Pharmaceutical composition for treating radiation-induced oral mucositis

Abstract

The invention provides a pharmaceutical composition for treating radiation-induced oral mucositis, which comprises two dosage forms, namely decoction and powder, the decoction is prepared from the following raw materials in parts by weight: 10-30 parts of radix rehmanniae, 9-20 parts of radix scrophulariae, 10-20 parts of radix ophiopogonis, 10-20 parts of moutan bark, 10-30 parts of honeysuckle, 5-20 parts of fructus forsythiae, 9-20 parts of scutellaria baicalensis, 9-15 parts of platycodon grandiflorum, 5-15 parts of oroxylum indicum and 10-20 parts of blackberry lily. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-30 parts of radix adenophorae, 10-20 parts of radix polygonati officinalis, 10-20 parts of radix trichosanthis, 20-50 parts of radix astragali, 10-30 parts of roasted rhizoma atractylodis macrocephalae, 9-15 parts of liquorice root, 10-30 parts of roasted malt and 10-30 parts of roasted fructus oryzae germinatus. The powder is prepared from the following raw materials in parts by weight: 0.15 to 0.5 part of calculus bovis cultured in vitro and 0.15 to 0.5 part of pearl powder; the decoction is orally taken after being decocted. The powder is blown into the diseased part of the oral cavity of a patient. According to the medicine composition, the whole body of a patient is conditioned from the basic pathogenesis of radiation-induced oral mucositis by adopting decoction oral administration, so that the effects of removing heat to cool blood, detoxifying, relieving sore throat, nourishing yin and promoting salivation are achieved; the powder is directly administered to a lesion part, so that the effects of clearing away heat and toxic materials, relieving swelling and pain, healing sore and promoting tissue regeneration are enhanced.

Description

Technical Field

[0001] The invention relates to a drug technology for treating radiation oral mucositis, and in particular to a drug composition for treating radiation oral mucositis. Background Art

[0002] Radiation oral mucositis (RIOM) is one of the common and serious complications of radiotherapy for head and neck tumors. In mild cases, it causes local mucosal damage and loss of taste, affecting normal eating and quality of life. In severe cases, it can cause ulceration and necrosis, secondary infection, and even interruption of radiotherapy, seriously affecting the patient's quality of life and treatment effect. Studies have shown that more than 80% of patients undergoing head and neck radiotherapy will develop RIOM during radiotherapy, and more than half of the patients will even develop grade 3-4 oral mucositis.

[0003] Although many studies have been conducted on the prevention and treatment of RIOM, many prevention and treatment strategies remain controversial. There is currently no specific drug for the prevention and treatment of radiation oral mucositis, and treatment mainly focuses on alleviating symptoms and reducing the occurrence of complications. Therefore, effective prevention and treatment of radiation oral mucositis remains a key issue that needs to be addressed. Traditional Chinese medicine preparations are believed to reduce the severity of radiation oral mucositis and relieve pain. However, traditional Chinese medicine treatment is either systemic or topical. However, starting from the basic pathogenesis, the combination of traditional Chinese medicine internal treatment and external treatment, based on the oral administration of syndrome differentiation decoctions, combined with the traditional Chinese medicine comprehensive treatment program of oral topical blowing is of great significance for the prevention and treatment of radiation oral mucositis of head and neck tumors. Summary of the invention

[0004] In view of the above technical problems, the present invention provides a pharmaceutical composition for treating radiation oral mucositis, which adopts the methods of clearing away heat and cooling blood, detoxifying and relieving sore throat, nourishing yin and promoting body fluid, and can effectively prevent and treat radiation oral mucositis and relieve the pain of patients.

[0005] The pharmaceutical composition for treating radiation oral mucositis of the present invention comprises two dosage forms, namely, a decoction and a powder, wherein the decoction is prepared from the following raw materials in weight ratio: 10-30 parts of raw rehmannia, 9-20 parts of scrophularia, 10-20 parts of ophiopogon, 10-20 parts of moutan bark, 10-30 parts of honeysuckle, 5-20 parts of forsythia, 9-20 parts of scutellaria, 9-15 parts of platycodon, 5-15 parts of oroxylum, 10-20 parts of belamcanda, and 10-20 parts of adenophora australis. 10-30 parts, 10-20 parts of polygonatum, 10-20 parts of trichosanthes, 20-50 parts of astragalus, 10-30 parts of stir-fried atractylodes, 9-15 parts of liquorice, 10-30 parts of stir-fried malt, and 10-30 parts of stir-fried rice sprouts; the powder is prepared from the following raw materials in weight ratio: 0.15-0.5 parts of in vitro cultivated bezoar and 0.15-0.5 parts of pearl powder; the decoction is decocted and taken orally; the powder is blown into the lesion in the patient's oral cavity.

