WO2017114372A1

WO2017114372A1 - Chinese patent medicine for treating gastroenteritis and preparation method therefor

Info

Publication number: WO2017114372A1
Application number: PCT/CN2016/112236
Authority: WO
Inventors: 张鹏
Original assignee: 张鹏
Priority date: 2015-12-30
Filing date: 2016-12-27
Publication date: 2017-07-06
Also published as: CN105535695A

Abstract

A Chinese patent medicine for treating gastroenteritis is prepared from the following raw materials in parts by weight: 10 to 17 parts of rhodiola rosea, 8 to 10 parts of begonia fimbristipula hance, 5 to 10 parts of folium apocyni veneti, 5 to 10 parts of rhizoma cibotii, 3 to 7 parts of flos chrysanthemi indici, 5 to 9 parts of albizia chinensis, 10 to 15 parts of colored malt, 3 to 6 parts of prepared rhizome of rehmannia, 2 to 6 parts of fructus tritici levis, and 150 to 200 parts of radix angelicae. The Chinese patent medicine is formed by common traditional Chinese medicine components that are mostly medicinal and edible ones, raw materials are cheap, and the Chinese patent medicine is easy to prepare and convenient to use; according to years of clinical application and pharmacological study, the Chinese patent medicine has a remarkable curative effect on gastrointestinal functional diseases such as irritable bowel syndrome, functional dyspepsia, functional bloating and functional constipation; active pharmaceutical ingredients together allow implementing the functions of promoting digestion and harmonizing stomach, descending adverse qi and arresting vomiting, promoting qi circulation and removing food retention and soothing liver and lowering qi and has a good curative effect on gastroenteritis caused by various reasons; and given the large quantity of patients suffering from the gastroenteritis and the characteristics of the Chinese patent medicine of non-toxicity and capability of being taken for a long time, the Chinese patent medicine has a broad market prospect.

Description

Chinese patent medicine for gastroenteritis and preparation method thereof

[0001] The present invention relates to a proprietary Chinese medicine for gastroenteritis and a preparation method thereof, and belongs to the field of traditional Chinese medicine.

Background technique

[0002] Chronic stomach disease is a common clinical disease, and belongs to the category of diseases such as "stomach cramps", "small fullness", "swallowing acid", "noisy", and "nano-stasis". Chinese medicine believes that chronic gastritis is caused by long-term emotional uneasiness, unhealthy diet, and disordered work, leading to liver qi stagnation, spleen loss and health, and stomach stagnation, and long-term qi deficiency, which causes various symptoms. The main symptoms of chronic gastritis are stomach acid, bloating, stomach pain, and some may cause indigestion. Other patients have hunger, chest tightness, tapping the back (ie, back sinking), and stomach ulcers. The main clinical manifestations of chronic gastritis are loss of appetite, upper abdominal discomfort and dull pain, hernia, pantothenic acid, nausea, vomiting and the like. At present, the drugs for clinical treatment of this disease are roughly divided into two categories: protection of gastric mucosa and elimination of drugs that damage the gastric mucosa, such as gastrointestinal ketone, gaipipine, cimetidine, metoclopramide, etc. There are obvious side effects such as diarrhea, headache, dizziness, edema, and hypokalemia, and the effect is single, the efficiency is low, and the recurrence is easy after the treatment. The first generation, such as metoclopramide, is a dopamine receptor antagonist with cholinergic characteristics. It has been replaced by second, third and fourth generation prokinetic drugs because of more central side effects. Metoclopramide has an injection and has an antiemetic effect, and is currently used as an antiemetic in clinical practice. The second generation of prokinetic drugs is domperidone, which is a peripheral dopamine receptor blocker. It is widely used clinically, mainly to promote gastric motility, but the intestinal motility is not good. The third generation is cisapride, a mesoclopramide that chemically replaces alkylated benzimidazole. However, in recent years, it has been found that QT interval prolongation or tip torsion may occur in patients with cisapride hypersensitivity. The tachycardia is still controversial for its further clinical application. The fourth generation is mosapride, a non-selective 5-HT4 receptor agonist, a novel gastrointestinal motility drug. Relatively safe, adverse reactions are usually stomach or esophagus and abdominal cramps, intestinal cramps, diarrhea, abdominal pain, occasional dizziness, nausea, headache, ALT, AST rise, itching, rash and other allergic reactions, and the price is more expensive. And Chinese medicine believes that stomach diseases are often caused by liver fire or spleen deficiency. The main treatment for stomach diseases lies in strong liver and spleen. In modern society, due to overwork, a common chronic stomach disease caused by spleen deficiency.

technical problem [0003] In view of the deficiencies of the prior art, the technical problem to be solved by the present invention is to provide a proprietary Chinese medicine for gastroenteritis and a preparation method thereof for treating irritable bowel syndrome, functional dyspepsia, and function Chronic stomach diseases such as bloating and functional constipation have remarkable curative effects, and are low in cost and safe to use.

