Traditional Chinese medicine composition for treating vitiligo and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating leucoderma and application thereof. The traditional Chinese medicine composition comprises peach kernel, safflower, fructus psoraleae, angelica sinensis, astragalus membranaceus, glossy privet fruit, radix paeoniae alba, radix angelicae, salvia miltiorrhiza, duckweed and honey-fried licorice root. The traditional Chinese medicine composition is particularly prepared from the following traditional Chinese medicines in parts by weight: 8-12 parts of peach kernel, 2-10 parts of safflower, 8-12 parts of fructus psoraleae, 8-12 parts of angelica sinensis, 12-16 parts of astragalus membranaceus, 8-12 parts of glossy privet fruit, 8-12 parts of radix paeoniae alba, 8-12 parts of radix angelicae, 8-12 parts of salvia miltiorrhiza, 2-10 parts of duckweed and 2-10 parts of honey-fried licorice root. In the traditional Chinese medicine, safflower and peach kernel are monarch drugs; fructus psoraleae, angelica sinensis, astragalus membranaceus and glossy privet fruit are used as ministerial drugs; radix paeoniae alba, radix angelicae and radix salviae miltiorrhizae are used as adjuvant drugs; the components are all derived from natural medicinal materials, the raw materials are easy to obtain, low in cost and free of toxic and side effects, skin pigment recovery is promoted by promoting blood circulation to remove blood stasis, nourishing liver and kidney, dispelling wind and removing obstruction in the meridians, the leucoderma symptom is effectively improved, and the traditional Chinese medicine composition can be used for treating leucoderma.

Description

Technical Field

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

[0002] Vitiligo is a common, acquired, progressive pigmentary disorder of the skin, characterized by the loss and / or dysfunction of functional epidermal melanocytes, resulting in white patches of varying sizes and irregular shapes on the skin and mucous membranes. Epidemiological data shows that the global prevalence of this disease is approximately 0.5%-2.0%, with no significant gender or racial differences, and it can occur at any age. In my country, the prevalence varies across regions, ranging from approximately 0.09% to 1.53%, also without significant gender bias. Modern medicine considers vitiligo to be a disease closely related to autoimmunity, with its occurrence and development intricately linked to genetic susceptibility, environmental factors, and various comorbidities (such as thyroid disease, psoriasis, and alopecia areata). This multifactorial pathogenesis leads to significant individual variability in clinical treatment responses. Although the lesions themselves are usually asymptomatic, their appearance severely affects patients' physical appearance, often causing persistent distress in their studies, work, social interactions, and mental health, easily triggering anxiety, low self-esteem, and other emotional disorders, thus reducing their quality of life. Currently, mainstream Western medical treatments mainly include narrowband UVB (NB-UVB) phototherapy, local or systemic application of glucocorticoids, calcineurin inhibitors, and immunomodulators. While these methods have some efficacy, they generally suffer from long treatment courses, inconvenience of use, and high costs. Furthermore, long-term or improper use may lead to significant side effects such as skin atrophy, telangiectasia, endocrine disorders, and liver and kidney damage, limiting their long-term safety and patient compliance.

[0003] Traditional Chinese medicine has a long history of understanding this disease. The Sui Dynasty text *Zhu Bing Yuan Hou Lun* (Treatise on the Causes and Symptoms of Various Diseases) clearly records: "Vitiligo is characterized by white discoloration of the skin on the face, neck, and body, different from the color of blood, without itching or pain; this is called vitiligo." Traditional Chinese medicine theory holds that "wind is the leader of all diseases," its nature being mobile and constantly changing, easily attacking the yang areas. The skin, as the outermost barrier of the body, is the first to be affected by wind pathogens. The core pathogenesis of vitiligo is largely attributed to "disharmony of qi and blood, and obstruction of the meridians." This may be due to external wind, dampness, or heat pathogens invading the skin; or internal damage from the seven emotions and overwork, leading to dysfunction of the liver, kidneys, spleen, and other organs, resulting in insufficient production or sluggish circulation of qi and blood. Ultimately, this causes stagnation of qi and blood in the local skin, obstruction of the meridians, and blockage of the pores, depriving the skin of nourishment from qi and blood and replenishment from kidney essence, thus resulting in white patches. Therefore, developing a traditional Chinese medicine compound preparation that is effective, safe to use, has few side effects, and is economical and convenient, starting from regulating qi and blood, clearing meridians, and nourishing the liver and kidneys, has become an important technical problem that urgently needs to be solved in this field. Summary of the Invention

[0004] In view of the above-mentioned problems in the prior art, the main objective of the present invention is to provide a traditional Chinese medicine composition for treating vitiligo.

