Zhuang medicine composition for preventing radiation-induced oral mucosa and preparation method of Zhuang medicine composition

Abstract

The invention discloses a Zhuang medicine composition for preventing radiation-induced oral mucosa and a preparation method thereof, and belongs to the field of medicines, the Zhuang medicine composition is prepared from the following raw materials by weight: 15 parts of oroxylum indicum, 10-15 parts of broadleaf holly leaf, 10-15 parts of zanthoxylum nitidum, 15-30 parts of indigo, 15-20 parts of fordia cauliflora, and 10-30 parts of bruise king. The Zhuang medicine composition provided by the invention has the characteristics of scientific and reasonable compatibility, safety, no toxicity and suitability for long-term use, can treat Zhuang medicine pathogenesis of heat toxin of radioactive rays, has obvious curative effect, can effectively prevent and relieve inflammatory response of radioactive rays to oral mucosa, improves the tolerance of head and neck malignant tumor irradiation areas to radiotherapy, and has wide application prospects. The occurrence of radioactive oral mucosa injury is delayed.

Description

Technical Field

[0001] The invention relates to the field of medicine, and in particular to a strong medicine composition for preventing radiation oral mucosa and a preparation method thereof. Background Art

[0002] Head and neck cancer is the sixth most common cancer worldwide, and it is estimated that its incidence will increase by 30% in the next decade. The head and neck have a complex anatomical structure compared to other parts, and there are many surrounding organs. Traditional surgical treatment has huge risks, while radiotherapy is favored because of its advantages such as non-invasive, painless and safe. Studies have shown that the 5-year survival rate of patients with head and neck malignant tumors after radiotherapy can reach about 50%. During radiotherapy, while killing malignant tumor cells, radiation will also damage normal glandular tissue, capillaries and endothelial cells, causing radiation oral mucositis, causing patients to experience burning, pain, dry mouth and loss of taste in the oropharynx, making it difficult for patients to eat, malnutrition and decreased immunity. The adverse consequences of radiation oral mucositis include complete parenteral nutrition, prolonged hospitalization, and even interruption of radiotherapy, which in turn reduces the control rate of tumors and the survival rate of patients. Therefore, how to avoid and alleviate radiation oral mucositis during radiotherapy for patients with head and neck cancer is an important research direction at present. At present, the preventive measures for radiation oral mucositis in clinical practice mainly include oral care, drug prevention, nutritional support and psychological care. Among them, oral care requires patients to rinse their mouths after eating to remove food residues in the mouth, reduce the number of bacteria in the mouth, relieve pain and bleeding, and prevent infection. However, there is no uniform standard for the selection of mouthwash and the frequency of rinsing; drug treatment mainly includes Kangfuxin liquid, honey, fluconazole combined with sodium bicarbonate, recombinant human epidermal growth factor oral spray and Chinese medicine mouthwash, such as Yuchuang Decoction, Dahuanglian Xiexin Decoction, Ophiopogon injection, etc. Although various literature studies have shown that it has a positive effect on improving clinical efficacy, there is no unified standardized treatment plan in clinical work. Although nutritional support can effectively provide the body with nutrients and trace elements to repair oral mucositis, and a positive psychological state is conducive to the enhancement of patients' immunity and collective recovery, it still needs to be combined with drug treatment. Zhuang medicine began to take shape in the pre-Qin period. After the development process of the Han, Wei and Six Dynasties, around the Tang and Song Dynasties, it had basically formed a multi-level structure of Zhuang medicine with more than 10 contents such as herbal medicine for internal use, external washing, fumigation, plastering, wearing medicine, bone scraping, horn therapy, moxibustion, acupuncture, and gold needles, and gradually had the prototype of a theory. Summary of the invention

[0003] One of the purposes of the present invention is to provide a Zhuang medicine composition for preventing radiation oral mucosa, which has suitable Zhuang medicine compatibility, is safe and non-toxic, can prevent the occurrence of radiation oral mucositis, and thus ensure the smooth completion of radiotherapy. Its preparation method is simple and easy to operate, and effectively solves the problems of radiation oral mucositis leading to decreased quality of life of patients, reduced tumor control rate and unsatisfactory efficacy.

[0004] The present invention is achieved through the following technical scheme. A strong medicine composition for preventing radioactive oral mucosa is prepared from the following raw materials in weight ratio: 15 parts of Thousand Layer Paper, 10-15 parts of Kuding Tea, 10-15 parts of Liangmianzhen, 15-30 parts of Blue Indigo, 15-20 parts of Shrimp Whisk Beans, and 10-30 parts of Dieda King.

