A traditional Chinese medicine composition for treating vitiligo, a preparation method thereof and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating vitiligo, and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw medicinal materials in parts by weight: Radix Bupleuri 5-15 parts, Fructus Aurantii Immaturus 5-15 parts, Radix Paeoniae Rubra 5-15 parts, Schizonepeta 5-30 parts, Radix Rehmanniae 5-30 parts, Radix Rehmanniae Preparata 5-30 parts, Angelica sinensis 5-30 parts, Chuanxiong Rhizoma 5-15 parts, Radix Paeoniae Alba 5-30 parts, Radix Paeoniae Alba 5-30 parts, Artemisia Annua 5-30 parts, and Radix Ginseng 5-30 parts.

Description

Technical Field

[0001] This application relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for treating vitiligo, its preparation method, and its application. Background Technology

[0002] Vitiligo is a common pigmentary disorder with an incidence rate of approximately 1%, which is showing an increasing trend year by year. Because the skin lesions caused by vitiligo directly affect the patient's appearance, it brings significant stress to their studies, work, and daily life, seriously impacting their physical and mental health. Studies have found a close correlation between vitiligo and the risk of developing various mental illnesses, including anxiety disorders, major depressive disorder, and bipolar disorder. However, to date, due to its incompletely understood pathogenesis, it is characterized by being easy to diagnose but difficult to treat.

[0003] Although there are many treatments available for vitiligo, none have yet achieved a definitive cure rate. Therefore, exploring new treatment methods for vitiligo has significant clinical and social value. Summary of the Invention

[0004] In order to address the above-mentioned deficiencies in this field, this application aims to provide a traditional Chinese medicine composition for treating vitiligo, its preparation method, and its application.

[0005] According to one aspect of this application, a traditional Chinese medicine composition for treating vitiligo is provided, which is made from the following raw materials in parts by weight: Bupleurum chinense 5-15 parts, Citrus aurantium 5-15 parts, Paeonia lactiflora 5-15 parts, Schizonepeta tenuifolia 5-30 parts, Rehmannia glutinosa 5-30 parts, Rehmannia glutinosa (processed) 5-30 parts, Angelica sinensis 5-30 parts, Ligusticum chuanxiong 5-15 parts, Astragalus membranaceus (processed) 5-30 parts, Phellodendron chinense 5-30 parts, Artemisia annua 5-30 parts, and Panax ginseng leaf 5-30 parts.

[0006] According to some embodiments of this application, a traditional Chinese medicine composition for treating vitiligo is made from the following raw materials in parts by weight: Bupleurum chinense 5-12 parts, Citrus aurantium 5-12 parts, Paeonia lactiflora 9-12 parts, Schizonepeta tenuifolia 15-30 parts, Rehmannia glutinosa 5-20 parts, Rehmannia glutinosa (processed) 15-30 parts, Angelica sinensis 5-20 parts, Ligusticum chuanxiong 5-12 parts, Astragalus membranaceus (processed) 15-30 parts, Phellodendron chinense 15-30 parts, Artemisia annua 15-30 parts, and Panax ginseng leaf 12-30 parts.

[0007] According to some embodiments of this application, a traditional Chinese medicine composition for treating vitiligo is made from the following raw materials in parts by weight: Bupleurum chinense 5-9 parts, Citrus aurantium 5-9 parts, Paeonia lactiflora 9-11 parts, Schizonepeta tenuifolia 20-30 parts, Rehmannia glutinosa 5-15 parts, Rehmannia glutinosa (processed) 20-30 parts, Angelica sinensis 5-15 parts, Ligusticum chuanxiong 5-10 parts, Astragalus membranaceus (processed) 20-30 parts, Phellodendron chinense 20-30 parts, Artemisia annua 20-30 parts, and Panax ginseng leaf 15-20 parts.

[0008] According to some embodiments of this application, a traditional Chinese medicine composition for treating vitiligo is made from the following raw materials in parts by weight: Bupleurum chinense 5-6 parts, Citrus aurantium 5-6 parts, Paeonia lactiflora 9-10 parts, Schizonepeta tenuifolia 25-30 parts, Rehmannia glutinosa 8-10 parts, Rehmannia glutinosa (processed) 25-30 parts, Angelica sinensis 5-10 parts, Ligusticum chuanxiong 5-8 parts, Astragalus membranaceus (processed) 25-30 parts, Phellodendron chinense 25-30 parts, Artemisia annua 25-30 parts, and Panax ginseng leaf 15-20 parts.

