Traditional Chinese medicine pill for treating stomach illness and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine pill for treating stomach diseases and a preparation method thereof, and relates to the technical field of traditional Chinese medicines. Active components of the traditional Chinese medicine pill for treating stomach illness comprise a traditional Chinese medicine composition; the traditional Chinese medicine composition is prepared from the following components in parts by weight: 25 to 35 parts of caulis bambusae in taeniam, 20 to 30 parts of rhizoma pinellinae praeparata, 15 to 25 parts of herba equiseti arvensis, 8 to 15 parts of radix scutellariae, 6 to 10 parts of rhizoma corydalis, 5 to 15 parts of rice sprout, 3 to 8 parts of husked sorghum, 2 to 8 parts of radix zanthoxyli, 3 to 5 parts of red halloysite and 2 to 8 parts of herba rabdosiae lophanthoidis. The traditional Chinese medicine pill provided by the invention has a good improvement effect on gastric mucosal lesion, submucosal hemorrhage and extravasated blood caused by bile regurgitation, and has a good treatment effect on inflammatory lesion of gastric mucosa.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine pill for treating gastric disease and a preparation method thereof. Background Art

[0002] Bile reflux gastritis (BRG), also known as alkaline reflux gastritis, refers to the influx of duodenal contents such as bile and pancreatic juice into the stomach due to pyloric sphincter dysfunction or pyloric surgery, which causes inflammation, erosion and bleeding of the gastric mucosa, weakens the barrier function of the gastric mucosa, and causes H. + The increased diffusion leads to chronic lesions of the gastric mucosa, with the main clinical manifestations being recurrent epigastric pain, burning sensation in the stomach, acid reflux, nausea, vomiting, bitter taste in the mouth, bad breath, loss of appetite, etc. If the condition is not controlled in time, the gastric mucosal damage will worsen, and intestinal metaplasia, atrophy, and even cancer may occur.

[0003] The pathogenesis of bile reflux gastritis is complex, mainly related to biliary diseases, gastrointestinal hormones, gastric acid secretion, Helicobacter pylori (Hp) infection, diet and lifestyle, mental and psychological factors, etc. At present, Western medicine mostly adopts symptomatic treatment, and commonly used drugs include bile acid neutralizing drugs, gastrointestinal motility enhancing drugs, acid suppressants, gastric mucosal protective agents, choleretics, anti-Hp drugs, anti-anxiety and depression drugs, etc. However, the above schemes can only improve the patient's symptoms to a certain extent, and the treatment cycle is long, it is easy to relapse after stopping the drug, and the side effects are obvious, which affects the patient's compliance and efficacy.

[0004] Traditional Chinese medicine has the advantages of definite clinical efficacy, relatively safe medication, flexible service methods, relatively low costs, huge innovation potential and broad development space. Therefore, it is very necessary to develop traditional Chinese medicine for the treatment of bile reflux gastritis. Summary of the invention

[0005] The purpose of the present invention is to provide a Chinese medicine pill for treating gastric disease and a preparation method thereof, so as to solve the problems existing in the above-mentioned prior art. The Chinese medicine pill has a good improvement effect on gastric mucosal damage caused by bile reflux and submucosal bleeding and congestion, and has a good therapeutic effect on inflammatory damage of gastric mucosa.

[0006] To achieve the above object, the present invention provides the following solutions:

[0007] The invention provides a traditional Chinese medicine composition for treating gastric disease, comprising the following components in parts by weight: 25-35 parts of ginger bamboo shavings, 20-30 parts of French pinellia tuber, 15-25 parts of equisetum arvense, 8-15 parts of scutellaria baicalensis, 6-10 parts of corydalis, 5-15 parts of malt sprout, 3-8 parts of sorghum rice, 2-8 parts of lianmianzhen, 3-5 parts of red ochre and 2-8 parts of cyperus rotundus;

[0008] The gastric disease is bile reflux gastritis.

[0009] Preferably, the Chinese medicine composition comprises the following components in parts by weight: 30 parts of ginger bamboo shavings, 25 parts of French pinellia, 20 parts of horsetail, 10 parts of scutellaria, 8 parts of Corydalis, 10 parts of malt sprout, 5 parts of sorghum, 5 parts of Zanthoxylum bungeanum, 5 parts of red ochre, 5 parts of red ochre and 5 parts of corydalis.

