CN105056128B - A kind of Chinese medicine composition and preparation method and application for treating atrophic gastritis and intestines - Google Patents

A kind of Chinese medicine composition and preparation method and application for treating atrophic gastritis and intestines Download PDF

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CN105056128B
CN105056128B CN201510503761.3A CN201510503761A CN105056128B CN 105056128 B CN105056128 B CN 105056128B CN 201510503761 A CN201510503761 A CN 201510503761A CN 105056128 B CN105056128 B CN 105056128B
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parts
intestines
treatment
atrophic gastritis
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CN105056128A (en
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朱方石
徐婷婷
田耀洲
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Jiangsu Provincial Insititute of Traditional Chinese Medicine
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Jiangsu Provincial Insititute of Traditional Chinese Medicine
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Abstract

The invention belongs to field of medicine preparations, specifically disclose a kind of Chinese medicine composition and its preparation method and application for treating atrophic gastritis and intestines, it includes the following raw material:Radix Codonopsis, rhizoma atractylodis macrocephalae, rhizoma pinellinae praeparata, Poria cocos, dried orange peel, oldenlandia diffusa, micarex, curcuma zedoary, Radix Curcumae, through water extract-alcohol precipitation, spray drying, addition auxiliary material is prepared into various preparations, energy strengthening the spleen and replenishing qi, regulating qi-flowing for harmonizing stomach, and have the function of improvement and anti-atrophy of gastric mucosa and intestines, the invention also discloses it to prepare for treating the application in atrophic gastritis and intestines chemical drug object.

Description

A kind of Chinese medicine composition that treating atrophic gastritis and intestines and preparation method and Using
Technical field
The invention belongs to technical field of traditional Chinese medicines, and in particular to a kind of Chinese medicine for treating atrophic gastritis and intestines Composition and preparation method and application.
Background technology
Atrophic gastritis (CAG) is most commonly seen one of the disease of digestive system, and the incidence in China is 7.5- 13.8%, atrophic gastritis is in close relations with intestinal metaplasia (IM) and incidence gastric cancer, is determined by WHO expert bodies within 1980 Justice is gastric precancerous lesion, canceration rate 2.55-7.46%.CAG and IM there is no the remedy measures and method of specificity so far, existing It is taken for medicine more and 1. thoroughly eradicates HP infection;2. strong barrier function promotes epithelial growth drug;3. promoting gastrointestinal peristalsis, subtracting Few intestinal juice backflows;4. supplementing the methods of chalybeate and vitamin B12 (for hypoferric anemia and pernicious anaemia), but still fail so far Fundamentally reverse the atrophy of stomach lining.
Chinese medicine study the result shows that, Chinese medicine has accumulated abundant experience to the treatment of CAG and IM, however, therapy now Different experience and prescription differs, lack unification, specification, standard therapeutic scheme.The present invention is in national Eleventh Five-Year Plan science and technology Under the premise of supporting plan is subsidized, syndrome-classification, the therapy grouped discussion of 10 years Chinese traditional treatment CAG nearly to China first carry out Investigation of wide scope, arrangement and processing analysis, on this basis, have carried out statistical analysis to recipe drug frequency of use, have obtained CAG Chinese medicine different TCM syndrome types distributed architectures and primary and secondary and main common method for the treatment of, the frame structure of drug;And it uses and meets DME design principles, it is solidifying according to result by clinical multicenter, random layering, the clinical test of Double-blind double-dummy, parallel control Practice the most efficient solution of a kind of practical, specification the Chinese medicine CAG and IM that summarize.
Invention content
The technical problems to be solved by the invention are to provide a kind of Chinese medicine for treating atrophic gastritis and intestines Composition and preparation method thereof.
The present invention also provides application of the above-mentioned Chinese medicine composition in preparing treatment atrophic gastritis and intestines chemical drug object.
A kind of Chinese medicine composition for treating atrophic gastritis and intestines, it is prepared by the bulk pharmaceutical chemicals of following parts by weight It obtains:8-12 parts of Radix Codonopsis, 6-14 parts of rhizoma atractylodis macrocephalae, 6-14 parts of rhizoma pinellinae praeparata, 6-14 parts of Poria cocos, 6-10 parts of dried orange peel, oldenlandia diffusa 30- 40 parts, 30-40 parts of micarex, 5-15 parts of curcuma zedoary, 5-15 parts of Radix Curcumae.
The Chinese medicine composition of the treatment atrophic gastritis and intestines, it is prepared by the bulk pharmaceutical chemicals of following parts by weight It obtains:10 parts of Radix Codonopsis, 10 parts of rhizoma atractylodis macrocephalae, 10 parts of rhizoma pinellinae praeparata, 10 parts of Poria cocos, 8 parts of dried orange peel, 30 parts of oldenlandia diffusa, micarex 30 Part, 10 parts of curcuma zedoary, 10 parts of Radix Curcumae.
The Chinese medicine composition of the treatment atrophic gastritis and intestines adds auxiliary material after the bulk pharmaceutical chemicals extraction, uses Capsule, tablet, granule is made in conventional formulation method.
The Chinese medicine composition of the treatment atrophic gastritis and intestines, auxiliary material are dextrin, lactose, starch, sucrose, Portugal One or more of grape sugar, microcrystalline cellulose, mannose.
The Chinese medicine composition of the treatment atrophic gastritis and intestines, preparation method include the following steps:Take mica Stone is smashed plus water first decocts 30 minutes, adds Radix Codonopsis, rhizoma atractylodis macrocephalae, rhizoma pinellinae praeparata, Poria cocos, dried orange peel, oldenlandia diffusa, curcuma zedoary, strongly fragrant Gold merges, and adds water to cook twice, collecting decoction, and relative density is 1.15-1.20 when being concentrated into 65 DEG C, and ethyl alcohol is added to make alcohol content Percent by volume reach 75-85%, stir, stand, filtering, when filtrate decompression is concentrated into 65 DEG C relative density be 1.20-1.30 simultaneously Ethyl alcohol is recycled, concentrate is obtained, concentrate is spray-dried to obtain dry extract, capsule, tablet, granule is made in addition auxiliary material.
The Chinese medicine composition of the treatment atrophic gastritis and intestines, decocting condition is in preparation method:For the first time Micarex is smashed plus water is 3-5 times of medicinal material and measures, add Radix Codonopsis, rhizoma atractylodis macrocephalae, rhizoma pinellinae praeparata, Poria cocos, dried orange peel, oldenlandia diffusa, After curcuma zedoary, Radix Curcumae merge, it is that 8-12 times of medicinal material weight is measured to add water for the second time, decocts 1-2h, and third time adds water for medicinal material weight 6-10 times measure, decoct 1-2h.
The Chinese medicine composition of the treatment atrophic gastritis and intestines, spray drying condition is in preparation method:Into Air temperature is 100-120 DEG C, and leaving air temp is 80-90 DEG C, and temperature of charge is 70-90 DEG C, and atomizing pressure is 0.2-0.4 megapascal, Spray velocity is 5-10ml/s.
The Chinese medicine composition of the treatment atrophic gastritis and intestines is preparing treatment atrophic gastritis and intestines Application in chemical drug object.
Chinese Pharmacopoeia pertinent regulations are met using the quality of pharmaceutical raw material (medicinal material) and dosage in the present invention.
Radix Codonopsis is Campanulaceae Radix Codonopsis (Codonopsis pilosula Nannf) or radix codonpsis tangshen (C.tangshen Olive root) is distributed mainly on northwest China various regions.It is sweet in flavor, it is mild-natured;With tonifying middle-Jiao and Qi;The effect promoted the production of body fluid.For the deficiency of vital energy Deficiency, lassitude hypodynamia;Spleen eating less;The edema of the face;It quenches one's thirst;The deficiency of blood;The diseases such as rush down prolapse of the anus for a long time.
Rhizoma Atractylodis Macrocephalae is the rhizome of feverfew Rhizoma Atractylodis Macrocephalae (Atractylodes maceocephala Koidz), is distributed mainly on The ground such as China Zhejiang, Hubei, Hunan.It is bitter, sweet, it is warm-natured;With invigorating the spleen and benefiting qi;Eliminate dampness and have diuretic effect;Hidroschesis;The effect of tocolysis;With In weakness of the spleen and the stomach;Diarrhea;Water-damp retention, phlegm and retained fluid, oedema;The diseases such as exterior deficiency spontaneous perspiration.
The tuber of pinellia is the stem tuber of the aroid tuber of pinellia (Pinellia ternata (Thunb) Breit), is distributed mainly on The areas such as China Yangtze river basin and northeast, North China.It is acrid flavour, warm-natured;It is toxic;With eliminating dampness and eliminating phlegm, stopping nausea and vomiting by lowering the adverse flow of QI, dissolving lump and resolving mass Effect.For damp phlegm, cold-phlegm syndrome;Vomiting;Epigastric fullness, accumulation of pathogens in chest, globus hysteriocus;Goiter and tumor, subcutaneous nodule, swollen ulcer drug, venomous snake bite etc. Disease.
Poria cocos is the dry sclerotia of On Polyporaceae Poria cocos (Poria cocos (Schw.) Wolf), mainly originates in cloud The ground such as south, Anhui, Hubei, Henan, Sichuan.It is sweet in flavor, light, mild-natured.With inducing diuresis for removing edema, excreting dampness, invigorating the spleen, the effect of calming heart.With In oedema;Phlegm and retained fluid;Splenasthenic diarrhea;Palpitaition, the diseases such as insomnia.
Dried orange peel is rutaceae orange (Citrus reticulate Blanco) and its ripe dried fruit of variety Skin is distributed mainly on the ground such as Guangdong, Fujian, Sichuan, Zhejiang, Jiangxi.Acrid flavour, hardship, it is warm-natured.It is eliminating dampness and eliminating phlegm with regulating qi-flowing for strengthening spleen Effect.For taste syndrome of qi stagnation;Vomiting, hiccup;Damp phlegm, cold productive cough are coughed;The diseases such as the obstruction of qi in the chest.
