A non-invasive topical skin-regenerating oil for treating onychomycosis, its preparation method and application

Abstract

This invention relates to the field of traditional Chinese medicine preparation technology, specifically disclosing a non-invasive, nail-removing topical skin-regenerating oil for treating onychomycosis, its preparation method, and its application. The topical skin-regenerating oil is composed of the following raw materials in parts by weight: Astragalus membranaceus 10-30 parts, Angelica sinensis 10-30 parts, Panax notoginseng 10-30 parts, Scutellaria baicalensis 10-30 parts, Coptis chinensis 10-30 parts, Phellodendron chinense 10-30 parts, Rheum palmatum 10-30 parts, Boswellia carterii 10-30 parts, Borneol 3-8 parts, edible vegetable oil 800-1000 parts, and Vaseline 200-500 parts. The oil is prepared by adding the edible vegetable oil in batches and heating the mixture. This topical skin-regenerating oil, when applied in a thin layer to the affected nail, effectively exerts its effects of "invigorating qi and blood circulation, removing blood stasis, killing parasites, detoxifying, and relieving itching," achieving a short-term, effective, and non-recurring treatment of onychomycosis without nail removal.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, and in particular to a non-invasive topical skin-regenerating oil for treating onychomycosis, its preparation method, and its application. Background Technology

[0002] Onychomycosis, also known as nail fungus, is a nail infection caused by dermatophytes (accounting for approximately 60%–70%), non-dermatophytes (accounting for approximately 20%), and yeasts (accounting for approximately 10%–20%; more common in people whose fingernails are frequently submerged in water). Symptoms include nail discoloration (yellow, white, or brown in areas with dense fungal growth), nail separation from the nail bed (onycholysis), brittleness, thickening of the nail, and subungual accumulation, even ridges and ingrown nails (ingrown nails). It is the most common and serious fungal nail infection in clinical practice. Its formation is closely related to external trauma, aging, a history of athlete's foot, and certain diseases such as diabetes, obesity, immunosuppression, and malignant tumors.

[0003] Onychomycosis (fungal nail infection) has a global incidence rate of 5.5%, but in North America, the rate is as high as 8.7%–13.8%; in Europe, the incidence rate is the highest, reaching 24%; and in some parts of China, the incidence rate is as high as 15%. Onychomycosis is common in the elderly, and its incidence gradually increases with age. In addition, people who frequently go to gyms, commercial swimming pools, or wear closed shoes also have a high incidence rate.

[0004] Onychomycosis is usually classified into the following categories based on the site of infection, side effects of treatment, and clinical symptoms: (1) the most common distal and lateral subungual onychomycosis (characterized by distal onycholysis accompanied by subungual hyperkeratosis, thickening of the nail plate, and yellow to brown discoloration); (2) superficial onychomycosis (superficial white patches that are easily scraped off on the upper surface of the nail plate; more common in immunocompromised patients); (3) proximal subungual onychomycosis (diffuse patches or transverse lines can be seen on the nail plate); (4) internal onychomycosis (lamellar splitting of the nail plate and milky white patches); (5) secondary onychomycosis. If it is not treated promptly and effectively, the condition will gradually worsen until the nail falls off.

[0005] Onychomycosis (fungal nail infection) has a high recurrence rate of 50%, which is generally related to incomplete treatment and reinfection. Incomplete treatment refers to situations where the pathogen is not completely eradicated after treatment. Many patients, after adopting treatment regimens targeting the fungal infection (commonly using oral antifungal drugs such as griseofulvin, itraconazole, terbinafine, and echinocandin, and topical antifungal drugs such as ciclopirox olamine, amorolfine, erucic acid, and tavaborone), even if clinical symptoms subside and mycological tests are negative, often find that topical medications are insufficient to completely eradicate the pathogens hidden deep within the nail unit (the nail bed epithelium and matrix). Furthermore, the significant side effects of oral medications (generally unsuitable for long-term use) lead to recurrence. Reinfection refers to a recurrence of onychomycosis when the person who previously had the infection is reinfected after exposure to the pathogen (shoes and socks are important hosts for the pathogen). Of course, for certain special nail diseases, nail removal treatment is required (such as surgical nail removal, which causes great damage to the human body and is very painful; chemical nail removal causes less damage to the nail matrix, but takes effect more slowly), or laser treatment is used (significant short-term effect, but burning damage to the tissue is unavoidable).

