CN100574790C - A kind of pharmaceutical composition of preventing and treating peptic ulcer - Google Patents

A kind of pharmaceutical composition of preventing and treating peptic ulcer Download PDF

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CN100574790C
CN100574790C CN200710028412A CN200710028412A CN100574790C CN 100574790 C CN100574790 C CN 100574790C CN 200710028412 A CN200710028412 A CN 200710028412A CN 200710028412 A CN200710028412 A CN 200710028412A CN 100574790 C CN100574790 C CN 100574790C
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CN101066389A (en
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刘晓伟
丁惠波
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Southern Medical University
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Southern Medical University
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Abstract

The invention provides a kind of pharmaceutical composition of preventing and treating peptic ulcer, the active component of said composition is prepared from by following materials of weight proportions: Herba Taraxaci 15~60%, Poria 15~60%, Pseudobulbus Bletillae (Rhizoma Bletillae) 15~60%, Radix Notoginseng 5~50%.The present composition can effectively be treated various gastritis; have spleen-benefiting mind-tranquilizing, promoting diuresis to eliminate damp pathogen, astringing to arrest bleeding; detumescence and promoting granulation; effects such as the protection stomach sticks and touches, anti-damage, the medicament for preparing with the present composition not only can be used for the treatment of peptic ulcer, can also take for a long time as stomach health care.

Description

A kind of pharmaceutical composition of preventing and treating peptic ulcer
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to prevent and treat the medicine of peptic ulcer.
Background technology
Peptic ulcer disease is a clinical common diseases, and its morbidity scope is wide, the pathogenesis complexity, and the symptom concealment is changeable, and the state of an illness is difficult repeatedly, affects human physical and mental health.Studies show that; peptic ulcer disease is by due to unbalance between gastric mucosa invasion and attack factor (comprising gastric acid, pepsin, power abnormality, cholic acid, some drugs, ethanol, nicotine and H p) and the mucosa protection factor (comprise mucosa barrier, mucosa blood flow, prostaglandin, bicarbonate secrete and epithelium regeneration); human body is only crossed when strong at defense factor effect decline or attack factor; just can cause the damage of gastric mucosa, diseases induced or do not heal repeatedly.Therefore, exploitation gastric mucosal protection preparation is the important channel of the various gastropathy of control.
At present, gastric mucosal protection agent class medicine has following several: traditional antacid such as sucralfate, must be happy, bismuth aluminate compound, roter tablets etc., outside a good appetite suddenly appearing in a serious disease and the gastric acid, also has the mucosa protective effect, though these medicines are inexpensive, but the moderate constipation can appear, xerostomia, feel sick, headache, urticaria or erythra untoward reaction; Newer mucosa protective agent such as prostaglandin analogue (misoprostol, enprostil etc.), teprenone, Rebamipide etc.; all have the ability that strengthens the anti-damage of mucosa and quicken the effect of ulcer healing; but these mucosa protective agents; except expensive price; also have in the medication phase ammonia flavor is arranged in the mouth, tongue, excrement are dyed black and the side effect of symptoms of digestive tract such as feeling sick occurred.
Herba Taraxaci has another name called Herba crotalariae albidae, is the Compositae herbaceos perennial, is the conventional Chinese medicine material, has the laudatory title of " natural antibiotics ", and its nature and flavor hardship, sweet, cold is returned liver, stomach warp.Studies show that Herba Taraxaci has broad-spectrum antibacterial and obvious sterilization effect, promote the active site of digestive tract power, be respectively ferulic acid and oleanolic acid, be usually used in preparing treatment is caused various gastritis by HP medicine, medicine as anti-gastric-ulcer commonly used: Chinese herbaceous peony glycosides sea cowry Pu art soup, stomachache Yiganning capsule, gastritis disappear, compound recipe Dan Putang etc. is contains the Herba Taraxaci medicaments compound, all has the effect of gastric mucosa reparation damage.But various medicines prevent and treat the emphasis difference, comprehensive inadequately to the treatment of peptic ulcer, only remarkable as Chinese herbaceous peony glycosides sea cowry Pu art soup to acute gastric mucosa injury in treating effect; Gastritis disappears and then tends to improve the pathological state of gastric mucosa precancerous lesion, recovers the atrophy body of gland, reduces dysplasia body of gland and intestinal epithelial metaplasia.
Summary of the invention
The purpose of this invention is to provide a kind of pharmaceutical composition of preventing and treating peptic ulcer.
A kind of pharmaceutical composition of preventing and treating peptic ulcer, said composition is made up of active component and adjuvant, and wherein active component is prepared from by following materials of weight proportions: Herba Taraxaci 15~60%, Poria 15~60%, Pseudobulbus Bletillae (Rhizoma Bletillae) 5~55%, Radix Notoginseng 15~60%; Proportioning is preferably: Herba Taraxaci 20~40%, Poria 20~40%, Pseudobulbus Bletillae (Rhizoma Bletillae) 10~35%, Radix Notoginseng 20~50%; Best proportioning is: Herba Taraxaci 27%, Poria 27%, Pseudobulbus Bletillae (Rhizoma Bletillae) 19%, Radix Notoginseng 27%.
The preparation method of active ingredient in pharmaceutical of the present invention: be after above-mentioned raw materials is taken by weighing by proportioning respectively routinely method extract its active component, mix getting final product then.
Active ingredient in pharmaceutical of the present invention can prepare in order to the below method:
(1) gets Poria, Pseudobulbus Bletillae (Rhizoma Bletillae) mixing, extract twice as follows, collecting decoction: add 10 times of water yields, decocted 1 hour; Add 95% ethanol of 3~4 times of medicinal liquids then in the decocting liquid, left standstill 15 minutes, centrifugal 20 minutes then with 3000rpm/min, get precipitation, intensive drying draws ointment I;
(2) get Radix Notoginseng, Herba Taraxaci mixing, extract as follows twice: add 10 times of 60% ethanol, refluxed 80 minutes, merge medicinal liquid; Reclaim ethanol then, concentrated, intensive drying draw ointment II;
(3) mix ointment I and II, get final product.
