An external traditional Chinese medicine composition for treating vitiligo

Abstract

This invention discloses a traditional Chinese medicine composition for treating skin diseases and its preparation method. The composition comprises fig leaves, black cumin seeds, anochela root, galangal, cinnamon, madder root, psoralea corylifolia, clove, and asyura seed as raw materials. The raw materials are extracted using purified water or organic solvent extraction processes to obtain aqueous extracts or organic solvent extracts. Various topical preparations are then prepared by adding conventional excipients according to conventional processes. This invention's composition has the effects of clearing abnormal local body fluids, promoting melanin production, activating melanin, and increasing skin photosensitivity. It has a definite curative effect, stable and reliable quality, and is particularly suitable for vitiligo.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine (Uyghur medicine). More specifically, this invention relates to a topical traditional Chinese medicine composition for treating vitiligo. Background Technology

[0002] Vitiligo is a common skin and mucous membrane disorder characterized by depigmentation due to specific damage and dysfunction of melanocytes. Its clinical features include white patches on the skin and mucous membranes, and whitening of the hair. Epidemiological surveys indicate a global prevalence of 0.5%–2%, but the exact incidence rate is difficult to estimate. The pathogenesis of vitiligo is not yet fully understood. Most studies conclude that vitiligo is related to autoimmunity, neurochemical factors, environmental factors, melanin destruction, trace elements, and genetic factors, with the autoimmune theory being the most widely accepted.

[0003] Vitiligo is the Uyghur medical term for the condition. Uyghur medicine believes that vitiligo is caused by an imbalance in the body's constitution and fluids due to factors such as genetics, environment, psychology, society, lifestyle, occupation, climate, trauma, and diet. This imbalance leads to a decline in the natural power and functional disorder of the organs (brain, heart, liver), especially the liver, causing changes in the quantity of normal fluids. Over time, this quantitative change leads to a qualitative change, resulting in impaired skin function, localized skin depigmentation, and skin diseases of varying sizes caused by impaired pigment formation. These diseases do not affect overall health or vital functions. Based on years of Uyghur medical experience, Uyghur medicine believes that vitiligo is caused by abnormal phlegm. Some scholars have shown that after comprehensive Uyghur medical treatment of patients with astringent phlegm-type vitiligo, serum transforming growth factor-β levels decreased, and the levels of immune-related factors IgG and IgM also significantly decreased. This indicates that Uyghur medical treatment for vitiligo has a function of regulating the body's immune system.

[0004] Classic prescriptions are the product of thousands of years of refinement of traditional Chinese medicine theory, and are treasures of the TCM heritage. These classic prescriptions are formulas recorded in ancient Chinese medical classics that are still widely used today, have good efficacy, and possess distinct characteristics and advantages. To protect and support the research and innovative development of classic prescriptions, the national government has introduced a number of policies related to the innovative development of compound preparations based on classic prescriptions, which has profound significance for the inheritance of TCM.

[0005] Drug therapy includes systemic drug therapy, topical drug therapy, targeted drug therapy, and other drug therapies. Common systemic drugs for vitiligo include glucocorticoids, cyclosporine, and methotrexate. Glucocorticoids are commonly used clinically, exerting anti-inflammatory and immunosuppressive effects by inhibiting the aggregation of leukocytes at the site of inflammation, reducing lymphocyte activity, interfering with the activation of the immune system, and lowering the concentration of immunoglobulins and complement. In domestic and international treatment guidelines, systemic glucocorticoids are often recommended for the treatment of progressive vitiligo, and can also promote repigmentation of white patches to varying degrees. However, the treatment cycle is long, generally 3-6 months, or even a year, to see results. Long-term use of glucocorticoids can lead to side effects such as local skin atrophy, itching, folliculitis, and hyperpigmentation. One of the reasons why many dermatologists find it difficult to carry out their work is the difficulty in finding a highly effective, low-toxicity, and reasonably priced drug that meets the needs of patients' conditions and financial capabilities.

[0006] Uyghur medicine offers numerous advantages in treating vitiligo, particularly the use of traditional Chinese medicine compound formulas. Clinical and experimental studies have demonstrated that Uyghur medicine can activate melanin production, improve skin microcirculation, increase the activation rate of tyrosinase, and enhance skin photosensitivity. This has greatly encouraged our search for traditional Chinese medicine treatments for eczema. However, our research reveals that the variety of Uyghur medical topical preparations for treating vitiligo is very limited compared to hormonal products. Therefore, actively seeking and developing a topical traditional Chinese medicine compound preparation for vitiligo that is effective, has few side effects, and is reasonably priced has significant clinical value and is of great practical importance in addressing patient needs. Summary of the Invention

[0007] This invention provides a topical traditional Chinese medicine composition for treating vitiligo. It is a systematic innovation based on the unique theories of Uyghur medicine and supported by modern pharmacological and clinical treatment evidence, resulting in synergistic and toxicity-reducing effects.

