Traditional Chinese medicine composition for treating verruca plantaris and preparation method thereof

Abstract

The invention relates to the field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating verruca plantaris and a preparation method thereof.The traditional Chinese medicine composition comprises winged euonymus twig, purslane, cortex dictamni, fructus cnidii, fructus kochiae, rhizoma smilacis glabrae, gallnut and dandelion, and preferably, the traditional Chinese medicine composition further comprises mirabilite and / or dried alum; the traditional Chinese medicine composition disclosed by the invention has the effects of clearing heat, drying dampness, activating blood and removing stasis, and aims to treat plantar wart, improve the treatment compliance of patients and improve the life quality of the patients with plantar wart.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for treating plantar warts and a preparation method thereof. Background Art

[0002] Palmoplantar warts belong to the categories of "dried tendon arrow", "Niu Chengjian", "thousand-day sore", and "warts" in traditional Chinese medicine, and belong to the category of viral warts in Western medicine. They are common and frequently occurring diseases in clinical dermatology, caused by human papillomavirus (HPV) infection. The main manifestations are painful keratotic papules and nodules on the palms and soles, which can affect walking. The incidence rate is higher in people with hyperhidrosis of the feet, such as medical staff, athletes, and soldiers, causing many inconveniences to patients' lives and work.

[0003] HPV usually enters the basal cells exposed in the wound by physical means and can only proliferate in human skin keratinocytes with a certain degree of differentiation, but it can also be latent in the basal cells, manifesting as clinical onset or subclinical infection.

[0004] There are many treatments for plantar warts. Most commonly used treatments are direct wart removal (such as surgical excision, carbon dioxide laser, high-frequency electrocautery, microwave, freezing and other physical therapies). Although these treatments have the advantage of simple operation, they are easy to leave local scars, especially when the number of warts is large. The pain, secondary infection, ulcers and other problems caused by deep destructive treatment will have a great impact on the patient's life and work. Some patients may also have fungal and bacterial infections, and about 1 / 3 of the warts will still recur, which brings huge physical, psychological and economic burdens to patients.

[0005] Therefore, there is an urgent need in the art for a Chinese medicine composition that has good efficacy, can improve patient treatment compliance, and improve the quality of life of plantar wart patients for the treatment of plantar warts. Summary of the invention

[0006] In order to solve the above-mentioned problems, the present invention aims to provide a Chinese medicine composition for treating plantar warts and a preparation method thereof.

[0007] Therefore, in a first aspect, the present invention provides a traditional Chinese medicine composition for treating plantar warts, comprising: Psoralea corylifolia, Portulaca oleracea, Cortex Dictamni, Fructus Cnidii, Fructus Kochiae, Smilax glabra, Galla chinensis, and Taraxacum mongolicum.

[0008] In a second aspect, the present invention provides a traditional Chinese medicine preparation, wherein the traditional Chinese medicine preparation is prepared from the traditional Chinese medicine composition of the first aspect of the present invention.

[0009] In a third aspect, the present invention provides use of the Chinese medicine composition of the first aspect of the present invention in preparing a Chinese medicine preparation for treating plantar warts.

[0010] The invention provides a traditional Chinese medicine composition for clearing away heat and drying dampness and a traditional Chinese medicine preparation prepared from the traditional Chinese medicine composition. The traditional Chinese medicine preparation is an external prescription summarized and condensed by the inventor based on clinical experience, has the effects of clearing away heat and drying dampness, promoting blood circulation and dispersing stagnation, can treat plantar warts, and improve patients' treatment compliance and the quality of life of patients with plantar warts. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 The changes in skin lesion area after using different Chinese medicine compositions prepared according to Example 2 are shown.

[0012] Figure 2 A typical clinical case of using the Chinese medicine composition of Example 1 of the present invention to treat plantar warts is shown. DETAILED DESCRIPTION

[0013] The Chinese medicine composition and Chinese medicine preparation for treating plantar warts of the present invention are described in more detail below. It should be noted that the above summary of the invention and the following specific embodiments are only for the purpose of specifically illustrating the present invention, and are not intended to limit the present invention in any way. Without departing from the spirit and purpose of the present invention, the present invention may be modified and improved, and these modifications and improvements are within the scope of the present invention. The scope of protection of the present invention is determined by the attached claims.

[0014] In this article, all parts refer to parts by weight, and the weight is calculated based on the weight of the crude drug or the raw material drug. The parts by weight can be a weight unit known in the medical field such as microgram (μg), milligram (mg), gram (g), kilogram (kg), etc., or a fraction thereof, such as 1 / 10, 1 / 100, or a multiple thereof, such as 10 times, 100 times, etc., but is not limited thereto.

[0015] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating plantar warts, comprising: Psoralea corylifolia, Portulaca oleracea, Cortex Dictamni, Fructus Cnidii, Fructus Kochiae, Smilax glabra, Galla chinensis, and Taraxacum mongolicum.

[0016] In a preferred embodiment, the traditional Chinese medicine composition further comprises Glauber's salt and / or alum.

