Traditional Chinese medicine self-microemulsion for relieving stomachache and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine self-microemulsion for relieving stomachache and a preparation method thereof. Honeysuckle flower, green fructus forsythiae and radix astragali seu hedysari are used as main medicinal materials, and the components are extracted to obtain respective extracts in cooperation with a proper extraction process. Furthermore, reasonable extract proportioning is carried out, and a self-microemulsion form is prepared through a self-microemulsion system. Animal experiments prove that the traditional Chinese medicine self-microemulsion with the stomachache relieving function is obtained.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine self-microemulsion for relieving stomach pain and a preparation method thereof. Background Art

[0002] Stomachache, also known as epigastric pain, is a disease characterized by pain in the epigastric region near the heart. The occurrence of stomachache is often related to factors such as cold evil invading the stomach, food damaging the stomach, liver qi invading the stomach, and spleen and stomach weakness. In modern medicine, diseases such as acute and chronic gastritis, peptic ulcer, and gastric spasm often present with symptoms of stomachache. Traditional Chinese medicine has a long history and rich experience in treating stomachache, emphasizing syndrome differentiation and treatment, and selecting appropriate Chinese medicine for treatment according to the specific cause.

[0003] Traditional Chinese medicine has shown multi-level and multi-pathway therapeutic advantages in regulating the gastrointestinal system and relieving stomach pain. It not only promotes normal peristalsis and emptying of the gastrointestinal tract by finely regulating the tension of gastrointestinal smooth muscles, but also can implement personalized treatment strategies based on the constitution and etiology of different patients. In terms of inhibiting gastric acid secretion, some traditional Chinese medicines such as Coptis chinensis and Scutellaria baicalensis contain alkaloid components, which can effectively reduce gastric acid levels and reduce the corrosive effect of gastric acid on the gastric mucosa, providing favorable conditions for the repair of the gastric mucosa.

[0004] At the same time, many Chinese medicines such as white peony root and licorice have significant mucosal protective effects. They can form a protective layer on the surface of the gastric mucosa to resist the invasion of harmful substances, promote the regeneration and repair of gastric mucosal cells, and accelerate the healing of ulcers. This protective effect not only alleviates stomach pain symptoms, but also fundamentally improves the health of the stomach.

[0005] Among traditional Chinese medicine prescriptions, Liangfu Pills are often used to treat stomachache caused by cold evil invading the stomach because of their effects of warming the stomach and dispelling cold, promoting qi and relieving pain; Baohe Pills focus on digesting food, relieving stagnation, harmonizing the stomach and relieving pain, and are effective for stomachache caused by food stagnation; Chaihu Shugan Powder, as mentioned above, is mainly used for stomachache caused by liver qi stagnation, and relieves pain by soothing the liver and relieving depression. These prescriptions all reflect the holistic concept of traditional Chinese medicine and the idea of ​​syndrome differentiation and treatment, and cleverly combine multiple Chinese medicines to exert synergistic effects to achieve the best therapeutic effect.

[0006] In addition, Chinese medicine also emphasizes the principle of treating both the inside and outside, and regulating the body and mind when treating stomach pain. In addition to drug treatment, it also combines various means such as diet adjustment and emotional adjustment to comprehensively improve the patient's physical and mental state, enhance the treatment effect, and reduce the recurrence of the disease. This comprehensive treatment method gives Chinese medicine a unique advantage and broad development prospects in relieving stomach pain.

[0007] However, the preparation technology of existing Chinese medicine preparations is relatively backward, resulting in a large dosage, poor patient compliance, and often not significant enough effect. Therefore, it is of great significance to further develop Chinese medicines for relieving stomach pain, improve drug efficacy, and reduce dosage. Summary of the invention

[0008] In view of this, the technical problem to be solved by the present invention is to provide a Chinese medicine self-microemulsion for relieving stomach pain and a preparation method thereof.

[0009] The Chinese medicine composition for relieving stomach pain provided by the present invention comprises the following raw materials in parts by weight:

[0010] 4-10 parts of honeysuckle volatile oil;

[0011] 3-7 parts of volatile oil of Rhizoma Cibotii;

[0012] 1-3 parts of Astragalus ethanol extract;

[0013] The honeysuckle volatile oil is obtained by continuous reflux extraction of honeysuckle;

[0014] The volatile oil of Rhizoma Cibotii is obtained by extracting Rhizoma Cibotii from Rhizoma Cibotii through supercritical carbon dioxide;

[0015] The astragalus alcohol extract is prepared by extracting astragalus through ethanol aqueous solution.

[0016] The present invention uses honeysuckle, cyperus rotundus, and astragalus as main medicinal materials, and extracts, separates, enriches, and purifies each component in accordance with a suitable extraction process to obtain respective extracts. The extraction processes of each medicinal flavor are screened, and the most suitable extraction method for the medicinal material to relieve stomach pain is selected. For example, the water extracts of honeysuckle, cyperus rotundus, or astragalus cannot relieve stomach pain after mixing. In addition, the present invention optimizes various parameters, improves the extraction efficiency, and increases the proportion of effective ingredients that relieve stomach pain, thereby further ensuring the efficacy of the composition.

[0017] In some embodiments, the preparation of the honeysuckle volatile oil includes: crushing the honeysuckle, soaking it in a sodium chloride aqueous solution with a mass of 15 to 25 times the mass of the honeysuckle for 5 to 8 hours, continuously refluxing to extract the volatile oil for 10 to 15 hours, and cooling to obtain the honeysuckle volatile oil; the mass fraction of sodium chloride in the sodium chloride aqueous solution is 3% to 7%.

[0018] Preferably, the preparation of the honeysuckle volatile oil comprises: crushing the honeysuckle, soaking it in a sodium chloride aqueous solution with a mass of 20 times that of the honeysuckle for 6 hours, continuously refluxing to extract the volatile oil for 12 hours, and cooling to obtain the honeysuckle volatile oil; the mass fraction of sodium chloride in the sodium chloride aqueous solution is 5%.

[0019] In some embodiments, the preparation of the volatile oil of the green osmanthus comprises: crushing the green osmanthus, extracting it by supercritical carbon dioxide extraction, the extraction parameters comprising: extraction temperature of 30-35°C, separation temperature of 30-35°C, extraction pressure of 30-40Mpa, separation pressure of 6.0-6.5Mpa, when the temperature and pressure reach the set values, adjusting the carbon dioxide flow rate to 15-20kg / hour, cyclic extraction for 150-200min, dissolving the product with an equal amount of anhydrous ethanol and recovering the ethanol to obtain the volatile oil of the green osmanthus.

[0020] Preferably, the preparation of the volatile oil of the Rhizoma Cibotii includes: crushing the Rhizoma Cibotii, extracting it by supercritical carbon dioxide extraction, wherein the extraction parameters include: extraction temperature of 30-35°C, separation temperature of 30-35°C, extraction pressure of 30-40Mpa, and separation pressure of 6.0-6.5Mpa, and when the temperature and pressure reach the set values, adjusting the carbon dioxide flow rate to 18kg / hour, circulating the extraction for 180min, dissolving the product with an equal amount of anhydrous ethanol, and recovering the ethanol to obtain the volatile oil of the Rhizoma Cibotii.

