CN1217688C - Medicine for treating chronic gastritis and preparing process thereof - Google Patents

Medicine for treating chronic gastritis and preparing process thereof Download PDF

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CN1217688C
CN1217688C CN031142222A CN03114222A CN1217688C CN 1217688 C CN1217688 C CN 1217688C CN 031142222 A CN031142222 A CN 031142222A CN 03114222 A CN03114222 A CN 03114222A CN 1217688 C CN1217688 C CN 1217688C
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medicine
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rhizoma
cream
stomach
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CN1451425A (en
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吴梅春
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Abstract

The present invention discloses a medicine for treating chronic gastritis, which is prepared from nine traditional Chinese medicinal materials, such as corydalis tuber, finger citron, trogopterus dung, rhubarb, zedoray rhizome, greater celandine herb, villous amomum fruit, largehead atractylodes rhizome, etc., and the present invention also discloses the preparation method of the medicine. The medicine of the present invention has the efficacy of regulating qi to dissipate blood stasis as well as harmonizing the stomach and alleviating pain, and is mainly used for treating stomach pain caused by qi stagnation and blood stasis. The present invention is suitable for patients with chronic superficial gastritis and chronic atrophic gastritis. Through clinic application, the present invention has the advantages of rapid action, notable effect and no adverse reaction.

Description

A kind of medicine for the treatment of chronic gastritis and preparation method thereof
Affiliated technical field
The present invention relates to a kind of medicine for the treatment of chronic gastritis, being specifically related to a kind of is the Chinese patent medicine of feedstock production with the Chinese herbal medicine, the invention still further relates to the preparation method of this medicine.
Background technology
Gastric abscess claims stomachache again, is meant that with the nearly pit of the stomach of gastral cavilty place pain be the disease of primary symptom.Primary disease is many by eating and drinking too much at one meal, the dysphagia related to QI disorder fatigue, and being invaded by exogenous pathogen etc. cause the mechanism of qi retardance of stomach, and stomach-QI being unable to descend normally forms, and often is attended by inappetence, nausea and vomiting, noisy acid regurgitation, belch singultus, gastrointestinal symptoms such as stool abnormity.Gastric abscess occupies extremely important status in internal disease, be one of commonly encountered diseases, frequently-occurring disease of internal medicine.The gastric abscess morbidity is extensive, and men and women, old and young all can suffer from.Its sick position is at the gastral cavilty place, and the internal organs that pathological changes relates generally to are stomach, spleen, liver.According to sick data of modern popular and clinical observation, the primary disease morbidity has certain seasonality.Chronic gastric abscess winter-spring season sickness rate, relapse rate are higher, and acute gastric abscess is seen autumn in summer more.
Chronic gastritis (chronic gestritis) means the chronic inflammatory disease or the atrophic lesion of the gastric mucosa that the different causes of disease cause, after its essence is that gastric epithelial suffers to damage repeatedly, because the special regeneration capacity of mucosa, so that mucosa is reconstructed, and finally cause the atrophy of irreversible intrinsic gastric gland body, even disappear.Primary disease is very common, accounts for to accept gastroscopy patient's 80~90%, and the male increases with the age growth sickness rate gradually more than the women.The clinical manifestation of chronic gastritis lacks specificity, and the weight of symptom is not consistent with the lesion degree of gastric mucosa.Most patient is normal asymptomatic or the different indigestion symptom of degree such as upper abdomen dull pain, loss of appetite, glutted, acid regurgitation etc. after the meal arranged.The atrophic gastritis patient can have anemia, becomes thin, glossitis, diarrhoea etc., and individual patients companion mucosal erosion person upper abdominal pain is more obvious, and can have hemorrhage.
Because chronic gastritis is the sickness rate height not only, and Chang Fanfu outbreak, prolongedly do not heal, last for life very then, chronic atrophic gastritis is as a kind of precancerous condition in addition, and its probability that gets a cancer of the stomach is high 3~4 times than the normal person, and canceration rate is 2.55~7.46%, therefore not only have a strong impact on the healthy of patient, and many patients are caused huge mental pressure.Yet up to the present, doctor trained in Western medicine does not still have specific short to chronic gastritis, advocates feed nonirritant food, gives gastric mucosa protectant, medicine for stomach dynamic, antacid, HP positive person and gives antibiotic etc.
Summary of the invention
The object of the present invention is to provide a kind of is the medicine of the treatment chronic gastritis of feedstock production with the Chinese herbal medicine, and this curative effect of medication is good, instant effect.
Another object of the present invention is to provide the preparation method of this medicine.
