Medicine for treating oral mucositis and preparation method thereof

Abstract

The invention discloses a medicine for treating oral mucositis and a preparation method thereof. The medicine for treating oral mucositis comprises traditional Chinese medicine effective components, the traditional Chinese medicine can specifically comprise 4-5 parts of liquorice, 1-2 parts of coptis chinensis, 1-2 parts of angelica sinensis, 3-4 parts of scutellaria baicalensis, 3-4 parts of ginseng and 1-2 parts of honeysuckle. The traditional Chinese medicine composition has the effects of clearing heat, detoxifying and purging fire, can be used for treating dry mouth, sticky mouth, astringent mouth, oral ulcer, oral pain and other symptoms caused by oral mucositis, has a very good clinical application effect, is particularly suitable for oral mucositis caused by chemotherapy, radiotherapy, targeting and immunotherapy, and has no toxic or side effect.

Description

Technical Field

[0001] The present invention relates to the field of therapeutic drugs for stomatitis, and in particular to a drug for treating oral mucositis and a preparation method thereof. Background Art

[0002] Oral mucositis refers to inflammatory and / or ulcerative lesions of the oral mucosal epithelium. For patients with malignant tumors, chemotherapy, radiotherapy, targeted and immunotherapy are the main causes of oral mucositis. Oral mucositis caused by radiotherapy and chemotherapy is mainly manifested by oral mucosal congestion, erythema, edema, erosion and ulcers of varying degrees. Oral mucositis often causes unbearable oral pain, which not only significantly affects the patient's eating, speaking and resting, but also may reduce the patient's tolerance and compliance to anti-tumor treatment, delay or even stop treatment, and reduce the quality of life and anti-tumor efficacy.

[0003] Most scholars believe that "heat accumulation in the heart and spleen" and "yin deficiency and fire excess" are the main causes of stomatitis. Clearing away heat and purging fire, nourishing yin and reducing fire are the main treatment methods. Some scholars also believe that the internal factors of aphthitis are the dysfunction of the internal organs caused by "spleen and stomach hidden fire" or "yin deficiency and fire excess", and their theories come from Li Dongheng's "Spleen and Stomach Theory" and "Children's Medicine and Evidence Direct Secrets". Hidden fire steams on the lips, tongue, and oral mucosa, which can cause local redness, swelling, pain, erosion, and form oral ulcers; when the virtual fire rises, the oral cavity will have ulcers that do not heal for a long time. Traditional medicine has accumulated rich experience in the treatment of oral mucositis. Licorice has the effects of clearing heat and detoxifying, tonifying the spleen and replenishing qi, and relieving pain. Licorice is often used as the main medicine in the first prescription of the formula, such as Licorice Xiexin Decoction, Yinhua Gancao Drink, etc. "Compendium of Materia Medica" records that honeysuckle has "the main detoxification, bloody diarrhea, watery diarrhea, and thick decoction", which can relieve the heat caused by chemical drugs and radiation. Statistical analysis found that traditional Chinese medicines are mostly sweet and bitter, which reduces patient compliance. At the same time, there is a lack of detailed research on the anti-inflammatory activity of related active ingredients and possible mechanisms of action, which makes it impossible to predict the efficacy and maximize the use of active ingredients. At present, Western medicine has no specific method for oral mucositis after radiotherapy, chemotherapy, and target immune therapy. It mostly uses antibiotics, local anesthetics, hormones, vitamins, cell colony stimulating factors, etc., but it has the disadvantages of low efficacy, high treatment cost and easy recurrence. Summary of the invention

[0004] In order to overcome the above-mentioned shortcomings and deficiencies of the prior art, the object of the present invention is to provide a medicine for treating oral mucositis, which has the effects of clearing away heat, detoxifying and purging fire, and can be used for symptoms such as dry mouth, sticky mouth, astringent mouth, oral ulcers, oral pain, etc. caused by oral mucositis. The clinical application effect is very good, and it is particularly suitable for oral mucositis caused by chemotherapy, radiotherapy, targeted and immunotherapy, and has no toxic side effects.

[0005] Another object of the present invention is to provide a method for preparing the above-mentioned drug for treating oral mucositis, which uses sugar and vinegar fermentation to convert small molecules into large molecules, saves materials, reduces production costs, enhances drug efficacy, and has a sweet and sour taste, better taste, and greatly improves patient compliance with medication.