[0017] In the Chinese medicine system, each Chinese medicine used in the Chinese medicine composition of the present invention has the following effects:

[0018] The Euonymus alatus (Thunb.) Sieb. plant of the Celastraceae family is a winged branch or winged appendage. It is bitter, pungent and cold in nature, and enters the liver and spleen meridians. It has the effects of breaking blood and dredging menstruation, detoxifying and relieving swelling, killing insects, cooling blood and stopping bleeding. It is often used to treat abdominal masses, dysmenorrhea, amenorrhea, abdominal pain, hernia, rheumatoid arthritis, bruises, furuncles, burns, poisonous insect bites, malaria and other diseases. It contains flavonoids, sesquiterpenes, triterpenes and other ingredients, and has anti-tumor, lipid-lowering and blood sugar-lowering, antibacterial and anti-inflammatory effects.

[0019] Portulaca oleracea is the dried aerial part of Portulaca oleracea L., a plant of the Portulacaceae family. It is sour and cold in nature, and enters the liver and large intestine meridians. It has the effects of clearing away heat and detoxifying, cooling blood and stopping bleeding, and stopping dysentery. It is often used to treat heat-toxic dysentery, carbuncles, erysipelas, snake and insect bites, eczema, blood in the stool, hemorrhoid bleeding, metrorrhagia, and diseases with symptoms of damp-heat syndrome. It contains pharmacological ingredients such as β-mannoresinol, butyl ether parfum, and parfum, and has inhibitory effects on Shigella dysenteriae, Salmonella typhi, Staphylococcus aureus, etc.

[0020] Dictamnus dasycarpus Turcz. is the dried root bark of the Rutaceae plant Dictamnus dasycarpus Turcz. It is bitter and cold in nature, and enters the spleen, stomach, and bladder meridians. It has the effects of clearing away heat and dampness, dispelling wind and detoxifying. It is often used for damp-heat sores, yellow water dripping, eczema, rubella, scabies, rheumatic fever, red urine, jaundice and other symptoms. It contains limonoid compounds such as dactyline, isodactyline, chalazine, and chalazine acid, which have inhibitory effects on skin fungi, and its volatile oil has anti-cancer effects in vitro.

[0021] Cnidium monnieri (L.) Cuss. is the dried mature fruit of the Apiaceae plant Cnidium monnieri (L.) Cuss. It is pungent, bitter, warm and slightly toxic in nature. It enters the kidney meridian and has the effects of drying dampness and dispelling wind, killing insects and relieving itching, warming the kidney and strengthening yang. It is used to treat vaginal itching, scabies, eczema itching, cold and damp leucorrhea, and dampness and arthralgia. It contains pharmacological ingredients such as osthole, zanthoxylum bungeanum, bergamot lactone, and angelica dahurica, which have inhibitory effects on fungal and bacterial skin diseases of the skin, and also have anti-inflammatory, anti-allergic, and anti-mutagenic effects.

[0022] Kochia scoparia (L.) Schrad. is the dried mature fruit of the Chenopodiaceae plant. It is pungent, bitter and cold in nature, and enters the kidney and bladder meridians. It has the effects of clearing away heat and dampness, dispelling wind and relieving itching. It is used to treat dysuria, dripping and painful urination, vulvar itching and leucorrhea, urticaria, eczema, and skin itching. It contains pharmacological ingredients such as kochia scoparia saponin B2, kochia scoparia saponin Ic, 20-hydroxyecdysone, oleanolic acid, etc., which have inhibitory effects on various bacteria on the skin.

[0023] Smilax glabra is the dried rhizome of Smilax glabra Roxb. of the Liliaceae family. It is sweet, light and flat in nature, and enters the liver and stomach meridians. It has the effects of detoxification, removal of dampness and unblocking joints. It is used for syphilis, damp-heat stranguria, leucorrhea, scabies, eczema itching, carbuncle, scrofula, limb cramps and muscle and bone pain caused by poisoning. It contains succinic acid, palmitic acid, ferulic acid, resveratrol, astilbin and other ingredients, which have inhibitory effects on a variety of bacteria, bacilli, and tumor-related diseases, can inhibit cellular immune function, and also have anti-ulcer, thrombosis, and vascular sclerosis effects.

[0024] Dandelion is the dried whole herb of Taraxacum mongolicum Hand.-Mazz., Taraxacum borealisinense Kitam. or several plants of the same genus in the Asteraceae family. It is bitter, sweet and cold in nature, and enters the liver and stomach meridians. It has the effects of clearing away heat and detoxifying, reducing swelling and dispersing stagnation, and promoting dampness and relieving stranguria. It is used for carbuncle, breast carbuncle, lung carbuncle, intestinal carbuncle, scrofula, damp-heat jaundice, hot stranguria, red and swollen eyes and other diseases. Its pharmacological ingredients, apigenin, rutin, luteolin, esculent acid, taraxacin, etc., have antibacterial, macrophage activation and anti-tumor activities.

