An anti-inflammatory and antibacterial composition and its preparation method and application

Abstract

The present invention discloses an anti-inflammatory and antibacterial composition, and a preparation method and application thereof. The composition is obtained by compounding a turmeric plant extract and a Chinese herbal medicine extract, wherein the turmeric plant extract is a volatile oil extract of the turmeric plant; the Chinese herbal medicine extract contains houttuynia cordata extract, chrysanthemum extract, bupleurum extract, yew lily extract, andrographis paniculata extract, and capillaris extract; the properly matched composition has a significant synergistic effect and can enhance its anti-inflammatory and antibacterial effects. At the same time, the promotion of transdermal absorption of the composition was studied, and it was found that the piperine compounding scheme can significantly improve the transdermal absorption effect and improve the bioavailability of the composition. The anti-inflammatory and antibacterial composition of the present invention has the effects of clearing away heat and detoxifying, reducing swelling and draining pus, stopping bleeding and relieving pain, and anti-inflammatory and sterilizing. At the same time, it has the advantages of a short treatment course, high efficacy, no toxic side effects, no recurrence of the disease, and is not easy to develop drug resistance. It can be used to treat oral inflammation and pharyngitis.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine compositions, and in particular relates to an anti-inflammatory and antibacterial composition, a preparation method and an application thereof. Background Art

[0002] Oral inflammation and pharyngitis (i.e. inflammation of the pharynx) are common inflammatory diseases that mainly occur in the mucosal tissues of the mouth and throat. They are often caused by bacterial, viral, or fungal infections or irritations. Typical symptoms of oral inflammation include oral pain, ulcers, inflammation, and bleeding, such as periodontitis and gingivitis. Typical symptoms of pharyngitis include sore throat, cough, dry throat, and red throat. Pharyngitis may also be accompanied by other symptoms, such as difficulty breathing and hoarseness. Severe oral inflammation can develop into pharyngitis, and pharyngitis can also cause oral inflammation. Once an inflammatory infection occurs, it will cause inconvenience to the patient's life and greatly affect eating and speech functions.

[0003] Currently, most drugs used to treat inflammation on the market work by inhibiting bacterial infection. The most common are penicillin-based antibiotics, including amoxicillin, penicillin G, ampicillin, and ticarcillin. However, repeated exposure to antibiotics can reduce or even eliminate the sensitivity of infected bacteria to the drugs, leading to antibiotic resistance and reduced or even ineffective efficacy. Secondly, nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, sodium salicylate, and acetaminophen, primarily work by inhibiting cyclooxygenase, which blocks the metabolism of arachidonic acid. These drugs have strong anti-inflammatory and antipyretic properties. However, NSAIDs also have certain side effects, including damage to intestinal function. Therefore, prolonged use of NSAIDs is not recommended, and the dosage should be kept to a minimum. Therefore, there is an urgent need for drugs that offer strong anti-inflammatory and antibacterial properties while being less susceptible to drug resistance and side effects, for the treatment of inflammatory diseases.

[0004] Traditional Chinese Medicine (TCM) believes that inflammatory diseases are often caused by qi and blood deficiency, excessive stomach fire, and kidney yin deficiency. Treatment of inflammation requires not only external treatment to eliminate inflammation but also internal treatment to regulate the body's qi, clear away heat and dampness, and purge fire and detoxify. Chinese herbal medicine is a traditional Chinese medicinal material with a 5,000-year history of use and extensive clinical experience. The use of Chinese herbal medicine to treat inflammation has gradually become a common practice. Modern pharmacological research has confirmed that many Chinese herbal medicines, such as Atractylodes macrocephala, Patrinia chinensis, Compound Pollen, Panax notoginseng, Rhizoma Lourendis, and Belamcanda chinensis, have certain anti-inflammatory and antibacterial properties, and bacteria do not develop resistance to them. By regulating the human internal environment, Chinese herbal medicines can nourish yin and reduce fire, clear away heat and detoxify, soften and dissolve hard masses, and activate blood circulation and remove blood stasis. Compared to Western medicines such as antibiotics and anti-inflammatory drugs, Chinese herbal medicines are less toxic and less likely to develop drug resistance and toxic side effects. For example, in the prior art CN108904539A, lozenges are prepared from Chinese medicinal ingredients with anti-inflammatory and antibacterial effects, such as licorice, black plum, dried orange peel, dandelion, and honeysuckle. These ingredients have anti-inflammatory, antibacterial, analgesic, and ulcer healing effects, and can be used to prevent and treat oral inflammation such as swollen gums, pharyngitis, laryngitis, and tonsillitis. However, this solution also adds a variety of vitamin ingredients to enhance the efficacy, and the efficacy of the Chinese medicinal ingredients needs to be improved, and their absorption and utilization needs to be strengthened. Although most Chinese medicinal ingredients have anti-inflammatory and antibacterial effects, their efficacy is often unsatisfactory.

[0005] Therefore, there is an urgent need to research and develop more anti-inflammatory and antibacterial drugs or compositions with excellent efficacy, high bioavailability, and natural and harmless drugs or compositions that are more conducive to drug absorption and use, can be used for a long time, and can be applied to common inflammatory diseases such as oral inflammation and pharyngitis. Summary of the Invention

[0006] The present invention aims to solve the problems and defects in the efficacy and bioavailability of existing anti-inflammatory or antibacterial Chinese herbal medicine compositions, and provides an anti-inflammatory and antibacterial composition, a preparation method and application thereof.

[0007] The first object of the present invention is to provide an anti-inflammatory and antibacterial composition.

[0008] The second object of the present invention is to provide a method for preparing the anti-inflammatory and antibacterial composition.

[0009] The third object of the present invention is to provide an application of the anti-inflammatory and antibacterial composition.

[0010] The fourth object of the present invention is to provide a medicine for treating oral inflammation or pharyngitis.

[0011] The above-mentioned purpose of the present invention is achieved through the following technical solutions:

[0012] The invention provides an anti-inflammatory and antibacterial composition, comprising a turmeric plant extract and a Chinese herbal medicine extract; the turmeric plant extract is a turmeric plant volatile oil extract; the Chinese herbal medicine extract comprises a houttuynia cordata extract, a chrysanthemum flower extract, a bupleurum root extract, a yellow yedoensis extract, an andrographis paniculata extract and a capillary wormwood extract.

