A traditional Chinese medicine composition for treating acne, its preparation method and application

Abstract

This invention provides a traditional Chinese medicine composition for treating acne, its preparation method, and its application, relating to the field of pharmaceutical technology. The traditional Chinese medicine composition comprises the following components by weight: 330-500 parts of Rehmannia glutinosa (raw), 330-500 parts of processed Polygonum multiflorum (processed), 200-300 parts of Saposhnikovia divaricata (prepared), 270-400 parts of Morus alba (leaf), 130-200 parts of Cicadae periostracum (sloughed), 270-400 parts of Sophora flavescens (prepared), 270-400 parts of Anemarrhena asphodeloides (prepared), and 270-400 parts of Lycium chinense (prepared). This traditional Chinese medicine composition clears heat, nourishes blood and yin, dispels wind and relieves itching. It is used for acne swelling and pain caused by heat toxin accumulation, and for skin itching. Pharmacological experiments show that this traditional Chinese medicine composition has good anti-inflammatory, analgesic, and antipruritic effects, and is used to treat acne.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, specifically relating to a traditional Chinese medicine composition for treating acne, its preparation method, and its application. Background Technology

[0002] Acne is a chronic inflammatory skin disease of the pilosebaceous unit, commonly occurring on the face, chest, and back, affecting appearance. If left untreated, it can lead to localized pigmentation and even scarring, negatively impacting the patient's psychological well-being and social life. While many treatments for acne have been available in the past, their effectiveness has been unsatisfactory. Topical medications such as retinoic acid, benzoyl peroxide, and adapalene are slow to take effect, require long-term use, and are prone to causing local reactions. Oral medications such as antibiotics and compound cyproheptadine acetate tablets have significant side effects and may induce other skin diseases.

[0003] Traditional Chinese medicine has accumulated rich experience in the treatment of acne. For example, Chinese invention patent application CN107296918A discloses a traditional Chinese medicine composition for treating skin itching and acne caused by blood deficiency and wind dryness. The components and their mass proportions of the traditional Chinese medicine composition are as follows: Polygonum multiflorum 100-300g, Schizonepeta tenuifolia 50-120g, processed Polygonum multiflorum 60-150g, Saposhnikovia divaricata 50-120g, Rehmannia glutinosa 90-200g, Scutellaria baicalensis 50-160g. The formula includes 50-120g of mulberry leaves, 80-180g of peony bark, 30-120g of sophora flavescens, 150-250g of red hemp, and 150-650g of smilax glabra. Chinese invention patent CN113577137B discloses a traditional Chinese medicine composition for treating acne, its preparation method, and its application. The composition consists of 20-70 parts of mulberry leaves, 30-80 parts of tribulus terrestris, 10-30 parts of sea buckthorn, and 1-15 parts of sophora flavescens. This formula achieves its therapeutic effect on acne by clearing damp-heat. However, the therapeutic effect of the drugs in the aforementioned patent literature on acne needs further improvement.

[0004] Therefore, there is an urgent need to develop a traditional Chinese medicine composition that is safe and has more significant therapeutic effects for the treatment of acne. Summary of the Invention

[0005] In view of the current status of acne treatment, the present invention provides a traditional Chinese medicine composition for treating acne, consisting of Rehmannia glutinosa, processed Polygonum multiflorum, Saposhnikovia divaricata, Morus alba leaf, Cicadae periostracum, Sophora flavescens, Anemarrhena asphodeloides and Lycium chinense root bark. According to pharmacological experimental results, the traditional Chinese medicine composition of the present invention has anti-inflammatory, analgesic and antipruritic effects and is used to treat acne.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0007] The first aspect of the present invention is to provide a traditional Chinese medicine composition for treating acne, the traditional Chinese medicine composition comprising the following components by weight: 330-500 parts of Rehmannia glutinosa, 330-500 parts of processed Polygonum multiflorum, 200-300 parts of Saposhnikovia divaricata, 270-400 parts of Morus alba leaf, 130-200 parts of Cicadae periostracum, 270-400 parts of Sophora flavescens, 270-400 parts of Anemarrhena asphodeloides, and 270-400 parts of Lycium chinense root bark.

