Traditional Chinese medicine compound preparation for treating helicobacter pylori infection and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine compositions, in particular to a traditional Chinese medicine compound preparation for treating helicobacter pylori infection and a preparation method thereof. The invention provides a traditional Chinese medicine compound preparation for treating helicobacter pylori infection. The traditional Chinese medicine compound preparation comprises the following components in parts by mass: 3-7 parts of coptis chinensis, 8-12 parts of scutellaria baicalensis, 13-17 parts of dandelion, 3-5 parts of fructus evodiae, 13-17 parts of fried coix seeds, 13-17 parts of codonopsis pilosula, 8-12 parts of rhizoma pinelliae preparata and 5-7 parts of liquorice. Research results show that the total effective rate of traditional Chinese medicine syndromes of a test group reaches 91.30% and is obviously higher than 69.57% of that of a control group. In addition, the Hp eradication rate of a test group also reaches 91.30%, which is obviously superior to the Hp eradication rate (69.57%) of a control group. Therefore, the traditional Chinese medicine compound has a synergistic enhancement effect in the aspects of improving clinical symptoms of patients and eradicating Hp, and is especially suitable for spleen and stomach damp-heat (or cold and heat intermingled) type patients after treatment failure of a standard quadruple therapy.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition technology, and in particular to a traditional Chinese medicine compound preparation for treating Helicobacter pylori infection and its preparation method. Background Technology

[0002] Helicobacter pylori (Hp) is a Gram-negative microaerophilic bacterium with a global infection rate exceeding 50%. It is a major pathogenic factor for chronic gastritis, peptic ulcers, gastric mucosa-associated lymphoid tissue lymphoma, and gastric cancer. Currently, quadruple therapy containing bismuth or proton pump inhibitors is mainly used as the first-line treatment in clinical practice. However, this approach suffers from problems such as increased antibiotic resistance, rising treatment failure rates, gut microbiota dysbiosis, and significant side effects. In particular, with the widespread use of antibiotics such as clarithromycin and metronidazole, the proportion of drug-resistant strains has been increasing year by year, leading to a significant decline in eradication rates. Therefore, there is an urgent need to develop alternative or adjuvant therapy strategies.

[0003] Traditional Chinese medicine (TCM) possesses unique advantages in treating Helicobacter pylori infection. Its multi-component, multi-target mechanism of action can effectively inhibit bacterial growth, reduce inflammatory responses, and regulate host immunity. Existing studies have shown that single herbs such as Coptis chinensis, Scutellaria baicalensis, and Rheum palmatum, as well as some compound formulas (such as Banxia Xiexin Decoction and Zuojin Pill), exhibit certain antibacterial and mucosal protective effects in vitro and in clinical practice. However, most traditional compound formulas suffer from fixed compatibility, insufficient dosage standardization, and unclear mechanisms of action. Furthermore, they lack optimized designs targeting modern drug-resistant strains, making it difficult to meet the current clinical demand for highly effective, safe, and standardized preparations.

[0004] Furthermore, the preparation process of traditional Chinese medicine compound preparations directly affects the dissolution, stability, and bioavailability of their active ingredients. Traditional decoction methods have low extraction efficiency and easily destroy components, while modern extraction technologies (such as ultrasonic extraction and supercritical fluid extraction) can improve the extraction rate. However, how to balance the physicochemical properties of multiple medicinal materials and ensure the synergistic effect of the overall efficacy of the compound remains a technical challenge. Therefore, developing a highly efficient compound preparation targeting the drug resistance characteristics of Helicobacter pylori and based on modern traditional Chinese medicine processes has significant clinical significance and market value. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine compound preparation for treating Helicobacter pylori infection and its preparation method.

[0006] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0007] This invention provides a traditional Chinese medicine compound preparation for treating Helicobacter pylori infection, comprising the following components in parts by weight: Coptis chinensis 3-7 parts, Scutellaria baicalensis 8-12 parts, Taraxacum mongolicum 13-17 parts, Evodia rutaecarpa 3-5 parts, Coix lacryma-jobi (fried) 13-17 parts, Codonopsis pilosula 13-17 parts, Pinellia ternata (processed) 8-12 parts, and Glycyrrhiza uralensis 5-7 parts.

[0008] This invention provides a method for preparing a traditional Chinese medicine compound preparation for treating Helicobacter pylori infection, comprising the following steps:

[0009] (1) Mix Coptis chinensis, Scutellaria baicalensis, Taraxacum mongolicum, Evodia rutaecarpa, stir-fried Coix lacryma-jobi, Codonopsis pilosula, Pinellia ternata and Glycyrrhiza uralensis to obtain material 1; mix material 1 with water, soak, decoct, and filter to obtain filtrate and residue;

[0010] (2) The filter residue is mixed with water and boiled, and then filtered to obtain the decoction;

[0011] (3) Simply mix the filtrate and the decoction.