[0006] Preferably, the decoction of the pharmaceutical composition is made of the following raw materials in weight ratio: 10-20 parts of raw rehmannia, 10-15 parts of scrophularia, 10-15 parts of ophiopogon, 10-15 parts of moutan bark, 10-20 parts of honeysuckle, 5-15 parts of forsythia, 10-15 parts of scutellaria, 10-15 parts of platycodon, 5-10 parts of oroxylum, 10-15 parts of belamcanda, 15-30 parts of adenophora, 10-15 parts of polygonatum, 10-15 parts of trichosanthes, 20-30 parts of astragalus, 15-30 parts of stir-fried atractylodes, 9-12 parts of liquorice, 15-30 parts of stir-fried malt, and 15-30 parts of stir-fried rice sprouts; the powder is made of the following raw materials in weight ratio: 0.15-0.45 parts of in vitro cultured bezoar and 0.15-0.45 parts of pearl powder.

[0007] More preferably, the decoction of the pharmaceutical composition is made of the following raw materials in weight ratio: 15 parts of raw rehmannia, 10 parts of scrophularia, 15 parts of ophiopogon, 10 parts of moutan bark, 15 parts of honeysuckle, 10 parts of forsythia, 10 parts of scutellaria, 15 parts of platycodon, 10 parts of oroxylum, 10 parts of belamcanda, 20 parts of adenophora, 15 parts of polygonatum, 15 parts of root of trichosanthes, 30 parts of astragalus, 20 parts of stir-fried atractylodes, 10 parts of liquorice, 30 parts of stir-fried malt, and 30 parts of stir-fried rice sprouts; the powder is made of the following raw materials in weight ratio: 0.3 parts of in vitro cultured bezoar and 0.3 parts of pearl powder.

[0008] The pharmaceutical composition for treating radiation oral mucositis adopts decoction for oral administration to regulate the whole body of the patient based on the basic pathogenesis of radiation oral mucositis, so as to achieve the effects of clearing away heat and cooling blood, detoxifying and relieving sore throat, nourishing yin and promoting body fluid; and adopts powder for direct administration to the lesion, so as to strengthen the effects of local heat-clearing and detoxifying, swelling-removing and pain-relieving, sore-healing and tissue-regenerating.

[0010] The following specific embodiments further illustrate the pharmaceutical composition for treating radiation oral mucositis of the present invention. DETAILED DESCRIPTION

[0011] Radiation oral mucositis belongs to the category of "mouth sores", "mouth erosions" and "deficient fire throat paralysis" in traditional Chinese medicine. Its basic pathogenesis is the accumulation of pathogenic heat and the deficiency of qi and yin. Radiation belongs to the evil of fire poison, which is most likely to damage body fluids and consume qi. The damage caused by direct radiation exposure to the oral cavity is that the fire and heat evil burns the skin, causing heat and poison accumulation, heat and flesh rot, and mouth sores. Long-term illness can lead to deficiency of vital energy, loss of qi, blood and body fluids, impaired organ function, liver and kidney yin deficiency and virtual fire inflammation, burning the lips, or spleen and stomach deficiency and lack of qi and blood production, which cannot nourish the lips, resulting in mouth sores. Traditional Chinese medicine treatment of RIOM often adopts a combination of disease differentiation and syndrome differentiation, with the treatment methods of clearing away heat and detoxification, nourishing yin and promoting body fluid, cooling blood and activating blood circulation, or replenishing qi and strengthening spleen.

