CN103356942B - Medicine for treating chronic gastritis, gastric ulcer and/or duodenal ulcer and preparation method thereof - Google Patents
Medicine for treating chronic gastritis, gastric ulcer and/or duodenal ulcer and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a pharmaceutical composition for treating chronic gastritis, gastric ulcer and/or duodenal ulcer and a preparation method thereof. The pharmaceutical composition comprises the following raw materials in parts by weight: 20-80 parts of pericarpium citri reticulatae (orange peel), 20-80 parts of radix angelicae, 20-80 parts of rheum officinale, 20-80 parts of the root of kudzu vine, 20-80 parts of jasmine, 4-36 parts of jasmine and 5-35 parts of liquorice. The method for preparing the pharmaceutical composition comprises the following steps of: adding water to the raw materials, decocting, extracting, collecting the filtrate; concentrating the filtrate to clear cream; cooling; then, adding 60-95% ethanol to the clear cream so that the content of ethanol reaches 30-70%; uniformly stirring; standing still; taking supernate; recovering all ethanol to obtain thick paste; drying and smashing to obtain medicine powder which is prepared into capsules or troches and the like. Clinical experiments show that the pharmaceutical composition has the effects of clearing away heat-fire, tonifying spleen and qi, relieving swelling and pain and stopping bleeding and is used for treating chronic gastritis, gastric ulcer and duodenal ulcer.
Description
Technical field
The present invention relates to and a kind ofly treat medicine of chronic gastritis, gastric ulcer and/or duodenal ulcer and preparation method thereof.
Background technology
Gastritis refers to the inflammation of the gastric mucosa that the various cause of disease causes.Acute and chronic two large classes are divided into by the anxious length relaxing the course of disease of morbidity.According to the order of severity of mucosa injury, gastritis can be divided into erosive gastritis and Non-erosive gastritis, also can carry out classify (as cardia, body of stomach, gastric antrum) according to the position of stomach.
Acute gastritis refers to a kind of acute inflammatory reaction of the gastric mucosa that a variety of causes causes.Cause the reason of acute gastritis a lot, have chemical principle because, physical cause and toxogen are because of/stress state etc.Acute gastritis patient often has Upper abdominal pain, feels sick, belch, vomiting and loss of appetite etc.Not etc., but disease is all not hurried, mostly has obvious paathogenic factor for the normal weight of its clinical manifestation, as eating and drinking too much at one meal, heavy drinking or eat unclean food by mistake, suffer from cold, drug administration etc.The gastritis caused by medicine and stressors, often only shows as hematemesis and melena, is generally a small amount of, in intermittent, from stopping, but also massive hemorrhage can occur.Acute gastritis can be divided into acute simple gastritis, acute erosive gastritis, acute corrosive gastritis and acute phlegmonous gastritis again.
The name very disunity of chronic gastritis.Chronic superficial gastritis, chronic erosive gastritis, chronic atrophic gastritis, chronic bile regurgitating gastritis, chronic gastritis verrucosa, drug induced gastritis, alcohol repellency gastritis etc. is had according to different diagnostic methods.Now clear and definite helicobacter pylori (Hp) infects the topmost cause of disease for chronic gastritis, and someone is referred to as Hp Gastritis.Expert points out, chronic gastritis cause of disease medical science is illustrated not yet completely, it is generally acknowledged relevant with the harmful factor of surrounding and susceptible body constitution.Physics, chemistry, the biological prolonged and repeated susceptible human body that acts on of harmful factor can cause primary disease.
Duodenal ulcer is gastral commonly encountered diseases, after being commonly considered as the pessimal stimulation due to the cerebral cortex acceptance external world, cause harmonization of the stomach duodenum parietal vessel and muscle generation spasm, the resistance of gastrointestinal wall cytotrophy generation obstacle and gastrointestinal mucosa is reduced, and cause gastrointestinal mucosa to be subject to Gastric juice digestion and form ulcer, someone thinks caused by helicobacter pylori infections at present, ulcer is often single property, but also have multiple ulcer, harmonization of the stomach duodenal bulbar ulcer, claims combined Peptic Ulcer when existing simultaneously.The main clinical manifestation of duodenal ulcer is epigastrium pain, can be dull pain, causalgia, distending pain or severe pain, also can show as the only dull pain discomfort when hunger.Typical case person shows as slightly or rest pain under moderate xiphoid-process, can be alleviated by antacid or feed.The pain of 2/3 is about had to be rhythmicity clinically.