[0025] Gallnut is a gall on the leaves of Rhus chinensis Mill., Rhus punjabensis Stew. Var. Sinica (Diels) Rehd. Et Wils. or Rhus potaninii Maxim., which are mainly caused by the gall aphid (Melaphis chinensis(Bell)Baker), is sour, astringent and cold in nature, has the effects of astringing the lungs and reducing fire, astringing the intestines and stopping diarrhea, astringing sweat and stopping bleeding, consolidating semen and stopping nocturnal emission, and astringing moisture and astringing sores. It is often used for chronic cough due to lung deficiency, cough due to lung heat, spontaneous sweating and night sweats, spermatorrhea, metrorrhagia and bloody stools, traumatic bleeding, wet and rotten skin, carbuncles, sores and other diseases. It contains pharmacological ingredients such as 1,2,3,4,6-penta-O galloyl-β-D-glucose, gallic acid, fatty acids, etc., which have astringent effects on tissue proteins of skin and mucous membranes, and also have antibacterial and anti-inflammatory mechanisms.

[0026] Glauber's salt is a sulfate mineral of the Glauber's salt family. It is a crystal that is processed and refined. It mainly contains hydrated sodium sulfate (Na 2 SO 4 10H 2 O), salty, bitter, cold in nature, enters the stomach and large intestine meridians, has the effects of purging and relieving constipation, moistening dryness and softening hard masses, clearing away heat and reducing swelling, and is used for damp-heat stagnation, abdominal distension and pain, dry stool, abdominal pain caused by intestinal carbuncle, breast carbuncle, hemorrhoidal swelling and pain, sore throat and mouth ulcer, red and swollen eyes, etc. Its pharmacological ingredient sodium sulfate (Na 2 SO4 ) forms a hypertonic solution in the intestine, stimulating intestinal peristalsis and causing diarrhea.

[0027] Alum is dehydrated alum, also known as calcined alum. Its main ingredient is potassium aluminum sulfate dodecahydrate. It has a slight odor, slightly sweet and astringent taste, and is easily soluble in water. It has the effects of eliminating phlegm, drying dampness, stopping diarrhea, stopping bleeding, detoxifying, and killing insects. It is often used for Chinese medical surgical diseases such as eczema, scabies, sores, hemorrhoids, etc. Its chemical component, potassium aluminum sulfate, has a wide range of antibacterial and healing effects.

[0028] In the Chinese medicine composition of the present invention, the main medicine is Radix Glechomae var. erythrorhizoma and Herba Portulacae oleraceae, and the auxiliary medicine is Cortex Dictamni, Fructus Cnidii, Fructus Kochiae, Smilax glabrae, Herba Taraxaci, and Galla chinensis. In addition, preferably, adjuvants such as Glauber's salt and / or Alum can also be added.

[0029] Among the main drugs, the herb of Radix Glechomae is bitter, pungent and cold, which can break blood and promote menstruation, detoxify and kill insects, cool blood and stop bleeding, while the herb of Purslane is sour and cold, which can clear away heat and detoxify, cool blood and stop bleeding; these two Chinese medicines are the main drugs, one pungent and cold, the other sour and cold, which can clear away heat and detoxify, break blood and stop bleeding, and make the warts lack the source of biochemical resources and shrink. Warts are mostly caused by dampness and heat, which lead to phlegm, blood stasis and stagnation. The above two Chinese medicines have the effects of breaking blood and promoting menstruation, detoxifying, stopping bleeding and cooling blood, which fit the pathogenesis.

[0030] Among the ministerial drugs, Dictamni can clear away heat and dampness, dispel wind and detoxify, Cnidium monnieri can dry dampness and dispel wind, kill insects and relieve itching, Kochia scoparia can clear away heat and dampness, dispel wind and relieve itching, Smilax glabra can detoxify and remove dampness, Taraxacum officinale can clear away heat and detoxify, reduce swelling and disperse knots, Gallic acid, astringent, cold and astringent can stop sweating and stop bleeding, and can absorb moisture and astringe sores. These six Chinese medicines are ministerial drugs, which have the effects of strengthening the effects of drying dampness and detoxification, reducing swelling and dispersing knots, and can also improve the environment of phlegm and blood stasis caused by dampness and heat in the feet, weaken the growth environment of warts, and promote the growth and metabolism of normal skin tissue. Plantar warts are mostly patients with concomitant symptoms such as excessive sweating, stuffiness, and maceration on the feet, which make the condition stubborn and difficult to treat. The combination of ministerial drugs can clear away heat and detoxify, dry dampness and kill insects, which fits the pathogenesis.

[0031] Among the adjuvant drugs, Glauber's salt is salty, bitter and cold in nature, and has the effects of moistening, softening, clearing heat and reducing swelling. On the one hand, it can prevent and treat the excessive bitterness, coldness and dampness of the main and auxiliary drugs. On the other hand, it has good moistening, softening, reducing swelling and dispersing nodules, which can help the warts dissipate. Alum can eliminate phlegm and dry dampness, detoxify and kill insects, disperse nodules and dry phlegm, and promote the healing of wart skin.

[0032] It is understandable that the adjuvant of the present invention is an adjuvant, that is, assisting the main medicine and the ministerial medicine to strengthen the therapeutic effect. The adjuvant can also be replaced by other appropriate Chinese medicines with the same medicinal properties, and it can be expected that the Chinese medicine composition after replacement still has the same medicinal effect.

