CN109620923B

CN109620923B - Traditional Chinese medicine composition for treating recurrent oral ulcer and application thereof

Info

Publication number: CN109620923B
Application number: CN201910097983.8A
Authority: CN
Inventors: 顾思臻; 窦丹波; 焦露露; 薛艳
Original assignee: Shuguang Hospital Affiliated to Shanghai University of TCM
Current assignee: Shuguang Hospital Affiliated to Shanghai University of TCM
Priority date: 2019-01-31
Filing date: 2019-01-31
Publication date: 2021-05-25
Anticipated expiration: 2039-01-31
Also published as: CN109620923A

Abstract

The invention relates to a traditional Chinese medicine composition for treating recurrent oral ulcer, which comprises the following raw material medicines: radix astragali, Gypsum Fibrosum, rhizoma anemarrhenae, radix rehmanniae, rhizoma Smilacis Glabrae, homo, rhizoma picrorhizae, folium Bambusae, rhizoma Bistortae, radix Paeoniae Rubra, cortex moutan, and BIYUSAN. The invention also provides application of the traditional Chinese medicine composition in preparing a medicine for treating recurrent oral ulcer. Its advantages are: 1. the selected raw material medicines of the invention have accurate and complete dialectics and good curative effect. 2. The traditional Chinese medicine composition and the proportion thereof have the advantage of obvious effect after experimental screening. 3. The raw material medicines of the invention have wide sources, the preparation method is simple and the cost is low. The effect is obvious.

Description

Traditional Chinese medicine composition for treating recurrent oral ulcer and application thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating recurrent oral ulcer and application thereof.

Background

Recurrent oral ulceration is a periodic episode of the oral mucosa, isolated circular or oval ulcerations, one of the most common conditions of oral mucosal disease. The prevalence rate in the population is generally considered to be over 10%, and can occur in all ages, most common in young and middle-aged people. It can occur in any part of the oral mucosa, and is common to lips, cheeks and tongues, and severe cases can involve the pharyngeal mucosa. The symptoms are related to endocrine disturbance, low immunity, genetic factors and nutritional factors. The oral ulcer not only brings endless pain to patients due to severe burning pain and repeated attack, but also poses great threat to local and physical and psychological health. At present, more medicaments are used for treating recurrent oral ulcer at home and abroad, but the medicaments have the defects of high price, high treatment cost, unsatisfactory effect and the like.

The Chinese patent application: CN104645300A discloses a traditional Chinese medicine decoction for treating recurrent oral ulcer, which belongs to the technical field of traditional Chinese medicine preparations, and the raw materials of the decoction are moxibustion wormwood, processed pinellia tuber, raw astragalus root, coptis root, angelica, platycodon root, lightyellow sophora root, dried ginger, red ginseng, liquorice, asarum and bezoar.

In addition, the compound chlorhexidine gargle, vitamin C, vitamin E, and the three-link tablet can be used for treating oral ulcer, but the medicines have the defects of high cost, poor treatment effect and extremely high recurrence rate.

Therefore, aiming at the existing problems, the inventor researches a traditional Chinese medicine for treating recurrent oral ulcer, and the traditional Chinese medicine has the advantages of low cost and good curative effect.

Disclosure of Invention

The first purpose of the present invention is to provide a traditional Chinese medicine composition for treating recurrent oral ulcer, which aims at overcoming the defects of the prior art.

The second purpose of the present invention is to provide the application of the above-mentioned Chinese medicinal composition to overcome the disadvantages of the prior art.

The third purpose of the invention is to provide a traditional Chinese medicine for treating recurrent oral ulcer aiming at the defects of the prior art.

In order to achieve the first purpose, the invention adopts the technical scheme that:

a traditional Chinese medicine composition for treating recurrent oral ulcer is prepared from the following raw material medicines in parts by weight: 5-25 parts of raw astragalus membranaceus, 5-25 parts of gypsum, 3-15 parts of rhizoma anemarrhenae, 5-25 parts of radix rehmanniae, 20-40 parts of rhizoma smilacis glabrae, 1-11 parts of Renzhongbai, 3-15 parts of rhizoma picrorhizae, 3-15 parts of lophatherum gracile, 5-25 parts of bistort, 2-22 parts of radix paeoniae rubra, 3-15 parts of cortex moutan and 5-25 parts of japanese powder.

