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

Abstract

The invention provides a traditional Chinese medicine compound composition as well as a preparation method and application thereof, and relates to the field of traditional Chinese medicine compositions. The composition comprises lacquer tree bark, cortex dictamni, radix curcumae, semen cuscutae, asiatic toddalia root, fructus kochiae, asarum, perfoliote knotweed herb, radix clematidis, sargentgloryvine stem, fructus evodiae, pomegranate seeds, adenosma indianum, spina gleditsiae, glechoma longituba and radix stemonae. The composition integrates four effects of dispelling wind, relieving itching, dredging collaterals and detoxifying, overcomes the defects in the prior art, is mainly used for treating diseases such as rheumatic arthralgia, skin itch, neurodermatitis, eczema and the like, has the effects of dispelling wind, eliminating dampness, relieving itching, dredging collaterals, resisting inflammation, easing pain and the like, has potential effects of resisting bacteria, resisting oxidation, regulating immunity and the like, and has a wide application prospect. The device is suitable for auxiliary treatment of dermatology, rheumatism and neurological diseases.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of traditional Chinese medicine compositions, in particular, to a traditional Chinese medicine compound composition, a preparation method and applications thereof. BACKGROUND

[0002] At present, when treating rheumatic arthralgia, skin itching, neurodermatitis, eczema and other diseases, external preparations such as glucocorticoid ointment, antihistamine gel and the like can be used for local application, but long-term use can easily lead to skin atrophy, drug resistance and other problems, and the curative effect on chronic itching or rheumatic pain is limited, and external preparations of traditional Chinese medicine compounds can also be used, but are mostly limited to single efficacy, such as only stopping itching or only anti-inflammatory, and lack of multi-target regulation of the pathogenesis of "wind, dampness and blood stasis".

[0003] In the prior art, Chinese patent CN105125850A discloses a composition for treating psoriasis, eczema, urticaria and neurodermatitis, which is composed of 23 kinds of raw medicinal materials such as Chinese herbaceous peony, honeysuckle, white willow bark, forsythia, goldthread, rehmannia, periploca, atractylodes, musk, ox gall, spina date, acorus and the like, which can be used as capsules, tablets, granules, sprays, liniments or tinctures and the like, has the effects of clearing heat, removing dampness, detoxifying, regulating qi and promoting blood circulation, and has remarkable effects on treating psoriasis, eczema, urticaria or neurodermatitis and other skin diseases, has no toxic side effects, and when the capsule is used for clinical treatment, the treatment cycle for patients with psoriasis, chronic eczema, urticaria and neurodermatitis is at least 15 days.

[0004] In addition, Chinese patent CN107397858A also discloses an external medicine for treating skin diseases and a preparation method, the raw materials of the medicine are composed of maple leaves, maple roots, water centipedes, ramie roots, wild licorice, fresh cactus and fresh pine needles, have the effects of expelling wind and removing dampness, promoting qi and stopping pain, killing insects and stopping itching, detoxifying and promoting tissue regeneration, relieving swelling and pain, and clearing heat and removing dampness, and have remarkable effects on treating eczema, skin tinea, skin tinea complicated with bacterial infection, high cure rate and extremely low recurrence rate, and have good effects on treating neurodermatitis, suppurative skin diseases, rhinitis, otitis media and lip herpes, also have the effects of relieving inflammation and pain, preventing ulceration and rapid healing on burns, scalds and trauma, but according to the clinical data of different patients, the treatment time of the external medicine for skin disease patients is as long as 20 days, and the cure rate is more than 96.67%. SUMMARY

[0005] The present application aims to provide a traditional Chinese medicine compound composition which is composed of 16 medicinal materials including Rhus succedaneum, Dictamnus dasycarpus, Curcuma zedoary, Semen Euryae, Drynaria fortunei, Fructus Terminaliae, Szechwan Lovage Rhizome, Angelica sinensis, Radix Clematidis, Radix Salviae Miltiorrhizae, Fructus Evodiae, Punica granatum, Muskroot, Gleditsia sinensis, Herba Siegesbeckiae and Radix Stachydis, integrates four functions of dispelling wind, relieving itching, dredging collaterals and detoxifying, makes up for the deficiency of the prior art, is mainly used for treating diseases such as rheumatic arthralgia, skin itching, neurodermatitis and eczema, has the effects of dispelling wind and dampness, relieving itching and dredging collaterals, resisting inflammation and relieving pain, and has potential effects of resisting bacteria, resisting oxidation and regulating immunity, and is suitable for the auxiliary treatment of diseases in dermatology, rheumatology and neurosis.

