A traditional Chinese medicine composition for preventing throat and oral cavity diseases and a preparation method thereof

Abstract

This invention discloses a traditional Chinese medicine composition for the prevention and treatment of throat and oral diseases, and its preparation method. The composition comprises poultry egg yolk oil, honey, platycodon root, dandelion, licorice, monk fruit, menthol, and maltose in specific weight proportions. Its preparation includes steps such as frying poultry egg yolk oil, preparing water extracts of platycodon root and dandelion, and mixing with maltose to form a final product. The composition of this invention uses only food-grade medicinal materials, ensuring safety and reliability. When formulated into topical dosage forms such as lozenges, it provides long-lasting effects on the affected area, offering multiple benefits including analgesia, anti-inflammation, mucosal repair, and cough suppression. It effectively solves the problems of significant side effects and limited duration of local application in existing oral medications. This product has a pleasant taste and high patient compliance, making it suitable for the prevention and treatment of throat and oral diseases such as pharyngitis, tonsillitis, oral ulcers, gingivitis, and sore throat.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition technology, specifically to a traditional Chinese medicine composition for preventing throat and oral diseases and its preparation method. Background Technology

[0002] Throat and oral diseases, such as pharyngitis, tonsillitis, oral ulcers, and gingivitis, are common and frequently occurring diseases in clinical practice. Current treatment methods mainly include Western medicine and traditional Chinese medicine.

[0003] Western medicine treatment typically involves using antibiotics (such as amoxicillin and cephalosporins) to combat bacterial infections and antipyretics (such as acetaminophen) or local anesthetics (such as compound benzocaine) to relieve symptoms. While this method is relatively fast-acting, it carries risks of allergies, gastrointestinal irritation, burden on liver and kidney function, and the potential to induce bacterial resistance. Topical mouthwashes or sprays (such as compound chlorhexidine and hydrogen peroxide solution) have a short duration of action, unpleasant taste, and long-term use may disrupt the balance of oral flora.

[0004] Traditional Chinese medicine (TCM) treatments often follow principles such as clearing heat and detoxifying, relieving sore throat and reducing swelling, and nourishing yin and moistening dryness. Commonly used medications include Pu Di Lan Anti-inflammatory Tablets, Pharyngitis Tablets, and Guilin Watermelon Frost. These medications are mostly oral preparations or topical sprays. Oral preparations require absorption through the gastrointestinal tract and the first-pass effect of the liver, resulting in a relatively slow onset of action and potential gastrointestinal discomfort. Topical sprays have a short drug retention time, limited effectiveness against deep mucosal inflammation, and some medications are highly irritating, leading to poor patient compliance.

[0005] While there have been attempts to make Chinese medicine into lozenges or candies in the existing technology, most of them focus on improving a single flavor or simple combination. They are still insufficient in terms of multiple synergistic effects such as analgesia, anti-inflammation, mucosal repair, and cough relief for throat and oral diseases, as well as in terms of using pure "medicine and food homology" raw materials to ensure long-term safety.

[0006] Therefore, developing a topical composition for the prevention and treatment of throat and oral diseases that is fast-acting, long-lasting, safe to use, has multiple effects, and is palatable is of great clinical significance and market value. Summary of the Invention

[0007] (a) Technical problems to be solved The technical problem to be solved by this invention is to propose a traditional Chinese medicine composition for the prevention and treatment of throat and oral diseases and its preparation method. The composition uses pure "food and medicine homology" raw materials, which is safer and increases the contact time between the drug and the disease site to increase the efficacy. It also takes into account the effects of analgesia, clearing heat and detoxifying, promoting tissue regeneration, and reducing cough caused by inflammatory stress in the throat. It solves the problems of the one-sidedness and poor efficacy of existing drug treatments.

[0008] (II) Technical Solution To solve the above-mentioned technical problems, the present invention provides the following technical solution: a traditional Chinese medicine composition for the prevention and treatment of throat and oral diseases, characterized in that it is composed of the following raw materials in parts by weight: 10-30 parts of poultry egg yolk oil; 1-3 parts honey; 5-15 parts of Platycodon grandiflorus extract; Dandelion extract 8-25 parts; Licorice 10-30 parts; Monk fruit 5-15 portions; 3-5 parts menthol; Maltose 80-200 parts.

[0009] As an improvement, the poultry egg yolk oil is the oil extracted from egg yolks through frying.

[0010] As an improvement, the dandelion, licorice, and monk fruit are extract powders obtained by decocting, concentrating, and drying.

