CN103845633B

CN103845633B - It is a kind of to treat Chinese medicine composition of canker sore and preparation method thereof

Info

Publication number: CN103845633B
Application number: CN201210511276.7A
Authority: CN
Inventors: 季绍良
Original assignee: Beijing Increase Pharmaceutical Institute Co Ltd
Current assignee: Beijing Increasepharm Co ltd
Priority date: 2012-12-03
Filing date: 2012-12-03
Publication date: 2017-08-25
Anticipated expiration: 2032-12-03
Also published as: CN103845633A

Abstract

The invention discloses a kind of Chinese medicine composition for treating canker sore and preparation method thereof, said composition is prepared from according to a certain weight ratio by radix bupleuri, the root of herbaceous peony, Radix Angelicae Sinensis, moutan bark, the wind-weed, radix scrophulariae, the tuber of dwarf lilyturf, Poria cocos, eupatorium, the root of bidentate achyranthes, lophatherum gracile, radix glycyrrhizae.It is prepared to a kind of oral formulations, and the Chinese medicine composition has the effect for the treatment of canker sore.

Description

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

Technical Field

The invention relates to a traditional Chinese medicine composition for treating oral ulcer and a preparation method thereof, belonging to the technical field of traditional Chinese medicines.

Background

Oral ulcer, which is generally called as oral cavity inflammation or aphtha in folk, is a local ulcer injury of oral mucosa which is characterized by recurrent attacks, can self-heal and can occur at any part of the oral mucosa. The mucosa of the lips, the cheeks, the soft palate or the gingiva and the like of the oral cavity is common, single or multiple round or oval ulcers with different sizes occur, the surface is covered with a gray or yellow false membrane, the center is sunken, the boundary is clear, the surrounding mucosa is red and slightly swollen, the local burning pain of the ulcer is obvious, and the oral cavity has the characteristics of periodicity, recurrence and self-limitation. The canker sore is also known as Recurrent Aphthous Stomatitis (RAS), Recurrent Oral Ulcer (ROU), recurrent aphthous ulcer (recarbentahthae) or canker sore. The causes of oral ulcers may be local trauma, stress, changes in food, medication, hormone levels, and vitamin or trace element deficiencies. Systemic diseases, heredity, immunity and microorganisms may play an important role in the development and development of oral ulcers. The treatment is mainly local treatment, and the serious one needs systemic treatment.

The traditional Chinese medicine considers that the oral ulcer has the following causes: firstly, six exogenous pathogens are mainly dryness-heat and fire, dryness-heat is dry and astringent, and tends to damage body fluid, fire is yang-heat, which causes body fluid consumption and burning fire, and aphtha is finally developed. Therefore, canker sores are likely to recur in autumn and when the climate changes suddenly. Secondly, improper diet can lead to endogenous fire-heat, attack along the meridians, fumigate the mouth and tongue, and often damage the yin and fluid of the heart, lung and kidney, resulting in aphtha due to overeating spicy and fat food or food preference. Third, excessive emotional depression, restlessness, insomnia, transformation of fire due to depression of five emotions, hyperactivity of heart-fire, inflammation and burning of the tongue, or the heart-fire moving down to the small intestine and attacking the mouth along the meridians, all of which can cause aphtha of the tongue; or depressed anger, liver qi stagnation, liver qi obstruction, fire transformation due to depression, and dark consumption of yin and blood, which may lead to disorder of the Chong and ren meridians, and mouth sores due to stagnation of qi during menstruation, exuberant liver fire and burning of the tongue and mouth. And fourthly, deficiency of body yin fluid of patients, or yin deficiency due to long-term illness, endogenous deficient fire, burning of mouth and tongue, and even mouth and tongue sores. Fifthly, aphtha is caused by overstrain and internal injury, spleen qi deficiency and spleen qi deficiency due to long-term illness, and water dampness failing to transport; or long-standing transforming into heat, damp-heat steaming upwards, which can also cause aphtha. Even more, spleen qi deficiency impairs spleen yang, spleen yang deficiency, cold-dampness and heat generation, which may cause mouth sores. Sixthly, the deficiency of the natural observation or the chronic use of the medicine can damage the spleen and kidney, the deficiency of the spleen and kidney yang, the internal cold of the yin, the cold-dampness over-soaking the mouth and tongue, the cold congealing and blood stasis, and the mouth and tongue can be sore after a long time. In conclusion, six exogenous pathogenic dry-fire affecting the zang-fu organs and internal injury of the zang-fu organs are the main causes of the disease, and the zang-fu organs are the heart and spleen (stomach).

Disclosure of Invention

The invention aims to provide a novel traditional Chinese medicine composition which has the effects of soothing liver-qi stagnation, clearing heat and cooling blood. Can be used for treating aphtha caused by stagnation of liver-qi and excessive heart-spleen fire, with symptoms of multiple ulcers in oral cavity, circular or elliptical shape, red color, pain, vexation, insomnia, thirsty, yellow urine, dry stool, red tongue, yellow fur, and wiry and rapid pulse; recurrent oral ulcer is seen in the above syndromes.

It is another object of the present invention to provide a process for the preparation of the above composition.

The invention is realized by the following technical scheme:

the invention is prepared from the following raw material medicines in parts by weight: 3-9 parts of radix bupleuri, 6-15 parts of radix paeoniae alba, 6-15 parts of angelica sinensis, 6-15 parts of cortex moutan radicis, 6-15 parts of rhizoma anemarrhenae, 6-15 parts of radix scrophulariae, 6-15 parts of radix ophiopogonis, 6-15 parts of poria cocos, 3-15 parts of eupatorium, 4.5-15 parts of radix achyranthis bidentatae, 2-10 parts of lophatherum gracile and 1.5-9 parts of liquorice.

