CN110680900B

CN110680900B - Medicine for treating recurrent oral ulcer and preparation method thereof

Info

Publication number: CN110680900B
Application number: CN201911104138.5A
Authority: CN
Inventors: 王岳峰
Original assignee: Individual
Current assignee: Individual
Priority date: 2019-11-13
Filing date: 2019-11-13
Publication date: 2021-12-21
Anticipated expiration: 2039-11-13
Also published as: CN110680900A

Abstract

The invention relates to a medicine for treating recurrent oral ulcer and a preparation method thereof, wherein the medicine is prepared from the following traditional Chinese medicine raw materials in parts by weight: 10-30 parts of coptis chinensis, 5-15 parts of bamboo leaves, 10-30 parts of prepared rehmannia roots, 15-20 parts of astragalus membranaceus, 3-5 parts of dried ginger, 5-10 parts of nacre, 5-10 parts of concha haliotidis, 3-5 parts of fructus evodiae, 3-5 parts of liquorice, 5-10 parts of Chinese yam, 5-15 parts of angelica sinensis, 5-10 parts of radix achyranthis bidentatae and 5-10 parts of radix asparagi.

Description

Medicine for treating recurrent oral ulcer and preparation method thereof

The technical field is as follows:

the invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition for treating recurrent oral ulcer, which is prepared from the following traditional Chinese medicines of coptis chinensis, bamboo leaves, prepared rehmannia roots, astragalus membranaceus, dried ginger, nacre, concha haliotidis, fructus evodiae, liquorice, Chinese yam, angelica sinensis, achyranthes bidentata, asparagus cochinchinensis and the like.

Background art:

oral ulcer, also called as "aphtha", is a common ulcerative injury occurring in oral mucosa, the prevalence rate is the first of oral mucosa diseases, and epidemiological investigation of various countries shows that about 1 person out of every 5 persons has at least one ulcer, and the ulcer can occur in all people, regardless of male and female, any age and any species. The disease is characterized by periodicity and recurrence. The symptoms are mostly found in the inner labial side, tongue, buccal mucosa, vestibular sulcus, soft palate, etc., where the mucosa lacks a cornified layer or is poorly cornified. The oral cavity ulcer has the clinical characteristics of yellow, red, concave and pain (namely, the affected surface is covered with a yellow false membrane, a hyperemia and areolar zone is arranged at the periphery, and burning pain at the central depression is obvious), the pain is severe when the oral cavity ulcer is attacked, local burning pain is obvious, diet and speaking can be affected when the oral cavity ulcer is serious, great inconvenience is caused to daily life, and the oral cavity ulcer can be complicated with the general symptoms of halitosis, chronic pharyngitis, constipation, headache, dizziness, nausea, hypodynamia, dysphoria, insomnia, lymphadenectasis and the like. According to the modern medical research, the causes of the disease mainly comprise the following aspects 1 and immune factors. The cellular immunity of the patient suffering from the dental ulcer is detected to be abnormal; 2. a genetic factor; 3. systemic disease factors; 4. environmental factors; 5. microcirculation disturbance and the like. The existing method for treating the oral ulcer mainly comprises two drug therapies of external treatment and internal administration. The main external medicine comprises propolis patch, watermelon crystal, 0.1% -0.2% chlorhexidine gluconate solution, 0.5% Povidone Pogostemon Stem solution, 0.1% ethacridine solution, etc.; the oral medicine mainly comprises vitamin B2 complex, vitamin C, bezoar detoxicating tablet and the like, in recent years, with the deepening of clinical research, some new products for treating oral ulcer such as cydiodine tablet, dexamethasone acetate patch, penicillin V potassium buccal tablet and the like appear on the market, but some medicines can not treat the symptoms and root causes, and some medicines can not be used with definite curative effect and are interrupted.