Problem solution

Technical solution

[0004] In order to solve the above technical problem, the technical solution adopted by the present invention is a Chinese patent medicine for gastroenteritis, which is prepared from the following raw materials by weight: 10-17 parts of Rhodiola, purple-backed sunflower 8-10 parts, 5-10 parts of Apocynum venetum, 5-10 parts of dog ridge, 3-7 parts of wild chrysanthemum, 5-9 parts of eucalyptus, 10-15 parts of fried malt, 3-6 parts of rehmannia, floating wheat 2 -6 parts, 150-200 parts of white peony.

[0005] Optimized, the above-mentioned proprietary Chinese medicine for gastroenteritis is prepared from the following raw materials by weight: Rhodiola 12-1 4 parts, Purple-backed sunflower 8.5-9.5 parts, Apocynum venetum 6.5-7.5 Servings, 7-9 portions of dog ridges, 4-6 parts of wild chrysanthemums, 6-8 parts of eucalyptus, 12-14 parts of fried malt, 4.5-5.5 parts of cooked land, 3-5.5 parts of floating wheat, and 160-190 parts of white peony. Optimized, the above-mentioned proprietary Chinese medicine for gastroenteritis is made up of the following raw materials by weight: 13 parts of Rhodiola, ₉ parts of Asteraceae, 7 parts of Apocynum venetum, 7.5 parts of dog ridge, Wild chrysanthemum 4.5 7.5 parts of eucalyptus, 13 parts of fried malt, 5 parts of rehmannia, 4.2 parts of floating wheat, and 180 parts of white peony.

[0006] A method for preparing a proprietary Chinese medicine for gastroenteritis is prepared by the following steps: (1) Rhodiola, Viola, Apocynum venetum, dog ridge, wild chrysanthemum, eucalyptus, rehmannia and The floating wheat is ground into a powder and stirred evenly; (2) Take half of the mixed powder of step (1) into distilled water and soak for 30-60 hours; (3) heat the aqueous solution completed in step (2), the heating temperature is low. At 80 ° C, the heated steam is condensed and recovered; (4) The other half of the powder of step (1) is placed in a chalk, heated at 60 ° C for 2.5 hours, and the juice is removed; (5) Step (4) The completed juice is mixed with the condensate recovered in the step (3), and then mixed and stirred twice; (6) The mixed solution obtained in the step (5) is added with fried malt, and stirred at a temperature of 50 ° C. After heating, after removing moisture, the paste mixture is kneaded into a pellet and then wax-sealed.

Advantageous effects of the invention

Beneficial effect

[0007] The Chinese patent medicine group of the invention is derived from commonly used traditional Chinese medicine components, and is mostly a medicine and food product, the raw material is cheap, the preparation is simple, the use is convenient, and after many years of clinical application and pharmacological research, the treatment of intestinal irritation Syndrome, work Gastrointestinal functional lesions such as dyspepsia, functional bloating, and functional constipation have significant curative effects; the drug substance plays a role in eliminating digestion and stomach, reducing vomiting, venting qi, eliminating liver and qi, Gastroenteritis caused by various reasons has a good curative effect; in view of the large number of cases of the disease, and the proprietary Chinese medicine of the present invention has the characteristics of being non-toxic and can be taken for a long time, it has broad market prospects.

