Traditional Chinese medicine composition for treating oral submucosal fibrosis as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating oral submucosal fibrosis, a preparation method and application. Comprising the following raw material components in parts by weight: 12-18 parts of sargentgloryvine stem, 12-18 parts of honeysuckle, 10-15 parts of radix salviae miltiorrhizae, 10-15 parts of radix isatidis, 10-15 parts of radix paeoniae rubra, 4-8 parts of pseudo-ginseng, 12-18 parts of sargentgloryvine stem, 12-18 parts of sculellaria barbata, 10-15 parts of dandelion, 10-15 parts of selfheal, 10-15 parts of thunberg fritillary bulb, 6-12 parts of earthworm, 12-18 parts of rehmannia, 7-13 parts of rhizoma bletillae, 10-15 parts of cordyceps flower, 10-15 parts of radix pseudostellariae and 4-8 parts of liquorice. The effect of treating the oral submucosal fibrosis is improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating oral submucous fibrosis, a preparation method and uses thereof. Background Art

[0002] Clinical research progress of traditional Chinese medicine in the treatment of oral submucous fibrosis, Guo Jin-cai, Xie Hui, Journal of Oral Science Research, May 2019, Vol. 35, No. 5, discloses that oral submucous fibrosis (OSF), also known as oral submucous fibrosis, is a chronic and occult inflammatory disease and is a recognized oral precancerous lesion. At present, it is considered to be related to factors such as genetics, immunity, malnutrition, betel nut chewing, and collagen metabolism disorders. Its pathogenesis is complex and not yet fully understood, and there is no effective treatment method currently.

[0003] The main treatment methods for OSF include drug treatment, physical treatment, hyperbaric oxygen treatment, and surgical treatment, etc., with drug treatment being the main one. The western medicines in drug treatment mainly include 5 categories: (1) Immunomodulators, such as glucocorticoids (triamcinolone acetonide, dexamethasone, betamethasone, cortisone, etc.), interferon-γ, levamisole, immune milk, etc.; (2) Antioxidants, such as vitamin A, vitamin E, β-carotene, lycopene, etc.; (3) Vasodilators, such as pentoxifylline, buflomedil hydrochloride, buphenine hydrochloride, phenoxypropanolamine, etc.; (4) Fibrinolysin, such as collagenase, hyaluronidase, chymotrypsin, etc.; (5) Nutritional elements, such as zinc, magnesium, iron, etc.

[0004] In the treatment of traditional Chinese medicine, the prescriptions mainly for promoting blood circulation to remove blood stasis and clearing heat and detoxifying are the top choices. Natural medicines mainly include salvia miltiorrhiza and aloe. Proprietary Chinese medicines include compound danshen dripping pills (the main components are salvia miltiorrhiza, notoginseng, and borneol), Danxuan Koukang tablets (the components are salvia miltiorrhiza, angelica sinensis, safflower, rehmannia glutinosa, scrophularia ningpoensis, oldenlandia diffusa, astragalus membranaceus, mint, etc.), Guihong injection (the prescription includes astragalus membranaceus, salvia miltiorrhiza, angelica sinensis, rehmannia glutinosa, clematis chinensis, peach kernel, bupleurum chinense, safflower, ligusticum wallichii, red peony root, curcuma aromatica, etc.), the prescription of Taohong Siwu Decoction (composed of Siwu Decoction (prepared rhizome of rehmannia, angelica sinensis, white peony root, ligusticum wallichii) plus peach kernel and safflower), Yuquan Decoction (composed of trichosanthes root, ophiopogon japonicus, pseudostellaria heterophylla, astragalus membranaceus, pueraria lobata, smoked plum, liquorice, etc.), Gancao Xiexin Decoction combined with Simiao Yong'an Decoction (composed of raw liquorice, scutellaria baicalensis, coptis chinensis, jujube, dried ginger, pinellia ternata, codonopsis pilosula, honeysuckle, scrophularia ningpoensis, angelica sinensis), self-made Jiexianyin (composed of peach kernel, ligusticum wallichii, angelica sinensis, safflower, red peony root, salvia miltiorrhiza, Corydalis yanhusuo, Bombyx batryticatus, Pheretima, curcuma aromatica, smilax glabra, white mustard seed, scrophularia ningpoensis, rehmannia glutinosa, oldenlandia diffusa, prunella vulgaris, honeysuckle, liquorice), Shugan Huoxue Decoction (composed of bupleurum chinense, salvia miltiorrhiza, angelica sinensis, ligusticum wallichii, red peony root, crocus sativus, artemisia capillaris, astragalus membranaceus, rehmannia glutinosa, anemarrhena asphodeloides, oldenlandia diffusa, liquorice), Huoxue Huayu Jiedu Decoction (the prescription is angelica sinensis, safflower, red peony root, salvia miltiorrhiza, scrophularia ningpoensis, rehmannia glutinosa, oldenlandia diffusa, honeysuckle). Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition, a preparation method and a use for treating oral submucous fibrosis, so as to improve the treatment effect of oral submucous fibrosis.