[0033] In one embodiment, the Chinese medicine composition of the present invention includes 10-15 parts of Psoralea corylifolia, 10-20 parts of Portulaca oleracea, 10-20 parts of Dictamni cortex, 5-20 parts of Cnidium monnieri, 5-25 parts of Kochia scoparia, 5-30 parts of Smilax glabra, 10-15 parts of Galla chinensis, 10-20 parts of Taraxacum officinale, 10-30 parts of Sodium sulfate and 10-30 parts of Alum, wherein the parts of each Chinese medicine are by weight.

[0034] More specifically, in the traditional Chinese medicine composition, by weight, the herb Radix Glehniae can be 10, 11, 12, 13, 14 or 15 parts, the herb Portulaca Oleracea can be 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 parts, the herb Dictamni can be 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 parts, the herb Fructus Cnidii can be 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 parts, Kochia scoparia can be 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 or 25 parts, and Smilax glabra can be 5, 6, 7, 8, 9, 10, 11 , 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 or 30 parts, gallnut can be 10, 11, 12, 13, 14 or 15 parts, dandelion can be 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 parts, and sodium sulfate can be 10 , 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 or 30 parts, and alum can be 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 or 30 parts.

[0035] In one embodiment, the Chinese medicine composition of the present invention includes 10-15 parts of Psoralea corylifolia, 10-15 parts of Portulaca oleracea, 10-15 parts of Dictamni cortex, 10-15 parts of Cnidium monnieri, 10-15 parts of Kochia scoparia, 10-15 parts of Smilax glabra, 10-15 parts of Galla chinensis, 10-20 parts of Taraxacum officinale, 10-30 parts of Sodium sulfate and 10-30 parts of Alum, wherein the parts of each Chinese medicine are by weight.

[0036] In a specific embodiment, the Chinese medicine composition of the present invention includes 10 parts of Herba Glehniae, 10 parts of Portulaca Oleracea, 10 parts of Cortex Dictamni, 10 parts of Fructus Cnidii, 10 parts of Fructus Kochiae, 10 parts of Smilax glabra, 10 parts of Galla chinensis, 20 parts of Herba Taraxaci, 20 parts of Sodium Sulfate and 20 parts of Alum.

[0037] In another specific embodiment, the Chinese medicine composition of the present invention includes 15 parts of Herba Glehniae, 15 parts of Herba Portulacae Oleraceae, 15 parts of Herba Dictamni, 10 parts of Fructus Cnidii, 10 parts of Fructus Kochiae, 10 parts of Smilax glabra, 10 parts of Galla chinensis, 10 parts of Herba Taraxaci, 10 parts of Sophora flavescens and 10 parts of Alum.

[0038] In another specific embodiment, the Chinese medicine composition of the present invention includes 10 parts of Herba Glehniae, 10 parts of Portulaca Oleracea, 10 parts of Cortex Dictamni, 10 parts of Fructus Cnidii, 10 parts of Fructus Kochiae, 10 parts of Smilax glabra, 10 parts of Galla chinensis, 10 parts of Herba Taraxaci, 10 parts of Sophora flavescens and 10 parts of Alum.

[0039] In another specific embodiment, the Chinese medicine composition of the present invention includes 15 parts of Herba Glehniae, 15 parts of Herba Portulacae Oleraceae, 15 parts of Herba Dictamni, 15 parts of Fructus Cnidii Monnieri, 15 parts of Fructus Kochiae, 15 parts of Fructus Smilacis Glabrae, 15 parts of Galla Chinensis, 20 parts of Herba Taraxaci, 30 parts of Sodium Sulfate and 30 parts of Alum.

[0040] In a second aspect, the present invention provides a traditional Chinese medicine preparation, which is prepared from the traditional Chinese medicine composition of the first aspect of the present invention.

[0041] In one embodiment, the traditional Chinese medicine preparation may be a powder, a decoction or a granule.

[0042] In a specific embodiment, the Chinese medicine preparation is a powder, which can be prepared by the following method: weigh each Chinese medicine in the Chinese medicine composition of the present invention according to the specified weight ratio, powder it, and then sieve it to obtain a fine powder with a particle size of ≤180μm, preferably a particle size of ≤75μm, which is the powder of the present invention.

[0043] In a specific embodiment, the Chinese medicine preparation is a decoction, which can be prepared by the following method: weigh each Chinese medicine in the Chinese medicine composition of the present invention according to the prescribed weight ratio, add 10 times the weight of water, boil and simmer for 10-30 minutes, then reflux and extract the decoction 3 times, each time for about 1 hour, combine the 3 extracts, mix and filter, and decoct and concentrate at low temperature to 50% of the mixed extract, which is the water decoction of the present invention.

[0044] In a specific embodiment, the Chinese medicine preparation is a granule, which can be prepared by the following method: weigh each Chinese medicine in the Chinese medicine composition of the present invention according to the prescribed weight ratio, add 10 times the weight of water, boil and simmer for 10-30 minutes, then reflux and extract the decoction 3 times, each time for about 1 hour, combine the 3 extracts, mix and filter, concentrate and filter at 50°C-60°C to an extract with a relative specific gravity of 1.30-1.35, dry and crush into fine powder to obtain a dry extract, mix the dry extract with soluble starch at a weight ratio of 1:1 and granulate, dry, and sieve to obtain particles with a particle size of ≤2mm, preferably a particle size of ≤0.25mm, which is the granule of the present invention.

[0045] In one embodiment, the obtained powder, decoction or granules can be filled into containers and sterilized.

