Traditional Chinese medicine gargle as well as preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine gargle which is prepared by the following method: crushing the following traditional Chinese medicine raw materials in parts by mass: 10-20 parts of honeysuckle, 10-15 parts of common andrographis herb, 10-15 parts of dandelion, 5-10 parts of coptis chinensis, 5-10 parts of white paeony root and 10-20 parts of vietnamese sophora root, preparing the crushed raw materials into a solution, extracting the solution to obtain traditional Chinese medicine effective components, and preparing the traditional Chinese medicine effective components into the traditional Chinese medicine gargle. The traditional Chinese medicine gargle provided by the invention can be applied to preparation of medicines for treating oral ulcer, has a very remarkable improvement effect on the oral ulcer, and can effectively relieve pain caused by the ulcer, remarkably reduce the quantity of the ulcer, shorten the duration time of single ulcer of a subject and prolong the recurrence interval. The traditional Chinese medicine gargle is mild in prescription, adopts natural traditional Chinese medicine components, is high in safety and wide in application range, and has a wide application prospect.

Description

Technical Field

[0001] The invention relates to a traditional Chinese medicine gargle, a preparation method and application thereof. Background Art

[0002] Oral ulcers are common on the lip and cheek mucosa, palate or tongue surface, and are characterized by round or oval ulcers. The pathogenic mechanism of oral ulcers is a complex and multi-factorial process, mainly including bacterial infection, immune response and environmental factors. Eliminating bacteria and maintaining oral hygiene are the most effective ways to prevent and treat oral ulcers. At present, there are many clinical treatments for oral ulcers, but most of them rely on Western medicine and have certain side effects.

[0003] my country is rich in traditional Chinese medicine resources. Traditional Chinese medicine has the characteristics of high safety, small toxic side effects, and not easy to develop tolerance. Therefore, developing a traditional Chinese medicine gargle with the effect of treating oral ulcers should have broad market prospects. Summary of the invention

[0004] The purpose of the invention is to provide a Chinese medicinal gargle with the effects of inhibiting bacteria and anti-inflammation and treating oral ulcers.

[0005] The technical solution adopted by the present invention is:

[0006] A Chinese medicine gargle, the Chinese medicine gargle is prepared by the following method:

[0007] The following Chinese medicinal raw materials in parts by weight are crushed: 10-20 parts of honeysuckle, 10-15 parts of andrographis paniculata, 10-15 parts of dandelions, 5-10 parts of coptis chinensis, 5-10 parts of white peony root, and 10-20 parts of sophora flavescens, the crushed raw materials are prepared into a solution, the solution is extracted to obtain effective components of Chinese medicinal materials, and the effective components of Chinese medicinal materials are prepared into the Chinese medicinal gargle.

[0008] Furthermore, the method for obtaining the effective components of traditional Chinese medicine from the extraction solution is an ultrasonic solid-liquid extraction and low-temperature crystallization method.

[0009] Furthermore, the Chinese medicine raw material is preferably prepared from the following raw materials in parts by weight:

[0010] 10-15 parts of honeysuckle, 12-15 parts of andrographis paniculata, 10-15 parts of dandelions, 8-10 parts of coptis chinensis, 6-8 parts of white peony root, and 12-15 parts of sophora flavescens.

[0011] More preferably, the Chinese medicine raw material is prepared from raw materials of one of the following formulas:

[0012] Formula A: 10 parts of honeysuckle, 12 parts of Andrographis paniculata, 15 parts of dandelion, 8 parts of coptis root, 6 parts of white peony root, 12 parts of Sophora flavescens;

[0013] Formula B: 18 parts of honeysuckle, 12 parts of Andrographis paniculata, 10 parts of dandelion, 10 parts of Coptis chinensis, 5 parts of white peony root, 15 parts of Sophora flavescens;

[0014] Formula C: 15 parts of honeysuckle, 14 parts of Andrographis paniculata, 13 parts of dandelion, 8 parts of coptis root, 10 parts of white peony root, 13 parts of Sophora flavescens;

[0015] Formula D: 12 parts of honeysuckle, 15 parts of Andrographis paniculata, 15 parts of dandelion, 6 parts of coptis root, 8 parts of white peony root, 12 parts of Sophora flavescens;

[0016] Formula E: 15 parts of honeysuckle, 14 parts of Andrographis paniculata, 13 parts of dandelion, 10 parts of Coptis chinensis, 5 parts of white peony root, 15 parts of Sophora flavescens;

[0017] Formula F: 18 parts of honeysuckle, 12 parts of Andrographis paniculata, 10 parts of dandelion, 6 parts of coptis root, 8 parts of white peony root, 12 parts of Sophora flavescens;

[0018] Formula G: 12 parts of honeysuckle, 15 parts of andrographis paniculata, 15 parts of dandelion, 8 parts of coptis chinensis, 10 parts of white peony root, and 13 parts of sophora flavescens.

[0019] Furthermore, the raw materials also contain 7 to 17 parts of other Chinese medicinal raw materials, and the other Chinese medicinal raw materials are one or more of plantain, Panax notoginseng, gentian, lithospermum officinale, Polygonum multiflorum, aloe, and Platycodon grandiflorum.