[0013] Curcuma is a large genus in the Zingiberaceae family, encompassing multiple species, the most famous of which is Curcuma longa (Curcumalonga L). Turmeric is a perennial herb found in subtropical and tropical regions and widely used to treat a variety of ailments. Turmeric extract, derived from the dried rhizome of the ginger plant Curcuma longa, contains volatile oils, the main components of which are curcumin, turmericone, argentinone, and zingiberene. Numerous experimental and clinical studies have confirmed the diverse pharmacological activities of turmeric, including antioxidant, anti-inflammatory, anti-tumor, antibacterial, and antiviral effects.

[0014] Houttuynia cordata (Houttuynia cordata Thunb.) is a perennial herb that grows from the tender stems and leaves of Houttuynia cordata, a member of the Saururaceae family. It's called "Houttuynia cordata" because of its fishy odor. Houttuynia cordata is pungent and slightly cold in nature, and enters the lung meridian. It belongs to the heat-clearing and detoxifying class of herbs, boasting heat-clearing, antiseptic, diuretic, and health-enhancing properties. It also eliminates harmful and undesirable substances from the body, effectively boosting immunity.

[0015] Chrysanthemum (Chrysanthemum × morifolium Ramat), a perennial herbaceous plant in the Asteraceae family, is a traditional Chinese medicinal herb, primarily used for its flower heads. Chrysanthemum has a sweet and bitter taste and a slightly cold nature. It enters the lung and liver meridians and has the effects of lowering blood pressure, dilating coronary arteries, improving eyesight, refreshing the mind, and clearing away heat and internal heat. Chrysanthemum tea is an excellent remedy for reducing internal heat, and drinking it in moderation can clear away heat and internal heat, relieving summer heat.

[0016] Bupleurum (Bupleurum chinense DC.) or Bupleurum corzonerifolium (Bupleurum chinense Wild.), both Umbelliferae plants, is a member of the liver meridian and has the effect of soothing the liver and relieving depression. It has a certain conditioning effect on symptoms such as chest and flank pain, menstrual irregularities, depression, and breast tenderness. Bupleurum has a slightly cold nature and can also reduce fever, relieving fever caused by diseases such as acute bronchitis, acute tracheitis, and viral pneumonia. In addition, Bupleurum has a yang-tonifying effect, which can improve symptoms such as qi deficiency and organ prolapse. Pharmacological studies have shown that Bupleurum has sedative and analgesic effects, and can also protect the liver and alleviate liver damage.

[0017] Taraxacum mongolicum Hand.-Mazz.Monogr.Tarax. is a plant of the genus Taraxacum in the Compositae family, an alias of dandelion, and is the whole herb with roots of dandelion. It is bitter, sweet, and cold in nature, and belongs to the liver and stomach meridians. It has the effects of clearing heat and detoxifying, and promoting diuresis and dispersing nodules.

[0018] Andrographis paniculata (Burm.f.) Wall.ex Nees in Wallich is an annual plant of the genus Andrographis in the Acanthaceae family. Traditional Chinese medicine believes that Andrographis paniculata is bitter and cold in nature, and belongs to the lung, stomach, large intestine, small intestine, liver, gallbladder, and bladder meridians. It can purge fire and detoxify, clear heat and dry dampness, and cool blood and reduce swelling. It can be used for the initial stage of febrile diseases, fever and headache, as well as lung heat cough, lung abscess, sore throat and other symptoms. It can be used alone or in combination with other drugs according to symptoms. It can also be pounded with fresh products and applied to boils and snake bites to detoxify and reduce swelling. It can enter the large and small intestine meridians and the liver and gallbladder meridians, clear heat and dry dampness, and treat various damp-heat syndromes, such as damp-heat diarrhea, eczema itching, etc. Modern pharmacological research shows that it has the effects of antipyretic, sedative, anti-inflammatory, enhancing the immune function of the body, and anti-tumor.

[0019] Artemisia capillaris Thunb. is a semi-shrubby herbaceous plant of the genus Artemisia in the Compositae family. It is the dried above-ground part of Artemisia scoparia Waldst.&Kit. or Artemisia capillaris Thunb. in the Compositae family, and is a diuretic and dampness-dispelling medicine. Artemisia capillaris Thunb. is bitter, pungent, and slightly cold in nature. It belongs to the spleen, stomach, liver, and gallbladder meridians; it is good at clearing and promoting damp-heat and reducing jaundice, and is the main medicine for treating jaundice; it also relieves itching and treats wet eczema and itching. It has the effects of clearing heat and detoxifying, promoting diuresis and defecation, and reducing swelling and pain.

[0020] Natural Chinese herbal medicines have the characteristics of low toxicity,不易产生耐药性 and no toxic and side effects; through a large number of screening studies in this embodiment, it is found that the extracts of Chinese herbal medicines (Houttuynia cordata, Chrysanthemum morifolium, Bupleurum chinense, Taraxacum mongolicum, Andrographis paniculata, Artemisia capillaris Thunb.) have good synergistic effects after reasonable compatibility, and the composition formed by the extracts of Curcuma plants (Curcuma longa, Curcuma aromatica, Zedoary, Curcuma longa, Polygonatum cirrhifolium, Curcuma wenyujin) in a specific dosage ratio can improve its anti-inflammatory and antibacterial properties; further compounded with piperine, it can promote the transdermal absorption effect, better improve the bioavailability of the composition, effectively improve and promote the absorption and utilization of the skin on the active ingredients; and the anti-inflammatory performance of the compounded composition is better than that of using the extracts of Curcuma plants alone, or different components of Chinese herbal medicine extracts, and there is a synergistic effect between the component drugs.