[0008] Uyghur medicine theory holds that the core pathogenesis of vitiligo (white disease) is an excess of "abnormal phlegm" in the body, which settles on the skin, hinders blood circulation, and leads to the dysfunction of melanocytes due to lack of nourishment. Therefore, the key to treatment lies in "matured and cleared abnormal phlegm, warming the skin and dispelling cold, and restoring pigmentation." Existing known compound prescriptions (such as CN107375474B) mainly use dry-heat drugs (such as anthelmintic chrysanthemum and black cumin seeds), focusing on "attacking cold," without addressing the "deficiency" caused by long-term disease or the adverse effects of the drugs' dryness and heat. Although this method can clear local abnormal fluids in the short term, long-term or improper use can easily lead to adverse effects. In practice, this method can easily lead to: depletion of normal body fluids, forming a "dry" and "astringent" constitution: Excessive dry-heat drugs can scorch the local skin, deplete the normal body fluids with nourishing functions (such as blood), leading to an imbalance in the local skin's constitution, producing secondary "dryness" or "astringent phlegm," forming a new pathological state (symptoms include dryness and peeling). Furthermore, extreme dryness breeds stagnation, leading to poor blood circulation. Without the proper lubrication of bodily fluids, the skin's blood vessels become sluggish, further hindering blood flow, much like a boat without water. In Uyghur pathology, this is called "qi stagnation and blood stasis," a functional microcirculatory disorder. This creates a "closed lesion," hindering pigment regeneration: The vicious cycle of local dryness and stagnation forms a "closed lesion" in the vitiligo area. Although this lesion no longer contains abnormal mucus, its obstructed microcirculation and impaired metabolism prevent the body's self-healing abilities from penetrating, and melanocytes from surrounding normal skin cannot migrate smoothly to the affected area, ultimately severely hindering complete repigmentation of vitiligo. Therefore, existing dry-heat medications have the drawback of "healing the disease but difficulty in restoring pigmentation."

[0009] The formulation of this invention embodies a more refined principle of "combining cleansing and tonifying," and the main drug, auxiliary drug, and regulating drug have been redesigned: Main ingredients: Black cumin seeds, psoralea corylifolia, and galangal. All three are considered to have a warming effect, powerfully clearing away abnormal phlegm and promoting melanin production—this is the "attack" aspect. Black cumin seeds are a classic Uyghur medicine, known for their effects of "generating heat and dryness, promoting hair growth and blackening, and enhancing pigmentation."

[0010] Auxiliary herbs: Anach root, clove, and asyvesal fruit. These assist the principal herbs in enhancing their ability to dispel cold and promote circulation.

[0011] Regulating ingredients: fig leaves, madder root, and cinnamon. This is one of the core highlights of this formula that surpasses existing technologies.

[0012] Fig leaves: They have the functions of clearing damp heat, detoxifying and reducing swelling. Firstly, they contain photosensitive active ingredients such as psoralen, which can directly promote melanin production; secondly, their "damp heat clearing" function can counteract the "dry heat" side effects that may be caused by the main dry and hot ingredients in the formula, making the overall medicinal properties of the formula more moderate.

[0013] Madder root: It has the effects of cooling blood, promoting blood circulation, removing blood stasis, and regulating menstruation. Its "blood-activating" effect can improve skin microcirculation, helping the medicine to reach the affected area directly, so that it is "nourishing without stagnation"; its "blood-cooling" property further counteracts the warm and dry nature of the whole formula.

[0014] Cinnamon: It has the effects of tonifying fire and assisting yang, warming the meridians and promoting blood circulation. It is not only an auxiliary medicine for warming yang, but also an important "guide medicine". Its effects of dispelling cold and relieving pain, and warming the meridians can guide the medicinal power of other medicines to penetrate to the skin lesions.

[0015] In summary, the formulation of this invention embodies the principle of "combining attack and tonification, and using both cold and warm herbs" in Uyghur medicine theory and practice. While using a large amount of dry and hot herbs (such as black cumin seeds and psoralea corylifolia) to clear pathogenic factors, it creatively combines fig leaves and madder root, which are cooling and blood-activating, to regulate the overall nature of the formula and prevent "overcorrection." This achieves a "combination of clearing and tonifying, warming without drying" effect. In clinical practice, it has achieved superior therapeutic effects compared to existing formulations in the treatment of vitiligo, with no symptoms such as dryness and peeling, and significant improvement in skin repigmentation.

[0016] Therefore, one object of the present invention is to provide a traditional Chinese medicine composition for treating skin diseases (especially vitiligo), and another object of the present invention is to provide a method for preparing the composition.

[0017] The objective of this invention is achieved through the following technical solution: The composition of the raw materials in the traditional Chinese medicine composition (compound traditional Chinese medicine) of this invention is as follows (by weight ratio): Fig leaves 5-40 parts, black cumin seeds 5-40 parts, galangal 5-30 parts, anach root 5-30 parts, madder root 2-20 parts, psoralea corylifolia 3-30 parts, clove 3-30 parts, asyura seed 2-20 parts, and cinnamon 2-20 parts.

