Mucosal repair anti-inflammatory formulation containing camellia oil and preparation method thereof

Abstract

The present application relates to a kind of mucosa repair anti-inflammatory preparation containing camellia oil and preparation method thereof, belong to medical and functional preparation technical field.The preparation is based on unified base composition construction, core component includes camellia oil, glycerol, bisabolol, glycyrrhizic acid salt etc., with certain fusion stability and mucosa tissue adaptability.A small amount of auxiliary materials can be added or replaced, respectively form oral liquid, external use spray, gel, nasal spray or anal suppository etc.Multiple dosage forms are suitable for different parts of mucosa use demand.Preparation process is set up stage mixing, solubilization optimization, fusion processing and clarification filtration etc.Technical steps, which helps to improve oil-water phase fusion efficiency and ingredient distribution uniformity.The present application proposes a kind of systematic solution with general base composition and adaptive process conditions for the problems such as formula not uniform, poor dosage form adaptability and process fusion difficulty etc.of plant oil preparation in multiple types of mucosa application.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical preparation technology, specifically to a mucosal repair and anti-inflammatory preparation containing camellia oil and its preparation method. Background Technology

[0002] With the fast pace of modern life, people are often under high pressure, experiencing irregular sleep patterns, unbalanced diets, and environmental pollution. As a result, mucous membrane systems in many parts of the body, particularly the oral cavity, gastrointestinal tract, respiratory tract, and reproductive tract, are increasingly prone to chronic irritation and mild inflammation, with a rising incidence of symptoms such as dryness, congestion, and erosion. Against this backdrop, functional preparations based on natural ingredients have attracted widespread attention, especially plant oils such as camellia oil, which possess certain mucosal affinity and nutritional properties, making them an important research direction. However, when used on mucous membranes in various locations, the compositional structure cannot be standardized, resulting in low adaptability to diverse environmental needs.

[0003] Currently, plant oil preparations generally adopt an individualized, targeted development model, that is, designing specific formulations for a particular type of mucosal disease. This results in a lack of versatility and difficulty in converting between dosage forms. Especially in the development of formulations, if one hopes to flexibly expand into different forms such as oral liquids, topical sprays, gels, nasal sprays, or rectal suppositories by adding a small amount of excipients, the stability of the ingredients and the adaptability to application often cannot be satisfied simultaneously, resulting in insufficient dosage form compatibility.

[0004] Furthermore, vegetable oils are difficult to blend in aqueous environments, and their processing often results in layering, turbidity, and oil droplet precipitation, severely affecting product clarity and the uniform release of active substances. It is also difficult to guarantee the efficiency of oil-water phase blending and to ensure standardization and batch-to-batch consistency in terms of the finished product's visual appeal and functionality.

[0005] In view of the above problems, a mucosal repair and anti-inflammatory preparation containing camellia oil and its preparation method are proposed. Summary of the Invention

[0006] The purpose of this invention is to provide a mucosal repair and anti-inflammatory preparation containing camellia oil and its preparation method, so as to solve the problems mentioned in the background art.

[0007] To achieve the above objectives, the present invention provides the following technical solution: a mucosal repair and anti-inflammatory preparation containing camellia oil, characterized in that, by weight, it comprises the following components: 30-60 parts camellia oil, 5-15 parts glycerin, 0.1-2 parts bisabolol, 0.5-3 parts glycyrrhizic acid monoammonium salt, and 15-50 parts of a base carrier for dissolving the above components;

[0008] The composition is suitable for local care and adjunctive treatment of human mucous membranes, including areas of the human body with mucous membranes, such as the digestive, respiratory and reproductive systems, for repair, anti-inflammatory and antibacterial applications.

[0009] Specifically, the formulation is based on the composition to form an oral liquid formulation, wherein the oral liquid formulation comprises, by weight, 1 to 5 parts of lecithin, 0.5 to 2 parts of sweetener, and the remainder is filled into the composition in proportion;

[0010] The oral liquid preparation is used as an adjunct therapy for the repair, anti-inflammatory, and antibacterial effects of the digestive system mucosa.

[0011] Specifically, the formulation is based on the composition to form a topical liquid formulation, wherein the topical liquid formulation comprises, by weight, 0.5 to 5 parts of gel matrix, 0.1 to 1 part of pH adjuster, and the remainder is filled into the composition in proportion;

[0012] The topical liquid preparation is used as an adjunct treatment for the repair, anti-inflammatory, and antibacterial effects of the mucous membranes of the respiratory and reproductive systems.

[0013] A method for preparing a mucosal repair and anti-inflammatory preparation containing camellia oil includes the following steps:

[0014] S1: Mix camellia oil, bisabolol, glycyrrhizic acid monoammonium salt and glycerin according to the weight parts, and stir for 10 to 30 minutes at a temperature not exceeding 40°C to form a homogeneous oil phase;

[0015] S2: Under continuous stirring, slowly add the base carrier, which includes pure water or vegetable oil, to form an oil-water dispersion system.

[0016] S3: Filter the obtained dispersion system through a 100-200 mesh filter to remove particulate impurities and obtain the original solution of the camellia oil composition.

[0017] A method for preparing an oral preparation containing camellia oil for mucosal repair and anti-inflammatory purposes includes the following steps:

[0018] S1: Add 1-5 parts of lecithin to the original solution of the camellia oil composition, stir or sonicate at 25-35°C for 10-30 minutes to form a water-in-oil (O / W) emulsion;

[0019] S2: Add 0.5 to 2 parts of sweetener to the emulsion, wherein the sweetener is selected from stevia, erythritol or sorbitol, to improve the taste;

[0020] S3: Mix thoroughly to obtain the oral liquid preparation.

[0021] A method for preparing an oral preparation containing camellia oil for mucosal repair and anti-inflammatory purposes includes the following steps:

[0022] S1: Add 0.1 to 1 part of pH adjuster to the emulsion to adjust the pH of the resulting liquid to the range of 5.0 to 6.5. The pH adjuster is sodium citrate or sodium lactate.

[0023] S2: The emulsion is homogenized or subjected to high-shear emulsification to make the average particle size D90 of the resulting emulsion less than 200 nm;

[0024] S3: After being sealed in a light-proof container, the stable oral liquid formulation is obtained.

[0025] A method for preparing a topical mucosal repair and anti-inflammatory preparation containing camellia oil includes the following steps:

[0026] S1: Add 0.5 to 5 parts of a gel matrix to the original camellia oil composition. The gel matrix is ​​selected from carbomer, xanthan gum, or sodium hyaluronate, and swells and disperses it under stirring conditions.

[0027] S2: Add 0.1 to 1 part of pH adjuster and stir to adjust the pH to the range of 5.0 to 6.5;

[0028] S3: The topical liquid formulation is prepared by thorough mixing and is suitable for application by coating, spraying or rinsing.

[0029] A method for preparing a topical mucosal repair and anti-inflammatory preparation containing camellia oil includes the following steps:

[0030] S1: Add 1 to 5 parts of a humectant to the liquid phase preparation, wherein the humectant is selected from glycerin, propylene glycol or sodium hyaluronate;

[0031] S2: Add 0.05-0.5 parts of antioxidant and stir evenly. The antioxidant is selected from tocopherol or sodium ascorbate.

[0032] S3: The resulting liquid-phase formulation is sealed in a light-proof container to form a stable external liquid-phase formulation.

