A traditional Chinese medicine composition for improving acne and application thereof

Abstract

The present application relates to the technical field of biological medicine, in particular to a traditional Chinese medicine composition for improving acne and application, which is made of medicinal raw materials including a first component, a second component and a third component, wherein the first component includes 25-35 parts of white yam, 25-35 parts of hawthorn, 25-35 parts of salvia miltiorrhiza, 13-17 parts of gardenia, and 8-12 parts of white peony; the second component includes 25-35 parts of nacre, 13-17 parts of tribulus terrestris, and 8-12 parts of safflower; and the third component includes 13-17 parts of raw rhubarb, 8-12 parts of gallnut, 8-12 parts of turmeric, 3-7 parts of ganoderma lucidum, and 3-7 parts of winter nightshade. The traditional Chinese medicine composition has the dual effects of inhibiting propionibacterium acnes and anti-inflammation, and especially, the whole composition shows a significant synergistic effect in anti-inflammation in vivo, which is better than each component alone or any two components in combination. The composition can be prepared into oral or external medicines for preventing, relieving and treating various types of acne, and can also improve post-acne pigmentation and post-acne scarring, and has a good application prospect with a significant clinical effect and high safety.

Description

Technical Field

[0001] This invention relates to the field of biomedical technology, and in particular to a traditional Chinese medicine composition for improving acne and its application. Background Technology

[0002] Acne is a chronic inflammatory skin disease of the pilosebaceous unit, commonly occurring on the face, back, and chest—areas rich in sebaceous glands. Its clinical manifestations are diverse, including comedones (blackheads, whiteheads), inflammatory papules, pustules, nodules, and cysts. Severe cases can leave atrophic or hypertrophic scars and pigmentation, significantly impacting the patient's appearance and mental health. Statistics show that approximately 80% of adolescents experience acne to varying degrees, and some middle-aged men and women are also troubled by it.

[0003] Modern medicine believes that the pathogenesis of acne is related to multiple factors, mainly including: elevated androgen levels leading to excessive sebum secretion, abnormal keratinization of the pilosebaceous duct, microbial infection such as Propionibacterium acnes, and the resulting inflammatory response and immune dysregulation. Currently, commonly used clinical treatments include topical retinoids, benzoyl peroxide, and antibiotics, as well as oral antibiotics, isotretinoin, and anti-androgens. However, these therapies generally suffer from problems such as skin irritation, drug resistance, high relapse rates after discontinuation, and poor patient compliance. In particular, oral antibiotics and isotretinoin, while effective, have systemic side effects such as intestinal flora imbalance, liver damage, and teratogenicity, limiting their long-term use.

[0004] Traditional Chinese medicine (TCM) has a long history of treating acne, emphasizing a holistic approach, syndrome differentiation and treatment, and combined internal and external therapies. It possesses unique advantages such as multi-target treatment, fewer side effects, and a lower likelihood of developing drug resistance. In recent years, several TCM compound formulas have been developed for the treatment of acne. For example, Chinese patent CN115779025B discloses a TCM preparation for treating female acne, composed of dandelion, forsythia, atractylodes macrocephala, angelica sinensis, poria cocos, chuanxiong rhizome, white peony root, alisma plantago-aquatica, angelica dahurica, apricot kernel, and platycodon grandiflorus. This preparation targets the heat-toxin accumulation and spleen deficiency with fluid retention in female acne, possessing the effects of clearing heat and detoxifying, strengthening the spleen and resolving fluid retention. Chinese patent CN115531495A discloses a traditional Chinese medicine composition composed of honeysuckle, sophora japonica, gromwell root, forsythia, scutellaria, violet, gleditsia sinensis thorns, prunella vulgaris, coix seed, raw atractylodes macrocephala, purslane, hawthorn, salvia miltiorrhiza, peony bark, and chrysanthemum. It is used to treat acne and seborrheic dermatitis, and has the effects of clearing damp-heat in the lungs and stomach, and reducing swelling and dissipating nodules. Chinese patent CN114377085A discloses a traditional Chinese medicine composition composed of scutellaria, loquat leaf, oldenlandia diffusa, hawthorn, bitter orange seed, angelica dahurica, lycium chinense root bark, coix seed, and salvia miltiorrhiza. It is used to treat acne and has the effects of clearing heat and detoxifying, cooling blood and reducing swelling. Chinese patent CN118767030A discloses a traditional Chinese medicine composition for treating acne, consisting of Rehmannia glutinosa, processed Polygonum multiflorum, Saposhnikovia divaricata, mulberry leaf, cicada slough, Sophora flavescens, Anemarrhena asphodeloides, and Lycium chinense root bark, used for acne swelling and pain caused by heat toxin accumulation.

[0005] The aforementioned patents offer valuable insights into the treatment of acne with traditional Chinese medicine from different perspectives. However, their components each have their own emphasis, and most are targeted at specific syndrome types, limiting their applicability. Existing traditional Chinese medicine compound formulas often have complex compositions, and the scientific implications of their compatibility and the mechanisms of interaction between components remain unclear, lacking support from modern pharmacological data. Particularly for oral administration of traditional Chinese medicine compound formulas, how to achieve the dual effects of systemic anti-inflammatory and inhibition of Propionibacterium acnes through scientific compatibility, while ensuring oral safety, is a pressing technical problem to be solved in this field. Therefore, developing a traditional Chinese medicine composition for improving acne with clear components, scientific compatibility, a well-defined mechanism of action, and suitability for oral administration has significant clinical and market value. Summary of the Invention

[0006] To address the aforementioned technical problems, the present invention aims to provide a traditional Chinese medicine composition and its application for improving acne. The traditional Chinese medicine composition has dual effects of inhibiting Propionibacterium acnes and anti-inflammation. In particular, the whole formula exhibits a significant synergistic effect in anti-inflammation in vivo. It can be prepared into an oral medicine for the prevention, relief and treatment of various types of acne and the improvement of acne marks and scars.

[0007] To achieve the above-mentioned technical effects, the present invention adopts the following technical solution: In a first aspect, the present invention provides a traditional Chinese medicine composition for improving acne. This traditional Chinese medicine composition is made from the following pharmaceutical raw materials, which are divided into three functional components according to the principles of monarch-minister-assistant-guide formulation: The first component consists of 25-35 parts of Ampelopsis japonica, 25-35 parts of Crataegus pinnatifida, 25-35 parts of Salvia miltiorrhiza, 13-17 parts of Gardenia jasminoides, and 8-12 parts of Bletilla striata. This component primarily targets the core pathogenesis of acne, namely "heat, blood stasis, and toxins," working together to clear heat and detoxify, cool the blood and promote blood circulation, and reduce swelling and dissipate nodules. Among them, Ampelopsis japonica clears heat and detoxifies, reduces swelling and dissipates nodules; Crataegus pinnatifida promotes blood circulation, removes blood stasis, and promotes digestion, addressing excessive sebum secretion; Salvia miltiorrhiza cools the blood, promotes blood circulation, clears the heart and relieves irritability, making it a key medicine for treating acne; Gardenia jasminoides clears heat, relieves irritability, cools the blood and detoxifies; and Bletilla striata astringes, stops bleeding, reduces swelling and promotes tissue regeneration, aiding in the healing of skin lesions.

[0008] The second component consists of 25-35 parts mother-of-pearl, 13-17 parts tribulus terrestris, and 8-12 parts safflower. This component primarily targets the pathological products and accompanying symptoms of acne related to "phlegm, dampness, and blood stasis," working synergistically to calm the liver and subdue yang, invigorate blood circulation and dispel wind, and soften and disperse nodules. Mother-of-pearl calms the liver and subdues yang, soothes the mind and calms the nerves, and has astringent and drying properties when used externally; tribulus terrestris calms the liver and relieves depression, invigorates blood circulation and dispels wind, and relieves itching; safflower invigorates blood circulation, unblocks menstruation, disperses blood stasis and relieves pain, improving local blood circulation and promoting the fading of pigmentation.

