CN115192646A - Application of traditional Chinese medicine composition in preparation of medicine for relieving and/or treating oral ulcer - Google Patents
Application of traditional Chinese medicine composition in preparation of medicine for relieving and/or treating oral ulcer Download PDFInfo
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Abstract
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating oral ulcer. The traditional Chinese medicine composition is mainly prepared from notopterygium root, radix angelicae pubescentis, poria cocos, divaricate saposhnikovia root, schizonepeta, ligusticum wallichii, platycodon grandiflorum, radix bupleuri, radix peucedani, fructus aurantii and liquorice. The traditional Chinese medicine composition can obviously relieve the injury degree of ulcer wounds, improve the symptoms of lip swelling and the like caused by oral ulcer, reduce the levels of inflammatory factors TNF-alpha, IL-2 and IL-6 in the blood of rats, and can be used for relieving and/or treating the oral ulcer caused by various factors.
Description
Technical Field
The invention relates to a traditional Chinese medicine composition and application thereof, in particular to a traditional Chinese medicine composition and application thereof in preparing a medicine for relieving and/or treating oral ulcer, and belongs to the technical field of traditional Chinese medicines.
Background
The oral ulcer is commonly called as canker sore, which is a common ulcerative injury disease occurring in oral mucosa, and is mostly seen in the inner side of lip, tongue, abdomen, buccal mucosa, vestibular sulcus, soft palate and other parts, and the mucosa of the parts lacks of cutinization layer or has poor keratosis. Tongue ulcer refers to oral ulcer occurring on tongue and tongue abdomen. The oral ulcer has severe pain during the attack, and the local burning pain is obvious, so that the serious patient can influence diet and speaking, and great inconvenience is caused to daily life; can be complicated with halitosis, chronic pharyngitis, constipation, headache, dizziness, nausea, debilitation, dysphoria, fever, lymphadenectasis, etc.
The dental ulcer belongs to the categories of aphtha and aphthous stomatitis in traditional Chinese medicine. Aphtha is originated in the mouth but has close relationship with the internal organs. The doctor of traditional Chinese medicine Liu Guo Ying believes that the spleen opens into the mouth, the heart opens into the tongue, the kidney vessels are connected with the pharynx and tie the tongue, the two cheeks and the gingiva belong to the stomach and the large intestine, and the conception vessel and the governor vessel are both connected with the lips and the tongue of the oral cavity, which indicates that the occurrence of aphtha is closely related to the five internal organs. Su Wen: to the true essentials theory states: all sores and itching sores belong to the heart. The fire of aphtha is not responsible for the heart. In normal times, worry and anger, the excessive intake of tobacco, wine, coffee and excessive eating of coffee can cause heat accumulation in the heart and spleen, stagnated heat in the lung and stomach and accumulated heat in the liver and gallbladder, and the aphtha is mostly excessive syndrome; deficiency of kidney yin and flaring-up of deficient fire often cause aphtha, which is often a deficiency syndrome, old and weak, tired and internal injury, impairment of spleen and stomach, causing dysfunction of middle-jiao hub, obstruction of qi movement, failure of yang in upper-jiao to descend, failure of yin in lower-jiao to ascend, and excessive heart fire, and flaming up along meridians. Just as Li Dongyuan in the theory of spleen and stomach: for the treatment, the method of treating the deficiency of spleen and stomach qi, deficiency of original qi, excessive heart fire, yin fire in the lower energizer, the heart being tied to the heart and the heart failing to control the function of the heart, and stomach diseases with short breath, mental deficiency and large heat, sometimes the stomach fire goes upward to burn the face alone can be selected as the treatment method of the traditional Chinese medicine.
Jingfang granules can induce sweat to release exterior, dispel wind and eliminate dampness. Can be used for treating wind-cold type common cold, headache, general pain, aversion to cold, no sweat, nasal obstruction, watery nasal discharge, cough, and white phlegm. At present, the Jingfang granules have no report on the treatment of oral ulcer.