[0005] Preferably, it is made of the following raw materials in the following weight ratio: 15 parts of Thousand Layer Paper, 12 parts of Kuding Tea, 12 parts of Liangmianzhen, 20 parts of Blue Indigo, 16 parts of Shrimp Beans, and 20 parts of Dieda King.

[0006] Furthermore, the pharmaceutical composition is prepared by using Thousand Layer Paper, Kuding Tea, Two-sided Needle, Indigo, Shrimp Bean, and Dieda King as raw materials and adding pharmaceutical excipients.

[0007] Furthermore, the pharmaceutical excipients include: sucrose, maltodextrin, and sodium carboxymethyl starch.

[0008] Preferably, the weight ratio of the raw materials and pharmaceutical excipients is 15 parts of melaleuca paper, 10-15 parts of kudingcha, 10-15 parts of lianmianzhen, 15-30 parts of indigo, 15-20 parts of shrimp beans, 10-30 parts of Dieda king, 5-30 parts of sucrose, 5-100 parts of maltodextrin, and 1-16 parts of sodium starch glycolate.

[0009] More preferably, the weight ratio of the raw materials and pharmaceutical excipients is 15 parts of Thousand Layer Paper, 12 parts of Kuding Tea, 12 parts of Liangmianzhen, 20 parts of Blue Indigo, 16 parts of Shrimp Beans, 20 parts of Dieda King, 20 parts of sucrose, 60 parts of maltodextrin, and 8 parts of sodium starch glycolate.

[0010] Specifically, the pharmacological effects of the components of the Zhuang medicine composition for preventing radioactive oral mucosa are as follows:

[0011] Thousand-layer paper: The Zhuang medicine name is Kegong, Gogoeg; the other name is Wood Butterfly, bitter and cold. Its efficacy is to ventilate the airway and the anal canal, clear away heat and toxins, remove dampness and toxins, and relieve swelling and pain. Its Zhuang medicine mainly treats sore throat, cough, rib pain, heart headache (stomach pain), hepatitis, Tudie disease (hepatomegaly), hemorrhoids, Shencangxiang (burns), Lindedingxiang (trauma). Modern pharmacological studies have shown that Thousand-layer paper has good antibacterial, antiviral and anti-inflammatory effects. The antibacterial activity of the alcohol extract of Wood Butterfly is the strongest, and it has some antiviral effects. Its chemical components, such as oroxylin A and chrysin, play a major anti-inflammatory role. Therefore, gargling can effectively inhibit the reproduction of bacteria and viruses in the oral cavity and relieve inflammatory reactions, thereby preventing oral mucositis caused by radiotherapy.

[0012] Kudingcha: Cazhaemz, cold, bitter, sweet. It enters the liver, lung, and stomach meridians, and has the effects of dispersing wind and heat, clearing the head and eyes, and eliminating thirst. "Yi Lin Zong Yao" records that it can "treat the fever of heaven"; "Sichuan Chinese Medicine Records" records that it "can clear away heat and disperse wind, eliminate restlessness and quench thirst". Modern pharmacological studies have shown that Kudingcha has anti-inflammatory, antibacterial, antiviral and immunomodulatory effects; Kudingcha water extract has inhibitory effects on Staphylococcus aureus with different drug-resistant phenotypes. Phenylethanol glycosides in Kudingcha have significant anti-influenza virus effects, and its mechanism may be related to inhibiting the gene expression of viral nucleoprotein, inhibiting the activity of viral neuraminidase, and reducing inflammatory response. Verbascoside in Kudingcha can inhibit inflammatory response by inactivating Janus kinase and signal transduction and transcription activator protein signaling pathways.

[0013] Zanthoxyli Radix: Zanthoxyli Radix, it is flat in nature, bitter and pungent in taste, slightly toxic, and enters the stomach and liver meridians; it has the effects of promoting qi and relieving pain, promoting blood circulation and removing blood stasis, detoxifying and reducing swelling, and removing wind and unblocking collaterals. Modern pharmacological studies have shown that Zanthoxyli Radix has anti-inflammatory, analgesic and antibacterial effects. Its active ingredient alkaloids play an important role in anti-inflammatory aspects, such as chelerythrine and nitidine chloride; the alkaloid component (±)-Zanthonitidine A can significantly inhibit the activity of Enterococcus faecalis and Staphylococcus aureus, and the coumarin components in Zanthoxyli Radix also have antibacterial activity. Therefore, the bacteria in the mouth can be inhibited by gargling, and the inflammatory response can be relieved at the same time. It can prevent oral mucositis.