[0020] Furthermore, the Chinese medicine gargle can be prepared from raw materials of one of the following formulas:

[0021] Formula H: 10 parts of honeysuckle, 12 parts of Andrographis paniculata, 15 parts of dandelion, 8 parts of coptis root, 6 parts of white peony root, 12 parts of Sophora flavescens, and 7 parts of Panax notoginseng;

[0022] Formula I: 10 parts of honeysuckle, 12 parts of Andrographis paniculata, 15 parts of dandelions, 8 parts of coptis chinensis, 6 parts of white peony root, 12 parts of Sophora flavescens, 7 parts of Panax notoginseng, and 10 parts of aloe.

[0023] The present invention also provides a preparation method of the Chinese medicine gargle, comprising the following steps: crushing the following Chinese medicine raw materials in parts by weight: 10-20 parts of honeysuckle, 10-15 parts of andrographis paniculata, 10-15 parts of dandelions, 5-10 parts of coptis chinensis, 5-10 parts of white peony root, and 10-20 parts of sophora flavescens, preparing the crushed raw materials into a solution, extracting the solution to obtain effective components of Chinese medicine, and preparing the effective components of Chinese medicine into the Chinese medicine gargle.

[0024] Furthermore, the method for obtaining the effective components of traditional Chinese medicine from the extraction solution is an ultrasonic solid-liquid extraction and low-temperature crystallization method.

[0025] Furthermore, the preparation method comprises the following steps:

[0026] (1) Raw material preparation: Take each component of the Chinese medicinal raw material according to the above-mentioned mass proportion, wash it repeatedly with water, and then dry it;

[0027] (2) crushing: crushing the dried Chinese medicine raw materials into powder in a Chinese medicine crusher;

[0028] (3) Ultrasonic extraction: The mixed powder of Chinese medicine is mixed with ethanol to make a solution, and then placed in an ultrasonic oscillator for extraction;

[0029] (4) Filtration: Filter the extract to remove medicinal material residues;

[0030] (5) Concentrating: concentrating the filtered extract;

[0031] (6) Low temperature crystallization: The concentrated extract is evaporated at low temperature to crystallize;

[0032] (7) Separation crystallization: separating the crystals from the mother liquor;

[0033] (8) Washing and drying: washing the crystals with a solvent to remove attached mother liquor and impurities, and drying to constant weight;

[0034] (9) Solution preparation: Add the crystals into purified water to prepare a Chinese medicine gargle solution.

[0035] Furthermore, the Chinese medicine raw material is preferably prepared from the following raw materials in parts by weight:

[0036] 10-15 parts of honeysuckle, 12-15 parts of andrographis paniculata, 10-15 parts of dandelions, 8-10 parts of coptis chinensis, 6-8 parts of white peony root, and 12-15 parts of sophora flavescens.

[0037] More preferably, the Chinese medicine raw material is prepared from raw materials of one of the following formulas:

[0038] Formula A: 10 parts of honeysuckle, 12 parts of Andrographis paniculata, 15 parts of dandelion, 8 parts of coptis root, 6 parts of white peony root, 12 parts of Sophora flavescens;

[0039] Formula B: 18 parts of honeysuckle, 12 parts of Andrographis paniculata, 10 parts of dandelion, 10 parts of coptis root, 5 parts of white peony root, 15 parts of Sophora flavescens;

[0040] Formula C: 15 parts of honeysuckle, 14 parts of Andrographis paniculata, 13 parts of dandelion, 8 parts of coptis root, 10 parts of white peony root, 13 parts of Sophora flavescens;

[0041] Formula D: 12 parts of honeysuckle, 15 parts of Andrographis paniculata, 15 parts of dandelion, 6 parts of coptis root, 8 parts of white peony root, 12 parts of Sophora flavescens;

[0042] Formula E: 15 parts of honeysuckle, 14 parts of Andrographis paniculata, 13 parts of dandelion, 10 parts of Coptis chinensis, 5 parts of white peony root, 15 parts of Sophora flavescens;

[0043] Formula F: 18 parts of honeysuckle, 12 parts of Andrographis paniculata, 10 parts of dandelion, 6 parts of coptis root, 8 parts of white peony root, 12 parts of Sophora flavescens;

[0044] Formula G: 12 parts of honeysuckle, 15 parts of andrographis paniculata, 15 parts of dandelion, 8 parts of coptis chinensis, 10 parts of white peony root, and 13 parts of sophora flavescens.

[0045] Furthermore, the raw materials also contain 7 to 17 parts of other Chinese medicinal raw materials, and the other Chinese medicinal raw materials are one or more of plantain, Panax notoginseng, gentian, lithospermum officinale, Polygonum multiflorum, aloe, and Platycodon grandiflorum.

[0046] Furthermore, the Chinese medicine gargle can be prepared from raw materials of one of the following formulas:

[0047] Formula H: 10 parts of honeysuckle, 12 parts of Andrographis paniculata, 15 parts of dandelion, 8 parts of coptis root, 6 parts of white peony root, 12 parts of Sophora flavescens, and 7 parts of Panax notoginseng;

[0048] Formula I: 10 parts of honeysuckle, 12 parts of Andrographis paniculata, 15 parts of dandelions, 8 parts of coptis chinensis, 6 parts of white peony root, 12 parts of Sophora flavescens, 7 parts of Panax notoginseng, and 10 parts of aloe.

[0049] Furthermore, in the method for preparing the medicinal gargle, in step (3), the tank temperature of the ultrasonic oscillator is set to 40-60°C.

[0050] Furthermore, in the method for preparing the medicinal gargle, in step (3), the power of the ultrasonic oscillator is set to 144-180W.