[0010] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition in preparing a medicine for treating gastric disease, wherein the gastric disease is bile reflux gastritis.

[0011] The present invention also provides a Chinese medicine pill for treating gastric disease, wherein the active ingredient comprises the above-mentioned Chinese medicine composition;

[0012] The gastric disease is bile reflux gastritis.

[0013] Furthermore, the Chinese medicine pills for treating gastric diseases also include pharmaceutically acceptable excipients.

[0014] Furthermore, the auxiliary material includes honey.

[0015] Furthermore, the mass ratio of the traditional Chinese medicine composition to the honey is 2:1.

[0016] The present invention also provides a method for preparing the above-mentioned Chinese medicine pills for treating gastric disease, comprising the following steps:

[0017] According to the raw material formula, all raw materials are weighed and mixed, rolled into fine powder, mixed evenly, sieved, and mixed powder is obtained;

[0018] The mixed medicine powder and honey are evenly mixed to prepare the Chinese medicine pills for treating gastric disease.

[0019] Furthermore, the sieving step uses a 80-100 mesh sieve.

[0020] Furthermore, the mass ratio of the mixed medicinal powder to the honey is 2:1.

[0021] Bamboo shavings are the dried middle layer of the stems of the grass family plants green bamboo, big head bamboo or light bamboo. Ginger bamboo shavings are bamboo shavings mixed with ginger juice and then fried until yellow. It has a sweet and slightly cold nature and enters the lung and stomach meridians. It has the effects of clearing heat and resolving phlegm, relieving restlessness and stopping vomiting.

[0022] French Pinellia is a processed product of Pinellia ternata. It has a pungent and warm nature. It enters the spleen, stomach, and lung meridians and has the effects of drying dampness and resolving phlegm.

[0023] Scutellaria baicalensis is the dried root of the Lamiaceae plant Scutellaria baicalensis; it is bitter and cold in nature; it enters the lung, gallbladder, spleen, large intestine and small intestine meridians; it has the functions of clearing away heat and dampness, purging fire and detoxifying.

[0024] Equisetum arvense is a medium-sized fern of the genus Equisetaceae. It tastes bitter and has a neutral nature. It has the effects of promoting blood circulation, diuresis, anthelmintic, lowering blood pressure, sedation and analgesia.

[0025] Xihuangcao is the dried whole herb of Xihuangcao and Linear Teasel, plants of the Lamiaceae family. It tastes bitter and is cold in nature. It enters the liver, gallbladder, and large intestine meridians. It has the effects of clearing away heat and detoxifying, promoting dampness and relieving jaundice, dispersing blood stasis and reducing swelling.

[0026] Corydalis yanhusuo is the dried tuber of the poppy family plant Corydalis yanhusuo; it tastes pungent and bitter, has a warm nature, and enters the liver and spleen meridians; its main effects are promoting blood circulation, promoting qi circulation, and relieving pain.

[0027] Guya is a processed product of the germinated and dried ripe fruit of the Gramineae plant Setaria italica (L.) Beauv. It tastes sweet and is neutral in nature. It enters the spleen and stomach meridians and has the effects of helping digestion, harmonizing the stomach, strengthening the spleen and stimulating appetite.

[0028] Sorghum is the sticky seed of Setaria italica (L.) Beauv. or Setaria italica (L.) Beauv. var. germanica (Mill.) Schrad. of the Poaceae family. It tastes sweet and is slightly cold in nature. It enters the lung, stomach, and large intestine meridians. It has the effects of dispelling wind and dampness, harmonizing the stomach and calming the nerves, and detoxifying and healing sores.

[0029] Zanthoxylum nitidum (Roxb.) DC. is a dried root of the Rutaceae plant. It tastes bitter and pungent, and is neutral in nature. It enters the liver and stomach meridians. It has the effects of promoting blood circulation and removing blood stasis, promoting qi and relieving pain, dispelling wind and unblocking meridians, and detoxifying and reducing swelling.