The treatment of gastritis, gastric ulcer and duodenal ulcer adopt usually the mode of Chinese medicine and western modern medicine treat.Although the medicine of market being treated gastropathy is numerous, kind is numerous and diverse, but vast patients with gastric disease is still endured tangling of the serious illness to the fullest extent and is corroded.Traditional antacid and anticholinergic agents curative effect satisfactory not, although a new generation's bisfentidine-cimetidine, ranitidine, famotidine and the present age the most powerful gastric acid secretion inhibitor-omeprazole short term effect better, long-term effect is not ideal enough.People are found by practice, and the powerful acid suppression medicine of clinical life-time service, by serious gastric acid secretion inhibiting, can cause the Hypertrophic change of stomach, may cause gastric cancer.In addition, many intestinal bacteria and parasitic infection rate also can be caused to increase, such as " cholera ", " Salmonella ", " Shigella " etc., the clustering and the harmful substance to body can be produced of antibacterial, as: IV-nitroso compound.And prolonged application antibiotic can cause nausea, vomit and even the infringement of Liver and kidney function.
Therefore develop a kind of energy rapid relief of symptoms, cure rate is high, relapse rate is low and the medicine of the treatment chronic gastritis, gastric ulcer and/or the duodenal ulcer that have no adverse reaction, has actual application value and major and immediate significance.
Summary of the invention
The object of this invention is to provide and a kind ofly treat pharmaceutical composition of chronic gastritis, gastric ulcer and/or duodenal ulcer and preparation method thereof.Wherein, described chronic gastritis comprises superficial gastritis, atrophic gastritis, erosive gastritis, gastritis verrucosa, bile reflux gastritis.Therapeutic domain also comprises prolapse of gastric mucosa, duodenitis, colitis.
Pharmaceutical composition provided by the present invention is made up of the raw material of following mass parts: Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae) 20-80 part, Radix Angelicae Dahuricae 20-80 part, Radix Et Rhizoma Rhei 20-80 part, Radix Puerariae 20-80 part, Fructus Gardeniae 20-80 part, Fructus Amomi 4-36 part and Radix Glycyrrhizae 5-35 part.
The mass parts of described Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae) specifically can be 20-80 part, 30-70 part, 40-80 part, 40-60 part; The mass parts of the described Radix Angelicae Dahuricae specifically can be 20-80 part, 40-80 part, 40-60 part, 60-80 part; The mass parts of described Radix Et Rhizoma Rhei specifically can be 20-80 part, 30-80 part, 30-70 part, 40-60 part; The mass parts of described Radix Puerariae specifically can be 20-80 part, 30-80 part, 30-70 part, 40-60 part; The mass parts of described Fructus Gardeniae specifically can be 20-80 part, 50-80 part, 30-70 part, 40-60 part; The mass parts of described Fructus Amomi specifically can be 4-36 part, 10-32 part, 10-25 part, 20-32 part; The mass parts of described Radix Glycyrrhizae specifically can be 5-35 part, 10-32 part, 10-25 part, 20-32 part.
Described pharmaceutical composition is preferably made up of following raw material: Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae) 40-80 part, Radix Angelicae Dahuricae 40-80 part, Radix Et Rhizoma Rhei 30-80 part, Radix Puerariae 30-80 part, Fructus Gardeniae 50-80 part, Fructus Amomi 10-32 part and Radix Glycyrrhizae 10-32 part.
The each crude drug making pharmaceutical composition of the present invention is as proportioning according to mass parts, can increase according to corresponding ratio when producing or reduce, as large-scale production can by kilogram or in units of ton, small-scale production also can be in grams, weight can increase or reduce, but crude drug quality ratio between each composition is constant.
Pharmaceutical composition of the present invention prepares according to the method comprised the steps:
1) take Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the Radix Angelicae Dahuricae, Radix Et Rhizoma Rhei, Radix Puerariae, Fructus Gardeniae, Fructus Amomi and Radix Glycyrrhizae seven flavor medicine material by described ratio of quality and the number of copies, decoct with water extraction, collect extracting solution;
2) described extracting solution is condensed into clear paste, lets cool, then in described clear paste, add ethanol or ethanol water makes alcohol volume content reach 30-70%, stir evenly, leave standstill; Leave standstill collection supernatant after terminating and reclaim ethanol, namely obtaining described pharmaceutical composition.