[0046] As used herein, the term "slow fire" refers to the temperature requirement in the Chinese medicine processing specification, which is usually 80-120° C. When using slow fire, the temperature rises slowly, the water evaporates slowly, and the medicinal liquid remains in a slightly boiling state, which is conducive to the decoction of the active ingredients of the medicine.

[0047] The Chinese medicine preparation of the present invention can be a Chinese medicine compound lotion, so the Chinese medicine preparation of the present invention needs to be prepared into a lotion with water when used according to the situation.

[0048] For example, when the traditional Chinese medicine preparation is in the form of powder, the powder can be prepared with water at a weight ratio of 1:5-20, preferably at a weight ratio of 1:10, so as to obtain an administrable traditional Chinese medicine compound lotion.

[0049] For another example, when the Chinese medicine preparation is in the form of a decoction, the decoction can be prepared with water at a weight ratio of 1:1-5, preferably at a weight ratio of 1:2, so as to obtain an administrable Chinese medicine compound lotion.

[0050] For another example, when the traditional Chinese medicine preparation is in the form of granules, the granules can be formulated with water at a weight ratio of 1:5-20, preferably at a weight ratio of 1:10, so as to obtain an administrable traditional Chinese medicine compound lotion.

[0051] In one embodiment, the Chinese medicine preparation can be used in combination with other active agents such as 5-Fluorouracil (5-FU) to treat plantar warts.

[0052] 5-Fluorouracil is a pyrimidine antimetabolite that can act directly on warts, causing blockage of wart blood vessels and resulting in obstruction of wart nutrition. It can also interfere with and block DNA synthesis, destroy viral reproduction, and ultimately cause warts to fall off. It can be used directly in the treatment of plantar warts clinically, or combined with other therapies for the treatment of plantar warts.

[0053] In a third aspect, the present invention provides use of the Chinese medicine composition of the first aspect in preparing a Chinese medicine preparation for treating plantar warts.

[0054] In one embodiment, the Chinese herbal preparation is used in combination with other active agents such as 5-fluorouracil to treat plantar warts.

[0055] In a preferred embodiment, the plantar warts are multiple plantar warts.

[0056] Example

[0057] Example 1

[0058] The inventors first applied a decoction prepared from the following Chinese medicines to a typical clinical case of multiple plantar warts: 15g of Radix Angelicae Pubescentis, 15g of Portulaca Oleracea, 15g of Cortex Dictamni, 15g of Fructus Cnidii, 15g of Fructus Kochiae, 15g of Smilax glabra, 15g of Galla chinensis, 20g of Taraxacum mongolicum, 30g of Sodium Sulfate and 30g of Alum.

[0059] The specific circumstances of this case are as follows: plantar hyperplasia and tenderness for one year, and the area of ​​lesions increased after freezing two months ago; the Western medical diagnosis was palmoplantar warts, and the Chinese medical diagnosis was verruca (damp-heat accumulation syndrome).

[0060] Specifically, the above Chinese medicines are mixed according to the weight ratio, 10 times the volume of water is added, boiled and simmered for 30 minutes, left to cool to about 40°C, and then fumigated and washed the affected area for 15-30 minutes, once a day, for 13 consecutive weeks.

[0061] The results showed that after 13 weeks of treatment with the decoction, the patient recovered and the skin lesions on the affected area changed as follows: Figure 2 As shown, from left to right are photos taken from the 0th week to the 13th week of administration, indicating that the prescription has good clinical efficacy.

[0062] Example 2

[0063] Therefore, after discovering the clinical efficacy of a traditional Chinese medicine formula consisting of Psoralea corylifolia, Portulaca oleracea, Cortex Dictamni, Fructus Cnidii, Fructus Kochiae, Smilax glabra, Galla chinensis, Herba Taraxaci, Sodium Sulfate and Alum on patients with multiple plantar warts, the inventors further studied the drug combination and ratio of the formula.

[0064] The Chinese medicine composition is prepared according to the following different drug combinations and proportions:

[0065]

[0066]

[0067] Note: The unit of each Chinese medicine in the table is gram (g).

[0068] In this study, the subjects were patients with multiple refractory plantar warts.

[0069] Mix the above-mentioned Chinese medicines in proportion, add 10 times the volume of water, boil and simmer for 30 minutes, let it cool to about 40℃, then fumigate the affected area for 15-30 minutes, once a day for 12 weeks, and judge the clinical efficacy by observing the regression rate of skin lesions on the affected area.

[0070] The results are displayed as skin lesion area, where the calculation method of skin lesion area is as follows: For fused warts, use a soft ruler to calculate the wart area, and for independent scattered warts not exceeding 1 cm 2 Warts, each according to 1cm 2 Calculate and then calculate the total area.