HERBA HEDYOTIS DIFFUSAE is the herb of madder wort oldenlandia diffusa (Oldenlandia diffusa (Willd.) Roxb.), Originate in the ground such as Fujian, Guangxi, Guangdong, Yunnan, Zhejiang, Jiangsu, Anhui.It is mildly bitter flavor, sweet, it is cold in nature;With clearing heat and detoxicating, dampness removing is logical Leaching.For carbuncle sore tumefacting virus, abscess of throat, venomous snake bite;The diseases such as puckery pain of heat gonorrhea.
Micarex is the sheet ore of branch crystallographic system muscovite (Muscovite), originates in the Inner Mongol, Liaoning, Jilin, river The ground such as north, Shandong, Yunnan, Zhejiang, Jiangsu, Anhui, Jiangxi.It is sweet in flavor, mild-natured.With kidney tonifying, astringing to arrest bleeding effect;For internal lesion caused by overexertion Deficient, dizziness is palpitated with fear, insomnia, epilepsy, sympotoms caused by cold factors chronic malaria, sore, carbuncle and painful swelling, knife wound bleeding.
Curcuma zedoary be zingiberaceous plant zedoary (Curcuma phaeocaulis Val.) rhizome, main product in Sichuan, Guangdong, The ground such as Guangxi.Acrid flavour, hardship, it is warm-natured;With blood-breaking, the effect of Xiao Ji Zhi Tong;Yong Yu lumps in the chest and abdomen, Amenorrhea, trusted subordinate's stasis caused pain; The diseases such as dyspepsia abdominal distention.
Radix Curcumae is the root tuber of zingiberaceous plant RADIX CURCUMAE (Curcuma petiolata.), and main product is in Zhejiang, with Wenzhou Area For genunie medicinal materials.Acrid flavour, hardship, it is cold in nature;With promoting blood circulation and stopping pain, promoting qi circulation and removing obstruction in the collateral, clear away heart-fire cool blood, the effect of normalizing gallbladder to cure jaundice;For gas Stagnant blood stasis pain is demonstrate,proved;Pyreticosis coma, epilepsy phlegm close;It spits blood, bleeding from five sense organs or subcutaneous tissue, vicarious menstruation, hematuria, blood strangury;Liver and gallbladder damp-heat, cholelithiasis etc..
Advantageous effect:The present invention has the following advantages that compared with prior art:1, the present invention be directed to atrophic stomaches Scorching and intestines pathogenesis and prescription, monarch are clear, it is dialectical that rationally flavour of a drug defective ejaculation, compatibility is accurate, in conjunction with the differentiation of disease, Have effects that the Traditional Chinese Medicine of strengthening the spleen and replenishing qi, nourishing the stomach and stomach, while there is protection stomach lining, anti-Mucosal atrophy, inhibit intestines Modern effect.Now studies have shown that the tcm syndrome of atrophic gastritis and intestines is various, we have found early-stage study, In 9995 CAG cases, 10 kinds of card types, weakness of the spleen and the stomach (accounting for 20.89%) is its different TCM syndrome types;It is believed that atrophic This is weakened body resistance for gastritis and intestinesization disease, weakness of the spleen and the stomach pathologic basis for morbidity, though also can behave as liver-stomach disharmony/or retention of damp-heat in the interior, The tcm syndromes such as deficiency of both qi and yin, but many pathological changes can be formed again it is weakness of the spleen and the stomach, it is weakness of the spleen and the stomach to be applied in its pathology mistake always Among journey.We have studied the rule of the distribution status and Prescription application of the tcm treatment method of atrophic gastritis and intestines simultaneously 8056 therapy and formulas are concluded, arranged and are summarized by rule, the results showed that, it ranks the first in more than 60 kind tcm treatment methods Be nourishing Qi therapy, prescription frequency of usage is more than that 10% rank the first is Xiangsha Liujunzi decoction, and result illustrates invigorating the spleen Invigorating Qi and its prescription have certain representativeness and generality in atrophic gastritis and intestines tcm treatment method.The present invention Legislation prescription be on the basis of theoretical and clinical research, it is condensed total by the research of national Eleventh Five-Year Plan science and technology supporting project It ties.
2, the result of study of existing report is less using multicenter, random, Double-blind double-dummy, parallel control method, originally Invention is to have carried out evaluation of clinical curative effect by 300 many cases atrophic gastritis of the above method pair or with the patient of intestines, Invention prescription can be obviously improved mucous membrane sign and stomach lining pathology atrophing state etc. under the clinical symptoms of CAG patient, gastroscope, Its total effective rate is more objective better than therapies group, curative effects such as soothing liver and harmonizing stomach, supplementing qi and nourishing yin and QI invigorating heat clearing and blood stasis dispersings.
3, the present invention takes the sweet temperature of Radix Codonopsis to replenish qi to invigorate the spleen the work(of nourishing the stomach, is monarch drug in a prescription.The sweet temperature gas supplementing of rhizoma atractylodis macrocephalae, bitter dry invigorating the spleen, with Radix Codonopsis is mutually assisted, and the power of QI invigorating more writes;Poria cocos is sweet light, invigorating the spleen excreting dampness, and with rhizoma atractylodis macrocephalae phase 5, more preferably, the two is ministerial drug altogether for invigorating the spleen.It is old Skin regulating qi-flowing for strengthening spleen helps spleen fortune nourishing the stomach gas and makes benefit without stagnant in;The main drop of rhizoma pinellinae praeparata pharmacological property, along stomach internal organs " to lead to for use, with drop Be suitable " duty, and adjust spleen and stomach without stop up it is stagnant, the two altogether for assistant system medicine;Micarex nature and flavor are sweet, flat, not only strong with QI invigorating The effect of spleen, and can removing blood stasis for promoting tissue regeneration, soft and moist stomach Tianjin (we have discovered that improving stomach lining nutrition and blood flow, and wither with anti- Contracting acts on), to help the medicine helped;The pungent logical hardship of curcuma zedoary, Radix Curcumae is let out, and not only enters blood system, but also enter qi leel, has promoting blood circulation to remove stagnation, promoting qi circulation and relieving pain The effect of, also for adjutant, (and the two modern study finds there is good inhibiting effect to the proliferation of tumour cell, also has The meaning of the differentiation of disease).Though oldenlandia diffusa has clearing heat and detoxicating Chinese medicine effect, but has the modern effect for adjusting immunity anticancer anti-cancer, Anticancer effect has obtained to be recognized altogether, the meaning for taking its differentiation of disease anticancer to preapre for an unfavorable turn of events.All medicines coordinate the not only dialectical but also differentiation of disease.
4, in view of atrophic gastritis, the illness rate of intestines is high, the course of disease is permanent and has cAMP content, is difficult to reverse and is Its main feature, modern medicine can reflect atrophic gastritis and intestines patient again without specificity therapeutic method and drug Clinical demand and market huge foreground.This achievement is invented, and energy product extremely effective prevents atrophic gastritis and intestines Occur and development, to improve existence and the quality of life of many patients, reduce early carcinoma of stomach incidence be of great significance and compared with High practical value.Since this disease incidence is high, it is contemplated that once marketing application, good social benefit and warp will be generated Ji benefit.
5, the active ingredient feature of medicinal material is directed in preparation process, using the extraction process of water extract-alcohol precipitation, reasonable design is protected Stay more active ingredients.
6, crude drug is that pharmacopeia records kind in this prescription, and Ji Yuan is clear, Small side effects, curative for effect, is suitable for length Phase medication.
7, a kind of with the clinical symptoms, the mitigation stomach that improve atrophic gastritis and intestines patient the invention reside in providing Mucosa injury, the reparation for promoting damage mucous membrane inhibit stomach lining body of gland to atrophy, intestinesization development controlling with good therapeutic effect Treat pharmaceutical composition.
Specific implementation mode
Below by way of example forms, the above of the present invention is described in further detail again, but this should not be managed Solution is only limitted to example below for the range of the above-mentioned theme of the present invention, and all technologies realized based on the above of the present invention are belonged to In the scope of the present invention.
Raw material weight number needed for 1 each embodiment of table, unit:g
Radix Codonopsis Rhizoma atractylodis macrocephalae Rhizoma pinellinae praeparata Poria cocos Dried orange peel Oldenlandia diffusa Micarex Curcuma zedoary Radix Curcumae
Embodiment 1 8 14 14 6 10 30 40 5 15
Embodiment 2 10 10 10 10 8 35 35 10 10
Embodiment 3 12 6 6 14 6 40 30 15 5
Embodiment 1:The preparation of capsule
It is prepared by 1 raw material proportioning of table and capsule dosage form conventional method, is prepared into capsule, the specific method is as follows:
It taking micarex to smash, adds water to cook 30 minutes, amount of water is 3 times of medicinal material weight, adds Radix Codonopsis, rhizoma atractylodis macrocephalae, Rhizoma pinellinae praeparata, Poria cocos, dried orange peel, oldenlandia diffusa, curcuma zedoary, Radix Curcumae medicinal material merge, add water to cook twice, and for the first time plus water is medicinal material weight 8 times of amounts of amount, decoct 1h, add 6 times of amounts that water is medicinal material weight for the second time, decoct 1h, collecting decoction is concentrated into opposite at 65 DEG C Density is 1.15, adds ethyl alcohol to make the percent by volume of alcohol content up to 75%, stirs, stand, filtering, filtrate decompression is concentrated into 65 DEG C When relative density be 1.20 and to recycle ethyl alcohol, obtain concentrate, be spray-dried to obtain dry extract, spray drying condition is:Into wind-warm syndrome Degree is 100 DEG C, and leaving air temp is 80 DEG C, and temperature of charge is 70 DEG C, and atomizing pressure is 0.2 megapascal, and spray velocity 5ml/s adds Enter appropriate amount of starch, dry granulation crosses 60 mesh sieve, and capsule can be obtained by being packed into No. 1 capsule.