Disclosure of Invention
The invention further develops the application of the traditional product 'Jingfang granule' and 'Jingfang mixture', the new application comes from the feedback of company staff, some employees accidentally find that the oral ulcer symptom is obviously relieved during the period of drinking the Jingfang granules and the Jingfang mixture to prevent cold. The applicant has therefore made further studies on its use in alleviating and/or treating oral ulcers, according to staff feedback.
The first purpose of the invention is to provide a traditional Chinese medicine composition for relieving or/and treating oral ulcer, wherein the traditional Chinese medicine composition comprises notopterygium root, radix angelicae pubescentis, poria cocos, radix sileris, schizonepeta, ligusticum wallichii, platycodon grandiflorum, radix bupleuri, radix peucedani, fructus aurantii and liquorice;
the traditional Chinese medicine composition comprises the following raw materials in specific proportion:
preferably, the first and second liquid crystal materials are,
the oral ulcer according to the present invention may be caused by one or more of local trauma, stress, malnutrition, food stimulation, drug stimulation, bacterial infection, viral infection, vitamin deficiency, hormone level, genetic factors, systemic diseases, immune factors;
specifically, systemic diseases include, but are not limited to, gastric ulcer, duodenal ulcer, ulcerative colitis, crohn's disease, hepatitis, female menstrual period, vitamin B group malabsorption, and vegetative nerve functional disturbance;
specifically, bacterial infections include, but are not limited to, candida infections, anaerobic infections, streptococcal infections, staphylococcus aureus infections, pneumococcal infections.
Further, the oral ulcer includes but is not limited to recurrent oral ulcer, behcet's syndrome, traumatic ulcer, cancerous ulcer, herpes simplex, radiation stomatitis, tuberculous ulcer, necrotic sialadenitis.
The oral ulcer includes but is not limited to oral ulcer occurring on the inner lip, tongue abdomen, buccal mucosa, vestibular groove, soft palate, tongue abdomen.
The second purpose of the invention is to provide application of the traditional Chinese medicine composition in preparing a medicine for alleviating or/and treating complications of oral ulcer.
Specifically, the oral ulcer complications include halitosis, chronic pharyngitis, constipation, headache, dizziness, nausea, asthenia, dysphoria, fever, lymphadenectasis and general symptoms.
The third purpose of the invention is to provide a preparation prepared from the traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials.
Specifically, the preparation comprises granules, mixtures, tablets, capsules, pills, powder, syrup, microcapsules and paste.
The invention also provides application of the Jingfang preparation prepared from the traditional Chinese medicine composition in preparing medicines for relieving or/and treating oral ulcer and complications thereof.
Further, the Jingfang preparation comprises Jingfang granules, jingfang mixture, jingfang capsules, jingfang tablets and Jingfang pills, and preferably comprises the Jingfang granules and the Jingfang mixture.
Compared with the prior art, the invention has the remarkable technical effects that:
(1) The traditional Chinese medicine composition can obviously inhibit inflammatory factors and reduce the content levels of TNF-alpha, IL-2 and IL-6 in blood of a model rat, thereby improving inflammatory response and effectively treating dental ulcer;
(2) The traditional Chinese medicine composition can obviously relieve the injury degree of the oral ulcer wound and relieve the symptoms of lip swelling and the like caused by light mouth ulcer.
DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION
The present invention will be described in further detail by way of examples for the purpose of making the objects and technical solutions of the present invention clearer, but it should not be understood that the scope of the above-described subject matter of the present invention is limited to the following examples. Such alterations and modifications are intended to be included herein within the scope of this disclosure as determined by those skilled in the art to which the invention pertains and by the annexed claims.
