Traditional Chinese medicine composition for treating vitiligo and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicines, and particularly discloses a traditional Chinese medicine composition for treating leucoderma and a preparation method thereof. The traditional Chinese medicine composition for treating leucoderma is prepared from the following raw materials in parts by weight: 700 to 900 parts of radix paeoniae rubra, 700 to 900 parts of radix angelicae sinensis, 700 to 900 parts of fructus ligustri lucidi, 500 to 700 parts of radix curcumae, 500 to 700 parts of rhizoma chuanxiong, 400 to 600 parts of fructus tribuli, 400 to 600 parts of radix scutellariae, 400 to 600 parts of fructus psoraleae, 400 to 600 parts of radix codonopsis and 400 to 600 parts of radix polygoni multiflori preparata. The traditional Chinese medicine composition prepared by the invention can be used for treating vitiligo, and has the advantages of multiple-effect synergism and treatment of both symptoms and root causes.

Description

Technical Field

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

[0002] Vitiligo is a common acquired depigmenting skin disease, mainly manifested as localized or generalized depigmented patches on the skin. Its pathogenesis is not fully understood, but it is currently believed to be closely related to multiple factors, including genetic susceptibility, autoimmune abnormalities, oxidative stress damage to melanocytes, neuroendocrine disorders, and microcirculatory disturbances. Among these, T-lymphocyte-mediated autoimmune responses leading to selective destruction of melanocytes are one of the core pathogenic mechanisms, manifested as weakened regulatory T cell (Treg) function, excessive activation of helper T cell 17 (Th17) cells, and elevated levels of pro-inflammatory factors such as IL-17 and IFN-γ, resulting in local immune imbalance.

[0003] Commonly used clinical treatments include topical corticosteroids, calcineurin inhibitors, phototherapy (such as NB-UVB), and autologous epidermal transplantation. While these treatments have some efficacy, they suffer from high recurrence rates, significant side effects with long-term use, slow onset of action, and limited applicability. Systemic immunosuppressants, although capable of regulating immune disorders, have high safety risks, limiting their widespread application. Therefore, developing a safe, effective, and novel treatment strategy that combines holistic regulation with targeted intervention is of great significance.

[0004] Traditional Chinese medicine (TCM) has a long history of treating vitiligo. TCM believes that the disease is mostly caused by "liver and kidney deficiency, disharmony of qi and blood, invasion of wind pathogens, and blood stasis obstructing the meridians." Treatment emphasizes "nourishing the liver and kidneys, replenishing qi and blood, promoting blood circulation and dispelling wind, and harmonizing qi and blood." Existing TCM compound formulas, such as Baibo Pills and Vitiligo Capsules, largely follow this principle, exerting their effects by improving microcirculation, regulating immune function, and promoting melanin synthesis. However, traditional TCM preparations generally suffer from low bioavailability, unclear targets, and slow onset of action, making it difficult to achieve efficient regulation of the immune microenvironment. Summary of the Invention

[0005] To address the aforementioned problems, this application provides a traditional Chinese medicine composition for treating vitiligo and a method for preparing the same.

[0006] Firstly, this application provides a traditional Chinese medicine composition for treating vitiligo, which adopts the following technical solution: A traditional Chinese medicine composition for treating vitiligo, comprising the following raw materials in parts by weight: Red peony root 700-900 parts, Angelica sinensis 700-900 parts, Ligustrum lucidum 700-900 parts, Curcuma longa 500-700 parts, Ligusticum chuanxiong 500-700 parts, Tribulus terrestris 400-600 parts, Scutellaria baicalensis 400-600 parts, Psoralea corylifolia 400-600 parts, Codonopsis pilosula 400-600 parts, processed Polygonum multiflorum 400-600 parts.

