Traditional Chinese medicine composition for treating radioactive dermatitis, preparation method and use thereof

Abstract

The present invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating radioactive dermatitis, a preparation method thereof, and uses thereof. The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 13-17 parts of red peony root, 28-32 parts of salvia miltiorrhiza, 13-17 parts of earthworm, 13-17 parts of phellodendron amurense, 10-14 parts of coptis chinensis, 13-17 parts of scutellaria baicalensis, 28-32 parts of astragalus membranaceus, 18-22 parts of honeysuckle flower, 28-32 parts of rehmannia glutinosa, 18-22 parts of Corydalis yanhusuo, and 18-22 parts of viola philippica. The traditional Chinese medicine composition provided by the present invention can effectively treat radioactive dermatitis, has good effects, quick onset, and low cost, and the related clinical manifestations of radioactive dermatitis significantly subside after patients use it.

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 radioactive dermatitis, a preparation method thereof, and uses thereof. Background Art

[0002] Radiotherapy is one of the main treatment methods for malignant tumors at present. Approximately 75% of cancer patients need to receive radiotherapy (abbreviated as RT) during the course of their disease. The goal of radiotherapy is to kill tumor cells while minimizing damage to normal tissues as much as possible. However, normal tissue cells in the irradiated area will trigger local inflammatory reactions due to reasons such as free radicals released by radiation damaging cell DNA, resulting in the release of cytokines, thus causing skin tissue damage, namely radioactive dermatitis. Acute skin damage usually begins in the 1st to 4th week of radiotherapy, manifested as itching, erythema, dry and wet desquamation to varying degrees, and then blisters, ulcers, and even necrosis. Severe skin damage can lead to the interruption of radiotherapy, thereby affecting the clinical efficacy and the quality of life of patients. Therefore, there is an urgent need to develop a drug for effectively preventing and treating radioactive dermatitis.

[0003] The traditional treatment methods for radioactive dermatitis mainly include the following aspects: 1. Topical ointments: Topical ointments such as arnebia root oil ointment, Jingwanhong ointment, moist burn ointment, aloe vera gel, etc. can help patients relieve local pain, effectively improve skin erythema caused by radiation, and promote wound healing; hyaluronic acid cream has a moisturizing and antibacterial effect and can improve the symptoms of patients; topical halometasone ointment can effectively reduce the severity of radioactive dermatitis. 2. Wound dressings: Using wound dressings such as Suoning, hydrogel dressings, silver ion dressings, etc. can keep the skin of the radiotherapy area clean, while reducing further damage to the wound site and promoting wound healing. 3. Steroid drugs: Topical corticosteroids can also be used for the treatment of radioactive dermatitis, and their anti-inflammatory effect is achieved by constricting blood vessels and reducing capillary permeability. 4. Non-steroidal topical drugs: The main component of the widely used Biaprofen cream in clinical practice at home and abroad is triethanolamine, which can play a role by recruiting macrophages at an early stage and stimulating granulation tissue. However, for many patients with radioactive dermatitis, the above traditional treatment methods do not achieve ideal effects. Summary of the Invention

[0004] The purpose of the present invention is to make up for the deficiencies of the prior art and provide a traditional Chinese medicine composition for treating radioactive dermatitis. This traditional Chinese medicine composition can effectively treat radioactive dermatitis, with good effects, quick onset, and low cost. After patients use it, the related clinical manifestations of radioactive dermatitis such as erythema, skin redness, ulceration, peeling, burning sensation, numbness, pain, etc. will significantly subside, enabling the skin to recover as before as soon as possible.