As a preferred embodiment of the invention, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 10-20 parts of raw astragalus membranaceus, 10-20 parts of gypsum, 6-12 parts of rhizoma anemarrhenae, 10-20 parts of radix rehmanniae, 25-35 parts of rhizoma smilacis glabrae, 3-9 parts of human urine sediment, 6-12 parts of rhizoma picrorhizae, 6-12 parts of lophatherum gracile, 10-20 parts of bistort rhizome, 7-17 parts of radix paeoniae rubra, 6-12 parts of cortex moutan and 10-20 parts of jasper powder.

As a preferred embodiment of the invention, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 15 parts of raw astragalus membranaceus, 15 parts of gypsum, 9 parts of rhizoma anemarrhenae, 15 parts of radix rehmanniae, 30 parts of rhizoma smilacis glabrae, 6 parts of human urine sediment, 9 parts of rhizoma picrorhizae, 9 parts of lophatherum gracile, 15 parts of bistort rhizome, 12 parts of radix paeoniae rubra, 9 parts of cortex moutan and 15 parts of jade powder.

As a preferred embodiment of the invention, the Chinese medicinal preparation is prepared into a clinically acceptable medicinal preparation according to a conventional Chinese medicinal preparation method.

As a preferred embodiment of the present invention, the pharmaceutical preparation is granules, powders, capsules, tablets, mixtures or oral liquids.

In order to achieve the second object, the invention adopts the technical scheme that:

the application of the traditional Chinese medicine composition in preparing a medicine for treating recurrent oral ulcer.

In order to achieve the third object, the invention adopts the technical scheme that:

a traditional Chinese medicine for treating recurrent oral ulcer is prepared from the traditional Chinese medicine composition.

As a preferred embodiment of the invention, the preparation method of the traditional Chinese medicine comprises the following steps:

(1) selecting a pottery medicine decocting pot with proper size, adding 15 g of raw astragalus root, 15 g of gypsum, 9 g of rhizoma anemarrhenae and 15 g of radix rehmanniae, adding 1500 ml of water, boiling with strong fire, and decocting with slow fire for 0.5-1.5 hours;

(2) adding rhizoma Smilacis Glabrae 30 g, homo 6 g, rhizoma picrorhizae 9 g, folium Bambusae 9 g, rhizoma Bistortae 15 g, radix Paeoniae Rubra 12 g, and cortex moutan 9 g, boiling with strong fire, and decocting with slow fire for 20-40 min;

(3) adding 15 g of jade powder, and decocting for 40 minutes with strong fire;

(4) leaching out juice, precipitating, collecting clear liquid, and bottling;

(5) the whole preparation process only needs to be decocted once.

baking 15 g of raw astragalus root, 15 g of gypsum, 9 g of rhizoma anemarrhenae, 15 g of dried rehmannia root, 30 g of glabrous greenbrier rhizome, 6 g of Renzhongbai, 9 g of figwortflower picrorhiza rhizome, 9 g of common lophatherum herb, 15 g of bistort rhizome, 12 g of red paeony root and 9 g of tree peony bark, grinding into fine medicinal powder, mixing with 15 g of Biyusan, sieving by a 120-mesh sieve, and bottling for later use to obtain the powder.

Raw astragalus root: invigorating qi, healing sore, removing toxic materials, and promoting granulation;

gypsum and rhizoma anemarrhenae are the meanings of white tiger, clear and purge yang-bright (stomach) excess heat, and radix rehmanniae, cortex moutan and radix paeoniae rubra nourish yin (kidney) to clear heat, and are used for treating deficiency fire flaring up, and the five medicines are combined, have the meanings similar to Yunv Jian, and have the meanings of qi and nutrient, so that pathogenic heat can be transmitted to heat and transformed into qi from qi system and blood system, and aphtha can be promoted to heal; the surrender of the six medicines is combined with the theory of ' mouth and tongue sores, which is proposed by Jingyue quan Shu & kou & lingua ' that the heat of the upper jiao is mostly strengthened, the heat is preferably cleared away, but the patients with excessive wine color, overstrain, weak pulse and deficiency of middle-qi can not be treated by cold and cool, so the medicine can not take effect after long-term use, or tonify heart and spleen, or nourish kidney water … … '; the bamboo leaves and the radix rehmanniae are matched to conduct red blood;

the jade powder contains natural indigo, Liuyi powder, natural indigo enters the liver, the heat clearing and toxicity is strong, Liuyi powder eliminates ulcer yellow fur, the Lophatherum gracile enables excess heat and damp heat to be removed from urine, and the jade powder has good effect of being externally applied to sores and can clear pathogenic fire of five internal organs which are easy to be over;