[0006] An embodiment of the present invention provides a traditional Chinese medicine composition for treating oral submucous fibrosis, which comprises the following raw material components in parts by weight: 12-18 parts of Sargentodoxa cuneata, 12-18 parts of Lonicera japonica, 10-15 parts of Salvia miltiorrhiza, 10-15 parts of Isatis tinctoria, 10-15 parts of Paeonia lactiflora, 4-8 parts of Panax notoginseng, 12-18 parts of Sargentodoxa cuneata, 12-18 parts of Scutellaria barbata, 10-15 parts of Taraxacum mongolicum, 10-15 parts of Prunella vulgaris, 10-15 parts of Fritillaria thunbergii, 6-12 parts of Pheretima aspergillum, 12-18 parts of Rehmannia glutinosa, 7-13 parts of Bletilla striata, 10-15 parts of Cordyceps flower, 10-15 parts of Pseudostellaria heterophylla, and 4-8 parts of Glycyrrhiza uralensis.

[0007] Preferably, it comprises the following raw material components in parts by weight: 14-16 parts of Sargentodoxa cuneata, 14-16 parts of Lonicera japonica, 11-13 parts of Salvia miltiorrhiza, 11-13 parts of Isatis tinctoria, 11-13 parts of Paeonia lactiflora, 5-7 parts of Panax notoginseng, 14-16 parts of Sargentodoxa cuneata, 14-16 parts of Scutellaria barbata, 11-13 parts of Taraxacum mongolicum, 11-13 parts of Prunella vulgaris, 11-13 parts of Fritillaria thunbergii, 8-10 parts of Pheretima aspergillum, 14-16 parts of Rehmannia glutinosa, 9-11 parts of Bletilla striata, 11-13 parts of Cordyceps flower, 11-13 parts of Pseudostellaria heterophylla, and 5-7 parts of Glycyrrhiza uralensis.

[0008] Preferably, it comprises the following raw material components in parts by weight: 15 parts of Sargentodoxa cuneata, 15 parts of Lonicera japonica, 12 parts of Salvia miltiorrhiza, 12 parts of Isatis tinctoria, 12 parts of Paeonia lactiflora, 6 parts of Panax notoginseng, 15 parts of Sargentodoxa cuneata, 15 parts of Scutellaria barbata, 12 parts of Taraxacum mongolicum, 12 parts of Prunella vulgaris, 12 parts of Fritillaria thunbergii, 9 parts of Pheretima aspergillum, 15 parts of Rehmannia glutinosa, 10 parts of Bletilla striata, 12 parts of Cordyceps flower, 12 parts of Pseudostellaria heterophylla, and 6 parts of Glycyrrhiza uralensis.

[0009] Preferably, the dosage form of the traditional Chinese medicine composition is tablets, capsules, granules, pills or oral liquids.

[0010] An embodiment of the present invention provides a preparation method of the traditional Chinese medicine composition, which comprises mixing the traditional Chinese medicine components, decocting twice with water. The first time, 8-12 times the amount of water is added, and the second time, 5-7 times the amount of water is added. The decoction liquids are combined, filtered, and concentrated to obtain the traditional Chinese medicine composition.

[0011] Preferably, 10 times the amount of water is added for the first time, and 6 times the amount of water is added for the second time.

[0012] Preferably, the decocting time for the first time is 1-2 h, and the decocting time for the second time is 0.5-1 h.

