Traditional Chinese medicine composition for treating oral ulcer as well as preparation method, medicine and application of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for treating oral ulcer as well as a preparation method, a medicine and application thereof, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following components in parts by mass: 4 to 15 parts of indigo naturalis, 4 to 15 parts of radix tinosporae, 1 to 10 parts of rhizoma bletillae, 4 to 15 parts of pearl powder, 1 to 10 parts of calculus bovis factitius, 4 to 15 parts of gallnut and 1 to 10 parts of borneol. The traditional Chinese medicine composition for treating oral ulcer provided by the invention can effectively prevent and treat oral diseases such as oral ulcer and oral inflammation, and is an empirical prescription which is clinically used for more than 30 years. The medication period is short, and toxic and side effects are avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating oral ulcers, a preparation method thereof, a medicine and an application thereof. Background Art

[0002] Oral ulcer is one of the most common oral mucosal diseases, characterized by inflammatory lesions of the mucosal epithelium and connective tissue. It is prone to occur in the tip of the tongue, tongue edge, lips, soft palate, palatine arch and buccal mucosa, and is characterized by pain, recurrence and self-limitation. Recurrent oral ulcers can affect the patient's language, eating, and even mood during the attack stage. The pain is severe and the condition is stubborn, which seriously affects the patient's quality of life. In severe cases, it may not heal for a long time and may become malignant. The cause of the disease is currently believed to be related to oral flora imbalance, immune dysfunction, microcirculation disorders, infection, trace element deficiency, endocrine disorders, gastrointestinal dysfunction, mental and psychological factors, changes in hormone levels, dietary factors and other factors.

[0003] Western medicine mainly uses local treatment for recurrent and refractory oral ulcers, including triamcinolone, fluocinolone and local anesthetics combined with anesthetic paste to relieve pain, prevent secondary infection and form a protective barrier. Doxycycline and minocycline antibiotic mouthwashes can inhibit metalloproteinases to relieve inflammation. Local surgical procedures, such as laser ablation and silver nitrate chemical cauterization, can lead to rapid improvement of pain and inflammation and increase the chance of re-epithelialization of oral ulcer mucosa. Although Western medicine is effective in treating oral ulcers, hormone therapy is often used, which has side effects on the human body.

[0004] According to traditional Chinese medicine, oral ulcers belong to the category of "oral sores" and "oral erosions". Although oral sores occur in the mouth, they are closely related to the internal organs. According to traditional Chinese medicine, the spleen opens to the mouth, the heart opens to the tongue, the kidney meridian connects the throat to the root of the tongue, the cheeks and gums belong to the stomach and large intestine, and the Ren and Du meridians both connect to the mouth, lips and tongue, indicating that the occurrence of oral sores is closely related to the five internal organs. "Suwen Zhizhen Yaoda Lun" says: "All pains, itches and sores belong to the heart." The fire of oral sores is not only the fault of the heart. Worrying, being angry, being addicted to tobacco, alcohol, and coffee, and overeating greasy and fatty foods can all lead to heat accumulation in the heart and spleen, heat stagnation in the lungs and stomach, and heat accumulation in the liver and gallbladder, which are mostly positive symptoms. Kidney yin deficiency leads to virtual fire inflammation, which is mostly deficiency syndrome. Old age, fatigue, and internal injuries can damage the spleen and stomach, which can lead to dysfunction of the middle jiao hub, obstruction of the upper and lower qi mechanisms, inability of the yang of the upper jiao to descend, and inability of the yin of the lower jiao to ascend. The heart fire is strong alone, and inflammation along the meridians can also cause mouth ulcers, which are mostly deficiency syndromes. As Li Dongyuan said in "Discussion on Spleen and Stomach": "Since the spleen and stomach qi are weak, the vital energy is insufficient, and the heart fire is strong alone. The heart fire is the yin fire, which originates from the lower jiao and is related to the heart. If the heart does not take charge, the phase fire will take over." "Stomach disease causes shortness of breath, lack of energy, and high fever. Sometimes the stomach fire ascends alone to burn the face." Currently, the Chinese medicine preparations available on the market have a long use cycle, slow efficacy, and are prone to recurrence.

[0005] For example, Chinese patent CN104306711A discloses a Chinese medicine for treating oral ulcers. The Chinese medicine for treating oral ulcers is made of the following raw materials: borax, Bletilla striata, Sanguisorba officinalis, Panax notoginseng, Coptis chinensis, Lithospermum officinale, Polygonum cuspidatum, Cuttlebone, Gallic acid fruit, Herba ergutis, Gentiana macrophyllae, Morus alba, Coptis chinensis, Pollen Typhae, and Borneol meihua. The medicinal materials of the invention complement each other, and the combination of the medicines has the effects of clearing away heat and detoxifying, removing fire and relieving pain, removing rot and promoting tissue regeneration, and has a significant therapeutic effect on treating oral ulcers, but the Chinese medicines involved are as high as 15 kinds, and the therapeutic effect is not obvious.

[0006] Chinese patent CN103893613A discloses a drug for treating oral ulcers and a preparation method, which belongs to the field of traditional Chinese medicine; the raw materials of the active ingredients of the drug are composed of 16 kinds of raw materials: white strawberry, propolis, medical stone, creeping vine, white ginseng, light bamboo leaves, wall money, wood shrimp, phoenix tail tea, wheat root, pokeweed, gallnut, taro, fragrant ash tree, musk and mountain grass, and the use cycle is long and the effect is slow. One course of treatment is 7 days, and it takes 2-3 courses of treatment to be effective.

[0007] Based on this, it is necessary to develop efficient, convenient and low-side effect Chinese herbal medicines, streamline the types of Chinese medicines, and achieve quick results. Summary of the invention

[0008] In view of the above problems, the present invention provides a Chinese medicine composition for treating oral ulcers, comprising the following components: Indigo Naturalis, Olea Europaea, Bletilla striata, pearl powder, artificial bezoar, Chinese gallnut, borneol and borax. It can effectively prevent and treat oral diseases such as oral ulcers and oral inflammation, has significant efficacy, short medication cycle and no toxic side effects.

[0009] To achieve the above purpose, the technical solution adopted by the present invention is as follows:

[0010] On the one hand, the present invention provides a traditional Chinese medicine composition for treating oral ulcers, comprising the following components, measured by mass fraction: 4-15 parts of Indigo Naturalis, 4-15 parts of Cyperus rotundus, 1-10 parts of Bletilla striata, 4-15 parts of pearl powder, 1-10 parts of artificial bezoar, 4-15 parts of Galla chinensis, and 1-10 parts of borneol.

