A cumin extract composition, and a preparation method and application thereof

Abstract

The application belongs to the technical field of traditional Chinese medicines, and particularly relates to a cumin extract composition, a preparation method and application thereof. The application provides a preparation method of a cumin extract composition, which comprises the following steps: mixing cumin powder and water to perform water vapor distillation extraction, so as to obtain a cumin volatile oil component, a first extract liquid and a first residue; mixing the first residue and water to perform decocting extraction, so as to obtain a second extract liquid; mixing and concentrating the first extract liquid and the second extract liquid, and then purifying the mixture through a macroporous resin column, so as to obtain a cumin water-soluble component; and mixing the cumin volatile oil component and the cumin water-soluble component, so as to obtain the cumin extract composition; the weight ratio of the cumin volatile oil component and the cumin water-soluble component is 1-3:2-4. The prepared compatible composition has a significant prevention and treatment effect on gastric mucosa damage, and can be preferably applied to stomach health care products.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a fennel extract composition, its preparation method, and its application. Background Technology

[0002] Fennel (Foeniculum vulgare) is the dried, ripe fruit of the fennel plant, belonging to the Apiaceae family. This medicinal herb is pungent and warm in nature, possessing the effects of dispelling cold, relieving pain, and regulating qi. It is listed in the *Chinese Pharmacopoeia*. Fennel contains various chemical components, including flavonoids, coumarins, phenolic acids, alkaloids, and volatile oils. Modern pharmacological studies have shown that fennel not only has significant antibacterial and diuretic effects, but also possesses hepatoprotective, choleretic, antibacterial, anti-inflammatory, antitumor, and sex hormone-like biological activities.

[0003] Alcohol abuse or chronic excessive drinking is one of the most common preventable diseases worldwide, causing approximately 3.3 million deaths annually, accounting for 6% of global deaths. Alcohol damages multiple organs, primarily the liver, gastrointestinal tract, and brain. Gastric mucosal damage is a prevalent chronic disease caused by long-term alcohol accumulation. After ethanol enters the stomach, it is metabolized into acetaldehyde, which binds to pepsin, damaging the gastric mucosal structure. This allows neutrophils to infiltrate the gastric mucosa and release myeloperoxidase, oxygen free radicals, reactive oxidative metabolites, and proteases, which adhere to the vascular endothelium, leading to mucosal damage. Therefore, the development of traditional Chinese medicine health products that prevent and treat alcohol-induced gastric mucosal damage with minimal side effects is receiving increasing attention. Summary of the Invention

[0004] In view of this, the purpose of this invention is to provide a fennel extract composition, its preparation method, and its application. The fennel extract composition prepared by this invention has a significant preventive and therapeutic effect on alcohol-induced gastric mucosal damage and has no toxic side effects.

[0005] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0006] This invention provides a method for preparing a fennel extract composition, comprising the following steps:

[0007] Fennel powder and the first portion of water were mixed and extracted by steam distillation to obtain fennel volatile oil components, the first extract and the first residue.

[0008] The first dregs and the second part of water were mixed and boiled to extract the second extract.

[0009] The first and second extracts were mixed and concentrated, and then purified by passing through a macroporous resin column to obtain the water-soluble component of fennel.

[0010] The volatile oil component and the water-soluble component of fennel are mixed to obtain the fennel extract composition; the weight ratio of the volatile oil component and the water-soluble component of fennel is 1-3:2-4.

[0011] Preferably, the weight ratio of the fennel volatile oil component to the fennel water-soluble component is 2:3.

[0012] Preferably, the weight ratio of the fennel powder to the first part of water is 1:8 to 12.

[0013] Preferably, the steam distillation extraction time is 4 to 6 hours.

[0014] Preferably, the weight ratio of the first medicinal residue to the second part of water is 1:10 to 16.

[0015] Preferably, the decoction extraction is performed 1 to 3 times, and each decoction extraction takes 1 hour.

[0016] Preferably, the specific gravity of the extract obtained after mixing and concentrating the first and second extracts is 1.05 to 1.20.

[0017] Preferably, the macroporous resin column is a D101 type macroporous adsorption resin column.

[0018] The present invention also provides a fennel extract composition obtained by the preparation method described above, wherein the fennel extract composition comprises fennel volatile oil components and fennel water-soluble components;

[0019] The weight percentage of trans-anetinoside in the fennel volatile oil component is 75.0-90.0%;

[0020] The total flavonoids in the fennel water-soluble component are 13.0-20.0% by weight, syringin is 5.0-8.0% by weight, and quercetin 3-O-β-D glucuronide is 4.0-6.0% by weight.

