An oral solution for improving skin inflammation and a preparation method thereof

Abstract

The application discloses a kind of health-care food oral solution of medicine and food homology and traditional Chinese medicine oral solution for improving skin inflammation, which is prepared from Fructus Mume, hawthorn, Semen Persicae, Coicis, Poria, small red bean, mulberry leaf, mulberry, perilla leaf, ginger, licorice, dried tangerine or orange peel and jujube.The A-type medicinal materials are homogenized after high-temperature frying and pasting treatment, and the B-type medicinal materials are treated by airflow pulverization at low temperature, extracted, and high-pressure homogenized to obtain the oral solution.The oral solution provided by the application is medicine and food homology, has good taste and good stability.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine with homology of medicine and food, and specifically relates to a health food with homology of medicine and food, an oral solution of traditional Chinese medicine for improving skin inflammation with homology of medicine and food, and a preparation method of the oral solution with homology of medicine and food. Background Art

[0002] At present, the conventional treatment of skin diseases is mainly based on topical glucocorticoids, calcineurin inhibitors and oral antihistamines. Most of such treatments are symptomatic interventions targeting local inflammation that has already occurred, and there are problems such as easy recurrence after drug withdrawal and side effects after long-term use. For chronic and recurrent skin inflammation, the existing treatment methods are difficult to meet the dual needs of immediate anti-inflammation and long-term conditioning, and there is a lack of oral conditioning regimens that are suitable for daily use and have high safety.

[0003] Traditional Chinese medicine has a long history in the treatment of skin diseases. Internal conditioning with traditional Chinese medicine occupies an important position in the treatment of skin diseases. Based on the theory of "pathogenic toxin causing diseases", Professor Xuan Guowei, a master of national traditional Chinese medicine, believes that intractable skin diseases are caused by "damp toxin, heat toxin and stasis toxin" stagnating in the skin. The "Skin Detoxification Decoction" he created (modified from the original Conge Detoxification Decoction) is a representative prescription of the detoxification method. In the prescription, dark plum is used as the monarch drug for nourishing yin and detoxifying, zedoary rhizome is used as the minister drug for removing stasis and detoxifying, rhizoma smilacis glabrae for removing dampness and detoxifying, lithospermum for cooling blood and detoxifying, perilla leaf for detoxifying from fish and shrimp, and cynanchum paniculatum for dredging collaterals and detoxifying are all used as adjuvant drugs, and licorice is used as the messenger drug for harmonizing all the drugs.

[0004] However, the application of Skin Detoxification Decoction in long-term or even daily conditioning scenarios has non-negligible limitations. First of all, the zedoary rhizome it contains has a risk of liver toxicity. "Bencao Shiyi" clearly records that zedoary rhizome is "sweet in flavor and highly toxic", and the "Chinese Pharmacopoeia" records that the efficacy of zedoary rhizome is "promoting qi circulation and breaking blood stasis, eliminating accumulation and alleviating pain", which is mostly used for attacking and treating diseases such as abdominal masses and amenorrhea due to blood stasis. Its power of "breaking blood stasis" is strong, and it is not a mild medicinal herb. Secondly, several varieties of medicinal materials in this prescription have not been included in the list of medicine and food homology announced by the National Health Commission of the People's Republic of China, so it is difficult to transform them into daily conditioning food that meets strict regulatory requirements in terms of product form. In addition, as a traditional Chinese medicine prescription in the form of decoction, there are also practical problems such as uneven quality of active ingredients, poor taste, inconvenient administration, and difficulty in industrialization.

[0005] Against this background, combining the concept of medicine and food homology with modern preparation technology to develop a modern health product that not only retains the core idea and curative effect of "Skin Detoxification Decoction", but also uses all medicine and food homologous substances and is suitable for long-term oral administration, is the key direction to solve the above problems.

[0006] There are some existing technologies addressing the aforementioned issues. For example, patent CN 116076713 B discloses an edible plant enzyme composition that synergistically improves skin moisture and inflammation. This existing technology provides a technical solution: using plant enzymes as the active ingredient. However, the production of plant enzymes typically involves a complex fermentation process involving multiple microorganisms such as yeast, lactic acid bacteria, and acetic acid bacteria. The fermentation process is affected by multiple coupled parameters, including temperature, pH, dissolved oxygen, and microbial ratio, making it difficult to precisely control the stability of the reaction system. This process suffers from high production costs and difficulty in controlling parameters.

[0007] Patent CN 108392620 B discloses a combined health and wellness product for treating dermatitis and its uses. This prior art provides an oral product prepared from coix seed, peach kernel, poria cocos, ginger, scutellaria baicalensis, purslane, angelica sinensis, safflower, prepared polygonatum sibiricum, and cinnamon. This technical solution employs a "treating both internal and external" approach, with the oral product regulating the body's constitution and the external product providing local anti-inflammatory effects. However, this combined "oral + external" treatment method involves the oral product containing safflower and scutellaria baicalensis, neither of which are currently listed in the catalog of medicinal and edible substances, making long-term use as food unsuitable. It can only be used in clinical prescription settings. Furthermore, besides being cumbersome to use, this solution only vaguely claims "significant efficacy against dermatitis" without elaborating on the specific mechanism and pathway of action.