Embodiment 2:The preparation of granule
It is prepared by 1 raw material proportioning of table and granule dosage form conventional method, is prepared into granule, the specific method is as follows:
It taking micarex to smash, adds water to cook 30 minutes, amount of water is 5 times of medicinal material weight, adds Radix Codonopsis, rhizoma atractylodis macrocephalae, Rhizoma pinellinae praeparata, Poria cocos, dried orange peel, oldenlandia diffusa, curcuma zedoary, Radix Curcumae medicinal material merge, add water to cook twice, and for the first time plus water is medicinal material weight 10 times of amounts of amount, decoct 1.5h, add 8 times of amounts that water is medicinal material weight for the second time, decoct 1.5h, collecting decoction is concentrated into 65 DEG C When relative density be 1.20, add ethyl alcohol to make the percent by volume of alcohol content up to 80%, stir, stand, filtering, filtrate decompression concentration It is 1.25 to relative density at 65 DEG C and recycles ethyl alcohol, obtains concentrate, be spray-dried to obtain dry extract, spray drying condition is: Inlet air temperature is 110 DEG C, and leaving air temp is 85 DEG C, and temperature of charge is 80 DEG C, and atomizing pressure is 0.3 megapascal, and spray velocity is The one of which such as appropriate dextrin, soluble starch, lactose, sucrose, mannitol or several are added in 7.5ml/s, with appropriate 80% (v/v) ethanol wet, softwood processed cross the sieve granulation of 14 mesh, and 50-80 DEG C of drying, 60 mesh whole grains obtain granule.
Embodiment 3:The preparation of tablet
It is prepared by 1 raw material proportioning of table and Tabules conventional method, prepares piece agent, the specific method is as follows:
It taking micarex to smash, adds water to cook 30 minutes, amount of water is 4 times of medicinal material weight, adds Radix Codonopsis, rhizoma atractylodis macrocephalae, Rhizoma pinellinae praeparata, Poria cocos, dried orange peel, oldenlandia diffusa, curcuma zedoary, Radix Curcumae medicinal material merge, add water to cook twice, and for the first time plus water is medicinal material weight 12 times of amounts of amount, decoct 2h, add 10 times of amounts that water is medicinal material weight for the second time, decoct 2h, collecting decoction is concentrated into 65 DEG C of phases It is 1.20 to density, adds ethyl alcohol to make the percent by volume of alcohol content up to 85%, stir, stand, filtering, filtrate decompression is concentrated into 65 DEG C when relative density be 1.30 and to recycle ethyl alcohol, concentrate is obtained, by concentrate plus water and auxiliaries at oral solution, or will concentration Liquid is spray-dried to obtain dry extract, and it is one such or several auxiliary that starch, dextrin, Icing Sugar, lactose, microcrystalline cellulose etc. is added Material is uniformly mixed, and with appropriate 80% (v/v) ethanol wet, softwood processed crosses the sieve granulation of 30 mesh, in 70~80 DEG C of dryings, with 60 mesh Whole grain is sieved, tabletting, sugar coating, packing, outer packing, inspection is qualified, obtains tablet.
Embodiment 4:The protective effect experimental study that the present invention damages gastric mucosa caused by ethyl alcohol
1. experiment material
1.1 experimental animal:
Healthy adult cleaning grade SD rats 48, half male and half female, 200 ± 20g of weight.Western Poole-Bi Kai the experiments in Shanghai are dynamic Object Co., Ltd provides, production licence SCXK (Shanghai) 2008-0016.It raises in the attached combination of Chinese tradiational and Western medicine of Nanjing University of Traditional Chinese Medicine Hospital's animal experimental center, animal feed use standard feed, and by the supply of Nanjing An Limo Science and Technology Ltd.s, (production is registered Number:The A that revives raises new word (2002) 503, executes standard:GB14924.2-2001).Using posture cage, 3 DEG C of 23 scholar of environment temperature, 55 scholar 5% of humidity.Animal is supported in adaptability examination to be started to test after a week.
1.2 experimental drug:
It is prepared according to the preparation method of granule in above-described embodiment 2, is produced by Jiangsu Tian Jiang pharmaceutcal corporation, Ltds, According to the equivalent metering scaling method of people mouse, face the used time is configured to 0.8068g/ml strength solutions with distilled water.
Teprenone:50mg/ pieces, defend the production of material (China) pharmaceutcal corporation, Ltd, lot number by 24/box:Chinese medicines quasi-word H20093656.According to the equivalent metering scaling method of people mouse, face be configured to distilled water a concentration of 1.6mg/ml suspension it is spare.
1.3 key instrument equipment and reagent:
Prostaglandin enzyme linked immunological kit, epidermal growth factor enzyme linked immunological kit, the examination of growth hormone release inhibiting hormone enzyme linked immunological Agent box is beneficial peak biology Co., Ltd product.Three use constant temperature water tank, are Cole-Parmer Products, and reverse biologic is micro- Mirror, is CKX31-12PHP Olympus Products, and biological clean bench is U.S.'s Labconco Products, enzyme mark Instrument, is ThermoLabsystemS Products, and centrifuge L600 produces for Hunan Xiang Yi groups;Ultra low temperature freezer is MDFu-281, Japanese SANY0 products, routine pathology slicer are produced by Lai Ka Instrument Ltd.;Automatic tissue embedding machine, The magnificent electronics corporation of Changzhou;Image analysis system, German LEICA companies;Poly-D-lysine slide, Foochow step neoformation technology Development company;Electronic balance, Shanghai Jingtian Electronic Instrument Co., Ltd.'s production;Homogenizer, Jiangsu Prov. Research Inst. Traditional Chinese Medical.
2. method
2.1 mucosal lesion model trial tests:4 hours, with 75% ethyl alcohol, 60% ethyl alcohol, 50% ethyl alcohol, gavage, 2ml/ Only, it is put to death after 1h, cuts open the belly and leak full stomach cruelly, discovery is rotten to the corn extensively with gastric mucosa after 75% ethyl alcohol modeling, and large stretch of ulcer is formed, And with focal bleeding, damage is heavier;Mucosal congestion and edema is apparent after 60% ethyl alcohol modeling, and large stretch of rotten to the corn, shallow aphtha is formed; 50% ethyl alcohol mucous membrane only has mild hyperaemia oedema, has no rotten to the corn;Therefore 60% ethyl alcohol gavage of selection causes mucosal lesion modeling.
2.2 modeling method:It by preliminary result, is deprived of food but not water before modeling 24 hours, with 60% ethyl alcohol, gavage, 2ml/ Only, mucosal lesion is caused.
2.3 group technologies and medication:
2.3.1 short term effect:It is Normal group to take 6 normal SD rats, takes successfully SD rat acute mucosal lesions Model 18 is only randomly divided into 3 groups, every group 6;Respectively A, B, C, D group observes the short term effect of drug therapy.
A:Normal group is normal to raise without any drug-treated.
B:Model control group, physiological saline, 0.1ml/1kg/d, gavage 1 day.
C:Invention drug granule group, invention drug granule solution, 0.1ml/1kg/d, gavage 1 day.
D:Teprenone group, Teprenone solution, 0.1ml/1kg/d, gavage 1 day.
2.3.2 late result:SD rat acute mucosal lesions model 18 is taken successfully to be only randomly divided into 3 groups, every group 6; Respectively E, F, G group observes the late result of drug therapy.
E:Model control group, physiological saline, 0.1ml/1kg/d, gavage 3 days.
F:Invention drug granule group, invention drug granule solution, 0.1ml/1kg/d, gavage 3 days.
G:Teprenone group, Teprenone solution, 0.1ml/1kg/d, gavage 3 days.
Normal group:Normal raising.
2.4 methods of sample collection:
2.4.1 serum specimen acquires:Each group rat eye after treatment end is extractd, peripheral blood 7.5ml is taken, sets respectively Enter to be poured in the test tube of label totally 3 pipe, make respectively the detection of serum prostate cellulose content, serum epidermal growth factor content detection and Serum Somatostatin content inspection.
2.4.2 gastric tissue collection of specimens:Eyeball is put to death after taking blood with cervical dislocation execution method, is then cut open the belly and is leaked full stomach cruelly, The detachment at away from cardia and pylorus 1.5cm, takes out full stomach, cuts off, flattens along greater curvature, observes mucosal lesion situation.Then The tissue of clip antrum portion same size is fixed with 10% neutral formalin solution immediately.
2.4.3 the preparation of gastric tissue homogenate:Therefore choose body of stomach tissue and dried with filter paper, 0.2g or so is weighed with electronics, Scales/electronic balance weighing moves in EP pipes after adding 9 times of 0.9% ice physiological saline, is cut with ophthalmology minor operation and shred tissue block as early as possible, then 3 pipes are homogenized out with homogenizer preparation, make the detection of tissue Prostaglandin, the detection of tissue Egf Content and group respectively Knit Somatostatin inspection.
2.5 detection method:
2.5.1 serum prostate cellulose content detection (ELISA)
1. setting 10 hole of gauge orifice, gradient dilution is carried out to it.
2. peripheral blood 2.5ml centrifuges 15min, 3000r/min, takes 10ul serum, be separately added into 96 holes for being coated with antigen In the plate hole of ELISA Plate.
3. homogenised tissue 2.5ml centrifuges 15min, 3000r/min, homogenate supernatant 10ul is taken, another plate packet is separately added into By in the plate hole of 96 hole elisa Plates of good antigen.
4. 37 DEG C of incubation 30min.
5. reject mixture, cleaning solution washs 5 times, gets rid of liquid in most plate, is patted dry with blotting paper.
6. enzyme marking reagent 50ul is added, mixing, 37 DEG C of incubation 30min are gently shaken.
7. color developing agent A50ul is added in washing 5 times, color developing agent B50ul, mixing, 37 DEG C are protected from light colour developing 15min.