[0009] The third component consists of 13-17 parts raw rhubarb, 8-12 parts gallnut, 8-12 parts turmeric, 3-7 parts Ganoderma lucidum, and 3-7 parts asparagus. This component plays a key role in "synergistic effect" and "harmony" in the formula. It assists the first and second components in clearing heat and detoxifying, promoting blood circulation and removing blood stasis, while also protecting the body's vital energy and preventing the bitter and cold herbs from harming the body's constitution. Raw rhubarb clears heat and promotes bowel movement, cools the blood and detoxifies, removes blood stasis and unblocks the meridians, and eliminates damp heat in the stomach and intestines; gallnut astringes the lungs and reduces fire, and astringes dampness and heals sores, inhibiting local exudation; turmeric breaks up blood stasis, promotes qi circulation, unblocks the meridians and relieves pain, making it an excellent medicine for promoting blood circulation and removing blood stasis; Ganoderma lucidum replenishes qi and calms the mind, stops cough and relieves asthma, and can enhance the body's immunity; asparagus nourishes yin and moistens dryness, clears the lungs and generates fluids, and can restrain the warm and dryness of the other herbs in the formula.

[0010] As a further preferred technical solution, the first component is made from the following medicinal raw materials: 30 parts of Ampelopsis japonica, 30 parts of Crataegus pinnatifida, 30 parts of Salvia miltiorrhiza, 15 parts of Gardenia jasminoides, and 10 parts of Bletilla striata; the second component is made from the following medicinal raw materials: 30 parts of pearl powder, 15 parts of Tribulus terrestris, and 10 parts of Carthamus tinctorius; the third component is made from the following medicinal raw materials: 15 parts of raw rhubarb, 10 parts of Galla chinensis, 10 parts of Curcuma longa, 5 parts of Ganoderma lucidum, and 5 parts of Asparagus cochinchinensis.

[0011] In this invention, "parts" refers to parts by weight.

[0012] Secondly, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition. The method includes: mixing the medicinal raw materials, extracting with water, concentrating and drying to obtain an extract of the traditional Chinese medicine composition.

[0013] As a preferred embodiment of the preparation method of the present invention, the extraction method includes: extracting with water three times. In the first extraction, 5-12 times the amount of water of the total amount of medicinal slices is added, and the extraction is carried out for 0.5-3 hours. In the second extraction, 5-12 times the amount of water of the total amount of medicinal slices is added, and the extraction is carried out for 0.5-3 hours. In the third extraction, 5-10 times the amount of water of the total amount of medicinal slices is added, and the extraction is carried out for 0.5-3 hours. The three extracts are combined, filtered, and the filtrate is concentrated under reduced pressure to a relative density of 1.05-1.10 (measured at 45-55℃). The filtrate is then spray-dried or freeze-dried to obtain a dry powder of the traditional Chinese medicine extract.

[0014] Thirdly, the present invention provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine for the prevention, relief and / or treatment of acne.

[0015] The types of acne include, but are not limited to, one or more of the following: comedones (blackheads, whiteheads), inflammatory papules, pustules, nodules, and cysts. Furthermore, the application of the herbal composition of this invention also includes improving post-acne erythema, post-acne pigmentation, and post-acne scars.

[0016] Fourthly, the present invention provides a medicine for improving acne, comprising the above-mentioned traditional Chinese medicine composition or its extract as an active ingredient, and pharmaceutically acceptable excipients. Depending on clinical needs and patient compliance, the medicine may be formulated as an oral or topical preparation.

[0017] More specifically, oral preparations include, but are not limited to, granules, capsules, tablets, oral liquids, pills, or powders. For example, Embodiment 3 of the present invention provides a specific method for preparing oral granules, which involves mixing dry extract powder with excipients such as dextrin and sucrose and then granulating the mixture.

[0018] Topical preparations include, but are not limited to, ointments, gels, creams, lotions, or liniments. For example, Example 5 of this invention provides a specific method for preparing a topical cream, which involves emulsifying a concentrated extract with excipients such as stearic acid and glycerin.

[0019] The pharmaceutically acceptable excipients may be selected from one or more of the following, depending on the dosage form: diluents, binders, disintegrants, lubricants, flavoring agents, bases, emulsifiers, thickeners, and transdermal penetration enhancers.

[0020] Specifically: For oral formulations, the diluent may be at least one of dextrin, starch, lactose, and microcrystalline cellulose; the binder may be at least one of povidone, hydroxypropyl methylcellulose, and sodium carboxymethyl cellulose; the disintegrant may be at least one of sodium carboxymethyl starch, crospovidone, and crospovidone; the lubricant may be at least one of magnesium stearate, micronized silica gel, and talc; and the flavoring agent may be at least one of steviol glycosides, sucralose, and aspartame.

[0021] For topical formulations, the base may be at least one of petrolatum, liquid paraffin, lanolin, and beeswax; the emulsifier may be at least one of Tween, Span, and sodium lauryl sulfate; the thickener may be at least one of carbomer, hydroxypropyl methylcellulose, and polyvinyl alcohol; and the transdermal penetration enhancer may be at least one of azone, propylene glycol, and menthol.

[0022] Fifthly, the present invention provides a combination drug product for improving acne. The combination drug product comprises: (a) The first active ingredient, which is a traditional Chinese medicine composition as described above (which can be prepared into an oral or topical formulation); and (b) A second active ingredient, which is a topical anti-acne drug, preferably azelaic acid or a pharmaceutically acceptable salt thereof. As shown in Example 4 of the present invention, this combination therapy (oral administration of the granules of the present invention + topical administration of the cream of the present invention) exhibited a significant synergistic effect in clinical application. Its overall effective rate, reduction of skin lesions and inflammation scores, and improvement of quality of life were significantly better than those of the control group using oral or topical medications alone, and the recurrence rate was extremely low, with no adverse reactions observed.

[0023] Compared with the prior art, the present invention has the following beneficial effects: First, the herbal composition of this invention is scientifically formulated, achieving a significant synergistic effect among its components. In vivo anti-inflammatory experiments in zebrafish showed that the overall formula's inhibitory effect on Propionibacterium acnes-induced inflammatory responses not only far exceeded the effects of any single component used alone, but was also significantly superior to the combined effect of any two components. This fully demonstrates that the three-component combination is not a simple additive effect, but rather produces a substantial synergistic effect in inhibiting inflammatory responses, reflecting the scientific nature of the formulation design of this invention.

[0024] Secondly, the herbal composition of this invention possesses dual effects of inhibiting Propionibacterium acnes and anti-inflammation, exhibiting comprehensive efficacy and high safety. In vitro antibacterial experiments show that the entire formula has a strong inhibitory effect on Propionibacterium acnes, effectively eliminating pathogenic bacteria. In vivo anti-inflammatory experiments in zebrafish further confirm that the entire formula can significantly reduce neutrophil infiltration and rapidly alleviate inflammatory responses. When administered orally, the drug components are absorbed through the gastrointestinal tract into the bloodstream, systematically regulating the body's inflammation levels and improving acne from the inside out. When administered topically, the drug components act directly on the skin lesions, exerting local antibacterial, anti-inflammatory, and repair-promoting effects, without irritating the skin and exhibiting extremely high safety.