BEST MODE FOR CARRYING OUT THE INVENTION

[0008] Example 1 The present invention is a proprietary Chinese medicine for gastroenteritis, which is prepared from the following raw materials by weight: 10 parts of Rhodiola, 8 parts of Viola, and 5 parts of Apocynum venetum L., dog 5 parts of ridge, 3 parts of wild chrysanthemum, 5 parts of eucalyptus, 10 parts of fried malt, 3 parts of cooked land, 2 parts of floating wheat, and 150 parts of white peony. A method for preparing a proprietary Chinese medicine for gastroenteritis, which is prepared by the following steps: (1) Rhodiola, purple-backed sunflower, Apocynum venetum, dog ridge, wild chrysanthemum, eucalyptus, radix and floating wheat Powder, stir well; (2) Take half of the mixed powder of step (1) into distilled water and soak for 45 hours; (3) Heat the aqueous solution completed in step (2), heat at 75 ° C, and heat Steam condensation recovery; (4) Put the other half of the powder of step (1) into the chalk, heat it at 60 °C for 2.5 hours, and remove the juice; (5) Prepare the juice of step (4) and In step (3), the condensate recovered by condensation is mixed, and then mixed and stirred under heating; (6) adding the fried malt to the mixed solution obtained in the step (5), stirring and heating at a temperature of 50 ° C to remove water. The paste mixture was kneaded into a pellet and then wax sealed.

In order to better illustrate the present invention, the beneficial effects of the medicament of the present invention are further illustrated by the summary of clinically validated cases of 100 cases of chronic gastrointestinal diseases treated with the medicament of the present invention. The medicament of the present invention used in the following test was prepared in accordance with the method of Example 1.

[0010] First, the observation method

[0011] (1) Observing subjects: This group of patients are outpatients of Qingdao Haici Hospital, including untreated or untreated, including functional diarrhea, functional dyspepsia, irritable bowel syndrome, chronic infectivity Diarrhea is the subject of observation.

[0012] (two) diagnostic criteria

[0013] Using the "Roman II Standard 1999", the selected cases met the diagnostic criteria for functional diarrhea, functional dyspepsia, irritable bowel syndrome, and chronic infectious diarrhea. All cases were examined by gastric, colon endoscopy or X-ray barium angiography to exclude gastric, duodenal and colonic organic lesions. [0014] (3) Exclusion criteria

[0015] 1, there are organic digestive diseases, such as polyps, tumors and so on. 2, there are liver and kidney, endocrine, immune system and severe primary disease of the blood system: diabetes, uremia, liver disease and so on. 3. Pregnant women and lactating women. 4. Does not meet the diagnostic criteria.

[0016] (four) symptom level assessment criteria

[0017] Refer to "Clinical Guidelines for New Drugs of Traditional Chinese Medicine": According to the light, medium and severe symptoms, score 1, 2, 3

[0018] 1. Symptom scoring method: (1) Asymptomatic (-): 0 points; (2) Mild (+): Occasionally 1 point; [0019] (3) Moderate (++) : 2 points are often recorded; (4) Severe (+++): 3 points are persisted.

[0020] 2, diarrhea:

[0021] (1) Asymptomatic and softening (-): 0 points per day 1-2 times; (2) Mild (+): mild symptoms, does not affect life and work, can endure, stool daily 2-3 times, 1 point for paste or mucus; (3) Moderate (++): The symptoms are heavy, have affected work and life, can still bear, stool is egg pattern, 4-5 times a day , or mucus will be moderately recorded 2 points; (4) severe (+++): severe symptoms, hinder work and life, unbearable, dilute watery stool, more than 6 times a day, or a large amount of 3 points of mucus.

[0022] 3, the degree of disease determination criteria

[0023] (1) Severity: Main symptom score => 70% of total score; (2) Moderate: 30% < = Main symptom score < 70% of total score; (3) Mild: Main symptom score < = 30% of the total points;

[0024] (5) Efficacy criteria and statistical methods

[0025] Refer to "Clinical Guiding Principles for New Drugs of Traditional Chinese Medicine" as a standard.

[0026] 1, the efficacy criteria: (1) cure: the main symptoms disappear, stool formation, 1-2 times a day, the efficacy index is 100%; (2) markedly effective: the main clinical symptoms basically disappeared stool times daily 2 3 times, 75% < = efficacy index < 100%; (3)

Effective: The main clinical symptoms improved, the shape and frequency of stool improved, 30% < = efficacy index < 75

0/

/0;

[0027] (4) Invalid: No major changes in clinical symptoms, efficacy index < 30%; disease efficacy index = (total score of main symptoms before treatment - total score of main symptoms after treatment) / total score of main symptoms before treatment χΐοο %.

