CN105435099A - Traditional Chinese medicine for treating superficial gastritis caused by damp heat in spleen and stomach - Google Patents

Traditional Chinese medicine for treating superficial gastritis caused by damp heat in spleen and stomach Download PDF

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CN105435099A
CN105435099A CN201510925940.6A CN201510925940A CN105435099A CN 105435099 A CN105435099 A CN 105435099A CN 201510925940 A CN201510925940 A CN 201510925940A CN 105435099 A CN105435099 A CN 105435099A
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rhizoma
chinese medicine
spleen
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王平平
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Abstract

The invention provides a traditional Chinese medicine for treating superficial gastritis caused by damp heat in the spleen and the stomach. The traditional Chinese medicine is prepared from wrinkled giant hyssop, fortune eupatorium herb, fresh lotus leaves, magnolia cortex, prepared pinellia tuber, round cardamon seeds, rhizoma atractylodis, lophantherum gracile, ricepaperplant pith, poria cocos, rhizoma alismatis, polyporus, dried orange peel, rhizoma cyperi, raw bighead atractylodes rhizome, rheum officinale, coptis root, radix scutellariae, phellodendron, gentrin knotweed, corydalis tuber, red sage root, curcuma rhizome, red peony root and raw licorice root. The traditional Chinese medicine can reduce gastritis-caused anorexia and absorption dysfunction, reduce disease-caused body weight reduction, improve stomach and intestine power and improve transportation and transformation functions of spleen and stomach. A clinical research result shows that the traditional Chinese medicine effects of treating superficial gastritis caused by damp heat in the spleen and the stomach are better than those of the western medicines so that the traditional Chinese medicine advantages are fully shown.

Description

Be used for the treatment of the Chinese medicine of spleen and stomach damp-heat type superficial gastritis
Technical field
The present invention relates to technical field of Chinese medicine, particularly relate to a kind of Chinese medicine being used for the treatment of spleen and stomach damp-heat type superficial gastritis.
Background technology
The disease of chronic superficial gastritis to be gastric mucosa be chronic superficial inflammation, is digestive system commonly encountered diseases, belongs to the one in chronic gastritis.Can because being addicted to drink, drinking espresso, bile reflux, or cause because of helicobacter pylori infections etc.Patient can have indigestion symptom in various degree, as epigastric discomfort, dull pain after taking food, companion's belch, feel sick, pantothenic acid, occasionally have vomiting.
The paathogenic factor of superficial gastritis is not yet completely clear so far, and the wherein clearer and more definite cause of disease has:
1., after acute gastritis is more common in by antibacterial, virus and toxin, gastric mucosal lesions is prolonged does not heal or recurrent exerbation, develops gradually and forms superficial gastritis.The chronic infection focus at nasal cavity, oral cavity, the position such as pharyngeal, as eating for a long time of the antibacterials such as teeth groove pyorrhea, tonsillitis, sinusitis or its toxin, can repetitious stimulation gastric mucosa and cause superficial gastritis.Through finding that 90% chronic tonsillitis gastric has chronic inflammatory disease to change.
2. in smoking Nicotiana tabacum L., main harmful components are nicotine, and long-term a large amount of smoking can make sphincter of pylorus relax, Duodenal reflux, and stomach vasoconstriction, and gastric acid output increases, thus destruction gastric mucosal barrier causes chronic inflammatory processes.
3. medicine some drugs is as Salicylic Acid Formulations, 17-hydroxy-11-dehydrocorticosterone, Folium Digitalis Purpureae, indometacin, Phenylbutazone etc., can cause chronic gastric mucosa lesions.
4. irritable food edible spirits, strong tea, coffee, pungent and roughage for a long time, and the irregular diet style such as starvation or satiety all can destroy gastric mucosal protection barrier and gastritis occurs.
5. circulation and metabolic dysfunction congestive heart failure or portal hypertension time, make stomach be in blood stasis and anaerobic condition for a long time, cause gastric mucosal barrier miopragia, gastric acid secretion reduce, antibacterial amount reproduction, easily causes gastric mucosa inflammatory damage.During chronic renal failure, carbamide is discharged from gastrointestinal tract and is increased, and produces ammonium carbonate and ammonia, produce irritative lesion, cause gastric mucosa congestion edema to gastric mucosa through antibacterial or intestinal hydrolases effect, even rotten to the corn.
6. bile or Duodenal reflux find through gastroscope or confirm that bile reflux is the major reason causing superficial gastritis.Due to sphincter of pylorus functional disorder or stomach operation metaduodenum liquid or bile can reflux to gastric, and destroy gastric mucosal barrier, impel H +and cause a series of pathological reaction in pepsin reverse disperse to mucosa, cause superficial gastritis.
7. helicobacter pylori (Hp) infects 1986, and gastrointestinal disease association of the world the 8th session proposing Hp infection is one of major reason of superficial gastritis.Hp pathogenesis mainly by destroying gastric mucosal barrier, may make H +reverse disperse, finally causes the inflammation of gastric mucosa.
8. psychological factor due to psychohygiene unhealthy, be in psychentonia, worry or depressive state for a long time, can cause that systemic sympathetic is neural and parasympathetic functions is unbalance.Cause gastric mucosa vasomotoricity disorderly, cause Gastric Mucosa Blood Flow amount to reduce, destroy gastric mucosal barrier effect, form gastric mucosa chronic inflammatory reaction.
Its main clinical manifestation has following characteristics: 1. most common sympton is Upper abdominal pain, and most of chronic superficial gastritis patient has this symptom.Epigastrium pain majority is irregular, has nothing to do with diet.Pain is generally diffusivity epigastrium causalgia, dull pain, distending pain etc.Usually because eaten cold drinks and snachs, hard food, pungent or other irritable foods and exacerbation of symptoms, minority is relevant with climate change.2. chronic superficial gastritis patient has abdominal distention more.Usually because gastric retention food, emptying delay, caused by dyspepsia.3. patient has belch.Show that gastric gas increases, discharge through esophagus, make Abdeminal pain respite.4. Repeated Hemorrhage is common sympton.Cause of bleeding is that a kind of gastric mucosa acute inflammation concurrent on chronic superficial gastritis basis changes.5. inappetence, acid regurgitation, Nausea and vomiting, weak, constipation or diarrhoea etc.6. have upper abdomen tenderness when sign checks, small number of patients can be become thin and anemia.
Modern medicine is many for the therapeutic scheme of chronic superficial gastritis, but induction and conclusion is following several: 1. eliminate the cause of disease as wine for giving off smoking, reduces Sal and takes in; Correct Bad Eating Habit, avoid the irritant diet of stomach, diet should be soft easy to digest, avoids too coarse, too strong spice and overheated, supercool diet.Eat salting, sootiness, stale food less; And withdraw the non-steroidal anti-inflammatory drugs such as medicine, particularly aspirin that some stimulates gastric mucosa; Nasal cavity and pharyngeal chronic infection stove is had to should give removing.2. Drug therapy: the medicine that (1) protection gastric mucosa medicine is conventional has colloidal bismuth subcitrate (CBS), sucralfate, dioctahedral smectite, Marzulene-S, gel aluminum hydroxide, gastric Mucin and gavirin tablet etc.(2) gastrointestinal motility function medicament Abdeminal pain metoclopramide or domperidone etc. is adjusted.Have the hiccups, abdominal distention or have reflux phenomenon to be main person, available medicine for stomach dynamic, as metoclopramide, dompendone, not husky Billy.(3) if antibiotic gastroscopy finds Helicobacter pylori, should antibiotic be taken, clarithromycin, amoxicillin etc., have and remove the effect of Hp, generally can select two kinds, normal and gastric mucosa protective agent and antacid use in conjunction.(4) medicine that antacid is conventional has cimetidine, ranitidine, famotidine, sodium bicarbonate (sodium bicarbonate), magnesium hydroxide, gel aluminum hydroxide, gavirin tablet etc.(5) analgesic Upper abdominal pain is good to eat compared with severe one takes atropine, probanthine, Semen daturae tablet, to reduce gastric acid secretion and to alleviate colic symptoms.(6) also available digestant as pancreatin, yeast tablet, lactasinum, flatulence relieving tablet etc.Also can with acid suppression medicine as safe stomach U.S., ranitidine, famotidine etc. if any acid regurgitation phenomenon.Prevent bile reflux from can take hydrotalcite, cholestyramine to adsorb gallbladder juice; Have the hematemesis person of having blood in stool, cimetidine is oral.
But western medical treatment superficial gastritis, although effect is fairly obvious, is only symptomatic treatment, treatment time is longer, and side effect is large, and drug dependence is strong, and after drug withdrawal, relapse rate is high, therefore, introduce and develop the treatment of motherland's medical science for the spleen-stomach disease, being extremely necessary.
Syndrome of dampness-heat of spleen and stomach is the important content of traditional Chinese medical science taste theory, is also clinical common excess syndrome.Epidemiological investigation shows, the disease kind that syndrome of dampness-heat of spleen and stomach relates to is extensive, diverse clinical manifestations, and it is the closest with digestive system disease relation, especially account for first place with chronic gastritis, use modern science and technology, from aspects such as entire and part, Macrocosm and microcosm, function and forms, multi objective exploration is carried out to syndrome, with one of target that the essence disclosing it is syndrome research, be also that tcm syndrome objectifies, only way that standardization and modern medicine integrate with.In recent years, domestic many scholars from different perspectives, different aspects are studied syndrome of dampness-heat of spleen and stomach.
Syndrome of dampness-heat of spleen and stomach diverse clinical manifestations, sick kind is not detected in taste system disease, and other are respectively also often relate to.Yang Chunbo etc. are with reference to syndrome of dampness-heat of spleen and stomach diagnostic criteria in " new Chinese medicine guideline of clinical investigations " (second volume), each systemic disease kind 400 example of investigation spleen and stomach damp-heat type, occupy the majority (239/400 example) with between twenty and fifty (20-49 year) to find syndrome of dampness-heat of spleen and stomach, disease performance relates to 29 kinds of symptoms and 14 kinds of abnormal tongue arteries and veins, except the dirty vexed swollen or main disease such as pain and inappetence of yellowish and greasy fur, stomach, defecation is abnormal, bitter taste is sticky also occupies higher proportion; Normal person is common for body of the tongue, tongue shape: the many strings of arteries and veins, cunning, and sick position mainly at middle burnt taste, but also relates to the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels, clear key, skin and muscles and bones.In 400 examples, cure the desease in relating to and plant 43 kinds, wherein digestive disease occupies the majority is 38.9%, and the scorching disease kind that becomes accounts for 59.7%.In chronic gastropathy, syndrome of dampness-heat of spleen and stomach ratio is higher, Yang Chunbo etc. also find in 399 routine chronic gastritiss of gastroscope, damp-heat syndrome 209 example (accounting for 52.38%), wherein CSG accounts for 67.94% " show that damp-heat syndrome and inflammation relation are very close, especially inflammation Acute phase and subacute stage, in investigation, also find that damp-heat syndrome is with in close relations addicted to tobacco and wine; and the morbidity of damp-heat syndrome with 30-40 year age group on the high side, the equal course of disease is 6.05 years.Guo Senren etc. observe 586 routine chronic superficial gastritiss, and wherein damp and hot middle resistance type accounts for 24.4%, and ratio is the highest.
As can be seen here, the difference of damp-heat syndrome proportion is except outside the Pass the reason of the technical elements such as research method, object, sample size with researcher has, also relevant with residing geographical position, living standard, diet etc., syndrome of dampness-heat of spleen and stomach is clinical common pattern of syndrome, the common pattern of syndrome of chronic gastritis especially, strengthen the development of Chinese herb products to damp-heat in the spleen and stomach pattern of syndrome superficial gastritis, there is very important clinical value.Therefore Chinese prescription of the present invention, for the etiology and pathogenesis of clinical spleen and stomach damp-heat type superficial gastritis, found through compatibility of drugs screening and dose proportion research, confirmed by clinical trial and animal experiment study, Chinese prescription of the present invention has good effect and basic research support, and therefore clinical application Chinese prescription of the present invention has very wide value.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of Chinese medicine being used for the treatment of spleen and stomach damp-heat type superficial gastritis, can alleviate loss of appetite and malabsorption that gastritis causes, thus alleviate the weight loss because disease causes; Can digestive tract power be strengthened, improve transformation and transportation of the spleen and stomach; The curative effect overall merit of its treatment spleen and stomach damp-heat type chronic superficial gastritis of clinical research confirmation is better than Western medicine, fully shows advantage of the present invention.