[0006] Another object of the present application is to provide a preparation method of the traditional Chinese medicine compound composition, which is simple and can fully utilize effective components in raw materials.

[0007] The present application solves the technical problem by using the following technical scheme: In one aspect, the present application provides a traditional Chinese medicine compound composition, which comprises Rhus succedaneum, Dictamnus dasycarpus, Curcuma zedoary, Semen Euryae, Drynaria fortunei, Fructus Terminaliae, Szechwan Lovage Rhizome, Angelica sinensis, Radix Clematidis, Radix Salviae Miltiorrhizae, Fructus Evodiae, Punica granatum, Muskroot, Gleditsia sinensis, Herba Siegesbeckiae and Radix Stachydis.

[0008] In some embodiments of the present application, the following raw materials are included in a weight ratio of 4-6 parts of Rhus succedaneum, 12-15 parts of Dictamnus dasycarpus, 7-9 parts of Curcuma zedoary, 3-5 parts of Semen Euryae, 4-6 parts of Drynaria fortunei, 2-4 parts of Fructus Terminaliae, 3-5 parts of Szechwan Lovage Rhizome, 8-10 parts of Angelica sinensis, 8-10 parts of Radix Clematidis, 8-10 parts of Radix Salviae Miltiorrhizae, 5-8 parts of Fructus Evodiae, 4-6 parts of Punica granatum, 5-7 parts of Muskroot, 4-6 parts of Gleditsia sinensis, 8-10 parts of Herba Siegesbeckiae and 8-10 parts of Radix Stachydis.

[0009] In some embodiments of the present application, the following raw materials are included in a weight ratio of 4 parts of Rhus succedaneum, 12 parts of Dictamnus dasycarpus, 7 parts of Curcuma zedoary, 3 parts of Semen Euryae, 4 parts of Drynaria fortunei, 2 parts of Fructus Terminaliae, 3 parts of Szechwan Lovage Rhizome, 8 parts of Angelica sinensis, 8 parts of Radix Clematidis, 8 parts of Radix Salviae Miltiorrhizae, 5 parts of Fructus Evodiae, 4 parts of Punica granatum, 5 parts of Muskroot, 4 parts of Gleditsia sinensis, 8 parts of Herba Siegesbeckiae and 8 parts of Radix Stachydis.

[0010] In a second aspect, the present application provides a preparation method of the traditional Chinese medicine compound composition, which comprises the following steps: S1, immersing medicinal materials in water at 5-10℃ for 2 hours, and then boiling at 90-95℃ for 4 hours; S2, the mixture after boiling in step S1 is filtered, the filtrate and the residue are collected, and after filtration, the residue is treated with ultrasonic waves, the frequency is 20-40 kHz, the power is 100-200 W, and the duration is 20-30 min; after ultrasonic treatment, the residue is extracted again with a press at a pressure of 0.3-0.5 MPa for 20-30 min to ensure that the effective components in the residue are fully extracted. The filtrate of the two times is combined and concentrated. The filtrate of the two times is combined, concentrated, and concentrated to 1 / 5-1 / 6 of the initial soaking liquid volume; S3, under stirring, 80℃, plant oil is added, completely dissolved, and then stirring is continued for 40-60 min; slowly cool to room temperature to ensure the stability of the medicament and avoid analysis or structure damage caused by sudden temperature change. After filling, appropriate methods such as ultraviolet sterilization or high-temperature instantaneous sterilization are used for sterilization to ensure the sterility of the product. Finally, seal packaging to ensure the stability of the product during storage and transportation.

[0011] In a third aspect, the application provides the use of the above-mentioned traditional Chinese medicine compound composition in the preparation of a medicament for dispelling wind, relieving itching, and unblocking collaterals, including a medicament for treating rheumatic arthralgia, skin itching, neurodermatitis, eczema, urticaria, psoriasis, diabetic foot ulcer, and senile dry skin.

[0012] Compared with the prior art, the embodiments of the application have at least the following advantages or beneficial effects: (1) The traditional Chinese medicine formula composition provided by the application solves the single efficacy of traditional Chinese medicine ointments or chemical ointments, adopts multi-target point synergy, and simultaneously regulates the complex pathogenesis of "wind, dampness, blood stasis, and deficiency", breaking through the limitations of existing single itching relief, analgesia, or immune regulation.

[0013] (2) The indications of the traditional Chinese medicine formula composition provided by the application can be in four fields of eczema, rheumatic pain, neuralgia, and barrier repair, solving the single indication of existing ointments, such as traditional Chinese medicine ointments only for eczema or only for analgesia, or existing chemical ointments only for the treatment of dermatitis or arthritis.

