CN117695357A - Traditional Chinese medicine composition for treating tumor targeting drug-related multiple dental ulcers - Google Patents
Traditional Chinese medicine composition for treating tumor targeting drug-related multiple dental ulcers Download PDFInfo
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- CN117695357A CN117695357A CN202311464191.2A CN202311464191A CN117695357A CN 117695357 A CN117695357 A CN 117695357A CN 202311464191 A CN202311464191 A CN 202311464191A CN 117695357 A CN117695357 A CN 117695357A
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Abstract
The invention discloses a traditional Chinese medicine composition for treating tumor-targeted drug-related multiple dental ulcers, which comprises the following raw materials in parts by weight: 28-32 parts of astragalus, 9.5-10.5 parts of ligusticum wallichii, 9.5-10.5 parts of rhizoma anemarrhenae, 9.5-10.5 parts of rhizoma bletillae, 9.5-10.5 parts of herba violae, 9.5-10.5 parts of paniculate swallowwort root and 9.5-10.5 parts of liquorice. The traditional Chinese medicine composition can treat dental ulcer caused by targeted drugs, and ensures that a tumor patient can finish the treatment cycle of foot dosage and foot treatment course.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating multiple oral ulcers related to an anti-tumor targeting drug, and a preparation method and application thereof.
Background
Canker sore (OM), also known as "aphtha", was first found in Huangdi's internal channel, a common ulcerative lesion occurring in the oral mucosa, with prevalence at the beginning of the oral mucosa disease. The symptoms are mostly seen in the parts of the inner lip, tongue and cheek mucous membrane, vestibular sulcus, soft palate and the like, the mucous membrane of the parts lacks keratinization layer or has poor keratinization, the clinical characteristics of yellow, red, concave and painful are provided (namely, the damaged surface is covered with yellow pseudomembrane, the periphery is provided with hyperemia and red halo, central concave causalgia is obvious), the pain is severe when the oral ulcer is in onset, the local causalgia is obvious, the diet and speaking are also influenced when the oral ulcer is severe, great inconvenience is caused to daily life, and the general symptoms such as halitosis, chronic pharyngitis, constipation, headache, dizziness, nausea, hypodynamia, dysphoria, insomnia, lymphadenectasis and the like can be complicated.
Aphtha can be caused by various factors such as exogenous pathogenic heat, improper diet, depression, and congenital deficiency. Fire heat is the basic cause of aphtha, heat congestion and blood stasis are the central links of the pathogenesis, and the diseased regions are related to the five zang organs, but the main diseases are the heart, spleen and kidney, especially the spleen is the heaviness of the heart. The differentiation and typing of the disease starts from the "treatise on disease origin and treatise on the pathogenesis of aphtha" by the traditional Chinese medicine, and can be summarized into 5 types: exogenous wind-heat type, heart-spleen heat type, yin deficiency fire excess type, spleen-stomach deficiency type, yang deficiency fire floating type. For tumor patients applying the targeted drug, the pathogenesis of the dental ulcer often presents the characteristic of deficiency and excess inclusion, which is related to the characteristic of deficiency and excess of the tumor origin and the adverse reaction of the targeted drug on blood and qi consumption.
Modern medicine holds that the causes of aphtha are mainly the following: immune factors, genetic factors, systemic disease factors, environmental factors, microcirculation disorders, etc. The tumor patients have various susceptibility factors, including immune dysfunction and nutrition disorder of the tumor patients, and also include radiotherapy and chemotherapy, targeting and immune postmultisystem injury. Numerous studies have been made on the mechanism, treatment, etc. of canker sore caused by radiotherapy and chemotherapy. The anti-tumor targeted drug and the immune drug are novel anti-tumor treatment means which are developed for more than 10 years, and patients who receive the targeted drug treatment are found to be easy to repeatedly generate canker sores in clinical use, so that the patients are influenced to eat, and even bleeding, infection and the like are caused to endanger the lives of the patients. Clinically common anti-tumor targeting drugs such as mTOR inhibitors, EGFR-TKI and the like can cause canker sores with different degrees. However, the oral ulcer related to the targeted drug is different from the oral ulcer caused by radiotherapy and chemotherapy. Compared with traditional Oral Mucositis (OM) caused by radiotherapy and chemotherapy, the OM caused by molecular targeted medicine and immunotherapy is different, the lesions are often diffuse, wide in range and unclear in limitation, a pseudomembrane consisting of fibrin, leucocytes and epithelial fragments is covered, and fungal infection is often combined, so that the life quality of a patient is seriously influenced, and the serious patients can cause medicine dosage adjustment or treatment suspension. Overall, compared with OM caused by radiotherapy and chemotherapy, OM caused by targeted drugs has lighter overall degree and smaller proportion of serious adverse events, but can seriously influence the life quality of patients in the treatment process and reduce the compliance of the patients. Thus, how to alleviate the symptoms of dental ulcers in patients is an important issue to be addressed in the application of targeted drugs.
