An external traditional Chinese medicine compound ointment for treating radioactive dermatitis and its preparation method

Abstract

The present invention discloses an external traditional Chinese medicine compound ointment for treating radioactive dermatitis and a preparation method thereof. The ointment is composed of the following components in parts by weight: 1-40 parts of the extract of the stem and leaf of Gynura Root, 1-10 parts of the extract of Poria cocos, 1-15 parts of the extract of Coix lacryma-jobi, 1-10 parts of the extract of Forsythia suspensa, 1-15 parts of the extract of Atractylodes macrocephala, 0.1-0.5 part of paraben, 1-500 parts of petrolatum, 1-2 parts of β-sitosterol, 1-5 parts of zinc oxide powder, 1-2 parts of talcum powder, 1-2 parts of sodium stearate, and 1-20 parts of ethanol. The traditional Chinese medicine of the present invention adopts traditional Chinese medicine extracts, which maximally reduces the residues of pesticides and heavy metals, improves the solubility, and makes the medicine more easily absorbed by the skin. The external traditional Chinese medicine compound ointment of the present invention can effectively treat radioactive dermatitis, with good effect, quick onset, and low cost. After the patients use it, the related adverse manifestations of radioactive dermatitis significantly subside.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine compositions, and particularly relates to an external traditional Chinese medicine compound ointment for treating radioactive dermatitis and a preparation method thereof. Background Art

[0002] Radiotherapy is one of the three major means for the treatment of malignant tumors in addition to surgery and chemotherapy. Radiation dermatitis is the most common complication after radiotherapy. Since radiotherapy can cause local skin redness, erythema formation, local burning sensation, flaky desquamation, etc. in the radiotherapy area, the quality of life of patients is decreased. The grading standard for radiation dermatitis by the Radiation Therapy Oncology Group (RTOG) of the United States is usually the RTOG grading standard, which is divided into 5 grades in total. Grade 0: basically no change; Grade I: blisters appear, mild erythema, easy hair loss, dry desquamation appears, and sweating decreases; Grade II: the skin has a sense of pain, obvious erythema appears, flaky wet desquamation, moderate edema; Grade III: confluent wet desquamation appears except at skin folds, severe edema; Grade IV: ulcers, bleeding, and tissue necrosis appear.

[0003] The traditional treatment methods for radiation dermatitis mainly include the following aspects:

[0004] 1. External ointments

[0005] External ointments such as arnebia root oil ointment, Jingwanhong ointment, moist burn cream, aloe vera gel, etc. can help patients relieve local pain, can effectively improve the 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 application of halometasone ointment can effectively reduce the severity of radiation dermatitis.

[0006] 2. Wound dressings

[0007] Using wound dressings such as Suoning, hydrogel dressings, silver ion dressings, etc. can keep the skin in the radiotherapy area clean, and at the same time reduce further damage to the wound site and promote wound healing.

[0008] 3. Steroid drugs

[0009] Local topical corticosteroids can also be used for the treatment of radiation dermatitis, and their anti-inflammatory effect is achieved by constricting blood vessels and reducing capillary permeability. A study comparing the efficacy of methylprednisolone with emollients showed that there was a tendency for the methylprednisolone group to reduce the incidence of moderate or more severe radiation dermatitis.

[0010] 4. Non-steroidal local topical drugs

[0011] The main component of the widely used Biaprofen cream clinically at home and abroad is triethanolamine, which can play a role by recruiting macrophages early and stimulating granulation tissue. Multiple clinical studies have shown that triethanolamine has significant advantages over supportive treatment in preventing radiation dermatitis.

[0012] 5 Anti-infection

[0013] After radioactive dermatitis occurs, the wound surface is prone to infection, especially deep skin damage. Anti-infection is one of the necessary measures. Wound secretion culture can be carried out when necessary, and antibiotics can be used empirically for treatment.

[0014] However, for many patients with radioactive dermatitis, the above traditional treatment methods have unsatisfactory effects. During the actual treatment process, the inventor found that the curative effect of using this ointment to treat radioactive dermatitis is better than the above traditional treatment methods. Summary of the Invention

[0015] The purpose of the present invention is to make up for the deficiencies of the prior art and provide an external Chinese medicine compound ointment for treating radioactive dermatitis and its preparation method. The external Chinese medicine compound ointment of the present invention can effectively treat radioactive dermatitis, with good effects, quick results, and low costs. After patients use it, the related clinical manifestations of radioactive dermatitis, such as erythema, skin redness and swelling, ulceration, desquamation, burning sensation, numbness, pain, etc., are significantly subsided, so that the skin can recover as before as soon as possible.