[0007] By employing the above-mentioned technical solution, Paeonia lactiflora, Angelica sinensis, and Ligusticum chuanxiong invigorate blood circulation and improve local microcirculation, providing nutrition to melanocytes; Ligustrum lucidum and processed Polygonum multiflorum nourish the liver and kidneys, replenish essence and blood, fundamentally supplementing the material basis for melanin production; Psoralea corylifolia warms the kidneys and assists yang, and its psoralen can significantly enhance skin photosensitivity, activate tyrosinase activity, and directly promote melanin synthesis; Tribulus terrestris dispels wind and evil, and harmonizes qi and blood; Curcuma longa soothes the liver and relieves depression, Scutellaria baicalensis clears heat and dries dampness, and Codonopsis pilosula invigorates qi and strengthens the spleen, together regulating the body's immune function and reducing abnormal attacks on melanocytes. The various medicinal ingredients work synergistically to invigorate blood circulation, remove blood stasis, nourish the liver and kidneys, and regulate immunity, thereby effectively promoting pigment recovery in the vitiligo area. Furthermore, the combination emphasizes overall conditioning, helping to reduce the risk of recurrence.

[0008] Optionally, the raw materials may also include 30-60 parts of a targeted immunomodulatory complex, which is prepared by encapsulating active ingredients in nanoliposomes, wherein the active ingredients are one or more of astragalus polysaccharide, ginsenoside Rg3 and resveratrol.

[0009] By employing the aforementioned technical solution, the traditional Chinese medicine composition, through the introduction of a targeted immunomodulatory complex encapsulated in nanoliposomes, achieves a synergistic enhancement of the traditional functions of regulating qi and blood and nourishing the liver and kidneys, combined with modern precision immunomodulation. Nanoliposomes, as a highly efficient delivery system, enhance the bioavailability of active ingredients and target them to immune cells. Astragalus polysaccharides regulate the balance of T lymphocyte subsets and inhibit the attack of abnormal autoimmune responses on melanocytes. Ginsenoside Rg3 and resveratrol further strengthen immunomodulation and protect melanocytes from oxidative stress damage through antioxidant and anti-inflammatory mechanisms. This complex, synergistically with the blood-activating, stasis-removing, liver- and kidney-nourishing, and photosensitizing active ingredients in the original formula, jointly promotes melanocyte proliferation, migration, and tyrosinase activation, thereby promoting pigment regeneration in the vitiligo area at multiple stages and reducing the risk of recurrence.

[0010] Optionally, the nanoliposomes are prepared from phosphatidylcholine, cholesterol, and polyethylene glycol-phosphatidylethanolamine in a mass ratio of 4-5:1-3:1.

[0011] By employing the above-mentioned technical solution, this nanoliposome carrier system utilizes phosphatidylcholine to construct a bilayer main structure, with cholesterol embedded within to enhance membrane stability and density, reducing drug leakage. Polyethylene glycol-phosphatidylethanolamine (PEG-PE) forms a hydration membrane on the liposome surface through its hydrophilic chains, significantly improving the liposome's stereotactic stability and long-term circulation characteristics. This structure not only protects the encapsulated immunomodulatory complex from rapid clearance by the reticuloendothelial system, prolonging its in vivo action time, but also enhances the retention and permeability of liposomes at lesion sites through the shielding effect of PEG, promoting targeted drug delivery. The synergistic effect of these three components ensures that the active ingredients reach immune cells efficiently and stably, thereby more persistently regulating T lymphocyte balance and inhibiting autoimmune attacks. Furthermore, it synergistically strengthens the melanocyte protection and regeneration mechanisms in conjunction with the original formula's blood-activating and stasis-removing, liver- and kidney-tonifying components.

[0012] Optionally, the mass ratio of the nanoliposomes to the encapsulated active ingredient is 8-15:1.

[0013] By employing the above-mentioned technical solution, the nanoliposomes formed at this ratio exhibit uniform particle size and high stability. They can target and accumulate at lesion sites through the EPR effect and promote intracellular uptake through membrane fusion. The similarity between the liposome phospholipid components and the cell membrane enhances biocompatibility and absorption efficiency. At the same time, the PEG-modified layer prolongs the in vivo circulation time, reduces immune clearance, and allows the active ingredients to act on immune regulatory targets more persistently.

[0014] Optionally, the active ingredients are obtained by mixing astragalus polysaccharide, ginsenoside Rg3 and resveratrol in a mass ratio of 3-5:1-2:1.