This pharmaceutical composition medicinal liquid directly can be taken or add appropriate correctives and/or pure water makes oral liquid.
Wherein, step 1) in the water yield that adds be the 5-10 of described medical material gross mass doubly; Described decoction extraction can be carried out 1-3 time, and each time decocting extraction can be 1-3 hour.Step 1) in the medical material that adopts be the medical material after clean system.
Step 2) in clear paste be 70 DEG C measure relative densities be the clear paste of 1.05-1.25; In described ethanol water, the volumn concentration of ethanol specifically can be 60-95%; The described standing time can be 12-96 hour.
In order to obtain solid-state medicine further, described method also comprises: described pharmaceutical composition being condensed into 70 DEG C of mensuration relative densities is the thick paste of 1.10-1.35, dry, pulverize, crosses 80-120 mesh sieve, obtain the step of pharmaceutical composition powder.
Another object of the present invention is to provide the application of described pharmaceutical composition.
This pharmaceutical composition can be used for preparing the medicine with following at least one effect: 1) gastritis; 2) gastric ulcer; 3) duodenal ulcer.Described gastritis comprises following at least one: chronic gastritis, prolapse of gastric mucosa, duodenitis and colitis; Described chronic gastritis comprises superficial gastritis, atrophic gastritis, erosive gastritis, gastritis verrucosa and bile reflux gastritis.
Also protection scope of the present invention is belonged to the medicine that pharmaceutical composition provided by the present invention is made for active component.The medicinal liquid prepared by said process and medicated powder, directly or add adjuvant, can be made into any pharmaceutically acceptable dosage form, such as capsule, tablet, granule, powder, pill, drop pill, sustained-release preparation, oral liquid, mixture or syrup etc.Pharmaceutically acceptable adjuvant may be used in medicine of the present invention, and when adjuvant is starch, the ratio of quality and the number of copies of described starch and described medicated powder is: starch: medicated powder=(0.01-1): 1.
In actual applications, the consumption of oral preparation medicament is generally 1.0-6.0g/ days in effective ingredient to medicine of the present invention, is generally 15 days the course for the treatment of.
The present invention is pure Chinese medicinal preparation, and wherein, Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae) has the effect of regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm, has anti-ulcer effect; The Radix Angelicae Dahuricae has the effect of the dehumidifying of loose wind, pain relieving, detumescence and apocenosis, Radix Angelicae Dahuricae glycyrrhiza decoction treatment stomach and duodenal bulbar ulcer, chronic gastritis, evident in efficacy; Radix Et Rhizoma Rhei has clearing away heat-fire, the effect of hemostasis and anti-inflammation, can the secretion of gastric acid inhibitory, reduces proteinase activity, thus reaches the object for the treatment of and pre-ulcer; Radix Puerariae has the effect of expelling pathogenic factors from muscles for reducing heat, promoting the production of body fluid to quench thirst, yang invigorating antidiarrheal; Fructus Gardeniae has the effect of pathogenic fire purging relieving restlessness, clearing away heat-damp and promoting diuresis, removing pathogenic heat from blood and toxic substance from the body, reducing swelling and alleviating pain; Fructus Amomi has removing dampness appetizing, warming spleen and stopping diarrha, antiabortive effect of regulating the flow of vital energy, and in Fructus Amomi, main active Folium Amomi oil is clinical is used for the treatment of taste-blindness rate and dyspepsia, and effective percentage reaches 90%; Radix Glycyrrhizae has the effect of invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription, has antiulcer action.All medicines coordinate, and have clearing away heat-fire, invigorating the spleen and replenishing QI, reducing swelling and alleviating pain, the effect of hemostasis, are used for the treatment of chronic gastritis, gastric ulcer and/or duodenal ulcer.Both avoided some side effect of Western medicine, and overcome again Chinese medicine slow curative effect, defect that relapse rate is high, there is important actual application value.
Detailed description of the invention
Below by specific embodiment, the present invention will be described, but the present invention is not limited thereto.
Experimental technique described in following embodiment, if no special instructions, is conventional method; Described solvent and adjuvant, if no special instructions, all can obtain from commercial channels.
Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae) used in following embodiment, the Radix Angelicae Dahuricae, Radix Et Rhizoma Rhei, Radix Puerariae, Fructus Gardeniae, Fructus Amomi, Radix Glycyrrhizae all meet the pertinent regulations under Chinese Pharmacopoeia (version in 2010) each medical material item of text.Before feeding intake, be tested and appraised, ingredients material object conforms to title, quality conformance with standard.