Disclosure of Invention
The present invention has been made based on the findings and knowledge of the inventors regarding the following facts and problems:
the medicines for treating the canker sore mainly comprise external treatment methods and oral administration medicines. The external medicine mainly comprises gargle, local patch, oral spray and the like; the oral medicine mainly comprises vitamin B2 complex, vitamin C, bezoar detoxification tablet and the like. In recent years, with the penetration of clinical researches, new products for treating canker sore such as cydiodine tablet, dexamethasone acetate patch, penicillin V potassium buccal tablet and the like are also appeared on the market, but the clinical use effect is poor due to the fact that canker sore caused by targeted drugs cannot be treated well. Various traditional Chinese medicine formulas aiming at OM caused by radiotherapy and chemotherapy are also disclosed in the related art, and the adopted traditional Chinese medicine formulas are different according to different understanding of etiology and pathogenesis of OM, but related researches on dental ulcer caused by targeted drugs are rarely carried out.
The present invention aims to solve at least one of the technical problems in the related art to some extent. Therefore, the embodiment of the invention provides a traditional Chinese medicine composition for treating multiple oral ulcers related to anti-tumor targeted drugs. Can treat or relieve dental ulcer caused by targeted drugs, and ensure the completion of treatment cycle of foot dosage and foot treatment course of tumor patients. The invention aims to utilize the advantages of the traditional Chinese medicine to relieve the discomforts such as the pains of the dental ulcers caused by the targeted medicine and improve the tolerance and the compliance of patients in the process of receiving the anti-tumor targeted medicine.
The embodiment of the invention adopts the following technical scheme:
the embodiment of the invention provides a traditional Chinese medicine composition for treating tumor-targeted drug-related multiple oral ulcers, which comprises the following raw materials in parts by weight:
28-32 parts of astragalus, 9.5-10.5 parts of ligusticum wallichii, 9.5-10.5 parts of rhizoma anemarrhenae, 9.5-10.5 parts of rhizoma bletillae, 9.5-10.5 parts of herba violae, 9.5-10.5 parts of paniculate swallowwort root and 9.5-10.5 parts of liquorice.
In the formula of the traditional Chinese medicine composition, the weight of each medicine is calculated by crude drugs, and can be increased or reduced according to corresponding proportion during production.
Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 30 parts of astragalus, 10 parts of ligusticum wallichii, 10 parts of rhizoma anemarrhenae, 10 parts of rhizoma bletillae, 10 parts of herba violae, 10 parts of paniculate swallowwort root and 10 parts of liquorice.
The embodiment of the invention also provides a traditional Chinese medicine preparation for treating the tumor targeting drug-related multiple dental ulcers, which comprises the traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials, and is prepared by adopting conventional technical means of pharmaceutics.
In some embodiments, the adjuvant comprises at least one of a slow 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.
In some embodiments, the dosage form of the traditional Chinese medicine preparation is decoction, granules or spray.
The embodiment of the invention also provides a preparation method of the traditional Chinese medicine preparation, wherein the traditional Chinese medicine preparation is a water decoction, and the preparation method of the water decoction comprises the following steps:
weighing the raw material decoction pieces according to the parts by weight, mixing, adding 1000 parts by volume of water, soaking for 30 minutes, decocting the water until the water is boiled, and continuously decocting the water for 30 minutes with small fire;
filtering the decoction to obtain a first filtrate and a first residue, taking out the first residue, decocting in water again, adding water without the residue, decocting with slow fire for 10 min after boiling, and filtering the decoction to obtain a second filtrate and a second residue;
mixing the first filtrate and the second filtrate, and decocting with slow fire to 150 parts by volume to obtain the water decoction.
