Preparation method and application of traditional Chinese medicine compound preparation for treating acne

Abstract

The invention discloses a preparation method and application of a traditional Chinese medicine compound preparation for treating acne, and relates to the technical field of traditional Chinese medicine preparations. Comprising 12 kinds of coptis chinensis, rheum officinale, scutellaria baicalensis, radix sophorae flavescentis, honeysuckle, dandelion, selfheal, rhizoma anemarrhenae, salvia miltiorrhiza, clove, pepper and pomegranate rind. The traditional Chinese medicine composition comprises the following components in parts by weight: 1-2 parts of coptis chinensis, 3-5 parts of rheum officinale, 1-3 parts of scutellaria baicalensis, 1-3 parts of radix sophorae flavescentis, 3-5 parts of honeysuckle, 3-5 parts of dandelion, 3-5 parts of selfheal, 2-4 parts of rhizoma anemarrhenae, 3-5 parts of salvia miltiorrhiza, 0.5-1.5 parts of clove, 1-2 parts of pepper and 1-3 parts of pomegranate rind. The traditional Chinese medicine compound preparation has the effects of clearing away heat and toxic materials, diminishing swelling and removing stasis, removing acnes and inhibiting bacteria. The traditional Chinese medicine composition for treating acne has the advantages of being safe, good in effect and convenient to use when being used for treating acne.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine compound preparation for treating acne. Background Art

[0002] Acne, also known as pimples, is a common chronic inflammatory skin disease involving the hair follicles and sebaceous glands. Western medicine believes that the disease is related to androgens, excessive keratinization of the hair follicles and sebaceous gland ducts, the proliferation of Propionibacterium acnes, inflammation and immune response. Traditional Chinese medicine believes that the onset of acne is mostly related to endogenous dampness and heat and exogenous six evil spirits. It is prone to occur on the head, face, chest and back, and often recurs, mainly manifested as skin lesions such as acne, papules, pustules, and cysts. If not properly treated, it is easy to leave erythema, pigmentation and scars, which will have adverse effects on the physical and mental health of patients. Western medicine often uses topical drugs as the basic treatment for mild acne, while moderate and severe acne is treated with systemic drugs and supplemented with topical drugs. Although it has a certain effect, it has disadvantages such as large adverse reactions, drug resistance, and easy recurrence after stopping the drug. Traditional Chinese medicine treats acne mainly based on the syndrome differentiation and treatment of the type of acne. In clinical practice, it is often combined with oral administration and external treatment. The treatment of acne with Chinese herbal decoctions is mainly based on the lung meridian wind-heat syndrome, phlegm and blood stasis syndrome, and phlegm and dampness condensation syndrome, which has the advantages of good efficacy and less adverse reactions. Therefore, the development of a topical Chinese herbal compound preparation that is effective, safe, convenient, and has stable and controllable quality for the treatment of acne has become an urgent issue to be solved.

[0003] In view of this, this application is hereby filed. Summary of the invention

[0004] In view of the above problems, the present invention provides a Chinese medicine compound preparation for external use for treating acne, comprising 12 kinds of Chinese medicines, namely, coptis root, rhubarb, scutellaria root, sophora flavescens, honeysuckle, dandelion, selfheal, anemarrhena asphodeloides, salvia miltiorrhiza, clove, Chinese prickly ash, and pomegranate peel. In particular, by weight, coptis root 1-2 parts, rhubarb 3-5 parts, scutellaria root 1-3 parts, sophora flavescens 1-3 parts, honeysuckle 4 parts, dandelion 3-5 parts, selfheal 3-5 parts, anemarrhena asphodeloides 2-4 parts, Chinese prickly ash 3-5 parts, clove 0.5-1.5 parts, Chinese prickly ash 1-2 parts, and pomegranate peel 1-3 parts. The Chinese medicine compound preparation uses coptis root and rhubarb to clear away heat and detoxify as the main medicine; scutellaria baicalensis, sophora flavescens, honeysuckle, dandelion, selfheal, and rhubarb as the assistant medicines to clear away heat and detoxify, reduce swelling and disperse knots; salvia miltiorrhiza cools blood and promotes blood circulation, cloves and prickly ash are aromatic and clear turbidity, and pomegranate peel kills insects and relieves itching, which are combined as adjuvants. Together, they have the effects of clearing away heat and detoxifying, reducing swelling and dispersing knots, removing acne and inhibiting bacteria. The external preparation is applied to the skin of the affected area, and is quickly absorbed through the skin. It has the advantages of safety, good effect and ease of use in treating acne.

[0005] Literature review shows that there are a lot of reports on clinical and experimental studies of single and compound Chinese medicines for the intervention of acne. [3]The antibacterial circle diameters of the water extracts and alcohol extracts of 11 traditional Chinese medicines were determined by the Oxford cup method. It was found that the antibacterial effects of the water extracts and alcohol extracts of the same traditional Chinese medicine were similar. Propionibacterium acnes was highly sensitive to Coptis chinensis, moderately sensitive to Phellodendron amurense, Scutellaria baicalensis, Salvia miltiorrhiza, and Scutellaria barbata, and resistant to the other 6 traditional Chinese medicines. When Coptis chinensis was compounded with the other 4 effective traditional Chinese medicines respectively, among the obtained compound water extracts, the compound of Coptis chinensis and Salvia miltiorrhiza had a better antibacterial effect. When the ratio of Coptis chinensis to Salvia miltiorrhiza was 1.5:8.5, its antibacterial circle diameter was larger, reaching 23.5 mm. It was suggested that Coptis chinensis and the compound of Coptis chinensis and Salvia miltiorrhiza had a good inhibitory effect on Propionibacterium acnes. Zhang et al. [4] The antibacterial effects of 20 traditional Chinese medicines against Propionibacterium acnes in vitro were investigated and compared. It was found that Anemarrhena asphodeloides, Scutellaria baicalensis, Scutellaria barbata, and Prunella vulgaris had obvious effects. The minimum inhibitory concentrations (MICs) of these 4 traditional Chinese medicines were 0.195 mg / ml, 6.250 mg / ml, 3.125 mg / ml, and 6.250 mg / ml respectively. It was proved that the above 4 traditional Chinese medicines had obvious inhibitory effects on Propionibacterium acnes, and Anemarrhena asphodeloides had the best antibacterial effect. Wei et al. [5] It was found that the extracts of 8 medicinal materials, including Syzygium aromaticum, Phyllanthus emblica, Sophora flavescens, Salvia miltiorrhiza, Scutellaria baicalensis, Punica granatum peel, Isatis indigotica, and green tea, had good inhibitory effects on Propionibacterium acnes at 1 g / ml. The test results showed that the MICs of Punica granatum peel, Syzygium aromaticum, and green tea were 3.13 mg / ml, 6.25 mg / ml, and 6.25 mg / ml respectively, that of Phyllanthus emblica was 12.5 mg / ml, that of Scutellaria baicalensis was 50 mg / ml, and that of Salvia miltiorrhiza and Isatis indigotica was 100 mg / ml. It was confirmed that the extracts of Syzygium aromaticum, Punica granatum peel, and green tea had significant antibacterial effects, with simple processes and low costs, and had great development potential.