[0021] The present invention also provides the use of the fennel extract composition described above in the preparation of medicaments for treating and / or preventing gastric mucosal damage.

[0022] Compared with the prior art, the present invention has the following beneficial effects:

[0023] This invention provides a method for preparing a fennel extract composition, comprising the following steps: mixing fennel powder and water for steam distillation extraction to obtain a fennel volatile oil component, a first extract, and a first residue; mixing the first residue and water for decoction extraction to obtain a second extract; mixing and concentrating the first and second extracts and purifying them through a macroporous resin column to obtain a fennel water-soluble component; mixing the fennel volatile oil component and the fennel water-soluble component to obtain the fennel extract composition; wherein the weight ratio of the fennel volatile oil component to the fennel water-soluble component is 1-3:2-4. This invention utilizes a combined method of steam distillation, water decoction extraction, and macroporous resin purification to sequentially separate and purify volatile oil components and water-soluble components from fennel. Furthermore, the volatile oil components and water-soluble components of fennel are combined, resulting in a significant synergistic effect in preventing and treating gastric mucosal damage. The scientifically formulated fennel extract composition obtained in this invention has a significant preventive and therapeutic effect on gastric mucosal damage caused by alcoholism or long-term excessive drinking, and has no toxic side effects. Attached Figure Description

[0024] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0025] Figure 1 The effect of fennel extract composition (FWEO) on the morphology of gastric mucosal tissue in mice with alcohol-induced gastric mucosal injury (AAGI);

[0026] Figure 2 Figure showing the effect of FWEO on the histopathological changes of gastric mucosa in AAGI mice (×200).

[0027] Wherein A is the normal control group; B is the model group; C is the omeprazole group (OEM, 26 mg / kg); D is the fennel water-soluble group (FWE, 100 mg / kg); E is the fennel volatile oil group (FEO, 260 mg / kg); F is the FWEO group (50 mg / kg); G is the FWEO group (100 mg / kg); H is the FWEO group (200 mg / kg). Detailed Implementation

[0028] This invention provides a method for preparing a fennel extract composition, comprising the following steps:

[0029] Fennel powder and the first portion of water were mixed and extracted by steam distillation to obtain fennel volatile oil components, the first extract and the first residue.

[0030] The first dregs and the second part of water were mixed and boiled to extract the second extract.

[0031] The first and second extracts were mixed and concentrated, and then purified by passing through a macroporous resin column to obtain the water-soluble component of fennel.

[0032] The volatile oil component and the water-soluble component of fennel are mixed to obtain the fennel extract composition; the weight ratio of the volatile oil component and the water-soluble component of fennel is 1-3:2-4.

[0033] Unless otherwise specified, all materials and equipment used in this invention are commercially available products in the field.

[0034] In this invention, fennel powder and a first portion of water are mixed and extracted by steam distillation to obtain fennel volatile oil components, a first extract, and a first residue.

[0035] In this invention, the weight ratio of the fennel powder to the first part of water is preferably 1:8 to 12.

[0036] In this invention, the process of steam distillation extraction preferably includes soaking, and the soaking time is preferably 3 to 5 hours, more preferably 4 hours.

[0037] In this invention, the steam distillation extraction time is preferably 4 to 6 hours, more preferably 5 hours.

[0038] In this invention, the steam distillation extraction preferably further includes drying the collected volatile oil to obtain fennel volatile oil components, and the drying is preferably anhydrous sodium sulfate drying.

[0039] In this invention, the weight percentage of trans-anetinoside in the fennel volatile oil component is preferably 75.0-90.0%, more preferably 79.16%; the fennel volatile oil component preferably also includes anisaldehyde, D-limonene, γ-terpinene, fennelene and artemisinin.

[0040] After obtaining the first dregs, the present invention mixes the first dregs with the second part of water and decocts them to extract the second extract.

[0041] In this invention, the weight ratio of the first medicinal residue to the second part of water is preferably 1:10 to 16, and more preferably 1:12.

[0042] In this invention, the decoction extraction is preferably performed 1 to 3 times, more preferably 2 times, and the decoction extraction time for each time is preferably 1 hour.