[0005] The present invention provides a traditional Chinese medicine composition for treating radioactive dermatitis, which is composed of the following raw materials by weight parts: 13-17 parts of Paeonia lactiflora Pall., 28-32 parts of Salvia miltiorrhiza Bunge, 13-17 parts of Pheretima aspergillum (E. Perrier), 13-17 parts of Phellodendron amurense Rupr., 10-14 parts of Coptis chinensis Franch., 13-17 parts of Scutellaria baicalensis Georgi, 28-32 parts of Astragalus membranaceus (Fisch.) Bunge, 18-22 parts of Lonicera japonica Thunb., 28-32 parts of Rehmannia glutinosa Libosch., 18-22 parts of Corydalis yanhusuo W. T. Wang, 18-22 parts of Viola philippica Cav..

[0006] Preferably, the traditional Chinese medicine composition is composed of the following raw materials by weight parts: 15 parts of Paeonia lactiflora Pall., 30 parts of Salvia miltiorrhiza Bunge, 15 parts of Pheretima aspergillum (E. Perrier), 15 parts of Phellodendron amurense Rupr., 12 parts of Coptis chinensis Franch., 15 parts of Scutellaria baicalensis Georgi, 30 parts of Astragalus membranaceus (Fisch.) Bunge, 20 parts of Lonicera japonica Thunb., 30 parts of Rehmannia glutinosa Libosch., 20 parts of Corydalis yanhusuo W. T. Wang, 20 parts of Viola philippica Cav..

[0007] The present invention also provides a preparation method of the traditional Chinese medicine composition, comprising the following steps:

[0008] Weigh Paeonia lactiflora Pall., Salvia miltiorrhiza Bunge, Pheretima aspergillum (E. Perrier), Phellodendron amurense Rupr., Coptis chinensis Franch., Scutellaria baicalensis Georgi, Astragalus membranaceus (Fisch.) Bunge, Lonicera japonica Thunb., Rehmannia glutinosa Libosch., Corydalis yanhusuo W. T. Wang, Viola philippica Cav. according to the weight parts;

[0009] Mix the weighed traditional Chinese medicine raw materials, add water for decocting, collect the decoction, and thus obtain the product.

[0010] Preferably, soak the medicinal material mixture for 0.5-2 h before adding water for decocting.

[0011] Preferably, the specific operation process of the water decocting is: add water equivalent to 6-8 times the amount of the medicinal material mixture, decoct for 2-3 times, 20-40 min each time, combine the decoctions, filter, and collect the filtrate, which is the traditional Chinese medicine composition.

[0012] The present invention also provides an extract for treating radioactive dermatitis, which is a solid obtained by concentrating and drying the water decoction of the traditional Chinese medicine composition.

[0013] The present invention also provides the use of the traditional Chinese medicine composition or the extract in the preparation of a drug for preventing and / or treating radioactive dermatitis.

[0014] Preferably, the dosage form of the drug is an oral preparation or an external preparation. Oral preparations such as granules, tablets, capsules, syrups, suspensions, etc., and external preparations are sprays, patches, ointments, gels, etc. Appropriate excipients can be selected according to the dosage form to be prepared during specific preparation, such as suspending agents, flavoring agents, stabilizers, emulsifiers, coloring agents, solubilizing agents, binders, wetting agents, antioxidants, etc.

[0015] Preferably, the drug is a traditional Chinese medicine fumigant.

[0016] Preferably, the traditional Chinese medicine fumigant is a water decoction of the traditional Chinese medicine composition or an aqueous solution of the extract. When using this traditional Chinese medicine fumigant, it is administered with the aid of a fumigation instrument. The fumigation instrument can be a commercially available one, and there is no special limitation here.

[0017] Traditional Chinese medicine believes that the reactions caused by radiation are due to the nature of radiation being poisonous and hot, consuming qi and injuring body fluids, damaging yin and scorching body fluids, and even burning blood vessels. Over time, it will also lead to blood stasis blocking collaterals. Patients after radiotherapy often have combined infections and show poisonous and hot symptoms such as fever, which is the manifestation of the transformation of stasis-toxin into heat. The poisonous heat invades and soaks the local skin, causing symptoms such as skin desquamation, erythema, itching, blisters, ulcers, etc. Skin ulceration belongs to the category of "sore and ulcer" in traditional Chinese medicine. Treatment based on syndrome differentiation is carried out according to the principles of clearing heat and detoxifying, supplementing qi and nourishing yin, promoting fluid production and moistening dryness, promoting blood circulation and removing stasis, etc.