[0018] The preferred composition of the raw materials in the traditional Chinese medicine composition of this invention is as follows (by weight): Fig leaves 5-40 (e.g., 5, 8, 10, 15, 20, 25, 30, 35, 40) parts, black cumin seeds 5-40 (e.g., 5, 8, 10, 15, 20, 25, 30, 35, 40) parts, galangal 5-30 (e.g., 5, 8, 10, 15, 20, 25, 30) parts, anachic root 5-30 (e.g., 5, 8, 10, 15, 20, 25, 30) parts, madder root 2-20 ( 2, 5, 8, 10, 12, 15, 18, 20) parts, Psoralea corylifolia 3-30 (3, 5, 8, 10, 15, 20, 25, 30) parts, Clove 3-30 (3, 5, 8, 10, 15, 20, 25, 30) parts, Ashoka 2-20 (2, 5, 8, 10, 12, 15, 18, 20) parts, and Cinnamon 2-20 (2, 5, 8, 10, 12, 15, 18, 20) parts.

[0019] The weight ratio of the raw materials in the traditional Chinese medicine composition of the present invention is more preferably as follows: Fig leaves 10-30 parts, black cumin seeds 10-30 parts, galangal 10-25 parts, anach root 10-25 parts, madder root 5-10 parts, psoralea corylifolia 10-25 parts, clove 10-25 parts, ashoka fruit 5-10 parts, and cinnamon 5-10 parts.

[0020] The optimal weight ratio of the raw materials in the traditional Chinese medicine composition of this invention is as follows: 20 parts fig leaves, 20 parts black cumin seeds, 20 parts galangal, 20 parts anchovy root, 5 parts madder root, 5 parts psoralea corylifolia, 10 parts cloves, 5 parts asyura seeds, and 10 parts cinnamon, or 10 parts fig leaves, 30 parts black cumin seeds, 20 parts galangal, 18 parts anchovy root, 10 parts madder root, 10 parts psoralea corylifolia, 15 parts cloves, 10 parts asyura seeds, and 15 parts cinnamon.

[0021] Take the above-mentioned raw materials, add conventional excipients, and prepare topical preparations such as creams or ointments according to conventional processes.

[0022] The preparation method of the topical formulation of the traditional Chinese medicine composition of the present invention is as follows: Ingredients: Prepare the following Chinese medicinal herbs: fig leaves, black cumin seeds, galangal, anachine root, madder root, psoralea corylifolia, cloves, asyura seeds, and cinnamon. Water extraction: Place the weighed fig leaves, black cumin seeds, galangal, anachine root, madder root, psoralea, cloves, asyura seeds, and cinnamon in an extraction tank, decoct with an appropriate amount of purified water, filter, collect the extract, and set aside. The above extracts are processed using conventional techniques and added with conventional excipients to produce topical preparations such as creams, ointments, sprays, or gels.

[0023] The extract of the present invention can also be extracted using organic solvents (e.g., alcohols, more preferably ethanol).

[0024] The herbal extraction step of this invention can be repeated 1-5 times. Each extraction takes 0.5-24 hours, preferably 0.5-6 hours. The amount of extraction solvent (water or organic solvent) used in each extraction is 1-30 times the weight of the raw material, preferably 2-15 times.

[0025] The above extract is processed using conventional techniques and added with conventional excipients to prepare topical preparations such as creams or ointments.

[0026] The percentage of raw Chinese medicinal materials in the preparation described in this invention refers to the ratio of the weight of the processed Chinese medicinal materials to the weight of the preparation.

[0027] The preparation described in this invention is a cream made from the above-mentioned traditional Chinese medicine compound with excipients, and the proportion of raw traditional Chinese medicine contained therein is 5-20%.

[0028] The traditional Chinese medicine cream formulation of this invention consists of 0.5-5 parts by weight of white petrolatum; 1-7 parts by weight of water-extracted or alcohol-extracted traditional Chinese medicine liquid; an appropriate amount of preservative (e.g., 0.01-1 parts by weight); an appropriate amount of pH adjuster (e.g., adjusting the pH value to 5.5-7.5); and purified water to make up the remaining amount to 100 parts by weight.

[0029] The preparation described in this invention is an ointment made from the above-mentioned traditional Chinese medicine compound with excipients, and the proportion of raw traditional Chinese medicine contained therein is (by weight): 5-20%.

[0030] The traditional Chinese medicine ointment formulation of this invention consists of 5-30 parts by weight of white petrolatum; 15-35 parts by weight of water-extracted or alcohol-extracted traditional Chinese medicine liquid; an appropriate amount of preservative (e.g., 0.01-1 parts by weight); an appropriate amount of pH adjuster (e.g., adjusting the pH value to 5.5-7.5); and purified water to make up the remaining amount to 100 parts by weight.

[0031] The above weight parts are in g / g ratios.

[0032] The external dosage forms of traditional Chinese medicine of the present invention include, but are not limited to, creams and ointments. Their formulations are not limited to the above-mentioned dosage form prescriptions. Many modifications can be made to the prescriptions without departing from the spirit of the present invention, and such modifications also fall within the scope of the present invention.

[0033] The traditional Chinese medicines used in this invention comply with the provisions of the "Drug Administration Law of the People's Republic of China".

[0034] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine for treating skin diseases such as vitiligo.