[0006] Therefore, the present invention aims to explore a method that can quickly and painlessly cure onychomycosis without relying on oral Western antibiotics or Chinese medicine for fungal infection, or using any form of nail avulsion or laser treatment, but only using Chinese medicine preparations externally. This method ensures that patients achieve safe, rapid, and non-disruptive effects on their daily lives during the treatment period. Summary of the Invention

[0007] In view of the shortcomings of the existing technology, the first objective of the present invention is to provide a non-removal, effective topical skin-regenerating oil for treating onychomycosis.

[0008] The second objective of this invention is to provide a method for preparing the above-mentioned topical skin-regenerating oil for treating onychomycosis.

[0009] A third objective of this invention is to provide the medicinal use of the above-mentioned topical skin-regenerating oil for treating onychomycosis.

[0010] Traditional Chinese medicine believes that "the health of the nails reflects the health of the liver" and that "the health of the nails is produced by the Qi of the liver," indicating that nail diseases are closely related to the liver. However, there is no unified explanation for their etiology and pathogenesis. Some physicians believe that onychomycosis (fungal nail infection) is caused by insects invading the skin and nail plate; others attribute the onychomycosis to spleen and kidney Yang deficiency, resulting in weak pores and poor defensive Qi, allowing cold pathogens to invade and congeal in the pores, obstructing the meridians, hindering the flow of Qi and blood, leading to disharmony between Ying and Wei (nutritive and defensive Qi), and malnourishment of the pores, thus exacerbating damage to the skin and nail plate.

[0011] Traditional Chinese medicine (TCM) taken internally excels at adjusting a patient's constitution and reducing the probability of fungal infection. External application of TCM works locally. Herbs such as *Pseudolarix amabilis* bark, turmeric, *Dictamnus dasycarpus* bark, *Houttuynia cordata*, and *Artemisia capillaris* all have good antifungal effects, inhibiting and killing superficial fungi. However, in actual treatment of onychomycosis (fungal nail infection), TCM is often used as an adjunct to Western medicine, and its true clinical value in rapidly treating onychomycosis on its own is not fully realized.

[0012] The applicant previously disclosed a skin-regenerating oil (CN201910049626.4) prepared by soaking fourteen kinds of traditional Chinese medicines, including Scutellaria baicalensis, Rheum palmatum, Astragalus membranaceus, Phellodendron chinense, Coptis chinensis, Sanguisorba officinalis, Rehmannia glutinosa, Angelica dahurica, Cynanchum paniculatum, Bletilla striata, Angelica sinensis, Boswellia carterii, Commiphora myrrha, and Borneol, in sesame oil. This oil has been proven to be effective in treating acne (closely related to bacterial infection). Astragalus membranaceus, Rehmannia glutinosa, Bletilla striata, Angelica dahurica, and Cynanchum paniculatum are used as the principal ingredients, invigorating qi and detoxifying, astringing yin and promoting tissue regeneration, detoxifying and healing sores, reducing swelling and draining pus. Scutellaria baicalensis, Coptis chinensis, Phellodendron chinense, and Rheum palmatum are used as the assistant ingredients, clearing heat and drying dampness, purging fire and detoxifying. Angelica sinensis, Sanguisorba officinalis, Boswellia carterii, and Commiphora myrrha are used as the adjuvant ingredients, promoting blood circulation, removing blood stasis, reducing swelling and relieving pain. Borneol, vegetable oil (sesame oil), and cream base are used to open the pores, moisturize the skin, and harmonize the effects of the other herbs to invigorate qi, detoxify, and promote tissue regeneration.

[0013] Therefore, based on the above-mentioned effects of Shengfu Oil in invigorating qi and blood circulation, removing necrotic tissue and detoxifying, the applicant modified the formula of Shengfu Oil to make a topical Shengfu Oil and explored whether it has the effect of treating onychomycosis. In this invention, five volunteers with onychomycosis of different ages and occupations were selected as test subjects. The monitoring results showed that the topical Shengfu Oil can effectively and without recurrence cure onychomycosis in a short period of time without nail removal: (1) beautifying the nails (including the disappearance of nail cloudiness, discoloration, concavity and convexity and nail bed separation); (2) restoring nail toughness and reducing thickness; (3) preventing paronychia.

