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

Abstract

This invention belongs to the field of traditional Chinese medicine, specifically relating to a traditional Chinese medicine composition for treating rosacea, its preparation method, and its application. This invention provides a traditional Chinese medicine composition for treating rosacea, comprising dandelion, purslane, sophora flavescens, sophora japonica flower, and rhubarb. The traditional Chinese medicine composition of this invention has the effects of clearing heat and detoxifying, reducing inflammation and antibacterial properties, cooling blood and promoting blood circulation, and repairing the skin barrier. It can be used to treat erythematous rosacea, relieving erythema, telangiectasia, papules, itching, and burning sensation on the skin, and reducing the risk of recurrence.

Description

Technical Field

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

[0002] Rosacea is a common chronic skin disease, mainly characterized by facial flushing, erythema, telangiectasia, papules, and pustules. Severe cases may be accompanied by symptoms such as stinging, burning, itching, and impaired skin barrier. The etiology of this disease is complex, related to multiple factors including genetics, environment, immune abnormalities, skin microecological imbalance, and neurovascular dysfunction. Currently, the pathogenesis of rosacea is not fully understood, and clinical treatment presents certain challenges.

[0003] Current conventional treatments for rosacea include topical medications such as metronidazole, azelaic acid, and ivermectin; oral tetracycline antibiotics and retinoids; and physical therapies (such as intense pulsed light and laser therapy). However, these treatments often have several drawbacks. For example, long-term use of antibiotics may lead to drug resistance, topical medications can easily cause irritation or dependence, and laser therapy is expensive and may cause skin sensitivity, which limits its clinical application.

[0004] In recent years, traditional Chinese medicine (TCM) treatment for rosacea has received increasing attention. TCM considers this disease to fall under the categories of "facial redness" and "rosacea," primarily related to factors such as lung and stomach heat accumulation, qi and blood stagnation, and wind-heat invasion. Clinically, treatments often employ methods such as clearing heat and detoxifying, promoting blood circulation and removing blood stasis, and cooling the blood and dispelling wind. However, existing TCM treatments are mostly oral decoctions or topical wet compresses, which suffer from inconvenience, poor stability, and insufficient permeability. Therefore, there is an urgent need for a topical TCM preparation with clear efficacy, convenient use, and simple manufacturing process to meet the clinical treatment needs of rosacea. Summary of the Invention

[0005] In view of this, the present invention provides a traditional Chinese medicine composition for treating rosacea, its preparation method, and its application. The traditional Chinese medicine composition of the present invention has the effects of clearing heat and detoxifying, reducing inflammation and antibacterial properties, cooling the blood and promoting blood circulation, and repairing the skin barrier. It can be used to treat erythematous rosacea, relieving erythema, telangiectasia, papules, itching, and burning sensation of the skin, and reducing the risk of recurrence.

[0006] In a first aspect, the present invention provides a pharmaceutical composition for treating rosacea, comprising dandelion, purslane, sophora flavescens, sophora japonica, and rhubarb.

[0007] In a second aspect, the present invention provides a traditional Chinese medicine preparation for treating rosacea, wherein the traditional Chinese medicine preparation is prepared from the traditional Chinese medicine composition of the first aspect of the present invention.

[0008] In a third aspect, the present invention provides the use of the traditional Chinese medicine composition of the first aspect of the present invention or the traditional Chinese medicine preparation of the second aspect of the present invention in the preparation of a medicament for treating rosacea.

[0009] The beneficial technical effects of the present invention include at least one or more of the following: The traditional Chinese medicine composition or preparation of the present invention is targeted at the typical inflammatory mechanism of rosacea, with clear pharmacological effects and good synergistic effect; The traditional Chinese medicine composition or preparation of the present invention can effectively relieve erythema, burning sensation and papules, and reduce the risk of recurrence; The traditional Chinese medicine preparation of this invention has a mild dosage form, provides a good user experience, and is suitable for long-term use by patients with sensitive and dry skin. The preparation method of this invention is simple in process and uses stable raw materials, and has strong prospects for industrialization. Attached Figure Description

[0010] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other implementation schemes can be obtained based on these drawings without creative effort.

[0011] Figure 1 and Figure 2 VISIA images of the treatment and control sides are shown on days 0, 14±3, 28±3, and 42±3 after using cream 2.

