Traditional Chinese medicine composition for rapidly curing oral ulcer and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for rapidly curing oral ulcer and a preparation method thereof. The traditional Chinese medicine composition for rapidly curing oral ulcer is prepared from the following raw materials: akebiaquinata, divaricate saposhnikovia root, rehmannia, radix bupleuri, coptis chinensis, cinnamon, poria cocos, angelica sinensis and liquorice. According to the theory of traditional Chinese medicine, properties, flavors and meridians tropism and effects of traditional Chinese medicines, treatment based on syndrome differentiation and reasonable compatibility are achieved, all the traditional Chinese medicines give full play to the synergistic effect, and the oral ulcer can be effectively and rapidly cured with the purposes of clearing away heat and toxic materials, dissipating blood stasis, diminishing swelling, promoting tissue regeneration and relieving pain.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for quickly curing oral ulcers and a preparation method thereof. Background Art

[0002] Oral ulcers are common oral mucosal diseases in clinical practice. Low immunity, endocrine disorders, vitamin deficiency and indigestion can all cause oral ulcers. Oral ulcers mainly occur in the patient's lips and tongue, where keratinization is relatively weak. The incidence rate is high regardless of the season.

[0003] Types of oral ulcers include recurrent oral ulcers and traumatic oral ulcers. Traumatic oral ulcers are generally caused by mechanical injuries, chemical burns, and hot or cold stimulation from diet. The cause of oral ulcers is still unclear, and a variety of factors can induce them, including dietary habits, genetic factors, and immune factors, which seriously affect patients' daily life and work. Summary of the invention

[0004] The present invention aims to provide a Chinese medicine composition with reasonable compatibility for quickly curing oral ulcers and a preparation method thereof. The Chinese medicine composition for quickly curing oral ulcers of the present invention can significantly shorten the ulcer healing time, accelerate the healing speed of the ulcer surface, shorten the ulcer healing time, relieve pain, and provide a better product for clinical relief and curing of oral ulcers.

[0005] In order to achieve the above object, the present invention provides the following technical solutions:

[0006] The first object of the present invention is to provide a Chinese medicine composition for quickly curing oral ulcers.

[0007] The second object of the present invention is to provide a method for preparing the above-mentioned Chinese medicine composition for quickly curing oral ulcers.

[0008] The third object of the present invention is to provide the use of the above-mentioned Chinese medicine composition for quickly curing oral ulcers.

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

[0010] The invention provides a traditional Chinese medicine composition for quickly curing oral ulcers. The traditional Chinese medicine composition is prepared from akebia, siler, rehmannia root, bupleurum root, coptis root, cinnamon bark, tuckahoe, angelica root and liquorice.

[0011] Furthermore, the Chinese medicine composition for quickly curing oral ulcers is made of the following raw materials in parts by weight: 10-15 parts of Akebia, 10-15 parts of Saposhnikovia divaricata, 10-15 parts of Rehmannia glutinosa, 7-10 parts of Bupleurum chinense, 15-18 parts of Coptis chinensis, 10-15 parts of Cinnamon bark, 25-30 parts of Poria cocos, 30-35 parts of Angelica sinensis and 10-15 parts of Licorice.

[0012] Furthermore, the Chinese medicine composition for quickly curing oral ulcers is made of the following raw materials in parts by weight: 12 parts of Akebia, 12 parts of Saposhnikovia divaricata, 12 parts of Rehmannia glutinosa, 8 parts of Bupleurum chinense, 16 parts of Coptis chinensis, 12 parts of Cinnamon bark, 28 parts of Poria cocos, 32 parts of Angelica sinensis and 12 parts of Licorice.

[0013] The Chinese medicine composition of the present invention also includes pharmaceutically acceptable excipients, including but not limited to solvents, solubilizers, co-solvents, colorants, disintegrants, fillers, lubricants, wetting agents, stabilizers, flavoring agents, preservatives, suspending agents, coating materials, anti-adhesive agents, integrities, plasticizers, etc.

[0014] Furthermore, the dosage form of the Chinese medicine composition for quickly curing oral ulcers is decoction, granules, tablets, capsules, mixtures, syrups, pills, gels, powders or pastes.