[0014] To achieve the first objective, the present invention employs the following technical measures:

[0015] A non-invasive topical skin-regenerating oil for treating onychomycosis is prepared from the following raw materials in the indicated weight proportions:

[0016] Astragalus membranaceus 10-30 parts by weight, Angelica sinensis 10-30 parts by weight, Panax notoginseng 10-30 parts by weight, Scutellaria baicalensis 10-30 parts by weight, Coptis chinensis 10-30 parts by weight, Phellodendron chinense 10-30 parts by weight, Rheum palmatum 10-30 parts by weight, Boswellia carterii 10-30 parts by weight, Borneol 3-8 parts by weight, edible vegetable oil 800-1000 parts by weight, and cream base 200-500 parts by weight;

[0017] The edible vegetable oil is selected from at least one of sesame oil, flaxseed oil, coconut oil and olive oil, preferably sesame oil;

[0018] The cream base is selected from at least one of petrolatum, paraffin and beeswax, preferably petrolatum, and more preferably liquefied medical petrolatum.

[0019] To achieve the second objective, the present invention employs the following technical measures:

[0020] A method for preparing the above-mentioned non-nail-removing topical skin-regenerating oil for treating onychomycosis, comprising the following steps:

[0021] Place edible vegetable oil in a container, then add the dry powders of Astragalus membranaceus, Scutellaria baicalensis, Rheum palmatum, Coptis chinensis, Phellodendron chinense, Angelica sinensis, Panax notoginseng, and Boswellia carterii. Stir and heat the mixture at an oil temperature of 55-85℃, then perform ultrasonic extraction (ultrasonic extraction power of 300-500W, ultrasonic extraction time of 30-60 minutes). After filtering to remove residue, wait for the oil temperature to drop to 40-50℃, then add borneol and liquefied cream base, stir thoroughly, and cool to room temperature to obtain a topical skin-nourishing oil for treating onychomycosis.

[0022] The dry powders of all the medicinal materials used, including Astragalus membranaceus, Scutellaria baicalensis, Rheum palmatum, Coptis chinensis, Phellodendron chinense, Angelica sinensis, Panax notoginseng, and Boswellia carterii, were sieved through a 200-mesh sieve.

[0023] To achieve the third objective of the present invention, the present invention also provides the application of the above-mentioned topical skin-regenerating oil or the topical skin-regenerating oil prepared by the above method in the preparation of a non-nail-removing topical medicine for treating onychomycosis, preferably in the preparation of a non-nail-removing topical medicine for treating onychomycosis that is effective and relapse-free within a short period (3 months).

[0024] The formulation principles of the raw materials in this invention are as follows:

[0025] Astragalus, Chrysanthemum indicum, and Panax notoginseng are used as the principal herbs to invigorate qi, detoxify, nourish yin, promote tissue regeneration, reduce swelling, and heal sores. Angelica sinensis and frankincense are used as the assistant herbs to invigorate blood, remove blood stasis, kill parasites, and relieve itching. Scutellaria baicalensis, Coptis chinensis, Phellodendron chinense, and Rheum palmatum are used as the adjuvant herbs to clear heat, dry dampness, purge fire, and detoxify. Borneol, edible vegetable oil, and cream base are used to open up the pores, moisturize the skin, and harmonize the effects of all the herbs to invigorate qi, detoxify, and promote tissue regeneration.