[0033] Specifically, the composition further comprises 0.05 to 0.5 parts of tocopherol.

[0034] Specifically, the composition further includes panthenol or ceramide in an amount of 0.1 to 3 parts.

[0035] Compared with the prior art, the beneficial effects of the present invention are:

[0036] 1. The formulation provided by this invention has a unified basic formula, and the core components have good compatibility and adaptability. It can be developed into a variety of dosage forms for oral or topical use according to the needs of different mucosal sites, which solves the problem that the components of plant oil are not easy to unify and have poor adaptability when used on multiple types of mucosa.

[0037] 2. Based on the stable compatibility of the basic composition, it has good dosage form compatibility. It can be flexibly transformed into different forms of use such as oral liquid, external spray, gel or suppository by adding or replacing a small amount of excipients. This solves the problems of traditional plant oil preparations being difficult to adapt to multiple mucosal sites and having limited dosage form and application.

[0038] 3. In terms of the preparation process, by setting up steps such as staged fusion, solubilization optimization and clarification treatment, the problems of difficult oil-water phase fusion and turbidity of the finished product have been solved. Detailed Implementation

[0039] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0040] This invention provides a technical solution: a mucosal repair and anti-inflammatory preparation containing camellia oil, characterized in that, by weight, it comprises the following components: 30-60 parts camellia oil, 5-15 parts glycerin, 0.1-2 parts bisabolol, 0.5-3 parts glycyrrhizic acid monoammonium salt, and 15-50 parts of a base carrier for dissolving the above components;

[0041] The composition is suitable for local care and adjunctive treatment of human mucous membranes, including areas of the human body with mucous membranes, such as the digestive, respiratory and reproductive systems, for repair, anti-inflammatory and antibacterial applications.

[0042] The camellia oil raw material used in this invention is preferably derived from mature and plump camellia seeds, and its extraction and refining process includes the following steps:

[0043] 1. Raw material screening and pretreatment: Select camellia seeds that have been screened and impurities removed, discard moldy, insect-infested and immature seeds, and air-dry them until the moisture content is ≤8% in order to improve the oil yield and avoid oil deterioration during the high-temperature pressing process.

[0044] 2. Cold rolling and crushing treatment: The dried seeds are physically crushed using a low-speed rolling device to maintain the integrity of the kernel structure. The temperature is controlled to not exceed 45℃ to avoid protein denaturation and fatty acid oxidation caused by high-speed shearing.

[0045] 3. Low-temperature physical pressing for oil extraction: The first round of low-temperature physical pressing is carried out using a screw press, with the pressing temperature controlled between 50 and 65°C. This process preserves the natural active phenols and unsaturated fatty acid components, yielding virgin crude oil.

[0046] 4. Hot-pressing refining (the innovation is primarily reflected here): After the crude oil is allowed to stand to remove suspended impurities, it undergoes a second "low-temperature hot-pressing refining." This step controls the temperature at 80-90℃ through indirect heat conduction, and involves continuous pressing under low oxygen conditions for 10-15 minutes, combined with slow stirring, to ensure uniform dispersion of high-viscosity components and accelerate the volatilization of free fatty acids. This process helps retain the effective components in camellia oil, such as camellia saponins, polyphenols, and squalene, improving overall clarity and stability.

[0047] 5. Microfiltration purification and refining: A three-stage membrane filtration process (pore sizes of 10μm, 5μm, and 0.45μm respectively) is used to remove impurities and particles. The water content is further reduced to ≤0.05% by natural clarification or vacuum dehydration to obtain high-purity camellia oil concentrate with high clarity and good stability, which is used as a base oil in the composition.

[0048] Specifically, the formulation is based on a composition to form an oral liquid formulation, which, by weight, includes 1 to 5 parts of lecithin, 0.5 to 2 parts of sweetener, and the remainder is filled with the composition in proportion.

[0049] Oral liquid preparations are used as an adjunct therapy for the repair, anti-inflammatory, and antibacterial effects of the digestive system mucosa.

[0050] Specifically, the formulation is based on a composition to form a topical liquid formulation, which, by weight, includes 0.5 to 5 parts of gel matrix, 0.1 to 1 part of pH adjuster, and the remainder is filled with the composition in proportion.

[0051] Topical liquid preparations are used for the repair, anti-inflammatory and antibacterial adjunctive treatment of mucous membranes in the respiratory and reproductive systems.

[0052] A method for preparing a mucosal repair and anti-inflammatory preparation containing camellia oil includes the following steps:

[0053] S1: Mix camellia oil, bisabolol, glycyrrhizic acid monoammonium salt and glycerin according to the weight parts, and stir for 10 to 30 minutes at a temperature not exceeding 40°C to form a homogeneous oil phase;

[0054] S2: Under continuous stirring, slowly add the base carrier, which includes pure water or vegetable oil, to form an oil-water dispersion system.

[0055] S3: Filter the obtained dispersion system through a 100-200 mesh filter to remove particulate impurities and obtain the original solution of camellia oil composition.

[0056] The bisabolol used in this invention is preferably extracted from natural dried chamomile flowers using the following extraction steps:

[0057] 1. Grind dried chamomile flowers into powder to 20 mesh, and add anhydrous ethanol (≥95%) at a solid-liquid ratio of 1:10;

[0058] 2. Heat to 80°C in a reflux apparatus and extract for 2 hours, then let stand and filter. Repeat the extraction twice.

[0059] 3. After concentrating the combined filtrates under reduced pressure to a paste, column chromatography was performed under inert gas conditions, using neutral polar silica gel as the stationary phase and eluting with an ethanol-ethyl acetate gradient.

[0060] 4. Collect the fraction rich in bisabolol, and obtain purified bisabolol by rotary evaporation and drying, which can be used for subsequent formulation.

[0061] A method for preparing an oral preparation containing camellia oil for mucosal repair and anti-inflammatory purposes includes the following steps:

[0062] S1: Add 1-5 parts of lecithin to the original camellia oil composition, stir or sonicate at 25-35℃ for 10-30 minutes to form a water-in-oil (O / W) emulsion;

[0063] S2: Add 0.5 to 2 parts of sweetener to the emulsion. The sweetener is selected from stevia, erythritol or sorbitol to improve the taste.

[0064] S3: Mix thoroughly to obtain an oral liquid preparation.

[0065] A method for preparing an oral preparation containing camellia oil for mucosal repair and anti-inflammatory purposes includes the following steps:

[0066] S1: Add 0.1 to 1 part of pH adjuster to the emulsion to adjust the pH of the resulting liquid to the range of 5.0 to 6.5. The pH adjuster is sodium citrate or sodium lactate.

[0067] S2: Homogenize or emulsify the emulsion to make the average particle size D90 of the resulting emulsion less than 200 nm;

[0068] S3: After being sealed in a light-proof container, a stable oral liquid formulation is obtained.

[0069] A method for preparing a topical mucosal repair and anti-inflammatory preparation containing camellia oil includes the following steps:

[0070] S1: Add 0.5 to 5 parts of gel matrix to the original solution of camellia oil composition. The gel matrix is ​​selected from carbomer, xanthan gum or sodium hyaluronate, and swell and disperse under stirring conditions.

[0071] S2: Add 0.1 to 1 part of pH adjuster and stir to adjust the pH to the range of 5.0 to 6.5;

[0072] S3: After thorough mixing, a topical liquid formulation is prepared, suitable for application by coating, spraying or rinsing.