[0009] According to some embodiments of this application, a traditional Chinese medicine composition for treating vitiligo is made from raw materials comprising the following parts by weight: 5 parts Bupleurum chinense, 5 parts Citrus aurantium, 9 parts Paeonia lactiflora, 30 parts Schizonepeta tenuifolia, 10 parts Rehmannia glutinosa (raw), 30 parts Rehmannia glutinosa (processed), 5 parts Angelica sinensis, 5 parts Ligusticum chuanxiong, 30 parts Astragalus membranaceus (processed), 30 parts Phellodendron chinense, 30 parts Artemisia annua, and 15 parts Panax ginseng leaf.

[0010] According to one aspect of this application, the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating vitiligo is provided.

[0011] According to one aspect of this application, a medicine is provided comprising the above-mentioned traditional Chinese medicine composition.

[0012] According to some embodiments of this application, the medicine includes tablets, granules, pills, ointments, capsules, decoctions, oral liquids, powders, and solid beverages.

[0013] According to some embodiments of this application, the medicament also includes acceptable excipients.

[0014] According to some embodiments of this application, the excipients are selected from one or more of maltodextrin, lactose, dextrin, corn starch, microcrystalline cellulose, silicon dioxide, magnesium stearate, white sugar, and sucralose.

[0015] According to one aspect of this application, a method for preparing the above-mentioned traditional Chinese medicine composition is also provided, comprising:

[0016] Weigh out the following ingredients according to the specified proportions: Bupleurum chinense, Citrus aurantium, Paeonia lactiflora, Schizonepeta tenuifolia, Rehmannia glutinosa (raw and processed), Angelica sinensis, Ligusticum chuanxiong, Astragalus membranaceus (processed), Phellodendron chinense, Artemisia annua, and Panax ginseng leaves. Wash and pulverize them, add 5-15 times the amount of water, and decoct and extract 2-4 times, 0.5-2 hours each time, to obtain the extract. Combine the extracts, filter, and concentrate to obtain the final product. Attached Figure Description

[0017] Figures 1-13 This is a comparison chart of the treatment effects in a sample case from this application. Detailed Implementation

[0018] The technical solution of this application will be clearly and completely described below with reference to the embodiments of this application. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0019] It should be particularly noted that similar substitutions and modifications made to this application are obvious to those skilled in the art, and they are all considered to be included in this application. Those skilled in the art can obviously make modifications or appropriate alterations and combinations to the methods and applications described herein without departing from the content, spirit, and scope of this application to implement and apply the technology of this application. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments.

[0020] Unless otherwise specified, this application shall be made in accordance with conventional conditions or conditions recommended by the manufacturer. The raw materials or excipients used, as well as the reagents or instruments used, whose manufacturers are not specified, are all conventional products that can be obtained commercially.

[0021] The following is a detailed description of this application.

[0022] Based on the characteristics of vitiligo's onset, it can be divided into a progressive stage and a stable stage, which can alternate. Vitiligo is quite challenging to treat. Currently, the treatment goals are: controlling lesion progression, promoting repigmentation, and maintaining treatment to prevent re-depigmentation. Of these three goals, controlling lesion progression and maintaining treatment to prevent re-depigmentation primarily target the progressive stage, highlighting the tendency of vitiligo to develop and recur. During the progressive stage, the rapid increase in the area and extent of white patches significantly impacts the patient's mood, leading to a stronger desire for treatment compared to the stable stage. Therefore, active intervention is necessary in the progressive stage to control the condition and reduce the area and extent of white patches as quickly as possible. However, there are currently no specific medications for the progressive stage of vitiligo.

[0023] Clinical control of vitiligo progression primarily relies on oral or intramuscular corticosteroids. However, systemic use of corticosteroids presents numerous side effects, a high relapse rate upon discontinuation, and poor patient adherence due to adverse steroid reactions. Therefore, exploring new, safe, and effective drugs for controlling vitiligo progression has significant medical value and will generate substantial social impact.

[0024] Due to the complexity of the pathogenesis of vitiligo, there is currently no universally accepted understanding of it in Traditional Chinese Medicine (TCM). Current TCM treatment for vitiligo primarily relies on syndrome differentiation and treatment based on the shape and color of the white patches, as well as the patient's etiology, complexion, mental state, diet, bowel movements, tongue, and pulse (the four diagnostic methods of TCM). These patterns are categorized into five types: Qi and Blood Disharmony, Liver Qi Stagnation, Spleen and Stomach Weakness, Meridian Obstruction, and Liver and Kidney Deficiency. This treatment approach does not explicitly differentiate between the progressive and stable stages of vitiligo, and clinical practice requires syndrome differentiation based on the shape and color of the white patches and the four diagnostic methods of TCM, which presents certain challenges for using TCM in treating vitiligo.