[0008] Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 370-460 parts of Rehmannia glutinosa, 370-460 parts of processed Polygonum multiflorum, 225-275 parts of Saposhnikovia divaricata, 300-370 parts of Morus alba leaf, 150-180 parts of Cicadae periostracum, 300-370 parts of Sophora flavescens, 300-370 parts of Anemarrhena asphodeloides, and 300-370 parts of Lycium chinense root bark.

[0009] Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 420 parts of Rehmannia glutinosa, 420 parts of processed Polygonum multiflorum, 252 parts of Saposhnikovia divaricata, 336 parts of Morus alba leaf, 168 parts of Cicadae periostracum, 336 parts of Sophora flavescens, 336 parts of Anemarrhena asphodeloides, and 336 parts of Lycium chinense root bark.

[0010] Preferably, the traditional Chinese medicine composition further includes pharmaceutically acceptable excipients.

[0011] More preferably, the excipient is selected from at least one of dextrin, maltodextrin, soluble starch, and lactose.

[0012] A second aspect of the present invention is to provide a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following preparation steps:

[0013] (1) Weigh out each medicinal component, add water together and decoct, then filter to obtain the filtrate;

[0014] (2) Concentrate the filtrate and add excipients to obtain the final product.

[0015] Preferably, in step (1), water is added and decocted 1-2 times, with the amount of water added in each decoction being 10-14 times the total amount of medicinal materials, and the decoction time being 0.5-1.5 hours.

[0016] More preferably, in step (1), water is added and decocted twice. The first time, 12 times the amount of water is added and decocted for 1 hour. The second time, 10 times the amount of water is added and decocted for 1 hour. The two decoctions are combined and filtered to obtain filtrate.

[0017] Preferably, in step (2), the filtrate is concentrated to a relative density of 1.05-1.10 (60°C); more preferably 1.06 (60°C).

[0018] Preferably, in step (2), drying and granulation are performed after the addition of excipients.

[0019] A third aspect of the present invention is to provide a formulation comprising the above-described Chinese medicine composition or a Chinese medicine composition prepared according to the above-described preparation method, wherein the dosage form of the formulation is tablet, capsule, granule, ointment, suppository, pill, oral liquid, injection or suspension; preferably granule.

[0020] A fourth aspect of the present invention relates to the use of the above-mentioned traditional Chinese medicine composition or preparations containing the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating acne.

[0021] Compared with the prior art, the present invention has the following beneficial effects: (1) Each component of the traditional Chinese medicine composition of the present invention is a traditional Chinese medicine, and the safety is relatively high; (2) The present invention focuses on acne swelling and pain and skin itching caused by heat toxin accumulation. The heat toxin includes damp heat (damp heat in the lung and stomach, damp heat in the spleen and stomach, damp heat in the liver and gallbladder), wind heat (wind heat in the lung meridian), and deficiency heat (yin deficiency in the liver and kidney, and heat generated by spleen deficiency). It clears heat, nourishes blood and yin, dispels wind and relieves itching, and is used for acne swelling and pain and skin itching caused by heat toxin accumulation; (3) Saposhnikovia divaricata and Cicadae Periostracum, Anemarrhena asphodeloides and Lycium chinense have synergistic effects and have significant effects in treating acne. In the anti-inflammatory, analgesic and antipruritic experiments, the traditional Chinese medicine composition of the present invention is better than each comparative example. Detailed Implementation

[0022] It is worth noting that the raw materials used in this invention are all commercially available products, and their sources are not specifically limited.

[0023] Rehmannia glutinosa (raw): The dried tuberous root of Rehmannia glutinosa Libosch., a plant in the Scrophulariaceae family. Harvested in autumn, the rhizome, fibrous roots, and dirt are removed, and it is slowly baked until about 80% dry. It clears heat and cools the blood, nourishes yin and generates fluids. Used for heat entering the blood level, febrile rashes, hematemesis, epistaxis, yin deficiency due to febrile diseases, red tongue with thirst, constipation due to fluid depletion, yin deficiency fever, steaming bone fever, and internal heat with thirst.

[0024] Saposhnikovia divaricata (Turcz.) Schishk., a plant in the Apiaceae family, is a dried root. The roots are harvested in spring and autumn from plants that have not yet produced flower stalks. The fibrous roots and dirt are removed, and the roots are then sun-dried. It is used to dispel wind and release the exterior, eliminate dampness and relieve pain, and stop spasms. It is used for colds with headaches, rheumatic pain, urticaria with itching, and tetanus.

