065] Step S5: Emulsification process:

[0066] ① Slow stirring: At a stirring speed of 40 rpm, slowly drop Phase B and Phase C into Phase A. Control the dropping speed at a rate that can uniformly wrap the oil phase to avoid unstable emulsification caused by too fast stirring.

[0067] ② Homogenization and stabilization: After dropping is completed, add Phase D (0.1 part of plum blossom essential oil). Increase the stirring speed to medium speed (60 rpm) and stir for 5 - 10 minutes to check whether the paste is uniform and delicate. Homogenize for 1 - 3 minutes using a high - shear emulsifier (2500 rpm) to improve emulsification stability. Stir again at medium speed (60 rpm) for 5 - 10 minutes to ensure the cream is uniform and delicate.

[0068] ③ Cooling and inspection: After emulsification is completed, slowly cool to room temperature. Take samples for inspection and discharge after meeting the quality standards.

[0069] Step S6: Quality inspection standards

[0070] ①pH (25 °C): 5 - 7.5

[0071] ②Viscosity (25 °C, mPa·s): 30,000 to 100,000

[0072] ③Stability test: Place at a constant temperature of 45 °C for 1 h, no layering or water separation; centrifuge at 2000 r / min for 30 min, no abnormal phenomenon.

[0073] ④Appearance requirements: Color: Brownish-yellow paste; Texture: Uniform and delicate, no obvious particles.

[0074] ⑤Microbiological detection: Total number of colonies ≤ 1000 CFU / g; Total number of molds and yeasts ≤ 100 CFU / g.

[0075] Example 1 Cream

[0076] ①Traditional Chinese medicine extraction process: Weigh 6 parts of Angelica sinensis, 4 parts of Rehmannia glutinosa, 4 parts of Polygonatum odoratum, 4 parts of Bletilla striata, and 2 parts of Astragalus membranaceus, decoct with 10 times the amount of water for 3 times, combine and concentrate the extract, and add an appropriate amount of preservative to obtain the prepared traditional Chinese medicine liquid.

[0077] ②Cream preparation:

[0078] Preparation of phase A raw materials: Put 10 parts of emollient polydimethylsiloxane, 10 parts of emollient polydimethylsiloxanol, 5 parts of emollient caprylic / capric triglyceride, and 9 parts of emulsifier into the pot, stir at medium speed (60 revolutions / min) at room temperature until uniform particles are formed, then defoam and set aside.

[0079] Preparation of phase B raw materials: 5 parts of butanediol, 0.5 parts of p-hydroxyacetophenone, 0.5 parts of 1,2-hexanediol, heat to 45 - 50 °C, and stir evenly (60 revolutions / min).

[0080] Preparation of phase C raw materials: 43.9 parts of deionized water, 10 parts of glycerol, 3 parts of traditional Chinese medicine extract.

[0081] Mixed emulsification: Under slow stirring (40 revolutions / min), slowly add phase B + C to phase A, and the dropping speed should be just right to be wrapped in, and the stirring speed should not be too fast during dropping.

[0082] Homogenizing and stirring: After dropping, add 0.1 part of plum blossom essential oil, increase the speed to medium (60 revolutions / min), stir for 5 - 10 minutes, check whether the paste is uniform and delicate, then homogenize at low - medium speed (2500 revolutions / min) for 1 - 3 minutes, and then stir at medium speed (60 revolutions / min) for 5 - 10 minutes to ensure the paste is uniform and delicate. Cool to room temperature.

[0083] Take samples for inspection, and discharge the product after passing the inspection.

[0084] Example 2 Cream

[0085] ① Chinese medicine extraction process: Weigh 6 parts of Angelica sinensis, 4 parts of Rehmannia glutinosa, 4 parts of Polygonatum odoratum, 4 parts of Bletilla striata, and 2 parts of Astragalus membranaceus. Add 10 times the amount of water and decoct for extraction 3 times. Combine and concentrate the extraction solution, and add an appropriate amount of preservative to obtain the prepared Chinese medicine liquid.

[0086] ② Cream preparation:

[0087] Preparation of phase A raw materials: Put 10 parts of the emollient polydimethylsiloxane, 10 parts of the emollient polydimethylsiloxane alcohol, 5 parts of the emollient caprylic / capric triglyceride, and 9 parts of the emulsifier into a pot, stir at medium speed (60 revolutions / min) at room temperature until uniform particles are formed, then defoam and set aside.

