Preparation and treatment method of traditional Chinese medicine composition for treating leukoplakia vulvae based on traditional Chinese medicine

By combining oral decoctions, topical ointments, and fumigation solutions, and by developing personalized treatment plans for patients with vulvar leukoplakia based on TCM syndrome differentiation, the problem of unstable efficacy in TCM treatment has been solved, achieving highly efficient and safe treatment results.

CN121401346APending Publication Date: 2026-01-27刘畅
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Patent Information

Application Number
CN202511838084.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-12-08
Publication Date
2026-01-27

AI Technical Summary

Technical Problem

Current medical treatments for vulvar leukoplakia suffer from significant side effects, difficulty in achieving a complete cure, and a high recurrence rate. Traditional Chinese medicine treatments lack individualized diagnosis and treatment, resulting in unstable efficacy.

Method used

The treatment employs a combination of three approaches: oral decoction, external application of Chinese herbal ointment, and external application of Chinese herbal fumigation. Based on the TCM syndrome differentiation, Chinese herbal prescriptions are matched for patients with different syndrome types, and personalized treatment is achieved through addition and subtraction modules, combining oral, external, and fumigation administration methods.

Benefits of technology

It achieves highly efficient and safe personalized treatment, with a clinical effectiveness rate of over 97% and a cure rate of over 80%, quickly relieving symptoms, reducing the risk of recurrence, and avoiding the side effects of Western medicine hormones.

✦ Generated by Eureka AI based on patent content.
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Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a preparation and treatment method of a traditional Chinese medicine composition for treating leukoplakia vulvae based on traditional Chinese medicine, which adopts three ways of oral decoction, external traditional Chinese medicine ointment and external traditional Chinese medicine fumigation and washing for synergistic treatment, and matches different traditional Chinese medicine formulas for patients with different syndrome types according to the traditional Chinese medicine syndrome differentiation and typing principle. One dose of the oral decoction is taken every day, the decoction is decocted with water and taken in two times, the external traditional Chinese medicine ointment is directly smeared on an affected part, and the fumigation-washing prescription is decocted with water, fumigated and then subjected to hip bath; wherein the syndrome differentiation types comprise a liver-kidney yin deficiency type, a qi-blood deficiency type, a liver channel damp-heat type and a blood stasis and wind dryness type, standardization and individualization are unified, the traditional Chinese medicine composition has the advantages of being remarkable in curative effect, low in recurrence rate, high in safety and the like, and a safe and effective new treatment strategy is provided for leukoplakia vulvae.
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Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a preparation and treatment method of a traditional Chinese medicine composition based on traditional Chinese medicine for treating vulvar leukoplakia. Background Technology

[0002] Vulvar leukoplakia, also known as vulvar white lesions or vulvar dystrophy, is a chronic gynecological condition characterized by loss of pigmentation of the vulvar skin, whitening of the mucous membranes, roughness, thickening, fissures, desquamation, or atrophy. This disease has a long course, is prone to recurrence, and its pathogenesis is unclear, causing significant physical and psychological suffering for patients. Currently, modern medicine mainly uses medications such as glucocorticoids, immunosuppressants, and sex hormones, as well as physical therapies such as laser, ultrasound, and surgery. While these methods can alleviate symptoms in the short term, long-term use has significant side effects, and it is difficult to cure completely, with a high recurrence rate.

[0003] Traditional Chinese medicine (TCM) believes that this disease is closely related to the dysfunction of the liver, kidneys, and spleen, leading to insufficient qi and blood, damp-heat accumulation, blood stasis, and wind-dryness. Current TCM treatments mostly employ fixed prescriptions, lacking individualized diagnosis and treatment, making it difficult to address complex and varied clinical manifestations, resulting in unstable efficacy. Therefore, based on years of clinical experience, this invention proposes a systematic and replicable "syndrome differentiation—basic prescription—modification module" treatment system, combining oral, external, and fumigation routes to achieve personalized and precise treatment, overcoming the shortcomings in current practical applications. Summary of the Invention