[0026] Compared with the prior art, the present invention has the following advantages and effects:

[0027] The research results show that the topical skin-regenerating oil prepared in this invention can effectively exert its effects of "invigorating qi and blood circulation, removing blood stasis, killing parasites, detoxifying and relieving itching" when applied in a thin layer to the affected nail. This achieves the effect of treating onychomycosis effectively and without recurrence in a short period without nail removal, and has the following advantages: (1) convenient for external application; (2) no nail removal required, no pain; (3) compared to the approximately one-year treatment time in hospitals (using nail removal), the recovery time with topical skin-regenerating oil is much shorter. Severe onychomycosis generally only requires about three months to treat. The topical skin-regenerating oil not only... It can kill superficial fungi and completely kill fungi hidden deep in the nail unit (nail bed epithelium and matrix), and has the effect of short-term effective and non-recurring recovery of onychomycosis: ① Beautiful nails (including the disappearance of nail turbidity, discoloration, concavity and convexity and nail bed separation); ② Nail toughness is restored and thickness is reduced; ③ Paronychia is eliminated; After the pathogens are eliminated, the nail can be cured through self-repair in the later stage and the affected nail is restored to its original state; (4) High treatment efficiency and low recurrence rate: In 5 patients with different degrees of onychomycosis, the total effective rate of external application of Shengfu Oil for the treatment of onychomycosis reached 100%, and the recovery was very good, with a low recurrence rate in the later stage. Attached Figure Description

[0028] Figure 1 This is a typical case of treating severe onychomycosis (distal lateral subungual type) with topical skin-nourishing oil in Example 3.

[0029] Figure 2 This is a typical case of treating severe onychomycosis (distal lateral subungual type) with topical skin-nourishing oil in Example 4.

[0030] Figure 3 This is a typical case three of the treatment of severe onychomycosis (proximal subungual type) with topical skin-nourishing oil in Example 5.

[0031] Figure 4 This is a typical case four of the treatment of onychomycosis (distal lateral subungual type) with topical Shengfu Oil in Example 6.

[0032] Figure 5 This is a picture showing the effect of the topical application of Shengfu Oil to treat onychomycosis (distal lateral subungual type) in Example 7, in typical case 5. Detailed Implementation

[0033] The applicant will now provide a more detailed description of the invention in conjunction with specific embodiments and accompanying drawings. It should be understood that the following content should not be construed as limiting the scope of protection of the invention in any way.

[0034] The petroleum jelly used in this example is ordinary commercially available white medical petroleum jelly, which can be liquefied by heating.

[0035] In the examples, the dry powders of Astragalus membranaceus, Scutellaria baicalensis, Rheum palmatum, Coptis chinensis, Phellodendron chinense, Angelica sinensis, Panax notoginseng and Boswellia carterii were all passed through a 200-mesh sieve.

[0036] Example 1: A method for preparing a topical skin-regenerating oil for treating onychomycosis, the steps of which are as follows:

[0037] Place 1000g of sesame oil in a container, then add 30g each of dried powders of Astragalus membranaceus, Angelica sinensis, and Panax notoginseng, 15g each of dried powders of Scutellaria baicalensis, Rheum palmatum, Coptis chinensis, and Phellodendron chinense, and 10g of dried powder of frankincense. Stir and heat, and extract once by ultrasound at 55℃ (30 minutes; power 300 watts). After filtering to remove residue, when the oil temperature drops to 50℃, add 3g of borneol and 500g of liquefied petroleum jelly, stir thoroughly, and cool to room temperature to obtain topical skin-nourishing oil 1 for treating onychomycosis. Bottle and store in a sealed container.

[0038] Example 2: A method for preparing a topical skin-regenerating oil for treating onychomycosis, the steps of which are as follows:

[0039] Place 800g of sesame oil in a container, then add 30g each of dried powders of Astragalus membranaceus, Angelica sinensis, and Panax notoginseng, 20g of dried powder of frankincense, and 10g each of dried powders of Scutellaria baicalensis, rhubarb, Coptis chinensis, and Phellodendron chinense. Stir and heat, and extract once by ultrasound at 85℃ (30 minutes; power 300 watts). After filtering to remove residue, when the oil temperature drops to 50℃, add 8g of borneol and 200g of liquefied petroleum jelly, stir thoroughly, and cool to room temperature to obtain topical skin-nourishing oil 2 for treating onychomycosis. Bottle and store in a sealed container.

