Compositions, drugs, and preparation methods for treating melasma caused by qi and blood stagnation

Abstract

This invention belongs to the field of traditional Chinese medicine technology, specifically disclosing a composition, drug, and preparation method for treating melasma caused by qi and blood stagnation. The composition comprises Angelica sinensis, Benincasa hispida seed, Angelica dahurica, Bletilla striata, apricot kernel, Scutellaria baicalensis, Salvia miltiorrhiza, Aconitum carmichaelii, Tribulus terrestris, and pearl powder. These herbs work together to invigorate blood circulation, moisten dryness, clear heat and detoxify, regulate qi and blood, tighten skin, reduce wrinkles, and beautify the skin. The herbal composition of this invention is easy to prepare, significantly alleviating the main symptoms, reducing the area and lightening the color of the melasma, improving secondary symptoms, alleviating the purplish-dark tongue or petechiae, and reducing the hesitant pulse. Some patients also experience improved mood.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and specifically discloses a composition, drug and preparation method for treating melasma caused by qi and blood stagnation. Background Technology

[0002] Melasma is a localized light to dark brown pigmentation that occurs on the face. It lies flat on the skin's surface, feels smooth to the touch, and is irregular in size and shape, but with clear borders. It commonly affects young and middle-aged adults, and is more prevalent in women than men. This is a physiological phenomenon and will not fade naturally. Melasma caused by blood stasis is a type of melasma, mainly due to poor blood circulation, leading to malnourishment of the face and disordered pigment metabolism, resulting in symmetrical yellowish-brown patches. This type of melasma is often seen in people with long-term emotional depression, irregular menstruation, dark purple menstrual blood with clots, a dark purple tongue or ecchymosis, and is often accompanied by a dull complexion, dry skin, and premenstrual stinging.

[0003] Clinically, the treatment of melasma caused by blood stasis often involves oral administration of vitamin C, vitamin E, tranexamic acid, and glutathione, combined with topical application of hydroquinone, kojic acid, azelaic acid, retinoic acid, or laser / radiofrequency therapy. These methods are relatively quick and effective. However, because acids or lasers are not only expensive and require professional operation, they also place a heavy burden on the skin and have many toxic side effects, easily damaging the skin barrier. Therefore, long-term or frequent treatment is not recommended. Furthermore, since the main causes of melasma caused by blood stasis are emotional stress and irregular work and rest, rebound is common after treatment. Therefore, the above methods should not be widely promoted and used.

[0004] Compared to Western medicine treatments, traditional Chinese medicine (TCM) combinations are gentler. However, most TCM treatments currently rely on internal administration, which has a relatively slow effect and affects patient compliance. A few external TCM treatments, such as acupuncture and scraping, often treat only a few areas, with limited effectiveness and the drawback of causing secondary damage to the skin.

[0005] Therefore, developing a more convenient, safe, and effective traditional Chinese medicine composition that can effectively improve various symptoms of melasma caused by blood stasis is of great clinical significance. Summary of the Invention

[0006] To address the aforementioned problems, this invention provides a composition for treating melasma caused by blood stasis. This composition can be taken internally or applied externally. The medicinal materials in the composition are readily available and inexpensive. The composition is simple to prepare, has a mild prescription, and exhibits significant therapeutic effects, significantly alleviating melasma symptoms and making it suitable for home treatment.

[0007] Specifically as follows: A composition for treating melasma caused by blood stasis, the composition comprising equal parts of Angelica sinensis, winter melon seeds, Angelica dahurica, Bletilla striata, apricot kernel, Scutellaria baicalensis, Salvia miltiorrhiza, Aconitum carmichaelii, Tribulus terrestris and pearl powder.

