Traditional Chinese medicine composition for treating oral ulcer and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating oral ulcer, which is prepared by extracting the following traditional Chinese medicine decoction pieces in parts by weight: 10-30 parts of cornu bubali, 5-15 parts of stiff silkworm stir-fried with bran, 4-8 parts of cicada slough, 4-8 parts of lophatherum gracile, 5-15 parts of honeysuckle, 5-15 parts of gardenia, 4-8 parts of gypsum, 4-8 parts of salted rhizoma anemarrhenae, 5-15 parts of cortex lycii radicis, 5-15 parts of radix scrophulariae and the like. The purpose of treating aphtha caused by internal organ heat accumulation is achieved by removing heat to cool blood, detoxifying and arresting convulsion, nourishing yin and blood, dissipating heat and arresting convulsion, nourishing yin and removing fire, eliminating dampness and heat, promoting blood circulation to remove blood stasis and resisting bacteria and viruses.

Description

Technical Field

[0001] The present invention relates to a Chinese medicine combination and a preparation method, and in particular to a Chinese medicine combination for treating oral ulcers and a preparation method. Background Art

[0002] Oral ulcer is the most common oral mucosal disease in clinical practice, manifested as scattered oval or round small erosions in the mouth, with surrounding congestion and edema, and patients feel pain, which affects their daily life. The prevalence of the general population can be as high as 20%, but its main cause of disease has not yet been determined. Limitations of existing therapeutic drugs: The most commonly used drugs for treating oral ulcers on the market are tetracycline tablets, Yiketie, Bingpengsan, Yangyin Shengjisan, etc., but the efficacy is not very significant. Problems with existing treatment methods: There is currently no effective radical cure, mainly using local treatment as the main and systemic treatment as the auxiliary method, such as local use of drug patches, powders, etc., and using low-concentration lidocaine or procaine diluted and rinsed, which can temporarily eliminate pain; if the ulcer surface is relatively large, potassium permanganate, furazolidone solution, compound boric acid solution, tetracycline, etc. can be used to make gargles to relieve pain, but these can only relieve pain and cannot promote the healing of the ulcer surface well.

[0003] Advantages of Chinese medicine compositions: The developed Chinese medicine compositions are intended to provide a green, safe, highly effective anti-inflammatory and analgesic compound Chinese medicine to overcome the defects of the prior art, and to provide a Chinese medicine composition for treating oral ulcers, hemostasis, analgesia and anti-inflammation, as well as its preparation method and application. Summary of the invention

[0004] In order to solve the deficiencies of the prior art, the present invention provides a Chinese medicine composition for treating oral ulcers with good efficacy and high cure rate and a preparation method thereof.

[0005] The technical scheme of the present invention is a traditional Chinese medicine composition for treating oral ulcers, which is prepared by extracting the following traditional Chinese medicine pieces in parts by weight: 10-30 parts of buffalo horn, 5-15 parts of fried silkworm pupa with bran, 4-8 parts of cicada molts, 4-8 parts of lonicera japonica, 5-15 parts of honeysuckle, 5-15 parts of gardenia, 4-8 parts of gypsum, 4-8 parts of salt anemarrhena, 5-15 parts of lycium bark, 5-15 parts of Scrophularia ningpoensis, 5-15 parts of fried coix seeds, 5-15 parts of Poria cocos, 4-8 parts of pomegranate peel, 5-15 parts of salvia miltiorrhiza and 4-8 parts of liquorice.

[0006] The Chinese medicine composition for treating oral ulcers is prepared by extracting the following Chinese medicine pieces in parts by weight: 20 parts of buffalo horn, 10 parts of fried silkworm pupa with bran, 6 parts of cicada shells, 6 parts of lonicera japonica leaves, 10 parts of honeysuckle, 10 parts of gardenia, 6 parts of gypsum, 6 parts of salt anemarrhena, 10 parts of lycium bark, 10 parts of Scrophularia ningpoensis, 10 parts of fried coix seeds, 10 parts of Poria cocos, 6 parts of pomegranate peels, 10 parts of salvia miltiorrhiza, and 6 parts of liquorice.