[0025] Currently, vitiligo treatment can be divided into two stages: the progressive stage and the stable stage. The progressive stage mainly manifests as rheumatic heat syndrome and liver qi stagnation syndrome, while the stable stage mainly manifests as liver and kidney deficiency syndrome, blood stasis obstructing the collaterals syndrome, and spleen and stomach weakness syndrome. Treatment is still based on syndrome differentiation. Currently, there are no traditional Chinese medicine drugs specifically for treating vitiligo in the progressive and stable stages.

[0026] If we can discover the core pathogenesis of vitiligo and formulate a relatively fixed compound prescription based on that core pathogenesis, just like the COVID-19 lung-clearing and detoxifying decoction, and achieve one prescription for one disease, then regardless of the difference in the diagnostic ability of clinicians, it can be used for treatment, which will bring significant benefits to vitiligo patients.

[0027] Based on traditional Chinese medicine theory and combined with the Western medical classification of vitiligo into progressive and stable stages, this application summarizes the core pathogenesis of vitiligo in the progressive stage according to the characteristics of progressive vitiligo based on long-term clinical practice. It explores a relatively fixed compound Chinese medicine formula applicable to the progressive stage of vitiligo, with one formula for each disease, which breaks through the cumbersome traditional Chinese medicine classification and differentiation of vitiligo and improves the efficiency of clinical use.

[0028] Based on the rapid development of vitiligo in the progressive stage, this application summarizes its core pathogenesis as: "Insufficient Qi and Blood as the root cause, external and internal wind as the cause, and spleen Qi deficiency and loss of melanocytes as the result."

[0029] External and internal wind are the causes: During the progression of vitiligo, the onset is often rapid and the rash has no fixed shape. It easily attacks yang locations, consistent with the characteristics of wind being a yang evil, characterized by its rapid movement and frequent changes. Furthermore, the onset is more pronounced in spring, a season with frequent winds; this is external wind. The onset of vitiligo is often related to mental stress, high pressure, and emotional distress. The liver governs the free flow of qi and regulates emotions; all wind-related dizziness and vertigo are attributed to the liver; this is internal wind.

[0030] The root cause is insufficient Qi and blood: The *Huangdi Neijing* states, "When Qi and blood flow smoothly, the pores become tight." The skin needs the nourishment of Qi and blood; sufficient Qi and blood result in plump skin with a strong ability to resist external pathogens, while deficient Qi and blood lead to withered skin and a weak ability to resist external pathogens. Under the influence of internal and external wind, the skin of a normal person is full of Qi and blood, showing no change; however, patients with vitiligo have insufficient Qi and blood, resulting in malnourishment of the skin. When internal and external wind attack the surface, the Qi and blood in the skin become further deficient, inducing the disease.

[0031] The result of spleen deficiency and melanocyte loss is that the lungs govern the skin and hair, while the spleen is the foundation of acquired constitution and the source of qi and blood production. The spleen is the mother of the lungs, and spleen deficiency is the cause of insufficient qi and blood. Insufficient qi and blood in the skin can further aggravate spleen deficiency, which is called "the child's disease affecting the mother," thus leading to spleen deficiency, melanocyte loss, and the formation of vitiligo.

[0032] Based on the core pathogenesis of progressive vitiligo, this application proposes a traditional Chinese medicine composition for treating vitiligo, using the principle of "strengthening qi and nourishing blood, dispelling wind and relieving wind".

[0033] The traditional Chinese medicine composition for treating vitiligo in this application is made from the following raw materials in parts by weight: Bupleurum chinense 5-15 parts, Citrus aurantium 5-15 parts, Paeonia lactiflora 5-15 parts, Schizonepeta tenuifolia 5-30 parts, Rehmannia glutinosa 5-30 parts, Rehmannia glutinosa (processed) 5-30 parts, Angelica sinensis 5-30 parts, Ligusticum chuanxiong 5-15 parts, Astragalus membranaceus (processed) 5-30 parts, Phellodendron chinense 5-30 parts, Artemisia annua 5-30 parts, and Panax ginseng leaf 5-30 parts.

[0034] In some examples, the traditional Chinese medicine composition for treating vitiligo of this application is made from the following raw materials in parts by weight: Bupleurum chinense 5-12 parts, Citrus aurantium 5-12 parts, Paeonia lactiflora 9-12 parts, Schizonepeta tenuifolia 15-30 parts, Rehmannia glutinosa 5-20 parts, Rehmannia glutinosa (processed) 15-30 parts, Angelica sinensis 5-20 parts, Ligusticum chuanxiong 5-12 parts, Astragalus membranaceus (processed) 15-30 parts, Phellodendron chinense 15-30 parts, Artemisia annua 15-30 parts, and Panax ginseng leaf 12-30 parts.

