Traditional Chinese medicine composition for treating radiation-induced oral ulceration and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating radiation-induced oral ulceration and application thereof. The traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials in parts by weight: 6-10 parts of radix sophorae flavescentis, 6-10 parts of liquorice, 6-10 parts of diaphragma juglandis and 6-9 parts of rhizoma corydalis. The inventor of the application screens the traditional Chinese medicine raw materials capable of clearing heat and drying dampness, promoting blood circulation to arrest pain, astringing and promoting tissue regeneration, strengthening body resistance and detoxifying according to many years of medicine practicing experience and in combination with the theory of traditional Chinese medicine, under the combined action of the raw materials, oral ulceration, red and swollen and pain symptoms caused by radiation can be remarkably improved, and the traditional Chinese medicine composition has a remarkable curative effect on radiation-induced oral ulceration.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine compositions, in particular to a traditional Chinese medicine composition for treating radiation-induced oral ulcer and application thereof. BACKGROUND

[0002] Radiation-induced oral ulcer, as the name implies, is a common complication of patients with head and neck tumor after receiving radiotherapy, which belongs to a kind of radiation-induced mucosal injury, is mainly caused by direct damage of oral mucosa epithelial cells by radiation and secondary inflammatory reaction, causes oral mucosa injury and ulceration, and stimulates nerve endings, which causes unbearable pain when eating and speaking, affects swallowing and communication, and is a chronic wound with high treatment difficulty.

[0003] Clinically, the treatment of radiation-induced oral ulcer depends on the degree of ulceration and the specific condition of the patient, and the existing treatment mostly uses antibiotic or hormone drugs, which is easy to produce drug resistance and difficult to promote deep tissue repair.

[0004] Therefore, the present application is proposed. SUMMARY

[0005] The present application aims to provide a traditional Chinese medicine composition for treating radiation-induced oral ulcer and application thereof, which achieves the effects of clearing heat and drying dampness, promoting blood circulation to stop pain, astringing and promoting skin regeneration, and strengthening body resistance and detoxification through the selection of each traditional Chinese medicine raw material and the combined action of each raw material, has significant curative effect on radiation-induced oral ulcer, and rapidly improves ulceration, redness and pain symptoms.

[0006] In order to achieve the above-mentioned purpose of the present application, the following technical solutions are adopted:

[0007] The present application provides a traditional Chinese medicine composition for treating radiation-induced oral ulcer, which comprises the following weight parts of traditional Chinese medicine raw materials:

[0008] Sophora flavescens 6-10 parts, Glycyrrhiza uralensis 6-10 parts, Fraxinus 6-10 parts and Corydalis 6-9 parts.

[0009] Preferably, the traditional Chinese medicine composition comprises the following weight parts of traditional Chinese medicine raw materials:

[0010] Sophora flavescens 7-9 parts, Glycyrrhiza uralensis 7-9 parts, Fraxinus 7-9 parts and Corydalis 7-8 parts.

[0011] Preferably, the traditional Chinese medicine composition comprises the following weight parts of traditional Chinese medicine raw materials:

[0012] Sophora flavescens 8 parts, Glycyrrhiza uralensis 8 parts, Fraxinus 8 parts and Corydalis 7 parts.

[0013] The second aspect of the present application provides a use of the above-mentioned traditional Chinese medicine composition in preparing a traditional Chinese medicine preparation for treating radiation-induced oral ulcer.

[0014] Preferably, the dosage form of the traditional Chinese medicine preparation includes decoction, powder, granules and tablets.

[0015] The third aspect of the present application provides a traditional Chinese medicine decoction for treating radiation-induced oral ulcer, and a preparation method of the traditional Chinese medicine decoction includes the following steps:

[0016] (a) weighing the traditional Chinese medicine raw materials according to the weight parts;

[0017] (b) adding each traditional Chinese medicine raw material to water for decoction, filtering, collecting the filtrate, adding water to the residue for secondary decoction, filtering, collecting the filtrate, and combining the filtrates to obtain the traditional Chinese medicine decoction for treating radiation-induced oral ulcer.

[0018] Preferably, in the step (b), the mass ratio of the total weight of each traditional Chinese medicine raw material to water is 1:(8-10).

[0019] Preferably, in the step (b), the decoction is boiled with large fire and then decocted with small fire for 30-60 min.