[0008] Patent CN 103238834 B discloses a composition for treating pruritus and its preparation method. This prior art provides a composition of extracts from peach kernel, mulberry leaf, perilla leaf, and dried plum. This technical solution explicitly targets allergic constitutions in individuals with atopic constitutions, inhibiting allergic factors through blood-nourishing, blood-circulating, and wind-dispelling effects. However, this technical solution employs an extract-based approach, resulting in cumbersome preparation steps and impacting the production cycle. Furthermore, the extracts retain limited and unclear active ingredients, interfering with the overall synergistic relationship of the medicinal materials, and making it difficult to fully preserve the multi-component characteristics of natural products.

[0009] The development of skin inflammation is not caused by a single pathway. Traditional Chinese medicine believes that the pathogenesis of stubborn and chronic skin diseases is often due to the interaction of wind, dampness, heat, toxins, and blood stasis: wind is prone to movement and changes frequently, causing itching; dampness is sticky and causes skin lesions to ooze and be difficult to heal; heat toxins enter the blood, which can cause erythema, papules, and pustules; blood stasis obstructs the flow of qi and blood, resulting in malnourishment of the skin, making it difficult to clear pathological products and causing the condition to recur.

[0010] Therefore, a food-medicine homology product that can improve skin condition from multiple perspectives of pathogenesis, has a pleasant taste, and is easy to carry and consume has broad application prospects. Against this background, this technical solution was completed. Summary of the Invention

[0011] Based on the formulation concept of "Skin Detoxification Decoction," this formula is improved according to the principle that all raw materials are of the same medicinal and edible origin. The whole formula takes dried plum as the chief ingredient, peach kernel, coix seed, poria cocos, and red adzuki bean as assistant ingredients, and perilla leaf, mulberry leaf, mulberry fruit, and hawthorn as adjuvant ingredients, with tangerine peel, ginger, jujube, and licorice as guiding ingredients. In particular, combined with the differentiated processing technology of medicinal materials provided by this invention, it not only synergistically enhances the effects from multiple angles such as dispelling wind, cooling blood, detoxifying, promoting diuresis, and removing blood stasis, but also achieves excellent results in terms of taste, flavor, stability, and industrialization of oral solutions.

[0012] This invention is achieved through the following means: This invention provides an oral solution of health food that is both food and medicine, an oral solution of traditional Chinese medicine that is both food and medicine for improving skin inflammation, and a method for preparing them.

[0013] In a first aspect, the present invention provides a method for preparing an oral solution that is both a medicine and food, comprising the following steps: S1. Peach kernel, coix seed, red adzuki bean, poria cocos, jujube, and hawthorn are classified as Class A medicinal materials, while dried plum, perilla leaf, mulberry leaf, mulberry fruit, dried tangerine peel, ginger, and licorice are classified as Class B medicinal materials. S2. Use a pulverizer with a 5mm mesh size to pulverize Class A medicinal materials to obtain coarse particles. Place the coarse particles in a stir-frying machine, stir-fry and gelatinize them at high temperature, and then immediately blow them with cold air. Then add purified water to the stir-fried material to homogenize it. S3. Dry the Class B medicinal materials in a low-temperature vacuum for 4-6 hours, coarsely pulverize them using a pulverizer and pass them through a 24-mesh sieve, and then use an air jet pulverizer for ultra-fine pulverization under low temperature and nitrogen protection. After pulverization, pass them through an 80-mesh sieve. S4. Add the slurry from S2 and the powder from S3 to purified water, and extract at 60-80℃ for 1-2 hours. Filter through a 100-mesh sieve, and homogenize the filtrate under high pressure to obtain the oral solution.

[0014] Furthermore, the high-temperature frying and gelatinization of the Class A medicinal materials involves frying at 150-180℃ for 10-20 minutes. After frying, the materials are immediately cooled to room temperature by blowing with cold air at 5-15℃. The fried material is then mixed with purified water at 1-2 times its weight in a colloid mill to form a homogenized slurry. The colloid mill operates at a speed of 5000-10000 rpm with a gap of 0.5 mm.

[0015] Furthermore, the vacuum drying of the Class B medicinal materials is carried out at 40℃ and a vacuum degree of -0.07 to -0.09 MPa for 4-6 hours; the ultrafine pulverization is carried out at 5-25℃ using an air jet mill, with nitrogen gas introduced for protection during the pulverization process, and the pulverized material is passed through an 80-mesh sieve, with a particle size D90 of 50-150 μm.

[0016] Furthermore, the homogenization pressure of the high-pressure homogenization is 50-80 MPa, and the homogenization is repeated 3 times.

