CN114159511B

CN114159511B - Traditional Chinese medicine preparation for preventing and treating radioactive skin injury and preparation method thereof

Info

Publication number: CN114159511B
Application number: CN202111670535.6A
Authority: CN
Inventors: 吴发胜; 谢家童; 鲁世金; 蒋华艳; 张钟群
Original assignee: RUIKANG HOSPITAL AFFILIATED TO GUANGXI UNIVERSITY OF CHINESE MEDICINE
Current assignee: RUIKANG HOSPITAL AFFILIATED TO GUANGXI UNIVERSITY OF CHINESE MEDICINE
Priority date: 2021-12-31
Filing date: 2021-12-31
Publication date: 2022-12-27
Anticipated expiration: 2041-12-31
Also published as: CN114159511A

Abstract

The invention discloses a traditional Chinese medicine preparation for preventing and treating radioactive skin injury and a preparation method thereof, wherein the traditional Chinese medicine preparation comprises the following raw materials in parts by weight: 400 to 500 portions of garden burnet, 250 to 350 portions of coptis, 250 to 350 portions of lithospermum, 100 to 200 portions of nacre, 100 to 200 portions of borneol and 4500 to 5500 portions of camellia oil. The selected medicinal materials are scientific and reasonable in compatibility, safe and nontoxic, are suitable for long-term use, can effectively prevent and reduce the damage of radiation to the skin, improve the tolerance of the head and neck malignant tumor irradiation area to radiotherapy, and delay the occurrence of radioactive skin damage. The external oil preparation is an external oil medicine, has the advantages of high local medicine concentration of effective wound surfaces, good curative effect, small influence on the whole body and the like, can keep local skin moist, provides proper temperature and humidity for the local skin and improves the cure rate of the wound surfaces. The preparation method of the invention has the advantages of simple and easy operation, low cost, less side effect, good curative effect in clinical application and convenient nursing.

Description

Traditional Chinese medicine preparation for preventing and treating radioactive skin injury and preparation method thereof

Technical Field

The invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine preparation for preventing and treating radioactive skin injury and a preparation method thereof.

Background

According to the data provided by the international epidemiological research organization, the annual incidence rate of head and neck tumors in recent years in China is 15.22/10 ten thousand, and accounts for 4.45 percent of the total malignant tumors. The head and neck tumors comprise three major parts of neck tumors, otorhinolaryngological tumors and oral and maxillofacial tumors, and the radiotherapy is the first choice for treating head and neck malignant tumors such as nasopharyngeal carcinoma, hypopharyngeal carcinoma, tongue carcinoma, laryngeal carcinoma and the like at present. However, radiation damages normal tissue cells while killing tumor cells, so radiation skin damage is one of the most common complications in radiotherapy of head and neck malignant tumors. The radioactive skin injury is characterized in that the skin or mucous membrane of the irradiated area has adverse reactions such as erythema, pigmentation, pruritus, pain and the like in the early stage, dry desquamation, wet desquamation and ulcer in severe cases, and contracture, scar formation and the like in the later stage. The radioactive skin damage not only causes the life quality of the patient to be reduced, but also can interrupt the radiotherapy or prolong the treatment time in serious cases, thereby reducing the control rate of tumors and the survival rate of the patient. Therefore, how to reduce the damage of radiotherapy to normal skin tissues as much as possible on the premise of not reducing the curative effect of radiotherapy, improve the life quality of tumor patients and increase the compliance of the patients to radiotherapy becomes a difficult problem to be solved urgently by clinicians. Clinically, many external medicines for preventing and treating radioactive skin injury are available, and mainly comprise plant extracts, vitamins, traditional Chinese medicine preparations, triethanolamine cream and the like. However, there is a certain variation in the evaluation of the therapeutic effect of drugs due to various confounding factors. Thus, there is currently a lack of accepted standardized treatment protocols for radioactive skin lesions.

Disclosure of Invention

Aiming at the prior art, the invention provides a traditional Chinese medicine preparation for preventing and treating radioactive skin injury and a preparation method thereof, and aims to provide the traditional Chinese medicine preparation which is suitable in medicinal material compatibility, safe and nontoxic and can effectively reduce the incidence rate of the radioactive skin injury.