The embodiment of the invention also provides a preparation method of the traditional Chinese medicine preparation, wherein the traditional Chinese medicine preparation is a granule, and the preparation method of the granule comprises the following steps:
weighing the raw material decoction pieces according to the parts by weight, mixing, and adding 500 parts by volume of water for soaking for 30 minutes; adding 580 parts by volume of water for decocting for 1.5 hours for the first time, and adding 460 parts by volume of water for decocting for 1.5 hours for the second time and the third time; combining the filtrates obtained by the three times of filtration, and filtering by a 200-mesh sieve; then concentrating under vacuum degree-0.06-0.08 MPa and temperature 70-80deg.C to relative density 1.20-1.25 (50deg.C) to obtain fluid extract. Adopts a one-step granulating method, and comprises the steps of: 1 as a base material, spraying the clear paste to obtain the granule.
The embodiment of the invention also provides application of the traditional Chinese medicine composition or the traditional Chinese medicine preparation as a medicine, wherein the medicine is used for at least one of the following:
(1) Preventing or treating multiple oral ulcers related to antitumor targeted drugs;
(2) Alleviating the adverse reaction symptoms of oral mucosa related to the antitumor targeted drug;
(3) Improving the quality of life of tumor patients during targeted drug therapy.
In some embodiments, the targeted drug comprises one or more of an mTOR inhibitor, an EGFR/Her2 inhibitor, a VEGF inhibitor, a BCR-ABL inhibitor, an ALK inhibitor, a multi-target TKI inhibitor.
In some embodiments, the targeted drug comprises one or more of everolimus, afatinib, lapatinib, gefitinib, erlotinib, dacatinib, cetuximab, apatinib, sorafenib, acitinib, pezopanib, sunitinib, lenvatinib, cabatinib, bevacizumab, imatinib, crizotinib, an Luoti.
The compatibility mechanism of the formula of the invention is as follows: the Chinese medicinal composition disclosed by the invention has the advantages of tonifying qi and spleen, expelling toxin and promoting granulation, treating carbuncles, chronic and abortive sores, reaching skin striae, and relieving exterior syndrome. Ligusticum wallichii has the effects of promoting qi and blood circulation, removing blood stasis and promoting stagnancy, clearing heat, relieving swelling and pain, and being matched with astragalus, promoting qi and blood circulation, and has no defect of damaging healthy qi. The bitter place Ding Guhan is directly folded, can clear heat and relieve swelling and detoxify, and can clear qi and disperse heat and relieve acute heat of blood system. The two medicines are combined to promote qi circulation and blood circulation, clear heat and reduce swelling and are jointly ministerial medicines. The bletilla striata has excellent swelling-reducing and tissue-promoting effects, is a good medicine for treating ulcers, and can accelerate the healing of the ulcers. The paniculate swallowwort root is pungent and warm, can strengthen the blood activating effect of the ligusticum wallichii, strengthen the effect of the bunge corydalis herb on detumescence, and has good analgesic effect. Zhi mu enters kidney and is a raw water preparation, and excessive water can stop fire and prevent astragalus root, chuan Xiong and paniculate swallowwort root from damaging fluids by heat. The three medicines are combined together to form an adjuvant medicine. Licorice root, radix Glycyrrhizae Praeparata, sweet in taste, neutral in nature, has effects of clearing away heat and toxic materials, harmonizing the drugs, relieving ulcer, reddening, swelling and pain, regulating qi, blood, yin and yang of viscera, and acting as an adjuvant and guiding drug. The medicines are matched, so that both symptoms and root causes are treated, qi and blood are regulated, qi and shape are compatible, and the astragalus, bletilla striata, ligusticum wallichii, paniculate swallowwort root and the like have good anti-tumor effects, and can assist in treating primary diseases.
The invention has the following advantages and beneficial effects:
through years of researches and observations, the inventor forms a prescription of the oral ulcer medicament related to the treatment targeting medicament, and the traditional Chinese medicine composition has the effects of tonifying qi, activating blood, clearing heat, relieving swelling, nourishing yin, purging fire and the like, and is mainly used for treating symptoms such as qi deficiency, blood stasis, yin deficiency, fire excess and the like. The invention overcomes the defect that other prescriptions are only used for treating canker sore by clearing heart fire in a weight-bias way, and distinguishes different clinical manifestations and reasons of canker sore caused by radiotherapy and chemotherapy and targeted drugs. From the whole concept, the effects of clearing fire, nourishing yin, tonifying qi and activating blood are comprehensively considered, and the principal and subordinate symptoms are considered, so that the dialectical thought is prominently reflected, the prescription Chinese medicinal materials can be modified through temporary symptoms, and the treatment of local ulcer and the balance of the whole organism are considered. Clinically, the traditional Chinese medicine is used for improving the immune disorder of organisms, improving the blood circulation of affected parts and promoting the healing of ulcer wound surfaces, and the traditional Chinese medicine has the effects of tonifying qi and removing blood stasis, clearing heat and nourishing yin, and treating deficiency and excess, and mainly treats excess. The Chinese medicinal composition has the advantages of balancing yin and yang, smoothing qi and blood, coordinating viscera functions, and remarkably improving clinical symptoms and Chinese medicinal symptoms of patients, along with convenient clinical use.