[0040] Example 3: Typical Case 1 of Treating Severe Onychomycosis (Distal Lateral Subungual Type) with Topical Skin-Nourishing Oil

[0041] 1. Treatment methods

[0042] A 67-year-old female patient (from a rural area) had suffered from onychomycosis (fungal nail infection) on both hands for several years due to years of working in the fields. After washing all ten fingers, a thin layer of topical skin-regenerating oil prepared in Example 1 was applied evenly. Food-grade disposable plastic gloves (while ensuring breathability) were then worn for at least 2 hours. The treatment was repeated twice daily, morning and evening, for three consecutive months. Photos were taken before and after the three-month treatment period.

[0043] 2. Treatment Results

[0044] like Figure 1As shown, before using the skin-regenerating oil, all ten nails on the patient's hands exhibited varying degrees of cloudiness, discoloration, thickening, and uneven surfaces, with noticeable nail grime. Some nails were also very brittle, crumbling into powder with slight cutting. After three months of continuous application of the skin-regenerating oil, the nails became brighter, the unevenness disappeared, the thickening subsided, and their resilience significantly improved, with no further powdering. Particularly noteworthy was the left little finger, which showed significant improvement in color, smoothness, thickness, and resilience, becoming indistinguishable from a normal nail. Therefore, it is evident that after three months of continuous application of the skin-regenerating oil, the patient's onychomycosis, which had plagued them for several years, was essentially cured. A follow-up photograph three years later showed all ten nails to be beautiful and completely free of any signs of onychomycosis (indicating no recurrence).

[0045] Example 4: Treatment of severe onychomycosis (distal lateral subungual type) with topical skin-nourishing oil - Typical Case 2

[0046] 1. Treatment methods

[0047] An 85-year-old female patient (from a rural area) had suffered from onychomycosis (fungal nail infection) on both feet for several years. Every night before bed, she washed her feet, including the toenails and soles, and then evenly applied a thin layer of the topical skin-regenerating oil prepared in Example 1. She then wrapped the feet with plastic wrap (while ensuring breathability) overnight. She applied the oil once a day for 48 consecutive days. Photos were taken every 3 or 7 days to record the results.

[0048] 2. Treatment Results

[0049] like Figure 2 As shown, before using the skin-regenerating oil, all ten toenails on the patient's feet exhibited varying degrees of cloudiness, discoloration, thickening, and uneven surfaces; the skin on the soles of the feet was also rough, cracked, and painful to the touch. After applying the skin-regenerating oil continuously for 48 days, the toenails became brighter, the uneven surfaces disappeared, the nail thickness was significantly reduced, and the roughness and cracking of the skin on the soles of the feet significantly subsided, with the pain disappearing (the elderly patient subsequently stopped using it almost every night, nearly discontinuing use). A follow-up photo taken three months after stopping application showed that all ten toenails were very healthy, indicating that the onychomycosis had not recurred.

[0050] Example 5: Topical application of skin-nourishing oil for the treatment of severe onychomycosis (proximal subungual type) - Typical Case 3

[0051] 1. Treatment methods

[0052] A 57-year-old female patient was prone to paronychia in her youth. Three years ago, she accidentally struck both feet with a heavy object, causing her toenails to become ingrown, which worsened her paronychia symptoms and led to onychomycosis (fungal nail infection). Over the next six months, the nail plates discolored severely, and the nails became increasingly brittle, further exacerbating the pain of the paronychia. Ms. Chen sought treatment at a clinic and purchased medication, but after six months of consistent use, her condition did not improve significantly. She then switched to topical application of a skin-regenerating oil. Each day, after washing her feet (including toenails), she evenly applied a thin layer of the skin-regenerating oil prepared in Example 2, then covered them with plastic wrap (while ensuring breathability) for at least two hours. She applied it twice daily, morning and evening, for 45 consecutive days. Photos were taken periodically to record the results.

[0053] 2. Treatment Results

[0054] like Figure 3 As shown, after applying the skin-regenerating oil topically for 45 days, the toenail shell changed from brittle to flexible, a new nail grew on the big toe, and the color of both toenails lightened significantly. During the application period, she did not experience paronychia again; Ms. Chen is already looking forward to wearing fashionable sandals normally in the summer of 2024.