[0007] The preparation method of the Chinese medicine composition for treating oral ulcers comprises the following steps:

[0008] (1) Prepare Chinese herbal medicine slices according to the above weight proportions and wash with water;

[0009] (2) adding water and decocting twice, the first time adding water is 10 times the weight of the Chinese medicine slice, decocting for 1-3 hours, the second time adding water is 8 times the weight of the Chinese medicine slice, decocting for 1-3 hours, filtering out the residue, combining the filtrate, and concentrating to a relative density of 1.10-1.20 at 25° C. to obtain a concentrated solution;

[0010] (3) cooling the concentrated solution obtained in step (2), adding 95% ethanol, mixing into a mixed solution containing 50-60% ethanol concentration, refrigerating the mixed solution at 2-8° C. for 20-30 hours, and taking the supernatant;

[0011] (4) The supernatant obtained in step (3) is concentrated under low temperature vacuum to a relative density of 1.20-1.30 at 25° C., spray dried, and excipients are added to prepare a traditional Chinese medicine preparation.

[0012] The Chinese medicine composition for treating oral ulcers is in the form of tablets, capsules, granules and oral liquid.

[0013] Application of the traditional Chinese medicine composition for treating oral ulcers in preparing medicine for treating oral ulcers.

[0014] The use of the traditional Chinese medicine composition for treating oral ulcers in preparing a medicine for treating oral ulcers, wherein the syndrome of the oral ulcers is heat accumulation in the internal organs.

[0015] The above-mentioned Chinese herbal medicines all meet the pharmacopoeia standards.

[0016] Oral ulcers are called oral ulcers for short. The name of oral ulcers first came from the Yellow Emperor's Classic of Internal Medicine. In the Suwen Qi Jiaobian Dalun, it is said that "when the metal is insufficient in the year, the fire will spread... people suffer from oral ulcers, and even heart pain." In the Essentials of Surgery, it is said that "carbuncle is originally caused by fire poison." It can be seen that "fire" is the basic cause of oral ulcers. The evil of fire and heat disturbs the meridians, causing sores in the mouth and tongue, and ulcers are self-generated. It can be divided into deficiency and excess. The heat of all meridians should be in the heart, and it will inflame the meridians and burn the mouth, causing oral ulcers, which is excess fire; Yin deficiency and fire are strong, and virtual fire inflames and causes oral ulcers, which is virtual fire. According to the symptoms, traditional Chinese medicine divides oral ulcers into internal organ heat accumulation, qi and blood deficiency, Yin deficiency and fire, yang deficiency and floating fire, and cold and heat. Among them, internal organ heat accumulation is the most common. Internal organ heat accumulation includes heat in the heart meridian, heat in the spleen meridian, heat in the stomach meridian, and damp heat in the liver and spleen, each with its own emphasis. Symptoms of heat accumulation in the internal organs: mouth ulcers of varying numbers and sizes, with mostly yellow-white secretions on the surface, bright red and slightly swollen surrounding areas, pain, accompanied by a burning sensation, dry mouth and thirst, dry and hard stools, yellow and short urine, red tongue, and rapid pulse.

[0017] When the internal organs are heat-accumulated, the pathogenic heat will inflame the mouth along the meridians, so mouth and tongue ulcers will appear, which are red and have a burning pain. The heat is more severe inside, so the mouth is dry, the stool is dry, and the urine is short and yellow. The tongue is red and the pulse is rapid, which is also a sign of real heat. The heart opens to the tongue, and when the heart meridian is inflamed, mouth ulcers are mostly formed on the tip of the tongue and are red, and the mouth is red and rotten. When the heart fire disturbs the mind, it will cause restlessness and insomnia. The Shaoyin Heart Meridian and the Taiyang Small Intestine Meridian are exterior and interior to each other, and the heart meridian transfers heat to the small intestine, so the urine is red, astringent and painful. The spleen opens to the mouth, and its flower is on the lips. The spleen pulse holds the root of the tongue, and the accumulated heat of the spleen meridian is smoked to the lips and ulcers appear. Dry lips, sweet mouth, and tongue rubbing are all caused by spleen heat. The mouth is the gateway to the stomach, and the gums are where the Stomach Meridian of Foot Yangming passes. There is heat accumulation in the stomach. If it is smoked on the upper body, it will cause ulcers in the mouth, swollen and painful cheeks, and eroded gums; evil heat forces blood to flow abnormally, causing vomiting and bleeding from the teeth; stomach fire causes internal heat, so the digestion is poor and hunger is rapid, and the chest and diaphragm are hot; damp heat and liver and spleen meridians are steamed up and cause mouth ulcers, and the heat is accompanied by dampness, so the area around the ulcer is swollen and has blisters, which are yellow and sticky; damp heat affects the spleen and stomach functions, causing chest tightness and abdominal distension, loss of appetite and nausea; bitter taste in the mouth, pain in the ribs, swollen and painful throat and chin, sweating, and yellow and smelly vaginal discharge; yellow and greasy tongue coating, all of which are caused by the evil damp heat of the liver and spleen going up or down through the meridians.