A kind of medicine for the treatment of chronic gastritis provided by the invention, make by the following weight Chinese medicinal raw materials:
Rhizoma Corydalis 8~12 Fructus Citri Sarcodactylis 3~7 Oletum Trogopteroris 3~7
Radix Et Rhizoma Rhei 3~7 Rhizoma Curcumae 2~5 Herba Chelidoniis 4~8
Fructus Amomi 1~5 Rhizoma Atractylodis Macrocephalae 3~7 Radix Glycyrrhizaes 1~3.
The above-mentioned medicine that is used for the treatment of chronic gastritis can be made said multiple dosage form on the pharmaceutics, as capsule, tablet, injection or powder.
Above-mentioned materials of weight proportions is made the method for medicine of the present invention, may further comprise the steps:
(1) get Rhizoma Corydalis and be ground into coarse powder and mix with Herba Chelidonii, with 70~80% alcohol reflux, reclaim ethanol and concentrate, transfer pH to 2~3, leave standstill, filter, filtrate transfers to neutrality again, through concentrating under reduced pressure, vacuum drying, Rhizoma Corydalis and celidoniol are promoted cream;
(2) get Radix Et Rhizoma Rhei with 70~80% ethanol through reflux, extract,, reclaim under reduced pressure and concentrate, vacuum drying, make rhababerone and promote cream;
(3) get Fructus Citri Sarcodactylis, Oletum Trogopterori, Rhizoma Curcumae, Fructus Amomi, the Rhizoma Atractylodis Macrocephalae and glycyrrhizic liuwei drug, decoct with water, it is standby to collect volatile oil simultaneously, and decocting liquid makes water promotion cream such as Fructus Citri Sarcodactylis through concentrated, precipitate with ethanol, recovery and concentrating under reduced pressure, vacuum drying;
(4) get above-mentioned volatile oil and slowly add in β-CD saturated aqueous solution,, make volatile oil beta-CD inclusion complex through heated and stirred, cold preservation, filtration, drying;
(5) get above-mentioned Rhizoma Corydalis and celidoniol and promote cream, rhababerone and promote water such as cream, volatile oil beta-CD inclusion complex and Fructus Citri Sarcodactylis and promote the cream mixed powders and be broken into fine powder, encapsulated, make capsule.
Prescription reasonable recipe of the present invention, rigorous and scientific is effective Chinese medicine preparation.We control card, are due to qi depression to blood stasis hinders.Rhizoma Corydalis in the side, suffering, hardship, temperature.GUIXIN, liver, spleen channel.Be the key medicine of blood-activating and qi-promoting pain relieving, its merit can be gone into blood system with blood circulation promoting and blood stasis dispelling, can go into edema caused by disorder of QI again and loose stagnant, distinguished with pain relieving effectiveness especially with circulation of qi promoting." Compendium of Materia Medica is rolled up 13 Rhizoma Corydalis " have " specially control all over the body up and down all pains, with among, simply fantastic " say, be widely used to show it.Clinically the gastral cavilty of all caused by energy stagnation and blood stasis have a pain, all pains of breast abdomen, abdominal pain during menstruation and limbs pain, all can use.At this with being monarch drug.Fructus Citri Sarcodactylis, suffering, hardship, temperature.Return liver, spleen, stomach, lung meridian.Its gas delicate fragrance and not strong, warm in nature and not high can be unclogged and readjusted stagnation of QI in spleen and stomach, but soothing liver-QI for relieving depression, promoting the circulation of QI to relieve pain again, so can be used for due to the stagnation of QI in spleen and stomach distension and fullness in the abdomen, oh, disease such as vomiting.Oletum Trogopterori, hardship, sweet, temperature.Return Liver Channel.The function promoting blood circulation and stopping pain.It specially goes into blood system, is longer than promoting blood circulation, and eliminating stasis to stop pain is the key medicine for the treatment of the stagnant all pains of the stasis of blood simply.SHIXIAO SAN in " formulary of peaceful benevolent dispensary ", promptly with this medicine and Pollen Typhae compatibility, all pains of treatment blood stasis.Radix Et Rhizoma Rhei is bitter, cold.Return spleen, stomach, large intestine channel.Good blood circulation promoting and blood stasis dispelling effect is arranged, make blood circulating out of vessels, from discharging down, the merit of pathogenic fire purging hemostasis is arranged simultaneously again, the upper gastrointestinal hemorrhage of clinical practice single Radix Et Rhizoma Rhei powder treatment has in recent years been obtained satisfactory effect.Rhizoma Curcumae, suffering, hardship, temperature.Return liver, spleen channel.Can promoting the circulation of