A traditional Chinese medicine composition for treating highland oral ulcer

Abstract

The application discloses a traditional Chinese medicine composition for treating highland oral ulcer, and the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: Rhizoma Coptidis 1-20 parts, Jiaogulans 5-30 parts, Anemarrhena 5-30 parts, Phellodendron 1-20 parts, Styrax 1-15 parts, Bletilla 5-30 parts, Evodia 5-30 parts and Glycyrrhiza 1-20 parts. The traditional Chinese medicine composition is highly targeted, directly attacks the core pathogenesis, and precisely adapts to the unique pathogenesis of highland oral ulcer, such as 'dry heat and external attack of fire toxin, deficiency of Zongqi', and is matched according to the corresponding therapeutic principle, and the traditional Chinese medicine composition has the functions of clearing toxin, tonifying Zongqi and nourishing body fluid, so that the problem of easy attack and difficult healing of ulcer is solved from the root, and the traditional Chinese medicine composition is superior to symptomatic treatment of western medicine.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and specifically relates to a traditional Chinese medicine composition for treating oral ulcers in high-altitude areas. Background Technology

[0002] Oral ulcers are a common clinical disease of the oral mucosa, mainly manifested as round or oval ulcers on the lips, tongue, cheeks, soft palate, and other oral mucosa. The ulcer surface is covered with a grayish-yellow pseudomembrane, surrounded by a red halo, with a central depression, and significant pain. In severe cases, it can affect the patient's normal speech and eating, reducing their quality of life. The etiology of this disease is complex. Currently, clinical research suggests that its pathogenesis is related to multiple factors, including genetic factors, immune dysfunction, endocrine disorders, vitamin and trace element deficiencies, and viral and bacterial infections. The pathogenesis is not yet fully understood.

[0003] It is particularly important to note that the pathogenesis of oral ulcers in high-altitude areas differs significantly from that in lowland areas due to the unique environment. In traditional Chinese medicine, it falls under the categories of "oral sores," "oral erosion," and "oral canker." The unique climate and frequent sandstorms in high-altitude regions allow these pathogens to combine with external dryness and heat, disrupting the body's defensive qi and allowing them to directly enter the oral cavity, causing lesions. Traditional Chinese medicine believes that "dryness leads to dehydration," and the dryness of high-altitude areas easily depletes the fluids of the lungs and stomach, resulting in insufficient moisture in the oral mucosa. Furthermore, the "fire nature" of the dryness and heat allows these pathogens to ascend along the meridians, attacking the oral cavity and scorching the mucosa, ultimately leading to ulcer formation. In addition, the low air pressure and thin oxygen in the high-altitude environment can easily lead to "insufficient clear qi and pervasive turbid qi" in the body. Insufficient generation of ancestral qi will result in weak defense against external pathogens, making it difficult to resist the invasion of pathogens. If clear yang does not rise, body fluids cannot ascend to nourish the oral cavity. The circulation of qi and blood will be slowed down due to insufficient propulsion, which will further aggravate the malnutrition of the oral mucosa, leading to ulcers that are easy to occur and difficult to heal, forming a vicious cycle.

[0004] Current Western medicine treatments for oral ulcers primarily focus on symptomatic relief, commonly using medications such as analgesics, anti-inflammatory drugs, corticosteroids, growth factors, and vitamins. While these treatments can quickly alleviate ulcer pain and reduce local inflammation, they are largely palliative and cannot fundamentally regulate bodily functions. Long-term use may also lead to adverse reactions and is difficult to control recurrent ulcers, thus limiting their clinical application. Therefore, developing a safe and effective traditional Chinese medicine formula that can prevent and treat oral ulcers at high altitudes from their root cause has become an urgent clinical need.

[0005] The information disclosed in this background section is intended only to enhance the understanding of the overall background of the invention and should not be construed as an admission or in any way implying that the information constitutes prior art known to those skilled in the art. Summary of the Invention

[0006] The purpose of this invention is to provide a traditional Chinese medicine composition for treating oral ulcers in high-altitude areas, thereby overcoming the defects in the prior art.