[0008] The pharmacological effects of each traditional Chinese medicine component are as follows: Angelica sinensis: Angelica sinensis is a key herb for nourishing and promoting blood circulation. Its core pharmacological effects include: anti-oxidation, promoting blood circulation, regulating immunity and anti-inflammation, and inhibiting tyrosinase, as detailed below: Antioxidant: Contains ingredients such as ferulic acid, which can scavenge free radicals and reduce the damage of oxidative stress to the skin and blood vessels; Promotes blood circulation: Tanshinone compounds can improve microcirculation, accelerate tissue oxygen supply and metabolism, and help alleviate blood stasis type melasma; Regulating immunity and anti-inflammation: Polysaccharide components can enhance macrophage activity and regulate immune function; Inhibits tyrosinase: Studies have shown that its extract can inhibit key enzymes in melanin production, thus aiding in skin whitening.

[0009] Winter melon seeds: Commonly used to clear the lungs and resolve phlegm, promote diuresis and drain pus. Core pharmacological effects: anti-inflammatory and antioxidant, diuretic and swelling-reducing, and skin-moisturizing and laxative effects, as detailed below: Anti-inflammatory and antioxidant properties: Rich in fatty acids and saponins, it has significant anti-inflammatory effects and can be used for symptoms such as lung heat cough and intestinal abscess. Diuretic and anti-edema effects: Promotes water metabolism, helps eliminate dampness from the body, and improves dull skin from the perspective of "strengthening the spleen and eliminating dampness" in traditional Chinese medicine. Moisturizing and laxative: The oily components can lubricate the intestines and promote bowel movements, indirectly reducing the accumulation of toxins in the body and benefiting skin health.

[0010] Angelica dahurica: Known for its effects of dispelling wind and relieving exterior syndromes, as well as whitening and removing blemishes, it possesses both photosensitizing and skin-care properties. Its main pharmacological effects include inhibiting tyrosinase activity and anti-inflammatory and metabolic regulation, as detailed below: Inhibiting tyrosinase activity: Coumarin compounds can reduce melanin synthesis and are commonly used ingredients in traditional Chinese medicine whitening formulas.

[0011] Anti-inflammatory and metabolic regulation: The active ingredients can relieve skin inflammation, regulate the renewal of the stratum corneum, and improve pigmentation.

[0012] Bletilla striata: It has astringent and hemostatic properties, promotes tissue regeneration and protects the skin membrane; it is an important medicinal material for external repair. Its main pharmacological effects include promoting wound healing, stopping bleeding and inflammation, and nourishing the skin, as detailed below: Promotes wound healing: Rich in mucopolysaccharides, it can form a protective film on the wound and promote epithelial cell regeneration.

[0013] Hemostasis and anti-inflammation: Hemostasis and swelling reduction are achieved by constricting local blood vessels and inhibiting the release of inflammatory factors.

[0014] Nourishing the skin: Commonly used in repair mask formulas for dry, sensitive, or damaged skin.

[0015] Almonds: The bitter almonds used in this invention have antitussive and antiasthmatic effects. Their main pharmacological effects are: antitussive and antiasthmatic, laxative and keratin-softening, as detailed below: Antitussive and antiasthmatic: Contains amygdalin, which releases trace amounts of hydrocyanic acid after hydrolysis, inhibiting excessive excitation of the respiratory center.

[0016] Promotes bowel movement: Fatty oils can lubricate the intestines and relieve constipation caused by intestinal dryness.

[0017] Softening the skin's stratum corneum: Topical application can soften the stratum corneum and is often used in exfoliating products, but the concentration needs to be controlled to prevent irritation.

[0018] Scutellaria baicalensis: Clears heat and dries dampness, drains fire and detoxifies; widely used for inflammatory diseases. Its main pharmacological effects include antibacterial and antiviral properties, anti-allergic and anti-inflammatory effects, and hepatoprotective and choleretic effects, as detailed below: Antibacterial and antiviral: Baicalin and baicalein have broad-spectrum antibacterial activity and inhibit Staphylococcus aureus and other bacteria.

[0019] Anti-allergy and anti-inflammatory: It can inhibit histamine release and reduce allergic reactions, and is suitable for skin inflammations such as eczema and acne.

[0020] Liver protection and bile promotion: Promotes bile secretion and assists the liver's detoxification function.