[0051] Furthermore, in the method for preparing the medicinal gargle, in step (3), the extraction time of the ultrasonic oscillator is 25 to 45 minutes.

[0052] Furthermore, in the method for preparing the medicinal gargle, in step (3), the tank temperature of the ultrasonic oscillator is set to 40-60°C.

[0053] Furthermore, in the method for preparing the medicinal gargle, in step (6), the low temperature is 0 to 8°C.

[0054] Furthermore, in the method for preparing the medicinal gargle, in step (6), the crystallization is repeated 3 to 5 times to improve the purity.

[0055] Furthermore, in the method for preparing the medicinal gargle, in step (8), the solvent is precooled to -10°C.

[0056] The invention also provides application of the traditional Chinese medicine gargle in preparing medicine for treating oral ulcer.

[0057] The method of using the Chinese medicine gargle is: gargle after meals, 2 to 3 meals per day, gargle 3 times per meal, 30 to 40 mL per time, 300 ml of the Chinese medicine gargle is a daily dosage, and the cycle is 1 week.

[0058] Honeysuckle is cold in nature and sweet in taste, and has anti-inflammatory, antiviral and antioxidant effects; Andrographis paniculata has antipyretic, antibacterial, antiviral and immunomodulatory effects; Taraxacum officinale is bitter, sweet and cold in nature, and has the effects of clearing away stagnation and swelling, clearing away heat and detoxifying, and clearing away dampness and heat; Coptis chinensis is bitter and cold in nature, and has the effects of clearing away heat and dampness, purging fire and detoxifying, and has a good inhibitory effect on Streptococcus mutans and Actinomyces viscosus; White peony root has analgesic and immunomodulatory effects; Sophora flavescens has antiviral and antioxidant effects. This formula combines the above six medicinal materials together to achieve a synergistic effect of antibacterial and anti-inflammatory effects, which is beneficial to the stability of the oral environment.

[0059] The present invention has innovated the extraction process of traditional Chinese medicine. Ultrasonic solid-liquid extraction uses the cavitation effect of ultrasound to accelerate the contact between the solvent and the medicinal material, selectively destroys the cell wall, improves the extraction efficiency, and improves the quality and stability of the effective ingredients in the extract. Compared with the traditional hot reflux or cold soaking method, ultrasonic extraction can significantly shorten the extraction time. Low-temperature crystallization helps to protect heat-sensitive components, such as certain alkaloids, volatile oils and some proteins; helps to improve the crystal purity of the target component, thereby obtaining a purer product; and reduces solvent consumption. Therefore, the ultrasonic solid-liquid extraction low-temperature crystallization method has a good antibacterial and anti-inflammatory effect.

[0060] The Chinese medicine gargle has been used in many patients in hospital and outpatient clinics, and the improvement effect is very significant. After the gargle is used for treatment, the duration of a single oral ulcer in the patient is shortened, the interval between recurrences is prolonged, the pain of the ulcer is alleviated, the number of ulcers is reduced, and the scope of the ulcer is also reduced, which is well received by patients. The Chinese medicine gargle of the present invention has a mild prescription, a wide range of application, and a broad application prospect. In addition, the gargle can also be used for daily care of oral hygiene to prevent the occurrence of oral diseases. DETAILED DESCRIPTION

[0061] The technical solution of the present invention is further described with specific embodiments, but the protection scope of the present invention is not limited thereto.

[0062] Example 1

[0063] According to formula A: 10 parts of honeysuckle, 12 parts of Andrographis paniculata, 15 parts of Taraxacum mongolicum, 8 parts of Coptis chinensis, 6 parts of White Peony Root, and 12 parts of Sophora flavescens, the total amount of Chinese medicine is 300 g.

[0064] Preparation method:

[0065] (1) Add the prepared herbs to 1 liter of water and soak for 30 minutes.

[0066] (2) Decoction of medicinal materials: After soaking, keep the soaking liquid and medicinal materials, and directly decoct them over medium heat. After boiling, turn to low heat and continue to boil for 30 minutes until the volume of the medicinal liquid is reduced to 300ml, and pour out the medicinal liquid. Then add 700ml of clean water to the remaining medicinal residue, repeat the heating and boiling, turn to low heat and decoct again to reduce the amount of medicine to 300ml, and pour out the medicinal liquid. Combine the two medicinal liquids and decoct them again over low heat to concentrate them to 300ml, ensuring that the amount of raw medicine is 1g / ml.

[0067] (3) Screening of the medicinal liquid: After decoction, filter the medicinal liquid to remove the residue and retain the clear liquid to obtain 300 ml of concentrated Chinese medicinal liquid.

[0068] Example 2

[0069] According to formula A: 10 parts of honeysuckle, 12 parts of Andrographis paniculata, 15 parts of Taraxacum mongolicum, 8 parts of Coptis chinensis, 6 parts of White Peony Root, and 12 parts of Sophora flavescens, the total amount of Chinese medicine is 300 g.

[0070] Preparation method:

[0071] (1) Raw material preparation: Wash the prepared medicinal materials repeatedly for 3 times and then dry them;

[0072] (2) crushing: crushing the dried Chinese medicine raw materials into powder in a Chinese medicine crusher;

[0073] (3) Ultrasonic extraction: The mixed powder of Chinese medicine was mixed with 65% ethanol solution at a mass ratio of 1:15, and placed in an ultrasonic oscillator for extraction. The tank temperature of the ultrasonic oscillator was set to 52°C, the power of the ultrasonic oscillator was 180W, the power ratio was set to 95%, and the extraction time was 30 min;

[0074] (4) Filtration: Filter the extract through filter paper to remove medicinal material residues;

[0075] (5) Concentration: The filtered extract was concentrated in a rotary evaporator until the volume of the Chinese medicine liquid was 300 ml. The rotary evaporator was set at normal pressure and temperature of 63°C.

