A Chinese medicine pill for treating gastric ulcer and duodenal ulcer and a preparation method thereof

Abstract

This invention relates to the field of traditional Chinese medicine preparation technology, specifically to a traditional Chinese medicine pill for treating gastric and duodenal ulcers and its preparation method. The raw materials for preparing the traditional Chinese medicine pill include the following components in parts by weight: 6-9 parts dandelion, 5-7 parts astragalus, 4-6 parts poria cocos, 2-3 parts licorice, 1-1.5 parts ginger, 4-6 parts bletilla striata, and 6-9 parts loquat leaf. The prepared traditional Chinese medicine pill can effectively inhibit ulcers.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, specifically to a traditional Chinese medicine pill for treating gastric ulcers and duodenal ulcers and its preparation method. Background Technology

[0002] Gastric and duodenal ulcers, also known as peptic ulcers, are common gastrointestinal diseases. Their causes include genetics and improper diet, such as excessive alcohol consumption, excessive aspirin use, mental stress, overwork, and other infections leading to excessive secretion of gastric acid and pepsin, spasms of the smooth muscles of the stomach and duodenum, poor blood supply, reduced resistance of the gastrointestinal mucosa to gastric acid erosion, and friction damage from food. They are often accompanied by symptoms such as gastrointestinal bleeding, gastric perforation, and pyloric obstruction; in severe cases, they can lead to cancer. Currently, the main medications for treating gastric and duodenal ulcers, both domestically and internationally, are aluminum magnesium gel and acetaminophen. These medications can only relieve symptoms or treat specific clinical symptoms, often failing to achieve a cure. Many Western medicine preparations inevitably have significant adverse reactions such as rashes, diarrhea, and liver damage in treating these diseases, resulting in significant side effects, liver damage, and a high recurrence rate. Summary of the Invention

[0003] To address the shortcomings of existing technologies, this invention proposes a traditional Chinese medicine pill for treating gastric and duodenal ulcers, and its preparation method.

[0004] This invention is achieved through the following technical solution: A traditional Chinese medicine pill for treating gastric and duodenal ulcers, the raw materials for preparation include the following components in parts by weight: 6-9 parts dandelion, 5-7 parts astragalus, 4-6 parts poria cocos, 2-3 parts licorice, 1-1.5 parts ginger, 4-6 parts bletilla striata, and 6-9 parts loquat leaf.

[0005] Furthermore, the raw materials for preparing the traditional Chinese medicine pills for treating gastric and duodenal ulcers also include the following components in parts by weight: 0.1-0.2 parts of compound fermentation agent.

[0006] Furthermore, the compound fermentation agent is composed of *Lactobacillus plantarum* and *Bifidobacterium longum* in a 1:1 mass ratio; the viable counts of *Lactobacillus plantarum* and *Bifidobacterium longum* are 5 × 10⁻⁶. 10 CFU / g and 1×10 10 CFU / g.

[0007] Furthermore, the present invention also provides a method for preparing the traditional Chinese medicine pills for treating gastric ulcers and duodenal ulcers, comprising the following steps: S1. Dry and pulverize dandelion, astragalus, poria cocos and licorice and pass them through an 80-100 mesh sieve. Add them to deionized water at a material-to-liquid ratio of 1 g: 10 mL. Sterilize at 80℃ for 30 min, inoculate with compound fermentation agent, ferment at 37℃ for 24 h, sterilize at 80℃ for 30 min, centrifuge, collect the supernatant and freeze dry to obtain fermentation extract. S2. Take fresh ginger, wash it, mash it, add an appropriate amount of distilled water, and press to obtain juice. Add an appropriate amount of water to the ginger residue and press again. Combine the two juices to obtain ginger juice. S3. Take Bletilla striata and loquat leaves, wash and dry them, pour in the ginger juice obtained in step S3, seal with plastic wrap and let it soak thoroughly until the ginger juice is absorbed, put it into a stir-frying machine and stir-fry at 80℃ for 50-60 minutes to obtain ginger-processed Chinese medicine. S4. Mix the fermented extract obtained in step S1 and the ginger-processed Chinese medicine obtained in step S3, pulverize them through a 100-mesh sieve to obtain mixed powder, and use a pill-making machine to make pills of 6-8 mm to obtain Chinese medicine pills for treating gastric ulcers and duodenal ulcers.

[0008] Furthermore, in step S3, the ratio of ginger juice to ginger is 1:1.