[0006] Wei Jing et al. [6] The research showed that the ethanol extract of Sophora flavescens had good antibacterial activity, and the antibacterial circle against Propionibacterium acnes was (14.35±0.64) mm, and the MIC was 0.20 mg / ml. The ethanol extract of Artemisia argyi had an inhibitory effect on the release of outer membrane vesicles, and the MIC was 10 μg / ml. The combination of the ethanol extract of Sophora flavescens and the ethanol extract of Artemisia argyi better inhibited the expression of inflammatory factors TNF-α, IL-1β, and IL-8 in THP-1 cells induced by Propionibacterium acnes. Therefore, it was considered that the combination of the ethanol extract of Sophora flavescens and the ethanol extract of Artemisia argyi had the effect of inhibiting acne. Guo et al. [7] Sophora flavescens alkaloids were extracted by ultrasonic-assisted alcohol extraction method, then extracted by ammonia-chlorine method and purified by macroporous adsorption resin. After concentration, freeze-drying, and re-dissolution, the antibacterial activity of the freeze-dried powder against acne pathogenic bacteria (Staphylococcus aureus, Staphylococcus epidermidis, and Propionibacterium acnes) was detected by the Oxford cup antibacterial circle method. The results showed that the Sophora flavescens extract had a significant inhibitory effect on the 3 acne pathogenic bacteria, especially on Propionibacterium acnes. The Sophora flavescens extract also had a good ability to scavenge oxidative free radicals, suggesting that the matrine extract had good application development value for acne-removing and repairing cosmetics.

[0007] Zhong et al. [8] The results of in vitro antibacterial experiments showed that the MIC values of the extracts of Salvia miltiorrhiza and Glycyrrhiza uralensis against Propionibacterium acnes in vitro were 16 mg / ml and 12.5 mg / ml, respectively. The experimental results of the acne model in rats with inflammation caused by Propionibacterium showed that the extracts of Salvia miltiorrhiza and Glycyrrhiza uralensis could significantly reduce the swelling degree of the auricles of rats with inflammation caused by Propionibacterium ( P < 0.05). The experimental results of ear swelling in mice caused by xylene showed that compared with the solvent group, after continuous application of the extracts of Salvia miltiorrhiza and Glycyrrhiza uralensis for 7 days, the swelling degree of the auricles of mice with inflammation caused by xylene could be significantly reduced ( P < 0.05). Therefore, it is considered that the extracts of Salvia miltiorrhiza and Glycyrrhiza uralensis have antibacterial, anti-inflammatory and anti-acne infection effects and can be widely used as raw materials for cosmetics. Clinically, Hao [9] Admitted 98 patients with mild to moderate acne and randomly divided them into a treatment group (treated with tanshinone capsules combined with zinc glycyrrhetate granules) and a control group (treated with zinc glycyrrhetate granules), with 49 cases in each group. After 4 weeks of treatment, the skin lesion symptom scores and quality of life changes of the two groups were observed, and the clinical efficacy was evaluated. The results showed that the skin lesion symptom scores and quality of life scores of the treatment group were significantly lower than those of the control group ( P < 0.05), and the total effective rate was 95.92%, which was significantly higher than 81.63% of the control group ( P < 0.05). Conclusion: Treating patients with mild to moderate acne with tanshinone capsules combined with zinc glycyrrhetate granules can significantly relieve the skin lesion symptoms of patients, improve the treatment effect of acne and improve the quality of life. Ma Hui

[10] Randomly divided 86 acne patients into two groups, with 43 cases in each group. The observation group was treated with tanshinone capsules and isotretinoin in combination, and the control group was treated with isotretinoin. After 6 weeks of treatment, the total effective rate of the observation group was higher than that of the control group ( P < 0.05); there were statistically significant differences in the skin lesion scores, IL-4, IL-18, and TNF-α between the two groups of patients ( P < 0.05); there were statistically significant differences in the scores of the visual analogue pain scale (VAS) and the skin sensitivity value -16 scores ( P < 0.05); the recurrence rate of the observation group was lower than that of the control group ( P < 0.05). Conclusion: The combined treatment of tanshinone capsules and isotretinoin can reduce the inflammatory reaction of acne patients, improve the skin lesion symptoms, help reduce the degree of skin lesion pain, lower the recurrence rate, and improve the quality of life of patients.

[0008] Wang et al.

[11] Pharmacodynamic experiments showed that after the intervention of baicalin liposome gel, histopathological staining showed that the degree of keratinization, local tissue congestion, and inflammatory degree were alleviated. From the perspective of the effects on the secretion of serum tumor necrosis factor α, IL-1β, IL-6, and IL-8 in the rabbit ear acne model, baicalin liposome gel could significantly reduce the levels of inflammatory factors in rabbit ear acne, and its curative effect was better than that of the positive control group of adapalene gel. Liu Jing, etc.

[12] Observed the effects of baicalein on compound acne in the auricles of model rats. The results showed that the contents of IL-4 and MMP-9 in the model group were significantly different from those in the blank group ( P <0.01). The contents of IL-4 and MMP-9 in the tissues of rats in the low, medium, and high dose groups of baicalein and the positive control group were reduced to varying degrees compared with those in the model group ( P <0.05). The content trend of each group was high dose group of baicalein < positive control group < medium dose group of baicalein < low dose group of baicalein. Conclusion: Baicalein has a definite curative effect on acne, which may be related to the reduction of IL-4 and MMP-9 in local tissues by baicalein.

[0009] Gao Fan, etc.

[13] After the intervention with pomegranate peel polyphenol cream, the animal model group and the matrix group had inflammatory manifestations such as dark red skin, swelling, hardening, scabs, and papules. The skin lesions in each concentration group of pomegranate peel polyphenols and the clindamycin group were improved to varying degrees compared with the model group. Pathology showed that there was epidermal keratinization, infiltration of inflammatory cells in the dermis, and sebaceous gland hyperplasia in the model group and the matrix group, while each treatment group was alleviated to varying degrees. Immunohistochemistry showed that compared with the model group, the levels of NLRP3 and Caspase-1 in each concentration group of pomegranate peel polyphenols and the clindamycin group were significantly decreased ( P <0.05). The expression of ASC in the medium and high concentration groups of pomegranate peel polyphenols was decreased ( P <0.05). The expression of MMP-2 in the low and high concentration groups of pomegranate peel polyphenols was decreased ( P <0.05). ELISA results showed that each group of pomegranate peel polyphenols and the clindamycin group were significantly decreased compared with the model group ( P <0.05). Conclusion: Pomegranate peel polyphenol cream can effectively improve the inflammatory response of the acne model in SD rats, which may be related to its mechanism of inhibiting the NLRP3 inflammasome to anti-inflammatory and anti-acne. Wei Lu, etc.