[0076] Example 3

[0077] According to formula A: 10 parts of honeysuckle, 12 parts of Andrographis paniculata, 15 parts of Taraxacum mongolicum, 8 parts of Coptis chinensis, 6 parts of White Peony Root, and 12 parts of Sophora flavescens, the total amount of Chinese medicine is 300 g.

[0078] Preparation method:

[0079] (1) Raw material preparation: Wash the prepared medicinal materials repeatedly for 3 times and then dry them;

[0080] (2) crushing: crushing the dried Chinese medicine raw materials into powder in a Chinese medicine crusher;

[0081] (3) Ultrasonic extraction: The mixed powder of Chinese medicine was mixed with 65% ethanol solution at a mass ratio of 1:15, and placed in an ultrasonic oscillator for extraction. The tank temperature of the ultrasonic oscillator was set to 52°C, the power of the ultrasonic oscillator was 180W, the power ratio was set to 95%, and the extraction time was 30 min;

[0082] (4) Filtration: Filter the extract through filter paper to remove medicinal material residues;

[0083] (5) Concentration: The filtered extract was concentrated in a rotary evaporator set at normal pressure and 63°C;

[0084] (6) Crystallization: The concentrated extract was placed in a crystallizer to evaporate the solvent for crystallization. The crystallization temperature was set at 4°C, the stirring speed was 65 r / min, and the crystallization time was 120 min each time. The above crystallization process was repeated 3 times.

[0085] (7) Separation crystallization: separating the crystals from the mother liquor;

[0086] (8) Washing and drying: Wash the crystals with anhydrous ethanol precooled to -10°C to remove attached mother liquor and impurities, and dry the washed crystals in a dryer to constant weight;

[0087] (9) Solution preparation: Place the crystals into 300 ml of pure water preheated to 25°C, and stir with a magnetic stirrer until the crystals are dissolved to prepare a Chinese medicine gargle solution. The stirring speed of the magnetic stirrer is 450 r / min, and the stirring time is 65 min.

[0088] In the above step (7), there are many ways to separate the crystals from the mother liquor, and filtration is preferred in this embodiment; in step (9), the temperature of the pure water can generally be selected to be around room temperature.

[0089] The antibacterial and anti-inflammatory properties of the traditional Chinese medicine gargles prepared in Examples 1 to 3 were measured, and the types of measurements included the measurement of the inhibition zone, the minimum inhibitory concentration, and the minimum bactericidal concentration.

[0090] Preparation of test bacterial suspension: Take one loop of activated Staphylococcus aureus, Candida albicans and Escherichia coli respectively, and culture on solid culture medium for 12 hours by plate streak method to form single colonies. Pick two loops of bacteria and grind them evenly in a grinder, adjust the bacterial concentration to 1.5×108cfu / ml using a 0.5 McFarland turbidimeter tube, and then dilute with sterile water to 1×108cfu / ml, which is the test bacterial suspension.

[0091] Determination of inhibition zone: Use the agar plate punching method, take 100ul of the test bacterial suspension and evenly spread it on the agar plate with a bacterial stick. After the test bacterial suspension on the agar plate is completely absorbed, use a 6mm diameter puncher to evenly punch holes on the agar plate, 5 holes per plate, and the hole spacing is >20mm. Add 1g / ml of Chinese medicine liquid to the hole as a control, put distilled water in the center of the plate as a negative control group, and use penicillin and streptomycin as positive controls. Place the agar plate in an incubator at 37°C for 24 hours, and measure the diameter of the inhibition zone after the incubation. Repeat the above process 3 times.

[0092] Determination of minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC): Prepare the solution by double dilution test tube method, prepare the solution with concentrations of 500mg / ml, 250mg / ml, 125mg / ml, 63mg / ml, 31mg / ml, 15.62mg / ml, 8mg / ml and 3.91mg / ml, and soak the circular filter paper with different concentrations. Take 100ul of the test bacterial suspension and spread it evenly on the agar plate with a bacterial stick. After the test bacterial suspension on the agar plate is completely absorbed, the filter paper soaked with different concentrations of the solution is flatly pasted on the agar plate in turn, and the agar plate is placed in an incubator for 24h. After the incubation is completed, the lowest drug concentration without bacterial growth is read as the MIC value of the drug, and the lowest drug concentration with no more than 5 colonies on the agar plate is read as the MBC value of the drug.

[0093] The measurement results are shown in Table 1 and Table 2:

[0094] Table 1

[0095]

[0096] Note: The antibacterial diameter ≥20mm is extremely sensitive, 15-19mm is highly sensitive, 10-14mm is moderately sensitive, and less than 10mm is low sensitive.