8. 50ul terminate liquids are added, reaction is terminated.
9. on microplate reader 450nm wavelength, OD values are surveyed, calculate Prostaglandin in serum.
2.5.2 serum and tissue Concentrations of Epidermal Growth Factor content detection (ELISA)
1. setting 10 hole of gauge orifice, gradient dilution is carried out to it.
2. peripheral blood 2.5ml centrifuges 15min, 3000r/min, takes 10ul serum, be separately added into 96 holes for being coated with antigen In the plate hole of ELISA Plate.
3. homogenised tissue 2.5ml centrifuges 15min, 3000r/min, homogenate supernatant 10ul is taken, another plate packet is separately added into By in the plate hole of 96 hole elisa Plates of good antigen.
4. 37 DEG C of incubation 30min.
5. reject mixture, cleaning solution washs 5 times, gets rid of liquid in most plate, is patted dry with blotting paper.
6. enzyme marking reagent 50ul is added, mixing, 37 DEG C of incubation 30min are gently shaken.
7. color developing agent A50ul is added in washing 5 times, color developing agent B50ul, mixing, 37 DEG C are protected from light colour developing 15min.
8. 50ul terminate liquids are added, reaction is terminated.
9. on microplate reader 450nm wavelength, OD values are surveyed, calculate Prostaglandin in serum.
2.5.3 serum and tissue in Somatostatin detection (ELISA)
1. setting 10 hole of gauge orifice, gradient dilution is carried out to it.
2. peripheral blood 2.5ml centrifuges 15min, 3000r/min, takes 10ul serum, be separately added into 96 holes for being coated with antigen In the plate hole of ELISA Plate.
3. homogenised tissue 2.5ml centrifuges 15min, 3000r/min, homogenate supernatant 10ul is taken, another plate packet is separately added into By in the plate hole of 96 hole elisa Plates of good antigen.
4. 37 DEG C of incubation 30min.
5. reject mixture, cleaning solution washs 5 times, gets rid of liquid in most plate, is patted dry with blotting paper.
6. enzyme marking reagent 50ul is added, mixing, 37 DEG C of incubation 30min are gently shaken.
7. color developing agent A50ul is added in washing 5 times, color developing agent B50ul, mixing, 37 DEG C are protected from light colour developing 15min.
8. 50ul terminate liquids are added, reaction is terminated.
9. on microplate reader 450nm wavelength, OD values are surveyed, calculate Prostaglandin in serum.
2.6 pathological examination
1. stomach sample is taken out, dehydration of alcohol, dimethylbenzene is by transparency of organization.
2. paraffin embedding, the paraffin section of thickness 5um is made in every part of wax stone.
3. row HE dyeing, dewaxing are washed wax, rinsed, dye, dehydration, dimethylbenzene is transparent, neutral gum mounting.
4. light microscopic observation gastric mucosa tissue Pathologic changes
5. computerized image is photographed
2.7 statistical method:Data processing is carried out using SPSS17.0 statistical analysis softwares.Measurement data meets normal state point Cloth uses t check analyses, does not meet the rank sum test that uses of normal distribution, and enumeration data uses variance analysis (F inspections).P< 0.05 indicates that difference is statistically significant.
3. result
The influence of 3.1 each group gastric mucosa pathology forms
3.1.1 short term effect compares
Normal group:Gastric mucosa morphosis is complete, body of gland queueing discipline, has no that body of gland deformation and necrosis etc. are sick Reason changes, without apparent cell infiltration.
Model control group:It is damaged, falls off with normal group comparison model group gastric mucosa epithelial cell, in the mucous membrane of part Disconnected, gland structure is disorderly, during which has a large amount of erythrocyte aggregations, submucosa Severe edema, the congestion of blood vessel that it is deep to form multiple sizes Shallow not equal rotten to the corn face, and have more inflammatory cell infiltration, mucosal thickness is obviously thinning compared with blank group, the visible gland of part sample Wall regeneration, nucleus missing occur for pipe.
Invention drug granule group:Gastric mucosa variation is light compared with model group lesion, and epithelial structure is gradually restored, and mucous membrane fills Watery blood is swollen to be mitigated, and blutpunkte is less, but treats 1 day difference unobvious with Teprenone.
3.1.2 late result compares
Model control group:With first day variation unobvious.
Invention drug granule group:Gastric mucosa is shown in that epithelial structure has gradually restored normal, and myxedema is substantially reduced, gland Pipe marshalling, gland cell form is normal, a small amount of inflammatory cell infiltration.Teprenone group:Restore compared with invention drug granule group Difference.
3.2.1 Short-term
2 each group gastric mucosal damage index of table compares
Invention drug granule group and Teprenone group mucosal lesion degree are reduced compared with model group, statistically significant (P<0.05), but two comparison among groups are not statistically significant, illustrate that the two short term effect indifference is anisotropic.
The comparison of 3 each group gastric mucosa damage index (UI) of table score
Note:The * * P compared with model control group<0.01, the △ P compared with Teprenone group<0.05
Table 3 is shown:Invention drug granule group and Teprenone group mucosal lesion degree are substantially reduced compared with model group, are had Statistical significance (P<0.01), invention medicinal granule group declines apparent, statistically significant (P compared with Teprenone group<0.05), Illustrate that invention drug granule late result is notable compared with Teprenone.
The comparison of 3.3 each group rat blood serum PGE2, EGF, SS contents
3.3.1 Short-term
Comparison (the ng/L of 4 recent each group rat blood serum PGE2, EGF, SS content of table)
Note:The * P compared with model control group<0.01,**P<0.01;The △ P compared with Teprenone group<0.05,△△P< 0.01。
Table 4 is shown:Model group serum PG E2, EGF, SS, which are more normally organized, is substantially reduced (P<0.01), invention drug granule (P is significantly increased after treatment<0.05, P<0.01);Wherein to the elevated-levels of the content of serum SS, invention drug granule group is better than Teprenone group, the two, which compares, significant difference (P<0.05).
3.3.2 late result observation
Comparison (the ng/L of each group rat blood serum PGE2, EGF, SS content at a specified future date of table 5)
Note:The * P compared with model group<0.05, * * P<0.01;The △ P compared with Teprenone group<0.05, △ △ P<0.01.
Table 5 is shown:Model group serum PG E2, EGF, SS, which are more normally organized, is substantially reduced (P<0.05, P<0.01), invention medicine (P is significantly increased after the treatment of composition granule group<0.01);Wherein to the elevated-levels of Serum EGF concentration, SS contents, invention drug granule group Better than Teprenone group, the two, which compares, significant difference (P<0.01).But to the elevated-levels of serum PG E2 contents, replace Puri Ketone group is better than invention drug granule group, and the two, which compares, significant difference (P<0.05).
The comparison of 3.4 each group rat tissue PGE2, EGF, SS contents
3.4.1 Short-term
Comparison (the ng/L of 6 recent each group rat tissue PGE2, EGF, SS content of table)
Note:The * P compared with model group<0.05, * * P<0.01;The △ P compared with Teprenone group<0.05, △ △ P<0.01.
Table 6 is shown:Model group tissue PGE2, EGF, SS, which are more normally organized, is substantially reduced (P<0.05, P<0.01), invention medicine (P is significantly increased after composition granule treatment<0.05, P<0.01);Wherein to the elevated-levels for organizing SS contents, invention drug granule group Better than Teprenone group, the two, which compares, significant difference (P<0.05).To organizing the elevated-levels of PGE2 contents, Teprenone Better than invention drug granule group, the two, which compares, significant difference (P<0.05).
3.4.2 late result observation
Comparison (the ng/L of each group at a specified future date of table 7 rat tissue PGE2, EGF, SS content)
Note:The * P compared with model group<0.05, * * P<0.01;The △ P compared with Teprenone group<0.05, △ △ P<0.01.
Table 7 is shown:Model group serum PG E2, EGF, SS, which are more normally organized, is substantially reduced (P<0.01), invention drug granule (P is significantly increased after treatment<0.05, P<0.01);Wherein to the elevated-levels of Serum EGF concentration, SS contents, invention drug granule group is excellent In Teprenone group, the two, which compares, significant difference (P<0.05, P<0.01).But to the elevated-levels of serum PG E2 contents, Teprenone group is better than invention drug granule group, and the two, which compares, significant difference (P<0.01).
4 conclusions:
This experiment is shown:Invention drug granule can significantly improve mucosal lesion gastric mucosa morphological changes of various tissue components, Mitigate mucosal lesion, has the function of protecting stomach lining, and be positively correlated with administration time, the explanation compared with model control group It is quick to mucosal lesion therapeutic effect, efficient, and compared with Teprenone, late result is more excellent.The mechanism of action may with add Fast stomach lining itself is repaired, and promotes synthesis of the gastric mucosal protections factor such as PGE2, EGF, SS etc. related.
Embodiment 5:To the inhibiting effect and its mechanism experimental study of CAG rat model Mucosal atrophies.
1. experiment material
1.1 experimental animal
Adult healthy cleaning grade SD rats 60, half male and half female, weight (200 ± 20) g are purchased from the western Poole-Bi Kai in Shanghai Experimental animal Co., Ltd, production licence SCXK (Shanghai) 2012-0002.It raises in Jiangsu branch of Chinese department of traditional Chinese medicine institute (river Revive Provincial Medicine Research Institute) SPF grade animal experimental centers, posture sub-cage rearing under air-conditioning, per 5, cage, total 12 cages, environment temperature It spends (23 ± 3) DEG C, humidity (55 ± 5) %, the raising of standard particle feed.
1.2. experimental drug
It is prepared according to the preparation method of granule in above-described embodiment 2, obtains granule.Drug is limited by Jiangsu Tian Jiang medicine companies Company produces, and according to the equivalent metering scaling method of people mouse, faces the liquid that the used time is configured to required concentration with distilled water.Teprenone glue Capsule, defends the manufacture of material (China) pharmaceutcal corporation, Ltd, authentication code by 50mg/:Chinese medicines quasi-word H20093656.Couteat of Folic Acid, 5mg/ Piece, Tianjin Lisheng Pharmaceutical Co., Ltd.'s manufacture, authentication code:Chinese medicines quasi-word H12020215.
