Traditional Chinese medicine composition as well as preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition and a preparation method and application thereof.The traditional Chinese medicine composition comprises, by weight, 20-30 parts of dandelion, 20-30 parts of sophora flavescens, 30-100 parts of honeysuckle, 10-30 parts of radix paeoniae rubra and 20-30 parts of fructus kochiae, and the traditional Chinese medicine composition comprises, by weight, 20-30 parts of dandelion, 20-30 parts of sophora flavescens, 30-100 parts of honeysuckle, 10-30 parts of radix paeoniae rubra and 20-30 parts of fructus kochiae. The invention aims to obtain the medicine with the effect of efficiently treating rash caused by cetuximab injection medicine.

Description

Technical Field

[0001] The present invention relates to the technical field of rash treatment, and in particular to a traditional Chinese medicine composition and a preparation method and application thereof. Background Art

[0002] At present, the expected annual incidence and mortality of colorectal cancer are at the forefront of malignant tumors, and both are showing a significant growth trend. Recently, it has been found that the epidermal growth factor signaling pathway is a target pathway in tumor treatment. Cetuximab, a monoclonal antibody targeting epidermal growth factor receptor (EGFR), is widely used in a variety of solid tumors such as metastatic colorectal cancer, non-small cell lung cancer, and head and neck squamous cell carcinoma. Rash is a common skin adverse reaction to cetuximab injection, with an incidence of more than 80%. It is characterized by acne-like lesions, which brings pain to patients and even affects the smooth progress of treatment. Existing treatments for cetuximab-induced rash include topical antibiotics (such as fusidic acid), steroid drugs (such as hydrocortisone) and moisturizers, oral antibiotics (such as doxycycline), short-term steroids and antihistamines, and supportive treatments such as photoprotection and immunomodulators. However, these methods are mainly symptomatic treatments with limited efficacy and are difficult to reverse skin toxicity. Long-term use of some treatments may cause side effects, such as steroids causing thinning of the skin, antibiotics causing drug resistance, etc., and patient compliance is poor. It can be seen that the existing methods lack skin toxicity caused by EGFR inhibition, and there are insufficient preventive measures. The treatment process is complicated and expensive, causing many patients to interrupt treatment due to insufficient efficacy or adverse reactions, affecting their quality of life and anti-cancer effects.

[0003] The existing invention patent with the publication number of CN113350438A discloses a Chinese medicine composition for treating rash, which includes the following raw materials in parts by weight: 12-18 parts of purslane, 8-10 parts of green pepper, 6-12 parts of atractylodes, 7-11 parts of siler, 28-32 parts of mirabilite, 8-12 parts of alum, 14-16 parts of forsythia, 8-10 parts of raw cypress leaves and 3-7 parts of scallion. The Chinese medicine composition has no obvious therapeutic effect in practical application and has certain limitations. And the invention patent with the publication number of CN118717905A discloses the use of a Chinese medicine composition in preparing a drug for treating skin diseases, which is composed of concentrated buffalo horn powder, peony bark, Scrophularia, gypsum, Imperata root, Gentiana macrophylla, Coptis chinensis slices, Dangshan peach kernel, dry dendrobium, honeysuckle, safflower and raw rehmannia. Similarly, the Chinese medicine composition is not effective enough in treating the rash caused by cetuximab in practical applications. Therefore, it is urgent to propose a safe, efficient, targeted and economical new treatment plan to deal with the problem of rash caused by cetuximab injection. Summary of the invention

[0004] The main purpose of the present invention is to provide a Chinese medicine composition and a preparation method and application thereof, aiming to solve the technical problem that the existing Chinese medicine composition has poor efficacy in treating rash caused by cetuximab injection.

[0005] To achieve the above purpose, the present invention provides a traditional Chinese medicine composition, which includes dandelion, sophora flavescens, honeysuckle, red peony root and kochia scoparia. According to the weight components, the dandelion is 20-30 parts, the sophora flavescens is 20-30 parts, the honeysuckle is 30-100 parts, the red peony root is 10-30 parts, and the kochia scoparia is 20-30 parts.