[0005] Another object of the present invention is to provide the application of the above-mentioned traditional Chinese medicine composition for treating vitiligo in the preparation of a drug.

[0006] To achieve the above objectives, the present invention provides the following technical solution:

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating vitiligo, the traditional Chinese medicine composition comprising the following traditional Chinese medicines: peach kernel, safflower, psoralea corylifolia, angelica sinensis, astragalus membranaceus, privet fruit, white peony root, angelica dahurica, salvia miltiorrhiza, duckweed, and prepared licorice root.

[0008] Preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 8-12 parts of peach kernel, 2-10 parts of safflower, 8-12 parts of psoralea corylifolia, 8-12 parts of angelica sinensis, 12-16 parts of astragalus membranaceus, 8-12 parts of privet fruit, 8-12 parts of white peony root, 8-12 parts of angelica dahurica, 8-12 parts of salvia miltiorrhiza, 2-10 parts of duckweed, and 2-10 parts of prepared licorice root.

[0009] Preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 9-11 parts of peach kernel, 4-8 parts of safflower, 9-11 parts of psoralea corylifolia, 9-11 parts of angelica sinensis, 13-15 parts of astragalus membranaceus, 9-11 parts of privet fruit, 9-11 parts of white peony root, 9-11 parts of angelica dahurica, 9-11 parts of salvia miltiorrhiza, 4-8 parts of duckweed, and 4-8 parts of prepared licorice root.

[0010] Preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 10 parts peach kernel, 6 parts safflower, 10 parts psoralea corylifolia, 10 parts angelica sinensis, 15 parts astragalus membranaceus, 10 parts privet fruit, 10 parts white peony root, 10 parts angelica dahurica, 10 parts salvia miltiorrhiza, 6 parts duckweed, and 6 parts prepared licorice root.

[0011] Preferably, the traditional Chinese medicine composition may be in the form of tablets, pills, oral solutions, capsules, drop pills, granules, powders, or decoctions.

[0012] More preferably, the traditional Chinese medicine composition is an oral solution.

[0013] In this invention, safflower and peach kernel are the principal herbs; psoralea, angelica, astragalus, and privet fruit are the assistant herbs; white peony root, angelica dahurica, and salvia miltiorrhiza are the adjuvant herbs; and duckweed and prepared licorice are the guiding herbs. Their common pharmacological effects in this field are as follows:

[0014] Peach kernel: Bitter and sweet in taste, neutral in nature, it enters the heart, liver, and large intestine meridians. It is an essential medicine for promoting blood circulation and removing blood stasis. It is moist and rich in oil, which can break up blood stasis and promote blood circulation, and also moisten dryness. Targeting the core pathogenesis of "blood stasis obstructing the collaterals" in the progressive stage, it focuses on clearing the stagnation between the skin and pores.

[0015] Safflower: pungent and warm, entering the heart and liver meridians. It excels at promoting blood circulation, regulating menstruation, dispersing blood stasis, and relieving pain. Its light and ascending nature allows it to easily reach the skin. When used synergistically with peach kernel, it forms a classic blood-activating herb pair, enhancing the power of blood circulation and stasis removal, aiming to quickly curb the pathological process of spots and lesions caused by blood stasis. Together, they serve as the principal herbs, aiming to "remove blood stasis and unblock the meridians to stop its spread."

[0016] Psoralea corylifolia: Bitter, pungent, and warm in nature, it enters the kidney and spleen meridians. Its function is to warm the kidneys and invigorate yang, making it a representative herb of "treating color with color" (its black color enters the kidneys). Modern research has confirmed its ability to stimulate melanocyte activity. Targeting the root cause of liver and kidney deficiency, it warms and tonifies kidney yang to promote the growth of vital energy.

[0017] Privet fruit: sweet, bitter, and cool in nature, it enters the liver and kidney meridians. Its main function is to nourish the yin of the liver and kidneys, darken hair, and improve eyesight. Combined with psoralea corylifolia, one warm and one cool, one yin and one yang, they work together to achieve the effect of "dual tonification of yin and yang, harmonizing the liver and kidneys," fundamentally nourishing the source of hair growth, in accordance with the theory that "the kidneys govern black."