[0014] (3) The traditional Chinese medicine formula composition provided by the application is composed of 16 medicinal materials, including Rhus succedaneum, Dictamnus dasycarpus, Curcuma zedoary, Semen Leonuri, Drynaria fortunei, Tribulus terrestris, Szechwan Lovage Rhizome, Aconitum carmichaeli, Radix Clematidis, Salvia miltiorrhiza, Evodia rutaecarpa, Punica granatum, Muskroot, Radix Sophorae Tonkinensis, Herba Gnaphalii, and Radix Stachydis, which can be used to construct a four-dimensional treatment system of dispelling wind and relieving itching, unblocking collaterals and relieving pain, detoxifying and healing sores, and strengthening the body resistance, wherein Dictamnus dasycarpus is the monarch herb, which focuses on solving the core symptom of wind itching; Tribulus terrestris (dampness) and Semen Leonuri (tonifying) are combined to eliminate evil and support the body resistance, preventing excessive dampness from damaging yin and achieving bidirectional regulation; Rhus succedaneum (antibacterial), Radix Stachydis (antifungal), and Muskroot (broad-spectrum bacteriostatic) construct a multi-level anti-infection defense line to achieve antibacterial coverage.

[0015] (4) The traditional Chinese medicine formula composition provided by the application can realize the effects of dispelling wind, relieving itching, and dredging collaterals by using the compatibility mechanism of cortex meliae, semen astragali complanati, asarum and radix clematidis, wherein the cortex meliae has the effects of clearing heat and dispelling wind, and can inhibit immune overreaction and relieve the itching symptoms of skin allergic diseases (such as urticaria and eczema); the semen astragali complanati can clear damp heat and relieve itching, and can synergistically enhance the effects of dispelling wind and relieving itching with the cortex meliae; the asarum has the effects of dispersing wind and clearing heat, and can promote the penetration of the medicinal effects; and the radix clematidis can dispel wind and damp and dredge meridians and collaterals, and can relieve rheumatic pain and numbness of the skin.

[0016] (5) The traditional Chinese medicine formula composition provided by the application can realize the effects of clearing heat and drying dampness, and detoxifying and relieving itching by using the compatibility mechanism of cortex toxicodendri, radix angelicae sinensis, herba gnaphii and radix stachydis, wherein the cortex toxicodendri and radix angelicae sinensis have the effects of clearing heat and detoxifying, and can significantly relieve the exudation and swelling of skin diseases of the damp heat type (such as eczema and contact dermatitis); the herba gnaphii can clear damp heat and relieve itching, and can assist in clearing damp heat toxins and reducing skin inflammatory reactions; and the radix stachydis can kill insects and relieve itching, and can inhibit the itching caused by fungal and parasitic infections.

[0017] (6) The traditional Chinese medicine formula composition provided by the application can realize the effects of activating blood and dredging collaterals, and improving microcirculation by using the compatibility mechanism of xue tong, gleditsia sinensis and curcuma, wherein the xue tong (radix sargentiae) can activate blood and regulate menstruation, and can improve local blood circulation and promote skin repair; the gleditsia sinensis can resolve swelling and discharge pus, and has strong penetration, and can enhance the penetration of the medicinal paste; and the curcuma can promote blood circulation and relieve pain, and can relieve skin induration or pain caused by blood stasis.

[0018] (7) The traditional Chinese medicine formula composition provided by the application can realize the effects of warming the meridians and dispelling cold, and regulating qi and blood by using the compatibility mechanism of evodia and cuscuta, wherein the evodia can dispel cold and relieve pain, and can relieve cold and damp skin itching and joint cold pain; and the cuscuta can tonify the liver and kidney, and protect the healthy qi, and can enhance the skin barrier function.

[0019] (8) The traditional Chinese medicine formula composition provided by the application also has the effects of antibacterial and antiviral, anti-inflammatory and immune regulation, promoting tissue repair, analgesia and sedation, antioxidant and anti-aging, such as for antibacterial and antiviral, the white peony bark contains components such as white peony alkaline and amur cork tree ketone, which has a significant inhibitory effect on staphylococcus aureus and fungi, and the pomegranate seed contains tannins and polyphenols, which can inhibit the proliferation of pathogenic microorganisms and prevent secondary infection; for anti-inflammatory and immune regulation, the alkaloids in the flying dragon blood can inhibit the release of inflammatory factors (such as TNF-alpha and IL-6) and reduce chronic inflammation, and the volatile oil components of muskroot have an anti-allergic effect and can relieve immune skin diseases (such as psoriasis); for promoting tissue repair, dodder promotes collagen synthesis through the antioxidant mechanism to accelerate wound healing, and the saponin components in the wilson root can stimulate fibroblast proliferation and repair damaged skin; for analgesia and sedation, the methyl eugenol of asarum has a central sedative effect and can relieve neurotic pruritus; for antioxidant and anti-aging, the Japanese knotweed and the Chinese knotweed contain flavonoids, which can scavenge free radicals and delay skin aging.