[0035] In some examples, the traditional Chinese medicine composition for treating vitiligo of this application is made from the following raw materials in parts by weight: Bupleurum chinense 5-9 parts, Citrus aurantium 5-9 parts, Paeonia lactiflora 9-11 parts, Schizonepeta tenuifolia 20-30 parts, Rehmannia glutinosa 5-15 parts, Rehmannia glutinosa (processed) 20-30 parts, Angelica sinensis 5-15 parts, Ligusticum chuanxiong 5-10 parts, Astragalus membranaceus (processed) 20-30 parts, Phellodendron chinense 20-30 parts, Artemisia annua 20-30 parts, and Panax ginseng leaf 15-20 parts.

[0036] In some examples, the traditional Chinese medicine composition for treating vitiligo of this application is made from the following raw materials in parts by weight: Bupleurum chinense 5-6 parts, Citrus aurantium 5-6 parts, Paeonia lactiflora 9-10 parts, Schizonepeta tenuifolia 25-30 parts, Rehmannia glutinosa 8-10 parts, Rehmannia glutinosa (processed) 25-30 parts, Angelica sinensis 5-10 parts, Ligusticum chuanxiong 5-8 parts, Astragalus membranaceus (processed) 25-30 parts, Phellodendron chinense 25-30 parts, Artemisia annua 25-30 parts, and Panax ginseng leaf 15-20 parts.

[0037] In some examples, the traditional Chinese medicine composition for treating vitiligo of this application is made from raw materials comprising the following parts by weight: 5 parts Bupleurum chinense, 5 parts Citrus aurantium, 9 parts Paeonia lactiflora, 30 parts Schizonepeta tenuifolia, 10 parts Rehmannia glutinosa (raw), 30 parts Rehmannia glutinosa (processed), 5 parts Angelica sinensis, 5 parts Ligusticum chuanxiong, 30 parts Astragalus membranaceus (processed), 30 parts Phellodendron chinense, 30 parts Artemisia annua, and 15 parts Panax ginseng leaf.

[0038] In some examples of this application, a medicine is provided that contains the above-mentioned traditional Chinese medicine composition.

[0039] The pharmaceutical products covered by this application include tablets, granules, pills, ointments, capsules, decoctions, oral liquids, powders, and solid beverages.

[0040] In some examples, the preparation of the tablets of this application includes: repeatedly reflux extraction with 65% ethanol of parts weighed Bupleurum chinense, Citrus aurantium, Paeonia lactiflora, Schizonepeta tenuifolia, Rehmannia glutinosa (raw and processed), Angelica sinensis, Ligusticum chuanxiong, Astragalus membranaceus (processed), Phellodendron chinense, Artemisia annua, and Panax ginseng leaves, followed by concentration and drying to obtain an extract powder; mixing the extract powder with pharmaceutically acceptable excipients, wetting it with a binder (such as PVP ethanol solution) to form a soft mass, sieving it to form wet granules, and then microwave or dry it to obtain dry granules; adding a lubricant (such as magnesium stearate) to the dry granules, mixing them evenly, and then compressing them into tablets using a tableting machine.

[0041] In some examples, the preparation of the granules and instant powders of this application includes: weighing out the following ingredients according to the specified proportions: Bupleurum chinense, Citrus aurantium, Paeonia lactiflora, Schizonepeta tenuifolia, Rehmannia glutinosa (raw and processed), Angelica sinensis, Ligusticum chuanxiong, Astragalus membranaceus (processed), Phellodendron chinense, Artemisia annua, and Panax ginseng leaves; decocting with water; combining the extracts; filtering; adding a clarifying agent (such as chitosan) to remove impurities; and then concentrating the extract into a thick paste; drying the thick paste into a dry extract powder. Following traditional wet granulation, the extract powder is mixed with excipients (such as lactose), softened with ethanol, sieved, dried, and the dry granules are sieved, granulated, and packaged. If the extract powder is directly mixed with sugar powder, flavoring agents, etc., without granulation, it can be made into an instant powder.

[0042] In some examples, the preparation of the decoction of this application includes: weighing out Bupleurum chinense, Citrus aurantium, Paeonia lactiflora, Schizonepeta tenuifolia, Rehmannia glutinosa (raw and processed), Angelica sinensis, Ligusticum chuanxiong, Astragalus membranaceus (processed), Phellodendron chinense, Artemisia annua, and Panax ginseng leaves according to the specified proportions, washing and pulverizing them, adding 5-15 times the amount of water, decocting and extracting 2-4 times, 0.5-2 hours each time, to obtain the extract, combining the extracts, filtering, and concentrating to obtain the final product.

