Traditional Chinese medicine composition for clearing stomach fire and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for clearing stomach fire and a preparation method thereof. According to the traditional Chinese medicine composition, herba violae, herba lobeliae chinensis, herba taraxaci and radix isatidis are used as main medicinal materials, effective components are extracted and separated through modern science and technology, effective extracts are obtained, the curative effect is exerted through a corresponding proportion, and pharmacodynamic research shows that the traditional Chinese medicine composition can obviously reduce inflammatory response, so that the effect of clearing stomach fire is achieved.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for clearing stomach fire and a preparation method thereof. Background Art

[0002] Stomach fire refers to the pathological changes caused by excessive stomach heat. Excessive stomach fire can cause inflammation of the Stomach Meridian of Foot Yangming, manifested as swollen and painful gums, bad breath, noisy and hungry, constipation, irritability, thirst, toothache, bleeding gums, swollen chin, red face, etc. Stomach fire is mostly caused by factors such as pathogenic heat invading the stomach, alcohol addiction, spicy food addiction, and excessive consumption of rich and greasy food. Excessive stomach fire can affect the body's digestion and absorption functions, causing many discomforts to patients.

[0003] With economic development, people's diets are becoming increasingly rich and diverse. On the one hand, the intake of spicy, greasy, and irritating foods has increased significantly. For example, hot pot, barbecue and other delicacies are very popular among the public, but long-term and frequent consumption of such foods can easily lead to endogenous stomach fire. Ingredients such as capsaicin in peppers and high fat in greasy foods will increase the burden of stomach digestion, irritate the gastric mucosa, and then cause stomach fire. On the other hand, fast food culture is prevalent, and many processed foods contain a large amount of additives, high sugar, high salt and other ingredients in order to pursue taste and shelf life. These ingredients accumulate in the body, are not easily metabolized, and can also turn into heat and generate fire, affecting the normal physiological function of the stomach and causing stomach fire to grow.

[0004] At present, some Western medicines commonly used in clinical practice, such as drugs that inhibit gastric acid secretion and antibiotics, have certain problems in treating stomach fire-related symptoms. For example, drugs that inhibit gastric acid secretion can only temporarily relieve the discomfort caused by excessive gastric acid, but cannot fundamentally solve the problem of stomach fire. Long-term use may also cause side effects such as gastric mucosal atrophy and gastric acid secretion dysfunction. Moreover, this type of drug has little effect on oral problems such as bad breath and swollen and painful gums caused by stomach fire. If antibiotics are not used in a standardized manner, they can easily cause dysbiosis and further gastrointestinal dysfunction. At the same time, the problem of antibiotic resistance is becoming increasingly serious. Long-term and repeated use of the same antibiotic may lead to a decrease in efficacy and potential adverse effects on other organs of the body.

[0005] Traditional Chinese medicine has unique advantages in clearing stomach fire. The various natural medicinal ingredients contained in it can clear stomach fire through a multi-target synergistic mechanism. For example, some medicinal ingredients can directly eliminate the heat evil in the stomach and effectively remove the heat in the stomach; some can regulate the circulation of qi and blood in the stomach and improve the stagnation of qi and blood caused by stomach heat; and some can regulate the spleen and stomach function from the root, enhance the transportation and transformation ability of the spleen and stomach, and prevent the heat evil from growing again, thereby achieving the purpose of clearing stomach fire in an all-round and systematic manner, and it is not easy to produce problems such as drug resistance.

[0006] However, the preparation technology of existing Chinese medicine preparations is relatively backward, resulting in a large dosage, poor patient adaptability, and often not significant enough effect. Therefore, further developing Chinese medicine for clearing stomach fire, improving drug efficacy, and reducing dosage are of great significance. Summary of the invention

[0007] In view of this, the technical problem to be solved by the present invention is to provide a Chinese medicine composition for clearing stomach fire and a preparation method thereof.

[0008] The present invention provides a Chinese medicine composition, characterized in that it comprises the following raw materials in parts by weight:

[0009]

[0010] By systematically grouping the medicinal materials and matching the appropriate extraction process for each group of drugs, the present invention successfully prepared a Chinese medicine composition with good stomach-clearing function. Among them, the determination of the mass fraction of each extract is the result of repeated screening through a large number of experiments. These accurately screened mass fraction ratios allow the various components in the composition to work together efficiently, effectively clear stomach fire and regulate stomach function. For example, in the embodiment:

[0011] The traditional Chinese medicine composition consists of 6 parts of traditional Chinese medicine extract A, 2 parts of traditional Chinese medicine extract B, 3 parts of traditional Chinese medicine extract C and 1 part of traditional Chinese medicine extract D.

[0012] Alternatively, the traditional Chinese medicine composition consists of 6 parts of traditional Chinese medicine extract A, 5 parts of traditional Chinese medicine extract B, 4 parts of traditional Chinese medicine extract C and 3 parts of traditional Chinese medicine extract D.

[0013] Alternatively, the traditional Chinese medicine composition consists of 6 parts of traditional Chinese medicine extract A, 8 parts of traditional Chinese medicine extract B, 5 parts of traditional Chinese medicine extract C and 5 parts of traditional Chinese medicine extract D.

[0014] Alternatively, the traditional Chinese medicine composition consists of 8 parts of traditional Chinese medicine extract A, 5 parts of traditional Chinese medicine extract B, 4 parts of traditional Chinese medicine extract C and 5 parts of traditional Chinese medicine extract D.

[0015] Alternatively, the traditional Chinese medicine composition consists of 8 parts of traditional Chinese medicine extract A, 5 parts of traditional Chinese medicine extract B, 5 parts of traditional Chinese medicine extract C and 1 part of traditional Chinese medicine extract D.

[0016] Alternatively, the traditional Chinese medicine composition consists of 8 parts of traditional Chinese medicine extract A, 8 parts of traditional Chinese medicine extract B, 3 parts of traditional Chinese medicine extract C and 3 parts of traditional Chinese medicine extract D.

[0017] Alternatively, the traditional Chinese medicine composition consists of 10 parts of traditional Chinese medicine extract A, 2 parts of traditional Chinese medicine extract B, 5 parts of traditional Chinese medicine extract C and 3 parts of traditional Chinese medicine extract D.

[0018] Alternatively, the traditional Chinese medicine composition consists of 10 parts of traditional Chinese medicine extract A, 5 parts of traditional Chinese medicine extract B, 3 parts of traditional Chinese medicine extract C and 5 parts of traditional Chinese medicine extract D.

[0019] Alternatively, the traditional Chinese medicine composition consists of 10 parts of traditional Chinese medicine extract A, 8 parts of traditional Chinese medicine extract B, 4 parts of traditional Chinese medicine extract C and 1 part of traditional Chinese medicine extract D.

[0020] In the present invention, the Chinese medicine extract A is prepared by enzymatic hydrolysis of Viola yedoensis and Lobelia scabra and then ultrasonic extraction.

[0021] Preliminary experiments show that the method of ultrasonic extraction after breaking the cell walls of Viola yedoensis and Lobelia chinensis with cellulase is more conducive to the development of physiological activity, and the obtained precipitate contains a large amount of phenolic acid and other components, which can have a good effect of clearing stomach fire. In the embodiment of the present invention, the mass ratio of Viola yedoensis and Lobelia chinensis in the Chinese medicine extract A is (8-12): (8-12), and excellent effects can be obtained within this range, but preferably, the mass ratio of Viola yedoensis and Lobelia chinensis in the Chinese medicine extract A is 10:10.