[0028] 2. Evaluation criteria for single symptom efficacy: [0029] (1) Cure: After the end of the treatment, the symptoms disappear; (2) markedly effective: After the end of the curative effect, the symptom grade is reduced by 2

[0030] (3) Effective: After the end of the curative effect, the symptom grade is reduced by 1 level; (4) Invalid: The above criteria are not met.

[0031] (6) Observation indicators

[0032] 1, curative observation:

[0033] (1) Changes in symptoms and signs before and during treatment. (2) The number and amount of daily stools.

[0034] (3) stool shape, such as pus and bloody stools, mucus and thin water. (4) routine examination of stool: the number of red blood cells, white blood cells and pus cells in the stool, whether or not to digest food fiber, fat droplets, etc. (5) Some patients do the training. (6) Some patients underwent colonoscopy, intestinal angiography, and gastroscope.

[0035] 3. Security observation:

[0036] (1) Blood and urine routine examination. (2) routine testing.

[0037] 4, the main clinical symptoms observed:

[0038] (1) Functional diarrhea: diarrhea, accompanied by urgency, watery stools, mucus. (2) Functional dyspepsia: upper abdominal fullness, early satiety, hernia, upper abdominal pain, nausea and vomiting, acid reflux. (3) Irritable bowel syndrome: abdominal pain, bloating, diarrhea, incontinence, stool frequency, shape. (4) Chronic infectious diarrhea: diarrhea, abdominal pain, urgency and heavy, mucus and blood.

[0039] Second, clinical data

[0040] Treatment method

[0041] In all cases, other therapeutic drugs were discontinued during the administration, and the drug of the present invention was used alone, and the dosage was 2 capsules/time, 3 times/day, and the course of treatment was 4 weeks.

Statistical method

[0043] The count data is applied to the X2 test, and the measurement data is applied to the t test.

[0044] Observation results

[0045] 1. The total curative effect of each disease before and after clinical treatment, as shown in Table 1.

[0046] Table 1 total efficacy table before and after clinical treatment of various diseases

[] [Table 1]

[0047] 2. Comparison of the effective efficiency before and after clinical treatment of various diseases, as shown in Table 2

[0048] Table 2 Comparison of the apparent efficiency of each disease before and after clinical treatment

[] [Table 2]

[0049] It is indicated that the drug has a significant therapeutic effect on the above four diseases.

[0050] Third, the result display

[0051] 1. The Chinese patent medicine of the invention has a good therapeutic effect on various chronic gastrointestinal diseases.

[0052] The clinical results show that there is no statistically significant difference in the effect of the drug of the present invention for treating chronic gastrointestinal diseases, indicating that it has a good therapeutic effect on various chronic gastrointestinal diseases.

[0053] 2. It has the effect of significantly improving the clinical symptoms of patients with chronic gastrointestinal diseases.

[0054] Clinical results indicate that the medicament of the present invention can significantly alleviate clinical symptoms. The improvement effect on single disease main symptoms is obvious, and the total effective rate is above 85%.

[0055] 3. No significant side effects were found during the medication.

Embodiments of the invention

[Example 2] The present invention is a proprietary Chinese medicine for gastroenteritis, which is prepared from the following raw materials by weight: Rhodiola 17 parts, Purple geranium 10 parts, Apocynum venetum 10 parts, dog 10 parts of ridges, 7 parts of wild chrysanthemums, 9 parts of eucalyptus, 15 parts of fried malt, 6 parts of cooked land, 6 parts of floating wheat, and 200 parts of white peony. A method for preparing a proprietary Chinese medicine for gastroenteritis, which is prepared by the following steps: (1) Rhodiola, purple-backed sunflower, Apocynum venetum, dog ridge, wild chrysanthemum, eucalyptus, radix and floating wheat Powder, stir well; (2) Take half of the mixed powder of step (1) into distilled water, soak for 30 hours; (3) Heat the aqueous solution completed in step (2), The heating temperature is 78 degrees Celsius, and the heated steam is condensed and recovered; (4) The other half of the powder of the step (1) is placed in 180 parts of white peony, heated at 60 degrees Celsius for 2.5 hours, and the medicinal juice is taken out; Mixing the juice completed in step (4) with the condensate recovered in step (3), mixing and heating and stirring; (6) adding the fried malt to the mixed solution obtained in step (5), stirring The mixture was heated at a temperature of 50 ° C, and after removing moisture, the paste mixture was kneaded into a pellet and then wax-sealed.