EXAMPLE 1 preparation of granules
Prescription:
the preparation method comprises the following steps:
extracting volatile oil from herba Schizonepetae, radix Saposhnikoviae, notopterygii rhizoma, radix Angelicae Pubescentis, radix Peucedani, rhizoma Ligustici Chuanxiong and fructus Aurantii respectively, and collecting the water solution of rhizoma Ligustici Chuanxiong and fructus Aurantii after distillation; percolating rhizoma Ligustici Chuanxiong and fructus Aurantii residue and Poria with 25% ethanol solution prepared from the above water solution as solvent; decocting the residues of herba Schizonepetae, radix Saposhnikoviae, notopterygii rhizoma, radix Angelicae Pubescentis and radix Peucedani with the rest bupleuri radix, radix Platycodi and Glycyrrhrizae radix in water twice for 1.5 hr each time, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; mixing the percolate and the soft extract, mixing, standing, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.30 (80-85 deg.C), mixing fluid extract 1 part with sucrose 6 parts, granulating, drying, adding the above volatile oil such as herba Schizonepetae, and mixing.
Example 2 preparation of granules
Prescription:
the preparation method comprises the following steps: the same as in example 1.
Example 3 preparation of granules
Prescription:
the preparation method comprises the following steps: the same as in example 1.
Example 4 preparation of cocktails
Prescription:
the preparation method comprises the following steps:
respectively distilling herba Schizonepetae, radix Saposhnikoviae, notopterygii rhizoma, radix Angelicae Pubescentis, fructus Aurantii, rhizoma Ligustici Chuanxiong and radix Peucedani to extract volatile oil, and collecting the distilled water solution; percolating rhizoma Ligustici Chuanxiong, fructus Aurantii residue and Poria with distilled water solution to obtain 25% ethanol as solvent, collecting percolate, and recovering ethanol under reduced pressure. Decocting the residue of the rest five medicinal materials, bupleuri radix, radix Platycodi and Glycyrrhrizae radix with water for three times, filtering, mixing filtrates, concentrating to about 1300ml, mixing with percolate, standing, filtering, concentrating to about 1000ml, adding sodium benzoate 3g and above volatile oil, stirring, and adding water to 1000 ml.
EXAMPLE 5 Capsule preparation
Prescription:
the preparation method comprises the following steps:
extracting volatile oil from herba Schizonepetae, radix Saposhnikoviae, notopterygii rhizoma, radix Angelicae Pubescentis, radix Peucedani, rhizoma Ligustici Chuanxiong and fructus Aurantii respectively, and collecting the water solution of rhizoma Ligustici Chuanxiong and fructus Aurantii after distillation; percolating rhizoma Ligustici Chuanxiong and fructus Aurantii residues and Poria with 25% ethanol solution as solvent; decocting the residues of herba Schizonepetae, radix Saposhnikoviae, notopterygii rhizoma, radix Angelicae Pubescentis and radix Peucedani and the rest three materials including bupleuri radix, radix Platycodi and Glycyrrhrizae radix in water twice for 1.5 hr each time, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; mixing the percolate and the soft extract, mixing, standing, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.30 (80-85 deg.C), adding sucrose 6 parts into the fluid extract 1 part, mixing, granulating, drying, adding the above volatile oil such as herba Schizonepetae, mixing, drying, pulverizing, and making into capsule.
EXAMPLE 6 tablet preparation
Prescription:
the preparation method comprises the following steps:
extracting volatile oil from herba Schizonepetae, radix Saposhnikoviae, notopterygii rhizoma, radix Angelicae Pubescentis, radix Peucedani, rhizoma Ligustici Chuanxiong and fructus Aurantii respectively, and collecting the water solution of rhizoma Ligustici Chuanxiong and fructus Aurantii after distillation; percolating rhizoma Ligustici Chuanxiong and fructus Aurantii residue and Poria with 25% ethanol solution prepared from the above water solution as solvent; decocting the residues of herba Schizonepetae, radix Saposhnikoviae, notopterygii rhizoma, radix Angelicae Pubescentis and radix Peucedani with the rest bupleuri radix, radix Platycodi and Glycyrrhrizae radix in water twice for 1.5 hr each time, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; mixing the percolate and the soft extract, mixing, standing, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.30 (80-85 deg.C), adding sucrose 6 parts into 1 part, mixing, granulating, adding adjuvant, mixing, and tabletting.