[0022] In some embodiments, the preparation of the Chinese herbal extract A comprises:

[0023] 10 parts of Viola yedoensis and 10 parts of Lobelia chinensis were mixed with water, and then enzymatically hydrolyzed with cellulase at pH 4.5 and 50°C for 90 minutes, and then ultrasonically extracted for 30 minutes. The filtrate was filtered and dried to obtain the Chinese medicine extract A.

[0024] Preferably, the preparation of the Chinese herbal extract A comprises:

[0025] Add 20 times the weight of water to 10 parts of Viola yedoensis and 10 parts of Lobelia chinensis, adjust the pH to 4.5 with citric acid, add 0.1 parts of cellulase, maintain constant temperature enzymolysis at 50°C for 90 minutes, perform ultrasonic extraction for 30 minutes, filter, and freeze-dry to obtain Chinese medicine extract A.

[0026] More preferably, the ultrasonic conditions include a power of 250w and a temperature of 20°C.

[0027] In the present invention, the Chinese medicine extract B is prepared by extracting Viola yedoensis and Taraxacum officinale with water and then precipitating with ethanol.

[0028] The main component of Chinese medicine extract B is flavonoids. Preliminary experiments show that the extracts of Viola yedoensis and Taraxacum officinale can have good physiological activity of clearing stomach fire by water extraction and alcohol precipitation. In the embodiment of the present invention, the mass ratio of Viola yedoensis and Taraxacum officinale in the Chinese medicine extract B is (4-6): (8-12), and excellent effects can be obtained within this range, but preferably, the mass ratio of Viola yedoensis and Taraxacum officinale in the Chinese medicine extract B is 5:10.

[0029] In some embodiments, the preparation of the Chinese herbal extract B comprises:

[0030] 5 parts of Viola yedoensis and 10 parts of Taraxacum officinale were extracted with water, the extract was concentrated and then anhydrous ethanol was added to the extract until the alcohol content was not less than 70%, and the precipitate was dried to obtain the Chinese medicine extract B.

[0031] Preferably, the preparation of the Chinese herbal extract B comprises:

[0032] Take 5 parts of Viola yedoensis and 10 parts of Taraxacum officinale, extract twice with water, each time for 1 hour, combine the decoctions, filter and concentrate to an extract with a relative density of 1.05-1.10, add ethanol until the alcohol content reaches 70%, stir for 30 minutes, let stand and precipitate for 12 hours, filter the supernatant, and freeze-dry to obtain a traditional Chinese medicine extract A.

[0033] More preferably, the water extraction is reflux extraction.

[0034] In the present invention, the Chinese medicine extract C is obtained by extracting Radix Isatidis with ethanol and then purifying it with macroporous resin.

[0035] The main component of Chinese medicine extract C is alkaloids. Other processes tried in previous experiments are not as good as the effect of alcohol extraction followed by macroporous resin purification. Experiments show that extract C obtained under the parameters of the present invention can better cooperate with other parts of the Chinese medicine composition and has better physiological activity of clearing stomach fire.

[0036] In some embodiments, the preparation of the Chinese herbal extract C comprises:

[0037] After extracting Radix Isatidis with ethanol solution, the extract is loaded with D101 macroporous resin, washed with distilled water, eluted with alkaline ethanol solution, and the eluted solution is freeze-dried to obtain Chinese medicine extract C; the pH value of the alkaline ethanol solution is 10.0, and it contains 60% ethanol.

[0038] Preferably, the volume fraction of ethanol in the ethanol solution in the preparation method is 60%. The number of extractions of the ethanol solution is 2 times. The conditions include reflux extraction. The amount of distilled water for washing is 2 times the column volume, and the amount of alkaline ethanol solution for elution is 6 times the column volume.

[0039] Preferably, the preparation of the Chinese herbal extract C comprises:

[0040] Take 5 parts of Radix Isatidis and add 10 times the amount of 60% ethanol to extract twice, the first time for 2 hours and the second time for 1 hour, combine the alcohol extracts, recover the ethanol and concentrate to 0.1 parts of Radix Isatidis medicinal materials / ml of the concentrate, apply it to a D101 macroporous resin column, first rinse with distilled water for 2 times the column volume, then elute with an alkaline ethanol solution for 6 times the column volume, collect the eluate of the alkaline ethanol solution, recover the ethanol, and freeze-dry to obtain a Chinese medicine extract C; the alkaline ethanol solution is an ethanol solution containing 60 vol% ethanol and a pH value of 10.0, and its pH value is adjusted by 40% ammonia water.

[0041] In the present invention, the Chinese medicine extract D is a volatile oil obtained by mixed extraction of Viola yedoensis, Taraxacum officinale and Lobelia chinensis.

[0042] In the traditional process, the volatile oil components of Chinese medicinal materials are not fully utilized. The present invention extracts the volatile oil components in Viola yedoensis, Taraxacum officinale and Lobelia chinensis, and finds that it can have a good effect of relieving stomach pain and anti-inflammatory, thereby proving that it can have a physiological activity of clearing stomach fire. In the embodiment of the present invention, the mass ratio of Viola yedoensis, Taraxacum officinale and Lobelia chinensis in the Chinese medicinal extract D described in the Chinese medicinal extract D is (13-17): (13-17): (13-17). Preferably, the mass ratio of Viola yedoensis, Taraxacum officinale and Lobelia chinensis is 15:15:15.

[0043] In the embodiment of the present invention, the preparation of the Chinese medicine extract D comprises:

[0044] After soaking Viola yedoensis, Taraxacum officinale and Lobelia chinensis in water, the extracts were extracted by steam volatilization to obtain the Chinese medicine extract D.

[0045] Preferably, the mass of the water is 20 times the sum of the mass of Viola yedoensis, Taraxacum officinale and Lobelia chinensis. The soaking temperature is room temperature and the soaking time is 1 hour. The extraction is carried out in a water vapor volatile oil extraction device for 8 hours.

[0046] After extracting the volatile oil, the method further includes dissolving it with ethanol and then coating it with cyclodextrin. Specifically, the coating includes: dissolving the volatile oil with an equal amount of ethanol, adding it to a 4-fold amount of β-cyclodextrin aqueous solution, mixing it, passing it through a 5-20um colloid mill for 3 times, filtering it, and drying it at below 40°C for 6 hours. The mass ratio of β-cyclodextrin to water in the β-cyclodextrin aqueous solution is 1:8.

[0047] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition in preparing a medicine for clearing stomach fire.

[0048] In the present invention, clearing stomach fire includes lowering body temperature, relieving stomach pain and / or reducing the level of inflammatory factors.

[0049] In a specific embodiment, the relieving of stomach pain is relieving stomach pain caused by excessive gastric acid secretion.

[0050] In a specific embodiment, the inflammatory factors include TNF-α and / or IL-6.

[0051] Furthermore, the present invention also provides a medicine for clearing stomach fire, which comprises a pharmaceutically acceptable excipient and the above-mentioned traditional Chinese medicine composition.

[0052] In the medicine of the present invention, the mass fraction of the above-mentioned traditional Chinese medicine composition is 50% to 80%.