1.3. experiment reagent
1.4. instrument and consumptive material
2. experimental method
2.1. group technology
Using random packet method, 60 SD rats are randomly divided into normal group 10, model group 10, invention drug Grain low dose group 10, middle dose group 10, high dose group 10 only reach positive controls 10.Each group rat body weight is shown in Table 8, adopts It is obtained with one-way analysis of variance method with SPSS17.0, P > 0.05, difference is not statistically significant between each group rat body weight, tool There is comparativity.
Weight (g) comparison in difference between 8 each group rat of table
2.2. modeling method
It is improved according to document modeling method, using comprehensive molding method.The specific method is as follows:Animal posture sub-cage rearing is in sky In transferring house, room temperature (23 ± 3) DEG C, humidity (55 ± 5) % dilutes the MNNG storing solutions of the 1g/L prepared in advance with deionized water For the solution of 170ug/ml, it is packed into the drinking bottle for being wrapped with masking foil respectively to model group, low dose group, middle dose group, high agent Amount group and positive controls rat are freely drunk, and replace 1 time within 24 hours, other drinking-water are no longer given during modeling.Irregular diet: Model group, positive controls, low dose group, middle dose group, high dose group rat give the ranitidine particle that 2d contains 0.03% Forage feed ensures enough, 1d fasting, 10 weeks modeling time.Normal rats give normal diet.
2.3. interference method
According between the refined cloud people of Xu and animal by the equivalent dose scaling method of body surface area conversion, rat equivalent dose coefficient with 6.32 conversions, each group rat drug concentration and dosage are as shown in table 9.
9 each group rat dosage list of table
Since modeling, model group is with 0.9%Nacl injection 2mL gavages, low dose group, middle dose group, high dose group Respectively with 1.16g/mL, 2.32g/mL, 4.64g/mL concentration invention medicinal granule liquid 2mL gavages, positive controls are to replace Puri ketone and the total 2mL gavages of Couteat of Folic Acid liquid 1.58mg/mL and 0.32mg/mL concentration are intervened 10 weeks once a day.
2.4. sample is prepared and is acquired
2.4.1 serum specimen:Each group rat is administered and is raised 10 weeks, after fasting for 24 hours, with 10% chloraldurate according to For 3ml/kg by after rat anesthesia, exposure abdominal cavity takes abdominal aorta blood 3ml, is packed into the markd rush of note and coagulates in pipe, centrifuging and taking supernatant Liquid is respectively charged into the markd EP pipes of note, -80 DEG C freeze it is spare.
2.4.2 gastric tissue sample:After rat is put to death, the full stomach of exposure, from section, takes at cardia and pylorus 1.0cm Go out full stomach, opens, flatten along big curved lateral incision, observe stomach lining general form situation, and photograph to record;Clip antrum portion about 0.5 × 1 piece of 1cm sizes tissue is fixed with 4% paraformaldehyde liquid, and pathology to be done detect sample.- 80 DEG C of remaining gastric tissue freezes standby With.
2.4.3 spleen and thymus gland sample:Each group Rats Spleen and thymic tissue are taken, after 0.9% normal saline flushing, Filter paper blots, and weighs tissue weight and records.
2.5. observation index and detection method
2.5.1 ordinary circumstance:Situations such as observing each group rat hair color, mobility, stool form.
2.5.2 changes of weight:1 each group rat is weighed weekly and drinks changes of weight, observes variation tendency.
2.5.3 pathology method:
1. gastric tissue sample takes out, after 4% paraformaldehyde liquid is fixed, serial dehydration, alcohol are carried out with various concentration alcohol Concentration and dewatering time are followed successively by 70% alcohol 30min, 80% alcohol 30min, 85% alcohol 30min, 90% alcohol 30min, 95% alcohol 30min, 100% alcohol 60min, transparent 2 times of dimethylbenzene, each 30min, after the completion of transparent after the completion of serial dehydration It carries out paraffin to impregnate 3 times, each 60min, rear tissue carries out routine paraffin wax embedding, is sliced (thickness 5um), and carries out booth piece and copy Manufactured paraffin section is put into 37 DEG C of incubator 12h by piece.
2. by slice with dimethylbenzene dewax 15min, with gradient concentration alcohol (100%, 95%, 90%, 80%, 75%, 70%, 60%, 50%, 30%) removal xylene each 3min of processing is carried out, rinse 3min in water.
3. haematoxylin dye liquor dyes 5min, rinsed in water.Hydrochloride alcohol breaks up 10s, and tap water rinses 5min.
4. gradient concentration alcohol (30%, 50%, 60%, 70%, 75%, 80%, 90%) is dehydrated 3min.Set Yihong liquid dye Color 12s.
5. 90% and 100% each 2min of concentration dehydration of alcohol, the transparent 10min of dimethylbenzene.It dries, resinene mounting.Light The Pathologic changes of microscopic observation gastric mucosa tissue.
2.5.4 pathology atrophy criterion:
Pathological diagnosis is carried out according to disease for digest branch of Chinese Medical Association 2012 " the pathological diagnosis standard of chronic gastritis ":It withers Contracting degree reduces each 1/3 to calculate with the intrinsic body of gland of stomach lining.Slightly:Intrinsic body of gland number reduces 1/3 no more than original body of gland; Moderate:Intrinsic body of gland number is reduced between the 1/3-2/3 of original body of gland;Severe:Intrinsic body of gland number reduces by more than 2/3, only residual A small number of bodies of gland are stayed, are even disappeared completely.
3. experimental result
3.1. rat ordinary circumstance
3.1.1 rat general form is observed:Normal rats experiment starts rear hair color brilliant white, and build is fat, and activity is quick. Hair color is dark and gloomy, sparse the 2nd week from modeling for model group rats, easy to fall off, and elapsing this group of rat with the modeling time, gradually happiness is poly- Collection, activity is reduced, and dilute soft or even dilute half congealed phenomenon of defecating occurs, and also relatively normal group is reduced for food-intake and amount of drinking water.Remaining each group In hair color, form, mobility etc. difference unobvious.
3.1.2 Rat mucosal morphologic observation:Normal group mucous membrane is visually observed in Chinese red, it is seen that Hypertrophic gastric folds;Model group Rat mucosal whitens, and pleat more normally organizes reduction and relatively thin, and residue is more in stomach, positive controls Rat mucosal color and luster and wrinkle Folds in a garment improves compared with model group, and invention drug granule low dosage, middle dosage and high dose group stomach lining pleat increase successively, mucous membrane color Pool is close.
3.2. the death rate compares during rat administration
Model group, each dead 1 at the 1st week, has no apparent after dissection with high dose group in addition to right lung apex pulmonis is shown in congestion and edema Damage, however not excluded that lethal died because the factors such as gavage skill lead to rat aspiration pneumonia.Positive control rats are because filling within 2nd week Stomach is improper to die instantly 1.5th week and the 6th week low dose group and each dead 1 of positive controls rat, reason is unknown, does not arrange Except dead caused by pneumonia or diet reduction etc..7th week and each dead 1 of the 8th week model group rats, dissection Hou Jian lungs 0.8 The big tags of × 1.0cm and 1.0 × 1.5cm, stomach and enteron aisle do not find obviously swollen object, do not make pathology, suspect that tumour causes Death, be also not excluded for other causes of death.The death rate is more as shown in table 10 during each group rat is administered.
The death rate compares during 10 each group rat of table is administered
3.3. changes of weight between rat administration phase
Each group after each group rat body weight comparison among groups no significant difference (P > 0.05) before modeling and administration, modeling and administration Rat body weight is in rising trend, and downward trend was presented the 1st week and the 2nd week weight in model group, it may be possible to modeling drug to its into The reason of food influences starts weight on the 3rd week and starts to be slowly increased.Model group has differences (P compared with each group rat body weight changes < 0.05), show that modeling drug has influence for the absorption of rats eating or food.Each administration group and control rats There was no significant difference for changes of weight (P > 0.05), the results are shown in Table 11.
Weight situation of change between 11 each group rat administration phase of table (Unit:g)
Note:*(P < 0.05) is had differences compared with each group rat body weight changes,Change phase with each administration group rat body weight Than indifference (P > 0.05).
3.4. to the influence of Rats Spleen, thymus index
Each group index and spleen index is below model group, and each group thymus index is above model group, and invention medicinal granule is not With dosage group and positive controls for the no significant difference of the change of organ index (P > 0.05), but from the variation of numerical value From the point of view of, invention medicinal granule various dose group seems to show that advantage is inclined to, as shown in table 12.
12 medicinal granule various dose group of the present invention of table to Rats Spleen, thymus index influence (Unit:g)
Note:* the P < 0.05 compared with model group, Western medicine group, low dose group, # P < 0.05 compared with high dose group.
3.5. to the influence of rat pathomorphism
Normal rats gastric epithelial is complete, body of gland dense arrangement, and size shape is more consistent to have no body of gland deformation and bad It waits indefinitely pathological change.Model group stomach lining is obviously thinning, and body of gland significantly reduces, with diffusing or stove inflammatory cell infiltration and fibre (flesh) hyperblastosis is tieed up, middle hyperphlogosis is shown as.Control group mucosal inflammation mitigates than model group, based on light moderate.It is low Dosage group stomach lining tapetum cell number is more than model group, and the variation of stomach lining structure disturbance degree is light compared with model group.Middle dose group stomach Mucosa structure is more visible, and epithelial cell arrangement is more regular than low dose group, and mucous layer has a small amount of cell infiltration.High dose group stomach is glutinous Film epithelial cell arranged regular, similar to Normal group, fibroblast is considerably less than model group.