Embodiment 1, prepare the capsule of Chinese medicine composition
Get 80g Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the 80g Radix Angelicae Dahuricae, 80g Radix Et Rhizoma Rhei, 80g Radix Puerariae, 80g Fructus Gardeniae, 32g Fructus Amomi and 32g Radix Glycyrrhizae seven taste only make after medical material, above-mentioned medical material is decocted with water extraction 2 times, amount of water is respectively 8 times and 6 times of medical material gross mass, extraction time is respectively 3 hours and 2 hours, after each extraction, filter, merging filtrate is concentrated into the clear paste that relative density is 1.10 (70 DEG C of surveys), let cool, the ethanol adding 80% (volumn concentration) makes alcohol content reach 50% (volumn concentration), stir evenly, leave standstill 48 hours, get supernatant and reclaim ethanol to most, concentration of liquid medicine to relative density is the thick paste of 1.20 (70 DEG C of surveys), dry, pulverize, cross 80-120 mesh sieve, add starch and 0.02 times of Pulvis Talci of gained medicated powder quality 0.1 times, mixing, with alcohol granulation, dry, incapsulate, obtain capsule 96.
Embodiment 2, prepare the capsule of Chinese medicine composition
Get 60g Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the 80g Radix Angelicae Dahuricae, 60g Radix Et Rhizoma Rhei, 50g Radix Puerariae, 70g Fructus Gardeniae, 25g Fructus Amomi and 30g Radix Glycyrrhizae seven taste only make after medical material, the water of medical material gross mass 10 times is added in above-mentioned medical material, decoct extraction 3 hours, after extraction, filter, filtrate is concentrated into the clear paste that relative density is 1.15 (70 DEG C of surveys), let cool, the ethanol adding 90% (volumn concentration) makes alcohol content reach 60% (volumn concentration), stir evenly, leave standstill 24 hours, get supernatant and reclaim ethanol to most, concentration of liquid medicine to relative density is the thick paste of 1.25 (70 DEG C of surveys), dry, pulverize, cross 80-120 mesh sieve, add the starch of gained medicated powder quality 0.08 times and the Pulvis Talci of 0.01 times, mixing, with alcohol granulation, dry, incapsulate, obtain capsule 72.
Embodiment 3, prepare the capsule of Chinese medicine composition
Get 20g Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the 50g Radix Angelicae Dahuricae, 20g Radix Et Rhizoma Rhei, 80g Radix Puerariae, 40g Fructus Gardeniae, 4g Fructus Amomi and 20g Radix Glycyrrhizae seven taste only make after medical material, above-mentioned medical material is decocted with water extraction 2 times, amount of water is respectively 8 times and 6 times of quality of medicinal material, extraction time is respectively 3 hours and 2 hours, after each extraction, filter, merging filtrate is concentrated into the clear paste that relative density is 1.15 (70 DEG C of surveys), let cool, the ethanol adding 70% (volumn concentration) makes alcohol content reach 40% (volumn concentration), stir evenly, leave standstill 12 hours, get supernatant and reclaim ethanol to most, concentration of liquid medicine to relative density is the thick paste of 1.35 (70 DEG C of surveys), dry, pulverize, cross 80-120 mesh sieve, obtain Chinese medicine composition medicated powder.Add the Pulvis Talci of gained medicated powder starch identical in quality and 0.05 times, mixing, granulation, incapsulate, obtain capsule 60.
Embodiment 4, prepare the oral liquid of Chinese medicine composition
Get 70g Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the 60g Radix Angelicae Dahuricae, 60g Radix Et Rhizoma Rhei, 40g Radix Puerariae, 20g Fructus Gardeniae, 15g Fructus Amomi and 25g Radix Glycyrrhizae seven taste only make after medical material, above-mentioned medical material is decocted with water extraction 2 times, amount of water is respectively 8 times and 7 times of quality of medicinal material, extraction time is respectively 2 hours, after each extraction, filter, merging filtrate is concentrated into the clear paste that relative density is 1.10 (70 DEG C of surveys), let cool, the alcoholic solution adding 80% (volumn concentration) makes alcohol content reach 50% (volumn concentration), stir evenly, leave standstill 36 hours, get supernatant and reclaim ethanol to most, add correctives, add pure water to 600ml, mixing, leave standstill, filter, be distributed into 60 bottles.