Preferably: 5-7 parts of radix bupleuri, 8-12 parts of radix paeoniae alba, 10-14 parts of angelica sinensis, 8-12 parts of cortex moutan, 8-12 parts of rhizoma anemarrhenae, 8-12 parts of radix scrophulariae, 8-12 parts of radix ophiopogonis, 10-14 parts of poria cocos, 8-12 parts of eupatorium fortunei, 8-12 parts of radix achyranthis bidentatae, 4-8 parts of lophatherum gracile and 3-7 parts of liquorice.

More preferably: 6 parts of radix bupleuri, 10 parts of radix paeoniae alba, 12 parts of angelica sinensis, 10 parts of moutan bark, 10 parts of rhizoma anemarrhenae, 10 parts of radix scrophulariae, 10 parts of radix ophiopogonis, 12 parts of poria cocos, 10 parts of herba eupatorii, 10 parts of radix achyranthis bidentatae, 6 parts of lophatherum gracile and 6 parts of liquorice.

The raw material medicaments can be any crude drug or combination of any processed product.

The invention is based on the theory of traditional Chinese medicine, adopts the mutual matching formula of the effective medicines to achieve the effects of soothing liver-qi stagnation and clearing heat and cooling blood, and can be used as an effective prescription for treating oral ulcer. Wherein,

bupleurum root, radix bupleuri is bitter in taste and slightly cold in nature. It enters liver and gallbladder meridians. Has the effects of dispelling pathogenic wind, relieving fever, invigorating yang and dispersing stagnated liver qi. Pharmacological research shows that the bupleurum has anti-inflammatory effect, and the active ingredient of the bupleurum saponin has inhibition effect on ankle swelling and connective tissue proliferative inflammation caused by various inflammatory agents. The bupleurum polysaccharide can enhance the phagocytic function of cells, enhance the function of natural killer cells, improve the titer of virus specific antibodies, improve the nuclear transfer rate of lymphocytes and improve the delayed anaphylactic reaction of skin.

White peony root, radix Paeoniae alba is bitter and sour in taste and cool in nature. It enters liver and spleen meridians. Has the effects of nourishing blood, softening liver, relieving pain, astringing yin and arresting sweating. Pharmacological research shows that the white peony root has an anti-inflammatory effect, and the paeoniflorin of the white peony root has a remarkable anti-inflammatory effect on rat foot swelling caused by carrageenan. The influence on immunity is shown in that the total glucosides of paeony have enhancement effect on delayed type hypersensitivity of mice, and in addition, the effects of reducing the titer of adenotrypsin, resisting bacteria and the like are realized; the effect of inhibiting the central nervous system is shown in that paeoniflorin injected into abdominal cavity of mouse can reduce spontaneous activity, prolong sleep time of cyclohexarbital sodium, inhibit writhing reaction caused by acetic acid injected into abdominal cavity and resist convulsion caused by pentylenetetrazol.

Dang Gui is sweet and pungent in flavor. It enters liver, heart and spleen meridians. Has effects of replenishing blood, promoting blood circulation, regulating menstruation, relieving pain, and loosening bowel to relieve constipation. Pharmacological research shows that the influence of the polypeptide on the immune system is that the polypeptide can obviously inhibit the generation of antibodies; the phagocytic function of mouse abdominal cavity macrophages can be obviously enhanced; the angelica neutral oil total acid has the functions of enhancing the phagocytic function of macrophages and promoting the lymphocyte transformation; the angelica polysaccharide has the functions of obviously promoting the formation rate of E-rosette and the positive rate of esterase staining; the total acid has effect in promoting specific antibody IgG production.

Mu Dan Pi is bitter, pungent and slightly cold in flavor. It enters heart, liver and kidney meridians. Has the functions of clearing away heat, cooling blood, promoting blood circulation and dissipating blood stasis. Pharmacological research shows that the tree peony bark has the functions of resisting inflammation and allergic reaction, and the paeonol which is the effective component of the tree peony bark has the inhibiting effect on animal experimental arthritis and allergic inflammation; the paeonol has anti-inflammatory effect on experimental arthritis and otitis, and can reduce permeability of capillary vessel, prevent mouse ulcer disease caused by stress, and inhibit gastric secretion of rat; has weak effects of resisting acetylcholine and histamine for isolated ileum of mouse and guinea pig, and can inhibit spontaneous movement of rat in uterus; the medicine has the effects of inhibiting rat paw swelling and rat pleurisy polymorphonuclear leukocyte migration caused by various medicines; it can be used for inhibiting allergic inflammation such as guinea pig Forssman cutaneous vasculitis, rat reverse skin anaphylaxis, rat active and passive Arthus reaction, and delayed hypersensitivity. The cortex moutan decoction is administered by intragastric administration, and has effects of inhibiting mouse auricle swelling caused by xylene, and rat foot swelling caused by carrageenan, egg white and formaldehyde; it can be used for inhibiting allergic inflammation such as passive skin anaphylaxis, reverse skin anaphylaxis, and Arthus reaction in rat caused by Trichosanthis radix.

Anemarrhena rhizome is bitter and sweet in flavor and cold in nature. It enters lung, stomach and kidney meridians. Has the effects of clearing heat, purging fire, promoting fluid production and moistening dryness. Pharmacological research shows that the rhizoma anemarrhenae has an antibacterial effect, and the rhizoma anemarrhenae decoction has an inhibitory effect on typhoid bacillus, paratyphoid bacillus, dysentery bacillus, escherichia coli, proteus bacillus, vibrio cholerae, staphylococcus and the like.