[0004] The purpose of this invention is to provide a traditional Chinese medicine composition preparation and treatment method for treating vulvar leukoplakia based on traditional Chinese medicine, so as to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, the present invention provides the following technical solution:

[0006] A treatment method based on traditional Chinese medicine for vulvar leukoplakia includes: synergistic treatment using three approaches: oral decoction, external application of Chinese herbal ointment, and external application of Chinese herbal fumigation. Based on the principles of TCM syndrome differentiation, different Chinese herbal formulas are matched for patients with different syndrome types. The oral decoction is taken once daily, decocted in water and taken twice daily. The external herbal ointment is applied directly to the affected area. The fumigation formula is decocted in water, followed by fumigation and then sitz bath. The syndrome differentiation includes liver and kidney yin deficiency, qi and blood deficiency, liver meridian damp-heat, and blood stasis and wind-dryness.

[0007] As a further aspect of the present invention: the formulation of the oral decoction is selected and determined from the following basic formulas according to the syndrome differentiation: for the liver and kidney yin deficiency type, the basic formula includes: 15-30 parts by weight of prepared Polygonum multiflorum, 10-15 parts by weight of Dipsacus asper, 10-15 parts by weight of Taxillus chinensis, 10-15 parts by weight of Angelica sinensis, 10-15 parts by weight of Lycium barbarum, 10-15 parts by weight of Ligustrum lucidum, 10-15 parts by weight of raw Rehmannia glutinosa, and 10-15 parts by weight of prepared Rehmannia glutinosa.

[0008] For those with deficiency of both Qi and Blood, the basic formula includes: 10-15 parts Angelica sinensis, 10-15 parts Lycium barbarum, 10-15 parts Eucommia ulmoides (fried), and 6-10 parts Ginseng.

[0009] For the damp-heat type of liver meridian, the basic formula includes: 10-15 parts by weight of gentian, 10-12 parts by weight of bupleurum, 10-12 parts by weight of akebia, and 10-15 parts by weight of alisma.

[0010] For the blood stasis and wind-dryness type, the basic formula includes: 10-12 parts by weight of peach kernel, 10-12 parts by weight of safflower, and 15-20 parts by weight of salvia miltiorrhiza.

[0011] As a further aspect of the present invention: the formulation of the external Chinese medicine ointment is selected and determined from the following basic formulas according to the syndrome differentiation: for the blood stasis and wind-dryness type and itching symptoms, the basic formula includes: 6-10 parts by weight of Polygonum cuspidatum, 12-15 parts by weight of Carthamus tinctorius, 10-12 parts by weight of Lithospermum erythrorhizon, and 3-5 parts by weight of Borneol.

[0012] For skin atrophy and nutritional repair, the basic formula is made by mixing broken cell wall powder of porcupine quills, bee honeycomb, dragon's blood, ginseng, sodium sulfate, calamine, and turmeric with badger oil and lauryl acetone.

[0013] As a further aspect of the present invention: the basic fumigation formula for external Chinese herbal fumigation includes: 25-30 parts by weight of Cnidium monnieri, 15-18 parts by weight of Sophora flavescens, 15-20 parts by weight of Zanthoxylum bungeanum, 18-20 parts by weight of Prunus mume, 25-30 parts by weight of Dictamnus dasycarpus, and 2-4 parts by weight of Borneol.

[0014] As a further aspect of the present invention: based on the basic formula, additional modification modules are added according to the patient's concurrent symptoms to achieve individualized treatment. The modification modules include: a severe itching module, a severe atrophy module, and a hypopigmentation module; wherein, the severe itching module includes adding Dictamnus dasycarpus root bark, Kochia scoparia fruit, and Sophora flavescens root; the severe atrophy module includes adding Placenta hominis and deer antler glue; the hypopigmentation module includes adding Angelica sinensis root, Ligusticum chuanxiong rhizome, and Salvia miltiorrhiza root.