Embodiment 5, prepare the oral liquid of Chinese medicine composition
Get 40g Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the 40g Radix Angelicae Dahuricae, 30g Radix Et Rhizoma Rhei, 30g Radix Puerariae, 50g Fructus Gardeniae, 10g Fructus Amomi and 10g Radix Glycyrrhizae seven taste only make after medical material, above-mentioned medical material is decocted with water extraction 3 times, amount of water is respectively 8 times of quality of medicinal material, 6 times and 5 times, extraction time is respectively 2 hours, 2 hours and 1 hour, after each extraction, filter, merging filtrate is concentrated into the clear paste that relative density is 1.10 (70 DEG C of surveys), let cool, the ethanol adding 60% (volumn concentration) makes alcohol content reach 30% (volumn concentration), stir evenly, leave standstill 96 hours, get supernatant and reclaim ethanol to most, add correctives, add pure water to 800ml, mixing, leave standstill, filter, be distributed into 80 bottles.
Embodiment 6, prepare the tablet of Chinese medicine composition
Get 40g Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the 50g Radix Angelicae Dahuricae, 60g Radix Et Rhizoma Rhei, 40g Radix Puerariae, 20g Fructus Gardeniae, 25g Fructus Amomi and 10g Radix Glycyrrhizae seven taste only make after medical material, above-mentioned medical material is decocted with water extraction 2 times, amount of water is respectively 8 times and 6 times of quality of medicinal material, extraction time is respectively 3 hours and 2 hours, after each extraction, filter, merging filtrate is concentrated into the clear paste that relative density is 1.08 (70 DEG C of surveys), let cool, the ethanol adding 90% (volumn concentration) makes alcohol content reach 50% (volumn concentration), stir evenly, leave standstill 60 hours, get supernatant and reclaim ethanol to most, concentration of liquid medicine to relative density is the thick paste of 1.25 (70 DEG C of surveys), dry, pulverize, cross 80-120 mesh sieve, add the starch of gained medicated powder quality 0.02 times, mixing, granulate, be pressed into tablet, obtain 84.
Embodiment 7, prepare the tablet of Chinese medicine composition
Get 40g Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the 80g Radix Angelicae Dahuricae, 40g Radix Et Rhizoma Rhei, 60g Radix Puerariae, 40g Fructus Gardeniae, 30g Fructus Amomi and 20g Radix Glycyrrhizae seven taste only make after medical material, above-mentioned medical material is decocted with water extraction 2 times, amount of water is respectively 8 times and 6 times of quality of medicinal material, extraction time is respectively 3 hours and 1 hour, after each extraction, filter, merging filtrate is concentrated into the clear paste that relative density is 1.25 (70 DEG C of surveys), let cool, the ethanol adding 70% (volumn concentration) makes alcohol content reach 40% (volumn concentration), stir evenly, leave standstill 72 hours, get supernatant and reclaim ethanol to most, concentration of liquid medicine to relative density is the thick paste of 1.15 (70 DEG C of surveys), dry, pulverize, cross 80-120 mesh sieve, add the starch of gained medicated powder quality 0.2 times, mixing, granulate, be pressed into tablet, obtain 125.
Embodiment 8, prepare the tablet of Chinese medicine composition
Get 50g Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the 50g Radix Angelicae Dahuricae, 50g Radix Et Rhizoma Rhei, 40g Radix Puerariae, 70g Fructus Gardeniae, 20g Fructus Amomi and 20g Radix Glycyrrhizae seven taste only make after medical material, above-mentioned medical material is decocted with water extraction 3 times, amount of water is respectively 8 times of quality of medicinal material, 6 times and 5 times, extraction time is respectively 3 hours, 2 hours and 1 hour, after each extraction, filter, merging filtrate is concentrated into the clear paste that relative density is 1.15 (70 DEG C of surveys), let cool, the ethanol adding 80% (volumn concentration) makes alcohol content reach 30% (volumn concentration), leave standstill 60 hours, get supernatant and reclaim ethanol to most, concentration of liquid medicine to relative density is the thick paste of 1.15 (70 DEG C of surveys), dry, pulverize, cross 80-120 mesh sieve, add the starch of gained medicated powder quality 0.5 times, mixing, granulate, be pressed into tablet, obtain 150.
