Traditional Chinese medicine preparation for treating gastritis and preparation method thereof

Abstract

The invention relates to a traditional Chinese medicine preparation for treating gastritis and a preparation method of the traditional Chinese medicine preparation. The traditional Chinese medicine preparation comprises the following raw materials in parts by weight: 40-50 parts of a traditional Chinese medicine composition, 10-15 parts of a sustained release agent, 25-32 parts of a filling agent and 3-8 parts of a flavoring agent, the slow release agent is modified carboxymethyl konjac glucomannan; the filling agent is cordyceps militaris polysaccharide and lactose; the flavoring agent is aspartame or sucralose. The sustained release agent is neohesperidin dihydrochalcone modified carboxymethyl konjac glucomannan, neohesperidin dihydrochalcone has the effect of inhibiting gastric acid secretion, and neohesperidin dihydrochalcone and the traditional Chinese medicine ingredient cuttlebone can synergistically play a role in preparing acid and jointly play a role in protecting gastric mucosa. Meanwhile, the cordyceps militaris polysaccharide has polysaccharide generality of thickening and stable film forming, and forms a compact network structure together with the modified carboxymethyl konjac glucomannan, and the obtained traditional Chinese medicine preparation has a good slow release effect.

Description

Technical Field

[0001] This invention belongs to the field of biopharmaceutical manufacturing technology, specifically relating to a traditional Chinese medicine preparation for treating gastritis and its preparation method. Background Technology

[0002] Gastritis is one of the most common digestive system diseases, often accompanied by epithelial damage, mucosal inflammation, and epithelial regeneration. Based on the speed of onset and duration of illness, gastritis is generally divided into acute gastritis and chronic gastritis. The former is an acute inflammation of the gastric mucosa caused by various etiologies; chronic gastritis is a chronic inflammation or atrophic lesion of the gastric mucosa caused by various etiologies, and is further divided into superficial gastritis, atrophic gastritis, bile reflux gastritis, etc. This disease has a long history, is prone to recurrence, and is difficult to cure completely. Clinically, it often manifests as upper abdominal pain, bloating, belching, loss of appetite, acid reflux, fatigue, constipation, or diarrhea. Over time, the gastric mucosa degenerates and atrophies, and gastric secretion function declines, leading to weight loss, decreased immunity, and even malignant transformation of the gastric mucosa. The occurrence and development of chronic gastritis are closely related to emotions, stress, and lifestyle. With the accelerated pace of life and increased life pressure, the incidence of chronic gastritis remains high, greatly endangering public health.

[0003] Currently, Western medicine primarily treats chronic gastritis symptomatically, employing methods such as inhibiting gastric acid, protecting the gastric mucosa, improving gastric motility, and supplementing with folic acid. While these medications offer good short-term efficacy, long-term use can easily lead to drug resistance and gastrointestinal adverse reactions, and there is a tendency for relapse. Ancient texts do not record "gastritis" as a specific disease; based on clinical manifestations, it is often categorized under terms like "gastric fullness," "stomach pain," and "heartburn." Gastritis is located in the stomach and is closely related to the liver and spleen. The causes are often due to inherent weakness, exposure to external pathogens, improper diet, and emotional imbalances, which damage the spleen and stomach, leading to disharmony between the spleen and stomach, and disordered qi circulation in the middle jiao. The pathogenesis is mainly characterized by deficiency of the root and excess of the branch, a mixture of both. The root deficiency includes spleen qi deficiency and stomach yin deficiency, while the branch excess includes qi stagnation and turbid toxins. For example, the *Miscellaneous Diseases: Origins and Development of Swelling* states: "Abdominal distension is a spleen disease. It originates from spleen qi deficiency and qi stagnation leading to impaired circulation... Therefore, it can be caused by insufficient middle qi and inability to transform and transport, food stagnation, phlegm accumulation, or excessive damp-heat." Traditional Chinese medicine often establishes individualized treatment plans based on patient symptoms when treating gastritis, employing a holistic approach and syndrome differentiation for treatment. It has advantages such as multiple target points and fewer adverse reactions, achieving significant efficacy in clinical applications. Therefore, this invention provides a traditional Chinese medicine preparation for treating gastritis and its preparation method. Summary of the Invention

[0004] The primary objective of this invention is to provide a traditional Chinese medicine preparation for treating gastritis.