[0015] A method for preparing a traditional Chinese medicine composition based on traditional Chinese medicine treatment of vulvar leukoplakia, applicable to the aforementioned treatment method based on traditional Chinese medicine treatment of vulvar leukoplakia, the preparation method comprising: a method for preparing an oral decoction, a method for preparing an external ointment, and a method for preparing an external fumigation solution.

[0016] As a further aspect of the present invention: the method for preparing the oral decoction includes: weighing each medicinal material according to the prescription based on syndrome differentiation, placing them in a decoction container, adding an appropriate amount of cold water to soak for 30-60 minutes, with the water level being 2-3 cm above the surface of the medicinal material, bringing it to a boil over high heat, then simmering over low heat for 20-30 minutes, filtering out the liquid; adding water again to decoct a second time, combining the two decoctions, concentrating to an appropriate amount, and then packaging to obtain the final product.

[0017] As a further aspect of the present invention: the preparation method of the external ointment includes: preparing porcupine quills, bee honeycomb, dragon's blood, ginseng and turmeric into cell wall-breaking powders; placing the cell wall-breaking powders into a mixer and mixing for 30 minutes; adding cell wall-breaking powders of sodium sulfate and calamine, and continuing to mix for 30 minutes to obtain mixed powders; adding an equal proportion of badger oil to the mixed powders and stirring evenly to obtain a mixed ointment; adding lauryl ketone to the mixed ointment and stirring evenly to obtain the external ointment.

[0018] As a further aspect of the present invention: the preparation method of the external fumigation solution includes: decocting the medicine in the fumigation formula with water to 2000 ml, filtering to remove the residue to obtain the medicinal liquid.

[0019] Compared with the prior art, the beneficial effects of the present invention are:

[0020] This treatment method, based on traditional Chinese medicine (TCM) principles for treating vulvar leukoplakia, establishes a clear system of syndrome differentiation and provides basic oral, topical, and fumigation formulas for each syndrome type, validated through years of clinical trials. Building upon this foundation, a "modification module" allows for the addition of specific herbs to address itching, atrophy, and insomnia, achieving personalized and precise treatment on a standardized basis—a "one patient, one formula" approach with highly targeted therapy. Oral medication regulates the internal organs to address the root cause, while topical fumigation directly targets the lesions to treat the symptoms, resulting in a synergistic effect that significantly enhances efficacy. Clinical studies show an effective rate exceeding 97% and a cure rate exceeding 80%, demonstrating significant overall therapeutic benefits. Topical ointments and fumigation formulas quickly relieve itching, pain, and other discomforts, providing rapid symptom relief. The overall conditioning provided by oral decoctions improves constitution and reduces recurrence. The use of purely natural Chinese medicine avoids the side effects of Western hormones, ensuring high safety. The systematic treatment pathway facilitates promotion and application, and is highly replicable. Detailed Implementation

[0021] The technical solution of this application will be further described in detail below with reference to specific embodiments.

[0022] The embodiments of this application are described in detail below, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout.

[0023] In one embodiment of the present invention, a treatment method based on traditional Chinese medicine for vulvar leukoplakia is provided. The method includes: synergistic treatment using three approaches: oral decoction, external application of traditional Chinese medicine ointment, and external application of traditional Chinese medicine fumigation. According to the principles of syndrome differentiation in traditional Chinese medicine, different traditional Chinese medicine formulas are matched for patients with different syndrome types. The oral decoction is taken once a day, decocted in water and taken twice a day. The external application of traditional Chinese medicine ointment is applied directly to the affected area. The fumigation formula is decocted in water and then used for fumigation followed by sitz bath. The syndrome differentiation includes liver and kidney yin deficiency type, qi and blood deficiency type, liver meridian damp-heat type, and blood stasis and wind-dryness type.