[0013] Preferably, the relative density of the concentrated medicinal liquid is 1.3-1.4.

[0014] An embodiment of the present invention provides a use of the traditional Chinese medicine composition, and the traditional Chinese medicine composition is used for preparing a medicament for treating oral submucous fibrosis.

[0015] The beneficial effects of the present invention are as follows: Sargentodoxa cuneata can clear heat and detoxify, activate blood circulation and relieve pain, and is mainly used for treating heat toxin stasis and blood stasis blocking the meridians; Flos Lonicerae can clear heat and detoxify, disperse stasis and cool the blood, and is good at resolving heat toxin in the blood aspect; Salvia miltiorrhiza can activate blood circulation to remove stasis, nourish blood and soothe the nerves, promote blood circulation without leaving stasis, and break stasis without damaging healthy qi; Isatis indigotica Fort. can clear heat and detoxify, cool the blood and reduce swelling, and has a significant curative effect on fire toxin stagnation and blood collaterals obstruction; the above four are the monarch drugs together, and jointly play the leading role of clearing heat and detoxifying, promoting blood circulation to remove stasis, and detoxifying and dredging collaterals. Paeonia lactiflora Pall. can clear heat and cool the blood, disperse stasis and relieve pain, and cooperate with Salvia miltiorrhiza and Sargentodoxa cuneata to achieve the effect of promoting blood circulation to remove stasis and relieve pain; Panax notoginseng is an important drug for promoting blood circulation to remove stasis, and also has the effects of stopping bleeding and relieving pain, and helps to promote local microcirculation; Sargentodoxa cuneata can clear heat and detoxify, activate blood circulation and disperse stasis, and cooperate with Scutellaria barbata D. Don and Taraxacum mongolicum Hand.-Mazz., synergistically enhancing the effects of clearing heat and detoxifying, anti-inflammatory and anti-fibrosis. The adjuvant drugs mainly soften hardness and disperse stasis, strengthen healthy qi and eliminate pathogenic factors. Prunella vulgaris L. and Fritillaria thunbergii Miq. are combined, softening hardness and clearing heat, resolving phlegm and dispersing stasis, and specifically treating phlegm-heat mutual binding and nodular cords; Pheretima can dredge collaterals and disperse stasis, clear heat and calm fright, and help the medicinal power reach the lesion site; Rehmannia glutinosa Libosch. can nourish yin and clear heat, cool the blood and promote the production of body fluid, preventing heat toxin from injuring yin and the disease from persisting; Bletilla striata (Thunb.) Reichb. can arrest bleeding and promote granulation, helping to repair the mucosa and promote healing; Cordyceps militaris (L.ex Fr.) Link can tonify the kidney and moisten the lungs, support toxin and strengthen healthy qi, and Pseudostellaria heterophylla (Miq.) Pax can replenish qi and promote the production of body fluid, tonify deficiency and boost strength, helping to enhance the body's disease resistance and regulate immune response, so that healthy qi can be nourished and the anti-pathogenic ability can be enhanced. Glycyrrhiza uralensis Fisch. can harmonize all the drugs and relieve the drug properties. The whole prescription is combined, tonifying qi and supporting toxin, promoting blood circulation to remove stasis, clearing heat and detoxifying, softening hardness and dispersing stasis, taking both the root cause and the symptoms into consideration, and treating both internally and externally.

[0016] The present invention discovers through experiments that, in the treatment of oral submucous fibrosis, compared with the compositions of Comparative Example 1 and Comparative Example 2, the traditional Chinese medicine composition of the present invention can effectively improve the qi and blood circulation disorder, nourish body fluids, restore healthy qi of OSF rats, and increase the mouth opening degree of rats; has a good effect of improving mucosal damage, the expression of inflammatory factors is significantly improved, has a good effect of inhibiting collagen deposition and improving fibrotic lesions. Detailed implementation manners

