Oral mucosa repair Chinese medicine compound extract, extraction method thereof, oral mucosa repair preparation and preparation method thereof

Abstract

The present invention relates to the technical field of extraction and preparation of traditional Chinese medicines, and in particular to a traditional Chinese medicine compound extract for oral mucosa repair, an extraction method thereof, an oral mucosa repair preparation and a preparation method thereof. The traditional Chinese medicine compound extract consists of the following components by weight: 4.8% scutellaria baicalensis, 4.3% phellodendron amurense, 4.0% notoginseng, 4.5% coptis chinensis, 4.4% indigo naturalis, 4.3% mother-of-pearl, 25.0% lithospermum officinale, 4.3% cnidium monnieri, 35.6% aloe vera, 4.3% magnolia bark, 4.3% dandelion, 0.1% borneol and 0.1% camphor. The present invention adopts natural traditional Chinese medicine ingredients, reduces the side effects of chemical drugs, avoids the adverse reactions that may be caused by long-term use of hormone drugs, is suitable for long-term use, and ensures that the product safety meets the standards required by drug supervision departments by strictly controlling the heavy metal content.

Description

Technical Field

[0001] The present invention relates to the technical field of extraction and preparation of traditional Chinese medicines, and in particular to a traditional Chinese medicine compound extract for oral mucosa repair, an extraction method thereof, an oral mucosa repair preparation and a preparation method thereof, and is particularly suitable for the treatment of oral mucosal erosion, congestion, ulcers and other lesions. Background Art

[0002] The oral mucosa is an important component of the oral cavity, responsible for protection, perception, and secretion. However, due to various reasons (such as infection, trauma, inflammation, etc.), the oral mucosa often develops lesions such as erosion, congestion, and ulcers, which seriously affect patients' quality of life. Existing treatments mostly use glucocorticoids, such as flucloxacillin, which can effectively reduce inflammation and promote repair. However, long-term use may lead to side effects, including oral infection and immunosuppression. Therefore, there is an urgent need to find a safe and effective alternative.

[0003] At present, the main types of topical preparations for oral mucosal repair are as follows:

[0004] 1) Western medicine: Many Western medicines, such as steroids, are used to treat oral mucosal lesions. Although these drugs are effective, their side effects make patients very cautious when using them.

[0005] 2) Chinese Herbal Medicine Preparations: In recent years, an increasing number of Chinese herbal medicines have been used for oral mucosal repair and health care. Common examples include Scutellaria baicalensis, Phragmites australis, and Licorice root, which have anti-inflammatory, antibacterial, and healing properties. Existing Chinese herbal topical preparations often utilize traditional decoctions or extracts, which have limited efficacy and pose limitations in formulation stability and controlled release of active ingredients.

[0006] 3) Gels and gargles: Several TCM gels and gargles are available on the market, but their primary ingredients are often single herbs or simple combinations. Lack of systematic research and scientific formulations makes it difficult to guarantee their efficacy and safety. Furthermore, existing formulations offer suboptimal oral mucosal repair and antibacterial effects, leading to persistent issues with patient satisfaction and dependency.

[0007] Although existing technologies have attempted to treat oral mucosa, the following problems still exist:

[0008] 1) Side effects: Long-term use of glucocorticoids brings obvious side effects, which reduces patients' willingness to use them.

[0009] 2) Insufficient efficacy: Many existing Chinese medicine preparations are not effective and lack sufficient clinical data support.

[0010] 3) Formula complexity: Existing Chinese medicine preparations often fail to rationally mix multiple medicinal materials, resulting in unstable efficacy.

[0011] 4) Single formulation form: The existing products on the market have relatively single formulation forms, which are difficult to meet the needs of different patients.

[0012] Therefore, this technical field still needs to develop a new type of Chinese herbal external preparation that can effectively promote the repair and antibacterial effect of oral mucosa and reduce dependence on hormone drugs. Summary of the Invention

[0013] The purpose of the present invention is to address the deficiencies in the existing technology and provide a Chinese herbal compound extract for oral mucosa repair, an extraction method thereof, an oral mucosa repair preparation and a preparation method thereof. The invention adopts a specific combination of Chinese herbal medicines and an advanced extraction process, which can effectively promote oral mucosa repair while avoiding the side effects of traditional treatment methods.

[0014] To achieve the above object, the present invention adopts the following technical solutions:

[0015] In a first aspect, the present invention provides a Chinese herbal compound extract for repairing oral mucosa. The Chinese herbal compound extract is composed of the following components by weight percentage: 4.8% Scutellaria baicalensis, 4.3% Phellodendron amurense, 4.0% Panax notoginseng, 4.5% Coptis chinensis, 4.4% Indigo naturalis, 4.3% Mother of Pearl, 25.0% Lithospermum officinale, 4.3% Cnidium monnieri, 35.6% Aloe vera, 4.3% Magnolia officinalis, 4.3% Taraxacum mongolicum, 0.1% Borneol, and 0.1% Camphor.

[0016] Preferably, the extract has a pH value of 4.5-5.0 and a density of 0.980-0.990 g / cm³.

[0017] Further preferably, the extract has the efficacy of inhibiting Staphylococcus aureus and Escherichia coli, wherein the inhibition rate against Staphylococcus aureus after 20 minutes of action is not less than 99.0%, and the inhibition rate against Escherichia coli after 20 minutes of action is not less than 99.5%.

[0018] In a second aspect, the present invention provides a method for extracting a compound extract of a traditional Chinese medicine for repairing oral mucosa, comprising the following steps:

[0019] a. Scutellaria, Phellodendron, Panax notoginseng, Coptis chinensis, Cnidium monnieri, Magnolia officinalis, and Taraxacum officinale were crushed to obtain medicinal powder;

[0020] b. The herbal powder and comfrey, mother of pearl are mixed with olive oil in a ratio of 1:4, so that the herbs are completely immersed in the oil;

[0021] c. The mixture obtained in step b was placed in a sealed container and soaked for 15 days, stirring regularly during this period;

[0022] d. on the 1st, 7th and 15th days of the soaking period, heating at 50-60°C for 30 minutes;

[0023] e. After soaking, the mixture is filtered through a filtration device to remove precipitates and undissolved solid particles, and the filtered oil extract is collected as a traditional Chinese medicine stock solution;

[0024] f. Add borneol and camphor to the traditional Chinese medicine stock solution and stir evenly to obtain the oral mucosa repair traditional Chinese medicine compound extract.

[0025] Preferably, the soaking environment temperature in step c is 20-25° C. and the relative humidity is 45-55%.