[0025] Furthermore, this invention has wide applications, can improve various acne-related symptoms, and is suitable for various oral and topical dosage forms. The herbal composition of this invention can not only effectively eliminate acne lesions such as pimples, inflammatory papules, pustules, nodules, and cysts, but also improve red acne marks, pigmentation, and pitted scars left after acne, comprehensively improving skin health. Simultaneously, this composition can be prepared into oral dosage forms such as granules, capsules, and tablets, as well as topical dosage forms such as ointments and creams, to meet the usage habits and condition needs of different patients.

[0026] Finally, the combined oral and topical medication regimen of this invention exhibits significant synergistic effects and reduces recurrence. Clinical trials have confirmed that the regimen using the oral medication of this invention combined with topical azelaic acid has a significantly higher overall effective rate than the control groups using only oral or topical medications, and the recurrence rate after treatment is far lower than that of the single-use groups. This indicates that, through the organic combination of systemic regulation and local intervention, the combined medication regimen of this invention achieves multiple therapeutic goals of rapid symptom control, deep anti-inflammation, and long-term recurrence prevention, providing a new and effective solution for the clinical treatment of acne. Attached Figure Description

[0027] Figure 1 This is a typical fluorescence micrograph of neutrophil aggregation in a zebrafish local inflammation model; Figure 2 These are before-and-after photos of a typical case (back acne) in Embodiment 3 of the present invention; Figure 3 These are before-and-after photos of a typical case (facial acne) in Example 4 of the present invention. Figure 4 These are comparative photos of a typical case in Example 5 of this invention after treatment with azelaic acid and after discontinuation of the drug; Figure 5 These are comparative photographs of a typical case in Experimental Example 5 of this invention before and after combined drug treatment. Detailed Implementation

[0028] The embodiments of the technical solution of the present invention will now be described in detail with reference to the accompanying drawings. These embodiments are merely illustrative of the technical solution of the present invention and are therefore intended to limit the scope of protection of the present invention.

[0029] Those skilled in the art will understand that the present invention can be practiced even without certain specific details. In some other embodiments, methods, means, apparatus, and steps well known to those skilled in the art have not been described in detail in order to highlight the spirit of the invention. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art. Unless otherwise specified, all units used in this specification are International Standard Units (SI), and all numerical values ​​and ranges appearing in this invention should be understood to include systematic errors unavoidable in industrial production.

[0030] All Chinese medicinal materials used in this embodiment were purchased from commercially available products that meet the standards of the Chinese Pharmacopoeia, and their pharmacopoeia basis is as follows: White peony root: the dried tuberous root of Ampelopsis japonica (Thunb.) Makino, a plant in the Vitaceae family.

[0031] Hawthorn: The dried, ripe fruit of Crataegus pinnatifida Bge. var. major NEBr. or Crataegus pinnatifida Bge., both belonging to the Rosaceae family.

[0032] Danshen: The dried root and rhizome of Salvia miltiorrhiza Bge., a plant of the Lamiaceae family.

[0033] Gardenia: The dried, ripe fruit of Gardenia jasminoides Ellis, a plant in the Rubiaceae family.

[0034] Bletilla striata: the dried tuber of Bletilla striata (Thunb.) Reichb.f., an orchid.

[0035] Mother-of-pearl: A processed product made by calcining the shells of the three-sailed mussels Hyriopsis cumingii (Lea), Cristariaplicata (Leach), or Pteria martensii (Dunker).

[0036] Tribulus terrestris L., a plant in the family Zygophyllaceae, is the dried, mature fruit of the plant.

[0037] Safflower: The dried tubular flowers of Carthamus tinctorius L., a plant in the Asteraceae family.

[0038] Raw rhubarb: The dried root and rhizome of Rheum palmatum L., Rheum tanguticum Maxim. ex Balf. or Rheum officinale Baill., belonging to the Polygonaceae family, without processing.

[0039] Gallnuts: Galls on the leaves of plants in the Anacardiaceae family, such as Rhus chinensis Mill., Rhus potaninii Maxim., or Rhus punjabensis Stew. var. sinica (Diels) Rehd. et Wils., are mainly formed by the gall aphid Melapis chinensis (Bell) Baker.

[0040] Turmeric: The dried rhizome of Curcuma longa L., a plant in the ginger family.

[0041] Lingzhi: The dried fruiting body of Ganoderma lucidum (Leyss. ex Fr.) Karst. or Ganoderma sinense Zhao, Xu et Zhang, belonging to the Polyporaceae family.

[0042] Asparagus: The dried tuberous root of Asparagus cochinchinensis (Lour.) Merr., a plant in the Liliaceae family. Example 1

[0043] The purpose of this embodiment is to provide a traditional Chinese medicine composition for improving acne and its preparation method, as detailed below: By weight, this traditional Chinese medicine composition for improving acne is made from the following pharmaceutical ingredients: First group: 30 parts of white peony root, 30 parts of hawthorn, 30 parts of salvia miltiorrhiza, 15 parts of gardenia, and 10 parts of bletilla striata; Second component: 30 parts mother-of-pearl, 15 parts tribulus terrestris, and 10 parts safflower; And the third component: 15 parts raw rhubarb, 10 parts gallnut, 10 parts turmeric, 5 parts Ganoderma lucidum, and 5 parts asparagus.

[0044] The preparation method of this traditional Chinese medicine composition is as follows: Accurately weigh each medicinal herb slice according to the above formula, mix them evenly, and put them into the extraction tank.

[0045] First extraction: Add 8 times the amount of purified water to the extraction tank, heat to a gentle boil, extract for 1 hour, filter, collect the first extract, and the separated residue enters the second extraction.

[0046] Second extraction: Add 7 times the amount of purified water to the dregs, heat to a gentle boil and extract for 1 hour, filter, collect the second extract, and the separated residue enters the third extraction.

[0047] Third extraction: Add 7 times the amount of purified water to the dregs, heat to a gentle boil and extract for 1 hour, filter, and collect the third extract.

[0048] The three extracts were combined and filtered through a 200-mesh filter cloth. The filtrate was transferred to a vacuum concentration tank and concentrated under reduced pressure at a temperature of 45-55℃ and a vacuum degree of -0.06 to -0.08 MPa until the relative density of the concentrate reached 1.05 to 1.10 (measured at 45-55℃). After spray drying, the extract powder of the traditional Chinese medicine composition of the present invention was obtained and stored in a cool, dark place in a sealed container for later use. Example 2

[0049] The purpose of this embodiment is to provide a traditional Chinese medicine composition for improving acne and its preparation method, as detailed below: By weight, this traditional Chinese medicine composition for improving acne is made from the following pharmaceutical ingredients: Group 1: 25 parts of Ampelopsis japonica, 35 parts of Crataegus pinnatifida, 25 parts of Salvia miltiorrhiza, 13 parts of Gardenia jasminoides, and 8 parts of Bletilla striata; Second component: 25 parts mother-of-pearl, 13 parts tribulus terrestris, and 8 parts safflower; The third component consists of 13 parts raw rhubarb, 8 parts gallnut, 8 parts turmeric, 3 parts Ganoderma lucidum, and 3 parts asparagus.

[0050] The origins of the above-mentioned medicinal materials are exactly the same as those described in Example 1, and all comply with the provisions of the Chinese Pharmacopoeia and related standards.

[0051] The preparation method of the traditional Chinese medicine composition provided in this embodiment is as follows: Accurately weigh each medicinal herb slice according to the above formula, mix them evenly, and put them into the extraction tank.

[0052] First extraction: Add 8 times the amount of purified water to the extraction tank, heat to a gentle boil, extract for 1 hour, filter, collect the first extract, and the separated residue enters the second extraction.