[0011] Preferably, the Chinese medicine composition comprises the following components by mass fraction: 4-12 parts of Indigo Naturalis, 4-12 parts of Cyperus rotundus, 1-8 parts of Bletilla striata, 4-12 parts of pearl powder, 1-8 parts of artificial bezoar, 4-12 parts of Galla Chinensis, and 1-5 parts of Borneol.

[0012] Further preferably, the Chinese medicine composition comprises the following components by mass fraction: 4-10 parts of Indigo Naturalis, 4-10 parts of Cyperus rotundus, 1-6 parts of Bletilla striata, 4-10 parts of pearl powder, 1-6 parts of artificial bezoar, 4-10 parts of Gallnut, and 1-3 parts of Borneol.

[0013] More preferably, the Chinese medicine composition comprises the following components by mass fraction: 6-8 parts of Indigo Naturalis, 6-8 parts of Cyperus rotundus, 4-6 parts of Bletilla striata, 4-8 parts of pearl powder, 4-6 parts of artificial bezoar, 4-8 parts of Galla Chinensis, and 1-3 parts of Borneol.

[0014] Preferably, the mass ratio of Indigo Naturalis, Jinguolan and Bletilla striata is 1-2:1-2:1; further preferably, the mass ratio of Indigo Naturalis, Jinguolan and Bletilla striata is 2:2:1.

[0015] In another aspect, the present invention provides a pharmaceutical preparation comprising the above-mentioned traditional Chinese medicine composition.

[0016] Preferably, the pharmaceutical preparation comprises pills, capsules, oral liquids, tablets, lozenges, powders, patches, pastes, granules, gels, sprays and syrups. Suitable pharmaceutical carriers in the art can be selected for different dosage forms.

[0017] The pharmaceutical carrier used can be solid, liquid or gas. Examples of solid carriers include lactose, kaolin, sucrose, talc, gelatin, agar, pectin, gum arabic, magnesium stearate and stearic acid. Examples of liquid carriers include syrup, peanut oil, olive oil and water. Examples of gaseous carriers include carbon dioxide and nitrogen.

[0018] When preparing the composition for oral dosage form, any convenient pharmaceutical medium can be used. For example, water, ethanol, oil, alcohol, flavoring agent, preservative, coloring agent, etc. can be used to form oral liquid preparations, such as suspensions, elixirs and solutions; while carriers, such as starch, sugars, microcrystalline cellulose, diluents, granulating agents, emulsifiers, lubricants, binders, disintegrants can be used to form oral solid preparations, such as powders, capsules and tablets. Tablets and capsules are preferred oral dosage units using solid pharmaceutical carriers due to their ease of administration. Tablets can be coated using standard aqueous or non-aqueous techniques.

[0019] Tablets containing the Chinese medicine composition of the present invention can be prepared by tableting or molding, and one or more auxiliary ingredients or adjuvants can be used. The active ingredient can be tableted in a free-flowing form (such as powder or granules) in a suitable machine, and can be mixed with an adhesive, a lubricant, an inert diluent, a surfactant or a dispersant to prepare a tablet. Molded tablets can be molded in a suitable machine, i.e., a powdered compound mixture moistened with an inert liquid diluent. Each tablet preferably contains about 0.05 mg to about 5 g of active ingredient, and each sachet or capsule preferably contains about 0.05 mg to about 5 g of active ingredient. For example, a preparation intended for oral administration to humans may contain about 0.5 mg to about 5 g of active drug, mixed with an appropriate and convenient carrier material, which may account for about 5% to 95% of the total composition. The unit dosage form usually contains about 1 mg to about 2 g of active ingredient, usually 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 800 mg or 1000 mg.

[0020] The pharmaceutical composition suitable for parenteral administration of the present invention can be prepared as an aqueous solution or suspension of the active compound. Suitable surfactants such as hydroxypropylcellulose can be included. Dispersions can also be prepared in glycerol, liquid polyethylene glycol and oil mixtures thereof. In addition, preservatives can be added to prevent the harmful growth of microorganisms.

[0021] Medicine of the present invention can be in the form suitable for topical use, for example aerosol, cream, ointment, lotion, powder or the like. In addition, composition can be in the form suitable for transdermal administration device. Can use Chinese medicine composition of the present invention, prepare these prescriptions by conventional processing method. For example, by mixing hydrophilic material and water, and about 5wt% to about 10wt% of compound, prepare cream or ointment with required consistency.

[0022] In addition to the above-mentioned carrier components, the above-mentioned pharmaceutical preparations may include (if applicable) one or more additional carrier components, such as diluents, buffers, flavoring agents, adhesives, surfactants, thickeners, lubricants, preservatives (including antioxidants), etc. In addition, other excipients, such as lactose, starch, cellulose derivatives, magnesium stearate, stearic acid, etc., colorants and flavoring agents, etc., may be added. The preparation is made isotonic with the blood of the intended recipient. The components containing the Chinese medicine composition of the present invention can also be prepared in the form of powder or concentrate.

[0023] Further preferably, the pharmaceutical preparation comprises powders, gels, patches and granules.

[0024] Preferably, the pharmaceutical preparation further contains excipients.

[0025] Preferably, the excipients include at least one of a disintegrant, a filler, a flavoring agent, a pH adjuster, a lubricant, and an antioxidant;

[0026] Preferably, the disintegrant can be selected from at least one of povidone, polyvinyl alcohol, low molecular weight HPC (hydroxypropyl cellulose), low molecular weight HPMC (hydroxypropyl methylcellulose), low molecular weight hydroxymethyl, cellulose acetate, gelatin, hydrolyzed gelatin, polyethylene oxide, gum arabic, and dextrin.

[0027] Preferably, the filler can be selected from at least one of hydroxyethyl cellulose, microcrystalline cellulose, lactose, glucose, sorbitol, galactose, fructose, sucrose, calcium hydrogen phosphate, sorbitol, mannitol, lactitol, xylitol, isomalt, erythritol, and hydrogenated starch hydrolysate.

[0028] Preferably, the flavoring agent can be selected from at least one of sucrose, fructose, aspartame, apple flavor, sorbitol, glucose, isomalt, erythritol and jasmine flavor.