Based on this, the invention provides a kind of Chinese medicine being used for the treatment of spleen and stomach damp-heat type superficial gastritis, its crude drug comprises Herba Pogostemonis, Herba Eupatorii, new lotus leaf, Cortex Magnoliae Officinalis, Rhizoma Pinelliae Preparatum, roud cardamon seed, Rhizoma Atractylodis, Herba Lophatheri, Medulla Tetrapanacis, Poria, Rhizoma Alismatis, Polyporus, Pericarpium Citri Reticulatae, Rhizoma Cyperi, Rhizoma Atractylodis Macrocephalae, Radix Et Rhizoma Rhei, Rhizoma Coptidis, Radix Scutellariae, Cortex Phellodendri, Rhizoma Polygoni Cuspidati, Rhizoma Corydalis, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, Radix Paeoniae Rubra and Radix Glycyrrhizae.
Wherein, the weight portion of each crude drug of described Chinese medicine is respectively Herba Pogostemonis 10 ~ 20 weight portion, Herba Eupatorii 10 ~ 15 weight portion, new lotus leaf 10 ~ 15 weight portion, Cortex Magnoliae Officinalis 10 ~ 15 weight portion, Rhizoma Pinelliae Preparatum 10 ~ 20 weight portion, roud cardamon seed 15 ~ 20 weight portion, Rhizoma Atractylodis 20 ~ 30 weight portion, Herba Lophatheri 10 ~ 15 weight portion, Medulla Tetrapanacis 10 ~ 15 weight portion, Poria 10 ~ 30 weight portion, Rhizoma Alismatis 10 ~ 20 weight portion, Polyporus 15 ~ 30 weight portion, Pericarpium Citri Reticulatae 10 ~ 20 weight portion, Rhizoma Cyperi 10 ~ 15 weight portion, Rhizoma Atractylodis Macrocephalae 10 ~ 25 weight portion, Radix Et Rhizoma Rhei 10 ~ 15 weight portion, Rhizoma Coptidis 10 ~ 30 weight portion, Radix Scutellariae 10 ~ 15 weight portion, Cortex Phellodendri 10 ~ 15 weight portion, Rhizoma Polygoni Cuspidati 10 ~ 20 weight portion, Rhizoma Corydalis 20 ~ 30 weight portion, Radix Salviae Miltiorrhizae 10 ~ 20 weight portion, Rhizoma Curcumae 10 ~ 15 weight portion, Radix Paeoniae Rubra 10 ~ 15 weight portion, Radix Glycyrrhizae 10 ~ 20 weight portion.
Wherein, the weight portion of each crude drug of described Chinese medicine is respectively Herba Pogostemonis 15 ~ 20 weight portion, Herba Eupatorii 10 ~ 15 weight portion, new lotus leaf 10 ~ 15 weight portion, Cortex Magnoliae Officinalis 10 ~ 15 weight portion, Rhizoma Pinelliae Preparatum 10 ~ 15 weight portion, roud cardamon seed 15 ~ 20 weight portion, Rhizoma Atractylodis 20 ~ 25 weight portion, Herba Lophatheri 10 ~ 15 weight portion, Medulla Tetrapanacis 10 ~ 15 weight portion, Poria 20 ~ 25 weight portion, Rhizoma Alismatis 15 ~ 20 weight portion, Polyporus 15 ~ 20 weight portion, Pericarpium Citri Reticulatae 10 ~ 15 weight portion, Rhizoma Cyperi 10 ~ 15 weight portion, Rhizoma Atractylodis Macrocephalae 15 ~ 20 weight portion, Radix Et Rhizoma Rhei 10 ~ 15 weight portion, Rhizoma Coptidis 20 ~ 25 weight portion, Radix Scutellariae 10 ~ 15 weight portion, Cortex Phellodendri 10 ~ 15 weight portion, Rhizoma Polygoni Cuspidati 15 ~ 20 weight portion, Rhizoma Corydalis 20 ~ 25 weight portion, Radix Salviae Miltiorrhizae 15 ~ 20 weight portion, Rhizoma Curcumae 10 ~ 15 weight portion, Radix Paeoniae Rubra 10 ~ 15 weight portion, Radix Glycyrrhizae 15 ~ 20 weight portion.
Wherein, the weight portion of each crude drug of described Chinese medicine is respectively Herba Pogostemonis 15 weight portion, Herba Eupatorii 10 weight portion, new lotus leaf 10 weight portion, Cortex Magnoliae Officinalis 10 weight portion, Rhizoma Pinelliae Preparatum 15 weight portion, roud cardamon seed 15 weight portion, Rhizoma Atractylodis 25 weight portion, Herba Lophatheri 10 weight portion, Medulla Tetrapanacis 10 weight portion, Poria 20 weight portion, Rhizoma Alismatis 20 weight portion, Polyporus 20 weight portion, Pericarpium Citri Reticulatae 10 weight portion, Rhizoma Cyperi 10 weight portion, Rhizoma Atractylodis Macrocephalae 20 weight portion, Radix Et Rhizoma Rhei 10 weight portion, Rhizoma Coptidis 25 weight portion, Radix Scutellariae 15 weight portion, Cortex Phellodendri 10 weight portion, Rhizoma Polygoni Cuspidati 20 weight portion, Rhizoma Corydalis 20 weight portion, Radix Salviae Miltiorrhizae 20 weight portion, Rhizoma Curcumae 10 weight portion, Radix Paeoniae Rubra 15 weight portion, Radix Glycyrrhizae 15 weight portion.
Adopt conventional fabrication process, Chinese medicine preparation of the present invention can be made into said dosage form on any one pharmaceutics, as tablet, capsule, granule, drop pill, oral liquid, pill, syrup, dispersible tablet, effervescent tablet, is preferably prepared into capsule.
Present invention also offers the preparation method of above-mentioned Chinese medicine, it comprises:
The first step, by Herba Pogostemonis, Herba Eupatorii, new lotus leaf, Cortex Magnoliae Officinalis, Herba Lophatheri, Pericarpium Citri Reticulatae, Rhizoma Cyperi, Rhizoma Coptidis, Radix Scutellariae, Cortex Phellodendri, Rhizoma Polygoni Cuspidati and this 12 taste medical material of Radix Glycyrrhizae are cleaned respectively, be mixed in proportion, the 3-5 first adding above-mentioned medical material gross weight soak by water doubly 2 hours, filter, the 3-5 that filtering residue adds above-mentioned medical material gross weight again soak by water doubly 1.5 hours, filter, merge 2 decoction liquor, filter, and relative density is 1.05 when being concentrated into 70 DEG C, to be cooled to room temperature, add dehydrated alcohol, making medicinal liquid contain alcohol volume is 70%, stir evenly, leave standstill 24 hours, get supernatant, after reclaiming ethanol, when being concentrated into 60 DEG C, relative density is the extractum of 1.25,
Second step, get surplus stock medical material again to mix in described ratio, add relative to the determining alcohol of above-mentioned medical material gross weight 3-6 times amount be soak with ethanol 1-2 hour of 85-90%, heating extraction 2 times, each 1-1.5 hour, merge extractive liquid, 100 orders filter, be the ultrafiltration post ultrafiltration of 10000 again through the molecular weight that dams, when ultrafiltrate is evaporated to 60 DEG C, relative density is the extractum of 1.30;
3rd step, the extractum mixing first step and second step obtained, adds suitable adjuvant and carrier, is prepared into said dosage form on any one pharmaceutics.
When the dosage form of prepared Chinese medicine is capsule, 3rd step is specially, the extractum mixing that the first step and second step are obtained, add relative to the mixture described in 100 weight portions subsequently, 5 ~ 7 weight portion carboxymethyl starch sodium, 5 ~ 50 weight starch mix homogeneously, adding 150 ~ 200 weight portion determining alcohols is 80% ~ 90% alcohol granulation, dry, granulate, adds 3 ~ 5 weight portion magnesium stearate, in then incapsulating subsequently.
Useful technique effect
The Chinese medicine being used for the treatment of spleen and stomach damp-heat type superficial gastritis provided by the invention, can alleviate loss of appetite and malabsorption that gastritis causes, thus alleviate the weight loss because disease causes; Can digestive tract power be strengthened, improve transformation and transportation of the spleen and stomach; The curative effect overall merit of its treatment spleen and stomach damp-heat type chronic superficial gastritis of clinical research confirmation is better than Western medicine, fully shows advantage of the present invention.
Detailed description of the invention
The invention provides a kind of Chinese medicine being used for the treatment of spleen and stomach damp-heat type superficial gastritis, its crude drug comprises Herba Pogostemonis, Herba Eupatorii, new lotus leaf, Cortex Magnoliae Officinalis, Rhizoma Pinelliae Preparatum, roud cardamon seed, Rhizoma Atractylodis, Herba Lophatheri, Medulla Tetrapanacis, Poria, Rhizoma Alismatis, Polyporus, Pericarpium Citri Reticulatae, Rhizoma Cyperi, Rhizoma Atractylodis Macrocephalae, Radix Et Rhizoma Rhei, Rhizoma Coptidis, Radix Scutellariae, Cortex Phellodendri, Rhizoma Polygoni Cuspidati, Rhizoma Corydalis, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, Radix Paeoniae Rubra and Radix Glycyrrhizae.
Further preferably, described Chinese medicine is only prepared from by above-mentioned raw materials medicine.
Chinese prescription of the present invention is on the basis of a large amount of clinical observations and rigorous experimentation, founded after the screening of medicament composing prescription compatibility and dose proportion research, according to the rule for the treatment of and the method for the treatment of of Chinese prescription foundation of the present invention, is divided into following level:
1. two points damp and hot, its sick legibility
Syndrome of dampness-heat of spleen and stomach has wet, hot double properties concurrently, wet and heat seal, during heat place is wet, outside wet intrinsic heat, as oil enters face, to be touchingly difficult to resolve, as XUE Sheng-bai institute cloud: " heat is the gas in sky, wets as the gas on ground; hot must wetting and more vehement, wet hot and more horizontal ", " damp and hot two points, it is sick light and delay; Damp and hot two close, and it is seriously ill and fast ".Wu Ju Tong is cloud also: " empty heat clearing away is then wet does not move back, and empty damp eliminating then heat is more vehement ".Therefore, treatment syndrome of dampness-heat of spleen and stomach should two points damp and hot, damp eliminating and heat clearing away develop simultaneously, when especially heavily damp eliminating.On the one hand, moist heavy viscous, does not deadlockedly change, and makes that patient's condition is touching not to be understood; On the other hand, damp and hot friendship mixes, and then becomes to hoodwink, do not open at this moment, then heat is had no way of and being reached, and damp eliminating has the method for removing dampness by means of aromatics, dispelling the damp pathogen with bitter and warm drugs, promoting diuresis with drugs of tasteless flavour, because spleen and stomach damp-heat type superficial gastritis, damp and hotly gather in middle Jiao, be three burnt hinge parts, therefore the method for employing, its effect is not enough, wetting, it is comparatively slow to dispel, and therefore adopts Herba Pogostemonis, Herba Eupatorii, new lotus leaf removing dampness by means of aromatics; Cortex Magnoliae Officinalis, the Rhizoma Pinelliae, roud cardamon seed, Rhizoma Atractylodis dispelling the damp pathogen with bitter and warm drugs; Folium Bambusae, Medulla Tetrapanacis, Poria, Rhizoma Alismatis, Polyporus promoting diuresis with drugs of tasteless flavour, three methods are share, and damp speed is dispelled.
2. clearing away heat-fire, onset is rapid
As previously mentioned, damp and hot two points, then pathogenic heat is easily gone, therefore under the application of damp eliminating three method, then add Radix Et Rhizoma Rhei, Rhizoma Coptidis, Radix Scutellariae, Cortex Phellodendri, Rhizoma Polygoni Cuspidati, Radix Glycyrrhizae can dispelling the damp pathogen with drugs of bitter in taste and cold in nature, clearing away heat-fire, make damp and hotly not fight mutually with heat, certainly will be lonely, as front method promoting diuresis with drugs of tasteless flavour medicine, heat is gone out from urine, all medicines share, damp disappears, and pathogenic heat is moved back, and onset is rapid.