[0018] Angelica sinensis: sweet, pungent, and warm in nature, it enters the liver, heart, and spleen meridians. It is a holy medicine for nourishing and invigorating blood, enabling blood to be abundant and circulate properly.

[0019] Astragalus: Sweet and slightly warm, it enters the lung and spleen meridians. It is a superior tonic for replenishing qi, greatly tonifying the qi of the spleen and lungs, benefiting qi to generate blood, and strengthening the exterior to ward off pathogens. The combination of these two herbs embodies the essence of "Dang Gui Bu Xue Tang" (Angelica Blood-Nourishing Decoction), achieving the effect of "tonifying qi and generating blood, simultaneously nourishing both qi and blood." When qi and blood are abundant, the skin is nourished, providing the material basis for removing blood stasis and generating new blood.

[0020] White peony root: bitter, sour, and slightly cold in nature, it enters the liver and spleen meridians. Its functions include nourishing blood and astringing yin, softening the liver and relieving pain. It has three uses: first, it nourishes blood and assists angelica root; second, its sourness and astringency prevent pungent and dispersing drugs such as peach kernel and safflower from depleting yin and blood; and third, it softens and calms the liver, relieving liver qi stagnation caused by emotional distress.

[0021] Angelica dahurica: pungent and warm, it enters the lung, stomach, and large intestine meridians. Aromatic and dispersing, it effectively dispels wind and cold, clears the orifices, and relieves pain. As a guiding herb for the Yangming meridian, it can "guide other herbs directly to the head, face, and skin," dispersing wind-evil stagnating on the surface of the body, targeting the root cause of "wind-evil attacking the exterior."

[0022] Danshen: Bitter and slightly cold, it enters the heart and liver meridians. Its effects are similar to Siwu Decoction, promoting blood circulation, removing blood stasis, cooling the blood, and reducing swelling. Its cold nature can both assist the principal herb in enhancing its blood-activating and stasis-removing effects and "cool the blood to prevent prolonged stasis from turning into heat," clearing away any micro-inflammatory states that may exist during the progression of the disease.

[0023] Duckweed: pungent and cold in nature, it enters the lung meridian. Light and floating, it is particularly effective in dispersing wind-heat, promoting rash eruption, and facilitating urination. Its light and agile nature allows it to open pores, acting like a "boat," carrying the power of various medicines upwards and outwards, dispersing lung qi, and ensuring the medicine's effects are fully applied to the affected areas on the skin surface.

[0024] Prepared licorice root: sweet and neutral in nature, it enters the heart, lung, spleen, and stomach meridians. Firstly, it "harmonizes the other herbs," moderating the potent blood-activating effect of the main herb and balancing the cold and warm properties of the formula. Secondly, it "tonifies qi and harmonizes the middle jiao," protecting the spleen and stomach, assisting astragalus in strengthening the spleen, and ensuring the safety of the spleen and stomach during long-term use.

[0025] A second aspect of the present invention provides the use of the traditional Chinese medicine composition in the preparation of a medicament for treating vitiligo.

[0026] Preferably, the active ingredients of the traditional Chinese medicine composition are extracted and then mixed to prepare a pharmaceutically acceptable drug preparation.

[0027] Preferably, the pharmaceutical preparation comprises an extract of the above-mentioned traditional Chinese medicine composition and a pharmaceutically acceptable drug carrier, and the dosage form of the pharmaceutical preparation is selected from at least one of the following formulations: tablets, pills, oral solutions, capsules, drop pills, granules, powders, or decoctions.

[0028] Preferably, the vitiligo described is vitiligo in the progressive (active) stage.

[0029] Compared with the prior art, the beneficial effects of the present invention are:

[0030] 1. The traditional Chinese medicine compositions of the present invention all use natural Chinese medicine raw materials. The preparation method is simple, the raw materials are widely available, and there are no irritating toxic side effects. They all meet the standards of the Chinese Pharmacopoeia. All raw materials are included in the "medicine and food homology" or "can be used in health food" catalogs, and the place of origin is fixed. They have the advantages of high safety and low cost.

