CN104622994A - Pharmaceutical composition for treating chronic gastritis - Google Patents

Abstract

The invention belongs to the field of traditional Chinese medicines and relates to a pharmaceutical composition for treating chronic gastritis. The pharmaceutical composition is prepared from the following raw materials in parts by weight: 12-36 parts of silvervine fleeceflower roots, 12-36 parts of rhizoma atractylodis macrocephalae, 6-24 parts of semen raphani, 6-24 parts of dutchmanspipe roots, 6-24 parts of astragalus, 3-12 parts of honeysuckle stems, 3-12 parts of salvia miltiorrhiza, 3-12 parts of rhizoma corydalis and 3-12 parts of Chinese dates. According to the total formula, the pharmaceutical composition is mainly used for clearing away heat and drying dampness, promoting qi and activating blood as well as harmonizing the stomach and relieving pain, and is capable of comprehensively regulating all organs, distinguishing deficiency and excess, removing while nourishing and nourishing while removing, remarkable in curative effect for chronic gastritis and particularly suitable for chronic superficial gastritis.

Description

A kind of pharmaceutical composition for the treatment of chronic gastritis

Technical field

The invention belongs to the field of Chinese medicines, relate to a kind of pharmaceutical composition for the treatment of chronic gastritis and preparation method thereof.

Background technology

Chronic gastritis means the various chronic gastric Mucosal inflammatory pathological changes that different pathogeny causes, a kind of common with the chronic inflammatory disease of epigastric discomfort or the pain gastric mucosa that is cardinal symptom or atrophic lesion, belong to the category such as the traditional Chinese medical science " gastric abscess ", " abdominal distention ", " noisy ", " feeling of fullness ", " syndrome of feeling fullness and distension in the upper abdomen ", change according to histopathology and pathological changes at the Germ distribution of stomach, in conjunction with the possibility cause of disease, chronic gastritis can be divided into shallow (non-atrophic), atrophic (atrophic) and specific type (special forms) three major types.

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 has: antibacterial, virus and toxin, through finding that 90% chronic tonsillitis gastric has chronic inflammatory disease to change; Smoking, 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; Medicine, some drugs, as Salicylic Acid Formulations, 17-hydroxy-11-dehydrocorticosterone, Folium Digitalis Purpureae, indometacin, Phenylbutazone etc., can cause chronic gastric mucosa lesions; Irritable food, for a long time edible spirits, strong tea, coffee, pungent and roughage, and the irregular diet style such as starvation or satiety all can destroy gastric mucosal protection barrier and gastritis occurs; Circulation and metabolic dysfunction, when congestive heart failure or portal hypertension, make stomach be in blood stasis and anaerobic condition for a long time, cause gastric mucosal barrier miopragia, and gastric acid secretion reduces, and 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; Bile or Duodenal reflux, find through gastroscope or confirm that bile reflux is the major reason causing superficial gastritis; Helicobacter pylori (Hp) infects, and Hp pathogenesis mainly by destroying gastric mucosal barrier, may make the reverse disperse of H+, finally causing the inflammation of gastric mucosa; Psychological factor, because psychohygiene is 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.

Have a lot for primary disease western medical treatment medicine, such as: the medicine that 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.Adjustment gastrointestinal motility function medicament Abdeminal pain metoclopramide or domperidone etc.Have the hiccups, abdominal distention or have reflux phenomenon to be main person, available medicine for stomach dynamic, as metoclopramide, dompendone, not husky Billy.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.The medicine that antacid is conventional has cimetidine, ranitidine, famotidine, sodium bicarbonate (sodium bicarbonate), magnesium hydroxide, gel aluminum hydroxide, gavirin tablet etc.Analgesic Upper abdominal pain is good to eat compared with severe one takes atropine, probanthine, Semen daturae tablet or 654-2, to reduce gastric acid secretion and to alleviate colic symptoms.Also available digestant is 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.

Although the Western medicine for the treatment of primary disease is numerous, none specific medicament, needs associating long-term prescription mostly, patient economy burden weight, easily recurrence after often curing.