3. invigorating the spleen and stomach, adjusts it to be elevated
The main pathogenesis of syndrome of dampness-heat of spleen and stomach is dysfunction of spleen and stomach, oneself is as aforementioned YE Tian shi cloud: " the normal function of the spleen tending to ascent; stomach should fall then and ", Wu Ju Tong is cloud also: " middle Jiao is seriously ill, therefore with burnt for wanting in lifting ", and treatment must invigorating the spleen and stomach, adjust it to be elevated, with medicines such as Pericarpium Citri Reticulatae, Rhizoma Cyperi, Rhizoma Atractylodis Macrocephalae, Cortex Magnoliae Officinalis, spleen invigorating helps fortune, convalescent period elevating function.
4. promoting flow of QI and blood, shortens the course of disease
Syndrome of dampness-heat of spleen and stomach has qi depression to blood stasis concurrently more, and the tune of mechanism of qi is freely conducive to damp and hot leading off, seat of local government as precious in Liu cloud: " control the disease of damp and hot simultaneous occurrence of syndromes in both YANG and YIN channels, must first tonneau mechanism of qi ", even if the stagnation of QI is not obvious, the product of helping to regulate the flow of vital energy also can improve the curative effect of clearing away heat and eliminating dampness; Invigorating blood circulation, it is capable to contribute to gas, regulate the flow of vital energy can and blood, QI and blood is adjusted smooth, be conducive to the recovery of pathological changes, therefore adds promoting flow of QI and blood medicine as the medicine such as Rhizoma Corydalis, Pericarpium Citri Reticulatae, Rhizoma Cyperi, Cortex Magnoliae Officinalis; First symptom of superficial gastritis is exactly stomach pain, therefore adds Rhizoma Corydalis, Radix Paeoniae Rubra, all right promoting flow of QI and blood pain relieving of Radix Glycyrrhizae, sour and sweet drugs can transforme into YIN, relieving spasm to stop pain.
5. disease combines, flexible
Primary disease gastroscopic observation, with gastric mucosa congestion edema or rotten to the corn hemorrhage, secretions thickness and measure and mostly be feature, clinical adding, can improve curative effect with the product of heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, select the medicines such as Rhizoma Polygoni Cuspidati, Radix Paeoniae Rubra, Rhizoma Curcumae, Radix Salviae Miltiorrhizae, Rhizoma Polygoni Cuspidati can heat-clearing and toxic substances removing removing dampness, again can blood circulation promoting and blood stasis dispelling relieving constipation, is the product that disease of effecting a permanent cure is conventional; Rhizoma Curcumae can be dispelled tired promoting the circulation of QI to relieve pain of holding concurrently again by removing blood stasis, and stasis in outstanding kind dispelling the stagnated QI, integrates blood stasis dispelling, circulation of qi promoting, removing food stagnancy, pain relieving, have the tired person of blood, successful for chronic gastritis.
In a word, primary disease treatment is with clearing away heat and eliminating dampness, and function of spleen and stomach regulating, for wanting, under clinical syndrome differentiation instructs, is applied Chinese prescription of the present invention, can well be treated spleen and stomach damp-heat type chronic superficial gastritis.
The weight portion of each crude drug of described Chinese medicine is respectively Herba Pogostemonis 10 ~ 20 weight portion, Herba Eupatorii 10 ~ 15 weight portion, new lotus leaf 10 ~ 15 weight portion, Cortex Magnoliae Officinalis 10 ~ 15 weight portion, Rhizoma Pinelliae Preparatum 10 ~ 20 weight portion, roud cardamon seed 15 ~ 20 weight portion, Rhizoma Atractylodis 20 ~ 30 weight portion, Herba Lophatheri 10 ~ 15 weight portion, Medulla Tetrapanacis 10 ~ 15 weight portion, Poria 10 ~ 30 weight portion, Rhizoma Alismatis 10 ~ 20 weight portion, Polyporus 15 ~ 30 weight portion, Pericarpium Citri Reticulatae 10 ~ 20 weight portion, Rhizoma Cyperi 10 ~ 15 weight portion, Rhizoma Atractylodis Macrocephalae 10 ~ 25 weight portion, Radix Et Rhizoma Rhei 10 ~ 15 weight portion, Rhizoma Coptidis 10 ~ 30 weight portion, Radix Scutellariae 10 ~ 15 weight portion, Cortex Phellodendri 10 ~ 15 weight portion, Rhizoma Polygoni Cuspidati 10 ~ 20 weight portion, Rhizoma Corydalis 20 ~ 30 weight portion, Radix Salviae Miltiorrhizae 10 ~ 20 weight portion, Rhizoma Curcumae 10 ~ 15 weight portion, Radix Paeoniae Rubra 10 ~ 15 weight portion, Radix Glycyrrhizae 10 ~ 20 weight portion.
Further preferably, the weight portion of each crude drug of described Chinese medicine is respectively Herba Pogostemonis 15 ~ 20 weight portion, Herba Eupatorii 10 ~ 15 weight portion, new lotus leaf 10 ~ 15 weight portion, Cortex Magnoliae Officinalis 10 ~ 15 weight portion, Rhizoma Pinelliae Preparatum 10 ~ 15 weight portion, roud cardamon seed 15 ~ 20 weight portion, Rhizoma Atractylodis 20 ~ 25 weight portion, Herba Lophatheri 10 ~ 15 weight portion, Medulla Tetrapanacis 10 ~ 15 weight portion, Poria 20 ~ 25 weight portion, Rhizoma Alismatis 15 ~ 20 weight portion, Polyporus 15 ~ 20 weight portion, Pericarpium Citri Reticulatae 10 ~ 15 weight portion, Rhizoma Cyperi 10 ~ 15 weight portion, Rhizoma Atractylodis Macrocephalae 15 ~ 20 weight portion, Radix Et Rhizoma Rhei 10 ~ 15 weight portion, Rhizoma Coptidis 20 ~ 25 weight portion, Radix Scutellariae 10 ~ 15 weight portion, Cortex Phellodendri 10 ~ 15 weight portion, Rhizoma Polygoni Cuspidati 15 ~ 20 weight portion, Rhizoma Corydalis 20 ~ 25 weight portion, Radix Salviae Miltiorrhizae 15 ~ 20 weight portion, Rhizoma Curcumae 10 ~ 15 weight portion, Radix Paeoniae Rubra 10 ~ 15 weight portion, Radix Glycyrrhizae 15 ~ 20 weight portion.
Most preferably, the weight portion of each crude drug of described Chinese medicine is respectively Herba Pogostemonis 15 weight portion, Herba Eupatorii 10 weight portion, new lotus leaf 10 weight portion, Cortex Magnoliae Officinalis 10 weight portion, Rhizoma Pinelliae Preparatum 15 weight portion, roud cardamon seed 15 weight portion, Rhizoma Atractylodis 25 weight portion, Herba Lophatheri 10 weight portion, Medulla Tetrapanacis 10 weight portion, Poria 20 weight portion, Rhizoma Alismatis 20 weight portion, Polyporus 20 weight portion, Pericarpium Citri Reticulatae 10 weight portion, Rhizoma Cyperi 10 weight portion, Rhizoma Atractylodis Macrocephalae 20 weight portion, Radix Et Rhizoma Rhei 10 weight portion, Rhizoma Coptidis 25 weight portion, Radix Scutellariae 15 weight portion, Cortex Phellodendri 10 weight portion, Rhizoma Polygoni Cuspidati 20 weight portion, Rhizoma Corydalis 20 weight portion, Radix Salviae Miltiorrhizae 20 weight portion, Rhizoma Curcumae 10 weight portion, Radix Paeoniae Rubra 15 weight portion, Radix Glycyrrhizae 15 weight portion.
Adopt conventional fabrication process, Chinese medicine of the present invention can be made into said dosage form on any one pharmaceutics, as tablet, capsule, granule, drop pill, oral liquid, pill, syrup, dispersible tablet, effervescent tablet, is preferably prepared into capsule.
Present invention also offers the preparation method of above-mentioned Chinese medicine, it comprises:
The first step, by Herba Pogostemonis, Herba Eupatorii, new lotus leaf, Cortex Magnoliae Officinalis, Herba Lophatheri, Pericarpium Citri Reticulatae, Rhizoma Cyperi, Rhizoma Coptidis, Radix Scutellariae, Cortex Phellodendri, Rhizoma Polygoni Cuspidati and this 12 taste medical material of Radix Glycyrrhizae are cleaned respectively, be mixed in proportion, the 3-5 first adding above-mentioned medical material gross weight soak by water doubly 2 hours, filter, the 3-5 that filtering residue adds above-mentioned medical material gross weight again soak by water doubly 1.5 hours, filter, merge 2 decoction liquor, filter, and relative density is 1.05 when being concentrated into 70 DEG C, to be cooled to room temperature, add dehydrated alcohol, making medicinal liquid contain alcohol volume is 70%, stir evenly, leave standstill 24 hours, get supernatant, after reclaiming ethanol, when being concentrated into 60 DEG C, relative density is the extractum of 1.25,
Second step, get surplus stock medical material again to mix in described ratio, add relative to the determining alcohol of above-mentioned medical material gross weight 3-6 times amount be soak with ethanol 1-2 hour of 85-90%, heating extraction 2 times, each 1-1.5 hour, merge extractive liquid, 100 orders filter, be the ultrafiltration post ultrafiltration of 10000 again through the molecular weight that dams, when ultrafiltrate is evaporated to 60 DEG C, relative density is the extractum of 1.30;
3rd step, the extractum mixing first step and second step obtained, adds suitable adjuvant and carrier, is prepared into said dosage form on any one pharmaceutics.
When the dosage form of prepared Chinese medicine is capsule, 3rd step is specially, the extractum mixing that the first step and second step are obtained, add relative to the mixture described in 100 weight portions subsequently, 5 ~ 7 weight portion carboxymethyl starch sodium, 5 ~ 50 weight starch mix homogeneously, adding 150 ~ 200 weight portion determining alcohols is 80% ~ 90% alcohol granulation, dry, granulate, adds 3 ~ 5 weight portion magnesium stearate, in then incapsulating subsequently.
Each crude drug pharmacology is as follows:
Herba Pogostemonis: acrid in the mouth, slightly warm in nature, returns lung, spleen, stomach warp, has dispelling summer-heat from superficies of the body, effect of removing dampness to restore normal function of the stomach.For summertime flu, cold and heat are had a headache, and breast gastral cavity painful abdominal mass is vexed, and vomiting is had loose bowels, vomiting during pregnancy, nasal sinusitis, the card such as hands, tinea pedis.
Herba Eupatorii: acrid in the mouth, property put down, return spleen, stomach, lung meridian, there is expelling summer-heat and damp, ward off dirty and in effect, cure mainly heat-damp in summer, cold and heat have a headache, accumulate in moistening, gastral cavity painful abdominal mass is not hungry, nausea and vomiting, sweet greasy in mouth, disappear truly wait card.
New lotus leaf: latin name FoliumNelumbinis, property is put down, and bitter in the mouth, returns Liver Channel, spleen channel, stomach warp, have clearing away summer-heat, sending up the lucid YANG, effect of cooling blood for hemostasis.For: summer-heat excessive thirst, diarrhea due to summer heat and dampness, diarrhea due to hypofunction of the spleen, heat in blood tells nosebleed, metrorrhagia of having blood in stool.Burnt FOLIUM NELUMBINIS astringent therapy removing stasis to stop bleeding.For multiple hemorrhage and puerperal blood faints.
Cortex Magnoliae Officinalis: bitter in the mouth, pungent, warm in nature, returns spleen channel; Stomach warp; Large intestine channel, has circulation of qi promoting removing food stagnancy; Dampness is except full; Effect of lowering the adverse QI to relieve asthma, cures mainly stagnation of QI due to dyspepsia; Abdominal distention constipation; Retention of dampness in middle-JIAO, gastral cavity painful abdominal mass is vomited and diarrhoea; Expectorant stops up QI rising in reverse order; Fullness in the chest such as to be breathed with cough at the card.
Rhizoma Pinelliae Preparatum: acrid in the mouth, warm in nature, returns spleen, stomach, lung meridian, has effect of drying dampness to eliminate phlegm, cures mainly abundant expectoration cough, dizziness due to wind-phlegm, the cards such as syncope due to accumulation of phlegm headache.