[0009] Compared with the prior art, the present invention has the following beneficial effects: This invention provides a traditional Chinese medicine pill for treating gastric and duodenal ulcers. Through the synergistic effects of herbal formulation, probiotic fermentation extraction, and ginger-processing techniques, it achieves comprehensive treatment of peptic ulcers with significant efficacy. The medicinal materials in this invention complement each other and enhance each other's effects. Dandelion has significant heat-clearing, detoxifying, antibacterial, and anti-inflammatory effects, effectively inhibiting inflammatory bacteria, reducing the release of inflammatory mediators, and alleviating gastric mucosal damage. Astragalus can enhance the body's immune function, improve the proliferation capacity of gastric mucosal cells, promote angiogenesis and granulation tissue formation, and accelerate ulcer healing. Poria can strengthen the spleen and eliminate dampness, improve gastrointestinal dysfunction, reduce gastrointestinal edema and inflammatory exudation, and provide a stable internal environment for tissue repair. Licorice has anti-inflammatory, antioxidant, and mucosal protective effects, and can enhance the gastric mucus and bicarbonate barrier. Bletilla striata is rich in Bletilla striata gum and polysaccharides, which form a protective film upon contact with water, covering the ulcer surface, reducing the continuous erosion of the wound by gastric acid and pepsin, and promoting hemostasis and epithelial regeneration. Loquat leaves have the effects of clearing stomach heat and relieving nausea and vomiting, which can alleviate acid reflux and nausea. Their flavonoid components also have good anti-inflammatory effects. Ginger can inhibit excessive gastric acid secretion, promote gastric emptying, improve local blood circulation, and reduce inflammation and oxidative damage. These medicinal materials exert their effects in multiple ways, including antibacterial, anti-inflammatory, acid-suppressing, gastric mucosal protection, and regeneration promotion, thus significantly improving the treatment efficacy of gastric and duodenal ulcers. This invention is the first to use *Lactobacillus plantarum* and *Bifidobacterium longum* for the synergistic fermentation of dandelion, astragalus, poria cocos, and licorice. During fermentation, microorganisms secrete various enzymes that effectively destroy the plant cell wall structure, allowing polysaccharides, flavonoids, saponins, and phenolic acids to be fully released. Simultaneously, glycosides are converted into more easily absorbed small-molecule aglycones, improving the solubility and intestinal absorption efficiency of the active ingredients. Fermentation also produces lactic acid, short-chain organic acids, and active metabolites, which help inhibit the growth of harmful bacteria, regulate the gastrointestinal microecology, and reduce inflammatory responses. Therefore, compared with traditional water extraction processes, the fermented extract of this invention has a higher content of active ingredients and a superior anti-ulcer effect. This invention utilizes ginger juice to process Bletilla striata and loquat leaves. During the soaking and stir-frying process, the volatile oils and gingerol in the ginger juice penetrate into the medicinal tissue, enhancing the astringent, hemostatic, and tissue-regenerating abilities of Bletilla striata, allowing it to form a denser and more stable protective layer on the ulcer surface; reducing the cold and irritating properties of loquat leaves, improving its suitability for patients with spleen and stomach deficiency; giving the medicinal materials a better warming and antiemetic effect, reducing symptoms such as acid reflux and nausea; and promoting component transformation through heating, increasing the release efficiency of active ingredients. Therefore, ginger processing makes the medicinal properties more mild and significantly enhances its protective and repairing effects on the gastric mucosa. Attached Figure Description

[0010] To more clearly illustrate the technical solutions in this invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only for this invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0011] Figure 1 The gastric ulcer inhibition rate of the traditional Chinese medicine pills described in Examples 1-3 and Comparative Examples 1-6 of this invention; Figure 2 This demonstrates the gastric ulcer inhibitory effect of the traditional Chinese medicine pills described in Example 1 of this invention. Figure 3 The duodenal ulcer inhibition rate of the traditional Chinese medicine pills described in Examples 1-3 and Comparative Examples 1-6 of this invention. Detailed Implementation

[0012] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to specific embodiments. However, this invention is not limited to the following embodiments. It should be noted that, unless otherwise specified, all chemical reagents involved in this invention are purchased through commercial channels.

[0013] Example 1: A traditional Chinese medicine pill for treating gastric ulcers and duodenal ulcers, the raw materials for preparation include the following components in parts by weight: 9 parts dandelion, 7 parts astragalus, 6 parts poria cocos, 3 parts licorice, 1.5 parts ginger, 6 parts bletilla striata, and 9 parts loquat leaf.

[0014] The raw materials for preparing traditional Chinese medicine pills for treating gastric and duodenal ulcers also include the following components by weight: 0.2 parts of compound fermentation agent.