[0018] This prescription is mainly used to treat radiation dermatitis. Eleven traditional Chinese medicines are carefully selected to precisely target the symptoms such as excessive heat of the skin caused by radiation, blood stasis and stagnation, and internal accumulation of dampness and heat.

[0019] First of all, Coptis chinensis, as one of the core monarch drugs, with its bitter taste and cold nature, directly enters the heart, liver, stomach, and large intestine meridians, strongly clearing heat and drying dampness, purging fire and detoxifying, and has a significant effect on symptoms such as damp-heat fullness and digestive tract discomfort caused by radioactive poisonous heat. At the same time, externally applied, it can also treat skin lesions such as eczema and moist sores caused by radioactive damage. Astragalus membranaceus is another important monarch drug, with a slightly warm and sweet nature, entering the spleen and lung meridians, having the functions of replenishing qi and consolidating the exterior, expelling toxins and promoting granulation, and diuretic and detumescence, and can effectively enhance the body's immune ability and anti-radiation ability, and help repair skin cells damaged by radiation. Rehmannia glutinosa, also acting as a monarch drug, with a sweet and cold nature, mainly enters the heart, liver, and kidney meridians, clearing heat and cooling blood, nourishing yin and promoting fluid production internally, and having the effect of reducing inflammation and swelling externally, and directly relieving symptoms such as redness, swelling, heat, and pain caused by radiation dermatitis.

[0020] Among the ministerial drugs, Scutellaria baicalensis, with its efficacy of clearing heat and drying dampness, purging fire and detoxifying, is combined with the functions of Lonicera japonica of clearing heat and detoxifying, cooling and dispersing wind-heat, and dredging collaterals, synergistically clearing the poisonous heat in the body, and reducing the skin redness, swelling, and pain caused by radiation dermatitis by improving microcirculation. Viola philippica, with its characteristics of clearing heat and detoxifying, cooling blood and detumescence, further strengthens the inhibition and repair of local skin inflammatory reactions.

[0021] In the level of assistant drugs, Phellodendron amurense, with its property of clearing heat and drying dampness, focuses on clearing damp-heat in the lower jiao, which helps improve the damp-heat symptoms complicated with radiation dermatitis; Corydalis yanhusuo is good at promoting qi circulation, activating blood circulation and relieving pain, and is effective in treating various pain symptoms caused by qi stagnation and blood stasis due to radiation dermatitis. Salvia miltiorrhiza and Paeonia lactiflora respectively play the effects of activating blood circulation to dredge meridians, removing stasis and relieving pain, clearing heat and cooling blood to stop bleeding, activating blood circulation to dissipate stasis and relieve pain. The two together promote smooth blood circulation, accelerate the dissipation of stasis and the generation of new blood in the area of radiation dermatitis, relieve skin pain and promote wound healing. Earthworm, with its unique effects of clearing heat and suppressing convulsion, dredging collaterals and relieving asthma, and inducing diuresis, helps improve symptoms such as local tissue edema, pain and limited activity accompanied by radiation dermatitis.

[0022] In summary, through the delicate combination of various drugs, this prescription clears heat and detoxifies, promotes blood circulation to remove blood stasis, reduces swelling and relieves pain in all aspects, fundamentally regulates problems such as skin heat-toxic stasis and internal accumulation of damp-heat caused by radiation exposure, helps restore the healthy state of the skin, and effectively treats radiation dermatitis.