[0088] Preparation of phase B raw materials: 5 parts of butanediol, 0.5 part of p-hydroxyacetophenone, 0.5 part of 1,2-hexanediol, heat to 45 - 50 °C, and stir evenly (60 revolutions / min).

[0089] Preparation of phase C raw materials: 43.9 parts of deionized water, 10 parts of glycerol, 6 parts of the Chinese medicine extraction solution.

[0090] Mixing and emulsifying: Under slow stirring (40 revolutions / min), slowly drop phase B + C into phase A. The dropping speed should be such that it can just be wrapped in, and the stirring speed should not be too fast during the dropping process.

[0091] Homogenizing and stirring: After dropping, add 0.1 part of plum blossom essential oil, increase the speed to medium (60 revolutions / min), stir for 5 - 10 minutes, check whether the cream is uniform and delicate, then homogenize at low - medium speed (2500 revolutions / min) for 1 - 3 minutes, and then stir at medium speed (60 revolutions / min) for 5 - 10 minutes to ensure that the cream is uniform and delicate. Cool to room temperature.

[0092] Take samples for testing, and discharge the product after passing the test.

[0093] Example 3 Cream

[0094] ① Chinese medicine extraction process: Weigh 6 parts of Angelica sinensis, 4 parts of Rehmannia glutinosa, 4 parts of Polygonatum odoratum, 4 parts of Bletilla striata, and 2 parts of Astragalus membranaceus. Add 10 times the amount of water and decoct for extraction 3 times. Combine and concentrate the extraction solution, and add an appropriate amount of preservative to obtain the prepared Chinese medicine liquid.

[0095] ② Cream preparation:

[0096] Preparation of phase A raw materials: Put 10 parts of the emollient polydimethylsiloxane, 10 parts of the emollient polydimethylsiloxane alcohol, 5 parts of the emollient caprylic / capric triglyceride, and 9 parts of the emulsifier into a pot, stir at medium speed (60 revolutions / min) at room temperature until uniform particles are formed, then defoam and set aside.

[0097] Preparation of Phase B raw materials: 5 parts of butanediol, 0.5 part of p-hydroxyacetophenone, 0.5 part of 1,2-hexanediol, heated to 45-50°C and stirred evenly (60 revolutions / min).

[0098] Preparation of Phase C raw materials: 43.9 parts of deionized water, 10 parts of glycerol, 12 parts of traditional Chinese medicine extract.

[0099] Mixing and emulsifying: Under slow stirring (40 revolutions / min), slowly add Phase B+C to Phase A, and the dropping speed should be just right to be wrapped in, and the stirring speed should not be too fast during dropping.

[0100] Homogenizing and stirring: After dropping, add 0.1 part of plum blossom essential oil, increase the speed to medium (60 revolutions / min), stir for 5-10 minutes, check whether the paste is uniform and delicate, then homogenize at low-medium speed (2500 revolutions / min) for 1-3 minutes, and then stir at medium speed (60 revolutions / min) for 5-10 minutes to ensure that the paste is uniform and delicate. Cool to room temperature.

[0101] Sampling and testing, discharging after passing the inspection.

[0102] Example 4: Oral traditional Chinese medicine liquid

[0103] ① Weigh 10 parts of Angelica sinensis, 5 parts of Rehmannia glutinosa, 3 parts of Polygonatum odoratum, 3 parts of Bletilla striata, and 1 part of Astragalus membranaceus.

[0104] ② Preparation method of traditional Chinese medicine liquid:

[0105] Weigh the above traditional Chinese medicinal materials according to the proportion, wash them and put them into a decocting pot, add 8 times the amount of water, soak for 30 minutes. First boil with high heat, then turn to low heat and decoct for 30 minutes. Filter the medicinal liquid and keep the filtrate. Add 6 times the amount of water to the medicinal residues again, decoct for 20 minutes, filter and combine the two medicinal liquids. Concentrate the combined medicinal liquid to 1 / 3 of the original volume, cool and bottle it, and sterilize and seal for storage.

[0106] Example 5: Oral traditional Chinese medicine liquid

[0107] ① Weigh 9 parts of Angelica sinensis, 3 parts of Rehmannia glutinosa, 3 parts of Polygonatum odoratum, 3 parts of Bletilla striata, and 2 parts of Astragalus membranaceus.