[0021] In some embodiments, the preparation of the astragalus alcohol extract includes: crushing the astragalus, extracting it with 50% to 90% ethanol for 1 to 3 times, each time for 1 to 2 hours, filtering the extract, combining the filtrate to recover ethanol, and obtaining the astragalus alcohol extract.

[0022] Preferably, the preparation of the astragalus alcohol extract comprises: crushing the astragalus, extracting it twice with 70% ethanol, each time for 1.5 hours, filtering the extract through 400 mesh, combining the filtrate and recovering ethanol to obtain the astragalus alcohol extract.

[0023] Furthermore, the present invention also explores the ratio of the extract combination, thereby obtaining a Chinese medicine composition with good effect of relieving stomach pain. Preferably, the Chinese medicine composition is composed of 4-7 parts of honeysuckle volatile oil, 3-7 parts of green osmanthus volatile oil and 2-3 parts of astragalus ethanol extract.

[0024] In some embodiments, the traditional Chinese medicine composition consists of 4 parts of honeysuckle volatile oil, 3 parts of cyperus rotundus volatile oil and 1 part of astragalus ethanol extract.

[0025] In other embodiments, the Chinese medicine composition consists of 4 parts of honeysuckle volatile oil, 5 parts of cyperus rotundus volatile oil and 2 parts of astragalus ethanol extract.

[0026] In other embodiments, the Chinese medicine composition consists of 4 parts of honeysuckle volatile oil, 7 parts of cyperus rotundus volatile oil and 3 parts of astragalus ethanol extract.

[0027] In other embodiments, the Chinese medicine composition consists of 7 parts of honeysuckle volatile oil, 3 parts of cyperus rotundus volatile oil and 2 parts of astragalus ethanol extract.

[0028] In other embodiments, the Chinese medicine composition consists of 7 parts of honeysuckle volatile oil, 5 parts of cyperus rotundus volatile oil and 2 parts of astragalus ethanol extract.

[0029] In other embodiments, the Chinese medicine composition consists of 7 parts of honeysuckle volatile oil, 7 parts of cyperus rotundus volatile oil and 1 part of astragalus ethanol extract.

[0030] In other embodiments, the Chinese medicine composition consists of 10 parts of honeysuckle volatile oil, 3 parts of cyperus rotundus volatile oil and 3 parts of astragalus ethanol extract.

[0031] In other embodiments, the Chinese medicine composition consists of 10 parts of honeysuckle volatile oil, 5 parts of cyperus rotundus volatile oil and 1 part of astragalus ethanol extract.

[0032] In other embodiments, the Chinese medicine composition consists of 10 parts of honeysuckle volatile oil, 7 parts of cyperus rotundus volatile oil and 2 parts of astragalus ethanol extract.

[0033] In other embodiments, the Chinese medicine composition consists of 2 parts of honeysuckle volatile oil, 4 parts of cyperus rotundus volatile oil and 3 parts of astragalus ethanol extract.

[0034] In other embodiments, the Chinese medicine composition consists of 4 parts of honeysuckle volatile oil, 8 parts of cyperus rotundus volatile oil and 5 parts of astragalus ethanol extract.

[0035] In other embodiments, the Chinese medicine composition consists of 6 parts of honeysuckle volatile oil, 4 parts of cyperus rotundus volatile oil and 6 parts of astragalus ethanol extract.

[0036] Furthermore, the present invention also provides a self-microemulsion for relieving stomach pain, which comprises the Chinese medicine composition and auxiliary materials; the auxiliary materials include an oil phase, an emulsifier and an auxiliary emulsifier.

[0037] The self-microemulsion provided by the present invention has good stability, is easy to take, and is conducive to enhancing drug absorption. In some embodiments, the self-microemulsion comprises 8-19 parts by weight of the above-mentioned traditional Chinese medicine composition, 5-7 parts of oil phase, 10-20 parts of emulsifier and 1-5 parts of auxiliary emulsifier.

[0038] Preferably, the oil phase is glyceryl monooleate; the emulsifier is oleoyl polyoxyethylene glyceride and RH40 polyoxyethylene hydrogenated castor oil; and the co-emulsifier is diethylene glycol monoethyl ether.

[0039] In a specific embodiment, the self-microemulsion includes 8-19 parts by weight of the traditional Chinese medicine composition as described above, 6 parts by weight of monooleyl glyceryl, 6 parts by weight of oleoyl polyoxyethylene glyceride, 10 parts by weight of RH40 polyoxyethylene hydrogenated castor oil and 3 parts by weight of diethylene glycol monoethyl ether.

[0040] The invention uses modern scientific technology to extract and separate effective ingredients to obtain effective extracts, and uses corresponding ratios and self-microemulsification systems to screen and obtain the optimal ratio for exerting therapeutic effects. Pharmacodynamic studies have shown that the Chinese medicine self-microemulsion of the invention can significantly relieve stomach pain.

[0041] The present invention also provides a method for preparing the self-microemulsion as described above, comprising:

[0042] The traditional Chinese medicine composition, oil phase, emulsifier and co-emulsifier are mixed and then emulsified to obtain the product.

[0043] In the embodiment of the present invention, the emulsification conditions include magnetic stirring in a closed water bath at 20-30° C. for 1 hour, and then shaking in a closed water bath at 20-30° C. for 24 hours.

[0044] 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.

[0045] Furthermore, the present invention also provides the use of the aforementioned traditional Chinese medicine composition or the aforementioned self-microemulsion in the preparation of a medicine for relieving stomach pain.

[0046] In the present invention, the relief of stomach pain includes increasing gastric acid pH, increasing the level of pepsin in serum, increasing the content of gastrin, reducing the level of inflammatory factors, inhibiting the degree of swelling and / or reducing the pain perception.

[0047] In the present invention, the stomach pain that can be relieved by the drug is stomach pain caused by inflammation, for example, stomach pain caused by Helicobacter pylori infection, chronic superficial gastritis, chronic atrophic gastritis, etc.

[0048] Furthermore, the present invention also provides a medicine for relieving stomach pain, which comprises the above-mentioned traditional Chinese medicine composition or the above-mentioned self-microemulsion.

[0049] 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.

[0050] The medicine of the present invention further comprises pharmaceutically acceptable excipients, which 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.

[0051] The medicine of the present invention also includes other medicines for relieving stomach pain. The Chinese medicine composition and other therapeutic agents may exist independently or in combination, and the present invention does not limit this.

[0052] The other drugs for relieving stomach pain include: at least one of omeprazole, lansoprazole, pantoprazole, rabeprazole, esomeprazole, magnesium aluminum carbonate, potassium bismuth citrate, sucralfate, aluminum hydroxide, cimetidine, ranitidine, famotidine, nizatidine, roxatidine, Weikangling, Qizhi Weitong Granules, Morodan, and Weisu Granules.

[0053] Furthermore, the present invention also provides a method for relieving stomach pain, which comprises administering the drug of the present invention. The administration method of the drug includes but is not limited to oral administration.