[0021] Danshen (Salvia miltiorrhiza): The premier herb for promoting blood circulation and removing blood stasis, suitable for both cardiovascular and skin conditioning. Its main pharmacological effects include improving microcirculation, anti-oxidation and anti-aging, and assisting in the removal of blemishes. Details are as follows: Improve microcirculation: Tanshinone can dilate blood vessels, prevent platelet aggregation, and promote the metabolism of blood stasis.

[0022] Antioxidant and anti-aging: It eliminates free radicals, protects cell membrane integrity, and delays skin aging.

[0023] Assisted in removing blemishes: Through the mechanism of "promoting blood circulation and removing blood stasis", it accelerates the metabolism and excretion of facial pigmentation.

[0024] White aconite: dispels wind and resolves phlegm, unblocks meridians and relieves spasms. It is mainly used for facial paralysis, migraines, etc. Its main pharmacological effects include nerve regulation and external application for facial ailments. Details are as follows: Neuroregulatory effects: Alkaloid components may affect nerve conduction and relieve facial muscle spasms.

[0025] External use for facial ailments: Traditionally used to "cure all facial diseases", it is now occasionally used as an adjunct treatment for stubborn facial neurodermatitis or pigmentation abnormalities.

[0026] Toxicity warning: The raw product is toxic and must be processed before use.

[0027] Tribulus terrestris: It calms the liver and dispels wind, relieves itching, and is commonly used for skin itching and liver yang hyperactivity. Its main pharmacological effects include: anti-allergy and antipruritic properties, regulating endocrine function, and protecting and improving eyesight. Details are as follows: Anti-allergy and anti-itch: The active ingredients can inhibit histamine release and relieve allergic skin diseases such as urticaria and eczema.

[0028] Regulating endocrine function: Studies suggest that it may affect sex hormone levels and can be used as an adjunct treatment for menstrual disorders and menopausal syndrome.

[0029] Protects and brightens the eyes: Traditionally used for eye diseases caused by liver fire, such as red eyes with excessive tearing and blurred vision.

[0030] Pearl powder: It has calming and soothing effects, improves eyesight, and moisturizes and whitens the skin. Its main pharmacological effects include promoting cell regeneration, calming the nerves, and providing whitening and antioxidant benefits, as detailed below: Promotes cell regeneration: Contains a variety of amino acids and trace elements, which can stimulate epidermal cell metabolism and accelerate repair.

[0031] Sedative and calming: Used for palpitations, insomnia, and anxiety, possibly related to calcium ions regulating nerve excitability.

[0032] Whitening and antioxidant: When used topically, it can brighten skin tone and inhibit melanin production. It is often used in high-end Chinese herbal beauty formulas.

[0033] The composition provided by this invention comprises Angelica sinensis, winter melon seeds, Angelica dahurica, Bletilla striata, apricot kernel, Scutellaria baicalensis, Salvia miltiorrhiza, Aconitum carmichaelii, Tribulus terrestris, and pearl powder. In this formula, Angelica sinensis invigorates blood circulation, moistens dryness, and nourishes the skin; winter melon seeds promote diuresis, resolve phlegm, remove skin impurities, and refresh the skin, serving as the principal herbs. Scutellaria baicalensis and Salvia miltiorrhiza clear heat, cool the blood, and detoxify, serving as assistant herbs. Angelica dahurica, Aconitum carmichaelii, and Tribulus terrestris whiten the skin and remove wind-evil from it; pearl powder beautifies and nourishes the skin; and apricot kernel nourishes yin and moistens dryness. Together, these herbs invigorate blood circulation, moisten dryness, clear heat and detoxify, regulate qi and blood, tighten skin, reduce wrinkles, and beautify the skin.

[0034] On the other hand, the present invention discloses a medicine for treating melasma of the blood stasis type, the medicine containing the above-mentioned composition.

[0035] Furthermore, the drug also contains pharmaceutically acceptable excipients or carriers.

