A traditional chinese medicine composition for treating vulvar leukoplakia or vulvar pruritus and preparation method thereof

Abstract

A traditional Chinese medicinal composition for treating vulvar leukoplakia or vulvar pruritus comprises Angelica sinensis, Angelica dahurica, calomel, Glycyrrhiza uralensis, Lithospermum erythrorhizon and dragon's blood resin in predetermined weight proportions. The medicinal preparation may be produced by soaking selected herbal materials in water, adding calomel and dragon's blood resin, introducing glycerol as a solvent, heating the mixture for extraction, and filtering to obtain a medicinal solution. The resulting preparation is suitable for topical administration to the vulvar region. The formulation has a relatively simple composition and convenient preparation process and may be used to alleviate symptoms associated with vulvar leukoplakia or vulvar pruritus, including itching, dryness and irritation.

Description

DescriptionTitle of the InventionA Traditional Chinese Medicine Composition for Treating Vulvar Leukoplakia or Vulvar Pruritus and Preparation Method ThereofTechnical Field

[0001] The present invention relates to the field of traditional Chinese medicine formulations.

[0002] More particularly, the present invention relates to a traditional Chinese medicinal composition for treating vulvar leukoplakia or vulvar pruritus and to a preparation method thereof.

[0003] The composition is suitable for topical administration to the vulvar area to alleviate symptoms such as itching, dryness, irritation, discoloration, discomfort, or related dermatological conditions affecting vulvar tissues.Background Art

[0004] Vulvar pruritus is a common gynecological symptom that may result from a variety of pathological conditions affecting the vulvar region. Persistent itching of the vulva may significantly impair daily activities and quality of life.

[0005] In traditional Chinese medicine theory, vulvar itching is often categorized under the condition known as “Yin Itch” ( TH'f ), which may be associated with liver and kidney deficiency or the downward infusion of damp-heat along the liver meridian.

[0006] Vulvar leukoplakia, also referred to as vulvar dystrophy or chronic vulvar hypoplastic dystrophy, is a chronic disorder characterized by degenerative changes in vulvar skin and mucosal tissues.

[0007] The condition may present symptoms including severe itching, whitening or discoloration of the skin, keratinization, dryness, fissures, or local irritation. In severe cases the skin may become thickened, atrophic, or ulcerated.

[0008] Current treatment methods commonly include topical steroid therapy, hormone therapy, laser therapy, or surgical intervention.

[0009] However, steroid and hormone therapies may provide only temporary relief and symptoms may recur after discontinuation of treatment.

[0010] Laser and surgical treatments can be invasive and may lead to pain, scarring, and poor patient compliance.

[0011] Traditional Chinese medicine has long been used to treat gynecological diseases and dermatological disorders. Herbal formulations may provide therapeutic benefits through mechanisms including reduction of inflammation, improvement of local blood circulation, promotion of tissue repair, and relief of itching.

[0012] However, many existing herbal formulations contain numerous ingredients and complicated preparation procedures, limiting their practical application.

[0013] Accordingly, there remains a need for a medicinal composition having a relatively simple formulation, convenient preparation method, and beneficial therapeutic effects for treating vulvar leukoplakia or vulvar pruritus.Summary of the Invention

[0014] The present invention provides a traditional Chinese medicinal composition suitable for treating vulvar leukoplakia or vulvar pruritus.

[0015] In one aspect, the composition comprises the following components in parts by weight:• 5-15 parts Angelica sinensis• 2-15 parts Angelica dahurica• 1-15 parts calomel• 4-15 parts Glycyrrhiza uralensis• 2-15 parts Lithospermum erythrorhizon• 1-15 parts dragon’s blood resin

[0016] In a preferred embodiment, which aligns with the technical breadth of the priority filing, the composition comprises:• 4.5-13 parts Angelica sinensis• 1.5-13 parts Angelica dahurica• 1-13 parts calomel• 3.5-13 parts Glycyrrhiza uralensis• 1.5-13 parts Lithospermum erythrorhizon• 1-13 parts dragon’s blood resin

[0017] In a further optimized embodiment, the composition comprises:• 10 parts Angelica sinensis8 parts Angelica dahurica• 7 parts calomel• 9 parts Glycyrrhiza uralensis• 8 parts Lithospermum erythrorhizon• 8 parts dragon’s blood resin

[0018] In certain embodiments, glycerol may be used as a solvent for preparing the medicinal formulation.

[0019] Glycerol possesses a high boiling point, low freezing point, and strong hygroscopicity (hygroscopic properties), which helps maintain stability of the preparation while providing moisturizing effects beneficial for dry or damaged skin.