[0043] In the herbal composition of this application, Bupleurum, Citrus aurantium, and Paeonia lactiflora are used to soothe the liver and regulate qi, mainly targeting internal wind; Schizonepeta tenuifolia dispels wind and releases the exterior, targeting external wind; Rehmannia glutinosa, Angelica sinensis, Ligusticum chuanxiong, Paeonia lactiflora, and Astragalus membranaceus are used to tonify qi and nourish blood, mainly targeting qi and blood deficiency; Ginseng leaf tonifies qi, and when combined with Astragalus membranaceus, it strengthens the spleen and prevents loss, targeting spleen qi deficiency; Rehmannia glutinosa nourishes blood and cools blood, also addressing the local redness and itching symptoms in some vitiligo patients during progression; Phellodendron amurense and Artemisia annua have been shown in modern pharmacological studies to have anti-inflammatory and anti-photosensitivity effects. The basic function of melanocytes is to produce pigment to protect the skin when exposed to ultraviolet radiation. Here, anti-inflammatory and anti-photosensitivity drugs are used to protect melanocytes and prevent them from overworking and losing their pigment.

[0044] Current vitiligo treatments mostly involve photosensitizing drugs that increase melanocyte activity, aiming to stimulate the remaining melanocytes. This application focuses on anti-inflammatory and anti-photosensitivity therapies, aiming to protect melanocytes from excessive depletion and addressing the root cause of the disease, in line with the principle of seeking the root cause in traditional Chinese medicine.

[0045] The technical solution of this application will be further described below with reference to specific embodiments.

[0046] Example Weigh the following amounts of the traditional Chinese medicine composition of this application and decoct them to prepare a decoction: Bupleurum chinense 5-15 parts, Citrus aurantium 5-15 parts, Paeonia lactiflora 5-15 parts, Schizonepeta tenuifolia 5-30 parts, Rehmannia glutinosa 5-30 parts, Rehmannia glutinosa (processed) 5-30 parts, Angelica sinensis 5-30 parts, Ligusticum chuanxiong 5-15 parts, Astragalus membranaceus (processed) 5-30 parts, Phellodendron chinense 5-30 parts, Artemisia annua 5-30 parts, Panax ginseng leaf 5-30 parts.

[0047] Including but not limited to: Bupleurum chinense 5 parts, Citrus aurantium 5 parts, Paeonia lactiflora 9 parts, Schizonepeta tenuifolia 30 parts, Rehmannia glutinosa 10 parts, Rehmannia glutinosa (processed) 30 parts, Angelica sinensis 5 parts, Ligusticum chuanxiong 5 parts, Astragalus membranaceus (processed) 30 parts, Phellodendron chinense 30 parts, Artemisia annua 30 parts, and Panax ginseng leaf 15 parts.

[0048] A clinical observational study was conducted using the traditional Chinese medicine composition for treating vitiligo described in the above embodiments of this application, employing a prospective, single-center, self-controlled pre- and post-treatment design. The aim was to systematically evaluate the clinical efficacy of this composition in treating vitiligo through clinical observation, providing higher-level evidence-based medical evidence for its application in treating vitiligo.

[0049] 1. Enrollment Status Sixty-three patients with progressive vitiligo who visited the outpatient clinic between June and December 2025 were selected as the study subjects. Among them, there were 37 males and 26 females; the youngest was 4 years old and the oldest was 73 years old, with an average age of 29.79 years; the longest course of disease was 20 years and the shortest was 1 month, with an average of 3.09 years.

[0050] 2. Intervention measures Weigh out the Chinese herbal composition of this application according to the specified amount, decoct in water and take warm (i.e., the above decoction), half an hour after breakfast and dinner. For children aged 18 and above, take one dose per day; for children aged 12-18, take one dose every 1.5 days; for children aged 8-12, take one dose every 2 days; for children aged 3-8, take one dose every 3 days.

[0051] 3. Statistical data Of the 63 patients, 58 had their vitiligo stop progressing after one month of medication, a stabilization rate of 92.06%. 38 patients (60.32%) showed repigmentation of their vitiligo after one month of medication.

[0052] Typical case: Case 1: Sun X, male, 23 years old Chief complaint: Vitiligo appeared on the body 8 months ago, and has progressed in the past month. Present illness: Hypopigmented patches on hands, trunk, neck, and lower extremities, positive on Wood's lamp examination. Appetite and sleep are good; bowel movements and urination are normal.

[0053] Treatment: The traditional Chinese medicine composition of this application Treatment Results: At the follow-up visit one month after medication, the patient reported no adverse reactions. After one month of treatment, the vitiligo had not expanded again, nor were any new lesions appearing. The area of ​​vitiligo on the lower limbs and neck had shrunk, and repigmentation had occurred compared to before treatment. Figure 1 (Left: before treatment; Right: 1 month after treatment).

[0054] Case 2: Wang XX, male, 59 years old Chief complaint: White patches appeared on the body for more than a month. Present illness: Hypopigmented patches on the face, jaw, and neck; Wood's lamp examination was positive. Appetite is good; sleep is restful with vivid dreams; bowel movements are formed; urination is normal.

