Traditional Chinese medicine composition for preventing and / or treating inflammatory skin diseases and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for preventing and / or treating inflammatory skin diseases and application thereof.The traditional Chinese medicine composition is composed of Sichuan rhizoma coptidis, Sichuan cortex phellodendri, scutellaria baicalensis and betel nuts, the Sichuan cortex phellodendri serves as a monarch drug to clear away heat and dry dampness, purge fire to remove toxin and astringe dampness and heal sores, the Sichuan rhizoma coptidis, the scutellaria baicalensis and the betel nuts serve as ministerial drugs, the Sichuan rhizoma coptidis purges fire to remove toxin and directly fold heat toxin, and the Sichuan cortex phellodendri and the betel nuts serve as monarch drugs. Baikal skullcap root is used for clearing heat, drying dampness, cooling blood and detoxifying, rhizoma coptidis from Sichuan of China and baikal skullcap root are cooperated with monarch drugs to strengthen the effects of eliminating dampness and detoxifying, betel nut is used for promoting the circulation of qi, promoting urination, helping rhizoma coptidis from Sichuan of China, baikal skullcap root and golden cypress to dredge damp evil and relieve swelling and exudation, and the pungent and divergent properties of betel nut can slightly prevent excessive stasis of drug properties, facilitate penetration of drug properties to skin, kill parasites to relieve itching and directly relieve itching caused by insect epidemic. According to the traditional Chinese medicine composition, only four medicines are combined, the composition is simple, all the medicines have a synergistic effect, damp-heat toxin can be attacked by drying, clearing, benefiting and killing, pathogenic factors can be strongly removed, and skin diseases such as acute eczema, impetigo and contact dermatitis can be effectively treated.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, and in particular to a traditional Chinese medicine composition for the prevention and / or treatment of inflammatory skin diseases and its application. Background Technology

[0002] Acute eczema, impetigo, and contact dermatitis are common inflammatory skin diseases. These skin diseases all exhibit skin lesions and a tendency to ooze. For example, eczema patients present with symmetrical rashes, intense itching, and polymorphic lesions, mainly manifesting as papules, vesicles, erosions, and scaling. It is caused by multiple factors, including abnormal immune function, impaired skin barrier function, genetics, and environmental factors. In modern medicine, the main treatments for acute eczema, impetigo, and contact dermatitis are antihistamines and topical corticosteroids. However, long-term use can easily cause various adverse reactions. Relapse is common after discontinuation of medication, and long-term use increases the risk of skin pigmentation, skin atrophy, and even serious side effects such as folliculitis. Traditional Chinese medicine (TCM) treatment for eczema has unique advantages of simplicity and affordability. However, some TCM herbs have many complex compositions and unclear pharmacology, which may not only result in unsatisfactory efficacy but also increase treatment costs. Summary of the Invention

[0003] Therefore, based on the above background, the present invention provides a traditional Chinese medicine composition for the prevention and / or treatment of inflammatory skin diseases and its application. The composition of the medicine is simple, and it can not only effectively treat skin diseases such as acute eczema, impetigo, and contact dermatitis, but also has low treatment costs.

[0004] The technical solution provided by this invention is as follows:

[0005] A traditional Chinese medicine composition for the prevention and / or treatment of inflammatory skin diseases, comprising, by weight, the following raw materials:

[0006] 15-35 parts of Coptis chinensis, 180-300 parts of Phellodendron chinense, 100-320 parts of Scutellaria baicalensis, and 70-120 parts of Areca catechu.

[0007] Preferably, by weight, it consists of the following raw materials:

[0008] 20-30 parts of Coptis chinensis, 200-280 parts of Phellodendron chinense, 120-160 parts of Scutellaria baicalensis, and 90-110 parts of Areca catechu.

[0009] Preferably, by weight, it consists of the following raw materials:

[0010] 24 parts of Coptis chinensis, 240 parts of Phellodendron chinense, 144 parts of Scutellaria baicalensis, and 96 parts of Areca catechu.