[0073] A method for preparing a topical mucosal repair and anti-inflammatory preparation containing camellia oil includes the following steps:

[0074] S1: Add 1 to 5 parts of a humectant to the liquid phase preparation. The humectant is selected from glycerin, propylene glycol or sodium hyaluronate.

[0075] S2: Add 0.05 to 0.5 parts of antioxidant and stir well. The antioxidant is selected from tocopherol or sodium ascorbate.

[0076] S3: The resulting liquid-phase formulation is sealed in a light-proof container to form a stable external liquid-phase formulation.

[0077] Specifically, the composition further includes 0.05 to 0.5 parts of tocopherol.

[0078] Specifically, the composition further includes panthenol or ceramide in an amount of 0.1 to 3 parts.

[0079] The following examples are provided to further illustrate the present invention, but are not intended to limit the invention.

[0080] Example 1 Camellia oil-based composition

[0081] This embodiment provides a camellia oil-based composition, the formulation of which is suitable for subsequent preparation into oral liquids, sprays or topical gel products.

[0082] The formula for this camellia oil base composition is as follows: 45 parts camellia oil, 10 parts glycerin, 1.0 part bisabolol, 1.5 parts glycyrrhizic acid monoammonium salt, 3.0 parts lecithin, and 30 parts purified water.

[0083] A method for preparing a camellia oil-based composition includes the following steps:

[0084] Step S1: Camellia oil, bisabolol and glycyrrhizic acid monoammonium salt are added together into a glass reaction flask and stirred at 400 rpm for 15 minutes using a magnetic stirrer at 25-30°C to initially disperse bisabolol and glycyrrhizic acid monoammonium salt in the oil phase.

[0085] Step S2: Add glycerol and lecithin to the oil phase above, and continue stirring at 25-35°C for 15 minutes to form a uniform viscous emulsion.

[0086] Step S3: Add 30 parts of purified water dropwise to the mixture at a rate of at least 2 mL per minute while stirring. Keep the temperature below 35°C and continue stirring for 20 minutes to form a milky white dispersion system.

[0087] Step S4: After the obtained mixture is left to stand in the dark for 30 minutes, it is filtered through a 100-mesh nylon screen to remove coarse particles or foam, and the original solution of camellia oil base composition is obtained.

[0088] The composition is a pale yellow or milky white liquid with a measured pH of 6.0 and a viscosity of approximately 95 mPa·s at 25°C. The formulation is stable, and no obvious oil-water separation or precipitation was observed after standing at room temperature for 24 hours.

[0089] Example 2: Camellia oil-based composition with enhanced antioxidant properties

[0090] This embodiment provides a camellia oil composition with enhanced antioxidant capacity, which adds tocopherol to the basic formulation of Example 1, thereby improving the storage stability of oil components. It is particularly suitable for the development of liquid formulations that require long-term storage and room temperature transportation.

[0091] The formula for this camellia oil composition is as follows: 45 parts camellia oil, 10 parts glycerin, 1.0 part bisabolol, 1.5 parts glycyrrhizic acid monoammonium salt, 3.0 parts lecithin, 0.2 parts tocopherol, and 30 parts purified water.

[0092] The preparation method is the same as in Example 1, except that tocopherol is added together with glycerol and lecithin in step S2, and stirring is continued for 15 minutes after ensuring that the tocopherol is fully dissolved.

[0093] The resulting composition is light milky yellow, with a faint aroma of vegetable oil and vitamin E. Its viscosity remains between 95 and 105 mPa·s, and its pH value is 6.0. After standing for 7 days in the dark, it shows no stratification or precipitation, demonstrating excellent initial storage stability.

[0094] Example 3: Camellia oil base composition with enhanced repair function

[0095] This embodiment provides a camellia oil composition with enhanced mucosal repair capabilities, suitable for rapid repair and care of damaged oral, intestinal, and vaginal mucosa. The composition replaces glycerol with panthenol (vitamin B5) and glycyrrhizic acid monoammonium salt with ceramide to enhance the stimulation of cell barrier and structural protein synthesis.

[0096] The composition is formulated as follows: 45 parts camellia oil, 10 parts panthenol, 1.0 part bisabolol, 0.5 parts ceramide, 3.0 parts lecithin, and 30 parts purified water.

[0097] The preparation steps are as follows:

[0098] Step 1: Add camellia oil, bisabolol, and ceramide to the reaction flask and stir at 25-30°C for 15 minutes to fully disperse the ceramide.

[0099] Step 2: Add panthenol and lecithin, keep the temperature below 30°C, and continue stirring for 15 minutes to form an oil phase system.

[0100] Step 3: Slowly add purified water, stir at 400 rpm with a dropping rate of <2 mL / min, and stir for 25 minutes to form an emulsion suspension.

[0101] Step 4: Let stand for 30 minutes, then filter through a 100-mesh nylon sieve to obtain the repair and enhancement base composition.

[0102] The liquid is milky white in appearance, has a uniform texture, and has a slight oily and B vitamin scent. After use, it leaves the skin feeling soft and moisturized, and no irritation was observed in oral tests.

[0103] Example 4: Camellia oil oral liquid formulation A based on Example 1

[0104] This embodiment uses the basic composition described in Example 1 as the stock solution to prepare an oral liquid formulation of camellia oil suitable for direct swallowing. Lecithin is added as an emulsifying structure stabilizer, and xylitol is added as a sweetener to adjust the taste.

[0105] The formulation for oral liquid preparations is as follows:

[0106] Example 1: 91.5 parts stock solution, 3.0 parts lecithin, 1.0 part xylitol, 0.5 parts sodium citrate, and purified water to make up to 100 parts.

[0107] The preparation method is as follows:

[0108] Step 1: Place the stock solution from Example 1 into a stirred reactor and stir at low speed at 25°C.

[0109] Step 2: Add 3.0 parts of lecithin, increase the speed to 600 rpm, maintain the temperature at 30℃ and stir for 15 minutes to make the oil phase evenly dispersed.

[0110] Step 3: Add xylitol and sodium citrate, and continue stirring for 10 minutes to make the taste smooth and adjust the pH to between 5.8 and 6.2.

[0111] Step 4: Place the tissue into an ultrasonic device at a frequency of 25 kHz and process for 10 minutes to stabilize the emulsion structure.

[0112] Step 5: Filter through a 0.22μm filter membrane, and fill into oral plastic bottles in the dark to obtain oral liquid preparation A.

[0113] This preparation is a light milky yellow liquid with a slight oily aroma and a sweet taste. It has a moderate viscosity and is suitable for daily oral administration of 10-15 mL. It meets the needs of oral, pharyngeal, and gastrointestinal mucosal care.

[0114] Example 5: Camellia oil antioxidant oral liquid formulation B based on Example 2

[0115] In this embodiment, the stock solution of Example 2 (containing tocopherol) was used as the base solution. Erythritol and food-grade vanillin were added as flavoring agents, and further emulsification was carried out to obtain an antioxidant oral emulsion suitable for long-term use.

[0116] The formula is as follows:

[0117] Example 2: 92 parts stock solution, 1.5 parts erythritol, 3.0 parts lecithin, 0.1 parts vanillin, 0.4 parts sodium citrate, and purified water to make up to 100 parts.