QI to relieve pain, again can removing blood stasis, the long-pending merit that helps digestion is still arranged.Can treat the epigastric pain of stagnation of QI due to dyspepsia and the abdominal distention of spleen insufficiency with the different pharmaceutical compatibility.Herba Chelidonii, bitter, cool.Has significant analgesia effect.Last five tastes principal drug assistance with strengthen circulation of qi promoting, invigorate blood circulation, the merit of pain relieving, be ministerial drug altogether.Fructus Amomi, hot, bitter, sweet, temperature.Return spleen, stomach warp.Abdominal distention due to the merit that circulation of qi promoting removing dampness, activating spleen and strengthening stomach are arranged, all stagnation of QI in spleen and stomach, wet resistance, anorexia, vomiting is had loose bowels etc., all can use.The Rhizoma Atractylodis Macrocephalae, bitter, sweet, temperature.Return spleen, stomach warp.Good air making-up and spleen enlivening effect is arranged.Can fundamentally improve deficiency of spleen-QI and stomach-QI, the pathogenesis of dysfunction of the spleen in transportation and transformation, with Fructus Amomi be adjuvant drug altogether.Radix Glycyrrhizae, sweet, flat.Return spleen, stomach, lung, heart channel.Can invigorating the spleen and replenishing QI, again can relieving spasm to stop pain, relax the property of medicine in addition, the merit of coordinating the actions of various ingredients in a prescription.With being messenger drug.All medicines share, and play the effect of vital energy regualting and blood circulation-promoting and stomach and alleviating pain altogether, so all diseases of the stomachache of qi depression to blood stasis can be separated.
Medicine of the present invention has the effect of regulating the flow of QI to dissipate blood stasis and stomach and alleviating pain, cures mainly the qi stagnation and blood stasis type gastric abscess.Disease is seen: gastral cavilty distending pain or twinge, and disease is tenderness for a long time, gets belch or vows that gas then relaxes, eat the back or go into nyctalgia to weigh, the disgruntled then outbreak of emotion, the abdominal distention poor appetite, it is not smooth to defecate, purplish tongue, or the petechia ecchymosis is arranged, tongue is white, stringy and hesitant pulse.Can be used for chronic superficial gastritis and chronic atrophic gastritis and see above-mentioned patient.After the clinic trial, effect is rapid, and effect is remarkable, has no adverse reaction.
The invention will be further described below by embodiment and toxicology and pharmacology experimental result.
Embodiment 1
Get Rhizoma Corydalis 1120g and be ground into coarse powder and mix, add 6 times of amount 80% ethanol, reflux 2 times with Herba Chelidonii 650g, each 2 hours, merge alcohol extract, reclaim ethanol and be concentrated into relative density 1.10 (50 ℃), transfer pH2~3 with 1mol/L hydrochloric acid, left standstill 20 hours, filter, filtrate adds 40% sodium hydroxide solution and transfers to neutrality, is evaporated to relative density 1.30~1.35 (60 ℃), vacuum drying gets alcohol promotion cream such as Rhizoma Corydalis.Other gets Radix Et Rhizoma Rhei 400g and adds 5 times of amount 75% ethanol, the heating and refluxing extraction secondary, each 1 hour, merge alcohol extract, decompression recycling ethanol also was concentrated into relative density 1.10 (50 ℃), in 5 ℃ of left and right sides cold preservations 18 hours, filter, filtrate decompression is concentrated into relative density 1.30~1.35 (60 ℃), and vacuum drying gets rhababerone and promotes cream.Get Fructus Citri Sarcodactylis 500g, Oletum Trogopterori 450g, Rhizoma Curcumae 350g, Fructus Amomi 330g, Rhizoma Atractylodis Macrocephalae 480g, Radix Glycyrrhizae 200g mixing again, the water logging that adds 12 times of amounts was steeped 3 hours, and heating decocts three times, and the time was respectively 3 hours, 2 hours and 1 hour, collected volatile oil simultaneously.Get volatile oil and slowly add in 6 times of amount saturated aqueous solutions that β-CD prepared, with the speed of 700r/min, 50 ℃ of heating in water bath stirred 2 hours, and cold preservation 24 hours filters, and 60 ℃ of dryings of inclusion complex get volatile oil beta-CD inclusion complex.It is 1.10 (50 ℃) that aqueous extracts such as Fructus Citri Sarcodactylis are evaporated to relative density, adds ethanol and makes solution contain alcohol amount to reach 80%, stir evenly, left standstill 24 hours, and filtered, filtrate decompression is concentrated into relative density 1.30~1.35 (60 ℃), vacuum drying gets water promotion cream such as Fructus Citri Sarcodactylis.