[0031] 2. The herbal composition of this invention is guided by traditional Chinese medicine syndrome differentiation and targets the core pathogenesis of progressive vitiligo: "wind attacking the exterior, disharmony of qi and blood, blood stasis obstructing the meridians, and deficiency of liver and kidney." It establishes the treatment principle of "activating blood circulation and dispelling wind to treat the symptoms, nourishing the liver and kidneys to strengthen the foundation, and replenishing qi and blood to support the body's resistance." The entire formula uses peach kernel and safflower as the chief herbs to break up blood stasis and unblock the meridians to inhibit the spread of vitiligo; psoralea corylifolia and privet fruit nourish the liver and kidneys and promote pigmentation; angelica sinensis and astragalus membranaceus replenish qi and blood and nourish the source of qi and blood production, serving as assistant herbs; white peony root softens the liver and nourishes blood; angelica dahurica dispels wind and reaches the exterior; and salvia miltiorrhiza activates blood circulation and prevents blood stasis and heat, serving as adjuvant herbs; duckweed gently guides the herbs to the surface of the skin, and roasted licorice root harmonizes the herbs and protects the spleen and stomach, serving as the guiding herbs. The synergistic effect of these herbs constitutes a three-dimensional treatment system that regulates liver and kidney qi and blood internally, unblocks skin meridians externally, and dispels wind, aiming to quickly control disease activity, promote internal stability, and lay the foundation for repigmentation of vitiligo.

[0032] 3. The traditional Chinese medicine composition of this invention is formulated into a suitable oral dosage form using modern pharmaceutical processes, making it particularly suitable for the treatment of progressive vitiligo. This allows the medication to reach the lesion site through systemic blood circulation, making it especially suitable for controlling newly occurring and spreading progressive vitiligo, and solving the problem of poor efficacy of topical medications for scattered and multiple skin lesions. Furthermore, the oral dosage form makes it easier to precisely control the dosage, avoids skin irritation that may be caused by topical application, and significantly improves patient compliance.

[0033] 4. This composition targets the pathogenesis of vitiligo, including imbalances in Qi and blood, and deficiency of the liver and kidneys. By promoting blood circulation, removing blood stasis, nourishing the liver and kidneys, and dispelling wind and unblocking the meridians, it promotes the recovery of skin pigmentation and can effectively improve the symptoms of vitiligo. Especially in the treatment of children with vitiligo, this compound preparation emphasizes the compliance and safety of oral medication. The medicine is mild and properly combined, aiming to reduce potential irritation to the gastrointestinal tract and improve the child's medication experience. This ensures the continuity of the treatment plan and the stability of the systemic drug concentration, which is particularly important for the management of vitiligo that requires long-term medication.

[0034] 5. The oral dosage form of the traditional Chinese medicine composition of this invention can be effectively absorbed through the gastrointestinal tract and exert a systemic regulatory effect after entering the systemic circulation. It aims to regulate the internal environment of the body through multiple targets, improve microcirculation, nourish the liver and kidneys, and harmonize qi and blood, thereby providing internal support for the recovery and function of skin melanocytes. Furthermore, good oral compliance helps patients adhere to treatment, creating a continuous and stable internal condition for fundamentally improving the condition and promoting repigmentation of vitiligo. Attached Figure Description

[0035] Figure 1 These are photos showing the effects of facial vitiligo in Case 3 before treatment (left) and one month after treatment (right).

[0036] Figure 2 These are photos showing the effects of acral vitiligo in Case 3 before treatment (left) and after 1.5 months of treatment (right).

[0037] Figure 3 These are photos showing the effects of treatment on the trunk of a patient in Case 3 before (left) and 1.5 months after treatment (right).

[0038] Figure 4 These are photos of different groups of animals after drug administration in Experiment Example 1. Detailed Implementation

[0039] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the described embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0040] Example 1

[0041] Take 12 parts of peach kernel, 10 parts of safflower, 12 parts of psoralea corylifolia, 12 parts of angelica sinensis, 16 parts of astragalus membranaceus, 12 parts of privet fruit, 12 parts of white peony root, 12 parts of angelica dahurica, 12 parts of salvia miltiorrhiza, 10 parts of duckweed, and 10 parts of prepared licorice root. Clean and select the above eleven Chinese medicinal materials, accurately weigh them according to the formula ratio, put the medicines into a decoction container, add 10 times the amount of water and soak for 30 minutes, decoct for 40 minutes the first time, add duckweed last, add 8 times the amount of water the second time and decoct for 60 minutes, combine the decoctions, concentrate and filter to obtain Chinese medicine composition 1.