[0011] Preferably, by weight, it consists of the following raw materials:

[0012] 30 parts of Coptis chinensis, 260 parts of Phellodendron chinense, 135 parts of Scutellaria baicalensis, and 90 parts of Areca catechu.

[0013] Based on the same inventive concept, the present invention also provides the application of the above-mentioned traditional Chinese medicine composition for the prevention and / or treatment of inflammatory skin diseases in the preparation of a topical medicine for treating skin diseases.

[0014] Furthermore, the skin conditions include acute eczema, impetigo, and contact dermatitis.

[0015] Furthermore, the drug uses the extract or extract prepared from the above-mentioned traditional Chinese medicine composition as its active ingredient.

[0016] Furthermore, the extract is prepared by extracting the above-mentioned traditional Chinese medicine composition with a solvent;

[0017] The extract is prepared by extracting the above-mentioned traditional Chinese medicine composition with a solvent to obtain an extract, and then concentrating and drying the extract.

[0018] Furthermore, the solvent is selected from water, ethanol, an aqueous solution of ethanol, or vegetable oil.

[0019] Based on the same inventive concept, the present invention also provides a medicated ointment for the prevention and / or treatment of skin diseases, the preparation of which includes the following steps:

[0020] 1) Take the raw materials according to the dosage of the traditional Chinese medicine composition described above;

[0021] 2) After mixing all the raw materials, immerse them in vegetable oil, steam them for 40-75 minutes, filter them, and take the filtered oil.

[0022] 3) While stirring, slowly add the filtered oil to the heated, liquid plaster base. Once cooled, it is ready.

[0023] The common pathogenesis of skin diseases such as acute eczema, impetigo, and contact dermatitis is internal damp-heat accumulation in the skin, accompanied by toxic pathogens or insect infestation. This invention rationally formulates a prescription based on this pathogenesis. Phellodendron bark is the principal herb, clearing heat and drying dampness, purging fire and detoxifying, and astringing and healing sores. Coptis root, Scutellaria root, and areca nut are the assistant herbs. Coptis root purges fire and detoxifies, directly counteracting heat toxins; Scutellaria root clears heat and dries dampness, cools the blood and detoxifies; Coptis root and Scutellaria root work synergistically with the principal herb to enhance the drying and detoxifying effects; areca nut promotes qi circulation and diuresis. This invention helps to clear away dampness and reduce swelling and exudation by using Coptis chinensis, Scutellaria baicalensis, and Phellodendron chinense. Their pungent and dispersing properties can also prevent the medicine from becoming too stagnant, allowing the medicine to penetrate the skin more effectively. They also kill parasites and relieve itching, directly alleviating itching caused by parasites. This invention uses only four herbs in its formula, which is simple in composition. The herbs work synergistically to effectively attack damp-heat toxins and eliminate pathogenic factors through drying, clearing, draining, and killing. It can effectively treat skin diseases such as acute eczema, impetigo, and contact dermatitis. Detailed Implementation

[0024] 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 clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0025] Example 1: A traditional Chinese medicine composition for the prevention and / or treatment of inflammatory skin diseases, comprising, by weight, the following raw materials:

[0026] 24 parts of Coptis chinensis, 240 parts of Phellodendron chinense, 144 parts of Scutellaria baicalensis, and 96 parts of Areca catechu.

[0027] Example 2: A traditional Chinese medicine composition for the prevention and / or treatment of inflammatory skin diseases, comprising, by weight, the following raw materials:

[0028] 30 parts of Coptis chinensis, 260 parts of Phellodendron chinense, 135 parts of Scutellaria baicalensis, and 90 parts of Areca catechu.

[0029] In specific applications, the traditional Chinese medicine compositions of Examples 1 and 2 can be directly pulverized and used as powder; or they can be pulverized and added to a plaster base, such as melted petrolatum, to prepare a plaster, or they can be mixed with water or vinegar to form a suspension for use.

[0030] It can also be prepared into an ointment for use using the following steps:

[0031] 1) Take the raw materials according to the specified quantities;

[0032] 2) After mixing all the ingredients, immerse them in camellia oil (enough to submerge them), steam over water for 40-75 minutes, filter, and take the filtered oil.