Get alcohol promotion cream, water promotion cream such as rhababerone promotion cream, volatile oil beta-CD inclusion complex and Fructus Citri Sarcodactylis such as above-mentioned Rhizoma Corydalis, grind, cross 80 mesh sieves, granulation, drying, granulate, encapsulated, promptly make capsule of the present invention.
Embodiment 2
Get Rhizoma Corydalis 1200g and be ground into coarse powder and mix, add 8 times of amount 75% ethanol, reflux 3 times with Herba Chelidonii 600g, each 1 hour, merge alcohol extract, reclaim ethanol and be concentrated into relative density 1.10 (50 ℃), transfer pH3 with 1mol/L hydrochloric acid, left standstill 28 hours, filter, filtrate adds 40% sodium hydroxide solution and transfers to neutrality, is evaporated to relative density 1.35 (60 ℃), vacuum drying gets alcohol promotion cream such as Rhizoma Corydalis.Other gets Radix Et Rhizoma Rhei 420g and adds 6 times of amount 80% ethanol, heating and refluxing extraction 3 times, each 1 hour, merge alcohol extract, decompression recycling ethanol also is concentrated into relative density 1.10 (50 ℃), cold preservation 20 hours, filter, filtrate decompression is concentrated into relative density 1.30 (60 ℃), and vacuum drying gets rhababerone and promotes cream.Get Fructus Citri Sarcodactylis 550g, Oletum Trogopterori 420g, Rhizoma Curcumae 360g, Fructus Amomi 350g, Rhizoma Atractylodis Macrocephalae 490g, Radix Glycyrrhizae 230g mixing again, the water logging that adds 13 times of amounts was steeped 5 hours, and heating decocts three times, and the time was respectively 3 hours, 3 hours and 3 hours, collected volatile oil simultaneously.Get volatile oil and slowly add in 6 times of amount saturated aqueous solutions that β-CD prepared, with the speed of 700r/min, 50 ℃ of heating in water bath stirred 3 hours, and cold preservation 48 hours filters, and 60 ℃ of dryings of inclusion complex get volatile oil beta-CD inclusion complex.It is 1.15 (50 ℃) that aqueous extracts such as Fructus Citri Sarcodactylis are evaporated to relative density, adds ethanol and makes solution contain alcohol amount to reach 80%, stir evenly, left standstill 48 hours, filter, and filtrate decompression is concentrated into relative density 1.32 (60 ℃), vacuum drying, water such as Fructus Citri Sarcodactylis are promoted cream.
Get pure cream, the water promotion cream such as rhababerone promotion cream, volatile oil beta-CD inclusion complex and Fructus Citri Sarcodactylis of promoting such as above-mentioned Rhizoma Corydalis, grind, sieve, granulation, drying, granulate, encapsulated, promptly make capsule of the present invention.
The capsular Pharmacodynamic test of active extract of the present invention
Test objective
Observe the main effect of capsule antiulcer of the present invention, analgesia, antiinflammatory etc., for clinical practice provides the pharmacodynamics foundation.
Be subjected to the reagent thing
Capsule of the present invention, experimental drug specification: 4.6g crude drug/g
The setting of dosage:, be mice low dosage, middle dosage and high dose with 1,3 and 9 times of amount of equivalent by the calculating of laboratory animal and people's dosage conversion factor computational methods.
Capsule adult of the present invention intends clinical usage and dosage: the per day for adults dosage is the 40.1g crude drug.If the adult calculates with 70kg, then maximum dosage is 0.67g/kg Coming-of-Age Day.With reference to the dosage scaling method in Qi Chen chief editor " herbal pharmacology research methodology ":
d B = d A × R B × W A 3 / ( R A × W B 3 )
D in the formula BBe the kg body weight dosage of desiring to ask the B kind animal (comprising the people) of calculation, d ABe the kg body weight dosage of known A kind animal (comprising the people); W AW BBe the body weight of known animal A, B, R A, R BIt is the build coefficient of A, B animal.(R The people=0.11, R Mice=0.06, R Rat=0.09, W The people=70kg, W Mice=20g, W Rat=200g)
Then: mice consumption every day equivalent is (40.1/70) * (0.06/0.11) * (70/0.02) 1/3=4.73g/kg
Low dosage 4.73*1=4.73g/kg
Middle dosage 4.73*3=14.19g/kg
High dose 4.73*9=42.57g/kg
It is (40.1/70) * (0.09/0.11) * (70/0.2) that rat consumptions etc. are handed over the effect amount 1/3=3.30g crude drug/kg
Low dosage 3.30*1=3.30g/kg
Middle dosage 3.30*3=9.90g/kg
High dose 3.30*9=29.70g/kg
Before the dilution method experiment, medicinal liquid is mixed with the experiment desired concn, puts into 4 ℃ of refrigerators and store standby with distilled water.