EXAMPLE 7 pellet preparation
Prescription:
the preparation method comprises the following steps:
extracting volatile oil from herba Schizonepetae, radix Saposhnikoviae, notopterygii rhizoma, radix Angelicae Pubescentis, radix Peucedani, rhizoma Ligustici Chuanxiong and fructus Aurantii respectively, and collecting the water solution of rhizoma Ligustici Chuanxiong and fructus Aurantii after distillation; percolating rhizoma Ligustici Chuanxiong and fructus Aurantii residues and Poria with 25% ethanol solution as solvent; decocting the residues of herba Schizonepetae, radix Saposhnikoviae, notopterygii rhizoma, radix Angelicae Pubescentis and radix Peucedani and the rest three materials including bupleuri radix, radix Platycodi and Glycyrrhrizae radix in water twice for 1.5 hr each time, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; mixing the percolate and the thick paste, mixing uniformly, standing, filtering, concentrating the filtrate into clear paste with the relative density of 1.30 (80-85 ℃), taking 1 part of the clear paste, adding 6 parts of cane sugar, mixing uniformly to prepare granules, drying, adding the volatile oil of the schizonepeta and the like, mixing uniformly, drying, crushing, sieving, adding 40-60 g of refined honey and a proper amount of water to prepare pills, and drying to obtain the traditional Chinese medicine composition.
Pharmacological experiments
The inventor carries out related pharmacodynamic experimental research to prove the efficacy of the traditional Chinese medicine composition for treating the oral ulcer. It should be noted that the following experimental studies are all performed based on the safety of the drug as proved by acute toxicity tests and long-term toxicity tests, and the administration dosage in the experimental studies is within the safe dosage range. The selected medicine in the pharmacodynamic test is a representative formula, a representative preparation formulation and a representative medicine prepared by the preparation method; the inventor also carries out pharmacodynamic experiments on the medicines obtained by other formulas, dosage forms and preparation methods, and the experimental results show that the medicines obtained by other formulas, dosage forms and preparation methods have the same or similar effects, but the medicines are not listed in the invention due to space limitation.
In addition, the pharmacodynamic experiments described below only take part of animal models as examples to verify the efficacy of the traditional Chinese medicine composition, and only show the pharmacodynamic experiment results of the traditional Chinese medicine composition for treating recurrent oral ulcer, and for oral ulcer and oral ulcer complications caused by other types and other pathogenic factors mentioned in the invention, the inventor also performs related pharmacodynamic experiments, and the experiment results show that the traditional Chinese medicine composition has the same or similar effects, and the pharmacodynamic experiment results are not listed one by one.
1 Material
1.1 Experimental drugs and reagents
1.1.1 medicaments
Granules obtained in examples 1, 2 and 3 of the present invention;
guilin watermelon frost capsule (Sanjin, national standard Z45021994, guilin Sanjin pharmaceutical industry Co., ltd.);
phenol; enzyme linked immunosorbent assay (ELISA) kit for TNF-alpha, IL-2 and IL-6.
1.1.2 dosage
Example 1 granules: 2.02g/kg (low dose), 4.05g/kg (medium dose), 8.10g/kg (high dose);
example 2 granules: 4.05g/kg;
example 3 granules: 4.05g/kg;
guilin watermelon frost capsule: 0.40g/kg.
1.2 Experimental animals
SD rat, SPF grade, 180-220g, laboratory animal license number: SYXK (lu) 20180008, supplied by lumnan pharmaceutical group, inc, was acclimatized for 1 week under standard conditions prior to the experiment.
2. Method for producing a composite material
2.1 grouping of Experimental animals
80 SD rats were randomly divided into a blank group, a model group, a Guilin watermelon gel capsule group, three dose groups of example 1 (high, medium and low), an example 2 group and an example 3 group, and each group contains 10 rats.