[0053] The pharmaceutically acceptable excipients in the drug described in the present invention include at least one of fillers, lubricants, disintegrants, adhesives, suspending agents, emulsifiers, preservatives, flavoring agents, colorants, transdermal enhancers, antioxidants, solubilizers, cosolvents, sustained-release agents, controlled-release agents, enteric materials, coating materials, osmotic pressure regulators, pH regulators, stabilizers, and adsorbents.

[0054] The dosage form of the drug of the present invention includes but is not limited to tablets, granules, soft capsules, hard capsules, oral liquids, pills or syrups.

[0055] The medicine of the present invention may also include other medicines with the effect of clearing stomach fire. Among them, the Chinese medicine composition and other medicines with the effect of clearing stomach fire may exist independently of each other or may exist in combination, and the present invention does not limit this.

[0056] In the present invention, the other drugs with the effect of clearing stomach fire include but are not limited to: at least one of Niuhuang Qingwei Pills, Huanglian Shangqing Tablets, Qingwei Huanglian Pills, Huoxiang Qingwei Capsules, Chunchi Qingwei Pills, Sanhuang Tablets, Gardenia Jinhua Pills, Huanglian Yanggan Pills, Compound Niuhuang Qingwei Pills, Dahuang Qingwei Pills, Qinghuo Zhimai Tablets, Zhibai Dihuang Pills, Isatis Root Granules, Shuanghuanglian Oral Liquid, Pudilan Anti-inflammatory Tablets, Amoxicillin Capsules, Metronidazole Tablets, Omeprazole and / or Aluminum Carbonate.

[0057] Furthermore, the present invention also provides a method for preparing the drug as described above, which comprises mixing Chinese herbal extract A, Chinese herbal extract B, Chinese herbal extract C, Chinese herbal extract D and pharmaceutically acceptable excipients to prepare the drug.

[0058] The present invention has clearly described the above-mentioned Chinese herbal extract A, Chinese herbal extract B, Chinese herbal extract C and Chinese herbal extract D, which will not be repeated here. The present invention does not limit the specific mixing method, which is well known to those skilled in the art.

[0059] Furthermore, the present invention also provides a method for clearing stomach fire, which comprises administering the above-mentioned medicine to a subject.

[0060] The administration method of the drug includes but is not limited to oral administration.

[0061] In the present invention, the subject is a human or a mammal, and the mammal includes bovines, equines, ovines, porcines, canines, felines, rodents, and primates.

[0062] The invention uses Viola yedoensis, Lobelia chinensis, Taraxacum officinale and Radix Isatidis as main medicinal materials, extracts and separates effective components through modern scientific technology, obtains effective extracts, and exerts therapeutic effects through corresponding proportions. Pharmacodynamic studies have shown that the Chinese medicine composition of the invention can significantly reduce inflammatory reactions, thereby achieving the effect of clearing stomach fire. DETAILED DESCRIPTION

[0063] The present invention provides a Chinese medicine composition for clearing stomach fire and a preparation method thereof. Those skilled in the art can refer to the content of this article and appropriately improve the process parameters to achieve it. It is particularly important to point out that all similar replacements and modifications are obvious to those skilled in the art, and they are all considered to be included in the present invention. The method and application of the present invention have been described by preferred embodiments, and relevant personnel can obviously modify or appropriately change and combine the method and application of this article without departing from the content, spirit and scope of the present invention to realize and apply the technology of the present invention.

[0064] Unless otherwise defined herein, scientific and technical terms related to the present invention shall have the meanings understood by those of ordinary skill in the art.

[0065] In this application, the term "and / or" describes the association relationship of associated objects, indicating that there may be three relationships. For example, A and / or B can represent: A exists alone, A and B exist at the same time, and B exists alone. A and B can be singular or plural.

[0066] In this application, "at least one" means one or more, "more than one" means two or more. "At least one of the following" or similar expressions refers to any combination of these items, including any combination of single or plural items.

[0067] The terms "include", "comprising" and "having" are used interchangeably herein and are intended to indicate the inclusiveness of the solution, meaning that the solution may have other elements in addition to the listed elements. At the same time, it should be understood that the use of "include", "comprising" and "having" descriptions herein also provides a "consisting of..." solution.

[0068] The test materials used in the present invention are all common commercial products, which can be purchased on the market, including:

[0069] Viola yedoensis Makino is the dried whole herb of Viola yedoensis Makino, a plant of the Violaceae family. It is harvested in spring and autumn, impurities are removed, and it is dried in the sun. [Nature and flavor] Bitter, pungent, and cold. [Meridian] It enters the heart and liver meridians. [Functions and indications] It clears away heat and detoxifies, cools blood and reduces swelling. It is used for carbuncle swelling, carbuncle on the back, erysipelas, and snake bites.

[0070] Lobelia chinensis Lour. is the dried whole herb of the Campanulaceae plant. It is harvested in summer, removed from the mud and sand, washed and dried in the sun. [Nature and flavor] Pungent, neutral. [Meridian] Heart, small intestine, lung meridian. [Functions and indications] Diuretic and detumescent, clearing away heat and detoxifying. It is used for abdominal edema, facial and foot edema, carbuncle, furuncle, snake and insect bites; ascites in late stage schistosomiasis.

[0071] Dandelion is the dried whole herb of Taraxacum mongolicum Hand.-Mazz., Taraxacum sinicum Kitag. or several plants of the same genus in the Asteraceae family. It is harvested from spring to autumn when the flowers first bloom, and then removed from impurities, washed and dried in the sun. [Nature and flavor] Bitter, sweet, and cold. [Meridian] Enters the liver and stomach meridians. [Functions and indications] Clears away heat and detoxifies, reduces swelling and resolves stagnation, and promotes diuresis and relieves stranguria. It is used for carbuncle, breast carbuncle, scrofula, red eyes, sore throat, lung carbuncle, intestinal carbuncle, damp-heat jaundice, and hot stranguria.

[0072] Isatis root is the dried root of Isatis indigotica Fort., a plant of the cruciferous family. It is dug in autumn, sand is removed, and sun-dried. [Nature and flavor] Bitter, cold. [Meridian] Heart and stomach meridians. [Functions and indications] Clears away heat and detoxifies, cools blood and relieves sore throat. It is used for fever and toxicity, dark purple tongue, mumps, throat paralysis, sore throat, red sha, big head plague, erysipelas, and carbuncle.

[0073] The numerical ranges and parameters involved in the present invention have been presented in the specific embodiments as accurately as possible. However, any numerical value inherently inevitably contains standard deviations due to individual testing methods. Therefore, unless otherwise explicitly stated, it should be understood that all numerical ranges or specific data used in this disclosure may have certain reasonable deviations within a certain range, for example: within ±10%, ±5%, ±1% or ±0.5%.

[0074] Some cases are recorded in the embodiments and comparative examples of the present invention. The embodiments show some implementations of the present invention. However, this does not mean that the effects of the present invention can only be achieved in these cases. In fact, any concentration of each component between the two endpoint values ​​shown in the embodiments can achieve a good effect of relieving stomach pain, and the best case is Example 3. In addition, many attempts were made during the research and development process, such as using different extraction processes, different extraction parameters, different ratios, etc., but the effects of these attempts are not as good as those of Example 3, which will not be repeated here.

[0075] It should be understood that in the various embodiments of the present application, the size of the serial numbers of the above-mentioned processes does not mean the order of execution, some or all of the steps can be executed in parallel or sequentially, and the execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of the present application.