[0054] In the present invention, when the medicine includes a Chinese medicine composition and other therapeutic agents, two or more medicines can be administered simultaneously or sequentially, and the present invention does not limit this. The administration frequency of two or more medicines can be the same or different, and the present invention does not limit this.

[0055] In the present invention, the subject for relieving stomach pain is a human or a mammal, and the mammal includes bovines, equines, ovines, porcines, canines, felines, rodents, and primates.

[0056] The invention uses honeysuckle, radix scutellariae, and radix astragali as main medicinal materials, and extracts the components by using a suitable extraction process to obtain respective extracts. Further, a reasonable extract ratio is performed, and a self-microemulsion formulation is prepared by a self-microemulsion system. Animal experiments prove that the invention obtains a traditional Chinese medicine self-microemulsion with the function of relieving stomach pain. DETAILED DESCRIPTION

[0057] The present invention provides a Chinese medicine self-microemulsion for relieving stomach pain 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.

[0058] 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.

[0059] 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.

[0060] 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.

[0061] 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.

[0062] 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%.

[0063] 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.

[0064] 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.

[0065] The test materials used in the present invention are all common commercial products and can be purchased on the market. The present invention is further described below in conjunction with the embodiments:

[0066] Embodiment 1:

[0067] Chinese herbal extract A (honeysuckle volatile oil) for relieving stomach pain:

[0068] Take 20 parts of honeysuckle, crush them into fine powder, add 20 times the amount of 5% sodium chloride aqueous solution, soak for 6 hours, connect to a volatile oil extractor, continuously reflux and extract volatile oil for 12 hours, cool, collect the volatile oil in the volatile oil extractor, and obtain a traditional Chinese medicine extract A for relieving stomach pain.

[0069] Chinese herbal extract B (Qingqiao volatile oil) for relieving stomach pain:

[0070] Take 10 portions of Qingqiao, grind them into fine powder, put them into an extraction reactor, adopt carbon dioxide supercritical extraction method, maintain the extraction temperature at 30-35°C, the separation temperature at 30-35°C, the extraction pressure at 30-40Mpa, and the separation pressure at 6.0-6.5Mpa, when the temperature and pressure reach the set values, adjust the carbon dioxide flow rate to 18kg / hour, circulate the extraction for 180min, dissolve them with an equal amount of anhydrous ethanol, recover the ethanol, and obtain a Chinese medicine extract B for relieving stomach pain.

[0071] Chinese herbal extract C (astragalus ethanol extract) for relieving stomach pain:

[0072] Take 2 portions of Astragalus, crush them into fine powder, add 70% ethanol to extract twice, each time for 1.5 hours, combine the extracts, filter through 400 mesh, recover the ethanol, freeze-dry, and obtain the Chinese medicine extract C for relieving stomach pain.

[0073] Mix Chinese herbal extract A, Chinese herbal extract B and Chinese herbal extract C for relieving stomach pain in the following proportions.

[0074] 4 servings of Chinese herbal extract A for stomach pain relief

[0075] 3 servings of Chinese herbal extract B for stomach pain relief

[0076] 1 serving of Chinese herbal extract C for stomach pain relief

[0077] Add 6 parts of monoolein glyceryl and 6 parts of oleoyl polyoxyethylene glyceride, add 10 parts of RH40 polyoxyethylene hydrogenated castor oil, add 3 parts of diethylene glycol monoethyl ether, stir for 30 minutes, place in a closed water bath at 20-30°C with magnetic stirring for 1 hour, and then shake in a closed water bath at 20-30°C for 24 hours to obtain a self-microemulsification system.

[0078] Embodiment 2:

[0079] Chinese herbal extract A (honeysuckle volatile oil) for relieving stomach pain:

[0080] Take 20 parts of honeysuckle, crush them into fine powder, add 20 times the amount of 5% sodium chloride aqueous solution, soak for 6 hours, connect to a volatile oil extractor, continuously reflux and extract volatile oil for 12 hours, cool, collect the volatile oil in the volatile oil extractor, and obtain a traditional Chinese medicine extract A for relieving stomach pain.

[0081] Chinese herbal extract B (Qingqiao volatile oil) for relieving stomach pain:

[0082] Take 10 portions of Qingqiao, grind them into fine powder, put them into an extraction reactor, adopt carbon dioxide supercritical extraction method, maintain the extraction temperature at 30-35°C, the separation temperature at 30-35°C, the extraction pressure at 30-40Mpa, and the separation pressure at 6.0-6.5Mpa, when the temperature and pressure reach the set values, adjust the carbon dioxide flow rate to 18kg / hour, circulate the extraction for 180min, dissolve them with an equal amount of anhydrous ethanol, recover the ethanol, and obtain a Chinese medicine extract B for relieving stomach pain.

[0083] Chinese herbal extract C (astragalus ethanol extract) for relieving stomach pain:

[0084] Take 2 portions of Astragalus, crush them into fine powder, add 70% ethanol to extract twice, each time for 1.5 hours, combine the extracts, filter through 400 mesh, recover the ethanol, freeze-dry, and obtain the Chinese medicine extract C for relieving stomach pain.

[0085] Mix Chinese herbal extract A, Chinese herbal extract B and Chinese herbal extract C for relieving stomach pain in the following proportions.

[0086] 4 servings of Chinese herbal extract A for stomach pain relief

[0087] 5 servings of Chinese herbal extract B for stomach pain relief

[0088] 2 servings of Chinese herbal extract C for stomach pain relief

[0089] Add 6 parts of monoolein glyceryl and 6 parts of oleoyl polyoxyethylene glyceride, add 10 parts of RH40 polyoxyethylene hydrogenated castor oil, add 3 parts of diethylene glycol monoethyl ether, stir for 30 minutes, place in a closed water bath at 20-30°C with magnetic stirring for 1 hour, and then shake in a closed water bath at 20-30°C for 24 hours to obtain a self-microemulsification system.

[0090] Embodiment 3:

[0091] Chinese herbal extract A (honeysuckle volatile oil) for relieving stomach pain:

[0092] Take 20 parts of honeysuckle, crush them into fine powder, add 20 times the amount of 5% sodium chloride aqueous solution, soak for 6 hours, connect to a volatile oil extractor, continuously reflux and extract volatile oil for 12 hours, cool, collect the volatile oil in the volatile oil extractor, and obtain a traditional Chinese medicine extract A for relieving stomach pain.

[0093] Chinese herbal extract B (Qingqiao volatile oil) for relieving stomach pain:

[0094] Take 10 portions of Qingqiao, grind them into fine powder, put them into an extraction reactor, adopt carbon dioxide supercritical extraction method, maintain the extraction temperature at 30-35°C, the separation temperature at 30-35°C, the extraction pressure at 30-40Mpa, and the separation pressure at 6.0-6.5Mpa, when the temperature and pressure reach the set values, adjust the carbon dioxide flow rate to 18kg / hour, circulate the extraction for 180min, dissolve them with an equal amount of anhydrous ethanol, recover the ethanol, and obtain a Chinese medicine extract B for relieving stomach pain.