2.2 Molding method
The method comprises the steps of establishing a model group, a Guilin watermelon frost capsule tablet group, establishing a canker sore animal model by adopting a chemical burning method of 90% phenol solution in the three dose groups in the embodiment 1, the embodiment 2 and the embodiment group, placing a filter paper sheet containing 90% phenol solution on the buccal mucosa of a rat, sticking the filter paper sheet on the buccal mucosa of the rat, burning for 30s, and observing after 24h, wherein a circular ulcer surface with the diameter of about 4mm can be seen on the buccal mucosa of the rat, the abdominal swelling and congestion of the peripheral tongue are caused, and yellow or grey white false membrane covering with different thicknesses is realized. The ulcer area size was comparable between groups immediately and 24h after modeling. 70 rats were successfully modeled. The blank was subjected to pseudo-ignition with sterile saline following the same procedure.
2.3 administration of drugs
The rats in each administration group were gavaged with the corresponding drugs, and the rats in the blank group and the model group were gavaged with an equal amount of physiological saline for 1 time per day for 7 days.
3 observation index
3.1 evaluation of ulcer severity
The severity of the ulcers was assessed according to literature reported criteria: (1) red and swollen ulcer mucosa; (2) ulcerated mucous membranes; (3) the surface of the ulcer is covered by a yellow-white pseudo membrane; (4) the center is sunken, and the edge is neat and raised; (5) swollen lips, running water; (6) the food intake is reduced, and the body constitution is reduced. Performing quantitative integration on the apparent indexes, and classifying by 3 levels: none, mild and significant, and respectively counted for 0, 1 and 2 points.
3.2 ulcer diameter size
The diameter of the canker sore of the rat is measured by a vernier caliper.
3.3 TNF-alpha, IL-2, IL-6 level determination
After blood was collected from the orbit of each rat group, the TNF-. Alpha.IL-2 and IL-6 levels were measured according to the protocol of the ELISA kit protocol. TNF-alpha plays an important role in regulating cellular immunocompetence and enhancing organism immunocompetence, the increase of the TNF-alpha level can stimulate cytokines such as IL-2 and IL-6, network balance of the cytokines is broken, and a plurality of inflammation injury factors are subjected to cascade reaction, so that inflammation reaction is caused or aggravated.
3.4 statistical treatment
Statistical analysis is carried out on the obtained data by adopting SPSS 22.0 software, and the data is measured
The results are shown in the following table, wherein the comparison among the groups is carried out by adopting one-factor analysis of variance, and the analysis between the two groups is carried out by adopting an independent sample T test mode. With P<A difference of 0.05 is statistically significant.
4. Results and conclusions
4.1 behavioral State in rats
The results of the comparison of the oral ulcer severity scores of the rats in each group show that the ulcer score of the model group is gradually reduced along with the prolonging of time, and the oral ulcer has certain self-healing condition. And (3) during molding 1 d: the model group and the blank group are respectively compared with the salt Guilin watermelon crystal capsule group, the three dose groups of the embodiment 1 (high, medium and low), the embodiment 2 and the embodiment 3, and the difference has statistical significance (P is less than 0.01); at the time of 7d administration: the model group and the blank group are respectively compared with the saline Guilin watermelon frost capsule group, the three dose groups of example 1 (high, medium and low), the example 2 group and the example 3 group, and the difference has statistical significance (P is less than 0.01). The rats in the three dose groups of example 1 (high, medium and low), example 2 and example 3 are shown to have significant relief of canker sore symptoms.
TABLE 2 rat canker sore score (
n＝10)
Note: p < 0.01 as compared to blank; in contrast to the model set, # P＜0.01。
4.2 ulcer diameter size
TABLE 2 rat ulcer diameter size: (
n＝10)
Note: p < 0.01 compared to blank; in contrast to the model set, # P＜0.01。
4.3 levels of TNF-alpha, IL-2, IL-6 in rat blood
TABLE 3 TNF-. Alpha.IL-2, IL-6 levels in rat blood after 7 days of administration (II)
n＝10)
Note: p < 0.01 as compared to blank;
in contrast to the model set, # P＜0.01。
in conclusion, according to the pharmacodynamic experiment results, the oral ulcer has a certain self-healing behavior, the traditional Chinese medicine composition can obviously relieve the wound degree of the oral ulcer, adjust the symptoms of lip swelling, inappetence, weight loss and the like caused by the oral ulcer, reduce the content levels of TNF-alpha, IL-2 and IL-6 in blood of a model rat, and show that the traditional Chinese medicine composition can effectively relieve and/or treat the oral ulcer.