[0006] The purpose of the present invention is achieved through the following technical solutions:

[0007] The present invention provides a medicine for treating oral mucositis, comprising effective ingredients of traditional Chinese medicine; the effective ingredients of traditional Chinese medicine include at least two of the following active ingredients:

[0008]

[0009] The groups on the left and right sides of R30 are both OH, and the one-letter group is O.

[0010] Preferably, the medicine for treating oral mucositis comprises 4-5 parts of licorice, 1-2 parts of coptis root, 1-2 parts of angelica root, 3-4 parts of scutellaria root, 3-4 parts of ginseng, and 1-2 parts of honeysuckle.

[0011] More preferably, the medicine for treating oral mucositis comprises 4 parts of licorice, 1 part of coptis chinensis, 1 part of angelica sinensis, 3 parts of scutellaria baicalensis, 3 parts of ginseng, and 1 part of honeysuckle.

[0012] Preferably, the oral mucositis is oral mucositis caused by chemotherapy, radiotherapy, targeted therapy or immunotherapy.

[0013] The present invention also provides a method for preparing a drug for treating oral mucositis, comprising the following steps:

[0014] 1) Add licorice, ginseng, angelica, scutellaria, coptis root, and honeysuckle into a stirring reaction pot, add water and stir;

[0015] 2) filtering to separate the residue I and the solution I, and taking out the solution I for later use;

[0016] 3) adding the residue I in step 2) into a stirring reaction pot, adding water and stirring;

[0017] 4) filtering to separate the residue II and solution II, and taking out solution II for later use;

[0018] 5) Weigh rice vinegar and sugar in a mass ratio of 3 to 5:1, and stir evenly until the sugar is completely dissolved to obtain a sweet and sour mixture;

[0019] 6) taking the medicinal residue II, adding it to the sweet and sour mixed solution of step 5), and stirring to obtain a mixture;

[0020] 7) The mixture in step 6) is placed in a sealed container for fermentation, sealed, and the temperature is controlled at 40-45° C. for 50-70 hours, and the residue is removed;

[0021] 8) adding water to the residue in step 7) and stirring;

[0022] 9) filtering and separating to obtain solution III and residue III;

[0023] 10) Solution III is filtered, concentrated and centrifuged, and the supernatant is sterilized by filtration.

[0024] Preferably, the step 1) of adding water for stirring specifically comprises: adding water at a ratio of the total mass of components to the total mass of water of 1:5-6, stirring for 5-6 hours, and a temperature of 70-80°C.

[0025] Preferably, step 3) wherein water is added for stirring is as follows: water is added at a mass ratio of the medicinal residue to water of 1:5-6, the stirring time is 5-6 hours, and the temperature is 70-80°C.

[0026] Preferably, the step 7) of adding water for stirring comprises: mixing the residues with water in a ratio of 1:5-6; heating to 80-90° C., and stirring for 4-5 hours.

[0027] Preferably, in step 6), the mass ratio of the medicinal residue II to the rice vinegar in the sweet and sour mixed solution is 1:(0.5-1).

[0028] Preferably, in step 10), the centrifugation is specifically: centrifugation at 3000-3500 rpm for 20-30 minutes. Specifically, the drug is a combined preparation, which can be a mixture or an oral solution.

[0029] Among them, mixture refers to a liquid preparation made by heating and extracting medicinal materials with water or other solvents in an appropriate way and concentrating them. It should be prepared in a clean and sterile environment and filled in a sterile, clean and dry container in a timely manner. Appropriate additives and preservatives should be added, and their types and amounts should comply with relevant regulations and should not affect the stability of the drug. It is packaged in multiple doses, which can not only maintain the characteristics of decoctions, but also avoid the troubles encountered in temporary decoctions. At the same time, the volume of the mixture is small, which is easy to carry, take and store.

[0030] Among them, oral liquid refers to a single-dose mixture, which is an oral liquid preparation made using the injection process. The oral liquid has a small dosage, is easily absorbed by the human body, has a good taste, acts on the human body quickly, and has stable quality. At the same time, the oral liquid is easy to carry and easy to store, but the cost of the oral liquid is relatively high.

[0031] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0032] (1) The drug for treating oral mucositis of the present invention has the effects of clearing away heat, detoxifying and purging fire, and can be used for symptoms such as dry mouth, sticky mouth, astringent mouth, oral ulcers, and oral pain caused by oral mucositis. The clinical application effect is very good, and it is particularly suitable for oral mucositis caused by chemotherapy, radiotherapy, targeted therapy and immunotherapy. It has no toxic side effects and will not interfere with the treatment of tumors.

