Traditional Chinese medicine composition containing boa oil for treating tinea of hands and feet and skin infection and preparation method of traditional Chinese medicine composition

Abstract

The invention provides a boa oil-containing traditional Chinese medicine composition for treating tinea of hands and feet and skin infection and a preparation method thereof, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition comprises the following raw materials: boa oil extract, pteris multifida, vespertilionum vespertilionum, adenosma indianum, carambola, ficus himalayana and radix clematidis. The traditional Chinese medicine composition disclosed by the invention is compatible, has the effects of clearing heat and drying dampness, purging fire for removing toxin, dispelling wind and arresting itching, has a remarkable fungus inhibition effect, is high in curative effect and short in treatment course, realizes simultaneous treatment of principal and subordinate symptoms, fundamentally eliminates bacterial infection, helps a patient to thoroughly get rid of the trouble of skin tinea manus and pedis tinea, and recovers a normal living state. Meanwhile, the traditional Chinese medicine composition has no side effect, does not irritate the skin and is high in safety.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition containing python oil for treating tinea pedis and skin infections, and its preparation method. Background Technology

[0002] Dermatophytes are superficial fungi that parasitize the keratinous tissue of the skin, causing tinea. It is the most common fungal infection in the world, with tinea pedis and tinea manuum being the most common. These diseases have an extremely high incidence rate and are highly contagious. Fungi thrive in warm and moist environments, and are particularly prone to recurrence in hot and humid regions.

[0003] Many medications are currently available for treating fungal infections such as tinea pedis and tinea manuum, including topical medications (miconazole cream, clotrimazole cream, compound benzoic acid lotion, compound resorcinol lotion) and oral medications (griseofulvin, ketoconazole, itraconazole, fluconazole, terbinafine). While these antifungal drugs offer some clinical inhibitory efficacy, recurrence is common upon discontinuation, and they have significant side effects. Topical application can cause irritation and a burning sensation, and prolonged use can lead to adverse reactions in the central nervous system. Fungal infections are chronic, with fungi residing and multiplying in the stratum corneum, requiring long-term medication for complete eradication. Relapse is common, and treatment does not achieve a comprehensive cure.

[0004] Currently, the main methods of treating fungal tinea infections such as tinea pedis and tinea manuum with traditional Chinese medicine are to attack the toxins and kill bacteria, warm and disperse to relieve itching, and clear heat and dry dampness. For example, CN103845665A discloses a traditional Chinese medicine for treating tinea manuum, tinea pedis, tinea corporis, tinea cruris, and psoriasis, using ingredients such as Dictamnus dasycarpus root bark, Stemona japonica root, Coptis chinensis root, Phellodendron chinense bark, Sophora flavescens root, Cnidium monnieri fruit, Kochia scoparia fruit, Pseudolarix amabilis root bark, Viola yedoensis root, and Belamcanda chinensis root. CN102641375A discloses a topical medicine for treating tinea capitis, tinea pedis, tinea manuum, onychomycosis, tinea corporis, and tinea cruris, with ingredients including: Impatiens balsamina whole herb, Pseudolarix amabilis root bark, Sophora flavescens root, Atractylodes lancea root, Phellodendron chinense bark, Picrorhiza scrophulariiflora root, Artemisia annua root, alum, borax, Cnidium monnieri fruit, Dictamnus dasycarpus root bark, Zanthoxylum bungeanum root, and vinegar. The above-mentioned traditional Chinese medicines have disadvantages such as long treatment courses and inconsistent efficacy.

[0005] Therefore, it is of practical significance to develop a traditional Chinese medicine composition that is highly effective in treating tinea pedis and other skin infections that are less prone to recurrence. Summary of the Invention

[0006] Therefore, this invention proposes a traditional Chinese medicine composition containing python oil for treating tinea manuum, tinea pedis and skin infections, and its preparation method.

[0007] The technical solution of this invention is implemented as follows: A traditional Chinese medicine composition containing python oil for treating tinea manuum, tinea pedis, and skin infections comprises the following ingredients: python oil extract, *Pteris vittata*, *Hypericum perforatum*, *Musca fusiforme*, *Starfruit*, *Ficus hirta*, and *Clematis chinensis*.