[0036] Furthermore, the excipients contain honey, medical petroleum jelly, or pure milk.

[0037] Furthermore, the dosage form of the drug is a traditional Chinese medicine dressing.

[0038] Furthermore, the herbal dressing is a facial mask.

[0039] On the other hand, the present invention also provides a method for preparing a composition for treating melasma caused by blood stasis, the preparation method comprising the following steps: (1) Processing of medicinal materials: Clean and remove impurities from various Chinese herbal medicines, dry them or air dry them at low temperature, and then grind them into fine powder using a pulverizer; (2) After mixing, pass through a 100-120 mesh sieve to remove coarse residue, and seal and store for later use.

[0040] On the other hand, the present invention provides a method for preparing a drug for treating melasma caused by qi and blood stasis, the preparation method comprising the following steps: Place the composition in a clean mixing bowl and add an appropriate amount of distilled water / sterile saline solution to mix.

[0041] Furthermore, honey, medical petroleum jelly, or pure milk may be added during the mixing process.

[0042] Honey, medical petroleum jelly, or pure milk have moisturizing and strengthening effects.

[0043] The "blending" described in this invention refers to adding ingredients while stirring clockwise until a smooth paste is formed that does not drip and is easy to spread.

[0044] On the other hand, the present invention also provides a method for facial application of the drug, the method comprising the following steps: (1) Cleanse your face and gently apply a warm compress to open your pores; (2) Apply the medicine evenly and thickly, avoiding the eye and mouth area, with a thickness of about 2 mm–5 mm; (3) Apply the mask to the room temperature for 15–20 minutes until it is slightly dry, then gently wash it off with warm water.

[0045] To further enhance the application effect of the composition described in this invention, moisture-locking measures can be taken to prevent the treated skin from being exposed to air, thus preventing environmental factors from affecting the therapeutic effect due to skin dehydration. The moisture-locking measures can be achieved by applying a moisturizing lotion or repair cream.

[0046] Furthermore, the facial application method also includes a pretreatment of the drug, wherein the pretreatment involves heating the drug to 38-40°C.

[0047] Furthermore, the heating method is low-temperature heating with insulated water.

[0048] After the drug of this invention is pretreated, that is, heated to a warm temperature (38–40℃) in warm water at a low temperature, it is then applied evenly and thickly. For people with cold and dampness in autumn and winter and poor blood circulation, it can effectively promote the circulation of blood and qi in the facial meridians and enhance the penetration of the drug.

[0049] Beneficial effects: The herbal composition of this invention is easy to prepare, and the main symptoms are significantly reduced, the area of ​​yellowish-brown patches decreases and the color becomes lighter, the secondary symptoms are improved, the purplish-dark tongue or petechiae and the choppy pulse are correspondingly reduced, and some patients experience mood improvement. Detailed Implementation

[0050] Numerous specific details are set forth in the following description to provide a full understanding of the invention. However, the invention can be practiced in many other ways different from those described herein, and similar modifications can be made by those skilled in the art without departing from the spirit of the invention. Therefore, the invention is not limited to the specific embodiments disclosed below.

[0051] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

[0052] Materials or reagents not specifically mentioned in this invention are all commercially available products or obtained through conventional technical means in the field.

[0053] Example 1: Preparation and application method of the drug 1. Weigh out equal portions of the following medicinal materials according to their weight: Angelica sinensis, winter melon seeds, Angelica dahurica, Bletilla striata, apricot kernel, Scutellaria baicalensis, Salvia miltiorrhiza, Aconitum carmichaelii, Tribulus terrestris, and pearl powder The weight can be selected according to needs. About 20g per person is enough to complete a thick application to the face. That is, each of the above-mentioned medicinal materials is 2g. Depending on the number of patients and the number of applications, more medicinal materials can be prepared in advance.

[0054] 2. The preparation method is as follows: (1) Preparation of the composition: Clean and remove impurities from various Chinese herbal medicines, dry or air dry at low temperature, grind them into fine powder using a pulverizer, mix them evenly, pass them through a 100-120 mesh sieve to remove coarse residue, and seal and store them for later use.