Roud cardamon seed: latin name AIpiniatonkinensisGagnep, warm in nature, acrid in the mouth, returns lung meridian, spleen channel, stomach warp, has regulating the flow of QI to ease the stomach, dry cold-damp, alcoholic intoxication effect, cures mainly disease such as stomachache abdominal distention, eructation regurgitation etc.
Rhizoma Atractylodis: acrid in the mouth, hardship, warm in nature, enter spleen, stomach, Liver Channel, have drying damp and strengthening spleen, expelling wind and dampness, the effect of improving eyesight, be mainly used in the stomachache dysentery of retention of dampness in middle-JIAO, the abdominal distention pain of incoordination between the spleen and stomach, vomits indigestion and loss of appetite; The abdomen side of body distending pain, the vomiting with acid regurgitation of incoordination between the liver and stomach; And the card such as the anemofrigid-damp arthralgia of the outer strongly fragrant meridians of cold-damp.
Herba Lophatheri: have another name called Folium Bambusae, sweet in the mouth, light, cold in nature, enter the heart, lung, stomach warp, have the effect of clearing heat and relieving fidgetness, inducing diuresis for treating stranguria syndrome, be mainly used in the cards such as fever caused by exogenous pathogenic factors, restlessness and thirst, heart stomach-fire Sheng, aphtha of the mouth and tongue, dark coloured urine stranguria with turbid discharge.
Medulla Tetrapanacis: sweet in the mouth, light, cold nature, attaches to the lung and stomach meridians, and has clearing away heat and promoting diuresis, and effect of ventilation stimulating milk secretion, cures mainly damp-heat gonorrhoea, edema oliguria, the cards such as agalactia.
Poria: sweet in the mouth, light, property is put down, and enters spleen, lung, bladder, heart channel, has the effect of eliminating dampness and diuresis, spleen invigorating mind calming, be mainly used in the edema of retention of water-damp, dysuria; The pyretic stranguria of damp-heat accumulation, the card such as anorexia and loose stool, phlegm retention stagnation, epilepsy of stagnation of dampness due to deficiency of the spleen, Poria has significant inhibitory action to staphylococcus aureus, Bacillus proteus.
Rhizoma Alismatis: sweet in the mouth, light, cold in nature, enters kidney, urinary bladder channel, has promoting diuresis to eliminate damp pathogen, purging heat and treating stranguria, the lung that clears away heart-fire, rushes down the effect of kidney fire, is mainly used in insufficiency of the spleen retention of water-damp, the wet hydrosarca of spreading unchecked of water; The tired resistance of the heresy of diseases caused by retention of fluid phlegm-damp, what cause that clear YANG failing to ascend voiced sound do not fall is dizzy; The dysuria of damp invasion of lower energizer, red short puckery pain, and the card such as jaundice due to damp-heat.
Polyporus: sweet in the mouth, light, property is put down, and enters kidney, urinary bladder channel, has the effect of promoting diuresis to eliminate damp pathogen, be mainly used in the edema of retention of water-damp, dysuria, and the having loose bowels of stagnation of dampness due to deficiency of the spleen, vomits; The card such as leucorrhea, nebulousurine of damp invasion of lower energizer.
Pericarpium Citri Reticulatae: warm in nature, acrid in the mouth, hardship; Return spleen, lung meridian, pungent loose logical temperature, fragrant odour, is longer than and regulates the flow of vital energy, and can enter spleen lung, therefore can go loose sluggishness of lung-QI, again can promoting the circulation of QI to alleviate the stagnation in middle-JIAO, gathers around stagnant, chest and diaphragm feeling of fullness and the card such as stagnation of QI in spleen and stomach, distension and fullness in the abdomen for lung qi.
Rhizoma Cyperi: acrid in the mouth, sweet, micro-hardship, property is put down, and return liver, tri-jiao channel, have resolving depression of regulating the flow of vital energy, effect of menstruction regulating and pain relieving, cures mainly stagnation of QI due to depression of the liver, breast, the side of body, abdominal distention, dyspepsia, menoxenia, amenorrhea dysmenorrhea, and colic of cold type is suffered from abdominal pain, the cards such as distending pain of the breast.
Rhizoma Atractylodis Macrocephalae: latin name atractylodismacrocephalaerhizoma, bitter in the mouth, sweet, warm in nature, enter spleen, stomach warp, there is invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive effect, for weakness of the spleen and stomach, lack of appetite distension, fatigue and weakness, has loose bowels, water-damp retention, phlegm retention, edema, the cards such as exterior deficiency spontaneous perspiration
Radix Et Rhizoma Rhei: bitter in the mouth, cold in nature, return stomach, large intestine, liver, spleen channel, there is the effect of attacking stagnant, clearing away damp-heat, pathogenic fire purging, removing heat from blood, blood stasis dispelling, removing toxic substances, cure mainly excess-heat constipation; The accumulation of heat feeling of stuffiness in chest; Damp-heat dysentery; Jaundice; Gonorrhea; Edema abdominal distention; Dysuria; Conjunctival congestion; Laryngopharynx swelling and pain; Aphtha of the mouth and tongue; Gastropyretic vomiting; Spit blood; Spitting of blood; Epistaxis; Have blood in stool; Hematuria; Blood-retention; Amenorrhea; The stagnant stomachache of the stasis of blood in puerperal; Lump in the abdomen; Traumatic injury; Pyretic toxicity carbuncle and ulcer; Erysipelas; The cards such as scald.
Rhizoma Coptidis: bitter in the mouth, cold in nature, GUIXIN, lung, gallbladder, stomach, large intestine channel, have effect of heat clearing and damp drying, eliminating fire and detoxication, cooling blood for improving eyesight, is longer than the fire of removing pathogen in the heart warp, cures mainly the prosperous caused dysphoria and insomnia of heart-fire, and the high fever coma of epidemic febrile disease, vexed, thirsty; Also can be used for damp and hot caused dysentery, tenesmus; The cards such as pyretic toxicity carbuncle sore, eczema, aphtha of the mouth and tongue, epidemic hemorrhagic conjunctivitis.
Radix Scutellariae: bitter in the mouth, cold in nature, enter the heart, lung, stomach, gallbladder, large intestine channel, have heat clearing and damp drying, eliminating fire and detoxication, antiabortive, the effect of hemostasis, is mainly used in damp and hot caused diarrhoea, dysentery, jaundice, pyretic stranguria; Cough due to lung-heat, thirsty pharyngalgia, also can be used for excessive fetal movement due to heat in pregnancy, and pyretic toxicity pathogenic fire invades the swollen card of carbuncle sore poison of excessive skin.
Cortex Phellodendri: bitter in the mouth, cold in nature, enter kidney, bladder, large intestine channel, heat clearing and damp drying, eliminating fire and detoxication, except hectic fever due to YIN-deficiency clearind deficient heat.For damp-heat dysentery, jaundice, leukorrhagia, pyretic stranguria, beriberi, flaccidity is warded off, hectic fever due to YIN-deficiency consumptive fever, night sweat, seminal emission, sore swollen toxin, the cards such as eczema pruritus.
Rhizoma Polygoni Cuspidati: mildly bitter flavor, cold nature, returns liver, gallbladder, lung meridian, has heat-clearing and toxic substances removing, promoting the function of the gallbladder to alleviate jaundice, expelling wind and removing dampness, dissipating blood stasis analgesic therapy, effect of relieving cough and resolving phlegm, for arthralgia, jaundice due to damp-heat, amenorrhea WEIJIA, cough with copious phlegm, burn due to hot liquid or fire, injury from falling down, the cards such as carbuncle sore tumefacting virus.
Rhizoma Corydalis: bitter in the mouth, pungent, warm in nature, enter liver, the heart, stomach warp, benefaction is wandered away, can rise and can fall, have promoting blood circulation to remove blood stasis, the effect of promoting the circulation of QI to relieve pain, cures mainly obstruction of qi in the chest and cardialgia, the side of body rib, all pains of gastral cavity abdomen, headache, lumbago, colicky, bones and muscles pain, dysmenorrhea, amenorrhea, puerperal, the stasis of blood was suffered from abdominal pain, the cards such as traumatic injury.
Radix Salviae Miltiorrhizae: bitter in the mouth, cold in nature, enters the heart, Liver Channel, has the effect of blood circulation promoting and blood stasis dispelling, promoting tissue regeneration by removing blood stasis, removing heat from blood mind calming, be mainly used in the ambition of stagnation of QI and blood, the twinge of the breast side of body, sensation of oppression over the chest with shortness of breath, abdominal distention; The menoxenia of women's disharmony between QI and blood, dysmenorrhoea amenorrhea; Stagnation of QI-blood, the cards such as trusted subordinate's pain.
Rhizoma Curcumae: acrid in the mouth, hardship, warm in nature, enter liver, spleen channel, have removing blood stasis circulation of qi promoting, effect of removing food stagnancy pain relieving, for the lump in the abdomen mass in the abdomen of caused by energy stagnation and blood stasis, breast abdomen stasis of blood pain, amenorrhea, dysmenorrhea, abdominal distention, traumatic injury, blood stasis such as to swell and ache at the card.
Radix Paeoniae Rubra: bitter in the mouth, micro-hardship, returns Liver Channel, has removing fire from the liver, clearing away heat and cooling blood, effect of stasis-dispelling and pain-killing, cure mainly the conjunctival congestion and swelling pain of high liver fire, have a dizzy spell, pain in chest and hypochondrium, the fever of the body crimson tongue of the epidemic febrile disease pathogenic heat attacking blood system in febrile diseases, and macule is hemorrhage, and blood stasis amenorrhea; The haematemesis hematuria of the absurd row of burning hot flourishing forcing blood; The trip of women's heat in blood is through too much; Various pain caused by blood retardance; The cards such as the furuncle carbuncle of heat in blood poison Sheng.
Radix Glycyrrhizae: sweet in the mouth, property put down, enter 12 warps, have heat-clearing and toxic substances removing, be in harmonious proportion the property of medicine, the effect of expelling phlegm for arresting cough, and can spleen invigorating and in, relieving spasm to stop pain, is mainly used in invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.For weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, the anxious pain of gastral cavity abdomen, extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong, QI invigorating neutralization can be played by adding Radix Glycyrrhizae, being in harmonious proportion the effect of each component.
Below adopt embodiment to describe embodiments of the present invention in detail, to the present invention, how application technology means solve technical problem whereby, and the implementation procedure reaching technique effect can fully understand and implement according to this.
Embodiment 1 capsule 1
By Herba Pogostemonis 15g, Herba Eupatorii 10g, new lotus leaf 10g, Cortex Magnoliae Officinalis 10g, Herba Lophatheri 10g, Pericarpium Citri Reticulatae 10g, Rhizoma Cyperi 10g, Rhizoma Coptidis 25g, Radix Scutellariae 15g, Cortex Phellodendri 10g, this 12 taste medical material of Rhizoma Polygoni Cuspidati 20g and Radix Glycyrrhizae 15g is cleaned respectively, mixing, first add the soak by water 2 hours of 5 times of above-mentioned medical material gross weight, filter, filtering residue adds the soak by water 1.5 hours of 5 times of above-mentioned medical material gross weight again, filters, merge 2 decoction liquor, filter, and when being concentrated into 70 DEG C, relative density is 1.05, to be cooled to room temperature, add dehydrated alcohol, making medicinal liquid contain alcohol volume is 70%, stirs evenly, and leaves standstill 24 hours, get supernatant, reclaim after ethanol, when being concentrated into 60 DEG C, relative density is the extractum of 1.25, then follows the example of Rhizoma Pinelliae 15g, roud cardamon seed 15g, Rhizoma Atractylodis 25g, Medulla Tetrapanacis 10g, Poria 20g, Rhizoma Alismatis 20g, Polyporus 20g, Rhizoma Atractylodis Macrocephalae 20g, Radix Et Rhizoma Rhei 10g, Rhizoma Corydalis 20g, Radix Salviae Miltiorrhizae 20g, Rhizoma Curcumae 10g, Radix Paeoniae Rubra 15g mixes, add relative to the determining alcohol of above-mentioned medical material gross weight 6 times amount be 90% soak with ethanol 2 hours, heating extraction 2 times, each 1.5 hours, merge extractive liquid, 100 orders filter, then are the ultrafiltration post ultrafiltration of 10000 through the molecular weight that dams, and when ultrafiltrate is evaporated to 60 DEG C, relative density is the extractum of 1.30, and by the extractum mixing obtained, add adjuvant, every 100g extractum mixture adds 6g carboxymethyl starch sodium, 30g starch mix homogeneously, adding 150g determining alcohol is 90% alcohol granulation, and dry, granulate, adds 5g magnesium stearate, in then incapsulating subsequently.