Figwort root is sweet, bitter, salty and slightly cold in nature. It enters lung, stomach and kidney meridians. Has effects of clearing heat, cooling blood, clearing pathogenic fire, removing toxic substance, and nourishing yin. Pharmacological research shows that radix scrophulariae has antibacterial effect, has inhibitory effect on Staphylococcus aureus, and also has inhibitory effect on various pathogenic and nonpathogenic fungi.

Mai Dong is sweet, slightly bitter and slightly cold in flavor. It enters heart, lung and stomach meridians. Has the effects of nourishing yin, promoting the production of body fluid, moistening lung and clearing away heart-fire. Pharmacological research shows that the fibrous root extract of ophiopogon japonicus has the function of improving cellular immunity. The effect on the central nervous system is shown in that the dwarf lilyturf tuber decoction has a sedative effect, can also enhance the sedative effect of chlorpromazine, enhance the hypnotic effect of pentobarbital sodium and antagonize the excitability of caffeine.

Poria cocos, sweet, bland and neutral. They enter heart, lung, spleen and kidney meridians. Has effects of promoting diuresis, eliminating dampness, invigorating spleen, and calming heart. Pharmacological research shows that the pachyman has the function of enhancing the immune function of normal and tumor-bearing mice and can enhance the phagocytic function of macrophages of the mice.

The eupatorium has pungent taste and mild property. It enters spleen, stomach and lung meridians. Has the effects of relieving summer-heat, eliminating dampness, removing dirt and regulating the middle warmer. Pharmacological research shows that the eupatorium 100% water decoction has effect of inhibiting laryngobacter albus, staphylococcus aureus, sarcina, proteus, typhoid bacillus, etc. by test tube dilution.

Niu xi is bitter and sour in taste and neutral in nature. Liver diseases entering; the kidney channel. Has effects in nourishing liver and kidney, strengthening muscle and bone, promoting blood circulation, dredging channels, purging pathogenic fire (blood), and inducing diuresis for treating stranguria. Pharmacological research shows that achyranthes bidentata has a relatively obvious inhibiting effect on the formaldehyde arthritis of rats; has weak inhibiting effect on egg white arthritis of rats; has obvious effect of promoting inflammation and swelling to subside for the egg white arthritis of the rat.

Lophatherum gracile is sweet and bland in flavor and cold in nature. It enters heart and kidney meridians. Sweet and bland in flavor, warm in nature, clear and descend, and good at guiding heart and small intestine fire downward to induce diuresis and treat stranguria. Pharmacological research shows that the lophatherum gracile decoction has an inhibitory effect on staphylococcus aureus and hemolytic streptococcus in vitro tests.

Licorice root, radix Glycyrrhizae is neutral in nature and sweet in flavor, entering twelve meridians. Has the effects of invigorating spleen and replenishing qi, clearing away heat and toxic materials, eliminating phlegm and relieving cough, relieving spasm and pain, and harmonizing the medicines. Pharmacological research shows that the liquorice has the function of regulating the organism immunity, the liquorice glucan can enhance the organism immunity, has the function of activating and proliferating splenic lymphocytes of mice, shows the characteristic of mitogen, and has the synergistic effect when being used together with ConA. Glycyrrhizic acid mainly has the functions of enhancing phagocytic function of macrophages and enhancing cellular immune function, but has an inhibitory effect on humoral immune function. The licorice also has antibacterial, antiviral, antiinflammatory, and antiallergic effects, and the licorice flavonoids have inhibitory effect on Staphylococcus aureus, Bacillus subtilis, yeast, fungi, streptococcus, etc. Glycyrrhizin has obvious inhibiting effect on Human Immunodeficiency Virus (HIV), hepatitis virus, vesicular stomatitis virus, adenovirus type III, herpes simplex virus type I, vaccinia virus, etc. The Glycyrrhrizae radix has corticoid-like antiinflammatory effect, and can be used for inhibiting mouse chemical auricle swelling, increased permeability of abdominal capillary, rat cotton ball granuloma, formaldehyde rat foot swelling, carrageenan rat arthritis, etc.

When the medicines are used, the medicines which are equivalent to the weight ratio can be respectively cleaned, dried, crushed and mixed to obtain granules or powder with the granularity meeting the preparation requirement for direct administration. The medicines which are equivalent to the weight proportion relation can be used as raw materials, and after proper treatment, the medicines can be added with pharmaceutic adjuvant and made into various preparations according to the needs. In the process of preparing the preparation from the raw material medicines, the raw material medicines can be processed by adopting the following method: extracting with water or ethanol of different concentrations, respectively, concentrating the extractive solution, and drying to obtain crude extract; or further refining by one or more of alcohol precipitation, water dissolution, organic solvent extraction, flocculation precipitation, and column chromatography to obtain refined extract; the specific operation and/or use method for extracting the effective medicinal components can be a mode of respectively extracting the effective medicinal components of the medicinal components in the proportional amounts as raw materials and then mixing the effective medicinal components, or a mode of mixing the medicinal components in the proportional amounts and then extracting the medicinal components together. Different extraction methods, equipment and ideal or optimal extraction temperature, solvent dosage, extraction time, extraction times and other specific conditions required during extraction are adopted, and the extract can be screened and found through experiments according to actual conditions.