[0017] Example 1

[0018] A traditional Chinese medicine composition for treating oral submucous fibrosis, comprising the following traditional Chinese medicine components in parts by weight: 15 g of Sargentodoxa cuneata, 15 g of Flos Lonicerae, 12 g of Salvia miltiorrhiza, 12 g of Isatis indigotica Fort., 12 g of Paeonia lactiflora Pall., 6 g of Panax notoginseng, 15 g of Sargentodoxa cuneata, 15 g of Scutellaria barbata D. Don, 12 g of Taraxacum mongolicum Hand.-Mazz., 12 g of Prunella vulgaris L., 12 g of Fritillaria thunbergii Miq., 9 g of Pheretima, 15 g of Rehmannia glutinosa Libosch., 10 g of Bletilla striata (Thunb.) Reichb., 12 g of Cordyceps militaris (L.ex Fr.) Link, 12 g of Pseudostellaria heterophylla (Miq.) Pax, and 6 g of Glycyrrhiza uralensis Fisch.

[0019] The preparation method of the traditional Chinese medicine composition for treating oral submucous fibrosis is to mix the above-mentioned traditional Chinese medicine components, decoct them twice with water. For the first time, add 10 times the amount of water and decoct for 2 hours. For the second time, add 6 times the amount of water and decoct for 1 hour. Combine the decoction liquids, filter, and concentrate to a relative density of 1.3 - 1.4 to obtain the traditional Chinese medicine composition.

[0020] Comparative Example 1

[0021] Compared with Example 1, the difference lies in that it includes the following traditional Chinese medicine components in parts by weight: 25 g of honeysuckle, 20 g of salvia miltiorrhiza, 20 g of isatis root, 20 g of red peony root, 10 g of notoginseng, 20 g of dandelion, 18 g of selfheal fruit-spike, 14 g of earthworm, 25 g of rehmannia root, 20 g of heterophylly falsestarwort root, and 10 g of licorice root. Others are the same as in Example 1.

[0022] Comparative Example 2

[0023] Compared with Example 1, the difference lies in that it includes the following traditional Chinese medicine components in parts by weight: 10 g of peach kernel, 10 g of chuanxiong rhizome, 15 g of angelica sinensis, 10 g of safflower, 10 g of red peony root, 15 g of salvia miltiorrhiza, 10 g of Corydalis yanhusuo, 10 g of bombyx batryticatus, 10 g of earthworm, 15 g of turmeric root-tuber, 20 g of glabrous greenbrier rhizome, 68 of white mustard seed, 15 g of scrophularia root, 15 g of raw rehmannia root, 10 g of oldenlandia diffusa, 10 g of selfheal fruit-spike, 10 g of honeysuckle, and 6 g of licorice root. Others are the same as in Example 1.

[0024] Example 2

[0025] 1. Experimental animals

[0026] 60 male SD rats, 6 - 7 weeks old, weighing 180 - 200 g, were provided by Hunan Slack Jingda Experimental Animal Co., Ltd. (License No.: SCXK(Xiang)2019 - 0004). The animals were housed in the Experimental Animal Center of Hunan University of Chinese Medicine (License No.: SYXK(Xiang)2019 - 0009). The environmental conditions were room temperature of 20 - 22 °C, relative humidity of 50% - 70%, 12-hour day-night alternating lighting, air change frequency of 8 - 12 times / hour, and free access to water and food. All animals entered the experimental stage after 7 days of adaptive feeding. The experimental protocol was approved by the Experimental Animal Ethics Committee of Hunan University of Chinese Medicine (HNUCM21 - 2407 - 12).

[0027] 2. Prescription composition

[0028] The test drug was the drug of Example 1, and in addition, the positive drug, the drugs of Comparative Example 1 and Comparative Example 2 were used as controls.

[0029] 3. Grouping and model establishment

[0030] According to the body weight, 60 SD rats were randomly divided into a normal group, a model group, a positive drug group, a comparative example group 1, a comparative example group 2, and a test drug group, with 10 rats in each group. Except for the normal group, the rest of the groups used the method of arecoline extract (ANE) to establish a rat OSF model, and injected 0.2ml of 10mg / kg arecoline solution into the buccal mucosa to make the mucosa bulge like a skin bump, and then applied locally on the surface again. After completion, fasting and water deprivation for 2h, once every 2 days, and continuous modeling for 8 weeks. After 8 weeks, the rats had significantly limited mouth opening, pale buccal mucosa, hardened by touch, and cords formed under the mucosa.

