Traditional Chinese medicine preparation for treating peptic ulcer as well as preparation method and application of traditional Chinese medicine preparation

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine preparation for treating peptic ulcer and a preparation method and application thereof. The traditional Chinese medicine preparation is prepared from the following traditional Chinese medicine raw materials in parts by weight: 10-20 parts of sun-dried ginseng, 9-15 parts of roasted rhizoma atractylodis macrocephalae, 9-15 parts of white poria, 3-9 parts of honey-fried licorice root, 9-15 parts of rhizoma pinelliae preparata, 10-20 parts of cuttlebone, 6-12 parts of fructus amomi, 6-12 parts of rhizoma coptidis and 9-15 parts of pericarpium citri reticulatae. Starting from the theory of syndrome differentiation and treatment of traditional Chinese medicine, the traditional Chinese medicine preparation has the functions of tonifying qi and spleen and resolving dampness and descending adverse-rising energy, has a remarkable treatment effect on peptic ulcer, is convenient to take and is easily accepted by patients.

Description

TECHNICAL FIELD

[0001] The application relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine preparation for treating peptic ulcer and a preparation method and application thereof. BACKGROUND

[0002] Peptic ulcer (PU) refers to local tissue defect, inflammatory reaction and necrosis of gastrointestinal mucosa under the action of one or more pathogenic factors, and the necrotic mucosa can reach the mucosal muscle layer or damage deeper layers. Peptic ulcer is a common and frequently-occurring disease of the digestive system, which has the characteristics of long course, different degrees of illness, high recurrence rate, etc. According to different main symptoms, peptic ulcer belongs to the category of diseases such as stomachache, dyspepsia and fullness in traditional Chinese medicine. The typical clinical manifestations of peptic ulcer are rhythmic and periodic pain in the upper abdomen, which can be expressed as distending pain, burning pain, dull pain, night pain or hunger pain, etc. At the same time, there are accompanying symptoms such as heartburn, acid regurgitation, poor sleep, etc. According to the different positions and properties of peptic ulcer, it is divided into gastric ulcer (GU), duodenal ulcer (DU) and special ulcer.

[0003] Modern medicine mainly uses proton pump inhibitors (PPI), H2 receptor antagonists and other acid inhibitors, as well as new bismuth quadruple regimen for eradicating Helicobacter pylori (Hp) to treat peptic ulcer. Bismuth agents, weak alkaline antacids and other drugs for repairing gastric mucosa can also be selected. Although modern medicine has achieved high clinical efficacy in the treatment of peptic ulcer, the adverse reactions of acid inhibitors and antibiotic resistance have become increasingly prominent over time, and the recurrence rate of peptic ulcer within 1 year can reach 60-95%. Ancient Chinese medicine has established a relatively systematic theoretical knowledge from the perspective of syndrome differentiation and treatment, established the basic principles and methods for treating peptic ulcer, and created a large number of effective prescriptions, providing rich theoretical knowledge and clinical experience for later generations of medical researchers and practitioners. The treatment of peptic ulcer with traditional Chinese medicine has been increasingly valued and gradually become a research hotspot. SUMMARY

[0004] In view of the above problems, the application provides a traditional Chinese medicine preparation for treating peptic ulcer and a preparation method and application thereof according to the principle of tonifying qi and invigorating the spleen and removing dampness and reversing adverse flow, which is applied in practice and has achieved good efficacy.

[0005] To solve the above technical problems, the technical scheme adopted by the application is:

[0006] A traditional Chinese medicine preparation for treating peptic ulcer is prepared from the following traditional Chinese medicine raw materials by weight: raw dried ginseng 10-20 parts, fried atractylodes 9-15 parts, white hoelen 9-15 parts, fried licorice 3-9 parts, clear pinellia 9-15 parts, cuttlebone 10-20 parts, amomum 6-12 parts, coptis 6-12 parts, dried tangerine or orange peel 9-15 parts.

[0007] Preferably, the traditional Chinese medicine preparation is prepared from the following traditional Chinese medicine raw materials by weight: raw dried ginseng 12-18 parts, fried atractylodes 11-13 parts, white hoelen 11-13 parts, fried licorice 5-7 parts, clear pinellia 11-13 parts, cuttlebone 12-18 parts, amomum 8-10 parts, coptis 8-10 parts, dried tangerine or orange peel 11-13 parts.

[0008] Preferably, the traditional Chinese medicine preparation is prepared from the following traditional Chinese medicine raw materials by weight: raw dried ginseng 15 parts, fried atractylodes 12 parts, white hoelen 12 parts, fried licorice 6 parts, clear pinellia 12 parts, cuttlebone 15 parts, amomum 9 parts, coptis 9 parts, dried tangerine or orange peel 12 parts.