[0043] After obtaining the first extract and the second extract, the present invention mixes and concentrates the first extract and the second extract, and then purifies them through a macroporous resin column to obtain the water-soluble component of fennel.

[0044] In this invention, the concentration is preferably vacuum concentration, and the conditions for vacuum concentration preferably include: a negative pressure of 0.09 to 0.10 MPa and a temperature of 50 to 55°C.

[0045] In this invention, the specific gravity of the extract obtained after mixing and concentrating the first extract and the second extract is preferably 1.05 to 1.20, more preferably 1.15.

[0046] In this invention, the concentration process preferably includes mixing the obtained extract with a third part of water, wherein the weight ratio of the extract to the third part of water is preferably 1:3. The present invention uses water to fully dissolve the extract, which facilitates column separation and purification.

[0047] In this invention, the macroporous resin column is preferably a D101 type macroporous adsorption resin column, and the diameter-to-height ratio of the D101 type macroporous adsorption resin column is preferably 1:6 to 10.

[0048] In this invention, the purification via the macroporous resin column preferably includes the following steps:

[0049] After the mixture of extract and water is loaded onto the sample, it is subjected to impurity removal and elution in sequence to obtain the eluent;

[0050] The eluent was concentrated and dried sequentially to obtain the fennel water-soluble component.

[0051] In this invention, the impurity removal preferably uses 8 to 10 column volumes of water, the elution preferably uses 5 to 8 column volumes of ethanol solution, and the volume concentration of the ethanol solution is preferably 50%.

[0052] In this invention, the concentration is preferably vacuum concentration, and the conditions for vacuum concentration preferably include: negative pressure of 0.09 to 0.10 MPa and temperature of 50 to 55°C.

[0053] In this invention, the drying is preferably vacuum drying, and the conditions for vacuum drying preferably include: negative pressure of 0.09 to 0.10 MPa and temperature of 55 to 60°C.

[0054] In this invention, the weight percentage of total flavonoids in the fennel water-soluble component is preferably 13.0-20.0%, more preferably 15.75%; the fennel water-soluble component preferably also includes β-carotene and coumarin.

[0055] In this invention, the weight percentage of syringin in the fennel water-soluble component is preferably 5.0-8.0%, more preferably 6.50%; the weight percentage of quercetin 3-O-β-D glucuronide in the fennel water-soluble component is preferably 4.0-6.0%, more preferably 4.32%.

[0056] After obtaining the volatile oil component and the water-soluble component of fennel, the present invention mixes the volatile oil component and the water-soluble component of fennel to obtain the fennel extract composition; the weight ratio of the volatile oil component and the water-soluble component of fennel is 1-3:2-4.

[0057] In this invention, the preferred weight ratio of the fennel volatile oil component to the fennel water-soluble component is 2:3.

[0058] The present invention does not have any special requirements for the method of mixing the volatile oil component and the water-soluble component of fennel; any method commonly used by those skilled in the art can be used.

[0059] The present invention also provides a fennel extract composition obtained by the preparation method described above, wherein the fennel extract composition comprises fennel volatile oil components and fennel water-soluble components;

[0060] The weight percentage of trans-anetinoside in the fennel volatile oil component is 75.0-90.0%;

[0061] The total flavonoids in the fennel water-soluble component are 13.0-20.0% by weight, syringin is 5.0-8.0% by weight, and quercetin 3-O-β-D glucuronide is 4.0-6.0% by weight.

[0062] In this invention, the weight percentage of trans-anetinoside is preferably 25.0-40.0%, more preferably 31.66%, based on the weight percentage of the fennel extract composition.

[0063] In this invention, the total flavonoids are preferably 7.0 to 12.0% by weight, more preferably 9.45%, based on the weight percentage of the fennel extract composition.

[0064] In this invention, the weight percentage of syringin is preferably 3.0 to 4.8%, more preferably 3.90%, based on the weight percentage of the fennel extract composition.

[0065] In this invention, the weight percentage of quercetin 3-O-β-D glucuronide is preferably 2.4-3.6%, more preferably 2.59%, based on the weight percentage of the fennel extract composition.

[0066] The present invention also provides the use of the fennel extract composition described above in the preparation of medicaments for treating and / or preventing gastric mucosal damage.

[0067] In this invention, the gastric mucosal injury is preferably gastric mucosal injury caused by chemical substances, and more preferably gastric mucosal injury caused by alcohol.

[0068] In this invention, the fennel extract composition can be further formulated into preparations for use in health products.