[0017] In the above-mentioned preferred preparation method, the starch components of Class A medicinal materials are gelatinized by high-temperature stir-frying, while the loss of volatile and heat-sensitive components is reduced by low-temperature vacuum drying combined with nitrogen-filled ultrafine pulverization of Class B medicinal materials. The combined extraction of these two types of materials after stepwise processing balances the dissolution efficiency of starch components with the retention of aromatic components, resulting in an oral solution with improved taste, flavor, and batch stability.

[0018] Secondly, the present invention also provides an oral solution prepared using the above-described method for preparing a food-medicine homology oral solution, which, by weight, comprises the following components: 10-20 parts dried plum, 3-9 parts hawthorn, 5-15 parts peach kernel, 15-25 parts coix seed, 5-15 parts poria cocos, 10-20 parts red adzuki bean, 5-11 parts mulberry leaf, 5-11 parts mulberry fruit, 10-20 parts perilla leaf, 2-8 parts ginger, 3-9 parts licorice root, 3-9 parts dried tangerine peel, and 5-15 parts jujube.

[0019] Furthermore, the oral solution prepared using the above-mentioned method for preparing oral solutions containing both medicinal and edible ingredients comprises, by weight, the following components: 13-17 parts dried plum, 5-7 parts hawthorn, 8-12 parts peach kernel, 18-22 parts coix seed, 8-12 parts poria cocos, 13-17 parts red adzuki bean, 6-10 parts mulberry leaf, 6-10 parts mulberry fruit, 13-17 parts perilla leaf, 4-6 parts ginger, 5-7 parts licorice root, 5-7 parts dried tangerine peel, and 8-12 parts jujube.

[0020] As the preferred option, the oral solution prepared using the above-mentioned method for preparing oral solutions derived from both food and medicine comprises, by weight, the following components: 15 parts dried plum, 6 parts hawthorn, 10 parts peach kernel, 20 parts coix seed, 10 parts poria cocos, 15 parts red adzuki bean, 8 parts mulberry leaf, 8 parts mulberry fruit, 15 parts perilla leaf, 5 parts ginger, 6 parts licorice root, 6 parts dried tangerine peel, and 10 parts jujube.

[0021] Thirdly, the present invention also provides the application of the above-mentioned technical solution in a medicine for improving skin inflammation.

[0022] Fourthly, this invention provides health foods that are both food and medicine prepared using the above-described technical solutions, including oral solutions, soluble powders, soluble granules, lumps, and soft products. It also provides traditional Chinese medicines that are both food and medicine prepared using the above-described technical solutions, including powders, granules, tablets, and capsules.

[0023] The technical solution provided by this invention has the following beneficial effects: 1. Significantly improves the taste and flavor of oral solutions. The specific differentiated preparation process adopted by the present invention effectively solves the common problems of heavy bitter and astringent taste and poor mouthfeel of traditional Chinese medicinal materials. After the two types of materials are processed step by step and jointly extracted, the obtained oral solution has uniform color, aromatic odor, mellow mouthfeel, and significantly improved palatability.

[0024] 2. Excellent stability and sedimentation volume ratio Through the control of formulation and process parameters, the stability of the oral solution obtained by the present invention is improved. The high-temperature gelatinization and rapid cooling of starch-containing medicinal materials as well as high-pressure homogenization enable the medicinal solution to form a stable dispersion system, which effectively inhibits the sedimentation and stratification of solids, and is beneficial to transportation and long-term storage. It provides a reliable guarantee for the industrialization of the product.

[0025] 3. Clear efficacy in improving skin inflammation Animal experimental studies show that the medicinal oral solution provided by the present invention has a significant improvement effect on the mouse skin inflammation model. In the formula, smoked plum is the monarch drug, which can astringe the lung and intestines, promote the production of body fluids and quench thirst; peach kernel, coix seed, poria cocos, and adzuki bean are the minister drugs, which can promote blood circulation and remove stasis, invigorate the spleen and drain dampness; perilla leaf, mulberry leaf, mulberry fruit, and hawthorn are the assistant drugs, which can dispel wind and clear heat, cool the blood and detoxify; tangerine peel, ginger, jujube, and licorice are the guide drugs, which can regulate qi and harmonize the middle, and harmonize all the drugs. The whole formula follows the composition idea of "Skin Detoxification Decoction", and achieves synergistic effects from multiple perspectives of dispelling wind, cooling blood, detoxifying, draining dampness, and removing stasis. Verified by mouse skin inflammation tests, it can effectively reduce inflammatory symptoms such as skin redness, swelling and exudation, and improve subcutaneous blood perfusion, providing an experimental basis for the development of traditional Chinese medicine drugs with the function of improving skin inflammation.