Route of administration and number of times are irritated stomach, and be consistent with the clinical application approach of intending recommending.
Experimental control negative control group: give the equal-volume distilled water.
Experimental data statistical experiment The data SPSS statistical software handles.
Animal cleaning level Kunming mouse, body weight 18-22g, male and female half and half, Guangdong probatio inspectionem pecuoarem word 2000A034 number.Cleaning level SD rat, male and female half and half, Guangdong probatio inspectionem pecuoarem word 2000A035 number provides by No.1 Military Medical Univ. Animal Experimental Study center.
The raising condition: mice enters (Guangdong probatio inspectionem pecuoarem word 2000A018 number) behind the cleaning level laboratory, male and female separately, 10 in every cage is by special messenger's feeding and management.Animal housing's illumination abundance, heating ventilation and air-conditioning equipment is good, and room temperature is controlled at 20-23 ℃, and relative humidity is 45-60%, and laboratory is sterilization regularly routinely.
Test method and result
13.1 antiulcer action
13.1.1 the influence of the mice gastric mucosa injury that dehydrated alcohol is caused
Method: 50 of Kunming mouses, body weight 18-22 gram, male and female half and half are divided into 5 groups, are respectively matched group (giving the equal-volume distilled water), bismuth potassium citrate group (the beautiful pearl in Zhuhai pharmaceutical factory produces, 991217), 3 dosage groups of capsule of the present invention.Gastric infusion, continuous 3 days, water was can't help in last administration fasting in preceding 24 hours.Irritated stomach with dehydrated alcohol in 30 minutes after the last administration, 0.1ml/10g, disconnected neck is put to death rat after 1 hour, gets stomach and cleans and put in 1% formaldehyde fixedly 24h, and counting ulcer number is as ulcer index.
The result: compare with matched group, high, medium and low three the dosage groups of capsule of the present invention are to the effect that ethanol induced mice gastric ulcer has obvious suppression ulcer, and the ulcer digital display work that ethanol is caused reduces.
The influence of the gastric mucosa injury that table 1 capsule of the present invention causes dehydrated alcohol
Group Dosage (g/kg) Ulcer index Suppression ratio (%)
Matched group capsule bismuth potassium citrate of the present invention - 4.73 14.19 42.57 0.42 45.3±9.66 32.4±7.75 ** 25.6±8.49 ** 20.9±6.87 ** 26.6±8.57 ** - 28.47 43.49 53.86 41.28
X ± s, n=10. and matched group compare, *P<0.01.
13.1.2 effect to the pyloric ligation ulcers gastric ulcer
Method: 50 of rats, body weight 180-220 gram, male and female half and half are divided into 5 groups, be respectively matched group, cimetidine group (Dongming, Shandong Province pharmaceutical factory produces, 00011151), 3 dosage groups of capsule of the present invention, administration 7d in advance, fasting 24h before the experiment can freely drink water and give and is subjected to the reagent thing.Use etherization after 3 hours, be fixed on the Mus plate, cut from the capable abdominal cavity of ensiform process of sternum lower edge ventrimeson under the aseptic condition relatively, expose stomach, pylorus ligation is sewed up the incision, and stops to supply water for food, behind 18h, put to death rat, open the abdominal cavity, the ligation esophagus takes out stomach, is soaked in 1% formaldehyde fixedly 24h, check the gastric mucosa face, record ulcer number.
The result: by table 2 as seen behind pylorus ligation rat ulcer obviously appears, cimetidine has shown 52.1% suppression ratio to rat gastric ulcer due to the pylorus ligation, each dosage group of capsule of the present invention can obviously reduce pylorus ligation and cause the ulcer number, suppression ratio is 12.1-53.2%, shows that capsule of the present invention has preventive effect preferably to the pyloric ligation ulcers gastric ulcer.
The influence of the gastric ulcer that table 2 capsule of the present invention causes pylorus ligation
Group Dosage (g/kg) The ulcer number Suppression ratio (%)
Matched group capsule cimetidine of the present invention - 3.3 9.9 29.7 0.100 53.9±10.10 47.4±8.29 ** 36.7±10.33 ** 25.2±9.93 ** 25.80±7.27 ** - 12.1 31.9 53.2 52.1
X ± s, n=10. and matched group compare, *P<0.01.