Drawings
FIG. 1 is a graph showing a comparison of typical case 1 before and after treatment with the decoction (gargle) of example 2 of the present invention (left side: 0 day, right side: 14 days).
FIG. 2 is a graph showing a comparison of typical case 1 before and after treatment with the decoction (gargling) of example 2 of the present invention (left side: 0 day, right side: 14 days).
Detailed Description
Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings. The embodiments described below by referring to the drawings are illustrative and intended to explain the present invention and should not be construed as limiting the invention.
Unless otherwise indicated, the starting materials and reagents used in the following examples were either commercially available or may be prepared by known methods.
Unless otherwise defined, scientific and technical terms used herein have the meanings commonly understood by one of ordinary skill in the art.
The terms "comprising," "including," and "comprising" are used herein in an open-ended fashion, i.e., to include what is indicated by the present invention, but not to exclude other aspects.
Where a value is described herein as a range, it is understood that such disclosure includes disclosure of all possible sub-ranges within the range, as well as specific values falling within the range, regardless of whether the specific value or sub-range is explicitly recited.
In this document, relational terms such as "first" and "second", and the like may be used solely to distinguish one entity or element from another entity or element without necessarily requiring or implying any actual such relationship or order between such entities or elements.
In this document, the meaning of "plurality" is at least two, unless explicitly defined otherwise.
Example 1:
a Chinese medicinal composition for treating tumor targeting drug-related multiple dental ulcer comprises the following raw materials:
30g of astragalus, 10g of ligusticum wallichii, 10g of rhizoma anemarrhenae, 10g of rhizoma bletillae, 10g of herba violae, 10g of paniculate swallowwort root and 10g of liquorice.
Example 2
A Chinese medicinal composition decoction for treating multiple oral ulcer related to antitumor targeting drug comprises the following steps:
taking 30g of astragalus, 10g of ligusticum wallichii, 10g of rhizoma anemarrhenae, 10g of rhizoma bletillae, 10g of bunge corydalis herb, 10g of paniculate swallowwort root and 10g of liquorice, mixing 90g in total, adding 1000ml of water, soaking for 30 minutes, decocting all medicinal materials and water until boiling, and continuing decocting for 30 minutes with slow fire.
Filtering the decoction to obtain a first filtrate and a first filter residue; taking out the first filter residue, decocting in water again, adding water without the residue, decocting over slow fire for 10 min after boiling, and filtering the decoction to obtain second filtrate and second filter residue;
mixing the first filtrate and the second filtrate, and decocting with slow fire to 150ml to obtain the Chinese medicinal composition decoction (collutory).
The composition is administered by gargling for 2-3 min each time, 20-30 ml/time, 5-6 times a day, and 2 weeks.
Example 3
A Chinese medicinal granule for treating multiple oral ulcer related to antitumor targeting drug comprises the following steps:
taking 30g of astragalus, 10g of ligusticum wallichii, 10g of rhizoma anemarrhenae, 10g of rhizoma bletillae, 10g of bunge corydalis herb, 10g of paniculate swallowwort root and 10g of liquorice, mixing 90g in total, and adding 500ml of water for soaking for 30 minutes. The first time of adding 580ml of water for 1.5 hours, the second time and the third time of adding 460ml of water for 1.5 hours. Mixing the filtrates obtained by three times of filtration, filtering with 200 mesh sieve, concentrating under vacuum degree of-0.06-0.08 MPa and temperature of 70-80deg.C to relative density of 1.20-1.25 (50deg.C) to obtain fluid extract; adopting a one-step granulating method, spraying the clear paste into the granules according to the proportion of dextrin to mannitol of 8:1 as a base material to obtain granules, subpackaging to obtain the traditional Chinese medicine composition granules,
when in use, the water is dissolved and then the mixture is rinsed for 2 to 3 minutes, 20 to 30 ml/time, 5 to 6 times a day for 2 weeks.