[0012] Preferably, the mass ratio of material 1 to water in step (1) is 1:5 to 8.

[0013] Preferably, the soaking time in step (1) is 25 to 35 minutes.

[0014] Preferably, the simmering time in step (1) is 20 to 30 minutes.

[0015] Preferably, the mass ratio of the filter residue to water in step (2) is 1:2 to 3.

[0016] Preferably, the simmering time in step (2) is 5 to 10 minutes.

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] The traditional Chinese medicine preparation provided by this invention is mainly used to treat *H. pylori*-associated gastritis of the spleen and stomach damp-heat (or mixed cold-heat) type. Symptoms include: burning or pain in the stomach; bitter, sticky or bad breath in the mouth; acid reflux and heartburn; belching; poor appetite; loose stools; fatigue. The tongue is red with a yellow and greasy or white and greasy coating, and the pulse is deep and thready.

[0019] The formula of the traditional Chinese medicine preparation provided by this invention is as follows: Pinellia ternata and Evodia rutaecarpa are pungent and hot, dispersing stagnation and opening the flow of Qi; Coptis chinensis and Taraxacum mongolicum are bitter and cold, clearing and draining damp-heat and inhibiting Hp. The combination of these two groups of drugs, pungent and cold, opens and drains damp-heat in the Qi level; Coix lacryma-jobi is stir-fried to strengthen the spleen and drain dampness; Codonopsis pilosula strengthens the spleen and replenishes Qi; Glycyrrhiza uralensis replenishes Qi and strengthens the spleen, harmonizing the effects of all the drugs. The entire formula works to regulate the stomach and strengthen the spleen, clear heat and resolve dampness, inhibit bacteria and regulate Qi, treating Hp-related gastritis of the spleen and stomach damp-heat (or mixed cold and heat) type.

[0020] The traditional Chinese medicine compound preparation of this invention has shown significant technical efficacy in treating Helicobacter pylori infection. Clinical research results show that the total effective rate of TCM syndrome in the experimental group reached 91.30%, significantly higher than the 69.57% in the control group. Furthermore, the Hp eradication rate in the experimental group also reached 91.30%, significantly better than the 69.57% in the control group. This indicates that the traditional Chinese medicine compound has a synergistic effect in improving patients' clinical symptoms and eradicating Hp, and is particularly suitable for patients with spleen and stomach damp-heat (or mixed cold-heat) type who have failed standard quadruple therapy. Detailed Implementation

[0021] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0022] Example 1

[0023] A method for preparing a traditional Chinese medicine compound for treating Helicobacter pylori infection, comprising the following steps:

[0024] (1) Mix 6 parts of Coptis chinensis, 11 parts of Scutellaria baicalensis, 14 parts of Taraxacum mongolicum, 5 parts of Evodia rutaecarpa, 14 parts of stir-fried Coix lacryma-jobi, 16 parts of Codonopsis pilosula, 9 parts of processed Pinellia ternata, and 7 parts of Glycyrrhiza uralensis to obtain material 1; mix material 1 with water at a mass ratio of 1:5 and soak for 27 minutes, decoct for 20 minutes, and filter to obtain filtrate and residue;

[0025] (2) Mix the filter residue with water at a mass ratio of 1:2 and boil for 5 minutes, then filter to obtain the decoction.

[0026] (3) Simply mix the filtrate and the decoction.

[0027] Example 2

[0028] A method for preparing a traditional Chinese medicine compound for treating Helicobacter pylori infection, comprising the following steps:

[0029] (1) Mix 4 parts of Coptis chinensis, 11 parts of Scutellaria baicalensis, 16 parts of Taraxacum mongolicum, 3 parts of Evodia rutaecarpa, 14 parts of stir-fried Coix lacryma-jobi, 14 parts of Codonopsis pilosula, 9 parts of processed Pinellia ternata, and 6 parts of Glycyrrhiza uralensis to obtain material 1; mix material 1 with water at a mass ratio of 1:8 and soak for 33 minutes, decoct for 30 minutes, and filter to obtain filtrate and residue;

[0030] (2) Mix the filter residue with water at a mass ratio of 1:3 and boil for 10 minutes, then filter to obtain the decoction.

[0031] (3) Simply mix the filtrate and the decoction.