Summary of the invention

The object of the invention is all drawbacks overcoming Western medicine existence, be to provide one group of good effect, short treating period, cure rate is high, and the pharmaceutical composition for the treatment of chronic gastritis without any side effects.

For achieving the above object, the pharmaceutical composition for the treatment of chronic gastritis of the present invention is prepared from by the raw material comprising following weight portion:

Preferably, the pharmaceutical composition for the treatment of chronic gastritis of the present invention is prepared from by the raw material comprising following weight portion:

The pharmaceutical composition for the treatment of chronic gastritis of the present invention, with pharmaceutically acceptable carrier combination, can make various common dosage forms.

Preferably, common dosage forms of the present invention can be prepared into tablet, dispersible tablet, slow releasing tablet, granule, capsule or decoction.

Described carrier comprises diluent, excipient, filler, binding agent, wetting agent, disintegrating agent, absorption enhancer, surfactant, absorption carrier, lubricant etc.

Described filler can be: starch, Icing Sugar, calcium phosphate, dextrin, microcrystalline Cellulose, lactose, pregelatinized Starch, mannitol etc.;

Described binding agent can be: sodium carboxymethyl cellulose, PVP-K30, hydroxypropyl cellulose, starch slurry, methylcellulose, ethyl cellulose, hydroxypropyl emthylcellulose, gelling starch etc.;

Described disintegrating agent can be: dried starch, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose etc.;

Described lubricant can be: magnesium stearate, Pulvis Talci, sodium lauryl sulphate, micropowder silica gel etc.

Present invention also offers a kind of preparation method for the treatment of the medicament composition capsule agent of chronic gastritis, comprise following steps:

Get whole 9 taste medical materials, cleaning, drying and sterilizing, pulverize, cross 80 order-l20 mesh sieves, incapsulate, every containing crude drug amount 0.2-0.5g.

The meridian distribution of property and flavor of each crude drug in Chinese medicine of the present invention, effect are as follows:

Radix polygoni aubertii:

Nature and flavor: bitter; Puckery; Cool in nature.

Gui Jing: the heart; Spleen; Stomach warp.

Function cures mainly, spleen invigorating and in; Heat-clearing and toxic substances removing; Regulating menstruation, hemostasis.Main bad; Stomachache; Dysentery; Menoxenia; Metrorrhagia; Furuncle from the beginning of; Traumatic hemorrhage dyspepsia; Stomachache; Metrorrhagia; Menoxenia; External controls furuncle from the beginning of, traumatic hemorrhage.

The Rhizoma Atractylodis Macrocephalae:

Nature and flavor: bitter, sweet, temperature.

Gui Jing: return spleen, stomach warp.

Function cures mainly: invigorating the spleen and benefiting QI, dampness diuretic, and hidroschesis is antiabortive.For insufficiency of the spleen lack of appetite, abdominal distention is had loose bowels, phlegm retention vertigo and palpitation, edema, spontaneous perspiration, frequent fetal movement.Rhizoma Atractylodis Macrocephalae spleen invigorating, stomach function regulating, antiabortive.For insufficiency of the spleen lack of appetite, loose stool of having loose bowels, frequent fetal movement.

Semen Raphani:

Nature and flavor: pungent, sweet are flat.

Gui Jing: return lung, spleen, stomach warp.

Function cures mainly: help digestion de-swelling, lowering the adverse-rising QI to resolve phlegm.For retention of food and drink, abdominal distention, constipation, stagnant dysentery, expectorant heap soil or fertilizer over and around the roots is breathed with cough.

Radix Aristolochiae:

Nature and flavor: pungent, bitter, cold.

Gui Jing: attach to the lung and stomach meridians.

Function cures mainly: suppressing the hyperactive liver pain relieving, removing toxic substances and promoting subsidence of swelling.For dizziness and headache, chest and abdomen swelling and pain, carbuncle furuncle, snake bite and insect sting.

The Radix Astragali:

Nature and flavor: sweet, temperature.

Gui Jing: return lung, spleen channel.