[0020] Preferably, in the step (b), the amount of water added in the secondary decoction process is 5-7 times the total weight of each traditional Chinese medicine raw material.

[0021] Compared with the prior art, the present application has at least the following beneficial effects:

[0022] The present inventors have screened various traditional Chinese medicine raw materials with the functions of clearing heat and removing dampness, promoting blood circulation to stop pain, astringing and promoting skin regeneration, and strengthening body resistance and detoxification based on years of medical experience and Chinese medicine theory. Under the combined action of the raw materials, the symptoms of oral ulceration, redness and pain caused by radiation can be significantly improved, and the traditional Chinese medicine composition has a significant effect on radiation-induced oral ulcer. DETAILED DESCRIPTION

[0023] The embodiments of the present application will be described in detail below with reference to the examples. The following examples are only used to more clearly illustrate the technical solutions of the present application, and therefore only serve as examples, but cannot be used to limit the protection scope of the present application.

[0024] It should be noted that, unless otherwise specified, the technical terms or scientific terms used in the present application should be understood as the usual meanings understood by the skilled in the art to which the present application belongs.

[0025] The embodiments of the present application provide a traditional Chinese medicine composition for treating radiation-induced oral ulcer, and the traditional Chinese medicine composition includes the following weight parts of traditional Chinese medicine raw materials:

[0026] Sophora flavescens 6-10 parts, Glycyrrhiza uralensis 6-10 parts, Fraxinus rhynchophylla 6-10 parts and Corydalis 6-9 parts.

[0027] The present application inventors, through years of medical experience, combined with TCM theory, screened various Chinese medicinal materials with the functions of clearing heat and drying dampness, promoting blood circulation to stop pain, astringing and skin healing, and strengthening the body to detoxify. Under the combined action of the various materials, the symptoms of oral mucosa ulceration, redness and pain caused by radiation can be significantly improved, and the present application has a significant effect on treating radiation-induced oral ulcer.

[0028] In some embodiments, the Chinese medicinal composition comprises the following weight parts of Chinese medicinal materials:

[0029] Sophora flavescens 7-9 parts, Glycyrrhiza uralensis 7-9 parts, Fraxinus rhynchophylla 7-9 parts and Corydalis 7-8 parts.

[0030] In an embodiment, the Chinese medicinal composition comprises the following weight parts of Chinese medicinal materials:

[0031] Sophora flavescens 8 parts, Glycyrrhiza uralensis 8 parts, Fraxinus rhynchophylla 8 parts and Corydalis 7 parts.

[0032] The present application can better improve the synergistic effect between the various materials, improve the efficacy of the various materials, and further improve the overall efficacy of the Chinese medicinal composition by further limiting the amount of each material.

[0033] Another embodiment of the present application provides a use of the above-mentioned Chinese medicinal composition in preparing a Chinese medicinal preparation for treating radiation-induced oral ulcer.

[0034] In an embodiment, the dosage form of the Chinese medicinal preparation includes decoction, powder, granules and tablets.

[0035] Still another embodiment of the present application provides a Chinese medicinal decoction for treating radiation-induced oral ulcer, and a preparation method of the Chinese medicinal decoction comprises the following steps:

[0036] (a) weighing the Chinese medicinal materials according to the weight parts;

[0037] (b) adding the Chinese medicinal materials to water for decoction, filtering, collecting the filtrate, adding water to the residue for secondary decoction, filtering, collecting the filtrate, and combining the filtrates to obtain the Chinese medicinal decoction for treating radiation-induced oral ulcer.

[0038] In an embodiment, in step (b), the mass ratio of the total weight of the Chinese medicinal materials to water can be any value between 1:8 and 1:10.

[0039] In an embodiment, in step (b), the decoction is boiled with a large fire and then decocted with a small fire for 30-60 minutes.

[0040] In one embodiment, in step (b), the amount of water added during the second decoction process is 5-7 times the total weight of the raw Chinese medicinal materials.

[0041] The technical solutions of the present application are further described in detail below through specific examples.