[0011] Its preparation method includes the following steps: S1. Preparation of poultry egg yolk oil: Boil poultry eggs, remove the yolks, stir-fry until oil is released, filter, and cool for later use. Filter honey and mix it with the cooled poultry egg yolk oil. S2. Preparation of Platycodon grandiflorus and Taraxacum mongolicum extracts: Platycodon grandiflorus and Taraxacum mongolicum were boiled in water to extract the extracts, filtered and concentrated to a thick paste, then dried, pulverized and sieved for later use. Preparation of S3, licorice and monk fruit extracts: Wash licorice and monk fruit, add water and decoct, filter, concentrate to a thick paste, then dry, pulverize and sieve for later use; S4. Mixing and Shaping: Heat maltose to a molten state, add the components obtained in steps S1-S3, stir evenly, then add menthol and mix quickly, pour into a mold and cool to set, thus obtaining the composition.

[0012] As an improvement, the frying temperature in step S1 is 120-160℃, and the frying time is 20-40 minutes.

[0013] As an improvement, in step S3, the number of decoctions is 2-3 times, the amount of water added each time is 8-12 times the total weight of the medicinal materials, and the decoction time is 1-2 hours each time.

[0014] As an improvement, in step S3, the mixture is concentrated to a thick paste with a relative density of 1,10-1,25.

[0015] It also includes the application of the aforementioned traditional Chinese medicine composition in the preparation of drugs and foods for the prevention and treatment of throat and oral diseases.

[0016] As an improvement, the throat and oral diseases include pharyngitis, tonsillitis, sore throat, oral ulcers, or gingivitis.

[0017] (III) Beneficial Effects The advantages of this invention compared to the prior art are: (1) Raw material safety: All raw materials are selected from "medicine and food homology" substances, which are extremely safe and suitable for long-term health care, reducing the risk of medication.

[0018] (2) Poultry egg yolk oil + honey: Together they have the effects of nourishing yin and moisturizing dryness, promoting tissue regeneration and repair, and providing protection and nutrition for damaged mucous membranes.

[0019] Platycodon grandiflorus + Glycyrrhiza uralensis: a classic herbal pair that enhances the effects of clearing the lungs, relieving sore throat, eliminating phlegm, and stopping cough.

[0020] Dandelion: Clears heat and detoxifies, reduces swelling and dissipates nodules, and is effective for sore throat with redness, swelling and heat.

[0021] Monk fruit: Clears heat and moistens the lungs, soothes the throat and improves voice, and can also improve the overall taste.

[0022] Menthol: It has local analgesic, cooling and antipruritic effects, and can quickly relieve discomfort. Detailed Implementation

[0023] The invention will now be described in further detail with reference to specific embodiments, but this should not be construed as limiting the scope of the subject matter of the invention to the following embodiments.

[0024] Example 1: Composition Formulation and Preparation of Oral Candy Formula (parts by weight): 20 parts egg yolk butter, 2 parts honey, 10 parts bellflower extract, 15 parts dandelion water extract, 20 parts licorice water extract powder, 10 parts monk fruit water extract powder, 4 parts menthol, and 150 parts maltose.

[0025] Preparation method: 1. Take 100 eggs, boil them, remove the yolks, stir-fry them at 140℃ for 30 minutes, filter to obtain about 200g of egg yolk butter, and cool. Filter the honey and mix it with the cooled egg yolk butter.

[0026] 2. Take about 85g of Platycodon grandiflorus extract.

[0027] 3. Take 150g of dandelion extract, 200g of licorice, and 100g of monk fruit, mix them, add 8 times the amount of water and decoct twice, 1.5 hours each time. Combine the filtrates and concentrate them to a thick paste with a relative density of 1.20 at 60℃. Spray dry to obtain about 180g of mixed water extract powder.

[0028] 4. Weigh 1500g of maltose and heat it to 110℃ to melt. Add the egg yolk butter from step 1, 85g of bellflower root powder from step 2, 180g of water extract powder from step 3, and 20g of honey in sequence, and stir vigorously until smooth.

[0029] 5. When the material temperature drops to about 50℃, add 40g of menthol and stir quickly.

[0030] 6. Pour the paste into lollipop molds, let it cool and solidify, then unmold and individually package to obtain approximately 2000g of finished product (about 100 lollipops).

[0031] Example 2: Experiments and efficacy verification of different formulation ratios To verify the scientific validity and optimality of the raw materials and their proportions described in this invention, the following series of comparative experiments were designed, focusing on their impact on the healing of oral ulcers.