[0018] This prescription is mainly used to treat oral ulcers caused by heat accumulation in the internal organs. The oral cavity is the gateway to the lungs and stomach. When exogenous pathogenic heat invades, the heat from the lungs and stomach rises, which can cause oral ulcers. As stated in Shoushibaoyuan·Koushe, "oral ulcers are caused by stagnation of spleen qi and wind-heat." Ye Tianshi's Wenre Lun mentioned, "If the tongue is crimson with broken white and yellow spots, it should be malnutrition, and if it is big red spots, it is heat poison invading the heart." In addition to exogenous pathogenic heat, overeating, overeating sweet, fatty, spicy, fried, roasted, and drunken, which damage the spleen and stomach, accumulate dampness and turn into heat; or excessive thinking, anger and anger damage the liver and turn into fire, and internal heat accumulation in the heart, spleen, liver, and stomach can all cause oral ulcers. The tongue is the orifice of the heart, and all pains and ulcers belong to the heart; the spleen opens to the mouth, and the spleen pulse holds the root of the tongue and disperses under the tongue: the cheeks and gums belong to the stomach and large intestine, so the problem of oral ulcers is most closely related to the accumulation of heat in the heart, spleen, liver, and stomach. Real fire goes up along the meridians and burns the mouth. The "Lingshu·Jingmai" records that the liver meridian of the foot Jueyin "circles the inside of the lips", and the "Suwen·Zhizhen Yaoda Lun" records that "all pains, itches and sores belong to the heart". Buffalo horns belong to the heart and liver meridians. In addition to clearing away heat and detoxifying, they can also nourish yin and blood, avoid the hot and evil qi from damaging yin and moving blood, and conform to the basic principle of clearing heat and preserving yin for febrile diseases. At the same time, in order to enhance the effect of buffalo horns, silkworm and cicada shells are used to dissipate heat and calm the nerves. Among them, silkworm pupa is pungent and flat, light and floating, and can raise yang, while cicada shells are cold and light, good at dispersing lungs and opening the orifices. The two are combined to lead the clear qi to reach up and penetrate the evil heat to the outside. This prescription uses buffalo horns as descending, silkworm and cicada shells as ascending, and both ascending and descending are used. Qi and blood drugs are used at the same time. In the process of ascending and descending, the clear yang is raised and the evil qi is descended, the lung qi is promoted and the stagnant fire is dispersed, the evil heat is removed, the evil toxins are resolved, and the blood vessels are activated. It also takes into account the fact that the real heat of the mouth sores consumes yin fluid due to the heat of the fire for a long time, and the virtual fire is inflamed, and the cavity orifices are burned. Therefore, the bitter and cold buffalo horn, silkworm and cicada shell are used as the main ingredients in the prescription, which can clear away heat and cool blood, detoxify and calm the nerves, nourish yin and blood, and treat both the symptoms and the root cause.