[0029] Preferably, the pH adjuster can be selected from at least one of citric acid, potassium citrate, lactic acid, tartaric acid, fumaric acid and sodium citrate.

[0030] Preferably, the lubricant is selected from at least one of magnesium stearate, silicon dioxide, polyethylene glycol, talc, micro-powdered silica gel and glycerin.

[0031] Preferably, the antioxidant can be selected from at least one of L-cysteine ​​hydrochloride, L-cysteine ​​base, 4,4 (2,3-dimethyltetramethylene dicatechol), tocopherol-rich extract (natural vitamin E), α-tocopherol (synthetic vitamin E), B-tocopherol, 6-tocopherol, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), propyl gallate, octyl gallate, dodecyl gallate, tert-butylhydroquinone (TBHQ), fumaric acid, malic acid, ascorbic acid (vitamin C), sodium ascorbate, calcium ascorbate, potassium ascorbate, ascorbyl palmitate, and ascorbyl stearate.

[0032] In another aspect, the present invention provides a method for preparing the above-mentioned Chinese medicine composition, comprising the following steps:

[0033] (1) crushing Indigo Naturalis, Euphorbia cerasifera and Bletilla striata, adding solvent for extraction, filtering the extract, concentrating and drying to obtain dry powder 1;

[0034] (2) soaking the Chinese gallnut in warm water, filtering, concentrating the filtrate, and drying to obtain dry powder 2;

[0035] (3) artificial bezoar, pearl powder and borneol ultrafine powder are added to obtain dry powder 3;

[0036] (4) Dry powder 1, dry powder 2 and dry powder 3 are mixed to obtain a powder for treating oral ulcers.

[0037] Preferably, the solvent in step (1) is an alcohol solution; further preferably, the solvent in step (1) is an ethanol solution.

[0038] In another aspect, the present invention provides the use of the above-mentioned Chinese medicine composition or pharmaceutical preparation in the preparation of a drug for preventing or treating oral ulcer disease.

[0039] Indigo and Olea europaea are the main ingredients, which can clear away heat, detoxify, reduce swelling and relieve pain.

[0040] The traditional Chinese medicine Qingdai has the effects of clearing heat, detoxifying, cooling blood and calming convulsions. Doctors of all dynasties have used it to treat sores, furunculosis, convulsions, agitation, vomiting blood and blood in the stool. In modern clinical practice, it is used to promote skin and mucosal healing, ulcerative colitis, leukemia, etc. Studies have shown that Qingdai can reduce inflammatory damage by regulating the expression of mucosal inflammatory factors TNF-α, IL-1β, IL-6, IL-10 and apoptosis-related proteins Bcl-2, Bax and Caspase-3.

[0041] Golden fruit olive is a commonly used heat-clearing, detoxifying, swelling-reducing and analgesic medicine in Guangxi Zhuang Autonomous Region. It is often used to treat chronic inflammation. It has significant efficacy and is known as the "broad-spectrum antibiotic in Zhuang medicine." Modern pharmacological studies have shown that golden fruit olive has anti-inflammatory, analgesic, antibacterial and anti-ulcer effects. Clinical studies have shown that golden fruit olive can improve immune response, restore and regulate the immune system, and as an immunostimulant and antiallergic agent, it can maintain the normal physiological function of the immune system.

[0042] Indigo and Rhizoma Chrysanthemi promote and coordinate each other, and together they serve as the main medicine to enhance the antibacterial, anti-inflammatory, and anti-swelling and analgesic effects.

[0043] Pearl powder, artificial bezoar and Bletilla striata are all assistant drugs. Pearl powder and artificial bezoar assist the main drug to enhance the effects of clearing away heat, detoxicating, reducing swelling and relieving pain.

[0044] Bletilla striata tastes bitter, sweet, astringent and cold, and has obvious astringent, hemostatic, anti-edema and tissue-stimulating effects. It can assist the main medicine in detoxifying, regenerating tissue and healing sores, and promote the healing of oral ulcers.

[0045] Gallnut is an adjuvant drug that can clear and reduce lung fire, astringe and stop bleeding, absorb moisture and heal sores. It can not only assist Indigo in clearing lung fire, but also absorb moisture and heal sores, slow down or eliminate the skin toxicity of the above drugs, and protect the skin from infection.

[0046] Borneol is an adjuvant drug, and they are used in conjunction with each other. It can clear away heat, reduce swelling and relieve pain, purge fire and detoxify, preserve and promote tissue regeneration, and it can also promote the penetration of drugs through mucous membranes to facilitate drug absorption.

[0047] Terms and Claims of the Present Invention:

[0048] 1. As used herein, the articles "a", "an" and "the" include plural referents unless expressly limited to one or more referents otherwise.

[0049] 2. As used herein, numerical range: Unless otherwise expressly indicated, all ranges or ratios disclosed herein will be understood to include any and all sub-ranges or sub-ratios contained therein. For example, a range or ratio of 1 to 30 stated should be considered to be included between a minimum value of 1 and a maximum value of 30, and any sub-range or sub-ratio, integer, decimal, or sub-range or sub-ratio consisting of integers or decimals including the end points.

[0050] 3. As used herein, the terms "comprises", "includes", "has", "may", "contain" and their variations are open-ended conjunctions or terms that do not exclude the possibility of additional compositions or structures.

[0051] Compared with the prior art, the present invention has the following beneficial effects:

[0052] 1. The Chinese medicine composition for treating oral ulcers provided by the present invention has a more scientific and reasonable formula after long-term clinical practice and combined with the results of modern pharmacological research.

[0053] 2. During the research process, the present invention found that Indigo Naturalis, Olea Europaea and Bletilla striata have synergistic effects in treating oral ulcers. The specific ratio of the present invention significantly improves the efficacy of the drugs.

[0054] 3. The Chinese medicine composition for treating oral ulcers provided by the present invention can effectively prevent and treat oral diseases such as oral ulcers and oral inflammation, has significant therapeutic effects, a short medication cycle, and no toxic side effects.