[0009] Preferably, the traditional Chinese medicine preparation is a capsule or a pill.

[0010] Further, the present application also provides a preparation method of the traditional Chinese medicine preparation, comprising the following steps:

[0011] (1) raw dried ginseng, fried atractylodes, white hoelen, fried licorice, clear pinellia, cuttlebone, amomum, coptis and dried tangerine or orange peel are weighed according to the prescription and then crushed and sieved to 80-120 mesh;

[0012] (2) the crushed medicinal materials are mixed and decocted with water for 2-3 times, the decocted liquid is combined and filtered, and the filtrate is concentrated to a thick paste with a relative density of 1.0-1.8 at 70-80℃;

[0013] (3) the thick paste is dried to prepare dry granules, impurities are removed by sieving, the powder is prepared, and the powder is filled into a capsule shell to prepare a capsule or is mixed with a binder to prepare a pill.

[0014] Preferably, in step (2), the decoction time is 1-2 hours each time, and the filtrate is concentrated to a thick paste with a relative density of 1.5 at 75℃.

[0015] Preferably, in step (3), the binder is honey.

[0016] Further, the present application also provides a use of the traditional Chinese medicine preparation in the preparation of a medicament for treating peptic ulcer.

[0017] Raw dried ginseng: raw dried ginseng tonifies qi, strengthens the body, calms the mind, benefits wisdom, and invigorates the spleen and stomach, promotes the transportation and transformation of the spleen and stomach, and helps digestion and absorption, and has good effects on digestive system diseases.

[0018] Fried atractylodes: Fried atractylodes can benefit the effect of tonifying qi, invigorating the spleen and stopping diarrhea. Modern pharmacological research has found that atractylodes mainly contains volatile oil and internal fat, etc. It has the functions of regulating gastrointestinal function and improving the overall structure of intestinal flora.

[0019] White Poria cocos: The chemical composition of white Poria cocos mainly includes triterpenoids and polysaccharides, etc. Its pharmacological effects are extensive. On the one hand, it can enhance the proliferation of gastrointestinal mucosal epithelial cells, and on the other hand, it can reduce the activity of urease, a virulence factor of Hp, thereby reducing peptic ulcer caused by Hp infection.

[0020] Baked licorice: Baked licorice contains glycyrrhizic acid and flavonoids, which have a strong effect of eliminating Helicobacter pylori. Studies have confirmed that licorice can inhibit the adhesion of Helicobacter pylori, thereby effectively reducing the recurrence rate of gastric ulcer, promoting ulcer healing and enhancing gastrointestinal mucosal protection.

[0021] Clearing pinellia: Pinellia belongs to the category of resolving phlegm. According to its processing method, it can be divided into ginger pinellia, law pinellia and clearing pinellia. Clearing pinellia tends to clear wind phlegm, dry dampness and resolve fluid. Related studies have found that it plays an active role in anti-ulcer, anti-inflammatory, antibacterial, anti-tumor, anti-emesis, phlegm-eliminating and asthma-relieving, and cough-relieving.

[0022] Concha arcae: Concha arcae mainly contains calcium carbonate, mucilage and calcium phosphate. It is generally believed that the neutralization of hydrochloric acid by calcium carbonate is the main mechanism for preventing excessive gastric acid. Concha arcae extract can protect the gastric mucosa. Its mechanism is not only to increase the pH of gastric acid, but also to increase the content of nitric oxide and glutathione in the tissue.

[0023] Cardamom: Cardamom is often used in clinical treatment of gastrointestinal diseases. It can increase the content of phospholipids and amino sugars in the gastric mucosa, thereby promoting the healing of ulcers and having a certain anti-recurrence effect.

[0024] Coptis: Coptis can enhance the immune function of the human body, regulate the internal environment, and has a certain inhibitory effect on various bacteria, especially Helicobacter pylori. Coptis can also effectively protect the gastric mucosa to inhibit the occurrence of ulcers.

[0025] Dried tangerine or orange peel: The chemical components of dried tangerine or orange peel include volatile oils, polysaccharides and flavonoids. It can regulate gastrointestinal factors, coordinate immune cytokines and avoid oxidative stress functional disorders, and also inhibit the expression of anti-inflammatory factors, thereby playing a certain role in regulating gastrointestinal function and anti-inflammatory.