[0006] Optionally, according to the weight components, 30 parts of dandelions, 30 parts of sophora flavescens, 30 parts of honeysuckle, 30 parts of red peony root, and 30 parts of Kochia scoparia.

[0007] In addition, to achieve the above object, the present invention also provides a method for preparing the above-mentioned Chinese medicine composition, the method comprising the following steps:

[0008] Step 1, weighing dandelion, sophora flavescens, honeysuckle, red peony root and Kochia scoparia in a preset weight ratio, placing them in a clean container and soaking them in cold water to allow the medicinal materials to fully absorb water;

[0009] Step 2, pouring the soaked medicinal materials together with the soaking liquid into a decoction pot, adding cold water with a volume of V1 so that the water surface submerges the medicinal materials by 2 to 3 cm, and then decocting for 1.5 to 3 hours. After the decoction is completed, filtering the medicinal residue with gauze to collect the medicinal liquid, the volume of the medicinal liquid is V2, and V2 is 15 to 25% of V1;

[0010] Step 3, boiling the medicinal liquid for a second time for 30 minutes to concentrate the volume to V3, thereby obtaining a second-boiled medicinal liquid, wherein V3 is 20% of V2;

[0011] Step 4, cooling the twice-decocted medicinal liquid to room temperature, letting it stand for precipitation, filtering it to remove residual impurities, collecting the clarified medicinal liquid and refrigerating it for later use.

[0012] Optionally, in step 1, the soaking time is 1 hour.

[0013] Optionally, in step 2, the decocting step is to first boil over high heat and then turn to low heat to maintain a slight boil.

[0014] Optionally, in step 3, the second decoction is performed over low heat to keep the medicinal solution slightly boiling, so as to facilitate the concentration of the medicinal effect.

[0015] Optionally, in step 4, filtering is performed using fine gauze or a liquid medicine filter.

[0016] In addition, to achieve the above-mentioned purpose, the present invention also provides a use of a traditional Chinese medicine composition in the preparation of a drug for treating skin rash caused by cetuximab injection.

[0017] Optionally, the drug is in liquid form.

[0018] In addition, to achieve the above purpose, the present invention also provides a use of a Chinese medicine composition in preparing a medicine for treating oral ulcers.

[0019] Beneficial effects:

[0020] The present invention adopts preset components of honeysuckle, dandelion, sophora flavescens, red peony root, and Kochia scoparia, and by clarifying their compatibility ratio, takes clearing away heat and detoxification, cooling blood and removing dampness, and relieving swelling and itching as the core therapeutic effects, so as to achieve the pathogenesis of the rash caused by cetuximab; and sequentially through soaking, decoction, concentration and filtration and other operations, by providing standardized and repeatable preparation processes, such as the specific parameters of the medicinal material soaking time, decoction conditions, concentration ratio and filtration process, the maximum extraction rate of the effective ingredients and the stability of the therapeutic effect are ensured. . The entire production process is environmentally friendly and feasible, avoids the use of chemical additives, has the advantage of low cost, and is suitable for large-scale industrial promotion. Compared with existing treatment methods, it has comprehensive advantages in efficacy, safety and economy. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a schematic flow chart of an embodiment of a method for preparing a Chinese medicine composition of the present invention;

[0022] Figure 2 Picture of the affected area after the patient was injected with cetuximab injection;

[0023] Figure 3 for Figure 2 The picture shows the recovery of the affected part of the patient after applying the Chinese medicine composition of the present invention for 1 week. DETAILED DESCRIPTION

[0024] It should be understood that the specific embodiments described herein are only used to explain the present invention, and are not used to limit the present invention.