[0026] 4. All ingredients are both medicinal and edible, with high safety All raw materials of the present invention are selected from the nationally published catalogue of substances that are both medicinal and edible, including smoked plum, hawthorn, peach kernel, coix seed, poria cocos, adzuki bean, mulberry leaf, mulberry fruit, perilla leaf, ginger, licorice, tangerine peel, jujube, etc. The raw materials have wide sources and high safety, and can be taken as health food for a long time, or used as traditional Chinese medicine under the guidance of physicians to improve skin inflammation, having broad market application prospects. Brief Description of the Drawings

[0027] Figure 1 Flow chart of the preparation process of the oral solution of the present invention Figure 2 Is the particle size distribution diagram of type B medicinal materials after airflow pulverization in Example 1 Figure 3 Is the particle size distribution diagram of type B medicinal materials after airflow pulverization in Example 2 Figure 4 Is the particle size distribution diagram of type B medicinal materials after airflow pulverization in Example 3 Detailed Description of the Embodiments

[0028] The following description illustrates exemplary embodiments of the present invention, including various details to aid understanding, and should be considered merely exemplary. Therefore, those skilled in the art will recognize that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of the invention. Similarly, for clarity and brevity, descriptions of well-known functions, operations, and structures are omitted in the following description.

[0029] Unless otherwise defined, the technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art. While similar or identical methods and materials may be applied in experimental or practical applications, the present invention describes materials and methods hereinafter. In case of conflict, the definitions included herein shall prevail.

[0030] Unless otherwise specified, all experiments in the following experiments were conducted under standard conditions or conditions recommended by the manufacturer. The raw materials or excipients used, as well as the reagents or instruments whose manufacturers are not specified, are all commercially available products. Unless otherwise stated, all percentages, ratios, proportions, or parts are by weight. Unless otherwise specified, the medicinal materials of this invention meet the requirements of the 2025 edition of the Chinese Pharmacopoeia without significantly affecting the overall efficacy of the prescription.

[0031] Example 1: Preparation of oral solution containing both medicinal and edible ingredients prescription:

[0032] Preparation process: S1. Crush Class A medicinal materials into coarse particles using a pulverizer with a 5mm mesh size. Place the coarse particles in a stir-frying machine and stir-fry at 170℃ for 15 minutes until the surface of the medicinal materials turns yellowish-brown and has a burnt aroma. Immediately after stir-frying, cool the material to room temperature by blowing with 10℃ cold air. Mix the stir-fried material with 1.5 times the weight of the medicinal materials (i.e., 1065g) of purified water through a colloid mill to homogenize the mixture. The colloid mill rotates at 8000 rpm and has a gap of 0.5mm.

[0033] S2. Dry the Class B medicinal materials in a low-temperature vacuum at 40℃ and a vacuum degree of -0.07 to -0.09MPa (gauge pressure) for 5 hours. Use a pulverizer to coarsely grind the materials and pass them through a 24-mesh sieve. Then use an air jet mill for ultra-fine grinding. The chamber temperature is controlled at 20℃ and the grinding working pressure is 0.75MPa. Nitrogen gas is introduced for protection during the grinding process. After grinding, pass the materials through an 80-mesh sieve. S3. Add the pulp of Class A medicinal materials and the powder of Class B medicinal materials to purified water, and add purified water in an amount that is 3 times the total weight of medicinal materials (i.e., 4020g). Extract at 70℃ for 1.5 hours, filter through a 100-mesh sieve, and homogenize the filtrate under high pressure at a pressure of 60MPa. Homogenize three times to obtain an oral solution.

[0034] The particle size distribution of the herbal material after air jet milling was determined using a laser particle size analyzer, and the D90 value was 119 μm.

[0035] Example 2 Preparation of oral solution containing both food and medicine prescription:

[0036] Preparation process: S1. Crush Class A medicinal materials into coarse particles using a pulverizer with a 5mm mesh size. Place the coarse particles in a stir-frying machine and stir-fry at 180℃ for 10 minutes until the surface of the medicinal materials turns yellowish-brown and has a burnt aroma. Immediately after stir-frying, cool the material to room temperature by blowing with 8℃ cold air. Mix the stir-fried material with 1.3 times the weight of purified water of the medicinal materials through a colloid mill to homogenize the mixture. The colloid mill rotates at 10,000 rpm and has a gap of 0.5mm.

[0037] S2. Dry the Class B medicinal materials in a low-temperature vacuum at 40℃ and a vacuum of -0.07 to -0.09 MPa for 6 hours. Use a pulverizer to coarsely grind the materials and pass them through a 24-mesh sieve. Then, use an air jet mill for ultra-fine grinding. The chamber temperature is controlled at 15℃ and the grinding working pressure is 0.85 MPa. Nitrogen gas is introduced for protection during the grinding process. After grinding, pass the materials through an 80-mesh sieve. S3. Add the pulp of Class A medicinal materials and the powder of Class B medicinal materials to purified water, and add purified water in an amount of 3.5 times the total weight of medicinal materials. Extract at 80°C for 1 hour, filter through a 100-mesh sieve, and homogenize the filtrate under high pressure at a pressure of 75 MPa. Homogenize three times to obtain an oral solution.