[Example 3] The present invention is a proprietary Chinese medicine for gastroenteritis, which is prepared from the following raw materials by weight: 13 parts of Rhodiola, 9 parts of Viola, and 7 parts of Apocynum venetum L., dog 7.5 parts of ridges, 4.5 parts of wild chrysanthemums, 7.5 parts of eucalyptus, 13 parts of fried malt, 5 parts of cooked land, 4.2 parts of floating wheat, and 180 parts of white peony. A method for preparing a proprietary Chinese medicine for gastroenteritis, which is prepared by the following steps: (1) Rhodiola, purple-backed sunflower, Apocynum venetum, dog ridge, wild chrysanthemum, eucalyptus, radix and floating wheat Powder, stir evenly; (2) Take half of the mixed powder of step (1) into distilled water and soak for 60 hours; (3) Heat the aqueous solution completed in step (2), heat at 70 ° C, and heat Steam condensation recovery; (4) Put the other half of the powder of step (1) into 180 parts of white peony, heat it at 60 degrees Celsius for 2.5 hours, and remove the medicinal juice; (5) Complete the step (4) The medicinal juice is mixed with the condensate recovered by the condensation in the step (3), and then mixed and heated and stirred twice; (6) adding the fried malt to the mixed solution obtained in the step (5), stirring and heating at a temperature of 50 ° C. After removing the moisture, the paste mixture was kneaded into a pellet and then wax-sealed.

Industrial applicability

The above description is of course not a limitation of the present invention, and the present invention is not limited to the above examples, and variations, modifications, additions or substitutions made by those skilled in the art within the scope of the present invention, All should fall within the scope of protection of the present invention.

[0059]

Claims

Claim

[Claim 1] A proprietary Chinese medicine for gastroenteritis, which is characterized in that it is made of the following raw materials by weight: 10-17 parts of Rhodiola, 8-10 parts of Viola, and Apocynum venetum leaves 5-10 parts, 5-10 parts of dog ridge, 3-7 parts of wild chrysanthemum, 5-9 parts of eucalyptus, 10-15 parts of fried malt, 3-6 parts of cooked land, 2-6 parts of floating wheat, 150-200 of white peony Share.

[Claim 2] The Chinese patent medicine for gastroenteritis according to claim 1, which is prepared from the following raw materials by weight: 12-14 parts of Rhodiola, 8.5-9.5 5.4 parts of Apocynum venetum L., 5-7.5 parts of dog's ridge, 7-9 parts of dog ridge, 4-6 parts of wild chrysanthemum, 6-8 parts of eucalyptus, 12-14 parts of fried malt, 4.5-5.5 parts of cooked land, floating wheat 3- 5.5 parts, 160-190 parts of white peony.

[Claim 3] The Chinese patent medicine for gastroenteritis according to claim 1, which is prepared from the following raw materials by weight: 13 parts of Rhodiola, 9 parts of Viola, and Apocynum venetum 7 parts of leaves, 7.5 parts of dog ridges, 4.5 parts of wild chrysanthemums, 7.5 parts of eucalyptus, 13 parts of fried malt, 5 parts of cooked land, 4.2 parts of floating wheat, and 180 parts of white peony.

[Claim 4] A method for producing a proprietary Chinese medicine for gastroenteritis according to any one of claims 1 to 3, characterized in that it is produced by the following steps: (1) Rhodiola rosea , apocynum venetum, dog ridge, wild chrysanthemum, eucalyptus, cultivar and floating wheat are ground into powder and stirred evenly; (2) Take half of the mixed powder of step (1) into distilled water and soak for 30-60 hours; 3) The aqueous solution completed in the step (2) is heated, the heating temperature is lower than 80 degrees Celsius, and the heated steam is condensed and recovered; (4) the other half of the powder of the step (1) is placed in a white crucible at 60 degrees Celsius. After heating for 2.5 hours, remove the juice; (5) Mix the juice completed in step (4) with the condensate recovered in step (3), mix and stir with heating; (6) Step (5) The obtained mixed solution was added with fried malt, stirred and heated at a temperature of 50 ° C. After removing the water, the paste mixture was kneaded into a pellet and then wax-sealed.