[0026] Further preferably, the filtration in step e uses a filtration device with a pore size of 0.5-1.0 μm.

[0027] In a third aspect, the present invention provides an oral mucosa repair preparation, which is in the form of a gel or a gargle, and contains the above-mentioned oral mucosa repair Chinese herbal compound extract.

[0028] Preferably, the gel dosage form further comprises a thickener and deionized water, wherein the weight ratio of the oral mucosa repair Chinese herbal compound extract, the thickener and the deionized water is 3:1:6; the gargle dosage form further comprises a moisturizer, a sweetener, a preservative and deionized water, wherein the weight ratio of the oral mucosa repair Chinese herbal compound extract, the moisturizer, the sweetener, the preservative and the deionized water is 2:0.5:0.3:0.2:7.

[0029] In a fourth aspect, the present invention provides a method for preparing an oral mucosal repair preparation, which comprises the following steps when preparing a gel dosage form:

[0030] a. The oral mucosal repair Chinese medicine compound extract and the thickener are mixed in a weight ratio of 3:1;

[0031] b. Add 6 times the weight of the oral mucosal repair Chinese medicine compound extract of deionized water and stir well;

[0032] c. Heat the mixture to 70-80°C and keep stirring to ensure uniformity;

[0033] d. After heating, cooling to room temperature to form a gel-like preparation;

[0034] e. Filter the gel preparation using a 0.22 micron filter, and seal it in a sterile packaging container.

[0035] When preparing the oral rinse dosage form, the following steps are included:

[0036] a. The oral mucosal repair herbal compound extract is mixed with a moisturizer, a sweetener, and a preservative in a weight ratio of 2:0.5:0.3:0.2;

[0037] b was added in a weight ratio of 7 times the oral mucosal repair Chinese medicine compound extract of deionized water, under stirring conditions to fully mix the ingredients to ensure uniformity;

[0038] c. Filter the mixed liquid using a 0.22 micron filter to remove particles and microorganisms to ensure the liquid is clear;

[0039] d. Fill the filtered gargle into sterile packaging bottles and seal them using aseptic technology.

[0040] The present invention has the following beneficial effects:

[0041] 1. High safety: This invention uses natural Chinese herbal ingredients, reducing the side effects of chemical drugs and avoiding the adverse reactions that may be caused by long-term use of hormone drugs, making it suitable for long-term use. By strictly controlling the heavy metal content, it ensures that the product safety meets the standards required by drug regulatory authorities.

[0042] 2. Significant comprehensive therapeutic effects: The formula combines multiple synergistic Chinese herbal remedies to effectively exert multiple effects, including anti-inflammatory, antibacterial, and healing, providing a more comprehensive therapeutic effect. Clinical studies have shown that the overall efficacy rate in the treatment group reached 95.99%, significantly higher than the 72.71% in the control group.

[0043] 3. Scientific and rational formula: This invention utilizes the Traditional Chinese Medicine (TCM) principle of "monarch, minister, assistant, and envoy" to precisely design the ratios of the various medicinal ingredients. Lithospermum erythrorhizon and aloe vera, as the "monarch" ingredients, account for the largest proportions. Lithospermum erythrorhizon promotes blood circulation and blood stasis, promoting wound healing, while aloe vera moisturizes and promotes cell regeneration. Scutellaria baicalensis, Phellodendron amurense, and Coptis chinensis form the "three yellows" combination as "minister" ingredients, enhancing anti-inflammatory and antibacterial effects. Borneol and camphor, though used in minimal amounts, play a crucial role as "envoy" ingredients, enhancing drug penetration.

[0044] 4. Extraction Process Innovation: Using oil immersion extraction instead of traditional water extraction more effectively extracts fat-soluble active ingredients from medicinal materials, such as flavonoids and terpenoids. Olive oil, as a solvent, is inherently pharmacologically active and can form a protective film, enhancing drug stability. Intermittent heating balances extraction efficiency with the stability of heat-sensitive ingredients.

[0045] 5. Optimized Dosage Form Design: This invention offers both gel and gargle formulations to meet the needs of different patients. The gel formulation improves drug adhesion and retention time in the oral mucosa, enhancing therapeutic efficacy; the gargle formulation is convenient for rinsing and is suitable for treating large-area oral mucosal problems.

[0046] 6. Good stability: After 14 days of accelerated testing at 54°C, the effective content decreased by only 2.8%, far below the standard limit of 10%, indicating that the product has good stability and can be stored for up to 1 year.

[0047] 7. Significant antibacterial effect: The antibacterial rate against Staphylococcus aureus and Escherichia coli is >90%, with strong antibacterial activity, effectively preventing secondary oral infection.

[0048] 8. Multi-target synergy: Through the synergistic action of multiple active ingredients, it simultaneously acts on multiple therapeutic targets, including inflammation, infection, and tissue repair, achieving a comprehensive therapeutic effect. The anti-inflammatory mechanism involves inhibiting COX-2 enzyme activity and reducing the expression of inflammatory factors. The antibacterial mechanism directly inhibits the growth of common oral pathogens through multiple active ingredients. Tissue repair promotes the expression of epidermal growth factor and vascular endothelial growth factor, stimulating cell proliferation and angiogenesis. DETAILED DESCRIPTION

[0049] The present invention will be further described in detail below with reference to specific embodiments, but the protection scope of the present invention is not limited thereto.

[0050] The Chinese herbal medicine external preparation of the present invention is composed of the following ingredients:

[0051] 1. Scutellaria baicalensis – 4.8%

[0052] Function: It has the effects of clearing away heat and dampness, anti-inflammatory and antibacterial, and can effectively relieve inflammation of the oral mucosa and promote healing.

[0053] 2. Phellodendron amurense – 4.3%

[0054] Function: Clears away heat and dampness, has antibacterial and anti-inflammatory properties, enhances the antibacterial effect of the overall formula, and helps relieve oral discomfort.

[0055] 3. Panax notoginseng - 4%

[0056] Function: Promotes blood circulation, has hemostatic and healing effects, and can accelerate the repair process of oral mucosa.

[0057] 4. Coptis chinensis – 4.5%

[0058] Function: Clears away heat and detoxifies, has significant antibacterial effect, and is suitable for auxiliary treatment of various oral infections.

[0059] 5. Indigo naturalis – 4.4%

[0060] Function: Clears away heat and detoxifies, has anti-inflammatory effects, and helps relieve inflammation of the oral mucosa.

[0061] 6. Mother of pearl (Pinctada margaritifera) – 4.3%

[0062] Function: Nourishes and repairs, has calming and anti-inflammatory effects, helps relieve oral discomfort.

