A traditional Chinese medicine composition for treating multiple oral ulcers associated with anti-tumor targeted drugs

Abstract

The present invention discloses a traditional Chinese medicine composition for treating multiple oral ulcers associated with anti-tumor targeted drugs. The raw materials and their weight percentages of the traditional Chinese medicine composition are as follows: 28-32 parts of Astragalus, 9.5-10.5 parts of Chuanxiong, 9.5-10.5 parts of Anemarrhena, 9.5-10.5 parts of Bletilla, 9.5-10.5 parts of Corydalis, 9.5-10.5 parts of Cynanchum, and 9.5-10.5 parts of Licorice. The traditional Chinese medicine composition can treat oral ulcers caused by targeted drugs, ensuring that tumor patients can complete the treatment cycle with sufficient dosage and duration.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition for treating multiple oral ulcers associated with anti-tumor targeted drugs, as well as a preparation method and application thereof. Background Art

[0002] Oral ulcers (OM), also known as "mouth sores," were first described in the Yellow Emperor's Classic of Internal Medicine. They are common ulcerative lesions of the oral mucosa and are the most common oral mucosal disease. The occurrence of OM is unrelated to age, gender, or ethnicity, and is characterized by universality, cyclicity, and recurrence. Symptoms commonly occur on the inner lips, tongue, buccal mucosa, vestibular groove, and soft palate. These mucosa lack or have poor keratinization, and exhibit clinical characteristics of "yellow, red, concave, and painful" (i.e., the lesion is covered with a yellow pseudomembrane, surrounded by a red, congested halo, and with a central depression and pronounced burning pain). OM attacks are characterized by intense pain, with pronounced localized burning pain. In severe cases, OM can affect eating and speaking, causing significant inconvenience in daily life. Symptoms can also include systemic symptoms such as bad breath, chronic pharyngitis, constipation, headache, dizziness, nausea, fatigue, irritability, insomnia, and lymphadenopathy.

[0003] Oral ulcers can be caused by a variety of factors, such as exogenous heat evil, improper diet, emotional depression, and congenital deficiency. Endogenous heat is the basic cause of oral ulcers, and heat congestion and blood stasis are the central link in the onset of the disease. The location of the lesions is related to the five internal organs, but the main disease is located in the heart, spleen, and kidney, with the spleen being the most serious. The earliest diagnosis and classification of oral ulcers can be found in the Treatise on the Origin and Symptoms of Various Diseases. The explanations of the etiology and pathogenesis of oral ulcers by doctors of all dynasties can be summarized into five types: exogenous wind-heat type, heart and spleen heat accumulation type, yin deficiency and fire excess type, spleen and stomach weakness type, and yang deficiency and fire floating type. For cancer patients using targeted drugs, the pathogenesis of oral ulcers often shows a mixed feature of deficiency and excess. This is related to the characteristics of the tumor as deficiency in the root and excess in the superficial, and is also related to the adverse reactions of targeted drugs that mobilize blood and consume qi.

[0004] Modern medicine believes that the main causes of oral ulcers include immune factors, genetic factors, systemic disease factors, environmental factors, and microcirculatory disorders. Cancer patients have multiple predisposing factors, including immune dysfunction and nutritional disorders, as well as multi-system damage caused by chemotherapy, radiotherapy, targeted therapy, and immunotherapy. Numerous studies have explored the mechanisms and treatments of oral ulcers caused by chemotherapy and radiotherapy. Targeted anti-tumor drugs and immunotherapies are emerging new anti-cancer treatments over the past decade. Clinical use has shown that patients receiving targeted drug therapy are also prone to recurrent oral ulcers, which can affect their ability to eat and even lead to life-threatening complications such as bleeding and infection. Commonly used targeted anti-cancer drugs in clinical practice, such as mTOR inhibitors and EGFR-TKIs, can cause oral ulcers to varying degrees. However, oral ulcers associated with targeted drugs are distinct from those caused by chemotherapy and radiotherapy. Compared to oral mucositis (OM) caused by traditional radiotherapy and chemotherapy, OM caused by molecularly targeted drugs and immunotherapy differs in that the lesions are often more diffuse, extensive, and poorly defined, covered with a pseudomembrane composed of fibrin, leukocytes, and epithelial fragments, and often complicated by fungal infections, which severely impact patients' quality of life. Severe cases may lead to drug dose adjustments or treatment discontinuation. Overall, compared to OM caused by radiotherapy and chemotherapy, OM caused by targeted drugs is generally milder and less likely to experience severe adverse events. However, it can significantly impact patients' quality of life during treatment and reduce their compliance. Therefore, alleviating patients' oral ulcer symptoms is a key issue that needs to be addressed during the application of targeted drugs. Summary of the Invention