[0012] The pharmaceutical composition for treating radiation oral mucositis of the present invention comprises two dosage forms, namely, a decoction and a powder, wherein the decoction is prepared from the following raw materials in weight ratio: 10-30 parts of raw rehmannia, 9-20 parts of scrophularia, 10-20 parts of ophiopogon, 10-20 parts of moutan bark, 10-30 parts of honeysuckle, 5-20 parts of forsythia, 9-20 parts of scutellaria, 9-15 parts of platycodon, 5-15 parts of oroxylum, 10-20 parts of belamcanda, and 10-20 parts of adenophora australis. 10-30 parts, 10-20 parts of polygonatum, 10-20 parts of trichosanthes, 20-50 parts of astragalus, 10-30 parts of stir-fried atractylodes, 9-15 parts of liquorice, 10-30 parts of stir-fried malt, and 10-30 parts of stir-fried rice sprouts; the powder is prepared from the following raw materials in weight ratio: 0.15-0.5 parts of in vitro cultivated bezoar and 0.15-0.5 parts of pearl powder; the decoction is decocted and taken orally; the powder is blown into the lesion in the patient's oral cavity. In the decoction of the pharmaceutical composition for treating radiation oral mucositis of the present invention, Radix Rehmanniae and Radix Scrophulariae clear away heat and cool blood, nourish yin and produce body fluid; Cortex Moutan clears heat, cools blood and promotes blood circulation; Radix Ophiopogonis, Radix Polygonati and Radix Trichosanthis strengthen the power of nourishing yin and producing body fluid; Flos Lonicerae and Fructus Forsythiae clear away heat and detoxify; Radix Scutellariae clears heat and purges fire; Radix Platycodonis, Radix Oroxylum and Radix Belamcandae clear heat, relieve sore throat and relieve pain; Radix Adenophorae invigorates qi and nourishes yin; Radix Astragali is good at replenishing the qi of spleen and lung, and can support toxins, discharge pus and promote tissue regeneration; Stir-fried Atractylodes macrocephala invigorates qi and strengthens spleen; Radix Glycyrrhizae clears heat, detoxifies and relieves sore throat, and harmonizes various medicines; Stir-fried malt and stir-fried rice sprouts invigorate spleen and harmonize stomach, and prevent cold and cool medicines from damaging spleen and stomach too much. The whole prescription has the effects of clearing heat and cooling blood, detoxifying and relieving sore throat, and nourishing yin and producing body fluid. In the powder, bezoar is cultivated in vitro to clear heat and detoxify; pearl powder detoxifies and promotes tissue regeneration; oral blowing medicine strengthens local heat clearing and detoxification, swelling and pain relief, sore astringent and tissue regeneration, and prevents and treats sore throat and ulceration.

[0013] As one of the preferred technical solutions, the decoction of the pharmaceutical composition is prepared from the following raw materials in weight ratio: 10-20 parts of raw rehmannia, 10-15 parts of scrophularia, 10-15 parts of ophiopogon, 10-15 parts of moutan bark, 10-20 parts of honeysuckle, 5-15 parts of forsythia, 10-15 parts of scutellaria, 10-15 parts of platycodon, 5-10 parts of oroxylum, 10-15 parts of belamcanda, 15-30 parts of adenophora, 10-15 parts of polygonatum, 10-15 parts of radix trichosanthis, 20-30 parts of astragalus, 15-30 parts of stir-fried atractylodes, 9-12 parts of liquorice, 15-30 parts of stir-fried malt, and 15-30 parts of stir-fried rice sprouts; the powder is prepared from the following raw materials in weight ratio: 0.15-0.45 parts of in vitro cultured bezoar and 0.15-0.45 parts of pearl powder.

[0014] As one of the more preferred technical solutions, the decoction of the pharmaceutical composition is made of the following raw materials in weight ratio: 15 parts of raw rehmannia, 10 parts of scrophularia, 15 parts of ophiopogon, 10 parts of moutan bark, 15 parts of honeysuckle, 10 parts of forsythia, 10 parts of scutellaria, 15 parts of platycodon, 10 parts of oroxylum, 10 parts of belamcanda, 20 parts of adenophora, 15 parts of polygonatum, 15 parts of root of trichosanthes, 30 parts of astragalus, 20 parts of stir-fried atractylodes, 10 parts of licorice, 30 parts of stir-fried malt, and 30 parts of stir-fried rice sprouts; the powder is made of the following raw materials in weight ratio: 0.3 parts of in vitro cultured bezoar and 0.3 parts of pearl powder.