3.6. to the influence of rat blood serum RegI
Influence of 13 medicinal granule of the present invention of table to CAG rat model serum RegI
Note:* the P < 0.01 compared with other each groups, # the P > 0.05 compared with Western medicine group and middle dose group, △ and high dose ratio P > 0.05
3.7. to the influence of rat blood serum PCNA:
Influence of the 14 invention medicinal granule of table to CAG rat model blood-serum Ps CNA
Note:* the P < 0.05 compared with normal group;# and control group ratio P > 0.05, the P < 0.05 compared with other administration groups;△ With low dose group ratio P > 0.05, with middle dosage and high dose ratio P < 0.05;☆ P < 0.05 compared with middle dosage and high dose, ★ and middle dosage ratio P > 0.05.
4. conclusion
This result of study shows that normal group is more equal with model group, control group, low dose group Thymus and Spleen index There were significant differences;The difference compared with model group is apparent to the change of index and spleen index for high dose group, and thymus index between each administration group Variation it is then not statistically significant, but certain alternation trend is then shown in numerical value change.The above results show with MNNG Based on joint factor to rat in immune function have certain influence, this, which may be it, leads to gastric mucosa One of the reason of atrophy.Thymus and Spleen index is changed significantly between administration group and normal group, it was demonstrated that drug therapy can change Dysimmunity caused by joint factor based on kind MNNG, although control group and medicinal granule group difference of the present invention are unknown It is aobvious, but also can be shown that medicinal granule of the present invention improves compared with control group Thymus and Spleen index from numerical value change Excellent effect trend, but still need to further study confirmation to its Immune Indexes or mechanism.
This research also found that model group rats stomach lining whitens, and pleat attenuates or reduces, and pathology shows that mucous membrane obviously becomes Thin, body of gland significantly reduces, and with inflammatory cell infiltration and proliferation of fibrous tissue.And medicinal granule group mucous membrane color and luster of the present invention Then close to the Chinese red normally organized, and pleat quantity and thickness have improvement, the variation of stomach lining structure disturbance degree compared with model group Light compared with model group, parietal cell quantity increases, and inflammatory cell quantity is reduced, and is consistent with clinical study results, it is therefore believed that this Invention medicinal granule is inhibited for CAG gastric mucosa atrophys.
By this research, it has been found that RegI has high expression in CAG rat models, illustrates that it participates in stomach lining inflammation Reaction and injury repair, RegI and its m-RNA expression quantity is on a declining curve after administration, and Chinese medicine group general trend is better than control Group, and certain dose dependent is showed, show that medicinal granule of the present invention there is preferable repair to make mucosal lesion With, this result of study is consistent with document report, by be it in CAG research experimental basis is provided, and thus illustrate that RegI can Can be the potential target spots of Chinese traditional treatment CAG.In addition model group blood-serum P CNA contents obviously increase, medicinal granule of the present invention for The reduction effect of PCNA contents is better than Western medicine group, and shows certain dose dependent, it is seen that medicinal granule tool of the present invention Play the role of reducing rat blood serum PCNA concentration.Illustrate that medicinal granule of the present invention is thin on mechanism the effect for the treatment of CAG and influence Born of the same parents' Proliferation, Differentiation has certain relationship, can adjust stomach lining Proliferation, Differentiation and tend to be normal, to slow down or reverse normal gastric mucosa To atrophy or the transformation of gastric cancer.
It summarizes above-mentioned experimental studies results and shows that the present invention can effectively improve CAG rat models ordinary circumstance, internal organs refer to Number, can improve Mucosal atrophy pathological state and inhibit atrophy process, and can regulate and control CAG rat blood serums and tissue in RegI and The effect of unconventionality expression of PCNA, thinks, medicinal granule of the present invention plays CAG mechanism may with adjust RegI and PCNA expression is related.
Embodiment 6:Clinical observation on the therapeutic effect and model case
Sample preparation:Clinical test sample is prepared by above-described embodiment 2.
101 patients are included in this research altogether, and Chinese medicine group is 62, wherein man 31, female 31, western medicine group It it is 39, wherein man 21, female 18, two groups of indifferences in sex ratio (P ﹥ 0.05).The average age for the treatment of group is 51.98 ± 8.16 years old, the average age of control group was 52.44 ± 7.37 years old, two groups of indifferences in age distribution (P ﹥ 0.05).
Diagnostic criteria:
Atrophic gastritis Gastroscope Diagnosis standard:The visible stria vascularis in the slight inflatable dilatation of stomach, mucous membrane wrinkle wall disappear or It is flat, it is seen that intestines stove, is in light gray stigma, and nearly sem observation is in villus sample.According to stria vascularis visibility be divided into it is light, in, severe. (1996《Gastritis is newly classified Sydney system》Atrophic gastritis diagnostic criteria)
Gastroscope grade scale:Endoscopic characteristics:Mucosal atrophy:Mucous membrane is in granular form, pleat flattens, blood vessel is seen through, can have ash Color intestinal metaplasia tubercle.(scope branch of Chinese Medical Association in 2004《The endoscopic classification grade scale of chronic gastritis and treatment examination Row opinion》)
Slightly:Fine grained, vasculature part are seen through.Single-shot grey intestinal metaplasia tubercle.
Moderate:Medium grain, blood vessel continuous uniform are seen through.Multiple grey intestinal metaplasia tubercle.
Severe:Big particle, pleat disappear, and blood vessel reaches surface layer.Diffuse grey intestinal metaplasia tubercle.
Pathological diagnosis standard:Chinese Medical Association's disease for digest credit meeting Second China National chronic gastritis consensus conference, " chronic stomach Scorching pathological diagnosis standard "《China's digestion magazine》The 1-2 phases in 2007 deliver.
1. atrophy refers to proper gastric glands reduction, it is divided into two types:
A metaplasia atrophys:Proper gastric glands are substituted by intestines or by false pylorus metaplasia body of gland;
The non-metaplasia atrophys of B:Proper gastric glands are substituted by fiber or fibromuscular tissues or inflammatory cell infiltration causes inherently Gland quantity is reduced.
2. atrophy degree:Each 1/3 is reduced with proper gastric glands to calculate.
Slightly:Intrinsic body of gland number reduces 1/3 no more than original body of gland;
Moderate:Intrinsic body of gland number is reduced between the 1/3~2/3 of original body of gland;
Severe:Intrinsic body of gland number reduces by more than 2/3, only remains a small number of bodies of gland, even disappears completely.
Note:● atrophy cannot be calculated by being confined to the intestinesization in foveolae gastricae region.
● mucous layer lymph follicle occurs not counting atrophy, should observe the body of gland situation of its peripheral region to determine.All are former Because cause the pathologic process of mucosa injury all can caused by body of gland quantity reduce, be such as derived from the biopsy of ulcer edge, be exactly not necessarily Atrophic gastritis.
Instructions of taking:
Treatment group:Invention drug granule, 1 bag/day, point 2 clothes, the course for the treatment of 3 months." Wei Mei Su Pian " simulation system is taken simultaneously Agent, instructions of taking and the same control group of the course for the treatment of.
Control group:Western medicine Wei Mei Su Pian, piece × 5 piece × 3 times/day 0.2g/ take orally." invention drug " is taken simultaneously exempts from pan-fried Grain simulation preparation, instructions of taking and the same treatment group of the course for the treatment of.
Curative effect determinate standard:1. effective:Clinical cardinal symptom, sign disappear, and total mark reduces >=70% before relatively treating, stomach Mirror checks mucous membrane chronic inflammation and improves, and histopathologic examination confirms that body of gland atrophy, intestinal metaplasia and dysplasia restore just Normal or 2 grade degree of mitigation.2. effectively:Cardinal symptom, sign are substantially reduced, and total mark reduces >=30% before relatively treating, and gastroscope is multiple Looking into 1/2 or more non-cancer lesion range shorter, histopathologic examination confirms that chronic inflammation mitigates 1 grade degree or more, body of gland atrophy, Intestinal metaplasia and dysplasia mitigate.3. invalid:The above standard or instead deterioration person is not achieved.
As a result:
Symptom integral situation during 15 each interview of table
Treatment group and the average value and standard deviation integral of control group symptom integral are in be gradually reduced trend during each interview.
The comparison of 16 treatment group of table and symptom integral improvement rate after control group treatment
Treatment group ﹥ 70% in terms of improving the semiotics change of primary symptom and minor symptom, it is shown that it is effective, and the equal ﹥ of control group 30%, ﹤ 70% is then shown effectively.Show that treatment group is substantially better than control group in terms of semiotics improvement rate.
17 two groups of symptom curative effect total effective rates of table compare
The total effective rate that treatment group improves in symptom curative effect after display treatment has a clear superiority (P ﹤ 0.05) compared with control group.
Two groups of symptom integral rank sum test P values during 18 each interview of table
Non-parametric test is carried out under the insolation level of α=0.05, P values are shown in Table 20, and as a result primary symptom is integrated from the 4th interview Since the 5th, the difference for the treatment of group and control group has statistical significance (P < 0.05) for beginning, minor symptom integral.After drug withdrawal (the 7th interview) control group primary symptom integral is in rising trend within 4 weeks, and treatment group's primary symptom integral still shows the trend of being decreased obviously.It is above-mentioned Show the primary symptom curative effect riding time for the treatment of group at the 4th week or so, the minor symptom curative effect riding time was at the 8th week or so;Meanwhile it treating The symptom curative effect advantage of group extends to after drug withdrawal 4 weeks or more.
19 pretherapy and post-treatment treatment group of table and control group gastroscope classification situation and rank sum test P values
Treatment group integrates with the pretherapy and post-treatment gastroscope of control group, and atrophy integral slip is 26.58% under treatment group's gastroscope, right It is 22.64% according to atrophy integral slip under group gastroscope, is not up to effectively improved the evaluation criterion of rate.