[0042] Example 2

[0043] Take 9 parts of peach kernel, 4 parts of safflower, 9 parts of psoralea corylifolia, 9 parts of angelica sinensis, 13 parts of astragalus membranaceus, 9 parts of privet fruit, 9 parts of white peony root, 9 parts of angelica dahurica, 9 parts of salvia miltiorrhiza, 4 parts of duckweed, and 4 parts of prepared licorice root, and obtain the traditional Chinese medicine composition 2 by the same preparation method as in Example 1.

[0044] Example 3

[0045] Take 10 parts of peach kernel, 6 parts of safflower, 10 parts of psoralea corylifolia, 10 parts of angelica sinensis, 15 parts of astragalus membranaceus, 10 parts of privet fruit, 10 parts of white peony root, 10 parts of angelica dahurica, 10 parts of salvia miltiorrhiza, 6 parts of duckweed, and 6 parts of prepared licorice root, and obtain the traditional Chinese medicine composition 3 by the same preparation method as in Example 1.

[0046] Experiment 1: Animal Experiment

[0047] 1. Experimental materials

[0048] 1.1 Experimental Drugs

[0049] 1.2 Preparation of 2.5% Hydroquinone Cream: Oil phase: 6g stearyl alcohol, 8g stearic acid, 8g white petrolatum, 2g azone; Aqueous phase: 1.6g triethanolamine, 5g glycerin, 8g ammonium dodecyl sulfate, 0.1g ethylparaben, 5g propylene glycol, 60.3g aqueous drug solvent; Other phase: 2g glycerin, 1g stearic acid. Grind 2.5g hydroquinone and 0.5g anhydrous sodium sulfite together, then add 57.3g water to obtain the aqueous drug solvent. Melt the oil phase at 70-75℃, and slowly add the aqueous phase to the oil phase after heating to 70-75℃, stirring in a directional direction until homogeneous. Add the homogeneous other phase, and continue stirring until cooled to obtain the 2.5% hydroquinone cream.

[0050] 1.3 Animal Model Preparation

[0051] Thirty-six male C57BL / 6 mice aged 4-6 weeks (purchased from Liaoning Changsheng Biotechnology Co., Ltd.) were randomly selected and housed in a sterile environment at 23±2℃, with 16 hours of light and 8 hours of darkness, and were provided with sterile water and standard feed. A 2cm × 2cm area of ​​skin was selected from the back of each mouse. The hair on the back was removed the day before the experiment. The control group received no treatment, while the other groups had 2.5% hydroquinone ointment applied to the shaved area once daily. The modeling period was 60 days.

[0052] 1.4 Experimental grouping and administration method

[0053] On day 20 of model establishment, mice were divided into groups by gavage. The prepared traditional Chinese medicine (TCM) solution was used as the medium-dose group. The medium-dose group was diluted by half to obtain the low-dose group, and the medium-dose group was concentrated by half to obtain the high-dose group. Except for the blank control group, the prepared model mice were randomly divided into 5 groups: model group, low-dose TCM group, medium-dose TCM group, high-dose TCM group, and Western medicine group, with 6 mice in each group. After model establishment, the TCM treatment groups were administered different concentrations of TCM solution by gavage, while the Western medicine treatment group was administered prednisone 2.73 mg / kg / day (according to the classic conversion table of human and animal body surface area ratio) by gavage for 40 days. The model group mice were administered the same volume of distilled water as the drug solution by gavage instead.

[0054] 2. Observation Indicators and Measurement Methods

[0055] 2.1 Macroscopic observation of mouse skin lesions

[0056] 2.2 Decolorization score of mouse dorsal hair

[0057] The depigmented areas were divided into medicated and unmedicated areas, with each area scored out of 5 points, for a total of 10 points per mouse. The scoring criteria for mouse hair depigmentation were as follows: 0 points for no hair depigmentation; 1 point for depigmented area <10%; 11% for depigmented area <2 points <25%; 26% for depigmented area <3 points <50%; 51% for depigmented area ≤4 points <75%; and 76% for depigmented area ≤5 points <100%.