[0035] Preferably, the drug is in the form of a topical dosage form, preferably a cream or ointment.

[0036] This invention follows the principles of syndrome differentiation and treatment in Uyghur medicine. Based on the theory of "combining clearing and tonifying, warming without drying," the formula uses black cumin seeds, galangal, and psoralea as the main ingredients, anachic root, cloves, and asyukul as auxiliary ingredients, and fig leaves, madder root, and cinnamon as regulating ingredients. This traditional Chinese medicine compound formula has the effects of clearing abnormal local body fluids, promoting melanin production, activating melanin, and increasing skin photosensitivity. It has definite curative effects, stable and reliable quality, and is particularly suitable for vitiligo. Furthermore, it avoids the "excessive dryness and stagnation" drawbacks of existing "dry heat" drug therapies, and shows significant repigmentation effects. Attached Figure Description

[0037] The above features and advantages of the present invention will become more apparent from the following detailed description taken in conjunction with the accompanying drawings, wherein: Figure 1 This is a schematic diagram of the vitiligo area before (a) and after (b) the use of the topical Chinese medicine preparation in Case 1 of this invention; Figure 2 This is a schematic diagram of the vitiligo area before (a) and after (b) the use of the topical Chinese medicine preparation in Case 2 of this invention; Figure 3 This is a schematic diagram of the vitiligo area before (a) and after (b) the use of the topical Chinese medicine preparation in Case 3 of this invention; Figure 4 This is a schematic diagram of the vitiligo area before (a) and after (b) the use of the topical Chinese medicine preparation in Case 4 of this invention; Figure 5 This is a schematic diagram of the vitiligo area before (a) and after (b) the use of the topical Chinese medicine preparation in Case 5 of this invention; Figure 6 This is a schematic diagram of the vitiligo area before (a) and after (b) the use of the topical Chinese medicine preparation in Case 6 of this invention; Figure 7 This is a schematic diagram of the vitiligo area before (a) and after (b) the use of the topical Chinese medicine preparation in Case 7 of this invention; Figure 8 This is a schematic diagram of the vitiligo area before (a) and after (b) the use of the topical Chinese medicine preparation in Case 8 of this invention; Figure 9 This is a schematic diagram showing the area of ​​vitiligo in Case 9 of this invention before (a) and after (b) the application of the topical Chinese medicine preparation; and Figure 10 This is a schematic diagram showing the area of ​​vitiligo before (a) and after (b) the use of the topical Chinese medicine preparation in Case 10 of this invention. Detailed Implementation

[0038] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0039] Unless otherwise specified, the experimental methods used in the examples are conventional methods.

[0040] Unless otherwise specified, all reagents involved in the embodiments of this invention are commercially available products and can be purchased through commercial channels.

[0041] The use of "comprising" or "including" in this invention is an open-ended description that includes all specified components or steps described, as well as other specified components or steps that do not materially affect the description.

[0042] The term "and / or" as used in this invention encompasses all combinations of items connected by the term, and should be considered as if each combination had been individually listed herein. For example, "A and / or B" includes "A", "A and B", and "B". As another example, "A, B and / or C" includes "A", "B", "C", "A and B", "A and C", "B and C", and "A and B and C".

[0043] Fig leaves are from the fig tree, a plant belonging to the genus Ficus in the family Moraceae. Ficus carica L. The leaves of the plant have the effects of clearing damp heat, relieving sores and toxins, reducing swelling and relieving pain. They are mainly used to treat damp-heat diarrhea, leukorrhea, hemorrhoids, carbuncles and boils, and scrofula.

[0044] Nigella seeds are a traditional Uyghur medicinal herb, known in Uyghur medicine as Siyadan, and also called Shouniz or Aibitusaiweida. It is the seed of *Nigella glandulosa*, a plant in the Ranunculaceae family. Nigella glandulifera The dried, mature seeds of Freyn et Sint. They possess the following properties: promotes heat and nourishes, darkens hair, enhances pigmentation, strengthens muscles and tendons, dispels cold and relieves pain, nourishes both intestines, disperses qi stagnation, promotes menstruation and lactation, kills parasites, and promotes diuresis and reduces swelling.

[0045] Galangal, also known as Chinese galangal, is a perennial herb belonging to the genus Alpinia in the family Zingiberaceae. It is known to have warming and soothing effects on the stomach, aiding digestion, and relieving hangovers.

[0046] Anachi root, also known as chrysanthemum root, is a commonly used medicinal herb among the Uyghur people. It has the functions of dispelling cold and strengthening muscles, clearing blockages, regulating qi and blood, and nourishing yin and yang.

[0047] Madder ( Rubia cordifolia L. It is a traditional Chinese medicine that cools the blood and stops bleeding. It has the effects of helping to stop bleeding, promoting blood circulation and removing blood stasis, and regulating menstruation. It is often used for nosebleeds, irregular menstruation, and swelling and pain from falls and injuries.

[0048] Psoralea corylifolia ( Psoralea corylifolia Linn. It is a traditional Chinese medicine that tonifies the kidneys and strengthens yang. It can enhance kidney function, improve lower back and knee pain and frequent urination at night, and is often used to relieve symptoms such as cold intolerance and fatigue caused by insufficient kidney yang.