[0095] Chinese herbal extract C (astragalus ethanol extract) for relieving stomach pain:

[0096] Take 2 portions of Astragalus, crush them into fine powder, add 70% ethanol to extract twice, each time for 1.5 hours, combine the extracts, filter through 400 mesh, recover the ethanol, freeze-dry, and obtain the Chinese medicine extract C for relieving stomach pain.

[0097] Mix Chinese herbal extract A, Chinese herbal extract B and Chinese herbal extract C for relieving stomach pain in the following proportions.

[0098] 4 servings of Chinese herbal extract A for stomach pain relief

[0099] 7 servings of Chinese herbal extract B for stomach pain relief

[0100] 3 servings of Chinese herbal extract C for stomach pain relief

[0101] Add 6 parts of monoolein glyceryl and 6 parts of oleoyl polyoxyethylene glyceride, add 10 parts of RH40 polyoxyethylene hydrogenated castor oil, add 3 parts of diethylene glycol monoethyl ether, stir for 30 minutes, place in a closed water bath at 20-30°C with magnetic stirring for 1 hour, and then shake in a closed water bath at 20-30°C for 24 hours to obtain a self-microemulsification system.

[0102] Embodiment 4:

[0103] Chinese herbal extract A (honeysuckle volatile oil) for relieving stomach pain:

[0104] Take 20 parts of honeysuckle, crush them into fine powder, add 20 times the amount of 5% sodium chloride aqueous solution, soak for 6 hours, connect to a volatile oil extractor, continuously reflux and extract volatile oil for 12 hours, cool, collect the volatile oil in the volatile oil extractor, and obtain a traditional Chinese medicine extract A for relieving stomach pain.

[0105] Chinese herbal extract B (Qingqiao volatile oil) for relieving stomach pain:

[0106] Take 10 portions of Qingqiao, grind them into fine powder, put them into an extraction reactor, adopt carbon dioxide supercritical extraction method, maintain the extraction temperature at 30-35°C, the separation temperature at 30-35°C, the extraction pressure at 30-40Mpa, and the separation pressure at 6.0-6.5Mpa, when the temperature and pressure reach the set values, adjust the carbon dioxide flow rate to 18kg / hour, circulate the extraction for 180min, dissolve them with an equal amount of anhydrous ethanol, recover the ethanol, and obtain a Chinese medicine extract B for relieving stomach pain.

[0107] Chinese herbal extract C (astragalus ethanol extract) for relieving stomach pain:

[0108] Take 2 portions of Astragalus, crush them into fine powder, add 70% ethanol to extract twice, each time for 1.5 hours, combine the extracts, filter through 400 mesh, recover the ethanol, freeze-dry, and obtain the Chinese medicine extract C for relieving stomach pain.

[0109] Mix Chinese herbal extract A, Chinese herbal extract B and Chinese herbal extract C for relieving stomach pain in the following proportions.

[0110] 7 servings of Chinese herbal extract A for stomach pain relief

[0111] 3 servings of Chinese herbal extract B for stomach pain relief

[0112] 2 servings of Chinese herbal extract C for stomach pain relief

[0113] Add 6 parts of monoolein glyceryl and 6 parts of oleoyl polyoxyethylene glyceride, add 10 parts of RH40 polyoxyethylene hydrogenated castor oil, add 3 parts of diethylene glycol monoethyl ether, stir for 30 minutes, place in a closed water bath at 20-30°C with magnetic stirring for 1 hour, and then shake in a closed water bath at 20-30°C for 24 hours to obtain a self-microemulsification system.

[0114] Embodiment 5:

[0115] Chinese herbal extract A (honeysuckle volatile oil) for relieving stomach pain:

[0116] Take 20 parts of honeysuckle, crush them into fine powder, add 20 times the amount of 5% sodium chloride aqueous solution, soak for 6 hours, connect to a volatile oil extractor, continuously reflux and extract volatile oil for 12 hours, cool, collect the volatile oil in the volatile oil extractor, and obtain a traditional Chinese medicine extract A for relieving stomach pain.

[0117] Chinese herbal extract B (Qingqiao volatile oil) for relieving stomach pain:

[0118] Take 10 portions of Qingqiao, grind them into fine powder, put them into an extraction reactor, adopt carbon dioxide supercritical extraction method, maintain the extraction temperature at 30-35°C, the separation temperature at 30-35°C, the extraction pressure at 30-40Mpa, and the separation pressure at 6.0-6.5Mpa, when the temperature and pressure reach the set values, adjust the carbon dioxide flow rate to 18kg / hour, circulate the extraction for 180min, dissolve them with an equal amount of anhydrous ethanol, recover the ethanol, and obtain a Chinese medicine extract B for relieving stomach pain.

[0119] Chinese herbal extract C (astragalus ethanol extract) for relieving stomach pain:

[0120] Take 2 portions of Astragalus, crush them into fine powder, add 70% ethanol to extract twice, each time for 1.5 hours, combine the extracts, filter through 400 mesh, recover the ethanol, freeze-dry, and obtain the Chinese medicine extract C for relieving stomach pain.

[0121] Mix Chinese herbal extract A, Chinese herbal extract B and Chinese herbal extract C for relieving stomach pain in the following proportions.

[0122] 7 servings of Chinese herbal extract A for stomach pain relief

[0123] 5 servings of Chinese herbal extract B for stomach pain relief

[0124] 3 servings of Chinese herbal extract C for stomach pain relief

[0125] Add 6 parts of monoolein glyceryl and 6 parts of oleoyl polyoxyethylene glyceride, add 10 parts of RH40 polyoxyethylene hydrogenated castor oil, add 3 parts of diethylene glycol monoethyl ether, stir for 30 minutes, place in a closed water bath at 20-30°C with magnetic stirring for 1 hour, and then shake in a closed water bath at 20-30°C for 24 hours to obtain a self-microemulsification system.

[0126] Embodiment 6:

[0127] Chinese herbal extract A (honeysuckle volatile oil) for relieving stomach pain:

[0128] Take 20 parts of honeysuckle, crush them into fine powder, add 20 times the amount of 5% sodium chloride aqueous solution, soak for 6 hours, connect to a volatile oil extractor, continuously reflux and extract volatile oil for 12 hours, cool, collect the volatile oil in the volatile oil extractor, and obtain a traditional Chinese medicine extract A for relieving stomach pain.

[0129] Chinese herbal extract B (Qingqiao volatile oil) for relieving stomach pain:

[0130] Take 10 portions of Qingqiao, grind them into fine powder, put them into an extraction reactor, adopt carbon dioxide supercritical extraction method, maintain the extraction temperature at 30-35°C, the separation temperature at 30-35°C, the extraction pressure at 30-40Mpa, and the separation pressure at 6.0-6.5Mpa, when the temperature and pressure reach the set values, adjust the carbon dioxide flow rate to 18kg / hour, circulate the extraction for 180min, dissolve them with an equal amount of anhydrous ethanol, recover the ethanol, and obtain a Chinese medicine extract B for relieving stomach pain.