[0033] (2) The method for preparing a drug for treating oral mucositis of the present invention uses sugar and vinegar fermentation to convert small molecules into large molecules, thereby saving materials, reducing production costs, and enhancing drug efficacy. At the same time, the drug has a sweet and sour taste and a better mouthfeel, and the patient's compliance with medication is greatly improved.

[0034] (3) The method for preparing the drug for treating oral mucositis of the present invention can effectively extract the components through multiple extractions, so that the components are organically integrated. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 The expression levels of IL-6 in experimental groups 1 to 5 of the examples of the present invention.

[0036] Figure 2 The expression levels of TNF-α in experimental groups 1 to 5 of the examples of the present invention. DETAILED DESCRIPTION

[0037] In order to make the purpose, technical scheme and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. Additional aspects and advantages of the present invention will be partially given in the following description, partially become apparent from the following description, or be understood through the practice of the present invention. It should be understood that the following description is only used to explain the present invention and is not intended to limit the present invention.

[0038] As used herein, the terms "comprises," "including," "having," "containing," or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a composition, process, method, article, or apparatus that comprises the listed elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such composition, process, method, article, or apparatus.

[0039] When amount, concentration or other value or parameter is expressed as range, preferred range or a series of upper preferred value and lower preferred value limit range, this should be understood as specifically disclosing all ranges formed by any pairing of any range upper limit or preferred value and any range lower limit or preferred value, regardless of whether the range is disclosed separately. For example, when disclosing range "1 to 5", described range should be interpreted as including range "1 to 4", "1 to 3", "1 to 2", "1 to 2 and 4 to 5", "1 to 3 and 5" etc. When numerical range is described in this article, unless otherwise stated, the range is intended to include its end value and all integers and fractions within the range.

[0040] Singular forms include plural references unless the context clearly indicates otherwise. "Optional" or "either" means that the subsequently described event or incident may or may not occur, and that the description includes instances where the event occurs and instances where it does not.

[0041] The indefinite articles "a" and "an" before the elements or components of the present invention have no limitation on the quantity requirements (i.e. the number of occurrences) of the elements or components. Therefore, "a" or "an" should be interpreted as including one or at least one, and the elements or components in the singular form also include the plural form, unless the quantity obviously refers to the singular form only.

[0042] In addition, the descriptions of the terms "one embodiment", "some embodiments", "examples", "specific examples", or "some examples" described below mean that the specific features, structures, materials, or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic expressions of the above terms do not necessarily refer to the same embodiment or example. Moreover, the technical features involved in the various embodiments of the present invention can be combined with each other as long as they do not conflict with each other.

[0043] Baicalin, beta-sitosterol, Stigmasterol, Berberine, Mairin, Cavidine, Coniferin and other pharmacological substances for the treatment of stomatitis have targets such as EGFR, MAPK3, AKT1, MAKP1, PIK3CA, TNF, NFKB1, SRC, etc. These targets activate related inflammatory response signaling pathways, such as Epithelial cell signaling in helicobacter pyloriinfection, IL-17signaling pathway, HIF-1signaling pathway, epithelial cell signaling in helicobacter pyloriinfection, PI3K-Akt signaling pathway, TNF signaling pathway, etc., leading to the occurrence of oral mucositis. The combined preparation of effective ingredients of the Chinese medicine formula of the present invention comprises at least two of compounds R126 (contained in licorice), R30 (contained in licorice), R38 (contained in coptis chinensis), R75 (contained in coptis chinensis), Rg5 (contained in ginseng), Rb3 (contained in ginseng), R13 (contained in scutellaria baicalensis), R83 (contained in honeysuckle), and R44 (contained in angelica sinensis). These compounds act on relevant targets of the signal pathway to achieve the effect of inhibiting inflammatory response, as shown in Table 1.

[0044] The present invention constructs a "chemical component-action target-signal pathway" network for treating oral mucositis. By analyzing the network topology, the core targets of the action network are screened out, as shown in Table 1.