[0014] Indigo: Golomj, bitter and cold in nature, has the effects of clearing away heat and detoxifying, removing blood stasis and stopping bleeding. Modern pharmacological studies have shown that the active ingredient of indigo, magnolol, has a variety of biological properties, including anti-inflammatory, antioxidant, and anti-cancer, so it can prevent the occurrence of oral mucositis through its different pathways and drug targets.

[0015] Shrimp bean: Duhmumqnyauq, sweet, slightly spicy, flat, has the effect of clearing heat and moistening the lungs, relieving cough and reducing phlegm. "Guangxi Chinese Medicine Records": "Disperse blood stasis, reduce swelling, relieve pain, and calm the mind. Treat bruises, swelling and pain." Modern pharmacological studies have shown that the active ingredient of shrimp bean, β-sitosterol, has anti-inflammatory, antioxidant and anti-tumor effects. Therefore, using shrimp bean for mouthwash before radiotherapy can effectively relieve oral mucositis caused by radiotherapy.

[0016] Venzhozcu, also known as mountain peony, kudzu vine, and vine knotweed. It is warm in nature and astringent in taste. It has the effects of astringent, muscle regeneration, lung moistening and cough relieving. "Guangxi Medicinal Plant List": "The whole plant: bone-retaining, hemostasis, muscle regeneration, astringent, heart-clearing, lung moistening, cough relieving. Treatment of internal injuries Modern pharmacological research shows that the active ingredient of Venzhozcu is geranyl isovalerate, which is beneficial to regulate normal physiological functions, maintain redox balance and the immune system, and promote the healing of radiation oral mucositis caused by radiotherapy.

[0017] Furthermore, the dosage form of the pharmaceutical composition is granules.

[0018] On the other hand, the present invention provides a method for preparing a Zhuang medicine composition for preventing radioactive oral mucosa, which is used to prepare the Zhuang medicine composition for preventing radioactive oral mucosa as described above. The method comprises the following steps: weighing Thousand Layer Paper, Kuding Tea, Liangmianzhen, Shrimp Bean, Dieda King, and Blue Indigo according to the weight ratio, placing them together in a casserole or enamelware, adding water and boiling for 2 times; combining the 2 decoctions, and concentrating them into a medicinal liquid with a relative density of 1.05; the 2 decoctions include: adding 10 times the amount of water for the first decoction, soaking for 20 minutes, and then boiling and boiling for 60 minutes; adding 8 times the amount of water for the second decoction, boiling and boiling for 40 minutes, and filtering.

[0019] Furthermore, the prepared liquid medicine with a relative density of 1.05 is spray-dried to collect the spray-dried powder; sodium carboxymethyl starch and maltodextrin are added to the collected spray-dried powder and mixed evenly, and then dry granulated and sieved to obtain particles with a particle size range of 12 to 60 mesh to prepare granules.

[0020] Furthermore, the liquid medicine with a relative density of 1.05 is concentrated into a fluid extract with a relative density of about 1.10, deionized water is used as a diluent to dilute the fluid extract, and 0.9 parts of sodium chloride and 1 part of peppermint essential oil are added to prepare a gargle.

[0021] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0022] 1. The selected medicinal materials of the present invention are scientifically and reasonably compatible, safe and non-toxic, suitable for long-term use, and can treat the Zhuang medical pathogenesis of "heat and toxicity" of radiation, with obvious curative effect, and can effectively prevent and reduce the inflammatory response of radiation to the oral mucosa, improve the tolerance of the irradiated area of ​​head and neck malignant tumors to radiotherapy, and delay the occurrence of radiation oral mucosal damage. The preparation method is simple and easy to operate, low in cost, and has few side effects, which effectively solves the problems of unsatisfactory drug efficacy and high production cost in the prior art.