[0042] Example 1

[0043] The present example is a Chinese medicinal decoction for treating radioactive oral ulcer, which is prepared from the following raw Chinese medicinal materials by weight:

[0044] Sophora flavescens 10 parts, Glycyrrhiza 6 parts, Fraxinus 6 parts, and Corydalis 9 parts;

[0045] The preparation method of the above Chinese medicinal decoction for treating radioactive oral ulcer comprises the following steps:

[0046] (a) The above raw Chinese medicinal materials are weighed according to the weight parts;

[0047] (b) The raw Chinese medicinal materials are added to water for decoction and filtration according to a mass ratio of the total weight of the raw Chinese medicinal materials to water of 1:10. The filtrate is collected. Then, 7 times the total weight of the raw Chinese medicinal materials is added to the residue for the second decoction and filtration. The filtrate is collected. The filtrates are combined to obtain the Chinese medicinal decoction for treating radioactive oral ulcer. The decoction is boiled with a large fire and then decocted with a small fire for 60 min.

[0048] Example 2

[0049] The present example is a Chinese medicinal decoction for treating radioactive oral ulcer, which is prepared from the following raw Chinese medicinal materials by weight:

[0050] Sophora flavescens 6 parts, Glycyrrhiza 10 parts, Fraxinus 10 parts, and Corydalis 6 parts;

[0051] The preparation method of the above Chinese medicinal decoction for treating radioactive oral ulcer comprises the following steps:

[0052] (a) The above raw Chinese medicinal materials are weighed according to the weight parts;

[0053] (b) The raw Chinese medicinal materials are added to water for decoction and filtration according to a mass ratio of the total weight of the raw Chinese medicinal materials to water of 1:8. Then, 5 times the total weight of the raw Chinese medicinal materials is added to the residue for the second decoction and filtration. The filtrate is collected. The filtrates are combined to obtain the Chinese medicinal decoction for treating radioactive oral ulcer. The decoction is boiled with a large fire and then decocted with a small fire for 30 min.

[0054] Example 3

[0055] The present embodiment is a traditional Chinese medicine decoction for treating radioactive oral ulcer, which is prepared from the following traditional Chinese medicine raw materials by weight:

[0056] Sophora flavescens 7 parts, Glycyrrhiza 9 parts, Alstonia scholaris 9 parts and Corydalis 7 parts;

[0057] The preparation method of the traditional Chinese medicine decoction for treating radioactive oral ulcer includes the following steps:

[0058] (a) The above traditional Chinese medicine raw materials are weighed according to the weight parts;

[0059] (b) The total weight of each traditional Chinese medicine raw material is added to water for decoction and filtration according to the mass ratio of 1:8, the filtrate is collected, 5 times the total weight of each traditional Chinese medicine raw material is added to the residue for secondary decoction and filtration, the filtrate is collected, and the filtrates are combined to obtain the traditional Chinese medicine decoction for treating radioactive oral ulcer, wherein the decoction is boiled with a large fire and then decocted with a small fire for 40 minutes.

[0060] Embodiment 4

[0061] The present embodiment is a traditional Chinese medicine decoction for treating radioactive oral ulcer, which is prepared from the following traditional Chinese medicine raw materials by weight:

[0062] Sophora flavescens 9 parts, Glycyrrhiza 7 parts, Alstonia scholaris 7 parts and Corydalis 8 parts;

[0063] The preparation method of the traditional Chinese medicine decoction for treating radioactive oral ulcer includes the following steps:

[0064] (a) The above traditional Chinese medicine raw materials are weighed according to the weight parts;

[0065] (b) The total weight of each traditional Chinese medicine raw material is added to water for decoction and filtration according to the mass ratio of 1:8, the filtrate is collected, 5 times the total weight of each traditional Chinese medicine raw material is added to the residue for secondary decoction and filtration, the filtrate is collected, and the filtrates are combined to obtain the traditional Chinese medicine decoction for treating radioactive oral ulcer, wherein the decoction is boiled with a large fire and then decocted with a small fire for 40 minutes.