[14] To observe the effects of pomegranate peel polyphenol cream on the area of sebaceous gland plaques and the expression of PI3K protein in golden hamsters. Through network pharmacology research, a total of 31 active ingredients, 193 drug targets, 1371 acne targets, and 79 intersection targets between active ingredients and diseases were obtained. The main active ingredients of pomegranate peel in the treatment of acne are quercetin, kaempferol, luteolin, etc.; the core targets are Akt1, IL-6, VEGFA, and PTSG2; the key signaling pathways may include the PI3K-Akt signaling pathway, TNF signaling pathway, T cell receptor signaling pathway, FoxO signaling pathway, etc. In vivo experiments confirmed that pomegranate peel can reduce the expression level of PI3K protein in sebaceous gland plaques of golden hamsters and resist the hyperplasia of sebaceous gland plaques.

[0010] Li Chang et al.

[15] Observed the therapeutic effect of honeysuckle on the rabbit ear acne model and explored its regulatory effect on the NF-κB signaling pathway. The results showed that compared with the model group, the contents of IL-1β and TNF-α in the honeysuckle granule group decreased significantly, and the protein expressions of NF-κBp65, IKK-α, and IKK-β in rabbit ear tissues were significantly reduced. Conclusion: Honeysuckle granules have a definite curative effect on acne, can reduce lipid embolism in rabbit ear hair follicles, inhibit the hyperplasia of sebaceous gland duct epithelium, and reduce inflammatory cell infiltration. Its mechanism is related to regulating the intracellular NF-κBp65, IKK-α, IKK-β protein concentrations and the serum TNF-α and IL-1β contents by regulating the NF-κB signaling pathway. Ren et al.

[16] Research has proved that the improved inverted powder (rhubarb powder: sulfur powder = 2:1) has a good antibacterial effect on Propionibacterium acnes, and the greater the drug concentration, the stronger the inhibition of the LDH enzyme activity of Propionibacterium acnes. Conclusion: The improved inverted powder can achieve the antibacterial purpose by inhibiting the LDH enzyme activity of Propionibacterium acnes. It shows that rhubarb has anti-Propionibacterium acnes activity. Yan Chun et al.

[17] Research has shown that pepper essential oil has a preventive effect on the inflammation of human immortalized keratinocytes (HaCaT) caused by Propionibacterium acnes, which may be related to its down-regulation of the expressions of TLR2 and NF-κB and inhibition of the inflammatory response. Liu et al.

[18] Investigated the effects of taraxasterol on acne in mice. The results showed that compared with the model group (Group B), the low-dose group (Group C) and high-dose group (Group D) of taraxasterol alleviated the swelling, redness, erythema, dry and rough texture of the ears of acne mice, and the ear thickness was also significantly reduced ( P <0.05); after intragastric treatment with taraxasterol, the inflammation of acne mice was effectively relieved, the number of infiltrating inflammatory cells was significantly reduced, and the epidermal thickening was alleviated; compared with Group B, Group C and Group D increased the thymic cortex thickness and lymphocyte number in the mouse acne model (both P <0.05); taraxasterol significantly reduced the expression levels of IL-1β and IL-8 in the serum of mice ( P <0.05 orP <0.01), and the positive expression rate of TNF-α in the ear tissues of mice decreased ( P <0.05); compared with group B, groups C and D down-regulated the expression of TGF-β1 and Smad3 proteins in the ear tissues of mice (both P <0.05). It is proved that taraxasterol has a good therapeutic effect on the acne model of mouse auricle, regulates the expression of inflammatory factors and improves the morphological structure of mouse thymus tissue, and it may be related to the TGF-β / Smad pathway.

[0011] The single and comparative pharmacodynamics and clinical studies of 12 traditional Chinese medicines in the prescription show that all the medicines have definite antibacterial effects on Propionibacterium acnes, the main pathogenic bacterium of acne, and each medicine has related pharmacological effects such as anti-inflammatory, anti-androgen, sebum secretion inhibition, and abnormal keratinization inhibition, which provide strong evidence for the treatment of acne by this traditional Chinese medicine compound preparation.

[0012] As a further improvement of the present invention, by weight, the traditional Chinese medicine compound preparation comprises 1.5 parts of Coptis chinensis, 4 parts of Rheum palmatum, 2 parts of Scutellaria baicalensis, 2 parts of Sophora flavescens, 4 parts of Lonicera japonica, 4 parts of Taraxacum mongolicum, 4 parts of Prunella vulgaris, 3 parts of Anemarrhena asphodeloides, 4 parts of Salvia miltiorrhiza, 1 part of Syzygium aromaticum, 1.5 parts of Zanthoxylum bungeanum, and 2 parts of Granatum pericarpium.

[0013] As a further improvement of the present invention, the traditional Chinese medicine compound preparation further comprises pharmaceutically acceptable excipients: chitosan, methylparaben, phenoxyethanol, and sodium benzoate.

[0014] As a further improvement of the present invention, the excipients include one or more of glycerol, silicone oil, allantoin, mineral oil, cellulose, chitosan, methylparaben, phenoxyethanol, fatty alcohol, fatty alcohol polyether, fatty acid ester, cellulose and its derivatives, carbomer, acrylate / C10-30 alkyl acrylate cross-linked polymer urea, butanediol, borneol, sodium benzoate, potassium sorbate, and essence.

[0015] As a further improvement of the present invention, the dosage form of the traditional Chinese medicine compound preparation is selected from: emulsion, aqueous solution, oil agent, tincture, ointment, plaster, cream, spray, drop, patch or gel.

[0016] As a further improvement of the present invention, the dosage form of the traditional Chinese medicine compound preparation is gel.

[0017] The present invention also provides a preparation method of the traditional Chinese medicine compound preparation, comprising the following steps: pulverizing, soaking, heating, ultrasonic extracting, filtering Coptis chinensis, Rheum palmatum, Scutellaria baicalensis, Sophora flavescens, Lonicera japonica, Taraxacum mongolicum, Prunella vulgaris, Anemarrhena asphodeloides, Salvia miltiorrhiza, Syzygium aromaticum, Zanthoxylum bungeanum, and Granatum pericarpium, and then adding phenoxyethanol and sodium benzoate, settling, suction filtering, centrifuging, concentrating, and decolorizing and deodorizing.

[0018] The preparation method of the traditional Chinese medicine compound preparation specifically comprises the following steps:

[0019] Step 1: Select raw materials according to the weight ratio: Coptis chinensis, Rheum palmatum, Scutellaria baicalensis, Sophora flavescens, Lonicera japonica, Taraxacum mongolicum, Prunella vulgaris, Anemarrhena asphodeloides, Salvia miltiorrhiza, Eugenia caryophyllata, Zanthoxylum bungeanum, Granatum pericarpium.