[0015] The compound fermentation agent is composed of *Lactobacillus plantarum* and *Bifidobacterium longum* in a 1:1 mass ratio; the viable counts of *Lactobacillus plantarum* and *Bifidobacterium longum* are 5 × 10⁻⁶. 10 CFU / g and 1×10 10 CFU / g.

[0016] This embodiment also provides a method for preparing the traditional Chinese medicine pills for treating gastric and duodenal ulcers, including the following steps: S1. The dandelion, astragalus, poria and licorice were dried, pulverized and passed through a 100-mesh sieve. They were added to deionized water at a material-to-liquid ratio of 1 g: 10 mL, sterilized at 80℃ for 30 min, inoculated with a compound fermentation agent, fermented at 37℃ for 24 h, sterilized at 80℃ for 30 min, and the supernatant was collected by centrifugation and freeze-dried to obtain the fermentation extract. S2. Take fresh ginger, wash it, mash it, add an appropriate amount of distilled water, and press to obtain juice. Add an appropriate amount of water to the ginger residue and press again. Combine the two juices to obtain ginger juice. The ratio of ginger juice to fresh ginger is 1:1. S3. Take Bletilla striata and loquat leaves, wash and dry them, pour in the ginger juice obtained in step S3, seal with plastic wrap and let it soak thoroughly until the ginger juice is absorbed, put it into a stir-frying machine and stir-fry at 80℃ for 60 minutes to obtain ginger-processed Chinese medicine. S4. Mix the fermented extract obtained in step S1 and the ginger-processed Chinese medicine obtained in step S3, pulverize them through a 100-mesh sieve to obtain mixed powder, and use a pill-making machine to make pills of 8 mm to obtain Chinese medicine pills for treating gastric ulcers and duodenal ulcers.

[0017] Example 2: A traditional Chinese medicine pill for treating gastric ulcers and duodenal ulcers, the raw materials for preparation include the following components in parts by weight: 6 parts dandelion, 5 parts astragalus, 4 parts poria cocos, 2 parts licorice, 1 part ginger, 4 parts bletilla striata, and 6 parts loquat leaf.

[0018] The raw materials for preparing traditional Chinese medicine pills for treating gastric and duodenal ulcers also include the following components by weight: 0.1 parts of compound fermentation agent.

[0019] The compound fermentation agent is composed of *Lactobacillus plantarum* and *Bifidobacterium longum* in a 1:1 mass ratio; the viable counts of *Lactobacillus plantarum* and *Bifidobacterium longum* are 5 × 10⁻⁶. 10 CFU / g and 1×10 10 CFU / g.

[0020] This embodiment also provides a method for preparing the traditional Chinese medicine pills for treating gastric and duodenal ulcers, including the following steps: S1. The dandelion, astragalus, poria and licorice were dried, pulverized and passed through an 80-mesh sieve. They were added to deionized water at a material-to-liquid ratio of 1 g: 10 mL, sterilized at 80℃ for 30 min, inoculated with a compound fermentation agent, fermented at 37℃ for 24 h, sterilized at 80℃ for 30 min, and the supernatant was collected by centrifugation and freeze-dried to obtain the fermentation extract. S2. Take fresh ginger, wash it, mash it, add an appropriate amount of distilled water, and press to obtain juice. Add an appropriate amount of water to the ginger residue and press again. Combine the two juices to obtain ginger juice. The ratio of ginger juice to fresh ginger is 1:1. S3. Take Bletilla striata and loquat leaves, wash and dry them, pour in the ginger juice obtained in step S3, seal with plastic wrap and let it soak thoroughly until the ginger juice is absorbed, put it into a stir-frying machine and stir-fry at 80℃ for 50 minutes to obtain ginger-processed Chinese medicine. S4. Mix the fermented extract obtained in step S1 and the ginger-processed Chinese medicine obtained in step S3, pulverize them and pass them through a 100-mesh sieve to obtain mixed powder, and use a pill-making machine to make pills of 6 mm to obtain Chinese medicine pills for treating gastric ulcers and duodenal ulcers.

[0021] Example 3: A traditional Chinese medicine pill for treating gastric ulcers and duodenal ulcers, the raw materials for preparation include the following components in parts by weight: 8 parts dandelion, 6 parts astragalus, 5 parts poria cocos, 2.5 parts licorice, 1.2 parts ginger, 5 parts bletilla striata, and 7 parts loquat leaf.

[0022] The raw materials for preparing traditional Chinese medicine pills for treating gastric and duodenal ulcers also include the following components by weight: 0.15 parts of compound fermentation agent.