[0118] Preparation method:

[0119] Step 1: Under constant temperature and magnetic stirring, slowly add the original solution of Example 2 to the base solution containing erythritol and vanillin, and stir for 10 minutes.

[0120] Step 2: Add lecithin, adjust the speed to 800 rpm, and emulsify for 15 minutes to form a stable emulsion.

[0121] Step 3: Adjust the pH to 5.6-6.0 to maintain system stability.

[0122] Step 4: Place the device into the ultrasound device and perform high-frequency ultrasound for 15 minutes (28kHz) to promote uniform droplet size (D90<200nm).

[0123] Step 5: Filter, fill with nitrogen, seal and store at room temperature.

[0124] This product is a milky white emulsion with a mild taste, a slightly pleasant fragrance, and no greasiness. It is suitable for the elderly and for long-term health maintenance.

[0125] Example 6: Camellia oil-based repair and enhancement oral liquid formulation C based on Example 3

[0126] This embodiment uses the composition rich in panthenol and ceramides from Example 3 as a basis to develop a camellia oil oral liquid with enhanced repair function for scenarios such as fragile gastrointestinal barrier, ulcers, and postoperative recovery.

[0127] The recipe is as follows:

[0128] Example 3: 90 parts stock solution, 4.0 parts lecithin, 2.0 parts sorbitol, 0.5 parts sodium lactate, 0.1 parts vitamin B1, and purified water to make up to 100 parts.

[0129] Preparation steps:

[0130] Step 1: Place the stock solution from Example 3 and lecithin together in a reaction flask and stir at 30°C for 20 minutes to form a preliminary emulsion.

[0131] Step 2: Add sorbitol and vitamin B1 solution, and stir until completely dissolved.

[0132] Step 3: Adjust the pH to 5.4–5.8 using sodium lactate; the system will then be stable.

[0133] Step 4: Perform ultrasonic emulsification for 20 minutes at a frequency of 24kHz to enhance uniformity.

[0134] Step 5: Seal in a light-proof glass bottle and store in the refrigerator.

[0135] The final product is white in color, with a viscosity slightly higher than that of ordinary oral liquids. It is gentle on the throat, has a mild sweetness, and does not leave a noticeable greasy feeling after consumption. It is suitable for postoperative and ulcer patients to take 20mL orally daily as an adjunct therapy.

[0136] Example 7: Camellia oil enteric-coated oral formulation D based on Example 3

[0137] This embodiment uses the repair-enhancing composition rich in panthenol and ceramides described in Example 3, which is formulated into an enteric oral dosage form through soft capsules. This prevents the composition from being released in the stomach, but instead targets and releases the active components of camellia oil in the intestines, thereby enhancing the repair effect on the intestinal mucosal barrier.

[0138] The base solution formula is as follows (parts by weight):

[0139] Example 3: Stock solution 100 (as filler)

[0140] Enteric coating raw materials:

[0141] Hydroxypropyl methylcellulose phthalate (HPMCP) 6

[0142] Talc 2

[0143] Polysorbate-80 0.5

[0144] An appropriate amount of isopropanol / ethanol mixed solvent (coating solution)

[0145] The preparation method is as follows:

[0146] Step 1: Fill the soft capsule shells (each capsule contains about 500 mg of liquid) with the composition obtained in Example 3 and seal them.

[0147] Step 2: Preparation of enteric coating solution: Add hydroxypropyl methylcellulose phthalate, talc, and polysorbate-80 to a mixed solution of isopropanol and water (4:1) and stir magnetically to form a uniform coating solution.

[0148] Step 3: Place the soft capsules in a fluidized bed coating machine, maintain the inlet air temperature at 35-45℃, the liquid spraying rate at 4-6 g / min, and control the coating thickness at 8-10% of the dry weight of the capsules.

[0149] Step 4: After coating, the formulation is dried at 40°C for 2 hours and then subjected to an enteric disintegration test to confirm that there is no lysis in gastric juice after 2 hours and disintegration within 30 minutes in pH 6.8 PBS.

[0150] The prepared enteric-coated camellia oil oral capsules are round and smooth in appearance, milky white or pale yellow in color, and have no obvious odor. The capsules remain intact in simulated gastric juice and soften and release within 30 minutes after being transferred to simulated intestinal juice, making them suitable for camellia oil preparations that are sensitive to the intestinal environment.

[0151] This dosage form is suitable for patients with chronic diseases who have a strong need for intestinal mucosal repair, such as irritable bowel syndrome, ulcerative colitis, or during the recovery phase after intestinal surgery. The recommended daily dose is 1–2 tablets, swallowed whole after meals.

[0152] Example 8: Camellia oil topical gel formulation A based on Example 1

[0153] This embodiment provides a transparent gel formulation suitable for external use on the skin, mouth, or vagina. Using the base composition prepared in Example 1 as the stock solution, a stable topical adhesive gel is prepared by adding a gel matrix and a small amount of moisturizer.

[0154] The formula is as follows (by weight):

[0155] Example 1: Stock solution 90.0

[0156] Carbomer 0.8

[0157] Glycerin 3.0

[0158] Triethanolamine (pH adjuster) 0.2

[0159] Replenish purified water to 100 servings.

[0160] Preparation method:

[0161] Step 1: Sprinkle 0.8 parts of carbomer into purified water, let it stand to pre-moisten, and then stir for 30 minutes to form a transparent and viscous hydrogel matrix.

[0162] Step 2: Slowly pour the stock solution from Example 1 into the carbomer hydrogel while stirring to form a preliminary mixture.

[0163] Step 3: Add 3.0 parts of glycerol and stir well. Adjust the pH to 6.0-6.5 with triethanolamine.

[0164] Step 4: Continue stirring for 20 minutes, degas and let stand, then pack into aluminum tubes or nozzles to obtain gel formulation A.

[0165] This gel is pale yellow and transparent. It is easily absorbed and non-sticky after application, and is suitable for repairing and moisturizing skin and mucous membranes, chapped lips, vaginal dryness, and other areas.

[0166] Example 9: Camellia oil spray formulation B based on Example 2

[0167] This embodiment provides a camellia oil spray suitable for throat spraying, skin wound protection, or nasal surface protection, using Example 2 (containing tocopherol) as the base liquid to further enhance its antioxidant storage stability.

[0168] The recipe is as follows:

[0169] Example 2: Stock solution 85.0

[0170] 5.0g of ethanol

[0171] Glycerin 4.0

[0172] Menthol 0.1

[0173] Replenish purified water to 100 servings.

[0174] Preparation method:

[0175] Step 1: Mix ethanol and menthol at room temperature and stir until completely dissolved.

[0176] Step 2: Add glycerin and the original solution from Example 2, and continue stirring for 10 minutes.

[0177] Step 3: Finally, add purified water, adjust the volume, adjust the pH to 6.0-6.3, filter, and pour into a brown spray bottle.

[0178] This spray is a pale milky white liquid that forms a fine mist upon application, with a refreshing scent and a slight plant oil aroma. It is suitable for use as a nasal spray for throat and nasal moisturizing, for antibacterial protection of the skin, and can also be used for soothing and conditioning the skin after shaving.

[0179] Example 10: Camellia oil soft film dressing solution C based on Example 3

[0180] This embodiment provides a semi-fluid dressing solution for mucosal wound repair, which can be used to prepare coating products, such as gynecological mucosal liquid films and oral spray films.