[0032] 1. Test materials: - Test samples: According to the scope of claim 1 of the present invention, the following four formulation compositions (150 parts of maltose as the basic excipient) were prepared: Group A (Low Egg Yolk Oil Group): 10 parts egg yolk oil, 1 part honey, 5 parts bellflower root, 8 parts dandelion, 10 parts licorice, 5 parts monk fruit, and 3 parts menthol.

[0033] Group B (Preferred Group of the Invention): 20 parts egg yolk oil, 2 parts honey, 10 parts platycodon root, 15 parts dandelion, 20 parts licorice, 10 parts monk fruit, and 4 parts menthol.

[0034] Group C (High Egg Yolk Oil Group): 30 parts egg yolk oil, 3 parts honey, 15 parts bellflower root, 25 parts dandelion, 30 parts licorice, 15 parts monk fruit, and 5 parts menthol.

[0035] Group D (missing core group): Contains no egg or butter, otherwise the same as Group B.

[0036] - Positive control drug: Commercially available Guilin Watermelon Frost Spray.

[0037] - Negative control: physiological saline.

[0038] - Experimental animals: SD rats, male, weighing 180-220g.

[0039] 2. Experimental Method (Oral Ulcer Model): A rat oral ulcer model was established using a chemical cauterization method. Acetic acid filter paper was applied to specific locations on the buccal mucosa of rats for 60 seconds, forming standardized ulcers approximately 3-4 mm in diameter. After successful model establishment, rats were randomly divided into 6 groups (groups A, B, C, and D above, plus a positive control group and a negative control group), with 8 rats in each group.

[0040] Treatment method for each group: Apply the corresponding sample paste (mix the sample with a small amount of water) or spray the control drug to the ulcer site twice a day for 5 consecutive days.

[0041] Observation indicators: ulcer area (mm²) was measured daily; animals were sacrificed on the 5th day, and tissue from the ulcer site was taken for pathological examination to assess the degree of inflammatory cell infiltration, epithelial regeneration, and histopathological scoring (0-5 points, the lower the score, the better the healing).

[0042] 3. Test Results: - Changes in ulcer area: On the 5th day of treatment, the average reduction rate of ulcer area in each group was as follows: negative control group 15%, group A 58%, group B (preferred in this invention) 85%, group C 70%, group D 45%, and positive control group 78%.

[0043] - Histopathological scores: On day 5, the average scores of each group were as follows: negative control group 4.2 points, group A 2.5 points, group B (preferred in this invention) 1.1 points, group C 1.8 points, group D 2.8 points, and positive control group 1.6 points. 4. Experimental Conclusions: Group B (the preferred formulation of this invention) showed the most significant effect in promoting ulcer area reduction and tissue repair, outperforming other formulations and the positive control drug.

[0044] Although Group A (low-dose group) and Group C (high-dose group) showed some effect, they were not as effective as Group B, indicating that there is an optimal synergistic point for each component within the range described in this invention, and the effect tends to decrease outside the range.

[0045] The effect of group D (lacking egg yolk oil) was significantly reduced, confirming the key role of egg yolk oil in the composition for mucosal repair.

[0046] The test results fully support the rationality and superiority of the raw material types and weight ratio ranges defined in claim 1 of this invention.

[0047] Example 3: Clinical Application Observation Case To preliminarily evaluate the effectiveness of the product of this invention in practical applications, two small-scale observational studies were conducted.

[0048] Study 1: Observation on the relief of symptoms of chronic pharyngitis 1. Subjects: Thirty outpatients with typical symptoms of chronic pharyngitis (dry throat, itchy throat, foreign body sensation, dry cough in the morning) were recruited and randomly divided into two groups.

[0049] 2. Methods: The experimental group (15 cases) was given the oral candy prepared in Example 1 of this invention, one candy per day, 4-6 times a day; the control group (15 cases) was given a placebo candy with a similar appearance (containing only maltose and mint). The treatment course was 2 weeks. The patients' pharyngeal symptom scores (VAS, 0-10 points) were recorded before treatment, on day 7 of treatment, and on day 14 of treatment.

[0050] 3. Results: On day 14 of treatment, the VAS scores for dry throat, foreign body sensation, and itchy throat in the experimental group decreased by an average of 78%, 70%, and 65%, respectively, while those in the control group decreased by only 15%, 12%, and 10%. The total effective rate (symptom score reduction ≥50%) in the experimental group was 86.7%, compared to 13.3% in the control group. The difference was statistically significant (P<0.01). No significant adverse reactions were reported during the trial.