[0025] The Chinese medicine composition prepared by the present invention is used to treat the rash caused by the drug of cetuximab injection, wherein the skin diseases such as acne-like rash are caused by the invasion of wind, dampness, heat and toxic evil, mainly caused by lung heat and blood heat and gastrointestinal dampness and heat, and the treatment is mainly to cool blood, clear lung heat and detoxify. Among them, the Chinese medicine composition includes dandelion, sophora flavescens, honeysuckle, red peony root and Kochia scoparia, and honeysuckle is a commonly used Chinese medicine, which is cold in nature and sweet in taste, and enters the lung, stomach and large intestine meridians, and has the effects of clearing heat and detoxifying, cooling and dispersing wind and heat. It is rich in organic acids, volatile oils, flavonoids and other compounds, and has antibacterial, antiviral and immunomodulatory effects. The human body is rich in subcutaneous blood vessels, and local medication can penetrate through the skin. The drug directly reaches the meridians and melts into the body fluids to play the effect of entering the meridians; and dandelion, sophora flavescens, red peony root and Kochia scoparia are also often used in clearing heat and detoxifying, drying dampness and relieving itching. The prescription of the present invention is made of pure Chinese medicine in a reasonable ratio, which conforms to the monarch-minister combination of traditional Chinese medicine and modern pharmacology, and the five herbs of dandelion, sophora flavescens, honeysuckle, red spoon and Kochia scoparia are used together to play the functions of clearing away heat and detoxifying, cooling blood and removing dampness, relieving itching and reducing swelling. It is mainly used to treat rash and related symptoms caused by damp-heat toxic evil, such as erythema, itching, papules and burning sensation, and has the effects of improving local microcirculation, repairing skin barrier and relieving inflammation. That is, the synergistic effect of the above-mentioned medicinal materials can solve skin and related problems caused by damp-heat, blood heat, etc.

[0026] Further, according to the weight components, the Chinese medicine composition includes 20-30 parts of dandelion, 20-30 parts of sophora flavescens, 30-100 parts of honeysuckle, 10-30 parts of red peony root, and 20-30 parts of Kochia scoparia; preferably, 30 parts of dandelion, 30 parts of sophora flavescens, 30 parts of honeysuckle, 30 parts of red peony root, and 30 parts of Kochia scoparia. More preferably, 20 parts of dandelion, 20 parts of sophora flavescens, 50 parts of honeysuckle, 15 parts of red peony root, and 20 parts of Kochia scoparia; or, 25 parts of dandelion, 25 parts of sophora flavescens, 100 parts of honeysuckle, 10 parts of red peony root, and 25 parts of Kochia scoparia.

[0027] Furthermore, the present invention also provides a method for preparing the above-mentioned Chinese medicine composition, see Figure 1 , the method comprises the following steps:

[0028] Step 1, weigh dandelion, sophora flavescens, honeysuckle, red peony root and Kochia scoparia in a preset weight ratio, put them in a clean container and soak them in cold water to allow the medicinal materials to fully absorb water; preferably, the soaking time is 1 hour.

[0029] Step 2, pouring the soaked medicinal materials together with the soaking liquid into a decoction pot, adding cold water with a volume of V1 to make the water surface submerge the medicinal materials by 2 to 3 centimeters, and then decocting for 1.5 to 3 hours. After the decoction is completed, filtering the medicinal residue with gauze and collecting the medicinal liquid, the volume of the medicinal liquid is V2, and V2 is 15 to 25% of V1; wherein the decoction step is to first boil with high heat, and then turn to low heat to maintain a slightly boiling state.

[0030] Step 3, boiling the medicinal liquid for a second time for 30 minutes to concentrate the volume to V3, thereby obtaining a second-boiled medicinal liquid, wherein V3 is 20% of V2; wherein, the second-boiled medicinal liquid is kept slightly boiling over a low heat to facilitate the concentration of the medicinal effect.

[0031] Step 4, cooling the twice-decocted medicinal liquid to room temperature, letting it stand for precipitation, filtering it to remove residual impurities, collecting the clarified medicinal liquid and refrigerating it for later use. Wherein, fine gauze or a medicinal liquid filter is used for filtering.