[0005] The second objective of this invention is to provide a method for preparing a traditional Chinese medicine preparation for treating gastritis.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows: This invention provides a traditional Chinese medicine preparation for treating gastritis, comprising the following raw materials in parts by weight: 40-50 parts of traditional Chinese medicine composition, 10-15 parts of sustained-release agent, 25-32 parts of filler, and 3-8 parts of flavoring agent; wherein the sustained-release agent is modified carboxymethyl konjac glucomannan; the filler is Cordyceps militaris polysaccharide and lactose; and the flavoring agent is aspartame or sucralose.

[0007] Preferably, the modified carboxymethyl konjac glucomannan is prepared by: (1) Add carboxymethyl konjac glucomannan to deionized water to obtain carboxymethyl konjac glucomannan aqueous solution; then add EDC and NHS and stir to obtain a mixed solution; (2) Add neohesperidin dihydrochalcone to anhydrous ethanol to obtain neohesperidin dihydrochalcone solution; add the neohesperidin dihydrochalcone solution to the mixed solution, and after the reaction, dialyze and freeze dry to obtain the final product.

[0008] Preferably, in step (1), the mass ratio of carboxymethyl konjac glucomannan, EDC, and NHS is 10:(8-9):(5-6); the concentration of the carboxymethyl konjac glucomannan aqueous solution is 2-3wt%; and the stirring time is 30-45min.

[0009] Preferably, in step (2), the mass ratio of neohesperidin dihydrochalcone to carboxymethyl konjac glucomannan is (6-7):10; the concentration of the neohesperidin dihydrochalcone solution is 5-10wt%; and the reaction time is 6-8h.

[0010] Preferably, the mass ratio of Cordyceps militaris polysaccharide to lactose is 1:(0.8-1).

[0011] This invention provides a method for preparing a traditional Chinese medicine preparation for treating gastritis, comprising the following steps: weighing each raw material according to weight parts: traditional Chinese medicine composition, sustained-release agent, filler, and flavoring agent, mixing and granulating to obtain the traditional Chinese medicine preparation.

[0012] Preferably, the traditional Chinese medicine preparation is a tablet.

[0013] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: cuttlebone 18-22 parts, astragalus 15-20 parts, white peony root 9-13 parts, two-colored maple 11-14 parts, atractylodes macrocephala 10-15 parts, corydalis 7-12 parts, codonopsis pilosula 5-10 parts, and licorice 3-5 parts.

[0014] Preferably, the preparation method of the traditional Chinese medicine composition is as follows: (a) Weigh each raw material of the Chinese medicine composition according to the weight parts, mix them evenly and crush them, and sieve them to obtain crude drug powder; (b) Add 8-12 times the weight of water to the crude drug powder, decoct to obtain a primary filtrate and a residue; add 8-10 times the weight of water to the residue, decoct to obtain a secondary filtrate, combine the primary and secondary filtrates, concentrate under reduced pressure to obtain an extract, thus obtaining the traditional Chinese medicine composition.

[0015] Preferably, in step (b), the decoction time is 1-2 hours; the relative density of the extract is 1.10-1.25.

[0016] The pharmacological properties of each component of the traditional Chinese medicine composition of this invention are as follows: Cuttlebone (Hai Piao Xiao) is salty, astringent, and slightly warm. It enters the liver and kidney meridians. It strengthens the kidneys and stops leukorrhea, astringes and stops bleeding, neutralizes acid and relieves pain, and promotes healing of sores. It is used for hematochezia and traumatic bleeding; stomach pain and acid reflux; damp sores, eczema, and non-healing ulcers. It can neutralize stomach acid, change the pH of gastric contents, reduce pepsin activity, and promote ulcer healing.

[0017] Astragalus membranaceus (Huang Qi) is sweet and slightly warm. It enters the spleen and lung meridians. It tonifies qi and strengthens the spleen, raises yang and lifts prolapse, benefits the defensive qi and consolidates the exterior, promotes diuresis and reduces edema, and promotes tissue regeneration and detoxification. It is used for spleen qi deficiency, lung qi deficiency, spontaneous sweating due to qi deficiency, and deficiency of qi and blood.