[0053] Second extraction: Add 6 times the amount of purified water to the dregs, heat to a gentle boil and extract for 1 hour, filter, collect the second extract, and the separated residue enters the third extraction.

[0054] Third extraction: Add 6 times the amount of purified water to the dregs, heat to a gentle boil and extract for 1 hour, filter, and collect the third extract.

[0055] The three extracts were combined and filtered through a 200-mesh filter cloth. The filtrate was transferred to a vacuum concentration tank and concentrated under reduced pressure at a temperature of 45-55℃ and a vacuum degree of -0.06 to -0.08 MPa until the relative density of the concentrate reached 1.05 to 1.10 (measured at 45-55℃). After spray drying, the extract powder of the traditional Chinese medicine composition of the present invention was obtained and stored in a cool, dark place in a sealed container for later use.

[0056] Experimental Example 1 Propionibacterium acnes is a Gram-positive anaerobic bacterium. Numerous studies have shown that Propionibacterium acnes is closely related to excessive sebum secretion, excessive keratinization, inflammation, and tissue damage. This experimental method uses an in vitro method to evaluate the acne-reducing efficacy of the traditional Chinese medicine composition for improving acne provided by this invention.

[0057] This test example aims to evaluate the antibacterial efficacy of the compositions claimed in this invention using an in vitro method, as follows: 1.1 Experimental Materials and Methods Experimental strain: Propionibacterium acnes; Experimental reagents: phosphate buffer, reinforced Clostridium difficile culture medium (RCM); Equipment: Anaerobic incubator, vertical autoclave; 1.2 Grouping and Sample Preparation: The following groups were set up in this experiment: Sample 1 (Complete Formula): The complete formula of Example 1, namely the first component (30 parts of Ampelopsis japonica, 30 parts of Crataegus pinnatifida, 30 parts of Salvia miltiorrhiza, 15 parts of Gardenia jasminoides, 10 parts of Bletilla striata), the second component (30 parts of pearl powder, 15 parts of Tribulus terrestris, 10 parts of Carthamus tinctorius), and the third component (15 parts of raw rhubarb, 10 parts of Galla chinensis, 10 parts of Curcuma longa, 5 parts of Ganoderma lucidum, 5 parts of Asparagus cochinchinensis), was extracted into powder according to the method of Example 1.

[0058] Sample 2 (first component single use group): only the first component medicinal materials (30 parts of white peony root, 30 parts of hawthorn, 30 parts of salvia miltiorrhiza, 15 parts of gardenia, and 10 parts of bletilla striata) were taken and extracted into powder according to the method of Example 1.

[0059] Sample 3 (second component single use group): only the second component medicinal materials (30 parts of mother-of-pearl, 15 parts of tribulus terrestris, and 10 parts of safflower) were taken and extracted into powder according to the method of Example 1.

[0060] Sample 4 (Third Component Single Use Group): Only the third component medicinal materials (15 parts of raw rhubarb, 10 parts of gallnut, 10 parts of turmeric, 5 parts of Ganoderma lucidum, and 5 parts of asparagus) were taken and extracted into powder according to the method in Example 1.

[0061] Sample 5 (Combined use of first and second components): Take the first and second component medicinal materials (the mass ratio of the two components in the whole formula is the same as that of the first component, i.e., the total amount of the first component is 115 and the total amount of the second component is 55), and extract them into powder according to the method of Example 1.

[0062] Sample 6 (Combined use of first and third components): Take the first and third components of medicinal materials (the mass ratio of the first and third components is the same as the ratio of the two components in the whole formula, that is, the total part of the first component is 115 and the total part of the third component is 45), and extract them into powder according to the method of Example 1.

[0063] Sample 7 (Combined use of second and third components): Take the second and third components of medicinal materials (the mass ratio of the two components in the whole formula is the same as that of the whole formula, that is, the total part of the second component is 55 and the total part of the third component is 45), and extract them into powder according to the method of Example 1.

[0064] All the above sample extract powders were prepared according to the method described in Example 1 (water decoction extraction, concentration, and drying). All samples were dissolved and diluted with phosphate-buffered saline (PBS) to the same dosage concentration before testing. The dosage concentration was calculated based on the raw medicinal material and was equivalent to a raw medicinal material concentration of 150 mg / mL.

[0065] 1.3 Experimental Methods: Propionibacterium acnes in the logarithmic growth phase was diluted with PBS to prepare approximately 10 6 CFU / mL bacterial suspension. The extract powders of the above samples were dissolved in PBS and diluted to the same concentration (the crude drug concentration was 150 mg / mL) to obtain the sample solution.

[0066] Mix 0.5 mL of bacterial suspension and 0.5 mL of sample solution in a sterile centrifuge tube and incubate at room temperature for 15 minutes. Use PBS as a blank control (control group) instead of the sample. After incubation, perform a 10-fold serial dilution of 100 μL of the mixture, and plate the appropriate dilution onto RCM plates, with three replicates for each dilution. Incubate the plates in an anaerobic incubator at 37°C for 48 hours, and then count the viable bacteria. Repeat the experiment three times. The inhibition rate is calculated using the following formula: Antibacterial rate (%) = (average colony count of control sample group - average colony count of test sample group) / average colony count of control sample group × 100%.

[0067] The antibacterial rate of the test sample is >50%, which indicates that the sample has a certain acne-removing effect. The higher the antibacterial rate of Propionibacterium acnes, the stronger the acne-removing effect of the sample.

[0068] 1.4 Experimental Results and Analysis The experimental results are shown in Table 1.

[0069] Table 1. Inhibition rate of each sample against Propionibacterium acnes (n=3) As shown in Table 1, under the same total drug concentration, the total formulation of this invention (Sample 1) exhibited a high inhibition rate of 99.89% against Propionibacterium acnes, with a surviving bacterial count of only 40 CFU / mL, demonstrating extremely strong in vitro antibacterial activity. Among the single-component formulations, the third component (Sample 4) showed the strongest antibacterial activity, with an inhibition rate of 98.97%; the first component (Sample 2) and the second component (Sample 3) also exhibited good antibacterial effects, with inhibition rates of 85.29% and 79.71%, respectively.

[0070] It is noteworthy that the antibacterial rate of the combination of the first and second components (Sample 5) (71.43%) was lower than that of either component used alone, suggesting that at this total concentration, the combined use of the first and second components may lead to a decrease in antibacterial effect due to interactions between the components. However, when the third component was added to the formulation, the situation changed significantly: the antibacterial rate of the combination of the first and third components (Sample 6) rebounded to 99.49%, and the antibacterial rate of the combination of the second and third components (Sample 7) reached 99.20%, both approaching the level of the complete formulation. The complete formulation (Sample 1) achieved the best antibacterial effect (99.89%), with the lowest number of surviving bacteria.

[0071] Experimental Example 2 This experiment used a transgenic neutrophil-based green fluorescent zebrafish model to evaluate the inhibitory effect of each sample on the inflammatory response induced by Propionibacterium acnes in vivo. The preparation of all samples was the same as in Experiment 1.

[0072] 2.1 Experimental Materials and Methods Experimental system: transgenic neutrophil-containing green fluorescent zebrafish (MPX).

[0073] Zebrafish age: 3 days post-fertilization (3 dpf).

[0074] Sample size per group: 15 tails.

[0075] Adult fish rearing and breeding methods: The rearing and breeding methods shall be carried out in accordance with laboratory standards and meet the requirements of international AAALAC certification (certification number: 001458).

[0076] 2.2 Grouping and Sample Preparation The following samples were prepared according to the formulation and extraction process of Example 1 and then freeze-dried into powder: Sample 1 (Full Formula): Extracted by mixing and extracting the first, second and third components according to the optimal prescription in Example 1.