[0030] Red ochre is a kind of kaolinite of the kaolinite family of silicate minerals. Its main functions are astringing the intestines, stopping bleeding, promoting tissue regeneration and healing sores.

[0031] The present invention discloses the following technical effects:

[0032] The invention develops a Chinese medicine composition for treating bile reflux gastritis, which uses ginger bamboo shavings, pinellia tuber and aralia arvense as main drugs, which can clear the gallbladder and harmonize the stomach, balance ascending and descending, relieve pain and activate blood circulation; uses scutellaria baicalensis and corydalis as assistant drugs, which can soothe the liver and promote bile secretion; uses malt sprout and sorghum rice as adjuvant drugs, which can stimulate appetite and harmonize the stomach; uses two-sided needle, red ochre and rhizoma cyrtonemae as guiding drugs, which can clear away heat and detoxify, promote dampness and invigorate qi. All the drugs are used together with cold and warm properties, and play the effects of harmonizing the stomach and relieving adverse reactions.

[0033] The Chinese medicine composition provided by the present invention has a good improvement effect on gastric mucosal damage, submucosal bleeding and congestion caused by bile reflux, and has a good therapeutic effect on inflammatory damage to the gastric mucosa. DETAILED DESCRIPTION

[0034] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as limiting the present invention, but should be understood as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0035] It should be understood that the terms described in the present invention are only for describing a particular embodiment and are not intended to limit the present invention. In addition, for the numerical range in the present invention, it should be understood that each intermediate value between the upper and lower limits of the scope is also specifically disclosed. The intermediate value in any stated value or stated range, and each smaller range between any other stated value or intermediate value in the described range is also included in the present invention. The upper and lower limits of these smaller ranges can be independently included or excluded in the scope.

[0036] Unless otherwise indicated, all technical and scientific terms used herein have the same meanings as those generally understood by those skilled in the art. Although the present invention describes only preferred methods and materials, any methods and materials similar or equivalent to those described herein may also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials associated with the documents. In the event of a conflict with any incorporated document, the content of this specification shall prevail.

[0037] It will be apparent to those skilled in the art that various modifications and variations may be made to the specific embodiments of the present invention description without departing from the scope or spirit of the present invention. Other embodiments derived from the present invention description will be apparent to those skilled in the art. The present invention description and examples are exemplary only.

[0038] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

[0039] Example 1

[0040] The raw material formula of the Chinese medicine composition: 25g of ginger bamboo shavings, 30g of French pinellia, 15g of horsetail, 15g of scutellaria, 10g of Corydalis, 15g of malt sprout, 8g of sorghum, 8g of Zanthoxylum bungeanum, 3g of red ochre and 8g of scutellaria baicalensis.

[0041] Preparation method of Chinese medicine pills:

[0042] According to the above raw material formula, all raw materials were weighed and mixed, rolled into fine powder, mixed evenly, and passed through a 100-mesh sieve to obtain a mixed powder; the mixed powder was evenly mixed with honey in a mass ratio of 2:1 to prepare 2g / pill Chinese medicine pills.

[0043] Example 2

[0044] The raw material formula of the Chinese medicine composition: 30g of ginger bamboo shavings, 25g of French pinellia, 20g of horsetail, 10g of scutellaria, 8g of Corydalis, 10g of malt sprout, 5g of sorghum rice, 5g of Zanthoxylum bungeanum, 5g of red ochre and 5g of scutellaria baicalensis.

[0045] Preparation method of Chinese medicine pills:

[0046] According to the above raw material formula, all raw materials were weighed and mixed, rolled into fine powder, mixed evenly, and passed through a 100-mesh sieve to obtain a mixed powder; the mixed powder was evenly mixed with honey in a mass ratio of 2:1 to prepare 2g / pill Chinese medicine pills.

[0047] Example 3

[0048] The raw material formula of the Chinese medicine composition: 35g of ginger bamboo shavings, 20g of French pinellia, 25g of horsetail, 8g of scutellaria, 6g of Corydalis, 5g of malt sprout, 3g of sorghum rice, 2g of Liangmianzhen, 5g of red ochre and 2g of cyperus rotundus.