[0045] Table 1 Potential active ingredients and targets for the treatment of oral mucositis

[0046]

[0047]

[0048] As can be seen from the table, drugs for treating oral mucositis may mainly play a role in treating oral mucositis by acting on key targets such as TP53, MAPK3, AKT1, MAKP1, EGFR, PIK3CA, TNF, NKB1, SRC, etc. The key signaling pathways of drugs for treating oral mucositis include Epithelial cell signaling in helicobacterpyloriinfection, IL-17signaling pathway, TNF signaling pathway, HIF-1signalingpathway, Ras signaling pathway, ErbB signaling pathway, MAPK signaling pathway, and PI3K-Akt signaling pathway.

[0049] In order to illustrate the effectiveness of the prescription of this embodiment, the following experiment was conducted: the experiment was set up with 6 groups, namely 1 model group, 1 group consisting of a liquid containing 16 parts of licorice + 4 parts of coptis chinensis, 2 groups consisting of a liquid containing 9 parts of ginseng, 3 parts of angelica, 9 parts of scutellaria, and 3 parts of honeysuckle, 3 groups consisting of a liquid containing licorice, 4 groups consisting of a liquid containing coptis chinensis, and 5 groups consisting of a liquid containing 4 parts of licorice, 3 parts of ginseng, 1 part of angelica, 3 parts of scutellaria, 1 part of coptis chinensis, and 1 part of honeysuckle.

[0050] Preparation of the drug:

[0051] 1. The preparation method of experimental group 5 is as follows:

[0052] 1) Add 4 parts of licorice, 3 parts of ginseng, 1 part of angelica, 3 parts of scutellaria, 1 part of coptis root, and 1 part of honeysuckle into a stirring reaction pot, add water at a total mass ratio of the above components to the total mass of water of 1:5-6, stir for 5-6 hours, and the temperature is 70-80°C;

[0053] 2) filtering to separate the residue I and the solution I, and taking out the solution I for later use;

[0054] 3) Add the residue I in step 2) into the reaction pot and stir, add water according to the mass ratio of the residue to water of 1:5-6, stir for 5-6 hours, and the temperature is 70-80°C;

[0055] 4) filtering to separate the residue II and solution II, and taking out solution II for later use;

[0056] 5) Take 5-10 kg of rice vinegar, add 2-3 kg of sugar, and stir evenly until the sugar is completely dissolved to obtain a sweet and sour mixture;

[0057] 6) taking 10 kg of the medicinal residue II, adding it to the sweet and sour mixed solution of step 5), and stirring to obtain a mixture;

[0058] 7) The mixture in step 6) is placed in a sealed container for fermentation, sealed, and the temperature is controlled at 40-45° C. for 50-70 hours. When the residue is fermented to produce a large amount of enzymes and mycelium, the residue is taken out;

[0059] 8) Mix the residue in step 7) with water in a ratio of 1:5-6; heat to 80-90°C and stir for 4-5 hours:

[0060] 9) filtering and separating to obtain solution III and residue III;

[0061] 10) Filter solution III and concentrate it into 100 ml. Centrifuge the obtained drug solution at 3000 rpm for 30 minutes, take the supernatant and sterilize it by filtering with a 0.22 μM filter, and dilute it with 1640 complete medium at a dilution ratio of 1:10, 1:100, 1:1000, and 1:10000.

[0062] In terms of invention preparation, Group 5 of this experiment used multiple extractions to effectively extract the ingredients, organically integrate the ingredients, and produce unexpected effects. Sweet and sour fermentation turned small molecules into large molecules, saving materials, reducing production costs, enhancing efficacy, and making the taste sweet and sour, with a better taste, greatly improving patient compliance with medication.

[0063] 2. Preparation method of experimental groups 1 to 4:

[0064] Weigh the corresponding drugs according to the formula ratio, add appropriate amount of water and boil twice, combine the drug solution, filter, and concentrate to 100 ml. Centrifuge the obtained drug solution at 3000rpm for 30min, take the supernatant and filter it with a 0.22uM filter for sterilization, and dilute it with 1640 complete culture medium. The dilution ratios are 1:10, 1:100, 1:1000, and 1:10000.

[0065] Effect of drug stimulation on the inhibition of THP-1 cell inflammatory response: THP-1 macrophages differentiated by PMA were stimulated with 1 μg / ml lipopolysaccharide. THP-1 cells in good growth state were cultured at 1×10 ^6 The cells were plated in 6-well plates. The control group was treated with 1ug / ml LPS. The experimental group was treated with culture medium containing different Chinese medicine components at different concentrations (the ratio of drug to culture medium was 1:10, 1:100, 1:1000, 1:10000) for 24 hours. The cell pellets were collected for qRT-PCR experiments, and total RNA was extracted. After reversal, the mRNA expression of IL-6 and TNF-α was detected. The amplified genes included TNF-α, IL-6 and GAPDH, and two replicate wells were set.

