CN105797049A - Medicinal preparation for treating spleen-deficiency gastric ulcer and application thereof - Google Patents

Medicinal preparation for treating spleen-deficiency gastric ulcer and application thereof Download PDF

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CN105797049A
CN105797049A CN201610284944.5A CN201610284944A CN105797049A CN 105797049 A CN105797049 A CN 105797049A CN 201610284944 A CN201610284944 A CN 201610284944A CN 105797049 A CN105797049 A CN 105797049A
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herba
fructus
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邱发龙
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Abstract

The invention relates to a medicinal preparation for treating spleen-deficiency gastric ulcer and an application thereof. The medicinal preparation contains the following components in parts by weight: 3-8 parts of mountain spicy tree fruit, 10-16 parts of tsaoko amomum fruit, 5-11 parts of eggshell, 8-14 parts of fortune eupatorium herb, 7-14 parts of lotus leaf, 3-8 parts of lapis chloriti, 10-25 parts of common dayflower herb, 8-14 parts of Chinese mosla herb, 4-8 parts of common andrographis herb, 8-17 parts of root of whiteflower hogfennel, 6-15 parts of licorice root, 5-10 parts of epipactis mairei, 7-13 parts of belleric terminalia fruit, 10-15 parts of codonopsis pilosula, 10-20 parts of milkvetch root, 8-14 parts of herb of marsh orchis, and 4-11 parts of bitter orange fruit. The medicinal preparation provided by the invention has good formulas of replenishing qi to invigorate spleen, and promoting qi circulation to relieve pain, and the formulas cooperate to achieve the effects of eliminating cold to stop pain, soothing liver regulating qi, warming collaterals to strengthen the middle warmer, nourishing and harmonizing stomach, and the like, so that the medicinal preparation can quickly eliminate stomachache, suppress ulcer, nourish gastrointestinal wall, and completely cure gastric ulcer.

Description

A kind of pharmaceutical preparation for treating insufficiency of the spleen gastric ulcer and application thereof
Technical field
The invention belongs to medical treatment field, relate to a kind of medicine treating gastrointestinal disease, particularly relate to a kind of for treating spleen Pharmaceutical preparation of empty gastric ulcer and application thereof.
Background technology
The every profession and trade great change of 21 century, dietary structure is no exception, and disease increases therewith, especially relevant to diet digestion Tract disease, gastric ulcer, as the representative of digestive disease system, has the trend of annual increase, and Peptic Ulcers or peptic ulcer are A kind of common digestive tract disease, can betide esophagus, stomach or duodenum, it is possible to betide near stomach-intestinal anastomosis mouth or In Meckel diverticulum containing gastric mucosa, because gastric ulcer and duodenal ulcer are most common, therefore general so-called digestibility is burst Infections refers to gastric ulcer and duodenal ulcer.Why it be referred to as peptic ulcer, is because previously thinking gastric ulcer and ten Mucosa autodigestion is formed by two Duodenalulcers due to gastric acid and pepsin, and in fact gastric acid and pepsin are simply The one of the main reasons of ulcer, also other reasons can form peptic ulcer.Owing to gastric ulcer and duodenum are burst The cause of disease of infections and clinical symptoms have many similarities, are sometimes difficult to differentiate between gastric ulcer or duodenal ulcer, the most past Toward being diagnosed as peptic ulcer, or taste-blindness rate.If the clear and definite ulcer of energy is at stomach or duodenum, that just can be straight Connect and be diagnosed as gastric ulcer or duodenal ulcer.
The medicine for the treatment of gastric ulcer has a lot both at home and abroad, and the medicine that such as protection gastric mucosa medicine is conventional has colloidal bismuth subcitrate (CBS), sucralfate, Marzulene-S, gel aluminum hydroxide, gastric Mucin etc.；Adjust gastrointestinal motility function medicament Abdeminal pain With domperidone etc..Have the hiccups, abdominal distention or to have reflux phenomenon be main person, available medicine for stomach dynamic；If antibiotic gastroscopy is sent out Existing Helicobacter pylori, should take antibiotic, clarithromycin, amoxicillin etc., has an effect removing Hp, and one As can be selected for two kinds, often and gastric mucosa protective agent and acid inhibitor use in conjunction；The medicine that antacid is conventional has sodium bicarbonate, hydrogen Magnesium oxide, gel aluminum hydroxide etc.；Analgesic Upper abdominal pain compared with the orally available atropine of severe one, probanthine, Semen daturae tablet, with Reduce gastric acid secretion and alleviate colic symptoms；Other symptomatic treatment medicines can use digestant, as pancreatin, yeast tablet, lactasinum, Simethicone sheet etc..Also acid suppression medicine such as cimetidine, ranitidine, famotidine etc. can be used if any acid regurgitation phenomenon.Prevent gallbladder Juice reflux can take hydrotalcite, cholestyramine to adsorb bile；Having the hematemesis person of having blood in stool, cimetidine is administered orally.
In patent, the medicine for the treatment of by Chinese herbs gastric ulcer constantly occurs, but Chinese medicine preparation effect is difficult to ensure that, western medicine is also Conventional means, but the course for the treatment of of routine clinical treatment gastric ulcer is longer, takes effect quickly, but drug side effect is big, and The frequent recurrent exerbation of disease, has had a strong impact on the life health of people.
There is provided at present a kind of definite effect, aobvious particularly important of the little Chinese medicine preparation of side reaction.
Summary of the invention
For the defect of prior art, the present invention be directed to treat at present the present situation of gastric ulcer, it is provided that a kind of therapeutic effect is good Pharmaceutical preparation, and have no side effect.