[0077] Sample 2 (Single use of the first component): Extraction was performed using only the first component of the drug (30g of Ampelopsis japonica, 30g of Crataegus pinnatifida, 30g of Salvia miltiorrhiza, 15g of Gardenia jasminoides, and 10g of Bletilla striata).

[0078] Sample 3 (second component single use group): only the second component drugs (30g of mother-of-pearl, 15g of tribulus terrestris, and 10g of safflower) were extracted.

[0079] Sample 4 (Third Component Single Use Group): Only the third component drugs (raw rhubarb 15g, gallnut 10g, turmeric 10g, Ganoderma lucidum 5g, asparagus 5g) were extracted.

[0080] Sample 5 (Combined use of first and second components): The first and second components of the drug were mixed and extracted.

[0081] Sample 6 (Combined use of first and third components): The first and third components of the drug were mixed and extracted.

[0082] Sample 7 (Combined use of second and third components): The second and third components of the drug were mixed and extracted.

[0083] 2.3 Experimental Methods Healthy zebrafish were randomly selected, and except for the normal control group, the other groups were administered 10 mg / L via microinjection. 9 A local inflammation model was established in zebrafish by injecting 10 nL of Propionibacterium acnes bacterial suspension at CFU / mL, while the normal control group was injected with an equal volume of PBS. After modeling, each sample group was given the corresponding sample test solution, and the dosage was kept consistent across groups based on the amount of raw drug.

[0084] 2.3.1 Dosage exploration To determine the appropriate drug concentration for this experimental system, a series of raw drug concentration gradients were first set up for sample 1 (the whole formula group) for preliminary experiments. According to the raw drug amount, the drug concentration range covered 0.083 mg / mL to 6.6 mg / mL, and 0.005% salicylic acid solution was used as a positive control.

[0085] 2.3.2 Acne-removing efficacy experiment Specific drug administration procedure: Add 100 μL of the corresponding concentration of sample test solution to each well, and then make up to a final volume of 3 mL with physiological saline; add an equal volume of physiological saline to the model control group and the normal control group. Incubate at 28°C in the dark for 3 hours.

[0086] After incubation, 10 zebrafish were randomly selected from each group and photographed under a fluorescence microscope. Some typical images of acne removal are shown below. Figure 1 As shown, in this Figure 1 In the image, the area within the yellow dashed box represents the neutrophil counting region. The number of neutrophils (N) in the zebrafish yolk sac was analyzed using NIS-Elements image analysis software. The formula for calculating the acne-reducing efficacy is as follows: Acne-removing efficacy (%) = [N(model control group) - N(sample group)] / [N(model control group) - N(normal control group)] × 100%.

[0087] Statistical analysis was performed using GraphPad Prism software with t-tests, and p < 0.05 was considered statistically significant.

[0088] 2.4 Experimental Results and Analysis 2.4.1 Study on dose-response relationship of the full-formula group First, the inhibitory effect of sample 1 on the inflammatory response induced by Propionibacterium acnes was investigated at multiple safe drug concentrations. The experimental results are shown in Table 2.

[0089] Table 2. Effects of different concentrations of crude drug on the number of neutrophils in zebrafish and its acne-reducing efficacy in Sample 1 (n=10) As shown in Table 2, Sample 1 significantly inhibited neutrophil aggregation induced by Propionibacterium acnes, exhibiting a favorable dose-response relationship. The normal control group showed very few neutrophils, while the model control group showed a significantly increased number, indicating successful propionibacterium acnes modeling. The positive control group (salicylic acid) significantly reduced the number of neutrophils.

[0090] At a crude drug concentration of 5.0 mg / mL, Sample 1 showed an acne-reducing efficacy of 84%, with neutrophil counts decreasing to near-normal levels, demonstrating highly effective anti-inflammatory activity. When the concentration increased to 6.6 mg / mL, the efficacy was 62%, slightly lower than the 5.0 mg / mL group, but still significantly better than the model control group. When the concentration decreased to 3.3 mg / mL, the efficacy was 59%, maintaining a high inhibition rate. As the concentration further decreased, the efficacies of the 1.7 mg / mL, 0.83 mg / mL, and 0.33 mg / mL groups were 47%, 43%, and 41%, respectively, with the inhibitory effect gradually weakening; while at 0.17 mg / mL and below, the efficacy decreased to 39% and 23%, respectively, with neutrophil counts approaching the level of the model control group, and the inhibitory effect essentially disappeared.

[0091] The above results indicate that sample 1 has a concentration-dependent inhibitory effect on the inflammatory response induced by Propionibacterium acnes, with 5.0 mg / mL being the optimal effective concentration. Considering both efficacy and safety, a crude drug concentration of 5.0 mg / mL was selected as the uniform test concentration for all samples in subsequent studies.

[0092] 2.4.2 Comparison of anti-inflammatory activities among different groups in the fractional formulation study To further observe the compatibility effects of each medicinal ingredient in this invention, we conducted a decomposition study on the optimal prescription described in Example 1. Based on the concentration exploration and dose-effect relationship study results in section 2.4.1 above, Sample 1 (whole extract) exhibited the best safety and anti-inflammatory activity at a crude drug concentration of 5.0 mg / mL. Therefore, 5.0 mg / mL was selected as the uniform test concentration for all samples in this section to compare the in vivo anti-inflammatory activity of different combinations under the same conditions. The experimental results are shown in Table 3, and the following groups were tested under the same conditions.

[0093] Table 3. Acne-reducing efficacy of each sample group in the zebrafish model (n=10) As shown in Table 3, at the same total drug concentration (5.0 mg / mL), compared with the model control group, the number of neutrophils in the zebrafish yolk sac of all sample groups was significantly reduced, indicating that each sample had in vivo anti-inflammatory activity and could effectively inhibit the inflammatory response induced by Propionibacterium acnes. Among them, sample one of the present invention had the highest acne-removing efficacy, reaching 85% (slightly different from 84% in section 2.4.1, due to rounding in data calculation and normal experimental fluctuations), which was not only much higher than the first, second, and third components used alone, but also significantly higher than the group using any two components in combination. This result clearly shows that, under the complex physiological environment in vivo, the anti-inflammatory effect obtained by the combined use of the first, second, and third components is far superior to any single component or combination of two components.

[0094] It is particularly noteworthy that while the combined efficacy of the first and second components was higher than that of either component alone, it was lower than that of the complete formula. However, the efficacy of the complete formula jumped significantly to 85% after the introduction of the third component. This suggests that the third component not only has its own anti-inflammatory activity, but more importantly, it can produce a synergistic effect with the first and second components, thereby maximizing the overall anti-inflammatory capacity. Example 3

[0095] The purpose of this embodiment is to provide an oral granule containing the traditional Chinese medicine composition of the present invention, and to observe its effect on improving acne through human oral administration.

[0096] 3.1 Preparation of oral granules According to the optimal prescription described in Example 1 (first component: 30 parts of Ampelopsis japonica, 30 parts of Crataegus pinnatifida, 30 parts of Salvia miltiorrhiza, 15 parts of Gardenia jasminoides, and 10 parts of Bletilla striata; second component: 30 parts of pearl powder, 15 parts of Tribulus terrestris, and 10 parts of Carthamus tinctorius; third component: 15 parts of raw rhubarb, 10 parts of Galla chinensis, 10 parts of Curcuma longa, 5 parts of Ganoderma lucidum, and 5 parts of Asparagus cochinchinensis), 1000 g of raw medicinal materials were weighed and extracted. The specific extraction method was the same as in Example 1. The three extracts were combined, filtered, and the filtrate was concentrated under reduced pressure at 45-55℃ to a relative density of 1.05-1.10 (measured by heat at 45-55℃) to obtain a concentrated extract of traditional Chinese medicine. The concentrated extract was spray-dried to obtain 239.5 g of dry powder of traditional Chinese medicine extract (derived from 1000 g of raw medicinal materials).