[0049] Preparation method of Chinese medicine pills:

[0050] According to the above raw material formula, all raw materials were weighed and mixed, rolled into fine powder, mixed evenly, and passed through a 100-mesh sieve to obtain a mixed powder; the mixed powder was evenly mixed with honey in a mass ratio of 2:1 to prepare 2g / pill Chinese medicine pills.

[0051] Comparative Example 1

[0052] Same as Example 2, except that the ginger bamboo shavings are replaced with raw bamboo shavings.

[0053] Comparative Example 2

[0054] Same as Example 2, except that French Pinellia is replaced by Raw Pinellia.

[0055] Comparative Example 3

[0056] Same as Example 2, except that the French Pinellia is replaced by the ginger Pinellia.

[0057] Effect verification example 1

[0058] 1. Experimental Animals

[0059] KM mice, SPF grade, body weight (20±1.5) g, half male and half female.

[0060] 2. Construction of Animal Model

[0061] The reflux fluid was given to the mice by gavage on an empty stomach, once a day, with each dose of 20 mL / kg, for 45 consecutive days, to establish the bile reflux gastritis model mice.

[0062] Preparation method of reflux solution: dissolve 2.5 g of sodium taurocholate, 1.5 g of pancreatic enzyme and 0.25 g of lecithin in 100 mL of normal saline, stir and mix well to prepare reflux solution.

[0063] 3. Experimental Grouping

[0064] 60 bile reflux gastritis model mice were randomly divided into 6 groups, with 10 mice in each group. Each group was intragastrically administered with the drug as shown in Table 1, once a day for 30 days. At the same time, healthy KM mice were used as blank controls.

[0065] Table 1 Experimental groups

[0066]

[0067]

[0068] 4.Indicator detection

[0069] After the last administration, the subjects were fasted for 24 hours, and 2 mL of blood was collected from the abdominal aorta and centrifuged to obtain serum. The serum interleukin-8 (IL-8), tumor necrosis factor (TNF-α) and serum gastrin (GAS) levels were determined using ELISA kits. At the same time, gastric tissue was taken to detect the content of prorepinephrine E2 (PGE2).

[0070] 5. Experimental Results

[0071] (1) Serum IL-8, TNF-α and GAS content test results

[0072] The results of serum IL-8, TNF-α and GAS content in each group are shown in Table 2. Compared with the blank control group, the serum IL-8 and TNF-α levels of mice in the model group were significantly increased (P < 0.01); the serum IL-8 and TNF-α levels of mice in the A1 group were significantly lower than those in the model group (P < 0.01); the serum IL-8 and TNF-α levels of mice in the A2-A4 groups did not decrease significantly.

[0073] GAS is an important gastrointestinal hormone secreted by G cells, which can promote the secretion function of the gastrointestinal tract, promote the contraction of the gastric antrum and gastric body, increase the motility of the gastrointestinal tract, and promote the contraction of the pyloric sphincter, reduce reflux, and play an important role in gastric acid secretion and mucosal protection. Compared with the model group, the GAS content in group A1 was significantly increased (P < 0.01); the GAS content in groups A2-A4 was not significantly increased.

[0074] Table 2 Results of serum IL-8, TNF-α and GAS levels in each group

[0075] Group IL-8 content (ng / L) TNF-α(ng / L) GAS(ng / L) Blank control group 71.2±3.64 70.3±6.42 221.0±7.25 Model Group <![CDATA[119.4±5.17 ** ]]> <![CDATA[157.8±8.24 ** ]]> <![CDATA[170.4±5.38 ** ]]> A1 <![CDATA[68.1±3.41 ## ]]> <![CDATA[92.4±5.67 ## ]]> <![CDATA[189.2±6.08 ## ]]> A2 <![CDATA[94.5±2.08 # ]]> <![CDATA[123.5±6.27 # ]]> <![CDATA[180.7±5.90 # ]]> A3 <![CDATA[96.7±3.91 # ]]> <![CDATA[118.4±4.91 ## ]]> 178.2±5.93 A4 115.2±4.38 <![CDATA[127.2±8.24 # ]]> 174.2±8.34 Positive control group <![CDATA[95.6±4.29 # ]]> <![CDATA[93.2±6.01 ## ]]> <![CDATA[200.6±4.19 ## ]]>

[0076] Note: Compared with the blank control group, ** P<0.01; compared with the model group, # P<0.05, ## P<0.01.