[0055] Treatment: The traditional Chinese medicine composition of this application Treatment Results: At the follow-up visit one month after medication, the patient experienced no adverse reactions. After one month of treatment, the vitiligo did not expand again, and no new lesions appeared. The hypopigmented patches on the face, jawline, and neck showed significant repigmentation compared to before. Figure 2 (Left: before treatment; Right: 1 month after treatment).

[0056] Case 3: Chen XX, male, 43 years old Chief complaint: White patches appeared on the body for more than a month. Present illness: Scattered white patches on hands, around the mouth, and abdomen, Wood's lamp examination (+). Appetite is good, sleep is poor, difficulty falling asleep, stools are slightly loose, urination is normal, dry mouth and cold drinks.

[0057] Treatment: The traditional Chinese medicine composition of this application Treatment Results: At the follow-up visit one month after medication, the patient reported no adverse reactions. After one month of treatment, the vitiligo had not expanded again, and no new lesions appeared. The hypopigmented patches around the mouth, abdomen, and hands showed significant repigmentation compared to before. Figure 3 (Left: before treatment; Right: 1 month after treatment).

[0058] Case 4: Xiong XX, male, 51 years old Chief complaint: Vitiligo has been present on the body for 4 years, and has progressed in the past 3 months. Present illness: Scattered white patches on hands and neck, which have developed over the past 3 months. Wood's lamp examination was positive. Appetite and sleep are good. Stools are formed and urination is normal.

[0059] Treatment: The traditional Chinese medicine composition of this application Treatment Results: At the follow-up visit one month after medication, the patient reported no adverse reactions. After one month of treatment, the vitiligo had not expanded again, and no new lesions appeared. The hypopigmented patches on the neck and hands showed signs of repigmentation. Figure 4 (Left: before treatment; Right: 1 month after treatment).

[0060] Case 5: Fan XX, female, 14 years old Chief complaint: Vitiligo has been present on the body for 2 years, and has progressed in the past month. Present illness: Two years ago, the patient developed white patches on the neck and jaw area, which repigmented after treatment. However, new white patches have appeared on the neck in the past month, and Wood's lamp examination was positive. Appetite and sleep are normal, bowel movements are formed, and urination is normal.

[0061] Treatment: The traditional Chinese medicine composition of this application Treatment Results: At the follow-up visit one month after medication, the patient reported no adverse reactions. After one month of treatment, the vitiligo had not expanded again, and no new lesions appeared. The hypopigmented patches on the neck showed significant repigmentation compared to before. Figure 5 (Left: before treatment; Right: 1 month after treatment).

[0062] Case 6: Liu XX, male, 23 years old Chief complaint: White patches on the body for more than 2 months Present illness: Two months ago, the patient developed two white patches on his trunk. He reported that one of the white patches was previously a pigmented nevus, which was positive on Wood's lamp examination. His appetite and sleep are good, his bowel movements are formed, and his urination is normal.

[0063] Treatment: The traditional Chinese medicine composition of this application Treatment Results: At the follow-up visit one month after medication, the patient reported no adverse reactions. After one month of treatment, the vitiligo had not expanded again, and no new lesions appeared. The hypopigmented patches on the trunk showed significant repigmentation compared to before. Figure 6 (Left: before treatment; Right: 1 month after treatment).

[0064] Case 7: Wang XX, male, 15 years old Chief complaint: Vitiligo has been present on the body for 3 years, and has been developing in the past 4 months. Present Illness: Three years ago, the patient developed vitiligo on his lower back, which gradually spread to his abdomen, lower limbs, and feet. He underwent oral treatment with methylprednisolone and baricitinib for over six months, with limited effectiveness. Wood's lamp examination was positive. Appetite and sleep are normal; bowel movements are formed; urination is normal.

[0065] Treatment: The traditional Chinese medicine composition of this application Treatment Results: At the follow-up visit one month after medication, the patient reported no adverse reactions. After one month of treatment, the vitiligo had not expanded again, and no new lesions appeared. The hypopigmented patches on the waist and lower limbs showed signs of repigmentation. Figure 7 (Left: before treatment; Right: 1 month after treatment).

[0066] Case 8: Liu XX, female, 73 years old Chief complaint: Facial vitiligo for over 3 months Present Illness: The patient reported developing white patches on her face three months prior after becoming angry. A Wood's lamp examination was positive. She had previously received oral treatment with total glucosides of paeony, but discontinued the medication due to dizziness. She then sought treatment at our hospital. The patient's appetite and sleep are normal, bowel movements are formed, and urination is normal.

[0067] Treatment: The traditional Chinese medicine composition of this application Treatment Results: At the follow-up visit one month after medication, the patient experienced no adverse reactions. After one month of treatment, the vitiligo had not expanded again, and no new lesions appeared. The vitiligo on the right side of the face showed signs of repigmentation. Figure 8 (Left: before treatment; Right: 1 month after treatment).