Clinical data
In clinic, 37 cases of canker sore patients caused by antitumor targeted drugs are randomly divided into a treatment group and a control group, wherein the control group is selected from a blank control, 3 cases of shedding are eliminated, and 34 cases of statistics are totally included, including 16 cases of experimental groups and 18 cases of control groups. Patient characterization information is shown in table 1.
TABLE 1 patient base Condition
Oral mucosal injury diagnostic criteria according to CTCAE5.0 common adverse events: oral mucosal lesions were graded as follows:
hierarchical clinical manifestations
Grade I asymptomatic or mild; without treatment
Grade II severe pain or ulcers; does not affect oral feeding; needs to adjust diet
Grade III severe pain; influence oral feeding
Class IV life threatening; emergency treatment is needed
Death at level V
The research method comprises the following steps: a prospective analytical clinical study procedure was employed.
Treatment protocol: continuing the original dose to receive the anti-tumor drug treatment while using the traditional Chinese medicine composition (prepared according to the method of the example 2); the drug delivery mode of the invention is as follows: the gargle liquid is used for 2-3 min, 20-30 ml/time, 5-6 times daily for 14 days continuously. The symptoms and signs of oral mucosa injury before and after treatment are compared on days 7 and 14, and the curative effect is evaluated.
Evaluation criteria:
the effect is shown: the medicine is graded and reduced by 1 grade after being used;
the method is effective: the medicine is graded and reduced by more than 1 grade after being used;
invalidation: the grading is unchanged or rises reversely by 1 grade or more after the medicine is taken.
The statistical method comprises the following steps: statistical analysis was performed using GraphPad Prism 5 software.
Results: on the premise of not changing the anti-tumor treatment intensity, through researching and treating various antitumor targeted drugs related OM in clinic, the traditional Chinese medicine prescription provided by the application is used for gargling, so that the pain caused by dental ulcer can be effectively relieved, and the ulcer wound healing is promoted. In total, 37 patients were observed clinically, the control group was selected as a blank control, and 3 cases of falling were excluded, and a total of 34 cases were included, 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 patient was rinsed for 2 weeks as a treatment course, and the degree of relief of the canker sore before and after treatment was evaluated, and the results were classified into significant effect, effective and ineffective, and are shown in Table 2. As can be seen from Table 2, the drug has obvious effect of reducing the associated multiple canker sore of the anti-tumor targeting drug, and the effective rate of the drug are both obviously higher than those of a control group.
Table 2 evaluation of efficacy after treatment
Typical case 1
Li Mou A female patient with 67 years old and advanced gynecological tumor has a patch-like ulcer on oral mucosa for 2 months after oral administration of lenvatinib, pain is accompanied, the patient is seriously affected in eating, the mouth wash is not improved for 1 month, a plurality of mouthwashes available in the market are used, the traditional Chinese medicine compound mouthwash of the example 2 is used for washing for 2-3 minutes each time, about 20-30 ml/time is carried out, pain is relieved every day for 5-6 times, symptoms are gradually relieved after 2 weeks, and targeted drugs are not reduced.
Typical case 2
Zhang Mou for female, 72 years old, advanced non-small cell lung cancer (adenocarcinoma) patients, oral mucosa ulcers appear 1 month after oral administration of Ornitini, with local pain discomfort, various mouthwashes and patches available in the gargle market are not improved for 1 month, the traditional Chinese medicine compound mouthwash of example 2 is used for 2-3 minutes each time, about 20-30 ml/time, 5-6 times a day, pain is relieved the next day, symptoms are gradually relieved after 2 weeks, and targeted drugs are not reduced.
For purposes of this disclosure, the terms "one embodiment," "some embodiments," "example," "a particular example," or "some examples," etc., mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, schematic representations of the above terms are not necessarily directed to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. Furthermore, the different embodiments or examples described in this specification and the features of the different embodiments or examples may be combined and combined by those skilled in the art without contradiction.
While embodiments of the present invention have been shown and described above, it will be understood that the above embodiments are illustrative and not to be construed as limiting the invention, and that variations, modifications, alternatives and variations may be made to the above embodiments by one of ordinary skill in the art within the scope of the invention.