[0055] 4. The medicinal flavors of the present invention have a wide range of sources and are low in price. The compatibility and preparation process are simple. The Chinese medicine composition has accurate dialectics, and the components act synergistically to treat both the symptoms and the root causes. BRIEF DESCRIPTION OF THE DRAWINGS

[0056] Figure 1 This is the histopathology (HE X40) image of the oral mucosa;

[0057] Note: A: normal control group, B: model control group, C: comparison group 5, D: low-dose group of Example 1, E: medium-dose group of Example 1, F: high-dose group of Example 1. DETAILED DESCRIPTION

[0058] In order to make the technical means, creative features, purpose and effect of the present invention easy to understand, the present invention is further explained below in conjunction with specific embodiments, but the following embodiments are only preferred embodiments of the present invention, not all. Based on the embodiments in the implementation mode, other embodiments obtained by those skilled in the art without making creative work all belong to the protection scope of the present invention. It is worth noting that the raw materials used in the present invention are all common commercial products, and their sources are not specifically limited. The technology and scientific terms used in the embodiments have the meanings commonly understood by those of ordinary skill in the art to which the present invention belongs.

[0059] Examples 1-4

[0060] A Chinese medicine composition for treating oral ulcers, the components of which are shown in Table 1;

[0061] The preparation method is as follows:

[0062] (1) Crush Indigo Naturalis, Olea Europaea, and Bletilla striata, add 6-12 times water or ethanol, soak for 1 hour, heat and extract 1-3 times, each time for 0.5-1.5 hours, filter the extract, concentrate the filtrate under low temperature and reduced pressure, and dry the concentrate to obtain dry powder 1.

[0063] (2) Soak the Chinese gallnut in water / ethanol for 8-24 hours, filter, concentrate the filtrate under reduced pressure at low temperature, and dry the concentrate to obtain dry powder 2.

[0064] (3) Pass artificial bezoar, pearl powder and borneol ultrafine powder through a 300-1000 mesh sieve to obtain dry powder 3.

[0065] (4) The above dry powders 1-3 are mixed by a dry powder mixer to obtain a powder for treating oral ulcers.

[0066] Table 1. Specific formula table of Examples 1-4 and Comparative Examples 1-5

[0067]

[0068]

[0069] Example 5

[0070] Weigh the components in Example 1, add 0.2 parts of jasmine essence, 2 parts of sorbitol, 2 parts of glycerol, and 2 parts of xylitol, mix well, add purified water to prepare 200 ml, and prepare oral ulcer mouthwash.

[0071] Example 6

[0072] By weight, 8 parts of indigo, 8 parts of jinguolan, 4 parts of bletilla, 8 parts of pearl powder, 4 parts of artificial bezoar, 8 parts of gallnut, and 1 part of borneol. Indigo, jinguolan, and bletilla are extracted with ethanol to prepare dry paste powder, and pearl powder, indigo, artificial bezoar, and borneol are ultrafinely ground. The above dry powders are mixed, and ingredients such as appropriate amounts of glycerin, carbomer, hydroxyethyl cellulose, and sorbitol are added to prepare a gel or patch, orodispersible film.

[0073] Comparative Example 1

[0074] A Chinese medicine composition for treating oral ulcers, the components of which are shown in Table 1:

[0075] The preparation method is as follows:

[0076] (1) After crushing the Euphorbia pulex and Bletilla striata, soak them in 6-12 times water or ethanol for 1 hour, heat and extract 1-3 times, each time for 0.5-1.5 hours, filter the extract, concentrate the filtrate under low temperature and reduced pressure, and dry the concentrate to obtain dry powder 1.

[0077] (2) Soak the Chinese gallnut in water / ethanol for 8-24 hours, filter, concentrate the filtrate under reduced pressure at low temperature, and dry the concentrate to obtain dry powder 2.

[0078] (3) Pass artificial bezoar, pearl powder and borneol ultrafine powder through a 300-1000 mesh sieve to obtain dry powder 3.

[0079] (4) The above dry powders 1-3 are mixed by a dry powder mixer to obtain a powder for treating oral ulcers.

[0080] Comparative Example 2

[0081] A Chinese medicine composition for treating oral ulcers, the components of which are shown in Table 1:

[0082] The preparation method is as follows:

[0083] (1) After crushing Indigo Naturalis and Bletilla striata, soak them in 6-12 times water or ethanol for 1 hour, heat and extract 1-3 times, each time for 0.5-1.5 hours, filter the extract, concentrate the filtrate under low temperature and reduced pressure, and dry the concentrate to obtain dry powder 1.

[0084] (2) Soak the Chinese gallnut in water / ethanol for 8-24 hours, filter, concentrate the filtrate under reduced pressure at low temperature, and dry the concentrate to obtain dry powder 2.

[0085] (3) Pass artificial bezoar, pearl powder and borneol ultrafine powder through a 300-1000 mesh sieve to obtain dry powder 3.

[0086] (4) The above dry powders 1-3 are mixed by a dry powder mixer to obtain a powder for treating oral ulcers.

[0087] Comparative Example 3

[0088] A Chinese medicine composition for treating oral ulcers, the components of which are shown in Table 1:

[0089] The preparation method is as follows:

[0090] (1) After crushing Indigo Naturalis and Oleander, soak them in 6-12 times water or ethanol for 1 hour, heat and extract 1-3 times, each time for 0.5-1.5 hours, filter the extract, concentrate the filtrate under low temperature and reduced pressure, and dry the concentrate to obtain dry powder 1.

[0091] (2) Soak the Chinese gallnut in water / ethanol for 8-24 hours, filter, concentrate the filtrate under reduced pressure at low temperature, and dry the concentrate to obtain dry powder 2.

[0092] (3) Pass artificial bezoar, pearl powder and borneol ultrafine powder through a 300-1000 mesh sieve to obtain dry powder 3.

[0093] (4) The above dry powders 1-3 are mixed by a dry powder mixer to obtain a powder for treating oral ulcers.

[0094] Comparative Example 4

[0095] A Chinese medicine composition for treating oral ulcers, the components of which are shown in Table 1:

[0096] The preparation method is as follows:

[0097] (1) Crush Indigo Naturalis, Olea Europaea, and Bletilla striata, add 6-12 times water or ethanol, soak for 1 hour, heat and extract 1-3 times, each time for 0.5-1.5 hours, filter the extract, concentrate the filtrate under low temperature and reduced pressure, and dry the concentrate to obtain dry powder 1.

[0098] (2) Soak the Chinese gallnut in water / ethanol for 8-24 hours, filter, concentrate the filtrate under reduced pressure at low temperature, and dry the concentrate to obtain dry powder 2.