In order to achieve the purpose, the invention adopts the technical scheme that: the traditional Chinese medicine preparation for preventing and treating radioactive skin injury comprises the following raw materials in parts by weight: 400 to 500 portions of garden burnet, 250 to 350 portions of coptis, 250 to 350 portions of lithospermum, 100 to 200 portions of nacre, 100 to 200 portions of borneol and 4500 to 5500 portions of camellia oil.

Garden burnet root: bitter, sour, astringent and slightly cold in nature. It enters liver and large intestine meridians. Has the effects of cooling blood, stopping bleeding, removing toxic substances and healing sore. It can be used for treating scald, carbuncle, suppurative sore, eczema, hematochezia, hemorrhoid, dysentery, metrorrhagia. Modern pharmacological research shows that sanguisorba contains various active ingredients mainly comprising saponin, tannin, polysaccharide and flavone, has various pharmacological effects of stopping bleeding, resisting inflammation, diminishing swelling, resisting bacteria, repairing epidermis and the like, and can promote epithelial tissue growth, granulation tissue proliferation and collagen generation by local application.

Coptis chinensis: bitter taste and cold nature, has the actions of clearing heat and drying dampness, purging fire and removing toxicity, and is commonly used for treating carbuncle, swelling and furuncle, conjunctival congestion and swelling pain, mouth and tongue sores, dysentery, blood heat hematemesis and epistaxis, etc. Modern researches show that the coptis has obvious inhibition effect on acute and chronic inflammatory reactions, and can reduce the mRNA level of STAT4, TNF alpha and IL-12, inhibit the transcriptional activity of E2F, inhibit cell proliferation and cell migration and play an anti-inflammatory role by bidirectionally regulating an STAT4 signal pathway. The coptis chinensis has wide pharmacological action, has great value for treating various diseases, and can play pharmacological roles of resisting tumors, resisting pathogenic microorganisms, resisting inflammation and the like through different approaches and action targets.

Lithospermum: sweet taste and cold nature, and entering heart and liver meridians, has the effects of clearing heat and cooling blood, promoting blood circulation and removing toxicity, promoting eruption and eliminating macula, and is commonly used for treating diseases such as blood heat and toxicity, macula purple black, measles without adequate eruption, pyocutaneous disease, eczema and scald. The chemical components in lithospermum mainly comprise naphthoquinones, polysaccharides, monoterpene phenol, benzoquinones, esters and the like. The results of modern pharmacological and clinical researches show that the active ingredients of alkannin and shikonin in lithospermum have the effects of resisting oxidation and promoting microcirculation, and the lithospermum has the effects of resisting inflammation, resisting tumors, inhibiting bacteria, protecting and protecting liver, regulating immunity and the like.

Mother-of-pearl: the mother-of-pearl is rich in various amino acids, biological calcium and trace elements, which are the main effective components for playing the pharmacological actions of anti-inflammation, antibiosis and the like. Wherein calcium as main component of Concha Margaritifera can reduce permeability of capillary wall, reduce exudate formation, and facilitate fresh granulation growth; potassium and sodium are main components of human body fluid and cell substances, exist in internal and external liquid of cells, and have the effects of diuresis, inflammation diminishing, antisepsis and the like; zinc is a constituent of many important enzymes that accelerate tissue repair in tissue healing. The Concha Margaritifera can be used for preventing and treating radiation dermatitis and stomatitis, and contains various amino acids, microelements, etc. with good protective effect on skin and oral cavity of head and neck radiotherapy patients.

Borneol: it is pungent, bitter and slightly cold in flavor, and has effects of inducing resuscitation, refreshing mind, clearing heat and relieving pain, and can be used for treating fever unconsciousness, thoracic obstruction, cardiodynia, aphtha, sore and ulcer, swelling and pain, intractable ulcer, burn and scald, etc. The borneol has rich pharmacological action, has an inhibitory effect on various pathogenic bacteria such as staphylococcus aureus, salmonella murine and the like, and can be commonly used for synergistically resisting bacteria with antibacterial drugs. Can improve ischemia reperfusion injury, inhibit thrombosis, has antithrombotic effect, and has significant positive effect in treating cardiovascular and cerebrovascular diseases. The borneol can promote the medicine to penetrate through skin, mucous membrane and other parts, promote the medicine to reach the optimal absorption and distribution state in the organism, effectively improve the transdermal penetration capacity of the medicine, and has better functions of detumescence, pain relief, anti-inflammation, wound healing promotion and the like.