[0031] 4. Drug administration

[0032] After modeling, gavage was started, with the positive drug group receiving 400 mg / kg hydrocortisone, and the control group 1, control group 2, and test drug group receiving the corresponding prescription drugs, with the dosage of 8.75 g / kg / d (clinically equivalent to 1 / 3 times the dose). Gavage was performed once a day for 4 weeks, with a gavage volume of 10 mL / kg. The normal group and the model group were given an equal volume of distilled water.

[0033] 5. Index detection

[0034] (1) Functional evaluation

[0035] ① Mouth opening test: The mouth opening of rats was tested before administration, 2 weeks after administration, and 4 weeks after administration. The vernier caliper was accurate to 0.1 mm. Each rat was tested 3 times and the average value was taken.

[0036] ② Buccal mucosa scoring: Before administration, 2 weeks after administration, and 4 weeks after administration, the buccal mucosa of the rats was scored based on its color, smoothness, and fiber cords (symptom disappearance: 0 points, mild symptoms: 1 point, moderate symptoms: 2 points, and severe symptoms: 3 points).

[0037] (2) Biochemical testing

[0038] After the last administration, the serum of rats in each group was collected, and the levels of inflammatory factors IL-1β, IL-6, and IL-10 were detected by enzyme-linked immunosorbent assay kit (ELISA method), strictly following the instructions of the kit.

[0039] (3) Collagen level detection

[0040] Take rat buccal mucosal tissue, add tissue protein extraction solution at a ratio of 1:10, and place it in an ice bath environment for full homogenization in a homogenizer to keep the temperature low to prevent protein degradation. The homogenate was centrifuged at 4°C, 3000rpm for 10 minutes, and the supernatant was taken and stored for later use. The content of hydroxyproline (Hyp) and type I collagen in the tissue sample was detected according to the instructions of the enzyme-linked immunosorbent assay kit.

[0041] 2. Experimental Results

[0042] 1. General observation

[0043] The rats in the normal group had normal body postures, smooth and shiny fur that was neatly arranged, normal drinking and feeding, sufficient activity levels, sensitive movements, rapid responses to external stimuli, good mental states, and no abnormal postures or behaviors.

[0044] As the modeling time extended, the rats in the model group gradually showed reduced activity, preferred to be quiet and move less, had rough, dry, and dull fur, and some rats had hair loss; their appetite for food decreased, food intake reduced, water intake varied, some rats had symptoms of dry mouth, their body postures were mostly curled up due to fear of cold with their backs arched, some rats had a significant decrease in body weight, their mental states were poor, and their reactions were slow.

[0045] After treatment with the test drug, the mental states of the rats were significantly improved compared with the model group, the fur luster gradually recovered, hair loss decreased, body weight increased steadily, drinking and feeding conditions improved, behavioral activities increased, activity levels improved, responses to external stimuli were sensitive, and body postures basically returned to normal, indicating that this prescription drug could effectively improve the qi and blood circulation disorders, nourish body fluids, and restore healthy qi in OSF rats.

[0046] The rats in Comparative Example Group 1 showed some improvement in behavioral states, hair, diet, etc. compared with the model group, but the overall improvement was limited, the activity level did not increase significantly, the hair was still slightly rough and disordered, and the mental state was still not good, indicating that the therapeutic advantages of this prescription drug were not fully demonstrated.

[0047] The improvement in the rats in Comparative Example Group 2 was more obvious than that in Comparative Example Group 1, the body weight recovery was better, the activity increased, and the diet condition improved relatively stably.

[0048] The general states of the rats in the positive drug group were also improved compared with the model group, the fur was smooth, the activities were normal, but some rats had appetite fluctuations and mild mental depression, which might be related to the side effects of glucocorticoids.

[0049] 2. Comparison of mouth opening degrees of rats in each group

[0050] Eight weeks after modeling, the mouth opening degrees of the rats were significantly limited; compared with the normal group, the mouth opening degrees of the rats in the model group were always significantly reduced (P < 0.01); compared with the model group, the mouth opening degrees of the rats in the test drug group, Comparative Example Group 2, and positive drug group were significantly increased 2 weeks after treatment (P < 0.01 or P < 0.05), and further increased 4 weeks after treatment (P < 0.01). The results are shown in Table 1.