The traditional Chinese medicine is a treasure of the traditional Chinese culture, and is increasingly accepted by the majority of patients as the traditional Chinese medicine starts from the holistic concept and takes the aspects of regulating the balance of yin and yang and improving the autoimmunity of the human body along with the development of the biological medicine technology. The method is used for better exploring the essence of the ancient books of traditional Chinese medicine and serving the majority of patients. The inventor develops a traditional Chinese medicine formula for clearing heat, nourishing yin, tonifying kidney and benefiting qi through years of research, has the efficacies of clearing heat, purging fire, nourishing yin, strengthening water and the like, and is mainly used for treating diseases such as imbalance of yin and yang, imbalance of heart and kidney, immune disorder and the like. The invention overcomes the defect that other prescriptions only use a heavier prescription to clear away heart fire when treating the dental ulcer, and the treatment effect is not obvious. From the holistic concept, the traditional Chinese medicine pill has the effects of clearing fire, nourishing yin, tonifying qi and promoting blood circulation, takes the effects of both principal and secondary aspects, takes the traditional Chinese medicine diagnosis and differentiation as the main and highlights the diagnosis and treatment thought, and is prepared by adding traditional Chinese medicine fine powder or traditional Chinese medicine extract into bonding auxiliary materials. The traditional Chinese medicine composition is clinically accepted, and is used for improving the immune disorder of an organism, improving the blood circulation of an affected part and promoting the healing of an ulcer wound surface. The body can reach the balance of yin and yang, smooth qi and blood and harmonize the functions of viscera, and can obviously improve the clinical symptoms and the Chinese medicine symptoms of patients.

Disclosure of Invention

The invention adopts modern traditional Chinese medicine preparation technology, and obtains the traditional Chinese medicine composition for treating the recurrent oral ulcer by the brand-new processing method comprising the combined application of a biotransformation method, an enzyme reaction technology, a high-efficiency separation and extraction technology and the like.

The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 10-30 parts of coptis chinensis, 5-15 parts of bamboo leaves, 10-30 parts of prepared rehmannia roots, 15-20 parts of astragalus membranaceus, 3-5 parts of dried ginger, 5-10 parts of nacre, 5-10 parts of concha haliotidis, 3-5 parts of fructus evodiae, 3-5 parts of liquorice, 5-10 parts of Chinese yam, 5-15 parts of angelica sinensis, 5-10 parts of radix achyranthis bidentatae and 5-10 parts of radix asparagi.

Preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 15 parts of coptis chinensis, 10 parts of bamboo leaves, 15 parts of prepared rehmannia roots, 18 parts of astragalus membranaceus, 3 parts of dried ginger, 6 parts of nacre, 6 parts of concha haliotidis, 3 parts of fructus evodiae, 3 parts of liquorice, 6 parts of Chinese yam, 10 parts of angelica sinensis, 9 parts of radix achyranthis bidentatae and 9 parts of radix asparagi.

In the above composition, the weight is calculated by weight parts, the weight of each medicine is calculated by crude drugs, and can be increased or decreased according to corresponding proportion during production, for example, the weight can be in kilogram unit in large-scale production, or in ton unit in small-scale production. The weight can be increased or decreased, but the proportion of the raw medicinal materials in the weight proportion is unchanged. The proportion of the weight proportion is obtained by scientific screening, and the proportion of the two components can be correspondingly adjusted to increase or decrease by no more than 100% for special patients such as severe or mild patients, obese patients or lean patients, and the drug effect is not changed.

The traditional Chinese medicine composition is prepared by extracting or processing traditional Chinese medicine raw materials in other modes to prepare a medicine active ingredient, then taking the active ingredient as a raw material, adding a pharmaceutically acceptable carrier if necessary, and preparing the medicine preparation composition according to the conventional technology of pharmaceutics and pharmaceutics. When the composition is prepared into a medicinal preparation, any medicinal preparation can be prepared. The dosage form is selected from: tablet, capsule, oral liquid, buccal agent, granule, pill, powder, unguent, pellet, suspension, suppository, unguent, spray, patch, and dripping pill.

The Chinese medicinal composition of the invention can be added with some pharmaceutically acceptable carriers according to requirements, and the pharmaceutical preparation can be prepared by adopting the conventional technology of pharmaceutics, for example, the pharmaceutically active substances are mixed with the pharmaceutically acceptable carriers, and the pharmaceutically acceptable carriers are selected from mannitol, sorbitol, amino acid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, cellulose and derivatives thereof, alginate, gelatin, polyvinylpyrrolidone, glycerol, propylene glycol, ethanol, tween 60-80, beeswax, lanolin, liquid paraffin, cetyl alcohol, gallates, agar, urea, allantoin, calcium carbonate, calcium bicarbonate, surfactant, polyethylene glycol, cyclodextrin, magnesium stearate and the like.