Embodiment 2 capsule 2
By Herba Pogostemonis 15g, Herba Eupatorii 10g, new lotus leaf 10g, Cortex Magnoliae Officinalis 10g, Herba Lophatheri 10g, Pericarpium Citri Reticulatae 10g, Rhizoma Cyperi 10g, Rhizoma Coptidis 20g, Radix Scutellariae 10g, Cortex Phellodendri 10g, this 12 taste medical material of Rhizoma Polygoni Cuspidati 15g and Radix Glycyrrhizae 15g is cleaned respectively, mixing, first add the soak by water 2 hours of 5 times of above-mentioned medical material gross weight, filter, filtering residue adds the soak by water 1.5 hours of 5 times of above-mentioned medical material gross weight again, filters, merge 2 decoction liquor, filter, and when being concentrated into 70 DEG C, relative density is 1.05, to be cooled to room temperature, add dehydrated alcohol, making medicinal liquid contain alcohol volume is 70%, stirs evenly, and leaves standstill 24 hours, get supernatant, reclaim after ethanol, when being concentrated into 60 DEG C, relative density is the extractum of 1.25, then follows the example of Rhizoma Pinelliae 10g, roud cardamon seed 15g, Rhizoma Atractylodis 20g, Medulla Tetrapanacis 10g, Poria 20g, Rhizoma Alismatis 15g, Polyporus 15g, Rhizoma Atractylodis Macrocephalae 15g, Radix Et Rhizoma Rhei 10g, Rhizoma Corydalis 20g, Radix Salviae Miltiorrhizae 15g, Rhizoma Curcumae 10g, Radix Paeoniae Rubra 10g mixes, add relative to the determining alcohol of above-mentioned medical material gross weight 6 times amount be 90% soak with ethanol 2 hours, heating extraction 2 times, each 1.5 hours, merge extractive liquid, 100 orders filter, then are the ultrafiltration post ultrafiltration of 10000 through the molecular weight that dams, and when ultrafiltrate is evaporated to 60 DEG C, relative density is the extractum of 1.30, and by the extractum mixing obtained, add adjuvant, every 100g extractum mixture adds 6g carboxymethyl starch sodium, 30g starch mix homogeneously, adding 150g determining alcohol is 90% alcohol granulation, and dry, granulate, adds 5g magnesium stearate, in then incapsulating subsequently.
Embodiment 3 capsule 3
By Herba Pogostemonis 20g, Herba Eupatorii 15g, new lotus leaf 15g, Cortex Magnoliae Officinalis 15g, Herba Lophatheri 15g, Pericarpium Citri Reticulatae 15g, Rhizoma Cyperi 15g, Rhizoma Coptidis 25g, Radix Scutellariae 15g, Cortex Phellodendri 15g, this 12 taste medical material of Rhizoma Polygoni Cuspidati 20g and Radix Glycyrrhizae 20g is cleaned respectively, mixing, first add the soak by water 2 hours of 5 times of above-mentioned medical material gross weight, filter, filtering residue adds the soak by water 1.5 hours of 5 times of above-mentioned medical material gross weight again, filters, merge 2 decoction liquor, filter, and when being concentrated into 70 DEG C, relative density is 1.05, to be cooled to room temperature, add dehydrated alcohol, making medicinal liquid contain alcohol volume is 70%, stirs evenly, and leaves standstill 24 hours, get supernatant, reclaim after ethanol, when being concentrated into 60 DEG C, relative density is the extractum of 1.25, then follows the example of Rhizoma Pinelliae 15g, roud cardamon seed 20g, Rhizoma Atractylodis 25g, Medulla Tetrapanacis 15g, Poria 25g, Rhizoma Alismatis 20g, Polyporus 20g, Rhizoma Atractylodis Macrocephalae 20g, Radix Et Rhizoma Rhei 15g, Rhizoma Corydalis 25g, Radix Salviae Miltiorrhizae 20g, Rhizoma Curcumae 15g, Radix Paeoniae Rubra 15g mixes, add relative to the determining alcohol of above-mentioned medical material gross weight 6 times amount be 90% soak with ethanol 2 hours, heating extraction 2 times, each 1.5 hours, merge extractive liquid, 100 orders filter, then are the ultrafiltration post ultrafiltration of 10000 through the molecular weight that dams, and when ultrafiltrate is evaporated to 60 DEG C, relative density is the extractum of 1.30, and by the extractum mixing obtained, add adjuvant, every 100g extractum mixture adds 6g carboxymethyl starch sodium, 30g starch mix homogeneously, adding 150g determining alcohol is 90% alcohol granulation, and dry, granulate, adds 5g magnesium stearate, in then incapsulating subsequently.
Embodiment 4 pharmacology acute toxicity test
1 experiment material
1.1 laboratory animal
SPF level, kunming mice, 40,20 ± 2g, male and female half and half, are provided by Shandong Traditional Chinese Medicine University's animal experimental center, animal quality certification SCXK (Shandong) 2013-0140.
1.2 test medicine
1.2.1 experimental group: Chinese medicine capsules 1 prepared by the embodiment of the present invention 1, water dissolution is made into the solution of crude drug content 1.75g/ml, and 4 DEG C save backup.
1.2.2 matched group: gavage normal saline, all the other conditions are with medicine group of the present invention.
2 experimental techniques
2.1 grouping
Get SPF level, kunming mice 40, male and female half and half, raise in Shandong Traditional Chinese Medicine University's animal experimental center, adaptability is raised one week.By table of random numbers method, mice being divided into 2 groups, is matched group 20 respectively, experimental group 20, male and female half and half, sub-cage rearing.
2.2 medication
Before experiment, the fasting of each group mice can't help water 12h, matched group gavage distilled water 0.2ml/20g body weight, 3 times/day, experimental group, gavage granule of the present invention, 0.2ml/20g body weight, 3 times/day, dosing interval 4h.Successive administration 7 days, drug withdrawal observes 3 days.
2.3 observation index
2.3.1 ordinary circumstance
Observe during administration and drug withdrawal viewing duration, the ordinary circumstance of each group mice, as developmental state (body temperature, body weight, heart rate), coat condition, the mental status, each natural hole situation, autonomic activities situation.
2.3.2 internal organs inspection and Physico-chemical tests
, there is animal dead during administration in experimentally requirement, dissects immediately, observes each internal organs situation, peel off each internal organs, weigh, and calculate organ index, heart extracting blood Physico-chemical tests; As nothing is dead, then experimentally requirement, after the observation period, gives 10% chloral hydrate anesthesia, opens abdominal cavity, observes each internal organs situation, and abdominal aortic blood is put to death, and does Physico-chemical tests, peels off each internal organs, weigh, and calculate organ index.
3 results
Experimental session, without dead mouse, experimentally arranges to carry out coherent detection.
3.1 ordinary circumstance
During administration and drug withdrawal viewing duration, each group mice at the baseline signs such as body weight, body temperature, Non Apparent Abnormality, two groups are compared, no difference of science of statistics, outward appearance is normal, without deformity, fur color and luster is normal, the mental status is good, and each natural hole is clean, secretions without exception, autonomic activities is normal, behavior without exception.
3.2 internal organs inspection and Physico-chemical tests
Experimentally requirement, after the observation period, gives 10% chloral hydrate anesthesia, and abdominal aortic blood is put to death, open abdominal cavity, observe each internal organs situation, the arrangement of each group mice organs is normal, without adhesion, without hemorrhage, blood of getting does Physico-chemical tests, each group of Mouse Blood routine is without exception, and liver function, kidney merit check without exception, peel off each internal organs, weigh, calculate organ index, through statistical analysis, no difference of science of statistics, two groups of same periods compare, statistics zero difference.
4 conclusions
Pass through acute toxicity test in mice, mice dosage is 52.5g/kg/d, be converted into adult normal dosage 525g/kg/d (mice and 60kg health adult conversion coefficient are 10.0), for 131.25 times (normal 60kg adult Chinese medicine intake is 4g/kg/d) that adult normal daily measures, it is generally acknowledged, in zoopery, administration behaves more than 100 times, and without obvious toxic-side effects, can think that medicine is safe.Can be confirmed by this experiment, Chinese medicine of the present invention, in acute toxicity test, without acute toxic reaction, without delayed toxicity, substantially can think safe, therefore Clinical practice is safe.
Embodiment 5 mice long term toxicity test of the present invention
1 experiment material
1.1 laboratory animal
SPF level, kunming mice, 40,20 ± 2g, male and female half and half, are provided by Shandong Traditional Chinese Medicine University's animal experimental center, animal quality certification SCXK (Shandong) 2013-0140.
1.2 test medicine
1.2.1 experimental group: Chinese medicine capsules 1 prepared by the embodiment of the present invention 1, water dissolution is made into the solution of crude drug content 1.15g/ml, 0.85g/ml, 0.55g/ml, and 4 DEG C save backup.
1.2.2 matched group: gavage normal saline, all the other conditions are with medicine group of the present invention.
2 experimental techniques
2.1 grouping
Get SPF level, kunming mice 40, male and female half and half, raise in Shandong Traditional Chinese Medicine University's animal experimental center, adaptability is raised one week.By table of random numbers method, mice being divided into 2 groups, is matched group 10, high dose group 10, middle dosage group 10, low dose group 10 respectively, male and female half and half, sub-cage rearing.
2.2 medication
Before experiment, the fasting of each group mice can't help water 12h, matched group gavage distilled water 0.2ml/20g body weight, 2 times/day, high, medium and low dosage group, capsule 1.0g/ml, 0.75g/ml, 0.5g/ml of the gavage embodiment of the present invention 1 preparation respectively, 0.2ml/20g body weight, 2 times/day, dosing interval 6h.Successive administration 14 days, drug withdrawal observes 7 days.
2.3 observation index
2.3.1 ordinary circumstance
Observe during administration and drug withdrawal viewing duration, the ordinary circumstance of each group mice, as developmental state (body temperature, body weight, heart rate), coat condition, the mental status, each natural hole situation, autonomic activities situation.
2.3.2 internal organs inspection and Physico-chemical tests
, there is animal dead during administration in experimentally requirement, dissects immediately, observes each internal organs situation, peel off each internal organs, weigh, and calculate organ index, heart extracting blood Physico-chemical tests; As nothing is dead, then experimentally requirement, after the observation period, gives 10% chloral hydrate anesthesia, opens abdominal cavity, observes each internal organs situation, and abdominal aortic blood is put to death, and does Physico-chemical tests, peels off each internal organs, weigh, and calculate organ index.
3 results
Experimental session, without dead mouse, experimentally arranges to carry out coherent detection.
3.1 ordinary circumstance
During administration and drug withdrawal viewing duration, each group mice at the baseline signs such as body weight, body temperature, Non Apparent Abnormality, two groups are compared, no difference of science of statistics, outward appearance is normal, without deformity, fur color and luster is normal, the mental status is good, and each natural hole is clean, secretions without exception, autonomic activities is normal, behavior without exception.
3.2 internal organs inspection and Physico-chemical tests
Experimentally requirement, after the observation period, gives 10% chloral hydrate anesthesia, and abdominal aortic blood is put to death, open abdominal cavity, observe each internal organs situation, the arrangement of each group mice organs is normal, without adhesion, without hemorrhage, blood of getting does Physico-chemical tests, each group of Mouse Blood routine is without exception, and liver function, kidney merit check without exception, peel off each internal organs, weigh, calculate organ index, through statistical analysis, no difference of science of statistics, two groups of same periods compare, statistics zero difference.
4 conclusions
By mice long term toxicity test, mice dosage is 23g/kg/d, 17.25g/kg/d, 11.5g/kg/d, be converted into adult normal dosage 230g/kg/d, 172.5g/kg/d, 115g/kg/d, 57.5 times, 43.125 times, 28.75 times that daily measure for adult normal, can be confirmed by this experiment, Chinese medicine of the present invention is in long term toxicity test, without cumulative toxicity, without delayed toxicity, substantially can think safe, therefore Clinical practice is safe.
