CN103356942A - 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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- CN103356942A CN103356942A CN2012100843060A CN201210084306A CN103356942A CN 103356942 A CN103356942 A CN 103356942A CN 2012100843060 A CN2012100843060 A CN 2012100843060A CN 201210084306 A CN201210084306 A CN 201210084306A CN 103356942 A CN103356942 A CN 103356942A
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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 a kind of medicine for the treatment 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 causes of disease cause.Be divided into acute and chronic two large classes by the anxious length that relaxes 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 classify according to the position of stomach (such as cardia, body of stomach, gastric antrum).
Acute gastritis refers to a kind of acute inflammatory reaction of the gastric mucosa that a variety of causes causes.The reason that causes acute gastritis is a lot, have chemical principle because of, physical cause and toxogen because of/stress state etc.Acute gastritis patient often has Upper abdominal pain, feels sick, belch, vomiting and loss of appetite etc.The normal weight of its clinical manifestation does not wait, but disease is all hurried, and apparent in view paathogenic factor is mostly arranged, such as eating and drinking too much at one meal, heavy drinking or eat unclean food by mistake, suffer from cold, drug administration etc.Gastritis by medicine and stressors cause often only shows as hematemesis and melena, is generally on a small quantity, is intermittent, can certainly end, 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 of chronic gastritis is disunity very.According to different diagnostic methods chronic superficial gastritis, chronic erosive gastritis, chronic atrophic gastritis, chronic bile regurgitating gastritis, chronic gastritis verrucosa, drug induced gastritis, ethanol gastritis etc. are arranged.Now clear and definite helicobacter pylori (Hp) infects and is the topmost cause of disease of chronic gastritis, and the someone is referred to as the Hp Gastritis.The expert points out that chronic gastritis cause of disease medical science is illustrated not yet fully, it is generally acknowledged relevant with harmful factor and the susceptible body constitution of surrounding.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, be commonly considered as because after the pessimal stimulation in the cerebral cortex acceptance external world, cause harmonization of the stomach duodenum parietal vessel and myogenesis spasm, the resistance of gastrointestinal wall cytotrophy generation obstacle and gastrointestinal mucosa is reduced, cause gastrointestinal mucosa to be subject to gastric juice digestion and formation ulcer, the someone thinks due to the helicobacter pylori infections at present, ulcer is single property often, but a plurality of ulcer are also arranged, and the harmonization of the stomach duodenal bulbar ulcer claims plyability 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 only dull pain discomfort when hunger.Typical case person shows as rest pain under slight or the moderate xiphoid-process, can be alleviated by antacid or feed.There is approximately clinically 2/3 pain to be rhythmicity.
In the treatment of gastritis, gastric ulcer and duodenal ulcer, usually adopt the mode of Chinese medicine and western modern medicine to treat.Although the medicine for the treatment of gastropathy is numerous on the market, kind is numerous and diverse, yet vast patients with gastric disease is still endured tangling of the serious illness to the fullest extent and corroded.Traditional antacid and anticholinergic agents curative effect are satisfactory not, although a new generation's bisfentidine-cimetidine, ranitidine, famotidine and the most powerful contemporary gastric acid secretion inhibitor-omeprazole short term effect are better, long-term effect is not ideal enough.People find that by practice clinical life-time service is powerful to press down sour medicine with the severe inhibition gastric acid secretion, can cause the hypertrophy variation of stomach, may cause gastric cancer.In addition, can cause that also many intestinal bacteria and parasitic infection rate increase, such as " cholera ", " Salmonella ", " Shigella " etc., the clustering and can produce harmful substance to body of antibacterial, as: the IV-nitroso compound.And the prolonged application antibiotic can cause nausea, the infringement of vomiting and even liver, renal function.
Therefore develop a kind of can the rapid recovery symptom, 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 purpose of this invention is to provide a kind of pharmaceutical composition for the treatment 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 by 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 by 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.