Specifically, the present invention is realized in.
Inventor provides the prescriptions of Chinese medicine of the pharmaceutical preparation treating insufficiency of the spleen gastric ulcer according to drug matching experience, including following Chinese medicine: Fructus Litseae, Fructus Tsaoko, Ovum crusta Gallus domesticus, Herba Eupatorii, Folium Nelumbinis, Lapis Chloriti, Herba Commelinae, Herba Moslae, spend in vain Herba Andrographis, Radix Peucedani, Radix Glycyrrhizae, Little purple with a smile, Fructus Terminaliae Billericae, Radix Codonopsis, the Radix Astragali, Herba Orchidis Latifoliae, FRUCTUS CITRI AURANTII AMARAE.
Each raw material dosage of prescription all has preferable curative effect, described formula and weight portion in the weight portion scope of the present invention: Fructus Litseae 3-8 part, Fructus Tsaoko 10-16 part, Ovum crusta Gallus domesticus 5-11 part, Herba Eupatorii 8-14 part, Folium Nelumbinis 7-14 part, Lapis Chloriti 3-8 part, the duck sole of the foot Grass 10-25 part, Herba Moslae 8-14 part, spend Herba Andrographis 4-8 part in vain, Radix Peucedani 8-17 part, Radix Glycyrrhizae 6-15 part, little purple have a smile on one's face 5-10 part, Fructus Terminaliae Billericae 7-13 part, Radix Codonopsis 10-15 part, Radix Astragali 10-20 part, Herba Orchidis Latifoliae 8-14 part, FRUCTUS CITRI AURANTII AMARAE 4-11 part.
For having reached the effect of optimum, to described formula and weight portion it is: Fructus Litseae 5.5 parts, Fructus Tsaoko 13 parts, Ovum crusta Gallus domesticus 8 Part, Herba Eupatorii 11 parts, 11.5 parts of Folium Nelumbinis, Lapis Chloriti 5.5 parts, Herba Commelinae 17.5 parts, Herba Moslae 11 parts, spend Herba Andrographis 6 parts, front in vain 12.5 parts recklessly, 10.5 parts of Radix Glycyrrhizae, little purple have a smile on one's face 7.5 parts, Fructus Terminaliae Billericae 10 parts, Radix Codonopsis 12.5 parts, the Radix Astragali 15 parts, Herba Orchidis Latifoliae 11 Part, FRUCTUS CITRI AURANTII AMARAE 7.5 parts.
Or:
Fructus Litseae 6.5 parts, Fructus Tsaoko 14 parts, Ovum crusta Gallus domesticus 8.5 parts, Herba Eupatorii 12 parts, 12 parts of Folium Nelumbinis, Lapis Chloriti 6.5 parts, Herba Commelinae 18.5 Part, Herba Moslae 12 parts, spend Herba Andrographis 6.5 parts in vain, Radix Peucedani 13.5 parts, 11.5 parts of Radix Glycyrrhizae, little purple have a smile on one's face 8 parts, Fructus Terminaliae Billericae 11 parts, Radix Codonopsis 13 parts, the Radix Astragali 15.5 parts, Herba Orchidis Latifoliae 11.5 parts, FRUCTUS CITRI AURANTII AMARAE 8 parts.
The function of each taste Chinese crude drug used in the pharmaceutical preparation of the treatment gastric ulcer of the present invention is as follows:
Fructus Litseae: acrid in the mouth, warm in nature.
Gui Jing: return spleen, stomach, kidney, bladder warp.
Effect: warming spleen and stomach for dispelling cold, promoting the circulation of QI to relieve pain, for cold syndrome of the stomach vomiting, coldness and pain in the epigastrium, colic of cold type stomachache, stagnancy of cold-damp, urine Muddy.
Fructus Tsaoko: acrid in the mouth, warm in nature.
Gui Jing: return spleen, stomach warp.
Function cures mainly: dampness warming middle-JIAO, expectorant preventing the attack (or recurrence) of malaria.For internal retention of cold wetness, abdominal distention, feeling of fullness vomiting, malaria cold and heat.
Ovum crusta Gallus domesticus: lightly seasoned, property is put down.
Function cures mainly: convergence antacid, replenishes the calcium.For chronic gastric ulcer, gastric and duodenal ulcers, rickets.
Herba Eupatorii: acrid in the mouth, property is put down.
Gui Jing: return spleen, stomach, lung meridian.
Function cures mainly: removing dampness by means of aromatics, appetizing of being amusing, and delivers expelling summer-heat.For turbid damp obstructing in middle-JIAO, gastral cavity painful abdominal mass vomiting and nausea, sweet greasy in mouth, halitosis, Sialism, heat-damp in summer table disease, feeling of fullness in the head is uncomfortable in chest.
Folium Nelumbinis: bitter in the mouth, property is put down.
Gui Jing: return liver, spleen, stomach warp.
Function cures mainly: clearing away summer-heat, sending up the lucid YANG, cooling blood for hemostasis.For summer-heat excessive thirst, diarrhea due to summer heat and dampness, diarrhea due to hypofunction of the spleen, heat in blood is told Nosebleed, metrorrhagia of having blood in stool.Burnt FOLIUM NELUMBINIS astringent therapy removing stasis to stop bleeding.For multiple hemorrhage and puerperal blood faints.
Lapis Chloriti: sweet in the mouth, property is put down.
Gui Jing: return lung, the heart, Liver Channel.
Function cures mainly: effect pendant expectorant therapeutic method to keep the adverse QI flowing downwards, checking hyperfunction of the liver for relieving convulsion.
Herba Commelinae: sweet in the mouth, cold in nature.