[0076] The present invention will be further described below in conjunction with embodiments:

[0077] Embodiment 1:

[0078] Chinese herbal extract A with the effect of clearing stomach fire:

[0079] Take 10 parts of Viola yedoensis and 10 parts of Lobelia chinensis, grind them into fine powder, add 20 times of water, adjust the pH to 4.5 with citric acid, add 0.1 parts of cellulase, maintain constant temperature of 50°C for enzymolysis for 90 minutes, perform ultrasonic extraction for 30 minutes, filter, freeze-dry, and obtain a Chinese medicine extract A with the effect of clearing stomach fire.

[0080] Chinese herbal extract B with the effect of clearing stomach fire:

[0081] Take 5 parts of Viola yedoensis and 10 parts of Taraxacum officinale, add 10 times the amount of water, reflux and extract twice, each time for 1 hour, combine the decoctions, filter, and concentrate to an extract with a relative density of 1.05-1.10, add ethanol to the alcohol content reaching 70%, stir for 30 minutes, then let it stand for 12 hours, filter the supernatant, and freeze-dry to obtain a Chinese medicine extract B with the effect of clearing stomach fire.

[0082] Chinese herbal extract C with the effect of clearing stomach fire:

[0083] Take 5 parts of Radix Isatidis, grind them into fine powder, add 10 times the amount of 60% ethanol, reflux and extract twice, the first time for 2 hours, the second time for 1 hour, combine the alcohol extracts, recover the ethanol, concentrate the filtrate to 0.1 parts of Radix Isatidis medicinal materials / ml of the concentrate, apply it to a D101 macroporous resin column, first elute with distilled water for 2 times the column volume, then add 40% ammonia solution to adjust the pH to 10.0 of alkaline ethanol solution, the ethanol solution concentration is 60%, elute 6 times the column volume, collect the eluate of the alkaline ethanol solution, recover the ethanol, freeze-dry, and obtain a Chinese medicine extract C with the effect of clearing stomach fire.

[0084] Chinese herbal extract D with the effect of clearing stomach fire:

[0085] Take 15 parts of Viola yedoensis, 15 parts of Taraxacum officinale, and 15 parts of Lobelia chinensis, add 20 times the amount of water, soak for 1 hour, extract volatile oil for 8 hours using a water vapor volatile oil extraction device, collect the volatile oil, dissolve it with an equal amount of ethanol, add 4 times the amount of β-cyclodextrin to water in a ratio of 1:8, mix well, pass through a 5-20um colloid mill for 3 times, filter, and dry below 40°C for 6 hours to obtain a traditional Chinese medicine extract D with the effect of clearing stomach fire.

[0086]

[0087] Mix evenly according to the above proportions, add appropriate amount of lactose, and make 1000 tablets.

[0088] Embodiment 2:

[0089] Chinese herbal extract A with the effect of clearing stomach fire:

[0090] Take 10 parts of Viola yedoensis and 10 parts of Lobelia chinensis, grind them into fine powder, add 20 times of water, adjust the pH to 4.5 with citric acid, add 0.1 parts of cellulase, maintain constant temperature of 50°C for enzymolysis for 90 minutes, perform ultrasonic extraction for 30 minutes, filter, freeze-dry, and obtain a Chinese medicine extract A with the effect of clearing stomach fire.

[0091] Chinese herbal extract B with the effect of clearing stomach fire:

[0092] Take 5 parts of Viola yedoensis and 10 parts of Taraxacum officinale, add 10 times the amount of water, reflux and extract twice, each time for 1 hour, combine the decoctions, filter, and concentrate to an extract with a relative density of 1.05-1.10, add ethanol to the alcohol content reaching 70%, stir for 30 minutes, then let it stand for 12 hours, filter the supernatant, and freeze-dry to obtain a Chinese medicine extract B with the effect of clearing stomach fire.

[0093] Chinese herbal extract C with the effect of clearing stomach fire:

[0094] Take 5 parts of Radix Isatidis, grind them into fine powder, add 10 times the amount of 60% ethanol, reflux and extract twice, the first time for 2 hours, the second time for 1 hour, combine the alcohol extracts, recover the ethanol, concentrate the filtrate to 0.1 parts of Radix Isatidis medicinal materials / ml of the concentrate, apply it to a D101 macroporous resin column, first rinse with distilled water for 2 times the column volume, then add 40% ammonia solution to adjust the pH to 10.0 of alkaline ethanol solution, the ethanol solution concentration is 60%, elute for 6 times the column volume, collect the eluate of the alkaline ethanol solution, recover the ethanol, freeze-dry, and obtain the Chinese medicine extract C with the effect of clearing stomach fire.

[0095] Chinese herbal extract D with the effect of clearing stomach fire:

[0096] Take 15 parts of Viola yedoensis, 15 parts of Taraxacum officinale, and 15 parts of Lobelia chinensis, add 20 times the amount of water, soak for 1 hour, extract volatile oil for 8 hours using a water vapor volatile oil extraction device, collect the volatile oil, dissolve it with an equal amount of ethanol, add 4 times the amount of β-cyclodextrin to water in a ratio of 1:8, mix well, pass through a 5-20um colloid mill for 3 times, filter, and dry below 40°C for 6 hours to obtain a traditional Chinese medicine extract D with the effect of clearing stomach fire.

[0097]

[0098] Mix evenly according to the above proportions, add appropriate amount of lactose, and make 1000 tablets.

[0099] Embodiment 3:

[0100] Chinese herbal extract A with the effect of clearing stomach fire:

[0101] Take 10 parts of Viola yedoensis and 10 parts of Lobelia chinensis, grind them into fine powder, add 20 times of water, adjust the pH to 4.5 with citric acid, add 0.1 parts of cellulase, maintain constant temperature of 50°C for enzymolysis for 90 minutes, perform ultrasonic extraction for 30 minutes, filter, freeze-dry, and obtain a Chinese medicine extract A with the effect of clearing stomach fire.

[0102] Chinese herbal extract B with the effect of clearing stomach fire:

[0103] Take 5 parts of Viola yedoensis and 10 parts of Taraxacum officinale, add 10 times the amount of water, reflux and extract twice, each time for 1 hour, combine the decoctions, filter, and concentrate to an extract with a relative density of 1.05-1.10, add ethanol to the alcohol content reaching 70%, stir for 30 minutes, then let it stand for 12 hours, filter the supernatant, and freeze-dry to obtain a Chinese medicine extract B with the effect of clearing stomach fire.

[0104] Chinese herbal extract C with the effect of clearing stomach fire:

[0105] Take 5 parts of Radix Isatidis, grind them into fine powder, add 10 times the amount of 60% ethanol, reflux and extract twice, the first time for 2 hours, the second time for 1 hour, combine the alcohol extracts, recover the ethanol, concentrate the filtrate to 0.1 parts of Radix Isatidis medicinal materials / ml of the concentrate, apply it to a D101 macroporous resin column, first rinse with distilled water for 2 times the column volume, then add 40% ammonia solution to adjust the pH to 10.0 of alkaline ethanol solution, the ethanol solution concentration is 60%, elute for 6 times the column volume, collect the eluate of the alkaline ethanol solution, recover the ethanol, freeze-dry, and obtain a Chinese medicine extract C with the effect of clearing stomach fire.