[0008] Furthermore, by weight, it includes the following ingredients: 20-25 parts python oil extract, 13-18 parts pteropus, 8-10 parts senna, 8-10 parts musk, 5-8 parts starfruit, 5-8 parts ficus benjamina and 2-5 parts clematis.

[0009] Furthermore, the preparation method of the python oil is as follows: take the subcutaneous fat of the python, clean it, remove blood vessels and connective tissue, add it to the extraction solution at a material-to-liquid ratio of 1:20-30 g / mL, shake, carry out supercritical CO2 extraction, concentrate under reduced pressure to obtain python oil, and mix python oil and β-glucan to obtain python oil extract.

[0010] Furthermore, the extract is composed of phycocyanin, polylactic acid, glucose, and water in a mass ratio of (1-3):(0.8-1.5):(0.5-0.9):20. The supercritical CO2 extraction temperature is 35-45℃, the pressure is 20-30MPa, the CO2 flow rate is 15-25L / h, and the time is 20-30min; The mass ratio of β-glucan to python oil is 0.1-0.3:1.

[0011] This invention also provides a method for preparing a traditional Chinese medicine composition containing python oil for treating tinea manuum, tinea pedis, and skin infections, the specific steps of which include: (1) According to the weight parts, the following herbs were ground into powder: *Pteris vittata*, *Hypericum fasciatus*, *Musca pubescens*, *Starfruit*, *Ficus hirta*, and *Clematis chinensis*. The powder was then added to an ethanol solution and microwaved. The powder was then concentrated under reduced pressure to obtain the herbal extract. (2) Add the Chinese herbal extract to deionized water and sonicate to obtain the Chinese herbal extract. Dissolve soybean lecithin and cholesterol in an organic solvent and evaporate under reduced pressure under water bath heating. Add the Chinese herbal extract and vortex hydration to obtain a Chinese herbal liposome suspension. (3) Python oil extract and Tween were added to the Chinese medicine liposome suspension, homogenized under high pressure, filtered, and freeze-dried to obtain the Chinese medicine composition.

[0012] Further, in step (1), the ratio of the mixed powder to the ethanol solution is 1:10-20 g / mL; the concentration of the ethanol solution is 40%-60% v / v; the power of the microwave treatment is 450-500 W, the temperature is 50-60℃, and the time is 1-3 h; the vacuum concentration is carried out until the relative density at 60℃ is 1.10-1.15.

[0013] Furthermore, in step (2), the ratio of the herbal extract to deionized water is 1:6-10 g / mL; the ultrasonic treatment is performed at 15-25 kHz and 35-45 ℃ for 20-30 min.

[0014] Furthermore, in step (2), the organic solvent is methanol or ethanol; the mass ratio of the herbal extract, soybean lecithin, cholesterol and organic solvent is 0.8-1.2:1-2:1-3:10.

[0015] Furthermore, in step (2), the temperature of the vacuum rotary evaporation under the water bath heating condition is 35-45℃, the vacuum degree is 100-150mbar, the rotation speed is 100-150rpm, and the time is 30-40min; the temperature of the vortex hydration is 45-50℃, the rotation speed is 150-200rpm, and the time is 10-20min.

[0016] Furthermore, in step (3), the mass ratio of python oil extract to Tween is 1:0.5-0.7; the pressure of high-pressure homogenization is 20-30 MPa, the rotation speed is 1000-2000 rpm, and the time is 5-10 min.

[0017] Compared with the prior art, the beneficial effects of the present invention are: The herbal composition of this invention uses python oil and phoenix tail as principal ingredients, which clear heat and dampness, cool blood and detoxify, reduce swelling and relieve pain, and moisturize the skin and promote tissue regeneration; it uses bat grass and hairy musk as assistant ingredients, which dispel wind and dry dampness, relieve itching and pain, and assist the principal ingredients; it uses star fruit and ficus benjamin as adjuvant ingredients, which disperse blood stasis, relieve pain, strengthen the spleen and promote diuresis; and it uses clematis as guiding ingredient. The combination of these ingredients has a significant antifungal effect, high efficacy, short treatment course, and achieves both symptomatic and root-cause treatment, fundamentally eliminating bacterial infection and helping patients completely get rid of skin and tinea pedis diseases, restoring a normal life. At the same time, the herbal composition of this invention has no side effects, does not irritate the skin, and is highly safe.