[0108] ② Preparation method of traditional Chinese medicine liquid:

[0109] Weigh the above traditional Chinese medicinal materials according to the proportion, wash them and put them into a decocting pot, add 8 times the amount of water, soak for 30 minutes. First boil with high heat, then turn to low heat and decoct for 30 minutes. Filter the medicinal liquid and keep the filtrate. Add 6 times the amount of water to the medicinal residues again, decoct for 20 minutes, filter and combine the two medicinal liquids. Concentrate the combined medicinal liquid to 1 / 3 of the original volume, cool and bottle it, and sterilize and seal for storage.

[0110] Example 6: Traditional Chinese medicine capsules

[0111] ① Weigh 3 parts of Chinese angelica root, 2 parts of rehmannia root, 2 parts of polygonatum odoratum, 2 parts of bletilla striata, and 1 part of astragalus membranaceus.

[0112] ② Preparation method: Weigh the Chinese medicinal materials according to the proportion, wash them, crush them into fine powder, and pass through a 100-mesh sieve. Put the medicinal powder into empty capsules, with each capsule containing 0.5 grams of medicinal powder. Bottles are sealed for storage.

[0113] Example 7: External wet compress Chinese medicinal liquid

[0114] ① Weigh 12 parts of Chinese angelica root, 6 parts of rehmannia root, 6 parts of polygonatum odoratum, 6 parts of bletilla striata, and 3 parts of astragalus membranaceus.

[0115] ② Weigh the above Chinese medicinal materials according to the proportion, wash them, put them into a decocting pot, add 12 times the amount of water, and soak for 30 minutes. First, bring to a boil over high heat, then turn to low heat and decoct for 20 minutes. Add 8 times the amount of water to the medicinal residues again, decoct for 15 minutes, filter, and combine the two decoctions. Cool the decoction to room temperature, bottle it, sterilize, and seal for storage. No dilution is required during use.

[0116] ③ Usage method: Take an appropriate amount of the decoction to soak sterile gauze or cotton pads, apply them to the cleaned skin lesions, 15 - 20 minutes each time, twice a day.

[0117] Experimental example 1: Pharmacodynamic study on psoriasis model in mice

[0118] 1.1 Research method

[0119] Thirty-six male BALB / c mice, 6 - 8 weeks old, weighing 20 - 25 g, were randomly and evenly divided into a blank group, a model group, a low-concentration ointment group (Example 1), a medium-concentration ointment group (Example 2), a high-concentration ointment group (Example 3), and a calcipotriol group. After adaptive feeding, physical hair removal was performed, and a modeling and drug administration synchronous experimental method was adopted. The blank group applied vaseline externally in the morning and evening, the model group applied imiquimod cream (IMQ) 62.5 mg and ointment base 100 mg externally in the morning and evening respectively, and the remaining groups applied IMQ 62.5 mg externally in the morning and the corresponding drug 100 mg externally in the evening, with a drug administration interval of more than 4 h twice a day for 7 consecutive days. On Day 8 after the experiment, PASI score was evaluated, and transcutaneous water loss (TWEL) and stratum corneum water content (SCH) were detected. On Day 8, the mice were sacrificed for sampling, and skin tissues were made into slides, stained with HE, and observed under the microscope for histological pathology of psoriasis skin (Baker score) and inflammatory cell infiltration score.

[0120] 1.2 Evaluation indicators

[0121] ① Lesion improvement: Visually observe and record the lesion conditions of mice in each group with a camera, and evaluate the severity of the lesions using the PASI score.

[0122] PASI score: It is evaluated from three aspects: erythema, scale, and degree of infiltration. 0 points are counted for none, 1 point for mild, 2 points for relatively obvious, 3 points for significant, and 4 points for very significant. The sum of the scores of the three items is the total score. The higher the total score, the more severe the skin lesions.

[0123] ② Skin barrier function indicators: TWEL and SCH were detected using a portable professional skin barrier function measuring instrument "GPskinBarrier".

[0124] ③ Histopathology: Baker score and inflammatory cell infiltration score were performed.

[0125] Baker score: Stratum corneum: 2 points are counted for the appearance of Munro microabscesses, 1 point for parakeratosis, and 0.5 points for hyperkeratosis; Epidermis: 1 point is counted for the disappearance of granular cell layer in the epidermis, and 1 point for acanthosis; Dermis: 5 points are counted for capillary dilation, and 2, 1, and 0.5 points are counted for severe, moderate, and mild single multinuclear cell infiltration respectively.