Embodiment 6 clinical research
1 diagnostic criteria
1.1 Western medicine diagnose standards
1.1.1 the diagnostic criteria of chronic superficial gastritis:
The course of disease is delayed, and has the symptom such as dyspepsia in various degree, anorexia, nauseating and relevant with feed epigastrium pain, can have left upper abdomen mild tenderness.Meet the diagnostic criteria of chronic superficial gastritis fibergastroscope and pathologic finding diagnostic criteria can be made a definite diagnosis.
1.1.2 chronic superficial gastritis Gastroscope Diagnosis standard and grade scale:
Formulate (see table 1) with reference to Chinese Medical Association digestive endoscopy branch " chronic gastritis endoscopic classification grade scale tries suggestion " (in JIUYUE, 2003, Dalian) simultaneously.
1. mucus increases, and is attached to difficult drop-off on mucosa, after rinsing with water, rubescent or the erosion of mucous membrane surface is stripped off, close with the white fur character of fester surface institute quilt, need differentiate mutually with the mucus of the mucus swallowed or Duodenal reflux, general reflux mucus contains bubble and mobile with wriggling.
2. stigma lamellar or wire rubescent, some places are congested, and some places are not congested, so in plaque-like, not clearly, tone is scarlet for rubescent boundary, wire hyperemia is common in wrinkle ancient piece of jade, round, flat and with a hole in its centre bump pad.
3. red and white or piebaldism, for being dispersed in even small red dot, the mucosa between red point and red point shows slightly pale, again as the skin of measles sick child.
4. edema, mucus is by force reflective, slightly pale, swelling sense, and stomach alveole is obvious.
5. rotten to the corn, wrinkle skirt face firewood film strips off, and often have white fur, can divide 3 types again: protrude type, as pimple shape, top has umbilicus sample to cave in; Flat type: do not exceed mucosa around; Umbilicate type, than around mucosa is low, rotten to the corn surrounding's mucosa often has the performance of inflammation.
The classification of table 1 chronic superficial gastritis gastroscope
Classification Endoscopic Features
Normally Normally (change can be learned in a organized way)
I degree (slightly) Dispersion or interruption wire; Rotten to the corn stove single-shot; There is hemorrhagic focus local
II degree (moderate) Intensive speckle or continuously wire; Rotten to the corn multiple local≤5 of stove; Hemorrhagic focus multiple location
III degree (severe) Extensive fusion; Rotten to the corn stove is extensively multiple >=and 6; Hemorrhagic focus fills the air
1.1.3 chronic superficial gastritis pathological diagnosis standard and histological grade standard:
Formulate (see table 2, table 3) with reference to national Second Committee chronic gastritis consensus conference " Chinese National Consensus on Chronic Gastritis " (in JIUYUE, 2006, Shanghai) simultaneously
1. inflammatory cells infiltrates is main and without the destruction of lamina propria body of gland, inflammatory cell infiltration scope the lighter is limited to the shallow-layer lamina propria of more than gastric pits level, and it is below horizontal that severe one can reach mucosa holostrome gastric pits deeply, is gone up micromicro again and occurs degeneration regeneration and intestinal.
2. be divided into gently by mucous layer inflammatory cell dense degree and intramural invasion, in, severe, involve gastric mucosa layer upper 1/3 is slight, and more than l/2 is moderate to 2/3, and more than 2/3 person is severe.
Table 2 chronic inflammatory disease histological grade
Note: according to dense degree and the intramural invasion classification of mucous layer chronic inflammatory cells, based on the former time all right one way or the other.
Table 3 Active inflammation histological grade
Note: Active inflammation-property inflammation background has neutrophil infiltration
1.1.4HP Infect And Diagnose standard
1.1.4.1 diagnostic criteria
Can perform the National Consensus of helicobacter pylori some problem (2003 China) with reference to Chinese Medical Association's disease for digest credit
Diagnostic criteria:
Clinical diagnosis: following wantonly 1 Current Infection diagnostic method is positive diagnosable is HP infection
Scientific research is diagnosed: positive bacterial culture or other wantonly two positives following.
The detection method of conventional Hp: the diagnostic method of Current Infection--antibacterial culturing; Histological examination (Warthin-Starry silver dye or improvement Giemsa dyeing); Urea breath test; Rapid urease test; Stool antigen test.The diagnostic method once infected: serum Hp antibody.
1.1.2.2Hp gradient of infection criterion
(see table 4) is formulated with reference in JIUYUE, 2006 whole nation Second Committee chronic gastritis consensus conference 5 Chinese National Consensus on Chronic Gastritis
Table 4Hp histological grade
1.2 tcm diagnosis standards
1.2.1 Syndrome Differentiation of Traditional Chinese Medicine standard
1.1.2.1 chronic superficial gastritis syndrome of dampness-heat of spleen and stomach CM syndrome differentiation criterion
Primary symptom: the dirty scorching hot distending pain of stomach, bitter taste halitosis, institute's abdomen painful abdominal mass is vexed, appetite stimulator.
Secondary disease: thirst but no desire to drink, nausea and vomiting, pantothenic acid, noisy, yellowish urine.
Picture of the tongue pulse condition: red tongue, limit point is dark red, and yellow fur is thick or greasy, rolling pulse or string.
1.1.2.2 the classification of tcm clinical practice symptom weight and score:
By stomach, the clinical symptoms such as de-or side of body rib distension, stomachache, heating installation, pantothenic acid, noisy, feeling of fullness, lack of appetite, weak, bitter taste, yellowish urine, the stool pool or stool is smooth, tongue fur presses scoring method, is divided into 0,1,2,3,4 point of totally 5 score-grade.O divides: asymptomatic; 1 point: have symptom once in a while; 2 points: have symptom (generally); 3 points: symptom is heavier; 4 points: symptom is very heavy, has a strong impact on orthobiosis.
1.3 case selection standards
1.3.1 inclusive criteria
1. the diagnostic criteria of doctor trained in Western medicine chronic superficial gastritis is met and Hp diagnosis is positive
2. the CM syndrome differentiation criterion of traditional Chinese medical science syndrome of dampness-heat of spleen and stomach is met.
3. the age 18-65 year between be in hospital or outpatient.
4. blood, urine, stool routine examination chemical examination and the normal person of Liver and kidney function.
5. the person that do not use western medicines in treatment in first quarter moon before treatment.
6. informed consent, conscious tested.
1.4 exclusion standard
1. the age is under-18s or over-65s person.
2. merge peptic ulcer, gastric mucosa has severe dysplasia or pathological diagnosis is suspected to have the person of cancerating.
3. merge intentionally, brain, liver, severe primary disease and the psychotic such as kidney and hemopoietic system.
4. recent application crosses the patient of antibiotic, acid inhibitor and proton pump inhibitor.
5. gestation or preparation gravid woman, women breast-feeding their children
6. to this institute with any one drug allergy person.
7. allly do not meet inclusive criteria, not by regulation medication, cannot judge that curative effect or data are not congruent and affect the treatment or safety judgement person.
1.4 case source and groupings
185 observed routine cases are all from outpatient service and the inpatient of in JIUYUE, 2012 in December ,-2014.Adopt random contrast clinical trial method, observed case is divided into treatment group and matched group.Treatment group 94 example, man 45 example, female 49 example; In age 21-62 year, the mean age is 43.27 ± 4.87 years old;-15 years April of the course of disease.Matched group 91 example, man 47 example, female 44 example; Age 19-64 year, 41.31 ± 5.17 years old mean age;-14 years March of the course of disease.Two groups at sex (X 2=0.2825, P>0.05), age (X 2=0.5934, P>0.05), the course of disease (X 2=0.9437, P>0.05), tcm clinical practice symptom integral (t=0.2881, P>0.05), Hp gradient of infection (X 2=0.4858, P>0.05), gastroscope classification (X 2=0.5861, P>0.05), the aspect such as diffuse inflammation histological grade (P>0.05) through statistical analysis there was no significant difference, there is comparability.
2 Therapeutic Method
2.1 treatment group
Capsule 1,3 times/day prepared by the embodiment of the present invention 1, every capsules 0.5g, each 3, point early, middle and late three decoction being taken warmly 2 weeks are a course for the treatment of.
2.2 matched group
Can eradicate to Hp in the National Consensus of helicobacter pylori some problem (2003-China) therapeutic scheme recommended according to Chinese Medical Association's disease for digest credit to perform.
Bismuth potassium citrate, 220mg, bid, take sooner or later on an empty stomach, and Guangdong Province's Livzon Pharmaceutical Factory, Livzon Group is produced, authentication code: the accurate word H10900O86 of traditional Chinese medicines
Metronidazole, 0.4g, bid, sooner or later one after each meal, Shanghai modern Ha Sen pharmaceutcal corporation, Ltd produces, authentication code: the accurate word H41022112 of traditional Chinese medicines
Amoxicillin, 0.5g, bid, sooner or later one after each meal, Zhuhai Federated Pharmaceutical Co., Ltd. Zhongshan Branch produces, authentication code: the accurate word H20003263 of traditional Chinese medicines
Course for the treatment of of more than taking medicine is 2 weeks, advises two groups of patients to be careful in one's diet at treatments period, avoids tobacco and wine, coffee, strong tea and emotional distress as far as possible.
3 observational techniques
Following observation was carried out in 4 weeks to two groups of patients before treatment and after treatment drug withdrawal:
3.1 observation of curative effect
1. observe clinical symptoms before and after treatment and improve situation.
2. gastroscope change before and after treatment is observed.
3. pathological change before and after treatment is observed.
4. the change that before and after treatment, Hp infects is observed.
3.2 safety observations
1. physical examination project is grasped
2. blood, urine, feces routine test, respectively looks into once before and after treatment
3. Liver and kidney function inspection, respectively looks into once before and after treatment
4. respectively look into once before and after electrocardiogram treatment
5. untoward reaction is monitored at any time.
3.3 criterion of therapeutical effect
3.3.1 Comprehensive Clinical curative effect determinate standard:
Cure: symptom, sign disappear; Gastroscope and biopsy, Active inflammation disappears, and chronic inflammatory disease alleviates more than 2 degree or disappearance.
Effective: symptom and sign all improves more than 2 grades; Gastroscope and biopsy, Active inflammation disappears substantially, and chronic inflammatory disease degree alleviates 1 degree.
Effective: symptom and sign all improves more than 1 grade; Gastroscope and biopsy, non-cancer lesion range shorter more than 1/2, Active inflammation or chronic inflammatory disease degree alleviate 1 degree.
Invalid: not reach effective standard person.
3.3.2 gastroscope and pathology curative effect determinate standard:
Cure: gastroscope check Active inflammation disappears, and gastric mucosa congestion, edema sign disappear; Pathologic finding inflammatory infiltration disappears substantially.
Effective: gastroscope check mucosa Active inflammation disappears, and the signs such as gastric mucosa blood, edema are clearly better; Pathologic finding inflammatory infiltration is in slight.
Effective: gastroscope check non-cancer lesion range shorter more than 1/2, the sign such as gastric mucosa congestion, edema makes moderate progress; Pathologic finding changes not obvious.
Invalid: not reach effective standard, but do not worsen.
3.3.3Hp standard is eradicated
Check after treatment terminated at least 4 weeks:
1. Hp morphology (smear or histological stain) is negative;
2. urease dependence test (rapid urease test, 14c breath test) negative.
In above-mentioned two, choosing does one.
3.3.4 tcm syndrome criterion of therapeutical effect:
Recovery from illness: clinical symptoms, sign disappear or substantially disappear; Syndrome integral reduces >=95%.
Effective: clinical symptoms, sign are obviously improved; Syndrome integral reduces >=70%.
Effective: clinical symptoms, sign all take a favorable turn; Syndrome integral reduces >=30%.
It is invalid: even clinical symptoms and sign increase the weight of without improvement; Syndrome integral reduces less than 30%.
3.4 statistical method
Adopt SPSS15.0 statistical analysis software to carry out statistical procedures, measurement data is used represent, adopt t inspection; Enumeration data X 2inspection; Ranked data Ridit analyzes or rank test.
4 therapeutic outcomes
4.1 liang of groups Comprehensive Clinical comparitive study (see table 5)
Table 5 liang group clinical efficacy overall merit
Group N Cure Effective Effectively Invalid Total effective rate
Treatment group 94 23 27 38 6 93.62％
Matched group 91 15 19 42 15 83.52％
There were significant differences to compare P=0.000<0.01 in group before and after treatment, illustrates there is significant difference before and after treatment; Treatment group compares with matched group, and analyze through ridit, obtain P<0.05, illustrate that two groups of direct curative effects have significant difference, treatment group curative effect is better than matched group.