[0007] To achieve the above objectives, the present invention provides a traditional Chinese medicine composition for treating oral ulcers in high-altitude areas, comprising the following raw materials in parts by weight: 1-20 parts of Coptis chinensis, 5-30 parts of Swertia japonica, 5-30 parts of Anemarrhena asphodeloides, 1-20 parts of Phellodendron chinense, 1-15 parts of Benzoin, 5-30 parts of Bletilla striata, 5-30 parts of Evodia rutaecarpa, and 1-20 parts of Glycyrrhiza uralensis.

[0008] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 3-18 parts of Coptis chinensis, 8-25 parts of Swertia japonica, 8-25 parts of Anemarrhena asphodeloides, 3-18 parts of Phellodendron chinense, 2-12 parts of Benzoin, 8-25 parts of Bletilla striata, 8-25 parts of Evodia rutaecarpa, and 3-18 parts of Glycyrrhiza uralensis.

[0009] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 5-15 parts Coptis chinensis, 10-20 parts Swertia japonica, 10-20 parts Anemarrhena asphodeloides, 5-15 parts Phellodendron chinense, 3-10 parts Benzoin, 10-20 parts Bletilla striata, 10-20 parts Evodia rutaecarpa, and 5-15 parts Glycyrrhiza uralensis.

[0010] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 8-12 parts of Coptis chinensis, 12-18 parts of Swertia japonica, 12-18 parts of Anemarrhena asphodeloides, 8-12 parts of Phellodendron chinense, 4-8 parts of Benzoin, 12-18 parts of Bletilla striata, 12-18 parts of Evodia rutaecarpa, and 8-12 parts of Glycyrrhiza uralensis.

[0011] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 6 parts Coptis chinensis, 9 parts Swertia japonica, 9 parts Anemarrhena asphodeloides, 6 parts Phellodendron chinense, 3 parts Benzoin, 9 parts Bletilla striata, 9 parts Evodia rutaecarpa, and 6 parts Glycyrrhiza uralensis.

[0012] Preferably, the preparation method of the traditional Chinese medicine composition is as follows: Mix all ingredients according to the specified ratio, add boiling water and steep for 10-120 minutes to obtain the drinking preparation.

[0013] Preferably, the preparation method of the traditional Chinese medicine composition is as follows: Mix all ingredients according to the specified ratio, soak in cold water for 20-40 minutes, bring to a boil over high heat, then simmer over low heat for 20-30 minutes to obtain the decoction preparation.

[0014] Preferably, the traditional Chinese medicine composition is used to treat oral ulcers at high altitudes.

[0015] Based on the fundamental theories of traditional Chinese medicine, this invention provides a Chinese herbal composition for treating oral ulcers at high altitudes, targeting the core pathogenesis of "external attack of dryness and fire toxins" and "deficiency of vital energy".

[0016] The properties, flavors, meridian tropisms, and effects of each ingredient are as follows (all are officially named using traditional Chinese medicine names to ensure that those skilled in the art can clearly identify each ingredient): Coptis chinensis: bitter in taste, cold in nature, and enters the heart, liver, stomach, and large intestine meridians.

[0017] Swertia japonica: bitter and cold in nature, and enters the stomach, heart, and liver meridians.

[0018] Anemarrhena asphodeloides: bitter and sweet in taste, cold in nature, and enters the lung, stomach, and kidney meridians.

[0019] Phellodendron bark: It has a bitter and cold taste and enters the kidney, bladder, and large intestine meridians.

[0020] Benzoin: It has a pungent and bitter taste, is neutral in nature, and enters the heart and spleen meridians.

[0021] Bletilla striata: slightly cold in nature, bitter, sweet and astringent in taste, and enters the lung and stomach meridians.

[0022] Evodia rutaecarpa: pungent, bitter, and hot; enters the liver, spleen, stomach, and kidney meridians.

[0023] Licorice: sweet, neutral, enters the heart, lung, spleen, and stomach meridians.