[0131] Chinese herbal extract C (astragalus ethanol extract) for relieving stomach pain:

[0132] Take 2 portions of Astragalus, crush them into fine powder, add 70% ethanol to extract twice, each time for 1.5 hours, combine the extracts, filter through 400 mesh, recover the ethanol, freeze-dry, and obtain the Chinese medicine extract C for relieving stomach pain.

[0133] Mix Chinese herbal extract A, Chinese herbal extract B and Chinese herbal extract C for relieving stomach pain in the following proportions.

[0134] 7 servings of Chinese herbal extract A for stomachache relief

[0135] 7 servings of Chinese herbal extract B for stomach pain relief

[0136] 1 serving of Chinese herbal extract C for stomach pain relief

[0137] Add 6 parts of monoolein glyceryl and 6 parts of oleoyl polyoxyethylene glyceride, add 10 parts of RH40 polyoxyethylene hydrogenated castor oil, add 3 parts of diethylene glycol monoethyl ether, stir for 30 minutes, place in a closed water bath at 20-30°C with magnetic stirring for 1 hour, and then shake in a closed water bath at 20-30°C for 24 hours to obtain a self-microemulsification system.

[0138] Embodiment 7:

[0139] Chinese herbal extract A (honeysuckle volatile oil) for relieving stomach pain:

[0140] Take 20 parts of honeysuckle, crush them into fine powder, add 20 times the amount of 5% sodium chloride aqueous solution, soak for 6 hours, connect to a volatile oil extractor, continuously reflux and extract volatile oil for 12 hours, cool, collect the volatile oil in the volatile oil extractor, and obtain a traditional Chinese medicine extract A for relieving stomach pain.

[0141] Chinese herbal extract B (Qingqiao volatile oil) for relieving stomach pain:

[0142] Take 10 portions of Qingqiao, grind them into fine powder, put them into an extraction reactor, adopt carbon dioxide supercritical extraction method, maintain the extraction temperature at 30-35°C, the separation temperature at 30-35°C, the extraction pressure at 30-40Mpa, and the separation pressure at 6.0-6.5Mpa, when the temperature and pressure reach the set values, adjust the carbon dioxide flow rate to 18kg / hour, circulate the extraction for 180min, dissolve them with an equal amount of anhydrous ethanol, recover the ethanol, and obtain a Chinese medicine extract B for relieving stomach pain.

[0143] Chinese herbal extract C (astragalus ethanol extract) for relieving stomach pain:

[0144] Take 2 portions of Astragalus, crush them into fine powder, add 70% ethanol to extract twice, each time for 1.5 hours, combine the extracts, filter through 400 mesh, recover the ethanol, freeze-dry, and obtain the Chinese medicine extract C for relieving stomach pain.

[0145] Mix Chinese herbal extract A, Chinese herbal extract B and Chinese herbal extract C for relieving stomach pain in the following proportions.

[0146] Chinese herbal extract A for stomach pain relief 10 servings

[0147] 3 servings of Chinese herbal extract B for stomach pain relief

[0148] 3 servings of Chinese herbal extract C for stomach pain relief

[0149] Add 6 parts of monoolein glyceryl and 6 parts of oleoyl polyoxyethylene glyceride, add 10 parts of RH40 polyoxyethylene hydrogenated castor oil, add 3 parts of diethylene glycol monoethyl ether, stir for 30 minutes, place in a closed water bath at 20-30°C with magnetic stirring for 1 hour, and then shake in a closed water bath at 20-30°C for 24 hours to obtain a self-microemulsification system.

[0150] Embodiment 8:

[0151] Chinese herbal extract A (honeysuckle volatile oil) for relieving stomach pain:

[0152] Take 20 parts of honeysuckle, crush them into fine powder, add 20 times the amount of 5% sodium chloride aqueous solution, soak for 6 hours, connect to a volatile oil extractor, continuously reflux and extract volatile oil for 12 hours, cool, collect the volatile oil in the volatile oil extractor, and obtain a traditional Chinese medicine extract A for relieving stomach pain.

[0153] Chinese herbal extract B (Qingqiao volatile oil) for relieving stomach pain:

[0154] Take 10 portions of Qingqiao, grind them into fine powder, put them into an extraction reactor, adopt carbon dioxide supercritical extraction method, maintain the extraction temperature at 30-35°C, the separation temperature at 30-35°C, the extraction pressure at 30-40Mpa, and the separation pressure at 6.0-6.5Mpa, when the temperature and pressure reach the set values, adjust the carbon dioxide flow rate to 18kg / hour, circulate the extraction for 180min, dissolve them with an equal amount of anhydrous ethanol, recover the ethanol, and obtain a Chinese medicine extract B for relieving stomach pain.

[0155] Chinese herbal extract C (astragalus ethanol extract) for relieving stomach pain:

[0156] Take 2 parts of Astragalus, crush them into fine powder, add 70% ethanol to extract twice, each time for 1.5 hours, combine the extracts, filter through 400 mesh, recover ethanol, freeze-dry, and obtain Chinese medicine extract C for relieving stomach pain. Mix Chinese medicine extract A, Chinese medicine extract B, and Chinese medicine extract C for relieving stomach pain in the following proportions.

[0157] Chinese herbal extract A for stomach pain relief 10 servings

[0158] 5 servings of Chinese herbal extract B for stomach pain relief

[0159] 1 serving of Chinese herbal extract C for stomach pain relief

[0160] Add 6 parts of monoolein glyceryl and 6 parts of oleoyl polyoxyethylene glyceride, add 10 parts of RH40 polyoxyethylene hydrogenated castor oil, add 3 parts of diethylene glycol monoethyl ether, stir for 30 minutes, place in a closed water bath at 20-30°C with magnetic stirring for 1 hour, and then shake in a closed water bath at 20-30°C for 24 hours to obtain a self-microemulsification system.

[0161] Embodiment 9:

[0162] Chinese herbal extract A (honeysuckle volatile oil) for relieving stomach pain:

[0163] Take 20 parts of honeysuckle, crush them into fine powder, add 20 times the amount of 5% sodium chloride aqueous solution, soak for 6 hours, connect to a volatile oil extractor, continuously reflux and extract volatile oil for 12 hours, cool, collect the volatile oil in the volatile oil extractor, and obtain a traditional Chinese medicine extract A for relieving stomach pain.

[0164] Chinese herbal extract B (Qingqiao volatile oil) for relieving stomach pain:

[0165] Take 10 portions of Qingqiao, grind them into fine powder, put them into an extraction reactor, adopt carbon dioxide supercritical extraction method, maintain the extraction temperature at 30-35°C, the separation temperature at 30-35°C, the extraction pressure at 30-40Mpa, and the separation pressure at 6.0-6.5Mpa, when the temperature and pressure reach the set values, adjust the carbon dioxide flow rate to 18kg / hour, circulate the extraction for 180min, dissolve them with an equal amount of anhydrous ethanol, recover the ethanol, and obtain a Chinese medicine extract B for relieving stomach pain.