Camellia oil: the camellia oil is fatty oil extracted from camellia seeds, and contains components such as camellin, tea polyphenol, squalene, beta carotene, liposoluble vitamin E and the like, and low-polarity polyphenol substances and vitamin E in the camellia oil are used as an antioxidant, so that the camellia oil has a radiation-proof function and a skin-protecting effect. The camellia oil has effects of promoting blood circulation, removing blood stasis, relieving swelling and pain, and preventing wound infection. The camellia oil also has the effect of promoting drug absorption. The camellia oil can directly influence the skin structure, has weakening effect on the barrier effect of the skin, has strong permeability, and is beneficial to the absorption of the medicine through the skin.

The combination of the selected medicinal materials is proper and reasonable in compatibility, and accords with the compatibility theory of the traditional Chinese medicine, wherein the lithospermum has the effects of clearing heat and cooling blood, promoting blood circulation and removing toxicity, promoting eruption and eliminating spots and is a monarch drug; the garden burnet root is used for cooling blood and stopping bleeding, detoxifying and healing sore, the coptis root is used for clearing heat and drying damp, purging fire and removing toxin, the mother-of-pearl is used for diminishing inflammation, astringing and promoting granulation, and the three medicines are used as ministerial medicines and have the effects of clearing heat and drying damp, detoxifying and relieving swelling, removing necrotic tissue and promoting granulation; the camellia oil is an adjuvant drug and has the effects of promoting blood circulation to remove blood stasis, relieving swelling and pain, and clearing away heat and toxic materials; borneol is a guiding drug and aims at clearing heat, relieving pain, promoting granulation and relieving itching; the whole formula is combined to play the effects of clearing heat and drying dampness, cooling blood and removing toxicity, reducing swelling and relieving pain, astringing and promoting tissue regeneration.

On the basis of the technical scheme, the invention can be improved as follows.

Further, 450 parts of garden burnet root, 300 parts of coptis root, 300 parts of lithospermum, 150 parts of mother-of-pearl, 150 parts of borneol and 5000 parts of camellia oil.

Furthermore, the Chinese medicinal preparation is in the form of oil.

The invention also provides a preparation method of the traditional Chinese medicine preparation, which comprises the following steps:

(1) Putting garden burnet, coptis chinensis, lithospermum and pearl shell into camellia oil for soaking for 20-40 min, boiling with strong fire, decocting with slow fire for 7-9 h, and filtering to obtain a crude medicinal oil product;

(2) Mixing the crude medicinal oil with Borneolum Syntheticum, and cooling to room temperature.

The invention has the beneficial effects that:

(1) The selected medicinal materials are scientific and reasonable in compatibility, safe and nontoxic, are suitable for long-term use, can aim at the pathological mechanism of fire-heat toxin of radioactive rays, have good curative effect, can effectively prevent and relieve the damage of the radioactive rays to the skin, improve the tolerance of a malignant tumor irradiation area at the head and neck to radiotherapy and delay the occurrence of radioactive skin damage.

(2) The external oil preparation medicament has the advantages of high local medicament concentration of the wound surface, small influence on the whole body and the like, can keep local skin moist, provides proper temperature and humidity for the local skin, improves the cure rate of the wound surface, and is mainly used for treating various radioactive wet skin injuries, damp-heat rashes, bedsores, heat-toxin sores and the like.

(3) The traditional Chinese medicine preparation disclosed by the invention is low in cost and less in side effect, the preparation method is simple and easy to operate, and the problems of poor curative effect, high production cost and the like of the traditional Chinese medicine in the prior art are effectively solved.

(4) The traditional Chinese medicine preparation has good clinical application curative effect, convenient nursing and economy, can make up the problem of economical and practical insufficient effective treatment medicines in the market for clinical development and popularization and application of the compound preparation, and has good economic and social benefits.

Detailed Description

The following examples are provided to illustrate specific embodiments of the present invention.