[0033] 3) Under stirring conditions, with a weight ratio of 1:4 between filtered oil and petroleum jelly, slowly add the filtered oil to the heated petroleum jelly, which is now in a liquid state. After it cools down, it is ready.

[0034] In practical applications, beeswax can be used as a substitute for petroleum jelly.

[0035] Comparative Example 1: A traditional Chinese medicine composition for the prevention and / or treatment of inflammatory skin diseases, comprising, by weight, the following raw materials:

[0036] 24 portions of Coptis chinensis, 384 portions of Scutellaria baicalensis, and 96 portions of Areca catechu.

[0037] Compared to Example 1, this comparative example replaces Phellodendron bark with Scutellaria baicalensis, which also has the effect of clearing heat and drying dampness.

[0038] Comparative Example 2: A traditional Chinese medicine composition for the prevention and / or treatment of inflammatory skin diseases, comprising, by weight, the following raw materials:

[0039] 240 samples of Phellodendron bark, 168 samples of Scutellaria baicalensis, and 96 samples of Areca catechu.

[0040] Compared to Example 1, this comparative example replaces Coptis chinensis with Scutellaria baicalensis, which also has the effect of clearing heat and drying dampness.

[0041] Comparative Example 3: A traditional Chinese medicine composition for the prevention and / or treatment of inflammatory skin diseases, comprising, by weight, the following raw materials:

[0042] 24 parts of Coptis chinensis, 240 parts of Phellodendron chinense, 144 parts of Scutellaria baicalensis, and 96 parts of Sophora flavescens.

[0043] Compared to Example 1, this comparative example replaces areca nut with Sophora flavescens, which has the same effects.

[0044] Comparative Examples 1 to 3 were prepared in the same manner as in Examples 1 and 2.

[0045] Sixty adult mice from Kunming were purchased, half male and half female. After one week of acclimatization feeding, they were randomly divided into 6 groups of 10 mice each: blank group, model group, example group, comparative example 1 group, comparative example 2 group, and comparative example 3 group.

[0046] One day before the eczema model was established, the backs of mice were shaved (2cm×2cm). On the day of the experiment, except for the control group, the mice in the other groups were sensitized by applying 100μl of 5% DNCB solution (acetone-olive oil mixed in a volume ratio of 4:1) to the shaved area and 25μl to the right ear. The control group mice were sensitized by applying an equal amount of acetone-olive oil solution. On days 6, 9, 12, and 15 of the experiment, the same area and dose of 7% DNCB solution (acetone-olive oil mixed in a volume ratio of 4:1) were applied to challenge the mice. The control group was sensitized by applying an equal amount of acetone-olive oil solution. If obvious swelling, redness, papules, itching, etc. appeared on the skin of the back and right ear of the mice, it indicated that the model was successfully established.

[0047] Starting from day 6 of the experiment, apply the corresponding ointment to the stimulated area daily:

[0048] Specifically, the blank group and the model group did not apply the drug, the example group applied the ointment prepared in Example 1 daily, the comparative example 1 group applied the ointment prepared in Comparative Example 1 daily, the comparative example 2 group applied the ointment prepared in Comparative Example 2 daily, and the comparative example 3 group applied the ointment prepared in Comparative Example 2 daily.

[0049] After 14 consecutive days of application, samples were taken 24 hours after the last administration to test various indicators.

[0050] 1) Skin score for back lesions:

[0051] Starting from day 6 of the experiment, the skin lesions on the backs of mice in each group were observed and photographed 24 hours after each stimulation. The results were scored according to Table 1 below, and the results are shown in Table 2.