The usage amount of the traditional Chinese medicine composition is determined according to the condition of a patient when the traditional Chinese medicine composition is used. When the traditional Chinese medicine composition is prepared into a preparation, a unit dose of medicament can contain 0.1-10000mg of the pharmaceutical active substance, and the balance is a pharmaceutically acceptable carrier. The weight of the pharmaceutically acceptable carrier can be 0.1% -99.9% of the total weight of the formulation.

The active pharmaceutical substances of the traditional Chinese medicine composition are prepared by the traditional pharmaceutical technology, such as the following processing methods:

pulverizing the Chinese medicinal materials into fine powder with a pulverizer, adding Mel, stirring, pressing the mixed medicinal mass into strip, kneading into pill, adding pharmaceutically acceptable carrier, and making into pill.

Or the following method:

decocting Concha Margaritifera and Concha Haliotidis with 2-4 times of water for 30-60 min for 1-3 times to obtain extractive solution; decocting the rest materials with 3-8 times of water for 1-3 times (each for 1-3 hr) to obtain extractive solution, mixing the above extractive solutions, decocting for 1 hr, filtering, concentrating to obtain extract, adding pharmaceutically acceptable carrier if necessary, and making into pharmaceutical preparation according to conventional pharmaceutical technology.

Or the following method:

decocting Concha Margaritifera and Concha Haliotidis with 2-4 times of water for 30-60 min for 1-3 times to obtain extractive solution; decocting the rest materials with 3-8 times of water for 1-3 times, each for 1-3 hr, mixing the above extractive solutions, decocting for 1 hr, filtering, concentrating, adding ethanol to reach 65% ethanol concentration, standing, filtering, distilling to obtain ethanol, concentrating to obtain extract, adding pharmaceutically acceptable carrier, and making into pharmaceutical preparation by conventional method.

Or the following method:

extracting traditional Chinese medicinal materials with 3-8 times of 90-95% ethanol under reflux for 1-3 times (each for 1-3 hr), collecting extractive solution, filtering, distilling to remove ethanol, concentrating to obtain extract, adding pharmaceutically acceptable carrier if necessary, and making into pharmaceutical preparation according to conventional pharmaceutical technology.

According to the traditional Chinese medicine composition, the angelica in the formula has the effects of nourishing blood and increasing blood, and the blood is filled to control heart fire; the prepared rhizome of rehmannia and the Chinese yam enter liver and kidney to nourish kidney yin, and the three medicines are combined to ensure that yin blood is filled and water can be used for producing fire, which are monarch medicines together. The coptis and the bamboo leaves clear away heart fire, and the astragalus is combined with the effects of tonifying middle-jiao and Qi, invigorating yang and strengthening exterior, so the coptis and the bamboo leaves are ministerial drugs. Concha Margaritifera and Concha Haliotidis have effects of tranquilizing mind, arresting convulsion, calming liver and suppressing yang, and can be used for improving symptoms such as insomnia and dysphoria caused by ulcer pain. Tian Dong and niu xi are used as adjuvant drugs for nourishing yin, replenishing vital essence, conducting heat, guiding blood and descending to lower the fire of ascending inflammation. Evodia rutaecarpa stops pain and dispels cold, and dried ginger warms the middle-jiao to dispel cold and is mixed with licorice to regulate the middle-jiao so as to prevent coptis root from bitter cold and abalone shell and pearl powder from seriously obstructing the stomach and protect the stomach and calm the middle-jiao. It is also used as a guiding drug. The medicines are combined to play the roles of clearing heat and nourishing yin, and nourishing yin and strengthening water. The symptoms can be cured. The formula has the effects of clearing heat and nourishing yin, and has the functions of tonifying qi and promoting blood circulation. So that yin is fixed and water can be used for producing water, and heat is clear, so that yin is consumed.

The beneficial effects of the present invention are further illustrated by experimental data below.