[0055] (2) Drug preparation: Take 20g of the fine powder after step (1) and place it in a clean mixing bowl. Add an appropriate amount of distilled water / sterile saline solution to mix.

[0056] This embodiment is for demonstrating the efficacy of the composition and no other excipients are added. However, in actual implementation, honey, medical petroleum jelly, or pure milk may be added during the mixing process.

[0057] Add the ingredients while stirring clockwise until you achieve a smooth paste that doesn't drip and is easy to spread.

[0058] 3. Disinfection and desensitization (standard nursing procedures) Strictly disinfect the tools before preparation; for patients with sensitive skin, first apply a small amount to the area behind the ear and on the jaw for 15 minutes. If there is no redness, swelling or itching, then apply to the whole face.

[0059] 4. Facial application procedure Cleanse your face, gently apply a warm compress to open pores, and then apply the medication evenly and thickly, avoiding the eye and mouth areas, to a thickness of approximately 2mm–5mm.

[0060] 5. Staying and Cleaning Apply the mask to a warm compress for 15–20 minutes at room temperature until it dries slightly. Then, gently wash it off with warm water and follow up with a moisturizing lotion and repair cream to lock in moisture.

[0061] Precautions (1) The medicinal materials should be prepared and used immediately. The powder should be sealed and stored away from light, moisture and mold. (2) Contraindicated in cases of ulceration, acute eczema, or broken skin; (3) Individualized medication prescriptions for pregnant women and those with special allergies after diagnosis; (4) It is advisable to use it 2 to 3 times a week, and it should not be applied thickly every day.

[0062] Example 2 Clinical Trial Eighty patients with melasma of the blood stasis type who visited the Department of Rehabilitation Medicine of Chongqing Traditional Chinese Medicine Hospital from June 2024 to June 2025 and met the inclusion criteria were selected. After signing the informed consent form, the patients were randomly divided into an experimental group and a control group, with 40 patients in each group.

[0063] Experimental group: Administered the drug prepared in Example 1. Application method: Take 20g of the drug prepared in Example 1, apply evenly to the face, avoiding the eye area and lips, to a thickness of approximately 2mm–5mm, leave on for 20–30 minutes, then rinse with water. Repeat once daily for 8 weeks.

[0064] Control group: Received a placebo mask (base consisting of starch, dextrin, etc., containing no traditional Chinese medicine ingredients; appearance, odor, and color similar to the experimental group). Application method was the same as the experimental group: 20g of the placebo mask was applied evenly to the face, left on for 20-30 minutes, then rinsed off with water. This was done once daily for 8 consecutive weeks.

[0065] There were no statistically significant differences in general characteristics such as gender, age, and course of disease between the two groups (P > 0.05). The clinical data of the two groups are shown in Table 1.

[0066] Table 1 Basic Information

[0067] (1) Diagnostic criteria Western medicine diagnostic criteria: Diagnosis is based on the "Chinese Expert Consensus on the Diagnosis and Treatment of Melasma (2021 Edition)" issued by the Pigmentary Diseases Group of the Dermatology and Venereology Committee of the Chinese Association of Integrative Medicine.

[0068] ① Light to dark brown, well-defined patches on the face, usually symmetrically distributed, without inflammation or scaling. ② No obvious subjective symptoms. ③ More common in women, mainly occurring after puberty. ④ The condition may be seasonal, often worse in summer and milder in winter. ⑤ Exclusion of other diseases (such as zygomatic nevus, Riehl's melanosis, actinic lichen planus, etc.) causing pigmentation.

[0069] Traditional Chinese Medicine (TCM) Diagnostic Criteria: According to the "Expert Consensus on TCM Treatment of Melasma," the TCM diagnosis of "melasma" is based on the Qi stagnation and blood stasis type. Clinical manifestations include: dark brown patches on the face; irritability; chest and rib pain; dark tongue with a thin white coating; and a deep, thready pulse.