[0020] Step 2: Crush Coptis chinensis, Rheum palmatum, Scutellaria baicalensis, Sophora flavescens, Lonicera japonica, Taraxacum mongolicum, Prunella vulgaris, Anemarrhena asphodeloides, Salvia miltiorrhiza, Eugenia caryophyllata, Zanthoxylum bungeanum, Granatum pericarpium, and then filter after crushing to obtain the coarsest powder (referring to the powder that can all pass through the No. 1 sieve but contains no more than 20% of the powder that can pass through the No. 3 sieve) of the medicinal powder.

[0021] Step 3: Add 5 times the amount of water to soak the medicinal powder for 8 - 12 h, then heat it to 50 °C in an ultrasonic extraction tank, and then perform ultrasonic extraction for 1 h.

[0022] Step 4: Filter the extracted medicinal liquid, then add phenoxyethanol and sodium benzoate and stir well. After standing for 24 h, perform suction filtration.

[0023] Step 5: The obtained liquid is centrifuged in a centrifuge at 19000 r / min for 30 minutes, then concentrated 1.5 times or 4 times, and decolorized or deodorized in a decolorizing membrane to obtain a traditional Chinese medicine compound preparation for treating acne.

[0024] The present invention also provides an application of the traditional Chinese medicine compound preparation in preparing a drug for externally treating acne.

[0025] As a further improvement of the present invention, there is an application of the traditional Chinese medicine compound preparation in preparing a drug for treating other skin diseases.

[0026] As a further improvement of the present invention, the traditional Chinese medicine compound preparation is for external disinfection, cosmetics and traditional Chinese medicine varieties. The usage method of the gel preparation developed this time is: Wash the affected area, wipe it clean, and then apply this product. 1 - 1.5 g / time, twice a day, and 2 weeks is one course of treatment.

[0027] Compared with the prior art, the advantages of the present invention are as follows:

[0028] 1. Under the guidance of traditional Chinese medicine theory, the traditional Chinese medicine compound preparation is combined based on comprehensive traditional Chinese medicine clinical experience and pharmacodynamic research results. The traditional Chinese medicine compound preparation has passed clinical verification and has good safety and effectiveness; currently, there are few traditional Chinese medicine preparations for acne disinfection, cosmetics and traditional Chinese medicine products, which can make up for the deficiencies in this regard.

[0029] 2. The water extraction preparation process selected for the traditional Chinese medicine compound preparation can ensure that active substances are extracted and utilized more fully.

[0030] 3. The traditional Chinese medicine compound preparation is made into a finished product, which is convenient to carry; as an external preparation, the usage method is simple and easy to accept.

[0031] 4. The traditional Chinese medicine compound preparation has sufficient drug sources, all from domestic sources, and can meet the needs of large-scale production. Description of the Drawings

[0032] The drawings are used to provide a further understanding of the present invention and constitute a part of the specification. Together with the embodiments of the present invention, they are used to explain the present invention and do not constitute a limitation to the present invention.

[0033] Figure 1 For the acne on the mental region of the patient before treatment.

[0034] Figure 2 For the acne on the left face of the patient before treatment.

[0035] Figure 3 For the acne on the mental region of the patient after treatment.

[0036] Figure 4 For the acne on the mental region of the patient after treatment. Detailed Embodiments

[0037] The following will describe the implementation schemes of the present invention in detail in combination with the embodiments. However, those skilled in the art will understand that the following embodiments are only used to illustrate the present invention and should not be regarded as limiting the scope of the present invention. For those not specified in the embodiments, they are carried out according to the conventional conditions or the conditions recommended by the manufacturer.

[0038] Example 1. Preparation of the traditional Chinese medicine compound preparation.

[0039] By weight, take 1.5 parts of Coptis chinensis, 4 parts of Rheum palmatum, 2 parts of Scutellaria baicalensis, 2 parts of Sophora flavescens, 4 parts of Lonicera japonica, 4 parts of Taraxacum mongolicum, 4 parts of Prunella vulgaris, 3 parts of Anemarrhena asphodeloides, 4 parts of Salvia miltiorrhiza, 1 part of Eugenia caryophyllata, 1.5 parts of Zanthoxylum bungeanum, and 2 parts of Granatum peel of the traditional Chinese medicine compound, crush them, filter after crushing to obtain drug powder, soak the powder for 8 - 12 h, and then perform ultrasonic extraction for 1 h. Filter the extracted medicinal liquid, then add phenoxyethanol and sodium benzoate and stir well. After standing for 24 h, perform suction filtration. Then, perform centrifugation, concentration, decolorization or deodorization in sequence to obtain the traditional Chinese medicine compound preparation for treating acne.

[0040] Example 2. Study on the in vitro antibacterial, anti-inflammatory activities and cytotoxicity of the traditional Chinese medicine compound preparation.

[0041] 2.1.1 Detection results of the activity of the traditional Chinese medicine compound preparation against Propionibacterium acnes.

[0042] Experimental materials.

[0043] ① Test articles: Traditional Chinese medicine compound preparation (concentration 42.2 mg / ml), chlorogenic acid (index component of the traditional Chinese medicine compound; purity 99.44%; batch number 21032502; Chengdu Pufeide Biotechnology Co., Ltd.).

[0044] ②Positive control drug: Resveratrol (purity 98%; batch number wkq23020605; Sichuan Vicibiotech Co., Ltd.).

[0045] ③Experimental strain: Propionibacterium acnes (ATCC6919; Shanghai Collection Center of Biotechnology).

[0046] ④Experimental reagents: Trypticase peptone: Beijing Aoboxing Co., Ltd. (250 g; batch number 20220418); Beef extract powder: Beijing BioStar Technology Co., Ltd. (250 g; batch number 202106); Yeast extract powder: Beijing Aoboxing Biotechnology Co., Ltd. (250 g; batch number 20220228); Agar powder: Tianjin Kemiou Chemical Reagent Co., Ltd. (250 g; batch number 20210117); Soluble starch: Tianjin Hengxing Chemical Reagent Manufacturing Co., Ltd. (500 g; batch number 20211011); Glucose: Tianjin Hengxing Chemical Reagent Manufacturing Co., Ltd. (500 g; batch number 20211018); Sodium chloride: Tianjin Hengxing Chemical Reagent Manufacturing Co., Ltd. (500 g; batch number 20221101); L-Cysteine hydrochloride: Tianjin Bodi Chemical Industry Co., Ltd. (10 g; batch number 20150926); Sodium acetate anhydrous: Tianjin Hengxing Chemical Reagent Manufacturing Co., Ltd. (500 g; batch number 20211123); PBS: Dalian Meilun Biotechnology Co., Ltd. (500 ml; batch number MA0015-May-11).