[0063] 7. Lithospermum erythrorhizon – 25%

[0064] Function: Promotes blood circulation and removes blood stasis, promotes wound healing, and also has a certain antibacterial effect.

[0065] 8. Cnidium monnieri – 4.3%

[0066] Function: Anti-inflammatory and analgesic, can relieve discomfort of oral mucosa.

[0067] 9. Aloe vera – 35.6%

[0068] Function: Lubricates, moisturizes, promotes cell regeneration, and accelerates the healing of oral mucosa.

[0069] 10. Magnolia officinalis – 4.3%

[0070] Function: Regulates qi and reduces swelling, has antibacterial effects, and helps improve the oral environment.

[0071] 11. Dandelion (Taraxacum officinale) – 4.3%

[0072] Function: Clears away heat and detoxifies, reduces inflammation, promotes body detoxification, and helps improve oral health.

[0073] 12. Borneol – 0.1%

[0074] Function: It has a cooling sensation, can relieve pain, and enhance the penetration of other ingredients.

[0075] 13. Camphor – 0.1%

[0076] Function: It has antibacterial and anti-inflammatory effects, can provide soothing feeling and improve oral discomfort.

[0077] The formula features are as follows:

[0078] 1. Synergistic effect: The above ingredients form a good synergistic effect through their respective pharmacological effects, and comprehensively exert multiple effects such as anti-inflammatory, antibacterial, and promoting healing.

[0079] 2. Natural ingredients: All ingredients are natural Chinese herbal medicines, which are highly safe and suitable for long-term use, reducing the side effects of chemical drugs.

[0080] 3. Highly targeted: The formula targets oral mucosal damage, inflammation, infection and other problems, and has good clinical application prospects.

[0081] Example 1: Basic formula of Chinese herbal compound extract for oral mucosa repair

[0082] This embodiment provides a Chinese herbal compound extract for oral mucosa repair, which is composed of the following components by weight: 4.8% Scutellaria baicalensis, 4.3% Phellodendron amurense, 4.0% Panax notoginseng, 4.5% Coptis chinensis, 4.4% Indigo naturalis, 4.3% Mother of Pearl, 25.0% Lithospermum officinale, 4.3% Cnidium monnieri, 35.6% Aloe vera, 4.3% Magnolia officinalis, 4.3% Taraxacum mongolicum, 0.1% Borneolum Syntheticum, and 0.1% Camphor.

[0083] The preparation method of the oral mucosa repairing Chinese medicine compound extract comprises the following steps:

[0084] First, scutellaria baicalensis, phellodendron chinense, panax notoginseng, coptis chinensis, cnidium monnieri, magnolia officinalis, and dandelion are ground into a powder that can pass through a 100-mesh sieve to obtain a medicinal material powder. In this step, the degree of grinding of the medicinal material significantly affects the subsequent extraction efficiency. The finer the grinding, the higher the extraction efficiency, but it should not be too fine to avoid filtering difficulties.

[0085] Next, the powdered herbs, along with comfrey and mother-of-pearl, are mixed in a 1:4 ratio with olive oil (selected from extra-virgin olive oil imported from Spain), completely immersing the herbs in the oil. Olive oil, as an extraction solvent, not only effectively dissolves the fat-soluble active ingredients in the herbs, but its inherent abundance of unsaturated fatty acids, such as oleic acid and linoleic acid, also contributes to the extract's biocompatibility and mucosal affinity.

[0086] The mixture was then placed in a sealed glass container and soaked for 15 days at 22°C and 50% relative humidity, stirring twice daily for three minutes to ensure adequate contact. During the soaking process, the active ingredients in the medicinal materials were gradually released into the oil phase, forming a stable oil solution.

[0087] On the first, seventh, and fifteenth days of the soaking period, heat the extract in a 55°C water bath for 30 minutes while stirring. This intermittent heating method improves extraction efficiency while preventing the degradation of heat-sensitive components caused by prolonged high temperatures, creating a balanced treatment approach that balances efficiency and quality.

[0088] After the soaking process, the mixture was filtered through a ceramic filter with a pore size of 0.75 μm to remove precipitates and undissolved solid particles. The filtered oil extract was collected as the traditional Chinese medicine stock solution. This filter, model HF-075, was manufactured by Jiangsu Haihua Ceramic Technology Co., Ltd. and features high-efficiency filtration and a lack of drug adsorption.

[0089] Finally, ground borneol and camphor were added to the traditional Chinese medicine stock solution and stirred evenly at 40°C for 30 minutes to obtain the final oral mucosal repair herbal compound extract. Borneol and camphor act as penetration enhancers, significantly improving the transmucosal absorption efficiency of other active ingredients. Although used in minimal amounts, their effects are crucial.

[0090] The Chinese herbal compound extract for oral mucosa repair prepared in this example is in a brownish-red translucent liquid state, has a pH value of 4.8, a density of 0.985 g / cm³, has a unique Chinese herbal aroma, and has a uniform texture without precipitation.

[0091] Example 2

[0092] This embodiment provides a Chinese herbal compound extract for oral mucosa repair with a pH value adjusted to an endpoint value. The component ratio is the same as that in Example 1, but the pH value of the final product is adjusted to 4.5 (endpoint value) through process adjustment.

[0093] The specific preparation method is essentially the same as that in Example 1, except that, in the final step, while adding borneol and camphor, a small amount of citric acid (food-grade, provided by Shanghai Aladdin Biochemical Technology Co., Ltd., purity ≥99.5%) is added to adjust the pH to a stable final pH of 4.5±0.1. This pH value is closer to the naturally acidic environment of the oral mucosa, which improves the product's biocompatibility during use and also helps inhibit certain pathogenic microorganisms that thrive in alkaline environments.

[0094] Testing has shown that the product's stability and antibacterial efficacy at pH 4.5 are superior to those at neutral or alkaline conditions, with a particularly significant inhibitory effect against common oral Candida species. This is consistent with the enhanced activity of alkaloids in components such as Coptis chinensis and Phellodendron amurense under weakly acidic conditions.

[0095] Example 3

[0096] This embodiment provides a Chinese herbal compound extract for oral mucosa repair with the pH value adjusted to another endpoint value. The component ratio is the same as that of Example 1, but the pH value of the final product is adjusted to 5.0.

[0097] The preparation method is essentially the same as that of Example 1, except for the final pH adjustment step. In this example, the pH of the product is precisely adjusted to 5.0 ± 0.1 by adding an appropriate amount of disodium hydrogen phosphate buffer (provided by Sinopharm Chemical Reagent Co., Ltd., analytical grade).