Each crude drug of making pharmaceutical composition of the present invention is as proportioning according to mass parts, when producing, can increase or reduce according to corresponding ratio, can be with kilogram or take ton as unit such as large-scale production, small-scale production also can be in grams, weight can increase or reduce, but the crude drug quality proportioning constant rate between each composition.
Pharmaceutical composition of the present invention is to prepare according to the method that comprises the steps:
1) takes by weighing 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 adding ethanol or ethanol water make alcohol volume content reach 30-70% in described clear paste, stir evenly, and leave standstill; Leave standstill and finish rear supernatant and the Recycled ethanol collected, namely obtain described pharmaceutical composition.
This pharmaceutical composition medicinal liquid can directly be taken or add an amount of correctives and/or pure water is made oral liquid.
Wherein, the water yield that adds step 1) is 5-10 times of described medical material gross mass; Described decoction is extracted and can be carried out 1-3 time, and each time that decocts extraction can be 1-3 hour.Step 1) medical material that adopts in is the medical material after the clean system.
Step 2) clear paste is that the relative density of 70 ℃ of mensuration is the clear paste of 1.05-1.25 in; The volumn concentration of ethanol specifically can be 60-95% in the described ethanol water; The described time of leaving standstill can be 12-96 hour.
In order further to obtain solid-state medicine, described method also comprises: it is the thick paste of 1.10-1.35 that described pharmaceutical composition is condensed into 70 ℃ of mensuration relative densities, and drying is pulverized, and crosses the 80-120 mesh sieve, obtains the step of pharmaceutical composition powder.
A further object of the present invention provides the application of described pharmaceutical composition.
This pharmaceutical composition can be used for preparing the medicine with following at least a effect: 1) gastritis; 2) gastric ulcer; 3) duodenal ulcer.Described gastritis comprises following at least a: 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.
The medicine of making take pharmaceutical composition provided by the present invention as active component also belongs to protection scope of the present invention.The medicinal liquid and the medicated powder that prepare by said process, 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 the medicine of the present invention, and when adjuvant was starch, the ratio of quality and the number of copies of described starch and described medicated powder was: starch: medicated powder=(0.01-1): 1.
Medicine of the present invention in actual applications, the consumption of oral preparation medicament is generally 1.0-6.0g/ days in effective ingredient, 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 loose wind dehumidifying, 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, and secretion that can gastric acid inhibitory reduces proteinase activity, thereby reaches the purpose 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, the antiabortive effect of regulating the flow of vital energy, clinical Stomach duodenum ulcer and the dyspepsia of being used for the treatment of of main active Folium Amomi oil in the Fructus Amomi, 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 cooperate, and have clearing away heat-fire, invigorating the spleen and replenishing QI, and reducing swelling and alleviating pain, the effect of hemostasis is used for the treatment of chronic gastritis, gastric ulcer and/or duodenal ulcer.Both avoid some side effect of Western medicine, overcome again Chinese medicine slow curative effect, defective that relapse rate is high, had important actual application value.
The specific embodiment
The present invention will be described below by specific embodiment, but the present invention is not limited thereto.
Experimental technique described in the following embodiment if no special instructions, is conventional method; Described solvent and adjuvant if no special instructions, all can obtain from commercial channels.
Used Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the Radix Angelicae Dahuricae, Radix Et Rhizoma Rhei, Radix Puerariae, Fructus Gardeniae, Fructus Amomi, Radix Glycyrrhizae all meets the pertinent regulations under each medical material item of text of Chinese Pharmacopoeia (version in 2010) among the following embodiment.Before feeding intake, be tested and appraised, ingredients is in kind to conform to the quality conformance with standard with title.