Gui Jing: return lung, stomach, small intestine meridian.
Function cures mainly: heat-clearing and toxic substances removing, inducing diuresis to remove edema.For anemopyretic cold, hyperpyrexia, laryngopharynx swelling and pain, edema oliguria, pyretic stranguria Puckery pain, carbuncle furunculosis.
Herba Moslae
Spend Herba Andrographis in vain: acrid in the mouth, cool in nature
Function cures mainly: dissipate wind heat；Lung qi dispersing gas；Adjust the intestines and stomach.Main cold, fever；Lung-heat cough with asthma；Vomiting；Have loose bowels
Radix Peucedani: bitter in the mouth, cold in nature.
Gui Jing: return lung meridian.
Function cures mainly: dissipate wind heat clearing away, lowering the adverse-rising QI to resolve phlegm.For cough due to pathogenic wind-heat's abundant expectoration, expectorant dyspnea of heat type is full, coughs up phlegm yellow thick.
Radix Glycyrrhizae: sweet in the mouth, property is put down.
Gui Jing: enter spleen, stomach, the heart, lung meridian.
Function cures mainly: invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain.
Little purple is had a smile on one's face: sweet in the mouth, and property is put down.
Function cures mainly: promoting flow of QI and blood；Heat-clearing and toxic substances removing.Main cough due to lung-heat；Stagnation of QI chest pain；Vomit and diarrhoea；Painful and swollen testis；Lumbago due to pathogenic wind-dampness；
Traumatic injury；Sore and toxic
Fructus Terminaliae Billericae: sweet in the mouth, warm in nature.
Function cures mainly: astringing intestine to stop diarrhea, astringes the lung, sending down the abnormal ascending QI.For chronic diarrhea, chronic dysentery, proctoptosis, chronic cough aphonia, discharging fresh blood stool, bleeding not during menses, Seminal emission night sweat.
Radix Codonopsis: sweet in the mouth, property is put down.
Gui Jing: return spleen, lung meridian.
Function cures mainly: invigorating the spleen and replenishing QI, strengthening spleen and tonifying lung.For deficiency of the spleen and lung, cardiopalmus of breathing hard, anorexia and loose stool, dyspnea due to deficiency cough, interior-heat disappears Yearningly.
The Radix Astragali: sweet in the mouth, warm in nature.
Gui Jing: return lung, spleen channel.
Function cures mainly: invigorating QI to consolidate the body surface resistance, diuresis toxin expelling, weak for the deficiency of vital energy, anorexia and loose stool, sinking of QI of middle-JIAO, and chronic diarrhea proctoptosis is had blood in stool Metrorrhagia, exterior deficiency spontaneous perspiration, deficiency of vital energy edema, carbuncle difficulty is burst, and bursts for a long time and does not holds back, and blood deficiency dull yellowish colored skin, interior-heat is quenched one's thirst.
Herba Orchidis Latifoliae: sweet in the mouth, property is put down.
Function cures mainly: heart tonifying, and the kidney invigorating is promoted the production of body fluid, and quenches the thirst, strengthening the spleen and stomach.
Irritated thirsty, anorexia, menoxenia.Asthenia anemia, dizzy, dim eyesight.Herba Orchidis Latifoliae, Radix seu Herba Spiranthis Lanceae, Rhizoma Polygonati, Radix Polygoni Multiflori Each 3 money, are decocted in water for oral dose.
FRUCTUS CITRI AURANTII AMARAE: cold in nature, sour in the mouth.
Function cures mainly: promoting the circulation of QI to alleviate the stagnation in middle-JIAO, helps digestion, and reduces phlegm.For the vexed distending pain of chest and abdomen, accumulation of food in the stomach and intes tine due to indigestion, phlegm retention, proctoptosis.
Pharmaceutical preparation of the present invention is suitable for treating various digestive tract ulcer, is especially suitable for treatment and treats insufficiency of the spleen gastric ulcer.
Pharmaceutical preparation of the present invention is the one in capsule, tablet, water decoction, granule.It is preferably granule.
The present invention is to above prescription through conscientious research, and according to the reasonability of middle medical drugs, invention proposes concrete one Plant the preparation method of the granule treating gastric ulcer, concretely comprise the following steps:
(1) by Fructus Tsaoko, Folium Nelumbinis, little purple with a smile, Herba Commelinae and Fructus Terminaliae Billericae add 2000ml water soaking 1 hour, after fast fire is fried open,
The most slowly decoct 30 minutes, pour out decocting liquid 500ml, add the pure water of 350ml, slow pan-fried 20 minutes, then pour out decocting liquid 200ml, Adding the water of 500ml, continue slow decocting 30 minutes, poured out by decocting liquid, the decocting liquid poured out with first twice mixes and stirs evenly；
(2) step (2) decocting liquid concentrating under reduced pressure is obtained the condensed cream that relative density is 1.05；
(3) Ovum crusta Gallus domesticus, Herba Eupatorii, Herba Moslae, Radix Peucedani, Radix Codonopsis, the Radix Astragali, Herba Orchidis Latifoliae and FRUCTUS CITRI AURANTII AMARAE grind to form coarse powder, add 80% second Alcohol extraction 2 times, each 1 hour, merges medicinal liquid, stands 24 hours, standby；
(4) by Fructus Litseae, Lapis Chloriti, Herba Andrographis is spent in vain and Radix Glycyrrhizae powder is broken into fine powder and crosses after 80 mesh sieves with appropriate 70% ethanol extraction 2 times, each 1.5 hours, collect extracting solution, stand 24 hours, standby；
(5) supernatant taking (3rd), preparing in (4) step, decompression recycling ethanol, it is concentrated into 70 DEG C, density is 1.05 Extractum, mix with the extractum of step (4) after drying, standby.