[0066] Depend on Figure 2 It can be seen that the expression of IL-6 in groups 2, 4, and 5 of this experiment was significantly lower than that in the other three groups (P < 0.05), among which, the expression of IL-6 in groups 4 and 5 of this experiment at a dilution ratio of 1:100 was significantly lower than that in the other four groups (P < 0.001), and the expression of IL-6 in group 5 of this experiment at a dilution ratio of 1:10 was significantly lower than that in the other three groups (P < 0.001). This suggests that the five groups of the present invention have a more significant anti-inflammatory effect.

[0067] Depend on Figure 2 It can be seen that the expression of TNF-α in the five groups of this experiment was significantly lower than that in the other four groups (P<0.05). Among them, the expression of TNF-α in the dilution ratio of 1:10 in the groups 2, 3 and 5 was significantly lower than that in the other two groups (P<0.001). The expression of TNF-α in the groups 3, 4 and 5 was significantly lower than that in the other three groups at a dilution ratio of 1:100 (P<0.001). The expression of TNF-α in the groups 4 and 5 was significantly lower than that in the other four groups at a dilution ratio of 1:1000 (P<0.01), indicating that the five groups of the drug of the present invention have obvious anti-inflammatory effects.

[0068] In order to further illustrate the efficacy of the formula of this embodiment, this embodiment provides the following clinical data (which has been reviewed by the Medical Ethics Committee of Dongyang People's Hospital, Ethics Approval No.: Dongrenyi2024-YX-297):

[0069] From September 2024 to December 2024, 60 subjects were recruited by random number method, and all patients were randomly divided into two groups, namely observation group and control group. There were 30 cases in the observation group, including 16 males and 12 females, aged 31-79 years old, with an average age of 56±6 years old; there were 30 cases in the control group, including 12 males and 18 females, aged 32-79 years old, with an average age of 59±3 years old. There was no statistically significant difference between the two groups in terms of age, symptoms, clinical tests, etc. (P>0.05).

[0070] 1. Inclusion criteria: 1) Patients with a confirmed pathological diagnosis of malignant tumors; 2) Patients with oral mucositis caused by chemotherapy, targeted therapy, immunotherapy or radiotherapy; 3) Expected survival period > 3 months; 4) Good general physical condition (ECOGPS < 2 points); 5) The patient signed the informed consent.

[0071] 2. Exclusion criteria: 1) Patients with oral mucositis confirmed by examination as allergic, mechanical injury (such as burns, bites or scrapes), autoimmune diseases (such as systemic lupus erythematosus), or vitamin B deficiency; 2) Patients who did not use the medication as prescribed; 3) Patients whose efficacy could not be determined or whose data were incomplete and affected the efficacy or safety judgment; 4) Patients who were pregnant or preparing to become pregnant, or were breastfeeding women; 5) Patients with allergic constitution; 6) Patients who had used other drugs to treat oral mucositis.

[0072] 3. Treatment methods: 1) Observation group: Take the Chinese medicine formula preparation of the embodiment (Group 5), 15 ml each time, orally, twice a day, 7 days as a course of treatment, two courses of treatment; 2) Control group: 5 tablets of nystatin + 1 enema mixture, appropriate amount, apply to the mouth, twice a day, 7 days as a course of treatment, two courses of treatment. After one month of medication, the big data will be used to export the patient information, randomly select the patient information that meets the requirements of the observer and control group medication, and follow up by telephone or outpatient follow-up to evaluate the therapeutic effect of the formula.

[0073] 4. Efficacy evaluation: 1) Cured: Clinical symptoms of oral mucositis are alleviated within 3 days of medication, and clinical symptoms of oral mucositis disappear within 7 days, and oral mucosal lesions disappear. 2) Significantly effective: Clinical symptoms of oral mucositis are alleviated within 7 days of medication, and oral lesions are significantly improved. 3) Ineffective: Clinical symptoms of oral mucositis are slightly alleviated, and there is no obvious change in oral mucosal lesions.

[0074] 5. Statistical methods: Using X 2 The data between the groups were compared by test, and P < 0.05 was considered statistically significant.