The capsule of embodiment 1, preparation Chinese medicine composition
Get 80g Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the 80g Radix Angelicae Dahuricae, the 80g Radix Et Rhizoma Rhei, the 80g Radix Puerariae, the 80g Fructus Gardeniae, medical material after 32g Fructus Amomi and the clean system of 32g Radix Glycyrrhizae seven flavors, 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 was respectively 3 hours and 2 hours, after each extraction is complete, filter, merging filtrate is concentrated into the clear paste that relative density is 1.10 (70 ℃ of surveys), let cool, the ethanol that adds 80% (volumn concentration) makes and contains the alcohol amount and reach 50% (volumn concentration), stirs evenly, left standstill 48 hours, get the supernatant Recycled ethanol to most, medicinal liquid is concentrated into the thick paste that relative density is 1.20 (70 ℃ of surveys), drying, pulverize, cross the 80-120 mesh sieve, add starch and 0.02 times of Pulvis Talci of 0.1 times of gained medicated powder quality, mixing, use alcohol granulation, drying incapsulates, and gets 96 of capsules.
The capsule of embodiment 2, preparation Chinese medicine composition
Get 60g Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the 80g Radix Angelicae Dahuricae, the 60g Radix Et Rhizoma Rhei, the 50g Radix Puerariae, the 70g Fructus Gardeniae, medical material after 25g Fructus Amomi and the clean system of 30g Radix Glycyrrhizae seven flavors, the water that adds 10 times of medical material gross masses in the above-mentioned medical material, decoct and extracted 3 hours, extract complete after, filter, filtrate is concentrated into the clear paste that relative density is 1.15 (70 ℃ of surveys), lets cool, the ethanol that adds 90% (volumn concentration) makes and contains the alcohol amount and reach 60% (volumn concentration), stir evenly, left standstill 24 hours, get the supernatant Recycled ethanol to most, medicinal liquid is concentrated into the thick paste that relative density is 1.25 (70 ℃ of surveys), drying is pulverized, and crosses the 80-120 mesh sieve, add the starch of 0.08 times of gained medicated powder quality and 0.01 times Pulvis Talci, mixing is used alcohol granulation, drying, incapsulate, get 72 of capsules.
The capsule of embodiment 3, preparation Chinese medicine composition
Get 20g Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the 50g Radix Angelicae Dahuricae, the 20g Radix Et Rhizoma Rhei, the 80g Radix Puerariae, the 40g Fructus Gardeniae, medical material after 4g Fructus Amomi and the clean system of 20g Radix Glycyrrhizae seven flavors, 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 was respectively 3 hours and 2 hours, after each extraction is complete, filter, merging filtrate is concentrated into the clear paste that relative density is 1.15 (70 ℃ of surveys), let cool, the ethanol that adds 70% (volumn concentration) makes and contains the alcohol amount and reach 40% (volumn concentration), stirs evenly, and leaves standstill 12 hours, get the supernatant Recycled ethanol to most, medicinal liquid is concentrated into the thick paste that relative density is 1.35 (70 ℃ of surveys), and drying is pulverized, cross the 80-120 mesh sieve, get Chinese medicine composition medicated powder.Add gained medicated powder starch identical in quality and 0.05 times Pulvis Talci, mixing, granulation incapsulate, and get 60 of capsules.
The oral liquid of embodiment 4, preparation Chinese medicine composition
Get 70g Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the 60g Radix Angelicae Dahuricae, the 60g Radix Et Rhizoma Rhei, the 40g Radix Puerariae, the 20g Fructus Gardeniae, medical material after 15g Fructus Amomi and the clean system of 25g Radix Glycyrrhizae seven flavors, 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 was respectively 2 hours, after each extraction is complete, filter, merging filtrate is concentrated into the clear paste that relative density is 1.10 (70 ℃ of surveys), let cool, the alcoholic solution that adds 80% (volumn concentration) makes and contains the alcohol amount and reach 50% (volumn concentration), stirs evenly, left standstill 36 hours, get the supernatant Recycled ethanol to the greatest extent, add correctives, add pure water to 600ml, mixing, leave standstill, filter, be distributed into 60 bottles.