[0015] Furthermore, the dosage form of the Chinese medicine composition for quickly curing oral ulcers is a decoction.

[0016] To achieve the second purpose, the technical solution adopted by the present invention is:

[0017] The preparation method of the Chinese medicine composition for quickly curing oral ulcers of the present invention is as follows: weighing raw materials according to the raw material ratio, adding water and boiling, and obtaining a decoction.

[0018] Furthermore, the preparation method of the present invention is as follows: weigh each raw medicinal material, crush it, soak it in water for 1-2 hours, decoct it twice, add water 5-8 times the total amount of medicinal materials each time, decoct it for 0.5-1.5 hours each time, and combine the two decoctions.

[0019] Furthermore, the preparation method of the present invention is as follows: weigh each raw medicinal material, crush it, soak it in water for 1.5 hours, boil it twice, add water 6 times the total amount of medicinal materials each time, boil it for 1 hour each time, and combine the two decoctions.

[0020] To achieve the third purpose, the technical solution adopted by the present invention is:

[0021] The present invention provides use of the Chinese medicinal composition for rapidly curing oral ulcers in preparing a medicine for treating oral ulcers.

[0022] The pharmacological effects of the raw materials in the Chinese medicine composition for quickly curing oral ulcers of the present invention are as follows:

[0023] Akebia: bitter in taste, cold in nature, enters the heart, small intestine, and bladder meridians, promotes diuresis and relieves stranguria, clears the heart and relieves restlessness, and promotes menstruation and lactation; used for stranguria, edema, restlessness and red urine, mouth and tongue ulcers, amenorrhea, oligolactation, and pain caused by damp-heat.

[0024] Saposhnikovia divaricata: spicy and sweet in taste, slightly warm in nature, enters the bladder, liver, and spleen meridians, can eliminate dampness, relieve pain, and stop spasms; used for colds and headaches, rheumatic pain, urticaria itching, and tetanus.

[0025] Rehmannia root: sweet and bitter in taste, cold in nature, enters the heart, liver and kidney meridians, clears away heat and cools blood, nourishes yin and produces body fluid; used for heat entering the blood, red tongue and thirst, macules, vomiting and bleeding, yin deficiency and internal heat, bone steaming and tuberculosis, thirst due to loss of body fluid, internal heat and polydipsia, and dry intestines and constipation.

[0026] Bupleurum: bitter in taste, slightly cold in nature, enters the liver and gallbladder meridians, harmonizes the exterior and interior, soothes the liver and raises yang; used for colds and fever, alternating chills and fever, malaria, liver depression and qi stagnation, and chest and rib pain.

[0027] Coptis chinensis: bitter in taste, cold in nature, enters the heart, spleen, stomach, liver, gallbladder, and large intestine meridians, clears away heat and dampness, purges fire and detoxifies; used for damp-heat and fullness, vomiting and acid regurgitation, diarrhea, jaundice, high fever and coma, hyperactivity of heart fire, restlessness and insomnia, vomiting and bleeding due to blood heat, red eyes, toothache, diabetes, carbuncles and furuncles.

[0028] Cinnamon bark: spicy in taste, warm in nature, enters the spleen, kidney, heart, and liver meridians, replenishes original yang, warms the spleen and stomach, removes accumulated cold, and unclogs blood vessels; it is used for deficiency of fire in the gate of life, cold limbs and weak pulse, yang loss and collapse, abdominal pain and diarrhea, cold hernia and running pig, cold pain in the waist and knees, amenorrhea, abdominal masses, yin carbuncle, leukorrhea, and floating of false yang, heat on the upper body and cold on the lower body.

[0029] Poria: It is mild in nature, sweet in taste, and enters the heart, spleen, kidney, and lung meridians. It can promote diuresis and eliminate dampness, strengthen the spleen, and calm the mind. It is used for edema, oliguria, phlegm and fluid, dizziness and palpitations, spleen deficiency, poor appetite, loose stools and diarrhea, restlessness, palpitations and insomnia.