[0012] Figure 3 The appearance of the prepared creams 1-3 (from left to right) is shown.

[0013] Figure 4 The image shows how creams 1-3 (from left to right) appear when applied to paper. Detailed Implementation

[0014] The present invention will now be clearly and completely described in conjunction with its embodiments and accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. All other embodiments that can be obtained by those skilled in the art based on the embodiments of the present invention are within the scope of protection of the present invention.

[0015] In this document, all parts refer to parts by weight, with weight calculated based on the weight of the crude drug or raw material. The parts by weight can be well-known units of weight in the pharmaceutical field, such as micrograms (μg), milligrams (mg), grams (g), kilograms (kg), or fractions thereof, such as 1 / 10, 1 / 100, or multiples thereof, such as 10 times, 100 times, etc., and are not limited thereto.

[0016] This invention scientifically combines five Chinese medicinal herbs—dandelion, purslane, sophora flavescens, sophora japonica, and rhubarb—with moisturizers such as glycerin and 1,2-hexanediol, as well as nonionic emulsifiers, to prepare a stable topical cream suitable for sensitive skin by optimizing the extraction ratio and emulsification process.

[0017] Therefore, in a first aspect, the present invention provides a pharmaceutical composition for treating rosacea, comprising dandelion, purslane, sophora flavescens, sophora japonica, and rhubarb.

[0018] In the traditional Chinese medicine composition of this invention, the principal ingredients are dandelion and purslane, and the assistant ingredients are sophora flavescens and sophora japonica. Dandelion is used to clear local inflammatory heat toxins from the skin, reducing redness, swelling, and inflammatory reactions. Purslane mainly exerts anti-inflammatory, antibacterial, and blood-cooling effects, helping to improve skin inflammation and the skin barrier microenvironment. Sophora flavescens is mainly used to relieve symptoms such as itching and exudation related to skin inflammation, enhancing the overall anti-inflammatory and antipruritic effects. Sophora japonica is mainly used to improve post-inflammatory skin microcirculation abnormalities and erythema, synergistically reducing local congestion. Rhubarb mainly plays an auxiliary role in clearing heat and detoxifying, and promoting the effects of active ingredients.

[0019] The following is a detailed description of the medicinal materials used in the traditional Chinese medicine composition of this invention: Dandelion ( Taraxacum mongolicum Hand.-Mazz. , Taraxacum sinicum Kitag. (or closely related plants), the medicinal part is the dried whole herb of dandelion, a plant of the Asteraceae family; properties and channels: bitter, sweet, cold, enters the liver and stomach channels; functions: clears heat and detoxifies, reduces swelling and dissipates nodules, promotes diuresis and relieves strangury.

[0020] purslane( Portulaca oleracea L. The medicinal part is the dried aerial part of Portulaca oleracea, a plant of the Portulacaceae family; its properties and channels are: sour, cold, and enter the large intestine and liver channels; its functions are: clearing heat and detoxifying, cooling blood and stopping dysentery, reducing swelling and relieving pain.

[0021] Sophora flavescens ( Sophora flavescens Ait. The medicinal part is the dried root of *Sophora flavescens*, a legume; its properties and channels are: bitter, cold, and enters the heart, liver, stomach, large intestine, and bladder channels; its functions are: clearing heat and drying dampness, dispelling wind and relieving itching, and killing parasites. In this invention...

[0022] locust flowers ( Sophora japonica L. The medicinal part is the dried flower buds or newly opened flowers of Sophora japonica, a legume; its properties and channels are: bitter, slightly cold, and enters the liver and large intestine channels; its functions are: clearing heat and purging fire, cooling blood and stopping bleeding.

[0023] rhubarb( Rheum palmatum L. , Rheum tanguticum Maxim. ex Balf. or Rheum officinale Baill. The medicinal part is the dried root and rhizome of rhubarb, a plant of the Polygonaceae family; its properties and channels are: bitter, cold, and enters the spleen, stomach, large intestine, liver, and pericardium channels; its functions are: purging heat and relieving constipation, clearing heat and purging fire, cooling blood and detoxifying.