[0075] 6. Crossover is allowed: 1) Crossover is allowed: if the patient has adverse reactions, the patient can be transferred to the control group; 2) if the patient voluntarily gives up the experiment, the patient can be transferred to the control group; 3) if the observation group is evaluated as ineffective after one course of treatment, the patient can be transferred to the control group. 4) if the control group is evaluated as ineffective after one course of treatment, the patient can be transferred to the observation group.

[0076] 7. Research results: The total effective rate of 30 cases in the observation group was 93.3%, and that in the control group was 96.7%. There was no significant difference between the two groups (P < 0.05). The results are shown in Table 2.

[0077] Table 2 Comparison of clinical efficacy of oral mucositis in the observation group and the control group

[0078]

[0079]

[0080] Conclusion: The prescription of the present invention has significant efficacy and can achieve a non-inferior effect to the use of antibiotics in improving oral mucositis. It can reduce the use of antibiotics in future anti-tumor drug (chemotherapy, targeted, immunotherapy) treatment and oral mucositis caused by radiotherapy.

[0081] The above embodiments are preferred implementation modes of the present invention, but the implementation modes of the present invention are not limited to the embodiments. Any other changes, modifications, substitutions, combinations, and simplifications that do not deviate from the spirit and principles of the present invention should be equivalent replacement methods and are included in the protection scope of the present invention.

Claims

1. A drug for treating oral mucositis, characterized in that: The effective ingredients of traditional Chinese medicine include at least two of the following active ingredients:

2. The medicament for treating oral mucositis according to claim 1, characterized in that By weight, it comprises 4-5 parts of licorice, 1-2 parts of coptis root, 1-2 parts of angelica root, 3-4 parts of scutellaria root, 3-4 parts of ginseng, and 1-2 parts of honeysuckle.

3. The medicament for treating oral mucositis according to claim 1, characterized in that Contains 4 parts of licorice, 1 part of coptis chinensis, 1 part of angelica, 3 parts of scutellaria baicalensis, 3 parts of ginseng, and 1 part of honeysuckle.

4. The medicament for treating oral mucositis according to claim 1, characterized in that The oral mucositis is oral mucositis caused by chemotherapy, radiotherapy, targeted therapy or immunotherapy.

5. The method for preparing the medicament for treating oral mucositis according to any one of claims 1 to 4, characterized in that: The following steps are involved: 1) Add licorice, ginseng, angelica, scutellaria, coptis root, and honeysuckle into a stirring reaction pot, add water and stir; 2) filtering to separate the residue I and the solution I, and taking out the solution I for later use; 3) adding the residue I in step 2) into a stirring reaction pot, adding water and stirring; 4) filtering to separate the residue II and solution II, and taking out solution II for later use; 5) Weigh rice vinegar and sugar in a mass ratio of 3 to 5:1, and stir evenly until the sugar is completely dissolved to obtain a sweet and sour mixture; 6) taking the medicinal residue II, adding it to the sweet and sour mixed solution of step 5), and stirring to obtain a mixture; 7) The mixture in step 6) is placed in a sealed container for fermentation, sealed, and the temperature is controlled at 40-45° C. for 50-70 hours, and the residue is removed; 8) Add water to the residue in step 7) and stir; 9) filtering and separating to obtain solution III and residue III; 10) Solution III is filtered, concentrated and centrifuged, and the supernatant is sterilized by filtration.

6. The method for preparing a drug for treating oral mucositis according to claim 5, characterized in that: The step 1) of adding water and stirring is specifically as follows: adding water at a ratio of the total mass of the components to the total mass of water of 1:5-6, stirring for 5-6 hours, and the temperature is 70-80°C.

7. The method for preparing a drug for treating oral mucositis according to claim 5, characterized in that: Step 3) adding water and stirring; specifically, adding water according to the mass ratio of the medicinal residue to water of 1:5-6, stirring time of 5-6 hours, temperature of 70-80°C.

8. The method for preparing a drug for treating oral mucositis according to claim 5, characterized in that: Step 7) adding water for stirring, specifically: mixing at a ratio of dregs to water of 1:5-6; heating to 80-90° C., stirring for 4-5 hours.

9. The method for preparing a drug for treating oral mucositis according to claim 5, characterized in that: In step 6), the mass ratio of the medicinal residue II to the rice vinegar in the sweet and sour mixed solution is 1:(0.5-1).

10. The method for preparing a drug for treating oral mucositis according to claim 5, characterized in that: In step 10), the centrifugation is specifically: centrifugation at 3000-3500 rpm for 20-30 minutes.

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