[0030] Angelica: spicy and bitter in taste, warm in nature, enters the heart, liver, and spleen meridians, replenishes blood and promotes blood circulation, regulates menstruation and relieves pain, moisturizes and lubricates the intestines; used for irregular menstruation, amenorrhea, dysmenorrhea, accumulation of masses, metrorrhagia, abdominal pain due to deficiency and cold, paralysis, numbness of the skin, dry intestines and difficulty in defecation, heaviness after dysentery, carbuncles, ulcers, and injuries from falls.

[0031] Licorice: sweet in taste, neutral in nature, enters the heart, lung, spleen, and stomach meridians, tonifies the spleen and replenishes Qi, clears away heat and detoxifies, removes phlegm and relieves cough, relieves pain, and harmonizes various medicines; it is used for spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough with excessive sputum, cramps and pain in the abdomen and limbs, carbuncles and sores, and relieves the toxicity and potency of drugs.

[0032] Compared with the prior art, the present invention has the following beneficial effects:

[0033] The invention is based on traditional Chinese medicine theory, the nature, flavor, meridians and efficacy of traditional Chinese medicine, syndrome differentiation and treatment, and reasonable compatibility. The synergistic effect of multiple traditional Chinese medicines such as Akebia, Saposhnikovia, Rehmannia, Bupleurum, Coptis, Cinnamon, Poria, Angelica and Licorice is fully exerted, with the purpose of clearing away heat and detoxifying, dispersing blood stasis and relieving swelling, promoting tissue regeneration and relieving pain, and can effectively and quickly cure oral ulcers.

[0034] Experiments show that the Chinese medicine composition of the present invention can significantly shorten the ulcer healing time, accelerate the healing speed of the ulcer surface, shorten the ulcer healing time, and relieve pain, providing a better product for clinical relief and healing of oral ulcers. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 Comparison of the number of ulcers in rats in each group. Different lowercase letters above the bar graph indicate significant differences among different groups (P<0.05).

[0036] Figure 2 Comparison of the interval time of rats in each group. Different lowercase letters above the bar graph indicate significant differences among different groups (P<0.05).

[0037] Figure 3 Comparison of clinical efficacy between the two groups.

[0038] Figure 4 Comparison of ulcer healing time between the two groups. Different lowercase letters above the bar graph indicate significant differences between the different groups (P<0.05).

[0039] Figure 5 Comparison of pain levels between the two groups, compared with before treatment, ** P<0.01, compared with the control group, ## P<0.01. DETAILED DESCRIPTION

[0040] The embodiments of the present invention will be described in detail below with reference to examples, but those skilled in the art will appreciate that the following examples are only used to illustrate the present invention and should not be construed as limiting the scope of the present invention.

[0041] Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0042] Example 1

[0043] Akebia 12g, Saposhnikovia 12g, Rehmannia glutinosa 12g, Bupleurum 8g, Coptis chinensis 16g, Cinnamon bark 12g, Poria 28g, Angelica sinensis 32g and Licorice root 12g.

[0044] The preparation method is as follows: weigh each raw medicinal material, crush it, soak it in water for 1.5 hours, decoct it twice, add water 6 times the total amount of medicinal materials each time, decoct it for 1 hour each time, and combine the two decoctions.

[0045] Example 2

[0046] Akebia 10g, Saposhnikovia 15g, Rehmannia glutinosa 15g, Bupleurum 7g, Coptis chinensis 15g, Cinnamon bark 15g, Poria 25g, Angelica sinensis 35g and Licorice root 15g.

[0047] The preparation method is as follows: weigh each raw medicinal material, crush it, soak it in water for 1 hour, decoct it twice, the amount of water added each time is 6 times the total amount of the medicinal material, decoct it for 1 hour each time, and combine the two decoctions.

[0048] Example 3

[0049] Akebia 15g, Saposhnikovia 10g, Rehmannia glutinosa 10g, Bupleurum 10g, Coptis chinensis 18g, Cinnamon bark 10g, Poria 30g, Angelica 30g and Licorice 10g.

[0050] The preparation method is as follows: weigh each raw medicinal material, crush it, soak it in water for 1.5 hours, decoct it twice, add 5 times the amount of water to the total amount of medicinal materials each time, decoct it for 0.5 hours each time, and combine the two decoctions.