[0020] The composition may be prepared as a topical medicinal preparation suitable for direct application to the vulvar region.Description of Herbal Components

[0021] Angelica sinensis (^J13) is widely used in traditional Chinese medicine as a bloodnourishing herb that promotes circulation and tissue nourishment.

[0022] Angelica dahurica ( El IE) is commonly used for dispelling wind, reducing inflammation, and alleviating itching or pain.

[0023] Calomel ($£ / ), Hydrargyri Chloridum Mite) is a specialized mineral medicine used externally in certain traditional preparations and provides potent antimicrobial and anti-pruritic properties.

[0024] Glycyrrhizapossesses anti-inflammatory and detoxifying properties and harmonizes the effects of other herbal ingredients while reducing irritation.

[0025] Lithospermumis known for cooling the blood, reducing inflammation, and promoting healing of skin lesions and ulcers.

[0026] Dragon’s blood resin (lllliM, Sanguis Draconis) promotes blood circulation, dispels blood stasis, and assists in tissue regeneration and the healing of chronic sores.

[0027] The combination of these six specific ingredients in the claimed proportions produces synergistic therapeutic effects for relieving both the symptomatic itching and the underlying tissue degeneration of vulvar leukoplakia.Preparation Method

[0028] The herbal composition according to the present invention may be prepared according to the following method.

[0029] Step 1 : Weigh the herbal components according to the specified weight parts.

[0030] Step 2: Place Angelica sinensis, Angelica dahurica, Glycyrrhiza uralensis, and Lithospermum erythrorhizon into a preparation vessel.

[0031] Step 3: Add water in an amount approximately five to ten times the total weight of the herbs.

[0032] Step 4: Allow the herbs to soak for approximately 24 hours to ensure full hydration of the plant tissues.

[0033] Step 5: Add calomel and dragon’s blood resin to the soaked mixture.

[0034] Step 6: Add medical-grade glycerol as a solvent in an amount approximately six to twelve times the total weight of the herbal formula.

[0035] Step 7: Heat the mixture over low heat for approximately 8 hours (or a range of six to ten hours) to allow extraction and integration of the active lipid-soluble and water-soluble components.

[0036] Step 8: Filter the mixture using medical gauze or another filtration method to remove solid residues.

[0037] The resulting filtered liquid constitutes the final topical medicinal preparation.Administration Method

[0038] Prior to application, the vulvar area may be cleaned using warm water and dried.

[0039] The medicinal preparation may then be applied using medical gauze, cotton swabs, or medical finger cots.

[0040] Depending on the severity of symptoms, the preparation may be applied once to three times daily.

[0041] The duration of treatment may vary depending on the severity of the condition and the individual response to therapy, though a standard observation cycle is four weeks.Example Formulations

[0042] Example 1:A formulation comprising: 5 parts Angelica sinensis, 2 parts Angelica dahurica, 1 part calomel, 4 parts Glycyrrhiza uralensis, 2 parts Lithospermum erythrorhizon, and 1 part dragon’s blood resin.

[0043] Example 2:A formulation comprising: 10 parts Angelica sinensis, 8 parts Angelica dahurica, 7 parts calomel, 9 parts Glycyrrhiza uralensis, 8 parts Lithospermum erythrorhizon, and 8 parts dragon’s blood resin.Clinical Observations

[0044] To verify efficacy, a study was conducted on 15 female patients (ages 35-74) suffering from vulvar leukoplakia or vulvar pruritus. Symptoms included intense itching, whitening of the skin, vaginal atrophy, and ulcers.

[0045] Efficacy Data (4-Week Treatment Cycle):The clinical results demonstrated a 100% total effective rate for both pruritus and leukoplakia.• Pruritus (15 cases): At 2 weeks, the effective rate was 93.3%. At 4 weeks, 10 cases were cured, 3 showed marked effects, and 2 showed improvement (100% effective).• Leukoplakia (5 cases): At 4 weeks, 2 cases were cured, 2 showed marked effects, and 1 showed improvement (100% effective).