[0047] Experimental methods.

[0048] ①Strain activation: Dissolve the freeze-dried bacteria with liquid medium, inoculate the bacterial suspension onto the solid medium plate at a volume of 200 μL / plate, and place the inoculated medium in an incubator at 37°C for cultivation. Bacteria will grow within 2 - 5 days. Pick a single colony for subculture on the solid plate until the 3rd generation can be used for the experiment.

[0049] ②MIC / MBC detection: Take the strains cultured in the logarithmic growth phase, adjust the bacterial density to 5.5×105 CFU / ml with sterile water, and set aside. Dilute the stock solution with liquid medium to the highest drug concentration to be tested. Take a sterile 96-well plate and serially dilute the drug to be tested by the two-fold dilution method. Set up a drug-free control and a bacteria-free control. Add an equal amount of the serially diluted bacterial suspension to each well of the drug at each concentration in turn. Place the 96-well plate in a 37°C bacterial incubator for incubation. The lowest drug concentration at which no bacteria grow is the minimum inhibitory concentration (MIC) of the drug. Take the bacterial suspension without growth and streak it on a solid medium. The minimum bactericidal concentration (MBC) of the drug is defined as no growth.

[0050] Experimental results Minimum inhibitory / bactericidal concentration (MIC / MBC) of traditional Chinese medicine compound preparation and chlorogenic acid against Propionibacterium acnes.

[0051] 2.1.2 Detection results of the antibacterial activity of traditional Chinese medicine compound preparation against Staphylococcus aureus.

[0052] Experimental materials

[0053] ① Test articles: Traditional Chinese medicine compound preparation (concentration 42.2 mg / ml), chlorogenic acid (index component of traditional Chinese medicine compound preparation; purity 99.44%; batch number 21032502; Chengdu Pufeide Biotechnology Co., Ltd.).

[0054] ② Experimental strains: Staphylococcus aureus (isolated from human fecal samples in the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine).

[0055] ③ Experimental reagents: Tryptone: Beijing Aoboxing Biotechnology Co., Ltd. (250 g; batch number 20220712); Yeast extract powder: Beijing Aoboxing Biotechnology Co., Ltd. (250 g; batch number 20220228); Agar powder: Tianjin Kemiou Chemical Reagent Co., Ltd. (250 g; batch number 20210117); Sodium chloride: Tianjin Hengxing Chemical Reagent Manufacturing Co., Ltd. (500 g; batch number 20221101); PBS: Dalian Meilun Biotechnology Co., Ltd. (500 ml; batch number MA0015-May-11).

[0056] Experimental methods

[0057] ① Strain activation: Take the glycerol bacteria stored at -80°C, use a sterile inoculation loop to scrape an appropriate amount of frozen bacteria in the cryopreservation tube, and streak inoculate on a solid medium. Place the inoculated medium in a 37°C incubator for incubation.

[0058] ②MIC / MBC detection: Take the strains cultured in the logarithmic growth phase, adjust the bacterial density to 5.5×105 CFU / ml with sterile water, and set aside. Dilute the stock solution with liquid medium to the highest drug concentration to be tested. Take a sterile 96-well plate and serially dilute the drug to be tested by the two-fold dilution method. Set up a drug-free control and a bacteria-free control. Add an equal amount of the diluted bacterial suspension to each well of the drug at each concentration in sequence, and place the 96-well plate in a 37°C bacterial incubator for culture. The lowest drug concentration at which no bacteria grow is the MIC of the drug. Take the bacterial suspension without bacterial growth and streak it on a solid medium, and no bacterial growth is the MBC of the drug.

[0059] Experimental results Table 1 Minimum inhibitory / bactericidal concentration (MIC / MBC) of traditional Chinese medicine compound preparation and chlorogenic acid against Staphylococcus aureus Sample Number Traditional Chinese Medicine Compound Preparation Chlorogenic Acid MIC (mg / ml) 10.55 ＞2.5 MBC (mg / ml) ＞21.10 ＞2.5

[0060] 2.1.3 Detection and research on the anti-Candida albicans activity of traditional Chinese medicine compound preparation.

[0061] Experimental materials

[0062] ① Test articles: Traditional Chinese medicine compound preparation (concentration 42.2 mg / ml), chlorogenic acid (ingredient of traditional Chinese medicine compound preparation; purity 99.44%; batch number 21032502; Chengdu Pufeide Biotechnology Co., Ltd.).

[0063] ② Experimental strains: Candida albicans (isolated from human fecal samples in the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine).

[0064] ③ Experimental reagents: PDB medium: Beijing Aoboxing Biotechnology Co., Ltd. (250 g; batch number 20230530); Agar powder: Tianjin Kemiou Chemical Reagent Co., Ltd. (250 g; batch number 20210117); PBS: Dalian Meilun Biotechnology Co., Ltd. (500 ml; batch number MA0015-May-11).

[0065] Experimental methods

[0066] ① Strain activation: Take the glycerol bacteria stored at -80°C, use a sterile inoculation loop to scrape an appropriate amount of frozen bacteria in the cryopreservation tube, streak and inoculate on a solid medium, and place the inoculated medium in a 37°C incubator for culture.

[0067] ②MIC / MBC determination: Strains cultured in the logarithmic growth phase were taken, and the bacterial density was adjusted to 5.5×105 CFU / ml with sterile water for standby. The stock solution was diluted with liquid medium to the highest drug concentration to be tested. A sterile 96-well plate was taken, and the drugs to be tested were diluted sequentially by the two-fold dilution method. A drug-free control and a bacteria-free control were set. An equal amount of the diluted bacterial suspension was added successively to the drug wells at each concentration, and the 96-well plate was placed in a 37°C bacterial incubator for culture. The lowest drug concentration without bacterial growth was the MIC of the drug. The bacterial solution without growth was streaked on a solid medium for culture, and the absence of growth was the MBC of the drug.

[0068] Experimental results Table 2 Minimum inhibitory / bactericidal concentration (MIC / MBC) of traditional Chinese medicine compound preparation and chlorogenic acid against Candida albicans Sample Number Traditional Chinese Medicine Compound Preparation Chlorogenic Acid MIC (mg / ml) 10.55 ＞2.5 MBC (mg / ml) 21.10 ＞2.5

[0069] Conclusion: The traditional Chinese medicine compound preparation has antibacterial and bactericidal activities against Propionibacterium acnes and Candida albicans. The MIC for both is 10.55 mg / ml, and the MBC is 21.10 mg / ml; it has an inhibitory activity against the growth of Staphylococcus aureus, with the MIC being 10.55 mg / ml and the MBC > 21.10 mg / ml.

[0070] 2.2 Anti-inflammatory activity study of traditional Chinese medicine compound preparation.

[0071] Experimental materials

[0072] ① Test articles: Traditional Chinese medicine compound preparation (concentration 42.2 mg / ml), chlorogenic acid (index component of traditional Chinese medicine compound preparation; purity 99.44%; batch number 21032502; Chengdu Pufeide Biotechnology Co., Ltd.).