[0098] Notably, products with a pH of 5.0 exhibit superior mucosal affinity and improved patient comfort, but their antibacterial efficacy is slightly lower than that of products with a pH of 4.5. This difference is primarily due to the varying ionization states and bioactivities of the active ingredients at different pH values. Therefore, in practical applications, products with different pH values ​​can be selected based on the patient's specific condition and treatment needs.

[0099] Example 4

[0100] This embodiment provides a Chinese herbal compound extract for oral mucosa repair with a density adjusted to an endpoint value. The component ratio is the same as that in Example 1, but the density of the final product reaches 0.980 g / cm³ by adjusting the preparation process.

[0101] The preparation method differed primarily from that in Example 1, primarily in the oil extraction stage. Specifically, this example used light olive oil (density approximately 0.910 g / cm³, supplied by Borges, Spain) as the base extraction solvent. The immersion time was extended to 18 days, and the heating frequency was reduced to once on the first and 18th days, with the temperature lowered to 50°C each time.

[0102] This adjustment results in a higher concentration of lightweight, volatile components in the extract, reducing the final product's density to 0.980 g / cm³. The low-density product exhibits improved flowability and dispersibility, making it particularly suitable for the formulation of a mouthwash, providing a lighter, less heavy sensation upon use.

[0103] Example 5

[0104] This embodiment provides a Chinese herbal compound extract for oral mucosa repair with a density adjusted to another endpoint value. The component ratio is the same as that of Example 1, but the density of the final product is 0.990 g / cm³.

[0105] Compared with Example 1, the extraction solvent used in this example is extra cold-pressed olive oil (density of about 0.920 g / cm³, provided by Filippo Berio, Italy), and the number of heating times during the immersion process is increased, with heating at 60°C performed once on the 1st, 5th, 10th, and 15th days, and the heating time each time is extended to 45 minutes.

[0106] This process adjustment allows for the extraction of more heavy components, while also allowing some volatile components to evaporate during the multiple heating steps, increasing the final product density to 0.990 g / cm³. This high-density product exhibits improved stability and adhesion, making it particularly suitable for the preparation of gel dosage forms, where it can form a durable protective layer on the oral mucosal surface.

[0107] Example 6

[0108] This embodiment provides a gel-type oral mucosal repair preparation prepared based on the extract in Example 1.

[0109] The specific preparation method includes the following steps: First, the oral mucosa repair Chinese herbal compound extract prepared in Example 1 is mixed with sodium carboxymethylcellulose (a thickener, pharmaceutical grade, provided by Shanghai MacLean Biochemical Technology Co., Ltd.) at a weight ratio of 3:1. Sodium carboxymethylcellulose not only provides a good thickening effect, but also has good biocompatibility and is non-toxic and non-irritating, making it an ideal material for preparing oral gels.

[0110] Next, add deionized water (resistivity ≥18.2 MΩ·cm, prepared using a Millipore Milli-Q ultrapure water system) at a weight ratio of six times the amount of the oral mucosa repair Chinese herbal compound extract and stir thoroughly. The amount of water added directly affects the gel's hardness and fluidity. After multiple optimization tests, a six-fold weight ratio was determined to provide the best user experience.

[0111] The mixture was then stirred at 300 rpm on a magnetic stirrer (Shanghai Jingxin Laboratory Equipment Co., Ltd., Model JB-2) while being heated to 75°C and maintained at this temperature for 10 minutes to ensure homogeneity. This heating process facilitates the full swelling and dispersion of the thickener, forming a uniform gel network structure.

[0112] After heating, the mixture is cooled to room temperature (25 ± 2°C) to form a gel-like preparation. The cooling process should be carried out slowly to avoid drastic temperature changes that may cause uneven gel structure.

[0113] Finally, the gel formulation was filtered using a 0.22-μm disposable sterile filter (Millipore, model SLGP033RS) and sealed in a sterilized plastic tube. This small-pore filtration effectively removes microorganisms, ensuring the sterility and safety of the product.

[0114] The prepared gel dosage form is light reddish brown, has a uniform texture, a pH value of 4.8, no obvious odor, has good adhesion and appropriate fluidity, is easy to apply to the surface of the oral mucosa and form a protective film.

[0115] Example 7

[0116] This embodiment provides an oral mucosal repair preparation in the form of a gargle formulation prepared based on the extract in Example 1.

[0117] The specific preparation method includes the following steps: first, the oral mucosa repair Chinese medicine compound extract prepared in Example 1 is mixed with glycerin (moisturizer, provided by Shanghai Myrel Chemical Technology Co., Ltd., USP grade), stevia (sweetener, provided by Anhui Jiren Pharmaceutical Co., Ltd., food grade), and sodium benzoate (preservative, provided by Sinopharm Chemical Reagent Co., Ltd., pharmaceutical grade) in a weight ratio of 2:0.5:0.3:0.2.

[0118] Glycerin, as a moisturizer, can prevent further dehydration of the oral mucosa during the use of the mouthwash; stevia, as a natural sweetener, improves the taste of the product and increases patient compliance; sodium benzoate, as a safe preservative, ensures that the product remains stable within its shelf life after opening.

[0119] Next, deionized water was added at a weight ratio of seven times the weight of the oral mucosa repair Chinese herbal compound extract. The mixture was oscillated at 40 kHz for 15 minutes in an ultrasonic oscillator (Shanghai Zhixin Instrument Co., Ltd., Model ZX-100D) to ensure that all components were fully dispersed and evenly mixed. Ultrasonic treatment helps the oil and water phases form a stable microemulsion, improving product uniformity and stability.

[0120] The mixture is then filtered through a 0.22 micron pore size, disposable sterile filter to remove particles and microorganisms, ensuring the clarity of the liquid. This step is crucial for the clarity and sterility of the rinse.

[0121] Finally, the filtered rinse is filled into UV-sterilized PET bottles and sealed using aseptic techniques. The filling equipment and environment must meet pharmaceutical-grade cleanliness requirements to prevent product contamination.

[0122] The prepared gargle dosage form is a light yellow transparent liquid with a pH value of 4.9. It has a light Chinese medicine aroma and a slight sweetness. It feels refreshing and non-irritating when used, and can form a protective film on the surface of the oral mucosa after gargling.

[0123] Example 8

[0124] This example explores the effect of the soaking environment temperature on product quality during the extraction process, particularly when the soaking temperature is adjusted to 20°C (endpoint value).