rhizoma smilacis glabrae and rhizoma hominis are special medicines for dental ulcer, and the rhizoma smilacis glabrae is sweet and light in taste and mild in nature and has the effects of clearing heat and removing dampness, and is commonly used for treating rheumatic immune diseases to regulate and inhibit immunity; white in the middle, salty and cool in nature, entering foot jueyin, taiyin, shaoyin and taiyang meridians. Compendium of materia Medica is called: "lowering ministerial fire, removing blood stasis and blood stasis, salty in the lid and moistening the lower part, so it is also effective in treating various sores on the mouth and tongue, and the test for lowering fire";

bidens bipinnata is good at cooling blood and clearing heat, because the cross section of the Bidens bipinnata is red and purple, and the rhizome of the Bidens bipinnata is similar to that of paris polyphylla, also called as the special medicine for stomatitis recommended by Mr. Ye-Juquan, the Bidens bipinnata is decocted in folk to be gargled to treat dental ulcer; picrorhiza rhizome, although bitter and cold, has a weak and pure bitter taste, is more excellent in treating aphtha than coptis root, has a stronger effect of clearing heat and eliminating dampness than coptis root, and has the effects of removing deficiency heat and benefiting yin, and is similar to phellodendron bark and rhizoma anemarrhenae. This is true for the pathogenesis of oral ulcers.

The human body is a whole body, and the lung and the liver are closely connected by deficiency and excess of the specimen, so that the syndrome differentiation and the type differentiation of the recurrent oral ulcer in the traditional Chinese medicine often do not exist independently, but appear by mixing and combining with each other. This means that, in terms of liver-lung dialectics, there is a more or less common syndrome type between each individual with recurrent oral ulceration and the whole liver and lung, and the degree of the syndrome type is slightly different.

The invention has the advantages that:

1. the traditional Chinese medicine composition disclosed by the invention is used for treating both cold and heat, has accurate and complete dialectics, takes effect together, is suitable for most patients, can be prepared into clinically acceptable preparation types, and is convenient to take.

2. The traditional Chinese medicine composition and the proportion thereof have the advantage of obvious effect after experimental screening.

3. The selected raw material medicines of the invention have accurate and complete dialectics, good curative effect and no toxic or side effect, and can treat both symptoms and root causes.

4. The raw material medicines of the invention have wide sources, the preparation method is simple and the cost is low. The traditional Chinese medicine has obvious effect, and the result of treatment by using the traditional Chinese medicine shows that the ulcer area is obviously reduced, the number is obviously reduced, the symptoms such as congestion, pain and the like are obviously relieved, the recurrence is greatly reduced, and the process of recovering the health of a patient is accelerated.

Drawings

FIG. 1 shows the results of the analysis of the pre-and post-treatment interval between the onset of 50 patients with recurrent oral ulceration.

Detailed Description

The invention will be further illustrated with reference to specific embodiments. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Furthermore, it should be understood that various changes and modifications can be made by those skilled in the art after reading the disclosure of the present invention, and equivalents fall within the scope of the appended claims.

EXAMPLE 1 Chinese medicinal composition for treating recurrent oral ulceration

Taking the following traditional Chinese medicine raw materials in parts by weight: 15 parts of raw astragalus membranaceus, 15 parts of gypsum, 9 parts of rhizoma anemarrhenae, 15 parts of radix rehmanniae, 30 parts of rhizoma smilacis glabrae, 6 parts of human urine sediment, 9 parts of rhizoma picrorhizae, 9 parts of lophatherum gracile, 15 parts of bistort rhizome, 12 parts of radix paeoniae rubra, 9 parts of cortex moutan and 15 parts of jade powder.

Example 2 Chinese medicinal composition for treating recurrent oral ulceration

Taking the following traditional Chinese medicine raw materials in parts by weight: 5 parts of raw astragalus membranaceus, 25 parts of gypsum, 3 parts of rhizoma anemarrhenae, 25 parts of radix rehmanniae, 20 parts of rhizoma smilacis glabrae, 11 parts of Renzhongbai, 3 parts of rhizoma picrorhizae, 15 parts of lophatherum gracile, 5 parts of bistort rhizome, 22 parts of radix paeoniae rubra, 3 parts of cortex moutan and 25 parts of jade powder.