Example 1

A traditional Chinese medicine preparation for preventing and treating radioactive skin injury comprises the following raw materials in parts by weight: 450 parts of garden burnet, 300 parts of coptis chinensis, 300 parts of lithospermum, 150 parts of mother-of-pearl, 150 parts of borneol and 5000 parts of camellia oil.

The preparation method of the traditional Chinese medicine preparation for preventing and treating the radioactive skin injury comprises the following steps:

(1) Soaking radix Sangusorbae, coptidis rhizoma, radix Arnebiae, and Concha Margaritifera in oleum Camelliae Japonicae for 30min, boiling with strong fire, decocting with slow fire for 8 hr, stirring to heat, and filtering to obtain medicinal oil;

Example 2

A traditional Chinese medicine preparation for preventing and treating radioactive skin injury comprises the following raw materials in parts by weight: 400 parts of garden burnet root, 250 parts of coptis root, 250 parts of lithospermum, 100 parts of mother-of-pearl, 100 parts of borneol and 4500 parts of camellia oil.

(1) Soaking radix Sangusorbae, coptidis rhizoma, radix Arnebiae, and Concha Margaritifera in oleum Camelliae Japonicae for 20min, boiling with strong fire, decocting with slow fire for 7 hr, stirring to heat, and filtering to obtain crude medicinal oil;

Example 3

A traditional Chinese medicine preparation for preventing and treating radioactive skin injury comprises the following raw materials in parts by weight: 500 parts of garden burnet root, 350 parts of coptis root, 350 parts of lithospermum, 200 parts of mother-of-pearl, 200 parts of borneol and 5500 parts of camellia oil.

(1) Soaking radix Sangusorbae, coptidis rhizoma, radix Arnebiae, and Concha Margaritifera in oleum Camelliae Japonicae for 40min, boiling with strong fire, decocting with slow fire for 9 hr, stirring to heat, and filtering to obtain medicinal oil;

(2) Mixing the crude product of the medicinal oil with Borneolum Syntheticum, and cooling to room temperature.

The following is an experimental study of the Chinese medicinal preparation for preventing and treating radiation skin injury of the present invention:

1. study subjects: 60 patients with head and neck malignant tumors who were admitted to the hospital for radiotherapy in 2018 from 1 month to 12 months were selected as study subjects. Inclusion criteria were: (1) the pathological examination confirms that the patient is the head and neck malignant tumor; (2) the patient who receives radiotherapy for the first time; (3) the Karnofsky score is more than or equal to 70; (4) 18-70 years old; (5) has read-write capability. Exclusion criteria: patients with severe basal disease; those with blood coagulation dysfunction; those with ulcerated and infected skin; those who have previously or currently received anxiolytic or antidepressant therapy. Numbering according to the sequence of radiotherapy, and dividing into 30 cases of test group and control group according to a random number table method. All patients signed an informed consent for radiotherapy before radiotherapy and the study was reviewed by the hospital ethics committee.

2. The treatment scheme comprises the following steps:

2.1 radiation therapy

The radiotherapy adopts a simulation positioning machine, a Multiplan planning system and an electronic linear accelerator to carry out intensity modulated radiotherapy, the irradiation range is determined according to the result of the imaging examination and clinical signs, the irradiation range comprises primary focus and regional lymph nodes, 5 times of irradiation are carried out every week, the radiotherapy dose of each target area is 2GY, 30-35 times of irradiation is a treatment course, and the total radiotherapy dose is 60-70 GY.

2.2 chemotherapeutic regimens

Cisplatin (PPD) single-agent concurrent chemotherapy for 3 cycles, 3 days/cycle.

2.3 all patients were given the conventional health announcements prior to treatment, strictly prohibiting the use of irritants to rub the skin on the area of radiation treatment.