[0070] (2) Inclusion criteria ① Meets the diagnostic criteria of both traditional Chinese medicine and Western medicine; ② Has not received laser treatment or oral and topical medications within the past 6 months, has no history of sun exposure within the past 3 months, and has no obvious inflammation, ulceration, or exudation; ③ Has normal cognitive function; ④ Has good compliance.

[0071] (3) Exclusion criteria ① Those with a history of photosensitivity; ② Those who have taken photosensitizing drugs such as retinoids within the past 6 months; ③ Those who are pregnant and have other skin diseases (such as nevus of Ota, freckles, Riehl's melanosis, nevus of Ota, café-au-lait spots); ④ Those with mental illness; ⑤ Those with infectious diseases; ⑥ Those with allergic constitution.

[0072] (4) Observation indicators Create a medical record collection form to record general information such as the patient's name, gender, age, and course of illness. Also collect data on the TCM syndrome scoring form and the color and area scoring form of melasma lesions 1 day before treatment and 8 weeks after treatment.

[0073] Traditional Chinese Medicine Syndrome Scoring Table: The primary and secondary symptoms are scored separately. The primary symptom, yellowish-brown patches on the face with a dark color, is scored as 0 points, mild as 2 points, moderate as 4 points, and severe as 6 points. The secondary symptoms, such as chest and rib pain, irritability, dark purple tongue or petechiae, and choppy pulse, are scored as 0, 1, 2, and 3 points respectively.

[0074] Melasma Lesion Color and Area Scoring Table: Lesion color score is normal skin (0 points), light brown (1 point), obvious brown (2 points), dark brown (3 points); Lesion area score is no lesion (0 points), area <10cm² 2 (1 point) 10cm 2 Area ≤ 30cm² 2 (2 points) Area > 30cm² 2 (3 points).

[0075] (5) Statistical methods: Statistical analysis was performed using SPSS 26.0 software. Quantitative data were expressed as (x±s). Paired-samples t-tests were used for comparisons within groups before and after treatment, and independent-samples t-tests were used for comparisons between groups. Chi-square tests were used for categorical data. P < 0.05 was considered statistically significant.

[0076] (6) Test results Traditional Chinese Medicine (TCM) syndrome scoring scale: The experimental group showed a significant decrease in TCM symptoms after treatment compared to before treatment (P < 0.05), while the control group showed no significant improvement after treatment (P > 0.05). This indicates that the experimental group significantly improved the patients' TCM symptoms. Before treatment, there was no significant difference between the two groups (P > 0.05). After treatment, the experimental group showed better improvement than the control group, indicating that the experimental group was superior in improving TCM symptoms. See Table 2 for details.

[0077] Table 2 Traditional Chinese Medicine Symptom Scoring Scale

[0078] Melasma lesion color and area scoring table: The experimental group showed a significant reduction in color and area after treatment compared to before treatment (P < 0.05), while the control group showed no significant improvement after treatment (P > 0.05). This indicates that the experimental group significantly improved the color and area of ​​melasma lesions. Before treatment, there was no significant difference between the two groups (P > 0.05). After treatment, the experimental group showed better results than the control group, indicating that the experimental group was superior in improving TCM symptoms. See Table 3 for details.

[0079] Table 3. Scoring Table for Color and Area of ​​Melasma Lesions

[0080] As can be seen from the table, the drug prepared by this invention has a definite curative effect. After clinical testing, the drug prepared by this invention significantly alleviates the main symptoms of patients with melasma of qi and blood stagnation type, reduces the area of ​​yellow-brown patches and lightens the color, improves secondary symptoms, and alleviates the symptoms of dark purple tongue or petechiae and choppy pulse. Some patients also experience mood improvement.