[0051] Study 2: Observation on analgesia and healing promotion of recurrent oral ulcers 1. Subjects: Twenty patients with recurrent mild oral ulcers (ulcer diameter 2-4 mm) during an acute episode were recruited.

[0052] 2. Methods: All patients used the product of this invention. One capsule was sublingually administered when ulcer pain was significant. Visual analog scale (VAS, 0-10) scores for pain were recorded before administration and at 5, 15, 30, and 60 minutes after administration. The capsule was administered four times daily until the ulcer healed, and the healing time was recorded.

[0053] 3. Results: - Analgesic effect: After sublingual administration, the average VAS score decreased from 8.2 to 5.1 within 5 minutes; to 3.0 within 15 minutes; and to 1.8 within 30 minutes. This indicates that the product has a rapid local analgesic effect.

[0054] - Healing time: The average ulcer healing time was (4.5±1.2) days, which was significantly shorter than the natural healing cycle (7-10 days) reported in the literature.

[0055] - Tolerability: All patients reported that the product had a cool taste and was easy to accept, with no discomfort such as increased local irritation during or after taking it.

[0056] in conclusion: The systematic experimental data from Example 2 above confirm the definite effect and optimal ratio range of the composition formulation described in this invention in promoting mucosal repair. Preliminary clinical application observations in Example 3 show that this product can effectively relieve symptoms of chronic pharyngitis and has a rapid analgesic and healing-promoting effect on recurrent oral ulcers, and is safe and well-tolerated. This provides strong preliminary evidence for the industrial development and clinical application of this invention.

[0057] The above embodiments further enrich and demonstrate the technical effects and practical value of the present invention. Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents. In short, if those skilled in the art are inspired by these claims and design similar structural methods and embodiments without departing from the inventive spirit of the present invention, they should all fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for the prevention and treatment of throat and oral diseases, characterized in that, By weight, it consists of the following raw materials: 10-30 parts of poultry egg yolk oil; 1-3 parts honey; 5-15 parts of Platycodon grandiflorus extract; Dandelion extract 8-25 parts; Licorice 10-30 parts; Monk fruit 5-15 portions; 3-5 parts menthol; Maltose 80-200 parts.

2. The traditional Chinese medicine composition for preventing and treating throat and oral diseases according to claim 1, characterized in that, The poultry egg yolk oil is the oil extracted from egg yolks through frying.

3. The traditional Chinese medicine composition for preventing and treating throat and oral diseases according to claim 1, characterized in that, The licorice and monk fruit are extract powders obtained by decocting, concentrating, and drying in water.

4. The method for preparing the traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, Includes the following steps: S1. Preparation of poultry egg yolk oil: Boil poultry eggs, remove the yolks, stir-fry until oil is released, filter, and cool for later use. Filter honey and mix it with the cooled poultry egg yolk oil. S2. Preparation of Platycodon grandiflorus and Taraxacum mongolicum extracts: Platycodon grandiflorus and Taraxacum mongolicum were boiled in water and extracted, then filtered to obtain the extract; Preparation of S3, licorice and monk fruit extracts: Wash licorice and monk fruit, add water and decoct, filter, concentrate to a thick paste, dry, pulverize and sieve for later use; S4. Mixing and Shaping: Heat maltose to a molten state, add the components obtained in steps S1-S3, stir evenly, then add menthol and mix quickly, pour into a mold and cool to set, thus obtaining the composition.

5. The method for preparing the traditional Chinese medicine composition according to claim 4, characterized in that, In step S1, the frying temperature is 120-160℃ and the frying time is 20-40 minutes.

6. The method for preparing the traditional Chinese medicine composition according to claim 4, characterized in that, In step S3, the decoction is performed 2-3 times, with the amount of water added each time being 8-12 times the total weight of the medicinal materials, and the decoction time being 1-2 hours each time.

7. The method for preparing the traditional Chinese medicine composition according to claim 4, characterized in that, In step S3, the mixture is concentrated to a thick paste with a relative density of 1.10-1.

25.

8. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of drugs and foods for the prevention and treatment of throat and oral diseases.

9. The method for preparing the traditional Chinese medicine composition according to claim 8, characterized in that, The throat and oral cavity diseases include pharyngitis, tonsillitis, sore throat, oral ulcers, or gingivitis.