[0015] In order to verify the therapeutic effect of the pharmaceutical composition for treating radiation oral mucositis of the present invention, 90 patients with head and neck tumors were actually verified by a randomized, single-blind and controlled study method. The 90 patients with head and neck tumors were randomly divided into three groups, 30 cases in each group, recorded as treatment group 1, treatment group 2 and control group. There were no significant differences in the gender composition, age and Karnofsky score of the three groups. All three groups of patients were radiotherapy according to relevant treatment specifications. Starting from the first day of radiotherapy, the control group did not take medicine. After the occurrence of radiation oral mucositis, it was treated according to the treatment plan of group 2. Treatment group 1 took Kangfuxin liquid (Sichuan Good Doctor Panxi Pharmaceutical Co., Ltd., National Medicine Standard Z51021834), 10ml each time, 3 times a day. Treatment group 2 took the decoction of the pharmaceutical composition of the present invention, 100ml each time, 3 times a day; powder oral blowing medicine, each dosage is selected between 0.5g-5.0g according to the specific lesion, 3 times a day, until the end of radiotherapy for 1 week (no need to stop taking medicine during the radiotherapy interval). All patients in the three groups were given routine oral care. The time of oral mucositis onset, the cumulative radiotherapy dose of oral mucositis, and the incidence of oral mucositis were observed in the three groups. The degree of oral mucositis damage and oral pain scores were observed in treatment groups 1 and 2. The adverse reactions during treatment in each group, as well as the indicators or manifestations such as blood routine, urine routine, stool routine, and liver and kidney function before and after treatment were observed.

[0016] 1. Case selection:

[0017] 1.1 Inclusion criteria

[0018] (1) Meet the tumor criteria of the Union Internationale de la Cancele Contre la Cancele (UICC) and be diagnosed by pathology and / or cytology

[0019] They are hospitalized patients with head and neck malignant tumors and concurrent radiotherapy.

[0020] (2) The oral mucosa was intact before radiotherapy, with no gingival or periodontal disease.

[0021] (3) No history of drug allergy, no intellectual or mental disorder, normal language expression ability, and self-confidence

[0022] The ability to make general judgement and collaborate in evaluating quality of life content.

[0023] (4) Aged 18-75 years, regardless of gender, with an expected survival period of more than 3 months.

[0024] (5) Those with good compliance and signed informed consent.

[0025] (6) The subjects agreed not to participate in other intervention studies during the treatment period.

[0026] 1.2 Exclusion criteria

[0027] (1) Combined with severe cardiovascular complications, cerebrovascular complications, active hepatitis, severe

[0028] People with abnormal liver and kidney function.

[0029] (2) Subjects who are known or suspected to be allergic to known ingredients in the study drug.

[0030] (3) Suffering from severe malabsorption or other diseases that affect gastrointestinal absorption.

[0031] (4) Pregnant or lactating women.

[0032] (5) Those who have mental disorders and are unable to cooperate with the evaluation.

[0033] (6) Those who are deemed unsuitable to participate in this study by the researcher.

[0034] 1.3 Exit criteria

[0035] Investigator's decision to withdraw:

[0036] (1) The study should be stopped at the discretion of the investigator due to allergic reactions or serious adverse reactions to the study drug.

[0037] (2) The subjects have poor compliance (study medication compliance <80% or >120%), or automatically change medications midway, or add other drugs or other therapies to treat the disease outside of this regimen, which affects the judgment of efficacy and safety.

[0038] (3) The inclusion or exclusion criteria were violated and the person should not have been included in the study.

[0039] Subjects voluntarily withdraw from the study:

[0040] (1) For whatever reason, the patient is unwilling or unable to continue the clinical study and requests to withdraw from the study to the attending physician.

[0041] (2) Research subjects who did not explicitly request to withdraw from the study but no longer accepted medication or testing and were lost to follow-up.

[0042] 2. Drug preparation

[0043] The pharmaceutical compositions prepared in Examples 1-4.