[0021] The anti-inflammatory and antibacterial composition provided by the present invention contains turmeric extract, houttuynia cordata extract, and bupleurum extract as the main anti-inflammatory components. These components exhibit synergistic anti-inflammatory effects, effectively inhibiting inflammatory reactions and alleviating inflammatory symptoms, thereby enhancing the inhibitory effect on inflammation. Furthermore, turmeric extract, houttuynia cordata extract, bupleurum extract, and capillary wormwood extract also serve as the main antibacterial components. These components exhibit synergistic antibacterial effects, combating infections caused by various bacteria, enhancing antibacterial effects, and improving antibacterial efficacy. Turmeric extract and chrysanthemum extract also have antioxidant effects, scavenging free radicals and reducing oxidative damage; turmeric extract and chrysanthemum extract can also enhance overall antioxidant capacity. Houttuynia cordata extract, chrysanthemum extract, and chrysanthemum extract have heat-clearing effects, reducing fever; houttuynia cordata extract, chrysanthemum extract, and chrysanthemum extract can enhance antipyretic effects and provide an auxiliary therapeutic effect for concurrent fever symptoms. Bupleurum extract and Andrographis paniculata extract also have analgesic effects, alleviating symptoms such as pain; and using bupleurum extract and Andrographis paniculata extract can enhance sedative effects and relieve nervous tension. As a natural osmotic agent, piperine helps substances to effectively penetrate cell barriers and can effectively improve the bioavailability of the composition.

[0022] More preferably, the mass ratio of the combination of the Curcuma plant extract and the Chinese herbal medicine extract is 100:(100-250).

[0023] More preferably, the mass ratio of the Curcuma plant extract to the Chinese herbal medicine extract is 100:150.

[0024] Preferably, the composition further contains piperine, and the mass ratio of the turmeric plant extract, the Chinese herbal medicine extract and piperine is 100:(100-250):(0.5-1.5).

[0025] More preferably, the mass ratio of the Curcuma plant extract, the Chinese herbal medicine extract and piperine is 100:150:1.5.

[0026] Furthermore, the Curcuma plant is: Curcuma zedoaria, Curcuma aromatica, Curcuma longa, Curcuma officinalis or Curcuma zedoaria.

[0027] Furthermore, the Chinese herbal medicine extract includes the following components in parts by weight: 1000-2000 parts of Houttuynia cordata extract, 2000-4000 parts of Chrysanthemum extract, 2000-4000 parts of Bupleurum chinense extract, 2000-3500 parts of Fructus yedoensis extract, 2000-4000 parts of Andrographis paniculata extract, and 2000-4000 parts of Artemisia capillaris extract.

[0028] Preferably, the Chinese herbal extract comprises the following ingredients in parts by weight: 1000-2000 parts of Houttuynia cordata, 2000-3500 parts of Chrysanthemum, 2000-3000 parts of Bupleurum, 2000-2500 parts of Flavouring Herba, 2000-2500 parts of Andrographis paniculata, and 2500-3000 parts of Artemisia capillaris.

[0029] The present invention provides a method for preparing a turmeric plant extract:

[0030] (1) drying the turmeric plant and preparing a powder;

[0031] (2) Boil with distilled water in a sealed container for 3 hours, condense the steam to liquefy it, and collect the condensate;

[0032] (3) extracting the condensate twice, collecting the extracts, and obtaining volatile oil from the genus Curcuma, i.e., volatile oil extract from the genus Curcuma.

[0033] The present invention provides a method for preparing a Chinese herbal medicine extract:

[0034] (1) Weigh Houttuynia cordata, Chrysanthemum Flos, Bupleurum Root, Herba Lycopodii, Andrographis Paniculatae, and Artemisia Capillaris respectively and prepare them into powder;

[0035] (2) boiling the medicinal material powder with distilled water for 1 to 3 hours, filtering to obtain filtrate 1 and filter residue 1; boiling the filter residue 1 with distilled water for 1 to 2 hours, filtering to obtain filtrate 2 and filter residue 2; mixing the filtrate 1 and the filtrate 2, concentrating under reduced pressure, extracting twice with ethanol, and recovering the ethanol;

[0036] (3) The extracts were concentrated, vacuum-dried, and pulverized to obtain Houttuynia cordata extract, Chrysanthemum flower extract, Bupleurum chinense extract, Herba Lycopodii Herba Extract, Andrographis paniculata extract, and Capillaris ternata extract.

[0037] As the most preferred embodiment, the present invention provides a specific method for preparing a Chinese herbal medicine extract:

[0038] (1) Weigh Houttuynia cordata, Chrysanthemum, Bupleurum, Herba Lycopodii, Andrographis paniculata, and Artemisia capillaris respectively, make them into powder, and mix them evenly;

[0039] (2) boiling the medicinal material powder with distilled water for 3 hours, filtering to obtain filtrate 1 and filter residue 1; boiling the filter residue 1 with distilled water for 2 hours, filtering to obtain filtrate 2 and filter residue 2; mixing the filtrate 1 and the filtrate 2, concentrating under reduced pressure, extracting twice with ethanol, and recovering the ethanol;

[0040] (3) The extracts are concentrated, vacuum-dried, and crushed to obtain Houttuynia cordata extract, Chrysanthemum flower extract, Bupleurum chinense extract, Herba Lycopodii Herba Extract, Andrographis paniculata extract, and Artemisia capillaris extract.

[0041] The present invention also provides a preparation method of the anti-inflammatory and antibacterial composition, comprising mixing a turmeric plant extract, a Chinese herbal medicine extract and piperine in proportion, stirring evenly, drying under low temperature and vacuum, and crushing to obtain the anti-inflammatory and antibacterial composition.

[0042] The present invention also provides the use of the anti-inflammatory and antibacterial composition in the preparation of anti-inflammatory / anti-inflammatory and antibacterial drugs.

[0043] Preferably, the drug is a drug for treating oral inflammation or pharyngitis.

[0044] More preferably, the oral inflammation is gingivitis or periodontitis.

[0045] In particular, the pharmaceutical dosage form provided by the present invention can be an oral preparation or a spray preparation.

[0046] The present invention also provides a method for preparing an anti-inflammatory and antibacterial oral spray (taking the preparation of 100 mL as an example):

[0047] 10 g of the anti-inflammatory and antibacterial composition was dissolved in sterile water, the volume was fixed to 100 mL, filtered through a filter with a filter diameter of 0.5 μm, and sterilized and bottled to obtain the oral spray.