[0020] (9) The traditional Chinese medicine formula composition provided by the application can replace chemical penetration enhancers and has the effect of transdermal synergism by forming a natural penetration enhancer combination with soapberry thorns and evodia.

[0021] (10) The traditional Chinese medicine formula composition provided by the application is safe and has no hormone components, and asarum is strictly limited to 3-5 parts to avoid excessive methyl eugenol from causing contact dermatitis and has no risk of skin atrophy with long-term use. BRIEF DESCRIPTION OF DRAWINGS

[0022] In order to more clearly illustrate the technical solutions of the embodiments of the application, the following will briefly introduce the drawings needed to be used in the embodiments, and it should be understood that the following drawings only show some embodiments of the application, and therefore should not be regarded as a limitation on the scope, and for those skilled in the art, other related drawings can also be obtained without creative labor on the basis of these drawings.

[0023] Figure 1 It is the composition of the embodiment 1 of the application. DETAILED DESCRIPTION

[0024] In order to make the purpose, technical scheme and advantages of the embodiments of the application more clear, the technical scheme in the embodiments of the application will be described clearly and completely in the following. The specific conditions are not specified in the embodiments, and the conventional conditions or the conditions recommended by the manufacturer are used. The reagents or instruments used are not specified by the manufacturer, and are all conventional products that can be purchased on the market.

[0025] It should be noted that the embodiments in the application and the features in the embodiments can be combined with each other without conflict. The application will be described in detail below with reference to specific embodiments.

[0026] The features and performances of the present application are further described in detail below in combination with examples.

[0027] Example 1: External ointment of Chinese medicine compound composition for treating rheumatic arthralgia The formula of the Chinese medicine component composition is as follows: Rhus succedaneum 4 parts, Dictamnus dasycarpus Turcz 12 parts, Curcuma 7 parts, Semen Nelumbinis 3 parts, Palmixia 4 parts, Semen Euphorbiae 2 parts, Asarum 3 parts, Rehmannia 8 parts, Radix Clematidis 8 parts, Xue Tong 8 parts, Evodia 5 parts, Punica granatum 4 parts, Musk 5 parts, Gleditsia 4 parts, Herba Gnaphlii 8 parts, Stemona 8 parts.

[0028] The composition of the present example is prepared as follows: S1, soak the medicinal materials in water at 5-10°C for 2 hours, then simmer at 90-95°C for 4 hours with small fire; S2, filter the mixture of step S1, collect the filtrate and residue, after filtration, perform ultrasonic treatment on the residue, frequency 40kHz, power 200W, for 30min. After ultrasonic treatment, use a press machine to extract the residue for the second time at a pressure of 0.5MPa for 30min, to ensure that the effective components in the residue are fully extracted. Combine the two filtrates and proceed to the next step of concentration, concentrate to 1 / 5 of the initial soaking liquid volume; S3, under stirring, add vegetable oil at 80°C, completely dissolve, continue stirring for 60min; slowly cool to room temperature to ensure the stability of the medicine, avoid analysis or structure damage caused by sudden temperature change. After filling, sterilize by appropriate method such as ultraviolet sterilization or high temperature instantaneous sterilization to ensure the sterility of the product. Finally, seal the package to ensure the stability of the product during storage and transportation; such as shown in the attached Figure 1

[0029] Example 2: External ointment of Chinese medicine compound composition for treating skin itching The formula of the Chinese medicine component composition is as follows: Rhus succedaneum 6 parts, Dictamnus dasycarpus Turcz 15 parts, Curcuma 9 parts, Semen Nelumbinis 3 parts, Palmixia 4 parts, Semen Euphorbiae 3 parts, Asarum 4 parts, Rehmannia 9 parts, Radix Clematidis 10 parts, Xue Tong 10 parts, Evodia 8 parts, Punica granatum 4 parts, Musk 6 parts, Gleditsia 5 parts, Herba Gnaphlii 9 parts, Stemona 9 parts.