The pretherapy and post-treatment gastroscope results contrast of 20 two groups of table
The total effective rate that treatment group improves with mucosal atrophy under control group gastroscope is without apparent significant difference (P ﹥ 0.05).But From the point of view of totally integrating improvement rate numerical value change, also show that treatment group is inclined to the advantage that gastroscope improves.
21 pretherapy and post-treatment treatment group of table and control group pathological grading situation and rank sum test P values
Treatment group integrates with the pretherapy and post-treatment pathological grading of control group, and treatment group's pathological grading integral slip is 35.48% (﹥ 30%), control group pathological grading integrate slip be 21.31%, show treatment group in terms of improving pathology atrophy classification compared with Control group has a clear superiority.
22 two groups of pretherapy and post-treatment pathological examinations of table compare
Treatment group improves efficient and does not show difference (P before and after treatment with control group pathology atrophy classification integral> 0.05), but from the point of view of totally integrating improvement rate numerical value change, the effect for the treatment of group is to improving Mucosal atrophy advantage is also shown Tendency.
The present invention is by showing clinical 101 due to weakness of spleen and stomach CAG observation of curative effect:Treatment group's drug granule of the present invention Agent, control group give Western medicine Wei Mei Su Pian, and the course for the treatment of is 3 months, the pretherapy and post-treatment clinical symptoms of two groups of patients of observation, sign, gastroscope, pathology Variation.As a result it shows:
In terms of the improvement of clinical symptoms integral, treatment group ﹥ 70% equal to the semiotics improvement rate of primary symptom and minor symptom, display It is effective, and the equal ﹥ 30% of control group, ﹤ 70%, then it shows effectively.The total effective rate for the treatment of group's symptom curative effect is 87.10%, The total effective rate of control group symptom curative effect is 56.41%, and two groups of numerical value are statistically significant (P < 0.05) through Chi-square Test.Table Bright treatment group has a clear superiority for the improvement of clinical symptoms compared with control group.Primary symptom is integrated since the 4th interview, minor symptom integrates Since the 5th, the score value comparison in difference for the treatment of group and control group has statistical significance (P < 0.05).After drug withdrawal 4 weeks it is right In rising trend according to group primary symptom integral, treatment group's primary symptom integral still shows the trend of being decreased obviously.Show the primary symptom curative effect for the treatment of group Riding time, the minor symptom curative effect riding time was at the 8th week or so at the 4th week or so;Meanwhile the symptom curative effect advantage for the treatment of group continues 4 weeks or more after to drug withdrawal.
Under gastroscope in terms of the improvement of mucous membrane sign and pathology atrophy classification, atrophy integral slip is under treatment group's gastroscope 26.58%, atrophy integral slip is 22.64% under control group gastroscope, under treatment group's gastroscope mucosal atrophy improve it is total effectively Rate is 27.4%, and the total effective rate that mucosal atrophy improves under control group gastroscope is 23.1%, and two groups of numerical value are shown through Chi-square Test Effect, total effective rate are P ﹥ 0.05, without apparent significant difference.Treatment group's pathological grading integral slip is 35.48% (﹥ 30%), control group pathological grading integral slip is 21.31%, and the total effective rate that treatment group's pathology atrophy classification improves is 20.97%, the total effective rate that control group pathology atrophy classification improves is 12.82%.Although under the insolation level of α=0.05 into Row non-parametric test, the improvement degree of mucous membrane sign and pathology atrophy classification is not shown bright compared with control group under the gastroscope for the treatment of group Different (the P of significant difference>0.05), but from the point of view of totally integrating improvement rate numerical value change, also show treatment group to improving Mucosal atrophy The advantage of curative effect is inclined to.
It is to sum up told, invention medicinal granule, which has due to weakness of spleen and stomach CAG, is relieved clinical symptoms and to a certain degree The upper clinical efficacy for improving Mucosal atrophy.
Model case is as follows:
1. Chen, female, 57 years old, people from Nanjing.
Main suit:Gastral cavilty portion secret anguish is more than 2 years uncomfortable.
Medical history:Patient over 2 years gastral cavilty portion secret anguish it is apparent, recurrent exerbation, when have turgor, but can endure, happiness is warm by happiness, occasionally has Appetite stimulator, loose watery stool.Once gastroscope was looked into show:Chronic atrophy gastritis;Pathology shows:Severe chronic atrophic in " antrum lesser curvature side " Gastritis is with intestinal metaplasia.
Quarter examines:Gastral cavilty portion secret anguish, happiness is warm by happiness, no dry mouth with bitter taste, no belch pantothenic acid, no nausea and vomiting, appetite stimulator, just Half congealed, pink tongue, tongue is thin white, and arteries and veins is thin.
The differentiation of disease:Chronic atrophy gastritis.
It is dialectical:Deficiency-cold in spleen and stomach.
The rules for the treatment of:Strengthening the spleen and replenishing qi.
Prescriptions:Take the granule of the present invention prepared by above-described embodiment 2.
Further consultation (after 1 week):Gastral cavilty portion secret anguish is not shown, pink tongue, and tongue is thin white, and arteries and veins is thin.
Drug of the present invention is taken after 3 months, gastral cavilty portion secret anguish is not shown, and diet is normal, and two just adjust.Check gastroscope shows:It is chronic shallow Table gastritis;Pathology shows:" antrum lesser curvature side " moderate chronic superficial gastritis is with intestines.Through paying a return visit no relapse.
2. Hu, man, 37 years old, people from Wuhu,
Main suit:Gastral cavilty portion turgor recurrent exerbation more than 1 year.
Medical history:Patient's gastral cavilty turgor recurrent exerbation one year over, is still endured, when have appetite stimulator, loose watery stool.Zeng Cha Gastroscope shows:Chronic erosive gastritis;Pathology shows:" antrum lesser curvature side " moderate chronic atrophic gastritis.
Quarter examines:Gastral cavilty turgor is apparent, loss of appetite, no nausea and vomiting, no sour regurgitation, bitter taste, and night sleeps difference, and two just adjust, pale tongue Red, tongue is thin white, and arteries and veins is thin and delicate.
The differentiation of disease:Atrophic gastritis.
It is dialectical:It is weakness of the spleen and the stomach, failing of the spleen to transport, disorder in ascending and descending.
The rules for the treatment of:Invigorating the spleen tonifying Qi.
Prescriptions:Take the granule of the present invention prepared by above-described embodiment 2.
Further consultation (after 2 weeks):It obviously takes effect, gastral cavilty portion turgor mitigates, and appetite increases, pink tongue, and tongue is thin white, and arteries and veins is thin.Clothes are originally Invention drug is checked gastroscope and is shown after 3 months:Chronic superficial gastritis;Pathology shows:" antrum lesser curvature side " moderate chronic shallow stomach It is scorching.Return visit is not recurred so far.
3. Yu so-and-so, man, 58 years old, people from Nanjing.
Main suit:Epigastric discomfort 1 year.
Medical history:Gastral cavilty portion is uncomfortable over one year by patient, based on secret anguish, when there is shouting pain, recurrent exerbation not to understand persistently, with mouth Dry bitter taste, belch sour regurgitation occasionally have indigestion and loss of appetite loose stool.Gastroscope is looked into show:Chronic atrophy gastritis;Pathology shows:It is slow that " antrum lesser curvature side " is slight Property atrophic gastritis accompanied intestines.
Quarter examines:The shouting pain of gastral cavilty portion, does not understand persistently, sore spot tenderness, dimly red tongue, while have petechia, thready and hesitant pulse.
The differentiation of disease:Chronic atrophy gastritis.
It is dialectical:The dysfunction of the spleen in transport, qi depression to blood stasis.
The rules for the treatment of:Invigorating spleen and reinforcing stomach, promoting qi circulation and relieving pain.
Prescriptions:Take the granule of the present invention prepared by above-described embodiment 2.
Further consultation (after 1 week):Gastral cavilty portion slightly has secret anguish, and without apparent shouting pain, dark tongue quality, tongue is thin white, and arteries and veins is thin.
Clothes drug of the present invention is checked gastroscope and is shown after 3 months:Chronic superficial-atrophic gastritis;Pathology shows:" antrum lesser curvature side " Moderate chronic superficial gastritis is with intestines.Through paying a return visit no relapse.
4. Guo so-and-so, man, 32 years old, people from Nanjing.
Main suit:Gastral cavilty portion is 2 years uncomfortable.
Medical history:The shouting pain of gastral cavilty portion often breaks out, with dry mouth with bitter taste, indigestion and loss of appetite loose stool.Gastroscope is looked into show:Chronic gastritis accompanied erosion; Pathology shows:Atrophic gastritis that " antrum lesser curvature side " is slight.
Quarter examines:The shouting pain of gastral cavilty portion is apparent, dimly red tongue, there is petechia, thready and hesitant pulse.
The differentiation of disease:Chronic erosive gastritis.
It is dialectical:It is weakness of the spleen and the stomach, qi depression to blood stasis.
The rules for the treatment of:Strengthening the spleen and replenishing qi, heat clearing and blood circulation promoting.
Prescriptions:Take the granule of the present invention prepared by above-described embodiment 2.
Further consultation (after 2 weeks):The shouting pain of gastral cavilty portion is not shown, red tongue body, and tongue is thin white, thready and hesitant pulse.
Clothes drug of the present invention is checked gastroscope and is shown after 3 months:Chronic erosive gastritis;Pathology shows:" antrum lesser curvature side " moderate Chronic superficial gastritis.Through paying a return visit no relapse.
5. the summer so-and-so, man, 47 years old, people from Nanjing,
Main suit:Upper abdomen secret anguish aggravates 5 days with receiving poor more than 7 years.
Medical history:Patient's upper abdomen secret anguish repeatedly over 7 years, when it is light when weight, like temperature happiness and press, difference of receiving is weak.Gastroscope is looked into show:It is chronic Atrophy gastritis;Pathology shows:In " antrum lesser curvature side "-severe chronic atrophic gastritis.Because tired above-mentioned symptom aggravates before 5 days.