(6) the extractum weight in determination step (5), adds the mannitol of its weight 10% and the mixture of dextrin, wherein manna In the mixture of alcohol and dextrin, the weight ratio of lactose and dextrin is 1:1；Add the starch slurry of appropriate 15%, cross 16 mesh sieve systems Grain, is dried, and subpackage i.e. obtains granule.
Granule of the present invention often wraps weight 20g.
Compared with prior art, prescription of the present invention has a good recipe of replenishing QI to invigorate the spleen, promoting the circulation of QI to relieve pain, all sides coordinate have dispersing cold for relieving pain, Logical effect such as invigorating middle warmer, nourishing the stomach stomach function regulating of depressed liver-energy dispersing and QI regulating, temperature, it is possible to eliminate rapidly stomach pain, potent reparation is rotten to the corn, and containment is burst Infections, rebuilds gastric mucosa, nutrition gastrointestinal wall, thoroughly cures the effect of gastric ulcer.By pharmacodynamic experiment it can be seen that this The effect of gastric ulcer is preferably treated having by daylight side, and its antiulcer action can be by strengthening protective factors, suppression attack The factor is come.
Specific embodiment
The detailed description of the invention of the following stated, the only present invention, protection scope of the present invention is not limited thereto, any familiar Those skilled in the art in the technical scope that the invention discloses, the change that can readily occur in or replacement, all should contain Within protection scope of the present invention.
Embodiment 1: a kind of granule for treating insufficiency of the spleen gastric ulcer, containing following raw material medicine:
Fructus Litseae 3 grams, Fructus Tsaoko 10 grams, Ovum crusta Gallus domesticus 5 grams, Herba Eupatorii 8 grams, 7 grams of Folium Nelumbinis, Lapis Chloriti 3 grams, Herba Commelinae 10 grams, Herba Moslae 8 grams, spend Herba Andrographis 4 grams in vain, Radix Peucedani 8 grams, 6 grams of Radix Glycyrrhizae, little purple have a smile on one's face 5 grams, Fructus Terminaliae Billericae 7 grams, Radix Codonopsis 10 grams, the Radix Astragali 10 grams, Herba Orchidis Latifoliae 8 grams, FRUCTUS CITRI AURANTII AMARAE 4 grams.
Concrete preparation method is:
(1) by Fructus Tsaoko, Folium Nelumbinis, little purple with a smile, Herba Commelinae and Fructus Terminaliae Billericae add 2000ml water soaking 1 hour, after fast fire is fried open, The most slowly decoct 30 minutes, pour out decocting liquid 500ml, add the pure water of 350ml, slow pan-fried 20 minutes, then pour out decocting liquid 200ml, Adding the water of 500ml, continue slow decocting 30 minutes, poured out by decocting liquid, the decocting liquid poured out with first twice mixes and stirs evenly；
(2) step (2) decocting liquid concentrating under reduced pressure is obtained the condensed cream that relative density is 1.05；
(3) Ovum crusta Gallus domesticus, Herba Eupatorii, Herba Moslae, Radix Peucedani, Radix Codonopsis, the Radix Astragali, Herba Orchidis Latifoliae and FRUCTUS CITRI AURANTII AMARAE grind to form coarse powder, add 80% second Alcohol extraction 2 times, each 1 hour, merges medicinal liquid, stands 24 hours, standby；
(4) by Fructus Litseae, Lapis Chloriti, Herba Andrographis is spent in vain and Radix Glycyrrhizae powder is broken into fine powder and crosses after 80 mesh sieves with appropriate 70% ethanol extraction 2 times, each 1.5 hours, collect extracting solution, stand 24 hours, standby；
(5) supernatant taking (3rd), preparing in (4) step, decompression recycling ethanol, it is concentrated into 70 DEG C, density is 1.05 Extractum, mix with the extractum of step (4) after drying, standby.
(6) the extractum weight in determination step (5), adds the mannitol of its weight 10% and the mixture of dextrin, wherein mannitol It is 1:1 with the weight ratio of lactose in the mixture of dextrin and dextrin；Add the starch slurry of appropriate 15%, cross 16 mesh sieves and pelletize, dry Dry, subpackage i.e. obtains granule, every bag of 20g.
Embodiment 2: a kind of granule for treating insufficiency of the spleen gastric ulcer, containing following raw material medicine:
Fructus Litseae 8 grams, Fructus Tsaoko 16 grams, Ovum crusta Gallus domesticus 11 grams, Herba Eupatorii 14 grams, 14 grams of Folium Nelumbinis, Lapis Chloriti 8 grams, Herba Commelinae 25 grams, Herba Moslae 14 grams, spend Herba Andrographis 8 grams in vain, Radix Peucedani 17 grams, 15 grams of Radix Glycyrrhizae, little purple have a smile on one's face 10 grams, Fructus Terminaliae Billericae 13 grams, Radix Codonopsis 15 grams, The Radix Astragali 20 grams, Herba Orchidis Latifoliae 14 grams, FRUCTUS CITRI AURANTII AMARAE 11 grams.
Preparation method is with embodiment 1.