[0019] In order to enhance the effect of the main medicine, the present invention further sends bamboo leaves to clear the heart fire and promote urination, and honeysuckle to disperse wind-heat, clear heat and detoxify. "Danxi's Heart Method·Oral Teeth 78" says "those who take cold medicine for oral ulcers do not heal because the middle-jiao earth is weak and cannot eat, and the phase fire rushes up without control". The present invention uses gardenia and gypsum to clear spleen heat, wherein gardenia clears fire and eliminates restlessness, clears heat and dampness, cools blood and detoxifies, gypsum clears heat and clears fire, eliminates restlessness and quenches thirst, astringes sores and promotes muscle growth, collects dampness, and stops bleeding; Anemarrhena, Rehmannia root bark, Scrophularia clears heat and cools blood, nourishes yin and removes fire, prevents kidney water deficiency, and is difficult to help fire, resulting in dragon fire moving rashly, following the pulse of the foot kidney yin, to the throat and into the mouth and tongue, causing repeated attacks of oral ulcers. The present invention uses bamboo leaves, honeysuckle, gardenia, gypsum, Anemarrhena, Rehmannia root bark, and Scrophularia as ministerial medicines, which can achieve clearing heart fire, clearing spleen heat, and clearing stomach heat together, and enhance the heat-clearing effect of the main medicine.

[0020] "Medical Abstracts" states: "When water overflows the soil, moisture will be generated by itself; when fire is depressed in the soil, heat will be generated by itself; when dampness and heat are fumigated, the breath will be foul and cause sores." Therefore, it is believed that due to the long-term dampness, the spleen will be trapped and dampness will be generated, and the heat will be transformed into blood stasis and poison, fumigating the breath, and causing foulness and sores. It can be seen that the root of the disease is fire, which originates from dampness, heat, toxicity and blood stasis. Therefore, coix seed and Poria cocos are used to clear dampness and heat. Coix seed and Poria cocos can strengthen the spleen, so that the spleen is strong and not affected by evil, and also make the spleen strong so that the qi and blood are active, so as to treat the root cause of the disease. Add coix seed and Poria cocos to clear dampness and heat and protect the middle jiao. Overall examination, taking into account both the symptoms and the root cause. Treat the three jiao separately to achieve the effect of "unblocking the qi mechanism of the three jiao and clearing the heat and toxicity of the three jiao". Qi stagnation and blood stasis may induce oral ulcers. Qi stagnation and blood stasis can lead to poor blood circulation, decreased immune function of the body, and thus make the oral mucosa vulnerable to invasion by exogenous pathogens and ulcers. In addition, qi stagnation and blood stasis can also affect the function of spleen and stomach transportation and transformation, leading to endogenous dampness and heat, further aggravating the occurrence of oral ulcers. The present invention uses salvia miltiorrhiza to promote blood circulation and remove blood stasis, cool blood and eliminate carbuncle, and pomegranate peel is sour and astringent in nature and flavor, astringent and hemostatic, and pomegranate peel has an inhibitory effect on diphtheria, Staphylococcus aureus, Shi and Shigella flexneri, and Proteus. It has an inhibitory effect on 10 kinds of skin fungi such as erythrocytes, Microsporum audouinii and Nocardia asteroides. It can inhibit the growth of influenza virus and genital herpes virus. Coix seed, Poria, salvia miltiorrhiza and pomegranate peel are adjuvants to enhance the heat-clearing and detoxifying effects of monarch and ministerial drugs. Finally, liquorice is used as a messenger to tonify the spleen and middle and reconcile various drugs, among which Poria, light bamboo leaf and liquorice can also promote diuresis and relieve stranguria, and guide heart heat out of urination.

[0021] In summary, the present invention is composed of buffalo horn, fried silkworm pupa with bran, cicada slough, loquat leaf, honeysuckle, gardenia, gypsum, salt anemarrhena, Chinese wolfberry bark, Scrophularia, fried coix seed, Poria, pomegranate peel, salvia miltiorrhiza, and liquorice, and can achieve the purpose of treating oral ulcers caused by internal heat accumulation by clearing away heat and cooling blood, detoxifying and calming the nerves, nourishing yin and blood, dissipating heat and calming the nerves, nourishing yin and removing fire, clearing away dampness and heat, promoting blood circulation and removing blood stasis, and having antibacterial and antiviral effects.