The oral liquid of embodiment 5, preparation Chinese medicine composition
Get 40g Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the 40g Radix Angelicae Dahuricae, the 30g Radix Et Rhizoma Rhei, the 30g Radix Puerariae, the 50g Fructus Gardeniae, medical material after 10g Fructus Amomi and the clean system of 10g Radix Glycyrrhizae seven flavors, 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 was respectively 2 hours, 2 hours and 1 hour, after each extraction is complete, filter, merging filtrate is concentrated into the clear paste that relative density is 1.10 (70 ℃ of surveys), let cool, the ethanol that adds 60% (volumn concentration) makes and contains the alcohol amount and reach 30% (volumn concentration), stirs evenly, left standstill 96 hours, get the supernatant Recycled ethanol to the greatest extent, add correctives, add pure water to 800ml, mixing, leave standstill, filter, be distributed into 80 bottles.
The tablet of embodiment 6, preparation Chinese medicine composition
Get 40g Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the 50g Radix Angelicae Dahuricae, the 60g Radix Et Rhizoma Rhei, the 40g Radix Puerariae, the 20g Fructus Gardeniae, medical material after 25g Fructus Amomi and the clean system of 10g Radix Glycyrrhizae seven flavors, 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 was respectively 3 hours and 2 hours, after each extraction is complete, filter, merging filtrate is concentrated into the clear paste that relative density is 1.08 (70 ℃ of surveys), lets cool, the ethanol that adds 90% (volumn concentration) makes and contains the alcohol amount and reach 50% (volumn concentration), stir evenly, left standstill 60 hours, get the supernatant Recycled ethanol to most, medicinal liquid is concentrated into the thick paste that relative density is 1.25 (70 ℃ of surveys), drying is pulverized, and crosses the 80-120 mesh sieve, the starch that adds 0.02 times of gained medicated powder quality, mixing, granulate, be pressed into tablet, get 84.
The tablet of embodiment 7, preparation Chinese medicine composition
Get 40g Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the 80g Radix Angelicae Dahuricae, the 40g Radix Et Rhizoma Rhei, the 60g Radix Puerariae, the 40g Fructus Gardeniae, medical material after 30g Fructus Amomi and the clean system of 20g Radix Glycyrrhizae seven flavors, 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 was respectively 3 hours and 1 hour, after each extraction is complete, filter, merging filtrate is concentrated into the clear paste that relative density is 1.25 (70 ℃ of surveys), lets cool, the ethanol that adds 70% (volumn concentration) makes and contains the alcohol amount and reach 40% (volumn concentration), stir evenly, left standstill 72 hours, get the supernatant Recycled ethanol to most, medicinal liquid is concentrated into the thick paste that relative density is 1.15 (70 ℃ of surveys), drying is pulverized, and crosses the 80-120 mesh sieve, the starch that adds 0.2 times of gained medicated powder quality, mixing, granulate, be pressed into tablet, get 125.
The tablet of embodiment 8, preparation Chinese medicine composition
Get 50g Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the 50g Radix Angelicae Dahuricae, the 50g Radix Et Rhizoma Rhei, the 40g Radix Puerariae, the 70g Fructus Gardeniae, medical material after 20g Fructus Amomi and the clean system of 20g Radix Glycyrrhizae seven flavors, 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 was respectively 3 hours, 2 hours and 1 hour, after each extraction is complete, filter, merging filtrate is concentrated into the clear paste that relative density is 1.15 (70 ℃ of surveys), lets cool, and the ethanol that adds 80% (volumn concentration) makes and contains the alcohol amount and reach 30% (volumn concentration), left standstill 60 hours, get the supernatant Recycled ethanol to most, medicinal liquid is concentrated into the thick paste that relative density is 1.15 (70 ℃ of surveys), drying, pulverize, cross the 80-120 mesh sieve, add the starch of 0.5 times of gained medicated powder quality, mixing, granulate, be pressed into tablet, get 150.