Embodiment 3: a kind of granule for treating insufficiency of the spleen gastric ulcer, containing following raw material medicine:
Fructus Litseae 5.5 grams, Fructus Tsaoko 13 grams, Ovum crusta Gallus domesticus 8 grams, Herba Eupatorii 11 grams, 11.5 grams of Folium Nelumbinis, Lapis Chloriti 5.5 grams, Herba Commelinae 17.5 Gram, Herba Moslae 11 grams, spend Herba Andrographis 6 grams in vain, Radix Peucedani 12.5 grams, 10.5 grams of Radix Glycyrrhizae, little purple have a smile on one's face 7.5 grams, Fructus Terminaliae Billericae 10 grams, Radix Codonopsis 12.5 grams, the Radix Astragali 15 grams, Herba Orchidis Latifoliae 11 grams, FRUCTUS CITRI AURANTII AMARAE 7.5 grams.
Preparation method is with embodiment 1.
Embodiment 4: a kind of granule for treating insufficiency of the spleen gastric ulcer, containing following raw material medicine:
Fructus Litseae 6.5 grams, Fructus Tsaoko 14 grams, Ovum crusta Gallus domesticus 8.5 grams, Herba Eupatorii 12 grams, 12 grams of Folium Nelumbinis, Lapis Chloriti 6.5 grams, Herba Commelinae 18.5 Gram, Herba Moslae 12 grams, spend Herba Andrographis 6.5 grams in vain, Radix Peucedani 13.5 grams, 11.5 grams of Radix Glycyrrhizae, little purple have a smile on one's face 8 grams, Fructus Terminaliae Billericae 11 grams, Radix Codonopsis 13 grams, the Radix Astragali 15.5 grams, Herba Orchidis Latifoliae 11.5 grams, FRUCTUS CITRI AURANTII AMARAE 8 grams.
Preparation method is with embodiment 1.
Embodiment 5: animal model test
Helicobacter pylori (Helicobacter pylori, Hp) is the important virulence factor of peptic ulcer, additionally it and gastric cancer And relevant (MALT) the lymphadenomatous relation of gastric mucosa is very close, on the other hand helicobacter pylori quantity and existing state are to judge Peptic ulcer look for a standard, in Experiment of Zoology, be commonly used to do the strain of Mouse Stomach ulcer modeling.
SANJIU WEITAI KELI be mainly composed of Foliumet Ramulus Evodiae, Folium Et Cacumen Murrayae, Radix Zanthoxyli, the Radix Aucklandiae, Radix Scutellariae, Poria, Radix Rehmanniae, the Radix Paeoniae Alba, In primary treatment stomach stomach in need not stomachache caused by the gentle foot of sun, retention of damp leading to blockage of QI, feeling of fullness, disease see stomachache indistinctly, oppression sensation over the epigastrium, Acid regurgitation, noisy discomfort, anorexia, extremity asthenia, be that a kind of gastric ulcer for the treatment of has the medicine of significant curative effect, this Bright being used for is cooked positive control test.
5.1, animal model and administration
Animal model: (1) antibacterial culturing: helicobacter pylori is cultivated+1% solubility with campylobacter jejuni agar based media and formed sediment The aseptic Sanguis caprae seu ovis of powder+7.5%, under micro-aerobic condition (oxygen 5%, carbon dioxide 10%, nitrogen 85%), cultivates 3-5 days for 37 DEG C, Animal model: SPF level BALB/C mice 40, inoculates helicobacter pylori bacterium solution, and 0.4ml/ (is only 109 containing about helicobacter pylori Individual/ml), all animals fill fasting 12 hours before feeding, and continuous 4 times, within 1 week, complete.Mice completes in modeling.
It is administered:
Each group of the present invention: dosage group (6g/kg), embodiment 3 in embodiment 3 high dose group (9g/kg), embodiment 3 Low dose group (3g/kg), often group 10, the granule of described embodiment 3 prepares according to the embodiment of the present invention 3. Model group is often organized 8:00 every day gastric infusion respectively and is fed embodiment 3 solution 1 time, and successive administration is observed after within 7 days, putting to death mice Result.
Model group: modeling mice 10, every day, 8:00 gastric infusion respectively fed normal saline 1 time, successive administration 7 days Put to death observed result after mice.
Positive controls: SANJIU WEITAI KELI is tested as positive control, and dose is 7g/kg, 10, every day, 8:00 filled Stomach is administered and feeds solution 1 time, and successive administration puts to death mice observed result in 7 days.
Normal group: separately take mice 10, every day, 8:00 gastric infusion respectively fed normal saline 1 time, successive administration 7 days Put to death observed result after mice.
5.2, therapeutic effect
5.2.1, helicobacter pylori eradication situation
The quantity of helicobacter pylori and removing embodies medicine to the prevention of gastric ulcer and curative properties, therefore detects under high power lens The quantity of the helicobacter pylori of Mouse Stomach inner surface and removing situation can intuitively understand treatment situation, and detailed results is shown in Table 1.
Each group helicobacter pylori eradication situation after table 1 treatment
Note: compare with model control group,@P ＜ 0.05,@@P ＜ 0.01；
Table 1 it can be seen that
(1) compared with model group body several with the Helicobacter pylori-Negative of normal group, mice modeling of the present invention success
(2) in embodiment 3 high dose group, embodiment 3, dosage group, embodiment 3 low dose group and positive controls all have bright Aobvious therapeutic effect, but in embodiment 3 high dose group of the medicine of the present invention, embodiment 3, dosage group therapeutic effect is better than I.e. positive controls.
The detection of 5.3 inflammatory factors
Use ELASA detection kit that U.S. R&D company produces, TECAN company multi-functional microplate reader (Infinite M200, Austria), by specification carries out the detection of the level of blood serum IL-6, IL-8.