[0023] 2. The selected medicinal materials of the composition of the present invention are suitable and reasonable, which conforms to the theory of Zhuang medicine (heat toxins should be treated by clearing away heat and detoxification, promoting blood circulation and removing blood stasis, and astringing and promoting tissue regeneration). Radiation oral mucositis is manifested by ulcers on the oral mucosa, redness around it, and local burning pain. In Zhuang medicine, it is called "mouth ulcer" and "mouth sore", etc., which are caused by the intense heat toxins brought by radiation or the accumulation of heat in the heart, which is a positive syndrome. In the Zhuang medicine composition used in this patent, the thousand-layer paper is bitter and cold in nature, and has the effects of clearing away heat and toxins, removing dampness and toxins, and relieving swelling and pain; the blue indigo is bitter and cold in nature, and has the power of clearing away heat and detoxification, removing blood stasis and stopping bleeding. The two medicines are the mother medicine and the main medicine. Liangmianzhen is mild in nature and bitter in taste. It has the effects of detoxification, swelling, blood circulation and blood stasis. It is a commonly used medicine for pus and ulcers (carbuncle, carbuncle); Xiaxudou is mild in nature and sweet in taste. It has the effects of clearing heat and moistening the lungs, relieving cough and reducing phlegm; Diedawang is warm in nature and astringent in taste. It can astringe and regenerate muscles. The combination of the three can not only clear radiating heat and toxins, promote blood circulation and remove blood stasis, promote blood circulation and improve tissue metabolism, but also astringe and regenerate muscles, and promote mucosal healing. They are all helper medicines. Kudingcha is cold in nature and bitter in taste. It can disperse wind and heat, clear the head and eyes, and lead all the medicines to go up to the mouth. It is a guide medicine. The combination of all the medicines can clear heat and toxins, promote blood circulation and blood stasis, astringe muscles, and the sore surface will heal itself.

[0024] 3. The present invention provides granules and gargles. The gargle medicine provided by the present invention has the advantages of high local drug concentration in ulcers and less impact on the whole body, and can keep the oral cavity clean and inhibit bacteria and inflammation, improve the cure rate of ulcers, and treat various radiation oral mucositis. The clinical application of the department has achieved good therapeutic effects, and is easy to use and economical, which conforms to the advantages of traditional ethnic medicine "simple, convenient, cheap, and effective". The clinical development and promotion of the gargle can make up for the lack of economical and effective therapeutic drugs in the market, and has good economic and social benefits. DETAILED DESCRIPTION

[0025] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in combination with the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments.

[0026] Unless otherwise specified, all technical and scientific terms used herein have the same meanings as commonly understood by those skilled in the art in the art of the present invention. Although the present invention describes only preferred methods and materials, any methods and materials similar or equivalent to those described herein may also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe methods and / or materials related to the documents. In the event of a conflict with any incorporated document, the content of this specification shall prevail. Regarding the "comprising", "including", "having", "containing" and the like used herein, they are all open-ended terms, that is, they mean including but not limited to. Unless the context clearly indicates otherwise, the expressions "a" and "one" used herein include plural references. The term "about" used herein means a range of ±20% of the value thereafter. In some embodiments, the term "about" means a range of ±10% of the value thereafter. In some embodiments, the term "about" means a range of ±5% of the value thereafter.

[0027] Embodiment 1,

[0028] The present embodiment provides a medicinal composition for preventing radiation-induced oral mucosa, comprising the following raw materials in weight ratio: 15 parts of Thousand Layer Paper, 12 parts of Kuding Tea, 12 parts of Liangmianzhen, 20 parts of Blue Indigo, 16 parts of Shrimp Beans, and 20 parts of Dieda King.

[0029] This embodiment may also include pharmaceutical excipients: 20 parts of sucrose, 60 parts of maltodextrin, and 8 parts of sodium carboxymethyl starch.

[0030] Embodiment 2,

[0031] The present embodiment provides a medicinal composition for preventing radiation-induced oral mucosa, comprising the following raw materials in weight ratio: 15 parts of melaleuca, 10 parts of kudingcha, 15 parts of lianmianzhen, 15 parts of blue indigo, 20 parts of shrimp bean, and 10 parts of dieda king.

[0032] This embodiment may also include pharmaceutical excipients: 5 parts of sucrose, 100 parts of maltodextrin, and 1 part of sodium carboxymethyl starch.

[0033] Embodiment 3,

[0034] The present embodiment provides a medicinal composition for preventing radiation-induced oral mucosa damage, comprising the following raw materials in the following weight ratio: 15 parts of melaleuca, 15 parts of kudingcha, 10 parts of lianmianzhen, 30 parts of indigo, 15 parts of shrimp bean, and 30 parts of dieda king.