[0025] Processed Polygonum multiflorum: A processed product of Polygonum multiflorum. Take slices or chunks of Polygonum multiflorum, and according to the stewing method (Chinese Pharmacopoeia 2020 Edition, Part IV, General Chapter 0213), mix with black bean juice, place in a suitable non-ferrous container, and stew until the juice is absorbed; or according to the steaming method (Chinese Pharmacopoeia 2020 Edition, Part IV, General Chapter 0213), steam or mix with black bean juice and steam until both inside and out are brownish-brown, or sun-dry until semi-dry, slice, and dry. It tonifies the liver and kidneys, nourishes essence and blood, blackens hair, strengthens muscles and bones, and clears turbidity and lowers lipids. It is used for blood deficiency and chlorosis, dizziness and tinnitus, premature graying of hair, soreness and weakness of the waist and knees, numbness of limbs, metrorrhagia and leukorrhea, and hyperlipidemia.

[0026] Mulberry leaves: Dried leaves of *Morus alba* L., a plant in the Moraceae family. Harvested after the first frost, impurities are removed, and the leaves are sun-dried. They disperse wind-heat, clear the lungs and moisten dryness, clear the liver and improve eyesight. Used for wind-heat colds, dry cough due to lung heat, dizziness, headache, and red, blurred vision.

[0027] Sophora flavescens Ait. (family Fabaceae): The dried root of Sophora flavescens Ait. Harvested in spring and autumn, the root head and small lateral roots are removed, washed, and dried, or sliced ​​while fresh and then dried. It clears heat and dries dampness, kills parasites, and promotes urination. Used for dysentery, hematochezia, jaundice, urinary retention, leukorrhea, vulvar swelling and itching, eczema, damp sores, pruritus, scabies, and leprosy; externally used to treat trichomonal vaginitis.

[0028] Lycium bark: The dried root bark of Lycium chinense Mill. or Lycium barbarum L., both belonging to the Solanaceae family. The roots are dug up in early spring or late autumn, washed, the bark is peeled off, and then dried. It cools the blood, eliminates steaming heat, clears the lungs, and reduces internal heat. It is used for yin deficiency with tidal fever, night sweats, cough due to lung heat, hemoptysis, epistaxis, and thirst due to internal heat.

[0029] Cicada molts: The exoskeleton shed by the nymphs of the cicada (Cryptotympana pustulata Fabricius) during molting. Collected in summer and autumn, cleaned of dirt and sand, and dried. Used to dispel wind-heat, soothe the throat, promote rash eruption, improve eyesight and clear corneal opacity, and relieve spasms. Indications include wind-heat colds, sore throat and hoarseness, incomplete measles eruption, itchy rashes, red and pterygium eyes, infantile convulsions, and tetanus.

[0030] Anemarrhena asphodeloides Bge., a plant in the Liliaceae family, is a dried rhizome. It is harvested in spring and autumn, the fibrous roots and soil are removed, and it is sun-dried, commonly known as "hairy Anemarrhena"; alternatively, the outer skin can be removed and it is sun-dried. It clears heat and purges fire, nourishes yin and moistens dryness. It is used for exogenous febrile diseases, high fever and thirst, dry cough due to lung heat, steaming bone fever, internal heat and thirst, and constipation due to intestinal dryness.

[0031] In this invention's herbal composition, Rehmannia glutinosa (raw) is sweet and cold in nature, clearing heat and cooling blood, nourishing yin and generating fluids, making it a key herb for heat entering the blood level. In this formula, it nourishes blood and yin, serving as the principal herb. Processed Polygonum multiflorum (prepared) tonifies the liver and kidneys, replenishes essence and blood, assisting the principal herb as the assistant herb. Saposhnikovia divaricata (foreign wind), Morus alba (mulberry leaf), and Cicadae periostracum (cicadae periostracum) are light and dispersing, dispelling wind and moistening dryness, promoting rash eruption and relieving itching. Sophora flavescens (sophora flavescens) and Anemarrhena asphodeloides (anemarrhena asphodeloides) clear heat and dry dampness, purge fire and strengthen yin. Lycium chinense (digupi) clears the lungs and cools blood, reduces fire and fever, assisting the principal and assistant herbs as adjuvant herbs. All these herbs work together to clear heat, nourish blood and yin, dispel wind and relieve itching.