[0081] Typical Case Examples Case 1 Ms. Chen, female, 32 years old, company employee. Chief complaint: Light brown patches on both cheekbones 8 months after cesarean section. Eight months prior to her cesarean section, light brown patches appeared on both cheekbones, with clear borders and a butterfly-wing-like distribution, accompanied by a dull complexion. She typically experienced scanty, dark red menstrual flow with clots, and lower abdominal pain before menstruation. Her tongue was purplish-dark with scattered petechiae on the edges, and her pulse was deep and hesitant. Traditional Chinese Medicine diagnosis: Melasma, Qi and blood stagnation type. Treatment: A facial mask for removing blemishes was applied topically once daily for 25 minutes each time. After 4 weeks of continuous treatment: The patient reported that her facial skin was more moisturized, the blemishes had lightened, and menstrual cramps had lessened. After another 8 weeks of treatment: The blemish area shrank by approximately 70%, with only light brown marks remaining on both cheekbones; her complexion became rosy, and the petechiae on her tongue decreased. No adverse reactions were observed during treatment.

[0082] Case 2 Ms. Wu, female, 28 years old, yoga instructor. Chief complaint: Pigmented patches on the right cheekbone area for 1 year following trauma. One year ago, the patient suffered an impact injury to her right cheekbone, after which brown patches gradually appeared at the injury site, covering an area of ​​approximately 2.5cm × 3cm. The color gradually changed from light brown to dark brown, accompanied by rough skin in the area. Menstrual blood was dark with clots, and the pigmentation on the right side of her face deepened before menstruation. Her tongue was dark red with visible ecchymosis on the edges, and her pulse was thready and hesitant. Traditional Chinese Medicine diagnosis: Melasma, Qi and blood stagnation type. Treatment: A facial mask for removing pigmentation was applied topically to the face once daily, focusing on the right cheekbone area, for 20 minutes each time. After 4 weeks of continuous treatment: The patient reported that the local skin was smoother than before, the pigmentation had lightened, and the area had shrunk by approximately 40%. After 8 weeks of continued treatment: The pigmentation had faded by approximately 80%, with only light brown traces remaining. The surrounding skin color became more uniform, and the ecchymosis on the tongue edges decreased. No adverse reactions were observed during the treatment.

[0083] Case 3 Ms. Zhou, female, 35 years old, works in self-media. Chief complaint: Scattered dark brown patches on the face for 2 years, worsening in the past 3 months. The patient developed scattered dark brown patches on her cheekbones and forehead due to long-term sleep deprivation and high stress levels. The patches had clear borders and a sallow complexion. She also experienced irritability, chest and rib pain, and irregular menstruation (dark purple menstrual blood with clots). Her tongue was dark purple with tortuous sublingual veins, and her pulse was wiry and hesitant. Traditional Chinese Medicine diagnosis: Melasma, Qi and blood stagnation type. Treatment: A facial mask for removing blemishes was applied topically once daily for 30 minutes each time. After 4 weeks of continuous treatment: The patient reported that her facial skin was more moisturized, the blemishes had lightened, and the chest and rib pain had lessened. After 8 weeks of continued treatment: The blemishes had faded by approximately 75%, with only light brown spots remaining on the forehead. Her complexion became rosy, her menstrual cycle became more regular, and the tortuous sublingual veins improved. No adverse reactions were reported during treatment.

[0084] Case 4 Ms. Gao, female, 48 years old, self-employed. Chief complaint: Purplish-brown patches on both cheekbones for 5 years, worsening in winter. For the past 5 years, the patient has had purplish-brown patches on both cheekbones with clear borders and a dark, bluish complexion. She is usually sensitive to cold, has cold limbs, scanty and dark menstrual flow with blood clots, and experiences menstrual cramps relieved by warmth. The color of the patches varies with temperature. Her tongue is pale purple with a white coating, and her pulse is deep, thready, and hesitant. Traditional Chinese Medicine diagnosis: Melasma, Qi and blood stagnation type. Treatment: Apply a facial mask to the face once daily for 25 minutes each time. After 4 weeks of continuous treatment: The patient reported that her facial skin was more moisturized, the color of the patches changed from purplish-brown to dark brown, and her sensitivity to cold decreased. After 10 weeks of continued treatment: The patches faded by approximately 85%, with only very faint brown marks remaining on both cheekbones. Menstrual blood clots decreased, abdominal pain lessened, and her complexion became rosy. No adverse reactions occurred during the treatment.