[0023] The traditional Chinese medicine composition provided by the present invention has good effects, quick results and low cost. After patients use it, related clinical manifestations of radiation dermatitis such as erythema, skin redness and swelling, ulceration, desquamation, burning sensation, numbness, pain, etc. significantly subside, enabling the skin to recover as before as soon as possible. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 shows the damage condition of radiation dermatitis in a typical case patient before treatment;

[0025] Figure 2 shows the skin healing condition after taking the medicine for 7 doses;

[0026] Figure 3 shows the skin healing condition after continuing radiotherapy and taking this prescription;

[0027] Figure 4 shows the skin healing condition after radiotherapy ended on January 15, 2023;

[0028] Figure 5 shows the skin healing condition 2 weeks after radiotherapy ended on January 30, 2023. DETAILED DESCRIPTION OF THE INVENTION

[0029] The technical solutions of the present invention will be further described in detail below in combination with specific implementation schemes.

[0030] Example 1

[0031] A traditional Chinese medicine composition for treating radiation dermatitis is composed of the following raw materials: 15 g of Paeonia lactiflora, 30 g of Salvia miltiorrhiza, 15 g of Pheretima aspergillum, 15 g of Phellodendron amurense, 12 g of Coptis chinensis, 15 g of Scutellaria baicalensis, 30 g of Astragalus membranaceus, 20 g of Lonicera japonica, 30 g of Rehmannia glutinosa, 20 g of Corydalis yanhusuo, 20 g of Viola philippica.

[0032] Example 2

[0033] A traditional Chinese medicine composition for treating radioactive dermatitis, which is composed of the following raw materials: 13 g of red peony root, 28 g of salvia miltiorrhiza, 13 g of earthworm, 13 g of phellodendron amurense, 10 g of coptis chinensis, 13 g of scutellaria baicalensis, 28 g of astragalus membranaceus, 18 g of honeysuckle flower, 28 g of rehmannia glutinosa, 18 g of Corydalis yanhusuo, 18 g of viola yedoensis.

[0034] Example 3

[0035] A traditional Chinese medicine composition for treating radioactive dermatitis, which is composed of the following raw materials: 17 g of red peony root, 32 g of salvia miltiorrhiza, 17 g of earthworm, 17 g of phellodendron amurense, 14 g of coptis chinensis, 17 g of scutellaria baicalensis, 32 g of astragalus membranaceus, 22 g of honeysuckle flower, 32 g of rehmannia glutinosa, 22 g of Corydalis yanhusuo, 22 g of viola yedoensis.

[0036] Example 4

[0037] A traditional Chinese medicine composition for treating radioactive dermatitis, which is composed of the following raw materials: 15 g of red peony root, 30 g of salvia miltiorrhiza, 16 g of earthworm, 15 g of phellodendron amurense, 12 g of coptis chinensis, 15 g of scutellaria baicalensis, 30 g of astragalus membranaceus, 22 g of honeysuckle flower, 28 g of rehmannia glutinosa, 18 g of Corydalis yanhusuo, 22 g of viola yedoensis.

[0038] Example 5

[0039] A traditional Chinese medicine composition for treating radioactive dermatitis, which is composed of the following raw materials: 16 g of red peony root, 28 g of salvia miltiorrhiza, 15 g of earthworm, 15 g of phellodendron amurense, 10 g of coptis chinensis, 15 g of scutellaria baicalensis, 32 g of astragalus membranaceus, 20 g of honeysuckle flower, 28 g of rehmannia glutinosa, 22 g of Corydalis yanhusuo, 18 g of viola yedoensis.

[0040] The traditional Chinese medicine compositions prepared in the above Examples 1 to 5 are all prepared according to the following steps:

[0041] Weigh red peony root, salvia miltiorrhiza, earthworm, phellodendron amurense, coptis chinensis, scutellaria baicalensis, astragalus membranaceus, honeysuckle flower, rehmannia glutinosa, Corydalis yanhusuo, viola yedoensis;

[0042] Mix the weighed traditional Chinese medicine raw materials, add water equivalent to 8 times the amount of the medicinal material mixture and soak for 0.5 h, decoct twice, 40 min each time, collect the decoction and combine, and filter to obtain the traditional Chinese medicine composition.