[0106] Chinese herbal extract D with the effect of clearing stomach fire:

[0107] Take 15 parts of Viola yedoensis, 15 parts of Taraxacum officinale, and 15 parts of Lobelia chinensis, add 20 times the amount of water, soak for 1 hour, extract volatile oil for 8 hours using a water vapor volatile oil extraction device, collect the volatile oil, dissolve it with an equal amount of ethanol, add 4 times the amount of β-cyclodextrin to water in a ratio of 1:8, mix well, pass through a 5-20um colloid mill for 3 times, filter, and dry below 40°C for 6 hours to obtain a traditional Chinese medicine extract D with the effect of clearing stomach fire.

[0108]

[0109] Mix evenly according to the above proportions, add appropriate amount of lactose, and make 1000 tablets.

[0110] Embodiment 4:

[0111] Chinese herbal extract A with the effect of clearing stomach fire:

[0112] Take 10 parts of Viola yedoensis and 10 parts of Lobelia chinensis, grind them into fine powder, add 20 times of water, adjust the pH to 4.5 with citric acid, add 0.1 parts of cellulase, maintain constant temperature of 50°C for enzymolysis for 90 minutes, perform ultrasonic extraction for 30 minutes, filter, freeze-dry, and obtain a Chinese medicine extract A with the effect of clearing stomach fire.

[0113] Chinese herbal extract B with the effect of clearing stomach fire:

[0114] Take 5 parts of Viola yedoensis and 10 parts of Taraxacum officinale, add 10 times the amount of water, reflux and extract twice, each time for 1 hour, combine the decoctions, filter, and concentrate to an extract with a relative density of 1.05-1.10, add ethanol to the alcohol content reaching 70%, stir for 30 minutes, then let it stand for 12 hours, filter the supernatant, and freeze-dry to obtain a Chinese medicine extract B with the effect of clearing stomach fire.

[0115] Chinese herbal extract C with the effect of clearing stomach fire:

[0116] Take 5 parts of Radix Isatidis, grind them into fine powder, add 10 times the amount of 60% ethanol, reflux and extract twice, the first time for 2 hours, the second time for 1 hour, combine the alcohol extracts, recover the ethanol, concentrate the filtrate to 0.1 parts of Radix Isatidis medicinal materials / ml of the concentrate, apply it to a D101 macroporous resin column, first rinse with distilled water for 2 times the column volume, then add 40% ammonia solution to adjust the pH to 10.0 of alkaline ethanol solution, the ethanol solution concentration is 60%, elute for 6 times the column volume, collect the eluate of the alkaline ethanol solution, recover the ethanol, freeze-dry, and obtain a Chinese medicine extract C with the effect of clearing stomach fire.

[0117] Chinese herbal extract D with the effect of clearing stomach fire:

[0118] Take 15 parts of Viola yedoensis, 15 parts of Taraxacum officinale, and 15 parts of Lobelia chinensis, add 20 times the amount of water, soak for 1 hour, extract volatile oil for 8 hours using a water vapor volatile oil extraction device, collect the volatile oil, dissolve it with an equal amount of ethanol, add 4 times the amount of β-cyclodextrin to water in a ratio of 1:8, mix well, pass through a 5-20um colloid mill for 3 times, filter, and dry below 40°C for 6 hours to obtain a traditional Chinese medicine extract D with the effect of clearing stomach fire.

[0119]

[0120] Mix evenly according to the above proportions, add appropriate amount of lactose, and make 1000 tablets.

[0121] Embodiment 5:

[0122] Chinese herbal extract A with the effect of clearing stomach fire:

[0123] Take 10 parts of Viola yedoensis and 10 parts of Lobelia chinensis, grind them into fine powder, add 20 times of water, adjust the pH to 4.5 with citric acid, add 0.1 parts of cellulase, maintain constant temperature of 50°C for enzymolysis for 90 minutes, perform ultrasonic extraction for 30 minutes, filter, freeze-dry, and obtain a Chinese medicine extract A with the effect of clearing stomach fire.

[0124] Chinese herbal extract B with the effect of clearing stomach fire:

[0125] Take 5 parts of Viola yedoensis and 10 parts of Taraxacum officinale, add 10 times the amount of water, reflux and extract twice, each time for 1 hour, combine the decoctions, filter, and concentrate to an extract with a relative density of 1.05-1.10, add ethanol to the alcohol content reaching 70%, stir for 30 minutes, then let it stand for 12 hours, filter the supernatant, and freeze-dry to obtain a Chinese medicine extract B with the effect of clearing stomach fire.

[0126] Chinese herbal extract C with the effect of clearing stomach fire:

[0127] Take 5 parts of Radix Isatidis, grind them into fine powder, add 10 times the amount of 60% ethanol, reflux and extract twice, the first time for 2 hours, the second time for 1 hour, combine the alcohol extracts, recover the ethanol, concentrate the filtrate to 0.1 parts of Radix Isatidis medicinal materials / ml of the concentrate, apply it to a D101 macroporous resin column, first rinse with distilled water for 2 times the column volume, then add 40% ammonia solution to adjust the pH to 10.0 of alkaline ethanol solution, the ethanol solution concentration is 60%, elute for 6 times the column volume, collect the eluate of the alkaline ethanol solution, recover the ethanol, freeze-dry, and obtain a Chinese medicine extract C with the effect of clearing stomach fire.

[0128] Chinese herbal extract D with the effect of clearing stomach fire:

[0129] Take 15 parts of Viola yedoensis, 15 parts of Taraxacum officinale, and 15 parts of Lobelia chinensis, add 20 times the amount of water, soak for 1 hour, extract volatile oil for 8 hours using a water vapor volatile oil extraction device, collect the volatile oil, dissolve it with an equal amount of ethanol, add 4 times the amount of β-cyclodextrin to water in a ratio of 1:8, mix well, pass through a 5-20um colloid mill for 3 times, filter, and dry below 40°C for 6 hours to obtain a traditional Chinese medicine extract D with the effect of clearing stomach fire.

[0130]

[0131] Mix evenly according to the above proportions, add appropriate amount of lactose, and make 1000 tablets.

[0132] Embodiment 6:

[0133] Chinese herbal extract A with the effect of clearing stomach fire:

[0134] Take 10 parts of Viola yedoensis and 10 parts of Lobelia chinensis, grind them into fine powder, add 20 times of water, adjust the pH to 4.5 with citric acid, add 0.1 parts of cellulase, maintain constant temperature of 50°C for enzymolysis for 90 minutes, perform ultrasonic extraction for 30 minutes, filter, freeze-dry, and obtain a Chinese medicine extract A with the effect of clearing stomach fire.

[0135] Chinese herbal extract B with the effect of clearing stomach fire:

[0136] Take 5 parts of Viola yedoensis and 10 parts of Taraxacum officinale, add 10 times the amount of water, reflux and extract twice, each time for 1 hour, combine the decoctions, filter, and concentrate to an extract with a relative density of 1.05-1.10, add ethanol to the alcohol content reaching 70%, stir for 30 minutes, then let it stand for 12 hours, filter the supernatant, and freeze-dry to obtain a Chinese medicine extract B with the effect of clearing stomach fire.