[0032] The present invention adopts honeysuckle, dandelion, sophora flavescens, red peony root, and Kochia scoparia of preset components, and sequentially through operations such as soaking, decoction, concentration and filtration, ensures efficient extraction of effective ingredients and formula stability. And the above-mentioned medicinal materials are decocted and then soaked in liquid medicine and directly acted on the corresponding area of ​​the patient by external application. Its principle is based on the heat-clearing and detoxifying, anti-inflammatory and antipruritic effects of ingredients such as dandelion, sophora flavescens, and honeysuckle, and then the above-mentioned preparation method can be used to make the effective ingredients produced after the medicinal materials are processed to act directly on the skin surface, quickly relieve the symptoms of redness, swelling, itching, etc. of the skin, can effectively improve the inflammatory reaction of the skin, and accelerate the healing process of the skin. And its formula targets the skin barrier damage, immune disorder and inflammatory mechanism caused by EGFR inhibition, has a significant symptom relief effect, reduces the risk of treatment interruption caused by rash, and significantly improves the treatment compliance and quality of life of patients. The above-mentioned prepared liquid medicine can be used to treat rashes caused by drugs such as cetuximab, and can also be used to treat oral ulcers.

[0033] Furthermore, the clear liquid medicine prepared above is used in treating rashes caused by drugs such as cetuximab, and the specific method of use is as follows:

[0034] Use clean, soft medical gauze or cotton wool, cut it into pieces that fit the size of the affected area, and ensure that the rash is completely covered. Soak the gauze or cotton wool completely in the liquid medicine, and gently wring it dry after fully absorbing the liquid medicine, keeping it moist but not dripping. Apply it 3 times a day at the beginning, 1 hour each time; if there is relief, change to 2 times a day, 1 hour each time; once a day, 1 hour each time during the stable period; subsequently, apply it once every 3 days, 1 hour each time. One week is a course of treatment. Keep the gauze moist when applying wet compresses, and replace or re-soak it in the liquid medicine if it is dry.

[0035] Example 1, Tong, male, 54 years old, developed multiple scattered rashes on the head, face, and neck after three infusions of cetuximab injection, covering less than 10% of the body surface area, without itching. After applying the Chinese medicine composition of the present invention, the rash improved by about 30% after 1 day, by about 50% after 2 days, by about 70% after 5 days, and by 90% after 1 week.

[0036] Example 2, Zhang, male, 45 years old, developed rashes in multiple parts of the head, face, neck, chest and back after 5 infusions of cetuximab injection, covering more than 30% of the body surface area, accompanied by itching. After applying the Chinese medicine composition of the present invention, the rash improved by about 20% after 1 day, about 30% after 2 days, about 60% after 5 days, and 80% after 1 week.

[0037] Example 3, Leng, female, 60 years old, developed multiple rashes on the head, face, chest and upper limbs after 4 infusions of cetuximab injection, covering 10% to 30% of the body surface area, accompanied by itching. After applying the Chinese medicine composition of the present invention, the rash improved by about 20% after 1 day, by about 50% after 2 days, by about 80% after 5 days, and by 90% after 1 week.

[0038] Example 4: Wan, male, 60 years old, developed multiple rashes on the neck, chest and upper limbs after 4 infusions of cetuximab injection, covering 10% to 30% of the body surface area, accompanied by itching. After applying the Chinese medicine composition of the present invention, the rash improved by about 20% after 1 day, about 50% after 2 days, about 80% after 5 days, and 90% after 1 week. Among them, Figure 2 Shown is a picture of the patient's affected area before treatment. Figure 3 The picture shown is the affected part of the patient after 1 week of treatment. It can be seen from the picture that the patient has obvious improvement after applying the above-mentioned Chinese medicine composition.

[0039] Comparative Example 1

[0040] 50 grams of honeysuckle was boiled in water and applied directly to the skin. The patient did not get better after using it.

[0041] It can be seen from the above examples 1-3 that the improvement rate after using the Chinese medicine composition of the present invention is greater than 80% after 1 week, and no other side effects occur.