[0018] In the preparation method of python oil of the present invention, the extract solution with a specific composition is subjected to oscillation treatment to improve dispersibility and stability, and to improve the efficiency of subsequent extraction. The subsequent supercritical CO2 extraction maximizes the preservation of the bioactivity of the active ingredients in python oil, thereby obtaining high-quality and stable python oil. Detailed Implementation

[0019] To better understand the technical content of this invention, specific embodiments are provided below to further illustrate the invention.

[0020] Unless otherwise specified, the experimental methods used in the embodiments of this invention are all conventional methods.

[0021] Unless otherwise specified, all materials and reagents used in the embodiments of this invention are commercially available.

[0022] The traditional Chinese medicine composition containing python oil prepared by this invention for treating tinea manuum, tinea pedis and skin infections can be prepared in dosage forms including but not limited to lotions, poultices, ointments and sprays.

[0023] Preparation Example The preparation method of python oil of the present invention is as follows: take python subcutaneous fat, clean it, remove blood vessels and connective tissue, refine it, add it to the extract at a material-to-liquid ratio of 1:25 g / mL and shake it to carry out supercritical CO2 extraction, specifically: extract for 20 min at 40℃, 25 MPa and CO2 flow rate of 20 L / h to obtain python oil, mix python oil and β-glucan at a mass ratio of 1:0.2 to obtain python oil extract.

[0024] The extract consisted of phycocyanin, polylactic acid, glucose, and water in a mass ratio of 2:1:0.7:20.

[0025] Example 1 A traditional Chinese medicine composition containing python oil for the treatment of hand and foot tinea and skin infections:

[0026] A method for preparing a traditional Chinese medicine composition containing python oil for treating tinea pedis and skin infections, comprising the following specific steps: (1) The bat grass, star fruit, clematis, ficus syriacus, musk and ferns are ground and pulverized to obtain a mixed powder. The mixed powder is added to a 50% v / v ethanol solution at a material-to-liquid ratio of 1:15 g / mL. The mixture is microwaved at 480W and 55℃ for 2 hours and concentrated under reduced pressure until the relative density is 1.10 at 60℃ to obtain the Chinese herbal extract. (2) According to the material-liquid ratio of 1:8 g / mL, the Chinese herbal extract was added to deionized water and ultrasonically treated at 20 kHz and 40 ℃ for 25 min to obtain the Chinese herbal extract. At the same time, soybean lecithin and cholesterol were dissolved in ethanol and evaporated under reduced pressure (130 mbar, 130 rpm) for 35 min under the condition of heating in a water bath at 40 ℃. The Chinese herbal extract was added and vortexed at 48 ℃ and 180 rpm for 150 min to obtain the Chinese herbal liposome suspension. The mass ratio of the herbal extract, soybean lecithin, cholesterol, and ethanol was 1:1.5:2:10. (3) Add python oil extract and Tween in a mass ratio of 1:0.6 to the traditional Chinese medicine liposome suspension in step (2), treat at 25 MPa and 1500 rpm for 8 min, filter, freeze dry to obtain the traditional Chinese medicine composition.

[0027] Example 2 A traditional Chinese medicine composition containing python oil for the treatment of hand and foot tinea and skin infections:

[0028] A method for preparing a traditional Chinese medicine composition containing python oil for treating tinea pedis and skin infections, comprising the following specific steps: (1) The bat grass, star fruit, clematis, ficus syriacus, musk and pine needle were ground and pulverized to obtain a mixed powder. The mixed powder was added to a 40% v / v ethanol solution at a material-to-liquid ratio of 1:10 g / mL. The mixture was microwaved at 450W and 50℃ for 1 h and concentrated under reduced pressure until the relative density was 1.10 at 60℃ to obtain the Chinese herbal extract. (2) According to the material-liquid ratio of 1:6 g / mL, the Chinese herbal extract was added to deionized water and ultrasonically treated at 15 kHz and 35 ℃ for 20 min to obtain the Chinese herbal extract. At the same time, soybean lecithin and cholesterol were dissolved in ethanol and evaporated under reduced pressure (100 mbar, 100 rpm) for 30 min under the condition of heating in a water bath at 35 ℃. The Chinese herbal extract was added and vortexed at 45 ℃ and 150 rpm for 10 min to obtain the Chinese herbal liposome suspension. The mass ratio of the herbal extract, soybean lecithin, cholesterol, and ethanol was 0.8:1:1:10. (3) Add python oil extract and Tween in a mass ratio of 1:0.5 to the traditional Chinese medicine liposome suspension in step (2), treat at 20 MPa and 1000 rpm for 5 min, filter, freeze dry to obtain the traditional Chinese medicine composition.