[0048] The present invention has the following beneficial effects:

[0049] The present invention provides an anti-inflammatory and antibacterial composition, which is obtained by compounding a combination of a turmeric plant extract, a Chinese herbal medicine extract, and piperine. The anti-inflammatory and antibacterial effects of the properly matched composition are better than those of using a turmeric plant extract or a Chinese herbal medicine extract alone, and its hyaluronidase inhibition rate and antibacterial rate are significantly higher than those of any combination of four or five Chinese herbal medicine extracts. It is shown that the turmeric plant extract has a significant synergistic effect when compounded with a specific Chinese herbal medicine extract, which can enhance its anti-inflammatory and antibacterial effects. After further compounding with piperine, the transdermal absorption effect is promoted, the bioavailability of the composition can be better improved, and the absorption and utilization of the active ingredients by the skin can be effectively improved and promoted.

[0050] The present invention effectively addresses the limitations of using a single Chinese herbal extract by combining different Chinese herbal extracts. This not only improves efficacy but also simultaneously exhibits anti-inflammatory and antibacterial, heat-clearing and detoxifying, analgesic, and antioxidant effects. While reducing medication dosage, it also promotes drug absorption and utilization, achieving significant anti-inflammatory and antibacterial therapeutic effects. Furthermore, the anti-inflammatory and antibacterial composition provided by the present invention can be used to treat oral inflammatory diseases and pharyngitis with good efficacy. Clinically, it has demonstrated excellent therapeutic efficacy for pharyngitis, with a total effective rate of 90%-96%. The composition, which primarily consists of Chinese herbal extracts, is safe, has stable efficacy, and facilitates absorption. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] Figure 1Anti-inflammatory effects of anti-inflammatory and antibacterial compositions with different component ratios. DETAILED DESCRIPTION

[0052] The present invention is further described below in conjunction with specific examples, but the examples are intended to explain the present invention and are not to be construed as limiting the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative work are within the scope of protection of the present invention. Specific techniques or conditions not specified in the examples are carried out in accordance with the techniques or conditions described in the literature in the art or in accordance with the product specifications.

[0053] Example 1 Determination of main components

[0054] Natural Chinese herbal medicines have the characteristics of low toxicity, not easy to produce drug resistance and toxic side effects; this embodiment found through a large number of screening studies that the turmeric plants (turmeric, turmeric, zedoary, turmeric, taro seven, warm turmeric) and Chinese herbal medicine extracts (houttuynia cordata, chrysanthemum, bupleurum, yellow flower yedoensis, andrographis paniculata, capillaris) through reasonable compatibility have a good synergistic effect, which can enhance their anti-inflammatory and antibacterial properties.

[0055] Among them, the turmeric plant extract is a volatile oil extract of the turmeric plant, which is obtained by drying the turmeric plant and making it into powder; boiling it with distilled water in a sealed container for 3 hours, condensing the steam to liquefy it, and collecting the condensate; then sending the condensate into a supercritical CO2 device, extracting it twice, and collecting the extract to obtain the volatile oil, which is the turmeric plant extract.

[0056] The Chinese herbal medicine extract is an aqueous extract of houttuynia cordata, chrysanthemum, bupleurum, yew lily, andrographis paniculata, and capillaris scutellariae, etc., and is prepared by powdering the medicinal materials; decocting them with distilled water for 3 hours, filtering, and obtaining filtrate 1 and filter residue 1; then decocting the filter residue 1 with distilled water for 2 hours, filtering, and obtaining filtrate 2 and filter residue 2; finally, mixing filtrate 1 and filtrate 2, concentrating under reduced pressure, and extracting twice with ethanol, and recovering the ethanol to obtain the Chinese herbal medicine extract. The houttuynia cordata extract, chrysanthemum extract, bupleurum extract, yew lily, andrographis paniculata extract, and capillaris scutellariae extract prepared from the Chinese herbal medicine are mixed in different proportions to obtain the Chinese herbal medicine extract.

[0057] Curcuma plant extract and Chinese herbal medicine extract were compounded at a mass ratio of 1:1.5, wherein the component ratios and dosages of different combinations of Chinese herbal medicine extracts are shown in Table 1 below.

[0058] Table 1 Ratios and dosages of different combinations of Chinese herbal medicine extracts

[0059]

[0060]

[0061] The composition obtained after compounding the components in Table 1 was measured by anti-inflammatory and antibacterial experiments. The anti-inflammatory efficacy used a hyaluronic acid-hyaluronidase reaction system to establish an in vitro reaction model for inhibiting inflammatory reactions, and the inhibitory effect of each component composition on hyaluronidase was evaluated for anti-inflammatory effect. The specific steps are: 100 μL (5wt%, solvent is sterile water) of the sample of each component composition was added to each reaction tube, 100 μL of sterile water was added to the blank control tube, and 50 μL of bovine hyaluronidase was added to each tube and the mixture was in a 37°C water bath for 20 min. 100 μL of 12.5 mM calcium chloride was added to each tube and the mixture was in a 37°C water bath for 20 min. After calcium activation of hyaluronidase, add 250 μL of sodium hyaluronate, mix thoroughly, and incubate in a 37°C water bath for 40 minutes. Add 100 μL each of 0.4N sodium hydroxide and 0.04M potassium borate. Boil in a water bath for 3 minutes. Cool to room temperature. Pipette 200 μL from each tube into a 96-well microplate assay well. Measure three wells per tube and average the values. Measure the OD value at a wavelength of 585 nm using a Shimadzu CS-9301PC microplate analyzer, using sterile water as a blank. Calculate the hyaluronidase activity inhibition rate based on the OD value.

[0062] Calculation method of hyaluronidase activity inhibition rate:

[0063] Inhibition rate (%) = [(OD C -OD S ) / OD C ]×100

[0064] OD C : OD value of control well;

[0065] OD S : OD value of experimental well.

[0066] The antibacterial effect was evaluated by referring to the “QB / T 2738-2012 Evaluation Method for Antibacterial and Bacteriostatic Effects of Daily Chemical Products” and the bactericidal test was conducted on the oral pathogen Helicobacter pylori (purchased from Shanghai Beinuo Biotechnology Co., Ltd.). The antibacterial rate results were rounded to two decimal places.