[0181] The recipe is as follows:

[0182] Example 3: Stock solution 80.0

[0183] Sodium hyaluronate 1.0

[0184] Chitosan 0.5

[0185] Polyvinylpyrrolidone (PVP K30) 2.5

[0186] 5.0g of ethanol

[0187] Sodium lactate 0.3

[0188] Replenish purified water to 100 servings.

[0189] Preparation method:

[0190] Step 1: Add PVP, sodium hyaluronate, and chitosan to purified water and stir at room temperature for 30 minutes to form a film-forming solution matrix.

[0191] Step 2: Add the original solution from Example 3, sodium lactate, and ethanol, and stir thoroughly until homogeneous and free of flocculation.

[0192] Step 3: Adjust the pH to 5.6-6.2, degas under vacuum, filter, and store in a dropper bottle or spray membrane device for later use.

[0193] This liquid can be sprayed evenly onto the skin, vagina, perianal area, mouth, etc., and forms a flexible and transparent film after 5 to 10 minutes. It has good adhesion and mucosal compatibility.

[0194] Example 11 Camellia oil nasal spray formulation D based on Example 2

[0195] This embodiment provides a camellia oil-based nasal spray formulation for the care of nasal dryness, local discomfort and micro-inflammation caused by allergic rhinitis. It uses Example 2 (containing tocopherol) as the base solution to enhance antioxidant and antibacterial properties, and is supplemented with a physiological saline system to improve spray permeability and comfort.

[0196] The formula is as follows (parts by weight):

[0197] Example 2: Stock solution 70.0

[0198] Sodium chloride 0.9

[0199] Glycerin 2.0

[0200] PEG-40 hydrogenated castor oil 1.5

[0201] Add purified water to 100ml

[0202] Preparation steps:

[0203] Sodium chloride is dissolved in purified water to form a 0.9% isotonic saline system.

[0204] Add the stock solution from Example 2, PEG-40 hydrogenated castor oil, and glycerin. Stir for 30 minutes to form an emulsion system. Sonicate for 15 minutes, adjust the pH to 6.0–6.5, and pour into a nasal spray bottle.

[0205] This spray is a milky white fine emulsion with a spray particle size distribution D90 of less than 80μm. It is non-irritating when used in the nasal cavity and leaves a moisturizing and slightly cooling sensation after spraying. It is suitable for use 2 to 3 times a day.

[0206] Example 12 Camellia oil rectal suppository E based on Example 3

[0207] This embodiment provides a repair suppository formulation suitable for hemorrhoids, anal fissures, and other anorectal conditions. It uses the main components of Example 3 (containing ceramide and panthenol) and is prepared in combination with a fusible lipid-based suppository matrix.

[0208] The recipe is as follows (per 100g):

[0209] Example 3: 30g of stock solution

[0210] 60g of cocoa butter

[0211] 5g of glyceryl monostearate

[0212] 2g of lanolin

[0213] 0.5g of silica (suspending agent)

[0214] Other fillers (such as monoglycerides) should be added as needed.

[0215] Preparation steps:

[0216] Step 1: Melt cocoa butter, lanolin, and glyceryl monostearate in a 70°C water bath to form a homogeneous mixture.

[0217] Step 2: Slowly add the stock solution from Example 3, and keep the temperature below 60°C under stirring conditions to form a homogeneous mixture.

[0218] Step 3: Add silica to prevent the active ingredients from settling.

[0219] Step 4: Pour the molten material into a pre-cooled suppository mold, let it cool and solidify, and then demold to obtain the finished product.

[0220] Each suppository contains approximately 0.3g of the ingredients from Example 3. After insertion into the anus, it completely melts at body temperature, releasing the active ingredients into the local rectal area, providing lubrication, anti-inflammation, and promoting wound healing.

[0221] Example 13 Camellia oil vulvar spray F based on Example 1

[0222] This embodiment develops a plant oil-based spray suitable for the care of the female vulva area. It is gentle, antibacterial, and moisturizing, suitable for sensitive skin. It is emulsified using the base liquid from Example 1 and adjusted with a low concentration of sodium lactate to regulate pH.

[0223] The recipe is as follows:

[0224] Example 1: Stock solution 80.0

[0225] Sodium lactate 0.2

[0226] Sorbitol 2.5

[0227] Carbomer 0.3

[0228] 3.0g of ethanol

[0229] Add purified water to 100ml

[0230] Preparation method:

[0231] Disperse carbomer in pure water and stir until fully expanded.

[0232] Add the stock solution from Example 1, sorbitol, and sodium lactate solution, stir well, then add ethanol to adjust the pH to 5.0–5.5.

[0233] Continue stirring for 10 minutes, then filter and pour into an atomizing spray bottle.

[0234] This preparation sprays out a fine mist that is refreshing and non-sticky. The formula is gentle and contains no fragrances or preservatives, making it suitable for situations such as vulvar itching, dryness, discomfort, and post-operative care.

[0235] To further verify the repair, anti-inflammatory, and antibacterial effects of the formulations described in the various embodiments of this invention on different mucosal tissues, corresponding in vitro and in vivo experimental models were constructed based on typical application scenarios to conduct systematic efficacy evaluations in areas such as oral, topical, nasal, rectal, and female reproductive system applications. The following experiments combine animal models, histopathology, biochemical indicators, and user experience evaluations to compare the actual application performance of the products of this invention with similar functional formulations.

[0236] Experiment 1: Evaluation of the repair effect of oral liquid preparation A on gastric mucosal damage in Example 4

[0237] To evaluate the repair and protective capabilities of the oral liquid formulation A described in Example 4 of this invention in the context of acute gastric mucosal injury, an ethanol-induced rat gastric mucosal injury model was established, and two representative commercially available formulations with similar functions were selected for comparison:

[0238] 1. Pure camellia oil oral soft capsules (without synergistic repair ingredients)

[0239] 2. Compound traditional Chinese medicine granules containing glycyrrhizic acid monoammonium salt (traditional anti-gastric mucosal damage drugs)

[0240] The experimental animals were SD rats, weighing 180–220 g, with half males and half females, randomly divided into five groups of 10 rats each. Except for the control group, all other groups were fasted for 18 hours before the experiment, with free access to water only. Acute gastric mucosal injury was induced by a single gavage administration of 1 mL of anhydrous ethanol per 100 g of body weight.

[0241] The processing for each group is as follows:

[0242] • Blank control group: No ethanol was administered by gavage, only purified water was given orally;

[0243] • Model group: After oral administration of ethanol, normal saline was administered daily;

[0244] • Comparative Group 1: Camellia oil oral capsules (approximately 1.5g / kg equivalent oil dose per capsule) were administered orally daily after ethanol gavage;

[0245] • Comparative group 2: Glycyrrhizic acid compound granules were administered daily after oral gavage with ethanol (calculated based on the human equivalent dose);

[0246] • Experimental group (Example 4): After oral administration of ethanol, the liquid preparation described in Example 4 was administered orally daily (dose 1 mL / 100 g body weight).

[0247] Once daily for 7 consecutive days. On the 8th day, the animal was euthanized, and samples were collected from the anterior wall of the stomach for the following tests:

[0248] • Take photos using a digital camera and measure the area of ​​gastric mucosal damage (mm²) using ImageJ software. 2 );

[0249] • Tissue samples were routinely embedded in paraffin, stained with hematoxylin and eosin (HE), and the mucosal thickness (μm) was measured under a microscope.