[0024] Coptis chinensis is effective in clearing heart fire and is a key herb for treating oral ulcers. Swertia japonica is effective in clearing heat and toxins from the liver and gallbladder, and can detoxify, promote diuresis, and cool the blood. The combination of these two herbs clears the fire and toxins from the heart and liver, making them the principal herbs for treating oral ulcers at high altitudes. Anemarrhena asphodeloides clears heat and drains fire, nourishes yin and moistens dryness, assisting the principal herb in clearing heat and replenishing the fluids lost due to heat. Phellodendron amurense clears heat and dries dampness, drains fire and detoxifies, specifically clearing damp heat in the lower burner. Styrax benzoin has the effects of opening orifices, dispelling foulness, promoting qi and blood circulation, and relieving pain. These three herbs assist the principal herb from the perspectives of "nourishing yin" and "resolving blood stasis," and are thus the assistant herbs. Evodia rutaecarpa is extremely pungent and hot. Adding a pungent and hot herb to the above-mentioned cold herbs prevents excessive coldness, suppresses qi, and guides fire back to its source. Together with Bletilla striata, which has astringent, hemostatic, swelling-reducing, and tissue-regenerating properties, they serve as adjuvant herbs. Licorice clears heat and detoxifies, relieves spasms and pain, harmonizes the bitter and cold properties of Coptis chinensis and Phellodendron chinense, protects the spleen and stomach, and harmonizes the overall properties of the formula, thus serving as the guiding herb. The entire formula clears heat, nourishes yin, resolves blood stasis, and promotes tissue regeneration, working together to treat oral ulcers at high altitudes.

[0025] Compared with the prior art, one aspect of the present invention has the following beneficial effects: (1) The Chinese medicine composition of the present invention is highly targeted, directly addresses the core pathogenesis, and is precisely adapted to the unique pathogenesis of oral ulcers in high altitude areas, such as "external attack of dryness, heat and fire toxins and deficiency of vital energy". It is matched with the corresponding treatment principle, taking into account detoxification, replenishing vital energy and nourishing body fluids, and solving the problem of easy ulceration and difficult healing from the root cause, which is superior to the symptomatic treatment of Western medicine. (2) The Chinese medicine composition of the present invention is scientifically formulated, safe and mild, follows the TCM syndrome differentiation and treatment, and the principal, assistant and adjuvant herbs work together. Evodia rutaecarpa restrains the bitter and cold properties of the medicine, and Glycyrrhiza uralensis harmonizes the spleen and stomach and the whole formula. It balances cold and heat, and combines tonification and purgation. It has no obvious toxic side effects and its long-term safety is higher than that of related Western medicines. (3) The raw materials of the Chinese medicine composition of the present invention are readily available and easy to prepare. The Chinese medicinal materials used are conventionally available and inexpensive. The preparation can be carried out in two ways: soaking in boiling water and decocting in cold water. No complicated equipment is required. It is suitable for high-altitude medical conditions, easy to prepare at home, and has broad prospects for promotion. (4) The present invention has comprehensive therapeutic effects and combines prevention and treatment. It can quickly relieve local symptoms of ulcers and regulate bodily functions to achieve both symptomatic and radical treatment. It can promote ulcer healing and prevent recurrence, overcome the limitations of Western medicine that can only treat the symptoms, and improve the quality of life of patients. (5) This invention is suitable for the physical condition of people in high-altitude areas, and fits the physical characteristics of people in high-altitude areas who are “insufficient in clear qi and pervasive in turbid qi”. It clears heat while replenishing qi and regulating qi, avoiding damage to the physical condition. It has strong adaptability and more stable therapeutic effect. Detailed Implementation

[0026] The specific embodiments of the present invention will be described in detail below, but it should be understood that the scope of protection of the present invention is not limited to the specific embodiments.

[0027] The following provides a brief overview of one or more aspects to offer a basic understanding of them. This overview is not an exhaustive summary of all conceived aspects, nor is it intended to identify key or decisive elements of all aspects, nor to define the scope of any or all aspects. Its sole purpose is to present some concepts of one or more aspects in a simplified form to prepare for the more detailed descriptions that follow.

[0028] Example 1:

[0029] Weigh out the following ingredients: 2g Coptis chinensis, 5g Swertia japonica, 5g Anemarrhena asphodeloides, 2g Phellodendron chinense, 2g Benzoin, 5g Bletilla striata, 5g Evodia rutaecarpa, and 3g Glycyrrhiza uralensis. Mix them evenly and then steep in boiling water for 10 minutes before drinking.

[0030] Example 2

[0031] Weigh out the following ingredients: 3g Coptis chinensis, 6g Swertia japonica, 6g Anemarrhena asphodeloides, 3g Phellodendron chinense, 5g Benzoin, 6g Bletilla striata, 6g Evodia rutaecarpa, and 5g Glycyrrhiza uralensis. Mix them evenly and then steep in boiling water for 11 minutes before drinking.