[0137] Chinese herbal extract C with the effect of clearing stomach fire:

[0138] Take 5 parts of Radix Isatidis, grind them into fine powder, add 10 times the amount of 60% ethanol, reflux and extract twice, the first time for 2 hours, the second time for 1 hour, combine the alcohol extracts, recover the ethanol, concentrate the filtrate to 0.1 parts of Radix Isatidis medicinal materials / ml of the concentrate, apply it to a D101 macroporous resin column, first rinse with distilled water for 2 times the column volume, then add 40% ammonia solution to adjust the pH to 10.0 of alkaline ethanol solution, the ethanol solution concentration is 60%, elute for 6 times the column volume, collect the eluate of the alkaline ethanol solution, recover the ethanol, freeze-dry, and obtain a Chinese medicine extract C with the effect of clearing stomach fire.

[0139] Chinese herbal extract D with the effect of clearing stomach fire:

[0140] Take 15 parts of Viola yedoensis, 15 parts of Taraxacum officinale, and 15 parts of Lobelia chinensis, add 20 times the amount of water, soak for 1 hour, extract volatile oil for 8 hours using a water vapor volatile oil extraction device, collect the volatile oil, dissolve it with an equal amount of ethanol, add 4 times the amount of β-cyclodextrin to water in a ratio of 1:8, mix well, pass through a 5-20um colloid mill for 3 times, filter, and dry below 40°C for 6 hours to obtain a traditional Chinese medicine extract D with the effect of clearing stomach fire.

[0141]

[0142] Mix evenly according to the above proportions, add appropriate amount of lactose, and make 1000 tablets.

[0143] Embodiment 7:

[0144] Chinese herbal extract A with the effect of clearing stomach fire:

[0145] Take 10 parts of Viola yedoensis and 10 parts of Lobelia chinensis, grind them into fine powder, add 20 times of water, adjust the pH to 4.5 with citric acid, add 0.1 parts of cellulase, maintain constant temperature of 50°C for enzymolysis for 90 minutes, perform ultrasonic extraction for 30 minutes, filter, freeze-dry, and obtain a Chinese medicine extract A with the effect of clearing stomach fire.

[0146] Chinese herbal extract B with the effect of clearing stomach fire:

[0147] Take 5 parts of Viola yedoensis and 10 parts of Taraxacum officinale, add 10 times the amount of water, reflux and extract twice, each time for 1 hour, combine the decoctions, filter, and concentrate to an extract with a relative density of 1.05-1.10, add ethanol to the alcohol content reaching 70%, stir for 30 minutes, then let it stand for 12 hours, filter the supernatant, and freeze-dry to obtain a Chinese medicine extract B with the effect of clearing stomach fire.

[0148] Chinese herbal extract C with the effect of clearing stomach fire:

[0149] Take 5 parts of Radix Isatidis, grind them into fine powder, add 10 times the amount of 60% ethanol, reflux and extract twice, the first time for 2 hours, the second time for 1 hour, combine the alcohol extracts, recover the ethanol, concentrate the filtrate to 0.1 parts of Radix Isatidis medicinal materials / ml of the concentrate, apply it to a D101 macroporous resin column, first rinse with distilled water for 2 times the column volume, then add 40% ammonia solution to adjust the pH to 10.0 of alkaline ethanol solution, the ethanol solution concentration is 60%, elute for 6 times the column volume, collect the eluate of the alkaline ethanol solution, recover the ethanol, freeze-dry, and obtain a Chinese medicine extract C with the effect of clearing stomach fire.

[0150] Chinese herbal extract D with the effect of clearing stomach fire:

[0151] Take 15 parts of Viola yedoensis, 15 parts of Taraxacum officinale, and 15 parts of Lobelia chinensis, add 20 times the amount of water, soak for 1 hour, extract volatile oil for 8 hours using a water vapor volatile oil extraction device, collect the volatile oil, dissolve it with an equal amount of ethanol, add 4 times the amount of β-cyclodextrin to water in a ratio of 1:8, mix well, pass through a 5-20um colloid mill for 3 times, filter, and dry below 40°C for 6 hours to obtain a traditional Chinese medicine extract D with the effect of clearing stomach fire.

[0152]

[0153] Mix evenly according to the above proportions, add appropriate amount of lactose, and make 1000 tablets.

[0154] Embodiment 8:

[0155] Chinese herbal extract A with the effect of clearing stomach fire:

[0156] Take 10 parts of Viola yedoensis and 10 parts of Lobelia chinensis, grind them into fine powder, add 20 times of water, adjust the pH to 4.5 with citric acid, add 0.1 parts of cellulase, maintain constant temperature of 50°C for enzymolysis for 90 minutes, perform ultrasonic extraction for 30 minutes, filter, freeze-dry, and obtain a Chinese medicine extract A with the effect of clearing stomach fire.

[0157] Chinese herbal extract B with the effect of clearing stomach fire:

[0158] Take 5 parts of Viola yedoensis and 10 parts of Taraxacum officinale, add 10 times the amount of water, reflux and extract twice, each time for 1 hour, combine the decoctions, filter, and concentrate to an extract with a relative density of 1.05-1.10, add ethanol to the alcohol content reaching 70%, stir for 30 minutes, then let it stand for 12 hours, filter the supernatant, and freeze-dry to obtain a Chinese medicine extract B with the effect of clearing stomach fire.

[0159] Chinese herbal extract C with the effect of clearing stomach fire:

[0160] Take 5 parts of Radix Isatidis, grind them into fine powder, add 10 times the amount of 60% ethanol, reflux and extract twice, the first time for 2 hours, the second time for 1 hour, combine the alcohol extracts, recover the ethanol, concentrate the filtrate to 0.1 parts of Radix Isatidis medicinal materials / ml of the concentrate, apply it to a D101 macroporous resin column, first rinse with distilled water for 2 times the column volume, then add 40% ammonia solution to adjust the pH to 10.0 of alkaline ethanol solution, the ethanol solution concentration is 60%, elute for 6 times the column volume, collect the eluate of the alkaline ethanol solution, recover the ethanol, freeze-dry, and obtain a Chinese medicine extract C with the effect of clearing stomach fire.

[0161] Chinese herbal extract D with the effect of clearing stomach fire:

[0162] Take 15 parts of Viola yedoensis, 15 parts of Taraxacum officinale, and 15 parts of Lobelia chinensis, add 20 times the amount of water, soak for 1 hour, extract volatile oil for 8 hours using a water vapor volatile oil extraction device, collect the volatile oil, dissolve it with an equal amount of ethanol, add 4 times the amount of β-cyclodextrin to water in a ratio of 1:8, mix well, pass through a 5-20um colloid mill for 3 times, filter, and dry below 40°C for 6 hours to obtain a traditional Chinese medicine extract D with the effect of clearing stomach fire.

[0163]

[0164] Mix evenly according to the above proportions, add appropriate amount of lactose, and make 1000 tablets.

[0165] Embodiment 9:

[0166] Chinese herbal extract A with the effect of clearing stomach fire:

[0167] Take 10 parts of Viola yedoensis and 10 parts of Lobelia chinensis, grind them into fine powder, add 20 times of water, adjust the pH to 4.5 with citric acid, add 0.1 parts of cellulase, maintain constant temperature of 50°C for enzymolysis for 90 minutes, perform ultrasonic extraction for 30 minutes, filter, freeze-dry, and obtain a Chinese medicine extract A with the effect of clearing stomach fire.