[0085] Case 5 Ms. Zheng, female, 55 years old, retired worker. Chief complaint: Diffuse dark brown patches on the face for 15 years, with repeated laser and drug treatments proving ineffective. Over the past 15 years, dark brown patches gradually appeared on the patient's face, affecting the forehead, cheekbones, bridge of the nose, and upper lip, exhibiting a diffuse distribution. The skin was rough and lacked luster. Previous treatments included laser therapy and topical and oral medications, all with poor results or rebound after discontinuation. She typically had a dull complexion, purplish lips, and numbness in her limbs. Her tongue was purplish-dark with numerous ecchymoses, prominent sublingual veins, and a thin, hesitant pulse. Traditional Chinese Medicine diagnosis: Melasma, Qi and blood stagnation type. Treatment: A facial mask for removing blemishes was applied topically once daily for 30 minutes each time. After 8 weeks of continuous treatment: The patient reported that her facial skin was more moisturized, the roughness was reduced, the color of the blemishes lightened, and the diffuse patches showed "island-like" fading. After 16 weeks of continued treatment: approximately 80% of the pigmentation had faded; light brown patches remained on the forehead and bridge of the nose, but the uniformity of color had significantly improved; limb numbness had lessened; and ecchymosis on the tongue had decreased. No adverse reactions were observed during the treatment.

[0086] Due to the large number of typical clinical treatment cases, it is impossible to list them all again.

[0087] In summary, the above embodiments are only for illustrating the relevant principles and implementation methods, and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made to the present invention without departing from the principles of the present invention should be included within the protection scope of the present invention.

[0088] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0089] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A composition for treating melasma caused by qi and blood stagnation, characterized in that, The composition comprises equal parts of Angelica sinensis, winter melon seeds, Angelica dahurica, Bletilla striata, apricot kernel, Scutellaria baicalensis, Salvia miltiorrhiza, Aconitum carmichaelii, Tribulus terrestris, and pearl powder.

2. A medicine for treating melasma caused by qi and blood stagnation, characterized in that, The drug contains the composition of claim 1.

3. The drug according to claim 2, characterized in that, The drug also contains pharmaceutically acceptable excipients or carriers.

4. The drug according to claim 3, characterized in that, The excipients include honey, medical petroleum jelly, or pure milk.

5. The drug according to any one of claims 1-4, characterized in that, The dosage form of the drug is a traditional Chinese medicine dressing.

6. The drug according to claim 5, characterized in that, The herbal dressing is a facial mask.

7. A method for preparing a composition for treating melasma of the qi and blood stagnation type, characterized in that, The preparation method includes the following steps: (1) Clean and remove impurities from the various Chinese herbal medicines in the composition of claim 1, dry or air dry at low temperature, and then grind them into fine powder using a pulverizer; (2) After mixing, pass through a 100-120 mesh sieve to remove coarse residue, and store in a sealed container.

8. A method for preparing a drug for treating melasma caused by qi and blood stagnation, characterized in that, The preparation method includes the following steps: Take the composition described in claim 1 and place it in a clean mixing bowl. Add an appropriate amount of distilled water / sterile saline solution to mix. Preferably, honey, medical petroleum jelly, or pure milk may be added during the mixing process.

9. A method for facial application of the drug according to any one of claims 1-4, characterized in that, The facial application method includes the following steps: (1) Cleanse your face and gently apply a warm compress to open your pores; (2) Apply the medicine evenly and thickly, avoiding the eye and mouth area, with a thickness of about 2 mm–5 mm; (3) Apply the mask to room temperature for 15–20 minutes until it is slightly dry, then gently wash it off with warm water.

10. The facial application method according to claim 9, characterized in that, The facial application method further includes pretreatment of the drug, wherein the pretreatment involves heating the drug to 38-40°C.

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