The tablet of embodiment 9, preparation Chinese medicine composition
Get 20g Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the 30g Radix Angelicae Dahuricae, the 20g Radix Et Rhizoma Rhei, the 20g Radix Puerariae, the 20g Fructus Gardeniae, medical material after 36g Fructus Amomi and the clean system of 5g Radix Glycyrrhizae seven flavors, 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 was respectively 3 and 2 hours, after each extraction is complete, filter, merging filtrate is concentrated into the clear paste that relative density is 1.05 (70 ℃ of surveys), lets cool, the ethanol that adds 95% (volumn concentration) makes and contains the alcohol amount and reach 70% (volumn concentration), stir evenly, left standstill 96 hours, get the supernatant Recycled ethanol to most, medicinal liquid is concentrated into the thick paste that relative density is 1.35 (70 ℃ of surveys), drying is pulverized, and crosses the 80-120 mesh sieve, the starch that adds 0.3 times of gained medicated powder quality, mixing, granulate, be pressed into tablet, get 106.
The tablet of embodiment 10, preparation Chinese medicine composition
Get 50g Pericarpium Citri Reticulatae (Pericarpium Citri tangerinae), the 80g Radix Angelicae Dahuricae, the 80g Radix Et Rhizoma Rhei, the 40g Radix Puerariae, the 70g Fructus Gardeniae, medical material after 4g Fructus Amomi and the clean system of 35g Radix Glycyrrhizae seven flavors, 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 was respectively 2 hours, 2 hours and 1 hour, after each extraction is complete, filter, merging filtrate is concentrated into the clear paste that relative density is 1.15 (70 ℃ of surveys), lets cool, the ethanol that adds 80% (volumn concentration) makes and contains the alcohol amount and reach 50% (volumn concentration), stir evenly, left standstill 72 hours, get the supernatant Recycled ethanol to most, medicinal liquid is concentrated into the thick paste that relative density is 1.25 (70 ℃ of surveys), drying is pulverized, and crosses the 80-120 mesh sieve, the starch that adds 0.08 times of gained medicated powder quality, mixing, granulate, be pressed into tablet, get 136.
Embodiment 11, the clinical test of pesticide effectiveness
Adopt embodiment 1 sample to carry out clinical trial.By being in hospital and out-patient's clinical observation 66 examples, the result shows: this medicine has good clearing away heat-fire, invigorating the spleen and replenishing QI, reducing swelling and alleviating pain, the effect of hemostasis.Be used for the treatment of chronic gastritis, gastric ulcer, use safely, have no side effect.
One, case is selected
66 routine patients are divided into treatment group and matched group at random.Treatment group 44 examples, male's 24 examples, women's 20 examples; Age 24-60 year.Matched group 22 examples, male's 12 examples, women's 10 examples, age 22-58 year.
Two, accept foundation for medical treatment
66 routine patients are diagnosed as chronic gastritis, gastric ulcer through electronic gastroscopy, pathological biopsy respectively.
Three, Therapeutic Method
The treatment group dosage is: oral, one time 4,3 times on the one.
It is oral that matched group gives " stomach-recovering capsule ", 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
Take clinical cardinal symptom, gastroscope check Active inflammation, chronic inflammatory disease improvement degree as the clinical appraisal index.
1. produce effects: clinical cardinal symptom disappears, and gastroscope check Active inflammation disappears, and chronic inflammatory disease is pass on well slightly.
2. effective: clinical cardinal symptom disappears substantially, and chronic inflammatory disease takes a turn for the better effectively, and cardinal symptom obviously alleviates, and gastroscopy mucosa infection scope is dwindled more than 1/2, and inflammation alleviates to some extent.
3. invalid: symptom is without improvement, and gastroscopy does not reach effective standard, also without deterioration person.
Five, interpretation of result
Use clinical drug of the present invention and observe chronic gastritis, patients w ith peptic ulcer disease 66 examples, the result is as follows:
Therapeutic outcome
From upper table as seen: treatment group 44 examples, produce effects 23 examples, effective 20 examples, invalid 1 example, total effective rate 97.73%.Matched group 22 examples, produce effects 5 examples, effective 14 examples, invalid 3 examples, total effective rate 86.36%.Two groups are compared X
2The curative effect comparing difference has significance between=7.084, P＜0.05, two group.