Pharmaceutical composition of the present invention can be granule, tablet or capsule, preparation method is specifically: the mixture of getting active ingredient in pharmaceutical of the present invention and be described ointment I and ointment II mixes fully pulverizing with dextrin, sugar by 3.5: 2.5: 1 weight ratio, add an amount of 95% ethanol and make soft material, sieve then, granule is made in 60 degrees centigrade of oven dry, but packaging of aluminium foil bag then, or directly be packaged into capsule, also can add this area excipient (as starch and water) commonly used again and be prepared into tablet.
Pharmaceutical composition of the present invention is rich in gluey composition; viscosity is strong; the function that fabulous protection gastrointestinal mucosa, promotion ulcer healing are arranged; and dosage form is applicable to the protection gastric mucosa, to being that the disease such as gastritis, peptic ulcer, gastrointestinal dysfunction of main pathological change all has therapeutical effect with the gastric mucosa damage.
In motherland's medical science, gastric ulcer belongs to " gastric abscess " " noisy " " acid regurgitation " category, the state of an illness repeatedly, the pathogenesis complexity mostly is deficiency in origin and excess in superficiality, its weakness of the spleen and stomach is common pathogenesis basis, qi depression to blood stasis is common pathogenesis, stomach network damage is basic lesion.The present invention is a monarch drug with the Herba Taraxaci that have " persons particularly liable to develop skin infection " laudatory title, can heat-clearing and toxic substances removing, kindly treat that furuncle is swollen, the disease of acute appendicitis is with Zhi Qiben; Poria is sweet, light, flat, can invigorating the spleen and regulating the stomach, again can promoting diuresis to eliminate damp pathogen, as ministerial drug and Herba Taraxaci compatibility, fundamentally treat insufficiency of the spleen this; Assistant is controlled its mark with Pseudobulbus Bletillae (Rhizoma Bletillae), Radix Notoginseng astringing to arrest bleeding, detumescence and promoting granulation, because Pseudobulbus Bletillae (Rhizoma Bletillae) contains gluey composition, so good anastalsis is arranged, can significantly shorten clotting time and prothrombing rise time, and quicken erythrocyte sedimentation rate, simultaneously, Pseudobulbus Bletillae (Rhizoma Bletillae) can be borrowed its high viscosity, in stomach, duodenum, form certain thickness gluey film, can protect gastrointestinal mucosa, promote ulcer healing; Full side's compatibility, reinforcement and elimination in combination, treating both the principal and secondary aspects of a disease.
Pharmaceutical composition of the present invention is prepared from by natural drug, has the effect of being good for the stomach, and does not contain any chemosynthesis material, takes no obvious adverse reaction and toxic and side effects for a long time, can be used as health product and takes for a long time.
For the present invention is described better, below will by zoopery prove that the present invention has to the health-care effect of stomach with to the therapeutic effect of peptic ulcer.
The health-care effect experiment of 1 pair of stomach
1.1 materials and methods
1.1 given the test agent pharmaceutical composition of the present invention: pitchy granule, every 6g (preparation method is seen preparation example 11), with distilled water will be tried thing be mixed with concentration be respectively 0.2g/ml, 0.4g/ml and 0.8g/ml be subjected to test solution to irritate stomach to use for laboratory animal, its dosage is equivalent to 5,10 and 20 times of human body recommendation consumption respectively, and other establishes 1 solvent control group (distilled water).
1.2 animal is provided by Nanfang Medical Univ's Experimental Animal Center, 160 of SPF level Kunming kind bull mices, body weight 18~22g, the animal quality certification: 2006B008 number.
1.3 method is divided into 4 groups at random with 160 mices.Gastric acidity determination, mucosa surface are observed and the observation down of paraffin embedding mirror, serum gastrin assay, 4 tests of serum levels of nitric oxide (NO) assay are all established 3 dosage groups and 1 solvent control group, every group of 10 mices.4 each dosage groups of test are all irritated stomach 1ml by above-mentioned dosage every day, and matched group waits the capacity distilled water.Behind the 30d, carry out the mensuration of following every index respectively continuously.
1.3.1 the gastric juice pH value is measured: mice is through lumbar injection 10% chloral hydrate 0.1ml deep anaesthesia, and the dorsal position extremity are fixed, the skin routine disinfection, along cutting off the abdominal cavity under the xiphoid-process, expose stomach, the ligation pylorus, take out the Mus stomach, in the PH reagent paper, measure PH by cardia fine-still a little gastric juice.
1.3.2 mucosa gross examination of skeletal muscle: mice is through lumbar injection 10% chloral hydrate 0.1ml deep anaesthesia, the dorsal position extremity are fixed, the skin routine disinfection, along cutting off the abdominal cavity under the xiphoid-process, expose stomach, the ligation pylorus, inject 10% formalin 5ml by cardia, behind the 30min, cut off body of stomach, observe mucosa surface along greater gastric curvature.
1.3.3 the mucosa pathological tissue is checked: get part glandular stomach tissue and put into and contain 10% formalin and fix 12~16h (4 ℃).Through the routine dehydration, paraffin embedding, HE dyes and observes under the rearmounted optical microscope.
1.3.4 gastrin (Gas) assay: eyeball is got blood 2ml in vacuum tube, tilts to place after one hour, and with 3000rpm, centrifugal 30 minutes, get supernatant, adopt radioimmunoassay, operation is carried out according to Gas test kit description.