[0029] Example 3 A traditional Chinese medicine composition containing python oil for the treatment of hand and foot tinea and skin infections:

[0030] A method for preparing a traditional Chinese medicine composition containing python oil for treating tinea pedis and skin infections, comprising the following specific steps: (1) The bat grass, star fruit, clematis, ficus syriacus, musk and pine needle were ground and pulverized to obtain a mixed powder. The mixed powder was added to a 60% v / v ethanol solution at a material-to-liquid ratio of 1:20 g / mL. The mixture was microwaved at 500W and 60℃ for 3 hours and concentrated under reduced pressure until the relative density at 60℃ was 1.15 to obtain the Chinese herbal extract. (2) According to the material-liquid ratio of 1:10 g / mL, the Chinese herbal extract was added to deionized water and ultrasonically treated at 25 kHz and 45 ℃ for 30 min to obtain the Chinese herbal extract. At the same time, soybean lecithin and cholesterol were dissolved in ethanol and evaporated under reduced pressure (150 mbar, 150 rpm) for 40 min under the condition of heating in a water bath at 45 ℃. The Chinese herbal extract was added and vortexed at 50 ℃ and 200 rpm for 20 min to obtain the Chinese herbal liposome suspension. The mass ratio of traditional Chinese medicine extract, soybean lecithin, cholesterol, and ethanol was 1.2:2:3:10. (3) Add python oil extract and Tween in a mass ratio of 1:0.7 to the traditional Chinese medicine liposome suspension in step (2), treat at 30 MPa and 2000 rpm for 10 min, filter, freeze dry to obtain the traditional Chinese medicine composition.

[0031] Comparative Example 1 The difference from Example 1 is that commercially available python oil was used, purchased from Hainan Dongshenghong Python Industry Technology Co., Ltd., while the rest is the same as Example 1.

[0032] This comparative example illustrates the formulation of a traditional Chinese medicine composition containing python oil for treating hand, foot, and skin infections:

[0033] Comparative Example 2 The difference from Example 1 is that bat grass is missing, and the mass of the missing bat grass is allocated according to the proportion of other substances; otherwise, it is the same as Example 1.

[0034] Comparative Example 3 The difference from Example 1 is that star fruit is missing, and the mass of the missing star fruit is allocated according to the proportion of other substances. Otherwise, it is the same as Example 1.

[0035] Test case 1. In vitro antibacterial effect Strains: Staphylococcus aureus, Candida albicans; Methods: Agar diffusion method. After inoculating the bacterial suspension, filter paper discs containing the composition (5 μL / disc) were attached and incubated at 37℃ for 24 h. The diameter of the inhibition zone was measured. Negative control: sterile physiological saline.

[0036] The test results are shown in Table 1.

[0037] Table 1

[0038] As can be seen from Table 1, the traditional Chinese medicine compositions prepared in Examples 1-3 of this invention have significant antibacterial effects against Staphylococcus aureus and Candida albicans.

[0039] 2. Animal experiments. The compositions prepared in Examples 1-3 and Comparative Examples 1-3 were prepared into detergents using conventional methods. The concentration of the composition was 5 wt%. A piece of gauze cut into 4×3 mm pieces was immersed in the detergent and wrung out until it no longer dripped. The experiment was then conducted.