[0052] Table 1: Skin Lesion Scoring Criteria

[0053]

[0054] Table 2: Skin lesion scores of mice in each group ( n=10)

[0055] Grouping First rating Second rating Third rating Fourth rating Blank group 0.00±0.00 0.00±0.00 0.00±0.00 0.00±0.00 control group 1.94±0.31 2.09±0.20 2.40±0.57 2.88±0.42 Example group 1.90±0.49 1.68±0.29 1.42±0.64 1.19±0.41 Comparative Example 1 1.87±0.38 1.78±0.54 1.70±0.25 1.43±0.51 Comparative Example 2 1.96±0.50 1.72±0.42 1.63±0.30 1.30±0.27 Comparative Example 3 Groups 1.89±0.41 1.81±0.17 1.74±0.44 1.57±0.33

[0056] As shown in Table 2 above, the skin lesions in the treatment group were significantly reduced. However, if other drugs were used to replace Phellodendron bark and Areca nut, the effect of reducing skin lesions was poor, especially when Areca nut was replaced with Sophora flavescens, which has the same effect.

[0057] 2) Ear swelling degree

[0058] After the treatment cycle was completed, ear patches of equal area were punched in the same location on both ears of the mice using a 6mm diameter punch. The ear patches were removed and weighed, and the degree of ear swelling was determined by the weight difference between the left and right ears. The results are shown in Table 3.

[0059] Table 3: Swelling degree in mice

[0060] Grouping Left ear weight weight of right ear ear swelling Blank group 9.28±1.01 9.41±1.17 0.15±0.16 control group 9.16±0.83 28.16±1.88 19.98.±1.05 Example group 9.31±1.65 17.64±0.98 7.83±0.67 Comparative Example 1 9.14±1.60 22.69±1.76 13.55±0.16 Comparative Example 2 8.99±1.04 19.77±2.45 10.78±1.41 Comparative Example 3 Groups 9.02±1.44 25.44±2.01 16.42±0.57

[0061] The example group showed a significant inhibitory effect on ear swelling induced by DNCB in mice with eczema, while the inhibitory effect decreased significantly after replacing areca nut with sophora flavescens.

[0062] Retrospective Case Study:

[0063] The present invention was used to treat 25 patients with acute eczema, including 10 males and 15 females; 27 patients with impetigo, including 16 males and 11 females; and 31 patients with contact dermatitis, including 14 males and 17 females.

[0064] All patients were treated with the ointment prepared in Example 1, applied to the affected area at least twice daily, with each application thick enough to be invisible to the skin. The efficacy was assessed after 7 consecutive days of treatment. Treatment was discontinued once the criteria for complete recovery were met.

[0065] The efficacy criteria for acute eczema:

[0066] Efficacy was assessed according to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines: Trial Implementation," with the following scores: Erythema: 0 (none), 2 (light red), 4 (red), 6 (deep red); Papules / Papillomas / Vessicles: 0 (none), 2 (few), 4 (moderate), 6 (excessive); Erosion: 0 (none), 2 (mild), 4 (moderate), 6 (severe); Exudation / Crusting / Scaling: 0 (none), 2 (few), 4 (moderate), 6 (excessive); Lesion Area: 0 (none), 2 (small), 4 (moderate), 6 (large); Pruritus: 0 (none), 2 (mild), 4 (moderate), 6 (severe).

[0067] Cure: Symptoms have basically disappeared, and the score has decreased by ≥95%;

[0068] Significantly effective: Symptoms are significantly improved, and the score is reduced by 70% to 95%;

[0069] Effective: Symptoms improved, and scores decreased by 30% to 70%.

[0070] Ineffective: No improvement in symptoms, score reduction <30%.

[0071] Effectiveness rate = (cured + significantly effective + effective) * 100% / / Total number of cases.

[0072] According to the above efficacy criteria, 9 patients with acute eczema were cured, 7 showed significant improvement, 8 showed improvement, and 1 showed no improvement, with an effective rate of 96%.

[0073] Efficacy criteria for impetigo:

[0074] Complete recovery: All pustules on the affected area disappear, the surface is smooth after the scab falls off, and no new pustules appear;

[0075] Effective: More than 50% of the pustules on the affected area have disappeared, and no new pustules have appeared;

[0076] Ineffective: Less than 50% of the pustules on the affected area have disappeared, and new pustules have appeared.

[0077] Effectiveness rate = (cured + effective) * 100% / total number of cases.

[0078] According to the above efficacy criteria, 7 patients with impetigo were cured, 15 patients showed improvement, and 5 patients showed no improvement, with an effective rate of 81.48%.