[0126] Inflammatory cell infiltration score: 0 points are counted when the proportion of inflammatory cell infiltration in the tissue is 0; 1 point is counted when the proportion of inflammatory cell infiltration in the tissue is less than 10%; 2 points are counted when the proportion of inflammatory cell infiltration in the tissue is 11% - 25%; 3 points are counted when the proportion of inflammatory cell infiltration in the tissue is 26% - 75%; 4 points are counted when the proportion of inflammatory cell infiltration in the tissue is greater than 75%.

[0127] 1.1.3 Data processing

[0128] The experimental data were expressed as mean ± standard error, and data analysis was performed using SPSS software. Quantitative data were expressed as mean and standard deviation. For those conforming to normal distribution, one-way ANOVA was used for analysis. If the variances were homogeneous, pairwise comparisons between groups were used; if the variances were inhomogeneous, the rank sum test was used. For those not conforming to normal distribution, the rank sum test was used for analysis.

[0129] 1.1.4 Results

[0130] ① PASI score and improvement of skin lesions:

[0131] In the blank group, the mice had normal behavioral activities, body weight, and diet. The skin on the back was light red, smooth, without scales, erythema, or erosion. In the model group, the mice showed irritability, reduced diet, decreased body weight, scratched the skin lesions, and there were infiltrative erythema and thick silver-white scales on the back skin. Hemorrhage points were visible in some mice. In the calcipotriol group and each concentration ointment group, the scales and erythema on the back skin of the mice were reduced compared with the model group, and the skin condition gradually recovered.

[0132] After treatment, the improvement of skin lesions in the psoriasis-like mouse models of each group was as Figure 1 shown.

[0133] From Figure 1It can be seen that compared with the model control group at the same time, in the low-concentration ointment group, medium-concentration ointment group, and high-concentration ointment group, the scales of the mice were significantly thinner and less, the scale thickness was reduced, the erythema was lighter in color and smaller in area, the degree of skin thickening was mild, the infiltration was not obvious, and the skin lesion symptoms were all alleviated.

[0134] After treatment, the PASI scores of the skin lesions of the mice in each group are shown in Table 1:

[0135] Table 1 PASI scores of skin lesions in the psoriasis-like mouse model in each group after treatment

[0136]

[0137] Note: Compared with the blank group, *P < 0.05; compared with the model group, #P < 0.05, * P < 0.01;

[0138] It can be seen from Table 1 that in terms of PASI scores, compared with the model group, the erythema, infiltration, and scales of the skin lesions on the backs of the mice in the treatment groups all showed an improvement trend, and the PASI scores in the medium-concentration ointment group and high-concentration ointment group were significantly reduced (P < 0.05).

[0139] ② Skin barrier function:

[0140] After treatment, the TEWL and SCH of the skin of the mice in each group are shown in Table 2:

[0141] Table 2 Effects of ointments with different concentrations on TEWL and SCH of skin lesions in the psoriasis-like mouse model

[0142]

[0143] Note: Compared with the blank group, *P < 0.05; compared with the model group, #P < 0.05, * P < 0.01;

[0144] It can be seen from Table 2 that compared with the model group, the transepidermal water loss of the mice in the treatment groups all decreased to some extent, and the water content of the stratum corneum showed an upward trend. The transepidermal water loss in the medium-concentration ointment group and high-concentration ointment group decreased significantly, and the water content of the stratum corneum increased significantly (P < 0.05).

[0145] ③ Histopathology:

[0146] The back skin structure of the mice in the blank group was intact, with no obvious abnormalities in the epidermal layer, a smooth basal layer, and no obvious inflammatory reaction or capillary dilation in the dermal layer. Compared with the blank group, the stratum corneum of the back skin in the model group was thickened and parakeratosis coexisted, Munro microabscesses were visible, the granular layer was thinned, the spinous layer was hypertrophied and protruded downward, capillary dilation occurred, and the inflammatory reaction in the dermal layer was severe. Compared with the model group, the spinous layer in the traditional Chinese medicine ointment groups with different concentrations was thinner, the basal layer was smooth, the inflammatory reaction and capillary dilation in the dermal layer were milder, and the abnormal proliferation and inflammatory reaction in the calcipotriol group were also milder.