[0066] Embodiment 5

[0067] The present embodiment is a traditional Chinese medicine decoction for treating radioactive oral ulcer, which is prepared from the following traditional Chinese medicine raw materials by weight:

[0068] Sophora flavescens 8 parts, Glycyrrhiza 8 parts, Alstonia scholaris 8 parts and Corydalis 7 parts;

[0069] The preparation method of the traditional Chinese medicine decoction for treating radioactive oral ulcer includes the following steps:

[0070] (a) taking the above-mentioned traditional Chinese medicinal materials according to weight parts;

[0071] (b) adding each of the traditional Chinese medicinal materials into water to decoct and filter according to a mass ratio of the total weight of each of the traditional Chinese medicinal materials to water of 1:8, collecting the filtrate, adding water with a mass of 6 times the total weight of each of the traditional Chinese medicinal materials into the residue to decoct and filter again, collecting the filtrate, and combining the filtrates to obtain the traditional Chinese medicinal decoction for treating radioactive oral ulcer, wherein the decocting is boiling with a large fire and then decocting with a small fire for 50 min.

[0072] Comparative Example 1

[0073] The present comparative example is a traditional Chinese medicinal decoction for treating radioactive oral ulcer, which is prepared from the following traditional Chinese medicinal materials according to weight parts:

[0074] Sophora flavescens Ait. 8 parts, Glycyrrhiza uralensis Fisch. 8 parts, and Corydalis 15 parts;

[0075] The preparation method of the above-mentioned traditional Chinese medicinal decoction for treating radioactive oral ulcer comprises the following steps:

[0076] (a) taking the above-mentioned traditional Chinese medicinal materials according to weight parts;

[0077] (b) adding each of the traditional Chinese medicinal materials into water to decoct and filter according to a mass ratio of the total weight of each of the traditional Chinese medicinal materials to water of 1:8, collecting the filtrate, adding water with a mass of 6 times the total weight of each of the traditional Chinese medicinal materials into the residue to decoct and filter again, collecting the filtrate, and combining the filtrates to obtain the traditional Chinese medicinal decoction for treating radioactive oral ulcer, wherein the decocting is boiling with a large fire and then decocting with a small fire for 50 min.

[0078] Comparative Example 2

[0079] The present comparative example is a traditional Chinese medicinal decoction for treating radioactive oral ulcer, which is prepared from the following traditional Chinese medicinal materials according to weight parts:

[0080] Sophora flavescens Ait. 8 parts, Glycyrrhiza uralensis Fisch. 8 parts, and Corydalis 15 parts;

[0081] The preparation method of the above-mentioned traditional Chinese medicinal decoction for treating radioactive oral ulcer comprises the following steps:

[0082] (a) taking the above-mentioned traditional Chinese medicinal materials according to weight parts;

[0083] (b) adding each of the traditional Chinese medicinal materials into water to decoct and filter according to a mass ratio of the total weight of each of the traditional Chinese medicinal materials to water of 1:8, collecting the filtrate, adding water with a mass of 6 times the total weight of each of the traditional Chinese medicinal materials into the residue to decoct and filter again, collecting the filtrate, and combining the filtrates to obtain the traditional Chinese medicinal decoction for treating radioactive oral ulcer, wherein the decocting is boiling with a large fire and then decocting with a small fire for 50 min.

[0084] Comparative Example 3

[0085] The present comparative example is a traditional Chinese medicine decoction for treating radioactive oral ulcer, which is prepared from the following traditional Chinese medicine raw materials by weight:

[0086] Sophora flavescens 8 parts, Glycyrrhiza 8 parts, Fraxinus 5 parts, and Corydalis 10 parts;

[0087] The preparation method of the above traditional Chinese medicine decoction for treating radioactive oral ulcer comprises the following steps:

[0088] (a) weighing the above traditional Chinese medicine raw materials according to the weight parts;

[0089] (b) adding each traditional Chinese medicine raw material to water in a mass ratio of 1:8 based on the total weight of each traditional Chinese medicine raw material and water, decocting, filtering, collecting the filtrate, adding 6 times the total weight of each traditional Chinese medicine raw material to the residue for secondary decocting, filtering, collecting the filtrate, and combining the filtrates to obtain the traditional Chinese medicine decoction for treating radioactive oral ulcer, wherein the decocting is boiling with a large fire and then decocting with a small fire for 50 min.