[0073] ② Experimental cell line and source: RAW264.7 (mouse mononuclear macrophage leukemia cells; Dalian Meilun Biotechnology Co., Ltd.).

[0074] ③ Experimental reagents Fetal bovine serum (FBS): Animal Blood Ware (500 ml; batch number AB20214311); DMEM high-glucose medium: Shanghai Dart Hill Biotechnology Co., Ltd. (500 ml; batch number 2310048); PBS: Dalian Meilun Biotechnology Co., Ltd. (500 ml; batch number MA0015-May-11); Lipopolysaccharide (LPS): Sigma-Aldrich, USA (10 mg; batch number 0000189847); Sodium nitrite: Tianjin Hengxing Chemical Reagent Manufacturing Co., Ltd. (500 g; batch number 20220506); Sulfanilamide: Tianjin Kemiou Chemical Reagent Co., Ltd. (100 g; batch number 20170110); Naphthylethylenediamine dihydrochloride: Shanghai Macklin Biochemical Co., Ltd. (5 g; batch number C10115788); Phosphoric acid: Tianjin Fuyu Fine Chemical Co., Ltd. (500 ml; batch number 20230522).

[0075] Experimental method

[0076] ① RAW264.7 cell culture: Prepare A - 10% DMEM high - glucose cell culture medium based on FBS medium. Cells are cultured in a 5% CO2, 37 °C incubator at a density of approximately 2.5×105 cells / ml. By the third day, when the cells cover about 80 - 90% of the bottom area of the culture flask, pipette and digest the cells and passage them to another culture flask.

[0077] ② Detection of NO concentration by Griess method: Take RAW264.7 cells cultured in the logarithmic growth phase, adjust the cell density to 2.5×105 cells / ml with A - 10% DMEM high - glucose medium, inoculate them into a 96 - well plate at 200 μL / well, and culture them in an incubator at 37 °C, 5% CO2. After the cells adhere and culture for 12 h, change to fresh culture medium, and at the same time, perform modeling (1 μg / ml LPS) and drug - adding treatment. Set different doses for the samples and set a blank control. After adding the drug, continue to culture the cells for 24 h. Pipette 100 μL / well of the cell supernatant into a 96 - well plate, add 50 μL / well of Griess A (1% sulfanilamide) and Griess B (0.1% naphthylethylenediamine dihydrochloride) respectively, incubate at room temperature for 30 min, and measure the optical density OD value at 546 nm. Calculate the NO content in each sample according to the standard curve of NaNO2.

[0078] Experimental results Effects of traditional Chinese medicine compound preparation and chlorogenic acid on the release of NO (μmol / L) from LPS - induced RAW264.7 cells (Mean±SEM).

[0079] Note: Comparison between the model group and the blank group P <0.001, comparison between the drug - administered group and the model group ns P >0.05, * P <0.05, ** P <0.01.

[0080] Conclusion: The sample of the traditional Chinese medicine compound preparation significantly inhibited the production of NO in LPS-induced RAW264.7 cells at 100 μg / ml, showing certain anti-inflammatory activity.

[0081] 2.3 Detection Report of Cytotoxicity of Traditional Chinese Medicine Compound Preparation.

[0082] Experimental Materials

[0083] ① Test articles: Traditional Chinese medicine compound preparation (concentration 42.2 mg / ml), chlorogenic acid (index component of traditional Chinese medicine compound preparation; purity 99.44%; batch number 21032502; Chengdu Pufeide Biotechnology Co., Ltd.).

[0084] ② Experimental cell lines and sources HaCat: Human epidermal keratinocytes (Shanghai Aoyin Biotechnology Co., Ltd.); RAW264.7: Mouse mononuclear macrophage leukemia cells (Dalian Meilun Biotechnology Co., Ltd.).

[0085] ③ Experimental reagents Fetal bovine serum (FBS): Animal Blood Ware (500 ml; batch number AB20214311); DMEM high-glucose medium: Shanghai Dartshire Biotechnology Co., Ltd. (500 ml; batch number 2310048); PBS: Dalian Meilun Biotechnology Co., Ltd. (500 ml; batch number MA0015-May-11); Trypsin containing EDTA: Gibco, USA (500 ml; batch number 2764713); Lipopolysaccharide (LPS): Sigma-Aldrich, USA (10 mg; batch number 0000189847); 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT): Dalian Meilun Biotechnology Co., Ltd. (1 g; batch number A0428D).

[0086] Experimental Methods

[0087] ① Culture of human epidermal keratinocytes: Prepare A-10% DMEM high-glucose cell culture medium based on FBS medium. Cells were cultured in a 5% CO2, 37 °C incubator at a density of approximately 2.5×105 cells / ml. By the third day, the adherent cells accounted for about 80-90% of the bottom area of the culture flask. The adherent cells were digested with trypsin and passaged to another culture flask.

[0088] ② Culture of mouse mononuclear macrophage leukemia cells: A-10% DMEM high-glucose cell culture medium was prepared based on FBS medium. The cells were cultured at a density of approximately 2.5×105 cells / ml in a 5% CO2, 37°C incubator. By the third day, the adherent cells accounted for about 80-90% of the bottom area of the culture flask. The adherent cells were digested with trypsin and passaged to another culture flask.

[0089] ③ Detection of the effect of samples on cell viability by MTT method: Logarithmically growing HaCat / RAW264.7 cells were taken respectively, and the cell density was adjusted to 2.5×105 cells / ml with A-10% DMEM high-glucose medium. They were inoculated into 96-well plates, 100 μL / well, and cultured in an incubator at 37°C and 5% CO2. After the cells adhered and were cultured for 12 h, they were replaced with fresh culture medium, and at the same time, drug treatment was carried out. Different doses of samples were set, and a blank control was also set. After the cells were treated with drugs and continued to be cultured for 48 h, then MTT solution was added to the cell culture medium, 50 μL / well. The cells and 2 mg / ml MTT were co-incubated at 37°C for 4 h. The culture medium was aspirated, and then 100 μL of DMSO solution was added to measure its optical density OD value. Calculate the average value of the OD values of 3 wells for each sample, and calculate the cell viability (cell viability, CV%) according to the following formula using the average value. Cell viability % = average value of the OD value of the sample group / average value of the OD value of the blank control group × 100%.

[0090] Experimental results Effects of traditional Chinese medicine compound preparation and chlorogenic acid on the survival rate of HaCat cells (Mean±SEM).

[0091] Note: ** P <0.01, *** P <0.001.

[0092] Experimental results Effects of traditional Chinese medicine compound preparation and chlorogenic acid on the survival rate (%) of RAW264.7 cells (Mean±SEM).

[0093] Note: ns P >0.05.