[0015] By adopting the above technical solution, the proportions of the three components are optimized synergistically. Astragalus polysaccharide provides basic immune regulation, ginsenoside Rg3 strengthens cell protection and immune surveillance, and resveratrol enhances anti-inflammatory and antioxidant defense. Together, they stabilize the local immune microenvironment, promote tyrosinase activity and melanin synthesis, and work synergistically with the original formula's blood-activating, stasis-removing, liver- and kidney-tonifying components to promote vitiligo repigmentation through multiple pathways, including immune regulation, anti-oxidation, anti-inflammation, and cell protection.

[0016] Optionally, the preparation of the targeted immune-modulating complex includes the following steps: Phosphatidylcholine, cholesterol, and polyethylene glycol-phosphatidylethanolamine were dissolved in an organic solvent in a certain proportion, and a lipid film was formed by rotary evaporation. A solution containing the active ingredients was added and hydrated at 50-60℃ for 40-50 minutes. The mixture was then subjected to ultrasonic treatment to form nanoliposomes, which were then filtered through a filter membrane to remove bacteria.

[0017] By employing the above-mentioned technical solution, this preparation method forms a uniform lipid film through rotary evaporation and efficiently encapsulates the active ingredients within nanoliposomes under mild hydration conditions, achieving the self-assembly of a phospholipid bilayer. During this process, phosphatidylcholine provides a biocompatible membrane structure as the main framework, cholesterol enhances membrane stability and reduces drug leakage, and polyethylene glycol-phosphatidylethanolamine prolongs the in vivo circulation time of the liposomes through steric hindrance. The resulting nanoliposomes have uniform particle size and can target and accumulate in vitiligo lesions through enhanced penetration and retention effects, promoting uptake by immune cells through membrane fusion. The encapsulated active ingredients are then slowly released, synergistically regulating the balance of T lymphocyte subsets, inhibiting autoimmune attacks, and working with the original formula's blood-activating and stasis-removing, liver- and kidney-tonifying components to strengthen the melanocyte protection and regeneration mechanisms, thereby improving the repigmentation effect of vitiligo from multiple aspects.

[0018] Optionally, the granules are obtained by mixing sucrose and dextrin in a weight ratio of 2.3-2.7:1.

[0019] By employing the above technical solution, sucrose provides suitable sweetness to improve palatability and enhance patient compliance with medication. Simultaneously, the hydroxyl groups in its molecules can form hydrogen bonds with drug components, helping to maintain the structural stability of the particles. Dextrin, acting as a good filler and binder, imparts suitable hardness and flowability to the particles and promotes disintegration and dissolution in vivo, ensuring the release and absorption of active ingredients. The two work synergistically in this ratio, maintaining the physical integrity of the particles to prevent moisture absorption and clumping, while balancing the dissolution rate to ensure the delivery efficiency of active ingredients such as those promoting blood circulation, nourishing the liver and kidneys, and regulating immunity, thereby supporting the core efficacy of the original formula in treating vitiligo.

[0020] Secondly, this application provides a method for preparing a traditional Chinese medicine composition for treating vitiligo, using the following technical solution: A method for preparing a traditional Chinese medicine composition for treating vitiligo includes the following steps: (1) Extraction: Weigh out the following ten medicinal materials according to the prescription: red peony root, angelica root, privet fruit, turmeric, chuanxiong rhizome, tribulus fruit, scutellaria root, psoralea fruit, codonopsis root, and prepared fleeceflower root. Add water and decoct three times, adding 10 times the amount of water each time. Each decoction lasts for 2 hours. Combine the decoctions and filter. (2) Concentration: The filtrate obtained in step (1) is concentrated under reduced pressure to a thick paste with a relative density of 1.30 to 1.35 at 50°C; (3) Granulation: Add granules to the thick paste obtained in step (2), mix evenly, add wetting agent to make soft material, granulate with a 12-mesh sieve, and dry to obtain the final product.