[0069] To further illustrate the present invention, the following detailed description of the fennel extract composition, its preparation method, and its application, in conjunction with the accompanying drawings and embodiments, is provided but should not be construed as limiting the scope of protection of the present invention.

[0070] Example 1: Preparation of Fennel Extract Composition

[0071] 2.0 kg of fennel seeds were crushed and sieved, soaked in 12 times their weight of water at room temperature for 4 hours, extracted by steam distillation for 5 hours, and the volatile oil was collected and dried with anhydrous sodium sulfate to obtain 38 mL of fennel volatile oil component (FEO), which was stored at -20℃ for later use.

[0072] After extraction, the residue was decocted twice with 12 times its weight of water, 1 hour each time. The extracts (including the extract remaining after the extraction of volatile oil) were combined and concentrated under reduced pressure at 0.09 MPa and 50°C to obtain 810 g of fluid extract with a specific gravity of 1.15. The extract was dissolved in 3 times its weight of deionized water and then loaded onto a D101 macroporous adsorption resin column (diameter-to-height ratio 1:10). First, it was purified with 10 column volumes of water, and then eluted with 8 column volumes of 50% ethanol. The 50% ethanol eluent was collected and concentrated under reduced pressure at 0.09 MPa. It was then vacuum dried at 0.09 MPa and 55°C to obtain 66.87 g of brownish-yellow powder, which is the water-soluble component of fennel (FWE).

[0073] The volatile oil component FEO and the water-soluble component FWE of fennel were mixed at a weight ratio of 2:3 to obtain the fennel extract composition FWEO.

[0074] 1. The total flavonoid content in FWE was determined using the method specified in the 2020 edition of the Chinese Pharmacopoeia:

[0075] Accurately weigh 10.0 mg of rutin reference standard, place it in a 50 mL volumetric flask, add an appropriate amount of methanol, heat gently in a water bath to dissolve, cool, add methanol to the mark, and shake well to obtain the reference solution (each 1 mL contains 0.2 mg of rutin). Accurately measure 1.0, 2.0, 3.0, 4.0, 5.0, and 6.0 mL of the reference solution and place them in separate 25 mL volumetric flasks. Add water to each flask to a final volume of 6.0 mL. Add 1.0 mL of 5% sodium nitrite solution, mix well, and let stand for 6 minutes. Add 1.0 mL of 10% aluminum nitrate solution, shake well, and let stand for 6 minutes. Add 10.0 mL of 4% sodium hydroxide solution, then add water to the mark, shake well, and let stand for 15 minutes. Using the corresponding reagents as blanks, measure the absorbance at 500 nm using UV-Vis spectrophotometry (General Rule 0401). Plot a standard curve with absorbance as the ordinate and rutin concentration as the abscissa. The obtained linear regression equation is y = 0.5259x - 0.0007 (R²). 2 =0.9986), showing a good linear relationship in the range of 0.2–1.2 mg. The results showed that the total flavonoid content in FWE was 15.75%.

[0076] 2. The contents of syringin and quercetin-3-O-β-D-glucuronide in FWE were determined by high performance liquid chromatography:

[0077] Chromatographic conditions: Agilent Eclipse XDB-C18 column (250 mm × 4.6 mm, 5 μm); mobile phase of chromatographic grade acetonitrile (B) and 0.1% phosphoric acid solution (A), gradient elution (0–25 min, 8% → 20%; 25–30 min, 20% → 45%; 30–35 min, 45% → 45%; 35–40 min, 45% → 8%; 40–45 min, 8% → 8%B); flow rate 1.0 mL / min, column temperature 30℃, detection wavelength 245 nm, injection volume 10 μL. Standard curve preparation: Accurately weigh appropriate amounts of syringin and quercetin-3-O-β-D-glucuronide reference standards, dilute with 70% methanol-water and bring to a final volume in a 10 mL volumetric flask, shake well and set aside. Accurately pipette 0.2, 0.5, 1.0, 2.0, and 5.0 mL of syringin reference solution into 10 mL volumetric flasks, respectively, and dilute to the mark with 70% methanol. Inject the sample according to the chromatographic conditions, record the peak area, plot the standard curve, and obtain the regression equation: Syringin: y = 10464x + 2.1828, R0 2 =0.999, showing good linearity in the range of 0.001-0.06 mg / mL; Quercetin-3-O-β-D-glucuronide: y = 19042x - 2.7027, R 2=0.999, showing good linearity in the range of 0.0006-0.06 mg / mL. The results showed that the contents of syringin and quercetin-3-O-β-D-glucuronide in FWE were 6.50% and 4.32%, respectively.