[0035] This embodiment may also include pharmaceutical excipients: 30 parts of sucrose, 59 parts of maltodextrin, and 1 part of sodium carboxymethyl starch.

[0036] Embodiment 4,

[0037] This embodiment provides a method for preparing a Zhuang medicine composition for preventing radiation oral mucosa. In this embodiment, the final product prepared is a granule of the Zhuang medicine composition. The specific preparation method includes the following:

[0038] According to the weight ratio of the raw materials in Example 1, weigh Thousand Layer Paper, Kuding Tea, Liangmianzhen, Shrimp Beans, Dieda King, and Indigo, place them together in a casserole or enamel container, add water and boil twice; add 10 times the amount of water for the first decoction, soak for 20 minutes, and then boil and boil for 60 minutes; add 8 times the amount of water for the second decoction, boil and boil for 40 minutes, and filter.

[0039] Then the two decoctions were combined and concentrated into a medicinal solution with a relative density of 1.05.

[0040] The concentrated drug solution is spray-dried and the spray-dried powder is collected.

[0041] Sodium carboxymethyl starch and maltodextrin are added to the collected spray-dried powder and mixed evenly, and then dry granulated and sieved to obtain particles with a particle size range of 30 mesh.

[0042] Embodiment 5,

[0043] This embodiment provides a method for preparing a Zhuang medicine composition for preventing radiation oral mucosa. In this embodiment, the final product prepared is a gargle of the Zhuang medicine composition. The specific preparation method includes the following:

[0044] According to the weight ratio of the raw materials in Example 1, weigh Thousand Layer Paper, Kuding Tea, Liangmianzhen, Shrimp Beans, Dieda King, and Indigo, place them together in a casserole or enamel container, add water and boil twice; add 10 times the amount of water for the first decoction, soak for 20 minutes, and then boil and boil for 60 minutes; add 8 times the amount of water for the second decoction, boil and boil for 40 minutes, and filter.

[0045] The two decoctions are then combined and concentrated into a fluid extract with a relative density of about 1.10.

[0046] The fluid extract was diluted with deionized water as a diluent, and 0.9 parts of sodium chloride and 1 part of peppermint essential oil were added to prepare a gargle solution.

[0047] Experimental example:

[0048] First, 90 patients with head and neck malignant tumors who underwent radiotherapy were selected as experimental subjects. The inclusion criteria were:

[0049] ① Patients diagnosed with head and neck malignant tumors by pathological examination; ② Patients receiving radiotherapy for the first time; ③ Karnofsky score ≥ 70; ④ Aged 18 to 70 years old; ⑤ Reading and writing ability. Exclusion criteria: patients with severe underlying diseases; patients with abnormal coagulation function; patients with oral ulcers and infections; patients who have received or are currently receiving anti-anxiety or anti-depression treatment. According to the random number table method, they were divided into the experimental group and the control group, 30 cases in each group, and the patients were numbered in the order of radiotherapy. All patients signed the informed consent form for radiotherapy before radiotherapy.

[0050] Treatment options include:

[0051] Radiotherapy: Radiotherapy uses a simulation positioning machine, Multiplan planning system, and electron linear accelerator for intensity-modulated radiotherapy. The irradiation range is determined according to the results of imaging examinations and clinical disease staging, including the primary lesion and regional lymph nodes. Irradiation is performed 5 times a week, with a radiotherapy dose of 2 GY for each target area each time. A course of treatment consists of 30 to 35 times, and the total radiotherapy dose is 60 to 70 GY.

[0052] The chemotherapy regimen is:

[0053] According to the clinical stage of the patient's condition, concurrent cisplatin (PPD) single-agent chemotherapy was performed, with chemotherapy once every 21 days for one cycle, for a total of 2 cycles. All patients were given routine health education before treatment, and it was strictly forbidden to use irritating items to rinse the mouth before and after radiotherapy, etc.