[0021] By employing the above-mentioned technical solution, and through three decoctions with 10 times the amount of water, the effective substances such as flavonoids, glycosides, and polysaccharides of the core ingredients, including Paeonia lactiflora, Angelica sinensis, Psoralea corylifolia, and Ligustrum lucidum, are fully extracted, ensuring the dissolution rate of the active ingredients. Vacuum concentration at 50℃ reduces the degradation of heat-sensitive components and maintains the stability of the efficacy. Finally, granulation with granules not only improves the stability and portability of the formulation but also optimizes solubility and absorption efficiency by controlling the particle size through a 12-mesh sieve. This process, overall, strengthens the synergistic effects of the original formula in promoting blood circulation, removing blood stasis, improving microcirculation, regulating immunity, reducing melanocyte attack, and promoting melanin synthesis, thereby enhancing the therapeutic effect on vitiligo.

[0022] Optionally, the ratio of the amount of paste to the amount of granules added is 1:2-4.

[0023] By adopting the above technical solution, at this ratio, granules (such as sucrose and dextrin) can fully adsorb the effective ingredients in the thick paste, forming a soft material with suitable hardness and good flowability, which facilitates granulation and avoids uneven particle size or clumping caused by excessive stickiness or dispersion. The sugar powder and dextrin in the granules not only act as excipients to ensure the integrity and rapid solubility of the granules, but also mask the bitterness of the traditional Chinese medicine, improving patient compliance. Furthermore, this ratio optimizes the hygroscopicity of the granules, reducing the risk of deliquescence during storage and ensuring the long-term stability of the active ingredients. After the active substances in the thick paste (such as blood-activating and stasis-removing, and immune-regulating components) are evenly combined with the granules, they are more easily disintegrated and absorbed in the body, thereby synergistically enhancing the core efficacy of the original formula in treating vitiligo.

[0024] In summary, this application has the following beneficial effects: 1. This composition improves microcirculation and promotes blood circulation by using Paeonia lactiflora, Angelica sinensis, and Ligusticum chuanxiong; Ligustrum lucidum and processed Polygonum multiflorum supplement the material basis for melanin production and nourish the liver and kidneys; Psoralea corylifolia enhances photosensitivity and directly activates tyrosinase; and Scutellaria baicalensis, Codonopsis pilosula, and Curcuma longa reduce the attack on melanocytes. Through multiple mechanisms of immune regulation, it synergistically promotes pigment regeneration in the vitiligo area and helps reduce the risk of recurrence by starting with overall conditioning.

[0025] 2. By introducing a targeted immunomodulatory complex encapsulated in nanoliposomes, the bioavailability and targeting of the drug are significantly improved. This design can more precisely regulate immune cells, reduce abnormal attacks on melanocytes, and protect melanocytes through antioxidant and anti-inflammatory mechanisms. In synergy with traditional Chinese medicine ingredients, it promotes repigmentation of vitiligo from multiple aspects.

[0026] 3. The method of this application, through specific water decoction, vacuum concentration, and granulation processes with an optimized ratio of sucrose to dextrin in both thick pastes and granules, fully extracts the active ingredients while reducing the degradation of heat-sensitive components, ultimately producing granules with a pleasant taste, good stability, and ease of administration. This not only ensures the stability of the drug efficacy and the portability of the formulation but also optimizes dissolution and absorption efficiency, improving patient compliance. Detailed Implementation

[0027] The following detailed description of this application is provided in conjunction with the embodiments. It should be noted that: unless otherwise specified, the conditions in the following embodiments are performed under conventional conditions or conditions recommended by the manufacturer. Unless otherwise specified, the raw materials used in the following embodiments are all from commercially available sources.

[0028] Preparation examples of raw materials and / or intermediates Preparation Example 1 A targeted immunomodulatory complex, prepared by the following steps: 225g of phosphatidylcholine, 100g of cholesterol, and 50g of polyethylene glycol-phosphatidylethanolamine were dissolved in 2000ml of a mixed organic solvent of anhydrous ethanol and chloroform in a 1:1 volume ratio. The solution was stirred in a 40℃ water bath until completely dissolved. Then, the solution was rotary evaporated at 55℃ and -0.09MPa vacuum at 90rpm until a uniform, transparent lipid film formed in the flask. 23g of astragalus polysaccharide, 8.7g of ginsenoside Rg3, and 5.8g of white... Resveratrol was dissolved in 1000 mL of phosphate-buffered saline (PBS, 0.01 M, pH 7.4) at 55 °C to obtain a solution containing the active ingredient. The above solution was added to a lipid membrane and hydrated by shaking at 130 rpm at 55 °C for 45 min. Then, it was sonicated at 400 W for 15 min to form a nanoliposome suspension. The suspension was filtered sequentially through 0.45 μm and 0.22 μm microporous membranes to obtain the targeted immunomodulatory complex.