[0005] The present invention is based on the inventor's discovery and understanding of the following facts and problems:

[0006] The drugs used to treat oral ulcers mainly include external treatment and oral drugs. External drugs mainly include gargles, local patches, oral sprays, etc.; internal drugs mainly include vitamin B2 complex, vitamin C, Niuhuang Jiedu tablets, etc. In recent years, with the deepening of clinical research, some new products for treating oral ulcers such as cedidiodine tablets, dexamethasone acetate patches, penicillin V potassium buccal tablets, etc. have appeared on the market. However, due to the failure to treat oral ulcers caused by targeted drugs, the clinical effect is not good. The relevant technology also discloses a variety of traditional Chinese medicine prescriptions for OM caused by radiotherapy and chemotherapy, and the traditional Chinese medicine prescriptions used are different according to the different understandings of the etiology and pathogenesis of OM, but there are few related studies on oral ulcers caused by targeted drugs.

[0007] The present invention aims to address, at least to a certain extent, one of the technical problems in the related art. To this end, embodiments of the present invention provide a traditional Chinese medicine composition for treating multiple oral ulcers associated with targeted anti-tumor drugs. This composition is capable of treating or alleviating oral ulcers caused by targeted drugs, ensuring that cancer patients can complete their treatment cycle with adequate dosage and duration. The present invention aims to leverage the advantages of traditional Chinese medicine to alleviate the pain and discomfort of oral ulcers caused by targeted drugs, thereby improving patient tolerance and compliance during treatment with targeted anti-tumor drugs.

[0008] The embodiment of the present invention adopts the following technical solutions:

[0009] The embodiment of the present invention provides a traditional Chinese medicine composition for treating multiple oral ulcers associated with anti-tumor targeted drugs. The raw materials and their mass fractions of the traditional Chinese medicine composition are as follows:

[0010] 28-32 parts of Astragalus, 9.5-10.5 parts of Chuanxiong, 9.5-10.5 parts of Anemarrhena, 9.5-10.5 parts of Bletilla, 9.5-10.5 parts of Corydalis, 9.5-10.5 parts of Cynanchum, and 9.5-10.5 parts of Licorice.

[0011] It should be noted that in the formula of the above-mentioned Chinese medicine composition, the weight of each medicine is calculated based on the raw medicine, and can be increased or decreased according to the corresponding proportion during production.

[0012] Preferably, the raw materials of the traditional Chinese medicine composition and their mass fractions are: 30 parts of Astragalus, 10 parts of Chuanxiong, 10 parts of Anemarrhena, 10 parts of Bletilla, 10 parts of Corydalis, 10 parts of Cynanchum, and 10 parts of Licorice.

[0013] An embodiment of the present invention also provides a traditional Chinese medicine preparation for treating multiple oral ulcers associated with anti-tumor targeted drugs. The traditional Chinese medicine preparation comprises the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable excipients, and is prepared using conventional pharmaceutical preparation techniques.

[0014] In some embodiments, the excipients include at least one of a sustained-release agent, a diluent, a lubricant, an emulsifier, a plasticizer, a glidant, a filler, a binder, a wetting agent, an absorption enhancer, and a surfactant.