Embodiment 9, prepare the tablet of Chinese medicine composition
Get 20g Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the 30g Radix Angelicae Dahuricae, 20g Radix Et Rhizoma Rhei, 20g Radix Puerariae, 20g Fructus Gardeniae, 36g Fructus Amomi and 5g Radix Glycyrrhizae seven taste only make after medical material, above-mentioned medical material is decocted with water extraction 2 times, amount of water is respectively 8 and 6 times of quality of medicinal material, extraction time is respectively 3 and 2 hours, after each extraction, filter, merging filtrate is concentrated into the clear paste that relative density is 1.05 (70 DEG C of surveys), let cool, the ethanol adding 95% (volumn concentration) makes alcohol content reach 70% (volumn concentration), stir evenly, leave standstill 96 hours, get supernatant and reclaim ethanol to most, concentration of liquid medicine to relative density is the thick paste of 1.35 (70 DEG C of surveys), dry, pulverize, cross 80-120 mesh sieve, add the starch of gained medicated powder quality 0.3 times, mixing, granulate, be pressed into tablet, obtain 106.
Embodiment 10, prepare the tablet of Chinese medicine composition
Get 50g Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the 80g Radix Angelicae Dahuricae, 80g Radix Et Rhizoma Rhei, 40g Radix Puerariae, 70g Fructus Gardeniae, 4g Fructus Amomi and 35g Radix Glycyrrhizae seven taste only make after medical material, above-mentioned medical material is decocted with water extraction 3 times, amount of water is respectively 8 times of quality of medicinal material, 6 times and 5 times, extraction time is respectively 2 hours, 2 hours and 1 hour, after each extraction, filter, merging filtrate is concentrated into the clear paste that relative density is 1.15 (70 DEG C of surveys), let cool, the ethanol adding 80% (volumn concentration) makes alcohol content reach 50% (volumn concentration), stir evenly, leave standstill 72 hours, get supernatant and reclaim ethanol to most, concentration of liquid medicine to relative density is the thick paste of 1.25 (70 DEG C of surveys), dry, pulverize, cross 80-120 mesh sieve, add the starch of gained medicated powder quality 0.08 times, mixing, granulate, be pressed into tablet, obtain 136.
Embodiment 11, the clinical test of pesticide effectiveness
Embodiment 1 sample is adopted to carry out clinical trial.By being in hospital and out-patient's clinical observation 66 example, result shows: this medicine has good clearing away heat-fire, invigorating the spleen and replenishing QI, reducing swelling and alleviating pain, effect of hemostasis.Be used for the treatment of chronic gastritis, gastric ulcer, use safety, have no side effect.
One, case selection
66 routine patients are divided into treatment group and matched group at random.Treatment group 44 example, male 24 example, women 20 example; Age 24-60 year.Matched group 22 example, male 12 example, women 10 example, age 22-58 year.
Two, foundation is accepted for medical treatment
66 routine patients are diagnosed as chronic gastritis, gastric ulcer through electronic gastroscopy, pathological biopsy respectively.
Three, Therapeutic Method
Treatment group dosage is: oral, one time 4,3 times on the one.
Matched group gives, and " stomach-recovering capsule " is oral, one time 4,3 times on the one.
" stomach-recovering capsule " Tonghua Zhenghe Pharmaceutical Industry Co., Ltd. produces, authentication code: the accurate word Z22023098 of traditional Chinese medicines.
The course for the treatment of: 15 days.
Four, criterion of therapeutical effect
Degree is improved for clinical appraisal index with clinical cardinal symptom, gastroscope check Active inflammation, chronic inflammatory disease.
1. effective: clinical cardinal symptom disappears, gastroscope check Active inflammation disappears, and chronic inflammatory disease is pass on well slightly.
2. effective: clinical cardinal symptom disappears substantially, chronic inflammatory disease takes a turn for the better effectively, and cardinal symptom obviously alleviates, and gastroscopy mucosa infection range shorter more than 1/2, inflammation alleviates to some extent.
3. invalid: symptom is without improvement, and gastroscopy does not reach effective standard, without deterioration person yet.
Five, interpretation of result
Apply clinical drug of the present invention and observe chronic gastritis, patients w ith peptic ulcer disease 66 example, result is as follows:
Therapeutic outcome
From upper table: treatment group 44 example, effective 23 examples, effective 20 examples, invalid 1 example, total effective rate 97.73%.Matched group 22 example, effective 5 examples, effective 14 examples, invalid 3 examples, total effective rate 86.36%.Two groups are compared X
2between=7.084, P < 0.05, two groups, comparitive study difference has significance.