[0067] The antibacterial rate calculation formula is:

[0068]

[0069] Where:

[0070] A: average colony count of control samples;

[0071] B: average colony count of test samples;

[0072] The results are shown in Table 2 below. Under the same dosage, the hyaluronidase inhibition rate and antibacterial rate against Helicobacter pylori of the compound of Curcuma plant extract and Chinese herbal extract with specific dosage components were significantly higher than those of the Curcuma plant extract or the combination of Chinese herbal extracts alone, as well as any combination of four or five Chinese herbal extracts. It can be seen that the Curcuma plant extract has a significant synergistic effect with the specific Chinese herbal extracts, which can enhance their anti-inflammatory and antibacterial effects. Among them, in compositions 1-3, the anti-inflammatory and antibacterial effects of the six Chinese herbal extract components, including Houttuynia cordata extract, Chrysanthemum extract, Bupleurum chinense extract, Herba Lycopodii extract, Andrographis paniculata extract, and Artemisia capillaris extract, combined with the Curcuma plant extract were the best, with a hyaluronidase inhibition rate of up to 98.71% and an antibacterial rate of up to 99.76%. The anti-inflammatory and antibacterial effects of the five Chinese herbal extract components combined with the Curcuma plant extract in compositions 4-9 were lower than those of compositions 1-3. The anti-inflammatory and antibacterial effects of the four Chinese herbal extract components combined with the Curcuma plant extract in compositions 10-12 were lower than those of compositions 1-9. The anti-inflammatory and antibacterial effects of the compositions using only six Chinese herbal extracts or only Curcuma plant extract were significantly lower than those of the compositions prepared by combining the two. Therefore, the use of Curcuma plant extract and the Chinese herbal extract in a specific dosage ratio has a synergistic effect and can significantly enhance the anti-inflammatory and antibacterial effects. Based on the results of the hyaluronidase inhibition test, we can find that the composition prepared by the present invention also has a significant anti-allergic effect. When the body is exposed to allergens, the immune system will produce an allergic reaction and release a series of inflammatory mediators, leading to an inflammatory reaction. Anti-allergic treatment can indirectly promote the anti-inflammatory process. By alleviating allergic reactions and reducing the release of allergic mediators, the degree of inflammatory response can be reduced to a certain extent, thereby promoting the progress of the anti-inflammatory process. Therefore, the results show that the composition of the present invention can have the dual effects of anti-allergic and anti-inflammatory.

[0073] Table 2 Anti-inflammatory and antibacterial effects

[0074]

[0075] The study also found that the dosage ratio of turmeric extract to Chinese herbal extract also affects its efficacy. Since the penetration ability of a drug is related to its efficacy, piperine, a natural permeant, helps the substance effectively penetrate cellular barriers, thereby improving the bioavailability of the combination. Therefore, the study further investigated the dosage ratio of turmeric extract and Chinese herbal extracts combined with piperine.

[0076] Curcuma extract, Chinese herbal extract, and piperine were compounded according to the mass ratios shown in Tables 3 and 4 below, with 2000 parts by weight of the turmeric extract actually used. After compounding, the anti-inflammatory, antibacterial, and transdermal absorption efficacy tests were performed. The anti-inflammatory and antibacterial efficacy test methods and steps were the same as above. A vertical diffusion cell was used for the in vitro transdermal absorption experiment, using nude mouse skin as a model (abdominal skin, subcutaneous fat layer and blood vessels removed; all experimental mice in the present invention were purchased from the Guangdong Medical Laboratory Animal Center). The receiving solution was a PBS solution. The skin sheet was fixed between the supply cell and the receiving cell with the skin layer facing up and equilibrated for 20 minutes. Each sample solution (5wt% aqueous solution of the composition) was added to the supply cell, and the receiving solution was taken after 8 hours. The content of the turmeric extract was then determined by high-performance liquid chromatography (HPLC, Shimadzu, Japan), and the cumulative permeation per unit area was calculated based on this. Three parallel experiments were performed for each group of experiments, and the experimental results were taken as the arithmetic mean.

[0077] Calculation method of cumulative permeation per unit area on the skin patch:

[0078]

[0079] Q n : Cumulative transmittance per unit area of ​​the sample at time t (μg / cm 2 );

[0080] A: permeable area;

[0081] C n : t time concentration measurement value;

[0082] C i : Concentration value measured before time t

[0083] V: total volume of receiving solution;

[0084] V0: sampling volume.

[0085] Table 3 Components in different mass ratios and their effects

[0086]

[0087] Table 4 Transdermal absorption effect of different piperine mass ratios

[0088]

[0089] As can be seen from the above, after further adopting piperine to carry out compounding, promote transdermal absorption effect, can better improve the bioavailability of composition; And after curcuma extract, Chinese herbal extract combination and piperine are compounded in a certain ratio, there is equally good anti-inflammatory, antibacterial action, there is synergistic effect between each extract component, after compounding piperine, still can effectively improve and promote the absorption and utilization of skin to functional ingredients. Simultaneously, the present invention is also to different curcuma plants: zedoary turmeric, turmeric, taro and warm turmeric have been extracted and prepared (method is referring to the above-mentioned extraction of turmeric) respectively, and are compounded according to table 3 with Chinese herbal extract combination and piperine, result display adopts zedoary turmeric extract, turmeric extract, taro and warm turmeric extract and Chinese herbal extract combination and piperine after compounding with turmeric extract after effect suitable (difference is not remarkable), with the compounding of different Chinese herbal extract combinations equally have consistency.