[0015] In some embodiments, the dosage form of the Chinese medicine preparation is a decoction, granules or spray.

[0016] The present invention also provides a method for preparing the above-mentioned Chinese medicine preparation, wherein the Chinese medicine preparation is a decoction, and the method for preparing the decoction comprises the following steps:

[0017] Weigh the raw material slices according to the above mass fractions, add 1000 parts by volume of water after mixing, soak for 30 minutes, boil in water, and continue to boil on low heat for 30 minutes;

[0018] The decoction was filtered to obtain a first filtrate and a first filter residue. The first filter residue was removed and decocted again with water until the water was enough to cover the residue. After boiling, the decoction was simmered for 10 minutes. The decoction was filtered to obtain a second filtrate and a second filter residue.

[0019] The first filtrate and the second filtrate are mixed, and decocted on low heat until the volume reaches 150 parts by volume, thereby obtaining the water decoction.

[0020] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine preparation, wherein the traditional Chinese medicine preparation is a granule. The method for preparing the granule comprises the following steps:

[0021] The raw medicinal pieces are weighed according to the above mass fractions, mixed, and then soaked in 500 parts by volume of water for 30 minutes. 580 parts by volume of water are added for the first decocting step, followed by 460 parts by volume of water for the second and third decocting steps, each for 1.5 hours. The filtrates from the three filtrations are combined and filtered through a 200-mesh sieve. The mixture is then concentrated under a vacuum of -0.06 to -0.08 MPa and a temperature of 70-80°C to a relative density of 1.20-1.25 (at 50°C) to obtain a clear paste. A one-step granulation method is used, using a base of dextrin and mannitol in a ratio of 8:1, and the clear paste is sprayed into the mixture to obtain granules.

[0022] The present invention also provides an embodiment of the use of the above-mentioned Chinese medicine composition or the above-mentioned Chinese medicine preparation as a medicine, wherein the medicine is used for at least one of the following:

[0023] (1) Prevent or treat multiple oral ulcers associated with anti-tumor targeted drugs;

[0024] (2) Alleviate the symptoms of oral mucosal adverse reactions associated with anti-tumor targeted drugs;

[0025] (3) Improve the quality of life of cancer patients during targeted drug treatment.

[0026] In some embodiments, the targeted drug includes one or more of an mTOR inhibitor, an EGFR / Her2 inhibitor, a VEGF inhibitor, a BCR-ABL inhibitor, an ALK inhibitor, and a multi-target TKI inhibitor.

[0027] In some embodiments, the targeted drug includes one or more of everolimus, afatinib, lapatinib, gefitinib, erlotinib, dacomitinib, cetuximab, apatinib, sorafenib, axitinib, pazopanib, sunitinib, lenvatinib, cabozantinib, bevacizumab, imatinib, crizotinib, and anlotinib.

[0028] The compatibility mechanism of the prescription of the present invention is as follows: the Chinese medicine composition of the present invention, in which the Radix Astragali can invigorate Qi and strengthen the spleen, dispel toxins and promote tissue regeneration, is used to treat carbuncle, long-term ulcer, is good at reaching the skin and skin, is specialized in clearing the skin surface, and is used to treat both the symptoms and the root cause, and is the main medicine. The Rhizoma Chuanxiong can promote Qi and blood circulation, resolve blood stasis and relieve stagnation, and when Qi and blood are unobstructed, heat is cleared, swelling is reduced, and pain is stopped. When it is matched with the Radix Astragali, the power of promoting Qi and blood circulation is increased, and there is no disadvantage of damaging the vital energy. The Radix Corydalis has a bitter and cold nature, which can directly break the heat, reduce swelling and detoxify, and can clear the heat in the Qi and relieve the heat in the blood. The two medicines are combined to promote Qi and blood circulation, clear heat and reduce swelling, and are the minister medicines. The power of Bletilla striata to reduce swelling and promote tissue regeneration is excellent, and it is a good medicine for treating ulcers and can accelerate the healing of ulcers. The Radix Cynanchum is pungent and warm, which can strengthen the power of Rhizoma Chuanxiong to promote blood circulation, enhance the power of Rhizoma Chuanxiong to reduce swelling, and the Radix Cynanchum has a good analgesic effect. Anemarrhena enters the kidneys and acts as a water-producing agent. Excessive water quenches fire, and it can prevent the heat-inducing damage to body fluids caused by Astragalus, Chuanxiong, and Cynanchum chinense. These three herbs together serve as an adjuvant. Licorice root, sweet in flavor and neutral in nature, clears away heat and detoxifies, harmonizes the other herbs, relieves the redness, swelling, heat, and pain of ulcers, and regulates the qi, blood, and yin and yang of the internal organs, serving as an adjuvant. The combination of these herbs treats both the symptoms and the root cause, regulates qi and blood, and balances both the physical and mental aspects. Astragalus, Bletilla striata, Chuanxiong, and Cynanchum chinense have excellent anti-tumor effects and can be used as an adjuvant in the treatment of the primary disease.