[0040] Specific methods: Eighty mice were randomly divided into a blank control group (n=10) and a model group (n=70). In the model group, 1 wt% carrageenan (50 μl / mouse) was injected subcutaneously into the right hind paw to induce inflammation; all mice successfully developed the model. The successfully modeled mice were then randomly divided into a model group, experimental groups 1-3, and comparative groups 1-3, with 10 mice in each group. For experimental groups 1-3 and comparative groups 1-3, gauze soaked in a 5 wt% solution (prepared using standard methods; gauze cut to 4×3 mm was soaked in the solution and wrung until no longer dripping) was wrapped around the right hind paw of each mouse, secured with adhesive tape, and applied for 15 minutes, twice daily for one week. For the model group and blank control group, gauze soaked in an equal volume of physiological saline was wrapped around the right hind paw of each mouse, secured with adhesive tape, and applied for 15 minutes, twice daily for one week.

[0041] After application, the circumference of the ankle joint at the fixation point was measured with a soft measuring tape. After measurement, the left and right hind feet were cut off along the joint and weighed. The swelling inhibition rate of each group was calculated.

[0042] The results are shown in Table 2.

[0043] Table 2

[0044] As can be seen from Table 2, the compositions prepared in Examples 1-3 of the present invention, when prepared into a lotion using conventional methods, can significantly improve redness and swelling in the hind paws of mice and have a good anti-swelling effect.

[0045] 3. Clinical trials Experimental group: The composition prepared in Example 1 was prepared into a paste using conventional methods, with a concentration of 2 wt%; Control group: Miconazole nitrate cream (manufacturer: Xi'an Janssen Pharmaceutical Co., Ltd.), a commercially available drug for treating tinea pedis and manuum, at a concentration of 2 wt%.

[0046] Two hundred patients with tinea pedis and manuum were selected, including 100 males and 100 females, aged 30-45 years. Inclusion criteria: clinical diagnosis met the diagnostic criteria for tinea pedis and manuum, fungal immunofluorescence test results showed positive for dermatophytes, and no other oral or topical antifungal drugs were used before the observation.

[0047] Patients with tinea pedis and manuum were randomly divided into two groups. The experimental group and the control group applied the medication to the affected area and gently massaged it into the skin until absorbed. The treatment was performed twice a day for two weeks. Data were processed using SPSS 19.0. P < 0.05 was considered statistically significant.

[0048] Criteria for evaluating therapeutic efficacy: Cure: Tinea pedis and manuum subsided, fungal immunofluorescence test results were negative, itching disappeared, and symptoms such as erythema, scaling, and papules and vesicles disappeared.

[0049] Significant effect: ≥60% of the area of ​​tinea pedis and tinea manuum has disappeared, the fungal immunofluorescence test result is negative, the itching is significantly relieved, and the symptoms such as erythema, scaling, papules and vesicles are significantly improved.

[0050] Effective: 20% ≤ area of ​​tinea pedis / manuum remission < 60%, fungal immunofluorescence test results are negative or positive, and itching and clinical symptoms are relieved.

[0051] Ineffective: The area of ​​tinea pedis rash that has subsided is <20%, the fungal immunofluorescence test result is positive, there is no improvement in itching at the affected area, and the clinical symptoms and signs are not improved or are aggravated.

[0052] Overall effective rate = (number of cured cases + number of cases with significant improvement) / total number of cases * 100%.

[0053] The results are shown in Table 3.

[0054] Table 3

[0055] As can be seen from Table 3, the composition prepared in Example 1 of the present invention has a good therapeutic effect on tinea pedis and manuum, which is better than that of the commercially available group, and is less prone to recurrence, showing good application prospects.

[0056] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition containing python oil for treating hand, foot tinea and skin infection, characterized in that, The composition comprises the following raw materials: python oil extract, sharp tail, bat grass, musk, ground leaf fig and wilson.

2. The Chinese medicinal composition containing python oil for treating hand, foot tinea and skin infection according to claim 1, wherein the Chinese medicinal composition is prepared by mixing the python oil with the Chinese medicinal ingredients. According to the weight parts, the composition comprises the following raw materials: 20-25 parts of python oil extract, 13-18 parts of sharp tail, 8-10 parts of bat grass, 8-10 parts of musk, 5-8 parts of ground leaf fig and 2-5 parts of wilson.