[0097] Table 2

[0098]

[0099]

[0100] As can be seen from Table 1 above, for the main bacteria in oral ulcers, Staphylococcus aureus, Candida albicans and Escherichia coli, the diameter of the inhibition zone of the traditional Chinese medicine gargle prepared by ultrasonic solid-liquid extraction and low-temperature crystallization is greater than that of the ultrasonic solid-liquid extraction method and greater than that of the traditional decoction method, indicating that the drug sensitivity of the traditional Chinese medicine gargle prepared by ultrasonic solid-liquid extraction and low-temperature crystallization method to the main bacteria in oral ulcers, Staphylococcus aureus, Candida albicans and Escherichia coli, is higher than that of ultrasonic solid-liquid extraction and traditional decoction method.

[0101] From Table 2 above, it can be seen that for Candida albicans and Escherichia coli, the MIC value of the Chinese medicine gargle prepared by ultrasonic solid-liquid extraction and low-temperature crystallization method is less than that of ultrasonic solid-liquid extraction method and less than that of traditional decoction method; for Staphylococcus aureus, the MBC value of the Chinese medicine gargle prepared by ultrasonic solid-liquid extraction and low-temperature crystallization method is less than that of ultrasonic solid-liquid extraction method and less than that of traditional decoction method; for Staphylococcus aureus, the MIC value of the Chinese medicine gargle prepared by ultrasonic solid-liquid extraction and low-temperature crystallization method is equal to that of ultrasonic solid-liquid extraction method and less than that of traditional decoction method; for Candida albicans and Escherichia coli, the MBC value of the Chinese medicine gargle prepared by ultrasonic solid-liquid extraction and low-temperature crystallization method is equal to that of ultrasonic solid-liquid extraction method and less than that of traditional decoction method. In summary, the Chinese medicine gargle prepared by ultrasonic solid-liquid extraction and low-temperature crystallization method has better bactericidal and antibacterial effects on Staphylococcus aureus, Candida albicans and Escherichia coli, the main bacteria in oral ulcers, is better than ultrasonic solid-liquid extraction and traditional decoction method.

[0102] It can be seen from Tables 1 and 2 above that the antibacterial and anti-inflammatory effects of the Chinese medicine gargle prepared by ultrasonic solid-liquid extraction and low-temperature crystallization are better than those by ultrasonic solid-liquid extraction and traditional decoction.

[0103] Ultrasonic solid-liquid extraction uses the cavitation effect of ultrasound to accelerate the contact between the solvent and the medicinal material, selectively destroy the cell wall, improve the extraction efficiency, and improve the quality and stability of the effective ingredients in the extract. Compared with traditional hot reflux or cold soaking methods, ultrasonic extraction can significantly shorten the extraction time. Low-temperature crystallization helps to protect heat-sensitive components, such as certain alkaloids, volatile oils, and some proteins; at the same time, low-temperature crystallization usually uses less solvent, which helps to reduce solvent consumption and related environmental impacts. Therefore, ultrasonic solid-liquid extraction low-temperature crystallization has a good antibacterial and anti-inflammatory effect.

[0104] Example 4

[0105] According to the following mass ratio, each formula takes 300g of total Chinese medicine:

[0106] Formula A: 10 parts of honeysuckle, 12 parts of Andrographis paniculata, 15 parts of dandelion, 8 parts of coptis root, 6 parts of white peony root, 12 parts of Sophora flavescens;

[0107] Formula B: 18 parts of honeysuckle, 12 parts of Andrographis paniculata, 10 parts of dandelion, 10 parts of coptis root, 5 parts of white peony root, 15 parts of Sophora flavescens;

[0108] Formula C: 15 parts of honeysuckle, 14 parts of Andrographis paniculata, 13 parts of dandelion, 8 parts of coptis root, 10 parts of white peony root, 13 parts of Sophora flavescens;

[0109] Formula D: 12 parts of honeysuckle, 15 parts of Andrographis paniculata, 15 parts of dandelion, 6 parts of coptis root, 8 parts of white peony root, 12 parts of Sophora flavescens;

[0110] Formula E: 15 parts of honeysuckle, 14 parts of Andrographis paniculata, 13 parts of dandelion, 10 parts of Coptis chinensis, 5 parts of white peony root, 15 parts of Sophora flavescens;

[0111] Formula F: 18 parts of honeysuckle, 12 parts of Andrographis paniculata, 10 parts of dandelion, 6 parts of coptis root, 8 parts of white peony root, 12 parts of Sophora flavescens;

[0112] Formula G: 12 parts of honeysuckle, 15 parts of andrographis paniculata, 15 parts of dandelion, 8 parts of coptis chinensis, 10 parts of white peony root, and 13 parts of sophora flavescens.

[0113] Preparation method: Same as Example 3.

[0114] Usage: Gargle after meals, 3 times a day, 30-40 mL / time. 300 ml of Chinese medicine gargle is a daily dosage.

[0115] A total of 199 subjects with oral ulcers admitted to the Fourth Affiliated Hospital of Soochow University from February to July 2024 were selected. The subjects were aged 18 to 53 years, with an average age of (39.12±0.71) years; the course of the disease was 5 months to 3 years, with an average of (2.13±0.81) years. Psychological counseling was given to the subjects in the early stage of the experiment to eliminate psychological concerns, and they were advised to ensure adequate sleep time. Inclusion criteria: The subjects had a history of recurrent oral ulcers; physical examinations revealed that the subjects had multiple isolated and scattered oral ulcers in the oral mucosa, and these ulcers were recurrent and could heal themselves; the subjects had not taken antibiotics in the past half month; the subjects were fully informed before the start of this study and their informed consent was obtained. Each subject was required to record relevant information in a timely manner at each ulcer attack and summarize it after the ulcer healed; it was recommended that the subjects maintain the accuracy of the records, review and update the record sheet once a week; the research team checked the records monthly to ensure the completeness and accuracy of the data.