[0125] The preparation method was essentially the same as in Example 1, except that the soaking environment temperature was precisely controlled at 20 ± 0.5°C (using a constant temperature incubator, Shanghai Yiheng Scientific Instrument Co., Ltd., model LRH-150), and the relative humidity was maintained at 45%. Low-temperature soaking facilitates the retention of certain heat-sensitive active ingredients, such as flavonoids and volatile oils, but also increases the time required for full extraction.

[0126] To compensate for the reduced extraction efficiency caused by low temperatures, this example extended the soaking time to 18 days, with heating at 55°C for 30 minutes on days 1, 6, 12, and 18. This adjustment retains the advantages of low-temperature soaking while improving overall extraction efficiency through intermittent heating.

[0127] The prepared product is dark reddish-brown, slightly more transparent, and has a richer aroma, primarily due to the preservation of more aromatic volatile oils at low temperatures. This product is particularly suitable for patients who are highly sensitive to aroma or prefer aromatic products.

[0128] Example 9

[0129] This example discusses the effect of adjusting the immersion environment temperature to 25°C (another endpoint value) on the product.

[0130] The preparation method was essentially the same as in Example 1, except that the immersion temperature was precisely controlled at 25 ± 0.5°C (using a constant-temperature incubator) and the relative humidity was maintained at 55%. Compared to immersion at 20°C, 25°C is closer to room temperature, making the process more convenient and improving extraction efficiency.

[0131] Under this temperature condition, the soaking time can be shortened to 14 days, and heating at 55°C for 30 minutes each time is performed on the 1st, 7th and 14th days. This operation ensures full extraction and optimizes the production cycle.

[0132] The prepared product is brown-red in color, has a uniform texture, a moderate aroma, and good overall performance. The product soaked at 25°C achieves a good balance between extraction efficiency, production cycle, and product quality, making it a process parameter choice suitable for large-scale production.

[0133] Example 10

[0134] This example discusses the effect of adjusting the filtration pore size to 0.5 μm (end point value) on product quality.

[0135] The preparation method was essentially the same as in Example 1, except that a 0.5 μm pore size ceramic filter (Jiangsu Haihua Ceramic Technology Co., Ltd., model HF-050) was used in the final filtration stage. A smaller pore size can remove more tiny particles and some macromolecular colloids, improving product clarity and stability.

[0136] As the filtration pore size decreases, the filtration speed decreases accordingly. To ensure production efficiency, this embodiment adopts a pressurized filtration method, using nitrogen to apply a pressure of 0.2 MPa to assist filtration. This method not only improves filtration efficiency but also avoids the risk of product contamination caused by pump-type pressurization.

[0137] The prepared product is light brown-red in color, highly transparent, has a uniform and fine texture, and exhibits excellent sedimentation stability, with no precipitation occurring after long-term storage. This highly transparent and stable product is particularly suitable for the preparation of gargle dosage forms requiring high aesthetic requirements.

[0138] Example 11

[0139] This example discusses the effect of adjusting the filtration pore size to 1.0 μm (another endpoint value) on the product.

[0140] The preparation method is essentially the same as that in Example 1, except that a ceramic filter with a pore size of 1.0 μm (Jiangsu Haihua Ceramic Technology Co., Ltd., Model HF-100) is used in the final filtration stage. Compared to a 0.5 μm pore size, a 1.0 μm pore size provides faster filtration and higher production efficiency, but may retain more colloidal substances in the product.

[0141] Due to the high filtration speed, this embodiment can directly adopt gravity filtration without additional pressure. This simplified operation is conducive to reducing production costs and equipment complexity.

[0142] The prepared product is dark brown-red with slightly reduced transparency, but its texture remains uniform. A small amount of precipitation may occur after prolonged storage, but it can be redispersed with gentle shaking. This product retains more high-molecular-weight active substances, such as polysaccharides and protein complexes, and may have better effects on certain specific therapeutic targets.

[0143] Comparative Example 1: Oral mucosa repair Chinese herbal compound extract omitting Lithospermum officinale

[0144] In order to verify the necessity and key role of Lithospermum erythrorhizon in the formula, this comparative example designed a Chinese herbal compound extract for oral mucosa repair in which Lithospermum erythrorhizon was omitted.

[0145] Except for not including lithospermum officinale, the ratios of other components were adjusted proportionally, and the preparation method was basically the same as that of Example 1. The specific composition was: 6.4% Scutellaria baicalensis, 5.7% Phellodendron amurense, 5.3% Panax notoginseng, 6.0% Coptis chinensis, 5.9% Indigo naturalis, 5.7% Mother of Pearl, 5.7% Cnidium monnieri, 47.5% Aloe vera, 5.7% Magnolia officinalis, 5.7% Taraxacum mongolicum, 0.1% Borneolum, and 0.1% Camphor.

[0146] The prepared product is light yellow and highly transparent, but lacks the distinctive red pigment and blood-activating and stasis-removing properties of lithospermum erythrorhizon. Testing has shown that this product is significantly less effective in promoting tissue repair than products containing lithospermum erythrorhizon, particularly in accelerating blood circulation and alleviating bruises. This demonstrates the irreplaceable role of lithospermum erythrorhizon as the "main ingredient" in the formula, with its components, such as shikonin and acetylshikonin, playing a key role in promoting tissue repair.

[0147] Comparative Example 2: Oral mucosa repair Chinese herbal compound extract omitting aloe vera

[0148] In order to verify the necessity of aloe vera in the formula, this comparative example designed a Chinese herbal compound extract for oral mucosa repair in which aloe vera was omitted.

[0149] Except for not containing aloe vera, the ratios of other components were adjusted proportionally, and the preparation method was basically the same as that of Example 1. The specific composition was: 7.5% Scutellaria baicalensis, 6.7% Phellodendron amurense, 6.2% Panax notoginseng, 7.0% Coptis chinensis, 6.8% Indigo naturalis, 6.7% Mother of Pearl, 38.8% Lithospermum officinale, 6.7% Cnidium monnieri, 6.7% Magnolia officinalis, 6.7% Taraxacum mongolicum, 0.1% Borneolum Syntheticum, and 0.1% Camphor.

[0150] The prepared product is deep red with moderate transparency, but lacks the moisturizing and cell regeneration benefits of aloe vera. Testing has shown that this product is significantly less effective than products containing aloe vera in maintaining oral mucosal moisture and accelerating epidermal cell regeneration. This is particularly true when used in dry environments, where the protective effect is insufficient and patient comfort is reduced. This demonstrates the importance of aloe vera as another "primary ingredient" in the formula. Its ingredients, such as aloe polysaccharides and aloe-emodin, play a unique role in maintaining oral mucosal moisture and promoting epithelial repair.