[0024] In one embodiment, the dandelion, purslane, sophora flavescens, sophora japonica, and rhubarb are in the form of extracts (such as water extracts, alcohol extracts, hydroalcohol extracts, or oil extracts). Water extraction, alcohol extraction, hydroalcohol extraction, or oil extraction are all well-known methods for extracting active ingredients from traditional Chinese medicine, and those skilled in the art can choose the appropriate method as needed.

[0025] In an embodiment where each of the traditional Chinese medicines is in the form of water-extracted granules, the traditional Chinese medicine composition of the present invention includes 2.5 to 5 parts by weight of water-extracted granules of dandelion, purslane, sophora flavescens, sophora japonica, and rhubarb. The water-extracted granules are prepared using conventional water extraction processes for traditional Chinese medicines, with an extraction ratio of approximately 5-10:1 (mass ratio of raw medicinal materials to water-extracted granules).

[0026] More specifically, in the said traditional Chinese medicine composition, the water extract granules of dandelion, purslane, sophora flavescens, sophora japonica and rhubarb can each be 2.5, 3, 3.5, 4, 4.5 or 5 parts by weight.

[0027] In a preferred embodiment, the traditional Chinese medicine composition of the present invention comprises 2.5 parts by weight of each of dandelion, purslane, sophora flavescens, sophora japonica and rhubarb water extract granules.

[0028] It is understood that the traditional Chinese medicine composition of the present invention is not limited to the above-described form. Those skilled in the art can deduce the corresponding proportions of each traditional Chinese medicine applicable to other forms of traditional Chinese medicine composition based on the dosage ratio of the above-described water extract granules.

[0029] In a second aspect, the present invention provides a traditional Chinese medicine preparation for treating rosacea, wherein the traditional Chinese medicine preparation is prepared from the traditional Chinese medicine composition of the first aspect of the present invention.

[0030] It is understood that the traditional Chinese medicine preparations of the present invention are generally topical preparations applied topically to the patient's skin. Therefore, in one embodiment, the traditional Chinese medicine preparation can be prepared in any dosage form suitable for topical application to the skin, such as a solution, emulsion, foam, gel, or cream.

[0031] Similarly, it is understood that when preparing the traditional Chinese medicine preparation of the present invention into a dosage form suitable for topical application to the skin, it is usually necessary to add pharmaceutically acceptable excipients. Therefore, in one embodiment, the traditional Chinese medicine preparation may further include excipients, which include one or more of the following: skin-acceptable solvents, semi-solid or liquid oils, humectants, preservatives, emulsifiers, transdermal penetration enhancers, and / or auxiliary active ingredients.

[0032] In a preferred embodiment, the skin-acceptable solvent includes water or an aqueous buffer.

[0033] In a preferred embodiment, the semi-solid grease includes petrolatum, lanolin, cocoa butter, shea butter, or natural waxes (such as beeswax).

[0034] In a preferred embodiment, the liquid oil includes silicone oil, natural plant oil (such as jojoba oil, almond oil, olive oil) or synthetic esters (such as isopropyl myristate, isopropyl palmitate).

[0035] In a preferred embodiment, the humectant includes polyols (such as glycerin, 1,2-hexanediol, propylene glycol, butylene glycol, or sorbitol), natural moisturizing factors (such as sodium hyaluronate, sodium pyrrolidone carboxylate, or urea), sugars (such as trehalose), or polymers (such as hydroxyethyl acrylate copolymer).

[0036] In a preferred embodiment, the preservative includes phenoxyethanol, hydroxyphenyl esters, pentylene glycol, and hexanediol.

[0037] In a preferred embodiment, the emulsifier is a nonionic surfactant, such as polyglycerol stearate, polyglycerol distearate, polyglycerol polyricinoleate, polysorbate, PEG stearate, or PEG hydrogenated castor oil.

[0038] More preferably, the polyglycerol stearate may be polyglycerol-4 stearate, polyglycerol-6 stearate, polyglycerol-8 stearate, polyglycerol-10 stearate, etc.; The polyglycerol distearate may be polyglycerol-4 distearate, polyglycerol-6 distearate, etc.; The polyglycerol polyricinoleate may be polyglycerol-3 polyricinoleate, polyglycerol-4 polyricinoleate, polyglycerol-10 polyricinoleate, etc.; The polysorbate may be polysorbate-20, polysorbate-60, etc.; The PEG stearate may be PEG-20 stearate, PEG-40 stearate, PEG-100 stearate, etc. The PEG-hydrogenated castor oil may be PEG-40 hydrogenated castor oil, PEG-60 hydrogenated castor oil, etc.