[0078] 3. The content of trans-anetinoside in FEO was determined by high performance liquid chromatography:

[0079] Chromatographic conditions: Shim-pack × C18 column (4.6 mm × 250 mm, 5 μm); mobile phase: methanol (B)-water (A). Gradient elution (0–19 min, 70% → 80%; 19–21 min, 80% → 95%; 21–30 min, 95% → 90%; 30–40 min, 90% → 70%B); flow rate: 1.0 mL / min; column temperature: 30 °C; detection wavelength: 254 nm; injection volume: 10 μL. Standard curve preparation: Accurately weigh trans-anetinoside reference standard and dissolve it in anhydrous ethanol to prepare a reference solution with a concentration of 0.0096 mg / mL. Accurately pipette 0.1, 0.2, 0.5, 1.0, and 2.0 mL of the above reference solution into 10 mL volumetric flasks, respectively. Dilute to the mark with anhydrous ethanol, mix well, and inject according to chromatographic conditions. Record the peak areas to obtain the regression equation: y = 81823535.493x + 20181.300, R0 2 =0.999, showing good linearity in the range of 0.000096–0.0096 mg / mL. The results showed that the trans-anetinoside content in FEO was 79.16%.

[0080] The compatibility composition of FEO and FWE contains 31.66% trans-anestochrome, 3.90% syringin, 2.59% quercetin 3-O-β-D glucuronide, and 9.45% total flavonoids in FWEO.

[0081] Example 2: Protective effect of fennel composition FWEO on mice with alcoholic gastric mucosal injury (AAGI).

[0082] Experimental methods: After 4 days of acclimatization feeding, 96 male Kunming mice were randomly divided into the following groups according to their body weight: normal control group (blank control group), model group, positive control group (OEM, 26 mg / kg), fennel flavonoid group (FWE, 100 mg / kg), fennel volatile oil group (FEO, 260 mg / kg), and fennel extract combination group (FWEO, 50, 100, 200 mg / kg), with 12 mice in each group. Before administration, the drugs were dissolved in 0.5wt% Tween-80 solution to the corresponding concentrations: 2.6 mg / mL for positive control drug, 10 mg / mL for FWE, 26 mg / mL for FEO, and 5, 10, and 20 mg / mL for FWEO. The corresponding drugs were administered at 10 mL / kg for 4 days. The normal group and the model group were given an equal volume of 0.5wt% Tween-80 solution by gavage. Starting from day 6, except for the normal group which was given physiological saline, the other groups were given 85% alcohol by gavage at 10 mL / kg one hour after administration. The alcohol was administered continuously for 3 days to establish an acute alcoholic gastric mucosal injury mouse model. One hour after the last alcohol administration, blood was collected by enucleation of the eyeballs, and the mice were euthanized by cervical dislocation. The stomach tissue was separated and weighed. The stomach cavity was cut open along the greater curvature, cleaned with ice-cold saline, and laid flat on a clean plate to observe gross changes, evaluate the degree of gastric tissue damage, and calculate the damage index and ulcer inhibition rate. The serum PEG2 level and the activities of MPO, IL-1β and TNF-α in the gastric tissue of mice were measured using biochemical reagent kits.

[0083] Experimental results:

[0084] During the experiment, the normal control group mice showed good growth, were active, had a good appetite, and had glossy fur; while the model group mice, after being administered alcohol by gavage, exhibited symptoms such as unsteady gait, reduced activity, decreased food intake, emaciation, and lethargy. Some mice also showed cyanosis of the lips and heavy breathing. There were no statistically significant differences in body weight changes among the groups. The results are shown in Table 1 and [example table missing]. Figure 1 In the normal group of mice, the gastric tissue showed normal macroscopic morphology and no obvious hemorrhagic lesions, while in the model group, the gastric tissue showed obvious congestion, swelling, and hemorrhagic lesions, with the most severe ulcers. FWEO (100, 200 mg / kg) could significantly improve these symptoms and significantly reduce the increase in gastric index caused by alcohol (P<0.05).

[0085] Table 1. Effects of FWEO on body weight and gastric index in AAGI mice.