[0151] Comparative Example 3: Oral mucosa repair Chinese herbal compound extract omitting borneol and camphor

[0152] In order to verify the effect of the penetration enhancer in the formula, this comparative example designed a Chinese herbal compound extract for oral mucosa repair in which borneol and camphor were omitted.

[0153] Except for excluding borneol and camphor, the ratio of other components remains unchanged, and the preparation method is basically the same as Example 1. The specific composition is: 4.8% of Scutellaria baicalensis, 4.3% of Phellodendron amurense, 4.0% of Panax notoginseng, 4.5% of Coptis chinensis, 4.4% of Indigo naturalis, 4.3% of Mother of Pearl, 25.0% of Lithospermum officinale, 4.3% of Cnidium monnieri, 35.6% of Aloe vera, 4.3% of Magnolia officinalis, and 4.3% of Taraxacum mongolicum.

[0154] The product's appearance and basic properties are similar to those containing borneol and camphor, but it lacks the cooling effect and penetration-enhancing properties. Transdermal absorption testing revealed that the active ingredient in this product has a significantly lower transmucosal permeability than products containing borneol and camphor. Under the same usage conditions, the drug's efficacy is slower and weaker. This demonstrates that despite the minimal dosage (0.1% each) of borneol and camphor, they play a significant role as "enhancers" in enhancing drug permeability and improving bioavailability.

[0155] Comparative Example 4: Oral mucosa repair Chinese medicine compound extract using traditional water extraction method

[0156] In order to verify the advantages of oil immersion extraction method over traditional water extraction method, this comparative example adopts traditional water extraction method to prepare Chinese medicine compound extract for oral mucosa repair.

[0157] The component ratio was the same as that in Example 1, but the preparation method was changed to the traditional water extraction method: after all the medicinal materials were crushed, 10 times the amount of purified water was added, and reflux extraction was carried out at 95°C for 2 hours. The filtrate was filtered and collected; the medicinal residue was then added with 8 times the amount of purified water for a second extraction for 1.5 hours; the two extracts were combined, concentrated under reduced pressure to twice the weight of the original medicinal materials, and an appropriate amount of preservative was added to obtain a water extract.

[0158] The prepared product is dark brown, has low transparency, exhibits significant precipitation, and exhibits poor stability. Component analysis revealed a high content of water-soluble components (such as polysaccharides, amino acids, and organic acids), but significantly lower levels of fat-soluble components (such as flavonoids, terpenes, and fatty acids) compared to products prepared using the oil extraction method. Clinical application testing has shown that the water extract exhibits inferior adhesion and retention time on the oral mucosa compared to the oil-infused extract, resulting in a corresponding reduction in therapeutic efficacy. This demonstrates the clear advantages of the oil-infused extraction method in extracting fat-soluble active ingredients and improving the mucosal compatibility of the formulation.

[0159] Comparative Example 5: Oral mucosal repair effect of single herbal extracts

[0160] In order to verify the synergistic effect of the compound, single extracts of Lithospermum officinale and Aloe vera were prepared in this comparative example, and their oral mucosal repair effects were evaluated.

[0161] The single-flavor extract of Lithospermum erythrorhizon was prepared by the same oil immersion extraction method as in Example 1, using only Lithospermum erythrorhizon; the single-flavor extract of Aloe vera was also prepared by the same method, using only Aloe vera.

[0162] Testing revealed that a single extract of Lithospermum officinale exhibited some blood-activating and blood-stasis-removing effects, but limited antibacterial efficacy. Aloe vera extract demonstrated good moisturizing and cell regeneration effects, but lacked anti-inflammatory properties. The overall efficacy of both single extracts was significantly lower than that of the compound extract. In particular, in antibacterial experiments, the compound extract exhibited over 20% and 25% higher inhibition rates against Staphylococcus aureus and Escherichia coli, respectively, demonstrating the synergistic antibacterial effect of the multiple components.

[0163] This result fully verifies the scientific nature of the TCM compatibility principle of "monarch, minister, assistant and envoy". The various medicinal materials produce synergistic effects through reasonable compatibility, and the overall therapeutic effect is better than the simple addition of each component.

[0164] Test experiment 1: antibacterial effect test

[0165] To evaluate the antibacterial effects of the products of each embodiment and comparative example, this test used the method specified in Appendix C of the Hygiene Standard for Disposable Sanitary Products GB 15979-2002 to conduct antibacterial tests on Staphylococcus aureus (ATCC6538) and Escherichia coli (8099).

[0166] Test conditions: The test concentration is the original solution, the action time is 2min, 5min, 10min, and 20min respectively, the test temperature is 20℃±1℃, and each sample is tested 3 times.

[0167] The test results are shown in Table 1 and Table 2:

[0168] Table 1. Inhibition rate of each sample against Staphylococcus aureus (%)

[0169] sample 2min 5min 10min 20min Example 1 97.5 98 98.5 99.2 Example 2 98.2 98.6 99 99.6 Example 3 97 97.8 98.2 99 Example 6 (Gel) 96.8 97.5 98.3 99.1 Example 7 (gargle) 97.2 98.1 98.7 99.3 Comparative Example 1 (without Lithospermum officinale) 85.3 87.6 89.2 92.1 Comparative Example 2 (without aloe vera) 88.5 90.2 91.6 94.3 Comparative Example 3 (no borneol camphor) 96.2 97 97.5 98.2 Comparative Example 4 (water extraction) 82.1 84.5 86.3 88.7 Comparative Example 5 (lithospermum officinale single flavor) 75.3 78.1 80.6 83.2 Comparative Example 5 (aloe vera single flavor) 72.6 74.5 77.2 80.5

[0170] Table 2. Inhibition rate of each sample against Escherichia coli (%)

[0171] sample 2min 5min 10min 20min Example 1 98.5 98.8 99.5 99.9 Example 2 99 99.2 99.6 99.9 Example 3 98 98.5 99.2 99.7 Example 6 (gel) 97.8 98.3 99 99.8 Example 7 (gargle) 98.3 98.9 99.4 99.9 Comparative Example 1 (without Lithospermum officinale) 87.5 89.3 91.7 94.2 Comparative Example 2 (without aloe vera) 90.2 92.1 93.8 95.6 Comparative Example 3 (no borneol camphor) 97.2 97.8 98.6 99.1 Comparative Example 4 (water extraction) 85.3 87.7 89.5 91.2 Comparative Example 5 (lithospermum officinale single flavor) 78.2 80.6 82.9 85.1 Comparative Example 5 (aloe vera single flavor) 75.1 77.3 79.8 82.3

[0172] The test results show that all the examples exhibited strong antibacterial effects against Staphylococcus aureus and Escherichia coli, with inhibition rates exceeding 99% after 20 minutes. Among them, the product in Example 2, with a pH of 4.5, showed the best antibacterial effect, which is consistent with the theory that a weakly acidic environment is conducive to the effectiveness of antibacterial ingredients.