[0068] Case 9: Wang X, male, 25 years old Chief complaint: Vitiligo on the right side of the face for more than six months, which has been developing in the past month. Present Illness: The patient developed vitiligo on the right side of his face six months ago, which gradually progressed. He received two intramuscular injections of Depo-Medrol, but the effect was unsatisfactory. Wood's lamp examination was positive. The patient's appetite and sleep are normal, bowel movements are formed, and urination is normal.

[0069] Treatment: The traditional Chinese medicine composition of this application Treatment Results: At the follow-up visit one month after medication, the patient experienced no adverse reactions. After one month of treatment, the vitiligo had not expanded again, and no new lesions appeared. The vitiligo on the right side of the face showed signs of repigmentation. Figure 9 (Left: before treatment; Right: 1 month after treatment).

[0070] Case 10: Jing XX, male, 11 years old Chief complaint: Leukoplakia on the mandible for more than one month Present illness: One month ago, the patient developed white patches on his mandible, which were positive on Wood's lamp examination. He believes the onset of the condition is related to high stress levels. The patient has a good appetite and sleep, loose stools, and normal urination.

[0071] Treatment: The traditional Chinese medicine composition of this application Treatment Results: At the follow-up visit one month after medication, the patient experienced no adverse reactions. After one month of treatment, the vitiligo did not expand again, nor did any new lesions appear. The vitiligo on the lower jaw showed significant repigmentation compared to before. Figure 10 (Left: before treatment; Right: 1 month after treatment).

[0072] Case 11: Ma X, female, 27 years old Chief complaint: Vitiligo has been present on the body for more than 2 years, and has progressed in the past 2 months.

[0073] Present Illness: Two years ago, the patient developed vitiligo on their face and hands. In the past two months, the vitiligo has worsened, and Wood's lamp examination was positive. The patient has previously been treated with oral hormones, total glucosides of paeony, and topical pimecrolimus cream, but the effects have been unsatisfactory. The patient believes the onset of the disease is related to emotional anxiety. The patient's appetite and sleep are normal, but they experience frequent late nights, loose stools, and normal urination.

[0074] Treatment: The traditional Chinese medicine composition of this application Treatment Results: At the follow-up visit one month after medication, the patient experienced no adverse reactions. After one month of treatment, the vitiligo did not expand again, nor did any new lesions appear. The facial vitiligo showed significant repigmentation compared to before. Figure 11 (Left: before treatment; Right: 1 month after treatment).

[0075] Case 12: Li XX, female, 46 years old Chief complaint: Perioral leukoplakia for more than 3 months.

[0076] Present Illness: Three months ago, leukoplakia appeared around the mouth following cheilitis. Wood's lamp examination was positive. The patient subsequently received oral hormone therapy, total glucosides of paeony, topical tacrolimus ointment, and 308nm treatment, but the effects were unsatisfactory. The leukoplakia showed no significant repigmentation and continued to enlarge. The patient's appetite and sleep are normal, bowel movements are loose, and urination is normal.

[0077] Treatment: The traditional Chinese medicine composition of this application Treatment Results: At the follow-up visit one month after medication, the patient experienced no adverse reactions. After one month of treatment, the vitiligo did not expand again, nor did any new lesions appear. The perioral vitiligo showed significant repigmentation compared to before. Figure 12 (Left: before treatment; Right: 1 month after treatment).

[0078] Case 13: Cui XX, male, 7 years old Chief complaint: White spots on both upper eyelids for more than 3 months.

[0079] Present illness: White spots appeared on both upper eyelids 3 months ago, Wood's lamp examination was positive. The patient's appetite and sleep are good, bowel movements are loose, and urination is normal.

[0080] Treatment: The traditional Chinese medicine composition of this application Treatment Results: At the follow-up visit one month after medication, the patient experienced no adverse reactions. After one month of treatment, the vitiligo had not expanded again, nor were any new lesions appearing. The vitiligo on both upper eyelids had largely repigmented compared to before. Figure 13(Left: before treatment; Right: 1 month after treatment).

[0081] The research results indicate that the traditional Chinese medicine composition of this application is suitable for the progressive stage of vitiligo, providing a single prescription for each disease, thus overcoming the cumbersome traditional Chinese medicine classification and differentiation of vitiligo and improving clinical efficiency. The traditional Chinese medicine composition of this application is based on the core pathogenesis of vitiligo in the progressive stage of traditional Chinese medicine, and also has anti-inflammatory and anti-photosensitivity properties. It is based on protecting melanocytes from excessive consumption, addressing the root cause of the disease, reflecting the principle of treating the root cause in traditional Chinese medicine.