The preparation method comprises the following steps:

a) weighing radix bupleuri, radix paeoniae alba, angelica sinensis, cortex moutan, rhizoma anemarrhenae, radix scrophulariae, radix ophiopogonis, poria cocos, eupatorium, radix achyranthis bidentatae, lophatherum gracile and liquorice;

b) extracting volatile oil from radix Angelicae sinensis and herba Eupatorii separately or together, collecting volatile oil in another container, collecting the residue as residue I, and filtering the extractive liquid to obtain liquid I;

c) distilling cortex moutan with water, and mixing the distillate; filtering the distilled liquid medicine to obtain liquid medicine II, and taking the extracted dregs of a decoction as dregs of a decoction II for later use;

d) mixing rhizoma anemarrhenae, radix scrophulariae, radix Ophiopogonis, Poria, folium Bambusae, Glycyrrhrizae radix, residue I and residue II, extracting with water, and mixing extractive solutions to obtain medicinal liquid III;

e) mixing the liquid medicine I, the liquid medicine II and the liquid medicine III, properly concentrating, adding ethanol for precipitation, standing overnight, and taking supernatant for later use;

f) extracting bupleuri radix, radix Paeoniae alba, and Achyranthis radix with 50-90% ethanol, mixing ethanol extractive solutions, mixing with the above supernatant, recovering ethanol, concentrating to obtain soft extract, and drying under reduced pressure to obtain dry extract;

g) spraying the distillate in the step c) into dry paste, dissolving the volatile oil by using a solvent, spraying the dissolved volatile oil into the dry paste or coating the volatile oil, mixing the volatile oil with the dry paste, drying, and crushing into fine powder to prepare the active ingredient of the composition.

The preparation method of the invention can also comprise the following steps:

extracting radix bupleuri, radix paeoniae alba, angelica sinensis, moutan bark, rhizoma anemarrhenae, radix scrophulariae, radix ophiopogonis, poria cocos, eupatorium, radix achyranthis bidentatae, lophatherum gracile and liquorice with water or 40-95% ethanol, combining filtrates, concentrating, drying, and crushing into fine powder to prepare the active ingredients of the composition.

The prepared active ingredients can be directly used as medicines or added with pharmaceutically acceptable auxiliary materials to prepare the required preparation according to the conventional process. For example, the composition can be made into oral medicines in solid preparation forms such as common tablets (dispersible tablets, effervescent tablets, orally disintegrating tablets, buccal tablets, chewable tablets and effervescent tablets), capsules (hard capsules and soft capsules), granules, pills (dripping pills, honey pills, water-honeyed pills and concentrated pills), powder, bagged tea and the like, and can also be made into oral medicines in liquid preparation forms such as syrup, oral liquid and the like. Therefore, the pharmaceutical composition can contain pharmaceutically acceptable auxiliary materials besides the active ingredients.

The auxiliary materials described herein may be different depending on different formulations, such as diluents, disintegrants, excipients, binders, lubricants, surfactants, fillers, etc., which are commonly used in solid formulations such as tablets, capsules, granules, etc.; surfactants, diluents, preservatives, stabilizers, flavoring agents, thickeners, glidants and the like are commonly used in liquid preparation forms such as syrups, oral liquids and the like.

The common adjuvants include starch, lactose, dextrin, sugar powder, microcrystalline cellulose, mannitol, xylitol, polyethylene glycol, calcium sulfate, calcium hydrogen phosphate, calcium carbonate, modified starch, sorbitol, polyvinylpyrrolidone, heavy magnesium carbonate, sodium carboxymethylcellulose, hydroxypropyl methylcellulose, ethyl cellulose, carboxymethyl starch sodium, hydroxypropyl cellulose, polyvidone K30, kaolin, pregelatinized starch, magnesium stearate, pulvis Talci, Gum Acacia, stevioside, betaine, aspartame, glycyrrhizin, saccharin sodium, citric acid, sorbic acid, potassium sorbate, ethylparaben, sucrose, starch syrup, guar gum, stevioside, sodium alginate, maltose, citric acid, malic acid, sucralose, menthol, coffee powder, monoglyceride, magnesium lauryl sulfate, etc.

For the above-mentioned formulations, the preparation method is exemplified as follows:

the granules are prepared by the following method:

adding 6-10 times of water into radix Angelicae sinensis and herba Eupatorii, extracting volatile oil for 6 hr, filtering the medicinal liquid after oil extraction to obtain medicinal liquid I, collecting the residue, clathrating the volatile oil with beta-cyclodextrin, refrigerating overnight, filtering, and drying the filter cake at low temperature to obtain clathrate of volatile oil beta-cyclodextrin; adding 4-10 times of water into cortex moutan, distilling for 1-5 hr, collecting distillate, and collecting the distillate to obtain medicinal liquid II and medicinal residue II; mixing rhizoma anemarrhenae, radix scrophulariae, radix Ophiopogonis, Poria, folium Bambusae, Glycyrrhrizae radix, residue I and residue II, decocting with 6-10 times of water for 1-3 times, each for 1-3 hr, mixing extractive solutions, mixing the extractive solutions with the medicinal liquid I and the medicinal liquid II, concentrating to relative density of 1.10-1.15 at 60 deg.C, cooling, adding ethanol to ethanol content of 50-80%, standing overnight, and filtering to obtain supernatant; extracting bupleuri radix, radix Paeoniae alba and Achyranthis radix with 6-10 times of 50-90% ethanol for 1-3 times, each time for 1-3 hr, mixing extractive solutions, filtering, mixing filtrate with the above supernatant, recovering ethanol until no alcohol smell exists, concentrating to obtain soft extract with relative density of 1.30-1.35 at 60 deg.C, drying under reduced pressure to obtain dry extract, spraying cortex moutan distillate, mixing with volatile oil times of cyclodextrin clathrate, drying, pulverizing into fine powder, adding appropriate amount of adjuvants, granulating, drying, and grading to obtain granule.

The above preparation method is only illustrative of the preparation method of the present invention, but it should not be understood that the preparation method of the present invention is limited to the above-listed method.