[0054] The treatment groups were:

[0055] On the basis of conventional radiotherapy, a Zhuang medicine composition is used for gargling before treatment. The Zhuang medicine composition (melaleuca, two-sided needle, blue indigo, shrimp bean, and bone-breaking king) is prepared by the method described in Example 5. The oral rinse is 250ml / bottle. Its use method is: on the basis of conventional radiotherapy and chemotherapy care, it is used from the first day of radiotherapy to one week after the end of radiotherapy. The responsible nurse rinses the mouth with saline before each radiotherapy and after three meals a day to keep the mouth clean, and then gargles with the Zhuang medicine composition gargle, 20-30ml each time, keep for 2-3 minutes, 4 to 5 times a day is appropriate, to ensure that the inflammatory reaction of the oral mucosa caused by radiotherapy can be alleviated and the pain level can be reduced. After each gargle, the responsible nurse promptly completes the "Case Observation Record Form" to ensure the number of gargles and avoid missing.

[0056] Control group:

[0057] The responsible nurse provides routine care and instructs the patients to rinse their mouths with normal saline before each radiotherapy and after three meals a day to keep their mouths clean. The patients are encouraged to eat more vegetables, fruits and high-protein foods and avoid greasy, spicy and irritating foods. At the same time, medication guidance is provided for patients with mucosal injuries, and psychological and social support is provided to patients.

[0058] Evaluation Tools

[0059] General information questionnaire: designed by the applicant, including 6 items: age, gender, weight, education level, clinical stage, and Karnofsky score.

[0060] Karnofsky scale: This scale is a status rating scale developed by Karnofsky (KPS) of ECOG (Eastern Cooperative Oncology Group) in 1948. It has been widely used in the assessment of clinical patient functional status at home and abroad. The patient's attending physician will give a score ranging from 0 to 100 points based on the patient's functional status, and the score will be graded on a 10-point scale. The higher the score, the better the patient's functional status. 10 points indicates that the patient's functional status is critical and will be close to death; 100 points indicates that the patient's functional status is intact and there are no other symptoms or signs. The Cronbach α value was measured to be 0.794, and the scale has high reliability and validity.

[0061] Observation indicators: The grading standard of radiation oral mucositis was adopted, and the oral toxicity scale of the World Health Organization (WHO) was used to record the first occurrence time of radiation oral mucositis of all levels during radiotherapy, and the incidence and degree of radiation oral mucositis under different irradiation doses. (See Table 1.)

[0062] Table 1. WHO RTOM grading scale

[0063]

[0064] Data collection method:

[0065] All data were collected by specialist nurses and responsible nurses who had received uniform training. Questionnaires were collected before radiotherapy, including general information questionnaire and Karnofsky scale. Patients were guided to fill in the questionnaires using uniform instructions, and the questionnaires were checked and collected on the spot. During radiotherapy, the quality of life of patients with oral mucositis was observed daily and recorded in the "Case Observation Record Form" until the oral mucositis was cured.

[0066] Statistical methods:

[0067] SPSS 22.0 software was used for data analysis. The measurement data were expressed as median and mean ± standard deviation, and the independent sample t test was used for inter-group comparison. The count data were expressed as percentages, and the chi-square test was used for inter-group comparison. P < 0.05 was considered statistically significant.

[0068] result:

[0069] The general information of the experimental subjects: 90 questionnaires were distributed in this experiment, and 90 valid questionnaires were collected, with an effective collection rate of 100%. During the experiment, there was no case of withdrawal. There was no statistically significant difference in the general information between the two groups before the intervention (P>0.05). The final data comparison is shown in Table 2.

[0070] Table 2. Comparison of general information between the two groups of patients

[0071]

[0072] Completion of radiotherapy and the incidence of oral mucositis after radiotherapy in the two groups of patients:

[0073] Both groups of patients completed radiotherapy according to the preset plan. The total radiation dose of the experimental group was 2847GY (64.27±4.35), and the total radiation dose of the control group was 2886GY (64.80±3.55). There was no significant difference in the total radiation dose between the two groups (t=0.710, P=0.387). With the increase of radiation dose, the incidence of radiation oral mucositis also increased. When the radiation dose was >60GY, the incidence of radiation dermatitis in both groups was as high as 100%, among which the incidence of grade III and grade IV radiation dermatitis in the control group accounted for 64.5% (29 / 45). The comparison of the incidence of radiation oral mucositis and the degree of radiation oral mucositis reaction between the two groups with different radiation doses was statistically significant (P<0.05). The final incidence of radiation oral mucositis in the two groups is shown in Table 3.

[0074] Table 3. The incidence of radiation oral mucositis in the two groups of patients

[0075]

[0076] Comparison of recovery time of radiation oral mucositis between the two groups of patients:

[0077] There was a significant difference in the time required for the two groups of patients to recover from radiation-induced oral mucositis after the end of radiotherapy (P < 0.05). Table 4 shows the comparison of the recovery time of radiation-induced oral mucositis between the two groups of patients.