[0029] The present invention has the following advantages and beneficial effects:

[0030] After years of research and observation, the inventor has formed a Chinese medicine prescription for treating oral ulcers related to targeted drugs. The Chinese medicine composition of the present invention has the effects of replenishing qi and activating blood circulation, clearing away heat and reducing swelling, nourishing yin and purging fire, and is mainly used to treat qi deficiency and blood stasis, yin deficiency and hyperactivity of fire, and other symptoms. The present invention overcomes the drawbacks of other prescriptions for treating oral ulcers that only focus on clearing away heart fire, and distinguishes the different clinical manifestations and causes of oral ulcers caused by chemotherapy and targeted drugs. From a holistic perspective, the effects of clearing fire, nourishing yin, replenishing qi, and activating blood circulation are taken into account, and both the symptoms and the root cause are taken into account. The Chinese medicine diagnosis and treatment are mainly based on disease differentiation and syndrome differentiation, and the dialectical thinking of treatment is highlighted. The Chinese medicinal materials in the prescription can be added or subtracted according to clinical symptoms, and the treatment of local ulcers and the balance of the whole body are taken into account. Clinical practice, using Chinese medicine to improve the body's immune disorder, improve blood circulation in the affected area, and promote the healing of ulcer wounds, the present invention's replenishing qi and removing blood stasis go hand in hand, clearing heat and nourishing yin are coordinated, and both deficiency and excess are treated, with treatment of excess as the main focus. It enables the body to achieve yin and yang balance, smooth flow of qi and blood, and coordinated function of internal organs. It can significantly improve the patient's clinical symptoms and TCM signs, and is easy to use clinically. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 1 is a comparison chart of typical case 1 before and after treatment with the water decoction (gargle) of Example 2 of the present invention (left side: 0 day, right side: 14 day).

[0032] Figure 2 1 is a comparison chart of typical case 1 before and after treatment with the water decoction (gargle) of Example 2 of the present invention (left side: 0 day, right side: 14 day). DETAILED DESCRIPTION

[0033] The embodiments of the present invention are described in detail below, and examples of the embodiments are shown in the accompanying drawings. The embodiments described below with reference to the accompanying drawings are exemplary and intended to be used to explain the present invention, but should not be understood as limiting the present invention.

[0034] Unless otherwise stated, the raw materials and reagents used in the following examples are commercially available or can be prepared by known methods.

[0035] Unless otherwise defined, scientific and technical terms used herein have the same meanings as commonly understood by those skilled in the art.

[0036] In this document, the terms “comprise” and “include” are open-ended expressions, that is, they include the contents specified in the present invention, but do not exclude other contents.

[0037] Where values ​​are described herein as ranges, it should be understood that such disclosure includes disclosure of all possible sub-ranges within that range, as well as specific values ​​falling within that range, regardless of whether a specific value or sub-range is explicitly stated.

[0038] In this document, relational terms such as “first” and “second” are used merely to distinguish one entity or element from another entity or element, but do not necessarily require or imply any actual relationship or order between these entities or elements.