[0022] In the pharmacodynamic study, for the change in the diameter of oral ulcers in rats with oral ulcer model, the present invention was compared with the model group. At 7d and 15d of administration, the ulcer diameter of the first group of the present invention and the Niuhuang Jiedu Tablets group was significantly reduced (P < 0.05), and the effect of the first group of the present invention after administration was better than that of the Niuhuang Jiedu Tablets group. For the severity score of oral ulcers in rats with oral ulcer model, the present invention was compared with the model group. At 7d and 15d of administration, the scores of the first group of the present invention and the Niuhuang Jiedu Tablets group were significantly reduced (P < 0.05), and the ulcer healing of the first group of the present invention after administration was better than that of the Niuhuang Jiedu Tablets group.

[0023] In a clinical study, for patients with oral ulcers caused by internal heat accumulation, after treatment, the total effective rate of the group 1 of the embodiment of the present invention was 96%, which was significantly higher than 84% of the control group (P < 0.05). The pain relief time and ulcer surface healing time of the group 1 of the embodiment of the present invention were significantly shorter than those of the control group (P < 0.05), indicating that the present invention is better than Niuhuang Jiedu Tablets in treating oral ulcers caused by internal heat accumulation. DETAILED DESCRIPTION

[0024] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention. In addition, it should be understood that after reading the content of the present invention, those skilled in the art can make various changes or modifications to the present invention, but these equivalent forms fall within the scope limited by the appended claims of the application equally.

[0025] Example 1: Take 200g of buffalo horn, 100g of fried silkworm with bran, 60g of cicada shell, 60g of light bamboo leaf, 100g of honeysuckle, 100g of gardenia, 60g of gypsum, 60g of salt anemarrhena, 100g of Lycium bark, 100g of Scrophularia, 100g of fried coix seed, 100g of Poria, 60g of pomegranate peel, 100g of Salvia miltiorrhiza, and 60g of liquorice, and the preparation method comprises the following steps:

[0026] (1) Prepare Chinese herbal medicine slices according to the above weight proportions and wash with water;

[0027] (2) adding water and decocting twice, the first time adding water is 10 times the weight of the Chinese medicine slice, decocting for 2 hours, the second time adding water is 8 times the weight of the Chinese medicine slice, decocting for 2 hours, filtering out the residue, combining the filtrate, and concentrating to a relative density of 1.15 at 25° C. to obtain a concentrated solution;

[0028] (3) cooling the concentrated solution obtained in step (2), adding 95% ethanol to form a mixed solution containing 55% ethanol, refrigerating the mixed solution at 5° C. for 25 hours, and taking the supernatant;

[0029] (4) The supernatant obtained in step (3) is concentrated under low temperature vacuum to a relative density of 1.25 at 25° C., spray dried, and starch is added to prepare granules.

[0030] Example 2: Take 100g of buffalo horn, 150g of fried silkworm with bran, 40g of cicada shell, 80g of light bamboo leaf, 50g of honeysuckle, 150g of gardenia, 40g of gypsum, 80g of salt anemarrhena, 50g of Lycium bark, 150g of Scrophularia, 50g of fried coix seed, 150g of Poria, 40g of pomegranate peel, 150g of Salvia miltiorrhiza, and 40g of liquorice, and the preparation method comprises the following steps:

[0031] (1) Prepare Chinese herbal medicine slices according to the above weight proportions and wash with water;

[0032] (2) adding water and decocting twice, the first time adding water in an amount of 10 times the weight of the Chinese herbal medicine slices, decocting for 1 hour, the second time adding water in an amount of 8 times the weight of the Chinese herbal medicine slices, decocting for 3 hours, filtering out the residue, combining the filtrate, and concentrating to a relative density of 1.10 at 25° C. to obtain a concentrated solution;

[0033] (3) cooling the concentrated solution obtained in step (2), adding 95% ethanol to form a mixed solution containing 60% ethanol, refrigerating the mixed solution at 2° C. for 30 hours, and taking the supernatant;

[0034] (4) The supernatant obtained in step (3) is concentrated under low temperature vacuum to a relative density of 1.20 at 25° C., spray dried, and dextrin is added to prepare tablets.