[0029] Preparation Example 2 A targeted immunomodulatory complex, prepared by the following steps: 250g of phosphatidylcholine, 50g of cholesterol, and 50g of polyethylene glycol-phosphatidylethanolamine were dissolved in 2000ml of a mixed organic solvent of anhydrous ethanol and chloroform in a 1:1 volume ratio. The solution was stirred in a 40℃ water bath until completely dissolved. Then, the solution was rotary evaporated at 55℃ and -0.09MPa vacuum at 90rpm until a uniform, transparent lipid film formed in the flask. 26.25g of Astragalus polysaccharide, 8.75g of ginsenoside Rg3, and 8.75g of Resveratrol were weighed out. Resveratrol was dissolved in 1000 mL of phosphate-buffered saline (PBS, 0.01 M, pH 7.4) at 55 °C to obtain a solution containing the active ingredient. The above solution was added to a lipid membrane and hydrated by shaking at 130 rpm at 50-60 °C for 40-50 min. Then, it was sonicated at 400 W for 15 min to form a nanoliposome suspension. The suspension was filtered sequentially through 0.45 μm and 0.22 μm microporous membranes to obtain the targeted immunomodulatory complex.

[0030] Preparation Example 3 A targeted immunomodulatory complex, prepared by the following steps: 200g of phosphatidylcholine, 150g of cholesterol, and 50g of polyethylene glycol-phosphatidylethanolamine were dissolved in 2000ml of a mixed organic solvent of anhydrous ethanol and chloroform in a 1:1 volume ratio. The solution was placed in a 40℃ water bath and stirred until completely dissolved. Then, the solution was rotary evaporated at 55℃ and -0.09MPa vacuum at 90rpm until a uniform, transparent lipid film formed in the flask. 16.5g of astragalus polysaccharide, 6.6g of ginsenoside Rg3, and 3.3g of resveratrol were weighed out. Alcohol was dissolved in 1000 mL of phosphate-buffered saline (PBS, 0.01 M, pH 7.4) at 55 °C to obtain a solution containing the active ingredient. The above solution was added to a lipid membrane and hydrated by shaking at 130 rpm at 50-60 °C for 40-50 min. Then, it was sonicated at 400 W for 15 min to form a nanoliposome suspension. The suspension was filtered sequentially through 0.45 μm and 0.22 μm microporous membranes to obtain the targeted immunomodulatory complex.

[0031] Example

[0032] Example 1

[0033] A traditional Chinese medicine composition for treating vitiligo is prepared by the following steps: (1) Extraction: Weigh 800g of red peony root, 800g of angelica root, 800g of privet fruit, 600g of turmeric, 600g of chuanxiong rhizome, 500g of tribulus fruit, 500g of scutellaria root, 500g of psoralea fruit, 500g of codonopsis root, and 500g of prepared he shou wu. Add 10 times the amount of water and decoct three times, each time for 2 hours. Filter the decoction through a 200-mesh sieve. Combine the three decoctions and filter. (2) Concentration: The filtrate obtained in step (1) is transferred to a vacuum concentrator and concentrated under reduced pressure at a vacuum of -0.05 MPa and a heating temperature of 50°C. During this process, the mixture is stirred continuously until it is concentrated into a thick paste with a relative density of 1.30 to 1.35. Heating is then stopped. (3) Granulation: Take 500g of the thick paste obtained in step (2) and transfer it to a mixer. Add 1000g of sucrose and 500g of dextrin, stir and mix thoroughly. Add 300g of 90% ethanol solution (wetting agent) to make soft material. Extrude the prepared soft material through a 12-mesh stainless steel sieve to granulate. Place it in a hot air circulating drying oven and dry at 75°C for 2 hours to obtain the final product.