[0058] 3. Experimental Results

[0059] 3.1 Macroscopic observation of mouse skin lesions

[0060] Throughout the experiment, the skin of the normal group mice showed no changes; other groups of mice developed varying degrees of vitiligo-like reactions on their backs after modeling, with specific symptoms including white patches and whitening of the hair roots. After drug treatment, the symptoms in the modeled area of ​​mice in different concentrations of traditional Chinese medicine and Western medicine groups were significantly improved, the number of white patches decreased, and the hair showed varying degrees of repigmentation. Among them, the high-dose traditional Chinese medicine group and the Western medicine group showed better treatment effects.

[0061] 3.2 Decolorization score of mouse dorsal hair

[0062] Table 1

[0063]

[0064] From Table 1 and Figure 4 The experimental results showed that, compared with the blank control group, the model group mice had significantly higher hair depigmentation scores, white spots on their backs, and pathological manifestations such as hair depigmentation and whitening. Mice in the traditional Chinese medicine and Western medicine groups using various doses of the present invention showed significant skin improvement, reduced white spots, and significantly lower hair depigmentation scores than the model group.

[0065] Trial Example 2: Clinical Study

[0066] 1. Research Methods

[0067] A standardized clinical study was conducted on patients with vitiligo (active phase) to verify the efficacy of an optimized TCM treatment plan for vitiligo.

[0068] 2. Case sources: All cases were patients from the vitiligo specialist clinic, including 2 males and 1 female. They had not received systematic treatment or medication for more than 6 months before treatment.

[0069] 3. Diagnostic, inclusion, and exclusion criteria for study subjects

[0070] 3.1 Inclusion Criteria

[0071] Those who meet the diagnostic criteria for vitiligo or are diagnosed with vitiligo by a hospital dermatology department;

[0072] Age: e.g., 12-65 years old;

[0073] Disease duration: ≥3 months, VIDA active phase score 3;

[0074] The skin lesions are non-segmental;

[0075] Those who voluntarily accept treatment with the traditional Chinese medicine preparation of this invention and sign informed consent.

[0076] 3.2 Exclusion Criteria

[0077] Those with combined serious organic diseases of the heart, liver, kidneys, hematopoietic system, etc.;

[0078] Pregnant and lactating women;

[0079] Patients with other active skin diseases or autoimmune diseases whose treatment efficacy is affected;

[0080] Those who have used systemic glucocorticoids, immunosuppressants, or other treatments that affect the assessment of efficacy within the past 1-3 months;

[0081] Individuals allergic to any of the ingredients in the traditional Chinese medicine preparation of this invention.

[0082] 4. Usage and course of treatment

[0083] Dosage form: oral solution, each mL contains 2g of crude drug;

[0084] Dosage and administration: Oral administration, 20 ml each time, 3 times a day, taken with warm water after meals;

[0085] Treatment course: One course of treatment lasts for 4 weeks;

[0086] The dosage can be adjusted according to the severity of the condition and the patient's weight.

[0087] 5. Evaluation Indicators

[0088] Key indicators:

[0089] Skin lesion repigmentation rate (graded by percentage of pigment recovery area: effective, effective, ineffective, etc.);

[0090] Overall efficiency.

[0091] Secondary indicators:

[0092] The patient reported improvement in symptoms (itching, burning sensation, etc.);

[0093] Changes in quality of life scores;

[0094] Laboratory indicators (liver and kidney function, blood routine and other safety indicators).

[0095] Incidence and severity of adverse reactions.

[0096] 6. Results

[0097] Compared with the control group, the total effective rate of the oral Chinese medicine preparation of the present invention was significantly improved after treating ×× patients;

[0098] The time for skin lesions to repigment is shortened, and the repigmented area is increased;

[0099] The adverse reactions are mild, mainly mild stomach discomfort, which can be relieved on their own after symptomatic treatment or discontinuation of the drug;

[0100] Laboratory indicators such as liver and kidney function showed no significant abnormalities.

[0101] 7. Conclusion

[0102] The oral Chinese medicine preparation provided by this invention can significantly promote skin repigmentation and improve the overall effective rate for the treatment of vitiligo. It also has good safety and mild adverse reactions, making it suitable for clinical application. It is recommended to further expand the sample size and extend the follow-up period to verify its long-term efficacy and safety.