[0166] Chinese herbal extract C (astragalus ethanol extract) for relieving stomach pain:

[0167] Take 2 parts of Astragalus, crush them into fine powder, add 70% ethanol to extract twice, each time for 1.5 hours, combine the extracts, filter through 400 mesh, recover ethanol, freeze-dry, and obtain Chinese medicine extract C for relieving stomach pain. Mix Chinese medicine extract A, Chinese medicine extract B, and Chinese medicine extract C for relieving stomach pain in the following proportions.

[0168] Chinese herbal extract A for stomach pain relief 10 servings

[0169] 7 servings of Chinese herbal extract B for stomach pain relief

[0170] 2 servings of Chinese herbal extract C for stomach pain relief

[0171] Add 6 parts of monoolein glyceryl and 6 parts of oleoyl polyoxyethylene glyceride, add 10 parts of RH40 polyoxyethylene hydrogenated castor oil, add 3 parts of diethylene glycol monoethyl ether, stir for 30 minutes, place in a closed water bath at 20-30°C with magnetic stirring for 1 hour, and then shake in a closed water bath at 20-30°C for 24 hours to obtain a self-microemulsification system.

[0172] Embodiment 10:

[0173] Chinese herbal extract A (honeysuckle volatile oil) for relieving stomach pain:

[0174] Take 20 parts of honeysuckle, crush them into fine powder, add 20 times the amount of 5% sodium chloride aqueous solution, soak for 6 hours, connect to a volatile oil extractor, continuously reflux and extract volatile oil for 12 hours, cool, collect the volatile oil in the volatile oil extractor, and obtain a traditional Chinese medicine extract A for relieving stomach pain.

[0175] Chinese herbal extract B (Qingqiao volatile oil) for relieving stomach pain:

[0176] Take 10 portions of Qingqiao, grind them into fine powder, put them into an extraction reactor, adopt carbon dioxide supercritical extraction method, maintain the extraction temperature at 30-35°C, the separation temperature at 30-35°C, the extraction pressure at 30-40Mpa, and the separation pressure at 6.0-6.5Mpa, when the temperature and pressure reach the set values, adjust the carbon dioxide flow rate to 18kg / hour, circulate the extraction for 180min, dissolve them with an equal amount of anhydrous ethanol, recover the ethanol, and obtain a Chinese medicine extract B for relieving stomach pain.

[0177] Chinese herbal extract C (astragalus ethanol extract) for relieving stomach pain:

[0178] Take 2 parts of Astragalus, crush them into fine powder, add 70% ethanol to extract twice, each time for 1.5 hours, combine the extracts, filter through 400 mesh, recover ethanol, freeze-dry, and obtain Chinese medicine extract C for relieving stomach pain. Mix Chinese medicine extract A, Chinese medicine extract B, and Chinese medicine extract C for relieving stomach pain in the following proportions.

[0179] 2 servings of Chinese herbal extract A for stomach pain relief

[0180] 4 servings of Chinese herbal extract B for stomach pain relief

[0181] 3 servings of Chinese herbal extract C for stomach pain relief

[0182] Add 6 parts of monoolein glyceryl and 6 parts of oleoyl polyoxyethylene glyceride, add 10 parts of RH40 polyoxyethylene hydrogenated castor oil, add 3 parts of diethylene glycol monoethyl ether, stir for 30 minutes, place in a closed water bath at 20-30°C with magnetic stirring for 1 hour, and then shake in a closed water bath at 20-30°C for 24 hours to obtain a self-microemulsification system.

[0183] Embodiment 11:

[0184] Chinese herbal extract A (honeysuckle volatile oil) for relieving stomach pain:

[0185] Take 20 parts of honeysuckle, crush them into fine powder, add 20 times the amount of 5% sodium chloride aqueous solution, soak for 6 hours, connect to a volatile oil extractor, continuously reflux and extract volatile oil for 12 hours, cool, collect the volatile oil in the volatile oil extractor, and obtain a traditional Chinese medicine extract A for relieving stomach pain.

[0186] Chinese herbal extract B (Qingqiao volatile oil) for relieving stomach pain:

[0187] Take 10 portions of Qingqiao, grind them into fine powder, put them into an extraction reactor, adopt carbon dioxide supercritical extraction method, maintain the extraction temperature at 30-35°C, the separation temperature at 30-35°C, the extraction pressure at 30-40Mpa, and the separation pressure at 6.0-6.5Mpa, when the temperature and pressure reach the set values, adjust the carbon dioxide flow rate to 18kg / hour, circulate the extraction for 180min, dissolve them with an equal amount of anhydrous ethanol, recover the ethanol, and obtain a Chinese medicine extract B for relieving stomach pain.

[0188] Chinese herbal extract C (astragalus ethanol extract) for relieving stomach pain:

[0189] Take 2 portions of Astragalus, crush them into fine powder, add 70% ethanol to extract twice, each time for 1.5 hours, combine the extracts, filter through 400 mesh, recover the ethanol, freeze-dry, and obtain the Chinese medicine extract C for relieving stomach pain.

[0190] Mix Chinese herbal extract A, Chinese herbal extract B and Chinese herbal extract C for relieving stomach pain in the following proportions.

[0191] 4 servings of Chinese herbal extract A for stomach pain relief

[0192] 8 servings of Chinese herbal extract B for stomach pain relief

[0193] 5 servings of Chinese herbal extract C for stomach pain relief

[0194] Add 6 parts of monoolein glyceryl and 6 parts of oleoyl polyoxyethylene glyceride, add 10 parts of RH40 polyoxyethylene hydrogenated castor oil, add 3 parts of diethylene glycol monoethyl ether, stir for 30 minutes, place in a closed water bath at 20-30°C with magnetic stirring for 1 hour, and then shake in a closed water bath at 20-30°C for 24 hours to obtain a self-microemulsification system.

[0195] Embodiment 12:

[0196] Chinese herbal extract A (honeysuckle volatile oil) for relieving stomach pain:

[0197] Take 20 parts of honeysuckle, crush them into fine powder, add 20 times the amount of 5% sodium chloride aqueous solution, soak for 6 hours, connect to a volatile oil extractor, continuously reflux and extract volatile oil for 12 hours, cool, collect the volatile oil in the volatile oil extractor, and obtain a traditional Chinese medicine extract A for relieving stomach pain.

[0198] Chinese herbal extract B (Qingqiao volatile oil) for relieving stomach pain:

[0199] Take 10 portions of Qingqiao, grind them into fine powder, put them into an extraction reactor, adopt carbon dioxide supercritical extraction method, maintain the extraction temperature at 30-35°C, the separation temperature at 30-35°C, the extraction pressure at 30-40Mpa, and the separation pressure at 6.0-6.5Mpa, when the temperature and pressure reach the set values, adjust the carbon dioxide flow rate to 18kg / hour, circulate the extraction for 180min, dissolve them with an equal amount of anhydrous ethanol, recover the ethanol, and obtain a Chinese medicine extract B for relieving stomach pain.