In table 2 rats models of gastric ulcer 4d serum, IL-6, IL-8 dynamically change
Group IL-6(pg/ml) IL-8(pg/ml)
Embodiment 3 high dose group 689.56±33.60@@$%% 440.02±51.23@@$$%%
Dosage group in embodiment 3 701.36±33.02@@$ 455.53±41.29@@$$
Embodiment 3 low dose group 711.63±37.31@@ 496.39±39.69@@
Positive controls 720.22±41.23@@ 500.91±45.23@@
Model group 844.36±41.36## 551.98±41.85##
Normal group 651.01±47.58 401.02±44.69
Note: compare with Normal group,##P ＜ 0.01；
Compare with model control group,@P ＜ 0.05,@@P ＜ 0.01；
Compared with SANJIU WEITAI KELI group,%P ＜ 0.05,%%P ＜ 0.01.
As can be seen from Table 2:
(1) model group is compared with IL-6, IL-8 of normal group, mice modeling of the present invention success.
(2) in 4d SANJIU WEITAI KELI group and granule of the present invention, positive controls and model control group, there is statistics Difference, and granule group IL-6 of the present invention, IL-8 are all significantly lower than SANJIU WEITAI KELI group, and it is poor that both has statistics Different, it is suitable for further genralrlization application.
5.4, animal acute toxicity test
Tested Chinese medicine preparation: the granule manufactured by embodiment of the present invention 5-8, adds purified water by 1:2, makes solution, standby.
Experimental animal: regular grade kunming mice, body weight 20g ± 5g, male and female half and half, female mice is all without pregnant.
The solution of mouse stomach Chinese medicine granules of the present invention preparation, when given low reaches 735.5g crude drug/kg dosage, after administration Mice occurs that light activity reduces, and within about 1 hour, recovers normal, Continuous Observation 7 days after administration, none animal dead, its whole body Situation, diet, take the photograph water, urine and body weight increase the most normal.
Result of the test shows: the maximum dosage-feeding of the granule manufactured by mouse stomach embodiment 5-8 is 735.5g crude drug / kg/d (LD50 ＞ 735.5g crude drug/kg).The Chinese medicine powder clinical application every day total amount of the present invention is 0.15g crude drug/kg/d to the maximum； By weighing machine, the dosis tolerata of mouse stomach water decoction is 4903.3 times of clinical patient.Point out this medicine acute toxicity extremely low, clinical Drug safety.
5.5, long-term toxicity test for animals
Tested Chinese medicine preparation: embodiment of the present invention 5-8 gained Chinese medicine granules, adds purified water by 1:2, makes solution, standby.
Experimental animal: regular grade SD rat, body weight 210g ± 14g, male and female half and half, female rats is all without pregnant.
12.3, method and result:
4 kinds of Chinese medicine decoctions: be divided into high, medium and low three dosage groups, per weight dosage be respectively patient's dose 180, 60,20 times；Experimental mouse is randomly divided into 13 groups, and wherein the granule solution of 12 groups of difference 3 kinds of three dosage of gavage, remains 1 group Gavage normal saline (40 times of patient's dose)；All 13 groups of gavages 180 days all continuously, observe animal general toxic reaction and tight Weight degree, place after death checks each position by rule of operation, and carries out hematology, ALT, BUN and the heart, liver, spleen, lung, kidney, The pathological examination of the main organs such as stomach；Through long-term feeding, all there is not toxic reaction in 13 groups of rats.Physically well develop.Naked eyes Outward appearance and main organs no abnormality seen.Peripheral hemogram and Serum ALT, BUN compare with matched group without pathologic change.Pathological replacement The most significant changes such as the heart, liver, spleen, lung, kidney, stomach, it is therefore contemplated that through proved by pathology, 3 kinds of Chinese medicine decoctions are to dynamic Thing shows without chronic toxicity.
By two above toxicity test, it was demonstrated that the present invention is safe by the granule that embodiment 5-8 makes, and has no side effect, Can be taken by patient.
Embodiment 6: animal model test and experiment in vitro
By the granule of the embodiment 3 of use in the granule alternate embodiment 9 of embodiment 1,2,4, repeat embodiment 5, Found that the preparation of embodiment 1,2,4 has preferable curative effect.
Embodiment 7, the present invention clinical setting in treatment gastric ulcer:
7.1, case selection:
Selecting patients w ith peptic ulcer disease 300 example to carry out clinical observation from 2013-2015, patient is randomly divided into three groups, treatment group 233 people, It is respectively treatment group and matched group, treatment group 117 people, matched group 116 example, respectively organizes patient medical record, age, sex, health etc. Factor is basically identical, without significant difference, has comparability.
7.2, Therapeutic Method:
Treatment group: the granule of the oral embodiment of the present invention 3 preparation, each 20g, every day 2 times, 7 days is a course for the treatment of, takes continuously With 3 courses for the treatment of.
Matched group: take omeprazole+JUYUANSUNMOSHABILI granule+Couoidal bismuth pectin capsules by therapeutic dose, 7 days is a course for the treatment of Wherein Couoidal bismuth pectin capsules takes i.e. drug withdrawal in 2 weeks, and 3 courses for the treatment of taken continuously by other two kinds of medicines.
7.3, diagnostic criteria:
(1) the chronic course of disease, periodical attack, often relevant with seasonal variations, Nervous and Mental Factors, improper diet；Or long-term taking energy Cause the medicine such as aspirin etc. of ulcer.
(2) upper abdomen dull pain, causalgia or dull pain, alleviates after taking alkalescent medicine.Typical case's gastric ulcer is often to the left under xiphoid-process, good Half an hour after the meal to 1～2 hour.Pain often accompanies acid regurgitation belch.
(3) acid amount is secreted on basis and maximum is secreted acidimetric estimation and helped diagnosis.The basis of gastric ulcer is secreted acid and is measured normal or slightly lower, but should Lack for free acid.