[0079] Criteria for the treatment of contact dermatitis (based on skin lesion scoring according to Table 1):

[0080] Cure: Clinical symptoms and signs have basically disappeared, and the skin lesion score has decreased by ≥95%;

[0081] Significant improvement: Clinical symptoms and signs are significantly improved, and the skin lesion score is reduced by ≥70% but <95%;

[0082] Effective: Clinical symptoms and signs slightly improved, and skin lesion scores decreased by ≥30% but <70%;

[0083] Invalid: Those that do not meet the above standards or have deteriorated.

[0084] Overall effective rate = (number of cured cases + number of cases with significant improvement + number of cases with improvement) * 100% / total number of cases.

[0085] According to the above efficacy criteria, 6 patients with contact dermatitis were cured, 8 showed significant improvement, 12 showed improvement, and 5 showed no improvement, with an effective rate of 83.87%.

[0086] For patients whose treatment is ineffective, the use of this invention should be discontinued. For patients with significant improvement, the use of this invention should continue. For patients with improvement, after evaluation, some patients should continue treatment with this invention, while others should discontinue treatment with this invention.

[0087] The present invention and its embodiments have been described above. This description is not restrictive, and the embodiments shown are only one of the embodiments of the present invention. The actual structure is not limited to this. In conclusion, if those skilled in the art are inspired by this description and design similar structures and embodiments without departing from the spirit of the present invention, they should all fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for the prevention and / or treatment of inflammatory skin diseases, characterized in that, By weight, it consists of the following raw materials: 15-35 parts of Coptis chinensis, 180-300 parts of Phellodendron chinense, 100-320 parts of Scutellaria baicalensis, and 70-120 parts of Areca catechu.

2. The traditional Chinese medicine composition for the prevention and / or treatment of inflammatory skin diseases according to claim 1, characterized in that, By weight, it consists of the following raw materials: 20-30 parts of Coptis chinensis, 200-280 parts of Phellodendron chinense, 120-160 parts of Scutellaria baicalensis, and 90-110 parts of Areca catechu.

3. The traditional Chinese medicine composition for the prevention and / or treatment of inflammatory skin diseases according to claim 2, characterized in that, By weight, it consists of the following raw materials: 24 parts of Coptis chinensis, 240 parts of Phellodendron chinense, 144 parts of Scutellaria baicalensis, and 96 parts of Areca catechu.

4. The traditional Chinese medicine composition for the prevention and / or treatment of inflammatory skin diseases according to claim 2, characterized in that, By weight, it consists of the following raw materials: 30 parts of Coptis chinensis, 260 parts of Phellodendron chinense, 135 parts of Scutellaria baicalensis, and 90 parts of Areca catechu.

5. The use of the traditional Chinese medicine composition for the prevention and / or treatment of inflammatory skin diseases according to any one of claims 1 to 4 in the preparation of a topical medicine for treating skin diseases.

6. The application according to claim 5, characterized in that, The inflammatory skin diseases mentioned include acute eczema, impetigo, and contact dermatitis.

7. The application according to claim 5 or 6, characterized in that, The drug is prepared using an extract or extract obtained from the traditional Chinese medicine composition according to any one of claims 1 to 4 as the active ingredient.

8. The application according to claim 7, characterized in that, The extract is prepared by extracting the traditional Chinese medicine composition according to any one of claims 1 to 4 using a solvent; The extract is prepared by extracting the traditional Chinese medicine composition according to any one of claims 1 to 4 with a solvent to obtain an extract, and then concentrating and drying the extract.

9. The application according to claim 8, characterized in that, The solvent may be water, ethanol, an aqueous solution of ethanol, or vegetable oil.

10. A medicated ointment for the prevention and / or treatment of inflammatory skin diseases, characterized in that, Its preparation includes the following steps: 1) The raw materials are taken from the traditional Chinese medicine composition according to any one of claims 1 to 4; 2) After mixing all the raw materials, immerse them in vegetable oil, steam them for 40-75 minutes, filter them, and take the filtered oil. 3) While stirring, slowly add the filtered oil to the heated, liquid plaster base. Once cooled, it is ready.

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