[0116] The efficacy evaluation is divided into significantly effective, effective and ineffective:

[0117] Significantly effective: After treatment, the ulcer wound in the mouth shrank rapidly or disappeared completely, and the edema around the ulcer basically disappeared. The pain was significantly improved or basically disappeared. The patient's ability to drink water was significantly improved, and the patient's speech pronunciation was not affected by the ulcer. The patient's anxiety and depression were reduced, and the quality of sleep was significantly improved, and the quality of life was improved.

[0118] Effective: Edema around the ulcer basically disappeared, the burning pain was relieved, and the depression of the wound surface was reduced or had no obvious change.

[0119] Ineffective: There was no significant improvement in clinical symptoms such as yellowing, redness, concavity, and pain, and the subjects' eating or speech was seriously affected.

[0120] Total effective rate = (number of significant effective cases + number of effective cases) / total number of cases × 100%. The comparison of the efficacy evaluation results of formulas A to G is shown in Table 3:

[0121] Table 3 Comparison of efficacy evaluation results

[0122]

[0123] It can be seen from Table 3 that the total effective rates of different formulations all exceeded 65%, causing the ulcer wounds in the patients' mouths to shrink rapidly or disappear completely and / or the edema around the ulcers to basically disappear, with good therapeutic effects, especially formulation A.

[0124] The treatment effect was evaluated by visual analogue scale (VAS), inflammatory index, ulcer duration, recurrence interval and number of ulcers. SPSS13.0 statistical software was used for data analysis. It means that, "s" represents the mean value of a set of data, and "s" represents the standard deviation of this set of data.

[0125] Visual Analog Scale (VAS): Based on the subjective feelings of the subjects, the visual analog scale was used to evaluate the degree of ulcer pain. The scoring standard was 10 points for the most severe pain, which was unbearable; 7-10 points for aggravated pain, affecting daily appetite and sleep; 4-6 points for pain affecting sleep, but still within the tolerable range; 1-3 points for mild pain, which the subjects could tolerate; 0 point for no pain. The pain score was recorded once a day at a fixed time point.

[0126] Inflammatory indexes: On the first and seventh days of using the Chinese medicine gargle, 2.5 mL of venous blood was drawn on an empty stomach at 7:00 in the morning for testing. Among them, 2 mL of venous blood was used to detect the C-reactive protein (CRP) level by immunofluorescence analyzer; 0.5 mL of venous blood was naturally coagulated at room temperature for 20 minutes, and the upper serum was separated in a microcentrifuge in a centrifuge tube. The speed of the microcentrifuge was set to 3000 r / min and the temperature was set to 4°C. Then, the serum interleukin-2 (IL-2) and tumor necrosis factor-α (TNF-α) levels were determined by enzyme-linked immunosorbent assay. The specific steps were performed according to the instructions of the ELISA kit.

[0127] Ulcer duration: the total number of days from the onset of each oral ulcer to complete healing. Recording method: Each time an ulcer occurs, the subject needs to record the onset date and healing date, and calculate and record the duration.

[0128] Recurrence interval: the number of days between two oral ulcer attacks. Recording method: The subjects need to record the date of each ulcer attack and calculate the number of days between two adjacent attacks.

[0129] The evaluation results of the visual analogue score (VAS), inflammatory index, ulcer duration, recurrence interval and number of ulcers of formula A to G are shown in Tables 4 to 6:

[0130] Table 4

[0131]

[0132] Table 5

[0133]

[0134] Note: Reference ranges for inflammatory indicators in serum or plasma of general adults:

[0135] TNF-α levels are usually less than 3 pg / mL; CRP levels are usually less than 10 mg / L; IL-2 levels are usually less than 11.4 pg / mL.

[0136] Table 6

[0137]

[0138]

[0139] Note: The average ulcer period and recurrence interval were recorded three months before the selected recurrent oral ulcer subjects took the Chinese medicine gargle. This is the average ulcer period and recurrence interval data before treatment. At this time, the subjects relied on their own immunity to heal without using any drugs.

[0140] As can be seen from Table 4 above, after treatment, the VAS score gradually decreased, effectively relieving the pain caused by ulcers. As can be seen from Table 5 above, the inflammatory indicators fell into the normal range after treatment. As can be seen from Table 6 above, after treatment, the duration of a single ulcer in the subject was shortened, the interval between recurrences was significantly prolonged, and the number of ulcers was reduced. In summary, it can be seen that the formula of the present invention has good antibacterial and anti-inflammatory effects.

[0141] Example 5

[0142] The gargle prescription was obtained by the inventor in long-term clinical practice after a long period of trial and error. The six herbs of honeysuckle, andrographis paniculata, dandelion, coptis root, white peony root and sophora flavescens are the basis. The prescription can be adjusted based on this basic formula.

[0143] According to the following mass ratio, take 300g of Chinese medicine for each formula:

[0144] Formula H: 10 parts of honeysuckle, 12 parts of Andrographis paniculata, 15 parts of dandelions, 8 parts of coptis root, 6 parts of white peony root, 12 parts of Sophora flavescens, and 7 parts of Panax notoginseng;

[0145] Formula I: 10 parts of honeysuckle, 12 parts of Andrographis paniculata, 15 parts of dandelions, 8 parts of Coptidis rhizome, 6 parts of white peony root, 12 parts of Sophora flavescens, 7 parts of Panax notoginseng, and 10 parts of aloe.