From the foregoing, it will be apparent that various other modifications, substitutions and variations can be made in the present invention without departing from the basic technical spirit of the invention, as defined by the common technical knowledge and common practice in the art.

Detailed Description

The beneficial effects of the compositions according to the invention are further illustrated by the following test examples:

1. test materials

Drug group: the examples 1, 2 and 3 of the present invention are drug group 1, drug group 2 and drug group 3, respectively, and are administered orally.

Control group: yumai oropharynx mixture, for oral administration.

2. Test method

320 out-patient cases were selected, 160 men, 160 women, the largest age 75 years, and the smallest age 16 years. The observation indexes are as follows: recurrent oral ulcer major symptomatic type: behcet's disease, oral mucosa injury ulcer, herpetic stomatitis, erythema multiforme, tuberculous ulcer, contact stomatitis, necrotizing gingivitis and malignant ulcer. The symptom selection criteria were: behcet's disease, oral mucosa lesion ulcer, herpetic stomatitis, erythema multiforme, tuberculous ulcer, contact stomatitis, necrotizing gingivitis, and malignant ulcer.

As a result: see table 1.

TABLE 1 comparison of before and after treatment with drugs

P <0.05, P <0.01, compared to control

Inventive examples 4-10 were similarly tested as described above, with the same results as described above.

3. Conclusion

In conclusion, the composition has a remarkable curative effect on treating recurrent oral ulcer, and the effect of treating the oral ulcer is prompted.

The present invention will be described in further detail with reference to the following examples. It should not be understood that the scope of the above-described subject matter of the present invention is limited to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.

Example 1

Bupleurum root 65g white peony root 100g Chinese angelica root 115g bark of peony root 100g

110g of rhizoma anemarrhenae, 100g of radix scrophulariae, 100g of radix ophiopogonis, 100g of poria cocos, and 120g of poria cocos

Herba Eupatorii 95g, Achyranthis radix 100g, herba Lophatheri 55g, Glycyrrhrizae radix 60g

b) extracting radix Angelicae sinensis and herba Eupatorii with 8 times of water for 6 hr, collecting volatile oil in another container, collecting the residue as residue I, and filtering the extractive solution to obtain solution I;

c) adding 6 times of water into cortex moutan, distilling for 4 hr, and mixing the distillate; filtering the distilled liquid medicine to obtain liquid medicine II, and taking the extracted dregs of a decoction as dregs of a decoction II for later use;

d) mixing rhizoma anemarrhenae, radix scrophulariae, radix Ophiopogonis, Poria, folium Bambusae, Glycyrrhrizae radix, residue I and residue II, extracting with 8 times of water for 2 times, each time for 2 hr, and mixing extractive solutions to obtain medicinal liquid III;

e) mixing the medicinal liquid I, II and III, concentrating to relative density of 1.10-1.15 at 60 deg.C, adding ethanol to make ethanol content reach 75%, standing overnight, and collecting supernatant;

f) extracting bupleuri radix, radix Paeoniae alba, and Achyranthis radix with 8 times of 75% ethanol for 2 times, each for 2 hr, mixing ethanol extractive solutions, mixing with the above supernatant, recovering ethanol, concentrating to obtain soft extract with relative density of 1.30-1.35 at 60 deg.C, and drying under reduced pressure to obtain dry extract;

g) spraying the distillate in the step c) into the dry paste, clathrating the volatile oil, mixing with the dry paste, drying, pulverizing into fine powder, adding appropriate amount of adjuvants, granulating, drying, and grading to obtain granule.

Example 2

Bupleurum root 90g white peony root 60g Chinese angelica root 150g bark of peony root 60g

150g of rhizoma anemarrhenae, 60g of radix scrophulariae, 150g of radix ophiopogonis, 60g of poria cocos, and 60g of radix ophiopogonis

Herba Eupatorii 150g, Achyranthis radix 45g, herba Lophatheri 100g, Glycyrrhrizae radix 15g

b) extracting radix Angelicae sinensis and herba Eupatorii with 6 times of water respectively for 6 hr, collecting volatile oil, mixing the residues to obtain residue I, filtering the extractive solution, and mixing to obtain solution I;

c) adding 4 times of water into cortex moutan, distilling for 5 hr, and mixing the distillate; filtering the distilled liquid medicine to obtain liquid medicine II, and taking the extracted dregs of a decoction as dregs of a decoction II for later use;

d) mixing rhizoma anemarrhenae, radix scrophulariae, radix Ophiopogonis, Poria, folium Bambusae, Glycyrrhrizae radix, residue I and residue II, extracting with 10 times of water for 1 time, each time for 3 hr, and mixing extractive solutions to obtain medicinal liquid III;

e) mixing the medicinal liquid I, II and III, concentrating to relative density of 1.10-1.15 at 60 deg.C, adding ethanol to ethanol content of 50%, standing overnight, and collecting supernatant;

f) extracting bupleuri radix, radix Paeoniae alba, and Achyranthis radix with 6 times of 50% ethanol for 3 times, each for 1 hr, mixing ethanol extractive solutions, mixing with the above supernatant, recovering ethanol, concentrating to obtain soft extract with relative density of 1.30-1.35 at 60 deg.C, and drying under reduced pressure to obtain dry extract;

g) spraying the distillate in step c) into the dry extract, dissolving the volatile oil with ethanol, spraying the dissolved volatile oil into the dry extract, drying, pulverizing into fine powder, adding appropriate amount of adjuvants, granulating, drying, and grading to obtain granule.