[0094] Experimental conclusion: When the traditional Chinese medicine compound preparation is at 10-100 μg / ml, the survival rates of RAW264.7 cells and HaCat cells after administration are both greater than 90%, and no cell toxicity is shown.

[0095] Example 3. Clinical study on the effectiveness of Acne No. 1 in treating acne.

[0096] Inclusion criteria for cases.

[0097] (1)Meet the acne diagnostic criteria in "Chinese Acne Treatment Guidelines (2019 Revised Edition)", regardless of gender; (2)Meet the syndrome of damp-heat accumulation in traditional Chinese medicine; (3)The condition is mild and moderate; (4)Ages 18 to 35 years old; (5)The subjects give informed consent to the study.

[0098] Exclusion criteria for cases.

[0099] (1)Ages < 18 years old or > 35 years old; (2)Patients with severe primary diseases such as heart, brain, liver, kidney, and hematopoietic systems, and psychiatric patients; (3)Pregnant or women planning pregnancy, lactating women; (4)Patients with allergic constitution and allergic to this agent; (5)Those who have used other acne treatment drugs within the past week.

[0100] Clinical severity grading of the condition.

[0101] Degree I (mild): Blackhead acne, with a small number of papules and pustules, and the total number of lesions less than 30.

[0102] Degree II (moderate): Acne, accompanied by a moderate number of papules and pustules, and the total number of lesions between 31 and 50.

[0103] Degree III (more severe): Acne, accompanied by a large number of papules and pustules, occasionally large inflammatory lesions, widely distributed, the total number of lesions between 51 and 100, and a small number of nodules.

[0104] Degree IV (severe): In addition to the above rashes, accompanied by nodules and cysts, most are painful and form cysts, and there are more than 3 nodule cysts.

[0105] General information of the included cases.

[0106] All the included subjects were cases that met the inclusion and exclusion criteria from the dermatology outpatient department between August 2022 and October 2023, a total of 72 cases. They were divided into an experimental group and a control group according to the random number table, with 36 cases in each group. In the experimental group, there were 25 males and 9 females; ages 18 to 35 years old, with an average of 26.2 ± 7.7 years old, the disease course was 0.5 to 5 years, with an average of 2.7 ± 2.2 years; 15 cases were in Degree I and 21 cases were in Degree II. In the control group, there were 27 males and 7 females, ages 18 to 34 years old, with an average of 25.8 ± 6.9 years old; the disease course was 1 to 5.5 years, with an average of 2.5 ± 2.4 years; 13 cases were in Degree I and 23 cases were in Degree II. After the chi-square test of gender and condition x 2 test and the t t-test of age and disease course, there were no significant differences ( P > 0.05), and the two groups of cases were comparable.

[0107] Comparison of general conditions before enrollment between the experimental group and the control group.

[0108] Test drug.

[0109] Test group: Acne No. 1 (Specification: 50g / tube, gel, containing 15g of crude drug. Dandong Xinshidai Biopharmaceutical Technology Co., Ltd., production batch number DXC20220601), storage conditions: light-shielded, sealed. Shelf life: 18 months.

[0110] Control group: Acne No. 1 (placebo) (Specification: 50g / tube, gel, Dandong Xinshidai Biopharmaceutical Technology Co., Ltd., production batch number DXC20220602), the placebo is a liquid gel preparation with no difference in appearance, size, shape and smell from Acne No. 1; the packaging is the same as the test drug; ingredients: caramel, bittering agent, stevioside, purified water, the company assigns one person to be responsible for packaging, distribution and management. Storage conditions: light-shielded, sealed. Shelf life: 18 months.

[0111] Usage and dosage.

[0112] First, clean the affected area thoroughly, then use your fingertips to gently apply 1-1.5g of the drug to the affected area, twice a day. Do not rub it after application. Continuous treatment for 2 weeks is one course of treatment.

[0113] Precautions for use: (1) During treatment, use a mild skin cleanser to clean the skin every morning and evening, and do not use cosmetics; (2) Do not squeeze or scratch the affected skin; (3) Eat a light diet, eat less fat, sugar and irritating foods, avoid drinking alcohol, eat more vegetables, fruits and foods rich in vitamins, and keep the bowel movements smooth; (4) Drink plenty of water and avoid exposure to the sun; (5) Maintain a regular work and rest schedule and ensure adequate sleep.

[0114] Acne treatment efficacy criteria.

[0115] (1) Clinical cure: All skin lesions disappear, leaving only pigmentation and scars.

[0116] (2) Significantly effective: Skin lesions subside by more than 70%, or the severity is reduced by more than 2 degrees.

[0117] (3) Effective: Skin lesions disappear by 30% to 70%, or the severity is reduced by more than 1 degree, but new lesions still appear.

[0118] (4) Ineffective: Skin lesions disappear by less than 30% or worsen.

[0119] The skin lesion score was based on the acne comprehensive grading system score, which is based on the density and distribution of the hair follicle sebum unit, and the facial skin lesions were divided into 5 areas: forehead, right cheek, left cheek, nose, and lower cheek (this clinical observation does not include chest and back skin lesions); because patients with grade I and II were included, the degree of facial skin lesions was divided into: no skin lesions 0 points; 1 comedones 1 point; 1 papules 2 points; 1 pustules 3 points. According to the number of comedones, papules and pustules in the 5 facial areas, the number, score and cumulative value were classified and counted, and the differences before and after treatment were compared.

[0120] Comparison of the curative effects between the experimental group and the control group (see Table 3) Table 3 Comparison of the clinical curative effects between the two groups Group Number of Cases Clinical Cure (%) Marked Improvement (%) Effective (%) Ineffective (%) Cure and Marked Improvement Rate (%) Experimental Group 36 22（61.1） 7 (19.5) 5 (13.9) 2(5.5) 80.6 Control Group 36 1（2.8） 4（11.1） 5 (13.9) 22（72.2） 13.9

[0121] During the observation period, the subjects had good compliance and there were no dropout cases. All completed the clinical observation as required. It can be seen from Table 3 that after treatment, 23 cases in the experimental group were clinically cured, 7 cases were markedly effective, 5 cases were effective, and 1 case was ineffective, with a marked cure rate of 83.3%; in the placebo control group, 1 case was clinically cured, 4 cases were markedly effective, 5 cases were effective, and 22 cases were ineffective, with a marked cure rate of 13.9%. The rank sum test showed that there was a significant difference in the curative effects between the two groups ( P <0.05), and the curative effect of Acne No. 1 was significantly better than that of the placebo group. During the trial period, no skin irritation adverse reactions occurred in both groups.

[0122] Comparison of the skin lesion scores between the experimental group and the control group (see Table 4) Table 4 Comparison of the skin lesion scores between the two groups before and after treatment (score, ±s) Group Number of Cases Score Before Treatment Score After Treatment Experimental Group 36 28. 12±5. 21 5. 23±3. 82△# Control Group 36 27. 93±2. 08 23. 33±5. 36△

[0123] Note: Compared with before treatment within the group, △ P <0. 05; compared with after treatment in the control group, # P <0. 05.