3. Treatment group

On the basis of conventional radiotherapy, the traditional Chinese medicine preparation for preventing and treating radioactive skin injury is externally applied to the skin of a radiotherapy area. The using method comprises the following steps: based on the conventional skin care of radiotherapy and chemotherapy, the traditional Chinese medicine composition is used from the 1 st day of radiotherapy to one week of radiotherapy. The responsibility nurse uniformly coats the traditional Chinese medicine preparation of the invention on the outside before each radiotherapy so as to irradiate the skin in a field, form a layer of lipid film on the skin, ensure that the lipid film is thin and does not flow on the skin, and lightly coat the skin for 1-2 min by using the finger abdomen; when II-grade radiodermatitis occurs, the medicine is smeared with a sterile cotton swab before and after radiotherapy, and the smearing frequency is determined according to the dry condition of the skin, preferably 2-3 times per day, so as to ensure that the radiation field skin is moist. The responsibility nurse finishes the case observation record form after each smearing, ensures the smearing quality and avoids the missing smearing.

4. Control group

The responsibility nurse carries out routine nursing for the patient, guides the patient to keep the skin of the radiotherapy area clean and dry, and achieves the following effects: the cotton clothes which are loose and soft are suitable to be worn; soap, alkaline solution and coarse towel are forbidden to scrub; local skin cannot be scratched or peeled; the product can not be adhered with adhesive plaster, coated with ethanol, ointment and irritant substance, and can not be shaved, and electric shaver can be used if necessary; when going out, the direct solar radiation is avoided; avoid cold and hot stimulation such as hot compress, ice compress, hot water bath, and the like; if there is flush and itching, the patient should be advised not to scratch the skin with hands. The patients are encouraged to eat more vegetables, fruits and high-protein food, and greasy, spicy and pungent food is avoided; meanwhile, medication guidance is provided for the patient, and psychological and social support is provided for the patient.

5. Treatment principles for grade iii and IV radiodermatitis: the iodophor is given to disinfect and externally coated with growth factors to protect the skin 1-2 times per day according to the medical advice.

6. Evaluation tool

6.1 general data questionnaire: including age, gender, weight, cultural degree, clinical stage, karnofsky score of 6 items.

6.2Karnofsky scale: the state score scale is developed by ECOG (eastern tumor collaboration group in usa) Karnofsky (Karnofsky score, KPS) in 1948, and is widely used for evaluating the functional state of tumor patients at home and abroad at present. The doctor in charge of the patient gives an assessment in the range of 0 to 100 points according to the functional state of the patient, and the higher the score is, the better the functional state of the patient is. 10 minutes indicates that the functional state of the patient is critical and is about to die; a score of 100 indicates that the patient is in good functional status and has no other symptoms or signs. The Cronbach alpha value is measured to be 0.794, and the scale has higher reliability and validity.

6.3 skin lesion grading: grade 5 according to the skin lesion grading criteria of the american tumor radiotherapy group (RTOG): level 0: no change in skin; stage I: dark red spots or desquamation like filter bubbles, dry desquamation and reduced sweating; and II, stage: tender or bright red spots, flaky wet desquamation or moderate edema; and (3) stage III: the skin has fused wet desquamation and sunken edema at the parts except the wrinkles; stage IV: ulcer, hemorrhage, and necrosis.

7. Data collection method

All data are collected by the specially-trained nurse and the responsible nurse which are trained uniformly. Questionnaires were collected prior to radiotherapy, including: general data questionnaires, karnofsky scale. The patient is instructed to fill in using the unified guidance, and the patient is checked for recovery on the spot. The conditions of dermatitis occurrence, classification, recovery time and the like are observed and recorded in a case observation record table every day by radiotherapy, and the dermatitis is observed to be cured.

8. Statistical method

SPSS 17.0 software is adopted for data analysis, the measured data is represented by median, mean plus or minus standard deviation, and independent samples are adopted for comparison among groups for t test; count data are expressed as percentages and comparisons between groups are by chi-square test. The difference is statistically significant when P is less than 0.05.

9. As a result, the

9.1 general data on the subjects

In the research, 60 parts of questionnaire are released together, and 60 parts of effective questionnaire are recovered, wherein the effective recovery is 100%. During the study, there were no withdrawal cases. The difference was not statistically significant (P > 0.05) when compared between the two groups of general data before intervention. See table 1.