Claims (10)
1. The application of a traditional Chinese medicine composition in preparing a medicine for relieving or/and treating oral ulcer is disclosed, wherein the traditional Chinese medicine composition comprises notopterygium root, radix angelicae pubescentis, poria cocos, divaricate saposhnikovia root, schizonepeta, ligusticum wallichii, platycodon grandiflorum, radix bupleuri, radix peucedani, fructus aurantii and liquorice.
2. The use of claim 1, wherein the traditional Chinese medicine composition comprises the following raw materials:
50-100 parts of schizonepeta, 50-100 parts of divaricate saposhnikovia root and 50-100 parts of notopterygium root
50-100 parts of pubescent angelica root, 50-100 parts of bupleurum root, 50-100 parts of peucedanum root
50-100 parts of ligusticum wallichii, 50-100 parts of fructus aurantii and 50-100 parts of poria cocos
50-100 parts of platycodon grandiflorum and 5-50 parts of liquorice
Preferably, the first and second liquid crystal materials are,
75 parts by weight of schizonepeta, 75 parts by weight of divaricate saposhnikovia root and 75 parts by weight of notopterygium root
75 parts of pubescent angelica root, 75 parts of bupleurum root, 75 parts of whiteflower hogfennel root
75 parts of ligusticum wallichii, 75 parts of fructus aurantii and 75 parts of poria cocos
75 parts of platycodon grandiflorum and 25 parts of liquorice.
3. The use of claim 1, wherein the oral ulcer is caused by one or more of topical trauma, stress, malnutrition, food irritation, drug irritation, bacterial infection, viral infection, vitamin deficiency, hormone levels, genetic factors, systemic diseases, immune factors; the systemic diseases include but are not limited to gastric ulcer, duodenal ulcer, ulcerative colitis, regional enteritis, hepatitis, female menstrual period, vitamin B group malabsorption and vegetative nerve functional disturbance; the bacterial infection comprises but is not limited to candida infection, anaerobic infection, streptococcus infection, staphylococcus aureus infection and pneumococcal infection.
4. The use of claim 1, wherein the oral ulcer includes, but is not limited to, recurrent oral ulcer, behcet's syndrome, traumatic ulcer, cancerous ulcer, herpes simplex, radiation stomatitis, tuberculous ulcer, necrotic sialadeniae metaplasia.
5. The use according to claim 1, wherein the oral ulcer includes, but is not limited to, oral ulcers occurring on the medial labial, tongue, lingual ventral, buccal mucosa, vestibular sulcus, soft palate, tongue, lingual ventral region.
6. The use of the traditional Chinese medicine composition according to claim 1 in the preparation of a medicament for alleviating or/and treating complications of oral ulcer.
7. The use of claim 1, wherein the complications of canker sores include bad breath, chronic pharyngitis, constipation, headache, dizziness, nausea, weakness, irritability, fever, swollen lymph nodes, and general symptoms.
8. The use according to any one of claims 1 to 7, wherein the Chinese medicinal composition is formulated with pharmaceutically acceptable excipients.
9. The use according to claim 8, wherein the formulation comprises granules, mixtures, tablets, capsules, pills, powders, syrups, microcapsules, pastes.
10. The application of the Jingfang preparation in preparing the medicine for alleviating or/and treating the oral ulcer and the complications thereof.
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| Title |
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| 帅兰英;: "人参败毒散的临床运用" * |
| 李永芳;曲文燕;: "中西医结合防治羊口疮" * |
| 鄢永等: "验方初编" * |
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