[0018] White peony root is bitter, sour, and slightly cold in nature. It enters the liver and spleen meridians. It nourishes blood and astringes yin, softens the liver and relieves pain, and balances yin and yang. It is used for liver blood deficiency, irregular menstruation, liver and spleen disharmony, chest, rib, and abdominal pain, spasms and pain in the limbs, liver yang hyperactivity, headache, and dizziness.

[0019] Two-colored maple, bitter, pungent, and neutral in nature. It enters the liver and kidney meridians. It dispels wind and dampness, invigorates blood circulation and relieves pain, strengthens tendons and bones. It is used for rheumatic pain, traumatic injuries, and soreness and weakness of the lower back and knees.

[0020] Atractylodes macrocephala is sweet, bitter, and warm in nature. It enters the spleen and stomach meridians. It is used for spleen qi deficiency, spontaneous sweating due to qi deficiency, and threatened abortion due to spleen deficiency.

[0021] Corydalis rhizome is pungent and bitter in taste, and warm in nature; it enters the liver and spleen meridians; it has the functions of promoting blood circulation, regulating qi, and relieving pain.

[0022] Codonopsis pilosula (Dang Shen) is sweet and neutral in nature. It enters the spleen and lung meridians. It tonifies spleen and lung qi, nourishes blood, and generates fluids. It is used for spleen and lung qi deficiency, qi and blood deficiency, and qi and fluid depletion. It can regulate gastrointestinal motility, has anti-ulcer properties, and enhances immune function.

[0023] Licorice root is sweet and neutral in nature. It enters the heart, lung, spleen, and stomach meridians. It tonifies the spleen and replenishes qi, relieves spasms and pain, clears heat and detoxifies, and harmonizes the effects of other herbs.

[0024] Compared with the prior art, the main advantages of the present invention are as follows: This invention relates to a traditional Chinese medicine preparation that uses modified carboxymethyl konjac glucomannan as a sustained-release agent and Cordyceps militaris polysaccharide and lactose as fillers. The modified carboxymethyl konjac glucomannan is specifically a neohesperidin dihydrochalcone-modified carboxymethyl konjac glucomannan. This invention involves activating the carboxyl group of carboxymethyl konjac glucomannan and then reacting it with neohesperidin dihydrochalcone via esterification to obtain neohesperidin dihydrochalcone-modified carboxymethyl konjac glucomannan. On one hand, neohesperidin dihydrochalcone has an inhibitory effect on gastric acid secretion, and can synergistically exert an antacid effect with the traditional Chinese medicine ingredient cuttlebone. Simultaneously, Cordyceps militaris polysaccharide possesses the common properties of thickening and film-stabilizing polysaccharides, forming a dense network structure with the modified carboxymethyl konjac glucomannan, giving the traditional Chinese medicine preparation good stability and mechanical strength, thereby improving the sustained-release effect. The resulting traditional Chinese medicine preparation is stable in efficacy and safe and reliable.

[0025] The traditional Chinese medicine composition of this invention comprises cuttlebone, astragalus, white peony root, two-colored maple, atractylodes macrocephala, corydalis, codonopsis, and licorice. Cuttlebone and astragalus are the principal herbs to neutralize stomach acid, relieve pain, and strengthen the body's defensive qi. White peony root, two-colored maple, and atractylodes macrocephala are the assistant herbs to nourish blood, soothe the liver, dispel wind and dampness, and invigorate the spleen and qi. Corydalis and codonopsis are the adjuvant herbs to promote blood circulation, relieve pain, generate fluids, and harmonize the stomach. Licorice is the guiding herb to harmonize the other herbs. The entire formula can quickly neutralize stomach acid and protect the gastric mucosa. The traditional Chinese medicine prescription provided by this invention is safe, non-toxic, and mild in nature. The composition ratio is reasonable, the preparation method is simple and effective, and its active ingredients are easily absorbed by the human body, thus neutralizing stomach acid and protecting the gastric mucosa. Attached Figure Description

[0026] Figure 1 This is a scanning electron microscope image of the modified carboxymethyl konjac glucomannan obtained in Example 1 of the present invention. Detailed Implementation

[0027] The technical solution of the present invention will be further described below with reference to specific embodiments. However, those skilled in the art should understand that the following embodiments are only for illustrating the present invention and should not be regarded as limiting the present invention. Specific conditions not specified in the embodiments are performed according to conventional conditions or conditions recommended by the manufacturer. Unless otherwise specified, the reagents or instruments used are all conventional products obtained through commercial channels.