[0039] In this document, "a plurality of" means at least two, unless otherwise clearly and specifically defined.

[0040] Example 1

[0041] A traditional Chinese medicine composition for treating multiple oral ulcers associated with anti-tumor targeted drugs, the raw materials comprising:

[0042] Astragalus 30g, Chuanxiong 10g, Anemarrhena 10g, Bletilla striata 10g, Corydalis 10g, Cynanchum chinense 10g, Licorice root 10g.

[0043] Example 2

[0044] A water decoction of a traditional Chinese medicine composition for treating multiple oral ulcers associated with anti-tumor targeted drugs comprises the following steps:

[0045] Take 90g of Chinese herbal medicine slices of Astragalus 30g, Chuanxiong 10g, Anemarrhena 10g, Bletilla striata 10g, Corydalis 10g, Cynanchum 10g, and Licorice 10g, mix them, add 1000ml of water and soak for 30 minutes. Decoct all the herbs with water until boiling, and continue to simmer for 30 minutes.

[0046] The decoction obtained is filtered to obtain a first filtrate and a first filter residue; the first filter residue is removed, and water is added and decocted again, with the amount of water added being sufficient to cover the decoction residue; after boiling, the decoction is simmered on low heat for 10 minutes, and the decoction obtained is filtered to obtain a second filtrate and a second filter residue;

[0047] The first filtrate and the second filtrate are mixed, and decocted on a low fire until the volume reaches 150 ml, thereby obtaining the water decoction of the Chinese medicine composition (mouthwash).

[0048] When using, rinse for 2-3 minutes each time, 20-30ml / time, 5-6 times a day, for 2 weeks.

[0049] Example 3

[0050] A Chinese medicine composition granule for treating multiple oral ulcers associated with anti-tumor targeted drugs, comprising the following steps:

[0051] Take 30g of Astragalus, 10g of Chuanxiong, 10g of Anemarrhena, 10g of Bletilla, 10g of Corydalis, 10g of Cynanchum, and 10g of Licorice, a total of 90g, mix them, add 500ml of water and soak for 30 minutes. Add 580ml of water for the first time and boil for 1.5 hours, add 460ml of water for the second and third times and boil for 1.5 hours. Combine the filtrates obtained by the three filtrations, filter through a 200-mesh sieve, and concentrate under a vacuum degree of -0.06 to -0.08MPa and a temperature of 70-80°C to a relative density of 1.20-1.25 (50°C) to obtain a clear paste; adopt a one-step granulation method, press dextrin and mannitol 8:1 as the base material, spray the clear paste into it, and obtain granules. After packaging, the Chinese medicine composition granules are obtained.

[0052] When using, dissolve it in warm water and rinse with water for 2-3 minutes each time, 20-30ml / time, 5-6 times a day, for 2 weeks.

[0053] Clinical data

[0054] A total of 37 patients with oral ulcers caused by targeted anti-tumor drugs were observed clinically and randomly divided into a treatment group and a control group. The control group consisted of a blank control. After excluding 3 patients who dropped out, a total of 34 patients were included in the analysis: 16 in the treatment group and 18 in the control group. Patient characteristics are shown in Table 1.

[0055] Table 1. Patients' basic information

[0056]

[0057] According to the CTCAE 5.0 common adverse event diagnostic criteria for oral mucosal injury: oral mucosal injury is graded as follows:

[0058] Graded clinical manifestations

[0059] Grade I: Asymptomatic or mild; no treatment required

[0060] Grade II: Severe pain or ulcer; does not affect oral intake; requires dietary adjustment

[0061] Grade III severe pain; affects oral intake

[0062] Grade IV Life-threatening; urgent treatment required

[0063] Level V Death

[0064] Research method: A prospective analysis clinical research method was used.