Example 3

Radix bupleuri 30g, radix paeoniae alba 150g, angelica sinensis 60g and cortex moutan 150g

60g of rhizoma anemarrhenae, 150g of radix scrophulariae, 60g of radix ophiopogonis, 150g of poria cocos, and 150g of radix ophiopogonis

30g of eupatorium fortunei, 150g of achyranthes bidentata, 20g of lophatherum gracile and 90g of liquorice

b) extracting radix Angelicae sinensis and herba Eupatorii with 10 times of water for 6 hr, collecting volatile oil in another container, collecting the residue as residue I, and filtering the extractive solution to obtain solution I;

c) adding 10 times of water into cortex moutan, distilling for 1 hr, and mixing the distillate; filtering the distilled liquid medicine to obtain liquid medicine II, and taking the extracted dregs of a decoction as dregs of a decoction II for later use;

d) mixing rhizoma anemarrhenae, radix scrophulariae, radix Ophiopogonis, Poria, folium Bambusae, Glycyrrhrizae radix, residue I and residue II, extracting with 6 times of water for 3 times, each for 1 hr, and mixing the extractive solutions to obtain medicinal liquid III;

e) mixing the medicinal liquid I, II and III, concentrating to relative density of 1.10-1.15 at 60 deg.C, adding ethanol to reach ethanol content of 80%, standing overnight, and collecting supernatant;

f) extracting bupleuri radix, radix Paeoniae alba, and Achyranthis radix with 10 times of 90% ethanol for 1 time, each for 3 hr, mixing ethanol extractive solutions, mixing with the above supernatant, recovering ethanol, concentrating to obtain soft extract with relative density of 1.30-1.35 at 60 deg.C, and drying under reduced pressure to obtain dry extract;

Example 4

Bupleurum root 60g white peony root 105g Chinese angelica root 105g bark of peony root 105g

105g of rhizoma anemarrhenae, 105g of radix scrophulariae, 105g of radix ophiopogonis, 105g of poria cocos, 105g of radix ophiopogonis

Herba Eupatorii 90g, Achyranthis radix 95g, herba Lophatheri 60g, radix Glycyrrhizae Preparata 55g

Adding 8 times of water into the angelica and the eupatorium, extracting volatile oil for 6 hours, filtering the liquid medicine after oil extraction to obtain liquid medicine I for later use, using the extracted dregs as dregs I for later use, coating the volatile oil with beta-cyclodextrin, refrigerating overnight, filtering, and drying a filter cake at low temperature to obtain a volatile oil beta-cyclodextrin inclusion compound for later use; adding 8 times of water into cortex moutan, distilling for 4 hr, collecting distillate, and collecting the distillate to obtain medicinal liquid II and medicinal residue II; mixing rhizoma anemarrhenae, radix scrophulariae, radix Ophiopogonis, Poria, folium Bambusae, Glycyrrhrizae radix with residue I and residue II, decocting with 8 times of water for 2 times, each time for 2 hr, mixing extractive solutions, mixing the extractive solutions with the residue I and the residue II, concentrating to relative density of 1.10-1.15 at 60 deg.C, cooling, adding ethanol to ethanol content of 60%, standing overnight, and filtering to obtain supernatant; extracting bupleuri radix, radix Paeoniae alba and Achyranthis radix with 10 times of 70% ethanol for 2 times, each for 2 hr, filtering, mixing the filtrate with the above supernatant, recovering ethanol, concentrating, spraying cortex moutan distillate, adding the volatile oil-times of cyclodextrin clathrate, adding appropriate amount of suspension, flavoring agent and antiseptic, mixing, adding water to desired volume, filtering, and packaging to obtain oral liquid preparation.

Example 5

Radix bupleuri 70g, radix paeoniae alba 80g, wine angelica sinensis 140g and cortex moutan radicis 80g

120g of rhizoma anemarrhenae, 80g of radix scrophulariae, 120g of radix ophiopogonis, 120g of poria cocos, and 100g of poria cocos

Herba Eupatorii 120g, Achyranthis radix 80g, herba Lophatheri 80g, radix Glycyrrhizae Preparata 30g

Adding 10 times of water into the angelica and the eupatorium, extracting volatile oil for 6 hours, filtering the liquid medicine after oil extraction to obtain liquid medicine I for later use, using the extracted dregs as dregs I for later use, coating the volatile oil with beta-cyclodextrin, refrigerating overnight, filtering, and drying a filter cake at low temperature to obtain a volatile oil beta-cyclodextrin inclusion compound for later use; adding 4 times of water into cortex moutan, distilling for 5 hr, collecting distillate, and collecting the distillate to obtain medicinal liquid II and medicinal residue II; mixing rhizoma anemarrhenae, radix scrophulariae, radix Ophiopogonis, Poria, folium Bambusae, Glycyrrhrizae radix with residue I and residue II, decocting with 6 times of water for 3 times, each time for 2 hr, mixing extractive solutions, mixing the extractive solutions with the residue I and the residue II, concentrating to relative density of 1.10-1.15 at 60 deg.C, cooling, adding ethanol to ethanol content of 65%, standing overnight, and filtering to obtain supernatant; extracting bupleuri radix, radix Paeoniae alba and Achyranthis radix with 9 times of 60% ethanol for 2 times, each for 3 hr, mixing extractive solutions, filtering, mixing filtrate with the above supernatant, recovering ethanol to remove ethanol smell, concentrating to obtain soft extract with relative density of 1.30-1.35 at 60 deg.C, drying under reduced pressure to obtain dry extract, spraying cortex moutan distillate, mixing with volatile oil times of cyclodextrin clathrate, drying, pulverizing into fine powder, granulating, drying, and grading to obtain granule.