[0039] It is understood that pharmaceutically acceptable nonionic surfactants can be used in the traditional Chinese medicine preparations of this invention.

[0040] In a preferred embodiment, the transdermal penetration enhancer includes azones (such as laurocapram), alcohols (such as ethanol, isopropanol, propylene glycol, menthol), fatty acids and their esters (such as oleic acid, isopropyl myristate).

[0041] In a preferred embodiment, the auxiliary active ingredient includes vitamin E or ceramide.

[0042] Those skilled in the art can select appropriate excipients based on the dosage form being prepared.

[0043] In one embodiment, the traditional Chinese medicine preparation is prepared as a cream, the cream comprising: extracts of dandelion, purslane, sophora flavescens, sophora japonica and rhubarb, and the following excipients: water, 1,2-hexanediol, anhydrous glycerin, and PEG-100 stearate.

[0044] The cream contains extracts of dandelion, purslane, sophora flavescens, sophora japonica, and rhubarb, which can be water extracts, alcohol extracts, hydroalcohol extracts, or oil extracts as described above, preferably in the form of water extract granules. Alternatively, the herbal extracts can be the extracts themselves obtained through an extraction process; in this case, these herbs can be mixed in the required proportions before extraction. Furthermore, the herbal extracts can also be a solution obtained by dissolving their water extract granules in a skin-acceptable solvent. In this case, each of the herbs—dandelion, purslane, sophora flavescens, sophora japonica, and rhubarb—can be individually extracted with water, and then the resulting extracts can be freeze-dried to obtain the corresponding water extract granules.

[0045] In the excipients contained in the cream, water is used as a solvent to dissolve the active pharmaceutical ingredient; glycerin and 1,2-hexanediol work synergistically to enhance moisturizing and antibacterial effects; and PEG-100 stearate emulsifier is used to form the cream formulation.

[0046] In a preferred embodiment, the cream comprises: 2.5 to 5 parts by weight (e.g., 2.5, 3, 3.5, 4, 4.5, or 5 parts by weight) of aqueous extract granules of dandelion, purslane, sophora flavescens, sophora japonica, and rhubarb; 80 to 120 parts by weight (e.g., 80, 90, 100, 110, or 120 parts by weight) of water; 8 to 15 parts by weight (e.g., 8, 9, 10, 11, 12, 13, 14, or 15 parts by weight) of 1,2-hexanediol; 20 to 35 parts by weight (e.g., 20, 22, 25, 27, 30, 32, or 35 parts by weight) of anhydrous glycerin; and 4 to 10 parts by weight (e.g., 4, 5, 6, 7, 8, 9, or 10 parts by weight) of PEG-100 stearate.

[0047] In a more preferred embodiment, the cream comprises 92 parts by weight of water, 11.5 parts by weight of 1,2-hexanediol, 27.6 parts by weight of anhydrous glycerin, and 6.9 parts by weight of PEG-100 stearate.

[0048] In one embodiment, the traditional Chinese medicine preparation can be prepared by the following method: 1) Add 1,2-hexanediol to the water extract granules of dandelion, purslane, sophora flavescens, sophora japonica and rhubarb and mix well to form an aqueous phase; 2) Mix anhydrous glycerol with PEG-100 stearate to form an oil phase; 3) Slowly add the oil phase to the aqueous phase and stir until homogeneous to form a cream.

[0049] Through the above-mentioned phase separation preparation and low-temperature emulsification process, the efficacy retention and skin absorption efficiency of the traditional Chinese medicine preparation of the present invention can be improved, so as to better exert its effects.

[0050] Furthermore, the traditional Chinese medicine preparation of the present invention prepared by the above method has high safety, good stability, and is suitable for sensitive skin. It can also be extended to other inflammatory skin diseases.

[0051] In a third aspect, the present invention provides the use of the traditional Chinese medicine composition of the first aspect of the present invention or the traditional Chinese medicine preparation of the second aspect of the present invention in the preparation of a medicament for treating rosacea.

[0052] In one implementation, the drug can be used in combination with other Western medicines such as metronidazole, azelaic acid, and ivermectin to treat rosacea.