[0032] Example 3

[0033] Weigh out the following ingredients: 3g Coptis chinensis, 8g Swertia japonica, 8g Anemarrhena asphodeloides, 3g Phellodendron chinense, 2g Benzoin, 8g Bletilla striata, 8g Evodia rutaecarpa, and 3g Glycyrrhiza uralensis. Mix them evenly and then steep in boiling water for 12 minutes before drinking.

[0034] Example 4

[0035] Weigh out the following ingredients: 5g Coptis chinensis, 10g Swertia japonica, 10g Anemarrhena asphodeloides, 5g Phellodendron chinense, 3g Benzoin, 10g Bletilla striata, 10g Evodia rutaecarpa, and 5g Glycyrrhiza uralensis. Mix them evenly and then steep in boiling water for 16 minutes before drinking.

[0036] Example 5

[0037] Weigh out the following ingredients: 8g Coptis chinensis, 12g Swertia japonica, 12g Anemarrhena asphodeloides, 8g Phellodendron chinense, 4g Benzoin, 12g Bletilla striata, 12g Evodia rutaecarpa, and 8g Glycyrrhiza uralensis. Mix them evenly and steep in boiling water for 18 minutes before drinking.

[0038] Example 6

[0039] Weigh out the following ingredients: 12g Coptis chinensis, 18g Swertia japonica, 18g Anemarrhena asphodeloides, 12g Phellodendron chinense, 8g Benzoin, 18g Bletilla striata, 18g Evodia rutaecarpa, and 12g Glycyrrhiza uralensis. Mix them evenly and steep in boiling water for 20 minutes before drinking.

[0040] Example 7

[0041] Weigh out the following ingredients: 15g Coptis chinensis, 20g Swertia japonica, 20g Anemarrhena asphodeloides, 15g Phellodendron chinense, 10g Benzoin, 20g Bletilla striata, 20g Evodia rutaecarpa, and 15g Glycyrrhiza uralensis. Mix them evenly and steep in boiling water for 20 minutes before drinking.

[0042] Example 8

[0043] Weigh out the following ingredients: 18g Coptis chinensis, 25g Swertia japonica, 25g Anemarrhena asphodeloides, 18g Phellodendron chinense, 12g Benzoin, 25g Bletilla striata, 25g Evodia rutaecarpa, and 18g Glycyrrhiza uralensis. Mix them evenly and steep in boiling water for 20 minutes before drinking.

[0044] Example 9

[0045] Weigh out the following ingredients: 16g Coptis chinensis, 20g Swertia japonica, 20g Anemarrhena asphodeloides, 15g Phellodendron chinense, 10g Benzoin, 20g Bletilla striata, 20g Evodia rutaecarpa, and 15g Glycyrrhiza uralensis. Mix them evenly and steep in boiling water for 19 minutes before drinking.

[0046] Example 10

[0047] Weigh out the following ingredients: 12g Coptis chinensis, 18g Swertia japonica, 20g Anemarrhena asphodeloides, 12g Phellodendron chinense, 8g Benzoin, 18g Bletilla striata, 18g Evodia rutaecarpa, and 12g Glycyrrhiza uralensis. Mix them evenly and steep in boiling water for 18 minutes before drinking.

[0048] Example 11

[0049] Weigh out the following ingredients: 10g Coptis chinensis, 20g Swertia japonica, 16g Anemarrhena asphodeloides, 15g Phellodendron chinense, 12g Benzoin, 16g Bletilla striata, 18g Evodia rutaecarpa, and 12g Glycyrrhiza uralensis. Mix them evenly and then steep in boiling water for 18 minutes before drinking.

[0050] Example 12

[0051] Weigh out the following ingredients: 15g Coptis chinensis, 16g Swertia japonica, 18g Anemarrhena asphodeloides, 13g Phellodendron chinense, 10g Benzoin, 15g Bletilla striata, 16g Evodia rutaecarpa, and 10g Glycyrrhiza uralensis. Mix them evenly and steep in boiling water for 120 minutes before drinking.