1.3.5NO assay: eyeball is got blood 2m in vacuum tube, leave standstill one hour after, with the centrifugal 30min of 3000rpm, get supernatant, by the test kit requirement, wavelength is transferred to the 550nm place respectively, distilled water zeroing is read absorbance on 721B type spectrophotometer.Extension rate (* 1) before NO content (μ mol/l)=(measuring pipe absorbance-blank pipe absorbance) ÷ (standard pipe absorbance-blank pipe absorbance) * standard substance concentration (100 μ mol/l) * sample test
1.4 statistical procedures: (x ± S) expression adds up with the SPSS11.5 software kit experimental data with mean ± standard deviation.
1.5 result and discussion
1.5.1 the gastric juice pH value is measured: each dosage group mice gastric juice pH value obviously raises than the solvent control group, high, medium and low group of gastric juice pH value is respectively (3.29 ± 0.30), (2.79 ± 0.61), (2.71 ± 0.40), the solvent control group is (2.64 ± 0.56), and wherein high dose group has significant difference (P<0.05).
1.5.2 mucosa gross examination of skeletal muscle: high, middle dosage group stomach serous coat is smooth, sees that the gastric mucosa polishing is intact after cutting coat of the stomach open, is pale red, does not have ANOMALOUS VARIATIONS such as hyperemia, edema, erosion.The low dose group serous coat is smooth, a little adhesion hypertrophy, and the gastric antrum mucous membrane surface is smooth.Solvent control group serosa surface is coarse, a little adhesion, and light dark, the gastric mucosa polishing is intact, accidentally is dispersed in congested point.
1.5.3 mucosa paraffin embedding mirror is observed down (* 40 times): in, low dose group mucous layer polishing is intact, glandular cell is arranged evenly, myocyte's densification is intact, the serous coat cellular layer is complete, does not see cell infiltration.The accidental fracture of high dose group epithelium, there is a little congestion at Submucosa blood vessel endothelium edge.The visible epidermis cell of solvent control group is damaged irregular, and Submucosa has a small amount of cell infiltration and the obvious thrombosis of minority.
1.5.4 serum gastrin assay: each dosage group mice serum gastrin content and solvent control group relatively all decrease, but difference not statistically significant (P>0.05).
1.5.5NO assay: each dosage group mice content NO obviously raises than the solvent control group, high, medium and low group of NO content is respectively (36.51 ± 5.03), (34.11 ± 4.68), (43.61 ± 7.23) μ mol/l, the solvent control group is (27.29 ± 6.5) μ mol/l, through variance analysis, its difference all has statistical significance (P<0.01; P<0.05).
Can reduce gastric acid secretion, reduce mice serum gastrin content through zoopery proof pharmaceutical composition of the present invention, fundamentally prevent the source of Gastric Diseases by Spraying; Find that also the present invention improves serum NO levels, the expansion local vascular is regulated gastric mucosa regional flow, confirms that from function assessment pharmaceutical composition of the present invention has the function of preventing disease of stomach widely.
The therapeutic effect experiment of 2 pairs of peptic ulcers
2.1 materials and methods
2.1.1 laboratory animal and grouping
Select 56 of Wistar male rats for use, 180-200g is provided by Nanfang Medical Univ's Experimental Animal Center, the animal quality certification number: 2005A048 number.56 rats are divided into 7 groups at random, 8 every group.Remove normal group, be divided into model group, spontaneous recovery group, the high, medium and low dosage group of pharmaceutical composition of the present invention, ranitidine group after all the other rat glacial acetic acid modelings, model group was put to death in the 4th day after surgery; Each medicine group all began to irritate stomach, 7 days time on the 4th day in postoperative; The then free diet of spontaneous recovery group.
2.1.2 experimental animal model is made
With reference to classical glacial acetic acid modeling method: with the rat fasting after 24 hours, routine disinfection, press 3.6ml/kg body weight intraperitoneal injection 10% chloral hydrate anesthesia, spread operation hole towel, cut a 2cm otch from xiphoid-process lower edge ventrimeson, body of stomach is shifted out gastral cavity, with the circular filter paper of the about 5mm of diameter, dip in 100% glacial acetic acid and be affixed on and also receive body of stomach behind the gastric antrum antetheca 1min, sew up abdominal muscle, skin.
2.1.3 experimental drug preparation
Pseudobulbus Bletillae (Rhizoma Bletillae), Radix Notoginseng, Herba Taraxaci, Poria are purchased the Chinese medicine pharmacy in Nanfang Hospital, through medicinal plants with to identify that the expert of teaching and research room verifies qualified, the medicament composition granule of the present invention that makes according to the method for embodiment 1, every bag of granule contains the dried cream of 3 grams, the dried cream of 1g=5.2g crude drug, used this product dosage (g/kg) is all calculated by grain amount in the literary composition.By people and rat body surface area coefficient conversion method, rat etc. are used dosage=(human dosage * 0.018 * 5) g/kg.Be made into desired concn with distilled water before the experiment, shake all back uses.High, medium and low 0.216g/ml, 0.108g/ml, the preparation of 0.054g/ml dosage, the 2ml filling every day stomach pressed respectively.The ranitidine capsule is made solution for standby by 0.003g/ml dosage.
2.1.4 reagent
100% glacial acetic acid lot number: 20060325, Guangdong Province brilliance chemistry Co., Ltd., Factory, ranitidine capsule lot number: 060501, Taiyuan, Shanxi pharmaceutcal corporation, Ltd produces, bio-engineering research institute is built up in NO, NOS test kit Nanjing, NT radioimmunity test kit PLA General Hospital Science and Technology Development Center put exempt from the institute epidermal growth factor (EGF) test kit, gastrin (Gas) radioimmunity test kit (Beijing North biotechnology research institute) are provided.