Example 3 Chinese medicinal composition for treating recurrent oral ulceration

Taking the following traditional Chinese medicine raw materials in parts by weight: 25 parts of raw astragalus membranaceus, 5 parts of gypsum, 15 parts of rhizoma anemarrhenae, 5 parts of radix rehmanniae, 40 parts of rhizoma smilacis glabrae, 1 part of Renzhongbai, 15 parts of rhizoma picrorhizae, 3 parts of lophatherum gracile, 25 parts of bistort rhizome, 2 parts of radix paeoniae rubra, 15 parts of cortex moutan and 5 parts of jade powder.

Example 4 Chinese medicinal composition for treating recurrent oral ulceration (IV)

Taking the following traditional Chinese medicine raw materials in parts by weight: 5 parts of raw astragalus membranaceus, 5 parts of gypsum, 3 parts of rhizoma anemarrhenae, 5 parts of radix rehmanniae, 20 parts of rhizoma smilacis glabrae, 1 part of Renzhongbai, 15 parts of rhizoma picrorhizae, 15 parts of lophatherum gracile, 25 parts of bistort rhizome, 22 parts of radix paeoniae rubra, 15 parts of cortex moutan and 25 parts of jade powder.

Example 5 Chinese medicinal composition for treating recurrent oral ulceration (V)

Taking the following traditional Chinese medicine raw materials in parts by weight: 25 parts of raw astragalus membranaceus, 25 parts of gypsum, 15 parts of rhizoma anemarrhenae, 25 parts of radix rehmanniae, 40 parts of rhizoma smilacis glabrae, 11 parts of human urine sediment, 3 parts of rhizoma picrorhizae, 3 parts of lophatherum gracile, 5 parts of bistort rhizome, 2 parts of radix paeoniae rubra, 3 parts of cortex moutan and 5 parts of jade powder.

Example 6 Chinese medicinal composition for treating recurrent oral ulceration (VI)

Taking the following traditional Chinese medicine raw materials in parts by weight: 10 parts of raw astragalus membranaceus, 10 parts of gypsum, 6 parts of rhizoma anemarrhenae, 10 parts of radix rehmanniae, 25 parts of rhizoma smilacis glabrae, 3 parts of human urine sediment, 12 parts of rhizoma picrorhizae, 12 parts of lophatherum gracile, 20 parts of bistort rhizome, 17 parts of radix paeoniae rubra, 12 parts of cortex moutan and 20 parts of jade powder.

Example 7 Chinese medicinal composition for treating recurrent oral ulceration

Taking the following traditional Chinese medicine raw materials in parts by weight: 20 parts of raw astragalus membranaceus, 20 parts of gypsum, 12 parts of rhizoma anemarrhenae, 20 parts of radix rehmanniae, 35 parts of rhizoma smilacis glabrae, 9 parts of human urine sediment, 6 parts of rhizoma picrorhizae, 6 parts of lophatherum gracile, 10 parts of bistort rhizome, 7 parts of radix paeoniae rubra, 6 parts of cortex moutan and 10 parts of jade powder.

EXAMPLE 8 Chinese medicinal composition (eight) for treating recurrent oral ulceration

Taking the following traditional Chinese medicine raw materials in parts by weight: 10 parts of raw astragalus membranaceus, 20 parts of gypsum, 6 parts of rhizoma anemarrhenae, 20 parts of radix rehmanniae, 25 parts of rhizoma smilacis glabrae, 9 parts of human urine sediment, 6 parts of rhizoma picrorhizae, 12 parts of lophatherum gracile, 10 parts of bistort rhizome, 17 parts of red paeony root, 6 parts of cortex moutan and 20 parts of jade powder.

Example 9 Chinese medicinal composition for treating recurrent oral ulceration (nine)

Taking the following traditional Chinese medicine raw materials in parts by weight: 20 parts of raw astragalus membranaceus, 10 parts of gypsum, 12 parts of rhizoma anemarrhenae, 10 parts of radix rehmanniae, 35 parts of rhizoma smilacis glabrae, 3 parts of human urine sediment, 12 parts of rhizoma picrorhizae, 6 parts of lophatherum gracile, 20 parts of bistort rhizome, 7 parts of radix paeoniae rubra, 12 parts of cortex moutan and 10 parts of jade powder.