[0044] 3. Treatment methods

[0045] All patients received radiotherapy in accordance with relevant treatment standards. Starting from the first day of radiotherapy, the control group did not take the medicine. After the occurrence of radiation oral mucositis, treatment was given according to the scheme of treatment group 2. Treatment group 1 took Kangfuxin liquid (Sichuan Good Doctor Panxi Pharmaceutical Co., Ltd., National Medicine Standard Z51021834) 10ml each time, held in the mouth for 3 to 5min, swallowed slowly, rinsed the mouth with normal saline before taking it, and avoided eating and drinking water within half an hour after taking the medicine, 3 times a day. Treatment group 2 took the decoction of the pharmaceutical composition of the present invention, 100ml each time, 3 times a day; powder oral blowing medicine, each dosage is selected between 0.5g-5.0g according to the specific lesion situation, 3 times a day, until the end of radiotherapy for 1 week (no need to stop taking medicine during the interval of radiotherapy); rinse the mouth with normal saline before blowing the medicine, and then blow the powder into the oral lesion, and avoid eating and drinking water within half an hour after blowing the medicine. Patients in the three groups were given routine oral care.

[0046] 4. Efficacy evaluation criteria

[0047] (1) Classification standards

[0048] The grading of oral mucositis in patients adopts the acute radiation injury grading standard of the North American Radiation Therapy Cooperation Group (RTOG), which divides the damage of the oral mucosa into the following grades: Grade 0: no change; Grade 1: mucosal congestion, redness and swelling, mild pain, and the patient can eat solid food; Grade 2: macular mucositis, moderate pain, the patient can eat soft food or liquid food, and needs to take analgesics; Grade 3: patchy mucositis, occupying less than 50% of the irradiated area, confluent fibrous mucositis, severe pain, and the patient needs to use anesthetic drugs; Grade 4: patchy mucositis occupies more than 50% of the irradiated area, with ulcers, bleeding, and necrosis.

[0049] (2) Pain scoring criteria

[0050] The pain degree of the two groups of patients was evaluated by the numerical pain rating scale (NRS) recommended by WHO: grade 0: NRS score 0; grade 1: NRS score 1-3, no impact on sleep, soft food can be eaten; grade 2: NRS score 4-6, semi-liquid food can be eaten, affecting sleep; grade 3: NRS score 7-10, difficulty in eating, and severely reduced sleep quality.

[0051] 5. Observation indicators

[0052] (1) Efficacy indicators

[0053] ① The onset time of oral mucositis in the three groups.

[0054] ②The cumulative radiotherapy dose for oral mucositis in the three groups.

[0055] ③The incidence of oral mucositis in the three groups.

[0056] ④The degree of oral mucosal inflammation and oral pain score in treatment group 1 and treatment group 2.

[0057] (2) Safety indicators

[0058] The adverse reactions during treatment, as well as blood routine, urine routine, stool routine, liver and kidney function before and after treatment were observed in each group.

[0059] 6. Statistical methods

[0060] All data were processed using SAS 9.4 statistical software, and the measurement data were expressed as mean ± standard deviation. , the mean and standard deviation will be displayed to two decimal places; count data will be summarized using frequency and percentage, and the percentage will be calculated based on the total number of non-missing data and displayed to one decimal place. This study will use t-test and ANOVA (Analysis of variance) to analyze continuous response variables that meet normality, homogeneity of variance, and balanced design; CMH (Cochran-Mantel-Haenszel) chi-square test will be performed on contingency tables of categorical variables. Statistical hypothesis tests are two-sided tests with a significance level of 0.05. All P values ​​will be displayed to four decimal places. If the rounded value is "p=0.00000", it will be expressed as "p<0.0001". Similarly, a value rounded to 1.0000 will be displayed as "p>0.9999".

[0061] 7. Results

[0062] (1) General Information

[0063] The 90 patients with NPC who participated in this validation were treated with conformal intensity modulated radiotherapy (IMRT), with GTVp+GTVn of nasopharyngeal primary lesions and cervical lymph nodes: 69.96Gy (2.12Gy / time), CTV1 of high-risk subclinical lesions of primary lesions and lymph nodes: 60.06Gy (1.82Gy / time), and CTV2 of low-risk subclinical lesions of primary lesions and preventive irradiation of cervical lymphatic drainage areas: 54.12Gy (1.64Gy / time). Combined with concurrent chemotherapy with cisplatin 80mg / m 2 , once every 3 weeks. There was no difference in gender, age, tumor stage, and differentiation degree among all patients (P>0.05) (see Table 1).