[0097] The general formula for oral granules provided in this embodiment (based on 1000g) is as follows: The dry powder of Chinese herbal extract (derived from 1000g of raw medicinal materials) contains 239.5g of sucrose, 9.5g of sucrose, 0.5g of steviol glycosides, 217g of dextrin, and an appropriate amount of 95% ethanol. The preparation steps are as follows: (1) The dry powder of Chinese herbal extract, dextrin, sucrose and steviol glycosides are pulverized and passed through an 80-mesh sieve, weighed according to the prescription amount, and mixed evenly to obtain a mixed powder.

[0098] (2) Add an appropriate amount of 95% ethanol to the mixed powder to form a soft material, and granulate it by extruding it through a 14-mesh sieve.

[0099] (3) Place the wet granules in an oven at 60-70℃ and dry them until the moisture content is ≤5.0%.

[0100] (4) The dried granules are sieved through a 12-mesh sieve and packaged into bags containing 15 g of raw medicinal material each to obtain the acne-removing oral granules of the present invention (full formula sample).

[0101] Dosage and administration: Take 1 packet twice a day (equivalent to 15 g of raw herb per oral dose, 30 g of raw herb per day), dissolved in warm water.

[0102] 3.2 Typical Cases Mr. Chen, male, 26 years old, had presented with scattered multiple cysts and nodular acne on his back and chest for 3 years, with poor response to topical retinoid creams. Upon examination, he had extensive dark red nodules and cysts on his back, some of which had merged to form inflammatory plaques, and some of which discharged purulent discharge upon squeezing, accompanied by severe spontaneous pain.

[0103] The entire formula granules of this invention were taken orally, one sachet twice daily, dissolved in warm water. After two weeks of treatment, the cystic nodules softened and shrank, the depth of inflammatory infiltration decreased, and the pain disappeared. After four weeks of treatment, most of the skin lesions on the back subsided, old lesions significantly flattened and lightened, and no new lesions were observed. No adverse reactions were observed during the treatment. Before and after treatment photos are shown below. Figure 2 , Figure 2 The left side shows the treatment before the procedure. Figure 2 The image on the right is taken 4 weeks after treatment. Example 4

[0104] The purpose of this embodiment is to provide a topical cream containing the traditional Chinese medicine composition of the present invention, and to observe its effect on improving and treating acne through human topical application tests.

[0105] 4.1 Preparation of topical creams The raw medicinal materials were weighed according to the optimal prescription described in Example 1 (calculated by mass parts, including: first component: 30 g of Ampelopsis japonica, 30 g of Crataegus pinnatifida, 30 g of Salvia miltiorrhiza, 15 g of Gardenia jasminoides, and 10 g of Bletilla striata; second component: 30 g of pearl powder, 15 g of Tribulus terrestris, and 10 g of Carthamus tinctorius; third component: 15 g of Rheum palmatum, 10 g of Galla chinensis, 10 g of Curcuma longa, 5 g of Ganoderma lucidum, and 5 g of Asparagus cochinchinensis). The mother liquor of the herbal extract was obtained by the extraction method described in Example 1 (three decoctions, combined filtrates, concentrated under reduced pressure to a relative density of 1.05-1.10 (measured at 45-55℃)). The dry powder of the herbal composition of the present invention was obtained by the extraction method described in Example 1 (three decoctions, combined filtrates, concentrated under reduced pressure to a relative density of 1.05-1.10 (measured at 45-55℃), and then spray-dried). Take an appropriate amount of the extract powder, dissolve it in water and make up the volume so that each 30 g solution contains the equivalent of 50 g of raw medicinal material extract, thus obtaining the standard mother liquor for later use.

[0106] The general formula for topical creams (per 1000g) is as follows: 200 g of standard stock solution (each 30 g corresponds to 50 g of crude drug); 120g of stearic acid; 35g of glyceryl monostearate; 60g of liquid paraffin; 10g of white petroleum jelly; Triethanolamine 4g; 50g of glycerin; Ethylparaben 1g; Add distilled water to bring the system weight to 1000g; The preparation steps are as follows: (1) Take stearic acid, glyceryl monostearate, liquid paraffin and white petrolatum, mix them and heat to 75-80℃ as the oil phase.

[0107] (2) Take the standard mother liquor of Chinese herbal extract, triethanolamine, glycerin, ethylparaben and an appropriate amount of distilled water, mix and heat to 75-80℃ as the aqueous phase.

[0108] (3) Add the aqueous phase slowly to the oil phase while stirring, and keep the temperature and stir until emulsification is complete.

[0109] (4) Continue stirring until condensation, and the acne-removing topical cream of the present invention (full formula sample) is obtained.

[0110] Dosage and administration: Apply an appropriate amount to the cleansed affected area twice daily and massage gently.

[0111] 4.2 Typical Cases Please see Figure 3 Ms. Li, 24 years old, had a history of recurrent inflammatory papules and pustules on her face for over three years. She had previously used various topical ointments and oral antibiotics with poor results and frequent relapses. Upon examination, scattered red inflammatory papules were observed on both cheeks, between the eyebrows, and on the jawline, some with pustules at the tips, accompanied by significant tenderness. The affected skin also showed marked seborrhea. Her tongue was red with a yellow, greasy coating, and her pulse was slippery and rapid. Traditional Chinese medicine diagnosis indicated a pattern of heat-toxin accumulation and dampness-stasis.

[0112] The ointment of this invention (prepared according to Example 4) was applied topically to the affected area after cleansing the face with warm water in the morning and evening. A thin, even layer was applied to the lesions, and the skin was gently massaged in until absorbed. This was done twice daily, morning and evening. After two weeks of treatment, a follow-up visit showed significant reduction in facial inflammatory lesions and a decrease in new lesions. The subject reported a significant reduction in local tenderness. After four weeks of treatment, the facial lesions had essentially subsided, leaving only a few light red acne marks. The subject reported a substantial improvement in skin oiliness. No adverse reactions were observed during the treatment. Before-and-after photos are shown below. Figure 3 ,in, Figure 3 The left side shows the treatment before the procedure. Figure 3 The image on the right shows the result after treatment. Example 5

[0113] To systematically evaluate the clinical efficacy and safety of the traditional Chinese medicine composition (whole formula granules) of this invention combined with topical 15% azelaic acid cream in the treatment of acne vulgaris, the following randomized controlled clinical trial was designed with reference to relevant clinical research methods [Nie Tingfen et al., 2023].

[0114] 1. Materials and Methods 1.1 General Information Ninety patients with acne vulgaris who visited the Department of Dermatology at Sichuan Provincial Hospital of Integrated Traditional and Western Medicine between May and October 2025 were selected. Among them, there were 44 males and 46 females, aged 18 to 35 years, with a mean age of (24.5±4.2) years and a disease duration of 6 months to 5 years, with a mean duration of (2.4±1.1) years.

[0115] Inclusion criteria: (1) meeting the diagnostic criteria for acne vulgaris in the Chinese Guidelines for the Treatment of Acne (2019 Revised Edition) and having a Pillsbury classification of I to III; (2) being aged 18 to 35 years, regardless of gender; (3) not having used oral or topical anti-acne medications in the month prior to the trial; and (4) voluntarily participating in the trial and signing an informed consent form.