[0051] Table 1 Comparison of mouth opening degrees of rats in each group( n = 10)

[0052]

[0053] Note: Compared with the normal group, **P < 0.01, *P < 0.05; compared with the model group ## P < 0.01, # P < 0.05.

[0054] 3. Comparison of buccal mucosa scores of rats in each group

[0055] Before treatment, there was no significant difference in the buccal mucosa scores of the modeled rats. After 2 weeks of treatment, compared with the model group, the buccal mucosa scores of the high-dose group of the test drug were significantly reduced (P < 0.01), and the scores of the positive drug group and the second control group were also significantly reduced (P < 0.05). After 4 weeks of treatment, the buccal mucosa scores of the rats in each drug administration group were further reduced, with significant statistical differences (P < 0.01), and the scores of the test drug group were the lowest, indicating its good efficacy in improving mucosal damage. The results are shown in Table 2.

[0056] Table 2 Comparison of buccal mucosa scores of rats in each group( n = 10)

[0057]

[0058]

[0059] Note: Compared with the normal group, **P < 0.01, *P < 0.05; compared with the model group ## P < 0.01, # P < 0.05.

[0060] 4. Serum levels of IL-1β, IL-6, and IL-10

[0061] OSF is a chronic progressive disease, and its occurrence and development run through the pathological process of intertwined inflammation and fibrosis. In the early stage, it is mainly characterized by chronic inflammatory reactions, with repeated hyperemia, edema of the local mucosa, and significant infiltration of inflammatory cells. In the middle stage, the inflammatory reaction persists and intensifies, promoting the abnormal proliferation of a large number of fibroblasts and excessive deposition of collagen. In the late stage, it is mainly characterized by fibrosis and scar tissue contracture, with a weakened inflammatory reaction but still a certain degree of chronic low-grade inflammation detectable. Therefore, this study evaluated the effects of the test drug on the inflammatory level of the model rats. The results showed that compared with the normal group, the levels of the pro-inflammatory factors IL-1β and IL-6 in the model group were significantly increased (P < 0.01), and the expression of the anti-inflammatory factor IL-10 was decreased (P < 0.01). Compared with the model group, the expressions of the above-mentioned inflammatory factors in the positive drug group, the second control group, and the test drug group were all significantly reversed (P < 0.01 or P < 0.05), and the first control group could only reduce the level of IL-1β (P < 0.05). See Table 3.

[0062] Table 3 Serum levels of IL-1β, IL-6, and IL-10 in rats in each group( n = 10)

[0063]

[0064] Note: Compared with the normal group, **P < 0.01, *P < 0.05; compared with the model group ## P < 0.01, # P < 0.05.

[0065] 5. Detection of collagen level in buccal mucosa

[0066] Excessive deposition of collagen is the main pathological feature of OSF. As a specific amino acid component of collagen, hydroxyproline, and type I collagen as the main deposited collagen type, the changes in their contents can directly reflect the degree of collagen deposition and the severity of fibrosis. The results of this study showed that compared with the normal group, the expression levels of hydroxyproline and type I collagen in the buccal mucosa tissues of rats in the model group were significantly increased (P < 0.01); compared with the model group, only the positive drug group and the test drug group had significantly decreased hydroxyproline and type I collagen contents (P < 0.01 or P < 0.05), the hydroxyproline content in the second control group was significantly decreased (P < 0.01), but there was no statistical difference in the regulation of type I collagen; compared with the first control group, the hydroxyproline content in the test drug group was significantly decreased (P < 0.01), indicating that the test drug has a good effect of inhibiting collagen deposition and improving fibrotic lesions. See Table 4.

[0067] Table 4 Comparison of hydroxyproline and type I collagen contents in buccal mucosa of rats in each group( n = 10)

[0068]

[0069]

[0070] Note: Compared with the normal group, **P < 0.01, *P < 0.05; compared with the model group ## P < 0.01, # P < 0.05; compared with the first control group △ P < 0.05.