[0250] • After serum separation, the concentrations (pg / mL) of IL-6 and TNF-α were detected by ELISA.

[0251] The experimental results are shown in the table below:

[0252] Table 1. Comparison of the gastric mucosal injury repair effects between Example 4 and the comparative formulation.

[0253]

[0254] The results showed that, compared with Comparative Example 1 containing only camellia oil, Example 4 group had significant advantages in all evaluation indicators, with a reduction of approximately 56.7% in mucosal damage area and a decrease of over 40% in IL-6 and TNF-α levels; at the same time, its repair effect was also superior to traditional glycyrrhizic acid compound drugs. Therefore, it is evident that the camellia oil in the formulation of this invention, together with synergistic components (such as bisabolol and lecithin), has a significant combined repair effect.

[0255] Experiment 2: Evaluation of the antioxidant capacity of antioxidant oral liquid formulation B (Example 5)

[0256] To verify the free radical scavenging ability and cellular antioxidant effect of the antioxidant camellia oil oral liquid preparation B described in Example 5, an in vitro free radical scavenging experiment (DPPH method) and an in vitro antioxidant model experiment of mouse hepatocytes were designed, and existing external products were used as comparison objects.

[0257] The settings for proportional products are as follows:

[0258] • Comparative Example 1: Commercially available vitamin E (VE) emulsion, commonly used as an oral antioxidant supplement;

[0259] • Comparative Example 2: Commercially available camellia oil soft capsules (without synergistic antioxidant components);

[0260] Experiment 1 used the DPPH free radical scavenging method to evaluate the free radical scavenging rate of the samples. Experiment 2 used the L02 line of mouse hepatocytes to establish a hydrogen peroxide (H2O2)-induced oxidative damage model and detected the cell SOD activity and ROS level.

[0261] Experiment 1: DPPH Free Radical Scavenging Experiment

[0262] The samples were diluted to different concentrations, reacted with DPPH ethanol solution for 30 minutes, and the absorbance was measured at 517 nm. The clearance rate was calculated, and the half-maximal effective concentration (EC50) was used as the comparison index.

[0263] Table 2 Comparison of DPPH free radical scavenging capabilities (EC50, μg / mL)

[0264] Sample Name EC50 value (μg / mL) ↓ Lower values ​​indicate stronger performance Comparative Example 1 (VE Emulsion) 28.7 Comparative Example 2 (Camellia Oil Capsules) 63.4 Example 5 Oral Liquid B 22.1

[0265] Experiment 2: Mouse hepatocyte oxidative stress model

[0266] L02 cells were seeded in 96-well plates, and oxidative damage was induced with 0.25 mM H2O2 after 24 hours. After 6 hours of sample pretreatment, the results were analyzed.

[0267] • Cellular SOD enzyme activity (U / mg prot);

[0268] • Intracellular ROS levels (fluorescence intensity F-value);

[0269] Table 3 Comparison of antioxidant effects of L02 cells

[0270]

[0271] The results showed that the camellia oil in Example 5, combined with synergistic antioxidant components such as tocopherol and lecithin, exhibited superior effects compared to external products in both free radical scavenging and enhancing cellular antioxidant defense. The DPPH scavenging ability was stronger than that of the vitamin E emulsion, and the cell experiments showed the greatest increase in SOD and the most significant inhibition of ROS levels, indicating that this compound formulation has a clear synergistic antioxidant effect.

[0272] Experiment 3: Animal experiment on the repair effect of the repair-enhancing oral liquid formulation C on the small intestinal mucosal barrier (Example 6)

[0273] To verify the repair and enhancement effect of the camellia oil oral liquid preparation C described in Example 6 on the intestinal epithelial mucosal barrier, an in vivo experiment was conducted using a rat model with impaired small intestinal barrier function induced by reserpine, and the results were compared with an external comparative preparation with similar functions.

[0274] The comparison settings are as follows:

[0275] Comparative Example 1: Commercially available Vitamin B5 drink (panthenol-based nutritional repair product)

[0276] • Comparative Example 2: Intestinal Barrier Repair Compound Granules (containing ceramides and prebiotics)

[0277] The experimental animals were SPF-grade SD rats, weighing 180–220g, randomly divided into groups of 10 rats each. Except for the control group, all other groups were subcutaneously injected with reserpine (1mg / kg / d) for 5 consecutive days to induce pathological changes such as increased intestinal mucosal permeability and decreased goblet cells.

[0278] Starting from the 6th day, administer oral medication as directed:

[0279] • Blank group: No modeling, only pure water;

[0280] • Model group: Administered saline solution after modeling;

[0281] • Comparative Group 1: Daily intake of vitamin B5 liquid (calculated based on human equivalent dose);

[0282] • Comparative group 2: Daily administration of intestinal barrier compound granule solution;

[0283] • Experimental group (Example 6): Daily oral administration of the liquid formulation C of Example 6 (1 mL / 100 ml)

[0284] g);

[0285] Animals were administered the medication continuously for 7 days. On the 13th day, they were sacrificed, and the jejunum segment was collected for the following analysis:

[0286] • The FITC-Dextran leakage assay is used to detect intestinal epithelial barrier permeability.

[0287] • Observe villus height, crypt depth, and goblet cell number under HE staining;

[0288] • RT-qPCR was used to detect the expression of ZO-1 (tight junction protein) and MUC2 (mucin) genes.

[0289] Table 4 Comparison of intestinal barrier repair effects in Example 6

[0290]

[0291] The results showed that the repair-enhancing liquid preparation C described in Example 6 could effectively reduce intestinal permeability, restore villous structure and mucus barrier, increase goblet cell density and related gene expression levels, and its repair effect was superior to that of single vitamins or traditional compound products.

[0292] This indicates that the camellia oil in the formula has a significant synergistic effect with panthenol, ceramide, bisabolol, etc., which can effectively improve the intestinal mucosal barrier function and is suitable for use as an adjunct support for irritable bowel syndrome, postoperative recovery, or chronic inflammatory bowel disease.

[0293] Experiment 4: Evaluation of skin irritation and mucosal repair ability of topical gel formulation A in Example 8

[0294] To verify the safety and repair performance of the camellia oil topical gel A described in Example 8 in mucosal and skin applications, two sets of experiments were designed to conduct acute skin irritation tests and epidermal wound repair tests, and to compare it with typical topical comparative products:

[0295] • Comparative Example 1: Commercially available camellia oil moisturizing cream (contains oil, does not contain synergistic repair components)

[0296] • Comparative Example 2: Commercially available panthenol gel (traditional product for minor wound healing)

[0297] New Zealand white rabbits and ICR mice were used as experimental animals, and the environment was kept under strict standards. The experimental procedure is as follows:

[0298] I. Acute Skin Irritation Test (ISO 10993-10 Methods Basic)

[0299] Two control areas for hair removal were created on the backs of New Zealand white rabbits. The preparation was applied to the skin on the left side, while purified water was applied to the right side as a negative control. The preparation was applied twice daily for three consecutive days, and local reactions such as erythema and edema were observed using a standard skin reaction scoring system (0–4).