Case 1:

the patient is in a age of 32 years old in Shitu, has a preliminary diagnosis date of 2019, 9 and 24 days, and has a chief complaint that the oral ulcer is repeated for more than 3 months and aggravated for 7 days. [ case history ] complaints include repeated and frequent oral ulcer on the lateral side of the buccal part and the tongue root for more than 3 months, aggravation of pain for 7 days, and influence on diet, and can be seen as the wound surface of the left lower lip ulcer of about 3-4mm, edema around the ulcer, white false membrane at the ulcer bottom, and symptoms of cold limbs, soreness and weakness of waist and knees, clear and abundant urine, loose stool and the like. A swollen tongue with teeth marks, pale-red coating, white and greasy tongue with red sides, and an unsmooth and thready and weak pulse. Traditional Chinese medicine diagnosis: aphtha, western medicine diagnosis: and (4) oral ulcer. [ DITIONAL TYPE ] insufficiency of both the spleen and the kidney [ therapeutic method ] warms and tonifies the spleen and the kidney, and induces fire to return to original. The prescription comprises 15g of coptis chinensis, 10g of bamboo leaves, 15g of prepared rehmannia roots, 18g of astragalus roots, 3g of dried ginger, 6g of nacre, 6g of abalone shells, 3g of fructus evodiae, 3g of liquorice, 6g of Chinese yam, 10g of angelica, 9g of achyranthes roots and 9g of asparagus. 3, decocting with water, taking one dose every day, and making the decoction in the morning and at night. In 2019, 9 and 27 months, the pain disappears after the chief complaint is taken, and the ulcer is healed completely and then is stopped.

Case 2:

korean is 40 years old for men, the date of initial diagnosis is 2019, 9 and 27, the chief complaint is about 4 months of oral ulcer, the weight is increased for 7 days, and the ulcer surface of the right lower lip is about 3-4mm in the case of [ medical history ]. About 2mm of the tongue surface, about 1mm of new hair at the tip of the tongue, edema around the ulcer, white false membrane at the bottom, thirst and preference for cold drinks. Yellow feces on eyes, pale red tongue coating, red tongue on both sides, slightly yellow coating, and slippery and rapid pulse. The treatment effect of once orally taking vitamin B2 is not obvious, and the treatment effect of traditional Chinese medicines for clearing heat and removing toxicity, promoting blood circulation and relieving pain is also not obvious. The diagnosis is the traditional Chinese medicine diagnosis of aphtha. [ DIFFERENTIAL TYPE ] heart-lung stagnated heat, yin-yang imbalance. [ TREATMENT METHOD ] to clear heat and harmonize yin and yang. Prescription: 15g of coptis chinensis, 10g of bamboo leaves, 15g of prepared rehmannia roots, 18g of astragalus roots, 3g of dried ginger, 6g of nacre, 6g of abalone shells, 3g of fructus evodiae, 3g of liquorice, 6g of Chinese yam, 10g of angelica, 9g of achyranthes roots and 9g of asparagus. 3, the medicine is decocted with water and taken one dose a day, and is taken in the morning and at night. [ second diagnosis ] in 2019, 10 months and 1 day, 3 doses of the traditional Chinese medicine are taken according to the prescription, the ulcer is healed, the pain disappears, and the disease does not relapse until the cure is stopped.

Case 3

Wu-Chi, male 33 years old, has recurrent oral ulceration for 1 year, aggravated for 8 days. The date of first visit was 2019, 9 months and 27 days. The main complaints are: the pain of the oral ulcer is intolerable, and the diet is influenced; [ case history ] ulcer surface is 3-4mm in size, red and swollen, white pseudomembrane at the bottom, accompanied by thirst, profuse drinking, yellow urine, constipation, pale and white tongue with tooth marks on the edge, red tongue tip, and thin and white fur. The treatment effect of taking the vitamin B2 and the vitamin C is not obvious once. No obvious improvement. [ DIAGNOSIS ] Chinese medicine diagnosis: aphtha, western medicine diagnosis: and (4) oral ulcer. [ DIFFERENTIAL TYPE ] hyperactivity of heart-fire and imbalance of yin and yang. [ TREATMENT METHOD ] to clear heat, purge fire and harmonize yin and yang. Prescription: 15g of coptis chinensis, 10g of bamboo leaves, 15g of prepared rehmannia roots, 18g of astragalus roots, 3g of dried ginger, 6g of nacre, 6g of abalone shells, 3g of fructus evodiae, 3g of liquorice, 6g of Chinese yam, 10g of angelica, 9g of achyranthes roots and 9g of asparagus. 5, the decoction is taken after being decocted with water, and one dose is taken every day in the morning and at night. "two diagnostic methods") 2019, 10 months and 1 day. The chief complaints are that the pain feeling of the ulcer disappears and the ulcer is not obviously changed before. The original prescription is 3 times, and the treatment is continued; [ SANDING ] in 2019, the doctor can make a double-visit in 10 months and 5 days, and complains: the pain disappeared and the ulcer healed. And (5) curing.