[0090] In the composition obtained after the above-mentioned compounding, the turmeric extract, houttuynia cordata extract and bupleurum extract used are the main anti-inflammatory components, and there is a synergistic anti-inflammatory effect between each component, which can effectively inhibit the inflammatory reaction and alleviate the symptoms of inflammation, and can enhance the inhibitory effect on inflammation. At the same time, the turmeric extract, houttuynia cordata extract, bupleurum extract and capillary wormwood extract used are also used as the main antibacterial components, and there is a synergistic antibacterial effect between each component, which can resist the infection of various bacteria, enhance the antibacterial effect and improve the antibacterial effect. Among them, the turmeric extract and chrysanthemum extract used in the present invention also have antioxidant effects, can scavenge free radicals, and reduce oxidative damage; using turmeric extract and chrysanthemum extract can improve the overall antioxidant capacity. The houttuynia cordata extract, chrysanthemum sylvestris extract and chrysanthemum extract used have a heat-clearing effect and can reduce fever; using houttuynia cordata extract, chrysanthemum sylvestris extract and chrysanthemum extract can enhance the antipyretic effect and have an auxiliary therapeutic effect on the fever symptoms concurrently. The bupleurum and Andrographis extracts used in the treatment also have analgesic properties, alleviating pain and other symptoms. They can also enhance sedative effects and relieve nervous tension. Piperine, a natural osmotic agent, helps substances effectively penetrate cellular barriers, effectively increasing the bioavailability of the combination.

[0091] In summary, by the rational compounding of the combination of Curcuma extract and Chinese herbal extract, it is shown that the anti-inflammatory performance of the compounded composition is better than that of using Curcuma extract alone, or one of the Chinese herbal extract combinations, and there is a synergistic effect between the component drugs; by the compounding of different Chinese herbal extracts, the limitation problem of using Chinese herbal extracts alone can also be effectively solved at the same time, not only can the drug efficacy be improved, but also the effects of anti-inflammatory and antibacterial, heat-clearing and detoxifying, analgesic, antioxidant, etc. can be achieved while reducing the dosage of the drug, and drug absorption and utilization can also be promoted, achieving significant anti-inflammatory and antibacterial therapeutic effects. The above-mentioned composition provided by the present invention has an inhibition rate of more than 90% on hyaluronidase and an antibacterial rate of more than 99% on Helicobacter pylori, so it can be used to treat oral inflammatory diseases and pharyngitis, with good effect; specifically, it can be used to treat gingivitis, periodontitis and pharyngitis, providing technical support for the development and utilization of subsequent compositions.

[0092] Example 2 Preparation of anti-inflammatory and antibacterial composition

[0093] The present invention provides an anti-inflammatory and antibacterial composition, the raw materials of which include a turmeric plant extract, a Chinese herbal medicine extract, and piperine. The preparation methods of the turmeric plant extract and the Chinese herbal medicine extract are as follows:

[0094] 1. Preparation of Curcuma Extract

[0095] (1) Dry the turmeric and make it into powder.

[0096] (2) Boil in distilled water in a sealed container for 3 hours, condense the steam to liquefy it, and collect the condensate.

[0097] (3) The condensate is sent to a supercritical CO2 device for extraction twice, and the extract is collected to obtain turmeric volatile oil, which is a turmeric plant extract.

[0098] 2. Preparation of Chinese herbal medicine extracts

[0099] (1) Chinese herbal medicine extracts include houttuynia cordata extract, chrysanthemum extract, bupleurum extract, chrysanthemum gensis extract, andrographis paniculata extract and capillaris extract.

[0100] (2) The medicinal materials Houttuynia cordata, Chrysanthemum, Bupleurum chinense, Herba syringae, Andrographis paniculata, and Herba Artemisiae Scopariae were weighed separately and powdered. The mixture was decocted with distilled water for 3 hours and filtered to obtain filtrate 1 and filter residue 1. The filter residue 1 was decocted with distilled water for 2 hours and filtered to obtain filtrate 2 and filter residue 2. The filtrate 1 and filtrate 2 were mixed, concentrated under reduced pressure, extracted twice with ethanol, and the ethanol was recovered to obtain the extract of Houttuynia cordata, Chrysanthemum, Bupleurum chinense, Herba syringae, Andrographis paniculata, and Herba Artemisiae Scopariae extract.

[0101] (3) Take the above-mentioned Houttuynia cordata extract, Chrysanthemum extract, Bupleurum chinense extract, Herba scutellariae extract, Andrographis paniculata extract and Herba Artemisiae Scopariae extract in proportion to each weight portion: 1500 parts of Houttuynia cordata extract, 2000 parts of Chrysanthemum extract, 3000 parts of Bupleurum chinense extract, 2000 parts of Herba scutellariae extract, 2000 parts of Andrographis paniculata extract and 3000 parts of Herba Artemisiae Scopariae extract, and mix them to obtain the Chinese herbal medicine extract.

[0102] The turmeric plant extract, the Chinese herbal medicine extract and the piperine prepared above are mixed in a mass ratio of 100:100:1. Specifically, 2000 parts by weight of the turmeric plant extract, 2000 parts by weight of the Chinese herbal medicine extract and 20 parts of piperine are mixed evenly, dried in a vacuum at low temperature and crushed to obtain an anti-inflammatory and antibacterial composition.

[0103] Example 3

[0104] The difference from Example 2 is that the mass ratios of the turmeric plant extract, the Chinese herbal medicine extract and piperine are different; the mass ratio of the turmeric plant extract: the Chinese herbal medicine extract: the piperine is 100:150:1.

[0105] Example 4

[0106] The difference from Example 2 is that the mass ratios of the turmeric plant extract, the Chinese herbal medicine extract and piperine are different; the mass ratio of the turmeric plant extract: the Chinese herbal medicine extract: the piperine is 100:250:1.

[0107] Example 5

[0108] The difference from Example 2 is that the Curcuma plant extract is a Curcuma zedoaria extract.

[0109] Comparative Example 1

[0110] The difference from Example 2 is that the houttuynia cordata extract in the Chinese herbal medicine extract is replaced by honeysuckle extract.

[0111] Comparative Example 2

[0112] The difference from Example 2 is that the Artemisia capillaris extract in the Chinese herbal medicine extract is replaced by Pulsatilla scabra extract.

[0113] Comparative Example 3

[0114] The difference from Example 2 is that the Andrographis paniculata extract in the Chinese herbal medicine extract is replaced by Taraxacum mongolicum extract.

[0115] Comparative Example 4

[0116] The difference from Example 2 is that the turmeric plant extract is replaced by the liquorice extract, and the liquorice extract is compounded with the Chinese herbal medicine extract and piperine to obtain the anti-inflammatory and antibacterial composition.