Function cures mainly: invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.Weak for the deficiency of vital energy, anorexia and loose stool, sinking of QI of middle-JIAO, chronic diarrhea proctoptosis, metrorrhagia of having blood in stool, exterior deficiency spontaneous perspiration, deficiency of vital energy edema, carbuncle difficulty is burst, and burst for a long time and do not hold back, blood deficiency dull yellowish colored skin, interior-heat is quenched one's thirst; Chronic nephritis proteinuria, diabetes.

Caulis Lonicerae:

Nature and flavor: sweet, cold.

Gui Jing: attach to the lung and stomach meridians.

Function cures mainly: heat-clearing and toxic substances removing, dispelling wind dredging collateral.For epidemic febrile disease heating, toxic-heat and blood stasis, carbuncle skin infection, beriberoid pyretic arthralgia, redness and swelling of joints burning pain.

Radix Salviae Miltiorrhizae:

Nature and flavor: bitter, are slightly cold.

Gui Jing: GUIXIN, Liver Channel.

Function cures mainly: blood circulation promoting and blood stasis dispelling, inducing menstruation to relieve menalgia, and clear away heart-fire relieving restlessness, removing heat from blood eliminating carbuncle.For obstruction of qi in the chest and cardialgia, gastral cavity abdomen hypochondriac pain, abdominal mass abdominal mass is gathered, pyretic arthralgia pain, dysphoria and insomnia, menoxenia, and dysmenorrhea amenorrhea, skin infection swells and ache.

Rhizoma Corydalis:

Nature and flavor: pungent, bitter, temperature.

Gui Jing: return liver, spleen channel.

Function cures mainly: invigorate blood circulation, promoting the circulation of QI, pain relieving.For the breast side of body, epigastric pain, amenorrhea dysmenorrhea, postpartum stagnation, tumbling and swelling.

Fructus Jujubae:

Nature and flavor: sweet, temperature.

Gui Jing: return spleen, stomach warp.

Function cures mainly: spleen reinforcing stomach function regulating, supplementing QI for promoting the production of body fluid, adjusts battalion to defend, separates poison of drug.

In side, Radix polygoni aubertii, Caulis Lonicerae, Fructus Jujubae, Rhizoma Atractylodis Macrocephalae heat clearing and damp drying stomach function regulating are with Zhi Qiben, and Semen Raphani, Radix Aristolochiae, the Radix Astragali, Rhizoma Corydalis, the pain relieving of Radix Salviae Miltiorrhizae promoting qi circulation, resolving food retention are to control its mark.Full side is based on heat clearing and damp drying, promoting flow of QI and blood and stomach and alleviating pain, each internal organs are regulated comprehensively, differentiate deficiency and excess, accomplish that invigorating middle warmer has clearly, have in clear and fall, have significant curative effect to chronic gastritis, be particularly useful for chronic superficial gastritis, obviously can improve gastralgia, abdominal distention poor appetite, feel sick, mouth is sticky, the symptom such as stool is smooth, tongue is red, yellow and greasy fur.

The pharmaceutical composition that the present invention treats chronic gastritis has the contribution that prior art is made:

1. preparation is easy, cost is low.

2. drug synergism is strong, and single dosage is few, has no side effect.

3. short treating period, good effect, non-relapse after healing.

Detailed description of the invention

Should be noted that: embodiment is only in order to illustrate technical scheme of the present invention and unrestricted, although with reference to preferred embodiment to invention has been detailed description, those of ordinary skill in the art is to be understood that, can modify to technical scheme of the present invention or equivalent replacement, and not departing from the spirit and scope of technical solution of the present invention, it all should be encompassed in the middle of right of the present invention.

Embodiment 1

Prescription:

Preparation method:

Get whole 9 taste medical materials, cleaning, drying and sterilizing, pulverize, cross 80 order-l20 mesh sieves, incapsulate, every containing crude drug amount 0.4g.

Embodiment 2

Prescription:

Preparation method:

Get whole 9 taste medical materials, cleaning, drying and sterilizing, pulverize, cross 80 order-l20 mesh sieves, incapsulate, every containing crude drug amount 0.4g.

Embodiment 3

Prescription:

Preparation method:

Get whole 9 taste medical materials, cleaning, drying and sterilizing, pulverize, cross 80 order-l20 mesh sieves, incapsulate, every containing crude drug amount 0.4g.