[0043] Example 6

[0044] A traditional Chinese medicine composition for treating radioactive dermatitis, which is only different from Example 1 in the preparation method, specifically:

[0045] Weigh red peony root, salvia miltiorrhiza, earthworm, phellodendron amurense, coptis chinensis, scutellaria baicalensis, astragalus membranaceus, honeysuckle flower, rehmannia glutinosa, Corydalis yanhusuo, viola yedoensis;

[0046] Mix the weighed traditional Chinese medicine raw materials, add water equivalent to 6 times the amount of the medicinal material mixture, soak for 2 h, decoct 3 times, 20 min each time, collect the decoction and combine, and filter to obtain the traditional Chinese medicine composition.

[0047] Example 7

[0048] A traditional Chinese medicine composition for treating radioactive dermatitis, which is only different from that in Example 1 in the preparation method, specifically:

[0049] Weigh radix paeoniae rubra, salvia miltiorrhiza, pheretima, cortex phellodendri, rhizoma coptidis, radix scutellariae, radix astragali, honeysuckle flower, radix rehmanniae, rhizoma corydalis, viola yedoensis;

[0050] Mix the weighed traditional Chinese medicine raw materials, add water equivalent to 8 times the amount of the medicinal material mixture, soak for 1.0 h, decoct 3 times, 30 min each time, collect the decoction and combine, and filter to obtain the traditional Chinese medicine composition.

[0051] Evaluation of the clinical treatment effect of traditional Chinese medicine

[0052] 1. Source of cases

[0053] Select 70 patients who meet the criteria of radioactive dermatitis from Tangdu Hospital, and randomly divide them into a control group and a treatment group, with 35 cases in each group. Among them, there are 16 patients with the excess syndrome type and 19 patients with the deficiency syndrome type in the control group, including 18 patients with acute radioactive dermatitis and 17 patients with chronic radioactive dermatitis. There are 17 patients with the excess syndrome type and 18 patients with the deficiency syndrome type in the experimental group, including 17 patients with acute radioactive dermatitis and 18 patients with chronic radioactive dermatitis.

[0054] There is no significant difference in the basic conditions of the two groups of patients.

[0055] 2. Identification of etiology:

[0056] (1) Medical history inquiry: Understand whether the patient has a clear history of radiation exposure.

[0057] (2) Combining the four diagnostic methods: Collect clinical data through inspection, auscultation and olfaction, interrogation, and palpation, observe the characteristics of skin lesions such as morphology, color, boundary, distribution, etc.; inquire about the course of disease and accompanying symptoms (such as itching, pain, hair loss, etc.); feel the skin temperature and degree of swelling; listen to the patient's main complaint.

[0058] 3. Syndrome differentiation and typing:

[0059] (1) Excess syndrome: In the initial stage, the skin lesions are red, swollen, hot, and painful, with severe itching, red tongue, yellow and greasy coating, and slippery and rapid pulse. It is differentiated as damp-heat toxin accumulation.

[0060] (2) Deficiency syndrome: The course of disease is relatively long, the skin lesions are dark red or purple, dry and desquamated, accompanied by fatigue, dry mouth, and five centers fever. The tongue is light red or slightly red, with little coating or cracks, and the pulse is thready and rapid. It is differentiated as deficiency of yin and blood, incomplete elimination of heat toxin, or deficiency of both qi and yin.

[0061] 4. Characteristics of syndromes:

[0062] (1) Acute radiation dermatitis: The skin lesions appear rapidly and develop relatively fast, with obvious redness, swelling, heat, and pain, conforming to the manifestations of damp-heat toxin accumulation or blazing fire-toxin.