[0065] Treatment plan: Continue with the original dose of the anti-tumor drug while simultaneously administering the Chinese medicine composition of the present invention (prepared according to the method in Example 2). Administration of the present invention involves gargling the composition for 2-3 minutes, 20-30 ml per rinse, 5-6 times daily for 14 consecutive days. Symptoms and signs of oral mucosal lesions were compared before and after treatment on days 7 and 14 to evaluate efficacy.

[0066] Markedly effective: the grade decreased by 1 level after medication;

[0067] Effective: The grade decreased by more than 1 level after medication;

[0068] Ineffective: No change in grade after medication or an increase of 1 grade or more.

[0069] Statistical methods: GraphPad Prism 5 software was used for statistical analysis.

[0070] Results: Without changing the intensity of anti-tumor treatment, through the clinical research and treatment of OM related to various anti-tumor targeted drugs, the use of the traditional Chinese medicine prescription provided by this application for gargling can effectively relieve the pain caused by oral ulcers and promote the healing of ulcer wounds. We observed a total of 37 patients in the clinic. The control group was selected as a blank control. Excluding 3 cases of dropout, a total of 34 cases were included in the statistics, including 16 cases in the experimental group and 18 cases in the control group. The targeted drugs covered included 8 cases of EGFR inhibitors and 26 cases of angiogenesis inhibitors. The patients gargled for 2 consecutive weeks as a course of treatment, and the degree of relief of oral ulcers before and after treatment was evaluated, and divided into significant effect, effective, and ineffective. The results are shown in Table 2. It can be seen from Table 2 that the drug of this application is effective in reducing multiple oral ulcers related to anti-tumor targeted drugs, and its significant efficacy and effectiveness are significantly higher than those of the control group.

[0071] Table 2 Evaluation of therapeutic efficacy after treatment

[0072]

[0073] Typical Case 1

[0074] Ms. Li, 67 years old, a patient with advanced gynecological cancer, developed patchy ulcers on the oral mucosa for 2 months after taking lenvatinib orally, accompanied by pain, which seriously affected the patient's eating. She gargled with various mouthwashes available on the market for 1 month without any improvement. She used the Chinese medicine compound mouthwash of Example 2, gargling for 2-3 minutes each time, about 20-30 ml / time, 5-6 times a day. The pain was relieved the next day, and the symptoms gradually alleviated after 2 weeks. The dose of targeted drug was not reduced.

[0075] Typical Case 2

[0076] Zhang, female, 72 years old, a patient with advanced non-small cell lung cancer (adenocarcinoma), developed oral mucosal ulcers with local pain and discomfort one month after taking osimertinib orally. She gargled with various mouthwashes and patches available on the market for one month without any improvement. She used the Chinese medicine compound mouthwash of Example 2, gargling for 2-3 minutes each time, about 20-30 ml / time, 5-6 times a day. The pain was relieved the next day, and the symptoms gradually alleviated after 2 weeks. The dose of targeted drug was not reduced.

[0077] In the present invention, the terms "one embodiment," "some embodiments," "example," "specific example," or "some examples" 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 representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described can be combined in any appropriate manner in any one or more embodiments or examples. In addition, those skilled in the art can combine and combine different embodiments or examples described in this specification, as well as features of different embodiments or examples, unless they are mutually inconsistent.

[0078] Although the embodiments of the present invention have been shown and described above, it will be understood that the above embodiments are illustrative and are not to be construed as limitations on the present invention. A person skilled in the art may change, modify, replace and modify the above embodiments within the scope of the present invention.

Claims

1. A Chinese medicine composition for treating multiple oral ulcers associated with anti-tumor targeted drugs, characterized in that: The raw materials and their weight fractions of the Chinese medicine composition are as follows: 28-32 parts of Astragalus, 9.5-10.5 parts of Chuanxiong, 9.5-10.5 parts of Anemarrhena, 9.5-10.5 parts of Bletilla, 9.5-10.5 parts of Corydalis, 9.5-10.5 parts of Cynanchum, and 9.5-10.5 parts of Licorice.