[0099] (3) Pass artificial bezoar, pearl powder, borax and borneol ultrafine powder through a 300-1000 mesh sieve to obtain dry powder 3.

[0100] (4) The above dry powders 1-3 are mixed by a dry powder mixer to obtain a powder for treating oral ulcers.

[0101] Comparative Example 5

[0102] A Chinese medicine composition for treating oral ulcers, the components of which are shown in Table 1:

[0103] The preparation method is as follows:

[0104] (1) After crushing Indigo Naturalis, add 6-12 times water or ethanol to soak for 1 hour, heat and extract 1-3 times, each time for 0.5-1.5 hours, filter the extract, concentrate the filtrate at low temperature and under reduced pressure, and dry the concentrate to obtain dry powder 1.

[0105] (2) Soak the Chinese gallnut in water / ethanol for 8-24 hours, filter, concentrate the filtrate under reduced pressure at low temperature, and dry the concentrate to obtain dry powder 2.

[0106] (3) Pass artificial bezoar, pearl powder, borax, alum, chicken gizzard lining and borneol ultrafine powder through a 300-1000 mesh sieve to obtain dry powder 3.

[0107] (4) The above dry powders 1-3 are mixed by a dry powder mixer to obtain a powder for treating oral ulcers.

[0108] Test Example 1

[0109] The clinical use of the Chinese medicine compositions prepared in Examples 1-4 and Comparative Examples 1-5 is as follows:

[0110] Case 1: Patient Lv Moumou, female, 43 years old, came to the clinic for oral ulcers 1 day ago. The patient had oral ulcers without obvious causes 1 day ago, and the pain significantly affected eating. Physical examination: 2 ulcers with a diameter of about 2mm-5mm can be seen on the left buccal mucosa. The ulcer surface is oval, sunken in the middle, covered with gray-white pseudomembrane, red and swollen around, and the patient's tongue is red and yellow. The patient reported that he had not been getting enough sleep recently and had a burning pain. Apply an appropriate amount of Example 1 to the affected area, 3 times / day, and the pain was relieved after 1 day of medication, and the ulcer was cured on the 3rd day.

[0111] Case 2: Patient Gao, male, 74 years old, was diagnosed with lung cancer for more than 2 months. He was admitted to the hospital on 2024-07-22 for consolidation chemotherapy. Combined with previous medical history, he was diagnosed with right lung malignant tumor adenocarcinoma stage IIIB T2bN3M0. He was given bevacizumab + AP chemotherapy on 2024-7-24. On 2024-7-30, he developed oral ulcers with severe pain. Physical examination: 5 sesame to soybean-sized ulcers were seen on the buccal mucosa and tongue. The tongue was pale, the tongue coating was greasy, and the pulse was stringy and thin. Routine blood test: white blood cells 3.07×10 9 / L, neutrophils 2.58×109 / L, red blood cells 2.45×10 12 / L, hemoglobin 86g / L, platelets 89×10 6 / L. Apply an appropriate amount of Example 2 to the affected area 3 times a day. The pain is relieved after 1 day of medication. The ulcer is cured after 4 days of continuous use.

[0112] Case 3: Patient Chi, female, 35 years old, came to the clinic for recurrent oral ulcers. The patient had oral ulcers without obvious causes 2 days ago, with mild pain. Physical examination: 3 ulcers with a diameter of about 3mm-6mm can be seen on the oral gums and buccal mucosa, with pseudomembranes on the surface and obvious congestion of the surrounding mucosa. The patient said that he had repeated oral ulcers many times before, accompanied by low fever and fatigue symptoms. Give an appropriate amount of Example 3, 3 times / day, gargle, and the pain is relieved after 2 days of medication, and the ulcer is cured on the 4th day.

[0113] Case 4: Patient Ding, female, 70 years old, was diagnosed with pancreatic cancer 2 months ago and was admitted to the hospital for further treatment on 2023-07-31. Blood routine examination showed white blood cell count of 3.15×10 9 / L, neutrophil count 2.71×10 9 / L, red blood cells 4.59×10 12 / L, hemoglobin 122g / L platelets 95×10 9 / L, combined with the previous diagnosis and treatment history, diagnosis: pancreatic malignant tumor CTN0M0, breast malignant tumor, hypertension grade 3, very high risk type 2 diabetes. Symptomatic supportive treatment was given. Oral ulcers appeared on 2023-8-4, and the pain significantly affected eating. Physical examination: 4 soybean-sized ulcers with a diameter of 5mm-10mm were visible on the oral tongue and superficial gums, red tongue, yellow and greasy fur, and thin and stringy pulse. Give an appropriate amount of Example 4 (patch) to the affected area, 3 times / day. The pain was relieved after 1 day of medication, and the ulcer was cured on the 4th day after continuing to use Example 4.

[0114] Case 5: Patient Wei, male, 71 years old, was diagnosed with rectal malignant tumor for more than 6 months. He was admitted to the hospital for further treatment on 2023-10-03. Combined with the previous diagnosis and treatment history, he was diagnosed with 1. Rectal malignant tumor, adenocarcinoma T3N0M1aIVA stage; 2. Radiation enteritis; 3. Type 2 diabetes; 4. Prostatic hyperplasia. Symptomatic supportive treatment was given. Oral ulcers appeared on 2023-11-8, and the pain significantly affected eating. Physical examination: 8 red and swollen bulges around the buccal mucosa and tongue, ulcers of 5mm-8mm in diameter, dark red tongue, less moss, and weak pulse. Apply an appropriate amount of Example 4 (gel) to the affected area, 2 times / day, and the pain is relieved after 3 days of medication, and the ulcer is cured on the 5th day.

[0115] Case 6: Patient Liu, male, 60 years old, came to the clinic for oral ulcers for 10 days. Past history: immune thrombocytopenia, oral Chinese medicine treatment. The patient had oral ulcers without obvious causes 10 days ago, and the pain significantly affected his eating. Physical examination: 5 superficial ulcers with a diameter of about 5mm-10mm were seen on the tongue and gums in the mouth. Example 4 (orodispersible film) was applied to the affected area, 2 times / day, and the pain was relieved after 1 day of medication, and the ulcer was cured on the 3rd day.