[0071] Those of ordinary skill in the art should understand that: The discussion of any of the above embodiments is only exemplary, and is not intended to imply that the scope of protection of this application is limited to these examples; under the concept of this application, the technical features in the above embodiments or different embodiments can also be combined, the steps can be implemented in any order, and there are many other variations in different aspects of one or more embodiments of this application as described above, and they are not provided in detail for the sake of brevity.

[0072] One or more embodiments of the present application are intended to cover all such substitutions, modifications, and variations that fall within the broad scope of the present application. Therefore, any omissions, modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of one or more embodiments of the present application shall be included within the protection scope of the present application.

Claims

1. A traditional Chinese medicine composition for treating oral submucous fibrosis, characterized in that, It comprises the following raw material components in parts by weight: 12 - 18 parts of Sargentodoxa cuneata, 12 - 18 parts of Lonicera japonica, 10 - 15 parts of Salvia miltiorrhiza, 10 - 15 parts of Isatis tinctoria, 10 - 15 parts of Paeonia lactiflora, 4 - 8 parts of Panax notoginseng, 12 - 18 parts of Sargentodoxa cuneata, 12 - 18 parts of Scutellaria barbata, 10 - 15 parts of Taraxacum mongolicum, 10 - 15 parts of Prunella vulgaris, 10 - 15 parts of Fritillaria thunbergii, 6 - 12 parts of Pheretima aspergillum, 12 - 18 parts of Rehmannia glutinosa, 7 - 13 parts of Bletilla striata, 10 - 15 parts of Cordyceps flower, 10 - 15 parts of Pseudostellaria heterophylla, 4 - 8 parts of Glycyrrhiza uralensis.

2. The traditional Chinese medicine composition according to claim 1, wherein It comprises the following raw material components in parts by weight: 14 - 16 parts of Sargentodoxa cuneata, 14 - 16 parts of Lonicera japonica, 11 - 13 parts of Salvia miltiorrhiza, 11 - 13 parts of Isatis tinctoria, 11 - 13 parts of Paeonia lactiflora, 5 - 7 parts of Panax notoginseng, 14 - 16 parts of Sargentodoxa cuneata, 14 - 16 parts of Scutellaria barbata, 11 - 13 parts of Taraxacum mongolicum, 11 - 13 parts of Prunella vulgaris, 11 - 13 parts of Fritillaria thunbergii, 8 - 10 parts of Pheretima aspergillum, 14 - 16 parts of Rehmannia glutinosa, 9 - 11 parts of Bletilla striata, 11 - 13 parts of Cordyceps flower, 11 - 13 parts of Pseudostellaria heterophylla, 5 - 7 parts of Glycyrrhiza uralensis.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, It comprises the following raw material components in parts by weight: 15 parts of Sargentodoxa cuneata, 15 parts of Lonicera japonica, 12 parts of Salvia miltiorrhiza, 12 parts of Isatis tinctoria, 12 parts of Paeonia lactiflora, 6 parts of Panax notoginseng, 15 parts of Sargentodoxa cuneata, 15 parts of Scutellaria barbata, 12 parts of Taraxacum mongolicum, 12 parts of Prunella vulgaris, 12 parts of Fritillaria thunbergii, 9 parts of Pheretima aspergillum, 15 parts of Rehmannia glutinosa, 10 parts of Bletilla striata, 12 parts of Cordyceps flower, 12 parts of Pseudostellaria heterophylla, 6 parts of Glycyrrhiza uralensis.

4. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The dosage form of the traditional Chinese medicine composition is tablet, capsule, granule, pill or oral liquid.

5. A preparation method of the traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, Mix the traditional Chinese medicine components, decoct twice with water. Add 8 - 12 times the amount of water for the first time and 5 - 7 times the amount of water for the second time. Combine the decoction liquid, filter, and concentrate to obtain the traditional Chinese medicine composition.

6. The preparation method according to claim 5, characterized in that, Add 10 times the amount of water for the first time and 6 times the amount of water for the second time.

7. The preparation method according to claim 5, characterized in that, The decocting time for the first time is 1 - 2 h, and the decocting time for the second time is 0.5 - 1 h.

8. The preparation method according to claim 5, characterized in that, The relative density of the concentrated medicinal liquid is 1.3 - 1.

4.

9. Use of a traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, The traditional Chinese medicine composition is used for preparing a drug for treating oral submucous fibrosis.

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