[0028] The preparation method of carboxymethyl konjac glucomannan in this embodiment of the invention is as follows: Konjac glucomannan and 70% (v / v) ethanol solution are mixed evenly, heated to 50°C, and then chloroacetic acid and sodium hydroxide are added and mixed evenly. The mass ratio of konjac glucomannan, ethanol solution, chloroacetic acid and sodium hydroxide is 1:6.5:0.5:0.85. After reacting for 3 hours, the pH is adjusted to neutral, washed with ethanol solution, filtered and dried to obtain the product.

[0029] The preparation method of Cordyceps militaris polysaccharide in this embodiment of the invention is as follows: 20 times the weight of water is added to Cordyceps militaris, and the mixture is decocted twice, once for 1 hour and once for 0.5 hours. The two filtrates are combined, and anhydrous ethanol is added until the final ethanol concentration is 70 v / v%. After standing for 12 hours, the mixture is centrifuged. The precipitate is collected, freeze-dried, and Cordyceps militaris polysaccharide is obtained.

[0030] Example 1:

[0031] This embodiment relates to a traditional Chinese medicine preparation for treating gastritis, comprising the following raw materials in parts by weight: 45 parts of a traditional Chinese medicine composition, 13 parts of a sustained-release agent, 30 parts of a filler, and 6 parts of a flavoring agent; the sustained-release agent is modified carboxymethyl konjac glucomannan; the filler is obtained by mixing Cordyceps militaris polysaccharide and lactose in a mass ratio of 1:0.9; and the flavoring agent is sucralose. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 20 parts of cuttlebone, 17 parts of Astragalus membranaceus, 11 parts of Paeonia lactiflora, 13 parts of Acer bistorta, 12 parts of Atractylodes macrocephala, 10 parts of Corydalis yanhusuo, 7 parts of Codonopsis pilosula, and 4 parts of Glycyrrhiza uralensis.

[0032] The preparation method of modified carboxymethyl konjac glucomannan in this embodiment is as follows: (1) Add carboxymethyl konjac glucomannan to deionized water, stir and dissolve to obtain a carboxymethyl konjac glucomannan aqueous solution with a concentration of 2.5 wt%; then add EDC (1-ethyl-3-(3-dimethylaminopropyl)carbodiimide) and NHS (N-hydroxysuccinimide), wherein the mass ratio of carboxymethyl konjac glucomannan, EDC and NHS is 10:8.5:6; adjust the pH to 5.5, stir at room temperature for 40 min to obtain a mixed solution; (2) Neohesperidin dihydrochalcone was added to anhydrous ethanol to obtain an 8 wt% neohesperidin dihydrochalcone solution; the neohesperidin dihydrochalcone solution was added to the mixed solution, wherein the mass ratio of neohesperidin dihydrochalcone to carboxymethyl konjac glucomannan was 6.5:10; the pH was adjusted to 5.8, the reaction was carried out for 7 h, and the modified carboxymethyl konjac glucomannan was obtained by dialysis and freeze-drying. The scanning electron microscope image of the obtained modified carboxymethyl konjac glucomannan is shown below. Figure 1 As shown.

[0033] The preparation method of the traditional Chinese medicine preparation for treating gastritis in this embodiment includes the following steps: S1. Weigh the following raw materials according to the following weight proportions: 20 parts cuttlebone, 17 parts astragalus, 11 parts white peony root, 13 parts two-colored maple, 12 parts atractylodes macrocephala, 10 parts corydalis, 7 parts codonopsis, and 4 parts licorice; mix them evenly and pulverize them, then pass them through an 80-mesh sieve to obtain coarse powder of the medicine. S2. Add 10 times the weight of water to the crude drug powder, decoct for 1.5 hours, filter to obtain a primary filtrate and a residue; add 9 times the weight of water to the residue, decoct for 1.5 hours, filter to obtain a secondary filtrate, combine the primary and secondary filtrates, concentrate under reduced pressure to obtain an extract (relative density of 1.15), thus obtaining the traditional Chinese medicine composition. S3. Weigh out the traditional Chinese medicine composition, sustained-release agent, filler, and flavoring agent according to the weight parts, mix and granulate, dry, and compress to obtain traditional Chinese medicine tablets.