[0053] Example The embodiments of the present invention will be described in detail below with reference to examples. Those skilled in the art will understand that the following examples are merely illustrative and should not be considered as limiting the scope of the present invention. Where specific techniques or conditions are not specified in the examples, they are performed according to the techniques or conditions described in the literature in the art or according to the product instructions. Reagents or instruments whose manufacturers are not specified are all conventional products that can be obtained commercially.

[0054] Preparation Example 1 This embodiment provides a cream 1 for treating rosacea, made from the following raw materials: 5 parts by weight of each of the water extract granules of purslane, sophora flavescens, sophora japonica, dandelion, and rhubarb (the water extract granules are prepared according to conventional Chinese medicine water extraction process, and the conversion ratio is approximately 5-10:1 by mass of raw materials to water extract granules); and excipients: 92 parts by weight of distilled water, 11.5 parts by weight of 1,2-hexanediol, 27.6 parts by weight of anhydrous glycerin, and 6.9 parts by weight of PEG-100 stearate.

[0055] The preparation method of cream 1 is as follows: ① Material preparation: Dissolve 5 parts by weight each of water extract granules of purslane, sophora flavescens, sophora japonica, dandelion and rhubarb in 92 parts by weight of distilled water, stir well and set aside; ② Add 11.5 parts by weight of 1,2-hexanediol to step ① and stir until homogeneous; ③ Take 27.6 parts by weight of anhydrous glycerin, add 6.9 parts by weight of PEG-100 stearate and stir until homogeneous; ④ Add the watery substance obtained in step ② to the oily substance obtained in step ③, stir well, and then package into medicine boxes for storage; ⑤ Ultraviolet sterilization.

[0056] Preparation Example 2 This embodiment provides a cream 2 for treating rosacea, made from the following raw materials: 2.5 parts by weight each of water extract granules of purslane, sophora flavescens, sophora japonica, dandelion and rhubarb; excipients: 92 parts by weight of distilled water, 11.5 parts by weight of 1,2-hexanediol, 27.6 parts by weight of anhydrous glycerin, and 6.9 parts by weight of PEG-100 stearate.

[0057] The preparation method of cream 2 is as follows: ① Material preparation: Dissolve 2.5 parts by weight each of the water extract granules of purslane, sophora flavescens, sophora japonica, dandelion and rhubarb in 92 parts by weight of distilled water, stir well and set aside; ② Add 11.5 parts by weight of 1,2-hexanediol to step ① and stir until homogeneous; ③ Take 27.6 parts by weight of anhydrous glycerin, add 6.9 parts by weight of PEG-100 stearate and stir until homogeneous; ④ Add the watery substance obtained in step ② to the oily substance obtained in step ③, stir well, and then package into medicine boxes for storage; ⑤ Ultraviolet sterilization.

[0058] Preparation Example 3 This embodiment provides a cream 3 for treating rosacea, made from the following raw materials: 12.5 parts by weight of starch granules, excipients: 92 parts by weight of distilled water, 11.5 parts by weight of 1,2-hexanediol, 27.6 parts by weight of anhydrous glycerin, and 6.9 parts by weight of PEG-100 stearate.

[0059] The preparation method of the cream 3 is as follows: ① Material preparation: Dissolve 12.5 parts by weight of starch granules in 92 parts by weight of distilled water, stir well, and set aside; ② Add 11.5 parts by weight of 1,2-hexanediol to step ① and stir until homogeneous; ③ Take 27.6 parts by weight of anhydrous glycerin, add 6.9 parts by weight of PEG-100 stearate and stir until homogeneous; ④ Add the watery substance obtained in step ② to the oily substance obtained in step ③, stir well, and then package into medicine boxes for storage; ⑤ Ultraviolet sterilization.

[0060] Table 1. Differences in the preparation of traditional Chinese medicine additives in Examples 1-3

[0061] Test Example 1 The purpose of this test case is to explore the efficacy and safety of the creams 1–3 prepared in Preparation Examples 1–3 in the treatment of rosacea.

[0062] Experimental method: A self-controlled method was used, and 24 patients with rosacea were included and randomly divided into 3 groups, with 8 patients in each group. Anhydrous glycerin was applied to the lesions on the control side, and creams 1-3 prepared in preparation examples 1-3 were applied to the lesions on the intervention side.