[0077] (2) Results of gastric tissue PGE2 content test

[0078] PGE2 is a physiological protective substance that has the functions of improving gastric mucus barrier function, improving gastric mucosal blood supply, protecting epithelial cells, reducing inflammatory response, and promoting gastric mucosal self-repair. The results of gastric tissue PGE2 content detection in each group are shown in Table 3. Compared with the model group, the PGE2 content in group A1 was significantly increased (P < 0.01); the PGE2 content in groups A2-A4 was not significantly increased.

[0079] Table 3 Results of gastric tissue PGE2 content detection in each group

[0080] Group <![CDATA[PGE2 content (ng / L)]]> Blank control group 389.1±15.46 Model Group <![CDATA[305.8±9.87 ** ]]> A1 <![CDATA[364.7±8.16 ## ]]> A2 <![CDATA[321.2±13.58 # ]]> A3 308.9±11.22 A4 315.2±18.34 Positive control group <![CDATA[346.3±7.08 # ]]>

[0081] Note: Compared with the blank control group, ** P<0.01; compared with the model group, # P<0.05, ## P<0.01.

[0082] In summary, the present invention uses a bile reflux gastritis mouse model to verify the therapeutic effect of the Chinese medicine pills prepared by the present invention on bile reflux gastritis. The results show that the Chinese medicine pills prepared by the present invention can significantly increase the PGE2 content in the tissue of bile reflux gastritis mice and the GAS content in the serum, and reduce the IL-8 and TNF-α content in the serum. Processing is an important technology in the pharmaceutical process of traditional Chinese medicine. The properties and efficacy of medicinal materials can be changed by processing. The present invention uses special processed products and other medicinal flavors to prepare Chinese medicine pills, which can play a good therapeutic and protective role on the stomach.

[0083] Effect verification example 2

[0084] 1. Materials and Methods

[0085] 1.1 General Information

[0086] A total of 80 patients with bile reflux gastritis who were treated in the Affiliated Hospital of Nanjing University of Chinese Medicine from February 2023 to December 2023 were selected as the research subjects.

[0087] Inclusion criteria: (1) Meet the diagnostic criteria of the 2017 edition of the “Expert Consensus on the Diagnosis and Treatment of Chronic Gastritis in Traditional Chinese Medicine”. (2) Confirmed diagnosis of reflux gastritis by gastroscopy. (3) Aged 20 to 65 years. (4) No recent use of gastric mucosal protective agents, acid suppressants, gastrokinetic drugs, etc.

[0088] Exclusion criteria: (1) Patients who do not meet the Western and Chinese medical diagnostic criteria for bile reflux gastritis; (2) Patients who are Hp positive; (3) Patients who need to exclude bile reflux caused by improper gastroscopy; (4) Patients who have recently taken any medication that may affect the study results; (5) Patients with other digestive system diseases, metabolic diseases, tumors, or mental illnesses; (6) Patients who are allergic to the drugs in this study; (7) Women who are preparing for pregnancy, pregnant, or breastfeeding; (8) Patients who are currently participating in other drug clinical studies. Exclusion criteria: (1) Patients who were misdiagnosed or misadmitted; (2) Patients with poor compliance, who did not take medication as required or stopped taking medication midway; (3) Patients with serious adverse reactions or complications midway; (4) Patients whose study must be terminated due to various force majeure factors during the process.

[0089] 1.2 Efficacy determination

[0090] A comprehensive evaluation was conducted with reference to the Guiding Principles for Clinical Research of New Chinese Medicines and the results of gastroscopy of patients before and after treatment.

[0091] Cure: The patient's clinical symptoms and signs completely disappeared, and endoscopy showed that the mucosa returned to normal, and there was no bile reflux.