[0034] Example 2:

[0035] This embodiment relates to a traditional Chinese medicine preparation for treating gastritis, comprising the following raw materials in parts by weight: 50 parts of a traditional Chinese medicine composition, 15 parts of a sustained-release agent, 32 parts of a filler, and 8 parts of a flavoring agent; the sustained-release agent is modified carboxymethyl konjac glucomannan; the filler is obtained by mixing Cordyceps militaris polysaccharide and lactose in a 1:1 mass ratio; and the flavoring agent is aspartame. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 22 parts of cuttlebone, 20 parts of Astragalus membranaceus, 13 parts of Paeonia lactiflora, 14 parts of Acer bistorta, 15 parts of Atractylodes macrocephala, 12 parts of Corydalis yanhusuo, 10 parts of Codonopsis pilosula, and 5 parts of Glycyrrhiza uralensis.

[0036] The preparation method of modified carboxymethyl konjac glucomannan in this embodiment is as follows: (1) Add carboxymethyl konjac glucomannan to deionized water, stir and dissolve to obtain a carboxymethyl konjac glucomannan aqueous solution with a concentration of 3wt%; then add EDC and NHS, wherein the mass ratio of carboxymethyl konjac glucomannan, EDC and NHS is 10:9:6; adjust the pH to 5.6, stir at room temperature for 45 min to obtain a mixed solution; (2) Neohesperidin dihydrochalcone was added to anhydrous ethanol to obtain a 10wt% neohesperidin dihydrochalcone solution; the neohesperidin dihydrochalcone solution was added to the mixed solution, wherein the mass ratio of neohesperidin dihydrochalcone to carboxymethyl konjac glucomannan was 7:10; the pH was adjusted to 6.0, the reaction was carried out for 8 hours, and the product was obtained by dialysis and freeze drying.

[0037] The preparation method of the traditional Chinese medicine preparation for treating gastritis in this embodiment includes the following steps: S1. Weigh the following raw materials according to the following weight proportions: 22 parts cuttlebone, 20 parts astragalus, 13 parts white peony root, 14 parts two-colored maple, 15 parts atractylodes macrocephala, 12 parts corydalis, 10 parts codonopsis, and 5 parts licorice; mix them evenly and pulverize them, then pass them through a 90-mesh sieve to obtain coarse powder of the medicine. S2. Add 12 times the weight of water to the crude drug powder, decoct for 2 hours, filter to obtain a primary filtrate and a residue; add 10 times the weight of water to the residue, decoct for 2 hours, filter to obtain a secondary filtrate, combine the primary and secondary filtrates, concentrate under reduced pressure to obtain an extract (relative density of 1.25), thus obtaining the traditional Chinese medicine composition. S3. Weigh out the traditional Chinese medicine composition, sustained-release agent, filler, and flavoring agent according to the weight parts, mix and granulate, dry, and compress to obtain traditional Chinese medicine tablets.

[0038] Example 3:

[0039] This embodiment relates to a traditional Chinese medicine preparation for treating gastritis, comprising the following raw materials in parts by weight: 40 parts of a traditional Chinese medicine composition, 10 parts of a sustained-release agent, 25 parts of a filler, and 3 parts of a flavoring agent; the sustained-release agent is modified carboxymethyl konjac glucomannan; the filler is obtained by mixing Cordyceps militaris polysaccharide and lactose in a mass ratio of 1:0.8; and the flavoring agent is sucralose. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 18 parts of cuttlebone, 15 parts of Astragalus membranaceus, 9 parts of Paeonia lactiflora, 11 parts of Acer buergerianum, 10 parts of Atractylodes macrocephala, 7 parts of Corydalis yanhusuo, 5 parts of Codonopsis pilosula, and 3 parts of Glycyrrhiza uralensis.