[0035] Example 3: Take 300g of buffalo horn, 50g of fried silkworm with bran, 80g of cicada shell, 40g of light bamboo leaf, 150g of honeysuckle, 50g of gardenia, 80g of gypsum, 40g of salt anemarrhena, 150g of Lycium bark, 50g of Scrophularia, 150g of fried coix seed, 50g of Poria, 80g of pomegranate peel, 50g of Salvia miltiorrhiza, and 80g of liquorice, and the preparation method comprises the following steps:

[0036] (1) Prepare Chinese herbal medicine slices according to the above weight proportions and wash with water;

[0037] (2) adding water and decocting twice, the first time adding water is 10 times the weight of the Chinese medicine slice, decocting for 3 hours, the second time adding water is 8 times the weight of the Chinese medicine slice, decocting for 1 hour, filtering out the residue, combining the filtrate, and concentrating to a relative density of 1.20 at 25° C. to obtain a concentrated solution;

[0038] (3) cooling the concentrated solution obtained in step (2), adding 95% ethanol to form a mixed solution containing 50% ethanol, refrigerating the mixed solution at 8° C. for 20 hours, and taking the supernatant;

[0039] (4) The supernatant obtained in step (3) is concentrated under low temperature vacuum to a relative density of 1.30 at 25° C., spray dried, and microcrystalline cellulose is added to prepare capsules.

[0040] Example 4: Take 200g of buffalo horn, 100g of fried silkworm with bran, 60g of cicada shell, 60g of light bamboo leaf, 100g of honeysuckle, 100g of gardenia, 60g of gypsum, 60g of salt anemarrhena, 100g of Lycium bark, 100g of Scrophularia, 100g of fried coix seed, 100g of Poria, 60g of pomegranate peel, 100g of Salvia miltiorrhiza, and 60g of liquorice, and the preparation method comprises the following steps:

[0041] (1) Prepare Chinese herbal medicine slices according to the above weight proportions and wash with water;

[0042] (2) adding water and decocting twice, the first time adding water is 10 times the weight of the Chinese medicine slice, decocting for 2 hours, the second time adding water is 8 times the weight of the Chinese medicine slice, decocting for 2 hours, filtering out the residue, combining the filtrate, and concentrating to a relative density of 1.15 at 25° C. to obtain a concentrated solution;

[0043] (3) cooling the concentrated solution obtained in step (2), adding 95% ethanol to form a mixed solution containing 55% ethanol, refrigerating the mixed solution at 5° C. for 25 hours, and taking the supernatant;

[0044] (4) The supernatant obtained in step (3) is concentrated under low temperature vacuum to a relative density of 1.20 at 25° C., and syrup is added to prepare an oral solution.

[0045] Example 5: Pharmacodynamics Study

[0046] Take 40 SD experimental rats, model after 7d of adaptive feeding, anesthetize with 10% chloral hydrate solution (300mg / kg) ip, add 30 μL80% glacial acetic acid solution to each 6mm filter paper, place the filter paper containing glacial acetic acid on one side of the rat buccal mucosa and apply cautery for 30s, and the blank control group applies an equal amount of normal saline, and oral ulcer can be formed after 24h. 24h after burn, observe and record the ulcer formation situation, including the occurrence rate, ulcer change, appearance, etc. of the formation ulcer. The rats with successful modeling are divided into blank control group, model group, embodiment of the present invention 1 group (100g / kg) (clinical dosage 50 times), positive medicine Niuhuang Jiedu Tablets group 6.43g / kg (clinical dosage 50 times) (National Medicine Standard Z44020155, Guangzhou Baiyunshan Huacheng Pharmaceutical Co., Ltd.), 10 in each group. The drug was dissolved in distilled water and administered ig. The model group and the control group were given the same amount of distilled water for 15 consecutive days. The diameter of the ulcer was measured and the severity of the ulcer was evaluated on the 1st, 7th and 15th day of modeling. The severity of the ulcer was evaluated according to the indicators reported in the literature: ① redness and swelling of the ulcer mucosa; ② ulcer mucosal ulceration; ③ the ulcer surface was covered with yellow-white pseudomembrane; ④ the central depression and neatly raised edges; ⑤ swollen lips and drooling; ⑥ reduced food intake and weight loss. The above-mentioned apparent indicators were quantitatively integrated and divided into 3 levels: none, mild, and significant, with 0, 1, and 2 points respectively.