[0030] The preparation method is the same as that of Example 1.

[0031] Example 3: External ointment of Chinese medicine compound composition for treating neurodermatitis ​The prescription of the Chinese medicine component composition is as follows: sumach bark 4 parts, bark of Chinese goldthread 12 parts, curcuma 8 parts, semen cuscutae 3 parts, dragon blood 4 parts, semen euryae 3 parts, asarum 5 parts, kadsura 0 parts, radix dispaci 10 parts, blood circulation 8 parts, evodia 5 parts, pomegranate seeds 4 parts, musk 7 parts, kikar thorn 6 parts, lycopus virginicus 10 parts, stachys 10 parts.

[0032] The preparation method is the same as that of Example 1.

[0033] Example 4: Chinese medicine composition and external ointment for treating eczema The prescription of the Chinese medicine component composition is as follows: sumach bark 4 parts, bark of Chinese goldthread 12 parts, curcuma 8 parts, semen cuscutae 3 parts, dragon blood 4 parts, semen euryae 3 parts, asarum 5 parts, kadsura 0 parts, radix dispaci 10 parts, blood circulation 8 parts, evodia 5 parts, pomegranate seeds 4 parts, musk 7 parts, kikar thorn 6 parts, lycopus virginicus 10 parts, stachys 10 parts.

[0034] The preparation method is the same as that of Example 1.

[0035] Example 5: Chinese medicine composition and external ointment for treating urticaria The prescription of the Chinese medicine component composition is as follows: sumach bark 4 parts, bark of Chinese goldthread 12 parts, curcuma 8 parts, semen cuscutae 3 parts, dragon blood 4 parts, semen euryae 3 parts, asarum 5 parts, kadsura 0 parts, radix dispaci 10 parts, blood circulation 8 parts, evodia 5 parts, pomegranate seeds 4 parts, musk 7 parts, kikar thorn 6 parts, lycopus virginicus 10 parts, stachys 10 parts.

[0036] The preparation method is the same as that of Example 1.

[0037] Example 6: Chinese medicine composition and external ointment for treating psoriasis The prescription of the Chinese medicine component composition is as follows: sumach bark 4 parts, bark of Chinese goldthread 12 parts, curcuma 8 parts, semen cuscutae 3 parts, dragon blood 4 parts, semen euryae 3 parts, asarum 5 parts, kadsura 0 parts, radix dispaci 10 parts, blood circulation 8 parts, evodia 5 parts, pomegranate seeds 4 parts, musk 7 parts, kikar thorn 6 parts, lycopus virginicus 10 parts, stachys 10 parts.

[0038] The preparation method is the same as that of Example 1.

[0039] Example 7: Chinese medicine composition and external ointment for treating diabetic foot ulcer The prescription of the Chinese medicine component composition is as follows: sumach bark 4 parts, bark of Chinese goldthread 12 parts, curcuma 8 parts, semen cuscutae 3 parts, dragon blood 4 parts, semen euryae 3 parts, asarum 5 parts, kadsura 0 parts, radix dispaci 10 parts, blood circulation 8 parts, evodia 5 parts, pomegranate seeds 4 parts, musk 7 parts, kikar thorn 6 parts, lycopus virginicus 10 parts, stachys 10 parts.

[0040] The preparation method is the same as that of Example 1.

[0041] Example 8: Traditional Chinese medicine composition and external ointment for treating senile dry dermatitis The formula of the traditional Chinese medicine component composition is as follows: Rhus succedaneum 5 parts, Dictamnus dasycarpus Turcz 15 parts, Curcuma 9 parts, Semen Nelumbinis 5 parts, Toddalia asiatica 4 parts, Semen Euphorbiae 2 parts, Asarum 3 parts, Rehmannia 9 parts, Radix Clematidis 10 parts, Xue Tong 10 parts, Evodia rutaecarpa 8 parts, Punica granatum 6 parts, Muskroot 5 parts, Gleditsia sinensis 4 parts, Herba Gnaphlii 8 parts, Radix Stachy 8 parts.

[0042] The preparation method is the same as that of Example 1.

[0043] Typical cases To systematically evaluate the clinical efficacy of the traditional Chinese medicine compound external preparation of the application on various skin diseases, this study used a retrospective case series observation method. All cases were from patients admitted to cooperative medical institutions from December 2024 to June 2025 who met the inclusion criteria. This study followed the principles of the Helsinki Declaration, and all participants gave informed consent.