[0040] The preparation method of modified carboxymethyl konjac glucomannan in this embodiment is as follows: (1) Add carboxymethyl konjac glucomannan to deionized water, stir and dissolve to obtain a 2wt% carboxymethyl konjac glucomannan aqueous solution; then add EDC and NHS, wherein the mass ratio of carboxymethyl konjac glucomannan, EDC and NHS is 10:8:5; adjust the pH to 5.4, stir at room temperature for 30 min to obtain a mixed solution; (2) Neohesperidin dihydrochalcone was added to anhydrous ethanol to obtain a neohesperidin dihydrochalcone solution with a concentration of 5 wt%; the neohesperidin dihydrochalcone solution was added to the mixed solution, wherein the mass ratio of neohesperidin dihydrochalcone to carboxymethyl konjac glucomannan was 3:5; the pH was adjusted to 5.5, the reaction was carried out for 6 h, and the product was obtained by dialysis and freeze drying.

[0041] The preparation method of the traditional Chinese medicine preparation for treating gastritis in this embodiment includes the following steps: S1. Weigh the following raw materials according to the following weight proportions: 18 parts cuttlebone, 15 parts astragalus, 9 parts white peony root, 11 parts two-colored maple, 10 parts atractylodes macrocephala, 7 parts corydalis, 5 parts codonopsis, and 3 parts licorice; mix them evenly and pulverize them, then pass them through a 70-mesh sieve to obtain coarse powder of the medicine. S2. Add 8 times the weight of water to the crude drug powder, decoct for 1 hour, filter to obtain a primary filtrate and a residue; add 8 times the weight of water to the residue, decoct for 1 hour, filter to obtain a secondary filtrate, combine the primary and secondary filtrates, concentrate under reduced pressure to obtain an extract (relative density of 1.10), thus obtaining the traditional Chinese medicine composition. S3. Weigh out the traditional Chinese medicine composition, sustained-release agent, filler, and flavoring agent according to the weight parts, mix and granulate, dry, and compress to obtain traditional Chinese medicine tablets.

[0042] Comparative Example 1

[0043] The difference between this comparative example and Example 1 is that the sustained-release agent modified carboxymethyl konjac glucomannan is replaced with carboxymethyl konjac glucomannan, otherwise it is the same as Example 1.

[0044] Comparative Example 2

[0045] The difference between this comparative example and Example 1 is that the Cordyceps militaris polysaccharide in the filler is replaced with lactose, otherwise it is the same as Example 1.

[0046] Comparative Example 3

[0047] The difference between this comparative example and Example 1 is that the two-colored maple in the raw materials of the traditional Chinese medicine composition is omitted, while the rest is the same as in Example 1.

[0048] Experimental Example 1

[0049] Following the method of determining release rate using the slurry method in the Dissolution and Release Determination Method of Part IV of the 2020 edition of the Chinese Pharmacopoeia, in vitro dissolution experiments were conducted on the traditional Chinese medicine preparations obtained in Examples 1-3 and Comparative Examples 1-2 in phosphate buffer solution at pH 6.8. The main test index was corydaline in Corydalis rhizome. Samples were taken at 0.5, 2, 4, 6, 8, and 10 hours during the dissolution experiment. The dissolution of corydaline was detected by HPLC, and the cumulative release rate (%) was calculated. The results are shown in Table 1.

[0050] Table 1

[0051] As shown in Table 1, the traditional Chinese medicine preparations obtained in Examples 1-3 of this invention release the drug evenly and slowly within 0-8 hours, while the traditional Chinese medicine preparations obtained in Comparative Examples 1-2 release the drug more rapidly within 0-4 hours, resulting in an unsatisfactory sustained-release effect. They achieve a high cumulative release rate in the early stages, lacking a sustained-release effect. The reason for this is that the traditional Chinese medicine preparations of this invention use modified carboxymethyl konjac glucomannan as a sustained-release agent and Cordyceps militaris polysaccharide and lactose as fillers. Cordyceps militaris polysaccharide possesses the common properties of thickening and film-stabilizing polysaccharides, forming a dense network structure together with modified carboxymethyl konjac glucomannan. This gives the traditional Chinese medicine preparation good stability and mechanical strength, improving its sustained-release effect. The resulting traditional Chinese medicine preparations are stable in efficacy and safe and reliable.