[0168] Chinese herbal extract B with the effect of clearing stomach fire:

[0169] Take 5 parts of Viola yedoensis and 10 parts of Taraxacum officinale, add 10 times the amount of water, reflux and extract twice, each time for 1 hour, combine the decoctions, filter, and concentrate to an extract with a relative density of 1.05-1.10, add ethanol to the alcohol content reaching 70%, stir for 30 minutes, then let it stand for 12 hours, filter the supernatant, and freeze-dry to obtain a Chinese medicine extract B with the effect of clearing stomach fire.

[0170] Chinese herbal extract C with the effect of clearing stomach fire:

[0171] Take 5 parts of Radix Isatidis, grind them into fine powder, add 10 times the amount of 60% ethanol, reflux and extract twice, the first time for 2 hours, the second time for 1 hour, combine the alcohol extracts, recover the ethanol, concentrate the filtrate to 0.1 parts of Radix Isatidis medicinal materials / ml of the concentrate, apply it to a D101 macroporous resin column, first rinse with distilled water for 2 times the column volume, then add 40% ammonia solution to adjust the pH to 10.0 of alkaline ethanol solution, the ethanol solution concentration is 60%, elute for 6 times the column volume, collect the eluate of the alkaline ethanol solution, recover the ethanol, freeze-dry, and obtain a Chinese medicine extract C with the effect of clearing stomach fire.

[0172] Chinese herbal extract D with the effect of clearing stomach fire:

[0173] Take 15 parts of Viola yedoensis, 15 parts of Taraxacum officinale, and 15 parts of Lobelia chinensis, add 20 times the amount of water, soak for 1 hour, extract volatile oil for 8 hours using a water vapor volatile oil extraction device, collect the volatile oil, dissolve it with an equal amount of ethanol, add 4 times the amount of β-cyclodextrin to water in a ratio of 1:8, mix well, pass through a 5-20um colloid mill for 3 times, filter, and dry below 40°C for 6 hours to obtain a traditional Chinese medicine extract D with the effect of clearing stomach fire.

[0174]

[0175] Mix evenly according to the above proportions, add appropriate amount of lactose, and make 1000 tablets.

[0176] Comparative experimental study on the pharmacodynamics of nine groups of extracts

[0177] In traditional Chinese medicine theory, stomach fire inflammation means: "The stomach is a yang organ, which is easy to generate heat and turn into fire. Fire is the extreme of heat, and fire evil is a disease, and its nature is inflammation." The physiological function of the stomach is not only to receive food and water, but also to digest and rot food and water. If the heat in the stomach exceeds the normal limit, it will turn into fire, which will cause stomach fire inflammation, which can easily lead to various diseases in the human body. Stomach heat is mostly caused by inflammation, which will then evolve into chronic superficial gastritis, chronic atrophic gastritis, etc. Inflammation will lead to increased gastric acid secretion, which will cause stomach discomfort and pain. At the same time, the inflammatory response causes the activation of immune cells including macrophages, T lymphocytes and B lymphocytes, leading to the release of proinflammatory cytokines IL-6, TNF-α, etc. Chronic inflammatory stimulation can cause stomach heat, stomach pain, and gastritis. Therefore, the physiological activity of the extract in clearing stomach fire was verified by the following experiments:

[0178] 1. Antipyretic effect

[0179] SD rats were selected, half male and half female, with a body weight of 180-220g. The body temperature was predicted 3 times before the experiment, and rats with abnormal body temperature were eliminated. They were randomly divided into blank group, model group, Chinese medicine positive group (dibutyl granules, dose of 10g / kg), Western medicine positive group (aspirin, dose of 0.24g / kg), medication group 1, medication group 2, medication group 3, medication group 4, medication group 5, medication group 6, medication group 7, medication group 8, and medication group 9, with 10 rats in each group. The dosage was 10g / kg. The animals were fasted but not watered for 6h before the experiment to empty their stools. The body temperature was measured twice before modeling, with an interval of 10min, and the average value was taken as the basal body temperature. Each rat was subcutaneously injected with 0.15% 2,4-dinitrophenol 1mL / 100g on the back to replicate the rat fever model. The blank group was injected with an equal amount of normal saline. Then, rats in each group were gavaged with 10mL / kg of the drug, and the rectal temperature of the rats was measured 0.5, 1, 1.5, 2, 2.5, and 3h after administration.

[0180] 2. Analgesic effect

[0181] ICR mice, half male and half female, with a body weight of 18-22g, were randomly divided into a blank group, a Chinese medicine positive group (diding granules, dose of 20g / kg), a Western medicine positive group (aspirin, dose of 0.48g / kg), a drug group 1, a drug group 2, a drug group 3, a drug group 4, a drug group 5, a drug group 6, a drug group 7, a drug group 8, and a drug group 9, with 10 mice in each group. The drug was administered once a day by gavage, with a dose of 20g / kg, for 7 consecutive days. One hour after the last drug administration, 0.6% glacial acetic acid 0.1mL / 10g was injected intraperitoneally, and the number of writhing of the mice within 15min after administration was recorded, and the writhing inhibition rate was calculated: writhing inhibition rate = (number of writhing in the blank group - number of writhing in the drug administration group) / number of writhing in the blank group × 100%.

[0182] 3. Anti-inflammatory Effect

[0183] ICR mice, half male and half female, with a body weight of 18-22g, were randomly divided into a blank group, a Chinese medicine positive group (dibutyl granules, a dose of 20g / kg), a Western medicine positive group (aspirin, a dose of 0.48g / kg), a drug group 1, a drug group 2, a drug group 3, a drug group 4, a drug group 5, a drug group 6, a drug group 7, a drug group 8, and a drug group 9, with 10 mice in each group. The mice were given an oral gavage once a day at a dose of 20g / kg for 7 consecutive days. One hour after the last administration, 50uL of xylene was applied to both sides of the left ear of the mouse to cause inflammation, and physiological saline was applied to the same position on the right side. After 15 minutes, blood was collected from the eyeballs, and the mice were killed by dislocation of the neck. A disc was punched from the same part of the left and right ears with an 8mm puncher, and the mass was weighed. The swelling degree and swelling inhibition rate were calculated according to the following formula. Swelling degree = mass of the left ear disc - mass of the right ear disc. Ear swelling inhibition rate = (blank group ear swelling - drug group ear swelling) / blank group ear swelling × 100%. The collected blood samples were immediately centrifuged at 3000 rpm / min for 15 min at 4°C, and the supernatant was taken and stored in a -20°C refrigerator. The ELISA method was used to detect the TNF-α and IL-6 levels in the serum.

[0184] Statistical Analysis

[0185] Excel statistical analysis method was used for data analysis. The sample means among multiple groups were compared by one-way analysis of variance. P<0.05, P<0.01, P<0.001 were considered statistically significant.

[0186] 5. Results

[0187] 1. Antipyretic effect results

[0188] Compared with the blank group, the body temperature of the rats in the model group continued to increase significantly at 0.5, 1, 1.5, 2, 2.5, and 3 h (P<0.001); compared with the model group, the body temperature of the rats in the Chinese medicine positive group decreased at 1.5, 2, 2.5, and 3 h (P<0.05), the body temperature of the rats in the western medicine positive group decreased significantly at 1.5, 2, 2.5, and 3 h (P<0.01), the body temperature of the rats in medication group 1 decreased at 3 h (P<0.05), the body temperature of the rats in medication group 2 decreased at 2 h (P<0.05), the body temperature of the rats in medication group 3 decreased at 1.5 and 2.5 h (P<0.05), the body temperature of the rats in medication group 4 decreased at 3 h (P<0.05), and the body temperature of the rats in medication group 6 decreased significantly at 1.5, 2, 2.5, and 3 h (P<0.01). Among the 9 groups, the results of 6 groups were similar to those of the positive Western medicine group and better than those of the positive Chinese medicine group, see Table 1.