[0124] As can be seen from Table 4, the score of the experimental group before treatment was 28. 12±5. 2 points, which decreased to 5. 23±3. 82 points after treatment, and the difference before and after treatment was extremely significant; although the skin lesion area of the placebo group also decreased to a certain extent, the difference was also very significant compared with that of the experimental group.

[0125] Thus, it can be seen that the traditional Chinese medicine compound preparation has a significant antibacterial and anti-inflammatory effect. Therefore, the clinical trial shows that the traditional Chinese medicine compound preparation has a significant curative effect and high safety in the treatment of acne-infected patients.

[0126] It should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: they can still modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements on some or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention.

[0127] References:

[0128] [1]Heng AHS, Chew FT. Systematic review of the epidemiology of acne vulgaris[J]. Sci Rep, 2020, 10(1):5754.

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[0130] [3] He Li, Hao Fei. Application guidelines of anti-acne skin care products in acne[J]. The Chinese Journal of Dermatovenereology, 2019, 33(10):1107-1109.

[0131] [4] Zhang Yuejia, Liang Sixin, Zhang Jiajia. Study on the in vitro antibacterial effect of 20 traditional Chinese medicines on Propionibacterium acnes[J]. The Journal of Medical Theory and Practice, 2021, 34(10):1630-1631,1658.

[0132] [5] Wei Yaowu, Yang Xiaqing, Tang Fangyong, et al. Inhibitory study of 25 Chinese herbal medicine extracts on Propionibacterium acnes[J]. Asia-Pacific Traditional Medicine, 2018, 14(4):15-16.

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[0135] [8] Zhong Chengzhi, Wu Desong, Yan Hong, et al. Study on the antibacterial and anti-inflammatory effects of Salvia miltiorrhiza and Glycyrrhiza uralensis extracts[J]. Yunnan Journal of Traditional Chinese Medicine and Materia Medica, 2023, 44(7):68-71.

[0136] [9] Wang Jiahui, Chen Lin, Sun Ping. Preparation, quality evaluation of baicalin liposome gel and its pharmacodynamic evaluation on acne[J]. Chinese Traditional and Herbal Drugs, 2021,52(16):4860-4872.

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Claims

1. A traditional Chinese medicine compound preparation for treating acne, characterized in that, It includes 12 traditional Chinese medicines, namely Coptis chinensis, Rheum palmatum, Scutellaria baicalensis, Sophora flavescens, Lonicera japonica, Taraxacum mongolicum, Prunella vulgaris, Anemarrhena asphodeloides, Salvia miltiorrhiza, Syzygium aromaticum, Zanthoxylum bungeanum, and Granatum peel. Among them, by weight, Coptis chinensis is 1 - 2 parts, Rheum palmatum is 3 - 5 parts, Scutellaria baicalensis is 1 - 3 parts, Sophora flavescens is 1 - 3 parts, Lonicera japonica is 3 - 5 parts, Taraxacum mongolicum is 3 - 5 parts, Prunella vulgaris is 3 - 5 parts, Anemarrhena asphodeloides is 2 - 4 parts, Salvia miltiorrhiza is 3 - 5 parts, Syzygium aromaticum is 0.5 - 1.5 parts, Zanthoxylum bungeanum is 1 - 2 parts, and Granatum peel is 1 - 3 parts.

2. The traditional Chinese medicine compound preparation according to claim 1, characterized in that, By weight, the traditional Chinese medicine compound preparation includes 1.5 parts of Coptis chinensis, 4 parts of Rheum palmatum, 2 parts of Scutellaria baicalensis, 2 parts of Sophora flavescens, 4 parts of Lonicera japonica, 4 parts of Taraxacum mongolicum, 4 parts of Prunella vulgaris, 3 parts of Anemarrhena asphodeloides, 4 parts of Salvia miltiorrhiza, 1 part of Syzygium aromaticum, 1.5 parts of Zanthoxylum bungeanum, and 2 parts of Granatum peel.

3. The traditional Chinese medicine compound preparation according to claim 1, characterized in that, The traditional Chinese medicine compound preparation also includes disinfection and sterilization products, cosmetics, or pharmaceutically acceptable excipients.

4. The traditional Chinese medicine compound preparation according to claim 3, characterized in that, The excipients include one or more of glycerol, silicone oil, allantoin, mineral oil, cellulose, chitosan, methylparaben, phenoxyethanol, fatty alcohol, fatty alcohol polyether, fatty acid esters, cellulose and its derivatives, carbomer, acrylate / C10 - 30 alkyl acrylate cross - polymer urea, butylene glycol, borneol, sodium benzoate, potassium sorbate, and essence.

5. The traditional Chinese medicine compound preparation according to any one of claims 1-4, characterized in that, The dosage form of the traditional Chinese medicine compound preparation is selected from: emulsion, aqueous solution, oil solution, tincture, ointment, plaster, cream, spray, drop, patch, or gel.

6. The traditional Chinese medicine compound preparation according to claim 5, characterized in that, The dosage form of the traditional Chinese medicine compound preparation is gel.

7. A preparation method of the traditional Chinese medicine compound preparation according to any one of claims 1-4, characterized in that, It includes the following steps: Step 1: Select raw materials according to the weight ratio: Coptis chinensis, Rheum palmatum, Scutellaria baicalensis, Sophora flavescens, Lonicera japonica, Taraxacum mongolicum, Prunella vulgaris, Anemarrhena asphodeloides, Salvia miltiorrhiza, Syzygium aromaticum, Zanthoxylum bungeanum, and Granatum peel; Step 2: Crush Coptis chinensis, Rheum palmatum, Scutellaria baicalensis, Sophora flavescens, Lonicera japonica, Taraxacum mongolicum, Prunella vulgaris, Anemarrhena asphodeloides, Salvia miltiorrhiza, Syzygium aromaticum, Zanthoxylum bungeanum, and Granatum peel, and after crushing, filter to obtain the coarsest powder (powder that can all pass through the No. 1 sieve but contains no more than 20% of the powder that can pass through the No. 3 sieve) drug powder; Step 3: Add 5 times the amount of water to soak the drug powder for 8 - 12 h, and then heat it to 50 °C in an ultrasonic extraction tank. Then carry out ultrasonic extraction for 1 h; Step 4: Filter the extracted medicinal liquid, then add phenoxyethanol and sodium benzoate and stir well. After standing for 24 h, carry out suction filtration; Step 5: The obtained liquid is centrifuged, concentrated, decolorized, or deodorized in sequence to obtain the traditional Chinese medicine compound preparation for treating acne.

8. Use of the traditional Chinese medicine compound preparation according to any one of claims 1-4 in the preparation of a drug for treating acne.

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