[0038] The particle size distribution of the herbal material after air jet milling was determined using a laser particle size analyzer, and the D90 value was 64 μm.

[0039] Example 3 Preparation of oral solution containing both medicinal and edible ingredients prescription:

[0040] Preparation process: S1. Crush Class A medicinal materials into coarse particles using a pulverizer with a 5mm mesh size. Place the coarse particles in a stir-frying machine and stir-fry at 150℃ for 20 minutes until the surface of the medicinal materials turns yellowish-brown and has a burnt aroma. Immediately after stir-frying, cool the material to room temperature by blowing with 10℃ cold air. Mix the stir-fried material with twice the weight of purified water in a colloid mill to form a homogenized slurry. The colloid mill rotates at 6000 rpm and has a gap of 0.5mm.

[0041] S2. Dry the Class B medicinal materials in a low-temperature vacuum at 40℃ and a vacuum of -0.07 to -0.09 MPa for 4.5 hours. Use a pulverizer to coarsely grind the materials and pass them through a 24-mesh sieve. Then, use an air jet mill for ultra-fine grinding. The chamber temperature is controlled at 25℃ and the grinding working pressure is 0.65 MPa. Nitrogen gas is introduced for protection during the grinding process. After grinding, pass the materials through an 80-mesh sieve. S3. Add the pulp of Class A medicinal materials and the powder of Class B medicinal materials to purified water, and add purified water in an amount of 2.5 times the total weight of medicinal materials. Extract at 65°C for 2 hours, filter through a 100-mesh sieve, and homogenize the filtrate under high pressure at a pressure of 55 MPa. Homogenize three times to obtain an oral solution.

[0042] The particle size distribution of the herbal material after air jet milling was determined using a laser particle size analyzer, and the D90 value was 139 μm.

[0043] Example 4: Preparation of granules of traditional Chinese medicine that is both food and medicine I. Preparation of oral solution The herbal formula and preparation process are the same as in Example 1; or The preparation process is carried out to "S3, add the slurry of Class A medicinal materials and the powder of Class B medicinal materials to purified water, add purified water in an amount that is 3 times the total weight of medicinal materials (i.e., 4020g), keep it at 70℃ for 1.5 hours for extraction, and filter through a 100-mesh sieve" to obtain the filtrate.

[0044] II. Preparation of Traditional Chinese Medicine Granules prescription

[0045] Preparation process: 1. Concentrate and extract the solution from step I to obtain a high-concentration solution or extract; 2. Add mannitol for adsorption, mix sucrose powder evenly, add purified water according to the dryness to prepare soft material, and use a rapid granulator to prepare wet granules; 3. Dry in a forced-air drying oven at 80℃ for 4-6 hours, then granulate; 4. Add fragrance and mix thoroughly to obtain Chinese medicine granules.

[0046] Comparative Example 1: Preparation of a medicinal and edible oral solution by double decoction prescription: Same as in Example 1.

[0047] Preparation process: S1. Grind the Class A medicinal materials into coarse particles using a pulverizer with a 5mm mesh size; grind the Class B medicinal materials into coarse powder using a pulverizer, pass it through a 24-mesh sieve, and set aside.

[0048] S2. Add water equal to 5 times the total weight of the dried herbs to the above-treated herbs and soak for 30 minutes. First bring to a boil over high heat, then simmer over low heat for 40 minutes. Filter the filtrate twice to obtain decoction 1.

[0049] S3. Add the dregs to water that is 5 times the total weight of the dried herbs, bring to a boil over high heat, then simmer over low heat for 30 minutes, filter, and obtain the second decoction filtrate 2.

[0050] S4. Combine the first decoction filtrate and the second decoction filtrate, mix well, and obtain the decoction liquid.

[0051] Comparative Example 2: Oral liquid containing medicinal and edible ingredients prepared without frying, gelatinization, temperature control, or oxidation control. prescription: Same as in Example 1.

[0052] Preparation process: S1. The Class A medicinal materials are crushed into coarse particles using a crusher with a crushing mesh size of 5mm. The crushed material is then mixed with 1.5 times the weight of the medicinal materials (i.e., 1065g) of purified water and homogenized through a colloid mill. The colloid mill rotates at 8000 rpm and has a gap of 0.5mm.

[0053] S2. Dry the Class B medicinal materials in a hot air drying oven at 80°C for 8 hours. Use a pulverizer to make coarse powder and pass it through a 24-mesh sieve. Then use an ultra-micro pulverizer to make fine powder and pass it through an 80-mesh sieve. S3. Add the pulp of Class A medicinal materials and the powder of Class B medicinal materials to purified water, and add purified water in an amount that is 3 times the total weight of medicinal materials (i.e., 4020g). Extract at 70℃ for 1.5 hours, filter through a 100-mesh sieve, and homogenize the filtrate under high pressure at a pressure of 60MPa. Homogenize three times to obtain an oral solution.