[0090] Experimental example

[0091] The traditional Chinese medicine decoction for treating radioactive oral ulcer was prepared according to the methods of Example 5 and Comparative Examples 1-3, respectively;

[0092] The above traditional Chinese medicine decoction for treating radioactive oral ulcer was used to treat subjects with radioactive oral ulcer, and each traditional Chinese medicine decoction was used to treat a total of 25 subjects; the specific treatment method is as follows:

[0093] The subjects orally took 200 ml of the traditional Chinese medicine decoction once in the morning and once in the evening every day, and continuously took it for 14 days; then, the efficacy of each traditional Chinese medicine decoction was evaluated;

[0094] The efficacy evaluation criteria are as follows:

[0095] Complete recovery (CR): the ulcer surface completely disappears, the mucosa returns to normal color and texture, there is no hyperemia, edema, and pain completely disappears, eating, speaking is not uncomfortable, saliva secretion and oral function return to normal;

[0096] Significant remission (PR): ulcer area is reduced by ≥50%, depth is shallower, surrounding hyperemia and edema are significantly reduced, pain is significantly relieved (such as pain score is reduced by ≥2 points, NRS or VAS score is used), and semi-liquid or soft food can be normally eaten;

[0097] Partial remission (MR): ulcer area is reduced by <50%, or ulcer depth is reduced, but there is still obvious hyperemia or pseudomembrane covering, pain is slightly relieved, only liquid or soft food can be eaten, and part of the life function is still affected;

[0098] Invalid (NR): ulcer area, depth of no change or aggravation, hyperemia edema and pseudomembrane no improvement, pain no relief or aggravation, need to rely on analgesics or enteral nutrition.

[0099] The results of the efficacy evaluation are shown in Table 1:

[0100] Table 1

[0101] Group Complete recovery Markedly effective Effective No effect Example 5 6 16 3 0 Comparative Example 1 0 14 8 1 Comparative Example 2 0 15 7 3 Comparative Example 3 2 17 6 0

[0102] From Table 1, it can be seen that:

[0103] Compared with the comparative examples, the traditional Chinese medicine decoction for treating radiation-induced oral ulcer prepared in the embodiments of the present application can better treat radiation-induced oral ulcer and has better effect.

[0104] Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the present application, but not to limit them; although the present application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that: it can still modify the technical solutions recorded in the foregoing embodiments, or make equivalent replacement for part or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present application, and they should be covered in the scope of the claims and the specification of the present application.

Claims

1. A traditional Chinese medicine composition for treating radiation-induced oral ulcer, characterized in that, The traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials by weight: Sophora flavescens 6-10 parts, Glycyrrhiza uralensis 6-10 parts, Fraxinus 6-10 parts, and Corydalis 6-9 parts.

2. The traditional Chinese medicine composition for treating radioactive oral ulcer according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials by weight: Sophora flavescens 7-9 parts, Glycyrrhiza uralensis 7-9 parts, Fraxinus 7-9 parts, and Corydalis 7-8 parts. 3.The traditional Chinese medicine composition for treating radiation-induced oral ulcer according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials by weight: Sophora flavescens 8 parts, Glycyrrhiza uralensis 8 parts, Fraxinus 8 parts, and Corydalis 7 parts.

4. Use of the traditional Chinese medicine composition of any one of claims 1-3 in the preparation of a traditional Chinese medicine preparation for treating radiation-induced oral ulcer.

5. Use according to claim 4, characterized in that, The dosage form of the traditional Chinese medicine preparation comprises decoction, powder, granules, and tablets.

6. A Chinese medicine decoction for treating radiation-induced oral ulcer, characterized in that, The preparation method of the traditional Chinese medicine decoction comprises the following steps: (a) weighing the traditional Chinese medicine raw materials of any one of claims 1-3 according to weight parts; (b) adding each traditional Chinese medicine raw material to water for decoction, filtering, collecting the filtrate, adding water to the residue for secondary decoction, filtering, collecting the filtrate, and combining the filtrates to obtain the traditional Chinese medicine decoction for treating radiation-induced oral ulcer.

7. The traditional Chinese medicine decoction according to claim 6, characterized in that, In step (b), the total weight of each traditional Chinese medicine raw material is 1: (8-10) times the mass of water.

8. The traditional Chinese medicine decoction according to claim 6, characterized in that, In step (b), the decoction is boiled at high heat and then decocted at low heat for 30-60 min.

9. The traditional Chinese medicine decoction according to claim 6, characterized in that, In step (b), the amount of water added during the secondary decoction is 5-7 times the total weight of each traditional Chinese medicine raw material.