Table 1 general data comparison of two groups of patients (n = 60)

1) the value of t; 2) Chi shape ² Value of

9.2 comparison of the completion of radiotherapy and the incidence of radiodermatitis in two groups of patients

The radiation treatment was completed according to the preset schedule for both groups of patients, the total radiation dose of the experimental group was 1898GY (63.27 ± 4.18), the total radiation dose of the control group was 1924GY (63.97 ± 3.41), and the difference was not statistically significant (t =0.710, p = 0.387) when compared between the two groups; wherein 3 cases in the experimental group delay the completion of the treatment for 6 days (2.00 +/-1.00), 5 cases in the control group delay the completion of the treatment for 24 days (4.80 +/-1.48), and the difference is statistically significant when the two groups delay the completion of the treatment (t =2.858, P = 0.029); the time of occurrence of radiodermatitis was statistically significant (P < 0.05) in the two groups of patients, as shown in Table 2. The incidence of radiodermatitis is increased continuously with the increase of the radiation dose, when the radiation dose is more than 60GY, the incidence of radiodermatitis of two groups of patients is as high as 100 percent, wherein the incidence of the radiodermatitis of III and IV grades accounts for 63.33 percent (19/30) of the control group; the occurrence of radiodermatitis and the degree of radiodermatitis reaction in two groups of different radiation doses are compared, and the difference has statistical significance (P is less than 0.05), which is shown in Table 3.

TABLE 2 comparison of the time of onset of radiodermatitis in two groups of patients

Group of	I grade (d)	Grade II (d)	Class III to IV (d)
				Test group	11.53±1.98	20.83±3.32	30.33±2.50
Control group	9.70±1.51	18.17±2.55	25.18±3.55
				t value	4.033	3.300	3.312
P value	0.000	0.002	0.003

TABLE 3 development of radiodermatitis in two groups of patients [ case (%) ]

9.3 comparison of recovery time for radiodermatitis in two groups of patients

The time from the end of radiotherapy to the recovery of radiodermatitis at all levels of the two groups of patients was compared, and the difference was statistically significant (P < 0.05), as shown in Table 4.

TABLE 4 comparison of radiodermatitis healing time for two groups of patients

Group of	I grade (d)	Grade II (d)	III to IV grade (d)	Total time (d)
					Test group	2.67±0.82	5.58±1.35	13.20±2.28	6.06±3.75
Control group	3.00±0.00	9.1±1.67	16.00±2.65	12.84±4.97
					Value of t	0.378	6.174	2.157	6.055
P value	0.721	0.000	0.042	0.000

10. Analysis of results

10.1 the traditional Chinese medicine preparation for preventing and treating the radioactive skin injury can effectively delay the occurrence of the radioactive skin injury.

The traditional Chinese medicine considers that the radioactive rays belong to the evil of heat toxin, and the excessive heat toxin causes the radiation skin injury caused by the fire toxin stagnating in the skin, burns the yin and blood for a long time, blocks the channels and collaterals, and has the symptoms of desquamation, ulcer, heat itching, burning pain and the like. The research shows that the traditional Chinese medicine preparation for preventing and treating the radioactive skin injury is applied to the local external application of the traditional Chinese medicine preparation for 30 times when the radiotherapy is started, the skin of 2 patients is still intact when the radiation dose reaches 60GY, the skin of a control group is irradiated for 20 times, 30 patients all have the radioactive dermatitis with different degrees when the radiation dose reaches 40GY, the occurrence time is earlier than that of the test group, and the difference has statistical significance (P < 0.05). When the radiation dose reaches 40GY, the incidence rate of the radiodermatitis is remarkably increased, 7 cases (23.4%) in the II-grade and above test groups and 18 cases (60.0%) in the control group are compared, and the two groups have statistical difference (P is less than 0.05), which shows that the traditional Chinese medicine preparation can improve the tolerance of a head and neck malignant tumor irradiation area to radiotherapy, thereby effectively preventing and relieving the damage of radiotherapy to the skin and delaying the occurrence of the radioactive skin damage. Because of this reason, in the Chinese medicinal preparation formula, the lithospermum, the coptis chinensis and the nacre have the functions of clearing away heat and toxic materials, promoting granulation, resisting bacteria, resisting oxidation and the like, and the borneol can clear away heat, eliminate swelling, relieve pain, prevent corrosion and relieve itching; sanguisorba has the effects of stopping bleeding, inhibiting bacteria, diminishing inflammation and promoting wound healing; the camellia oil has the functions of promoting blood circulation, removing blood stasis and relieving swelling, and the medicines are compatible to play the effects of clearing away heat and toxic materials, promoting tissue regeneration, relieving itching and relieving pain.