[0024] In one embodiment of the present invention, the formulation of the oral decoction is selected and determined from the following basic formulas according to the syndrome differentiation: For the liver and kidney yin deficiency type, the basic formula includes: 15-30 parts by weight of prepared Polygonum multiflorum, 10-15 parts by weight of Dipsacus asper, 10-15 parts by weight of Taxillus chinensis, 10-15 parts by weight of Angelica sinensis, 10-15 parts by weight of Lycium barbarum, 10-15 parts by weight of Ligustrum lucidum, 10-15 parts by weight of Rehmannia glutinosa, and 10-15 parts by weight of Rehmannia glutinosa (processed).

[0025] For those with deficiency of both Qi and Blood, the basic formula includes: 10-15 parts Angelica sinensis, 10-15 parts Lycium barbarum, 10-15 parts Eucommia ulmoides (fried), and 6-10 parts Ginseng.

[0026] For the damp-heat type of liver meridian, the basic formula includes: 10-15 parts by weight of gentian, 10-12 parts by weight of bupleurum, 10-12 parts by weight of akebia, and 10-15 parts by weight of alisma.

[0027] For the blood stasis and wind-dryness type, the basic formula includes: 10-12 parts by weight of peach kernel, 10-12 parts by weight of safflower, and 15-20 parts by weight of salvia miltiorrhiza.

[0028] In one embodiment of the present invention, the formulation of the external Chinese medicine ointment is selected and determined from the following basic formulas according to the syndrome differentiation: For the blood stasis and wind-dryness type and itching symptoms, the basic formula includes: 6-10 parts by weight of Polygonum cuspidatum, 12-15 parts by weight of Carthamus tinctorius, 10-12 parts by weight of Lithospermum erythrorhizon, and 3-5 parts by weight of Borneol.

[0029] For skin atrophy and nutritional repair, the basic formula is made by mixing broken cell wall powder of porcupine quills, bee honeycomb, dragon's blood, ginseng, sodium sulfate, calamine, and turmeric with badger oil and lauryl acetone.

[0030] In one embodiment of the present invention, the basic fumigation formula for external use of traditional Chinese medicine includes: 25-30 parts by weight of Cnidium monnieri, 15-18 parts by weight of Sophora flavescens, 15-20 parts by weight of Zanthoxylum bungeanum, 18-20 parts by weight of Prunus mume, 25-30 parts by weight of Dictamnus dasycarpus, and 2-4 parts by weight of borneol.

[0031] In one embodiment of the present invention, based on the basic formula, a modification module is added according to the patient's concurrent symptoms to achieve individualized treatment. The modification module includes: a severe itching module, a severe atrophy module, and a hypopigmentation module; wherein, the severe itching module includes adding Dictamnus dasycarpus root bark, Kochia scoparia fruit, and Sophora flavescens root; the severe atrophy module includes adding Placenta hominis and deer antler glue; the hypopigmentation module includes adding Angelica sinensis root, Ligusticum chuanxiong rhizome, and Salvia miltiorrhiza root.

[0032] A method for preparing a traditional Chinese medicine composition based on traditional Chinese medicine treatment of vulvar leukoplakia, applicable to the aforementioned treatment method based on traditional Chinese medicine treatment of vulvar leukoplakia, the preparation method comprising: a method for preparing an oral decoction, a method for preparing an external ointment, and a method for preparing an external fumigation solution.

[0033] In one embodiment of the present invention, the method for preparing the oral decoction includes: weighing each medicinal material according to the prescription based on syndrome differentiation, placing them in a decoction container, adding an appropriate amount of cold water to soak for 30-60 minutes, with the water level being 2-3 cm above the surface of the medicinal material, bringing it to a boil over high heat, then simmering over low heat for 20-30 minutes, filtering out the liquid; adding water again to decoct a second time, combining the two decoctions, concentrating to an appropriate amount, and then packaging to obtain the final product.