[0116] Comparative Example 1: Patient Wang, female, 35 years old, diagnosed with aplastic anemia for more than 10 months, was admitted to the hospital for further treatment on 2024-04-28, and developed oral ulcers on the 5th day of hospitalization. Physical examination showed 3 sesame to soybean sized ulcers on the buccal mucosa and tongue, which were oval in shape and covered with gray-white pseudomembranes. The surrounding congestion and pain were obvious, but did not affect eating. Blood routine: hemoglobin: 88g / L, white blood cells: 2.93×10 9 / L, neutrophils: 1.89×10 9 / L, platelets: 26×10 9 / L. Comparative Example 1 was applied to the affected area in an appropriate amount, 3 / day, and the pain was relieved after 5 days of medication, and the ulcer area was reduced after 7 days of medication, but the ulcer was not healed.

[0117] Comparative Example 2: Patient Sun, male, 53 years old, suffered from pale complexion and fatigue for 6 months, which worsened for 2 months. He was admitted to the hospital on 2024-03-20 for further treatment. Blood routine: Platelets: 37×10 9 / L, white blood cells: 0.48×10 9 / L, hemoglobin: 55g / L. Combined with the previous medical history, the diagnosis was myelodysplastic syndrome. Treatment with integrated Chinese and Western medicine was given. Oral ulcers appeared on the second day of admission. Physical examination showed 4 ulcers with a diameter of 3mm-5mm on the tongue and superficial gums of the mouth. The ulcer surface was sunken in the middle and congested around. The pain was obvious but did not affect eating. The control sample 2 was applied to the affected area in an appropriate amount, 3 / day. The pain was relieved after 5 days of medication. The ulcer was still not healed on the 10th day after continued use.

[0118] Comparative Example 3: Patient Nan, female, 70 years old, came to the clinic for oral ulcers 3 days ago. The patient had oral ulcers without obvious causes 3 days ago. Physical examination of the oral gums and buccal mucosa showed an ulcer with a diameter of about 10mm, which was oval in shape, with a depression in the middle of the ulcer surface and congestion around it. The pain was obvious, but it did not affect eating. Apply an appropriate amount of comparative example 3 to the affected area, 3 / day, and the pain was relieved after 2 days of medication. The ulcer congestion disappeared on the 7th day, but the ulcer was not healed.

[0119] Comparative Example 4: Patient Ren, male, 13 years old, came to the clinic for oral ulcers 10 days ago. The patient had oral ulcers without obvious causes 10 days ago, with obvious pain, but did not affect eating. Physical examination: 3 ulcers with a diameter of about 3mm-5mm were seen on the buccal mucosa. Apply an appropriate amount of Kouchuang Powder to the affected area 3 times / day. The pain was relieved after 3 days of medication, but the patient said that the pain was strong when using the drug. The ulcer was cured on the 5th day after continued use.

[0120] Comparative Example 5: Patient Zhang, female, 24 years old, came to the clinic for oral ulcers 1 day ago. The patient had oral ulcers without obvious causes 1 day ago. Physical examination showed an oval ulcer the size of a soybean on the palate of the buccal mucosa. The ulcer surface was sunken in the middle, covered with gray-white pseudomembrane, and surrounded by congestion. The pain was obvious but did not affect eating. Comparative Example 5 was applied to the affected area in an appropriate amount, 3 times / day. The pain was relieved after 3 days of medication. The ulcer area was reduced on the 7th day, but the ulcer was not healed.

[0121] Test Example 2. Pharmacodynamics test was carried out using the high, medium and low doses of Example 1 and Comparative Example 5

[0122] 1. Research objectives

[0123] According to the characteristics of the proposed functions and indications of Example 1, this study used the sodium hydroxide burning method to induce an oral ulcer model in rats. By observing the oral ulcer area, the level of inflammatory factors in oral ulcer tissue, and the pathological changes in oral ulcer tissue after administration, the pharmacological effect of Example 1 on oral ulcers in rats was investigated to provide a basis for subsequent clinical trials.

[0124] 2. Experimental Materials

[0125] 2.1 Test substances

[0126] Example 1, batch number: 240710, specification: 10g / bottle, properties: blue-grey powder, valid until: 2025.07.10, manufacturer: Hebei Ping An Health Group Co., Ltd.

[0127] Comparative Example 5, batch number 240609, specification: 10g / bottle, properties: blue-grey powder, valid until: 2025.06.10, manufacturer: Hebei Ping An Health Group Co., Ltd.

[0128] 2.2 Experimental animals

[0129] Thirty-six SPF-grade SD rats, half male and half female, weighing 188.2-220.7 g, animal certificate number: 430727241102408316, were purchased from Hunan Slake Jingda Experimental Animal Co., Ltd. (SCXK (Xiang) 2021-0002), and the animals were raised in area A of the barrier environment animal laboratory. The experimental animal use license number is SYXK (Xiang) 2020-0015.

[0130] 2.4 Main instruments

[0131] RM2235 paraffin slicer (produced by Leica, Germany), ASP200S fully automatic dehydrator (produced by Leica, Germany), HI1220 slice baking machine (produced by Leica, Germany), EG1150H+C tissue embedding machine (produced by Leica, Germany), CX31 biological microscope (produced by Leica, Germany), BX43 biological microscope + MD50 digital imaging system (produced by Leica, Germany), Autostainer XL+CV5030 automatic slide stainer + automatic coverslip machine (Leica, Germany), etc.

[0132] 3. Test methods

[0133] 3.1 Grouping, modeling and drug administration

[0134] Thirty-six SPF SD rats that passed quarantine were selected, half male and half female, and the animals were randomly divided into a normal control group (6 rats) and a model control group (30 rats) according to gender and weight. In addition to the normal control group, the rats in the model control group were burned with sodium hydroxide to replicate the oral ulcer model. The specific modeling method was as follows: the labial mucosa of the SD rats was dried with a sterile cotton ball, and a 3mm×3mm NaOH crystal was placed on the labial mucosa. After maintaining for 30 seconds, the NaOH crystal was removed, and the treated area was wiped with a sterile cotton ball containing 0.9% sodium chloride injection to remove the residual NaOH crystals. Two wounds were burned for each rat. On the second day after modeling, the model control group was divided into two groups according to the ulcer area, taking into account gender and weight (ulcer area: 26.86-75.30mm 2 The animals were randomly divided into a model control group, low-, medium- and high-dose groups of Example 1, and 5 comparative example groups, with 6 animals in each group. The low-, medium- and high-dose groups of Example 1 (5, 10, 15 mg / wound / day) and the comparative example group 5 (10 mg / wound / day) were all given 5 mg / wound / time, with a dosing area of ​​4 mm×4 mm. The low-dose group of Example 1 was given once a day, the medium-dose group of Example 1 and the comparative example group 5 were given twice a day (with an interval of 4 h), and the high-dose group of Example 1 was given 3 times a day (with an interval of 4 h). The drugs were administered for 7 consecutive days. The animals in the normal control group and the model control group were not treated.