[0071] The results are as follows Figure 1 As shown, the skin lesion regression rates of compositions 1-5 are 50%, 100%, 75%, 80% and 67% respectively. It can be seen that compositions 1 (clinical experience prescription), 2, 3, 4, and 5 can all achieve good clinical efficacy in the 12th week, but the effects of compositions 2, 3, 4, and 5 are more outstanding. Therefore, based on clinical experience, it is speculated that the drug composition can achieve a relatively satisfactory clinical efficacy according to the following ratio: 10-15 parts of Radix Angelicae Pubescentis, 10-20 parts of Portulaca Oleracea, 10-20 parts of Dictamni Cortex, 5-20 parts of Cnidium monnieri, 5-25 parts of Kochia scoparia, 5-30 parts of Smilax glabra, 10-15 parts of Galla chinensis, 10-20 parts of Taraxacum officinale, 10-30 parts of Sodium Sulfate, and 10-30 parts of Alum.

[0072] In addition, the patient also gave feedback on the feeling of using the above-mentioned composition, indicating that the skin on the affected area was relatively dry after using composition 2, while the feeling of using composition 3 did not cause the problem of dryness. Therefore, although the efficacy of composition 2 is better, based on the feedback of the patient's feeling of use, the feeling of use of composition 3 is better, the patient's treatment compliance will be better, and accordingly, the universality is also stronger. Therefore, the inventor further selected composition 3 for larger-scale clinical application.

[0073] Example 3

[0074] The inventors conducted further clinical trial comparative studies on the Chinese medicine preparation of the present invention, wherein the relevant contents and results of the clinical trials are as follows.

[0075] (1) Research subjects

[0076] The study subjects were 41 patients with multiple plantar warts who visited Shaanxi Provincial Hospital of Traditional Chinese Medicine from April 1, 2023 to March 31, 2024, including 21 males and 20 females. The youngest was 5 years old and the oldest was 84 years old. The average age was 31.34±16.78. See Table 1 for details.

[0077] (2) Diagnostic criteria

[0078] ① The Western medical diagnosis of plantar warts refers to the "Chinese Clinical Dermatology" (Zhao Bian. Chinese Clinical Dermatology and Venereology. Nanjing: Jiangsu Science and Technology Press, 2013: 414-415). The diagnostic criteria for multiple plantar warts are as follows: rough and uneven wart-like growths on the soles of the feet, gray, light yellow or skin color, round or irregular in shape, with keratinized hyperplasia on the surface. After scraping off the surface keratin, a soft core, bleeding spots or small black spots caused by blood coagulation can be seen.

[0079] ② The diagnostic criteria of traditional Chinese medicine refer to the diagnostic criteria for warts in the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases and Syndromes" (State Administration of Traditional Chinese Medicine. Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases and Syndromes. 2019 Edition: 261-262): The skin lesions are hemispherical papules and nodules ranging in size from millet to soybean, with a rough and uneven surface like thorns.

[0080] (3) Inclusion criteria

[0081] ①Meet the Western medical diagnostic criteria for plantar warts and the Chinese medical diagnostic criteria for warts; ②The symptoms of plantar warts are typical, and the number is ≥3 or they are fused together into a piece larger than 2 cm 2 ; ③ Patients whose main treatment is external drug intervention; ④ The treatment outcome is recovery: no obvious warts.

[0082] (4) Exclusion criteria

[0083] ① Patients with other skin diseases in the treatment area; ② Patients with other skin diseases characterized by verrucous hyperplasia of the feet; ③ Patients who have taken Chinese medicine / Western medicine for the disease one month before the enrolled subjects; ④ Patients who have been treated with physical and chemical methods such as laser, photodynamic therapy, and surgery.

[0084] (5) Elimination criteria

[0085] ① Patients whose treatment measures seriously violate the inclusion criteria; ② Patients whose efficacy and treatment cycle cannot be evaluated.

[0086] (6) Efficacy indicators

[0087] ①Main efficacy evaluation indicators: recovery period (days) and 8-week efficacy rate (efficacy in the 8th week of treatment); ②Secondary evaluation indicators: 8-week pain / foreign body sensation index (VAS score, full score 10 points) and skin lesion thickness according to: no obvious thickness, very thin, thin, general hypertrophy, hypertrophy, very hypertrophy, evaluated as 0, 1, 2, 3, 4, 5 points respectively.

[0088] (7) Efficacy evaluation

[0089] The efficacy was evaluated by the nimodipine method, and the efficacy rate = [(lesion area before treatment - lesion area after treatment) / lesion area before treatment] * 100%, referring to the efficacy standards for warts in the "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes" [State Administration of Traditional Chinese Medicine. Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes. 2019 Edition: 261]: ① Cured, lesions completely disappeared, no new rash; ② Lesions became flatter than before, disappeared by more than 30% or some new rashes appeared; ③ Uncured: The rash did not change, or disappeared by less than 30%. The degree of improvement in lesion hypertrophy and pain was evaluated with reference to the above efficacy indicators.

[0090] (8) Safety indicators

[0091] Extract adverse reactions during treatment and evaluate the safety of treatment.

[0092] (9) Statistical methods

[0093] SPSS 22.0 was used for statistical analysis. Count data were analyzed by composition ratio or frequency count and chi-square test. Measurement data were expressed as mean ± standard deviation, and data that met normal distribution were analyzed by one-way analysis of variance. All tests were two-sided, and P < 0.05 was considered statistically significant.

[0094] Study Results

[0095] (1) Analysis of the patient's general condition

[0096] The male-female ratio of the selected patients was equal, and the age distribution (31.34±16.78 years old) was mainly young and middle-aged patients, with an average skin lesion area of ​​8.27±8.27cm 2 The average hypertrophy of skin lesions was 3.78±0.82 points, and the average pain / foreign body sensation VAS score was 4.29±2.36 points.