[0173] The antibacterial efficacy of the comparative examples was significantly lower than that of the examples, particularly those lacking key ingredients (such as lithospermum erythrorhizon and aloe vera) or using inappropriate extraction methods (such as water extraction). The antibacterial efficacy of the single herbal extracts was the worst, fully demonstrating the synergistic antibacterial advantage of the combined formula.

[0174] Test experiment 2: stability test

[0175] To evaluate the stability of the products of each embodiment, this test adopts the "Standards for Disinfection Technology" Ministry of Health (2002 edition) 2.2.3.2.1 Stability Determination of Disinfection Products (Chemical Determination Method: Accelerated Test Method).

[0176] Test conditions: temperature 54°C, storage time 14 days, test environment temperature 20-21°C, relative humidity 53-55%.

[0177] The test results are shown in Table 3:

[0178] Table 3. Changes in effective content of each sample before and after storage at 54°C for 14 days

[0179] sample Effective content before stabilization (%) Effective content after stabilization (%) Decline rate (%) Example 1 0.36 0.35 2.8 Example 2 0.37 0.36 2.7 Example 3 0.35 0.34 2.9 Example 6 (Gel) 0.34 0.33 2.9 Example 7 (gargle) 0.35 0.34 2.9 Comparative Example 1 (without Lithospermum officinale) 0.33 0.3 9.1 Comparative Example 2 (without aloe vera) 0.34 0.31 8.8 Comparative Example 3 (no borneol camphor) 0.35 0.33 5.7 Comparative Example 4 (water extraction) 0.31 0.26 16.1

[0180] According to test results, all examples demonstrated excellent stability. After 14 days of accelerated testing at 54°C, the effective content decreased by less than 3%, well below the standard limit of 10%. This indicates that the products can be stored at room temperature for over a year.

[0181] In contrast, the stability of the products in the comparative examples was significantly poorer, particularly in Comparative Example 4, prepared by the water extraction method, which exhibited a 16.1% drop in stability, exceeding the standard limit and indicating that its shelf life at room temperature may be less than six months. This fully demonstrates the significant contribution of the oil extraction method and scientific formulation design employed in this invention to product stability.

[0182] Test experiment three: clinical efficacy evaluation

[0183] In order to comprehensively evaluate the clinical efficacy of the product of the present invention, we conducted a controlled clinical study.

[0184] Study subjects: A total of 252 patients with oral lichen planus (OLP) who met the diagnostic criteria and visited the Department of Traditional Chinese Medicine, West China Hospital of Stomatology, Sichuan University between January 2023 and August 2024 were selected, and 130 cases were screened for study.

[0185] Grouping method: Patients were divided into a treatment group (75 cases) and a control group (55 cases). There was no statistical difference in gender, age, disease course and other general information between the two groups (P>0.05), indicating that the two groups were comparable.

[0186] Treatment:

[0187] Treatment group: Use the gel product prepared in Example 6, take an appropriate amount and cover the affected area for half an hour each time, 3 times a day, and gently wash with warm water once a day.

[0188] Control group: commercially available triamcinolone acetonide ointment (National Medicine Standard No. H22024267) was used, and the usage method was the same as that of the treatment group.

[0189] Treatment cycle: 2 weeks as one course of treatment, 6 courses of treatment are required, and the efficacy will be evaluated at the 1st and 3rd month after treatment.

[0190] Efficacy evaluation standards: With reference to the "Guiding Principles for Clinical Research of New Chinese Medicines (Trial)", the following standards are used to evaluate efficacy:

[0191] Recovery: Symptom score reduced by ≥95%

[0192] Markedly effective: symptom score reduced by ≥70%

[0193] Effective: Symptom score reduced by ≥30%

[0194] Ineffective: Symptom score decreased by <30%

[0195] Total effective rate (%) = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases × 100%

[0196] Result analysis:

[0197] Table 4. Comparison of treatment effects between the two groups of patients [cases (%)]

[0198] Group Number of cases get well Significantly effective efficient invalid Total effective rate (%) control group 55 7(12.72) 14(25.45) 19(34.54) 13(23.67) 72.71 Treatment group 75 24(32.00) 31(41.33) 17(22.66) 3(4.00) 95.99*

[0199] Note: *Compared with the control group, P<0.05

[0200] Table 5. Comparison of oral lesion severity between the two groups (x±s, points)

[0201] Group Number of cases Before treatment After treatment Difference control group 55 3.95±0.81 2.65±1.13* 0.61±0.63 Treatment group 75 3.92±0.83 0.52±0.55** 3.36±1.05△△

[0202] Note: Difference = before treatment - after treatment; compared with the group before treatment, *P<0.05, P<0.01; compared with the control group during the same period, △△P<0.01

[0203] Clinical research results showed that the total effective rate in the treatment group (95.99%) was significantly higher than that in the control group (72.71%) (P<0.05). In terms of oral lesion severity scores, the treatment group's score after treatment (0.52±0.55) was significantly lower than that in the control group (2.65±1.13) (P<0.01), and the difference between before and after treatment was also significantly greater than that in the control group (P<0.01).

[0204] These results fully demonstrate that the oral mucosal repair preparation of the present invention has significant advantages in the clinical treatment of oral lichen planus. Not only is the overall efficacy high, but the effect on improving the severity of oral lesions is more pronounced. In particular, in a follow-up visit three months after treatment, the relapse rate in the treatment group was significantly lower than that in the control group, indicating that this product has a more lasting therapeutic effect.

[0205] Test experiment 4: skin irritation test

[0206] In order to evaluate the skin safety of the product of the present invention, multiple complete skin irritation tests were conducted to ensure that the product would not cause irritation to the skin in contact during actual application.

[0207] Test basis: "Technical Specifications for Disinfection" (2002 edition) 2.3.3.3 "Multiple Complete Skin Irritation Test".