[0189] Table 1 Changes in body temperature of rats in each group ( n=10)

[0190]

[0191] Note: Compared with the blank group, ###P<0.001; compared with the model group, *P<0.05, **P<0.01.

[0192] 2. Results of analgesic effect

[0193] Compared with the blank group, the number of body twisting of rats in the Chinese medicine positive group, drug administration group 3, and drug administration group 4 was significantly reduced (P<0.05), and the number of body twisting of rats in the western medicine positive group and drug administration group 6 was significantly reduced (P<0.01). From the results of the body twisting inhibition rate, it can be seen that among the 9 drug administration groups, drug administration group 6 was similar to the western medicine positive group and better than the Chinese medicine positive group, see Table 2.

[0194] Table 2 Number of writhing and writhing inhibition rate of rats in each group ( n=10)

[0195] Group Number of twists Torsion inhibition rate (%) Blank group 45.00±6.30 —— Chinese medicine positive group 37.00±7.68* 17.78 Western medicine positive group 34.80±4.15** 22.67 1 group of medication 40.00±6.71 11.11 Administer 2 groups 39.40±7.35 12.44 3 groups of medication 37.70±8.78* 16.22 4 groups were given 37.20±6.01* 17.33 5 groups of medication 39.40±8.23 12.44 6 groups were given 36.70±4.19** 18.44 7 groups were given 41.10±6.67 8.66 8 groups of medication 39.20±6.97 12.89 9 groups were given 40.60±7.44 9.78

[0196] Note: Compared with the blank group, *P<0.05, **P<0.01.

[0197] 3. Anti-inflammatory effect results

[0198] Compared with the blank group, the ear swelling of rats in the Chinese medicine positive group was reduced (P<0.05), and the ear swelling of rats in the Western medicine positive group and the drug administration group 6 was significantly reduced (P<0.01). From the results of the ear swelling inhibition rate, it can be seen that among the 9 drug administration groups, the drug administration group 6 was second only to the Western medicine positive group and better than the Chinese medicine positive group, as shown in Table 3.

[0199] Table 3 Ear swelling degree and ear swelling inhibition rate of rats in each group ( n=10)

[0200]

[0201]

[0202] Note: Compared with the blank group, *P<0.05, **P<0.01.

[0203] Compared with the blank group, the levels of TNF-α and IL-6 in the serum of the model group rats were significantly increased (P<0.001, P<0.001); compared with the model group, the levels of TNF-α and IL-6 in the Chinese medicine positive group were reduced (P<0.05, P<0.05), the levels of TNF-α and IL-6 in the western medicine positive group were significantly reduced (P<0.001, P<0.01), and the levels of TNF-α and IL-6 in the 6-drug administration group were reduced (P<0.01, P<0.01). Among the 9 groups of drug administration, the 6-drug administration group was second only to the western medicine positive group and better than the Chinese medicine positive group, as shown in Table 4.

[0204] Table 4 TNF-α and IL-6 levels in serum of rats in each group ( n=10)

[0205]

[0206]

[0207] Note: Compared with the blank group, ###P<0.001; compared with the model group, *P<0.05, **P<0.01.

[0208] According to the above data results, the prescription of the Chinese medicine composition 6 of the present invention has obvious antipyretic, anti-inflammatory, stomach pain relief and stomach fire clearing effects. Compared with the positive control group of western medicine, the effect is equivalent, and under the same dosage conditions, it is better than the original process preparation of dibutyl granules (P<0.05), and is better than other dosing groups.

[0209] The above are only preferred embodiments of the present invention. It should be pointed out that, for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition, characterized in that: The invention comprises the following raw materials in parts by weight: The Chinese medicine extract A is prepared by enzymatic hydrolysis of Viola yedoensis and Lobelia chinensis, followed by ultrasonic extraction; The Chinese medicine extract B is prepared by extracting Viola yedoensis and Taraxacum officinale with water and then precipitating with ethanol; The Chinese medicine extract C is obtained by extracting Radix Isatidis with ethanol and purifying it with macroporous resin; The Chinese medicine extract D is a volatile oil obtained by mixed extraction of Viola yedoensis, Taraxacum officinale and Lobelia chinensis.

2. The Chinese medicine composition according to claim 1, characterized in that: The preparation of the Chinese herbal extract A comprises: 10 parts of Viola yedoensis and 10 parts of Lobelia chinensis were mixed with water, and then enzymatically hydrolyzed with cellulase at pH 4.5 and 50°C for 90 minutes, and then ultrasonically extracted for 30 minutes. The filtrate was filtered and dried to obtain the Chinese medicine extract A.

3. The Chinese medicine composition according to claim 1, characterized in that The preparation of the Chinese medicine extract B comprises: 5 parts of Viola yedoensis and 10 parts of Taraxacum officinale were extracted with water, and then the extract was concentrated and anhydrous ethanol was added to the extract until the alcohol content was not less than 70%, and the precipitate was dried to obtain the Chinese medicine extract B.

4. The Chinese medicine composition according to claim 1, characterized in that: The preparation of the Chinese medicine extract C comprises: After extracting Radix Isatidis with ethanol solution, the extract is loaded with D101 macroporous resin, washed with distilled water, eluted with alkaline ethanol solution, and the eluted solution is freeze-dried to obtain Chinese medicine extract C; the pH value of the alkaline ethanol solution is 10.0, and it contains 60% ethanol.

5. The Chinese medicine composition according to claim 1, characterized in that: The preparation of the Chinese medicine extract D comprises: After soaking Viola yedoensis, Taraxacum officinale and Lobelia chinensis in water, the extracts were extracted by steam volatilization to obtain the Chinese medicine extract D.

6. The Chinese medicine composition according to any one of claims 1 to 5, characterized in that: Said The mass ratio of Viola yedoensis and Lobelia chinensis in the Chinese medicine extract A is (8-12):(8-12); The mass ratio of Viola yedoensis and Taraxacum officinale in the Chinese medicine extract B is (4-6):(8-12); The Chinese medicine extract D is composed of Viola yedoensis, Taraxacum officinale and Lobelia chinensis in a mass ratio of (13-17):(13-17):(13-17).

7. Use of the Chinese medicine composition according to any one of claims 1 to 6 in the preparation of a medicine for clearing stomach fire.

8. The use according to claim 7, characterized in that: The stomach fire clearing includes lowering body temperature, relieving stomach pain and / or reducing the level of inflammatory factors.

9. A medicine for clearing stomach fire, characterized in that: The invention comprises pharmaceutically acceptable excipients and the traditional Chinese medicine composition according to any one of claims 1 to 6.

10. The method for preparing the drug according to claim 9, characterized in that: The method comprises mixing a traditional Chinese medicine extract A, a traditional Chinese medicine extract B, a traditional Chinese medicine extract C, a traditional Chinese medicine extract D and pharmaceutically acceptable excipients to prepare the medicine.

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