EXAMPLE 10 preparation of decoction

The Chinese medicinal composition of any one of embodiments 1 to 9 is taken and added with water to be decocted according to a conventional method. The Chinese medicinal materials are taken according to the weight part ratio, and are decocted into decoction by adding water.

EXAMPLE 11 preparation of powders

EXAMPLE 12 preparation of granules

Selecting a pottery medicine decocting pot with proper size, adding 15 g of raw astragalus root, 15 g of gypsum, 9 g of rhizoma anemarrhenae and 15 g of radix rehmanniae, adding 1500 ml of water, boiling with strong fire, and decocting with slow fire for 0.5-1.5 hours; adding rhizoma Smilacis Glabrae 30 g, homo 6 g, rhizoma picrorhizae 9 g, folium Bambusae 9 g, rhizoma Bistortae 15 g, radix Paeoniae Rubra 12 g, and cortex moutan 9 g, boiling with strong fire, and decocting with slow fire for 20-40 min; adding 15 g of jade powder, and decocting for 40 minutes with strong fire; draining juice, precipitating to obtain clear solution, concentrating the clear solution into fluid extract, and making into granule. The whole preparation process only needs to be decocted once.

EXAMPLE 13 preparation of tablets/capsules

Selecting a pottery medicine decocting pot with proper size, adding 15 g of raw astragalus root, 15 g of gypsum, 9 g of rhizoma anemarrhenae and 15 g of radix rehmanniae, adding 1500 ml of water, boiling with strong fire, and decocting with slow fire for 0.5-1.5 hours; adding rhizoma Smilacis Glabrae 30 g, homo 6 g, rhizoma picrorhizae 9 g, folium Bambusae 9 g, rhizoma Bistortae 15 g, radix Paeoniae Rubra 12 g, and cortex moutan 9 g, boiling with strong fire, and decocting with slow fire for 20-40 min; adding 15 g of jade powder, and decocting for 40 minutes with strong fire; leaching out juice, precipitating, taking clear liquid, and concentrating the clear liquid into thick extract; adding pharmaceutical adjuvants, vacuum drying, pulverizing, granulating, and making into tablet or capsule. The whole preparation process only needs to be decocted once.

EXAMPLE 14 clinical trial one

1 data of

1.1 general data

50 patients with recurrent oral ulceration were selected for visits by the affiliated eosin hospital of Shanghai medical university between 2016 and 2017, 11 months. The basic condition, age, course and the like of 50 patients have no significant difference.

1.2 diagnostic criteria

Ulcers, pains, burning sensation, dry mouth and throat, feverish palms and soles, soreness and weakness of waist and knees, spontaneous perspiration, yellow urine, dry stool, palpitation, chest distress, chest pain, dizziness, insomnia, dreaminess, vexation, irritability, nasal itching, nasal obstruction, bitter taste in the mouth and lusterless complexion.

1.3 inclusion criteria

(1) No infection, no allergy to the drug, and no mental disorder.

(2) Meets the diagnosis standard of recurrent oral ulcer.

(3) The patients who do not use the same kind of medicines before treatment and do not perform other similar medicine testers;

(4) completing informed consent and related notification.

1.4 termination and withdrawal of clinical trial criteria: other diseases appear in the test, affecting the test performers; other situations are not foreseeable.

2 method

2.1 methods of treatment

50 patients were given the following treatments: the traditional Chinese medicine composition in the embodiment 1 is taken and added with water to be decocted according to a conventional method. The traditional Chinese medicine raw materials are taken according to the weight part ratio, water is added for decoction, one dose is taken twice every day, and the decoction is respectively taken half an hour before breakfast and one hour after supper. Three months are taken as a course of treatment, and 50 patients all take the medicine for one course of treatment. Follow-up observations and recordings were made during dosing.

Observation indexes are as follows: the method comprises the analysis of the recent and the long-term curative effects of 50 patients with recurrent oral ulcer.

Recent efficacy analysis in 50 patients with recurrent oral ulceration: comparing the local integral of the initial ulcer and the recurrent ulcer after treatment; the pre-treatment systemic symptom score is compared to the post-treatment score.

Long-term efficacy analysis of 50 patients with recurrent oral ulceration: all cases were followed for three months and the recurrence of ulcers was observed.

(the initial local integral method, the local integral method after treatment, the initial whole body integral method and the whole body integral method after one treatment period are respectively shown in tables 1, 2, 3 and 4).