[0300] Table 5. Skin irritation score of gel in Example 8

[0301] Group Erythema score (0-4) Edema score (0-4) Average Stimulus Index Blank control 0.0 0.0 0.0 Comparative Example 1 (Ointment) 1.3±0.3 1.1±0.2 1.2±0.2 Comparative form 2 (panthenol) 0.6±0.1 0.5±0.1 0.55±0.1 Example 8 Gel 0.3±0.1 0.2±0.1 0.25±0.1

[0302] The results showed that the gel irritation index of Example 8 was much lower than 1.0, which met the ISO 10993-10 "non-irritating" standard and was lower than that of the comparative formulation, indicating that the formulation has excellent safety in skin application.

[0303] II. Mouse Skin Wound Repair Experiment

[0304] A 2mm diameter wound was created by pricking the back of ICR mice to establish a mild open wound model. Different preparations were applied to the wound daily, and after 7 consecutive days of observation, wound tissue was collected for histological sections and parameter measurements.

[0305] • Wound closure rate = (Initial area - Residual area on day 7) / Initial area

[0306] ×100%

[0307] Granulation tissue score, epidermal regeneration score

[0308] • Detection of IL-1β and TNF-α levels (wound homogenate, ELISA)

[0309] Table 6. Wound repair effect of topical gel in Example 8.

[0310]

[0311] The results showed that the gel of Example 8 performed excellently in terms of wound repair speed, inflammation relief and tissue regeneration, outperforming traditional oils and panthenol gels and other repair-type topical preparations. It also had lower irritation and was suitable for application on sensitive skin and various types of mucosal epidermal surfaces.

[0312] Experiment 5: Evaluation of the nasal spray formulation's irritation and clearance ability on the nasal mucosa (Example 9)

[0313] To verify the safety and effectiveness of the camellia oil-based nasal spray described in Example 9 in clearing inflammatory nasal secretions, a rabbit nasal irritation experiment and a rat nasal mucosal clearance experiment were designed, and a typical comparative sample product was set up for comparison:

[0314] • Comparative Example 1: Commercially available isotonic sea salt nasal spray (cleansing product, without active repair ingredients);

[0315] • Comparative Example 2: Commercially available anti-inflammatory nasal sprays containing corticosteroids (such as mometasone furoate);

[0316] New Zealand white rabbits and SD rats were used as animals, and the experimental process followed animal ethics and standard operating procedures.

[0317] I. Local Stimulation Experiment in Rabbit Nasal Cavity

[0318] After fixation, the formulation was sprayed into the left nostril of the rabbits, with the right nostril serving as a control. The spray volume was 0.2 mL per application, twice daily for three consecutive days. Behavioral indicators and histological findings, such as local redness and swelling, frequency of scratching, runny nose, and frequency of sneezing, were observed.

[0319] Table 7 Nasal mucosa irritation score (0-4 points)

[0320]

[0321] The results showed that the formulation in Example 9 had very mild local irritation, which was significantly better than that of hormone nasal sprays, and its safety was comparable to that of isotonic saline.

[0322] II. Experiment on a rat model of nasal inflammatory clearance

[0323] SD rats were injected with LPS (lipopolysaccharide) via the nasal cavity to induce the accumulation of inflammatory secretions. Twenty-four hours later, 0.1 mL was administered via nasal spray daily for five consecutive days. The levels of thick nasal discharge, olfactory dysfunction scores, nasal inflammatory cell infiltration, and MUC5AC secretion were observed.

[0324] • Nasal mucus scoring: Tissue staining to assess residual secretions;

[0325] • MUC5AC protein levels (ELISA) are used to assess the intensity of mucus secretion;

[0326] MPO activity serves as a marker of inflammatory cell exudation.

[0327] Table 8 Results of the experiment on nasal inflammation and secretion clearance

[0328] index Comparative Example 1 Comparative type 2 Example 9 Nasal Spray Mucus Residue Score (0–5) ↓ 3.1±0.6 2.3±0.5 1.5±0.4 MUC5AC (ng / mg) ↓ 84.3±9.2 62.5±8.4 45.2±6.1 MPO activity (U / mg) ↓ 3.8±0.6 2.9±0.5 1.8±0.3

[0329] Experimental results show that the nasal spray formulation of Example 9 is superior to traditional saline and hormonal products in relieving rhinitis symptoms, inhibiting mucus secretion, and clearing inflammatory exudate. It also has lower irritation and is suitable for long-term auxiliary care of the nasal mucosa and non-prescription treatment of mild inflammatory conditions.

[0330] Experiment 6: Animal Experiment Evaluation of the Rectal Local Irritation and Barrier Repair Effects of Anal Suppositories (Example 10)

[0331] To verify the safety and repair effect of the anal suppository formulated based on camellia oil and synergistic repair components in Example 10 on the rectal mucosa, a rat intestinal barrier injury model was designed and compared with commonly used clinical anal suppository products.

[0332] The comparison settings are as follows:

[0333] • Comparative Example 1: Commercially available compound dexamethasone rectal suppositories (hormonal product)

[0334] Comparative Example 2: Commercially available glycerin suppositories (for lubrication and bowel movements, but with weaker auxiliary repair function).

[0335] Experimental animals: SPF grade SD rats, weighing 200–240g, regardless of sex, randomly divided into groups of 10.

[0336] I. Rectal irritation test

[0337] After warming the prepared suppository, slowly insert it into the rectum and use it continuously for 3 days. After treatment, take a segment of the intestine for HE staining to observe the rectal epithelial structure, edema, congestion and exudation, and evaluate it according to the scoring standard (0-5, the higher the score, the stronger the stimulation).

[0338] Table 9. Results of Rectal Irritation Scores

[0339] Group edema seepage Inflammatory cell infiltration Overall rating ↓ Comparative type 1 (hormone suppositories) 1.6 1.7 2.0 5.3±0.7 Comparative type 2 (glycerin suppository) 1.2 1.1 1.4 3.7±0.6 Example 10: Anal Suppository 0.6 0.4 0.7 1.7±0.4

[0340] The results showed that the anal suppository described in Example 10 caused minimal irritation to the rectal tissue, which was far superior to hormone-based anal suppositories and even lower than ordinary glycerin suppositories, making it suitable for long-term, repetitive auxiliary treatment scenarios.

[0341] II. Intestinal Barrier Repair Experiment

[0342] A mild colitis model was induced using low-dose DSS (sodium dextran sulfate) in drinking water, resulting in increased intestinal barrier permeability and submucosal structural disorder. Appropriate suppositories were inserted daily during the experiment.

[0343] The animals were euthanized on day 8, and tests were conducted.

[0344] • DAO (intestinal diamine oxidase) and D-lactic acid (serum marker);

[0345] ●ZO-1 and Occludin expression (RT-qPCR);

[0346] HE sections were used to evaluate villus integrity and gland arrangement.

[0347] Table 10 Comparison of intestinal barrier repair effects

[0348]

[0349] Experimental results show that the anal suppository described in Example 10 not only has extremely low irritation, but also significantly improves the intestinal barrier structure, enhances the expression of tight junction proteins, and effectively controls intestinal leakage and inflammatory exudation. It is suitable for adjunctive treatment of patients with anal fissures, post-hemorrhoid surgery, and mild to moderate proctitis.

[0350] Experiment 7: Example 11 Vulvar Spray Skin pH Restoration and Microecological Protection Experiment

[0351] To verify the safety and functionality of the camellia oil compound vulvar spray described in Example 11 when used in sensitive areas of women, a dual evaluation test was conducted focusing on the vulvar pH regulation ability and the ability to protect local beneficial bacteria.