[0052] Example 13

[0053] Weigh out the following ingredients: 12g Coptis chinensis, 16g Swertia japonica, 20g Anemarrhena asphodeloides, 12g Phellodendron chinense, 12g Benzoin, 16g Bletilla striata, 18g Evodia rutaecarpa, and 10g Glycyrrhiza uralensis. Mix them evenly and then steep in boiling water for 17 minutes before drinking.

[0054] Example 14

[0055] Weigh out the following ingredients: 11g Coptis chinensis, 16g Swertia japonica, 16g Anemarrhena asphodeloides, 11g Phellodendron chinense, 5g Benzoin, 16g Bletilla striata, 16g Evodia rutaecarpa, and 11g Glycyrrhiza uralensis. Mix them evenly and steep in boiling water for 16 minutes before drinking.

[0056] Example 15

[0057] Weigh out the following ingredients: 6g Coptis chinensis, 9g Swertia japonica, 9g Anemarrhena asphodeloides, 6g Phellodendron chinense, 3g Benzoin, 9g Bletilla striata, 9g Evodia rutaecarpa, and 6g Glycyrrhiza uralensis. Mix them evenly and steep in boiling water for 10 minutes before drinking.

[0058] 1. Experimental Methods: 1.1 Cases and Grouping Based on the diagnostic, inclusion, and exclusion criteria, this study enrolled 60 patients with high-altitude oral ulcers between July 10, 2025, and September 21, 2025. The patients were of unrestricted gender and aged 18-45 years. A block randomization method was used, with random numbers generated using SPSS 26.0 software and a block length of 4. The 60 patients were randomly assigned in a 1:1 ratio to either a treatment group or a waiting-for-treatment group, with 30 patients in each group. The randomization scheme was hidden in sequentially coded, sealed, and opaque envelopes. After patients signed informed consent and were enrolled, the envelopes were opened by designated personnel, and the corresponding intervention plan was implemented. The treatment group received the traditional Chinese medicine composition obtained in Example 15, one dose per day, soaked in cold water for 60 minutes, brought to a boil over high heat, then simmered over low heat for 10 minutes, yielding approximately 600ml of liquid, taken half an hour after meals, three times a day for 7 consecutive days. The waiting-for-treatment group received the traditional Chinese medicine composition obtained in Example 15 7 days after enrollment, using the same method.

[0059] 1.2 Diagnostic criteria 1.2.1 Western Medicine Diagnostic Criteria Refer to the diagnostic criteria for oral ulcers in "Oral Science".

[0060] The appearance of round or oval ulcers on the mucous membranes of the lips, tongue, cheeks, soft palate, etc., with the ulcer surface covered by a grayish-yellow pseudomembrane, surrounded by a red halo, centrally depressed, and with obvious pain, exhibiting the characteristics of "yellow, red, depressed, and painful", can be used for diagnosis.

[0061] 1.2.2 Traditional Chinese Medicine Diagnostic Criteria Based on the diagnostic criteria for oral ulcers in the "Standards for Diagnosis and Treatment of Diseases and Syndromes in Traditional Chinese Medicine" issued by the State Administration of Traditional Chinese Medicine, and considering the characteristics of oral ulcers at high altitudes, the following criteria are proposed: Main symptoms: Ulcers are round or oval in shape and vary in size. There are many ulcers, which may merge into patches. The area around the ulcer is red, swollen and raised, with a central depression. There is local burning pain and thirst. Concurrent symptoms: Patients often experience facial flushing, fatigue, shortness of breath, irritability, constipation, and dark yellow urine; Tongue and pulse: Red tongue with dry yellow or thin white coating, and floating, rapid and thready pulse; If the patient meets the disease diagnostic criteria and also meets all the main symptoms in the above syndrome diagnostic criteria, plus at least two secondary symptoms, and the tongue and pulse are taken into account, a diagnosis can be made.

[0062] 1.3 Inclusion Criteria (1) High-altitude patients who meet the diagnostic criteria; (2) Age 18-45, gender not limited; (3) The patient has not received any related treatment in the past week; (4) The subjects voluntarily participate in the clinical trial and sign an informed consent form; 1.4 Exclusion Criteria (1) Those who do not meet the diagnostic criteria; (2) Oral ulcers treated within the past week; (3) Pregnant or lactating women; (4) Individuals allergic to this drug; (5) Comorbid oral diseases; (6) Accompanied by diseases such as blood disorders, immune disorders, severe organ dysfunction, or malignant tumors; 1.5 Shedding Criteria (1) Severe adverse reactions, allergies, etc. occur; (2) Those who fail to take medication as prescribed; (3) Cases that withdrew from the experiment before the course of treatment was completed or lost to follow-up for various other reasons; (4) Patients whose condition deteriorates rapidly and who urgently need to receive other treatments.