[0200] Chinese herbal extract C (astragalus ethanol extract) for relieving stomach pain:

[0201] Take 2 parts of Astragalus, crush them into fine powder, add 70% ethanol to extract twice, each time for 1.5 hours, combine the extracts, filter through 400 mesh, recover ethanol, freeze-dry, and obtain Chinese medicine extract C for relieving stomach pain. Mix Chinese medicine extract A, Chinese medicine extract B, and Chinese medicine extract C for relieving stomach pain in the following proportions.

[0202] 6 servings of Chinese herbal extract A for stomach pain relief

[0203] 4 servings of Chinese herbal extract B for stomach pain relief

[0204] 6 servings of Chinese herbal extract C for stomach pain relief

[0205] Add 6 parts of monoolein glyceryl and 6 parts of oleoyl polyoxyethylene glyceride, add 10 parts of RH40 polyoxyethylene hydrogenated castor oil, add 3 parts of diethylene glycol monoethyl ether, stir for 30 minutes, place in a closed water bath at 20-30°C with magnetic stirring for 1 hour, and then shake in a closed water bath at 20-30°C for 24 hours to obtain a self-microemulsification system.

[0206] Drug efficacy experiment

[0207] 1. Experimental Methods

[0208] 1. Comparative experimental study on the pharmacodynamics of twelve groups of extracts

[0209] Common inflammations that cause stomach pain are Helicobacter pylori infection, chronic superficial gastritis, chronic atrophic gastritis, etc. These inflammations may cause gastric mucosal damage and pain, which are closely related to the inflammatory response of the gastric mucosa. At the same time, inflammation can lead to increased gastric acid secretion, which in turn causes stomach discomfort and pain. Helicobacter pylori infection can cause the activation of immune cells including macrophages, T cells and B cells, leading to the release of proinflammatory cytokines such as IL-6 and TNF-α. Stomach pain is mostly caused by inflammation, which can lead to a decrease in pepsin and gastrin, which in turn causes stomach discomfort and pain. The core indicators of gastric function testing are pepsin and gastrin, which can clearly reflect whether the gastric function is normal.

[0210] 2. Relieve stomach pain

[0211] ICR mice, half male and half female, with a body weight of 18-22g, were randomly divided into a blank group, a compound honeysuckle granule original process preparation group (compound honeysuckle granule, dose of 4.68g crude drug / kg), a western medicine positive group (aspirin, dose of 0.48g / kg), a Chinese medicine composition group I, a Chinese medicine composition group II, a Chinese medicine composition group III, a Chinese medicine composition group IV, a Chinese medicine composition group V, a Chinese medicine composition group VI, a Chinese medicine composition group VII, a Chinese medicine composition group VIII, a Chinese medicine composition group IX, a Chinese medicine composition group X, a Chinese medicine composition group XI, and a Chinese medicine composition group XII, with 10 mice in each group. The mice were given oral administration once a day at a dose of 4.68g crude drug / kg for 7 consecutive days. One hour after the last dose, 0.6% glacial acetic acid (0.1 mL / 10 g) was injected intraperitoneally. The number of writhing times of the mice within 15 minutes after administration was recorded, and the writhing inhibition rate was calculated: writhing inhibition rate = (number of writhing times in the blank group - number of writhing times in the administration group) / number of writhing times in the blank group × 100%.

[0212] 3. Anti-inflammatory effect

[0213] ICR mice, half male and half female, with a body weight of 18-22g, were randomly divided into blank group, model group, original process preparation group of compound honeysuckle granules (compound honeysuckle granules, dose of 4.68g / kg), western medicine positive group (aspirin, dose of 0.48g / kg), Chinese medicine composition group I, Chinese medicine composition group II, Chinese medicine composition group III, Chinese medicine composition group IV, Chinese medicine composition group V, Chinese medicine composition group VI, Chinese medicine composition group VII, Chinese medicine composition group VIII, Chinese medicine composition group IX, Chinese medicine composition group X, Chinese medicine composition group XI, Chinese medicine composition group XII, Chinese medicine composition group, Chinese medicine composition group XII, 10 mice in each group. The mice were given oral administration once a day, with a dose of 4.68g crude drug / kg, for 7 consecutive days. One hour after the last administration, except for the blank group, 20μL of xylene was evenly applied on the front and back sides of the left ear of the mice in the other groups to establish the ear swelling model, and physiological saline was applied to the same position on the right side. After 15 minutes, blood was collected from the eyeballs, and the animals were killed by dislocation of the neck. The same discs of the left and right ears were punched with an 8mm puncher, and the mass was weighed. The swelling degree and swelling inhibition rate were calculated as follows. Swelling degree = left ear slice mass - right ear slice mass. Ear swelling inhibition rate = (left ear slice mass - right ear slice mass) / right ear slice mass × 100%. The collected blood samples were immediately centrifuged at 3000 rpm / min at 4°C for 15 minutes, and the supernatant was taken and stored in a -20°C refrigerator. The ELISA method was used to detect the levels of TNF-α and IL-6 in serum.

[0214] 4. Detection of gastric acid pH in mice

[0215] ICR mice, half male and half female, with a body weight of 18-22g, were randomly divided into a blank group, a model group, a compound honeysuckle granule original process preparation group (compound honeysuckle granule, dose of 4.68g crude drug / kg), a western medicine positive group (omeprazole, dose of 0.48g / kg), a Chinese medicine composition group I, a Chinese medicine composition group II, a Chinese medicine composition group III, a Chinese medicine composition group IV, a Chinese medicine composition group V, a Chinese medicine composition group VI, a Chinese medicine composition group VII, a Chinese medicine composition group VIII, a Chinese medicine composition group IX, a Chinese medicine composition group X, a Chinese medicine composition group XI, and a Chinese medicine composition group XII, with 10 mice in each group. The mice were given intragastric administration once a day at a dose of 4.68g crude drug / kg for 7 consecutive days. 30 minutes after the last drug administration, all the other groups except the blank group were given 3mg / kg loperamide by intragastric administration. Gastric juice volume determination: After the last administration, mice were fasted but not watered for 16 h. Blood was collected from the mouse eyeballs, and the mice were killed by cervical dislocation. The whole stomach was cut out and the gastric contents were poured out. The total acidity of the gastric juice was obtained by testing with precision pH test paper and comparing with colorimetric cards.

[0216] 5. Detection of pepsin and gastrin content in mouse serum

[0217] Blood was collected from the eyeballs of the mice in the above groups, and centrifuged at 3500 r / min for 10 min to separate the serum, which was stored in a -20°C refrigerator and tested according to the instructions of the pepsin and gastrin test kits.

[0218] 6. Statistical analysis

[0219] Excel statistical analysis was used for data analysis. Data were expressed as mean ± s, and one-way analysis of variance was used to compare the sample means among multiple groups. P < 0.05, P < 0.01, P < 0.001 were considered statistically significant.

[0220] 2. Experimental Results

[0221] 1. The results of relieving stomach pain

[0222] Compared with the blank group, the number of body twisting of rats in the original preparation group of Compound Honeysuckle Granules, the positive western medicine group, and the Chinese medicine composition group III was significantly reduced (P<0.001), as well as the Chinese medicine composition group IV, the Chinese medicine composition group V, the Chinese medicine composition group VI, the Chinese medicine composition group VII, and the Chinese medicine composition group VIII (P<0.05). From the results of the body twisting inhibition rate, it can be seen that among the 12 groups of Chinese medicine compositions, the Chinese medicine composition group III was better than the original preparation group of Compound Honeysuckle Granules, and better than the other Chinese medicine composition groups, see Table 1.