2.2 Scoring criteria

2.2.1 the initial local integration method is shown in Table 1:

TABLE 1 preliminary local integration method

2.2.2 the local integration method after treatment is shown in Table 2:

TABLE 2 local integration method for recurrence after treatment

2.2.3 Primary diagnosis Total body integration method is shown in Table 3:

TABLE 3 preliminary diagnosis Total integral method

2.2.4 Total body integration method after one treatment period is shown in Table 4:

TABLE 4 Total body integration method after one treatment period

2.3 therapeutic efficacy criteria

And (3) clinical control: after treatment, the symptoms disappear, and the disease does not relapse after the follow-up visit for 3 months.

The effect is shown: the time of attack intermission after treatment is prolonged by more than 1 time compared with that before treatment, the general symptoms are improved, local symptoms are relieved when the disease recurs, the healing time is shortened, and the general symptoms are improved.

The method has the following advantages: the intermittent time of attack after treatment is prolonged, but less than 1 time, the general symptoms are improved, local symptoms are relieved when the disease recurs, the healing time is shortened, and the general symptoms are improved.

And (4) invalidation: the intermittent time of attack and symptoms are not obviously changed after treatment. (local and systemic symptoms were assessed by symptom score.)

2.4 statistical treatment

Data processing and statistics were analyzed using Excel version 2003 and SPSS version 19.0, respectively, with a significance level of 0.05.

Adopting a research method of self-contrast before and after treatment of a patient, adopting rank sum test of pairing design data for statistical test, and having statistical significance when the P value is less than 0.05; p >0.05 is not statistically significant.

3 results

Recent efficacy analysis of 3.150 patients with recurrent oral ulceration

3.1.1 comparison of the initial ulcer and the local integral of recurrent ulcer after treatment is shown in Table 5.

TABLE 5 comparison of the local integral of initial ulcer and recurrent ulcer after treatment

At the test level of 0.05, P <0.001, statistically significant.

3.1.2 Total symptom score before treatment and Total symptom score after treatment results are shown in Table 6.

TABLE 6 score of pre-treatment and score of post-treatment systemic symptoms

At the test level of 0.05, P <0.001, statistically significant.

Long term efficacy analysis of 3.250 patients with recurrent oral ulceration

3.2.1 results of the analysis of the seizure intervals before and after treatment are shown in Table 7 and FIG. 1.

TABLE 7 analysis of seizure intervals before and after treatment

In days, P <0.001, at a test level of 0.05, is statistically significant.

The results of the efficacy analysis of 3.350 patients with recurrent oral ulceration are shown in table 8.

Effective rate analysis of 850 patients with recurrent oral ulcer in Table

Note: the total effective rate is (number of clinical control cases + number of cases showing effect) ÷ total number of cases in the group × 100%, and the interval between attacks is taken as a main standard.

4 conclusion

The experimental results show that the traditional Chinese medicine composition has remarkable effect after treatment, local symptoms and general symptoms of patients are obviously improved, the recurrence is reduced, and the recurrence interval time is prolonged.

EXAMPLE 15 clinical trial (two)

1 data of

1.1 general data

200 patients with recurrent oral ulceration were selected for visits by the eosin hospital affiliated with the university of medicine in shanghai, between 10 months in 2015 and 10 months in 2017. The medicine is divided into four groups according to a random digital table method, wherein the four groups are respectively a treatment group, a treatment group and a control group. The basic condition, age, course and the like of 200 patients have no significant difference.

1.2 diagnostic criteria

1.3 inclusion criteria

(1) No infection, no allergy to the drug, and no mental disorder.

(2) Meets the diagnosis standard of recurrent oral ulcer.

(4) completing informed consent and related notification.

2 method

2.1 methods of treatment

Treatment a group of patients was given the following treatment: the traditional Chinese medicine composition in the embodiment 1 is taken and added with water to be decocted according to a conventional method. The traditional Chinese medicine raw materials are taken according to the weight part ratio, water is added for decoction, one dose is taken twice every day, and the decoction is respectively taken half an hour before breakfast and one hour after supper. Three months of medicine taking is a course of treatment, and patients all take the medicine for one course of treatment. Follow-up observations and recordings were made during dosing.

Treatment two groups of patients were given the following treatments: the traditional Chinese medicine composition in the embodiment 2 is taken and added with water to be decocted according to a conventional method. The traditional Chinese medicine raw materials are taken according to the weight part ratio, water is added for decoction, one dose is taken twice every day, and the decoction is respectively taken half an hour before breakfast and one hour after supper. Three months of medicine taking is a course of treatment, and patients all take the medicine for one course of treatment. Follow-up observations and recordings were made during dosing.