[0034] Example 2

[0035] A traditional Chinese medicine composition for treating vitiligo is prepared by the following steps: (1) Extraction: Weigh 700g of red peony root, 900g of angelica root, 900g of privet fruit, 500g of turmeric, 700g of chuanxiong rhizome, 400g of tribulus fruit, 400g of scutellaria root, 600g of psoralea fruit, 600g of codonopsis root, and 400g of prepared he shou wu. Add 10 times the amount of water and decoct three times, each time for 2 hours. Filter the decoction through a 200-mesh sieve, combine the three decoctions, and filter. (2) Concentration: The filtrate obtained in step (1) is transferred to a vacuum concentrator and concentrated under reduced pressure at a vacuum of -0.05 MPa and a heating temperature of 50°C. During this process, the mixture is stirred continuously until it is concentrated into a thick paste with a relative density of 1.30 to 1.35. Heating is then stopped. (3) Granulation: Take 550g of the thick paste obtained in step (2) and transfer it to a mixer. Add 700g of sucrose and 400g of dextrin, stir and mix thoroughly. Add 300g of 90% ethanol solution (wetting agent) to make soft material. Extrude the prepared soft material through a 12-mesh stainless steel sieve to granulate. Place it in a hot air circulating drying oven and dry at 75°C for 2 hours to obtain the final product.

[0036] Example 3

[0037] A traditional Chinese medicine composition for treating vitiligo is prepared by the following steps: (1) Extraction: Weigh 900g of red peony root, 700g of angelica root, 700g of privet fruit, 700g of turmeric, 500g of chuanxiong rhizome, 600g of tribulus fruit, 600g of scutellaria root, 400g of psoralea fruit, 400g of codonopsis root, and 600g of prepared he shou wu. Add 10 times the amount of water and decoct three times, each time for 2 hours. Filter the decoction through a 200-mesh sieve. Combine the three decoctions and filter. (2) Concentration: The filtrate obtained in step (1) is transferred to a vacuum concentrator and concentrated under reduced pressure at a vacuum of -0.05 MPa and a heating temperature of 50°C. During this process, the mixture is stirred continuously until it is concentrated into a thick paste with a relative density of 1.30 to 1.35. Heating is then stopped. (3) Granulation: Take 375g of the thick paste obtained in step (2) and transfer it to a mixer. Add 1200g of sucrose and 300g of dextrin, stir and mix thoroughly. Add 300g of 90% ethanol solution (wetting agent) to make soft material. Extrude the prepared soft material through a 12-mesh stainless steel sieve to granulate. Place it in a hot air circulating drying oven and dry at 75°C for 2 hours to obtain the final product.

[0038] Example 4

[0039] A traditional Chinese medicine composition for treating vitiligo, differing from Example 1 in that this example also includes 45g of a targeted immune-modulating complex, specifically comprising the following steps: (3) Granulation: Take 500g of the thick paste obtained in step (2) and transfer it to a mixer. Add 1000g of sucrose, 500g of dextrin and 45g of the targeted immunomodulatory complex prepared in Example 1. Stir and mix thoroughly. Add 300g of 90% ethanol solution (wetting agent) to make a soft mass. Extrude the prepared soft mass through a 12-mesh stainless steel sieve to granulate. Place it in a hot air circulating drying oven and dry at 75°C for 2 hours to obtain the final product. The remaining steps are the same as in Example 1.

[0040] Example 5

[0041] A traditional Chinese medicine composition for treating vitiligo, which differs from Example 4 in that 30g of the targeted immune-modulating complex prepared in Preparation Example 2 is added in this example.

[0042] Example 6

[0043] A traditional Chinese medicine composition for treating vitiligo, which differs from Example 4 in that 60g of the targeted immune-modulating complex prepared in Preparation Example 3 is added in this example.

[0044] Comparative Example Comparative Example 1 A traditional Chinese medicine composition for treating vitiligo, which differs from Example 1 in that Paeonia lactiflora, Angelica sinensis, and Ligusticum chuanxiong are not added in this comparative example.