[0135] 3.2 Dosage design

[0136] According to the information provided by the client, combined with the dosage area of ​​the oral wound of rats, the dosage of the low, medium and high dose groups of Example 1 was 5, 10 and 15 mg / wound / day, respectively, wherein the low dose group of Example 1 was administered once a day, the medium dose group of Example 1 was administered twice a day (4h interval), and the high dose group of Example 1 was administered 3 times a day (4h interval). The dosage and dosage area of ​​Group 5 of the comparative example were consistent with those of the medium dose group in Example 1, i.e., 10 mg / wound / day, administered twice a day (4h interval). No medication was given to the normal control group and the model control group. The specific dosages and groupings are shown in Table 2.

[0137] Table 2. Groups and doses

[0138]

[0139]

[0140] 3.3 Detection indicators

[0141] 3.3.1 Oral mucosal scoring

[0142] The left lip mucosal tissue of each group of animals was scored the day after the last administration. Scoring criteria: redness and swelling of the ulcer mucosa; ulcer mucosal ulceration; yellow-white pseudomembrane covering the ulcer surface; depression in the center of the ulcer and neat bulges at the edges; swollen lips and drooling. The above five apparent indicators were quantitatively scored and divided into 0, 1, and 2 grades, with 0, 1, and 2 points respectively.

[0143] 3.3.2 Determination of ulcer area

[0144] The maximum transverse diameter (d1) and maximum longitudinal diameter (d2) of the left lip mucosal tissue of rats in each group were measured with a vernier caliper before administration, D1, D3, D5 after administration, and the day after the last administration, and the ulcer area (ulcer area = π × d1 × d2 × 1 / 4, π is 3.14) and the healing rate were calculated.

[0145] 3.3.3 Detection of inflammatory factors

[0146] The next day after the last administration, the rats in each group were euthanized by bleeding from the abdominal aorta after isoflurane inhalation anesthesia, and the right lip mucosal tissue was collected. 0.9% sodium chloride injection was added at a ratio of tissue mass (g): 0.9% sodium chloride injection (mL) = 1:9, and the tissue was ground and homogenized to make a tissue suspension. The supernatant was obtained by centrifugation at 3000 r / min for 10 min, and the ELISA kit was used to detect the contents of IL-6 and TNF-α in the tissue homogenate.

[0147] 3.3.3 Histopathological examination

[0148] The next day after the last administration, the rats in each group were euthanized by bleeding from the abdominal aorta under isoflurane inhalation anesthesia, and the left lip mucosal tissue was collected and fixed in 10% neutral formalin solution for 24 hours. HE staining was performed, and the pathological changes of oral mucosal tissue were observed under a microscope.

[0149] 3.4 Statistics

[0150] The significant figures of the test data were rounded off and statistical analysis was performed in accordance with SOP regulations. The statistical software used was SPSS23.0. The mean ± standard deviation ( X±s), and normality and variance homogeneity tests were performed. If normality was met (P>0.05), one-way analysis of variance (ANOVA) was used for statistical analysis, and LSD+Dunnet (homogeneous variance) or Tamhane's T2 (unhomogeneous variance) was used for comparative analysis according to the variance homogeneity. If normality was not met (P≤0.05), Nonparametric Tests were used. Pain threshold belongs to repeated measurement data. Repeated measurement data meet spherical symmetry and homogeneity. Repeated measurement data variance analysis was used. When spherical symmetry was not met, the F boundary value should be corrected. The statistical results were tested with α=0.05 as the test limit, where P≤0.05 indicated statistical significance, and P≤0.01 indicated that the difference tested was very significant.

[0151] 4. Experimental Results

[0152] 4.1 Effects on oral mucosal scores of rats

[0153] As shown in Table 3, compared with the model control group, the oral mucosal scores of rats in the low, medium, and high dose groups of Example 1 and the comparative example were significantly reduced (P≤0.01).

[0154] Table 3. Effects of each group on the oral mucosal scores of rats ( n=6)

[0155]

[0156] Note: Compared with the model control group ** P≤0.01.

[0157] 4.2 Effect on the area of ​​oral mucosal ulcers in rats

[0158] As shown in Table 4, compared with the model control group, the oral mucosal ulcer areas of rats in the low-dose group of Example 1 and the comparative example 5 group were significantly reduced on administration D3, D5, and D7 (P≤0.01 or P≤0.05); the oral mucosal ulcer areas of rats in the medium and high-dose groups of Example 1 were significantly reduced on administration D1, D3, D5, and D7 (P≤0.01 or P≤0.05).

[0159] As shown in Table 5, compared with the model control group, the oral mucosal ulcer healing rates of rats in the low, medium and high dose groups of Example 1 and the comparative example 5 group were significantly increased on administration D1, D3, D5 and D7 (P≤0.01 or P≤0.05). Compared with the comparative example 5 group, the oral mucosal ulcer healing rate of rats in the high dose group of Example was significantly increased on administration D1 and D3 (P≤0.01 or P≤0.05).

[0160] Table 4. Effects of each group on the area of ​​oral mucosal ulcers in rats ( n=6)

[0161]

[0162]

[0163] Note: Compared with the model control group, *P≤0.05, **P≤0.01.

[0164] Table 5. Effects of each group on the healing rate of oral mucosal ulcers in rats ( n=6)

[0165]

[0166] 4.3 Effects on the levels of inflammatory factors in rat oral mucosal tissue

[0167] As shown in Table 6, compared with the normal control group, the levels of TNF-α and IL-6 in the oral mucosal tissue of the rats in the model control group were significantly increased (P≤0.01); compared with the model control group, the level of TNF-α in the oral mucosal tissue of the rats in the high-dose group of Example 1 and the comparative example 5 group was significantly reduced (P≤0.05), and the level of IL-6 in the oral mucosal tissue of the rats in the low-, medium- and high-dose groups of Example 1 and the comparative example 5 group was significantly reduced (P≤0.01 or P≤0.05).