[0034] In one embodiment of the present invention, the method for preparing the external ointment includes: preparing porcupine quills, bee honeycomb, dragon's blood, ginseng, and turmeric into cell-wall-broken powder; placing the cell-wall-broken powder into a mixer and mixing for 30 minutes; adding cell-wall-broken powders of sodium sulfate and calamine, and continuing to mix for 30 minutes to obtain a mixed powder; adding an equal proportion of badger oil to the mixed powder and stirring evenly to obtain a mixed ointment; adding lauryl acetone to the mixed ointment and stirring evenly to obtain the external ointment.

[0035] In one embodiment of the present invention, the method for preparing the external fumigation solution includes: decocting the medicinal ingredients in the fumigation formula with water to 2000 ml, filtering to remove residue, and obtaining the medicinal liquid. The affected area is first fumigated for 15 minutes daily, and then the affected area is sitz bathed for 30 minutes after the water has cooled slightly.

[0036] This treatment method, based on traditional Chinese medicine (TCM) principles for treating vulvar leukoplakia, establishes a clear system of syndrome differentiation (liver and kidney yin deficiency, qi and blood deficiency, liver meridian damp-heat, and blood stasis and wind-dryness). It provides basic oral, topical, and fumigation formulas for each syndrome, validated through years of clinical trials. Building upon this, a "modification module" allows for the addition of herbs to address itching, atrophy, and insomnia, achieving personalized and precise treatment on a standardized basis—a "one patient, one formula" approach with highly targeted therapy. Oral medication regulates the internal organs to address the root cause, while topical fumigation directly targets the lesions, significantly enhancing efficacy through synergistic effects. Clinical trials show an effective rate exceeding 97% and a cure rate exceeding 80%, demonstrating significant overall therapeutic benefits. Topical ointments and fumigation formulas quickly relieve itching, pain, and other discomforts, providing rapid symptom relief. Oral decoctions improve overall health and reduce recurrence. The use of purely natural Chinese medicine avoids the side effects of Western hormones, ensuring high safety. The systematic treatment pathway facilitates promotion and application, and is highly replicable.

[0037] The following typical cases illustrate the application of this solution.

[0038] Typical Case 1 (Damp-Heat in the Liver Meridian)

[0039] The patient is a 42-year-old female who has experienced vulvar atrophy, dryness, and burning pain for 3 years, accompanied by dizziness, tinnitus, and weakness in the lower back and knees. The diagnosis is vulvar leukoplakia of the liver and kidney yin deficiency type. The treatment plan includes: oral medication: prepared Polygonum multiflorum 20g, Dipsacus asper 12g, Taxillus chinensis 12g, Angelica sinensis 12g, Lycium barbarum 12g, Ligustrum lucidum 12g, Rehmannia glutinosa 12g, prepared Rehmannia glutinosa 12g; external ointment: Angelica sinensis 50g, Paeonia lactiflora 50g, Salvia miltiorrhiza 80g, Rehmannia glutinosa 120g; and fumigation and washing: Cnidium monnieri 25g, Prunus mume 18g, prepared Polygonum multiflorum 18g.

[0040] The symptoms improved significantly after 3 months of treatment, and the atrophy recovered somewhat after 6 months.

[0041] Typical Case 2 (Damp-Heat in the Liver Meridian)

[0042] The patient is a 35-year-old female presenting with vulvar redness, swelling, and severe itching, thick yellow leukorrhea with a foul odor, bitter taste in the mouth, and dry throat. The diagnosis is vulvar leukoplakia of the liver meridian damp-heat type. The treatment plan includes: oral decoction: 30g of *Gynostemma pentaphyllum*, 25g of *Gynostemma pentaphyllum*, 25g of *Chrysanthemum indicum*, 12g of *Euphorbia helioscopia*, 12g of *Artemisia argyi*, and 18g of *Spatholobus suberectus*. One dose daily, decocted in water and taken in two divided doses; external ointment: 9g of *Phellodendron chinense*, 10g of *Sophora flavescens*, 6g of *Polygonum cuspidatum*, and 3g of borneol, mixed with a base to form an ointment, applied externally to the affected area twice daily; fumigation and washing formula: 16g of *Sophora flavescens*, 18g of *Zanthoxylum bungeanum*, 28g of *Dictamnus dasycarpus*, 25g of *Cnidium monnieri*, and 18g of *Hibiscus syriacus*, decocted in water to 2000ml, first used for fumigation and then for washing, once daily.