[0116] Exclusion criteria: (1) pregnant or lactating women; (2) those allergic to azelaic acid or the drug components of this study; (3) those with serious systemic diseases such as heart, liver, and kidney; (4) those with other facial skin diseases (such as seborrheic dermatitis, rosacea, contact dermatitis, etc.) that interfere with the evaluation of efficacy; (5) those who have participated in other clinical trials within the past 3 months.

[0117] 1.2 Test Drugs The drug of this invention: The oral granules of this invention were prepared according to the method of Example 3, and the samples were prepared by Sichuan Academy of Traditional Chinese Medicine. Control group medication: 15% azelaic acid cream (commercially available); 1.3 Grouping and Dosing Regimen The 90 patients were randomly divided into 3 groups of 30 patients each using a random number table method, as follows; The invention group: Orally administer the granules of the present invention, twice a day, one packet each time (equivalent to 15g of raw herbs, the daily dose of raw herbs is 30g), dissolved in warm water.

[0118] Azelaic acid group: Apply 15% azelaic acid cream topically. After cleansing the face with warm water in the morning and evening, apply a thin, even layer to the affected area and gently massage until absorbed. Apply once in the morning and once in the evening.

[0119] Combined medication group: Oral administration of the granules of this invention (usage as in the group of this invention) combined with topical application of 15% azelaic acid cream (usage as in the azelaic acid group), with the same usage and dosage of each component as above.

[0120] All participants received standardized basic skincare guidance during the trial, including sun protection, moisturizing, avoiding spicy and irritating foods, and maintaining a regular sleep schedule. The treatment course for each group lasted 8 weeks.

[0121] 1.4 Observation Indicators 1.4.1 Clinical efficacy evaluation criteria The guidelines were formulated in accordance with the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines". The reduction rate of skin lesions was calculated based on the total number of skin lesions (including acne, papules, and pustules) before and after treatment.

[0122] Cure rate: Skin lesion reduction rate ≥90%; Effective: 60% ≤ skin lesion reduction rate < 90%; Effective: 20% ≤ skin lesion reduction rate < 60%; Ineffective: Skin lesion reduction rate <20% or worsening; The overall effective rate is calculated as follows: Overall effective rate = (number of cured cases + number of cases with significant effect + number of cases with effect) / total number of cases × 100%.

[0123] 1.4.2 Skin lesion count and inflammation score The total number of facial skin lesions (acne, papules, and pustules were counted separately) was recorded before treatment, 4 weeks after treatment, and 8 weeks after treatment. The Investigator Global Assessment (IGA) score was used to measure the degree of inflammation of the skin lesions, using a 5-point scale from 0 to 4, with higher scores indicating more severe inflammation.

[0124] 1.4.3 Dermatology Quality of Life Index (DLQI) score: It includes 10 dimensions such as physical, psychological and daily life (0-3 points for each item, total score of 30 points). The higher the score, the worse the quality of life.

[0125] 1.4.4 Recurrence Rate Follow-up: After treatment, all subjects who showed effective treatment results (including cure, significant effect, and effective) were followed up for 4 weeks to record recurrence status. If the total number of skin lesions increased by 30% or more compared to the end of treatment during the follow-up period, it was considered a recurrence.

[0126] 1.4.5 Adverse Reaction Observation: All subjects using azelaic acid underwent a 1-week tolerance period (week 1 was not included in the adverse reaction statistics). From week 2 onwards, adverse reactions occurring during treatment were recorded, including but not limited to skin irritation (redness, burning, desquamation), gastrointestinal discomfort, etc. The incidence of adverse reactions was calculated based on the number of cases observed during weeks 2-8.

[0127] 1.5 Statistical Analysis Data analysis was performed using specialized statistical software. Quantitative data were... The data were analyzed using paired t-tests for comparisons before and after treatment within each group, one-way ANOVA for comparisons among multiple groups, and LSD-t tests for further pairwise comparisons. Categorical data were expressed as percentages (%), and comparisons between groups were performed using the χ² test. 2 Test. P < 0.05 is considered statistically significant.

[0128] 2. Experimental Results 2.1 Comparison of baseline data among the three groups of patients There were no statistically significant differences among the three groups of patients in terms of gender, age, disease duration, and total number of skin lesions before treatment (P > 0.05), indicating that they were comparable.

[0129] 2.2 Comparison of clinical efficacy among the three groups After 8 weeks of treatment, the total effective rate of the combined drug group was 96.7%, which was significantly higher than 83.3% in the group of the present invention and 80.0% in the azelaic acid group (see Table 5).

[0130] Table 5 Comparison of clinical efficacy among the three groups 2.3 Comparison of lesion counts and IGA scores among the three groups Before treatment, there were no significant differences in the total number of skin lesions and IGA scores among the three groups. After 4 and 8 weeks of treatment, the total number of skin lesions and IGA scores in each group decreased significantly compared with before treatment (P < 0.01), with the combined medication group showing the largest decrease. After 8 weeks of treatment, the differences between the combined medication group and the group of the present invention and the azelaic acid group were statistically significant (P < 0.05 or P < 0.01), as shown in Table 6.

[0131] Table 6 Comparison of skin lesion counts and IGA scores before and after treatment in the three groups ( ) Compared with the same group before treatment: **P <0.01; Compared with the same period of the present invention group: ## P < 0.01, # P < 0.05; compared with the azelaic acid group at the same time: △△ P < 0.01, △ P < 0.05; 2.4 Comparison of DLQI scores among the three groups Before treatment, there were no significant differences in DLQI scores among the three groups. After 4 and 8 weeks of treatment, the DLQI scores of all groups decreased significantly compared with those before treatment (P < 0.01), with the most significant decrease observed in the combination therapy group. After 8 weeks of treatment, the differences between the combination therapy group and the group using this invention and the azelaic acid group were statistically significant (P < 0.05), as shown in Table 7.

[0132] Table 7 Comparison of DLQI scores before and after treatment in the three groups ( ,point) Compared with the same group before treatment: **P <0.01; Compared with the same period of the present invention group: ##P <0.01, #P <0.05; Compared with the same period of the azelaic acid group: △△P <0.01, △P <0.05; 2.5 Comparison of recurrence rates among the three groups After treatment, patients with effective results were followed up for 4 weeks. The relapse rate in the combination therapy group was significantly lower than that in the invention group and the azelaic acid group, indicating that the combination therapy has better long-term efficacy (see Table 8).

[0133] Table 8 Comparison of relapse rates among the three groups 4 weeks after treatment 2.6 Safety evaluation and adverse reaction analysis (1) Occurrence of adverse reactions in each group During treatment, no significant adverse reactions were observed in the experimental group. In the azelaic acid group, after the one-week tolerance period, 14 cases (46.7%) still experienced local skin irritation, mainly manifested as mild to moderate redness, swelling, itching, and desquamation. Most of these patients experienced gradual symptom relief after continued medication, while 2 cases had significant symptoms that did not affect treatment. In the combined medication group, only 5 cases (16.7%) experienced mild local skin irritation, and the severity of their symptoms was significantly milder than in the azelaic acid group, gradually subsiding with continued treatment. None of the adverse reactions led to treatment interruption, and no serious adverse events were observed in any group.

[0134] (2) Safety evaluation conclusion Experimental results show that the oral granules provided by this invention have extremely high safety. More importantly, in combination therapy, the composition of this invention appears to have a certain alleviating and protective effect on local skin irritation caused by azelaic acid, demonstrating the scientific nature and superior efficacy and toxicity reduction of this invention in clinical application.