Embodiment 12, the clinical test of pesticide effectiveness
Embodiment 5 sample is adopted to carry out clinical trial.By being in hospital and out-patient's clinical observation 57 example, result shows: this medicine has good clearing away heat-fire, invigorating the spleen and replenishing QI, reducing swelling and alleviating pain, effect of hemostasis.Be used for the treatment of chronic gastritis, gastric ulcer, use safety, have no side effect.
One, case selection
57 routine patients are divided into treatment group and matched group at random.Treatment group 38 example, male 21 example, women 17 example, age 23-58 year.Matched group 19 example, male 11 example, women 8 example, age 25-59 year.
Two, foundation is accepted for medical treatment with embodiment 11.
Three, Therapeutic Method
Treatment group dosage is: oral, a 20ml, 3 times on the one.
All the other are with embodiment 11.
Four, criterion of therapeutical effect is with embodiment 11.
Five, interpretation of result
Apply clinical drug of the present invention and observe chronic gastritis, patients w ith peptic ulcer disease 57 example, result is as follows:
Therapeutic outcome
From upper table: treatment group 38 example, effective 24 examples, effective 12 examples, invalid 2 examples, total effective rate 94.74%.Matched group 19 example, effective 5 examples, effective 10 examples, invalid 4 examples, total effective rate 78.95%.Two groups are compared X
2between=7.834, P < 0.05, two groups, comparitive study difference has significance.
Embodiment 13, the clinical test of pesticide effectiveness
Embodiment 1 sample is adopted to carry out clinical trial.By being in hospital and out-patient's clinical observation 45 example, result shows: this medicine has good clearing away heat-fire, invigorating the spleen and replenishing QI, reducing swelling and alleviating pain, effect of hemostasis.Be used for the treatment of duodenal ulcer, use safety, have no side effect.
One, case selection
45 routine patients are divided into treatment group and matched group at random.Treatment group 30 example, male 18 example, women 12 example, age 25-59 year.Matched group 15 example, male 9 example, women 6 example, age 24-58 year.
Two, foundation is accepted for medical treatment
45 routine patients are diagnosed as duodenal ulcer through gastroscopy respectively.
Three, Therapeutic Method
Treatment group dosage is: oral, one time 4,3 times on the one.
Matched group gives, and " KUIYANGLING JIAONANG " is oral, one time 4,3 times on the one.
" KUIYANGLING JIAONANG " Jilin Ji Bang pharmaceutcal corporation, Ltd produces, authentication code: the accurate word Z22020361 of traditional Chinese medicines.
The course for the treatment of: 15 days.
Four, criterion of therapeutical effect
Curative effect, with due regard to clinical symptoms, sign is judged with gastroscope.
1. effective: clinical cardinal symptom disappears, ulcer surface disappears only cicatrix, and upper abdominal pain disappears or substantially disappears.
2. effective: clinical cardinal symptom disappears substantially, and ulcer transfers healing stage to by active stage, ulcer major diameter reduces > 50%.Upper abdominal pain alleviates.
3. invalid: symptom is without improvement, and ulcer major diameter reduces < 50% or unchanged.
Five, interpretation of result:
Apply clinical drug of the present invention and observe duodenal ulcer patients 45 example, result is as follows:
Therapeutic outcome
Two groups of Clinical efficacy comparisons: treatment group 30 example, effective 19 examples, effective 10 examples, invalid 1 example, total effective rate 96.66%.Matched group 15 example, effective 2 examples, effective 10 examples, invalid 3 examples, total effective rate 80%.Two groups are compared X
2between=10.982, P < 0.01, two groups, comparitive study difference has significance.
Embodiment 14, the clinical test of pesticide effectiveness
Embodiment 5 sample is adopted to carry out clinical trial.By being in hospital and out-patient's clinical observation 51 example, result shows: this medicine has good clearing away heat-fire, invigorating the spleen and replenishing QI, reducing swelling and alleviating pain, effect of hemostasis.Be used for the treatment of duodenal ulcer, use safety, have no side effect.
One, case selection
51 routine patients are divided into treatment group and matched group at random.Treatment group 34 example, male 19 example, women 15 example, age 26-58 year.Matched group 17 example, male 10 example, women 7 example, age 25-59 year.
Two, foundation is accepted for medical treatment with embodiment 13.
Three, Therapeutic Method
Treatment group dosage is: oral, a 20ml, 3 times on the one.
All the other are with embodiment 13.