[0064] Table 1 Comparison of general information of patients in the three groups

[0065]

[0066] Note: *P<0.05; **P<0.01

[0067] (2) Comparison of the time to grade 1 oral mucosal lesions and cumulative radiation doses among the three groups

[0068] The patients in the three groups completed the treatment as planned, and the incidence of grade 1 radiation oral mucositis was 100%. Among them, the duration of grade 1 radiation oral mucositis in treatment groups 1 and 2 was longer than that in the control group, and the difference was statistically significant (P < 0.05). The cumulative radiation dose of grade 1 radiation oral mucositis in treatment groups 1 and 2 was higher than that in the control group, and the difference was statistically significant (P < 0.05) (see Table 2).

[0069] Table 2 Time to onset of grade 1 oral mucositis and cumulative radiation dose in the three groups

[0070]

[0071]

[0072] Note: Comparison between groups, *P<0.05; **P<0.01

[0073] (3) Comparison of the grading of acute radiation stomatitis between treatment groups 1 and 2

[0074] During the trial, the highest grade of oral mucositis in the cases was counted. The incidence of grade 1 mucositis in treatment group 2 was 53.3%, which was higher than that in treatment group 1 (16.7%). The incidence of grade II and grade III mucositis in treatment group 2 was 33.3% and 13.3%, which were lower than those in treatment group 1 (56.7% and 26.7%). The comparison of the grading of acute radiation stomatitis between the two groups showed a statistically significant difference (P < 0.05) (see Table 3).

[0075] Table 3 Comparison of the incidence of acute radiation stomatitis in the two groups of patients [cases (%)]

[0076]

[0077] Note: Compared with treatment group 1, *P<0.05; **P<0.01

[0078] (4) Comparison of oropharyngeal pain severity between treatment groups 1 and 2

[0079] During the trial, the highest level of pain experienced by the patients was statistically analyzed. The incidence of grade 1 pain in treatment group 2 was 56.7%, which was higher than that in treatment group 1 (26.7%). The incidence of grade 2 and grade 3 pain in treatment group 2 was 33.3% and 10.0%, respectively, which were lower than those in treatment group 1 (50.0% and 23.3%). The distribution of oropharyngeal pain levels between the two groups was compared, and the difference was statistically significant (P < 0.05) (see Table 4).

[0080] Table 4 Comparison of oropharyngeal pain between the two groups (cases (%))

[0081]

[0082] Note: Compared with treatment group 1, *P<0.05; **P<0.01

[0083] (5) Comparison of the cumulative radiotherapy dose for oral mucositis of all grades between treatment groups 1 and 2

[0084] The cumulative radiotherapy doses for grade 1, 2, and 3 oral mucositis were (37.09±5.63) Gy, (51.34±7.59) Gy, and (59.36±7.14) Gy, respectively, in treatment group 2, and (27.07±6.14) Gy, (40.79±5.78) Gy, and (52.47±5.04) Gy, respectively, in treatment group 1. When grade 1 and grade 2 mucositis occurred, the cumulative radiotherapy dose completed in treatment group 2 was significantly higher than that in treatment group 1, and the difference was statistically significant (P<0.05) (see Table 5).

[0085] Table 5 Comparison of the cumulative radiotherapy doses for oral mucositis of all levels between the two groups

[0086]

[0087] Note: Compared with treatment group 1, *P<0.05; **P<0.01

[0088] (6) Comparison of the time to onset of oral mucositis at various levels between treatment groups 1 and 2

[0089] The time to develop grade 1, 2, and 3 mucositis in treatment group 2 was (23.27±3.90) days, (32.64±5.09) days, and (8.00±4.97) days, respectively; and in treatment group 1, it was (17.93±4.23) days, (25.72±3.85) days, and (32.25±5.80) days, respectively. The time to develop grade 1 and grade 2 oral mucositis in treatment group 2 was later than that in treatment group 1, and the difference was statistically significant (P<0.05) (see Table 6).

[0090] Table 6 Comparison of the time of oral mucositis between the two groups

[0091]

[0092] Note: Compared with treatment group 1, *P<0.05; **P<0.01

[0093] From the above data, it can be seen that after receiving the treatment with the pharmaceutical composition of the present invention, the time to oral mucosal lesions of various levels, the cumulative radiotherapy dose, the incidence of grade 2 and grade 3 mucositis, the incidence of grade 2 and grade 3 pain and other indicators were significantly improved, which fully demonstrates that the pharmaceutical composition for treating radiation oral mucositis of the present invention has obvious advantages in reducing the incidence and severity of mucositis, alleviating oral pain and improving the quality of life, and has obvious effects on the prevention and treatment of radiation oral mucositis.