Case 4

Guo in a man, 38 years old, complaining of recurrent oral ulceration for 6 months in 24 months in 2019. For 1 day, the lower lip of the right side is scattered under the ulcer, the mixture is fused into a tablet, the bottom is red, the periphery is bright red, the symptoms such as soreness and pain of waist and knees, night sweat, dysphoria with feverish sensation in chest, etc., the tongue is pale red, the tongue root is yellow and greasy, and the pulse is thready, rapid and weak. [ DIAGNOSIS ] Chinese medicine diagnosis: aphtha, western medicine diagnosis: and (4) oral ulcer. [ DITIONAL TYPE ] hyperactivity of fire due to yin deficiency and imbalance of yin and yang. [ TREATMENT METHOD ] to nourish yin, consolidate fire and regulate yin and yang. The prescription comprises 15g of coptis chinensis, 10g of bamboo leaves, 15g of prepared rehmannia roots, 18g of astragalus roots, 3g of dried ginger, 6g of pearl powder, 6g of abalone shells, 3g of fructus evodiae, 3g of liquorice, 6g of Chinese yam, 10g of angelica, 9g of achyranthes roots and 9g of asparagus roots, and 3 doses of the raw materials are decocted with water for taking one dose per day. Taken in the morning and at night. "two diagnostic methods" in 2019, 9 months and 27 days. Chief complaints about ulcer did not improve significantly, and it was seen that the lower lip of the right side was scattered over the ulcer, red in the base and bright red in the periphery. The original prescription is continued to be treated by 3 doses. [ SANDING ]2019, 10 months and 1 day. The ulcer is reduced, the pain is relieved, and the original prescription is continued to treat 2 pairs of the traditional Chinese medicines. The doctor can make a double-check in 2019, 10 months and 5 days; the ulcer heals and the pain disappears. And (5) curing.

Compared with the medicaments in the prior art, the medicament has the advantages that:

1. by adding the effective components with the functions of relieving pain and activating blood, the symptoms of red swelling, pain and the like of the ulcer surface can be quickly relieved, so that the pain of a patient is greatly relieved.

2. By adding the effective components with the functions of soothing the nerves and tonifying qi, the bad experiences of dysphoria, insomnia and the like caused by pain of patients are effectively improved, and the life quality of the patients is obviously improved.

3. Strengthens the holistic concept of the traditional Chinese medicine, not only clears away heart fire, but also nourishes yin and kidney, improves the whole immunity of the organism and greatly improves the cure rate of recurrent oral ulcer.

The specific implementation mode is as follows:

the present invention is further illustrated by the following examples, which are not to be construed as limiting the invention thereto.

Example 1

15 parts of coptis chinensis, 10 parts of bamboo leaves, 15 parts of prepared rehmannia roots, 18 parts of astragalus membranaceus, 3 parts of dried ginger, 6 parts of nacre, 6 parts of concha haliotidis, 3 parts of fructus evodiae, 3 parts of liquorice, 6 parts of Chinese yam, 10 parts of angelica sinensis, 9 parts of radix achyranthis bidentatae and 9 parts of radix asparagi.

The components are prepared into pills by weight ratio with unit of kilogram, and the method comprises the following steps: pulverizing the Chinese medicinal materials into fine powder with a pulverizer; mixing, adding appropriate amount of Mel, and stirring. The mixed medicinal mass is pressed into a strip shape and is kneaded into 1000 pills.