[0052] Experimental Example 2

[0053] One hundred and thirty-two four-week-old male SPF-grade Wistar rats were randomly divided into 11 groups (blank control group, model group, positive control group, low-dose group of Example 1, medium-dose group of Example 1, high-dose group of Example 1, group 2 of Example 1, group 3 of Example 1, comparative example 1, comparative example 2, and comparative example 3), with 12 rats in each group. All rats were housed under constant temperature and humidity conditions with free access to food and water, and their day and night cycles were alternating for 12 hours each. After a one-week acclimatization period before the experiment, the experiment was conducted.

[0054] Except for the control group, rats in all other experimental groups were kept in a normal environment for the first 12 weeks, with free access to 0.5 g / L ammonia water as drinking water; 2 mL of 20 mmol / L sodium deoxycholate solution was administered by gavage once daily; and 2 mL of 60% ethanol was administered by gavage on an empty stomach twice weekly. After 12 weeks, rats in all experimental groups were fed a high-fat, high-sugar diet, i.e., free access to 200 mL / L honey water, and 0.1 g / kg of fat was administered by gavage every other day. After 14 days, rats in all experimental groups were placed in an artificial climate chamber at a temperature of 32±2℃ and a relative humidity of 95% for 12 hours a day for 5 days. Rats in the control group had normal food and water.

[0055] After modeling, the positive control group was administered vitamin B complex 300 mg / kg by gavage daily for 30 consecutive days; the high-dose group of Example 1 was administered the traditional Chinese medicine preparation obtained in Example 1 by gavage daily at 5.0 g crude drug / kg for 30 consecutive days; the medium-dose group of Example 1 was administered the traditional Chinese medicine preparation obtained in Example 1 by gavage daily at 3.0 g crude drug / kg for 30 consecutive days; the low-dose group of Example 1 was administered the traditional Chinese medicine preparation obtained in Example 1 by gavage daily at 1.0 g crude drug / kg for 30 consecutive days; and the group of Example 2 was administered the traditional Chinese medicine preparation obtained in Example 2 by gavage daily at 1.0 g crude drug / kg. The following groups were administered the following medications daily for 30 consecutive days: Example 3 group received the herbal preparation obtained in Example 3 via gavage at a dose of 1.0 g crude drug / kg for 30 consecutive days; Comparative Example 1 group received the herbal preparation obtained in Comparative Example 1 via gavage at a dose of 1.0 g crude drug / kg for 30 consecutive days; Comparative Example 2 group received the herbal preparation obtained in Comparative Example 2 via gavage at a dose of 1.0 g crude drug / kg for 30 consecutive days; Comparative Example 3 group received the herbal preparation obtained in Comparative Example 3 via gavage at a dose of 1.0 g crude drug / kg for 30 consecutive days; Blank control group and model group received physiological saline via gavage at a dose of 4 mL / kg for 30 consecutive days.

[0056] After drug intervention, the patient fasted for 24 hours and received an intraperitoneal injection of 100 g / L chloral hydrate (3 mL / kg). Following successful anesthesia, the abdominal cavity was opened along the midline, and blood was collected from the abdominal aorta. Blood samples were allowed to stand at room temperature for 2 hours, then centrifuged at 3000 rpm for 15 minutes. Serum IL-10 (interleukin-10), NO (nitric oxide), GAS (gastrin), and plasma MTL (motilin) ​​levels were measured using enzyme-linked immunosorbent assay (ELISA). The results are shown in Table 2.

[0057] Table 2

[0058] As shown in Table 2, compared with the blank control group, the serum IL-10 and GAS concentrations in the model group were significantly lower, while the serum NO and plasma MTL levels were significantly higher. Compared with the model group, the serum IL-10 and GAS concentrations in all experimental groups were increased, while the serum NO and plasma MTL levels were decreased, with the high-dose group in Example 1 showing the most significant increases. The reason for this is that the traditional Chinese medicine composition in the present invention uses cuttlebone and astragalus as the principal herbs to neutralize acid, relieve pain, and strengthen the body's defenses; white peony root, two-colored maple, and atractylodes macrocephala are the assistant herbs to nourish blood, soften the liver, dispel wind and dampness, and strengthen the spleen and replenish qi; corydalis and codonopsis are the adjuvant herbs to invigorate blood, relieve pain, promote body fluid production, and harmonize the stomach; and licorice is the guiding herb to harmonize the other herbs. The entire formula can quickly neutralize gastric acid and protect the gastric mucosa. Meanwhile, the slow-release agent modified carboxymethyl konjac glucomannan of the present invention is a neohesperidin dihydrochalcone modified carboxymethyl konjac glucomannan. Neohesperidin dihydrochalcone has the effect of inhibiting gastric acid secretion and can work synergistically with the traditional Chinese medicine ingredient cuttlebone to exert an acid-neutralizing effect and jointly play a role in protecting the gastric mucosa.