[0094] Obviously, the pharmaceutical composition for treating radiation oral mucositis of the present invention adopts decoction for oral administration to regulate the patient's overall condition based on the basic pathogenesis of radiation oral mucositis, so as to achieve the effects of clearing away heat and cooling blood, detoxifying and relieving sore throat, nourishing yin and promoting body fluid; and adopts powder for direct administration to the lesion, so as to enhance the local effects of clearing away heat and detoxifying, reducing swelling and relieving pain, and astringing sores and promoting tissue regeneration.

Claims

1. A pharmaceutical composition for treating radiation oral mucositis, characterized in that: The pharmaceutical composition comprises two dosage forms, namely, a decoction and a powder. The decoction is prepared from the following raw materials in weight proportion: 10-30 parts of Radix Rehmanniae, 9-20 parts of Radix Scrophulariae, 10-20 parts of Radix Ophiopogonis, 10-20 parts of Cortex Moutan, 10-30 parts of Flos Lonicerae, 5-20 parts of Fructus Forsythiae, 9-20 parts of Radix Scutellariae, 9-15 parts of Radix Platycodonis, 5-15 parts of Oroxylum indica, 10-20 parts of Radix Belamcandae, 10-30 parts of Radix Adenophorae, 10-20 parts of polygonatum, 10-20 parts of trichosanthes, 20-50 parts of astragalus, 10-30 parts of stir-fried atractylodes, 9-15 parts of liquorice, 10-30 parts of stir-fried malt, and 10-30 parts of stir-fried rice sprouts; the powder is prepared from the following raw materials in weight ratio: 0.15-0.5 parts of in vitro cultured bezoar and 0.15-0.5 parts of pearl powder; the decoction is decocted and taken orally; the powder is blown into the lesion in the patient's oral cavity.

2. The pharmaceutical composition for treating radiation oral mucositis according to claim 1, characterized in that: The decoction of the pharmaceutical composition is prepared from the following raw materials in weight proportion: 10-20 parts of Radix Rehmanniae, 10-15 parts of Scrophulariae, 10-15 parts of Radix Ophiopogonis, 10-15 parts of Cortex Moutan, 10-20 parts of Flos Lonicerae, 5-15 parts of Fructus Forsythiae, 10-15 parts of Radix Scutellariae, 10-15 parts of Platycodon Grandiflorum, 5-10 parts of Oroxylum Indici, 10-15 parts of Rhizoma Belamcandae, 15-30 parts of Glehnia littoralis, 10-15 parts of Radix Polygonati Odorati, 10-15 parts of Radix Trichosanthis, 20-30 parts of Radix Astragali, 15-30 parts of Rhizoma Atractylodis Macrocephalae, 9-12 parts of Radix Glycyrrhizae, 15-30 parts of Rhizoma Maltae, and 15-30 parts of Rhizoma Rice Sprouts; the powder is prepared from the following raw materials in weight proportion: 0.15-0.45 parts of in vitro cultured bezoar and 0.15-0.45 parts of pearl powder.

3. The pharmaceutical composition for treating radiation oral mucositis according to claim 1 or 2, characterized in that: The decoction of the pharmaceutical composition is prepared from the following raw materials in weight proportion: 15 parts of raw rehmannia, 10 parts of scrophularia, 15 parts of ophiopogon, 10 parts of moutan bark, 15 parts of honeysuckle, 10 parts of forsythia, 10 parts of scutellaria, 15 parts of platycodon, 10 parts of oroxylum, 10 parts of belamcanda, 20 parts of adenophora, 15 parts of polygonatum, 15 parts of radix trichosanthis, 30 parts of astragalus, 20 parts of stir-fried atractylodes, 10 parts of liquorice, 30 parts of stir-fried malt, and 30 parts of stir-fried rice sprouts; the powder is prepared from the following raw materials in weight proportion: 0.3 parts of in vitro cultured bezoar and 0.3 parts of pearl powder.

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