Four, criterion of therapeutical effect is with embodiment 13.
Five, interpretation of result:
Apply clinical drug of the present invention and observe duodenal ulcer patients 51 example, result is as follows:
Therapeutic outcome
From upper table: treatment group 34 example, effective 22 examples, effective 10 examples, invalid 2 examples, total effective rate 94.12%.Matched group 17 example, effective 3 examples, effective 12 examples, invalid 2 examples, total effective rate 88.24%.Two groups are compared X
2between=10.075, P < 0.01, two groups, comparitive study difference has significance.
Claims (11)
1. be used for the treatment of a pharmaceutical composition for chronic gastritis, gastric ulcer and/or duodenal ulcer, be made up of following raw material: Pericarpium Citri Reticulatae 40-80 parts, the Radix Angelicae Dahuricae 40-80 parts, Radix Et Rhizoma Rhei 30-80 parts, Radix Puerariae 30-80 parts, Fructus Gardeniae 50-80 parts, Fructus Amomi 10-32 parts and 10-32 parts, Radix Glycyrrhizae.
2. prepare the method for pharmaceutical composition described in claim 1, comprise the steps:
1) the seven flavor medicine material making described pharmaceutical composition according to claim 1 is decocted with water extraction, collect extracting solution;
2) described extracting solution is condensed into clear paste, lets cool, then in described clear paste, add ethanol or ethanol water makes alcohol volume content reach 30-70%, stir evenly, leave standstill; Leave standstill collection supernatant after terminating and reclaim ethanol, namely obtaining described pharmaceutical composition.
3. want the method described in 2 according to right, it is characterized in that: step 1) in the water yield that adds be 5-10 times of described medical material gross mass; Described decoction extraction is carried out 1-3 times, and each time decocting extraction is 1-3 hours.
4. according to the method in claim 2 or 3, it is characterized in that: step 1) described in medical material be medical material after clean system.
5. method according to claim 2, is characterized in that: step 2) in clear paste be 70 DEG C measure relative densities be the clear paste of 1.05-1.25;
Step 2) described in ethanol water the volumn concentration of ethanol be 60-95%; The described standing time is 12-96 hours.
6. method according to claim 2, it is characterized in that: described method also comprises the steps: that described pharmaceutical composition being condensed into 70 DEG C of mensuration relative densities is the thick paste of 1.10-1.35, dry, pulverize, cross 80-120 mesh sieves, obtain pharmaceutical composition powder.
7. pharmaceutical composition according to claim 1 is preparing the application had in the medicine of following at least one effect: 1) chronic gastritis; 2) gastric ulcer; 3) duodenal ulcer.
8. application according to claim 7, is characterized in that: described chronic gastritis is selected from following at least one: superficial gastritis, atrophic gastritis, erosive gastritis, gastritis verrucosa and bile reflux gastritis.
9. be used for the treatment of a medicine for chronic gastritis, gastric ulcer and/or duodenal ulcer, its active component is pharmaceutical composition according to claim 1.
10. medicine according to claim 9, is characterized in that: the dosage form of described medicine is any pharmaceutically acceptable dosage form.
11. medicines according to claim 10, is characterized in that: described dosage form is capsule, tablet, granule, powder, pill, drop pill, sustained-release preparation, oral liquid, mixture or syrup.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101264232A (en) * | 2008-04-25 | 2008-09-17 | 北京中泰天和科技有限公司 | Medicine for treating gastric ulcer and duodenal ulcer and preparation |
| CN102274444A (en) * | 2011-07-29 | 2011-12-14 | 钟升萍 | Medicine for treating gastrointestinal diseases |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101264232A (en) * | 2008-04-25 | 2008-09-17 | 北京中泰天和科技有限公司 | Medicine for treating gastric ulcer and duodenal ulcer and preparation |
| CN102274444A (en) * | 2011-07-29 | 2011-12-14 | 钟升萍 | Medicine for treating gastrointestinal diseases |
Non-Patent Citations (3)
| Title |
|---|
| 胃痞辨证用药体会;李兆吉;《陕西中医》;20101231;第31卷(第6期);767-768 * |
| 胃肠动力功能障碍性疾病的中医辨证与治疗;危北海;《中国中西医结合消化杂志》;20031231;第11卷(第5期);259-261 * |
| 脾胃用药规律初探;李文龙;《安徽中医临床杂志》;20031231;第15卷(第1期);47-49 * |
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