[0044] To scientifically verify the repair effect of the traditional Chinese medicine compound ointment described in the application on skin fissures, the following inclusion criteria are formulated to screen eligible observation objects: 1. Inclusion criteria for subjects Western medicine diagnostic criteria: Refer to relevant works on clinical dermatology or Chinese clinical dermatology to clearly diagnose the corresponding disease (such as psoriasis, eczema, urticaria, acne, tinea manuum, etc.).

[0045] TCM syndrome differentiation criteria: Refer to the Guiding Principles for Clinical Research of New Drugs of Traditional Chinese Medicine or the Diagnostic and Efficacy Criteria for TCM Syndromes.

[0046] Inclusion population: Age 18-85 years old, gender unrestricted. Target skin lesions are in the active phase, and the severity score reaches mild and above. Sign the informed consent form, and can cooperate with the treatment plan and receive regular follow-up.

[0047] Exclusion criteria: Pregnant or lactating women. Those allergic to any known ingredients of the product. Those with severe heart, liver, kidney dysfunction or immune system diseases.

[0048] Efficacy evaluation criteria: Evaluate the efficacy before treatment (baseline), within 24 hours of treatment, at 1 week, 2 weeks, and 4 weeks.

[0049] 1. Primary efficacy indicator: improvement of lesion severity and area Disease-specific severity scoring method is used. Redness, papules / infiltration, scales / serous fluid, and area of skin lesions are quantitatively scored.

[0050] Efficacy determination levels (based on score reduction rate): Clinical recovery: the skin lesions completely disappeared, the symptoms disappeared, and the score reduction rate was ≥90%.

[0051] Marked effect: most of the skin lesions disappeared, the symptoms were significantly relieved, and the score reduction rate was 60%-89%.

[0052] Effective: the skin lesions partially disappeared, the symptoms were partially relieved, and the score reduction rate was 30%-59%.

[0053] Ineffective: the skin lesions did not obviously disappear or were aggravated, the symptoms were not improved or were aggravated, and the score reduction rate was <30%.

[0054] Total effective rate calculation: total effective rate = (number of clinical recovery cases + number of marked effect cases + number of effective cases) / total observation cases × 100%.

[0055] 2. Secondary efficacy index: Pruritus visual analogue scale: the patient marked the pruritus degree on a 0-10 scale (0 for no itching and 10 for severe itching).

[0056] Patient overall evaluation: at the end of treatment, the patient evaluated the overall satisfaction with the efficacy (divided into very satisfied, satisfied, general, and dissatisfied).

[0057] Traditional Chinese medicine syndrome score: the main symptoms of each patient (such as dry mouth, irritability, tongue appearance, and pulse appearance) were quantitatively scored to observe the improvement.

[0058] 3. Safety evaluation: The occurrence time, degree, duration, and outcome of all adverse reactions (such as local irritation and allergy) during treatment were recorded.

[0059] To specifically illustrate the clinical application and efficacy of the present application, several typical cases are listed.

[0060] Case 1: chronic eczema (damp-heat invading the skin type) Patient condition: male, 45 years old, with recurrent lower limb eczema for many years, aggravated in summer. The symptoms included skin erythema, papules, severe pruritus, exudation and scabbing after scratching, red tongue with yellowish greasy fur, and slippery and rapid pulse. Traditional Chinese medicine syndrome differentiation: damp-heat accumulation in the skin, blood deficiency and dryness-evil. The external ointment of Example 4 was used to smear the affected area twice a day. On the 3rd day of treatment: the pruritus was significantly reduced, and the exudation was reduced. On the 7th day of treatment (1 week): the erythema and papules basically disappeared, the skin tended to be dry, and the scab fell off. The pruritus symptoms disappeared.

[0061] Efficacy determination: clinical recovery. Follow-up for 1 month showed no recurrence.

[0062] Conclusion: the preparation of the present application can quickly dry dampness, relieve itching, and promote skin lesion healing for the damp-heat invading the skin type of chronic eczema, and has a significant effect.

[0063] Case 2: Rheumatoid arthritis (cold dampness blocking type) Patient condition: Female, 60 years old, joint pain and deformation of both hands for 10 years, aggravated by cold. Symptoms include joint swelling, flexion and extension difficulty, morning stiffness, pale tongue with white and greasy fur, and tight pulse. TCM syndrome differentiation: Cold dampness blocks meridians, and blood circulation is not smooth. The external ointment of Example 1 is used to apply externally on the joint pain of both hands after heating, once a day, and each time lasts for 6 hours.

[0064] Treatment for 7 days (1 week): The degree of joint pain and morning stiffness is reduced.