[0026] Compared with the prior art, the present application has the following advantages:

[0027] The traditional Chinese medicine preparation of the present application is prepared according to the theory of syndrome differentiation and treatment in traditional Chinese medicine, and the raw and dried ginseng, fried atractylodes, white poria, fried licorice, clear pinellia, cuttlefish bone, sand ginger, coptis and dried tangerine peel are reasonably matched and used, and outstanding clinical effects are achieved. In the present prescription: the raw and dried ginseng tonifies qi and strengthens the body, and tonifies the spleen and strengthens the stomach; the cuttlefish bone astringes and stops bleeding, and checks acid and promotes healing; the two are the monarch drugs, clear and warm, and the spleen and stomach, not only improving the treatment effect of ulcers, but also making the spleen and stomach regulating effect doubled; the fried atractylodes tonifies qi and invigorates the spleen, the white poria benefits water and removes dampness, the clear pinellia resolves cold phlegm and regulates the spleen and stomach, and the dried tangerine peel regulates qi and warms the stomach, and the four are the minister drugs, which have the effect of invigorating the spleen and stomach; the sand ginger and the spleen promote qi and dissipate distension, and the coptis has strong bacteriostatic effect and protects the gastric mucosa, and the two are the auxiliary drugs, which help to promote the spleen and stomach; the fried licorice regulates the other drugs, and tonifies the spleen and benefits qi, and relieves pain, which has the effects of analgesia, anti-inflammatory and acid inhibition. The drugs are matched, and have the effects of tonifying qi and invigorating the spleen, resolving dampness and reversing adverse flow, which has a significant treatment effect on peptic ulcer, and is convenient to take and easy for patients to accept. In addition, through modern medical experiments, it is confirmed that the traditional Chinese medicine preparation of the present application has good effect on peptic ulcer, and no toxic and side effects are found. DETAILED DESCRIPTION

[0028] The technical solutions in the embodiments of the present application will be described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all the other embodiments obtained by those skilled in the art without creative work belong to the protection scope of the present application. The materials, reagents and the like used, if not specially stated, are the reagents and materials available from commercial channels.

[0029] Example 1: Traditional Chinese medicine capsule for treating peptic ulcer

[0030] Prescription amount: raw and dried ginseng 18g, fried atractylodes 13g, white poria 13g, fried licorice 7g, clear pinellia 13g, cuttlefish bone 18g, sand ginger 10g, coptis 10g, dried tangerine peel 13g.

[0031] Preparation method:

[0032] (1) The raw and dried ginseng, fried atractylodes, white porya, fried licorice, clear pinellia, cuttlefish bone, sand ginger, coptis and dried tangerine peel are weighed according to the prescription, crushed and passed through a 120-mesh sieve;

[0033] (2) The crushed medicinal materials are mixed, decocted with water for 2 times, and the extraction time is 2 hours each time. The decoction liquid is combined and filtered, and the filtrate is concentrated to the extract with a relative density of 1.5 at 75℃;

[0034] (3) The thick paste is dried to prepare dry granules, impurities are removed by sieving, the powder is filled into the capsule shell to prepare the capsule.

[0035] Example 2: Traditional Chinese medicine capsule for treating peptic ulcer

[0036] Prescription amount: raw Shensai 12g, fried Baizhu 11g, Bai Fuling 11g, Zhigancao 5g, Qingbanxia 11g, Haikelong 12g, Sharen 8g, Huanglian 8g, Chenpi 11g.

[0037] Preparation method same as Example 1.

[0038] Example 3 Chinese medicine capsule for treating peptic ulcer

[0039] Prescription amount: raw Shensai 15g, fried Baizhu 12g, Bai Fuling 12g, Zhigancao 6g, Qingbanxia 12g, Haikelong 15g, Sharen 9g, Huanglian 9g, Chenpi 12g.

[0040] Preparation method same as Example 1.

[0041] Comparative Example 1 (compared with Example 3, using Dangshen and pearl instead of raw Shensai and Haikelong respectively)

[0042] Prescription amount: Dangshen 15g, fried Baizhu 12g, Bai Fuling 12g, Zhigancao 6g, Qingbanxia 12g, pearl 15g, Sharen 9g, Huanglian 9g, Chenpi 12g.

[0043] Preparation method same as Example 1.

[0044] Comparative Example 2 (compared with Example 3, using Huangqi, Shanyao, Tiannanxing, Houpu instead of fried Baizhu, Bai Fuling, Qingbanxia, Chenpi respectively)

[0045] Prescription amount: raw Shensai 15g, Huangqi 12g, Shanyao 12g, Zhigancao 6g, Tiannanxing 12g, Haikelong 15g, Sharen 9g, Huanglian 9g, Houpu 12g.