[0117] Experimental Example 1 Evaluation of anti-inflammatory efficacy

[0118] To further verify the anti-inflammatory effect of the anti-inflammatory and antibacterial composition of the present invention, this experiment will use a phorbol ester (TPA)-induced mouse ear swelling model. TPA is dissolved in acetone to obtain TPA solvent. The dose of TPA solvent used for each mouse is 2.0 μg / ear. After 6 hours, the mouse ears reach maximum swelling.

[0119] The experiment content is as follows:

[0120] Forty mice with the same physiological state (purchased from Guangdong Medical Experimental Animal Center) were divided into four groups, with 10 mice in each group.

[0121] After the first group of mice were treated with TPA solvent, they were gavage-fed 10 mL of the prepared solution (prepared at a mass-to-volume ratio of Example 2: water = 1:10) daily starting from the second day at 6:00 PM.

[0122] After the second group of mice were treated with TPA solvent, they were gavage-fed 10 mL of the prepared solution (prepared at a mass volume ratio of Example 3: water = 1:10) daily starting from the second day at 6:00 PM.

[0123] After the third group of mice were treated with TPA solvent, they were gavage-fed 10 mL of the prepared solution (prepared at a mass volume ratio of Example 4: water = 1:10) daily starting from the second day at 6:00 PM.

[0124] After the fourth group of mice were treated with TPA solvent, they were gavage-fed 10 mL of the prepared solution (starch:water=1:10 by mass volume ratio) every day starting from the second day at 6:00 PM.

[0125] To prevent other unrelated factors from influencing the experimental results, the four groups of mice were fed the same amount and at the same time, just enough to ensure normal life. Furthermore, all other unrelated factors (such as temperature and humidity) in the growth environment of the four groups of mice were identical and suitable, and the drug concentration and dosage were controlled to be the same in each group.

[0126] The mice were gavage-fed twice as described above, then sacrificed. The ears were punched with a laboratory hole puncher (7 x 1 mm, Changzheng Chemical Reagent Company). The ear tissue discs obtained were weighed and recorded. (Note: The smaller the ear tissue disc mass, the greater the anti-inflammatory effect.)

[0127] The experimental results are shown in Table 5 below, which show that the average weight of the ear tissue discs of the first, second, and third groups using the anti-inflammatory and antibacterial composition is about 10.5 mg, while the weight of the ear tissue discs of the fourth group of the control group is about 15.5 mg. This shows that after the mice took the anti-inflammatory and antibacterial composition of the present invention, the ear tissue swelling was reduced faster and the anti-inflammatory effect was better than that of the mice that did not take it. The specific statistical results are as follows Figure 1 As shown, it is shown that the anti-inflammatory and antibacterial composition provided by the present invention has a significant anti-inflammatory effect.

[0128] Table 5 Anti-inflammatory effect of anti-inflammatory and antibacterial compositions with different composition ratios (unit: mg)

[0129]

[0130]

[0131]

[0132] Experimental Example 2 Clinical Test

[0133] In order to verify the clinical efficacy and safety of the anti-inflammatory and antibacterial composition of the present invention, this experiment was conducted in accordance with the requirements of the guidelines for clinical research of new Chinese medicines, and the anti-inflammatory and antibacterial compositions of Examples 2 to 5 and Comparative Examples 1 to 4 were clinically administered and observed. The clinical research plan is as follows:

[0134] 1. Case selection criteria:

[0135] 1.1 Diagnostic criteria for TCM syndromes:

[0136] Main symptoms: sore throat, dry and burning throat, and difficulty swallowing;

[0137] Secondary symptoms: fever, chills, thirst;

[0138] Examination: red or bloody pharyngeal mucosa, redness and swelling of the lateral pharyngeal mucosa, and hyperplasia of lymphoid follicles on the posterior pharyngeal wall.

[0139] 1.2 Inclusion criteria:

[0140] (1) Those who meet the diagnostic criteria of TCM syndromes;

[0141] (2) Both men and women;

[0142] (3) no limit on the duration of disease;

[0143] (4) Patients who are aware of the situation and agree to it.

[0144] 1.3 Exclusion criteria:

[0145] (1) Those who do not meet the diagnostic criteria;

[0146] (2) the subjects were unwilling to participate in the experiment;

[0147] (3) Those with allergic constitution or allergies to multiple drugs;

[0148] (4) Patients with severe primary diseases of the heart, brain, liver, kidney, hematopoietic system, endocrine system, and mental illness;

[0149] (5) Patients whose condition is critical and it is difficult to make an accurate evaluation of the effectiveness and safety of the drug.

[0150] Study subjects: 800 confirmed patients who met the above case selection criteria were randomly selected as observation cases, including 400 males and 400 females, aged between 14 and 58 years old.

[0151] 2. Treatment method: The anti-inflammatory and antibacterial compositions prepared in Examples 2 to 5 and Comparative Examples 1 to 4 were respectively brewed with water and taken orally twice a day, with a dosage of 10 g at the same concentration, for 7 consecutive days.

[0152] 3. Efficacy assessment:

[0153] (1) Cure: Pharyngitis symptoms disappear and the body recovers;

[0154] (2) Effective: Pharyngitis symptoms are alleviated, but medication is still needed;

[0155] (3) Ineffective: Pharyngitis symptoms did not improve or did not improve significantly.

[0156]

[0157] The statistical results of therapeutic effect are shown in Table 6 below. It can be seen that the anti-inflammatory and antibacterial composition prepared by the present invention has a good therapeutic effect on pharyngitis, with a total effective rate of 90%-96%, with significant economic and social benefits, and its components are Chinese herbal medicine extracts, safe medication, stable efficacy, and conducive to absorption. In Comparative Examples 1 to 4, after replacing any of the extract components in the anti-inflammatory and antibacterial composition provided by the present invention, its efficiency has changed significantly, and the main anti-inflammatory, antibacterial, analgesic and heat-clearing ingredients therein are replaced with other Chinese herbal medicines that also have anti-inflammatory, antibacterial, analgesic and heat-clearing effects. The medicinal properties and interactions between the extract components change, and its drug effect also changes. It can be seen that the anti-inflammatory and antibacterial composition provided by the present invention has better effects.