[0086]

[0087] Remark: # P < 0.05 ## P < 0.01, compared with the normal group; *P < 0.05, **P < 0.01, compared with the model group; ΔP<0.05, ΔΔ P<0.01, compared with the FWE group; ○ P<0.05, ○○ P<0.01 compared with the FEO group; the gastric index is an organ index, which is the weight of the stomach / body weight × 100%.

[0088] Further, the ulcer index was calculated according to the Guth criteria to evaluate the activity of FWEO in improving gastric mucosal injury. As shown in Table 2, compared with the model group (18.72), FWEO significantly reduced the ulcer index of alcohol-induced gastric mucosal injury mice (16.42, 13.28, 10.63, P<0.05). Among them, the high dose (100, 200 mg / kg, P<0.05) was more effective than FWE (100 mg / kg, 16.83, P<0.05), and the high dose (200 mg / kg) was more effective than FEO (260 mg / kg, 13.09). The efficacy was almost the same as omeprazole (26 mg / kg, 10.83), and the inhibition rate reached 43.23%.

[0089] Table 2. Effects of FWEO on the gastric ulcer index in AAGI mice.

[0090]

[0091] Note: According to Duncan's multiple range test, different letters in the same column indicate significant differences, with a p-value of <0.05.

[0092] PGE2 is an important anti-inflammatory marker in gastric tissue. It can protect the gastric mucosa by promoting gastric mucus secretion, strengthening the gastric mucosal barrier, and improving gastric mucosal circulation. As shown in Table 3, excessive alcohol intake caused a significant decrease in serum PGE2 levels in the model group mice, which was 63.96% lower than that in the normal group. This indicates that the gastric mucosa of the model group mice was damaged to some extent. Continuous gavage administration of FWE, FEO, and FWEO for 7 days all had a certain preventive and therapeutic effect on the damage, with FWEO showing the most significant effect. Compared with the model group, FWEO (200 mg / kg) significantly increased serum PGE2 levels in mice (P < 0.01), and was superior to FEO (260 mg / kg) and FWE (100 mg / kg), with a significant difference (P < 0.01). MPO is a peroxidase that is highly expressed and secreted by activated neutrophils. MPO activity can be used to assess the leukocyte infiltration in mouse gastric tissue. The serum MPO activity in the model group mice was significantly higher than that in the normal group (P<0.01), indicating that after alcohol-induced gastric mucosal damage in mice, inflammatory cells invaded the submucosa. FWEO (100, 200 mg / kg) could significantly reduce the elevated serum MPO activity in mice stimulated by alcohol, and the effect was significantly better than FEO (260 mg / kg) and FWE (100 mg / kg).

[0093] Table 3. Effects of FWEO on serum PGE2 and MPO levels in AAGI mice.

[0094]

[0095]

[0096] Remark: # P < 0.05 ## P < 0.01, compared with the normal group; *P < 0.05, **P < 0.01, compared with the model group; Δ P<0.05, ΔΔ P<0.01, compared with the FWE group; ○ P<0.05, ○○ P<0.01, compared with the FEO group.

[0097] TNF-α and IL-1β are common inflammatory factors in the body and play important roles in the inflammatory response. As shown in Table 4, oral administration of alcohol significantly increased the levels of TNF-α and IL-1β in the gastric tissue of mice (P<0.05). FWEO (50, 100, 200 mg / kg), FEO (260 mg / kg), and FWE (100 mg / kg) significantly alleviated the increase in TNF-α and IL-1β levels caused by alcohol intake (P<0.05). Among them, the high dose of FWEO was significantly more effective than FEO and FWE, and the inhibitory effect of the high dose was close to that of the positive control OEM. The results indicate that FWEO can protect against gastric mucosal damage by inhibiting the expression of pro-inflammatory cytokines.

[0098] Table 4. Effects of FWEO on TNF-α and IL-1β levels in gastric tissue of AAGI mice.

[0099]

[0100] Remark: # P < 0.05 ## P < 0.01, compared with the normal group; *P < 0.05, **P < 0.01, compared with the model group; Δ P<0.05, ΔΔ P<0.01, compared with the FWE group; ○ P<0.05, ○○ P<0.01, compared with the FEO group.