[0051] Example 4

[0052] Akebia 12g, Saposhnikovia 15g, Rehmannia glutinosa 10g, Bupleurum 8g, Coptis chinensis 15g, Cinnamon bark 10g, Poria 25g, Angelica sinensis 30g and Licorice root 15g.

[0053] The preparation method is as follows: weigh each raw medicinal material, crush it, soak it in water for 1.5 hours, decoct it twice, add water 5 times the total amount of medicinal materials each time, decoct it for 0.5 hours each time, and combine the two decoctions.

[0054] Example 5

[0055] Akebia 10g, Saposhnikovia 12g, Rehmannia glutinosa 12g, Bupleurum 10g, Coptis chinensis 18g, Cinnamon bark 12g, Poria 30g, Angelica 30g and Licorice 10g.

[0056] The preparation method is as follows: weigh each raw medicinal material, crush it, soak it in water for 2 hours, decoct it twice, the amount of water added each time is 8 times the total amount of the medicinal material, decoct it for 1 hour each time, and combine the two decoctions.

[0057] Example 6

[0058] Akebia 10g, Saposhnikovia 10g, Rehmannia glutinosa 12g, Bupleurum 7g, Coptis chinensis 16g, Cinnamon bark 15g, Poria 28g, Angelica sinensis 30g and Licorice root 12g.

[0059] The preparation method is as follows: weigh each raw medicinal material, crush it, soak it in water for 1.5 hours, decoct it twice, add water 6 times the total amount of medicinal materials each time, decoct it for 1 hour each time, and combine the two decoctions.

[0060] Example 7

[0061] Akebia 10g, Saposhnikovia 15g, Rehmannia glutinosa 12g, Bupleurum 10g, Coptis chinensis 15g, Cinnamon bark 12g, Poria 25g, Angelica sinensis 32g and Licorice root 15g.

[0062] The preparation method is as follows: weigh each raw medicinal material, crush it, soak it in water for 2 hours, decoct it twice, add 8 times the amount of water to the total amount of the medicinal material each time, decoct it for 1.5 hours each time, and combine the two decoctions.

[0063] Comparative Example 1

[0064] Saposhnikovia 24g, Rehmannia glutinosa 12g, Bupleurum 8g, Coptis chinensis 16g, Cinnamon bark 12g, Poria 28g, Angelica sinensis 32g and Licorice root 12g.

[0065] Compared with Example 1, the difference is that Akebia is not contained and the amount of Saposhnikovia divaricata is increased.

[0066] The preparation method is similar to that of Example 1.

[0067] Comparative Example 2

[0068] Akebia 12g, Rehmannia glutinosa 24g, Bupleurum 8g, Coptis chinensis 22g, Cinnamon bark 12g, Poria 28g, Angelica sinensis 32g and Licorice root 12g.

[0069] Compared with Example 1, the difference is that Saposhnikovia divaricata is not contained and the dosage of Rehmannia glutinosa is increased.

[0070] The preparation method is similar to that of Example 1.

[0071] Comparative Example 3

[0072] Akebia 12g, Saposhnikovia 12g, Rehmannia glutinosa 12g, Bupleurum 8g, Coptis chinensis 22g, Poria 34g, Angelica 32g and Licorice 12g.

[0073] Compared with Example 1, the difference is that cinnamon bark is not contained, and the dosage of coptis root and poria is increased.

[0074] The preparation method is similar to that of Example 1.

[0075] Efficacy Example 1 Experimental study on the effect of the Chinese medicine composition of the present invention on oral ulcer model rats

[0076] 1. Establishment of rat oral ulcer model

[0077] 60 SPF SD rats, weighing 160-200g, were anesthetized and the oral mucosa was peeled off. 0.1mol / L PBS buffer (pH7.4) was added to make a tissue homogenate. The tissue homogenate was mixed with Freund's adjuvant in equal proportions to make an antigen emulsifier for immunizing animals. The hair on both sides of the spine of each group of rats was cut off, disinfected with iodine, and 0.1ml of antigen emulsifier was subcutaneously injected on each side, once a week, for 3 times. The changes in the oral mucosa of the rats were observed. One week after the third injection of antigen emulsion, oral ulcers appeared in the rat models of each group.