[0042] Furthermore, for the treatment of oral ulcers, the specific method of use is: gargle with the Chinese medicine composition. It can not only effectively reduce inflammation and relieve pain, but also promote the healing of oral ulcers, improve the repair ability of oral mucosa, and achieve the effect of alleviating symptoms and promoting recovery. The principle is that oral ulcers are mostly caused by excessive fire poison and abnormal immune function in the body. Honeysuckle, dandelion and red peony root have significant heat-clearing and detoxifying effects, which can relieve the pain and inflammation of oral ulcers.

[0043] In summary, the Chinese medicine composition prepared in the present application can effectively treat the rash caused by cetuximab through the dual methods of external application and oral gargle, and also has a good therapeutic effect on other types of rashes and oral ulcers, and has good clinical application value.

[0044] It should be noted that, in this article, the terms "include", "comprises" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, article or system including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or system. In the absence of further restrictions, an element defined by the sentence "comprises a ..." does not exclude the existence of other identical elements in the process, method, article or system including the element.

[0045] The serial numbers of the above embodiments of the present invention are only for description and do not represent the advantages or disadvantages of the embodiments.

[0046] The above are only preferred embodiments of the present invention, and are not intended to limit the patent scope of the present invention. Any equivalent structure or equivalent process transformation made using the contents of the present invention specification and drawings, or directly or indirectly applied in other related technical fields, are also included in the patent protection scope of the present invention.

Claims

1. A Chinese medicine composition, characterized in that: The traditional Chinese medicine composition comprises dandelion, sophora flavescens, honeysuckle, red peony root and kochia scoparia. According to the weight components, the dandelion comprises 20-30 parts, the sophora flavescens comprises 20-30 parts, the honeysuckle comprises 30-100 parts, the red peony root comprises 10-30 parts and the kochia scoparia comprises 20-30 parts.

2. The Chinese medicine composition according to claim 1, characterized in that According to the weight components, there are 30 parts of dandelions, 30 parts of sophora flavescens, 30 parts of honeysuckle, 30 parts of red peony root, and 30 parts of Kochia scoparia.

3. A method for preparing the Chinese medicine composition according to claim 1 or 2, characterized in that: The method comprises the following steps: Step 1, weighing dandelion, sophora flavescens, honeysuckle, red peony root and Kochia scoparia in a preset weight ratio, placing them in a clean container and soaking them in cold water to allow the medicinal materials to fully absorb water; Step 2, pouring the soaked medicinal materials together with the soaking liquid into a decoction pot, adding cold water with a volume of V1 so that the water surface submerges the medicinal materials by 2 to 3 cm, and then decocting for 1.5 to 3 hours. After the decoction is completed, filtering the medicinal residue with gauze to collect the medicinal liquid, the volume of the medicinal liquid is V2, and V2 is 15 to 25% of V1; Step 3, boiling the medicinal liquid for a second time for 30 minutes to concentrate the volume to V3, thereby obtaining a second-boiled medicinal liquid, wherein V3 is 20% of V2; Step 4, cooling the twice-decocted medicinal liquid to room temperature, letting it stand for precipitation, filtering it to remove residual impurities, collecting the clarified medicinal liquid and refrigerating it for later use.

4. The method for preparing the Chinese medicine composition according to claim 3, characterized in that: In step 1, the soaking time is 1 hour.

5. The method for preparing the Chinese medicine composition according to claim 3, characterized in that: In step 2, the decocting step is to first boil over high heat, then turn to low heat and maintain a slight boil.

6. The method for preparing the Chinese medicine composition according to claim 3, characterized in that: In step 3, the second decoction is performed over low heat to keep the medicinal liquid slightly boiling to help concentrate the medicinal effects.

7. The method for preparing the Chinese medicine composition according to claim 3, characterized in that: In step 4, filter using fine gauze or a liquid medicine filter.

8. Use of the Chinese medicine composition according to any one of claims 1 or 2 in the preparation of a drug for treating skin rash caused by cetuximab injection.

9. The use as claimed in claim 8, characterized in that The dosage form of the drug is liquid.

10. Use of the Chinese medicine composition according to any one of claims 1 or 2 in the preparation of a medicament for treating oral ulcers.

Images