[0208] Test Materials:

[0209] Test sample: Oral mucosa repair preparation of Example 1 (Batch No. 240426)

[0210] Test animals: Japanese large-eared white rabbits, standard grade, 3 males, weighing approximately 2.0 kg, provided by Henan Chunying Biotechnology Co., Ltd., certificate number 410998241100008286

[0211] Breeding environment: ordinary environment, use license number: SYXK (Yu) 2023-0011

[0212] Feed: Maintenance feed provided by Henan Huanyu Hekang Biotechnology Co., Ltd., certificate number 41097824000327899

[0213] Test method:

[0214] Ambient temperature: 20℃~24℃, relative humidity: 40%~70%

[0215] Exposure method: percutaneous exposure

[0216] Skin treatment method: trim and remove hair with scissors

[0217] Test Procedure: 24 hours before the test, use pet clippers to remove the hair on both sides of the animal's back spine, covering an area of ​​3 cm x 3 cm. Avoid damaging the epidermis. Apply 0.5 mL of the sample directly to the depilated skin on one side of the animal (the other side serves as a blank control), covering an area of ​​2.5 cm x 2.5 cm. Four hours after application, rinse with water or a suitable non-irritating solvent to remove any residue. Apply once daily for 14 consecutive days. Observe and score the skin irritation reaction 24 hours after each application according to the "Technical Specifications for Disinfection" (2002 edition).

[0218] Test results:

[0219] Table 6. Results of multiple intact skin irritation tests on rabbits

[0220] Application days Number of animals Stimulus response integral mean comparison erythema edema Total score erythema edema Total score 1 3 0 0 0 0 0 0 2 3 0 0 0 0 0 0 3 3 0 0 0 0 0 0 4 3 0 0 0 0 0 0 5 3 0 0 0 0 0 0 6 3 0 0 0 0 0 0 7 3 0 0 0 0 0 0 8 3 0 0 0 0 0 0 9 3 0 0 0 0 0 0 10 3 0 0 0 0 0 0 11 3 0 0 0 0 0 0 12 3 0 0 0 0 0 0 13 3 0 0 0 0 0 0 14 3 0 0 0 0 0 0 Average score per animal per day 0 0

[0221] Results: After 14 consecutive days of application, all test animals showed no skin irritation, erythema, edema, or other adverse reactions. According to the skin irritation intensity grading evaluation standards in the "Technical Specifications for Disinfection" (2002 edition), the oral mucosal repair preparation of this invention is non-irritating and meets the requirements of Q / BJC00015-2024, "Han'er Shen™ Antibacterial Gel."

[0222] This result further demonstrates the safety advantages of the product of the present invention. It is not only non-irritating to the oral mucosa but also exhibits excellent skin safety, which is crucial for a topical preparation for long-term use. In particular, compared with Comparative Example 4 (water extraction), the product prepared using the oil immersion extraction method of the present invention exhibits significant advantages in tissue compatibility, making it more suitable for use in sensitive areas such as the oral cavity.

[0223] The oral mucosal repair Chinese herbal compound extract and its preparation provided by this invention successfully address the challenges of conventional oral mucosal treatment preparations through scientific formulation design and innovative extraction processes. Experimental data and clinical research results fully demonstrate that the product of this invention has significant antibacterial effects, good stability, and excellent clinical efficacy, making it particularly suitable for treating oral mucosal erosions, congestion, ulcers, and other lesions.

[0224] Compared with the prior art, the main innovations of the present invention are:

[0225] 1. Adopting the TCM compatibility principle of "monarch, minister, assistant and envoy", the ratio of each medicinal material is optimized to achieve multi-component synergistic effect

[0226] 2. The innovative oil immersion extraction method replaces the traditional water extraction method, which significantly improves the extraction rate of fat-soluble active ingredients.

[0227] 3. Through the optimization of dosage form design, the drug adhesion and residence time in the oral mucosa are improved

[0228] 4. Multi-target synergistic mechanism, simultaneously targeting multiple therapeutic targets such as inflammation, infection, and tissue repair

[0229] The product of the present invention can not only effectively treat oral mucosal diseases, but also has the advantages of high safety, easy use, and a wide range of applications. It is expected to provide a safer and more effective treatment option for the majority of patients with oral mucosal diseases.

[0230] The foregoing is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Various modifications and variations are possible for those skilled in the art. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention are intended to fall within the scope of protection of the present invention.

Claims

1. A Chinese herbal compound extract for oral mucosa repair, characterized in that: The Chinese herbal compound extract consists of the following components by weight: Scutellaria baicalensis 4.8%, Phellodendron amurense 4.3%, Panax notoginseng 4.0%, Coptis chinensis 4.5%, Indigo naturalis 4.4%, Mother of pearl 4.3%, Lithospermum officinale 25.0%, Cnidium monnieri 4.3%, Aloe vera 35.6%, Magnolia officinalis 4.3%, Taraxacum officinale 4.3%, Borneol 0.1%, Camphor 0.1%; The method for extracting the oral mucosa repairing Chinese medicine compound extract comprises the following steps: a. Scutellaria, Phellodendron, Panax notoginseng, Coptis chinensis, Cnidium monnieri, Magnolia officinalis, and Taraxacum officinale were crushed to obtain medicinal powder; b. The herbal powder and comfrey, mother of pearl are mixed with olive oil in a ratio of 1:4, so that the herbs are completely immersed in the oil; c. The mixture obtained in step b was placed in a sealed container and soaked for 15 days, stirring regularly during this period; d. on the 1st, 7th and 15th days during the soaking period, heating at 50-60 ℃ for 30 minutes; e. After soaking, the mixture is filtered through a filtration device to remove precipitates and undissolved solid particles, and the filtered oil extract is collected as a traditional Chinese medicine stock solution; f. Add borneol and camphor to the traditional Chinese medicine stock solution and stir evenly to obtain the oral mucosa repair traditional Chinese medicine compound extract.

2. The Chinese herbal compound extract for oral mucosa repair according to claim 1, characterized in that: The soaking environment temperature in step c is 20-25° C. and the relative humidity is 45-55%.

3. The Chinese herbal compound extract for oral mucosa repair according to claim 1, characterized in that: The filtration in step e uses a filtration device with a pore size of 0.5-1.0 μm.

4. An oral mucosal repair preparation, characterized in that: The preparation is a gargle, comprising the oral mucosa repair Chinese herbal compound extract according to any one of claims 1 to 3.

5. The method for preparing the oral mucosa repair preparation according to claim 4, characterized in that: When preparing the oral rinse dosage form, the following steps are included: a. The oral mucosal repair herbal compound extract is mixed with a moisturizer, a sweetener, and a preservative in a weight ratio of 2:0.5:0.3:0.2; b was added in a weight ratio of 7 times the oral mucosal repair Chinese medicine compound extract of deionized water, under stirring conditions to fully mix the ingredients to ensure uniformity; c. Filter the mixed liquid using a 0.22 micron filter to remove particles and microorganisms to ensure the liquid is clear; d. Fill the filtered gargle into sterile packaging bottles and seal them using aseptic technology.