[0054] Comparative Example 3: Oral liquid containing both medicinal and edible ingredients, excluding the auxiliary ingredients hawthorn and perilla leaf. prescription:

[0055] The prescriptions in this set of examples, compared to the solutions provided in this invention, do not include the assistant herb hawthorn and the adjuvant herb perilla leaf. The design of this set of experiments confirmed that these two herbs together constitute the important efficacy of the entire prescription in "synergistic action of assistant herbs, dispelling wind, cooling blood, and detoxifying."

[0056] Preparation process: S1. Crush Class A medicinal materials into coarse particles using a pulverizer with a 5mm mesh size. Place the coarse particles in a stir-frying machine and stir-fry at 170℃ for 15 minutes until the surface of the medicinal materials turns yellowish-brown and has a burnt aroma. Immediately after stir-frying, cool the material to room temperature by blowing with 10℃ cold air. Mix the stir-fried material with 1065g of purified water and homogenize the mixture using a colloid mill with a rotation speed of 8000 rpm and a gap of 0.5mm.

[0057] S2. Dry the Class B medicinal materials in a low-temperature vacuum at 40℃ and a vacuum of -0.07 to -0.09 MPa for 5 hours. Use a pulverizer to coarsely grind the materials and pass them through a 24-mesh sieve. Then, use an air jet mill for ultra-fine grinding. The chamber temperature is controlled at 20℃ and the grinding working pressure is 0.75 MPa. Nitrogen gas is introduced for protection during the grinding process. After grinding, pass the materials through an 80-mesh sieve. S3. Add the pulp of Class A medicinal materials and the powder of Class B medicinal materials to purified water, and add 4020g of purified water. Extract at 70℃ for 1.5 hours, filter through a 100-mesh sieve, and homogenize the filtrate under high pressure at a pressure of 60MPa. Homogenize three times to obtain an oral solution.

[0058] Experimental Example 1: Taste and Flavor Evaluation The sensory evaluation method was based on the group standard of China Association of Traditional Chinese Medicine T / CACM 1574-2024 "Technical Specification for Sensory Evaluation of Bitterness of Oral Liquid Preparations of Traditional Chinese Medicine", and the evaluation indicators of alcohol content and aroma were added.

[0059] Test samples: The test samples for each group of experiments were randomly numbered and packaged into brown glass bottles with identical appearance. Each volunteer tasted 10-20 mL each time. The sample temperature was controlled at 25±2℃. After tasting each sample, the volunteer rinsed their mouth with purified water and waited 2 minutes before tasting the next sample.

[0060] Test participants: 20 health evaluators, aged 20-40, half male and half female, with no taste disorders.

[0061] Quantitative testing: A 0-10 point scoring system was used. Bitterness: the degree of bitterness, with 0 points indicating no bitterness and 10 points indicating extreme bitterness; Smoothness of taste: the degree of smoothness of the taste, with 0 points indicating extremely unsmoothness and 10 points indicating extremely smoothness; Aroma acceptability: the pleasantness of the aroma, with 0 points indicating extremely unacceptableness and 10 points indicating extremely acceptableness.

[0062] Data processing: SPSS 26.0 statistical software was used for data analysis. Experimental data are expressed as mean ± standard deviation. The differences in each scoring item between the two groups were compared using a paired t-test, with p < 0.05 indicating a statistically significant difference.

[0063] Test results: See the table below.

[0064]

[0065] Note: * indicates that each case was compared with Example 1 using a paired t-test, and p < 0.05.

[0066] Results Analysis and Conclusions: The bitterness of Example 1 was slightly lower than that of Examples 2 and 3, and significantly lower than that of each comparative example, and each example was lower than that of Comparative Examples 1, 2 and 3; in terms of mellowness, the value of Example 1 was slightly higher than that of Examples 2 and 3, and significantly higher than that of each comparative example, and each example was higher than that of the comparative examples; in terms of aroma acceptability, the value of Example 1 was slightly higher than that of Examples 2 and 3, and significantly higher than that of each comparative example, and each example was higher than that of the comparative examples.

[0067] The medicinal materials formulated in this invention, through a specific differentiated preparation process, exhibit excellent palatability and broad market application prospects in reducing bitterness and off-flavors while enhancing mellowness and aroma acceptability.

[0068] Experimental Example 2: Stability and Settlement Volume Ratio The properties, sedimentation volume ratio, and redispersibility of the samples prepared in the relevant examples and comparative examples were tested in accordance with the Chinese Pharmacopoeia. The samples from Example 1 and Comparative Example 2 were then filled into oral liquid bottles (PP bottles) and placed in an accelerated test (40℃±2℃, 75%±5% RH) for 3 months for observation.

[0069] Characteristics: Observe directly by sight to see if the color is uniform and whether there are obvious color changes.