[0158] Table 6 Effects of anti-inflammatory and antibacterial compositions with different composition ratios on the treatment of pharyngitis

[0159] Total number of cases cure efficient invalid Total efficiency Example 2 100 90 4 6 94％ Example 3 100 91 5 4 96％ Example 4 100 90 5 5 95％ Example 5 100 85 5 10 90％ Comparative Example 1 100 81 7 12 88％ Comparative Example 2 100 74 10 16 84％ Comparative Example 3 100 81 5 14 86％ Comparative Example 4 100 79 8 13 87％

[0160] Finally, it should be noted that the above embodiments are merely examples for the purpose of illustrating the present application and are not intended to limit the implementation methods. Those skilled in the art will readily appreciate that other variations or modifications based on the above descriptions are possible. It is not necessary and impossible to enumerate all possible implementation methods here, and obvious variations or modifications derived therefrom remain within the scope of protection of this application.

Claims

1. An anti-inflammatory and antibacterial composition, characterized in that: The composition comprises a turmeric plant extract and a Chinese herbal medicine extract; the turmeric plant extract is a volatile oil extract of the turmeric plant; the Chinese herbal medicine extract comprises the following components in parts by weight: 1000-2000 parts of houttuynia cordata extract, 2000-4000 parts of chrysanthemum extract, 2000-4000 parts of bupleurum extract, 2000-3500 parts of genus yedoensis extract, 2000-4000 parts of andrographis paniculata extract, and 2000-4000 parts of capillaris extract; the mass ratio of the turmeric plant extract to the Chinese herbal medicine extract is 100:(100-250); The preparation method of the turmeric plant extract is as follows: (1) Drying the turmeric plant and preparing it into powder; (2) Boil in distilled water in a sealed container for 3 hours, condense the steam to liquefy it, and collect the condensate; (3) sending the condensate into a supercritical CO2 device for extraction twice, collecting the extract to obtain volatile oil of the genus Curcuma, i.e., volatile oil extract of the genus Curcuma; The preparation method of the Chinese herbal medicine extract comprises the following steps: (1) Weigh Houttuynia cordata, Chrysanthemum Flos, Bupleurum Root, Herba Lycopodii, Herba Andrographis Paniculatae, and Herba Artemisiae Scopariae separately and prepare them into powder; (2) Decoction the medicinal material powder with distilled water for 1 to 3 hours, filter, and obtain filtrate 1 and filter residue 1; decoct filter residue 1 with distilled water for 1 to 2 hours, filter, and obtain filtrate 2 and filter residue 2; mix filtrate 1 and filtrate 2, concentrate under reduced pressure, extract twice with ethanol, and recover ethanol; (3) The extracts are concentrated, vacuum-dried, and crushed to obtain Houttuynia cordata extract, Chrysanthemum extract, Bupleurum chinense extract, Herba Lycopodii Herba Extracts, Andrographis paniculata extract, and Artemisia capillaris extract, which are then mixed to obtain the Chinese herbal medicine extracts.

2. An anti-inflammatory and antibacterial composition, characterized in that: The composition comprises a turmeric plant extract, a Chinese herbal medicine extract, and piperine, wherein the mass ratio of the turmeric plant extract, the Chinese herbal medicine extract, and the piperine is 100:(100-250):(0.5-1.5); the turmeric plant extract is a volatile oil extract of turmeric plant; and the Chinese herbal medicine extract comprises the following components in parts by weight: 1000-2000 parts of houttuynia cordata extract, 2000-4000 parts of chrysanthemum extract, 2000-4000 parts of bupleurum extract, 2000-3500 parts of genus yew extract, 2000-4000 parts of andrographis paniculata extract, and 2000-4000 parts of capillaris extract; The preparation method of the turmeric plant extract is as follows: (1) Drying the turmeric plant and preparing it into powder; (2) Boil in distilled water in a sealed container for 3 hours, condense the steam to liquefy it, and collect the condensate; (3) sending the condensate into a supercritical CO2 device for extraction twice, collecting the extract to obtain volatile oil of the genus Curcuma, i.e., volatile oil extract of the genus Curcuma; The preparation method of the Chinese herbal medicine extract comprises the following steps: (1) Weigh Houttuynia cordata, Chrysanthemum Flos, Bupleurum Root, Herba Lycopodii, Herba Andrographis Paniculatae, and Herba Artemisiae Scopariae separately and prepare them into powder; (2) Decoction the medicinal material powder with distilled water for 1 to 3 hours, filter, and obtain filtrate 1 and filter residue 1; decoct filter residue 1 with distilled water for 1 to 2 hours, filter, and obtain filtrate 2 and filter residue 2; mix filtrate 1 and filtrate 2, concentrate under reduced pressure, extract twice with ethanol, and recover ethanol; (3) The extracts are concentrated, vacuum-dried, and crushed to obtain Houttuynia cordata extract, Chrysanthemum extract, Bupleurum chinense extract, Herba Lycopodii Herba Extracts, Andrographis paniculata extract, and Artemisia capillaris extract, which are then mixed to obtain the Chinese herbal medicine extracts.

3. The composition according to claim 1 or 2, characterized in that The Curcuma plant is: Curcuma longa, Curcuma zedoaria, Curcuma aromatica or Curcuma zedoaria.

4. The composition according to claim 2, characterized in that The anti-inflammatory and antibacterial composition is prepared by the following method: a turmeric plant extract, a Chinese herbal medicine extract and piperine are mixed in proportion and stirred evenly; low-temperature vacuum drying and crushing are performed to obtain the anti-inflammatory and antibacterial composition.

5. Use of the anti-inflammatory and antibacterial composition according to any one of claims 1 to 3 in the preparation of a drug for treating pharyngitis.

6. Use of the anti-inflammatory and antibacterial composition according to any one of claims 1 to 3 in the preparation of antibacterial drugs, characterized in that: The antibacterial agent is anti-Helicobacter pylori.

7. A medicine for treating pharyngitis, characterized in that: Contains the anti-inflammatory and antibacterial composition according to any one of claims 1 to 3.

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