Embodiment 4

Prescription:

Preparation method:

Get whole 9 taste medical materials, cleaning, drying and sterilizing, pulverize, cross 80 order-l20 mesh sieves, incapsulate, every containing crude drug amount 0.4g.

Acute toxinology experiment

The object of this test observes the acute toxic reaction and death condition that occur after mice single oral gavage gives pharmaceutical composition of the present invention, for further medicament research and development provides reference material.According to test objective and EXPERIMENTAL DESIGN requirement, 1 administration group and 1 blank group (giving equal-volume distilled water) are established in this test, often organize 10 kunming mices (female, hero half and half); Adopt the administration of maximum dosage-feeding method single oral gavage, dosage is 20.g/kg body weight, the acute toxic reaction of animal after observation administration, Continuous Observation 14 days.Dead mouse is not had at the end of experiment.Observed result shows: be showed no notable difference compared with administration treated animal body weight contrasts with the same period, with sex.Put to death animal postmortem during off-test to be showed no obvious abnormalities.

Long_term toxcity is tested

The object of this test evaluates the rat oral gavage pharmaceutical composition repeat administration of the present invention toxic reaction of 180 days, understands the target organ of toxic action and the reversibility of infringement thereof, determine nontoxic crude protein, provides reference material for working out clinical application scheme.Result of the test shows, each treated animal body weight of duration of test, food ration, behavioral activity, the mental status, glandular secretion, body surface mucosa, feces character etc. show no obvious abnormalities.Test each treated animal ophthalmologic examination no abnormality seen of each phase.14 hematological indices detected and 16 blood parameters all belong to the change in normal range, have no the abnormal change that test medicine toxic reaction can be described.Histopathologic examination's result shows, within the scope of existing dosage, does not find the obvious pathologic damage of Rats Organs and Tissues.

Clinical experimental data is summed up

1. physical data

Select internal clinic and CSG patient 120 example of inpatient's treatment in year February in January, 2012 to 2015, be divided into 2 groups at random, treatment group 60 example, matched group 60 example.Male 37 example in treatment group, women 23 example, the oldest person 60 years old, minimum 22 years old, average 38.8 years old; The course of disease 1 month-9 years, average 4.2 years.Male 38 example in matched group, women 22 example; The oldest 61 years old, minimum 21 years old, average 39.1 years old, the course of disease 3 months-10 years, average 3.8 years.Difference that two groups of case sexes, age, symptom and courses of disease etc. compare that there are no significant, has comparability (P > 0.05).

2. diagnostic criteria and case include/exclusion standard in

The diagnostic criteria of 2.1 chronic superficial gastritiss:

Selected case meets " new Chinese medicine guideline of clinical investigations " and " Chinese Internal Medicine " relevant discussion, and all cases is all made a definite diagnosis through gastroscope and pathological biopsy, and diagnostic point is as follows:

1) primary symptom is gastralgia, abdominal distention poor appetite, and stool is not smooth, and tongue is red, yellow and greasy fur, and lack of appetite is indigestion and loss of appetite;

2) secondary disease is recurred or increases the weight of for meeting angry or nervous (emotional factors impact), acid regurgitation belch, and feel sick, mouth is sticky;

3) erosion of mucosa congestion and edema and petechia is seen under mirror;

4) see in glandular epithelium in biopsy specimen and occur cell infiltration.

2.2 inclusive criterias:

1) the 18-65 year patient of above-mentioned doctor trained in Western medicine chronic superficial gastritis diagnostic criteria is met;

2) the Syndrome Differentiation of Chinese Medicine disease person that belongs to syndrome of dampness-heat of spleen and stomach;

3) voluntarily and can coordinate participation experimenter.

2.3 exclusion standard

1) chronic atrophic gastritis, esophagus, taste-blindness rate, tumor, the digestive tract organic disease persons such as liver, gallbladder, pancreas;

2) severe cardiac, brain, lung, kidney and hemopoietic system disease patient is suffered from;

3) diabetics;

4) age is less than 18 years old and is greater than 65 years old person;

5) allergic constitution and those who are allergic to this drug;

6) gestation or women breast-feeding their children;

7) psychotic and can not coordinate check patient;

8) not by regulation medication or data is not congruent affects the treatment and safety judgement person.