Embodiment 12, the clinical test of pesticide effectiveness
Adopt embodiment 5 samples to carry out clinical trial.By being in hospital and out-patient's clinical observation 57 examples, the result shows: this medicine has good clearing away heat-fire, invigorating the spleen and replenishing QI, reducing swelling and alleviating pain, the effect of hemostasis.Be used for the treatment of chronic gastritis, gastric ulcer, use safely, have no side effect.
One, case is selected
57 routine patients are divided into treatment group and matched group at random.Treatment group 38 examples, male's 21 examples, women's 17 examples, age 23-58 year.Matched group 19 examples, male's 11 examples, women's 8 examples, age 25-59 year.
Two, accept foundation for medical treatment with embodiment 11.
Three, Therapeutic Method
The treatment group dosage is: oral, and 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
Use clinical drug of the present invention and observe chronic gastritis, patients w ith peptic ulcer disease 57 examples, the result is as follows:
Therapeutic outcome
From upper table as seen: treatment group 38 examples, produce effects 24 examples, effective 12 examples, invalid 2 examples, total effective rate 94.74%.Matched group 19 examples, produce effects 5 examples, effective 10 examples, invalid 4 examples, total effective rate 78.95%.Two groups are compared X
2The curative effect comparing difference has significance between=7.834, P＜0.05, two group.
Embodiment 13, the clinical test of pesticide effectiveness
Adopt embodiment 1 sample to carry out clinical trial.By being in hospital and out-patient's clinical observation 45 examples, the result shows: this medicine has good clearing away heat-fire, invigorating the spleen and replenishing QI, reducing swelling and alleviating pain, the effect of hemostasis.Be used for the treatment of duodenal ulcer, use safely, have no side effect.
One, case is selected
45 routine patients are divided into treatment group and matched group at random.Treatment group 30 examples, male's 18 examples, women's 12 examples, age 25-59 year.Matched group 15 examples, male's 9 examples, women's 6 examples, age 24-58 year.
Two, accept foundation for medical treatment
45 routine patients are diagnosed as duodenal ulcer through gastroscopy respectively.
Three, Therapeutic Method
The treatment group dosage is: oral, one time 4,3 times on the one.
It is oral that matched group gives " KUIYANGLING JIAONANG ", one time 4,3 times on the one.
" KUIYANGLING JIAONANG " Jilin pharmaceutcal corporation, Ltd of Ji nation produces authentication code: the accurate word Z22020361 of traditional Chinese medicines.
The course for the treatment of: 15 days.
Four, criterion of therapeutical effect
Judge curative effect, with due regard to clinical symptoms, sign with gastroscope.
1. produce effects: clinical cardinal symptom disappears, the ulcer surface only cicatrix that disappears, and upper abdominal pain disappears or basic the disappearance.
2. effective: clinical cardinal symptom disappears substantially, and ulcer transfers healing stage to by active stage, and the ulcer major diameter dwindles＞and 50%.Upper abdominal pain alleviates.
3. invalid: symptom is without improvement, and the ulcer major diameter dwindles＜and 50% or unchanged.
Five, interpretation of result:
Use clinical drug of the present invention and observe duodenal ulcer patients 45 examples, the result is as follows:
Therapeutic outcome
Two groups of Clinical efficacy comparisons: treatment group 30 examples, produce effects 19 examples, effective 10 examples, invalid 1 example, total effective rate 96.66%.Matched group 15 examples, produce effects 2 examples, effective 10 examples, invalid 3 examples, total effective rate 80%.Two groups are compared X
2The curative effect comparing difference has significance between=10.982, P＜0.01, two group.
Embodiment 14, the clinical test of pesticide effectiveness
Adopt embodiment 5 samples to carry out clinical trial.By being in hospital and out-patient's clinical observation 51 examples, the result shows: this medicine has good clearing away heat-fire, invigorating the spleen and replenishing QI, reducing swelling and alleviating pain, the effect of hemostasis.Be used for the treatment of duodenal ulcer, use safely, have no side effect.