Claims (10)
1. A traditional Chinese medicine composition for treating tumor-targeted drug-related multiple dental ulcers is characterized by comprising the following raw materials in parts by weight:
28-32 parts of astragalus, 9.5-10.5 parts of ligusticum wallichii, 9.5-10.5 parts of rhizoma anemarrhenae, 9.5-10.5 parts of rhizoma bletillae, 9.5-10.5 parts of herba violae, 9.5-10.5 parts of paniculate swallowwort root and 9.5-10.5 parts of liquorice.
2. The traditional Chinese medicine composition for treating the anti-tumor targeting drug-related multiple oral ulcer according to claim 1, which is characterized by comprising the following raw materials in parts by weight: 30 parts of astragalus, 10 parts of ligusticum wallichii, 10 parts of rhizoma anemarrhenae, 10 parts of rhizoma bletillae, 10 parts of herba violae, 10 parts of paniculate swallowwort root and 10 parts of liquorice.
3. The traditional Chinese medicine preparation for treating the tumor-targeted drug-related multiple dental ulcers is characterized by comprising the traditional Chinese medicine composition as claimed in claim 1 or 2 and pharmaceutically acceptable auxiliary materials, and is prepared by adopting conventional technical means of pharmaceutics.
4. The Chinese medicinal preparation for treating tumor-targeted drug-related multiple oral ulcers according to claim 3, wherein the auxiliary materials comprise at least one of a slow release agent, a diluent, a lubricant, an emulsifier, a plasticizer, a glidant, a filler, an adhesive, a wetting agent, an absorption promoter and a surfactant.
5. The traditional Chinese medicine preparation for treating tumor-targeted drug-related multiple oral ulcers according to claim 3, wherein the traditional Chinese medicine preparation is in the form of decoction, granules or spray.
6. The method for preparing the traditional Chinese medicine preparation according to claim 5, wherein the traditional Chinese medicine preparation is a water decoction, and the method for preparing the water decoction comprises the following steps:
the raw material decoction pieces are weighed according to the mass parts of claim 1 or 2, 1000 parts of water by volume is added after mixing, the mixture is soaked for 30 minutes, the water is decocted to boiling, and the decoction is continued for 30 minutes with small fire;
filtering the decoction to obtain a first filtrate and a first residue, taking out the first residue, decocting in water again, adding water without the residue, decocting with slow fire for 10 min after boiling, and filtering the decoction to obtain a second filtrate and a second residue;
mixing the first filtrate and the second filtrate, and decocting with slow fire to 150 parts by volume to obtain the water decoction.
7. The method for preparing the traditional Chinese medicine preparation according to claim 5, wherein the traditional Chinese medicine preparation is granules, and the method for preparing the granules comprises the following steps:
weighing raw material decoction pieces according to the mass parts of claim 1 or 2, mixing, adding 500 volume parts of water, and soaking for 30 minutes; adding 580 parts by volume of water for decocting for 1.5 hours for the first time, and adding 460 parts by volume of water for decocting for 1.5 hours for the second time and the third time; combining the filtrates obtained by the three times of filtration, and filtering by a 200-mesh sieve; concentrating under vacuum degree-0.06-0.08 MPa at 70-80deg.C to relative density of 1.20-1.25 (50deg.C) to obtain fluid extract; adopts a one-step granulating method, and comprises the steps of: 1 as a base material, spraying the clear paste to obtain the granule.
8. Use of a traditional Chinese medicine composition according to claim 1 or 2 or a traditional Chinese medicine preparation according to claim 3,4 or 5 as a medicament, characterized in that the medicament is used for at least one of the following:
(1) Preventing or treating multiple oral ulcers related to antitumor targeted drugs;
(2) Alleviating the adverse reaction symptoms of oral mucosa related to the antitumor targeted drug;
(3) Improving the quality of life of tumor patients during targeted drug therapy.
9. The use of claim 8, wherein the targeted drug comprises one or more of mTOR inhibitor, EGFR/Her2 inhibitor, VEGF inhibitor, BCR-ABL inhibitor, ALK inhibitor, multi-target TKI inhibitor.
10. The use of claim 8, wherein the targeted drug comprises one or more of everolimus, afatinib, lapatinib, gefitinib, erlotinib, dacatinib, cetuximab, apatinib, sorafenib, acitinib, pezopanib, sunitinib, lenvatinib, cabozantine, bevacizumab, imatinib, crizotinib, an Luoti.
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