Quarter examines:Upper abdomen secret anguish eats postemphasis, receives and eats not good enough, weak loose stool, and tongue is thin white, dimly pale tongue, small and weak pulse.It distinguishes Disease:Chronic atrophy gastritis.
It is dialectical:Weakness of the spleen and the stomach, transporting is lost strong.
The rules for the treatment of:It replenishes qi to invigorate the spleen, Wen Yang helps fortune.
Prescriptions:Take the granule of the present invention prepared by above-described embodiment 2.
Further consultation (after 2 weeks):Abdominal pain receives difference and improves, and bitter taste dry do not show, stool day row 2 times, thin white fur of tongue, dark tongue quality, arteries and veins It is thin powerless.
Drug of the present invention is taken after 3 months, above-mentioned symptom has removed, and check gastroscope shows:Atrophic gastritis;Pathology shows:" stomach In sinus lesser curvature side "-severe chronic superficial gastritis.Through paying a return visit no relapse.
6. youth so-and-so, man, 60 years old, people from Anhui Chuzhou.
Main suit:Epigastric pain recurrent exerbation 3 years.
Medical history:Gastral cavilty portion secret anguish, does not understand persistently, it is difficult to endure, when have a sensation of fullness, with dry mouth with bitter taste, occasionally there is epigastric upset, Dry and hard excrement.Gastroscope is looked into show:Moderate chronic atrophic gastritis;Pathology shows:In " antrum lesser curvature side "-severe chronic atrophic stomach It is scorching.
Quarter examines:Gastral cavilty portion secret anguish, turgor, pink tongue, tongue is thin white, veins string.
The differentiation of disease:Atrophic gastritis.
It is dialectical:It is weakness of the spleen and the stomach, functional activity of QI being not smooth.
The rules for the treatment of:Strengthening the spleen and replenishing qi and stomach promoting the circulation of qi.
Prescriptions:Take the granule of the present invention prepared by above-described embodiment 2.
Further consultation (after 2 weeks):Epigastric pain is not shown, pale tongue, and tongue is thin white, veins string.
Clothes drug of the present invention is checked gastroscope and is shown after 3 months:Moderate chronic atrophic gastritis;Pathology shows:" antrum lesser curvature side " Slight atrophic gastritis.Continue to take half a year Mucosal atrophy and reverse.
7. it is husky so-and-so, female, 52 years old, people from Nanjing,
Main suit:Epigastric discomfort 2 years.
Medical history:Patient often feels gastral cavilty portion secret anguish over 2 years, breaks out, still endures often, companion's spiritlessness and weakness, no sour regurgitation belch, Receive can, stool is adjusted, pink tongue, and arteries and veins is thin and delicate.Gastroscope is looked into show:Superficial gastritis is with rotten to the corn;Pathology shows:" sinus is small " is slight atrophic stomach Inflammation has apparent activity with slight intestines.
Quarter examines:Gastral cavilty portion secret anguish, spiritlessness and weakness, pink tongue, arteries and veins are thin and delicate.
The differentiation of disease:Atrophic gastritis.
It is dialectical:Deficiency of spleen-QI and stomach-QI.
The rules for the treatment of:Strengthening the spleen and replenishing qi, righting nourishing the stomach.
Prescriptions:Take the granule of the present invention prepared by above-described embodiment 2.
Further consultation (after 2 weeks):Above-mentioned symptom mitigates, pink tongue, and tongue is thin white, and arteries and veins is thin.
Clothes drug of the present invention is checked gastroscope and is shown after 3 months:Atrophic gastritis is with rotten to the corn;Pathology shows:" sinus is small " is slight Chronic superficial gastritis.Through paying a return visit no relapse.
8. so-and-so is applied, man, 53 years old, people from Nantong.
Main suit:Epigastric discomfort 2 years.
Medical history:Patient's two years ago is broken out often without occurring gastral cavilty portion gastral cavity turgor secret anguish under apparent inducement, and happiness is warm by happiness, indigestion and loss of appetite Deficiency of food, two is just fine, and tongue nature is light, and tongue is thin white, and arteries and veins is thin.Gastroscope is looked into show:Chronic erosive gastritis;Pathology shows:It is slow that " before sinus " is slight Property atrophic gastritis accompanied intestinal metaplasia, acute activity.
Quarter examines:Gastral cavilty portion gastral cavity turgor secret anguish, indigestion and loss of appetite deficiency of food, tongue nature is light, and tongue is thin white, and arteries and veins is thin.
The differentiation of disease:Atrophic gastritis.
It is dialectical:It is weakness of the spleen and the stomach, failing of the spleen to transport.
The rules for the treatment of:Invigorating spleen and reinforcing stomach, QI invigorating help fortune.
Prescriptions:Take the granule of the present invention prepared by above-described embodiment 2.
Further consultation (after 2 weeks):Gastral cavilty portion gastral cavity turgor secret anguish is not shown.
Clothes drug of the present invention is checked gastroscope and is shown after 3 months:Chronic superficial-atrophic gastritis accompanied is rotten to the corn;Pathology shows:" before sinus " Moderate chronic superficial gastritis, there is activity.Through paying a return visit no relapse.
Typical pathologic inspection:
1. Wang Xiu and pretherapy and post-treatment pathological replacement:(the moderate atrophy of stomach angle, in, severe intestinesization improve, atresia, intestines Switch to focal)
2. the pretherapy and post-treatment stomach lining pathology of Jiang Bin:(the moderate atrophy of stomach angle, the improvement of moderate intestinesization are slight)
3. king seeks auspicious pretherapy and post-treatment pathology:Moderate atresia, moderate intestines switch to special mess intestines
4. wearing the pretherapy and post-treatment gastroscopy pathology of beautiful plum:(slight atresia)
5. the new gastroscopy pathology variation before and after treatment of week appearance:(the small curved moderate atrophy of antrum)
6. the beautiful variation of gastroscopy pathology before and after treatment of week celebrating (the small moderate atrophy of sinus, moderate intestinesization disappear)
7. face deposits letter:1st inspection:Sinus body has a common boundary slight atrophy, slight intestines, low level intraepithelial neoplasia (cin) (Dou little Wei It looks into);The small moderate atrophy of 2nd inspection sinus, moderate intestines;3rd inspection:Moderate atresia becomes slight intestines
Finally it is pointed out that above example is only the representative example of the present invention.Obviously, technology of the invention Scheme is not limited to above-described embodiment, and acceptable there are many deformations.Those skilled in the art can be from disclosed by the invention All deformations that content is directly exported or associated, are considered as protection scope of the present invention.

Claims (6)

1. a kind of Chinese medicine composition for treating atrophic gastritis and intestines, which is characterized in that it is by following parts by weight Bulk pharmaceutical chemicals are prepared:8-12 parts of Radix Codonopsis, 6-14 parts of rhizoma atractylodis macrocephalae, 6-14 parts of rhizoma pinellinae praeparata, 6-14 parts of Poria cocos, 6-10 parts of dried orange peel, in vain 30-40 parts of HERBA HEDYOTIS DIFFUSAE of flower, 30-40 parts of micarex, 5-15 parts of curcuma zedoary, 5-15 parts of Radix Curcumae, preparation method includes the following steps:Take cloud Female stone smash plus water first decoct 30 minutes, add Radix Codonopsis, rhizoma atractylodis macrocephalae, rhizoma pinellinae praeparata, Poria cocos, dried orange peel, oldenlandia diffusa, curcuma zedoary, Radix Curcumae merges, and adds water to cook twice, collecting decoction, and relative density is 1.15-1.20 when being concentrated into 65 DEG C, and ethyl alcohol is added to make alcohol content Percent by volume reach 75-85%, stir, stand, filtering, when filtrate decompression is concentrated into 65 DEG C relative density be 1.20-1.30 And ethyl alcohol is recycled, concentrate is obtained, concentrate is spray-dried to obtain dry extract, capsule, tablet, particle is made in addition auxiliary material Agent.
2. the Chinese medicine composition for the treatment of atrophic gastritis and intestines as described in claim 1, which is characterized in that it is by as follows The bulk pharmaceutical chemicals of parts by weight are prepared:10 parts of Radix Codonopsis, 10 parts of rhizoma atractylodis macrocephalae, 10 parts of rhizoma pinellinae praeparata, 10 parts of Poria cocos, 8 parts of dried orange peel, white flower 30 parts of HERBA HEDYOTIS DIFFUSAE, 30 parts of micarex, 10 parts of curcuma zedoary, 10 parts of Radix Curcumae.
3. treating the Chinese medicine composition of atrophic gastritis and intestines according to claim 1, which is characterized in that auxiliary material is One or more of dextrin, lactose, starch, sucrose, glucose, microcrystalline cellulose, mannose.
4. the Chinese medicine composition for the treatment of atrophic gastritis and intestines as described in claim 1, which is characterized in that preparation method Middle decocting condition is:First time micarex, which is smashed, adds water to be that 3-5 times of medicinal material is measured, and adds Radix Codonopsis, rhizoma atractylodis macrocephalae, rhizoma pinellinae praeparata, Fu After Siberian cocklebur, dried orange peel, oldenlandia diffusa, curcuma zedoary, Radix Curcumae merge, it is that 8-12 times of medicinal material weight is measured to add water for the second time, decocts 1-2h, the Three times plus water is 6-10 times of medicinal material weight and measures, and decocts 1-2h.
5. the Chinese medicine composition for the treatment of atrophic gastritis and intestines as described in claim 1, which is characterized in that preparation method Middle spray drying condition is:Inlet air temperature is 100-120 DEG C, and leaving air temp is 80-90 DEG C, and temperature of charge is 70-90 DEG C, atomization Pressure is 0.2-0.4 megapascal, spray velocity 5-10ml/s.
6. the Chinese medicine composition for the treatment of atrophic gastritis and intestines is preparing treatment atrophic as described in claim 1 Application in gastritis and intestines chemical drug object.
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