[0049] Clove is a plant of the Myrtaceae family called clove. Eugenia caryophyllata Thunb. The dried flower buds. Primarily used for spleen and stomach deficiency-cold, hiccups and vomiting, poor appetite and diarrhea, cold pain in the heart and abdomen, and kidney deficiency-induced impotence.

[0050] Ashoka is actually the dried, mature fruit of Ashoka, a plant belonging to the genus Ashoka in the family Apiaceae. The mature fruit is used in medicine; it is warm in nature and pungent and bitter in taste, and has the effects of dispelling cold and dampness, regulating qi and stimulating appetite, and relieving pain.

[0051] Cinnamon( Cinnamomum cassia (L.) D. Don It is the dried bark and branch bark of cinnamon, a plant of the Lauraceae family. It has the effects of warming the middle and tonifying the kidneys, dispelling cold and relieving pain. It is mainly used to treat diseases such as cold pain in the waist and knees, cold stomach pain, chronic indigestion, abdominal pain and vomiting and diarrhea, and amenorrhea due to cold.

[0052] The following embodiments further illustrate the present invention in detail, but should not be construed as limiting the scope of the present invention or the specific methods described herein.

[0053] Example 1: Preparation of Traditional Chinese Medicine External Ointment Ingredients: Weigh out 20 parts fig leaves, 20 parts black cumin seeds, 20 parts galangal, 20 parts anchovy root, 5 parts madder root, 5 parts psoralea corylifolia, 10 parts cloves, 5 parts asyura seeds, and 10 parts cinnamon.

[0054] Water extraction: Place the weighed ingredients in an extraction tank, boil with 2000 ml of purified water for 100 minutes, filter, collect the filtrate, and set aside.

[0055] 20 parts by weight of the above-mentioned aqueous extract of traditional Chinese medicine were mixed with 10 parts by weight of pharmaceutical excipients such as white petrolatum, and the pH was adjusted to 6.0-7.5. The ointment was prepared according to the conventional ointment preparation procedure. The ointment contained 8.5% (w / w) of raw medicinal materials.

[0056] Example 2: Preparation of Traditional Chinese Medicine External Cream Ingredients: Weigh out 10 parts fig leaves, 30 parts black cumin seeds, 20 parts galangal, 18 parts anchovy root, 10 parts madder root, 10 parts psoralea corylifolia, 15 parts cloves, 10 parts asyura seeds, and 15 parts cinnamon.

[0057] Water extraction: Place the weighed ingredients in an extraction tank, boil with 2000 ml of purified water for 120 minutes, filter, collect the filtrate, and set aside.

[0058] Five parts by weight of the above-mentioned aqueous extract of traditional Chinese medicine were mixed with five parts by weight of pharmaceutical excipients such as white petrolatum, and the pH was adjusted to 6.0-7.5. The mixture was then prepared into an ointment according to conventional ointment preparation procedures. The ointment contained 5.6% (w / w) of raw medicinal materials.

[0059] Example 3: Preparation of Traditional Chinese Medicine External Cream Ingredients: Same as in Example 1.

[0060] Alcohol extraction: Place the weighed ingredients in an extraction tank and reflux twice with 2000 ml of 75% ethanol, 1.5 hours each time. Filter, combine the filtrates, recover the ethanol under reduced pressure, and concentrate to approximately 500 ml of a clear extract with a relative density of 1.15-1.25 (60℃). Mix 20 parts by weight of the above-mentioned ethanol extract of traditional Chinese medicine with 10 parts by weight of pharmaceutical excipients such as white petrolatum, adjust the pH to 6.0-7.5, and prepare an ointment according to conventional ointment preparation procedures. The ointment contains approximately 10.1% (w / w) of raw medicinal materials.

[0061] Example 4: Clinical efficacy of topical Chinese medicine ointment in treating vitiligo. Experimental materials Experimental drug: The traditional Chinese medicine ointment prepared in Example 1.

[0062] Experimental methods Diagnostic criteria Western medicine diagnostic criteria: According to the 2011 Global Consensus on the Diagnosis and Treatment of Vitiligo, a diagnosis is made through typical skin lesion characteristics, Wood's lamp examination, and exclusion of other diseases.

[0063] Traditional Chinese Medicine Diagnostic Criteria: Refer to the "Standards for Diagnosis and Treatment of Diseases and Syndromes in Traditional Chinese Medicine" (National Standard of the People's Republic of China for Traditional Chinese Medicine, ZY / T 001.1-94). Inclusion criteria: Patients meeting the above diagnostic criteria in both traditional Chinese and Western medicine, without serious primary diseases of the cardiovascular, cerebrovascular, liver, kidney, or hematopoietic systems, chronic wasting diseases, or mental illness; women excluding those who are pregnant or breastfeeding; those who have not received glucocorticoids or other immunosuppressants within the past month, who take medication as prescribed, and who regularly return for follow-up visits or telephone surveys; those who provide informed consent and are able to adhere to treatment.