Example 6

Bupleurum root 50g white peony root 120g Chinese angelica root 100g bark of peony root 120g

80g of rhizoma anemarrhenae, 120g of radix scrophulariae, 80g of radix ophiopogonis, 80g of poria cocos, 140g of poria cocos

Herba Eupatorii 80g achyranthis bidentatae charcoal 120g lophatherum gracile 40g liquorice 70g

Adding 7 times of water into the angelica and the eupatorium, extracting volatile oil for 6 hours, filtering the liquid medicine after oil extraction to obtain liquid medicine I for later use, using the extracted dregs as dregs I for later use, coating the volatile oil with beta-cyclodextrin, refrigerating overnight, filtering, and drying a filter cake at low temperature to obtain a volatile oil beta-cyclodextrin inclusion compound for later use; adding 5 times of water into cortex moutan, distilling for 3 hr, collecting distillate, and collecting the distillate to obtain medicinal liquid II and medicinal residue II; mixing rhizoma anemarrhenae, radix scrophulariae, radix Ophiopogonis, Poria, folium Bambusae, Glycyrrhrizae radix with residue I and residue II, decocting with 9 times of water for 2 times, each time for 1 hr, mixing extractive solutions, mixing the extractive solutions with the residue I and the residue II, concentrating to relative density of 1.10-1.15 at 60 deg.C, cooling, adding ethanol to ethanol content of 55%, standing overnight, and filtering to obtain supernatant; extracting bupleuri radix, radix Paeoniae alba and Achyranthis radix with 6 times of 70% ethanol for 3 times, each time for 1 hr, mixing extractive solutions, filtering, mixing filtrate with the above supernatant, recovering ethanol to remove ethanol smell, concentrating to obtain soft extract with relative density of 1.30-1.35 at 60 deg.C, drying under reduced pressure to obtain dry extract, spraying cortex moutan distillate, mixing with volatile oil BETA-cyclodextrin clathrate, drying, pulverizing into fine powder, mixing, granulating, drying, and making into capsule.

Example 7

Bupleurum root 40g white peony root 95g Chinese angelica root 130g prepared moutan bark 140g

140g of rhizoma anemarrhenae, 70g of radix scrophulariae, 80g of radix ophiopogonis, 70g of poria cocos, and 70g of radix ophiopogonis

140g of eupatorium fortunei, 50g of achyranthes bidentata, 30g of lophatherum gracile and 20g of honey-fried licorice root

Adding 9 times of water into the angelica and the eupatorium, extracting volatile oil for 6 hours, filtering the liquid medicine after oil extraction to obtain liquid medicine I for later use, using the extracted dregs as dregs I for later use, coating the volatile oil with beta-cyclodextrin, refrigerating overnight, filtering, and drying a filter cake at low temperature to obtain a volatile oil beta-cyclodextrin inclusion compound for later use; adding 7 times of water into cortex moutan, distilling for 2 hr, collecting distillate, and collecting the distillate to obtain medicinal liquid II and medicinal residue II; mixing rhizoma anemarrhenae, radix scrophulariae, radix Ophiopogonis, Poria, folium Bambusae, Glycyrrhrizae radix with residue I and residue II, decocting with 7 times of water for 2 times, each time for 2 hr, mixing extractive solutions, mixing the extractive solutions with the residue I and the residue II, concentrating to relative density of 1.10-1.15 at 60 deg.C, cooling, adding ethanol to ethanol content of 60%, standing overnight, and filtering to obtain supernatant; extracting bupleuri radix, radix Paeoniae alba and Achyranthis radix with 9 times of 85% ethanol for 1-3 times, each time for 1-3 hr, mixing extractive solutions, filtering, mixing filtrate with the above supernatant, recovering ethanol until no alcohol smell exists, concentrating to obtain soft extract with relative density of 1.30-1.35 at 60 deg.C, drying under reduced pressure to obtain dry extract, spraying cortex moutan distillate, mixing with volatile oil BETA-cyclodextrin clathrate, drying, pulverizing into fine powder, adding appropriate amount of excipient and filler, mixing, granulating, drying, adding lubricant, mixing, tabletting, and optionally coating to obtain tablet.

Example 8

Bupleurum root 85g white peony root 125g Chinese angelica root 70g bark of peony root 70g

70g of rhizoma anemarrhenae, 140g of radix scrophulariae, 140g of radix ophiopogonis, 140g of poria cocos, 140g of radix ophiopogonis

40g of eupatorium fortunei, 140g of achyranthes bidentata, 90g of lophatherum gracile, 85g of liquorice

Adding 8 times of water into the angelica and the eupatorium, extracting volatile oil for 6 hours, filtering the liquid medicine after oil extraction to obtain liquid medicine I for later use, using the extracted dregs as dregs I for later use, coating the volatile oil with beta-cyclodextrin, refrigerating overnight, filtering, and drying a filter cake at low temperature to obtain a volatile oil beta-cyclodextrin inclusion compound for later use; adding 8 times of water into cortex moutan, distilling for 2 hr, collecting distillate, and collecting the distillate to obtain medicinal liquid II and medicinal residue II; mixing rhizoma anemarrhenae, radix scrophulariae, radix Ophiopogonis, Poria, folium Bambusae, Glycyrrhrizae radix with residue I and residue II, decocting with 8 times of water for 2 times, each time for 2 hr, mixing extractive solutions, mixing the extractive solutions with the residue I and the residue II, concentrating to relative density of 1.10-1.15 at 60 deg.C, cooling, adding ethanol to ethanol content of 70%, standing overnight, and filtering to obtain supernatant; extracting bupleuri radix, radix Paeoniae alba and Achyranthis radix with 8 times of 60% ethanol for 2 times, each time for 1.5 hr, mixing extractive solutions, filtering, mixing filtrate with the above supernatant, recovering ethanol until no alcohol smell is present, concentrating to obtain soft extract with relative density of 1.30-1.35 at 60 deg.C, drying under reduced pressure to obtain dry extract, spraying cortex moutan distillate, mixing with volatile oil BETA-cyclodextrin clathrate, drying, pulverizing into fine powder, and making into bagged tea by conventional method.