[0016] In order to achieve the above purpose, the present invention adopts the following technical solutions:

[0017] An external Chinese medicine compound ointment for treating radioactive dermatitis, which is composed of the following components in parts by weight: 1-40 parts of Gynura Root Extract, 1-10 parts of Poria Extract, 1-15 parts of Coix Seed Extract, 1-10 parts of Forsythia Extract, 1-15 parts of Atractylodes Macrocephala Extract, 0.1-0.5 part of p-Hydroxybenzoate, 1-500 parts of Vaseline, 1-2 parts of β-Sitosterol, 1-5 parts of Zinc Oxide Powder, 1-2 parts of Talc Powder, 1-2 parts of Sodium Stearate, and 1-20 parts of Ethanol.

[0018] Preferably, the ointment is composed of the following components in parts by weight: 20-40 parts of Gynura Root Extract, 5-10 parts of Poria Extract, 5-15 parts of Coix Seed Extract, 2-10 parts of Forsythia Extract, 3-15 parts of Atractylodes Macrocephala Extract, 0.1-0.3 part of p-Hydroxybenzoate, 100-500 parts of Vaseline, 1-2 parts of β-Sitosterol, 1-5 parts of Zinc Oxide Powder, 1-2 parts of Talc Powder, 1-2 parts of Sodium Stearate, and 5-20 parts of Ethanol.

[0019] More preferably, the ointment is composed of the following components in parts by weight: 25-35 parts of Gynura Root Extract, 5-8 parts of Poria Extract, 5-10 parts of Coix Seed Extract, 2-8 parts of Forsythia Extract, 5-10 parts of Atractylodes Macrocephala Extract, 0.2-0.3 part of p-Hydroxybenzoate, 250-300 parts of Vaseline, 1-2 parts of β-Sitosterol, 1-3 parts of Zinc Oxide Powder, 1-2 parts of Talc Powder, 1-2 parts of Sodium Stearate, and 10-20 parts of Ethanol.

[0020] The present invention also provides a preparation method of the above-mentioned external-use traditional Chinese medicine compound ointment, which includes the following steps:

[0021] (1) Soak the fresh Gynura Root Leaf after repeated cleaning in 75% medical alcohol. After filtering the soaking solution through a fine mesh, boil it into a viscous fluid state, mix it with several times the volume of petrolatum, and then add talcum powder and zinc oxide, and stir well to prepare the Gynura Root Leaf alcohol extract.

[0022] (2) Disperse the Poria cocos extract, Coix seed extract, Forsythia suspense extract, and Atractylodes macrocephala extract in ethanol for mixing, and then boil it over low heat to volatilize the ethanol. Then add petrolatum and sodium stearate, and boil it into a paste for standby.

[0023] (3) After mixing the pastes obtained in steps (1) and (2), stir well, further add β-sitosterol and paraben for mixing, and then subpackage it. Wait for the ointment to solidify to obtain the traditional Chinese medicine compound ointment.

[0024] The present invention has the following technical characteristics:

[0025] 1. Aiming at the pathogenesis characteristics of radiation, this prescription is mainly composed of traditional Chinese medicines for promoting blood circulation, removing stasis, expelling toxins, anti-inflammation, and promoting granulation, combined with traditional Chinese medicine extracts with low toxicity and high efficiency, and excipients with astringent and antioxidant effects, which enhances the curative effect of the traditional Chinese medicine ointment and reduces the cost.

[0026] 2. This ointment is sterilized at high temperature, which is convenient for storage and use, has a long drug penetration time, and has a definite curative effect.

[0027] 3. The components of the ointment are conveniently sourced and simple to prepare, and can be made at home.

[0028] 4. The traditional Chinese medicines of the present invention are obtained by extraction methods to obtain traditional Chinese medicine extracts, which minimizes the residues of pesticides and heavy metals, improves the solubility, and makes the drugs more easily absorbed by the skin.

[0029] 5. This ointment has a certain curative effect on burn and scald wounds with epidermal damage, superficial bedsore and ulcer, acne, mild soft tissue infection and ulcerated wound, paronychia, skin chapping, external hemorrhoids, vasculitis, diabetic foot, psoriasis, freckles, eczema, skin diseases caused by chemotherapy, etc. Specific embodiments

[0030] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be described clearly and completely below. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of them. All other embodiments obtained by those of ordinary skill in the art based on the described embodiments of the present invention without creative efforts fall within the protection scope of the present invention.

[0031] Unless otherwise defined, the technical terms or scientific terms used in this disclosure shall have the ordinary meanings understood by those of ordinary skill in the art to which the present invention pertains.

[0032] Example 1

[0033] An external Chinese medicine compound ointment for treating radioactive dermatitis, the ointment being composed of the following components in parts by weight: 20 parts of Gynura Root Extract, 10 parts of Poria, 15 parts of Coix Seed, 8 parts of Forsythia, 10 parts of Atractylodes Macrocephala, 0.2 part of p-Hydroxybenzoate, 200 parts of Vaseline, 1 part of β-Sitosterol, 2 parts of Zinc Oxide Powder, 1 part of Talc Powder, 1 part of Sodium Stearate, and 5 parts of Ethanol.