[0046] Preparation method same as Example 1.

[0047] Comparative Example 3 (compared with Example 3, using Bailongren, Chuanxinlian instead of Sharen, Huanglian)

[0048] Prescription amount: raw Shensai 15g, fried Baizhu 12g, Bai Fuling 12g, Zhigancao 6g, Qingbanxia 12g, Haikelong 15g, Bailongren 9g, Chuanxinlian 9g, Chenpi 12g.

[0049] Preparation method same as Example 1.

[0050] Pharmacodynamic experiment research

[0051] Pepsin is a direct attacking factor of peptic ulcer, and nitric oxide is a key index for judging the cure standard of peptic ulcer. The present application adopts acetic acid gavage method to manufacture mouse gastric ulcer model, and judges the treatment effect of Chinese medicine preparation on peptic ulcer by detecting the above two indexes.

[0052] Main experimental materials

[0053] 90 BALB / c male mice, weighing (20±2g), were purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd.

[0054] Mouse pepsinogen C ELISA kit was purchased from Shanghai Jianglai Biotechnology Co., Ltd.

[0055] Mouse nitric oxide ELISA detection kit was purchased from Shanghai Xitang Biotechnology Co., Ltd.

[0056] Animal grouping and modeling method

[0057] The BALB / c male mice were randomly divided into 9 groups, namely normal control group, model control group, positive control group (omeprazole group), example 1-3 groups and comparative example 1-3 groups. After conventional feeding for 7 days, the gastric ulcer model was created by acetic acid gavage. Except for the normal control group, the mice in the other groups were fasted without water after the last feeding, and 1 day later, they were gavaged with acetic acid solution (7.2×10 - 4 mol / L concentration) once. Then the mice were closely observed for abnormal reactions, and the modeling was successful after 24 hours and the normal diet was restored.

[0058] Administration method and route

[0059] The normal group and the gastric ulcer model group of mice were normally raised, and conventional feed and drinking water were given.

[0060] The positive control group (omeprazole group) and the traditional Chinese medicine administration group (example 1-3 groups and comparative example 1-3 groups, the contents of the capsules were dissolved in water to prepare traditional Chinese medicine liquid with a concentration of 20g / L) were gavaged once a day at a fixed time in the evening, and the administration lasted for 14 days. Before daily administration, the mice's eating, drinking, mental state and activity were observed, and the mouse's weight was accurately weighed and recorded with an electronic scale. According to the body surface area conversion, the administration dose of mice was calculated as follows: the positive control group (omeprazole group) was 4mg / kg / d; the traditional Chinese medicine administration group (example 1-3 groups and comparative example 1-3 groups) was 15g / kg / d.

[0061] Sampling method

[0062] After the last administration, the mice were fasted and watered for 12 hours, and the mice were killed before collecting the eye blood of each group of mice. The EP tube containing the mouse eye blood was placed at room temperature for 20 min, and then centrifuged by using a high-speed centrifuge, and the serum was separated and stored in a refrigerator at -20°C for detection. The mouse pepsinogen CELISA kit and the mouse nitric oxide ELISA detection kit were used to detect the expression level of pepsin and the content of nitric oxide in the mouse serum, and the specific operation could refer to the instruction manual of the detection kit.

[0063] Statistical analysis

[0064] The experimental data was expressed as (mean X ± standard deviation S), and the SPSS22.0 software was used for statistical analysis.

[0065] Experimental results

[0066] 1. Effect of traditional Chinese medicine preparation on body weight of gastric ulcer mice (see Table 1)

[0067] Table 1

[0068]

[0069]

[0070] 2. Effect of traditional Chinese medicine preparation on pepsin activity of gastric ulcer mice (see Table 2)

[0071] Table 2

[0072]

[0073] 3. Effect of traditional Chinese medicine preparation on the content of serum nitric oxide of gastric ulcer mice (see Table 3)

[0074]

[0075]