[0097] (2) Study medication and grouping

[0098] In this study, the Chinese medicine preparation of the present invention (referred to as Chinese medicine preparation), the currently commonly used clinical Xixisan (an empirical medicine), the Western medicine 5-fluorouracil (5-Fluorouracil, 5-FU) and the combined use of the above Chinese and Western medicines were mainly used. The Chinese medicine preparation of the present invention is a decoction prepared from composition 3 in Example 1, and the decoction is prepared from the following Chinese medicines: 30 parts each of raw Sanguisorba officinalis, Sophora flavescens, Phellodendron amurense, and Portulaca oleracea, and 20 parts each of Atractylodes macrocephala and Alum (see Bian Xu, Shi Liang, Sun Dan, Yan Xiaoning, Zhao Yiding. Observation on the efficacy of Dexisan combined with 0.05% desonide cream in the treatment of acute atopic dermatitis [J]. Journal of Modern Integrated Traditional Chinese and Western Medicine, 2023, 32(01): 80-84; and Zhao Yiding, Tian Gaimiao, Sun Dan, Yan Xiaoning. Observation on the clinical efficacy of Dexisan in the treatment of tinea pedis and in vitro antibacterial experimental study [J]. Chinese Journal of Mycology, 2019, 14(04): 240-244).

[0099] The 41 selected patients were divided into groups according to the treatment method, among which experimental group 1 was treated with the Chinese medicine preparation of the present invention alone, experimental group 2 was treated with Luxisan alone, experimental group 3 was treated with 5-FU alone, combined group 1 was treated with the Chinese medicine preparation of the present invention and 5-FU, and combined group 2 was treated with Luxisan and 5-FU together; in addition, the Chinese medicine preparation of the present invention was used as an exposure factor and divided into a Chinese medicine preparation group (i.e., a group treated with the Chinese medicine preparation of the present invention, including experimental group 1 and combined group 1) and a non-Chinese medicine preparation group (i.e., a group not treated with the Chinese medicine preparation of the present invention, including experimental groups 2, 3 and combined group 2). The gender composition, course of disease, age, and skin lesion condition (area, thickness, pain / foreign body sensation) of the patients in the groups were statistically comparable (P>0.05), as shown in Tables 1 and 2 for details.

[0100] (3) Efficacy analysis

[0101] The overall recovery period of the Chinese medicine preparation group was 35.00±18.98 days, which was significantly shorter than that of the non-Chinese medicine preparation group (83.95±37.10 days), and the difference was statistically significant. The efficacy rate of the Chinese medicine preparation group at week 8 was 0.97±0.05, which was better than that of the non-Chinese medicine preparation group (0.76±0.21); the wart lesion area and wart pain / foreign body sensation in the Chinese medicine preparation group at week 8 were also better than those in the non-Chinese medicine preparation group, and the difference was statistically significant (Table 1).

[0102] Subgroup analysis showed that the 8-week efficacy rate of combined group 1 (administering the Chinese medicine preparation of the present invention + 5-FU) was 0.97±0.04, slightly higher than 0.95±0.06 of experimental group 1 (administering the Chinese medicine preparation of the present invention alone), but no significant statistical difference was found, and no significant statistical difference was found in the total recovery period of the two groups. In addition, experimental group 1 and combined group 1 were significantly better than experimental group 2 (administering the Chinese medicine preparation of the present invention alone), experimental group 3 (administering 5-FU alone) and combined group 2 (administering the Chinese medicine preparation of the present invention + 5-FU) in terms of recovery period, combined group 1 was significantly better than combined group 2, experimental group 2 and experimental group 3 in terms of 8-week efficacy rate, and experimental group 1 was also significantly better than combined group 2 and experimental group 2 in terms of 8-week efficacy rate (Table 2 and Table 3).

[0103] Table 1 General condition of patients and clinical efficacy

[0104]

[0105] Table 2 Subgroup analysis and efficacy analysis of patients' general conditions

[0106]

[0107] Table 3 Efficacy subgroup analysis and comparison between groups

[0108]

[0109]

[0110] (4) Safety analysis

[0111] In the non-TCM preparation group, 3 cases developed ulcers, 2 of which had ulcers subside and warts disappear after stopping treatment, and the ulcer of the other 1 case was difficult to subside after stopping the medication. Compound polymyxin B ointment was used for symptomatic treatment and the ulcer subsided after 1 week of symptomatic treatment. In the TCM preparation group, no obvious side effects were observed.