[0034] The preparation method of the ointment includes the following steps:

[0035] (1) Soak the repeatedly washed fresh Gynura Root and Stem in 75% medical alcohol. After filtering the soaking solution through a fine mesh, boil it into a viscous fluid state, mix it with several times the volume of Vaseline, and then add Talc Powder and Zinc Oxide, and stir well to prepare Gynura Root Alcohol Extract.

[0036] (2) Disperse Poria Extract, Coix Seed Extract, Forsythia Extract, and Atractylodes Macrocephala Extract in Ethanol for mixing, and then boil it over low heat to evaporate the Ethanol. Then add Vaseline and Sodium Stearate and boil it into an ointment state for standby.

[0037] (3) After mixing the ointment substances obtained in steps (1) and (2), stir well, further add β-Sitosterol and p-Hydroxybenzoate for mixing, and then subpackage it. Wait for the ointment to solidify to obtain the Chinese medicine compound ointment.

[0038] Example 2

[0039] An external Chinese medicine compound ointment for treating radioactive dermatitis, the ointment being composed of the following components in parts by weight:

[0040] 30 parts of Gynura Root Extract, 8 parts of Poria, 10 parts of Coix Seed, 5 parts of Forsythia, 5 parts of Atractylodes Macrocephala, 0.3 part of p-Hydroxybenzoate, 100 parts of Vaseline, 2 parts of β-Sitosterol, 3 parts of Zinc Oxide Powder, 2 parts of Talc Powder, 2 parts of Sodium Stearate, and 10 parts of Ethanol.

[0041] The preparation method of the ointment includes the following steps:

[0042] (1) Soak the freshly harvested and repeatedly washed Gynura Root Leaf Stem in 75% medical alcohol. After filtering the soaking solution through a fine mesh, boil it into a viscous fluid state, add several times the volume of petrolatum and mix well, then add talcum powder and zinc oxide, and stir thoroughly to prepare the alcohol extract of Gynura Root Leaf Stem.

[0043] (2) Disperse the extracts of Poria, Coix Seed, Forsythia Fruit, and Atractylodes Macrocephala in ethanol and mix them. Then, simmer them over low heat to evaporate the ethanol. Next, add petrolatum and sodium stearate and boil them into a paste for later use.

[0044] (3) Mix the pastes obtained in steps (1) and (2), stir thoroughly, further add β-sitosterol and paraben, and then divide them into portions. Wait for the ointment to solidify to obtain the traditional Chinese medicine compound ointment.

[0045] Example 3

[0046] An externally applied traditional Chinese medicine compound ointment for treating radiation dermatitis, which is composed of the following components in parts by weight: 40 parts of the extract of Gynura Root Leaf Stem, 10 parts of Poria, 5 parts of Coix Seed, 5 parts of Forsythia Fruit, 10 parts of Atractylodes Macrocephala, 0.3 part of paraben, 350 parts of petrolatum, 1 part of β-sitosterol, 4 parts of zinc oxide powder, 1 part of talcum powder, 2 parts of sodium stearate, and 20 parts of ethanol.

[0047] The preparation method of the ointment includes the following steps:

[0048] (1) Soak the freshly harvested and repeatedly washed Gynura Root Leaf Stem in 75% medical alcohol. After filtering the soaking solution through a fine mesh, boil it into a viscous fluid state, add several times the volume of petrolatum and mix well, then add talcum powder and zinc oxide, and stir thoroughly to prepare the alcohol extract of Gynura Root Leaf Stem.

[0049] (2) Disperse the extracts of Poria, Coix Seed, Forsythia Fruit, and Atractylodes Macrocephala in ethanol and mix them. Then, simmer them over low heat to evaporate the ethanol. Next, add petrolatum and sodium stearate and boil them into a paste for later use.

[0050] (3) Mix the pastes obtained in steps (1) and (2), stir thoroughly, further add β-sitosterol and paraben, and then divide them into portions. Wait for the ointment to solidify to obtain the traditional Chinese medicine compound ointment.

[0051] The efficacy test of the external Chinese medicine compound ointment for treating radiation dermatitis of the present invention. At present, the most widely used grading standard in China is the grading standard of the American Radiation Therapy Oncology Group (RTOG), which is divided into 5 levels, level 0: basically no change; level I: blisters, light red spots, easy hair loss, dry peeling, reduced sweating; level II: skin tenderness, obvious red spots, flaky wet peeling, moderate edema; level III: fusion wet peeling except for skin wrinkles, severe edema; level IV: ulcers, bleeding, tissue necrosis.