[0070] Sedimentation volume ratio: Take the sample and shake thoroughly. Measure 50 ml using a graduated cylinder, seal tightly, shake vigorously for 1 minute, and record the initial height of the suspension. After standing for 3 hours, record the final height H of the suspension and calculate it using the following formula: Settlement volume ratio =

[0071] Redispersibility: After completing the sedimentation volume ratio determination, gently shake or rotate the graduated cylinder and visually observe whether the precipitate can be completely dispersed, while timing with a stopwatch.

[0072] Test results: See the table below.

[0073]

[0074] #Note: Because the starch components in the A-type medicinal materials in Comparative Example 1 were filtered out during the extraction process, and the B-type medicinal materials were decocted in water to extract the effective components and then the residue was discarded, the resulting samples were not suspension-type oral solutions, and therefore were not suitable for sedimentation volume ratio and redispersibility determination.

[0075] Result analysis and conclusion: The properties of the samples prepared by each example meet the public consumption preference, the variation range of the sedimentation volume ratio is small, and the redispersibility is good. After 3 months of accelerated test investigation, the sample of Example 1 is stable, and all quality attributes are basically unchanged; after the sample of Comparative Example 2 is placed under accelerated conditions, the quality is significantly reduced. This indicates that the method provided by the present invention, which combines high-temperature stir-frying and gelatinization of Class A medicinal materials, low-temperature airflow pulverization of Class B medicinal materials, and then high-pressure homogenization, significantly improves the stability of the suspension system.

[0076] Test Example 3 Test for Efficacy in Improving Skin Inflammation 1. Laboratory Animals SPF-grade male Balb / c mice, aged 6-8 weeks, weighing 18-22g, were provided by the Laboratory Animal Management Center of Southern Medical University, with the production license number SCXK (Yue) 2021-0041, and were adaptively fed for 1 week.

[0077] 2. Animal Grouping and Treatment (8 animals in each group)

[0078] Modeling method: On days 1, 3, 5, and 7 of the experiment, 200 μL of 1% DNCB (2,4-dinitrochlorobenzene) solution was applied to the shaved back of the mice, and 20 μL of the same solution was applied to the shaved right ear auricle to induce skin inflammation.

[0079] The drugs prepared in Example 1, Comparative Example 2 and Comparative Example 3 are basically the same in terms of crude drug concentration, and are directly administered by gavage in the same volume. The traditional Chinese medicine liquid of Comparative Example 1 is concentrated so that its crude drug concentration is basically the same as that of Example 1. The gavage volume of each group is 0.1 mL / 10g, once a day, starting from the 4th day of modeling, and the administration is continued until the 8th day (a total of 5 days of administration).

[0080] 3. Detection Indicators 3.1 Macroscopic Score of Skin Lesions Scoring criteria for skin lesions:

[0081] Scores are assigned according to different severity levels, and the scores of each item are accumulated to obtain the final score.

[0082] 3.2 Detection of Subcutaneous Blood Perfusion A laser speckle blood flow imager is used to detect the blood perfusion in the skin lesion area on the back of the mice. 12 perfusion images are recorded for each mouse within 60 seconds, and the blood perfusion value of the lesion area is automatically calculated and saved.

[0083] 3.3 Histopathological Observation of Skin Tissue After the experiment, the mice were euthanized, and skin tissue from the backs of each group of mice was collected, fixed in 4% paraformaldehyde, embedded in paraffin, stained with hematoxylin and eosin (HE), and observed and measured under a light microscope.

[0084] 3.4 Statistical Analysis Statistical analysis was performed using SPSS 26.0 software. Data are presented as mean ± standard deviation. The results are presented in the table. One-way ANOVA was used for comparisons among multiple groups, and LSD-t tests were used for pairwise comparisons between groups. A p-value < 0.05 was considered statistically significant.

[0085] 4. Results 4.1 Impact on macroscopic skin lesion scores ( (n=8)

[0086] Note: Compared with the model group, *p<0.05, ***p<0.001.

[0087] 4.2 Effect on subcutaneous blood perfusion ( (n=8)

[0088] Note: Compared with the model group, *p<0.05, ***p<0.01.

[0089] 4.3 Effect on epidermal thickness of skin tissue ( (n=8)

[0090] Note: Compared with the model group, ***p<0.001.

[0091] 5. Conclusion Animal experiments showed that the oral solution of Example 1 of this invention significantly reduced DNCB-induced skin inflammation in mice. Compared with the model group, the group of this invention significantly reduced skin damage scores, inhibited epidermal proliferation, and reduced abnormally elevated subcutaneous blood perfusion. Although Comparative Examples 1, 2, and 3 reduced skin damage scores and epidermal thickness to some extent, their improvement on subcutaneous blood perfusion was slightly weaker, and all indicators were inferior to those of Example 1.