[0063] (2) Chronic radiation dermatitis: The skin lesions recur and do not heal for a long time, or there are pigmentation, atrophy, scars, etc. left, conforming to the manifestations of qi and blood deficiency, blood stasis blockage, or liver and kidney deficiency.

[0064] 5. Exclusion criteria in traditional Chinese medicine

[0065] When diagnosing radiation dermatitis in traditional Chinese medicine, it is necessary to exclude similar dermatitis manifestations caused by other non-radiation factors, such as contact dermatitis, eczema, drug dermatitis, dermatitis related to autoimmune diseases, etc. This invention involves in the treatment:

[0066] (1) Exclusion by medical history: There is no clear history of exposure to radiation.

[0067] (2) Exclusion by clinical features: The morphology, distribution, and evolution process of the skin lesions do not conform to the characteristics of radiation dermatitis.

[0068] (3) Laboratory tests: Conduct auxiliary tests such as allergen detection and blood immunological indexes to exclude other etiologies.

[0069] 6. Evaluation criteria for treatment effects

[0070] Evaluation indexes for curative effects:

[0071] (1) Improvement of symptoms: The erythema subsides, itching is relieved, pain is alleviated, skin temperature drops, hair regrows, etc.

[0072] (2) Changes in signs: The area of the skin lesions shrinks, the color returns to normal, the edema subsides, desquamation decreases, and there are no new skin rashes.

[0073] (3) Quality of life: Improvement of subjective feelings such as sleep quality, daily activity ability, and mental state.

[0074] 7. Criteria for judging curative effects:

[0075] Referring to the Diagnostic and Therapeutic Criteria for Syndromes and Diseases in Traditional Chinese Medicine or other relevant industry standards, the curative effects are usually divided into four grades: cured, markedly effective, effective, and ineffective.

[0076] Cured: The skin lesions completely subside, the symptoms disappear, the skin returns to normal, and there is no sign of recurrence.

[0077] Markedly effective: The area of the skin lesions decreases by ≥70%, the symptoms are significantly improved, and the quality of life is significantly improved.

[0078] Effective: The skin lesion area is reduced by ≥ 30% but < 70%, the symptoms are alleviated, and the quality of life is improved to a certain extent.

[0079] Ineffective: The skin lesion area is reduced by less than 30%, the symptoms show no obvious improvement or get worse, and the quality of life shows no obvious change.

[0080] 8. Treatment method

[0081] The control group adopted: Applying 10% cod liver oil ointment + mupirocin ointment to the affected area, 2 times a day;

[0082] On the basis of the treatment of the control group, the treatment group adopted the traditional Chinese medicine composition provided in Example 1 of the present invention, decocted in water to 400 ml, taken orally in the morning and evening, one dose a day.

[0083] Both groups were continuously medicated for 2 weeks.

[0084] 9. Results

[0085] The treatment effects of the two groups are shown in Table 1.

[0086] Table 1 Comparison of treatment effects between the two groups

[0087] Recovery Effective Marked effect Ineffective Total effective rate Treatment group 13 8 10 4 88.57％ Control group 7 7 9 12 65.71％

[0088] As can be seen from Table 1, the treatment effect of the treatment group on radiation dermatitis is significantly better than that of the control group. At the same time, whether it is patients with excess syndrome or deficiency syndrome, or patients with acute radiation dermatitis or chronic radiation dermatitis, the treatment method of the treatment group can achieve better curative effects. It shows that the traditional Chinese medicine composition provided by the present invention has a significant curative effect on radiation dermatitis and can be used as an alternative drug for the treatment of radiation dermatitis.

[0089] Typical case

[0090] Brief medical history: The patient is a 61-year-old male. He was admitted to the hospital for radiotherapy due to "nasopharyngeal carcinoma, stage T3N2M0, III stage". The patient underwent radical radiotherapy for nasopharyngeal carcinoma on November 10, 2022, and the radiotherapy ended on December 29, 2022.