[0045] Comparative Example 2 A traditional Chinese medicine composition for treating vitiligo, which differs from Example 1 in that no Ligustrum lucidum or processed Polygonum multiflorum were added in this comparative example.

[0046] Comparative Example 3 A traditional Chinese medicine composition for treating vitiligo, which differs from Example 1 in that no psoralen is added in this comparative example.

[0047] Comparative Example 4 A traditional Chinese medicine composition for treating vitiligo, differing from Example 4 in that the active ingredients of the targeted immunomodulatory complex are directly physically mixed into the thick paste during granulation without encapsulation by nanoliposomes, specifically including the following steps: (3) Granulation: Take 500g of the thick paste obtained in step (2) and transfer it to a mixer. Add 1000g of sucrose, 500g of dextrin, 23g of astragalus polysaccharide, 8.7g of ginsenoside Rg3 and 5.8g of resveratrol. Stir and mix thoroughly. Add 300g of 90% ethanol solution (wetting agent) to make soft material. Extrude the prepared soft material through a 12-mesh stainless steel sieve to granulate. Place it in a hot air circulating drying oven and dry at 75℃ for 2 hours to obtain the final product.

[0048] Performance testing Detection methods / test methods Healthy C57BL / 6 mice aged 6-8 weeks, half male and half female, weighing 18-22g, were selected. All mice were housed in an SPF-grade animal facility with free access to food and water, and were allowed to acclimatize for one week before the experiment. The mice were divided into groups of at least 10 each: a blank control group (healthy mice administered an equal volume of physiological saline by gavage), a positive control group (compound calamine tincture), an example group, and a comparative group. The positive control group, example group, and comparative group were used to induce a vitiligo model using monobenzone (MBZ) chemical depigmentation. Approximately 2cm × 2cm of black hair was removed from the back of the mice using an electric shaver, and the area was cleaned with physiological saline to ensure no skin damage. 40% monobenzone cream (approximately 50mg) was applied to the depigmented area daily for 50 days. During this period, the area was re-depigmented every 3 days to maintain drug penetration until persistent white patches of depigmented skin and hair were visible to the naked eye in the applied area and surrounding area, indicating successful model establishment. After successful modeling, drug administration began and continued for 8 weeks. During this period, the recovery of mouse skin pigmentation was observed weekly under fixed light, angle, and distance, and the pigmentation recovery rate was calculated. Blood was collected from the orbital rim of mice, serum was separated, and the content of interleukin-10 (IL-10) was detected using an ELISA kit. Tyrosinase activity (spectrophotometry) and MDA content (TBA method) were measured in diseased skin tissue from the back of mice, and melanocyte density was analyzed by TYR immunohistochemistry. Mononuclear cells were prepared from the spleen, and the Treg / Th17 ratio was detected by flow cytometry.

[0049] Table 1 Test Results

[0050] Combining Examples 1-3 and Comparative Examples 1-3 with Table 1, it can be seen that the experimental data of Examples 1-3 are all better than those of Comparative Examples 1-3. This indicates that the three groups of drugs in the formula—red peony root, angelica root, chuanxiong rhizome for promoting blood circulation and removing blood stasis, privet fruit and prepared he shou wu for nourishing the liver and kidneys, and psoralea corylifolia for enhancing photosensitivity—are indispensable and have a significant synergistic effect. The traditional Chinese medicine composition in this application achieves multi-target intervention and improves the treatment effect of vitiligo through a three-in-one mechanism of promoting blood circulation to unblock collaterals, nourishing the kidneys to generate essence, and photosensitizing to promote enzymes.

[0051] Combining Examples 1-3 and Comparative Example 4 with Table 1, it can be seen that the experimental data of Examples 1-3 are all superior to those of Comparative Example 4, indicating that nanoliposome encapsulation significantly improves the bioavailability and targeting of the active ingredients. Although the repigmentation rate of Comparative Example 4 is slightly higher than that of Example 1, it is much lower than that of Example 4, and the improvement in the Treg / Th17 ratio and IL-10 level is limited, while the decrease in MDA is not significant. This is because the free components are easily metabolized and cleared, making it difficult to sustainably regulate the immune microenvironment. In contrast, the nanoliposomes in Example 4 can target and accumulate at the site of skin lesions, slowly releasing the active ingredients and achieving long-term immune regulation.