2. A Chinese medicine composition for treating multiple oral ulcers associated with anti-tumor targeted drugs according to claim 1, characterized in that: The raw materials of the traditional Chinese medicine composition and their weight parts are: 30 parts of astragalus, 10 parts of chuanxiong, 10 parts of anemarrhena, 10 parts of bletilla, 10 parts of scutellaria, 10 parts of cynanchum, 10 parts of licorice.

3. A Chinese medicine preparation for treating multiple oral ulcers associated with anti-tumor targeted drugs, characterized in that: The Chinese medicine preparation is prepared from the Chinese medicine composition according to claim 1 or 2 and pharmaceutically acceptable excipients using conventional pharmaceutical preparation techniques.

4. A Chinese medicine preparation for treating multiple oral ulcers associated with anti-tumor targeted drugs according to claim 3, characterized in that: The auxiliary materials include at least one of a sustained-release agent, a diluent, a lubricant, an emulsifier, a plasticizer, a glidant, a filler, a binder, a wetting agent, an absorption promoter and a surfactant.

5. A Chinese medicine preparation for treating multiple oral ulcers associated with anti-tumor targeted drugs according to claim 3, characterized in that: The dosage form of the traditional Chinese medicine preparation is water decoction, granules or spray.

6. The method for preparing the Chinese medicine preparation according to claim 5, characterized in that: The Chinese medicine preparation is a water decoction, and the preparation method of the water decoction comprises the following steps: Weigh the raw material medicine slices according to the mass fractions of claim 1 or 2, add 1000 parts by volume of water after mixing, soak for 30 minutes, boil in water, and continue to boil on low heat for 30 minutes; The decoction was filtered to obtain a first filtrate and a first filter residue. The first filter residue was removed and decocted again with water until the water was enough to cover the residue. After boiling, the decoction was simmered for 10 minutes. The decoction was filtered to obtain a second filtrate and a second filter residue. The first filtrate and the second filtrate are mixed, and decocted on low heat until the volume reaches 150 parts by volume, thereby obtaining the water decoction.

7. The method for preparing the Chinese medicine preparation according to claim 5, characterized in that: The Chinese medicine preparation is a granule, and the preparation method of the granule comprises the following steps: The raw medicinal slices are weighed according to the mass fractions described in claim 1 or 2, mixed, and then 500 parts by volume of water are added and soaked for 30 minutes; 580 parts by volume of water are added for the first time and decocted for 1.5 hours, and 460 parts by volume of water are added for the second and third times and decocted for 1.5 hours; the filtrates obtained by the three filtrations are combined and filtered through a 200-mesh sieve; then, the filtrates are concentrated under a vacuum degree of -0.06 to -0.08 MPa and a temperature of 70-80°C, and the relative density at 50°C is 1.20-1.25 to obtain a clear paste; a one-step granulation method is adopted, dextrin and mannitol are used as a base material in a ratio of 8:1, and the clear paste is sprayed into the base to obtain granules.

8. Use of the Chinese medicine composition according to claim 1 or 2 or the Chinese medicine preparation according to claim 3, 4 or 5 in preparing medicines, characterized in that: The drug is used for at least one of the following: (1) Prevent or treat multiple oral ulcers associated with anti-tumor targeted drugs; (2) Alleviate the symptoms of oral mucosal adverse reactions associated with anti-tumor targeted drugs; (3) Improve the quality of life of cancer patients during targeted drug treatment.

9. The use according to claim 8, characterized in that The targeted drugs include one or more of mTOR inhibitors, EGFR / Her2 inhibitors, VEGF inhibitors, BCR-ABL inhibitors, ALK inhibitors, and multi-target TKI inhibitors.

10. The use according to claim 8, characterized in that The targeted drugs include one or more of everolimus, afatinib, lapatinib, gefitinib, erlotinib, dacomitinib, cetuximab, apatinib, sorafenib, axitinib, pazopanib, sunitinib, lenvatinib, cabozantinib, bevacizumab, imatinib, crizotinib, and anlotinib.

Images