13.1.3 effect to the stress in rats gastric ulcer
Method: 40 of rats, body weight 180-220 gram, male and female half and half, be divided into 5 groups, be respectively matched group, bismuth potassium citrate group, 3 dosage groups of capsule of the present invention, capsule of the present invention is by 1 of clinical consumption, 3,9 times of administrations, bismuth potassium citrate treatment group is by 3 times of administrations of clinical consumption (120mg/kg), animal is all irritated the Weishang by the 1.0ml/100g body weight and states medicinal liquid or equal-volume distilled water, continuous 7 days.1h after the last administration presses literature method, and the rat extremity of fasting 24h are fixed on the Mus plate, uprightly puts into the pond 18h (under the horizontal xiphoid-process) of 25 scholar 0.5C, puts to death and gets stomach, injects 1% formalin 10mL, places observational record ulcer number behind the 15min.
The result: by table 3 as seen, give the capsule of the present invention of various dose after, ulcer index all obviously reduces, and shows that ulcer is subjected to obvious inhibition.
Table 3 capsule of the present invention is to the influence of stress in rats type gastric ulcer
Group Dosage (g/Kg) The ulcer number Suppress percentage rate (%)
Matched group bismuth potassium citrate capsule of the present invention - 0.120 3.3 9.9 29.7 50.3±10.46 24.7±5.48** 38.0±9.30* 29.7±6.02** 21.1±5.55** - 50.89 26.84 40.95 58.05
X ± s, n=8. and matched group compare, *P<0.05, *P<0.01.
13.1.4 the influence of the chronic gastritis that capsule of the present invention causes sodium deoxycholate
Method: 80 of SD rats, male and female half and half, body weight 200~215g, male and female sub-cage rearing, 5 in every cage, routine feeding standard feed.Wherein 10 as the normal control group, all the other animals carry out modeling: first month gavaged 60% ethanol ml/ only once every 10 days, rat makes beverage with 20mmol/L deoxycholic acid sodium solution (distilled water preparation) and arbitrarily drinks, drink with 30% ethanol and 10mmol/L deoxycholic acid sodium solution respectively in second and third month, by turns once every 7 days.Randomly draw the minority animal before modeling finishes and do the pathology of gastric mucosa histological examination, after confirming the model success, in modeling 0 day with modeling animal random packet: non-treatment group, 3 dosage groups of capsule of the present invention, bismuth potassium citrate treatment group, and establish the normal control group simultaneously.Capsule of the present invention is by 1 of clinical consumption, 3,9 times of administrations, bismuth potassium citrate treatment group is by 3 times of administrations of clinical consumption (120mg/kg), animal is all irritated the Weishang by the 1.0ml/100g body weight and states medicinal liquid or equal-volume distilled water, once a day, and successive administration, each treated animal routine feeding carries out relevant index after administration finishes and detects.
Observation index and method of testing:
(1) body weight change duration of test, per two weeks weigh once, and off-test is each treated animal body weight change relatively.
(2) histopathology observe along lesser gastric curvature from glandular stomach to pylorus get one of holostrome coat of the stomach (3 * 20mm), use 10% formalin fixed, the routine paraffin wax embedded section, HE dyes, and makes om observation.The inflammation degree is observed rank scores and the thickness measure of sticking to mould flesh is undertaken by literature method.
The result
(1) the modeling rat that influences that rat body weight changes is finished from the 2nd thoughtful modeling, and the normal matched group of its body weight gain descends gradually, and outward appearance fur drying, lacks gloss, and movable the minimizing becomes thin.Through Drug therapy, in the capsule of the present invention, tall person's dosage group and the more non-treatment group of bismuth potassium citrate treatment group rat body weight rate of increase increase to some extent.
(2) pathology of gastric mucosa histological observation perusal normal rat gastric mucosa pinkiness, surfacing is smooth, and the coat of the stomach muscular tension is stronger.More shallow or the kermesinus of non-treatment treated animal gastric mucosa color, the surface lacks gloss, and there is tongue shape thing on the gastric mucosa of animal surface that has, erases with hands, and blood vessel is easily seen under the sticking to mould, and the coat of the stomach muscular tension is relatively poor.Capsule for treating group gastric mucosa pale red of the present invention or kermesinus, surperficial tongue shape thing is less.