[0101] Figure 2 The image shows the effect of FWEO on the histopathological changes of gastric mucosa in AAGI mice (×200 magnification). A represents the normal control group; B represents the model group; C represents the OEM group (26 mg / kg); D represents the FWE group (100 mg / kg); E represents the FEO group (260 mg / kg); F represents the FWEO group (50 mg / kg); G represents the FWEO group (100 mg / kg); and H represents the FWEO group (200 mg / kg). HE staining results showed that the gastric mucosa of the blank control group mice had clear and intact structures in all layers, with no hemorrhage or inflammatory cell infiltration. Figure 2 (A). In the model group mice, the gastric mucosa was severely damaged, with muscle layer cells ruptured and sloughed off, various cells severely damaged, extensive local hemorrhage and necrosis, and a large number of inflammatory cell infiltrations were observed. Figure 2 In mice in the FWE group (100 mg / kg) and FWEO group (50 mg / kg), the degree of gastric mucosal damage was reduced compared with that in the model group, but severe shedding of mucosal epithelial cells was observed, along with congestion and inflammatory cell infiltration. Figure 2 China D and Figure 2In the FEO (260 mg / kg) and FWEO (100 mg / kg) groups, the degree of gastric mucosal damage in mice was significantly reduced, the structure of each layer of gastric tissue was relatively clear, there was no obvious damage to the mucosal epithelium and glands, some surface lesions, and a small amount of local congestion and inflammatory cell infiltration. Figure 2 China E and Figure 2 In mice in the omeprazole-positive group (26 mg / kg) and the FWEO group (260 mg / kg), no obvious damage was observed in the gastric mucosa; the structure of each layer was clear and intact, and inflammatory cell infiltration was not obvious. Figure 2 C and Figure 2 (H).

[0102] The results showed that FEO and FWE had good preventive and therapeutic effects on alcohol-induced gastric mucosal damage, and that FEO and FWE had a significant synergistic effect. The FWEO group (composed of fennel volatile oil component FEO and fennel water-soluble component FWE in a weight ratio of 2:3) had a significant preventive and therapeutic effect on alcohol-induced gastric mucosal damage, and the pharmacodynamic test results were significantly better than those of the FEO group and FWE group used alone.

[0103] Although the above embodiments have provided a detailed description of the present invention, they are only some embodiments of the present invention, not all embodiments. People can obtain other embodiments based on the present invention without creative effort, and these embodiments all fall within the protection scope of the present invention.

Claims

1. The use of a fennel extract composition in the preparation of a medicament for treating and / or preventing alcoholic gastric mucosal injury, characterized in that, The preparation method of the fennel extract composition includes the following steps: Fennel powder and the first portion of water were mixed and extracted by steam distillation to obtain fennel volatile oil components, the first extract and the first residue. The first dregs and the second part of water were mixed and boiled to extract the second extract. The extract obtained by mixing and concentrating the first and second extracts was purified by passing it through a macroporous resin column to obtain the water-soluble component of fennel. The volatile oil component and the water-soluble component of fennel are mixed to obtain the fennel extract composition; the weight ratio of the volatile oil component and the water-soluble component of fennel is 2:

3. The macroporous resin column is a D101 type macroporous adsorption resin column, and the diameter-to-height ratio of the D101 type macroporous adsorption resin column is 1:6~10. The purification via macroporous resin column includes the following steps: After loading the mixture of extract and water onto the sample, it is subjected to impurity removal and elution sequentially to obtain the eluent. The impurity removal uses 8-10 column volumes of water, and the elution uses 5-8 column volumes of ethanol solution with a volume concentration of 50%. The eluent was concentrated and dried sequentially to obtain the fennel water-soluble component.

2. The application according to claim 1, characterized in that, The weight ratio of the fennel powder to the first portion of water is 1:8~12.

3. The application according to claim 1 or 2, characterized in that, The steam distillation extraction time is 4 to 6 hours.

4. The application according to claim 1, characterized in that, The weight ratio of the first part of the dregs to the second part of water is 1:10~16.

5. The application according to claim 1 or 4, characterized in that, The decoction and extraction are performed 1 to 3 times, with each decoction and extraction lasting 1 hour.

6. The application according to claim 1, characterized in that, The specific gravity of the extract obtained by mixing and concentrating the first and second extracts is 1.05~1.

20.

7. The application according to claim 1, characterized in that, The fennel extract composition comprises fennel volatile oil components and fennel water-soluble components; The weight percentage of trans-anetinoside in the fennel volatile oil component is 75.0~90.0%; The total flavonoids in the fennel water-soluble component are 13.0-20.0% by weight, syringin is 5.0-8.0% by weight, and quercetin 3-O-β-D glucuronide is 4.0-6.0% by weight.

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