[0046] Case Studies:1 . A 38-y ear-old female with lichen sclerosus-type leukoplakia. After 5 weeks of daily application, the white patches and itching were essentially cured.2. A 68-year-old female with hyperplastic-type leukoplakia. After 4 weeks, the itching disappeared and skin color returned to a normal healthy tone.3. A 49-y ear-old female with atrophic-type leukoplakia and ulcers. After 4 weeks, ulcers healed and atrophy significantly improved.4. A 38-year-old female with vaginitis and severe pruritus. Symptoms disappeared after 2 weeks of use.Advantages of the Invention

[0048] Compared with existing treatment methods, the present invention provides the following advantages:1 . Relatively simple herbal formulation using synergistic ingredients.2. Convenient preparation process using glycerol as a stable, moisturizing carrier.3. High patient compliance due to its non-invasive topical administration.4. Superior clinical efficacy in both symptomatic relief and tissue recovery.Scope of the Invention

[0049] The foregoing description illustrates certain embodiments of the present invention and is not intended to limit the scope of the invention.

[0050] Various modifications, substitutions, and variations may be made by those skilled in the art without departing from the spirit and scope of the invention.

[0051] All such modifications, substitutions, and variations are intended to fall within the scope of the appended claims.

Claims

Claims1. A traditional Chinese medicinal composition for treating vulvar leukoplakia or vulvar pruritus, comprising the following components in parts by weight:5-15 parts Angelica sinensis,2-15 parts Angelica dahurica,1-15 parts calomel,4-15 parts Glycyrrhiza uralensis,2-15 parts Lithospermum erythrorhizon, and1-15 parts dragon’s blood resin.

2. The traditional Chinese medicinal composition according to claim 1, wherein the composition comprises: Angelica sinensis 4.5-13 parts, Angelica dahurica 1.5-13 parts, calomel 1-13 parts, Glycyrrhiza uralensis 3.5-13 parts, Lithospermum erythrorhizon 1.5-13 parts, and dragon’s blood resin 1-13 parts.

3. The traditional Chinese medicinal composition according to claim 1, wherein the composition comprises: 5 parts Angelica sinensis, 2 parts Angelica dahurica, 1 part calomel, 4 parts Glycyrrhiza uralensis, 2 parts Lithospermum erythrorhizon, and 1 part dragon’s blood resin.

4. The traditional Chinese medicinal composition according to claim 1, wherein the composition comprises: 15 parts Angelica sinensis, 15 parts Angelica dahurica, 15 parts calomel, 15 parts Glycyrrhiza uralensis, 15 parts Lithospermum erythrorhizon, and 15 parts dragon’s blood resin.

5. The traditional Chinese medicinal composition according to claim 1, wherein the composition comprises: 10 parts Angelica sinensis, 8 parts Angelica dahurica, 7 partscalomel, 9 parts Glycyrrhiza uralensis, 8 parts Lithospermum erythrorhizon, and 8 parts dragon’s blood resin.

6. A medicinal preparation for treating vulvar leukoplakia or vulvar pruritus, prepared from the composition according to any one of claims 1 to 5.

7. The medicinal preparation according to claim 6, wherein the preparation further comprises medical-grade glycerol as a solvent.

8. The medicinal preparation according to claim 7, wherein the amount of glycerol is at least six times the total weight of the herbal components.

9. The medicinal preparation according to claim 7 or 8, wherein the amount of glycerol is six to twelve times the total weight of the herbal components.

10. A preparation method of the medicinal preparation according to claim 6, comprising the steps of:soaking Angelica sinensis, Angelica dahurica, Glycyrrhiza uralensis an Lithospermum erythrorhizon in water.

11. The preparation method according to claim 10, wherein the soaking water amount is five to ten times the total weight of Angelica sinensis, Angelica dahurica, Glycyrrhiza uralensis and Lithospermum erythrorhizon.

12. The preparation method according to claim 10, further comprising mixing dragon’s blood resin and calomel with the soaked herbal materials.

13. The preparation method according to claim 12, further comprising adding medical-grade glycerol.

14. The preparation method according to claim 13, wherein the glycerol amount is six to twelve times the total weight of the herbal composition.

15. The preparation method according to claim 10, wherein the mixture is heated under low heat conditions.

16. The preparation method according to claim 15, wherein the heating process is maintained for approximately eight hours.

17. The preparation method according to claim 10, further comprising filtering the decoction to remove herbal residues to obtain a medicinal solution.

18. Use of the medicinal preparation according to claim 6 in the manufacture of a medicament for treating vulvar leukoplakia.

19. Use of the medicinal preparation according to claim 6 in the manufacture of a medicament for treating vulvar pruritus.

20. Use of the medicinal preparation according to claim 6 in the manufacture of a medicament for treating vaginitis.

21. The use according to any one of claims 18-20, wherein the medicament is administered topically to the vulvar area.

22. The use according to claim 21, wherein the medicament is applied once to three times per day.

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