The om observation stomach lining inflammation changes: the normal rats gastric epithelial is complete, the body of gland that dense arrangement is arranged in the lamina propria, as seen a small amount of lymphocyte that is dispersed in the lamina propria of glandular stomach and glandular stomach intersection, the lymphocyte that as seen part gastric antrum portion, hole body interface are dispersed on a small quantity in the sticking to mould bottom, body of stomach does not have obvious cell infiltration.The inflammation degree of non-treatment group rat gastric antrum portion, glandular stomach and glandular stomach interface is heavier, body of stomach lamina propria endolymph cell and neutrophilic infiltration, little vasodilation hyperemia has more lymphocyte and neutrophilic infiltration in the gastric antrum portion lamina propria of part animal.In the capsule of the present invention, gastric antrum portion, body of stomach, hole body interface, glandular stomach and the glandular stomach interface inflammation of tall person's dosage group and bismuth potassium citrate treatment treated animal all alleviate than non-treatment group, improve obviously with gastric antrum portion, hole body intersection.
The gastric mucosa connective tissue changes: the sticking to mould flesh layer religion of intact animal's body of stomach is thin, and be thicker at Zou Bichu.Hole portion sticking to mould flesh layer is then thicker, especially with near the pylorus place for very, the position that has can reach about 1/4 of sticking to mould thickness, sticking to mould flesh layer is mainly the muscle fiber tissue, and a small amount of connective tissue is only arranged.The sticking to mould flesh layer of non-treatment group obviously thickens, and all there is significant difference at hole portion, body flesh layer thickness and normal group supplementary angle.The muscle fiber of the position sticking to mould flesh layer that has is arranged disorderly, and upwards hypertrophy is cut apart and held intrinsic body of gland.In the capsule of the present invention, the gastric antrum portion of tall person's dosage group and bismuth potassium citrate treatment group or the sticking to mould flesh layer thickness of body of stomach are all thin than non-treatment group, and change heavy dose of with capsule of the present invention and the bismuth potassium citrate group is comparatively remarkable.
13.2 the analysis of gastric juice
Method: the SD rat of 180-220g body weight is got in the influence to pyloric ligation ulcers gastric ulcer rat stomach liquid measure, gastric acidity, and male and female half and half are divided into 5 groups at random by body weight, administration every day 1 time, 3d continuously.In fasting in the 2nd day of administration, 24h ligation pylorus after the fasting.Animal is put to death in the cervical vertebra dislocation behind the 4h, collects gastric juice.Collect gastric juice behind the centrifugal 15min of 1500r/min and survey its volume, survey gastric acidity,, survey total acidity with 0.01mol/LNaOH titration gastric acid with the pH reagent paper.
The result: as seen from Table 5, to behind the capsule of the present invention of rat various dose, gastric juice amount and total acidity gastric juice do not have significant change, but middle and high dosage group pH value is obviously greater than model group.
Table 5 capsule of the present invention is to the influence of the gastric juice index of pyloric ligation ulcers gastric ulcer rat
Group Dosage (g/Kg) Gastric juice amount (ml) PH value Total acidity (mmol/L)
Matched group cimetidine capsule of the present invention - 0.100 3.3 9.9 29.7 6.75±2.23 4.62±2.16 * 5.44±2.51 5.40±2.51 5.34±2.75 1.78±0.42 3.28±0.66 ** 1.85±0.30 2.32±0.48 * 2.80±0.66 ** 112.3±18.0 79.1±16.9 ** 101.7±19.8 100.0±15.8 92.3±21.1
X ± s, n=10. and matched group compare, *P<0.05, *P<0.01.
13.3 the capsular analgesic and anti-inflammatory effects of the present invention
13.3.1 analgesic experiment
Method: select 50 of 18-22g Kunming mouses for use, male and female half and half, five groups of random packet, respectively by the dosage gastric infusion of having set, after the administration 1 hour, every Mus lumbar injection 0.6% acetic acid (0.1ml/10g body weight) is observed behind the injection acetic acid in 15 minutes the number of times of hour turning round body (abdominal part indent and body twist).Select the positive contrast medicine of aspirin (Sigma company product) for use.
The result: the body number of times of turning round by the high, medium and low dosage group of the visible capsule of the present invention of following table reduces than obvious with the blank group, and statistical significance is arranged, and the positive drug group also has notable difference.
Table 6 capsule of the present invention is turned round the inhibitory action of body to mouse peritoneal injection acetic acid
Group Dosage (g/kg) Turn round the body number of times The P value
Control Aspirin of the present invention - 4.73 14.19 42.57 0.20 47.5±11.46 36.0±8.92 27.2±8.75 20.9±6.12 22.6±8.49 - <0.05 <0.01 <0.01 <0.01
X ± s, n=10. and matched group compare, *P<0.05, *P<0.01.