After 4.2 liang of group treatments, the improvement of tcm clinical practice symptom is compared (see table 6)
The improvement of table 6 symptom integral is compared
There were significant differences to compare P=0.000<0.01 in group before and after treatment, illustrates there is significant difference before and after treatment; Treatment group compares with matched group, and analyze through ridit, obtain P<0.05, illustrate that two groups of direct curative effects have significant difference, treatment group curative effect is better than matched group.
Before and after two groups of treatments, each cardinal symptom and sign are all obviously improved, the scorching hot distending pain of gastral cavilty for the treatment of group, ball abdomen painful abdominal mass is vexed, bitter taste halitosis, appetite stimulator, thirst but no desire to drink, yellowish urine and yellow fur are thick or greasy change effective percentage are apparently higher than matched group, analyze through statistics Ridit, two groups of contrasts have significant difference (P<0.05)
After 4.3 liang of group treatments, gastroscopy effect compares
Front and back gastroscopy effect treated by table 7
Group N Cure Effective Effectively Invalid Total effective rate
Treatment group 94 19 33 33 9 90.43％
Matched group 91 11 26 40 24 73.63％
There were significant differences to compare P=0.000<0.01 in group before and after treatment, illustrates there is significant difference before and after treatment; Treatment group compares with matched group, and analyze through ridit, obtain P<0.05, illustrate that two groups of direct curative effects have significant difference, treatment group curative effect is better than matched group.
Pathological change comparitive study after 4.4 liang of group treatments
Analyze through Ridit, two group differences have statistical significance (P<0.05), and prompting treatment group is better than matched group (see table 8) in pathology curative effect.
Pathological change comparitive study after table 8 liang group treatment
Group N Cure Effective Effectively Invalid Total effective rate
Treatment group 94 21 35 29 8 91.49％
Matched group 91 11 20 38 22 75.82％
There were significant differences to compare P=0.000<0.01 in group before and after treatment, illustrates there is significant difference before and after treatment; Treatment group compares with matched group, and analyze through ridit, obtain P<0.05, illustrate that two groups of direct curative effects have significant difference, treatment group curative effect is better than matched group.
4.5 liang of group Hp eradication rates compare
A table 9 liang group Hp eradication rate compares
Group N RUT(+) RUT(-) Hp eradication rate
Treatment group 94 71 23 75.53％
Matched group 91 39 52 42.86％
There were significant differences to compare P=0.000<0.01 in group before and after treatment, illustrates there is significant difference before and after treatment; Treatment group compares with matched group, and analyze through ridit, obtain P<0.05, illustrate that two groups of direct curative effects have significant difference, treatment group curative effect is better than matched group.
4.6 safety indexes are observed
4.6.1 lab testing
All make blood, urine, routine inspection of excrement before and after treatment group and treatment of control group, Liver and kidney function and Electrocardioscopy show no obvious abnormalities change.
4.6.2 untoward reaction
Treatments period treatment group and matched group all have no adverse reaction.
5 conclusions
Pass through clinical experimental study, the clinical comparison of capsule of the present invention and clinical western medicine routine treatment is visible, invention formulation has good clinical efficacy, its comprehensive therapeutic effect and tcm syndrome improvement etc. are all better than Western medicine, by safety detection etc., all without obvious toxic-side effects, therefore clinical efficacy is good, is applicable to promote.
Embodiment 7 animal experiment study
1 experiment material
1.1 laboratory animal
Male and healthy wistar rat 40, SPF level, 180-210g, Shandong Traditional Chinese Medicine University's Experimental Animal Center provides.Feedstuff is provided by Shandong Traditional Chinese Medicine University's Experimental Animal Center.
1.2 experiment reagent
Dehydrated alcohol, Weifang Common Chem. Co., Ltd.
Sodium deoxycholate, Anhui Kebao Biology Engineering Co., Ltd
Gastrin ria-determination box (GASRIAKit), English biotechnology research institute of Beijing China
Motilin radioimmunological kit (MTLRIAKit), English biotechnology research institute of Beijing China
Superoxide dismutase (SOD) measures test kit, Shanghai Jie Mei gene Pharmaceutical Technology Co., Ltd
Malonaldehyde (MDA) measures test kit, Shanghai Jie Mei gene Pharmaceutical Technology Co., Ltd
1.3 experimental drug
Capsule prepared by the embodiment of the present invention 1.
Bismuth potassium citrate: Guangdong Province's Livzon Pharmaceutical Factory, Livzon Group is produced, authentication code: the accurate word H10900086 of traditional Chinese medicines
First nitre: Shanghai modern Ha Sen pharmaceutcal corporation, Ltd produces, authentication code: the accurate word H41022112 of traditional Chinese medicines
Amoxicillin: Zhuhai Federated Pharmaceutical Co., Ltd. Zhongshan Branch produces, authentication code: the accurate word H20003263 of traditional Chinese medicines.
2 experimental techniques
2.1HP bacterium solution preparation
Helicobacter pylori Strains, by separation and Culture in Gastric mucosa biopsy piece of tissue, turns out to be helicobacter pylori through biochemical identification, and turbidimetry adjustment bacterial concentration is 10 8/ m1, bacterium liquid is kept in the refrigerator of 4 DEG C.
2.2 animal model preparations
40 wistar rat adaptabilities are fed 1 week, is divided into normal group 10 and modeling group 40 at random.Normal group is normally fed, and modeling treated animal is pressed Pan Shi method, copies chronic gastritis model, and with reference to Chen Shi method, to modeling group rat infection Hp.
Specific practice is:
Chronic gastritis model copy: to modeling group rat at first month every 5 days, second month every 7 days, administered by oral gavage alcoholic solution, first concentration is 50%, later use 60%, at every turn every 2ml, and with the deoxycholic acid sodium solution of 20mmol/L for beverage is arbitrarily drunk; Three month is then beverage with the alcoholic solution of 30% and the sodium deoxycholate of 20mmol/L respectively, every rotation in 7 days once, drinks arbitrarily, and drink in deoxycholic acid sodium solution 7 days within second day and the 5th day, to gavage alcoholic solution each once, to add strong stimulation.
Damp-heat in the spleen and stomach model copy: modeling group rat starts monthly to give high glucose and high fat feedstuff at first month and (is mixed into 12% Adeps Sus domestica in normal diet, 8% Mel) feed 10 days, then modeling case (temperature 32 ± 2 DEG C is placed in, relative humidity 90 ~ 100%) 10 days, after shift out natural environment.
Hp infects: to above-mentioned modeling animal, from March, infects Hp.First fasting 12-14 hour before every subinfection, direct oral cavity slowly pours into the NaHCO of 5% 32ml, pours into Hp bacterium liquid 2ml, feeding after 30 minutes after skilful minute.Infect weekly once, totally 4 times.
2.3 medication
Modeling animal is divided at random model group, western medicine group and Chinese drug-treated group 3 groups, often organizes each 10.Western medicine group gives amoxicillin 100mg/kg, first nitre 80mg/kg, bismuth potassium citrate 44mg/kg, and consumption is all equivalent to 5 times of adult human dose, and above each medicine is made into the suspension of respective concentration.
Capsule group of the present invention, give 5 times that take medicine with adult normal, be mixed with containing crude drug 1g/ml solution, dosage is 1ml/100g body weight.Normal group, model group are with normal saline gavage.Every day 1 time, continuous January.
2.4 statistical method
Adopt SPSS15.0 statistical analysis software to carry out statistical procedures, measurement data is used represent, adopt t inspection; Enumeration data X 2inspection; Ranked data Ridit analyzes or rank test.
3 laboratory observation content and observational techniques
3.1 ordinary circumstance
Normal rats is closely next to the skin by hair, and color is white, and glossy, two have god, and movable quick, diet is normal, and the bodily form is stout and strong, defecates into graininess.Modeling group, in model copy process, rat gradually appetite declines, movable minimizing, lethargy, emaciated physique, and fluffy by hair, lackluster, hair color turns yellowish, and phenomenon is let out on most appearance stool pool.
After treatment, all there is improvement in various degree in each treatment group rat, it is ingested, activity, hair color gloss, the passing all in time such as stool and gradually improving.And model group has no significant change.
3.2 body weight change
Before modeling, each group rat body weight does not have significant difference (P>0.05).From modeling the 2nd week, by the 12nd week, modeling group rat body weight highly significant lower than normal group (P<0.01).Each modeling group rat body weight there was no significant difference (P>0.05) before treatment.After giving Drug therapy, although the body weight of rat has no significant difference (P>0.05) between 1-3 week model group and each treatment group, but usually there is negative growth in the body weight of model group, Western medicine group rat, and Chinese medicine capsules group of the present invention keeps growth trend always.The body weight for the treatment of rat between rear 4th week model group and each treatment group demonstrates difference, the body weight of Western medicine group rat and model group without significant difference (P>0.05), the body weight of capsule group rat of the present invention and model group significant difference (P<0.05).
3.3 merge the impact of Hp infected rats hematogaster secretin, motilin to chronic gastritis syndrome of dampness-heat of spleen and stomach
3.3.1 experimental technique
At the end of administration, animal fasting, can't help water 24 hours, femoral vein blood 2 is managed, 1 pipe separation of serum, illustrates survey serum gastrin (Gas) by gastrin ria-determination box; Another 1 pipe separated plasma, illustrates by motilin radioimmunological kit and surveys Plasma Motilin Levels and Colonic Motility (MTL).
3.3.2 result
Model group serum GaS is significantly higher than normal group (P<0.05), and motilin in plasma is significantly higher than normal group (P<0.05).After treatment, compared with model group, capsule group serum GaS of the present invention is decreased significantly (P<0.05), though Western medicine group has decline, difference is not significantly (P>0.05); Capsule group motilin in plasma of the present invention is decreased significantly (P<0.05), though Western medicine group has decline, difference is not significantly (P>0.05).
Table 10 respectively group rat serum gastrin, motilin compares
*compare with normal group, P<0.05; *compare with model group, P<0.05
3.4 merge the impact of HP infected rats superoxide dismutase, malonaldehyde to chronic gastritis syndrome of dampness-heat of spleen and stomach
3.4.1 experimental technique
After administration terminates, animal fasting, can't help water 24 hours, venous blood collection, separation of serum.Illustrate by superoxide dismutase, Mda test kit and survey superoxide dismutase (SOD) and malonaldehyde (MDA).
3.4.2 result
Model group SOD in serum highly significant lower than normal group (P<0.01); After treatment, each treatment group SOD in serum raises all to some extent, significant difference (P<0.05) compared with model, capsule group difference highly significant (P<0.01) of the present invention.Model group serum MDA highly significant higher than normal group (P<0.01); After treatment, each treatment group serum MDA declines all to some extent, capsule group difference highly significant (P<0.01) of the present invention compared with model group, though Western medicine group has decline, difference is not significantly (P>0.05).
Table 11 respectively group rat blood serum SOD, MDA compares
*compare with normal group, P<0.05; *compare with model group, P<0.05
3.5 merge the impact of HP infected rats gastric mucosal histology to chronic gastritis syndrome of dampness-heat of spleen and stomach
3.5.1 experimental technique
After administration terminates, the equal fasting of animal, can't help water 24 hours, put to death, cut open the belly immediately, ligation cardia and pylorus, extract full stomach, blots surperficial blood stains with filter paper, cuts gastral cavity open, with distilled water rinsing gently, shakeout along curved greatly.Perusal gastric mucosa, and perform record.Take a morsel stomach firewood film direct smear, and dry voluntarily, Gram’s staining, searches HP under oily mirror.Separately at close pylorus place clip 3 × 10mm 2, flat holostrome coat of the stomach one piece, 10% formalin is fixed, stone vinegar embedded section, Hematoxylin-eosin dyeing (HE dyeing), observes gastric mucosal histology change.
3.5.2 observed content and method:
1. gastric mucosa pathological change:
A. perusal: gastric mucosa color and luster, form, thickness etc.
B. pathological examination: a. mycogastritis cellular infiltration;
B. body of gland atrophy;
C. muscularis mucosae hypertrophy.
Above-mentioned three kinds of pathological changes all with light, in, heavily classification, be denoted as 1 point, 2 points, 3 points respectively; Pathological changes is not obvious, or without this pathological changes person, then in 0 point.