[0023] The compound fermentation agent is composed of *Lactobacillus plantarum* and *Bifidobacterium longum* in a 1:1 mass ratio; the viable counts of *Lactobacillus plantarum* and *Bifidobacterium longum* are 5 × 10⁻⁶. 10 CFU / g and 1×10 10 CFU / g.

[0024] This embodiment also provides a method for preparing the traditional Chinese medicine pills for treating gastric and duodenal ulcers, including the following steps: S1. The dandelion, astragalus, poria and licorice were dried, pulverized and passed through a 90-mesh sieve. They were added to deionized water at a material-to-liquid ratio of 1 g: 10 mL, sterilized at 80℃ for 30 min, inoculated with a compound fermentation agent, fermented at 37℃ for 24 h, sterilized at 80℃ for 30 min, and the supernatant was collected by centrifugation and freeze-dried to obtain the fermentation extract. S2. Take fresh ginger, wash it, mash it, add an appropriate amount of distilled water, and press to obtain juice. Add an appropriate amount of water to the ginger residue and press again. Combine the two juices to obtain ginger juice. The ratio of ginger juice to fresh ginger is 1:1. S3. Take Bletilla striata and loquat leaves, wash and dry them, pour in the ginger juice obtained in step S3, seal with plastic wrap and let it soak thoroughly until the ginger juice is absorbed, put it into a stir-frying machine and stir-fry at 80℃ for 55 minutes to obtain ginger-processed Chinese medicine. S4. Mix the fermented extract obtained in step S1 and the ginger-processed Chinese medicine obtained in step S3, pulverize them through a 100-mesh sieve to obtain mixed powder, and use a pill-making machine to make 7 mm pills to obtain Chinese medicine pills for treating gastric ulcers and duodenal ulcers.

[0025] The only difference between Comparative Example 1 and Example 1 is that Bletilla striata and loquat leaves are not processed with ginger.

[0026] The only difference between Comparative Example 2 and Example 1 is that the fermentation extract was replaced with an aqueous extract of dandelion, astragalus, poria cocos and licorice.

[0027] The only difference between Comparative Example 3 and Example 1 is that loquat leaves were not added.

[0028] The only difference between Comparative Example 4 and Example 1 is that Poria cocos and licorice were not added.

[0029] The only difference between Comparative Example 5 and Example 1 is that ginger-processed Chinese medicine was not added.

[0030] The only difference between Comparative Example 6 and Example 1 is that no fermentation extract was added.

[0031] Experimental Example 1: Wistar rats (male, 180-220 g) were acclimatized for 7 days and then randomly divided into a model group, Example 1-3 groups, and Comparative Example 1-6 groups, with 8 rats in each group. Before surgery, all rats were fasted and deprived of water for 24 hours. They were anesthetized by intraperitoneal injection of 10% chloral hydrate (3 mL / kg), fixed, and the upper abdomen was prepared, disinfected, and draped with surgical drapes. A longitudinal incision of approximately 1.5-2.0 cm below the xiphoid process was made to expose the stomach. 0.3 mL of 30% acetic acid solution was injected subserosa in the anterior wall of the stomach near the pylorus (at the junction of the stomach and body near the lesser curvature). Iodine-soaked cotton was applied to the bleeding site until no significant bleeding occurred. The abdomen was then rinsed with physiological saline, and the stomach was returned to the abdominal cavity. The peritoneum, muscle layer, and skin were sutured layer by layer, and the area was disinfected with iodine-soaked cotton multiple times. One day post-surgery, mice in Examples 1-3 and Comparative Examples 1-6 were administered the traditional Chinese medicine pills prepared in Examples 1-3 and Comparative Examples 1-6, respectively, at a dosage of 5 g / kg, once daily. Mice in the blank control group and model group were administered 10 mL of physiological saline. Administration continued for 7 days. Twelve hours after administration on the 7th day, rats were anesthetized, the abdominal cavity was opened, and stomach tissue was harvested. The tissue was cut along the greater curvature of the stomach, cleaned with physiological saline, and fixed in 4% paraformaldehyde. The ulcer area was measured, and the ulcer inhibition rate was calculated. The results are as follows: Figure 1 As shown. HE staining was performed on the model group and the Example 1 group, and the results are as follows. Figure 2 As shown.