[0063] The reasons for the dropout of cases are not included in the statistical data.

[0064] 1.6 Observation Indicators 1.6.1 Traditional Chinese Medicine Syndrome Score Assessment Referencing the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs" and the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine" Establish scoring criteria. Primary symptoms and secondary symptoms are scored as follows: 0, 2, 4, 6 points; 0, 1, 2, 3 points.

[0065] 1.6.2 Therapeutic Indicators Significant effect: After treatment, symptoms are essentially back to normal, most clinical signs disappear, and the syndrome score reduction rate is ≥67%; Effective: After treatment, symptoms and signs were somewhat relieved compared to before treatment, but not significantly; the syndrome score decreased by ≥33% and <67%. Ineffective: No significant changes in symptoms and signs before and after treatment, with virtually no improvement, and a decrease in syndrome score of ≤33%.

[0066] 1.6.3 Detection of inflammatory factors Serum levels of tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) were measured using ELISA.

[0067] 1.6.4 Adverse reaction observation indicators Record any adverse reactions that occur during treatment, including their type, severity, management, and outcome.

[0068] Severity classification and treatment measures: 1.7 Statistical Analysis Statistical analysis was performed using SPSS 26.0. Data conforming to a normal distribution were analyzed using independent samples t-tests between groups and paired samples t-tests within groups. Data not conforming to a normal distribution were analyzed using the rank-sum test. Categorical data were expressed using the chi-square test. 2 Tests were performed; Ridit analysis was used for ordinal data, and the rank-sum test was used for small sample sizes. A p-value < 0.05 was considered statistically significant between the two groups.

[0069] 2. Experimental Results 2.1 General Case Based on the inclusion and exclusion criteria, this study included 60 patients with oral ulcers at high altitudes, with 30 patients in the treatment group and 30 patients in the waiting-for-treatment group. There were no significant differences between the two groups in terms of age, sex, BMI, body temperature, pulse, systolic blood pressure, diastolic blood pressure, and blood oxygen saturation (P>0.05).

[0070] Table 1 Comparison of the two sets of baseline data 2.2 Traditional Chinese Medicine Syndrome Scoring As shown in Table 2, there was no significant difference in symptom and sign scores between the two groups before enrollment (P > 0.05). Seven days after enrollment, the treatment group showed significantly lower scores for ulcers, number of ulcers, redness and swelling, burning pain, thirst, facial flushing, fatigue, irritability, constipation, and dark yellow urine, as well as a significantly lower total score compared to before enrollment (P < 0.05). Similarly, the waiting-for-treatment group showed significantly lower scores for ulcers, number of ulcers, redness and swelling, burning pain, as well as a significantly lower total score compared to before enrollment (P < 0.05). Seven days after enrollment, the treatment group showed significantly lower scores for ulcers, number of ulcers, redness and swelling, burning pain, thirst, fatigue, and constipation, as well as a significantly lower total score compared to the waiting-for-treatment group (P < 0.05).

[0071] Table 2 Comparison of symptom and sign scores between the two groups before treatment ( ±S) Note: **** P < 0.0001, ** P < 0.01, * P < 0.05, compared with pre-admission values ​​in this group; #### P < 0.0001, ### P < 0.001, ## P < 0.01, # P < 0.05, compared with the waiting-for-treatment group at the same time point. 2.3 Clinical efficacy results As shown in Table 3, after 7 days, the total effective rate of the treatment group was 83.33%, which was significantly higher than the total effective rate of 33.33% of the waiting treatment group (P<0.05).

[0072] Table 3. Comparison of clinical efficacy between the two groups 7 days after enrollment (cases) Note: * P < 0.05, compared with the waiting treatment group 2.4 Changes in inflammatory factors As shown in Table 4, there was no significant difference in TNF and IL-6 protein levels between the treatment groups before enrollment (P > 0.05). Seven days after enrollment, TNF and IL-6 levels in both groups were significantly lower than before treatment (P < 0.0001), and the TNF and IL-6 protein levels in the treatment group were significantly lower than those in the waiting-for-treatment group (P < 0.0001).