[0064] Exclusion criteria: Individuals with autoimmune deficiencies, systemic infectious diseases, severe organic diseases, or congenital diseases; individuals who have received glucocorticoids or other immunosuppressants within one month prior to treatment; individuals who are breastfeeding or pregnant; individuals with poor compliance, who do not cooperate with treatment, or who withdraw midway; and individuals who do not agree to participate in this trial.

[0065] Efficacy assessment: Refer to the "Standards for Diagnosis and Efficacy Evaluation of Diseases and Syndromes in Traditional Chinese Medicine" (Standard of the People's Republic of China for Traditional Chinese Medicine Industry, ZY / T001.1-94). Administration method: Apply about 1 g of the traditional Chinese medicine ointment prepared in Example 1 to the affected skin once in the morning and once in the evening. Follow up once every 1-2 months. The treatment course is up to 6 months. The efficacy is statistically analyzed.

[0066] Patient information: In the past 3 years (June 2022 - July 2025), a total of 120 cases of vitiligo were treated at the Uyghur Medicine Hospital in Kashgar Prefecture, aged 18-60 years.

[0067] Overall efficacy evaluation: This clinical trial involved 120 patients, of whom 109 completed the entire course of treatment.

[0068] The efficacy statistics after 6 months of treatment are as follows: Clinical cure (complete disappearance of vitiligo and restoration of normal skin color): 15 cases, accounting for 14.6%; Significant improvement (≥50% reduction in vitiligo area): 36 cases, accounting for 33%; Effective (violet light fading area ≥10%, <50%): 53 cases, accounting for 48.6%; Ineffective (violet light fading area <10% or no change): 3 cases, accounting for 2.8%; The overall effective rate (clinically cured + significantly effective + effective) was 97.2%.

[0069] Typical case: Case 1 The patient presented with well-defined vitiligo on their face for 4 months, which then spread for 1 month. A routine physical examination revealed no trauma or history of surgery. The parents are healthy and there is no family history of the condition.

[0070] The patient's mother reported that four months ago, indistinctly bordered white patches appeared on the face without any obvious cause, accompanied by mild itching. No treatment was sought. Over the past month, the affected area gradually expanded. The patient came to our hospital for treatment. The patient's mental state was fair, appetite was fair, bowel movements and urination were normal. Body temperature was 36.5℃, the patient was alert but lethargic, and breathing was stable. Specialist examination revealed scattered, irregularly shaped, porcelain-white hypopigmented patches on the face, without pigment rings or spots. The largest patch was approximately 4*2 cm. The skin was cool to the touch, moist, and non-tender. The diagnosis was vitiligo.

[0071] The compound traditional Chinese medicine ointment of Example 1 of this invention is used externally twice daily; the before-and-after treatment comparison diagram is shown below. Figure 1 As shown in (a) and (b) in the figure.

[0072] Case 2 The patient has had vitiligo on their face for 2 years, which has spread over the past 6 months. A routine physical examination revealed no trauma or history of surgery. The parents are healthy and there is no family history of the condition.

[0073] The patient reported that two years ago, due to a long-term diet high in protein and cold foods, irregularly shaped white patches of varying sizes appeared on their facial skin. At that time, the patient did not seek treatment, and the condition gradually worsened. They received treatment at a local traditional Chinese medicine hospital, but the effect was not significant. The condition has spread again in the past six months, so the patient came to our outpatient clinic. The patient's mental state is fair, appetite is fair, bowel movements and urination are normal. Body temperature is 36.2℃, the patient is alert but lethargic, and breathing is stable. Specialist examination: Scattered, irregularly shaped, porcelain-white hypopigmented patches are visible on the face, some with visible pigment rings, no pigment spots, the skin is cool and moist to the touch, and there is no tenderness. The diagnosis is vitiligo.

[0074] The compound traditional Chinese medicine ointment of Example 1 of this invention is used externally twice daily; the before-and-after treatment comparison diagram is shown below. Figure 2 As shown in (a) and (b) in the figure.

[0075] Case 3 The patient had white patches on his forehead and face for 3 years, which recurred and spread 7 months ago. A routine physical examination revealed no trauma or history of surgery. His parents are healthy and there is no family history of the condition.

[0076] The patient reported developing well-defined white patches on their forehead and face due to long-term poor dietary habits (excessive consumption of cold foods, yogurt, and sugary drinks). These patches were non-scaly and non-itchy. The patient was initially diagnosed with vitiligo at Henan Provincial People's Hospital, with satisfactory results; the condition was controlled and did not spread. However, in the past seven months, the condition has recurred, with new white patches appearing on other parts of the face. The patient then sought treatment at our outpatient clinic. The patient's mental state is fair, appetite is fair, bowel movements and urination are normal. Body temperature is 36.7℃. The patient is alert but lethargic, and breathing is stable. Specialist examination revealed scattered, irregularly shaped, porcelain-white hypopigmented patches on the face, some with visible pigment rings and dots. The skin was warm to the touch, moist, and non-tender. The diagnosis was vitiligo.

[0077] The compound traditional Chinese medicine ointment of Example 1 of this invention is used externally twice daily; the before-and-after treatment comparison diagram is shown below. Figure 3 As shown in (a) and (b) in the figure.