[0146] Preparation method: Same as Example 3.

[0147] Usage: Same as Example 4.

[0148] Therapeutic effect determination method: same as Example 4.

[0149] The comparison of the efficacy evaluation effects, visual analogue score (VAS), inflammatory index, ulcer duration, recurrence interval and number of ulcers of formula H to I are shown in Tables 7 to 10:

[0150] Table 7 Comparison of efficacy evaluation results

[0151] Group n / example Significantly effective / case Valid / Example Invalid / Example Total effective rate / % Recipe H 14 11 1 2 85.7 Recipe I 16 14 1 1 93.8

[0152] Table 8

[0153]

[0154] Table 9

[0155]

[0156] Table 10

[0157]

[0158] As can be seen from Table 7 above, the total effective rates of different formulas far exceeded 65%, which caused the ulcer wounds in the patient's mouth to shrink rapidly or disappear completely and / or the edema around the ulcers to basically disappear, with good therapeutic effects. As can be seen from Table 8 above, after treatment, the VAS score gradually decreased, effectively relieving the pain caused by the ulcers, and was lower than the VAS score in Table 4 above. As can be seen from Table 9 above, the inflammatory indicators fell within the normal range after treatment. As can be seen from Table 10 above, after treatment, the duration of a single ulcer in the subject was shortened, the interval between recurrences was significantly prolonged, the number of ulcers was reduced, and the duration of a single ulcer was shorter than that in Table 6 above.

[0159] In summary, it can be seen that the formula of the present invention still has good antibacterial and anti-inflammatory effects after adding one or more medicinal materials such as Panax notoginseng and aloe vera, especially the formula with both Panax notoginseng and aloe vera added has significant antibacterial and anti-inflammatory effects.

[0160] Comparative Example 1

[0161] The prescription for the gargle was developed by the inventor through long-term clinical practice and trial and error. The six basic herbs are honeysuckle, andrographis paniculata, dandelion, coptis chinensis, white peony root, and sophora flavescens. The lack of any one of them will lead to a decrease in efficacy. Adding other commonly used gargle formulas besides plantain, panax notoginseng, gentian, lithospermum officinale, polygonum multiflorum, aloe vera, and platycodon will also lead to a decrease in efficacy.

[0162] According to the following mass ratio, take 300g of Chinese medicine for each formula:

[0163] Formula J: 10 parts of honeysuckle, 15 parts of dandelions, 8 parts of coptis roots, 6 parts of white peony roots, and 12 parts of sophora flavescens;

[0164] Formula K: 10 parts of honeysuckle, 12 parts of Andrographis paniculata, 15 parts of dandelions, 8 parts of Coptis chinensis, and 12 parts of Sophora flavescens;

[0165] Formula L: 10 parts of honeysuckle, 12 parts of Andrographis paniculata, 15 parts of dandelion, 8 parts of coptis root, 6 parts of white peony root, 12 parts of Sophora flavescens, and 5 parts of Astragalus;

[0166] Formula M: 10 parts of honeysuckle, 12 parts of andrographis paniculata, 15 parts of dandelions, 8 parts of coptis chinensis, 6 parts of white peony root, 12 parts of sophora flavescens, and 5 parts of smilax glabra.

[0167] Preparation method: Same as Example 3.

[0168] Usage: Gargle after meals, 3 times a day, 30-40 mL / time. 300 ml of Chinese medicine gargle is a daily dosage.

[0169] Therapeutic effect determination method: same as Example 4.

[0170] The comparison of the efficacy evaluation effects, visual analogue score (VAS), inflammatory index, ulcer duration, recurrence interval and number of ulcers of formula J to M are shown in Tables 11 to 14:

[0171] Table 11

[0172] Group n / example Significantly effective / case Valid / Example Invalid / Example Total effective rate (%) Recipe J 15 6 3 6 60 Recipe K 15 5 3 7 53.3 Formula L 17 6 3 8 52.9 Recipe M 14 7 2 5 64.3

[0173] Table 12

[0174]

[0175] Table 13

[0176]

[0177] Table 14

[0178]

[0179]

[0180] It can be seen from Table 11 above that the total effective rate of different formulas is less than 65%, and the efficacy is worse than that in Table 4 above. It can be seen from Table 12 above that after treatment, although the VAS score gradually decreased, it was still in a relatively high range, and even the subjects of Formula M were still in a state of increased pain, affecting daily appetite and sleep. It can be seen from Table 13 above that after treatment, the inflammatory indicators fell within the normal range, but the values ​​of TNF-α and CRP were very close to the upper limit of the normal range. It can be seen from Table 14 above that after treatment, the duration of a single ulcer of the subject was shortened, the interval between recurrences was prolonged, and the number of ulcers was reduced, but compared with Table 6 above, the duration of a single ulcer was longer, the interval between recurrences was shorter, and the number of remaining ulcers was larger.

[0181] From the above, it can be seen that after removing Andrographis paniculata, White Peony Root and other medicinal materials from the six-medicinal material formula of the present invention, the antibacterial and anti-inflammatory effects of the medicinal materials are reduced, and the therapeutic effect on oral ulcers is significantly reduced; while adding Astragalus or Smilax glabra to the six-medicinal material formula does not show obvious advantages in improving the average cycle and recurrence interval of oral ulcers.