[0352] The following settings are used for proportional products:

[0353] ●Comparative Example 1: Commercially available mildly acidic feminine wash (such as a wash-type product with a pH of 5.5)

[0354] • Comparative Example 2: Commercially available disinfectant sprays containing ingredients such as chlorhexidine or alcohol (kills germs but is highly irritating).

[0355] Experimental subjects: 18 female SD rats, whose fur was shaved and treated with local spray twice a day for 7 consecutive days; some animals were used for bacterial flora detection and others for pH recovery curve plotting.

[0356] I. Vulvar pH Recovery Capacity Test

[0357] The vulvar area was shaved to expose the skin and pretreated with an alkaline solution (pH 8.5) to simulate an environment disrupted by the sebum film. Test samples were then sprayed on the vulva. Local pH values ​​were collected at 0 min, 30 min, 60 min, 120 min, 6 h, and 24 h and measured using a microelectrode.

[0358] The data are compiled into Table 11: Local pH recovery capacity after spraying (unit: pH)

[0359]

[0360] Example 11: The spray can quickly restore the skin pH to near the normal value of the female vulva (4.0–5.5) in a short time. The restoration efficiency is better than that of conventional care solutions and significantly better than disinfectant spray products.

[0361] II. Vulvar Microecological Community Protection Experiment

[0362] Vulvar swabs were collected from mice before and after spraying. Bacterial cultures were performed on MRS selective medium and blood agar plates. The relative abundance changes of lactobacillus (beneficial bacteria) and Escherichia coli (gold standard contaminant bacteria) were quantified to assess dysbiosis and repair capacity.

[0363] Table 12 Changes in the proportion of beneficial bacteria in the vulva

[0364]

[0365] Note: The spray in Example 11 achieves mild antibacterial effect without destroying beneficial bacteria, maintaining the stability of the local microecology of the vulva, and has the dual value of preventing infection and daily care.

[0366] The experimental results support the long-term safety of Example 11 in the female reproductive area and have a comprehensive effect of regulating pH, protecting the microecology, and assisting in repair. It is suitable for intimate care and intervention for mild inflammatory conditions.

[0367] Although the present invention has been described in conjunction with specific embodiments, those skilled in the art should understand that equivalent adjustments or substitutions to its composition, preparation steps, usage forms, or applicable sites, without departing from the principles and core concepts of the present invention, are all within the scope of protection of the present invention. For example, the camellia oil composition can be formulated into different forms such as liquid, gel, suppository, or atomized spray according to specific mucosal types, and some excipients can also be reasonably replaced to adapt to the physiological characteristics of different tissue sites.

Claims

1. A mucosal repair anti-inflammatory formulation comprising camellia oil, characterized in that, By weight, it includes the following components: 30-60 parts of camellia oil, 5-15 parts of glycerin, 0.1-2 parts of bisabolol, 0.5-3 parts of glycyrrhizic acid monoammonium salt, and 15-50 parts of base carrier for dissolving the above components; The composition is suitable for local care and adjunctive treatment of human mucous membranes, including areas of the human body with mucous membranes, such as the digestive, respiratory and reproductive systems, for repair, anti-inflammatory and antibacterial applications.

2. The oral formulation based on the mucosal repair anti-inflammatory formulation containing camellia oil according to claim 1, characterized in that: The formulation is prepared into an oral liquid formulation based on the composition, wherein the oral liquid formulation comprises, by weight, 1 to 5 parts of lecithin, 0.5 to 2 parts of sweetener, and the remainder is filled into the composition in proportion; The oral liquid preparation is used as an adjunct therapy for the repair, anti-inflammatory, and antibacterial effects of the digestive system mucosa.

3. A mucosal healing anti-inflammatory formulation based on camellia oil according to claim 1, characterized in that: The formulation is based on the composition and is prepared as a topical liquid formulation, wherein the topical liquid formulation comprises, by weight, 0.5 to 5 parts of gel matrix, 0.1 to 1 part of pH adjuster, and the remainder is filled into the composition in proportion; The topical liquid preparation is used as an adjunct treatment for the repair, anti-inflammatory, and antibacterial effects of the mucous membranes of the respiratory and reproductive systems.

4. The preparation method of a mucosal repair and anti-inflammatory preparation containing camellia oil according to claim 2, comprising the following steps: S1: Mix camellia oil, bisabolol, glycyrrhizic acid monoammonium salt and glycerin according to the weight parts, and stir for 10 to 30 minutes at a temperature not exceeding 40°C to form a homogeneous oil phase; S2: Under continuous stirring, slowly add the base carrier, which includes pure water or vegetable oil, to form an oil-water dispersion system. S3: Filter the obtained dispersion system through a 100-200 mesh filter to remove particulate impurities and obtain the original solution of the camellia oil composition.

5. The preparation method of the oral preparation containing camellia oil for mucosal repair and anti-inflammatory purposes according to claim 4, comprising the following steps: S1: Add 1-5 parts of lecithin to the original solution of the camellia oil composition, stir or sonicate at 25-35°C for 10-30 minutes to form a water-in-oil (O / W) emulsion; S2: Add 0.5 to 2 parts of sweetener to the emulsion, wherein the sweetener is selected from stevia, erythritol or sorbitol, to improve the taste; S3: Mix thoroughly to obtain the oral liquid preparation.

6. The preparation method of the oral preparation containing camellia oil for mucosal repair and anti-inflammatory purposes according to claim 5, comprising the following steps: S1: Add 0.1 to 1 part of pH adjuster to the emulsion to adjust the pH of the resulting liquid to the range of 5.0 to 6.

5. The pH adjuster is sodium citrate or sodium lactate. S2: The emulsion is homogenized or subjected to high-shear emulsification to make the average particle size D90 of the resulting emulsion less than 200 nm; S3: After being sealed in a light-proof container, the stable oral liquid formulation is obtained.

7. The preparation method of a mucosal repair and anti-inflammatory topical preparation containing camellia oil according to claim 4, comprising the following steps: S1: Add 0.5 to 5 parts of a gel matrix to the original camellia oil composition. The gel matrix is ​​selected from carbomer, xanthan gum, or sodium hyaluronate, and swells and disperses it under stirring conditions. S2: Add 0.1 to 1 part of pH adjuster and stir to adjust the pH to the range of 5.0 to 6.5; S3: The topical liquid formulation is prepared by thorough mixing and is suitable for application by coating, spraying or rinsing.

8. A method for preparing a mucosal repair and anti-inflammatory topical preparation containing camellia oil according to claim 7, comprising the following steps: S1: Add 1 to 5 parts of a humectant to the liquid phase preparation, wherein the humectant is selected from glycerin, propylene glycol or sodium hyaluronate; S2: Add 0.05-0.5 parts of antioxidant and stir evenly. The antioxidant is selected from tocopherol or sodium ascorbate. S3: The resulting liquid formulation is sealed in a light-proof container to form a stable external liquid formulation.

9. A mucosal healing anti-inflammatory formulation containing camellia oil according to claim 1, and a method of preparing the same, characterized by: The composition further comprises 0.05 to 0.5 parts of tocopherol. A mucosal repair anti-inflammatory formulation containing camellia oil according to claim 1 and a preparation method thereof, characterized by: The composition further includes panthenol or ceramide, in an amount of 0.1 to 3 parts.

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