[0168] Table 6. Effects of each group on the levels of inflammatory factors in the oral mucosal tissue of rats ( n=6)

[0169]

[0170]

[0171] Note: Compared with the normal control group, ++P≤0.01; compared with the model control group, *P≤0.05, **P≤0.01.

[0172] 4.4 Effects on rat oral mucosal histopathology

[0173] like Figure 1 As shown, there was no obvious change in the oral mucosal epithelium of the normal control group, and no inflammatory cell infiltration was observed; the rats in the model control group developed focal mucosal ulcers, submucosal edema, hemorrhage, fibrous connective tissue hyperplasia, and inflammatory cell infiltration; the next day after the last administration, the oral mucosal tissue lesions of the rats in the low, medium, and high dose groups of Example 1 and the comparative example 5 groups were alleviated to varying degrees compared with the model control group.

[0174] As shown in Table 7, compared with the normal control group, the oral mucosal pathological scores of rats in the model control group were significantly increased (P≤0.01); compared with the model control group, the oral mucosal pathological scores of rats in the low, medium, and high dose groups of Example 1 and the comparative example 5 group were significantly reduced (P≤0.05), and the medium and high dose scores of Example 1 were better than those of the comparative example 5 group.

[0175] Table 7. Effects of each group on rat oral mucosal histopathology ( n=6)

[0176]

[0177] Note: Compared with the normal control group, ++P≤0.01; compared with the model control group, *P≤0.05.

[0178] 5. Conclusion and evaluation

[0179] Oral ulcer is a common localized ulcerative injury disease occurring in the oral mucosa, with the characteristics of recurrence, periodicity, self-limitation, etc., and is often found in the lips, tongue, cheeks, soft palate and other parts with poor keratinization. The pain is severe during the attack, and the local burning pain is obvious. In severe cases, systemic symptoms such as halitosis, chronic pharyngitis, dizziness, nausea and lymphadenopathy may occur. In this experiment, the oral ulcer model was replicated by sodium hydroxide burning method, and Example 1 was administered at different frequencies. The pharmacological effect of Example 1 on oral ulcer in rats was investigated by observing the oral ulcer score, oral ulcer area, inflammatory factor level of oral ulcer tissue, and pathological changes of oral ulcer tissue after administration.

[0180] The severity of the occurrence and development of oral ulcers can be predicted by detecting the oral ulcer score and oral ulcer area. TNF-α and IL-6 are inflammatory factors produced by activated mononuclear macrophages, which are highly expressed when oral ulcers or oral mucosa inflammation occurs. In this study, the levels of TNF-α and IL-6 in the oral mucosa of rats in the model control group were significantly increased after the intervention of sodium hydroxide, and the degree of oral mucosal tissue lesions was significantly increased, proving that the oral ulcer model was successfully constructed. After the model rats were given different concentrations of Example 1, the oral ulcer score, oral ulcer area, oral mucosal TNF-α, and IL-6 levels were significantly reduced, and the degree of oral mucosal lesions was significantly improved.

[0181] In summary, under the experimental conditions, Example 1 can significantly reduce the oral mucosal score, ulcer area, tissue inflammatory factor level and lesion degree of the model rats. In terms of ulcer healing rate, the improvement effect and onset time of Example 1 are significantly better than those of the comparative example 5 group, which proves that Example 1 has a significant therapeutic effect on oral ulcers, and the effective dose is a low dose (5 mg / rat).

[0182] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for treating oral ulcers, characterized in that: Calculated by mass, the invention comprises the following components: 4-18 parts of Indigo Naturalis, 4-18 parts of Cyperus rotundus, 1-10 parts of Bletilla striata, 2-16 parts of pearl powder, 1-12 parts of artificial bezoar, 2-18 parts of Galla Chinensis, and 1-5 parts of Borneol.

2. The Chinese medicine composition according to claim 1, characterized in that: The invention comprises the following components by mass fraction: 6-16 parts of Indigo Naturalis, 6-16 parts of Cyperus rotundus, 4-9 parts of Bletilla striata, 4-15 parts of pearl powder, 1-10 parts of artificial bezoar, 4-15 parts of Galla Chinensis, and 1-3 parts of Borneol.

3. The Chinese medicine composition according to claim 2, characterized in that: The Chinese medicine composition comprises the following components by mass fraction: 6-8 parts of Indigo Naturalis, 6-8 parts of Olea Europaea, 4-6 parts of Bletilla striata, 4-8 parts of pearl powder, 4-6 parts of artificial bezoar, 4-8 parts of Galla Chinensis, and 1-2 parts of Borneol.

4. The Chinese medicine composition according to claim 1, characterized in that: The mass ratio of Indigo Naturalis, Euphorbia Chinensis and Bletilla striata is 1-2:1-2:

1.

5. The Chinese medicine composition according to claim 4, characterized in that: The mass ratio of the Indigo Naturalis, Olea corylifolia and Bletilla striata is 2:2:

1.

6. A pharmaceutical preparation, characterized in that A Chinese medicine composition comprising any one of claims 1 to 5.

7. The pharmaceutical preparation according to claim 6, characterized in that The pharmaceutical preparations include pills, capsules, oral liquids, tablets, lozenges, powders, patches, pastes, granules, gels, sprays and syrups.

8. The pharmaceutical preparation according to claim 6, characterized in that The pharmaceutical preparation further contains excipients.

9. The pharmaceutical preparation according to claim 8, characterized in that The auxiliary material comprises at least one of a disintegrant, a filler, a flavoring agent, a pH regulator, a lubricant, and an antioxidant.

10. The method for preparing the Chinese medicine composition according to any one of claims 1 to 5, characterized in that: The following steps are involved: (1) crushing Indigo Naturalis, Euphorbia cerasifera and Bletilla striata, adding solvent for extraction, filtering the extract, concentrating and drying to obtain dry powder 1; (2) soaking the Chinese gallnut in warm water, filtering, concentrating the filtrate, and drying to obtain dry powder 2; (3) artificial bezoar, pearl powder and borneol ultrafine powder are added to obtain dry powder 3; (4) Dry powder 1, dry powder 2 and dry powder 3 are mixed to obtain a powder for treating oral ulcers.

11. Use of the Chinese medicine composition according to any one of claims 1 to 5 or the pharmaceutical preparation according to any one of claims 6 to 9 in the preparation of a drug for preventing or treating oral ulcer disease.

Images