Three groups of patients were treated with the following treatments: taking the following raw material medicines in parts by weight: 15 g of raw astragalus root, 15 g of gypsum, 9 g of rhizoma anemarrhenae, 15 g of dried rehmannia root, 30 g of glabrous greenbrier rhizome, 9 g of figwortflower picrorhiza rhizome, 12 g of red paeony root, 9 g of cortex moutan and 15 g of jade powder, and adding water to decoct according to a conventional method. Decocting in water to obtain decoction, and taking one dose of the decoction twice a day, half an hour before breakfast and one hour after supper. Three months of medicine taking is a course of treatment, and patients all take the medicine for one course of treatment. Follow-up observations and recordings were made during dosing.

Control patients were given the following treatments: the triple tablet is taken 6 tablets each time, 3 times a day, and a treatment course is provided. Follow-up observations and recordings were made during dosing.

Observation indexes are as follows: including the analysis of the recent and long-term efficacy of recurrent oral ulceration patients.

Recent efficacy analysis of patients with recurrent oral ulceration: comparing the local integral of the initial ulcer and the recurrent ulcer after treatment; the pre-treatment systemic symptom score is compared to the post-treatment score.

Long-term efficacy analysis of patients with recurrent oral ulceration: all cases were followed for three months and the recurrence of ulcers was observed.

2.2 Scoring criteria

The initial local integral method, the local integral method after treatment, the initial whole body integral method and the whole body integral method after one treatment period are shown in tables 1, 2, 3 and 4 respectively.

2.3 therapeutic efficacy criteria

And (4) invalidation: the intermittent time of attack and symptoms are not obviously changed after treatment. (local and systemic symptoms were assessed by integration of symptoms).

3 results

The results of the efficacy analysis of four groups of patients with recurrent oral ulceration are shown in table 9. The treatment group is clinically controlled by 8 cases, has obvious effect of 15 cases, has effective 17 cases and ineffective 8 cases, and has a total effective rate of 83.3 percent; 6 cases of clinical control of two groups of treatment, 15 cases of obvious effect, 17 cases of effective effect, 16 cases of ineffective effect, the total effective rate is 70.4 percent, 5 cases of clinical control of three groups of treatment, 12 cases of obvious effect, 16 cases of effective effect, 13 cases of ineffective effect, the total effective rate is 71.7 percent; the control group is clinically controlled to 2 cases, the obvious effect is 10 cases, the effective effect is 15 cases, the ineffective effect is 25 cases, and the total effective rate is 51.9 percent. The total effective rate of a group of the traditional Chinese medicine composition is obviously higher than that of a control group, which shows that the traditional Chinese medicine composition has the obvious effect of treating recurrent oral ulcer. Compared with the treatment of the first group and the treatment of the second group, the total effective rate of the treatment of the first group is superior to that of the treatment of the second group, which shows that the traditional Chinese medicine composition of the formula has the advantages of obvious effect of treating recurrent oral ulcer and obviously improved anti-fatigue effect within a certain proportion range. Compared with the three groups of treatment, the total effective rate of the treatment group is better than that of the treatment group, which shows that the composition of bamboo leaves, white ginseng and bistort rhizome in the formula has the advantage of remarkable effect of treating recurrent oral ulcer.

TABLE 9 analysis of the effectiveness of four groups of patients with recurrent oral ulceration

Group of	Number of examples	Clinical control	Show effect	Is effective	Invalidation	Total effective rate
							Control group	52	2	10	15	25	51.9％
Treatment of a group	48	8	15	17	8	83.3％
							Two groups of treatment	54	6	15	17	16	70.4％
Three groups of treatment	46	5	12	16	13	71.7％