2.2. method
2.2.1 the mucosa pathological tissue is checked: get around the part ulcer glandular stomach tissue and put into and contain 10% formalin and fix 12~16h (4 ℃).Through the routine dehydration, paraffin embedding, HE dyes and observes under the rearmounted optical microscope.
2.2.2 the gastric juice pH value is measured: rat is through lumbar injection 10% chloral hydrate 1ml deep anaesthesia, and the dorsal position extremity are fixed, the skin routine disinfection, along cutting off the abdominal cavity under the xiphoid-process, expose stomach, the ligation pylorus, take out the Mus stomach, in the PH reagent paper, measure PH by cardia fine-still a little gastric juice.
2.2.3 the mensuration of ulcer area: inject 10% formalin 10ml by cardia, behind the 30min, cut off body of stomach, measure maximum transverse diameter and maximum vertical footpath, be designated as d respectively by the ulcer center along greater gastric curvature 1And d 2, according to formula S=π d 1/ 2d 2/ 2 calculate the ulcer area.
2.2.4NO content and NOS determination of activity: rat aorta blood sampling 4ml, leave standstill one hour after, with the centrifugal 30min of 3000rpm, get supernatant,, wavelength is transferred to 550nm, 530nm place respectively by the test kit requirement, the distilled water zeroing is read absorbance on 721B type spectrophotometer.Extension rate (* 1) before NO content (μ mol/l)=(measuring pipe absorbance-blank pipe absorbance) ÷ (standard pipe absorbance-blank pipe absorbance) * standard substance concentration (100 μ mol/l) * sample test; NOS vigor (u/ml)=(NOS measures pipe absorbance-blank pipe absorbance) ÷ colour generation thing nanomole extinction coefficient (3g.3 * 10 -6) * 2.54/0.03 * 1/ response time (15min) ÷ 1000, cNOS=tNOS-iNOS.
2.2.5NT assay: the ventral aorta blood sampling, insert edtaK2 anticoagulant negative pressure blood taking tube, get blood 3ml.Add aprotinin (500U/20ul) 60ul, mixing, 4 ℃, the centrifugal 15min of 3000r/min, separated plasma adopts radioimmunoassay, and operation is carried out according to NT test kit description.
2.2.6EGF assay: 4ml is in vacuum tube in the ventral aorta blood sampling, tilts to place after one hour, and with 3000rpm, centrifugal 30 minutes, get supernatant, adopt radioimmunoassay, operation is carried out according to EGF test kit description.
2.2.7Gas assay: 4ml is in vacuum tube in the ventral aorta blood sampling, tilts to place after one hour, and with 3000rpm, centrifugal 30 minutes, get supernatant, adopt radioimmunoassay, operation is carried out according to Gas test kit description.
2.2.8 statistical procedures: experimental data mean ± standard deviation (x ± S) expression.The multisample mean is relatively used single factor variance (One-wayANOVA) analysis, and mean is in twos relatively if homogeneity of variance is used the LSD method between group; If heterogeneity of variance is used Dunnett ' sT3 method.Above data are all added up with the SPSS11.5 software kit.
2.3. result
2.3.1 the pathological section mirror is observed down (* 40 times): 1. normal group: the mucous layer polishing is intact, and glandular cell is arranged evenly, and myocyte's densification is intact, and the serous coat cellular layer is complete, does not see cell infiltration.2. model group: more damaged through flesh layer, the equal arrangement disorder of each confluent monolayer cells; The mucous layer attenuation, visible massive inflammatory cells infiltrated in Submucosa leucorrhea district and congestion speckle.3. each dosage group of the present invention: high and low dose group of the present invention can be seen the damaged glandular cell layer that reaches, idol and muscularis mucosae, glandular cell density irregularity more; The Submucosa cell infiltration.The middle accidental fracture of dosage group mucosal epithelium, there is a little lymphocyte at Submucosa blood vessel endothelium edge.4. ranitidine group: the accidental damaged glandular cell layer that reaches, Submucosa lymphocytic infiltration, rare congestion, flesh confluent monolayer cells arrangement disorder.5. spontaneous recovery group: damagedly reach flesh layer under glandular cell layer or the mucosa, the glandular cell arrangement disorder, Submucosa has cell infiltration, visible obviously thrombosis; The myocyte is partly ruptured, lymphocytic infiltration.
2.3.2 the variation of gastric juice pH value
The result is as shown in table 1, and the model group pH value is apparently higher than normal group (P>0.05).The present invention can promote the acinus hypertrophy, recovers acinus secretory function (P<0.05), the nearly normal group level of wherein high, middle dosage winding (P>0.05).
Table 1 is respectively organized rat gastric juice pH value mutation analysis table
Figure C20071002841200081
Annotate: compare △ P<0.05 with normal group; Compare * P<0.05, * * PP<0.01 with model group
2.3.3 the variation of ulcer area
The result is as shown in table 2, and model group ulcer area is apparently higher than normal group (P<0.01), and the present invention can make rat experiment ulcer area dwindle, and promotes ulcer healing (P<0.01), but between each group and normal group still variant (P<0.01).Ranitidine group and model group relatively have significant difference (P<0.01), high and low dose group of the present invention and ranitidine there was no significant difference (P>0.05), middle dosage group and ranitidine group exist difference (P<0.05), show that the dosage treatment effect is better than ranitidine among the present invention.
Table 2 is respectively organized rat ulcer area (mm 2) the mutation analysis table
Figure C20071002841200091
Annotate: compare △ P<0.05 with normal group; Compare * P<0.05, * * P<0.01 with model group; Compare #P<0.05, ##P<0.01 with the spontaneous recovery group; Compare with ranitidine &dtri; P < 0.05 .