[0055] Example 6: Topical application of skin-nourishing oil for the treatment of onychomycosis (distal lateral subungual type) - Typical Case 4

[0056] 1. Treatment methods

[0057] A 54-year-old male patient, four years ago, accidentally slammed his finger against the truck bed while unloading goods, causing half of his nail to fall off. Due to a lack of timely treatment, he unfortunately developed onychomycosis (fungal nail infection). Initially, the nail stump became brittle, easily producing debris, and the stump frequently rubbed against the nail bed, causing not only pain but also significant inconvenience for deliveries. Mr. Wang tried wiping with iodine and wrapping with gauze, but this did not improve the situation, and his local doctor recommended nail removal (which would greatly disrupt his daily work). Mr. Wang refused nail removal and tried various methods recommended by friends and online over the next few years, but none were effective. He then switched to topical application of a skin-regenerating oil. After washing his hands, including the affected nail, he evenly applied the skin-regenerating oil 2 prepared in Example 2, using only a thin layer, then wore a rubber finger cot (ensuring it was breathable) for at least 2 hours. He applied it twice daily, morning and evening, for 30 consecutive days. Photos were taken periodically to document the process.

[0058] 2. Treatment Results

[0059] like Figure 4 As shown, after applying the skin-regenerating oil topically for 30 days, nail clippings were significantly reduced, nail color was noticeably lighter, the base of the nail finally revealed pink, and the nail bed became much smoother. During the application period, no paronychia occurred, and it did not cause any inconvenience to work. It is recommended that the user continue using the product to strive for a speedy recovery.

[0060] Example 7: Topical application of skin-nourishing oil for the treatment of onychomycosis (distal lateral subungual type) - Typical Case 5

[0061] 1. Treatment methods

[0062] A 70-year-old female patient (a rural housewife) had suffered from onychomycosis (fungal nail infection) on both hands for several years, despite rarely working in the fields. After washing all ten fingers, she evenly applied a thin layer of the topical skin-regenerating oil prepared in Example 2, then wore food-grade disposable plastic gloves (while ensuring breathability) for at least 2 hours. She applied the oil twice daily, morning and evening, for four consecutive months. Photos were taken periodically during this period to record the results.

[0063] 2. Treatment Results

[0064] like Figure 5 As shown, before using the skin-regenerating oil, the patient's five right fingernails exhibited varying degrees of cloudiness, discoloration, thickening, and uneven surfaces, with significant nail bed separation. Some nails were also very brittle, easily crumbling into powder with slight cutting force. After four months of continuous application of the skin-regenerating oil, the nails became brighter, the unevenness lessened, nail separation disappeared, and their resilience significantly improved, with no further powdering. To prevent recurrence, it is recommended to apply the oil consistently, using a "three days on, two days off" approach.

Claims

1. The use of an external skin oil in the manufacture of an external medicament for the treatment of onychomycosis by non-excision, characterised in that, The external use skin oil for treating onychomycosis by non-extraction method is prepared from the following raw materials in parts by weight: 10-30 parts of Astragalus membranaceus, 10-30 parts of Angelica sinensis, 10-30 parts of Gynura japonica, 10-30 parts of Scutellaria baicalensis, 10-30 parts of Coptis chinensis, 10-30 parts of Phellodendron amurense, 10-30 parts of Rheum officinale, 10-30 parts of Boswellia carterii, 3-8 parts of borneol, 800-1000 parts of edible vegetable oil and 200-500 parts of cream base; the preparation method comprises the following steps: The edible vegetable oil is put into a container, and then the dry powders of the above-mentioned raw materials are added into the container, and then heated and stirred under the ultrasonic extraction with the oil temperature of 55-85 ℃, the ultrasonic extraction power of 300-500 W and the ultrasonic extraction time of 30-60 minutes; after filtration, the borneol and the liquefied cream base are added into the container when the oil temperature is lowered to 40-50 ℃, and then stirred evenly; after cooling to room temperature, the external use skin oil for treating onychomycosis is obtained.

2. Use according to claim 1, characterized in that, The edible vegetable oil is at least one selected from the group consisting of sesame oil, linseed oil, coconut oil and olive oil.

3. Use according to claim 1, characterized in that, The cream base is at least one selected from the group consisting of vaseline, paraffin and beeswax.

4. Use according to claim 1, characterized in that, The dry powders of the above-mentioned raw materials are all sieved through a 200-mesh screen.

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