[0078] The rats after modeling were randomly divided into a model control group, Example 1 group, Example 2 group, Comparative Example 1 group, Comparative Example 2 group, and Comparative Example 3 group, with 10 rats in each group.

[0079] After modeling, each drug group was gavaged with 8 g / kg of the corresponding drug once a day for 6 consecutive days. The model control group was gavaged with an equal volume of normal saline.

[0080] 2.Indicator observation

[0081] The number and interval of ulcers in each group of rats were observed and recorded.

[0082] 3. Statistical methods

[0083] Graphpad Prism 9.0 software was used for data processing, and the measured data were expressed as mean ± standard deviation. One-way analysis of variance was used for comparison among multiple groups, and SNK-q was used for pairwise comparison among groups. The difference was considered statistically significant when P < 0.05.

[0084] 4. Experimental Results

[0085] Compared with the model control group, the number of rats with oral ulcers in Example 1 and Example 2 groups was significantly reduced, and the effect of reducing the number of oral ulcers in Example 1 and Example 2 groups was significantly better than that in each control group. Figure 1 .

[0086] Compared with the model control group, the interval between ulcers in the rats in Example 1 and Example 2 was significantly prolonged, and the effect of prolonging the interval between ulcers in Example 1 and Example 2 was significantly better than that in the control group. Figure 2 .

[0087] After the oral ulcer model rats were treated with the Chinese medicinal composition for quickly curing oral ulcers of the present invention, the number of oral ulcers in the rats was significantly reduced and the interval between ulcers was prolonged. The Chinese medicinal composition of the present invention has a positive therapeutic effect on oral ulcers.

[0088] Clinical example: Observation on the therapeutic effect of the Chinese medicine composition of the present invention on patients with oral ulcers

[0089] 1. Materials and Methods

[0090] 1. General Information

[0091] A total of 80 patients with oral ulcers admitted to our hospital were selected as research subjects and randomly divided into a control group and a treatment group, with 40 people in each group. There were 18 males and 22 females in the control group, with an average age of (48.9±9.5) years old; there were 20 males and 20 females in the treatment group, with an average age of (47.2±8.6) years old.

[0092] There was no statistical difference in the general information of patients in each group (P>0.05), and they were comparable.

[0093] 2. Inclusion criteria

[0094] The patient was diagnosed with oral ulcers; the clinical data were complete; the patient had no allergic symptoms to the drugs used; the patient and his family were informed of this study and signed the informed consent.

[0095] 3. Exclusion criteria

[0096] Patients with drug allergies; patients with other oral diseases; patients with mental illness; patients with severe systemic and psychological diseases; patients participating in other research during treatment; patients with immune system diseases, etc.

[0097] 4. Treatment Methods

[0098] Patients in the control group took the Chinese medicine ulcer capsules orally, 0.4g per capsule, 5 capsules each time, 3 times a day.

[0099] The patients in the treatment group took the decoction of Example 1 orally, once in the morning and once in the evening.

[0100] Both groups were treated for 7 days.

[0101] 5. Observation indicators

[0102] 5.1 Clinical efficacy

[0103] Markedly effective: the local severe burning pain disappeared or improved significantly, and the healing range was ≥80%; effective: the local severe burning pain was improved, and the healing range was 30%-79%; ineffective: the local severe burning pain did not change or worsened, and the healing range was <30%.

[0104] Total effective rate = (number of markedly effective + effective) cases / total number of cases × 100%.

[0105] 5.2 Ulcer healing time

[0106] Record the time it takes for the ulcer surface to gradually decrease or disappear and the surrounding tissue to no longer become red or swollen.

[0107] 5.3 Ulcer pain degree

[0108] The degree of ulcer pain of patients before and after treatment was determined by VAS score, which ranged from 0 to 10. The higher the score, the more severe the pain.

[0109] 6. Statistical methods

[0110] SPSS 22.0 software was used for data processing. The data of each group were subjected to normal distribution test and variance homogeneity test, and the inter-group comparison was performed with one-way analysis of variance, with P < 0.05 as the difference being statistically significant.