[0032] Example 3

[0033] A method for preparing a traditional Chinese medicine compound for treating Helicobacter pylori infection, comprising the following steps:

[0034] (1) Mix 3 parts of Coptis chinensis, 8 parts of Scutellaria baicalensis, 13 parts of Taraxacum mongolicum, 3 parts of Evodia rutaecarpa, 13 parts of stir-fried Coix lacryma-jobi, 13 parts of Codonopsis pilosula, 8 parts of processed Pinellia ternata, and 5 parts of Glycyrrhiza uralensis to obtain material 1; mix material 1 with water at a mass ratio of 1:6 and soak for 27 minutes, decoct for 23 minutes, and filter to obtain filtrate and residue;

[0035] (2) Mix the filter residue with water at a mass ratio of 1:3 and boil for 6 minutes, then filter to obtain the decoction.

[0036] (3) Simply mix the filtrate and the decoction.

[0037] Example 4

[0038] A method for preparing a traditional Chinese medicine compound for treating Helicobacter pylori infection, comprising the following steps:

[0039] (1) Mix 7 parts of Coptis chinensis, 12 parts of Scutellaria baicalensis, 17 parts of Taraxacum mongolicum, 5 parts of Evodia rutaecarpa, 17 parts of stir-fried Coix lacryma-jobi, 17 parts of Codonopsis pilosula, 12 parts of processed Pinellia ternata, and 7 parts of Glycyrrhiza uralensis to obtain material 1; mix material 1 with water at a mass ratio of 1:7 and soak for 29 minutes, decoct for 28 minutes, and filter to obtain filtrate and residue;

[0040] (2) Mix the filter residue with water at a mass ratio of 1:3 and boil for 9 minutes, then filter to obtain the decoction.

[0041] (3) Simply mix the filtrate and the decoction.

[0042] Example 5

[0043] A method for preparing a traditional Chinese medicine compound for treating Helicobacter pylori infection, comprising the following steps:

[0044] (1) Mix 5 parts of Coptis chinensis, 10 parts of Scutellaria baicalensis, 15 parts of Taraxacum mongolicum, 4 parts of Evodia rutaecarpa, 15 parts of stir-fried Coix lacryma-jobi, 15 parts of Codonopsis pilosula, 10 parts of processed Pinellia ternata, and 6 parts of Glycyrrhiza uralensis to obtain material 1; mix material 1 with water at a mass ratio of 1:6 and soak for 30 minutes, decoct for 25 minutes, and filter to obtain filtrate and residue;

[0045] (2) Mix the filter residue with water at a mass ratio of 1:3 and boil for 8 minutes, then filter to obtain the decoction.

[0046] (3) Simply mix the filtrate and the decoction.

[0047] Experimental Example 1

[0048] Clinical study: Forty-six patients who had failed to eradicate Hp(+) and whose CNAG syndrome was of the spleen and stomach damp-heat (or cold-heat mixed type) after first treatment with standard bismuth quadruple therapy (rabeprazole + amoxicillin + clarithromycin + bismuth pectin) at the outpatient clinic of the Department of Gastroenterology, Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine from June 2020 to December 2022 were selected as the study subjects. They were randomly divided into an experimental group (23 cases) and a control group (23 cases) using a random number table.

[0049] In the experimental group, there were 13 males and 10 females, aged 22–72 years, with a mean age of (43.1±10.6) years. In the control group, there were 14 males and 9 females, aged 21–71 years, with a mean age of (42.2±10.4) years. There were no statistically significant differences in the general characteristics of the two groups (P>0.05), indicating comparability.

[0050] Inclusion criteria: ① Meets the clinical diagnostic criteria for Hp(+) and CNAG, and the TCM syndrome type belongs to spleen and stomach damp-heat (or cold-heat mixed) type; ② Meets the criteria for failure of the first standard bismuth quadruple therapy (esomeprazole + amoxicillin + clarithromycin + bismuth) eradication therapy, with an interval of more than 3 months between the time of the current treatment, and has no history of use of Chinese medicine, antibiotics, PPIs, or bismuth preparations that may affect Hp test results in the past month; ③ All patients meeting the inclusion criteria had their clinical symptoms recorded at our hospital before the start of the trial, and underwent 13C-UBT and safety index tests (electrocardiogram, routine blood, urine, and stool tests, liver and kidney function tests, etc.); ④ Age 18-65 years, no gender requirement; ⑤ No underlying diseases such as heart, brain, lung, stomach cancer, liver cancer, or cirrhosis; ⑥ Subjects have good compliance, voluntarily accept and understand the relevant matters of this study, and sign informed consent forms for treatment;

[0051] Exclusion criteria: ① Patients with Hp-negative, chronic atrophic gastritis, or those not exhibiting spleen and stomach damp-heat (mixed cold and heat) syndrome; ② Patients whose first Hp eradication therapy used a non-standard bismuth quadruple therapy (esomeprazole + amoxicillin capsules + clarithromycin + bismuth), with an interval of less than 3 months between treatments and this treatment, and a history of using traditional Chinese medicine, antibiotics, PPIs, or bismuth preparations that may affect Hp test results within 1 month prior to this treatment; ③ Patients with bleeding, obstruction, perforation, or space-occupying lesions; ④ Patients over 65 years of age or under 18 years of age; ⑤ Pregnant or postpartum breastfeeding women; ⑥ Patients with legally defined disabilities; ⑦ Patients with other systemic diseases or mental illnesses; ⑧ Patients allergic to the investigational treatment drugs.