(4) ulcer active stage stool blood is positive.
(5) niche seen from the barium meal examination of x line and the medium direct sign of mucosal fold collection.Simple local tenderness, between excitation deformation etc. Connect sign and only make reference.
(6) gastroscopy, can in stomach see circle or oval, bottom is smooth, the ulcer of neat in edge.According to ulcer surface finding, Can be divided into: 1. active stage: ulcer surface is greyish white or brown tongue film covers, and edge swelling, color and luster is ruddy, smooth and soft.② Healing stage: tongue film is thinning, and ulcer reduces, the about blush of visible mucous epithelium regeneration；Or ulcer surface almost disappears, on it There is few thin coating.3. cicatricial phase: ulcer surface white fur disappears, becomes red congested cicatrix；Visible pleat is concentrated.
Possessing above (1) (2) (5) or (2) (6) Xiang Zheke and make Gastric Ulcer, to being diagnosed as gastric ulcer, person must be with evil Property ulcer differentiate, all can carry out gastroscopy person and should do Mucosa Biopsy and made a definite diagnosis.
7.4, therapeutic outcome:
Cure: ulcer and inflammation all disappear, stomach dull pain, dull pain, distending pain, burn the disappearance of the stomach pain such as sample pain, gastric motility Recovering, metabolism recovers normal.
Effective: ulcer disappears or ulcer area reduces more than 50%, tissue inflammatory reaction alleviates or disappears about, stomach discomfort Alleviating, gastric motility has recovered.
Invalid: ulcer area is unchanged or reduces less than 50% or symptom is unchanged.
The therapeutic effect of table 3 treatment group and matched group is as follows
Group Cure Effective Invalid Effective percentage (%)
Treatment group 99 17 1 99.14
Matched group 33 51 22 80.17
From table 3 it can be seen that through treating wherein treatment group: curing 99 examples, effective 17 examples, invalid 1 example, effective percentage is 99.14%； Matched group cures 33 examples, effective 51 examples, invalid 22 examples, and total effective rate is 80.17%.Result above shows, the healing for the treatment of group Rate and total effective rate are apparently higher than matched group.
Table 4 treatment group and matched group to follow up a case by regular visits to individual treatment effect as follows
Group Follow up a case by regular visits to individuality Relapse individual Relapse rate (%)
Treatment group 95 1 1.05
Matched group 33 8 24.24
Be can be seen that by table 4 ulcer healing patient is carried out when 6 months after terminating the course for the treatment of scope follows up a case by regular visits to, add up ulcer recurrence Rate.Wherein treatment group 95 example obtains and follows up a case by regular visits to, and matched group healing person 33 people obtains and follows up a case by regular visits to, and two groups of gastric ulcer recurrence rates compare and are shown in Table 2. More than test result indicate that, Chinese medicine composition of the present invention, when for the treatment of gastric ulcer, has cure rate high, is difficult to recurrence Advantage, every statistical data, all due to Western medicine group, is suitable for further genralrlization application in clinic.
7.5, typical case
Case 1: Shandong, female 35 years old, people from Chengdu, Sichuan, over 2014, my institute checks, patient's private prosecution was made gastroscope, eaten various The medicine for the treatment of gastrointestinal disease, as taking omeprazole enteric-coated capsules, JUYUANSUNMOSHABILI granule, poor effect, effect Not notable, it is diagnosed as patients w ith peptic ulcer disease at local hospital, the phenomenons such as anorexia, abdominal distention occurs in the recent period, is in a bad way, main suit is nearest Often having a stomachache, pressing pain is more violent, introduces my institute through friend and checks, takes the granule of the embodiment of the present invention 3,7 days Afterwards, patient's private prosecution stomach is the most comfortable, pain abdominal distention this disappearance of sensillary base, after continue to take medicine of the present invention 14 days, recovery from illness, 6 months Effect of follow-up visit by telephone does not recur.
Case 2: Xue, man 40 years old, people from Zaozhuang, Shandong, over 2015, my institute checks, private prosecution HP is 4, takes colloidal bismmth pectin Capsule some months, does not feels any better, and occurs stomachache, vomiting phenomenon in the recent period, Hacebar to be administered orally when my institute checks and makees gastroscope Checking, Stomach in Patients is fishhook-type, on an empty stomach without stomach pool stream；Antrum pleat irregular arrangement, increases thick.Coat of the stomach wriggling is poor, Pyloric cap form is normal, is diagnosed as chronic gastric ulcer, takes the granule of the embodiment of the present invention 4, after 7 days, and patient Private prosecution stomach is the most comfortable, pain abdominal distention this disappearance of sensillary base, appetite increase, after continue to take medicine of the present invention 14 days, recovery from illness, 6 months Effect of follow-up visit by telephone does not recur.

Claims (9)

1. one kind for treating the pharmaceutical preparation of insufficiency of the spleen gastric ulcer, it is characterised in that described pharmaceutical preparation includes following Chinese crude drug: Fructus Litseae, Fructus Tsaoko, Ovum crusta Gallus domesticus, Herba Eupatorii, Folium Nelumbinis, Lapis Chloriti, Herba Commelinae, Herba Moslae, spend in vain Herba Andrographis, Radix Peucedani, Radix Glycyrrhizae, Little purple with a smile, Fructus Terminaliae Billericae, Radix Codonopsis, the Radix Astragali, Herba Orchidis Latifoliae, FRUCTUS CITRI AURANTII AMARAE.