[0052] A total of 117 patients were selected for the efficacy test, including 58 cases in the treatment group and 59 cases in the control group. The treatment group applied the ointment once in the morning and evening in the irradiated skin area after radiotherapy from the beginning of radiotherapy. The affected area needs to be washed and dried before use, and the remaining Chinese medicine ointment should be refrigerated in the refrigerator after use; the control group kept the skin dry and clean, and was prohibited from applying any other drugs or skin creams. The efficacy was evaluated after one month of application. Table 1 lists the comparison of the grading of radiation dermatitis on the skin of the two groups of patients.

[0053] Table 1 Comparison of the grading of skin radiation dermatitis between the two groups of patients

[0054] Group Number of cases Grade 0 Grade I Grade II Grade III Grade IV Control group 59 10 16 25 5 3 Treatment group 58 26 23 7 2 0

[0055] Note: Inter-group comparison, P<0.05

[0056] As can be seen from the above table, the proportion of grade 0 and grade I radiation dermatitis in the treatment group was 84.5%, while that in the control group was 44.1%; the proportion of moderate grade II radiation dermatitis in the treatment group was 12.1%, and the proportion of more serious grade III and grade IV radiation dermatitis was only 3%; while the proportion of moderate and severe radiation dermatitis in the control group was significantly higher than that in the treatment group. Therefore, the external Chinese medicine compound ointment of the present invention can effectively treat radiation dermatitis, and the relevant clinical manifestations of radiation dermatitis are significantly reduced after the patient uses it.

[0057] The above embodiments are only used to help understand the method of the present invention and its core concept. It should be noted that, for those skilled in the art, without departing from the principles of the present invention, several improvements and modifications may be made to the present invention, and these improvements and modifications also fall within the scope of protection of the claims of the present invention.

Claims

1. An external traditional Chinese medicine compound ointment for treating radioactive dermatitis, characterized in that, The paste is composed of the following components in parts by weight: 1-40 parts of Gynura Root Extract, 1-10 parts of Poria Cocos Extract, 1-15 parts of Coix Seed Extract, 1-10 parts of Forsythia Suspensa Extract, 1-15 parts of Atractylodes Macrocephala Extract, 0.1-0.5 part of p-Hydroxybenzoate, 1-500 parts of Vaseline, 1-2 parts of β-Sitosterol, 1-5 parts of Zinc Oxide Powder, 1-2 parts of Talc Powder, 1-2 parts of Sodium Stearate, and 1-20 parts of Ethanol; The preparation method of the paste includes the following steps: (1) Soak the repeatedly washed fresh Gynura Root Stem Leaves in 75% medical alcohol. After filtering the soaking solution through a fine mesh, boil it into a viscous fluid state, add several times the volume of Vaseline and mix, then add Talc Powder and Zinc Oxide, and stir well to prepare Gynura Root Alcohol Extract; (2) Disperse Poria Cocos Extract, Coix Seed Extract, Forsythia Suspensa Extract, and Atractylodes Macrocephala Extract in Ethanol for mixing, then simmer to evaporate the Ethanol, and then add Vaseline and Sodium Stearate, and boil into a paste for standby; (3) Mix the pastes obtained in step (1) and step (2), stir well, further add β-Sitosterol and p-Hydroxybenzoate for mixing, and pack. Wait for the ointment to solidify to obtain the traditional Chinese medicine compound paste.

2. The external-use traditional Chinese medicine compound ointment for treating radioactive dermatitis according to claim 1, wherein, The paste is composed of the following components in parts by weight: 20-40 parts of Gynura Root Extract, 5-10 parts of Poria Cocos Extract, 5-15 parts of Coix Seed Extract, 2-10 parts of Forsythia Suspensa Extract, 3-15 parts of Atractylodes Macrocephala Extract, 0.1-0.3 part of p-Hydroxybenzoate, 100-500 parts of Vaseline, 1-2 parts of β-Sitosterol, 1-5 parts of Zinc Oxide Powder, 1-2 parts of Talc Powder, 1-2 parts of Sodium Stearate, and 5-20 parts of Ethanol.

3. The external-use traditional Chinese medicine compound plaster for treating radioactive dermatitis according to claim 1, wherein The paste is composed of the following components in parts by weight: 25-35 parts of Gynura Root Extract, 5-8 parts of Poria Cocos Extract, 5-10 parts of Coix Seed Extract, 2-8 parts of Forsythia Suspensa Extract, 5-10 parts of Atractylodes Macrocephala Extract, 0.2-0.3 part of p-Hydroxybenzoate, 250-300 parts of Vaseline, 1-2 parts of β-Sitosterol, 1-3 parts of Zinc Oxide Powder, 1-2 parts of Talc Powder, 1-2 parts of Sodium Stearate, and 10-20 parts of Ethanol.