[0065] Treatment for 15 days (half a month): Joint swelling is significantly subsided, joint mobility is improved, and pain is basically disappeared.

[0066] Efficacy evaluation: Clinical recovery (referring to the disappearance of local symptoms of joints).

[0067] Conclusion: The preparation of Example 1 has the effects of warming meridians, dispelling cold and dampness, and relieving obstruction, which can effectively relieve joint swelling and pain of cold dampness blocking type.

[0068] Case 3: Neurodermatitis (blood deficiency and dryness) Patient condition: Male, 32 years old, thickening and mossification of skin on the neck for 3 years, repeated itching, and aggravated at night. Symptoms include dryness and scales of skin lesions, pale red tongue with little fur, and thin and rapid pulse. TCM syndrome differentiation: Blood deficiency and dryness, and skin malnutrition. The external ointment of Example 3 is used to apply on the affected part of the neck twice a day, and gently massage until absorption.

[0069] Treatment for 1 week: Itching is greatly relieved, and the degree of dry skin is improved.

[0070] Treatment for 2 weeks: The mossification of skin lesions on the neck is thinned and softened, the color is close to normal skin, and itching is disappeared.

[0071] Efficacy evaluation: Clinical recovery.

[0072] Conclusion: The preparation of Example 3 combined with internal treatment method, internal and external treatment, has the effects of nourishing blood, dispelling wind, moisturizing dryness and relieving itching, and has good effect on blood deficiency and dryness type of chronic skin lesions.

[0073] Case 4: Psoriasis in the progressive stage (blood heat and dryness) Patient condition: Female, 28 years old, red patches all over the body and limbs, covered with silver-white scales, severe itching, and aggravated in winter. Accompanied by dry mouth and throat, irritability, red tongue with thin yellow fur, and stringy pulse. TCM syndrome differentiation: blood heat, wind invasion, and skin malnutrition. The external ointment of Example 6 is used for cold compress on the affected area, 2 times a day, 20 minutes each time. After two weeks of treatment, the scales are significantly reduced, the total score is reduced to 6, and the itching score is reduced to 3. After four weeks of treatment, the skin lesions are basically subsided, the itching score is reduced to 1, and the total score is reduced to 0. The efficacy is determined as clinical recovery. The patient is highly satisfied with the efficacy.

[0074] Case 5: Chronic urticaria (wind-cold binding the surface type) Patient condition: Female, 35 years old, recurrent hives with itching for 2 years, aggravated by cold or wind. The hives are white, and the itching score is 7. TCM syndrome differentiation: wind-cold binding the surface, imbalance of Ying and Wei, and skin malnutrition. The external ointment of Example 5 is used for smearing on the affected area, 3 times a day. After 1 week of treatment, the hives are controlled, and no new skin lesions are found. After 1 month of continuous medication, the patient is cured, and no recurrence is found in 1 month of follow-up. The efficacy is determined as clinical recovery.

[0075] Case 6: Eczema (spleen deficiency and dampness) Patient condition: Male, 45 years old, red patches and papules on both lower limbs, accompanied by oozing and itching, aggravated by moisture. The disease has a history of 3 years, and recurrent attacks. The patient has fatigue, poor appetite, and loose and thin stool. The tongue is pale and thick with white and greasy fur, and the pulse is soft and slow. TCM syndrome differentiation: spleen deficiency and dampness, dampness and heat accumulation, and skin imbalance. The external ointment of Example 7 is used, and an appropriate amount is applied to the affected area, 2 times a day, morning and evening.

[0076] After 1 week of treatment: oozing stops, and itching symptoms are reduced.

[0077] After 2 weeks of treatment: red patches and papules gradually subside.

[0078] After 3 weeks of treatment: skin lesions are basically healed, and symptoms such as fatigue and poor appetite are also improved.

[0079] Efficacy determination: clinical recovery.

[0080] Conclusion: The preparation of the present application has the functions of dampness and itching, and spleen invigoration, and is suitable for patients with eczema with prolonged course and spleen deficiency.

[0081] Case 7: Acne (heat in the lung meridian) Patient condition: Female, 19 years old, dense acne on the face, accompanied by red papules and pustules, painful to touch, dry mouth, constipation, red tongue with yellow fur, and floating pulse. TCM syndrome differentiation: heat in the lung meridian, accumulation in the skin, and imbalance of the interstices. The external ointment of Example 4 is used, and an appropriate amount is evenly applied to the face, 1 time in the morning and evening.

[0082] Treatment day 3: Pustules and comedones significantly reduced, and the color of papules became lighter.