[0182] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention.

Claims

1. A Chinese medicine gargle, characterized in that: The Chinese medicine gargle is prepared by the following method: crushing the following Chinese medicine raw materials in parts by weight: 10-20 parts of honeysuckle, 10-15 parts of andrographis paniculata, 10-15 parts of dandelions, 5-10 parts of coptis chinensis, 5-10 parts of white peony root, and 10-20 parts of sophora flavescens, preparing the crushed raw materials into a solution, extracting the solution to obtain effective components of Chinese medicine, and preparing the effective components of Chinese medicine into the Chinese medicine gargle.

2. The Chinese medicine gargle according to claim 1, characterized in that: The method for obtaining effective components of traditional Chinese medicine by extracting solution is ultrasonic solid-liquid extraction and low-temperature crystallization.

3. The Chinese medicine gargle according to claim 1, characterized in that: The Chinese medicinal raw materials are: 10-15 parts of honeysuckle, 12-15 parts of andrographis paniculata, 10-15 parts of dandelion, 8-10 parts of coptis root, 6-8 parts of white peony root and 12-15 parts of sophora flavescens.

4. The Chinese medicine gargle according to claim 1, characterized in that: The Chinese medicine raw material is one of the following formulas: Formula A: 10 parts of honeysuckle, 12 parts of Andrographis paniculata, 15 parts of dandelion, 8 parts of coptis root, 6 parts of white peony root, 12 parts of Sophora flavescens; Formula B: 18 parts of honeysuckle, 12 parts of Andrographis paniculata, 10 parts of dandelion, 10 parts of Coptis chinensis, 5 parts of white peony root, 15 parts of Sophora flavescens; Formula C: 15 parts of honeysuckle, 14 parts of Andrographis paniculata, 13 parts of dandelion, 8 parts of coptis root, 10 parts of white peony root, 13 parts of Sophora flavescens; Formula D: 12 parts of honeysuckle, 15 parts of Andrographis paniculata, 15 parts of dandelion, 6 parts of coptis root, 8 parts of white peony root, 12 parts of Sophora flavescens; Formula E: 15 parts of honeysuckle, 14 parts of Andrographis paniculata, 13 parts of dandelion, 10 parts of Coptis chinensis, 5 parts of white peony root, 15 parts of Sophora flavescens; Formula F: 18 parts of honeysuckle, 12 parts of Andrographis paniculata, 10 parts of dandelion, 6 parts of coptis root, 8 parts of white peony root, 12 parts of Sophora flavescens; Formula G: 12 parts of honeysuckle, 15 parts of andrographis paniculata, 15 parts of dandelion, 8 parts of coptis chinensis, 10 parts of white peony root, and 13 parts of sophora flavescens.

5. The Chinese medicine gargle according to claim 1, characterized in that: The Chinese medicinal raw materials also contain 7 to 17 parts of other Chinese medicinal raw materials, and the other Chinese medicinal raw materials are one or more of plantain, Panax notoginseng, gentian, lithospermum officinale, Polygonum multiflorum, aloe, and Platycodon grandiflorum.

6. The Chinese medicine gargle according to claim 5, characterized in that: The Chinese medicine raw material is one of the following formulas: Formula H: 10 parts of honeysuckle, 12 parts of Andrographis paniculata, 15 parts of dandelion, 8 parts of coptis root, 6 parts of white peony root, 12 parts of Sophora flavescens, and 7 parts of Panax notoginseng; Formula I: 10 parts of honeysuckle, 12 parts of Andrographis paniculata, 15 parts of dandelions, 8 parts of coptis chinensis, 6 parts of white peony root, 12 parts of Sophora flavescens, 7 parts of Panax notoginseng, and 10 parts of aloe.

7. A method for preparing a Chinese medicine gargle, comprising the following steps: The Chinese medicine raw material as claimed in any one of claims 1 to 6 is crushed, the crushed raw material is prepared into a solution, the solution is extracted to obtain effective components of the Chinese medicine, and the effective components of the Chinese medicine are prepared into the Chinese medicine gargle.

8. The method for preparing the Chinese medicine gargle according to claim 7, characterized in that The method for obtaining effective components of traditional Chinese medicine by extracting solution is ultrasonic solid-liquid extraction and low-temperature crystallization.

9. The method for preparing the Chinese medicine gargle according to claim 8, characterized in that The preparation method comprises the following steps: (1) Raw material preparation: taking each component of the Chinese medicinal raw material according to the mass ratio of any one of claims 1 to 6, repeatedly washing with water, and then drying; (2) crushing: crushing the dried Chinese medicine raw materials into powder in a Chinese medicine crusher; (3) Ultrasonic extraction: The mixed powder of Chinese medicine is mixed with ethanol to make a solution, and then placed in an ultrasonic oscillator for extraction; (4) Filtration: Filter the extract to remove medicinal material residues; (5) Concentrating: concentrating the filtered extract; (6) Low temperature crystallization: The concentrated extract is evaporated at low temperature to crystallize; (7) Separation crystallization: separating the crystals from the mother liquor; (8) Washing and drying: washing the crystals with a solvent to remove attached mother liquor and impurities, and drying to constant weight; (9) Solution preparation: Add the crystals into purified water to prepare a Chinese medicine gargle solution.

10. Use of the traditional Chinese medicine gargle according to any one of claims 1 to 6 in preparing a medicine for treating oral ulcers.

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