2.3.4NO the active variation of changes of contents and NOS
2.3.4.1NO changes of contents
Model group NO content is apparently higher than normal group level (P<0.01), the present invention can make that NO content descends to some extent in the rat blood serum (P<0.05), wherein with high, middle dosage group curative effect particularly significantly (P<0.01), ranitidine group and model group comparison can reduce NO content in the rat blood serum (P<0.01), and height of the present invention, middle dosage group and ranitidine group be there was no significant difference (P>0.05) relatively.More all there were significant differences for spontaneous recovery group and normal group, model group (P<0.05).(the results are shown in Table 3)
2.3.4.2NOS inducing type NOS (iNOS) activity, active variation model group is higher than normal group level (P<0.05), height of the present invention, middle dosage group all can obviously suppress iNOS activity (P<0.01), strengthen structural type NOS (cNOS) vigor (P<0.05), the ranitidine group can significantly suppress iNOS activity (P<0.05) than model group, strengthen cNOS vigor (P<0.05), height of the present invention, middle dosage group and ranitidine group there was no significant difference (P>0.05).Spontaneous recovery group iNOS is active, and relatively there were significant differences (P<0.05) with normal group, ranitidine.(the results are shown in Table 3)
NO content in the rat blood serum (μ mol/l) respectively organized by table 3 and NOS activity (u/ml) is measured
Figure C20071002841200093
Annotate: compare △ P<0.05 with normal group; Compare * P<0.05, * * P<0.01 with model group; Compare #P<0.05 with the spontaneous recovery group.
2.3.5NT the variation of content
The result is as shown in table 5, and model group can significantly reduce NT level, and of the present invention group can return to normal level with NT level in the blood plasma.
Table 4 is respectively organized NT level relatively
Figure C20071002841200101
Annotate: compare with normal group: △ P<0.05, △ △ P<0.01; Compare with model group: * P<0.05, * * P<0.01; Compare with the spontaneous recovery group: #P<0.05, ##P<0.01.
2.3.6 the variation of Serum EGF concentration content
The result is as shown in table 5, compares with the spontaneous recovery group, and high dose group of the present invention can reduce serum EGF, has diversity (P<0.05); The dosage group can significantly reduce serum EGF (P<0.01) among the present invention.
Table 5 is respectively organized the variation of serum EGF
Figure C20071002841200102
Annotate: compare * P<0.05, * * P<0.01 with the spontaneous recovery group.
2.3.7Gas the variation of content
The result is as shown in table 6, and each is organized mean and meets homogeneity of variance, but group difference and not statistically significant.
Table 6 is respectively organized serum Gas level relatively
Figure C20071002841200103
Annotate: compare with normal group: △ P<0.05, △ △ P<0.01; Compare with model group: * P<0.05, * * P<0.01; Compare with the spontaneous recovery group: #P<0.05, ##P<0.01.
Experimental result shows that pharmaceutical composition of the present invention can be repaired the damage acinus effectively, recovers the acinus secretory function; Reduce the gastric mucosa damage, promote the gastric mucosa hypertrophy: show and reduce NO, iNOS content, rising blood plasma NT and Gas level reduce serum EGF.Above-mentioned drug effect does not present dose dependent trend, and middle dosage group is better than other two kinds of dosage groups.The modeling group was put to death in the operation back on the 4th day, opened the visible flatulence of rat abdominal cavity naked eyes, and the degree weight differs, and the serosal surface congestion and edema has adhesion organization.The visible ulcer point in gastric antrum and mucosa many places, pylorus place.Medicine high and low dose group is opened visible gastric antrum of rat abdominal cavity naked eyes or the single or multiple irregular ulcer points of body of stomach mucosa, and the degree weight differs, other no abnormal change.Middle dosage group serous coat is smooth, and mucosa surface is difficult to find ulcer point or rarely seen scar hyperplasia among a small circle.The more damaged through flesh layer of histopathologic examination's display model group, the equal arrangement disorder of each confluent monolayer cells; The mucous layer attenuation, visible massive inflammatory cells infiltrated in Submucosa leucorrhea district and congestion speckle.Pharmaceutical composition high and low dose group of the present invention can be seen the damaged glandular cell layer that reaches, idol and muscularis mucosae, glandular cell density irregularity more; The Submucosa cell infiltration.The middle accidental fracture of dosage group mucosal epithelium, there is a little lymphocyte at Submucosa blood vessel endothelium edge.
The specific embodiment
Example 1
The prescription of active component: 22% Poria, 31% Pseudobulbus Bletillae (Rhizoma Bletillae), 19% Radix Notoginseng, 28% Herba Taraxaci.
The preparation of active component:
(1) gets Poria 600 grams, Pseudobulbus Bletillae (Rhizoma Bletillae) 800 gram mixings, add 10 times of water yields, decocted 1 hour, extract twice, collecting decoction to medical material.Add 3 times of ethanol of 95% then in the decocting liquid, left standstill 15 minutes to medicinal liquid, with 3000rpm/min centrifugal 20 minutes, precipitation, intensive drying draws ointment I.
(2) get Radix Notoginseng 500 grams, Herba Taraxaci 750 gram mixings add 10 times of 60% ethanol to medical material, reflux 80 minutes, extract twice, merge medicinal liquid.Reclaim ethanol then, concentrated, intensive drying draw ointment II.
(3) mix ointment I and II, get final product.
Make granule: get the mixture of above-mentioned ointment I and II, by weight 3.5: 2.5: 1 with dextrin and sugared mix homogeneously and pulverize, add an amount of 95% ethanol and make soft material, cross No. 1, No. 4 sieves after, 60 degrees centigrade of oven dryings.Get above-mentioned granule 1000 grams, packaging of aluminium foil bag, every bag 6 gram.Using method: eliminating cold for resuscitation mouth of a river clothes, 2 times/day.
Example 2
The prescription of active component: 23% Poria, 26% Pseudobulbus Bletillae (Rhizoma Bletillae), 22% Radix Notoginseng, 29% Herba Taraxaci.