[0032] Figure 1 The results showed that, 7 days after administration, the ulcer inhibition rate of Examples 1-3 was significantly better than that of Comparative Examples 1-6. Figure 2 The results showed that in the model group rats, multifocal necrosis was observed, with numerous gastric glands necrosis and disappearance, a small amount of fibroblast proliferation (black arrows), accompanied by focal infiltration of a large number of lymphocytes and a small number of granulocytes (red arrows). The gastric glands around the injury were irregular in shape and arrangement, with a small number of gastric glands dilated. Inflammatory cells and necrotic tissue fragments were visible in the lumen (yellow arrows). In contrast, in the Example 1 group, the gastric mucosa surface was a single layer of columnar epithelium with normal epithelial cell morphology and structure. The gastric glands were tubular glands composed of chief cells and parietal cells, abundant in number, regularly arranged, and without obvious abnormalities. These results indicate that the important pill prepared in this invention can effectively treat gastric ulcers.

[0033] Experimental Example 2: Following the method in Experimental Example 1, SD rats were divided into groups. After anesthetizing, the skin was disinfected, the abdominal cavity was opened, and a glass tube with an inner diameter of 3 mm was placed vertically and gently on the serosa of the anterior wall of the duodenum, 0.5 cm below the pylorus. 0.075 mL of 70% acetic acid was injected into the tube. After 15 seconds, the acetic acid was aspirated, and the abdomen was closed, thus obtaining a duodenal ulcer model. The drug was administered one day post-surgery, using the same method as in Experimental Example 1.

[0034] Figure 3 The results showed that after 7 days of administration, the ulcer inhibition rate of Examples 1-3 was significantly better than that of Comparative Examples 1-6. Comparative Example 1 did not involve ginger-processing of Bletilla striata and loquat leaves; Comparative Example 2 used water extracts of dandelion, Astragalus membranaceus, Poria cocos, and licorice instead of the fermented extract; Comparative Example 3 did not add loquat leaves; Comparative Example 4 did not add Poria cocos or licorice; Comparative Example 5 did not add ginger-processed herbs; and Comparative Example 6 did not add the fermented extract. All of these modifications reduced the ulcer inhibition rate, indicating that the components of this invention have a synergistic effect and are effective in treating gastric and duodenal ulcers.

[0035] Those skilled in the art should understand that the discussion of any of the above embodiments is merely exemplary and is not intended to imply that the scope of the invention is limited to these examples; within the framework of the invention, the technical features of the above embodiments or different embodiments can also be combined, the steps can be implemented in any order, and there are many other variations of the different aspects of the invention as described above, which are not provided in detail for the sake of brevity.

Claims

1. A traditional Chinese medicine pill for treating gastric and duodenal ulcers, characterized in that, The raw materials for preparation include the following components in parts by weight: 6-9 parts dandelion, 5-7 parts astragalus, 4-6 parts poria cocos, 2-3 parts licorice, 1-1.5 parts ginger, 4-6 parts bletilla striata, and 6-9 parts loquat leaf.

2. The traditional Chinese medicine pill for treating gastric and duodenal ulcers according to claim 1, characterized in that, The raw materials also include the following components by weight: 0.1-0.2 parts of compound fermentation agent.

3. The traditional Chinese medicine pill for treating gastric and duodenal ulcers according to claim 2, characterized in that, The compound fermentation agent is composed of *Lactobacillus plantarum* and *Bifidobacterium longum* in a 1:1 mass ratio; the viable counts of *Lactobacillus plantarum* and *Bifidobacterium longum* are 5 × 10⁻⁶. 10 CFU / g and 1×10 10 CFU / g.

4. A method for preparing a traditional Chinese medicine pill for treating gastric ulcers and duodenal ulcers as described in any one of claims 1-3, characterized in that, Includes the following steps: S1. Dry and pulverize dandelion, astragalus, poria cocos and licorice, add them to deionized water, sterilize, inoculate with compound fermentation agent, ferment, sterilize, centrifuge to collect supernatant, freeze dry to obtain fermentation extract; S2. Take fresh ginger, wash it, mash it, add an appropriate amount of distilled water, and press to obtain juice. Add an appropriate amount of water to the ginger residue and press again. Combine the two juices to obtain ginger juice. S3. Take Bletilla striata and loquat leaves, wash and dry them, pour in the ginger juice obtained in step S3, seal and let it soak thoroughly until the ginger juice is absorbed, stir-fry to obtain ginger-processed Chinese medicine; S4. Mix the fermented extract obtained in step S1 and the ginger-processed Chinese medicine obtained in step S3, pulverize them to obtain mixed powder, and make pills to obtain Chinese medicine pills for treating gastric ulcers and duodenal ulcers.

5. The method for preparing the traditional Chinese medicine pills for treating gastric and duodenal ulcers according to claim 4, characterized in that, In step S3, the ratio of ginger juice to ginger is 1:1.

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