[0092] Markedly effective: The patient's symptoms were significantly improved (symptoms were significantly alleviated or the frequency of attacks was significantly reduced), physical signs were significantly alleviated, and gastroscopy showed that the mucosa basically returned to normal and bile reflux basically disappeared.

[0093] Effective: The patient's symptoms improved (symptoms were milder or the frequency of attacks decreased), physical signs were alleviated, and gastroscopy showed improvement in the gastric mucosa and reduced bile reflux.

[0094] Invalid: The above criteria are not met.

[0095] 1.3 Experimental groups and treatment methods

[0096] 80 patients were randomly divided into two groups. One group was a treatment group, taking 2.5 g of the Chinese medicine pills prepared in Example 2 once in the morning and evening each time, for 4 consecutive weeks; the other group was a control group, taking hydrotalcite and domperidone three times a day, wherein hydrotalcite was taken 1 g each time and domperidone was taken 10 mg each time.

[0097] 2. Results

[0098] The efficacy statistics of the two experimental groups are shown in Table 4. The results show that the total effective rate of the treatment group is significantly higher than that of the control group. The Chinese medicine pills prepared by the present invention have a good improvement effect on gastric mucosal damage caused by bile reflux, submucosal bleeding, and congestion, and have a good therapeutic effect on inflammatory damage to the gastric mucosa.

[0099] All patients were followed up six months after the treatment, and the recurrence rates in the treatment group and the control group were 7.5% and 36.8%, respectively. This shows that the long-term effect of the treatment group is better than that of the control group.

[0100] Table 4 Statistical results of the efficacy of the treatment group and the control group

[0101]

[0102] The embodiments described above are only descriptions of the preferred modes of the present invention, and are not intended to limit the scope of the present invention. Without departing from the design spirit of the present invention, various modifications and improvements made to the technical solutions of the present invention by ordinary technicians in this field should all fall within the protection scope determined by the claims of the present invention.

Claims

1. A Chinese medicine composition for treating gastropathy, characterized in that: The invention comprises the following components in parts by weight: 25-35 parts of ginger bamboo shavings, 20-30 parts of French pinellia tuber, 15-25 parts of equisetum arvense, 8-15 parts of scutellaria baicalensis, 6-10 parts of corydalis, 5-15 parts of malt sprout, 3-8 parts of millet rice, 2-8 parts of lanceolate, 3-5 parts of red ochre and 2-8 parts of cyperus rotundus; The gastric disease is bile reflux gastritis.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition comprises the following components in parts by weight: 30 parts of ginger bamboo shavings, 25 parts of French pinellia, 20 parts of horsetail, 10 parts of scutellaria, 8 parts of corydalis, 10 parts of malt sprout, 5 parts of sorghum, 5 parts of zelkova, 5 parts of red ochre and 5 parts of rhizoma scutellariae.

3. Use of the Chinese medicine composition according to claim 1 or 2 in preparing a medicine for treating gastric disease, characterized in that: The gastric disease is bile reflux gastritis.

4. A Chinese medicine pill for treating gastric disease, characterized in that: The active ingredient comprises the Chinese medicine composition according to claim 1 or 2; The gastric disease is bile reflux gastritis.

5. The Chinese medicine pill for treating gastric disease according to claim 4, characterized in that: The Chinese medicine pills for treating gastric diseases also include pharmaceutically acceptable excipients.

6. The Chinese medicine pill for treating gastric disease according to claim 5, characterized in that: The auxiliary material includes honey.

7. The Chinese medicine pill for treating gastric disease according to claim 6, characterized in that: The mass ratio of the traditional Chinese medicine composition to the honey is 2:

1.

8. A method for preparing the Chinese medicine pills for treating gastric disease as claimed in claim 4, characterized in that: The following steps are involved: According to the raw material formula, all raw materials are weighed and mixed, rolled into fine powder, mixed evenly, sieved, and mixed powder is obtained; The mixed medicine powder and honey are evenly mixed to prepare the Chinese medicine pills for treating gastric disease.

9. The preparation method according to claim 8, characterized in that: The sieving step uses a 80-100 mesh sieve.

10. The preparation method according to claim 8, characterized in that: The mass ratio of the mixed medicinal powder to the honey is 2:1.

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