One, case is selected
51 routine patients are divided into treatment group and matched group at random.Treatment group 34 examples, male's 19 examples, women's 15 examples, age 26-58 year.Matched group 17 examples, male's 10 examples, women's 7 examples, age 25-59 year.
Two, accept foundation for medical treatment with embodiment 13.
Three, Therapeutic Method
The treatment group dosage is: oral, and 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:
Use clinical drug of the present invention and observe duodenal ulcer patients 51 examples, the result is as follows:
Therapeutic outcome
From upper table as seen: treatment group 34 examples, produce effects 22 examples, effective 10 examples, invalid 2 examples, total effective rate 94.12%.Matched group 17 examples, produce effects 3 examples, effective 12 examples, invalid 2 examples, total effective rate 88.24%.Two groups are compared X
2The curative effect comparing difference has significance between=10.075, P＜0.01, two group.
Claims (12)
1. a pharmaceutical composition is made by the raw material of following mass parts: Pericarpium Citri Reticulatae 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.
2. pharmaceutical composition according to claim 1, it is characterized in that: described pharmaceutical composition is made by following raw material: Pericarpium Citri Reticulatae 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.
3. prepare the method for claim 1 or 2 described pharmaceutical compositions, comprise the steps:
1) claim 1 or the 2 described seven flavor medicine materials of making described pharmaceutical composition are decocted with water extraction, collect extracting solution;
2) described extracting solution is condensed into clear paste, lets cool, then adding ethanol or ethanol water make alcohol volume content reach 30-70% in described clear paste, stir evenly, and leave standstill; Leave standstill and finish rear supernatant and the Recycled ethanol collected, namely obtain described pharmaceutical composition.
4. want 3 described methods according to right, it is characterized in that: step 1) in the water yield that adds be described medical material gross mass 5-10 doubly; Described decoction is extracted and is carried out 1-3 time, and each time that decocts extraction is 1-3 hour.
5. it is characterized in that: step 1 according to claim 3 or 4 described methods) described in the medical material of medical material after for clean system.
6. each described method is characterized in that: step 2 according to claim 3-5) in clear paste be that the relative density of 70 ℃ of mensuration is the clear paste of 1.05-1.25;
Step 2) described in the ethanol water volumn concentration of ethanol be 60-95%; The described time of leaving standstill is 12-96 hour.
7. each described method according to claim 3-6, it is characterized in that: described method comprises the steps: that also it is the thick paste of 1.10-1.35 that described pharmaceutical composition is condensed into 70 ℃ of mensuration relative densities, and drying is pulverized, cross the 80-120 mesh sieve, obtain the pharmaceutical composition powder.
8. claim 1 or 2 described pharmaceutical compositions have application in the medicine of following at least a effect in preparation: 1) chronic gastritis; 2) gastric ulcer; 3) duodenal ulcer; 4) prolapse of gastric mucosa; 5) duodenitis; 6) colitis.
9. application according to claim 8 is characterized in that: described chronic gastritis comprises superficial gastritis, atrophic gastritis, erosive gastritis, gastritis verrucosa and bile reflux gastritis.
10. medicine, its active component is claim 1 or 2 described pharmaceutical compositions.
11. medicine according to claim 10 is characterized in that: the dosage form of described medicine is any pharmaceutically acceptable dosage form.
12. medicine according to claim 11 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 |
|---|
| 危北海: "胃肠动力功能障碍性疾病的中医辨证与治疗", 《中国中西医结合消化杂志》, vol. 11, no. 5, 31 December 2003 (2003-12-31), pages 259 - 261 * |
| 李兆吉: "胃痞辨证用药体会", 《陕西中医》, vol. 31, no. 6, 31 December 2010 (2010-12-31), pages 767 - 768 * |
| 李文龙: "脾胃用药规律初探", 《安徽中医临床杂志》, vol. 15, no. 1, 31 December 2003 (2003-12-31), pages 47 - 49 * |
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