[0147] After treatment, the Baker scores and inflammatory cell infiltration scores of the mice in each group were shown in Table 3:

[0148] Table 3 Baker scores and inflammatory cell infiltration scores of the skin lesions of the mice in each group

[0149]

[0150] Note: Compared with the blank group, *P<0.05; compared with the model group, #P<0.05, * P<0.01;

[0151] It can be seen from Table 3 that: compared with the model group, the Baker scores and inflammatory cell infiltration scores of the mice in the treatment group were both improved. The inflammatory cell infiltration scores in the medium-concentration ointment group and high-concentration ointment group were significantly reduced (P<0.05), and the Baker score in the high-concentration ointment group was significantly reduced (P<0.05).

[0152] Experimental Example 2 Safety study of rats

[0153] 2.1 Research methods

[0154] Fifteen Wistar rats were randomly divided into a blank group, a matrix group, a low-concentration ointment group, a medium-concentration ointment group, and a high-concentration ointment group. After each rat was anesthetized with gas, hair on the back was removed by physical hair removal in an area of 4 cm×4 cm, and the back skin was scratched with a scalpel until a little blood oozed out. Using the self-control method, the rats in the blank group were not treated. The intact skin and damaged skin of the rats in the matrix group, low-concentration ointment group, medium-concentration ointment group, and high-concentration ointment group were externally applied with the corresponding drugs at 50 mg. After 4 h, they were washed with warm water. The erythema, edema and their recovery of the back skin of the rats were observed at 1 h, 24 h, 48 h and 72 h after washing. The Draize scale was used to evaluate skin irritation. The skin irritation intensity evaluation score = (total erythema score + total edema score) / total number of animals (see Table 4). The irritation intensity was graded with a stimulation score between 0 and 4 (see Table 5), from no reaction to severe reaction. After 72 h, the rats were anesthetized and sacrificed, and skin tissues were taken for section preparation, HE staining, and then the histological morphology of the skin was observed under the microscope.

[0155] Table 4 Skin irritation intensity scoring criteria

[0156]

[0157] Table 5 Skin irritation reaction scoring criteria

[0158]

[0159] 2.2 Evaluation indicators

[0160] ① Skin irritation intensity scoring: Visually observe and record the skin lesions of rats in each group with a camera, and use the Draize scale to evaluate the severity of skin irritation.

[0161] ② Observe the histopathological manifestations.

[0162] 2.3 Data processing

[0163] The experimental data are expressed as mean ± standard error, and data analysis is performed using SPSS software. Quantitative data are expressed as mean and standard deviation. For data conforming to the normal distribution, one-way ANOVA is used for analysis. If the variances are homogeneous, pairwise comparisons between groups are performed; if the variances are not homogeneous, the rank sum test is used. For data not conforming to the normal distribution, the rank sum test is used for analysis.

[0164] 2.4 Results

[0165] ① Skin irritation experiment scoring (see Table 6)

[0166] Table 6 Skin irritation experiment scoring results

[0167]

[0168] As can be seen from Table 6, the ointments and matrices at different concentrations have no irritation to the skin of normal intact rats; for damaged skin, the skin irritation experiment scores of the ointments and matrices at different concentrations are all > 0.4 points but < 1.9 points 1 hour after administration, indicating that the ointments have mild irritation to damaged skin. The skin irritation experiment scores are all < 0.4 points 48 hours after administration, indicating that this irritation disappears.

[0169] ② Histopathological manifestations:

[0170] The local skin tissue irritation experiment shows that there are no obvious changes in the intact skin of rats at each time point, and there are no macroscopically visible lesions in the basal cells and spinous layer cells of the damaged skin in each group, and mild dyskeratosis can be slightly seen. It is suggested that the ointments at different concentrations have no irritation to the normal skin of rats and have mild irritation to the damaged skin.

[0171] Experimental Example 3 Human effect study

[0172] Conduct a clinical efficacy study on the ointment of Example 2.

[0173] 1 Research plan

[0174] 1.1 Research method

[0175] Prospective, self - controlled study

[0176] 1.2 Sample size

[0177] It is planned to include 11 patients who meet the criteria.

[0178] 1.3 Inclusion criteria:

[0179] ODS score (overall dry skin score ods) > 1 point.