[0047] Experimental results: The results of ulcer diameter are shown in Table 1, and the scores for evaluating ulcer severity are shown in Table 2.

[0048] Table 1 Effect of the present invention on changes in the diameter of oral ulcers

[0049]

[0050] Compared with the blank control group, ### P<0.001, compared with the model group * P<0.05, ** P<0.01

[0051] As shown in Table 1, compared with the model group, the ulcer diameters of the Example 1 group and the Niuhuang Jiedu Tablets group were significantly reduced at 7 and 15 days after administration (P < 0.05), and the effect of the Example 1 group after administration was better than that of the Niuhuang Jiedu Tablets group.

[0052] Table 2 Effect of the present invention on the severity score of oral ulcer

[0053]

[0054] Compared with the blank control group, ### P<0.001, compared with the model group * P<0.05, ** P<0.01

[0055] As shown in Table 2, the ulcer score of the model group gradually decreased with time, indicating that the ulcer had a certain degree of self-healing. Compared with the model group, the scores of the Example 1 group and the Niuhuang Jiedu Tablets group were significantly reduced at 7d and 15d of administration (P < 0.05), and the ulcer healing of the Example 1 group after administration was better than that of the Niuhuang Jiedu Tablets group.

[0056] Example 6: Clinical study:

[0057] Case data: 100 patients with oral ulcers admitted to Nanjing Hospital of Traditional Chinese Medicine from August 2022 to December 2023 were selected, including 46 males and 54 females, aged 18 to 65 years.

[0058] Inclusion criteria: (1) meeting the diagnostic criteria for oral ulcers [Zhang Zhenkang, Fan Mingwen, Fu Minkui. Modern Stomatology [M]. Beijing: Beijing Science and Technology Press, 2003: 729-732.]; (2) the onset of the disease was within 3 days; (3) voluntarily signing the informed consent form; (4) no concurrent tumors or mental illness; (5) no recent use of antibiotics, analgesics, healing drugs and other related therapeutic drugs; (6) age 18 to 65 years old.

[0059] TCM diagnostic criteria: mouth ulcers of varying numbers and sizes, with mostly yellow-white secretions on the surface, bright red and slightly swollen surrounding areas, pain, accompanied by a burning sensation, dry mouth and thirst, dry and hard stools, yellow and short urine, red tongue, and rapid pulse, consistent with symptoms of internal heat accumulation.

[0060] Exclusion criteria: (1) patients diagnosed with hand, foot and mouth disease, herpetic stomatitis, oral candidiasis or similar diseases; (2) oral ulcers caused by allergies, chemotherapy drugs, etc.; (3) abnormal liver and kidney function affecting drug metabolism; (4) allergy to any ingredient in Kangfuxin Liquid or Compound Pearl Oral Ulcer Granules; (5) patients with other oral diseases; (6) patients with severe malnutrition, acute or chronic infections.

[0061] Drug treatment: divided into a control group and a treatment group according to the random number table method, with 50 cases in each group. Among them, there were 24 males and 26 females in the control group; there were 23 males and 27 females in the treatment group. There was no statistically significant difference between the two groups, which was comparable. All patients avoided drinking and eating spicy and stimulating foods during treatment. The control group took Niuhuang Jiedu Tablets (National Medicine Standard Z44020155, Guangzhou Baiyunshan Huacheng Pharmaceutical Co., Ltd.), 2 tablets at a time (0.3g per tablet), 3 times a day. The granules prepared in Example 1 of the present invention were taken in the treatment group and used three times a day. The daily dosage was 20g of buffalo horn, 10g of bran fried silkworm, 6g of cicada shell, 6g of light bamboo leaf, 10g of honeysuckle, 6g of salt anemarrhena, 10g of ground bone bark, 10g of Scrophularia, 10g of stir-fried coix seed, 10g of Poria, 6g of pomegranate peel, 10g of salvia miltiorrhiza, and 6g of licorice. The course of treatment for both groups was 1 week. The therapeutic effects were observed and the pain relief time and ulcer surface healing time between the two groups were compared. The results are shown in Tables 3 and 4.

[0062] Efficacy evaluation criteria: Cured: oral ulcers heal and local discomfort disappears; Effective: although oral ulcers recur from time to time, the severity and number of them are reduced; Ineffective: there is no obvious change in the symptoms of ulcers and oral ulcers.