[0223] Table 1 Number of writhing times and writhing inhibition rate of rats in each group (mean ± s, n = 10)

[0224]

[0225]

[0226] Note: Compared with the blank group, *P<0.05, ***P<0.001.

[0227] 2. Anti-inflammatory effect results

[0228] Compared with the blank group, the ear swelling of rats in the western medicine positive group and the Chinese medicine composition group III was reduced (P<0.001, P<0.01), and the ear swelling of rats in the compound honeysuckle granules original process preparation group and the Chinese medicine composition group IX was reduced (P<0.05). From the results of the ear swelling inhibition rate, it can be seen that among the 12 groups of Chinese medicine compositions, the Chinese medicine composition group III was better than the compound honeysuckle granules original process preparation group and the other Chinese medicine composition groups, as shown in Table 2.

[0229] Table 2 Ear swelling degree and ear swelling inhibition rate of rats in each group (mean ± s, n = 10)

[0230]

[0231]

[0232] Note: Compared with the blank group, *P<0.05, **P<0.01, ***P<0.001.

[0233] 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 original process preparation group of compound honeysuckle granules were reduced (P<0.05), the levels of TNF-α and IL-6 in the positive western medicine group were significantly reduced (P<0.01), and the levels of TNF-α and IL-6 in the Chinese medicine composition III group were significantly reduced (P<0.01, P<0.05). Among the 12 groups of Chinese medicine compositions, the Chinese medicine composition III group was superior to the original process preparation group of compound honeysuckle granules and the other Chinese medicine composition groups, as shown in Table 3.

[0234] Table 3 TNF-α and IL-6 levels in serum of rats in each group (mean ± s, n = 10)

[0235]

[0236]

[0237] Note: Compared with the blank group, ###P<0.001; compared with the model group, *P<0.05, **P<0.01, ***P<0.001

[0238] 3. Results of gastric acid pH, serum pepsin and gastrin in mice

[0239] Compared with the blank group, the gastric acid pH, serum pepsin and gastrin content of the model group rats decreased significantly (P<0.01); compared with the model group, the gastric acid pH, serum pepsin and gastrin content of the compound honeysuckle granules original process preparation group increased (P<0.05), the gastric acid pH, serum pepsin and gastrin content of the western medicine positive group increased significantly (P<0.01), and the gastric acid pH, serum pepsin and gastrin content of the Chinese medicine composition III group increased significantly (P<0.001, P<0.01, P<0.01). Among the 12 groups of Chinese medicine compositions, the Chinese medicine composition III group was better than the compound honeysuckle granules original process preparation group and the other Chinese medicine composition groups, as shown in Table 4.

[0240] Table 4 Gastric acid pH, serum pepsin and gastrin levels in mice in each group (mean ± s, n = 10)

[0241]

[0242]

[0243] Note: Compared with the blank group, ###P<0.001; compared with the model group, *P<0.05, **P<0.01, ***P<0.001

[0244] According to the above data results, the prescription of the Chinese medicine composition III of the present invention has obvious anti-inflammatory and stomach pain relief 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 compound honeysuckle granules (P<0.05), and is better than other Chinese medicine combination groups.

[0245] 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 for relieving stomachache, comprising the following raw materials in parts by weight: 4-10 parts of honeysuckle volatile oil; 3-7 parts of volatile oil of Rhizoma Cibotii; 1-3 parts of Astragalus ethanol extract; The honeysuckle volatile oil is obtained by continuous reflux extraction of honeysuckle; The volatile oil of Rhizoma Cibotii is obtained by extracting Rhizoma Cibotii from Rhizoma Cibotii through supercritical carbon dioxide; The astragalus alcohol extract is prepared by extracting astragalus through ethanol aqueous solution.

2. The Chinese medicine composition according to claim 1, characterized in that: The preparation of the honeysuckle volatile oil comprises: crushing the honeysuckle, soaking it in a sodium chloride aqueous solution with a mass of 15 to 25 times the mass of the honeysuckle for 5 to 8 hours, continuously refluxing to extract the volatile oil for 10 to 15 hours, and cooling to obtain the honeysuckle volatile oil; the mass fraction of sodium chloride in the sodium chloride aqueous solution is 3% to 7%.

3. The Chinese medicine composition according to claim 1, characterized in that The preparation of the volatile oil of the Chinese osmanthus fragrans comprises: crushing the Chinese osmanthus fragrans, extracting it by supercritical carbon dioxide extraction, wherein the extraction parameters include: extraction temperature of 30-35°C, separation temperature of 30-35°C, extraction pressure of 30-40Mpa, and separation pressure of 6.0-6.5Mpa, when the temperature and pressure reach the set values, adjusting the carbon dioxide flow rate to 15-20kg / hour, performing cyclic extraction for 150-200min, dissolving the product with an equal amount of anhydrous ethanol, and then recovering the ethanol to obtain the volatile oil of the Chinese osmanthus fragrans.

4. The Chinese medicine composition according to claim 1, characterized in that: The preparation of the astragalus alcohol extract comprises the following steps: crushing the astragalus, extracting it with 50% to 90% ethanol for 1 to 3 times, each time for 1 to 2 hours, filtering the extract, combining the filtrate and recovering the ethanol to obtain the astragalus alcohol extract.

5. A self-microemulsion for relieving stomach pain, characterized in that: The invention comprises the Chinese medicine composition according to any one of claims 1 to 4 and auxiliary materials; the auxiliary materials comprise an oil phase, an emulsifier and an auxiliary emulsifier.

6. The self-microemulsion according to claim 5, characterized in that The invention comprises 8 to 19 parts by weight of the traditional Chinese medicine composition according to any one of claims 1 to 4, 5 to 7 parts of an oil phase, 10 to 20 parts of an emulsifier and 1 to 5 parts of an auxiliary emulsifier.

7. The self-microemulsion according to claim 6, characterized in that The oil phase is glyceryl monooleate; The emulsifiers are oleoyl polyoxyethylene glyceride and RH40 polyoxyethylene hydrogenated castor oil; The auxiliary emulsifier is diethylene glycol monoethyl ether.

8. The method for preparing the self-microemulsion according to any one of claims 5 to 7, characterized in that: include: The preparation method is prepared by mixing the traditional Chinese medicine composition according to any one of claims 1 to 4, an oil phase, an emulsifier and an auxiliary emulsifier, and then emulsifying the mixture.

9. Use of the Chinese medicine composition according to any one of claims 1 to 4 or the self-microemulsion according to any one of claims 5 to 7 in the preparation of a medicament for relieving stomach pain.

10. A medicine for relieving stomach pain, comprising the traditional Chinese medicine composition according to any one of claims 1 to 4 or the self-microemulsion according to any one of claims 5 to 7.

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