[0180] 0 point: No dry symptoms;

[0181] 1 point: There is slight peeling, and the skin appearance is slightly rough and dull;

[0182] 2 points: There are fine scales or a small amount of large - scale scales attached to the skin surface, and the appearance is slightly rough and white;

[0183] 3 points: The scales are evenly distributed, the skin appearance is significantly rough, slightly red, and there are a small number of cracks;

[0184] 4 points: A large amount of scales shed, the skin appearance is rough, red, accompanied by eczema - like changes and chapping.

[0185] 1.4 Exclusion criteria:

[0186] ① The skin is in the acute inflammation stage;

[0187] ② Patients who are allergic to known components and patients with severe allergic constitution.

[0188] 1.5 Intervention measures

[0189] In addition to the conventional baseline treatment, the patients are instructed to apply the corresponding concentration of ointment to the affected area. Provide guidance on ointment application to the patients, strictly control the scope of medication and the dosage of application. Use one fingertip unit (the amount of ointment squeezed from a standard packaging hose with a diameter of 5 mm to an adult's fingertip, that is, from the fingertip of the index finger to the horizontal line of the first finger joint, about 0.5 g) of ointment to apply to the skin lesions in an area the size of a palm (about 1% of the body surface area), apply evenly, and gently knead with the pulp of the finger for a moment to promote drug absorption, once a day, and the course of treatment is 4 weeks.

[0190] 1.7 Efficacy indicators

[0191] ① Skin barrier function indicators: Use the German CK non - invasive skin function detector to detect TWEL and SCH of the skin.

[0192] ②Dermatology Life Quality Index (DLQI score): This scale is specifically designed to evaluate the impact of skin diseases on patients' quality of life. The scale consists of 10 questions covering different aspects of life, including symptoms and feelings, daily activities, leisure, work and school, interpersonal relationships, and treatment. Patients answer these questions based on their experiences in the past week. The answers to each question have different scores ranging from 0 to 3 points, where 0 points represent "no impact" and 3 points represent "very large impact". The scores of all questions are added together, and the total score ranges from 0 to 30 points. The higher the score, the greater the negative impact of the skin disease on the patient's quality of life.

[0193] ③Total score of specific symptoms (SRRC score): It is evaluated from four aspects: degree of dandruff shedding, roughness, redness, and cracks. Each symptom is scored on a 5-point scale, with 0 - 4 representing "none, mild, moderate, severe, extremely severe" respectively, and each level has corresponding evaluation criteria.

[0194] ④Patient / Doctor Simple Visual Analogue Scale (VAS score): It uses a visual analogue scale for scoring, with the scale ranging from 0 - 10, representing the skin from no dryness symptoms to very dry.

[0195] ⑤Dry Skin Area and Severity Index (DASI score): It is evaluated from four aspects: dandruff, roughness, cracks, and redness. Each symptom is scored on a 5-point scale, with 0 - 4 representing "none, slight, moderate, severe, extremely severe with eczema" respectively. Affected areas: head and neck (10% of the total area), upper limbs (20% of the total area), trunk (30% of the total area), lower limbs (40% of the total area). Calculate the product of the sum of the severity scores of each body part and the percentage of the affected area from the four aspects of dandruff, roughness, cracks, and redness, and record the sum of the four body parts.

[0196] ⑥Dermoscope: DermLiteCam digital dermoscope, 5 million pixel camera, 10x optical magnification, field of view range 25mm; It adopts advanced polarized light dermoscopy patented technology, does not require immersion liquid, and has two light sources: cross-polarized light and normal white light. Use this device to collect dermoscopic images and observe.

[0197] ⑦Safety indicators: Observe and record the adverse reactions that occur in patients, such as discomfort symptoms like erythema, stinging, itching, dryness, burning, etc.

[0198] 2 Results

[0199] ①Improvement of skin barrier function after immediate use

[0200] Table 7 Improvement of skin barrier function after immediate use

[0201]

[0202] Note: Compared with before use, #P < 0.05, *P < 0.01

[0203] As shown in Table 7, after using the ointment of Example 2, the TEWL and SCH of the patients were significantly improved immediately, indicating that this product showed good performance in immediate use effect and could quickly supplement moisture to the skin.