[0063] Evaluation methods: The VISIA skin analysis system, Clinician's Erythema Assessment (CEA) scale, and IGA score (Investigator's Global Assessment) were used for evaluation.

[0064] The VISIA skin analysis system is an objective and quantitative instrumental testing tool that uses multispectral imaging technology (such as standard white light, ultraviolet light, and polarized light) to capture the condition of the skin surface and deep layers.

[0065] The Clinician's Erythema Assessment (CEA) is a scoring tool specifically designed to assess the severity of facial erythema (flushing, persistent erythema). It is commonly used in clinical trials and severity assessments of rosacea. Its scoring criteria (typically a 5-point scale) are as follows: 0 points - Cleared: No erythema; slight color difference may remain. 1 point - Almost clear: slight erythema (pink); 2 points - Mild: Obvious erythema (red) and / or a small amount of telangiectasia; 3 points - Moderate: Significant erythema (deep red) and / or significant telangiectasia; 4 points - Severe: Deep red / purplish-red erythema and / or extensive telangiectasia.

[0066] The IGA score is a comprehensive assessment of the overall severity of rosacea by observing all key skin symptoms (such as erythema, papules, pustules, nodules, and desquamation) at a specific time point. For rosacea, the IGA scoring criteria (typically on a 5-point scale) are as follows: 0 points - Clearance: No papules / pustules; no persistent erythema; 1 point - Almost clear: very few, scattered papules / pustules; very slight erythema; 2 points - Mild: A few papules / pustules (e.g., 5-10); mild erythema; 3 points - Moderate: Moderate number of papules / pustules (e.g., 11-20); moderate erythema; 4 points - Severe: Numerous papules / pustules (e.g., >20); severe erythema.

[0067] Papules were red or dark red, solid, and raised, typically 2-5 mm in diameter; pustules were papules with white / yellowish-white pustules at the top. The number of papules and pustules in each patient was counted and is shown in Table 2.

[0068] Results analysis: As shown in Table 2, cream 2 showed the most significant improvement in the intervention area score, and could significantly improve the erythema degree of patients with rosacea. Moreover, the efficacy was stable during use, and no recurrence or aggravation was observed.

[0069] Cream 1 showed some improvement in rosacea, but the improvement was not significant. Cream 3 did not show any statistically significant improvement in the severity of skin lesions in patients with rosacea, as detailed in Table 2.

[0070] Table 2. Comparison of clinical efficacy of creams 1-3

[0071] Test Example 2 The purpose of this test case is to further compare the efficacy and safety of the cream with superior efficacy in this invention with commonly used clinical topical drugs in the treatment of rosacea, based on the aforementioned screening.

[0072] Experimental Methods: Based on the aforementioned test results, Cream 2, which showed superior efficacy, was selected as the study subject. Using a self-controlled method, eight additional patients with rosacea were included. Patients were randomly assigned to either the control or experimental sides of their face. The experimental side received Cream 2, while the control side received metronidazole gel, a commercially available topical medication. The usage, frequency, and dosage of both creams were performed according to the recommended regimen in the drug's instructions.

[0073] Evaluation method: Objective image analysis was performed using the VISIA skin detection system, and the changes in efficacy before and after treatment were evaluated by combining the Clinician's Erythema Assessment (CEA) scale and the Investigator's Global Assessment (IGA) score.

[0074] Results Analysis: As shown in Table 3, compared with metronidazole gel, cream 2 showed a certain improvement trend in reducing the severity of erythema in patients with rosacea, and its overall efficacy evaluation score was significantly higher than that of the metronidazole gel group. Both groups showed good tolerability during treatment, and no significant adverse reactions or symptom exacerbations were observed.

[0075] The above results suggest that the preferred cream of the present invention has potential advantages in improving rosacea-related erythema, and its efficacy needs to be further verified in studies with larger sample sizes.

[0076] Table 3. Comparison of clinical efficacy between cream 2 and metronidazole gel

Claims

1. A traditional Chinese medicine composition for treating rosacea, comprising dandelion, purslane, sophora flavescens, sophora japonica flower and rhubarb.

2. The traditional Chinese medicine composition according to claim 1, wherein the dandelion, purslane, sophora flavescens, sophora japonica and rhubarb are in the form of extracts (such as water extracts, alcohol extracts, hydroalcohol extracts or oil extracts).