[0043] After one month of treatment, the redness and itching of the vulva were significantly reduced; after three months of treatment, the symptoms basically disappeared.

[0044] Typical Case 3 (Blood Stasis and Wind-Dryness Type)

[0045] The patient is a 50-year-old female presenting with white, cracked, and scaly vulvar skin, accompanied by severe itching, which worsens at night. The diagnosis is vulvar leukoplakia of the blood stasis and wind-dryness type. The treatment plan includes: oral decoction: peach kernel 10g, safflower 10g, salvia miltiorrhiza 15g, bupleurum chinense 12g, angelica sinensis 12g, white peony root 12g, and rehmannia glutinosa 12g. One dose daily, decocted in water and taken in two divided doses; external ointment: 6g polygonum cuspidatum, 12g safflower, 10g lithospermum erythrorhizon, 30g clematis chinensis, and 3g borneol, mixed with a base to form an ointment, applied to the affected area twice daily; and fumigation and washing formula: 19g salvia miltiorrhiza, 3g borneol, 25g cnidium monnieri, and 18g zanthoxylum bungeanum, decocted in water to 2000ml, first used for fumigation and then for washing, once daily.

[0046] Two months after treatment, the vulvar fissures healed and the scaling decreased; five months after treatment, the color of the vulvar skin basically returned to normal.

[0047] The above are merely preferred embodiments of the present invention. It should be noted that those skilled in the art can make several modifications and improvements without departing from the concept of the present invention, and these should also be considered within the scope of protection of the present invention. These will not affect the effectiveness of the implementation of the present invention or the practicality of the patent.

Claims

1. A treatment method based on traditional Chinese medicine for vulvar leukoplakia, characterized in that, The method includes: synergistic treatment using three approaches: oral decoction, external application of Chinese herbal ointment, and external application of Chinese herbal fumigation. Based on the principles of TCM syndrome differentiation, different Chinese herbal formulas are matched for patients with different syndrome types. The oral decoction is taken once a day, decocted in water and taken twice a day. The external Chinese herbal ointment is applied directly to the affected area. The fumigation formula is decocted in water and then used for fumigation followed by sitz bath. The syndrome differentiation includes liver and kidney yin deficiency type, qi and blood deficiency type, liver meridian damp-heat type, and blood stasis and wind-dryness type.

2. The treatment method for vulvar leukoplakia based on traditional Chinese medicine according to claim 1, characterized in that, The formula for the oral decoction is selected and determined from the following basic formulas based on syndrome differentiation: For the liver and kidney yin deficiency type, the basic formula includes: 15-30 parts by weight of prepared Polygonum multiflorum, 10-15 parts by weight of Dipsacus asper, 10-15 parts by weight of Taxillus chinensis, 10-15 parts by weight of Angelica sinensis, 10-15 parts by weight of Lycium barbarum, 10-15 parts by weight of Ligustrum lucidum, 10-15 parts by weight of raw Rehmannia glutinosa, and 10-15 parts by weight of prepared Rehmannia glutinosa. For those with deficiency of both Qi and Blood, the basic formula includes: 10-15 parts Angelica sinensis, 10-15 parts Lycium barbarum, 10-15 parts stir-fried Eucommia ulmoides, and 6-10 parts ginseng. For the damp-heat type of liver meridian, the basic formula includes: 10-15 parts by weight of gentian, 10-12 parts by weight of bupleurum, 10-12 parts by weight of akebia, and 10-15 parts by weight of alisma. For the blood stasis and wind-dryness type, the basic formula includes: 10-12 parts by weight of peach kernel, 10-12 parts by weight of safflower, and 15-20 parts by weight of salvia miltiorrhiza.