[0204] ② Improvement of patients' symptoms before and after 4-week treatment

[0205] Table 8 Improvement of patients' symptoms before and after 4-week treatment

[0206]

[0207] Note: Compared with the first week, #P < 0.05, *P < 0.01

[0208] As shown in Table 8, after 2 weeks of topical application of the ointment in Example 2, the skin barrier function and quality of life of patients with xerosis improved, but there was no statistical significance (P > 0.05). The dry VAS score and DASI score were significantly improved (P < 0.05). After 4 weeks of using the ointment, the TEWL of the patients decreased significantly and the SCH increased significantly (P < 0.05), indicating that the skin barrier function was significantly improved and the quality of life was significantly improved. The SRRC score, VAS score, and DASI score all decreased significantly (P < 0.05), indicating that symptoms such as skin flaking, roughness, redness, and cracks of the patients were significantly relieved.

[0209] ③ Adverse reactions before and after treatment: During the treatment, the vital signs of all subjects were stable, and no adverse reactions such as erythema, stinging, itching, dryness, and burning occurred, indicating that topical application of this ointment for the treatment of xerosis has good safety.

[0210] 2.3 Satisfaction with skin care products

[0211] 2.3.1 Satisfaction scoring principle

[0212] After 4 weeks, ask the patients to conduct a questionnaire survey on the satisfaction with the emollient, and evaluate from 7 aspects including appearance, smell, absorbability, convenience, packaging rationality, effectiveness, and acceptability. Each aspect is scored from 0 to 4 points. The total score of 21 - 28 points is very satisfied, 14 - 20 points is satisfied, 7 - 13 points is average, and 0 - 6 points is dissatisfied.

[0213] 2.3.2 Satisfaction scoring results

[0214] Table 9 Satisfaction scoring results of skin care products

[0215]

[0216] As shown in Table 9, 11 patients had a satisfaction score of >21 points for this product, indicating that patients generally had a high level of satisfaction with this product.

[0217] Case study of the subjects in Experimental Example 3

[0218] The traditional Chinese medicine ointment prepared in Example 2 was used to treat Subject A.

[0219] As Figure 2 shown, before treatment, the skin surface of the lower limbs of Subject A was dry, rough, desquamated, chapped, with obvious pruritus, scattered red papules, scratch marks and blood scabs could be seen. Under dermoscopy, there were white scales distributed in flakes and granules on the erythema with unclear boundaries, dot-like vasodilators and reticular blood vessel distribution could be seen, and the skin texture was thickened. After using the traditional Chinese medicine ointment of Example 2 for 2 weeks, the skin lesions were significantly improved, the dryness and roughness of the skin surface were reduced, desquamation decreased, chaps healed, pruritus was relieved, some of the red papules regressed, no new ones appeared, scratch marks and blood scabs decreased. Dermoscopy showed that the erythema became lighter in color, scales decreased, and the phenomenon of vascular dilation was alleviated. After 4 weeks, symptoms such as skin dryness and desquamation further decreased, the skin became thinner, pruritus was significantly relieved, dermoscopy showed that the erythema significantly regressed, leaving brown pigmentation, blood vessel distribution returned to normal, and the skin texture was smooth. During the medication period, the skin barrier function was detected. For this patient, the TEWL gradually decreased and the SCH gradually increased, and the skin barrier function was improved, and no adverse reactions occurred during clinical observation.

[0220] Case study of the subjects in Experimental Example 4

[0221] The traditional Chinese medicine ointment prepared in Example 1 was used to treat Subject B.

[0222] As Figure 3 shown in No. ①, before treatment, the skin of the lower leg of Subject B was dry, rough, desquamated, with occasional pruritus, scattered red patches. Under dermoscopy, the skin lines were deepened and rough, showing a grid-like appearance, and there were granular white scales covering the areas where the skin lines were deepened. After using the traditional Chinese medicine ointment of Example 1 for 2 weeks, the skin dryness was slightly relieved compared with before, desquamation decreased, pruritus was reduced, and dermoscopy showed that the roughness of the skin lines was reduced, scales decreased, and the grid-like appearance was improved (as Figure 3 shown in No. ②). After 4 weeks, the skin dryness was significantly improved, roughness basically disappeared, scales completely regressed, no pruritus, dermoscopy showed that the skin lines returned to normal, scales disappeared, and the skin surface was smooth. (As Figure 3 shown in No. ③) No adverse reactions occurred during clinical observation.

[0223] The technical solution of the present invention is not limited to the limitations of the above specific embodiments. Any technical deformation made according to the technical solution of the present invention falls within the protection scope of the present invention.