[0078] Table 4. Comparison of recovery time of radiation oral mucositis between the two groups of patients

[0079]

[0080] From the above experimental content and statistical tables, we can see that:

[0081] 1. The Zhuang medicine composition provided by the present invention can effectively reduce the incidence of radiation oral mucositis.

[0082] Zhuang medicine believes that radiotherapy belongs to the evil of "heat poison", and its mechanism is that excessive heat damages body fluid, and body fluid cannot be carried to the mouth and tongue, which leads to symptoms such as dry mouth, dry throat, and oral pain. The present invention uses the Zhuang medicine composition for the prevention and treatment of radiation oral mucositis in patients with head and neck malignant tumors. The results in the experimental example show that when the Zhuang medicine composition is used for gargling at the beginning of radiotherapy, 3 patients still have intact skin when the radiation dose reaches 60GY after 30 radiotherapy sessions; while in the control group, at the 20th radiotherapy session, when the radiation dose reached 40GY, all 45 patients developed radiation oral mucositis of varying degrees, and the onset time was earlier than that of the experimental group, and the difference was statistically significant (P<0.05). When the radiation dose reached 40GY, the incidence of radiation oral mucositis increased significantly, with 10 cases (22.3%) in the experimental group and 26 cases (57.8%) in the control group at or above grade II. There was a statistically significant difference between the two groups (P < 0.05), indicating that the Zhuang medicine combination can improve the tolerance of the oral mucosa of patients with head and neck malignant tumors to radiotherapy, and can therefore effectively prevent and reduce the damage of radiotherapy to the oral mucosa and delay the occurrence of radiation oral mucositis. The reason is that the Thousand Layer Paper in the Zhuang medicine combination can clear away heat and toxins, remove dampness and toxins, and relieve swelling and pain; Kudingcha can disperse wind and heat, clear the head and eyes, and relieve thirst; Liangmianzhen can promote qi and relieve pain, activate blood circulation and remove blood stasis, remove toxins and reduce swelling, and remove wind and dredge collaterals; Blue indigo can clear away heat and toxins, remove blood stasis and stop bleeding; Shrimp bean can clear heat and moisten the lungs, relieve cough and resolve phlegm; Dieda King can astringe and promote muscle growth, moisten the lungs and relieve cough. And through the study of modern pharmacology, it is shown that this group of Zhuang medicine combination has the effects of antibacterial and anti-inflammatory, improving local circulation, and the combination of various medicines has the effect of clearing away heat, detoxifying and relieving pain.

[0083] 2. The Zhuang medicine composition provided by the present invention can effectively reduce the severity of radiation oral mucositis and reduce the incidence of grade III to IV radiation oral mucositis.

[0084] Radiation oral mucositis treatment is mostly heat-clearing and detoxifying, swelling and pain relief as treatment methods. The results in the experimental examples of the present invention show that when the radiation dose is <20GY, the radiation dermatitis in the test group is only 28.9%, and all are grade I. Although the incidence of radiation oral mucositis at the end of radiotherapy reaches 100%, it is mainly grade II, accounting for 64.4%, and grade III to IV only accounts for 15.6%, while the control group is mainly grade III to IV, also accounting for 64.5%, and the two groups are statistically different (P <0.05). Zhuang medicine composition can reduce the degree of radiation oral mucosal damage, reduce the incidence of grade III to IV radiation oral mucositis, and then ensure the smooth completion of radiotherapy, mainly because of its reasonable formula, taking into account the main links of radiation oral mucositis, keeping the mouth clean and eliminating inflammatory reactions. At the same time, the results in the experimental examples of the present invention also show that the Zhuang medicine composition cannot completely prevent radiation from causing radiation oral mucositis. With the continuous increase of radiation dose, a certain degree of oral mucosal inflammatory reaction will still occur.

[0085] 3. The Zhuang medicine composition provided by the present invention can effectively shorten the recovery time of radiation oral mucositis.