3. The traditional Chinese medicine composition according to claim 2, wherein when each of the traditional Chinese medicines is in the form of water extract granules, the traditional Chinese medicine composition comprises 2.5 to 5 parts by weight of water extract granules of dandelion, purslane, sophora flavescens, sophora japonica and rhubarb; Preferably, the traditional Chinese medicine composition comprises 2.5 parts by weight of water extract granules of dandelion, purslane, sophora flavescens, sophora japonica and rhubarb.

4. A traditional Chinese medicine preparation for treating rosacea, wherein the traditional Chinese medicine preparation is prepared from the traditional Chinese medicine composition according to any one of claims 1-3.

5. The traditional Chinese medicine preparation according to claim 4, wherein the traditional Chinese medicine preparation is prepared in the form of a solution, emulsion, foam, gel or cream.

6. The traditional Chinese medicine preparation according to claim 4 or 5, wherein the traditional Chinese medicine preparation further comprises excipients, the excipients comprising one or more of the following: skin-acceptable solvents, semi-solid or liquid oils, moisturizers, preservatives, emulsifiers, transdermal penetration enhancers and / or auxiliary active ingredients; Preferably, the skin-acceptable solvent includes water or an aqueous buffer; Preferably, the semi-solid oil includes petrolatum, lanolin, cocoa butter, shea butter, or natural waxes (such as beeswax). Preferably, the liquid oil includes silicone oil, natural plant oil (such as jojoba oil, almond oil, olive oil) or synthetic esters (such as isopropyl myristate, isopropyl palmitate). Preferably, the moisturizer includes polyols (such as glycerin, 1,2-hexanediol, propylene glycol, butylene glycol or sorbitol), natural moisturizing factors (such as sodium hyaluronate, sodium pyrrolidone carboxylate, urea), sugars (such as trehalose) or polymers (such as hydroxyethyl acrylate copolymer). Preferably, the preservative includes phenoxyethanol, hydroxyphenyl esters, pentylene glycol, and hexanediol; Preferably, the emulsifier is a nonionic surfactant, such as polyglycerol stearate, polyglycerol distearate, polyglycerol polyricinoleate, polysorbate, PEG stearate, or PEG hydrogenated castor oil. Preferably, the transdermal penetration enhancer includes azones (such as laurocapram), alcohols (such as ethanol, isopropanol, propylene glycol, menthol), fatty acids and their esters (such as oleic acid, isopropyl myristate). Preferably, the auxiliary active ingredient includes vitamin E or ceramide.

7. The traditional Chinese medicine preparation according to any one of claims 4-6, wherein the traditional Chinese medicine preparation is prepared as a cream, the cream comprising: Extracts of dandelion, purslane, sophora flavescens, sophora japonica and rhubarb, and the following excipients: water, 1,2-hexanediol, anhydrous glycerol, PEG-100 stearate; Preferably, the cream comprises 2.5 to 5 parts by weight of water extract granules of dandelion, purslane, sophora flavescens, sophora japonica and rhubarb, as well as 80-120 parts by weight of water, 8-15 parts by weight of 1,2-hexanediol, 20-35 parts by weight of anhydrous glycerin and 4-10 parts by weight of PEG-100 stearate. More preferably, the cream comprises 92 parts by weight of water, 11.5 parts by weight of 1,2-hexanediol, 27.6 parts by weight of anhydrous glycerin, and 6.9 parts by weight of PEG-100 stearate.

8. The traditional Chinese medicine preparation according to claim 7, wherein the traditional Chinese medicine preparation is prepared by the following method: 1) Add 1,2-hexanediol to the water extract granules of dandelion, purslane, sophora flavescens, sophora japonica and rhubarb and mix well to form an aqueous phase; 2) Mix anhydrous glycerol with PEG-100 stearate to form an oil phase; 3) Slowly add the oil phase to the aqueous phase and stir until homogeneous to form a cream.

9. Use of the traditional Chinese medicine composition according to any one of claims 1-3 or the traditional Chinese medicine preparation according to any one of claims 4-8 in the preparation of a medicament for treating rosacea.

10. The use according to claim 9, wherein the drug can be used in combination with other Western medicines such as metronidazole, azelaic acid, and ivermectin to treat rosacea.

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