[0032] Example 1

[0033] Components: 330 parts of raw Rehmannia glutinosa, 500 parts of processed Polygonum multiflorum, 200 parts of Saposhnikovia divaricata, 270 parts of mulberry leaf, 200 parts of cicada slough, 400 parts of Sophora flavescens, 270 parts of Anemarrhena asphodeloides, and 400 parts of Lycium chinense root bark.

[0034] Example 2

[0035] 500 parts of raw Rehmannia glutinosa, 330 parts of processed Polygonum multiflorum, 300 parts of Saposhnikovia divaricata, 400 parts of mulberry leaf, 130 parts of cicada slough, 270 parts of Sophora flavescens, 400 parts of Anemarrhena asphodeloides, and 270 parts of Lycium chinense root bark.

[0036] Example 3

[0037] 370 parts of raw Rehmannia glutinosa, 370 parts of processed Polygonum multiflorum, 275 parts of Saposhnikovia divaricata, 300 parts of mulberry leaf, 150 parts of cicada slough, 300 parts of Sophora flavescens, 370 parts of Anemarrhena asphodeloides, and 370 parts of Lycium chinense root bark.

[0038] Example 4

[0039] 460 parts of raw Rehmannia glutinosa, 460 parts of processed Polygonum multiflorum, 225 parts of Saposhnikovia divaricata, 370 parts of mulberry leaf, 180 parts of cicada slough, 370 parts of Sophora flavescens, 300 parts of Anemarrhena asphodeloides, and 300 parts of Lycium chinense root bark.

[0040] Example 5

[0041] 420 parts of raw Rehmannia glutinosa, 420 parts of processed Polygonum multiflorum, 252 parts of Saposhnikovia divaricata, 336 parts of mulberry leaf, 168 parts of cicada slough, 336 parts of Sophora flavescens, 336 parts of Anemarrhena asphodeloides, and 336 parts of Lycium chinense root bark.

[0042] Comparative Example 1

[0043] 200 parts of raw Rehmannia glutinosa, 650 parts of processed Polygonum multiflorum, 252 parts of Saposhnikovia divaricata, 336 parts of mulberry leaf, 50 parts of cicada slough, 336 parts of Sophora flavescens, 600 parts of Anemarrhena asphodeloides, and 150 parts of Lycium chinense root bark.

[0044] Comparative Example 2

[0045] 420 parts of raw Rehmannia glutinosa, 420 parts of processed Polygonum multiflorum, 420 parts of Saposhnikovia divaricata, 336 parts of mulberry leaf, 336 parts of Sophora flavescens, 336 parts of Anemarrhena asphodeloides, and 336 parts of Lycium chinense root bark.

[0046] Comparative Example 3

[0047] 420 parts of raw Rehmannia glutinosa, 420 parts of processed Polygonum multiflorum, 336 parts of mulberry leaf, 420 parts of cicada slough, 336 parts of Sophora flavescens, 336 parts of Anemarrhena asphodeloides, and 336 parts of Lycium chinense root bark.

[0048] Comparative Example 4

[0049] 420 parts of raw Rehmannia glutinosa, 420 parts of processed Polygonum multiflorum, 252 parts of Saposhnikovia divaricata, 336 parts of mulberry leaf, 168 parts of cicada slough, 336 parts of Sophora flavescens, and 672 parts of Lycium chinense root bark.

[0050] Comparative Example 5

[0051] 420 parts of raw Rehmannia glutinosa, 420 parts of processed Polygonum multiflorum, 252 parts of Saposhnikovia divaricata, 336 parts of mulberry leaf, 168 parts of cicada slough, 336 parts of Sophora flavescens, and 672 parts of Anemarrhena asphodeloides.

[0052] Preparation method: The medicinal materials of Examples 1-5 and Comparative Examples 1-5 were decocted twice with water. The first decoction was prepared with 12 times the amount of water for 1.0 hour, and the second decoction was prepared with 10 times the amount of water for 1.0 hour. The decoctions were filtered, and the filtrates were combined and concentrated under reduced pressure to a clear extract with a relative density of 1.06 (60℃). An appropriate amount of dextrin was added, mixed well, and dried. Then, an appropriate amount of dextrin was added again, mixed well, and granulated to obtain the granules of Examples 1-5 and Comparative Examples 1-5. Distilled water was used for dissolution in the following pharmacological experiments.