[0078] Case 4 The patient presented with vitiligo on their face for 6 months, which had spread for 1 month. A routine physical examination revealed no external trauma or surgical history. The parents are healthy and there is no family history of the condition.

[0079] The patient reported that white patches appeared on their face 6 months ago without any obvious cause. They did not seek treatment, and the color gradually deepened. In the past month, the white patches spread, without scaling or itching. The patient came to our outpatient clinic for further treatment. Their mental state was fair, appetite was fair, bowel movements and urination were normal. Their temperature was 36.4℃, they were alert but lethargic, and breathing was stable. Specialist examination revealed irregularly shaped, porcelain-white hypopigmented patches on the face, without pigment rings or spots. The skin was cool to the touch, moist, and non-tender. The diagnosis was vitiligo.

[0080] The compound traditional Chinese medicine ointment of Example 1 of this invention is used externally twice daily; the before-and-after treatment comparison diagram is shown below. Figure 4 As shown in (a) and (b) in the figure.

[0081] Case 5 The patient has had white patches on his neck for one year. A routine physical examination revealed no trauma or surgical history. His parents are healthy and there is no family history of the condition.

[0082] The patient reported that irregularly shaped white patches appeared on two areas of the neck one year ago without any obvious cause. The patient self-medicated with purchased medication, but without significant improvement. Therefore, the patient visited our outpatient clinic. The patient's mental state was fair, appetite was fair, bowel movements and urination were normal. Body temperature was 36.5℃. The patient was alert but lethargic, and breathing was stable. Specialist examination revealed two irregularly shaped hypopigmented patches on the neck, without pigment rings or spots. The skin was cool to the touch, moist, and non-tender. The diagnosis was vitiligo.

[0083] The compound traditional Chinese medicine ointment of Example 1 of this invention is used externally twice daily; the before-and-after treatment comparison diagram is shown below. Figure 5 As shown in (a) and (b) in the figure.

[0084] Case 6 The patient presented with white patches on the back of their hand for two years, which had spread over the past five months. A routine physical examination revealed no history of trauma or surgery. The parents are healthy and there is no family history of the condition.

[0085] The patient reported that two years ago, irregularly shaped white patches appeared on the back of their hands without any obvious cause. They self-medicated with purchased medications, but without significant improvement. Over the past five months, the existing white patches have spread, prompting the patient to seek treatment at our outpatient clinic. The patient's mental state is fair, appetite is fair, bowel movements and urination are normal. Body temperature is 36.4℃. The patient is alert but lethargic, and breathing is stable. Specialist examination revealed irregularly shaped hypopigmented patches on the back of the hands, without pigmented rings or spots. The skin was cool to the touch, moist, and non-tender. The diagnosis was vitiligo.

[0086] The compound traditional Chinese medicine ointment of Example 1 of this invention is used externally twice daily; the before-and-after treatment comparison diagram is shown below. Figure 6 As shown in (a) and (b) in the figure.

[0087] Case 7 The patient had white patches on his scalp for 2 years, which had spread for 1 month. A routine physical examination revealed no external injury or surgical history. The parents are healthy and there is no family history of the condition.

[0088] The patient reported that two years ago, irregularly shaped white patches appeared on the scalp without any obvious cause. There was no scaling, itching, or whitening of the hair. The patient sought treatment at a local traditional Chinese medicine hospital, where the condition was controlled and no new lesions appeared. In the past month, the existing white patches have spread, and some hair has turned white, prompting the patient to seek treatment at our outpatient clinic. The patient's mental state is fair, appetite is fair, bowel movements and urination are normal. Body temperature is 36.5℃. The patient is alert but lethargic, and breathing is stable. Specialist examination revealed irregularly shaped hypopigmented patches on the scalp, without pigmented rings or spots. The skin was warm to the touch, moist, and non-tender. The diagnosis was vitiligo.

[0089] The compound traditional Chinese medicine ointment of Example 1 of this invention is used externally twice daily; the before-and-after treatment comparison diagram is shown below. Figure 7 As shown in (a) and (b) in the figure.

[0090] Case 8 The patient presented with white patches on his testicles for 3 months. A routine physical examination revealed no external trauma or surgical history. His parents are healthy and there is no family history of the condition.

[0091] The patient reported developing irregularly shaped white patches on his testicles three months prior without any obvious cause. There was no scaling, itching, or whitening of the hair. The patient did not receive treatment and visited our outpatient clinic today. His mental state was fair, appetite was fair, bowel movements and urination were normal. His temperature was 36.4℃. He was alert but lethargic, and his breathing was stable. Specialist examination revealed irregularly shaped hypopigmented patches on the testicles, without pigment rings or spots. The skin was warm and moist to the touch, and there was no tenderness. He was diagnosed with vitiligo.

[0092] The compound traditional Chinese medicine ointment of Example 1 of this invention is used externally twice daily; the before-and-after treatment comparison diagram is shown below. Figure 8 As shown in (a) and (b) in the figure.