[0111] 2. Results

[0112] 1. Comparison of clinical efficacy between the two groups

[0113] Table 1 Comparison of clinical efficacy

[0114]

[0115]

[0116] Depend on Figure 3 As shown in Table 1, the total effective rate of the control group was 82.5%, and the total effective rate of the treatment group was 95.0%. The clinical efficacy of the treatment group in improving oral ulcer patients was significantly better than that of the control group.

[0117] 2. Comparison of ulcer healing time between the two groups

[0118] The ulcer healing time of the treatment group was (3.5±0.3) days, and the ulcer healing time of the control group was (5.6±1.1) days, and the difference between the two groups was statistically significant. Figure 4 .

[0119] 3. Comparison of pain levels between the two groups

[0120] Before treatment, there was no significant difference in VAS scores between the two groups; after treatment, the VAS scores of the treatment group were lower than those of the control group, and the difference was statistically significant. Figure 5 .

[0121] The Chinese medicine composition of the present invention can significantly shorten the ulcer healing time, accelerate the healing speed of the ulcer surface, shorten the ulcer healing time, relieve pain, and provide a better product for clinical relief and healing of oral ulcers.

[0122] The present invention has been described in detail above by general description and specific embodiments, but it is obvious to those skilled in the art that some modifications or improvements can be made on the basis of the present invention. Therefore, these modifications or improvements made on the basis of not departing from the spirit of the present invention all belong to the scope of protection claimed by the present invention.

Claims

1. A Chinese medicine composition for quickly curing oral ulcers, characterized in that: The Chinese medicine composition for quickly curing oral ulcers is prepared from the following raw materials in parts by weight: 10-15 parts of Akebia, 10-15 parts of Saposhnikovia divaricata, 10-15 parts of Rehmannia root, 7-10 parts of Bupleurum root, 15-18 parts of Coptis chinensis, 10-15 parts of Cinnamon bark, 25-30 parts of Poria cocos, 30-35 parts of Angelica sinensis and 10-15 parts of Licorice root.

2. A Chinese medicine composition for quickly curing oral ulcers according to claim 1, characterized in that: The Chinese medicine composition for quickly curing oral ulcers is prepared from the following raw materials in parts by weight: 12 parts of Akebia, 12 parts of Saposhnikovia, 12 parts of Rehmannia, 8 parts of Bupleurum, 16 parts of Coptis, 12 parts of Cinnamon, 28 parts of Poria, 32 parts of Angelica and 12 parts of Licorice.

3. A Chinese medicine composition for quickly curing oral ulcers according to claim 1 or 2, characterized in that: The Chinese medicine composition for rapidly curing oral ulcers also includes pharmaceutically acceptable adjuvants.

4. A Chinese medicine composition for quickly curing oral ulcers according to claim 3, characterized in that: The Chinese medicine composition for rapidly curing oral ulcers is a clinically acceptable dosage form.

5. A Chinese medicine composition for quickly curing oral ulcers according to claim 4, characterized in that: The dosage form of the Chinese medicine composition for quickly curing oral ulcers is decoction, granules, tablets, capsules, mixtures, syrups, pills, gels, powders or pastes.

6. A Chinese medicine composition for quickly curing oral ulcers according to claim 5, characterized in that: The dosage form of the Chinese medicine composition for quickly curing oral ulcers is a decoction.

7. A Chinese medicine composition for quickly curing oral ulcers according to claim 1 or 2, characterized in that: The preparation method of the Chinese medicine composition for quickly curing oral ulcers is as follows: weigh each raw medicinal material, crush it, soak it in water for 1-2 hours, decoct it twice, add water 5-8 times the total amount of medicinal materials each time, decoct it for 0.5-1.5 hours each time, and combine the two decoctions.

8. A Chinese medicine composition for rapidly curing oral ulcers according to claim 7, characterized in that: The preparation method of the Chinese medicine composition for quickly curing oral ulcers is as follows: weigh each raw medicinal material, crush it, soak it in water for 1.5 hours, decoct it twice, add water 6 times the total amount of medicinal materials each time, decoct it for 1 hour each time, and combine the two decoctions.

9. Use of the Chinese medicinal composition for rapidly curing oral ulcers according to claim 1 or 2 in preparing a medicine for treating oral ulcers.

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