[0103] Trial Example 3: Clinical Case

[0104] Case 1

[0105] A 67-year-old male developed facial vitiligo after sun exposure approximately one month prior. He was treated for one month with the oral Chinese medicine preparation provided by this invention, as detailed below:

[0106] Dosage form: oral solution, each mL contains 2g of crude drug;

[0107] Dosage and administration: Oral administration, 20 ml each time, 3 times a day, taken with warm water after meals;

[0108] Treatment course: One course of treatment lasts for 4 weeks;

[0109] For example, the effect before treatment and one month after treatment Figure 1 As shown.

[0110] Case 2

[0111] A 39-year-old male presented with unexplained itching followed by the discovery of vitiligo on his extremities. He was treated for 1.5 months with the oral Chinese medicine preparation provided by this invention, as detailed below:

[0112] Dosage form: oral solution, each mL contains 2g of crude drug;

[0113] Dosage and administration: Oral administration, 20 ml each time, 3 times a day, taken with warm water after meals;

[0114] Treatment course: One course of treatment lasts for 4 weeks, and a total of 1.5 courses of treatment are required.

[0115] The effects before treatment and 1.5 months after treatment, for example... Figure 2 As shown.

[0116] Case 3

[0117] A 48-year-old woman experienced the spread of vitiligo on her trunk after exertion. She was treated for 1.5 months with the oral Chinese medicine preparation provided by this invention, as detailed below:

[0118] Dosage form: oral solution, each mL contains 2g of crude drug;

[0119] Dosage and administration: Oral administration, 20 ml each time, 3 times a day, taken with warm water after meals;

[0120] Treatment course: One course of treatment lasts for 4 weeks, and a total of 1.5 courses of treatment are required.

[0121] The effects before treatment and 1.5 months after treatment, for example... Figure 3 As shown.

[0122] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A traditional Chinese medicine composition for treating vitiligo, characterized in that, The traditional Chinese medicine composition includes the following herbs: peach kernel, safflower, psoralea corylifolia, angelica sinensis, astragalus membranaceus, privet fruit, white peony root, angelica dahurica, salvia miltiorrhiza, duckweed, and prepared licorice root.

2. The traditional Chinese medicine composition for treating vitiligo according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 8-12 parts of peach kernel, 2-10 parts of safflower, 8-12 parts of psoralea corylifolia, 8-12 parts of angelica sinensis, 12-16 parts of astragalus membranaceus, 8-12 parts of privet fruit, 8-12 parts of white peony root, 8-12 parts of angelica dahurica, 8-12 parts of salvia miltiorrhiza, 2-10 parts of duckweed, and 2-10 parts of prepared licorice root.

3. The traditional Chinese medicine composition for treating vitiligo according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 9-11 parts of peach kernel, 4-8 parts of safflower, 9-11 parts of psoralea corylifolia, 9-11 parts of angelica sinensis, 13-15 parts of astragalus membranaceus, 9-11 parts of privet fruit, 9-11 parts of white peony root, 9-11 parts of angelica dahurica, 9-11 parts of salvia miltiorrhiza, 4-8 parts of duckweed, and 4-8 parts of prepared licorice root.

4. The traditional Chinese medicine composition for treating vitiligo according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 10 parts peach kernel, 6 parts safflower, 10 parts psoralea corylifolia, 10 parts angelica sinensis, 15 parts astragalus membranaceus, 10 parts privet fruit, 10 parts white peony root, 10 parts angelica dahurica, 10 parts salvia miltiorrhiza, 6 parts duckweed, and 6 parts prepared licorice root.

5. The traditional Chinese medicine composition for treating vitiligo according to claim 1, characterized in that, The traditional Chinese medicine composition may be in the form of tablets, pills, oral solutions, capsules, drop pills, granules, powders, or decoctions.

6. The traditional Chinese medicine composition for treating vitiligo according to claim 5, characterized in that, The traditional Chinese medicine composition is an oral solution.

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

8. The application according to claim 7, characterized in that, The active ingredients of the traditional Chinese medicine composition are extracted and then mixed to prepare a pharmaceutically acceptable drug preparation.

9. The application according to claim 8, characterized in that, The pharmaceutical preparation comprises an extract of the above-mentioned traditional Chinese medicine composition and a pharmaceutically acceptable drug carrier, and the dosage form of the pharmaceutical preparation is selected from at least one of the following formulations: tablets, pills, oral solutions, capsules, drop pills, granules, powders, or decoctions.

10. The application according to claim 7, characterized in that, The vitiligo described is vitiligo in the progressive (active) stage.

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