[0052] As can be seen from Examples 1-6 and Table 1, the experimental data of Examples 4-6 are all better than those of Examples 1-3, indicating that the introduction of a nanodelivery system can significantly enhance the overall efficacy and reduce the risk of recurrence.

[0053] This specific embodiment is merely an explanation of this application and is not intended to limit it. After reading this specification, those skilled in the art can make modifications to this embodiment without contributing any inventive step, but such modifications are protected by patent law as long as they fall within the scope of the claims of this application.

Claims

1. A traditional Chinese medicine composition for treating vitiligo, characterized in that, Including the following parts by weight of raw materials: Red peony root 700-900 parts, Angelica sinensis 700-900 parts, Ligustrum lucidum 700-900 parts, Curcuma longa 500-700 parts, Ligusticum chuanxiong 500-700 parts, Tribulus terrestris 400-600 parts, Scutellaria baicalensis 400-600 parts, Psoralea corylifolia 400-600 parts, Codonopsis pilosula 400-600 parts, processed Polygonum multiflorum 400-600 parts.

2. The traditional Chinese medicine composition for treating vitiligo according to claim 1, characterized in that: The raw materials also include 30-60 parts of a targeted immunomodulatory complex, which is prepared by encapsulating active ingredients in nanoliposomes. The active ingredients are one or more of astragalus polysaccharide, ginsenoside Rg3, and resveratrol.

3. The traditional Chinese medicine composition for treating vitiligo according to claim 2, characterized in that: The nanoliposomes are prepared from phosphatidylcholine, cholesterol and polyethylene glycol-phosphatidylethanolamine in a mass ratio of 4-5:1-3:

1.

4. A traditional Chinese medicine composition for treating vitiligo according to claim 2, characterized in that: The mass ratio of the nanoliposomes to the encapsulated active ingredient is 8-15:

1.

5. A traditional Chinese medicine composition for treating vitiligo according to claim 2, characterized in that: The active ingredients are obtained by mixing astragalus polysaccharide, ginsenoside Rg3 and resveratrol in a mass ratio of 3-5:1-2:

1.

6. A traditional Chinese medicine composition for treating vitiligo according to claim 2, characterized in that: The preparation of the targeted immunomodulatory complex includes the following steps: Phosphatidylcholine, cholesterol, and polyethylene glycol-phosphatidylethanolamine were dissolved in an organic solvent in a certain proportion, and a lipid film was formed by rotary evaporation. A solution containing the active ingredients was added and hydrated at 50-60℃ for 40-50 minutes. The mixture was then subjected to ultrasonic treatment to form nanoliposomes, which were then filtered through a filter membrane to remove bacteria.

7. A traditional Chinese medicine composition for treating vitiligo according to claim 1, characterized in that: The granules are obtained by mixing sucrose and dextrin in a weight ratio of 2.3-2.7:

1.

8. A method for preparing a traditional Chinese medicine composition for treating vitiligo according to any one of claims 1-6, characterized in that, Includes the following steps: (1) Extraction: Weigh out the following ten medicinal materials according to the prescription: red peony root, angelica root, privet fruit, turmeric, chuanxiong rhizome, tribulus fruit, scutellaria root, psoralea fruit, codonopsis root, and prepared fleeceflower root. Add water and decoct three times, adding 10 times the amount of water each time. Each decoction lasts for 2 hours. Combine the decoctions and filter. (2) Concentration: The filtrate obtained in step (1) is concentrated under reduced pressure to a thick paste with a relative density of 1.30 to 1.35 at 50°C; (3) Granulation: Add granules to the thick paste obtained in step (2), mix evenly, add wetting agent to make soft material, granulate with a 12-mesh sieve, and dry to obtain the final product.

9. A method for preparing a traditional Chinese medicine composition for treating vitiligo according to claim 8, characterized in that: The ratio of the amount of thick paste to the amount of granules added is 1:2-4.

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