[0092] The above results show that the oral solution of Example 1 of the present invention is significantly superior to the traditional water decoction method (Comparative Example 1) and the preparation process without frying, gelatinization, temperature control, and oxidation control (Comparative Example 2) and the formula lacking hawthorn and perilla leaves (Comparative Example 3) in improving skin inflammation, verifying the synergistic effect of the specific preparation process and the overall formula of the present invention.

Claims

1. A method for preparing an oral solution that is both medicinal and edible, characterized in that, Includes the following steps: S1. Peach kernel, coix seed, red adzuki bean, poria cocos, jujube, and hawthorn are classified as Class A medicinal materials, while dried plum, perilla leaf, mulberry leaf, mulberry fruit, dried tangerine peel, ginger, and licorice are classified as Class B medicinal materials. S2. Use a pulverizer with a 5mm mesh size to pulverize Class A medicinal materials to obtain coarse particles. Place the coarse particles in a stir-frying machine and stir-fry them at a high temperature of 150-180℃ to gelatinize them. Immediately afterward, blow them with cold air. Then, add purified water to the stir-fried material and homogenize it. S3. Dry the Class B medicinal materials under vacuum at a low temperature of 40℃ for 4-6 hours, coarsely pulverize them using a pulverizer and pass them through a 24-mesh sieve, and then use an air jet pulverizer for ultra-fine pulverization at a low temperature of 5-25℃ under nitrogen protection. After pulverization, pass them through an 80-mesh sieve. S4. Add the slurry from S2 and the powder from S3 to purified water, and extract at 60-80℃ for 1-2 hours. Filter through a 100-mesh sieve, and homogenize the filtrate under high pressure to obtain the oral solution. The oral solution is prepared from the following raw material components in parts by weight: 10-20 parts dried plum, 3-9 parts hawthorn, 5-15 parts peach kernel, 15-25 parts coix seed, 5-15 parts poria cocos, 10-20 parts red adzuki bean, 5-11 parts mulberry leaf, 5-11 parts mulberry fruit, 10-20 parts perilla leaf, 2-8 parts ginger, 3-9 parts licorice root, 3-9 parts dried tangerine peel, and 5-15 parts jujube.

2. The method for preparing the oral solution of food and medicine according to claim 1, characterized in that, The high-temperature frying and gelatinization of the Class A medicinal materials involves frying at 150-180℃ for 10-20 minutes. After frying, the materials are immediately cooled to room temperature by blowing with cold air at 5-15℃. The fried materials are then mixed with purified water at 1-2 times their weight in a colloid mill to form a homogenized slurry. The colloid mill operates at a speed of 5000-10000 rpm with a gap of 0.5 mm.

3. The method for preparing the oral solution of food and medicine according to claim 1, characterized in that, The Class B medicinal materials are vacuum dried at 40℃ and a vacuum degree of -0.07 to -0.09 MPa for 4-6 hours; the air jet mill ultrafine pulverization is carried out at 5-25℃, with a pulverization working pressure of 0.6-0.9 MPa, nitrogen gas is introduced for protection during the pulverization process, and the pulverized material is passed through an 80-mesh sieve.

4. The method for preparing the oral solution of food and medicine according to claim 1, characterized in that, The high-pressure homogenization process involves a homogenization pressure of 50-80 MPa and three cycles of homogenization.

5. An oral solution of medicinal and edible origin as described in claim 1, characterized in that, It is prepared from the following raw material components in parts by weight: 13-17 parts dried plum, 5-7 parts hawthorn, 8-12 parts peach kernel, 18-22 parts coix seed, 8-12 parts poria cocos, 13-17 parts red adzuki bean, 6-10 parts mulberry leaf, 6-10 parts mulberry fruit, 13-17 parts perilla leaf, 4-6 parts ginger, 5-7 parts licorice root, 5-7 parts dried tangerine peel, and 8-12 parts jujube.

6. The oral solution of medicinal and edible origin according to claim 5, characterized in that, It is prepared from the following raw material components in parts by weight: 15 parts dried plum, 6 parts hawthorn, 10 parts peach kernel, 20 parts coix seed, 10 parts poria cocos, 15 parts red adzuki bean, 8 parts mulberry leaf, 8 parts mulberry fruit, 15 parts perilla leaf, 5 parts ginger, 6 parts licorice root, 6 parts dried tangerine peel, and 10 parts jujube.

7. The use of the oral solution prepared by the method according to claim 1 or the oral solution according to claim 5 in the preparation of a medicament for improving skin inflammation.

8. A health food product, characterized in that, The oral solution prepared by the method of claim 1 or the one described in claim 5 is then concentrated and dried, and excipients, flavoring agents, fragrances, and acid-base regulators are added to prepare resoluble powders, resoluble granules, or lumps.

9. A traditional Chinese medicine, characterized in that, The traditional Chinese medicine is prepared by the method of claim 1 or the oral solution of food and medicine as described in claim 5; the traditional Chinese medicine is prepared into powder, granules, tablets or capsules.

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