[0053] Experimental Example 1: Anti-inflammatory effect of the herbal composition of the present invention

[0054] SD rats, weighing 200±20g, were selected, with half male and half female. Each rat was injected intradermally with 100μL of Propionibacterium acnes (concentration 6×10⁻⁶) into the right ear. 7 The rats were successfully modeled when they received a 14-day injection of Propionibacterium acnes (CFU / mL) once daily. The rats showed obvious redness, swelling, hardening, thickening, and pimple-like protrusions in the auricle on the side injected with the propionibacterium.

[0055] One hundred and twenty rats that successfully developed the model were randomly divided into a model group, a positive control group, Example 1-5 groups, and Comparative Example 1-5 groups, with ten rats in each group. Ten healthy rats were used as a blank control group. Example 1-5 groups and Comparative Example 1-5 groups were administered the corresponding granules by gavage at a dose of 8.5 g crude drug / kg and a volume of 20 mL / kg. The positive control group was administered isotretinoin soft capsules by gavage at a concentration of 3.125 mg / mL and a volume of 20 mL / kg. The model group and blank control group were administered the same volume of distilled water by gavage once a day for 14 consecutive days.

[0056] After a 24-hour fasting period with no restriction on water intake following the last administration of medication, rats in each group were anesthetized with 10% chloral hydrate. Blood was collected from the abdominal aorta, allowed to stand at room temperature for 4 hours, and then centrifuged at 3500 rpm for 15 minutes at 4°C. The supernatant was collected, and the levels of TNF-α and IL-6 in rat serum were detected by enzyme-linked immunosorbent assay (ELISA). The results are shown in Table 1.

[0057] Table 1. Effects of the herbal composition of the present invention on the levels of TNF-α and IL-6 in rat serum.

[0058]

[0059]

[0060] Note: Compared with the blank control group, ** P < 0.01; compared with the model group, #P < 0.05 ## P < 0.01; compared with Example 5 group, △ P < 0.05.

[0061] The data in the table show that, compared with the blank control group, the serum levels of TNF-α and IL-6 in the model group rats were significantly increased, indicating successful model establishment. Compared with the model group, all treatment groups could reduce the serum levels of TNF-α and IL-6 in the model rats, but the reduction in serum TNF-α and IL-6 levels in the positive control group and groups 1-5 was more significant than that in groups 1-5. Compared with group 5, the differences in serum TNF-α and IL-6 levels in groups 1-5 were statistically significant. The effect of group 5 in reducing serum TNF-α and IL-6 levels in the model rats was comparable to that of the positive control group.

[0062] Experimental Example 2: Analgesic effect of the herbal composition of the present invention

[0063] One hundred and ten Kunming mice, half male and half female, weighing 20±2g, were randomly divided into 11 groups of 10 mice each: blank control group, Example 1-5 groups, and Comparative Example 1-5 groups.

[0064] After 3 days of acclimatization, mice in each group were administered the drug via gavage. Groups 1-5 of Examples and Groups 1-5 of Comparative Examples were given the corresponding granules at a dose of 13 g crude drug / kg, with a volume of 0.2 mL / 10 g. The blank control group was given an equal volume of distilled water via gavage. Two hours after administration, each mouse was injected intraperitoneally with 0.2 mL of 0.5% glacial acetic acid. The number of writhing episodes and the latency period of writhing in each group were observed within 10 minutes. The results are shown in Table 2.

[0065] Table 2. Results of the analgesic effect of the traditional Chinese medicine composition of the present invention.

[0066]

[0067]

[0068] Note: Compared with the blank control group, * P < 0.05 ** P < 0.01; compared with Example 5 group, △ P < 0.05.

[0069] According to the analgesic results, compared with the blank control group, all drug administration groups can reduce the number of writhing movements in mice and prolong the latency period of writhing movements. Compared with the group in Example 5, the effects of comparative groups 2-5 are statistically significant. The effect of Example 5 in reducing the number of writhing movements in mice and prolonging the latency period of writhing movements is significantly better than that of comparative groups 2-5.

[0070] Experimental Example 3: Antipruritic effect of the herbal composition of the present invention

[0071] One hundred and ten Kunming mice, half male and half female, weighing 20±2g, were randomly divided into 11 groups of 10 mice each: blank control group, Example 1-5 groups, and Comparative Example 1-5 groups.