[0112] discuss

[0113] The Chinese medicine composition of the present invention is mainly composed of "Gui Jian Yu, Purslane, Dictamni, Cnidium monnieri, Kochia scoparia, Rhizoma Smilacis Glabrae, Galla chinensis, Herba Taraxaci, Sophora flavescens, Alum", in which the bitter, pungent and cold properties of Gui Jian Yu are compatible with the sour and cold properties of Purslane, and the two medicines are monarch medicines, one pungent and cold, and the other sour and cold, which are used to clear away heat and toxic substances, break blood and stop bleeding, so that the wart body is biochemically deficient and atrophied. Warts are mostly formed by phlegm, blood stasis and stagnation due to dampness and heat, and the above two medicines have the effects of breaking blood, dredge meridians, detoxification, hemostasis and cooling blood, which are in line with the pathogenesis. Dictamni, Cnidium monnieri, Kochia scoparia, Rhizoma Smilacis Glabrae, Herba Taraxaci, and Herba Gallae six-flavor ministerial medicines strengthen the effects of drying dampness and detoxification, detumescence and dispersing stagnation, improve the environment of phlegm and stasis caused by damp heat in the foot at the same time, weaken the wart body growth environment, and promote the growth and metabolism of normal skin tissue. The adjuvant drug Glauber's salt is salty, bitter and cold in nature, and has the effects of moistening dryness, softening hard masses, clearing heat and reducing swelling. Combined with alum, it can eliminate phlegm, dry dampness, detoxify and kill insects. On the one hand, it can prevent and treat the excessive bitterness, coldness and drying dampness of the main and auxiliary drugs. On the other hand, it has a good effect of moistening dryness, softening hard masses, reducing swelling and dispersing nodules to help the warts disappear. The whole formula has the effects of clearing away heat, detoxifying and drying dampness, softening hard masses, dispersing nodules and removing warts.

Claims

1. A Chinese medicine composition for treating plantar warts, comprising: Ghost arrow feather, purslane, Dictamni cortex, Cnidium monnieri, Kochia scoparia, Smilax glabra, Gallnut, and Taraxacum officinale.

2. The Chinese medicine composition according to claim 1, further comprising sodium sulfate and / or alum.

3. The Chinese medicine composition according to claim 1, comprising: 10-15 parts of Radix Phellodendri, 10-20 parts of Portulaca Oleracea, 10-20 parts of Dictamni Cortex, 5-20 parts of Cnidium monnieri, 5-25 parts of Kochia scoparia, 5-30 parts of Smilax glabra, 10-15 parts of Galla chinensis, and 10-20 parts of Taraxacum officinale; preferably, 10-30 parts of Sodium Sulfate and / or 10-30 parts of Alum; more preferably, the Chinese medicine composition comprises 10-15 parts of Radix Phellodendri, 10-15 parts of Portulaca Oleracea, 10-15 parts of Dictamni Cortex, 10-15 parts of Cnidium monnieri, 10-15 parts of Kochia scoparia, 10-15 parts of Smilax glabra, 10-15 parts of Galla chinensis, 10-20 parts of Taraxacum officinale, 10-30 parts of Sodium Sulfate and 10-30 parts of Alum, wherein the portion of each Chinese medicine is by weight.

4. The Chinese medicine composition according to claim 3, comprising: (1) 10 parts of Radix Psoraleae, 10 parts of Herba Portulacae, 10 parts of Cortex Dictamni, 10 parts of Fructus Cnidii, 10 parts of Fructus Kochiae, 10 parts of Rhizoma Smilacis Glabrae, 10 parts of Galla Chinensis, 20 parts of Herba Taraxaci, 20 parts of Sodium Sulfate and 20 parts of Alum; (2) 15 parts of Herba Euphorbiae Radix Psoraleae, 15 parts of Herba Portulacae Oleraceae, 15 parts of Herba Dictamni, 10 parts of Fructus Cnidii Monnieri, 10 parts of Fructus Kochiae, 10 parts of Herba Smilacis Glabrae, 10 parts of Herba Gallicae Sinensis, 10 parts of Herba Taraxaci, 10 parts of Sodium Sulfate and 10 parts of Alum; (3) 10 parts of Herba Lycopodii, 10 parts of Herba Portulacae, 10 parts of Herba Dictamni, 10 parts of Fructus Cnidii, 10 parts of Fructus Kochiae, 10 parts of Herba Smilacis Glabrae, 10 parts of Herba Gallicae Sinensis, 10 parts of Herba Taraxaci, 10 parts of Herba Sophorae Flavescentis, and 10 parts of Alum; or (4) 15 parts of Radix Psoraleae, 15 parts of Herba Portulacae, 15 parts of Cortex Dictamni, 15 parts of Fructus Cnidii, 15 parts of Fructus Kochiae, 15 parts of Rhizoma Smilacis Glabrae, 15 parts of Galla Chinensis, 20 parts of Herba Taraxaci, 30 parts of Sodium Sulfate and 30 parts of Alum.

5. A Chinese medicine preparation, which is prepared from the Chinese medicine composition according to any one of claims 1 to 4.

6. The Chinese medicine preparation according to claim 5, wherein the Chinese medicine preparation is a powder, a decoction or a granule.

7. The Chinese medicine preparation according to claim 5 or 6, wherein the Chinese medicine preparation further comprises a pharmaceutically acceptable excipient.

8. The Chinese medicine preparation according to any one of claims 5 to 7, wherein the Chinese medicine preparation is used in combination with other active agents such as 5-fluorouracil to treat plantar warts.

9. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a Chinese medicine preparation for treating plantar warts.

10. The use according to claim 9, wherein the Chinese medicine preparation is used in combination with other active agents such as 5-fluorouracil to treat plantar warts; preferably, the plantar warts are multiple plantar warts.

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