[0083] Treatment day 2: Facial inflammatory response was significantly reduced, and only a small amount of new papules were occasionally observed.

[0084] Treatment day 4: Facial lesions were basically eliminated, and the skin was smooth, and no new lesions were observed.

[0085] Efficacy evaluation: clinical cure.

[0086] Conclusion: The preparation of the embodiment of the present application can clear lung meridian wind-heat, effectively inhibit the inflammatory response of the hair follicle, and promote the regression of acne lesions.

[0087] Case 8: Hand and foot tinea (damp-heat downward flowing type) Patient condition: male, 25 years old, redness, blisters and peeling on both hands, soles and interdigital spaces, accompanied by itching and burning sensation, with a history of 1 year, and repeated episodes. Symptoms include dry mouth, yellow urine, red tongue, yellow and greasy fur, and slippery pulse. TCM syndrome: damp-heat downward flowing, accumulating in the skin, and wind invasion. Use the external ointment of Example 10, take an appropriate amount and apply to the affected area, 3 times a day.

[0088] After 3 days of treatment: The blisters gradually subsided, the range of desquamation decreased, and the itching and burning sensation significantly reduced.

[0089] After 1 week of treatment: The lesions were basically eliminated, and the clinical symptoms were almost gone.

[0090] After 2 weeks of treatment: The lesions were completely eliminated, and the skin condition returned to normal. After 2 weeks of follow-up after stopping the drug, no recurrence was observed.

[0091] Efficacy evaluation: clinical cure.

[0092] Conclusion: The preparation of the embodiment of the present application has the effects of clearing heat and drying dampness, killing insects and relieving itching, and has a rapid and stable effect on damp-heat downward flowing type hand and foot tinea.

[0093] The above-described embodiments are part of the embodiments of the present application, but not all. The detailed description of the embodiments of the present application is not intended to limit the scope of the claimed application, but only represents selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative labor are within the scope of protection of the present application.

Claims

1. A traditional Chinese medicine compound composition, characterized in that, By weight, it includes the following ingredients: 4-6 parts of lacquer tree bark, 12-15 parts of dictamnus dasycarpus bark, 7-9 parts of turmeric, 3-5 parts of dodder seed, 4-6 parts of strychnos nux-vomica, 2-4 parts of kochia scoparia fruit, 3-5 parts of asarum, 8-10 parts of angelica sinensis, 8-10 parts of clematis chinensis, 8-10 parts of gentian root, 5-8 parts of evodia rutaecarpa, 4-6 parts of pomegranate seed, 5-7 parts of musk, 4-6 parts of soapberry thorn, 8-10 parts of creeping jenny, and 8-10 parts of stemona japonica.

2. The traditional Chinese medicine compound composition according to claim 1, characterized in that, By weight, it includes the following ingredients: 4 parts of lacquer tree bark, 12 parts of white peony bark, 7 parts of turmeric, 3 parts of dodder seed, 4 parts of galangal root, 2 parts of Kochia scoparia fruit, 3 parts of asarum, 8 parts of angelica sinensis, 8 parts of clematis root, 8 parts of blood-activating herb, 5 parts of evodia fruit, 4 parts of pomegranate seed, 5 parts of musk, 4 parts of soapberry thorn, 8 parts of creeping jenny, and 8 parts of stemona root.

3. A method for preparing a traditional Chinese medicine compound composition as described in any one of claims 1-2, characterized in that, Includes the following steps: S1. Soak the medicinal materials in water at 5-10℃ for 2 hours, and then boil them at 90-95℃ for 4 hours. S2, filter the mixture after boiling in step S1, collect the filtrate and the residue, and treat the residue with ultrasound at a frequency of 20-40kHz and a power of 100-200W for 20-30 minutes; after the ultrasound treatment, use a press to extract a second time at a pressure of 0.3-0.5MPa for 20-30 minutes, combine the two filtrates, and concentrate the liquid to a volume of 1 / 5-1 / 6 of the initial soaking liquid; S3, while stirring at 80°C, add vegetable oil and stir for 40-60 minutes until completely dissolved; then slowly cool to room temperature, fill, sterilize, and seal the packaging.

4. The use of a traditional Chinese medicine compound composition as described in any one of claims 1-2 in the preparation of a drug for dispelling wind, relieving itching, and unblocking meridians.

5. The application according to claim 4, characterized in that, This includes drugs used to prepare treatments for rheumatic pain, pruritus, neurodermatitis, eczema, urticaria, psoriasis, diabetic foot ulcers, and senile dry dermatitis.

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