[0072] After 3 days of acclimatization, mice in each group were administered the drug via gavage. Groups 1-5 of Examples and Groups 1-5 of Comparative Examples were given the corresponding granules at a dose of 13 g crude drug / kg, with a volume of 0.2 mL / 10 g. The blank control group was given an equal volume of distilled water via gavage. The administration was once daily for 7 consecutive days. One hour after the last administration, dextran-40 was injected intravenously into the tail vein of each group at a dose of 1.25 mg / kg.

[0073] Scratching of the head with the forepaws, scratching of the trunk with the hindaws, and biting of various parts of the body by mice were used as indicators of itch. The itch latency, the number of times mice itch within 30 minutes, and the duration of itch were observed and recorded. The results are shown in Table 3.

[0074] Itching incubation period: the time from the end of dextran-40 injection to the onset of the first scratch.

[0075] Number of scratching events: The number of times mice scratched within 30 minutes after the injection of dextran-40.

[0076] Duration of itching: The sum of the duration of each scratching session within 30 minutes after the injection of dextran-40.

[0077] Table 3 Results of the antipruritic effect of the traditional Chinese medicine composition of the present invention

[0078]

[0079]

[0080] Note: Compared with the blank control group, * P < 0.05 ** P < 0.01; compared with Example 5 group, △ P < 0.05 △△ P < 0.01.

[0081] Based on the above results, compared with the blank control group, all drug administration groups could prolong the itch latency period, reduce the frequency of itch, and shorten the duration of itch. However, there was no statistically significant difference in the prolongation of the itch latency period between comparative groups 1-5 and the blank control group, and there was no statistically significant difference in the reduction of the frequency of itch and the shortening of the duration of itch between comparative groups 2-5 and the blank control group. Compared with the group in Example 5, the effects of comparative groups 1-5 were significantly different.

[0082] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A traditional Chinese medicine composition for treating acne, characterized in that, The traditional Chinese medicine composition is prepared by weight of the following components: 330-500 parts of Rehmannia glutinosa, 330-500 parts of processed Polygonum multiflorum, 200-300 parts of Saposhnikovia divaricata, 270-400 parts of Morus alba leaf, 130-200 parts of Cicadae periostracum, 270-400 parts of Sophora flavescens, 270-400 parts of Anemarrhena asphodeloides, and 270-400 parts of Lycium chinense root bark.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared by weight of the following components: 370-460 parts of Rehmannia glutinosa, 370-460 parts of processed Polygonum multiflorum, 225-275 parts of Saposhnikovia divaricata, 300-370 parts of Morus alba leaf, 150-180 parts of Cicadae periostracum, 300-370 parts of Sophora flavescens, 300-370 parts of Anemarrhena asphodeloides, and 300-370 parts of Lycium chinense root bark.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following components by weight: 420 parts of Rehmannia glutinosa, 420 parts of processed Polygonum multiflorum, 252 parts of Saposhnikovia divaricata, 336 parts of Morus alba leaf, 168 parts of Cicadae periostracum, 336 parts of Sophora flavescens, 336 parts of Anemarrhena asphodeloides, and 336 parts of Lycium chinense root bark.

4. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The traditional Chinese medicine composition is further supplemented with pharmaceutically acceptable excipients.

5. The traditional Chinese medicine composition according to claim 4, characterized in that, The excipients are selected from at least one of dextrin, maltodextrin, soluble starch and lactose.

6. A method for preparing a traditional Chinese medicine composition according to any one of claims 1-5, characterized in that, The preparation steps include the following: (1) Weigh each medicinal component, add water together and decoct, then filter to obtain the filtrate; (2) Concentrate the filtrate and add excipients to obtain the final product.

7. The preparation method according to claim 6, characterized in that, In step (1), water is added and decocted 1-2 times. The amount of water added for each decoction is 10-14 times the total amount of medicinal materials, and the decoction time for each decoction is 0.5-1.5 hours.

8. The preparation method according to claim 6, characterized in that, The relative density of the filtrate concentrated to 60°C in step (2) is 1.05-1.

10.

9. The use of a traditional Chinese medicine composition according to any one of claims 1-5 or a traditional Chinese medicine composition prepared by the preparation method according to any one of claims 6-8 in the preparation of a drug for treating acne.

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