[0073] Table 4. Changes in IL-6 and CRP levels before and after enrollment in both groups. Note: **** P < 0.0001, compared with pre-enrollment values ​​in this group; #### P < 0.0001, ### P < 0.001, compared with the waiting-for-treatment group at the same time point. 2.5 Occurrence of Adverse Reactions During the study, neither group of subjects experienced any significant adverse reactions.

[0074] The foregoing description of specific exemplary embodiments of the invention is for illustrative and explanatory purposes. These descriptions are not intended to limit the invention to the precise forms disclosed, and it will be apparent that many changes and variations can be made in accordance with the foregoing teachings. The exemplary embodiments were chosen and described in order to explain the specific principles of the invention and its practical application, thereby enabling those skilled in the art to implement and utilize various different exemplary embodiments of the invention, as well as various different choices and variations. The scope of the invention is intended to be defined by the claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for treating oral ulcers at high altitudes, characterized in that, It is composed of the following ingredients in parts by weight: Coptis chinensis 1-20 parts, Swertia japonica 5-30 parts, Anemarrhena asphodeloides 5-30 parts, Phellodendron chinense 1-20 parts, Benzoin 1-15 parts, Bletilla striata 5-30 parts, Evodia rutaecarpa 5-30 parts, Glycyrrhiza uralensis 1-20 parts.

2. The traditional Chinese medicine composition for treating oral ulcers at high altitudes according to claim 1, characterized in that, It is composed of the following ingredients in parts by weight: Coptis chinensis 3-18 parts, Swertia japonica 8-25 parts, Anemarrhena asphodeloides 8-25 parts, Phellodendron chinense 3-18 parts, Benzoin 2-12 parts, Bletilla striata 8-25 parts, Evodia rutaecarpa 8-25 parts, Glycyrrhiza uralensis 3-18 parts.

3. The traditional Chinese medicine composition for treating oral ulcers at high altitudes according to claim 1, characterized in that, It is composed of the following ingredients by weight: Coptis chinensis 5-15 parts, Swertia japonica 10-20 parts, Anemarrhena asphodeloides 10-20 parts, Phellodendron chinense 5-15 parts, Benzoin 3-10 parts, Bletilla striata 10-20 parts, Evodia rutaecarpa 10-20 parts, Glycyrrhiza uralensis 5-15 parts.

4. The traditional Chinese medicine composition for treating oral ulcers at high altitudes according to claim 1, characterized in that, It is composed of the following ingredients in parts by weight: Coptis chinensis 8-12 parts, Swertia japonica 12-18 parts, Anemarrhena asphodeloides 12-18 parts, Phellodendron chinense 8-12 parts, Benzoin 4-8 parts, Bletilla striata 12-18 parts, Evodia rutaecarpa 12-18 parts, Glycyrrhiza uralensis 8-12 parts.

5. The traditional Chinese medicine composition for treating oral ulcers at high altitudes according to claim 1, characterized in that, It is composed of the following ingredients by weight: 6 parts Coptis chinensis, 9 parts Swertia japonica, 9 parts Anemarrhena asphodeloides, 6 parts Phellodendron chinense, 3 parts Benzoin, 9 parts Bletilla striata, 9 parts Evodia rutaecarpa, and 6 parts Glycyrrhiza uralensis.

6. A traditional Chinese medicine composition for treating oral ulcers at high altitudes according to any one of claims 1-5, characterized in that, The preparation method of the traditional Chinese medicine composition is as follows: Mix all ingredients evenly according to the specified ratio, add boiling water and steep for 10-120 minutes to obtain the drinking preparation.

7. A traditional Chinese medicine composition for treating oral ulcers at high altitudes according to any one of claims 1-5, characterized in that, The preparation method of the traditional Chinese medicine composition is as follows: Mix all ingredients evenly according to the ratio, soak in cold water for 20-40 minutes, bring to a boil over high heat, then simmer over low heat for 20-30 minutes to obtain the decoction preparation.

8. A traditional Chinese medicine composition for treating oral ulcers at high altitudes according to any one of claims 1-5, characterized in that, The traditional Chinese medicine composition is used to treat oral ulcers in high-altitude areas.

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