Example 9

Bupleurum root 80g white peony root 95g Chinese angelica root 120g bark of peony root 130g

130g of rhizoma anemarrhenae, 130g of radix scrophulariae, 130g of radix ophiopogonis, 130g of poria cocos, 100g of poria cocos

Herba Eupatorii 120g, Achyranthis radix 120g, herba Lophatheri 50g, Glycyrrhrizae radix 50g

Decocting the above 12 materials in water, filtering, mixing filtrates, concentrating, drying, pulverizing into fine powder, adding appropriate amount of adjuvant, mixing, and making into pill.

Example 10

35g of radix bupleuri, 65g of white peony root, 90g of angelica sinensis and 90g of moutan bark

75g of rhizoma anemarrhenae, 110g of radix scrophulariae, 110g of radix ophiopogonis, 110g of poria cocos, and 110g of radix ophiopogonis

50g of eupatorium fortunei, 110g of achyranthes bidentata, 25g of lophatherum gracile, 25g of liquorice and 30g of liquorice

Extracting the above 12 materials with 70% ethanol, filtering, mixing ethanol extractive solutions, recovering ethanol until no ethanol smell exists, concentrating under reduced pressure, drying, pulverizing into fine powder, adding appropriate amount of adjuvant or no adjuvant, mixing, and making into powder.

Claims

1. A traditional Chinese medicine composition for treating oral ulcer is characterized by being prepared from the following raw materials in parts by weight: 3-9 parts of radix bupleuri, 6-15 parts of radix paeoniae alba, 6-15 parts of angelica sinensis, 6-15 parts of cortex moutan radicis, 6-15 parts of rhizoma anemarrhenae, 6-15 parts of radix scrophulariae, 6-15 parts of radix ophiopogonis, 6-15 parts of poria cocos, 3-15 parts of eupatorium, 4.5-15 parts of radix achyranthis bidentatae, 2-10 parts of lophatherum gracile and 1.5-9 parts of liquorice; the preparation method of the traditional Chinese medicine composition comprises the following steps: a) weighing radix bupleuri, radix paeoniae alba, angelica sinensis, cortex moutan, rhizoma anemarrhenae, radix scrophulariae, radix ophiopogonis, poria cocos, eupatorium, radix achyranthis bidentatae, lophatherum gracile and liquorice;

g) spraying the distillate in the step c) into the dry paste, dissolving the volatile oil with a solvent, spraying the dissolved volatile oil into the dry paste or coating the volatile oil, mixing the volatile oil with the dry paste, drying, and crushing into fine powder to prepare the traditional Chinese medicine composition.

2. The traditional Chinese medicine composition for treating oral ulcer according to claim 1, which is prepared from the following raw materials in parts by weight: 5-7 parts of radix bupleuri, 8-12 parts of radix paeoniae alba, 10-14 parts of angelica sinensis, 8-12 parts of cortex moutan, 8-12 parts of rhizoma anemarrhenae, 8-12 parts of radix scrophulariae, 8-12 parts of radix ophiopogonis, 10-14 parts of poria cocos, 8-12 parts of eupatorium fortunei, 8-12 parts of radix achyranthis bidentatae, 4-8 parts of lophatherum gracile and 3-7 parts of liquorice.

3. The preparation method of the traditional Chinese medicine composition of claim 1 or 2, which is characterized in that the preparation method comprises the following steps:

4. The preparation method of the traditional Chinese medicine composition according to claim 3, wherein the prepared traditional Chinese medicine composition is prepared into a pharmaceutically acceptable preparation by a conventional process with or without adding auxiliary materials.

5. The method for preparing a Chinese medicinal composition according to claim 4, wherein the preparation is in the form of tablet, capsule, granule, pill, powder, oral liquid, or bagged tea.

6. The preparation method of claim 5, wherein the tablet is a common tablet, a dispersible tablet, an effervescent tablet, an orally disintegrating tablet, a buccal tablet, a chewable tablet; the capsule is hard capsule or soft capsule; the pill is dripping pill, honeyed pill, water-honeyed pill, or concentrated pill.

7. The method of claim 5, wherein the formulation is in the form of granules.

8. The method of claim 7, wherein the granules are prepared by:

9. A traditional Chinese medicine composition for treating oral ulcer is characterized by being prepared from the following raw material medicines in parts by weight: 3-9 parts of radix bupleuri, 6-15 parts of radix paeoniae alba, 6-15 parts of angelica sinensis, 6-15 parts of cortex moutan radicis, 6-15 parts of rhizoma anemarrhenae, 6-15 parts of radix scrophulariae, 6-15 parts of radix ophiopogonis, 6-15 parts of poria cocos, 3-15 parts of eupatorium, 4.5-15 parts of radix achyranthis bidentatae, 2-10 parts of lophatherum gracile and 1.5-9 parts of liquorice; the preparation method of the traditional Chinese medicine composition comprises the following steps: extracting bupleuri radix, radix Paeoniae alba, radix Angelicae sinensis, cortex moutan, rhizoma anemarrhenae, radix scrophulariae, radix Ophiopogonis, Poria, herba Eupatorii, Achyranthis radix, folium Bambusae, and Glycyrrhrizae radix with water or 40-95% ethanol, mixing filtrates, concentrating, drying, and pulverizing into fine powder.

10. Use of a composition according to claim 1 or 2 for the manufacture of a medicament for the treatment of oral ulcer disease.