The preparation of active component:
(1) gets Poria 800 grams, Pseudobulbus Bletillae (Rhizoma Bletillae) 900 gram mixings, add 10 times of water yields, decocted 1 hour, extract twice, collecting decoction to medical material.Add 4 times of ethanol of 95% then in the decocting liquid, left standstill 15 minutes to medicinal liquid, with 3000rpm/min centrifugal 20 minutes, precipitation, intensive drying draws ointment I.
(2) get Radix Notoginseng 750 grams, Herba Taraxaci 1000 gram mixings add 10 times of 60% ethanol to medical material, reflux 80 minutes, extract twice, merge medicinal liquid.Reclaim ethanol then, concentrated, intensive drying draw ointment II.
(3) mix ointment I and II, get final product.
Make capsule: get the mixture of above-mentioned ointment I and II, by weight 3.5: 2.5: 1 with dextrin and sugared mix homogeneously and pulverize, add an amount of 95% ethanol and make soft material, cross No. 1, No. 4 sieves after, 60 degrees centigrade of oven dryings.Get the direct encapsulation of above-mentioned soft material 1000g and make capsule, 6g/ grain.Using method: eliminating cold for resuscitation mouth of a river clothes, 2 times/day.
Example 3:
The prescription of active component: 15% Herba Taraxaci, 15% Poria, 51% Pseudobulbus Bletillae (Rhizoma Bletillae), 19% Radix Notoginseng.
The preparation of active component:
(1) gets Poria 150 grams, Pseudobulbus Bletillae (Rhizoma Bletillae) 510 gram mixings, add 10 times of water yields, decocted 1 hour, extract twice, collecting decoction to medical material.Add 4 times of ethanol of 95% then in the decocting liquid, left standstill 15 minutes to medicinal liquid, with 3000rpm/min centrifugal 20 minutes, precipitation, intensive drying draws ointment I.
(2) get Radix Notoginseng 190 grams, Herba Taraxaci 150 gram mixings add 10 times of 60% ethanol to medical material, reflux 80 minutes, extract twice, merge medicinal liquid.Reclaim ethanol then, concentrated, intensive drying draw ointment II.
(3) mix ointment I and II, get final product.
Make capsule: get the mixture of above-mentioned ointment I and II, by weight 3.5: 2.5: 1 with dextrin and sugared mix homogeneously and pulverize, add an amount of 95% ethanol and make soft material, cross No. 1, No. 4 sieves after, 60 degrees centigrade of oven dryings.Get the direct encapsulation of above-mentioned soft material 1000g and make capsule, 6g/ grain.Using method: eliminating cold for resuscitation mouth of a river clothes, 2 times/day.
Example 4:
The prescription of active component: 60% Herba Taraxaci, 18% Poria, 6% Pseudobulbus Bletillae (Rhizoma Bletillae), 16% Radix Notoginseng.
The preparation of active component:
(1) gets Poria 180 grams, Pseudobulbus Bletillae (Rhizoma Bletillae) 60 gram mixings, add 10 times of water yields, decocted 1 hour, extract twice, collecting decoction to medical material.Add 4 times of ethanol of 95% then in the decocting liquid, left standstill 15 minutes to medicinal liquid, with 3000rpm/min centrifugal 20 minutes, precipitation, intensive drying draws ointment I.
(2) get Radix Notoginseng 160 grams, Herba Taraxaci 600 gram mixings add 10 times of 60% ethanol to medical material, reflux 80 minutes, extract twice, merge medicinal liquid.Reclaim ethanol then, concentrated, intensive drying draw ointment II.
(3) mix ointment I and II, get final product.
Make granule: get the mixture of above-mentioned ointment I and II, by weight 3.5: 2.5: 1 with dextrin and sugared mix homogeneously and pulverize, add an amount of 95% ethanol and make soft material, cross No. 1, No. 4 sieves after, 60 degrees centigrade of oven dryings.Get above-mentioned granule 1000 grams, packaging of aluminium foil bag, every bag 6 gram.Using method: eliminating cold for resuscitation mouth of a river clothes, 2 times/day.
Example 5:
The prescription of active component: 57% Herba Taraxaci, 15% Poria, 10% Pseudobulbus Bletillae (Rhizoma Bletillae), 18% Radix Notoginseng.
The preparation of active component:
(1) gets Poria 150 grams, Pseudobulbus Bletillae (Rhizoma Bletillae) 100 gram mixings, add 10 times of water yields, decocted 1 hour, extract twice, collecting decoction to medical material.Add 4 times of ethanol of 95% then in the decocting liquid, left standstill 15 minutes to medicinal liquid, with 3000rpm/min centrifugal 20 minutes, precipitation, intensive drying draws ointment I.
(2) get Radix Notoginseng 180 grams, Herba Taraxaci 570 gram mixings add 10 times of 60% ethanol to medical material, reflux 80 minutes, extract twice, merge medicinal liquid.Reclaim ethanol then, concentrated, intensive drying draw ointment II.
(3) mix ointment I and II, get final product.
Make granule: get the mixture of above-mentioned ointment I and II, by weight 3.5: 2.5: 1 with dextrin and sugared mix homogeneously and pulverize, add an amount of 95% ethanol and make soft material, cross No. 1, No. 4 sieves after, 60 degrees centigrade of oven dryings.Get above-mentioned granule 1000 grams, packaging of aluminium foil bag, every bag 6 gram.Using method: eliminating cold for resuscitation mouth of a river clothes, 2 times/day.
Example 6:
The prescription of active component: 16% Herba Taraxaci, 60% Poria, 8% Pseudobulbus Bletillae (Rhizoma Bletillae), 16% Radix Notoginseng.