[0086] As can be seen from Table 4, the recovery time and total recovery time of grade II, grade III and grade IV radiation oral mucositis in the experimental group were shorter than those in the control group, and there was a statistically significant difference between the two groups (P < 0.05). The study proved that the Zhuang medicine composition can shorten the recovery time of radiation oral mucositis. This is because the experimental group gargled with the Zhuang medicine composition from the beginning of radiotherapy to protect the oral mucosa, thereby increasing the tolerance of the oral mucosa to radiotherapy. The radiation oral mucositis was mainly grade I and grade II, and the degree of damage was significantly reduced, which further verified the advantages of the Zhuang medicine composition in the prevention and treatment of radiation oral mucositis.

[0087] The specific implementation methods described above further illustrate the objectives, technical solutions and beneficial effects of the present invention in detail. It should be understood that the above description is only a specific implementation method of the present invention and is not intended to limit the scope of protection of the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A medicinal composition for preventing radiation-induced oral mucosa damage, characterized in that: Made from the following raw materials in the following weight ratio: 15 parts of Thousand Layer Paper, 10-15 parts of Kuding Tea, 10-15 parts of Liangmianzhen, 15-30 parts of Blue Indigo, 15-20 parts of Shrimp Beans, and 10-30 parts of Dieda King.

2. The strong medicine composition for preventing radiation oral mucosa according to claim 1, characterized in that: Made from the following raw materials in the following weight ratio: 15 parts of Thousand Layer Paper, 12 parts of Kuding Tea, 12 parts of Liangmianzhen, 20 parts of Blue Indigo, 16 parts of Shrimp Beans, and 20 parts of Dieda King.

3. The strong medicine composition for preventing radiation oral mucosa according to claim 1, characterized in that, The medicine composition is prepared by taking melaleuca, kudingcha, lianmianzhen, blue indigo, shrimp bean and dieda king as raw materials and adding pharmaceutical excipients.

4. The strong medicine composition for preventing radiation oral mucosa according to claim 3, characterized in that, The pharmaceutical excipients include: Sucrose, maltodextrin, sodium starch glycolate.

5. The strong medicine composition for preventing radiation oral mucosa according to claim 4, characterized in that, The weight ratio of the raw materials and pharmaceutical excipients is: 15 parts of melaleuca, 10-15 parts of kudingcha, 10-15 parts of lianmianzhen, 15-30 parts of blue indigo, 15-20 parts of shrimp bean, and 10-30 parts of dieda king. 5-30 parts of sucrose, 5-100 parts of maltodextrin, and 1-16 parts of sodium carboxymethyl starch.

6. The strong medicine composition for preventing radiation oral mucosa according to claim 5, characterized in that: The weight ratio of the raw materials and pharmaceutical excipients is: 15 parts of melaleuca, 12 parts of kudingcha, 12 parts of lianmianzhen, 20 parts of blue indigo, 16 parts of shrimp bean, and 20 parts of dieda king. 20 parts of sucrose, 60 parts of maltodextrin, 8 parts of sodium carboxymethyl starch.

7. The strong medicine composition for preventing radiation oral mucosa according to any one of claims 1 to 6, characterized in that: The dosage form of the pharmaceutical composition is granules.

8. A method for preparing a strong medicine composition for preventing radiation oral mucosa as claimed in any one of claims 1 to 7, characterized in that: The steps include: Weigh Thousand Layer Paper, Kuding Tea, Two-sided Needle, Shrimp Bean, Dieda King, and Blue Indigo according to the weight ratio, put them together in a casserole or enamel container, add water and boil twice; Combine the two decoctions and concentrate them into a medicinal solution with a relative density of 1.05; The decoction for 2 times comprises: For the first decoction, add 10 times the amount of water, soak for 20 minutes, and then boil for 60 minutes. Add 8 times the amount of water for the second decoction, boil for 40 minutes, and filter.

9. The method for preparing the strong medicine composition for preventing radiation oral mucosa according to claim 8, characterized in that: The preparation method further comprises the following steps: Taking the prepared drug solution with a relative density of 1.05, spray drying it, and collecting the spray dried powder; Sodium carboxymethyl starch and maltodextrin are added to the collected spray-dried powder and mixed evenly, and then dry granulated and sieved to obtain particles with a particle size range of 12 to 60 meshes to prepare granules.

10. The method for preparing the strong medicine composition for preventing radiation oral mucosa according to claim 8, characterized in that: The preparation method further comprises the following steps: The liquid medicine with a relative density of 1.05 is concentrated into a fluid extract with a relative density of about 1.10, The fluid extract was diluted with deionized water as a diluent, and 0.9 parts of sodium chloride and 1 part of peppermint essential oil were added to prepare a gargle solution.

Images