Pharmaceutical preparation the most according to claim 1, it is characterised in that described pharmaceutical preparation includes following weight portion Chinese crude drug: Fructus Litseae 3-8 part, Fructus Tsaoko 10-16 part, Ovum crusta Gallus domesticus 5-11 part, Herba Eupatorii 8-14 part, Folium Nelumbinis 7-14 part, Lapis Chloriti 3-8 Part, Herba Commelinae 10-25 part, Herba Moslae 8-14 part, spend Herba Andrographis 4-8 part, Radix Peucedani 8-17 part, Radix Glycyrrhizae 6-15 part, little in vain Purple 5-10 part, Fructus Terminaliae Billericae 7-13 part, Radix Codonopsis 10-15 part, Radix Astragali 10-20 part, Herba Orchidis Latifoliae 8-14 part, CitrusaurantiumL.Var.amara Engl. with a smile Fructus Aurantii 4-11 part.
Pharmaceutical preparation the most according to claim 1, it is characterised in that described pharmaceutical preparation includes following weight portion Chinese crude drug: Fructus Litseae 5.5 parts, Fructus Tsaoko 13 parts, Ovum crusta Gallus domesticus 8 parts, Herba Eupatorii 11 parts, 11.5 parts of Folium Nelumbinis, Lapis Chloriti 5.5 parts, the duck sole of the foot Grass 17.5 parts, Herba Moslae 11 parts, spend Herba Andrographis 6 parts in vain, Radix Peucedani 12.5 parts, 10.5 parts of Radix Glycyrrhizae, little purple have a smile on one's face 7.5 parts, Fructus Terminaliae Billericae 10 parts, Radix Codonopsis 12.5 parts, the Radix Astragali 15 parts, Herba Orchidis Latifoliae 11 parts, FRUCTUS CITRI AURANTII AMARAE 7.5 parts.
Pharmaceutical preparation the most according to claim 1, it is characterised in that described pharmaceutical preparation includes following weight portion Chinese crude drug: Bi Clear eggplant 6.5 parts, Fructus Tsaoko 14 parts, Ovum crusta Gallus domesticus 8.5 parts, Herba Eupatorii 12 parts, 12 parts of Folium Nelumbinis, Lapis Chloriti 6.5 parts, Herba Commelinae 18.5 parts, Herba Moslae 12 parts, spend Herba Andrographis 6.5 parts in vain, Radix Peucedani 13.5 parts, 11.5 parts of Radix Glycyrrhizae, little purple have a smile on one's face 8 parts, Fructus Terminaliae Billericae 11 parts, Radix Codonopsis 13 parts, the Radix Astragali 15.5 parts, Herba Orchidis Latifoliae 11.5 parts, FRUCTUS CITRI AURANTII AMARAE 8 parts.
5. according to the pharmaceutical preparation described in claim 1, it is characterised in that described pharmaceutical preparation be capsule, tablet, water decoction, One in granule, preferably granule.
6. the pharmaceutical preparation prepared described in claim 1-5, it is characterised in that the concrete step of described granule is:
(1) by Fructus Tsaoko, Folium Nelumbinis, little purple with a smile, Herba Commelinae and Fructus Terminaliae Billericae add 2000ml water soaking 1 hour, after fast fire is fried open, The most slowly decoct 30 minutes, pour out decocting liquid 500ml, add the pure water of 350ml, slow pan-fried 20 minutes, then pour out decocting liquid 200ml, Adding the water of 500ml, continue slow decocting 30 minutes, poured out by decocting liquid, the decocting liquid poured out with first twice mixes and stirs evenly；
(2) step (2) decocting liquid concentrating under reduced pressure is obtained the condensed cream that relative density is 1.05；
(3) Ovum crusta Gallus domesticus, Herba Eupatorii, Herba Moslae, Radix Peucedani, Radix Codonopsis, the Radix Astragali, Herba Orchidis Latifoliae and FRUCTUS CITRI AURANTII AMARAE grind to form coarse powder, add 80% second Alcohol extraction 2 times, each 1 hour, merges medicinal liquid, stands 24 hours, standby；
(4) by Fructus Litseae, Lapis Chloriti, Herba Andrographis is spent in vain and Radix Glycyrrhizae powder is broken into fine powder and crosses after 80 mesh sieves with appropriate 70% ethanol extraction 2 times, each 1.5 hours, collect extracting solution, stand 24 hours, standby；
(5) supernatant taking (3rd), preparing in (4) step, decompression recycling ethanol, it is concentrated into 70 DEG C, density is 1.05 Extractum, mixes with the extractum of step (4) after drying, standby；
(6) the extractum weight in determination step (5), adds the mannitol of its weight 10% and the mixture of dextrin, wherein manna In the mixture of alcohol and dextrin, the weight ratio of lactose and dextrin is 1:1；Add the starch slurry of appropriate 15%, cross 16 mesh sieve systems Grain, is dried, and subpackage i.e. obtains granule.
Pharmaceutical preparation the most according to claim 6, it is characterised in that the granule described in step (6) often wraps weight 20g.
Pharmaceutical preparation the most according to claim 1, it is characterised in that described pharmaceutical preparation answering in preparing Gastric Ulcer Treatment With.
Pharmaceutical preparation the most according to claim 1, it is characterised in that described pharmaceutical preparation is in preparing insufficiency of the spleen Gastric Ulcer Treatment Application.
CN201610284944.5A 2016-04-29 2016-04-29 Medicinal preparation for treating spleen-deficiency gastric ulcer and application thereof Withdrawn CN105797049A (en)

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Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
姬爱冬 等: "健中愈疡片治疗脾虚型胃溃疡的临床与实验研究 ", 《辽宁中医杂志》 *

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Application publication date: 20160727