The preparation of active component:
(1) gets Poria 600 grams, Pseudobulbus Bletillae (Rhizoma Bletillae) 80 gram mixings, add 10 times of water yields, decocted 1 hour, extract twice, collecting decoction to medical material.Add 3 times of ethanol of 95% then in the decocting liquid, left standstill 15 minutes to medicinal liquid, with 3000rpm/min centrifugal 20 minutes, precipitation, intensive drying draws ointment I.
(2) get Radix Notoginseng 160 grams, Herba Taraxaci 160 gram mixings add 10 times of 60% ethanol to medical material, reflux 80 minutes, extract twice, merge medicinal liquid.Reclaim ethanol then, concentrated, intensive drying draw ointment II.
(3) mix ointment I and II, get final product.
Make tablet: get the mixture of above-mentioned ointment I and II, by weight 3.5: 2.5: 1 with dextrin and sugared mix homogeneously and pulverize, add an amount of 95% ethanol and make soft material, cross No. 1, No. 4 sieves after, 60 degrees centigrade of oven dryings.Get above-mentioned soft material 1000 grams, add an amount of starch and water (excipient) mixing, granulation then, dry again, granulate adopts the conventional method tabletting, is pressed into the 6g/ sheet.Using method: eliminating cold for resuscitation mouth of a river clothes, 2 times/day.
Example 7:
The prescription of active component: 24% Herba Taraxaci, 36% Poria, 5% Pseudobulbus Bletillae (Rhizoma Bletillae), 35% Radix Notoginseng.
The preparation of active component:
(1) gets Poria 360 grams, Pseudobulbus Bletillae (Rhizoma Bletillae) 50 gram mixings, add 10 times of water yields, decocted 1 hour, extract twice, collecting decoction to medical material.Add 3 times of ethanol of 95% then in the decocting liquid, left standstill 15 minutes to medicinal liquid, with 3000rpm/min centrifugal 20 minutes, precipitation, intensive drying draws ointment I.
(2) get Radix Notoginseng 350 grams, Herba Taraxaci 240 gram mixings add 10 times of 60% ethanol to medical material, reflux 80 minutes, extract twice, merge medicinal liquid.Reclaim ethanol then, concentrated, intensive drying draw ointment II.
(3) mix ointment I and II, get final product.
Make tablet: get the mixture of above-mentioned ointment I and II, by weight 3.5: 2.5: 1 with dextrin and sugared mix homogeneously and pulverize, add an amount of 95% ethanol and make soft material, cross No. 1, No. 4 sieves after, 60 degrees centigrade of oven dryings.Get above-mentioned soft material 1000 grams, add an amount of starch and water (excipient) mixing, granulation then, dry again, granulate adopts the conventional method tabletting, is pressed into the 6g/ sheet.Using method: eliminating cold for resuscitation mouth of a river clothes, 2 times/day.
Example 8:
The prescription of active component: 55% Herba Taraxaci, 20% Poria, 10% Pseudobulbus Bletillae (Rhizoma Bletillae), 15% Radix Notoginseng.
The preparation of active component:
(1) gets Poria 200 grams, Pseudobulbus Bletillae (Rhizoma Bletillae) 100 gram mixings, add 10 times of water yields, decocted 1 hour, extract twice, collecting decoction to medical material.Add 3 times of ethanol of 95% then in the decocting liquid, left standstill 15 minutes to medicinal liquid, with 3000rpm/min centrifugal 20 minutes, precipitation, intensive drying draws ointment I.
(2) get Radix Notoginseng 150 grams, Herba Taraxaci 550 gram mixings add 10 times of 60% ethanol to medical material, reflux 80 minutes, extract twice, merge medicinal liquid.Reclaim ethanol then, concentrated, intensive drying draw ointment II.
(3) mix ointment I and II, get final product.
Make tablet: get the mixture of above-mentioned ointment I and II, by weight 3.5: 2.5: 1 with dextrin and sugared mix homogeneously and pulverize, add an amount of 95% ethanol and make soft material, cross No. 1, No. 4 sieves after, 60 degrees centigrade of oven dryings.Get above-mentioned soft material 1000 grams, add an amount of starch and water (excipient) mixing, granulation then, dry again, granulate adopts the conventional method tabletting, is pressed into the 6g/ sheet.Using method: eliminating cold for resuscitation mouth of a river clothes, 2 times/day.
Example 9:
The prescription of active component: 15% Herba Taraxaci, 15% Poria, 55% Pseudobulbus Bletillae (Rhizoma Bletillae), 15% Radix Notoginseng.
The preparation of active component:
(1) gets Poria 150 grams, Pseudobulbus Bletillae (Rhizoma Bletillae) 550 gram mixings, add 10 times of water yields, decocted 1 hour, extract twice, collecting decoction to medical material.Add 3 times of ethanol of 95% then in the decocting liquid, left standstill 15 minutes to medicinal liquid, with 3000rpm/min centrifugal 20 minutes, precipitation, intensive drying draws ointment I.
(2) get Radix Notoginseng 150 grams, Herba Taraxaci 150 gram mixings add 10 times of 60% ethanol to medical material, reflux 80 minutes, extract twice, merge medicinal liquid.Reclaim ethanol then, concentrated, intensive drying draw ointment II.
(3) mix ointment I and II, get final product.
Make tablet: get the mixture of above-mentioned ointment I and II, by weight 3.5: 2.5: 1 with dextrin and sugared mix homogeneously and pulverize, add an amount of 95% ethanol and make soft material, cross No. 1, No. 4 sieves after, 60 degrees centigrade of oven dryings.Get above-mentioned soft material 1000 grams, add an amount of starch and water (excipient) mixing, granulation then, dry again, granulate adopts the conventional method tabletting, is pressed into the 6g/ sheet.Using method: eliminating cold for resuscitation mouth of a river clothes, 2 times/day.