3. The treatment method for vulvar leukoplakia based on traditional Chinese medicine according to claim 2, characterized in that, The formulation of the external Chinese medicine ointment is selected and determined from the following basic formulas according to the syndrome differentiation: For the blood stasis and wind-dryness type and itching symptoms, the basic formula includes: 6-10 parts by weight of Polygonum cuspidatum, 12-15 parts by weight of Carthamus tinctorius, 10-12 parts by weight of Lithospermum erythrorhizon, and 3-5 parts by weight of Borneol. For skin atrophy and nutritional repair, the basic formula is made by mixing broken cell wall powder of porcupine quills, bee honeycomb, dragon's blood, ginseng, sodium sulfate, calamine, and turmeric with badger oil and lauryl acetone.

4. The treatment method for vulvar leukoplakia based on traditional Chinese medicine according to claim 3, characterized in that, The basic fumigation formula for external use of traditional Chinese medicine includes: 25-30 parts by weight of Cnidium monnieri, 15-18 parts by weight of Sophora flavescens, 15-20 parts by weight of Zanthoxylum bungeanum, 18-20 parts by weight of Prunus mume, 25-30 parts by weight of Dictamnus dasycarpus, and 2-4 parts by weight of Borneol.

5. The treatment method for vulvar leukoplakia based on traditional Chinese medicine according to claim 4, characterized in that, Based on the basic formula, additional modification modules are added according to the patient's concurrent symptoms to achieve individualized treatment. The modification modules include: a severe itching module, a severe atrophy module, and a hypopigmentation module. The severe itching module includes adding Dictamnus dasycarpus root bark, Kochia scoparia fruit, and Sophora flavescens root. The severe atrophy module includes adding Placenta hominis and deer antler glue. The hypopigmentation module includes adding Angelica sinensis root, Ligusticum chuanxiong rhizome, and Salvia miltiorrhiza root.

6. A method for preparing a traditional Chinese medicine composition based on traditional Chinese medicine for treating vulvar leukoplakia, applied to the treatment method based on traditional Chinese medicine for treating vulvar leukoplakia as described in claims 1-5, characterized in that, The preparation methods include: oral decoction preparation method, external ointment preparation method, and external fumigation and washing solution preparation method.

7. The method for preparing the traditional Chinese medicine composition based on traditional Chinese medicine treatment of vulvar leukoplakia according to claim 6, characterized in that, The method for preparing the oral decoction includes: weighing each herb according to the prescription based on syndrome differentiation, placing them in a decoction container, adding an appropriate amount of cold water to soak for 30-60 minutes, with the water level 2-3 cm above the herbs, bringing it to a boil over high heat, then simmering over low heat for 20-30 minutes, filtering out the liquid; adding water again to decoct a second time, combining the two decoctions, concentrating to an appropriate amount, and then packaging.

8. The method for preparing the traditional Chinese medicine composition based on traditional Chinese medicine treatment of vulvar leukoplakia according to claim 6, characterized in that, The preparation method of the external ointment includes: making porcupine quills, bee honeycomb, dragon's blood, ginseng and turmeric into cell wall-breaking powders; placing the cell wall-breaking powders into a mixer and mixing for 30 minutes; adding cell wall-breaking powders of sodium sulfate and calamine, and continuing to mix for 30 minutes to obtain mixed powder; adding an equal proportion of badger oil to the mixed powder and stirring evenly to obtain a mixed ointment; adding lauryl ketone to the mixed ointment and stirring evenly to obtain the external ointment.

9. The method for preparing the traditional Chinese medicine composition based on traditional Chinese medicine treatment of vulvar leukoplakia according to claim 7, characterized in that, The preparation method of the external fumigation solution includes: decocting the medicine in the fumigation formula with water to 2000 ml, filtering to remove the residue to obtain the medicinal liquid.