Claims

1. A Chinese medicine composition for improving skin barrier function, which is made from the following Chinese medicinal materials in parts by weight: 3-12 parts of Angelica sinensis, 2-6 parts of Rehmannia glutinosa, 2-6 parts of Polygonatum odoratum, 2-6 parts of Bletilla striata, and 1-3 parts of Astragalus membranaceus.

2. The Chinese medicine composition according to claim 1, wherein 3 parts of Angelica sinensis, 2 parts of Rehmannia glutinosa, 2 parts of Polygonatum odoratum, 2 parts of Bletilla striata, and 1 part of Astragalus membranaceus.

3. The Chinese medicine composition according to claim 1, wherein 6 parts of Angelica sinensis, 4 parts of Rehmannia glutinosa, 4 parts of Polygonatum odoratum, 4 parts of Bletilla striata, and 2 parts of Astragalus membranaceus.

4. The Chinese medicine composition according to claim 1, wherein 12 parts of Chinese Angelica sinensis, 6 parts of Radix Rehmanniae, 6 parts of Polygonatum odoratum, 6 parts of Bletilla striata, and 3 parts of Astragalus.

5. A Chinese medicine composition preparation for improving skin barrier function, which is composed of the Chinese medicine composition according to any one of claims 1 to 4 and pharmaceutically acceptable excipients.

6. The Chinese medicine composition preparation according to claim 5, which is an ointment, comprising the following composition in parts by weight: 3-12 parts of Chinese medicinal extract prepared by boiling angelica sinensis, radix rehmanniae, odoratum odoratum, bletilla striata and astragalus, 8-10 parts of emulsifier, 23-28 parts of emollient, 13-16 parts of moisturizer, 1-2 parts of preservative and appropriate solvent.

7. The Chinese medicine composition preparation according to claim 6, wherein the Chinese medicine extract is prepared in the following manner: Take corresponding weight portions of angelica, raw rehmannia, polygonatum, bletilla striata and astragalus, add times amount of water, heat and boil to extract once or multiple times, combine the extracts and concentrate to obtain the product.

8. The Chinese medicine composition preparation according to claim 6, wherein the emulsifier is selected from one or more combinations of PEG-10 polydimethylsiloxane, disteardimonium hectorite, and cyclopentasiloxane.

9. The Chinese medicine composition preparation according to claim 6, wherein the emollient is selected from one or more combinations of dimethicone, dimethiconol, and caprylic / capric triglyceride.

10. The Chinese medicine composition preparation according to claim 6, wherein the humectant is selected from a combination of one or more of butylene glycol and glycerol.

11. The Chinese medicine composition preparation according to claim 6, wherein the preservative is selected from a combination of one or more of p-hydroxyacetophenone and 1,2-hexanediol.

12. The Chinese medicine composition preparation according to claim 6, further comprising essential oil.

13. The Chinese medicine composition preparation according to claim 12, comprising 0.1 parts of plum blossom essential oil.

14. The Chinese medicine composition preparation according to claim 6, wherein the solvent is water.

15. The Chinese medicine composition preparation according to claim 14, comprising 37.9-46.9 parts of deionized water.

16. A method for preparing the Chinese medicine composition preparation according to claims 6-15, comprising the following steps: (1) Preparing Chinese herbal medicine extracts: taking corresponding weight portions of angelica sinensis, raw rehmannia root, polygonatum odoratum, white twig and astragalus root, adding times the amount of water, heating and boiling for extraction once or multiple times, combining the extracts, concentrating and adding preservatives; (2) Prepare phase A: Take the emulsifier and emollient and stir at room temperature until they are uniformly emulsified; (3) Prepare phase B: Heat and stir the moisturizer and preservative until uniform; (4) Preparation of phase C: Take glycerol, solvent and Chinese herbal medicine extract and stir evenly at room temperature; (5) Emulsification: Slowly drop the phase B and phase C into phase A and stir slowly to emulsify evenly. After the dropwise addition is completed, stir evenly at medium speed and homogenize to obtain a fine paste by uniform emulsification. Cool to room temperature to obtain the paste.

17. The preparation method according to claim 16, in step (5), when phase B and phase C are added, phase D, i.e., the essential oil component, can also be added, stirred and homogenized to obtain a fine paste, and then cooled to room temperature.

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