Example 2

10 parts of coptis chinensis, 5 parts of bamboo leaves, 10 parts of prepared rehmannia roots, 15 parts of astragalus membranaceus, 3 parts of dried ginger, 5 parts of nacre, 5 parts of concha haliotidis, 3 parts of fructus evodiae, 3 parts of liquorice, 5 parts of Chinese yam, 5 parts of angelica sinensis, 5 parts of radix achyranthis bidentatae and 5 parts of radix asparagi.

The components are prepared into pills by weight ratio with unit of kilogram, and the method comprises the following steps: decocting Concha Margaritifera and Concha Haliotidis with 3 times of water for 2 times (30-60 min each time) to obtain extractive solution. Decocting the rest materials with 4 times of water for 2 times, each for 2 hr, mixing the above Margarita powder and Concha Haliotidis, decocting for 1 hr, filtering the extractive solution, concentrating to appropriate amount, making into extract, adding pharmaceutically acceptable carrier, and making into pill 1000 pills according to conventional pharmaceutical technology.

Example 3

30 parts of coptis chinensis, 15 parts of bamboo leaves, 30 parts of prepared rehmannia roots, 20 parts of astragalus membranaceus, 5 parts of dried ginger, 10 parts of nacre, 10k of concha haliotidis, 5 parts of fructus evodiae, 5 parts of liquorice, 10 parts of Chinese yam, 15 parts of angelica sinensis, 10 parts of radix achyranthis bidentatae and 10 parts of radix asparagi.

The components are prepared into tablets by weight ratio with unit of kilogram, and the method comprises the following steps:

decocting Concha Margaritifera and Concha Haliotidis with 3 times of water for 2 times (30-60 min each time) to obtain extractive solution. Decocting the rest materials with 4 times of water for 2 times, each for 2 hr, mixing the above Margarita powder and Concha Haliotidis, decocting for 1 hr to obtain extractive solution, filtering, concentrating to appropriate amount, adding ethanol to reach 65% ethanol concentration, standing, filtering, distilling the solution to obtain ethanol, concentrating to obtain extract, adding pharmaceutically acceptable carrier, and making into 10000 tablet according to conventional pharmaceutical technology.

Example 4

The capsule is prepared from the components in kilogram by weight ratio by the following steps:

taking the traditional Chinese medicines, adding 90-95% (v/v) ethanol with 5 times of weight, performing reflux extraction for 2 times, each time for 2 hours, separating an extracting solution, filtering, distilling the ethanol out of the solution, concentrating into an extract, taking the extract as an active ingredient, adding a pharmaceutically acceptable carrier if necessary, and preparing 10000 capsules according to a conventional pharmaceutical technology.

Claims

1. A traditional Chinese medicine composition for treating recurrent oral ulcer is prepared from the following traditional Chinese medicine raw materials in parts by weight: 15 parts of coptis chinensis, 10 parts of bamboo leaves, 15 parts of prepared rehmannia roots, 18 parts of astragalus membranaceus, 3 parts of dried ginger, 6 parts of nacre, 6 parts of concha haliotidis, 3 parts of fructus evodiae, 3 parts of liquorice, 6 parts of Chinese yam, 10 parts of angelica sinensis, 9 parts of radix achyranthis bidentatae and 9 parts of radix asparagi.

2. The traditional Chinese medicine composition of claim 1, wherein the dosage form is selected from the group consisting of: tablet, capsule, oral liquid, buccal agent, granule, pill, powder, paste, or suspension.

3. The preparation method of the traditional Chinese medicine composition of claim 1, which is characterized by comprising the following steps: pulverizing the Chinese medicinal materials into fine powder with a pulverizer, adding Mel, stirring, pressing the mixed medicinal mass into strip, and making into pill.

4. The preparation method of the traditional Chinese medicine composition of claim 1, which is characterized by comprising the following steps: decocting Concha Margaritifera and Concha Haliotidis with 2-4 times of water for 30-60 min for 1-3 times to obtain extractive solution; decocting the rest materials with 3-8 times of water for 1-3 times (each for 1-3 hr) to obtain extractive solution, mixing the above extractive solutions, decocting for 1 hr, filtering, concentrating to obtain extract, adding pharmaceutically acceptable carrier, and making into pharmaceutical preparation by conventional method.