[0135] 2.7 Typical Cases Mr. Zhang, male, 26 years old, previously sought medical treatment at the Dermatology Department of Sichuan Provincial Hospital of Integrated Traditional and Western Medicine for "recurrent inflammatory papules and comedones on the face for more than 2 years". Two years prior, the patient developed scattered red papules and comedones on his face without any obvious cause. From March 2025, he used 15% azelaic acid cream twice daily for four consecutive weeks. Figure 4 As shown ( Figure 4 The left image shows the result after treatment with azelaic acid. Figure 4 The right image shows the result three weeks after discontinuing azelaic acid treatment. During treatment, a significant reduction in the number of acne lesions was observed, with marked improvement in inflammatory papules and comedones. However, significant local irritation symptoms appeared, including diffuse redness, itching, and scaling, leading to damage to the skin barrier and affecting daily skincare and social interactions. After discontinuing azelaic acid, the acne rapidly relapsed, with the number of lesions returning to pre-treatment levels, after which treatment was discontinued.

[0136] Clinical presentation at the time of consultation in July 2025: Scattered inflammatory papules and closed comedones were visible on the face, mainly on both cheeks and jawline, accompanied by mild seborrhea. No obvious pustules or cysts were observed. Due to recurrent flare-ups and irritation from topical medications, the patient experienced significant anxiety, with a DLQI score of 16. This patient was enrolled in the combination therapy group for treatment. Figure 5 As shown ( Figure 5 (Right image shows the patient after 8 weeks of combined drug treatment). The subject returned for a follow-up visit after 8 weeks of treatment, and the results showed: ① Significantly improved tolerability: During the treatment, subjects reported no skin irritation as they had experienced with azelaic acid cream alone during this combination therapy. Clinical monitoring showed that facial redness and desquamation completely disappeared (see...). Figure 5 ① The subjects' adherence to the treatment plan was significantly improved. ② The skin lesions basically subsided: the inflammatory papules and acne on the face basically subsided, the skin texture returned to normal, and only a small amount of light red post-inflammatory pigmentation was seen.

[0137] In summary, the oral medication of this invention offers dual advantages in clinical application: firstly, it synergistically enhances efficacy, as oral administration of this invention can regulate the inflammatory state from within the systemic environment; secondly, topical azelaic acid can directly act on the skin lesions, treating both internal and external factors, resulting in significantly better long-term efficacy (complete lesion resolution) compared to topical medications alone. Secondly, it enhances efficacy while reducing toxicity, as the composition of this invention effectively counteracts the local irritation side effects caused by topical chemical drugs, eliminating redness, swelling, and desquamation by regulating the skin's immune microenvironment or enhancing the skin barrier's tolerance. This effect is crucial for improving treatment adherence in acne patients and reducing recurrence rates.

[0138] 3. Discussion The results of this study indicate that the traditional Chinese medicine composition of this invention, combined with topical application of 15% azelaic acid cream, has a significant synergistic effect in the treatment of acne vulgaris. The total effective rate of the combined treatment group (96.7%) was significantly higher than that of the single-use group (83.3%) and the single-use group of azelaic acid (80.0%) (P < 0.05). Furthermore, the combined treatment group was superior to the single-use group in improving lesion count, reducing inflammation scores, and improving quality of life, confirming the synergistic therapeutic advantages of the combined treatment. Of particular note is the difference in recurrence rate after discontinuation of medication; the recurrence rate in the combined treatment group was extremely low, indicating that the combined application of the traditional Chinese medicine composition and topical azelaic acid provided by this invention achieves a synergistic effect of treating both internal and external ailments, and solves the technical problem of easy recurrence of acne.

[0139] The above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the present invention, and all such modifications and substitutions should be covered within the scope of the claims of the present invention. Technical aspects, shapes, and structures not described in detail in this invention are all well-known technologies.

Claims

1. A traditional Chinese medicine composition for improving acne, characterized in that, The traditional Chinese medicine composition is made from the following pharmaceutical raw materials: First group: 25-35 parts of white peony root, 25-35 parts of hawthorn, 25-35 parts of salvia miltiorrhiza, 13-17 parts of gardenia, and 8-12 parts of bletilla striata; Second component: 25-35 parts mother-of-pearl, 13-17 parts tribulus terrestris, 8-12 parts safflower; The third component consists of 13-17 parts of raw rhubarb, 8-12 parts of gallnut, 8-12 parts of turmeric, 3-7 parts of Ganoderma lucidum, and 3-7 parts of asparagus.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The first component is made from the following medicinal materials: 30 parts of Ampelopsis japonica, 30 parts of Crataegus pinnatifida, 30 parts of Salvia miltiorrhiza, 15 parts of Gardenia jasminoides, and 10 parts of Bletilla striata; the second component is made from the following medicinal materials: 30 parts of pearl powder, 15 parts of Tribulus terrestris, and 10 parts of Carthamus tinctorius; the third component is made from the following medicinal materials: 15 parts of raw rhubarb, 10 parts of Galla chinensis, 10 parts of Curcuma longa, 5 parts of Ganoderma lucidum, and 5 parts of Asparagus cochinchinensis.

3. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicine for the prevention, relief and / or treatment of acne.

4. The application according to claim 3, characterized in that, The acne includes one or more of comedones, inflammatory papules, pustules, nodules, and cysts; and / or the application also includes improving post-acne erythema, post-acne hyperpigmentation, and post-acne scars.

5. The application according to claim 3, characterized in that, The traditional Chinese medicine composition has the effect of inhibiting the activity of Propionibacterium acnes and / or inhibiting the inflammatory response induced by Propionibacterium acnes.

6. A medicine for improving acne, characterized in that, The medicine comprises the traditional Chinese medicine composition or its extract as described in claim 1 or 2 as an active ingredient, and pharmaceutically acceptable excipients; the medicine is prepared as an oral or topical formulation.

7. The pharmaceutical product according to claim 6, characterized in that, The oral preparations are granules, capsules, tablets, oral liquids, pills, or powders; the external preparations are ointments, gels, creams, lotions, or liniments.

8. The pharmaceutical product according to claim 7, characterized in that, The pharmaceutically acceptable excipients are selected from one or more of the following: diluents, binders, disintegrants, lubricants, flavoring agents, bases, emulsifiers, thickeners, and transdermal penetration enhancers. The diluent used in the oral formulation is at least one of dextrin, starch, lactose, and microcrystalline cellulose; the binder is at least one of povidone, hydroxypropyl methylcellulose, and sodium carboxymethyl cellulose; the disintegrant is at least one of sodium carboxymethyl starch, crospovidone, and crospovidone; the lubricant is at least one of magnesium stearate, micronized silica gel, and talc; and the flavoring agent is at least one of steviol glycosides, sucralose, and aspartame. The base of the topical preparation is at least one of petrolatum, liquid paraffin, lanolin, and beeswax; the emulsifier is at least one of Tween, Span, and sodium lauryl sulfate; the thickener is at least one of carbomer, hydroxypropyl methylcellulose, and polyvinyl alcohol; and the transdermal penetration enhancer is at least one of azone, propylene glycol, and menthol.

9. A method for preparing the pharmaceutical product according to any one of claims 6-8, characterized in that, This includes mixing the raw materials of the traditional Chinese medicine composition according to claim 1 or 2, extracting with water, concentrating and drying to obtain an extract, and then mixing it with pharmaceutically acceptable excipients to prepare an oral or topical preparation.

10. A combination drug product for improving acne, characterized in that, Include: The first active ingredient is the traditional Chinese medicine composition according to claim 1 or 2; as well as, (b) A second active ingredient, which is a topical anti-acne drug, preferably azelaic acid or a pharmaceutically acceptable salt thereof.

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