[0052] Treatment methods: ① Control group: Standard bismuth quadruple therapy (pantoprazole sodium enteric-coated capsules + amoxicillin capsules + furazolidone tablets + colloidal bismuth pectin capsules) orally. Pantoprazole sodium enteric-coated capsules, 40mg / dose, taken before breakfast and dinner; amoxicillin capsules, 1000mg / dose, taken immediately after breakfast and dinner; furazolidone tablets, 100mg / dose, taken immediately after breakfast, lunch, and dinner; colloidal bismuth pectin capsules, 150mg / dose, taken before breakfast, lunch, and dinner. Treatment course: 2 weeks. ② Treatment group: In addition to the treatment given to the control group, a traditional Chinese medicine antibacterial and stomach-regulating formula (prepared according to the method in Example 5) was given, 200ml twice daily, one hour before breakfast and dinner. Treatment course: 2 weeks.

[0053] Criteria for determining efficacy: Cured: Patient's symptoms and signs completely disappear, and urease test is negative; Significantly effective: Patient's symptoms and signs significantly improve, and urease test is negative; Effective: Symptoms and signs improve to some extent, and urease test is negative or weakly positive; Ineffective: Symptoms and signs do not improve, and urease test is positive.

[0054] Treatment results:

[0055] 1. Results of TCM syndrome differentiation in the two groups of patients: Experimental group: 6 cases were cured, 8 cases showed significant improvement, 7 cases were effective, and 2 cases were ineffective, with a total effective rate of 91.30%; Control group: 2 cases were cured, 4 cases showed significant improvement, 10 cases were effective, and 7 cases were ineffective, with a total effective rate of 69.57%.

[0056] 2. HP eradication rates of the two groups: experimental group: 91.30%, control group: 69.57%.

[0057] The traditional Chinese medicine compound preparation of this invention has shown significant technical efficacy in treating Helicobacter pylori infection. Clinical research results show that the total effective rate of TCM syndrome in the experimental group reached 91.30%, significantly higher than the 69.57% in the control group. Furthermore, the Hp eradication rate in the experimental group also reached 91.30%, significantly better than the 69.57% in the control group. This indicates that the traditional Chinese medicine compound has a synergistic effect in improving patients' clinical symptoms and eradicating Hp, and is particularly suitable for patients with spleen and stomach damp-heat (or mixed cold-heat) type who have failed standard quadruple therapy.

[0058] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine compound preparation for treating Helicobacter pylori infection, characterized in that, The components include the following parts by weight: Coptis chinensis 3-7 parts, Scutellaria baicalensis 8-12 parts, Taraxacum mongolicum 13-17 parts, Evodia rutaecarpa 3-5 parts, Coix lacryma-jobi (fried) 13-17 parts, Codonopsis pilosula 13-17 parts, Pinellia ternata (processed) 8-12 parts, and Glycyrrhiza uralensis 5-7 parts.

2. The method for preparing a traditional Chinese medicine compound preparation for treating Helicobacter pylori infection as described in claim 1, characterized in that, Includes the following steps: (1) Mix Coptis chinensis, Scutellaria baicalensis, Taraxacum mongolicum, Evodia rutaecarpa, stir-fried Coix lacryma-jobi, Codonopsis pilosula, Pinellia ternata and Glycyrrhiza uralensis to obtain material 1; mix material 1 with water, soak, decoct, and filter to obtain filtrate and residue; (2) The filter residue is mixed with water and boiled, and then filtered to obtain the decoction; (3) Simply mix the filtrate and the decoction.

3. The preparation method according to claim 2, characterized in that, The mass ratio of material 1 to water in step (1) is 1:5 to 8.

4. The preparation method according to claim 2, characterized in that, The soaking time in step (1) is 25 to 35 minutes.

5. The preparation method according to claim 2, characterized in that, The simmering time in step (1) is 20 to 30 minutes.

6. The preparation method according to claim 2, characterized in that, The mass ratio of filter residue to water in step (2) is 1:2 to 3.

7. The preparation method according to claim 2, characterized in that, The simmering time in step (2) is 5 to 10 minutes.