[0063] Total effective rate = (number of cured cases + number of effective cases) / total number of cases.

[0064] Table 3 Comparison of clinical efficacy between the two groups

[0065] Group get well efficient invalid Effectiveness (%) Control group 18 24 8 84 Example 1 Group 26 22 2 96

[0066] Table 4 Comparison of pain relief time and ulcer healing time between the two groups

[0067] Group Pain relief time (d) Ulcer surface healing time (d) Control group 5.67±1.34 7.15±1.76 Example 1 Group 2.98±1.25 3.83±1.59

[0068] As shown in Tables 3 and 4, for patients with oral ulcers caused by internal heat accumulation, after treatment, the total effective rate of the group 1 of Example 1 of the present invention was 96%, which was significantly higher than 84% of the control group (P < 0.05). The pain relief time and ulcer surface healing time of the group 1 of Example 1 of the present invention were significantly shorter than those of the control group (P < 0.05), indicating that the present invention is better than Niuhuang Jiedu Tablets in treating oral ulcers caused by internal heat accumulation.

[0069] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicine composition for treating oral ulcers, characterized in that: The invention is prepared by extracting the following Chinese medicinal pieces in parts by weight: 10-30 parts of buffalo horn, 5-15 parts of fried silkworm pupa with bran, 4-8 parts of cicada molt, 4-8 parts of lonicera japonica, 5-15 parts of honeysuckle, 5-15 parts of gardenia, 4-8 parts of gypsum, 4-8 parts of salt anemarrhena, 5-15 parts of rehmannia root, 5-15 parts of Scrophularia ningpoensis, 5-15 parts of fried coix seeds, 5-15 parts of Poria, 4-8 parts of pomegranate peel, 5-15 parts of salvia miltiorrhiza and 4-8 parts of liquorice.

2. A Chinese medicine composition for treating oral ulcers as claimed in claim 1, characterized in that: The preparation method is prepared by extracting the following Chinese herbal medicine pieces in parts by weight: 20 parts of buffalo horn, 10 parts of fried silkworm pupa with bran, 6 parts of cicada shells, 6 parts of lonicera japonica leaves, 10 parts of honeysuckle, 10 parts of gardenia, 6 parts of gypsum, 6 parts of salt anemarrhena, 10 parts of rehmannia root, 10 parts of Scrophularia ningpoensis, 10 parts of fried coix seeds, 10 parts of Poria, 6 parts of pomegranate peels, 10 parts of salvia miltiorrhiza, and 6 parts of liquorice.

3. A Chinese medicine composition for treating oral ulcers as claimed in claim 1, characterized in that: The preparation method comprises the following steps: (1) Prepare Chinese herbal medicine slices according to the above weight proportions and wash with water; (2) adding water and decocting twice, the first time adding water is 10 times the weight of the Chinese medicine slice, decocting for 1-3 hours, the second time adding water is 8 times the weight of the Chinese medicine slice, decocting for 1-3 hours, filtering out the residue, combining the filtrate, and concentrating to a relative density of 1.10-1.20 at 25° C. to obtain a concentrated solution; (3) cooling the concentrated solution obtained in step (2), adding 95% ethanol, mixing into a mixed solution containing 50-60% ethanol concentration, refrigerating the mixed solution at 2-8° C. for 20-30 hours, and taking the supernatant; (4) The supernatant obtained in step (3) is concentrated under low temperature vacuum to a relative density of 1.20-1.30 at 25° C., spray dried, and excipients are added to prepare a traditional Chinese medicine preparation.

4. A Chinese medicine composition for treating oral ulcers as claimed in claim 3, characterized in that: The dosage form of Chinese medicine preparations is one of tablets, capsules, granules, and oral liquids.

5. Use of a Chinese medicine composition for treating oral ulcers as claimed in claim 1 in preparing a medicine for treating oral ulcers.

6. Use of a Chinese medicine composition for treating oral ulcers as claimed in claim 1 in preparing a drug for treating oral ulcers, wherein the syndrome of the oral ulcer is heat accumulation in the internal organs.

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