13.3.2 rat granuloma is swollen
Method: select 180-220g Wistar rat for use, male, random packet, the ether light anaesthesia is at the descending abdominal incision of aseptic condition, with the sterilization cotton balls (autoclaving of 50 ± 1 milligrams of weights, add 1 milligram/0.1 milliliter/of penbritin, 50 ℃ of stove-dryings) to implant rat homonymy groin subcutaneous, and operation began administration the same day, continuous 7 days, took off neck on the 8th and put to death rat, take out cotton balls, it is roasting to constant weight to put 60 ℃ of baking ovens, weigh with analytical balance, deduct cotton balls weight and be the granuloma dry weight.
Result: obviously be lighter than matched group by visible middle and high dosage group of capsule of the present invention of table 7 and positive drug group granulation dry weight, show that capsule of the present invention has antiinflammatory action preferably.
Table 7 capsule of the present invention is to the bullate effect of rat granuloma
Group Dosage (g/kg) The granuloma dry weight (x ± s, mg)
Control Aspirin of the present invention - 3.3 9.9 28.7 0.10 97.4±5.5 96.0±5.8 91.6±6.9* 87.0±5.2* 73.6±9.4**
X ± s, n=10. and matched group compare, *P<0.05, *P<0.01.
13.4 conclusion
Experimental results show that capsule of the present invention all has antagonism preferably to 4 kinds of acute and chronic experimental gastric ulcer models, obviously reduce the ulcer number or reduce ulcer index; Reduce the gastric juice amount of pyloric ligation ulcers rat gastric ulcer, the total degree of its gastric juice acid is not had significant change, but middle and high dosage group pH value is obviously greater than model control group; The chronic gastritis histopathological examination that sodium deoxycholate causes shows that Capsules group pathological change of the present invention obviously is lighter than model control group.Analgesia, antiinflammatory test show that capsule of the present invention has easing pain and diminishing inflammation effect preferably.

Claims (3)

1, a kind of medicine for the treatment of chronic gastritis is characterized in that it is the medicament of being made by the following weight Chinese medicinal raw materials:
Rhizoma Corydalis 8~12 Fructus Citri Sarcodactylis 3~7 Oletum Trogopteroris 3~7
Radix Et Rhizoma Rhei 3~7 Rhizoma Curcumae 2~5 Herba Chelidoniis 4~8
Fructus Amomi 1~5 Rhizoma Atractylodis Macrocephalae 3~7 Radix Glycyrrhizaes 1~3.
2, the medicine of treatment chronic gastritis according to claim 1 is characterized in that described medicament is a capsule.
3, the preparation method of the medicine of the described treatment chronic gastritis of claim 2 may further comprise the steps:
(1) get Rhizoma Corydalis and be ground into coarse powder and mix with Herba Chelidonii, with 70~80% alcohol reflux, reclaim ethanol and concentrate, transfer pH to 2~3, leave standstill, filter, filtrate transfers to neutrality again, through concentrating under reduced pressure, vacuum drying, Rhizoma Corydalis and celidoniol are promoted cream;
(2) get Radix Et Rhizoma Rhei with 70~80% ethanol through reflux, extract,, reclaim under reduced pressure and concentrate, vacuum drying, make rhababerone and promote cream;
(3) get Fructus Citri Sarcodactylis, Oletum Trogopterori, Rhizoma Curcumae, Fructus Amomi, the Rhizoma Atractylodis Macrocephalae and glycyrrhizic liuwei drug, decoct with water, it is standby to collect volatile oil simultaneously, and decocting liquid makes water promotion cream such as Fructus Citri Sarcodactylis through concentrated, precipitate with ethanol, recovery and concentrating under reduced pressure, vacuum drying;
(4) get above-mentioned volatile oil and slowly add in β-CD saturated aqueous solution,, make volatile oil beta-CD inclusion complex through heated and stirred, cold preservation, filtration, drying;
(5) get above-mentioned Rhizoma Corydalis and celidoniol and promote cream, rhababerone and promote water such as cream, volatile oil beta-CD inclusion complex and Fructus Citri Sarcodactylis and promote the cream mixed powders and be broken into fine powder, encapsulated, make capsule.
CN031142222A 2003-04-15 2003-04-15 Medicine for treating chronic gastritis and preparing process thereof Expired - Fee Related CN1217688C (en)

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CN101700382B (en) * 2009-11-12 2014-12-10 张国营 Cancer pain elimination pill
CN105727176A (en) * 2016-03-02 2016-07-06 金丽丽 Medicine for treating chronic gastritis

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