3. The Chinese medicinal composition containing python oil for treating hand, foot tinea and skin infection according to claim 1, wherein the Chinese medicinal composition is prepared by mixing the python oil with the Chinese medicinal ingredients. The preparation method of the python oil is as follows: the subcutaneous fat of python is washed, the blood vessels and connective tissue are removed, the material liquid ratio is 1:20-30 g / mL, the extraction liquid is added and oscillated, supercritical CO2 extraction is carried out, vacuum concentration is carried out, the python oil is obtained, the python oil and beta-glucan are mixed, and the python oil extract is obtained.

4. A traditional Chinese medicine composition containing python oil for treating tinea manuum, tinea pedis, and skin infections as described in claim 3, characterized in that, The extraction liquid is composed of phycocyanin, polylactic acid, glucose and water in a mass ratio of (1-3):(0.8-1.5):(0.5-0.9):20; The temperature of the supercritical CO2 extraction is 35-45℃, the pressure is 20-30 MPa, the CO2 flow rate is 15-25 L / h, and the time is 20-30 min; The mass ratio of beta-glucan and python oil is 0.1-0.3:

1.

5. A method for preparing the Chinese medicine composition containing python oil for treating hand, foot tinea and skin infection according to any one of claims 1-4, characterized in that, The specific steps include: (1) according to the weight parts, the sharp tail, bat grass, musk, ground leaf fig and wilson are ground and crushed to obtain a mixed powder, which is added into an ethanol solution for microwave treatment, vacuum concentration to obtain a traditional Chinese medicine extract; (2) the traditional Chinese medicine extract is added into deionized water for ultrasonic treatment to obtain a traditional Chinese medicine extract liquid, soybean phospholipid and cholesterol are dissolved in an organic solvent, vacuum rotary evaporation is carried out under water bath heating conditions, the traditional Chinese medicine extract liquid is added, vortex hydration is carried out to obtain a traditional Chinese medicine liposome suspension; (3) the python oil extract and Tween are added into the traditional Chinese medicine liposome suspension, high-pressure homogenization treatment is carried out, filtration is carried out, freeze-drying is carried out to obtain a traditional Chinese medicine composition.

6. The method of claim 5, wherein the preparation method of the Chinese medicine composition containing the python oil for treating hand, foot tinea and skin infection is characterized in that, In step (1), the material liquid ratio of the mixed powder and the ethanol solution is 1:10-20 g / mL; the concentration of the ethanol solution is 40%-60% v / v; the microwave treatment power is 450-500 W, the temperature is 50-60℃, and the time is 1-3 h; the vacuum concentration is carried out to 1.10-1.15 at 60℃.

7. A method for preparing the Chinese medicine composition containing the python oil for treating hand, foot tinea and skin infection according to claim 5, characterized in that, In step (2), the material liquid ratio of the traditional Chinese medicine extract and deionized water is 1:6-10 g / mL; the ultrasonic treatment is carried out at 15-25 kHz and 35-45℃ for 20-30 min.

8. The method of claim 5, wherein the preparation method of the Chinese medicine composition containing the python oil for treating hand, foot tinea and skin infection is characterized in that, In step (2), the organic solvent is methanol or ethanol; the mass ratio of the traditional Chinese medicine extract, soybean phospholipid, cholesterol and organic solvent is 0.8-1.2:1-2:1-3:

10.

9. The method of claim 5, wherein the preparation method of the Chinese medicine composition containing the python oil for treating hand, foot tinea and skin infection is characterized in that, In step (2), the vacuum rotary evaporation under water bath heating conditions is carried out at 35-45℃, the vacuum degree is 100-150 mbar, the rotation speed is 100-150 rpm, and the time is 30-40 min; the vortex hydration temperature is 45-50℃, the rotation speed is 150-200 rpm, and the time is 10-20 min.

10. The method of claim 5, wherein the preparation method of the Chinese medicine composition containing the python oil for treating hand, foot tinea and skin infection is characterized in that, In step (3), the mass ratio of the python oil extract and Tween is 1:0.5-0.7; the pressure of the high-pressure homogenization is 20-30 MPa, the rotating speed is 1000-2000 rpm, and the time is 5-10 min.

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