The raw astragalus in the recipe: invigorating qi, healing sore, removing toxic materials, and promoting granulation; gypsum and rhizoma anemarrhenae are the meanings of white tiger, clear and purge yang-bright (stomach) excess heat, and radix rehmanniae, cortex moutan and radix paeoniae rubra nourish yin (kidney) to clear heat, and are used for treating deficiency fire flaring up, and the five medicines are combined, have the meanings similar to Yunv Jian, and have the meanings of qi and nutrient, so that pathogenic heat can be transmitted to heat and transformed into qi from qi system and blood system, and aphtha can be promoted to heal; the surrender of the six medicines is combined with the theory of ' mouth and tongue sores, which is proposed by Jingyue quan Shu & kou & lingua ' that the heat of the upper jiao is mostly strengthened, the heat is preferably cleared away, but the patients with excessive wine color, overstrain, weak pulse and deficiency of middle-qi can not be treated by cold and cool, so the medicine can not take effect after long-term use, or tonify heart and spleen, or nourish kidney water … … '; the bamboo leaves and the radix rehmanniae are matched to conduct red blood; the jade powder contains natural indigo, Liuyi powder, natural indigo enters the liver, the heat clearing and toxicity is strong, Liuyi powder eliminates ulcer yellow fur, the Lophatherum gracile enables excess heat and damp heat to be removed from urine, and the jade powder has good effect of being externally applied to sores and can clear pathogenic fire of five internal organs which are easy to be over; rhizoma smilacis glabrae is sweet and light in taste and mild in nature, has the effects of clearing heat and removing dampness, is commonly used for treating rheumatic immune diseases, and has the effects of regulating and inhibiting immunity; white in the middle, salty and cool in nature, entering foot jueyin, taiyin, shaoyin and taiyang meridians. Compendium of materia Medica is called: "lowering ministerial fire, removing blood stasis and blood stasis, salty in the lid and moistening the lower part, so it is also effective in treating various sores on the mouth and tongue, and the test for lowering fire"; bidens bipinnata is good at cooling blood and clearing heat, because the cross section of the Bidens bipinnata is red and purple, and the rhizome of the Bidens bipinnata is similar to that of paris polyphylla, also called as the special medicine for stomatitis recommended by Mr. Ye-Juquan, the Bidens bipinnata is decocted in folk to be gargled to treat dental ulcer; picrorhiza rhizome, although bitter and cold, has a not just bitter taste, and is not as bitter and pure as coptis, so it is better for treating aphtha than coptis, and is better at clearing heat and drying dampness than coptis, and it also has the efficacy of removing deficiency heat and benefiting yin.

The raw material medicines of the invention have wide sources, the preparation method is simple and the cost is low. The effect is obvious, the process of recovering the health of the patient is accelerated, and the method has strong practicability and good application prospect.

The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and additions can be made without departing from the principle of the present invention, and these should also be considered as the protection scope of the present invention.

Claims

1. The traditional Chinese medicine composition for treating recurrent oral ulcer is characterized by being prepared from the following raw material medicines in parts by weight: 10-20 parts of raw astragalus membranaceus, 10-20 parts of gypsum, 6-12 parts of rhizoma anemarrhenae, 10-20 parts of radix rehmanniae, 25-35 parts of rhizoma smilacis glabrae, 3-9 parts of human urine sediment, 6-12 parts of rhizoma picrorhizae, 6-12 parts of lophatherum gracile, 10-20 parts of bistort rhizome, 7-17 parts of radix paeoniae rubra, 6-12 parts of cortex moutan and 10-20 parts of jasper powder.

2. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight: 15 parts of raw astragalus membranaceus, 15 parts of gypsum, 9 parts of rhizoma anemarrhenae, 15 parts of radix rehmanniae, 30 parts of rhizoma smilacis glabrae, 6 parts of human urine sediment, 9 parts of rhizoma picrorhizae, 9 parts of lophatherum gracile, 15 parts of bistort rhizome, 12 parts of radix paeoniae rubra, 9 parts of cortex moutan and 15 parts of jade powder.

3. The Chinese medicinal composition according to any one of claims 1 to 2, which is prepared into a clinically acceptable medicinal preparation according to a conventional Chinese medicinal preparation method.

4. The traditional Chinese medicine composition of claim 3, wherein the pharmaceutical preparation is a granule, powder, capsule, tablet or oral liquid.

5. Use of the Chinese medicinal composition of any one of claims 1-2 in the preparation of a medicament for the treatment of recurrent oral ulceration.

6. A traditional Chinese medicine for treating recurrent oral ulceration, wherein the traditional Chinese medicine is prepared from the traditional Chinese medicine composition of claim 1.

7. The traditional Chinese medicine for treating recurrent oral ulcer according to claim 6, wherein the preparation method of the traditional Chinese medicine is as follows:

(3) adding 15 g of jade powder, and decocting for 40 minutes with strong fire;

(4) leaching out juice, precipitating, collecting clear liquid, and bottling;

(5) the whole preparation process only needs to be decocted once.