[0059] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them. The basic principles and main features of the present invention have been described above with specific implementation schemes. Based on the present invention, some modifications or substitutions can be made, but these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of protection claimed by the present invention.

Claims

1. A traditional Chinese medicine preparation for treating gastritis, characterized in that, The raw materials include the following parts by weight: 40-50 parts of traditional Chinese medicine composition, 10-15 parts of sustained-release agent, 25-32 parts of filler, and 3-8 parts of flavoring agent; wherein the sustained-release agent is modified carboxymethyl konjac glucomannan; wherein the filler is Cordyceps militaris polysaccharide and lactose; and wherein the flavoring agent is aspartame or sucralose.

2. The traditional Chinese medicine preparation for treating gastritis according to claim 1, characterized in that, The preparation method of the modified carboxymethyl konjac glucomannan is as follows: (1) Add carboxymethyl konjac glucomannan to deionized water to obtain carboxymethyl konjac glucomannan aqueous solution; then add EDC and NHS and stir to obtain a mixed solution; (2) Add neohesperidin dihydrochalcone to anhydrous ethanol to obtain neohesperidin dihydrochalcone solution; add the neohesperidin dihydrochalcone solution to the mixed solution, and after the reaction, dialyze and freeze dry to obtain the final product.

3. The traditional Chinese medicine preparation for treating gastritis according to claim 2, characterized in that, In step (1), the mass ratio of carboxymethyl konjac glucomannan, EDC, and NHS is 10:(8-9):(5-6); the concentration of the carboxymethyl konjac glucomannan aqueous solution is 2-3wt%; and the stirring time is 30-45min.

4. The traditional Chinese medicine preparation for treating gastritis according to claim 2, characterized in that, In step (2), the mass ratio of neohesperidin dihydrochalcone to carboxymethyl konjac glucomannan is (6-7):10; the concentration of neohesperidin dihydrochalcone solution is 5-10wt%; and the reaction time is 6-8h.

5. The traditional Chinese medicine preparation for treating gastritis according to claim 1, characterized in that, The mass ratio of Cordyceps militaris polysaccharide to lactose is 1:(0.8-1).

6. The method for preparing a traditional Chinese medicine preparation for treating gastritis according to any one of claims 1-5, characterized in that, Includes the following steps: Weigh out the raw materials according to the following proportions by weight: traditional Chinese medicine composition, sustained-release agent, filler, and flavoring agent. Mix and granulate to obtain the traditional Chinese medicine preparation.

7. The method for preparing the traditional Chinese medicine preparation for treating gastritis according to claim 6, characterized in that, The traditional Chinese medicine preparation is in the form of tablets.

8. The method for preparing the traditional Chinese medicine preparation for treating gastritis according to claim 6, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: cuttlebone 18-22 parts, astragalus 15-20 parts, white peony root 9-13 parts, two-colored maple 11-14 parts, atractylodes macrocephala 10-15 parts, corydalis 7-12 parts, codonopsis pilosula 5-10 parts, and licorice 3-5 parts.

9. The method for preparing the traditional Chinese medicine preparation for treating gastritis according to claim 8, characterized in that, The preparation method of the traditional Chinese medicine composition is as follows: (a) Weigh each raw material of the Chinese medicine composition according to the weight parts, mix them evenly and crush them, and sieve them to obtain crude drug powder; (b) Add 8-12 times the weight of water to the crude drug powder, decoct to obtain a primary filtrate and a residue; add 8-10 times the weight of water to the residue, decoct to obtain a secondary filtrate, combine the primary and secondary filtrates, concentrate under reduced pressure to obtain an extract, thus obtaining the traditional Chinese medicine composition.

10. The method for preparing the traditional Chinese medicine preparation for treating gastritis according to claim 9, characterized in that, In step (b), the decoction time is 1-2 hours; the relative density of the extract is 1.10-1.25.

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