Example 10:
The prescription of active component: 17% Herba Taraxaci, 16% Poria, 7% Pseudobulbus Bletillae (Rhizoma Bletillae), 60% Radix Notoginseng.
The preparation of active component:
(1) gets Poria 160 grams, Pseudobulbus Bletillae (Rhizoma Bletillae) 70 gram mixings, add 10 times of water yields, decocted 1 hour, extract twice, collecting decoction to medical material.Add 3 times of ethanol of 95% then in the decocting liquid, left standstill 15 minutes to medicinal liquid, with 3000rpm/min centrifugal 20 minutes, precipitation, intensive drying draws ointment I.
(2) get Radix Notoginseng 600 grams, Herba Taraxaci 170 gram mixings add 10 times of 60% ethanol to medical material, reflux 80 minutes, extract twice, merge medicinal liquid.Reclaim ethanol then, concentrated, intensive drying draw ointment II.
(3) mix ointment I and II, get final product.
Make capsule: get the mixture of above-mentioned ointment I and II, by weight 3.5: 2.5: 1 with dextrin and sugared mix homogeneously and pulverize, add an amount of 95% ethanol and make soft material, cross No. 1, No. 4 sieves after, 60 degrees centigrade of oven dryings.Get the direct encapsulation of above-mentioned soft material 1000g and make capsule, 6g/ grain.Using method: eliminating cold for resuscitation mouth of a river clothes, 2 times/day.
Example 11:
The prescription of active component: 27% Herba Taraxaci, 27% Poria, 19% Pseudobulbus Bletillae (Rhizoma Bletillae), 27% Radix Notoginseng.
The preparation of active component:
(1) gets Poria 150 grams, Pseudobulbus Bletillae (Rhizoma Bletillae) 100 gram mixings, add 10 times of water yields, decocted 1 hour, extract twice, collecting decoction to medical material.Add 3 times of ethanol of 95% then in the decocting liquid, left standstill 15 minutes to medicinal liquid, with 3000rpm/min centrifugal 20 minutes, precipitation, intensive drying draws ointment I.
(2) get Radix Notoginseng 150 grams, Herba Taraxaci 150 gram mixings add 10 times of 60% ethanol to medical material, reflux 80 minutes, extract twice, merge medicinal liquid.Reclaim ethanol then, concentrated, intensive drying draw ointment II.
(3) mix ointment I and II, get final product.
Make granule: get the mixture of above-mentioned ointment I and II, by weight 3.5: 2.5: 1 with dextrin and sugared mix homogeneously and pulverize, add an amount of 95% ethanol and make soft material, cross No. 1, No. 4 sieves after, 60 degrees centigrade of oven dryings.Get above-mentioned granule 1000 grams, packaging of aluminium foil bag, every bag 6 gram.Using method: eliminating cold for resuscitation mouth of a river clothes, 2 times/day.

Claims (8)

1, a kind of pharmaceutical composition of preventing and treating peptic ulcer, said composition is made up of active component and adjuvant, and wherein active component is prepared from by following materials of weight proportions: Herba Taraxaci 15~60%, Poria 15~60%, Pseudobulbus Bletillae (Rhizoma Bletillae) 15~60%, Radix Notoginseng 5~50%.
2, a kind of pharmaceutical composition of preventing and treating peptic ulcer according to claim 1 is characterized in that the proportioning of described active component raw material is: Herba Taraxaci 20~40%, Poria 20~40%, Pseudobulbus Bletillae (Rhizoma Bletillae) 20~40%, Radix Notoginseng 10~30%.
3, a kind of pharmaceutical composition of preventing and treating peptic ulcer according to claim 1 is characterized in that the proportioning of described active component raw material is: Herba Taraxaci 27%, Poria 27%, Pseudobulbus Bletillae (Rhizoma Bletillae) 26%, Radix Notoginseng 20%.
4, the pharmaceutical composition of claim 1,2 or 3 described control peptic ulcers, the preparation method of described active component is made up of following steps:
(1) gets Poria, Pseudobulbus Bletillae (Rhizoma Bletillae) mixing, extract twice as follows, collecting decoction: add 10 times of water yields, decocted 1 hour; Add 95% ethanol of 3~4 times of medicinal liquids then in the decocting liquid, left standstill 15 minutes, centrifugal 20 minutes then with 3000rpm/min, get precipitation, intensive drying draws ointment I;
(2) get Radix Notoginseng, Herba Taraxaci mixing, extract as follows twice: add 10 times of 60% ethanol, refluxed 80 minutes, merge medicinal liquid; Reclaim ethanol then, concentrated, intensive drying draw ointment II;
(3) mix ointment I and II, get final product.
5, the pharmaceutical composition of claim 1,2 or 3 described control peptic ulcers is characterized in that this pharmaceutical composition is granule, capsule or tablet.
6, the pharmaceutical composition of control peptic ulcer according to claim 5, the preparation method that it is characterized in that described granule is as follows: the weighting profit requires 1 described active component to mix fully pulverizing with dextrin, sugar by 3.5: 2.5: 1 weight ratio, add an amount of 95% ethanol and make soft material, sieve then, 60 degrees centigrade of oven dry get final product.
7, the pharmaceutical composition of the described control peptic ulcer of claim 5 is characterized in that granule that described capsule is made by claim 6 directly incapsulates to make.
8, the pharmaceutical composition of the described control peptic ulcer of claim 5 is characterized in that granule that described tablet is made by claim 6 adds tablet excipient commonly used again and is prepared into.
CN200710028412A 2007-06-05 2007-06-05 A kind of pharmaceutical composition of preventing and treating peptic ulcer Expired - Fee Related CN100574790C (en)

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CN103520509A (en) * 2013-10-25 2014-01-22 刘晓伟 Traditional Chinese medicine for treating mesenteric panni culitis
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