[0093] Case 9 The patient had white patches on their face for 3 years, which had spread for 1 month. A routine physical examination revealed no trauma or surgical history. The parents are healthy and there is no family history of the condition.

[0094] The patient reported that three years ago, irregularly shaped white patches appeared on the face without any obvious cause. There was no scaling or itching, and some hair was white. The patient sought treatment at a local hospital, and the condition was controlled, with visible pigment rings but no pigment spots. In the past month, the white patches on the patient's face have spread to the jawline. The patient visited our outpatient clinic today. The patient's mental state is fair, appetite is fair, bowel movements and urination are normal. Body temperature is 36.2℃. The patient is alert but lethargic, and breathing is stable. Specialist examination: Irregularly shaped hypopigmented patches are visible on the face, with visible pigment rings but no pigment spots. The skin is cool to the touch, moist, and non-tender. The diagnosis is vitiligo.

[0095] The compound traditional Chinese medicine ointment of Example 1 of this invention is used externally twice daily; the before-and-after treatment comparison diagram is shown below. Figure 9 As shown in (a) and (b) in the figure.

[0096] Case 10 The patient presented with white patches on both eyelids for 3 months. A routine physical examination revealed no trauma or surgical history. Parents are healthy and there is no family history of the condition.

[0097] The patient reported that three years ago, irregularly shaped white patches appeared on both eyelids without any obvious cause. There was no scaling, itching, or whitening of hair. The patient self-medicated without significant improvement, and the patches gradually spread. The patient visited our outpatient clinic today. The patient's mental state is fair, appetite is fair, bowel movements and urination are normal. Body temperature is 36.4℃. The patient is alert but lethargic, and breathing is stable. Specialist examination revealed irregularly shaped hypopigmented patches on both eyelids, without pigment rings or spots. The skin was cool to the touch, moist, and non-tender. The diagnosis was vitiligo.

[0098] The compound traditional Chinese medicine ointment of Example 1 of this invention is used externally twice daily; the before-and-after treatment comparison diagram is shown below. Figure 10 As shown in (a) and (b) in the figure.

[0099] The above clinical statistics and the treatment effects of typical cases 1-10 prove that the traditional Chinese medicine ointment of the present invention has excellent efficacy for vitiligo, without symptoms such as dryness and peeling, and significantly improves the skin repigmentation effect.

[0100] The preferred embodiments of the present invention have been described in detail above. However, the present invention is not limited to the specific details of the above embodiments. Within the scope of the technical concept of the present invention, various simple modifications can be made to the technical solution of the present invention, and these simple modifications all fall within the protection scope of the present invention.

Claims

1. A topical traditional Chinese medicine composition for treating vitiligo, which is prepared from the following raw materials in the indicated weight ratios: 5-40 parts fig leaves, 5-40 parts black cumin seeds, 5-30 parts galangal, 5-30 parts anaceus root, 2-20 parts madder root, 3-30 parts psoralea corylifolia, 3-30 parts cloves, 2-20 parts asyura seeds, and 2-20 parts cinnamon.

2. The traditional Chinese medicine composition according to claim 1 is prepared from the following raw materials in the indicated weight ratios: 10-30 parts fig leaves, 10-30 parts black cumin seeds, 10-25 parts galangal, 10-25 parts anaceus root, 5-10 parts madder root, 10-25 parts psoralea corylifolia, 10-25 parts cloves, 5-10 parts asyura seeds, and 5-10 parts cinnamon.

3. The traditional Chinese medicine composition according to claim 1 is prepared from the following raw materials in the indicated weight ratios: 20 parts fig leaves, 20 parts black cumin seeds, 20 parts galangal, 20 parts anchovy root, 5 parts madder root, 5 parts psoralea corylifolia, 10 parts clove, 5 parts asyura seed, and 10 parts cinnamon.

4. A topical preparation comprising a traditional Chinese medicine composition according to any one of claims 1-3 and pharmaceutically acceptable excipients.

5. The topical preparation according to claim 4 is a cream or ointment.

6. The topical preparation according to claim 5, wherein it is prepared by a method comprising the following steps: Place the weighed fig leaves, black cumin seeds, galangal, anachine root, madder root, psoralea, cloves, asyura seeds, and cinnamon in an extraction tank, decoct with an appropriate amount of purified water or organic alcohol, filter, and collect the water or alcohol extract for later use; add the above water or alcohol extract to excipients to make creams or ointments.

7. The topical preparation according to claim 6, wherein it is in the form of a cream, and the formulation is as follows: 0.5-5 parts by weight of white petrolatum; 1-7 parts by weight of water-extracted or alcohol-extracted Chinese herbal medicine; appropriate amount of preservative; appropriate amount of pH adjuster; add purified water to make up to 100 parts by weight.

8. The topical preparation according to claim 6, which is in the form of an ointment, has the following formulation: 5-30 parts by weight of white petrolatum; 15-35 parts by weight of water-extracted or alcohol-extracted Chinese herbal medicine; appropriate amount of preservative; appropriate amount of pH adjuster; add purified water to make up to 100 parts by weight.

9. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicament for treating vitiligo.

10. The application according to claim 9, wherein the drug is a cream or ointment.

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