[0076] The occurrence of gastric ulcer is caused by the imbalance of gastric mucosa damage factors and gastric mucosa protection factors. Among them, pepsin is the main damage factor of gastric mucosa, and NO is the main protection factor of gastric mucosa. Specifically, pepsin can reduce the process of decomposing protein molecules and attack the gastric mucosa, thereby causing peptic ulcer; NO can reduce the damage of various causes to the gastric mucosa, play a defense role, and thereby prevent gastric mucosa damage. As can be seen from the experimental results in Tables 1-3, after acetic acid gavage, the mice in the model control group produced obvious ulcer lesions, the mice grew slowly, and the expression level of pepsin in the serum of the mice was significantly increased, and the content of NO was significantly decreased. After gavage treatment with the traditional Chinese medicine preparation of the application for 14 days, the body weight of the mice in the example 1-3 groups was significantly increased, the expression level of pepsin in the serum of the mice was reduced, and the content of NO was increased to different degrees, which proved that the traditional Chinese medicine preparation of the application had obvious improvement effect on the gastric mucosa damage of mice. Among them, the treatment effect of the example 3 group was the best, which was close to the treatment effect of the positive control group omeprazole. In addition, by replacing the similar medicinal ingredients of the raw material components of the traditional Chinese medicine preparation, the treatment effects of the comparative example 1-3 groups were obviously inferior to the application, which again proved that the traditional Chinese medicine preparation of the application was based on the theory of TCM syndrome differentiation and treatment, and the reasonable combination of raw materials of shengsaoren, chaobaishu, bai fuling, zhi gancao, qingbanxia, haipengjiao, sharen, huanglian and chenpi was used to obtain outstanding results. The traditional Chinese medicine preparation for treating peptic ulcer prepared by the application has reasonable combination, low cost, wide drug source and high bioavailability, and has significant effect on the symptoms of peptic ulcer such as nausea, hiccups, acid reflux, abdominal pain, diarrhea, loss of appetite, fatigue and the like caused by spleen deficiency and dampness rising.

[0077] The above only describes the preferred embodiments of the present application, and it should be noted that for those skilled in the art, without departing from the principles of the present application, the technical solutions can be modified or replaced by equivalents, and these modifications or equivalent replacements should also be considered as the protection scope of the present application.

Claims

1. A traditional Chinese medicine preparation for treating peptic ulcers, characterized in that, It is made from the following Chinese medicinal materials in parts by weight: 10-20 parts of sun-dried ginseng, 9-15 parts of stir-fried Atractylodes macrocephala, 9-15 parts of Poria cocos, 3-9 parts of prepared licorice root, 9-15 parts of prepared Pinellia ternata, 10-20 parts of cuttlebone, 6-12 parts of Amomum villosum, 6-12 parts of Coptis chinensis, and 9-15 parts of dried tangerine peel.

2. The traditional Chinese medicine preparation according to claim 1, characterized in that, It is made from the following Chinese medicinal materials in parts by weight: 12-18 parts of sun-dried ginseng, 11-13 parts of stir-fried Atractylodes macrocephala, 11-13 parts of Poria cocos, 5-7 parts of prepared licorice root, 11-13 parts of processed Pinellia ternata, 12-18 parts of cuttlebone, 8-10 parts of Amomum villosum, 8-10 parts of Coptis chinensis, and 11-13 parts of dried tangerine peel.

3. The traditional Chinese medicine preparation according to claim 2, characterized in that, It is made from the following Chinese medicinal materials in parts by weight: 15 parts sun-dried ginseng, 12 parts stir-fried Atractylodes macrocephala, 12 parts Poria cocos, 6 parts prepared licorice root, 12 parts prepared Pinellia ternata, 15 parts cuttlebone, 9 parts Amomum villosum, 9 parts Coptis chinensis, and 12 parts dried tangerine peel.

4. The traditional Chinese medicine preparation according to any one of claims 1-3, characterized in that, The traditional Chinese medicine preparation is in the form of capsules or pills.

5. A method for preparing a traditional Chinese medicine preparation according to any one of claims 1-4, characterized in that, Includes the following steps: (1) Weigh out the following ingredients according to the formula: raw ginseng, stir-fried atractylodes macrocephala, poria cocos, roasted licorice root, prepared pinellia ternata, cuttlebone, amomum villosum, coptis chinensis and tangerine peel, pulverize them and pass them through an 80-120 mesh sieve; (2) Mix the pulverized medicinal materials, add water and decoct 2-3 times, combine the decoctions and filter, concentrate the filtrate to a thick paste with a relative density of 1.0-1.8 at 70-80℃; (3) After the thick paste is dried, it is made into dry granules, sieved to remove impurities, ground into powder, and filled into capsule shells to make capsules, or it is made into pills by adding binder.

6. The preparation method according to claim 5, characterized in that, In step (2), the water decoction is used for 1-2 hours each time, and the filtrate is concentrated to an extract with a relative density of 1.5 at 75°C.

7. The preparation method according to claim 5, characterized in that, The adhesive mentioned in step (3) is honey.

8. Use of the traditional Chinese medicine preparation according to any one of claims 1-4 in the preparation of a medicament for treating peptic ulcers.

Images