10.2 the traditional Chinese medicine preparation for preventing and treating the radiation skin injury can reduce the reaction degree of the radiation dermatitis and reduce the incidence rate of III-IV grade radiation dermatitis.

The radioactive skin injury adopts the major treatment methods of clearing heat and drying dampness, cooling blood and removing toxicity, relieving swelling and pain, astringing and promoting granulation, and is assisted with oxidation resistance, growth factor supplement, moist healing environment maintenance and the like. The results of this study showed that at a radiation dose <20GY, the test group showed only 13.3% and all I-grade radiodermatitis, and at the end of the radiotherapy, the incidence of radiodermatitis reached 100%, but mainly II, 63.33%, and only 16.7%, while the control group showed mainly III-IV, and also 63.33%, with statistical differences (P < 0.05) between the two groups. The traditional Chinese medicine preparation can reduce the reaction degree of radioactive skin damage, reduce the incidence rate of III-IV-level radioactive skin damage, further ensure the smooth completion of radiotherapy, mainly take the main links of the radioactive skin damage treatment into consideration due to reasonable formula, and always maintain a wet healing environment. Meanwhile, the research also shows that the detoxifying and tissue regeneration promoting oil can not completely prevent the skin from being damaged by radiation, and the skin can be damaged to a certain degree with the continuous increase of the radiation dose.

10.3 the traditional Chinese medicine preparation for preventing and treating the radiation skin injury can shorten the recovery time of the radiodermatitis.

When the radiodermatitis occurs, the radiodermatitis is in an irreversible state during the radioactive treatment period, and the skin damage is continuously aggravated along with the increase of the radiation dose, which means that the progress of preventing and treating the radiodermatitis during the radiotherapy is the key of skin care, and the care of the skin is still required to be strengthened within a period of time after the radiotherapy is finished so as to promote the recovery of the radiodermatitis. The research result table 4 shows that the rehabilitation time and the total rehabilitation time of the II-grade and III-IV-grade radiodermatitis of the test group are shorter than those of the control group, the two groups have statistical difference (P is less than 0.05), and the research proves that the traditional Chinese medicine preparation can shorten the rehabilitation time of the radiodermatitis, so that the benefit is realized that the skin is protected by synchronously externally coating the detoxifying and tissue regeneration promoting oil from the test group to the beginning of radiotherapy, the tolerance of the skin in an irradiation area to the radiotherapy is increased, the radiodermatitis is mainly I-grade and II-grade, the damage degree is obviously reduced, and the advantages of the detoxifying and tissue regeneration promoting oil in preventing and treating the radiodermatitis are further verified and known.

While the present invention has been described in detail with reference to the embodiments, it should not be construed as limited to the scope of the patent. Various modifications and changes may be made by those skilled in the art without inventive work within the scope of the appended claims.

Claims

1. The traditional Chinese medicine preparation for preventing and treating radioactive skin injury is characterized by being prepared from the following raw materials in parts by weight: 400 to 500 parts of garden burnet, 250 to 350 parts of coptis, 250 to 350 parts of lithospermum, 100 to 200 parts of nacre, 100 to 200 parts of borneol and 4500 to 5500 parts of camellia oil;

the traditional Chinese medicine preparation is prepared by the following method:

(1) Soaking garden burnet, coptis chinensis, lithospermum and nacre in camellia oil for 20 to 40min, boiling with strong fire, decocting with slow fire for 7 to 9h, and filtering to obtain a crude medicinal oil product;

2. The traditional Chinese medicine preparation according to claim 1, which is prepared from the following raw materials in parts by weight: 450 parts of garden burnet, 300 parts of coptis chinensis, 300 parts of lithospermum, 150 parts of mother-of-pearl, 150 parts of borneol and 5000 parts of camellia oil.

3. The traditional Chinese medicine preparation according to claim 1 or 2, characterized in that: the dosage form of the traditional Chinese medicine preparation is oil.