[0082] The above description of the embodiments is only for the purpose of helping to understand the method and core ideas of this application. It should be noted that, for those skilled in the art, several improvements and modifications can be made to this application without departing from the principles of this application, and these improvements and modifications also fall within the protection scope of the claims of this application.

Claims

1. A traditional Chinese medicine composition for treating vitiligo, characterized in that, It is made from the following raw materials in parts by weight: Bupleurum chinense 5-15 parts, Citrus aurantium 5-15 parts, Paeonia lactiflora 5-15 parts, Schizonepeta tenuifolia 5-30 parts, Rehmannia glutinosa 5-30 parts, Rehmannia glutinosa (processed) 5-30 parts, Angelica sinensis 5-30 parts, Ligusticum chuanxiong 5-15 parts, Astragalus membranaceus (processed) 5-30 parts, Phellodendron chinense 5-30 parts, Artemisia annua 5-30 parts, and Panax ginseng leaf 5-30 parts.

2. The traditional Chinese medicine composition for treating vitiligo according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: Bupleurum chinense 5-12 parts, Citrus aurantium 5-12 parts, Paeonia lactiflora 9-12 parts, Schizonepeta tenuifolia 15-30 parts, Rehmannia glutinosa 5-20 parts, Rehmannia glutinosa (processed) 15-30 parts, Angelica sinensis 5-20 parts, Ligusticum chuanxiong 5-12 parts, Astragalus membranaceus (processed) 15-30 parts, Phellodendron chinense 15-30 parts, Artemisia annua 15-30 parts, and Panax ginseng leaf 12-30 parts.

3. The traditional Chinese medicine composition for treating vitiligo according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: Bupleurum chinense 5-9 parts, Citrus aurantium 5-9 parts, Paeonia lactiflora 9-11 parts, Schizonepeta tenuifolia 20-30 parts, Rehmannia glutinosa 5-15 parts, Rehmannia glutinosa (processed) 20-30 parts, Angelica sinensis 5-15 parts, Ligusticum chuanxiong 5-10 parts, Astragalus membranaceus (processed) 20-30 parts, Phellodendron chinense 20-30 parts, Artemisia annua 20-30 parts, and Panax ginseng leaf 15-20 parts.

4. The traditional Chinese medicine composition for treating vitiligo according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: Bupleurum chinense 5-6 parts, Citrus aurantium 5-6 parts, Paeonia lactiflora 9-10 parts, Schizonepeta tenuifolia 25-30 parts, Rehmannia glutinosa 8-10 parts, Rehmannia glutinosa (processed) 25-30 parts, Angelica sinensis 5-10 parts, Ligusticum chuanxiong 5-8 parts, Astragalus membranaceus (processed) 25-30 parts, Phellodendron chinense 25-30 parts, Artemisia annua 25-30 parts, and Panax ginseng leaf 15-20 parts.

5. The traditional Chinese medicine composition for treating vitiligo according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: Bupleurum chinense 5 parts, Citrus aurantium 5 parts, Paeonia lactiflora 9 parts, Schizonepeta tenuifolia 30 parts, Rehmannia glutinosa 10 parts, Rehmannia glutinosa (processed) 30 parts, Angelica sinensis 5 parts, Ligusticum chuanxiong 5 parts, Astragalus membranaceus (processed) 30 parts, Phellodendron chinense 30 parts, Artemisia annua 30 parts, and Panax ginseng leaf 15 parts.

6. The use of the traditional Chinese medicine composition according to any one of claims 1-5 in the preparation of a medicament for treating vitiligo.

7. A drug, characterized in that, The traditional Chinese medicine composition comprising any one of claims 1-5.

8. The medicament according to claim 7, characterized in that, The drugs include tablets, granules, pills, ointments, capsules, decoctions, oral liquids, powders, and solid beverages; The drug also includes acceptable excipients.

9. The medicament according to claim 8, characterized in that, The excipients are selected from one or more of maltodextrin, lactose, dextrin, corn starch, microcrystalline cellulose, silicon dioxide, magnesium stearate, white sugar, and sucralose.

10. A method for preparing a medicine comprising the traditional Chinese medicine composition according to any one of claims 1-5, characterized in that, include: Weigh out the following ingredients according to the specified proportions: Bupleurum chinense, Citrus aurantium, Paeonia lactiflora, Schizonepeta tenuifolia, Rehmannia glutinosa (raw and processed), Angelica sinensis, Ligusticum chuanxiong, Astragalus membranaceus (processed), Phellodendron chinense, Artemisia annua, and Panax ginseng leaves. Wash and pulverize them, add 5-15 times the amount of water, and decoct and extract 2-4 times, 0.5-2 hours each time, to obtain the extract. Combine the extracts, filter, and concentrate to obtain the final product.

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