2. gastric mucosa Hp infection conditions:
Hp gradient of infection is divided into 4 grades.0 point: do not find Hp; 1 point: the Hp be dispersed on a small quantity; 2 points: more occur Hp; 3 points: in a large number, occur Hp clustering.
3.5.3 result
1. gastric mucosa pathological change:
A. finding of naked eye
Normal group: gastric mucosa is light red, smooth surface is smooth, and with one deck mucus, elasticity is better, and without granular sensation, thickness is even.Model group: the greyish white or pale of gastric mucosa, even pale, or have lamellar flushing, lackluster, some positions are thin as Cicadae plumage, and some positions thicken, rough surface.The stomach firewood film even had is shown in the petechia having and be dispersed in.Each treatment group all has improvement in various degree.
B. pathological change
Normal group: gastric mucosa is normal.Show as mucosal epithelium (surface) not hypertrophy, invariance is downright bad; Glandular epithelium is without atrophy; Without cell infiltration in lamina propria, blood vessel is not congested; Muscularis mucosae is hypertrophy not, without cell infiltration.Submucosa is not congested, not edema, also without cell infiltration.Muscle layer and placenta percreta NIP.
Model group: each animal all demonstrates chronic gastritis pathological changes, show as in lamina propria and have diffusivity or collections chronic inflammation cellular infiltration, the body of gland at nearly muscularis mucosae place has atrophy, raises with muscularis mucosae hypertrophy.Cell infiltration, body of gland atrophy and muscularis mucosae hypertrophy three kinds of pathological changes integrations, all have highly significant difference P<0.05 compared with normal group.
Western medicine group: chronic gastritis pathological changes comparatively model group makes moderate progress, wherein cell infiltration obviously alleviates, significant difference (P<0.05) compared with model group, though and body of gland atrophy, muscularis mucosae hypertrophy have and alleviate, there is no significant difference P<0.05.
Capsule group of the present invention: chronic gastritis pathological changes recovers normal substantially.Only have the slight stove cell infiltration of 1 example, the slight atrophy of 4 routine body of gland, the slight muscularis mucosae hypertrophy of 2 example, all the other each animals are all normal.Cell infiltration, body of gland atrophy, muscularis mucosae hypertrophy compare the difference (P<0.01) having highly significant with model group.
3. Hp infection conditions
It is the highest that model group gastric mucosa HP infects integration, has highly significant meaning (P<0.01) compared with normal group.Each treatment group declines all to some extent, and significantly (P<0.05), Chinese medicine heavy dose is organized and model group comparing difference highly significant (P<0.01) for its Chinese medicine and western medicine group, model group comparing difference.
4 conclusions
Study by experiment; prove that invention formulation has adjustment gastrointestinal motility function, regulates gastric acid secretion, protect gastric mucosa, improve gastric mucosa microcirculation, increase gastric mucosal barrier defense function, analgesic activity and reconditioner body immunity function, antiinflammatory, anti-Hp effect.In sum, invention formulation has the effect of good treatment superficial gastritis, and has no side effect, and is applicable to clinical expansion.
All above-mentioned this intellectual properties of primary enforcement, not setting restriction this new product of other forms of enforcement and/or new method.Those skilled in the art will utilize this important information, and foregoing is revised, to realize similar implementation status.But all modifications or transformation belong to the right of reservation based on new product of the present invention.
The above is only preferred embodiment of the present invention, and be not restriction the present invention being made to other form, any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the Equivalent embodiments of equivalent variations.But everyly do not depart from technical solution of the present invention content, any simple modification, equivalent variations and the remodeling done above embodiment according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.

Claims (9)

1. be used for the treatment of a Chinese medicine for spleen and stomach damp-heat type superficial gastritis, it is characterized in that: crude drug comprises Herba Pogostemonis, Herba Eupatorii, new lotus leaf, Cortex Magnoliae Officinalis, Rhizoma Pinelliae Preparatum, roud cardamon seed, Rhizoma Atractylodis, Herba Lophatheri, Medulla Tetrapanacis, Poria, Rhizoma Alismatis, Polyporus, Pericarpium Citri Reticulatae, Rhizoma Cyperi, Rhizoma Atractylodis Macrocephalae, Radix Et Rhizoma Rhei, Rhizoma Coptidis, Radix Scutellariae, Cortex Phellodendri, Rhizoma Polygoni Cuspidati, Rhizoma Corydalis, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, Radix Paeoniae Rubra and Radix Glycyrrhizae.
2. be used for the treatment of the Chinese medicine of spleen and stomach damp-heat type superficial gastritis as claimed in claim 1, it is characterized in that: the weight portion of each crude drug is respectively Herba Pogostemonis 10 ~ 20 weight portion, Herba Eupatorii 10 ~ 15 weight portion, new lotus leaf 10 ~ 15 weight portion, Cortex Magnoliae Officinalis 10 ~ 15 weight portion, Rhizoma Pinelliae Preparatum 10 ~ 20 weight portion, roud cardamon seed 15 ~ 20 weight portion, Rhizoma Atractylodis 20 ~ 30 weight portion, Herba Lophatheri 10 ~ 15 weight portion, Medulla Tetrapanacis 10 ~ 15 weight portion, Poria 10 ~ 30 weight portion, Rhizoma Alismatis 10 ~ 20 weight portion, Polyporus 15 ~ 30 weight portion, Pericarpium Citri Reticulatae 10 ~ 20 weight portion, Rhizoma Cyperi 10 ~ 15 weight portion, Rhizoma Atractylodis Macrocephalae 10 ~ 25 weight portion, Radix Et Rhizoma Rhei 10 ~ 15 weight portion, Rhizoma Coptidis 10 ~ 30 weight portion, Radix Scutellariae 10 ~ 15 weight portion, Cortex Phellodendri 10 ~ 15 weight portion, Rhizoma Polygoni Cuspidati 10 ~ 20 weight portion, Rhizoma Corydalis 20 ~ 30 weight portion, Radix Salviae Miltiorrhizae 10 ~ 20 weight portion, Rhizoma Curcumae 10 ~ 15 weight portion, Radix Paeoniae Rubra 10 ~ 15 weight portion, Radix Glycyrrhizae 10 ~ 20 weight portion.
3. be used for the treatment of the Chinese medicine of spleen and stomach damp-heat type superficial gastritis as claimed in claim 1 or 2, it is characterized in that: the weight portion of each crude drug is respectively Herba Pogostemonis 15 ~ 20 weight portion, Herba Eupatorii 10 ~ 15 weight portion, new lotus leaf 10 ~ 15 weight portion, Cortex Magnoliae Officinalis 10 ~ 15 weight portion, Rhizoma Pinelliae Preparatum 10 ~ 15 weight portion, roud cardamon seed 15 ~ 20 weight portion, Rhizoma Atractylodis 20 ~ 25 weight portion, Herba Lophatheri 10 ~ 15 weight portion, Medulla Tetrapanacis 10 ~ 15 weight portion, Poria 20 ~ 25 weight portion, Rhizoma Alismatis 15 ~ 20 weight portion, Polyporus 15 ~ 20 weight portion, Pericarpium Citri Reticulatae 10 ~ 15 weight portion, Rhizoma Cyperi 10 ~ 15 weight portion, Rhizoma Atractylodis Macrocephalae 15 ~ 20 weight portion, Radix Et Rhizoma Rhei 10 ~ 15 weight portion, Rhizoma Coptidis 20 ~ 25 weight portion, Radix Scutellariae 10 ~ 15 weight portion, Cortex Phellodendri 10 ~ 15 weight portion, Rhizoma Polygoni Cuspidati 15 ~ 20 weight portion, Rhizoma Corydalis 20 ~ 25 weight portion, Radix Salviae Miltiorrhizae 15 ~ 20 weight portion, Rhizoma Curcumae 10 ~ 15 weight portion, Radix Paeoniae Rubra 10 ~ 15 weight portion, Radix Glycyrrhizae 15 ~ 20 weight portion.
4. the Chinese medicine being used for the treatment of spleen and stomach damp-heat type superficial gastritis as described in claims 1 to 3, it is characterized in that: the weight portion of each crude drug is respectively Herba Pogostemonis 15 weight portion, Herba Eupatorii 10 weight portion, new lotus leaf 10 weight portion, Cortex Magnoliae Officinalis 10 weight portion, Rhizoma Pinelliae Preparatum 15 weight portion, roud cardamon seed 15 weight portion, Rhizoma Atractylodis 25 weight portion, Herba Lophatheri 10 weight portion, Medulla Tetrapanacis 10 weight portion, Poria 20 weight portion, Rhizoma Alismatis 20 weight portion, Polyporus 20 weight portion, Pericarpium Citri Reticulatae 10 weight portion, Rhizoma Cyperi 10 weight portion, Rhizoma Atractylodis Macrocephalae 20 weight portion, Radix Et Rhizoma Rhei 10 weight portion, Rhizoma Coptidis 25 weight portion, Radix Scutellariae 15 weight portion, Cortex Phellodendri 10 weight portion, Rhizoma Polygoni Cuspidati 20 weight portion, Rhizoma Corydalis 20 weight portion, Radix Salviae Miltiorrhizae 20 weight portion, Rhizoma Curcumae 10 weight portion, Radix Paeoniae Rubra 15 weight portion, Radix Glycyrrhizae 15 weight portion.
5. the Chinese medicine being used for the treatment of spleen and stomach damp-heat type superficial gastritis as described in Claims 1-4, is characterized in that: described Chinese medicine can be made into said dosage form on any one pharmaceutics.
6. the Chinese medicine being used for the treatment of spleen and stomach damp-heat type superficial gastritis as described in claim 1 to 5, is characterized in that: described Chinese medicine can be prepared into tablet, capsule, granule, drop pill, oral liquid, pill, syrup, dispersible tablet, effervescent tablet.
7. the Chinese medicine being used for the treatment of spleen and stomach damp-heat type superficial gastritis as described in claim 1 to 6, is characterized in that: described Chinese medicine can be prepared into capsule.
8. the preparation method of Chinese medicine described in claim 1 to 7, is characterized in that, comprising:
The first step, by Herba Pogostemonis, Herba Eupatorii, new lotus leaf, Cortex Magnoliae Officinalis, Herba Lophatheri, Pericarpium Citri Reticulatae, Rhizoma Cyperi, Rhizoma Coptidis, Radix Scutellariae, Cortex Phellodendri, Rhizoma Polygoni Cuspidati and this 12 taste medical material of Radix Glycyrrhizae are cleaned respectively, be mixed in proportion, the 3-5 first adding above-mentioned medical material gross weight soak by water doubly 2 hours, filter, the 3-5 that filtering residue adds above-mentioned medical material gross weight again soak by water doubly 1.5 hours, filter, merge 2 decoction liquor, filter, and relative density is 1.05 when being concentrated into 70 DEG C, to be cooled to room temperature, add dehydrated alcohol, making medicinal liquid contain alcohol volume is 70%, stir evenly, leave standstill 24 hours, get supernatant, after reclaiming ethanol, when being concentrated into 60 DEG C, relative density is the extractum of 1.25,
Second step, get surplus stock medical material again to mix in described ratio, add relative to the determining alcohol of above-mentioned medical material gross weight 3-6 times amount be soak with ethanol 1-2 hour of 85-90%, heating extraction 2 times, each 1-1.5 hour, merge extractive liquid, 100 orders filter, be the ultrafiltration post ultrafiltration of 10000 again through the molecular weight that dams, when ultrafiltrate is evaporated to 60 DEG C, relative density is the extractum of 1.30;
3rd step, the extractum mixing first step and second step obtained, adds suitable adjuvant and carrier, is prepared into said dosage form on any one pharmaceutics.
9. the preparation method of Chinese medicine described in claim 8, it is characterized in that: when the dosage form of prepared Chinese medicine is capsule, 3rd step is specially, the extractum mixing that the first step and second step are obtained, add relative to the mixture described in 100 weight portions subsequently, 5 ~ 7 weight portion carboxymethyl starch sodium, 5 ~ 50 weight starch mix homogeneously, adding 150 ~ 200 weight portion determining alcohols is 80% ~ 90% alcohol granulation, dry, granulate, add 3 ~ 5 weight portion magnesium stearate subsequently, in then incapsulating.
CN201510925940.6A 2015-12-11 2015-12-11 Traditional Chinese medicine for treating superficial gastritis caused by damp heat in spleen and stomach Pending CN105435099A (en)

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Application publication date: 20160330