[0091] Treatment process:

[0092] On December 15, 2022, the skin in the radiotherapy area of both sides of the neck began to turn red with dry peeling, local skin itching, and there was an ulcer on the right neck, accompanied by pharyngeal pain, poor appetite, fatigue, infectious fever, etc., as shown in Figure 1 . On December 16, 2022, this prescription was given for oral treatment intervention (decocted in water to 400 ml, taken orally in the morning and evening, one dose a day), and other treatments such as morphine and other drugs for pain relief, nutritional support, and anti-infection were given.

[0093] On December 22, 2022, after taking 7 doses, the skin at the ulcerated area on the right neck showed obvious signs of healing, as shown in Figure 2 .

[0094] On December 30th, radiotherapy continued. During this period, the prescription was continued to be taken. The skin healing signs at the ulcerated area on the right neck were obvious, as shown Figure 3 .

[0095] On January 15, 2023, radiotherapy ended. The skin healing signs at the ulcerated area on the right neck were obvious, as shown Figure 4 .

[0096] Two weeks after radiotherapy ended on January 30, 2023, the skin healing signs at the ulcerated area on the right neck were obvious, as shown Figure 5 .

[0097] As described above, it is only the preferred specific implementation mode of the present invention. The protection scope of the present invention is not limited thereto. Any simple change or equivalent replacement of the technical solution that can be obviously obtained by those skilled in the art within the technical scope disclosed by the present invention falls within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating radioactive dermatitis, characterized in that, It consists of the following raw materials by weight parts: 13-17 parts of Radix Paeoniae Rubra, 28-32 parts of Radix Salviae Miltiorrhizae, 13-17 parts of Pheretima, 13-17 parts of Cortex Phellodendri, 10-14 parts of Rhizoma Coptidis, 13-17 parts of Radix Scutellariae, 28-32 parts of Radix Astragali, 18-22 parts of Flos Lonicerae, 28-32 parts of Radix Rehmanniae, 18-22 parts of Rhizoma Corydalis, 18-22 parts of Viola philippica Cav., and the traditional Chinese medicine composition is used for treating acute and chronic radiation dermatitis.

2. The traditional Chinese medicine composition according to claim 1, wherein It consists of the following raw materials by weight parts: 15 parts of Radix Paeoniae Rubra, 30 parts of Radix Salviae Miltiorrhizae, 15 parts of Pheretima, 15 parts of Cortex Phellodendri, 12 parts of Rhizoma Coptidis, 15 parts of Radix Scutellariae, 30 parts of Radix Astragali, 20 parts of Flos Lonicerae, 30 parts of Radix Rehmanniae, 20 parts of Rhizoma Corydalis, 20 parts of Viola philippica Cav.

3. A method for preparing the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, It includes the following steps: Weigh Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Pheretima, Cortex Phellodendri, Rhizoma Coptidis, Radix Scutellariae, Radix Astragali, Flos Lonicerae, Radix Rehmanniae, Rhizoma Corydalis, Viola philippica Cav. according to weight parts; Mix the weighed traditional Chinese medicine raw materials, decoct with water, collect the decoction, and you will get it.

4. The preparation method of the traditional Chinese medicine composition according to claim 3, characterized in that, Soak the medicinal material mixture for 0.5-2 h before decocting with water.

5. The preparation method of the traditional Chinese medicine composition according to claim 4, wherein, The specific operation process of the water decoction is as follows: Add 6-8 times the amount of water equivalent to the medicinal material mixture, decoct 2-3 times, 20-40 min each time, combine the decoctions, filter, and collect the filtrate, which is the traditional Chinese medicine composition.

6. An extract for treating radioactive dermatitis, characterized in that, It is a solid obtained by concentrating and drying the water decoction of the traditional Chinese medicine composition described in claim 1.

7. Use of the traditional Chinese medicine composition described in claim 1 or 2 or the extract described in claim 6 in the preparation of a drug for preventing and / or treating radiation dermatitis.

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