3. Therapeutic Method

Treatment group: take the embodiment of the present invention 1 prepare capsule, every day 3 times, each 6, after meal half an hour mixing in water for oral taking.

Matched group: take commercially available SANJIU WEITAI KELI (composition: Foliumet Ramulus Evodiae, Folium Et Cacumen Murrayae, Radix Zanthoxyli, the Radix Aucklandiae, Radix Scutellariae, Poria, Radix Rehmanniae, the Radix Paeoniae Alba), each 1 bag, every day 2 times, half an hour, warm water was taken after mixing it with water after meal.

Take medicine all continuously 1 month for two groups, patient's period in a medicine does not take the medicine of other any treatment gastropathy.

4. disease observation of curative effect and curative effect determinate standard

Observe gastralgia, abdominal distention poor appetite, the main clinic symptoms such as defecate not smooth, according to conditions of patients degree, point without, gently, in, severe, remember 0,2,4,6 point respectively; Observe acid regurgitation belch, feel sick, the clinical minor symptoms such as mouth is sticky, emotional factors impact, according to conditions of patients degree, point without, light, in, severe, remember 0,1,2,3 point respectively; Picture of the tongue and pulse condition only as a reference, do not participate in integral and calculating; Cardinal symptom and minor symptom integration add up to total mark; The state of an illness is heavier, marks higher.

Curative effect determinate standard

Cure: symptom, sign disappear or substantially disappear, disease integration reduces >=95%;

Effective: symptom, sign are obviously improved, disease integration reduces >=70% and < 95%;

Effective: symptom, sign all take a favorable turn, disease integration reduces >=30% and < 70%;

Invalid: symptom, sign all take a favorable turn, disease integration reduces less than 30%.

Disease integral formulas following (nimodipine method):

5. statistical procedures

Data acquisition SPSS17.0 statistical software analyzes.Ranked data adopt Ridit to analyze, enumeration data X 2 test.

6. results and analysis

6.1 liang of group comparitive study refer to table 1.

Table 1. liang group Clinical efficacy comparison

Group

Number of cases

Recovery from illness N (%)

Effective N (%)

Effective N (%)

Invalid N (%)

Total effective rate N (%)

Treatment group

60

22(36.67％) *

30(50.00％)

7(11.67％)

1(1.67％) *

59(98.33％) *

Matched group

60

7(11.67％)

27(45.00％)

16(26.67％)

10(16.67％)

50(83.33％)

Note: compare with matched group ^*p < 0.05.

Visible, treatment group general curative effect is obviously better than matched group, has significant difference.Illustrate that medicine of the present invention is better than existing commercially available Chinese medicine.

6.2 liang of group relapse rates compare

All follow up a case by regular visits to half a year for two groups, treatment group 60 example, cure 22 examples, no case was recurrence.Matched group 60 example, cures 7 examples, and recurrence 2 example, accounts for 28.6%.

6.3 untoward reaction

All obvious adverse reaction is there is not in two groups of therapeutic processes.

Claims (8)

1. treat a pharmaceutical composition for chronic gastritis, it is characterized in that being prepared from by the raw material comprising following weight portion:

2. the pharmaceutical composition for the treatment of chronic gastritis as claimed in claim 1, it is characterized in that being prepared from by the raw material comprising following weight portion:

3. the pharmaceutical composition of the treatment chronic gastritis as described in claim 1,2, is characterized in that with pharmaceutically acceptable carrier combination, to make various common dosage forms.

4. the pharmaceutical composition for the treatment of chronic gastritis as claimed in claim 3, is characterized in that described common dosage forms is tablet, dispersible tablet, slow releasing tablet, granule, capsule or decoction.

5. the pharmaceutical composition for the treatment of chronic gastritis as claimed in claim 3, it is characterized in that described carrier comprises in diluent, excipient, filler, binding agent, wetting agent, disintegrating agent, absorption enhancer, surfactant, absorption carrier or lubricant one or more.

6. the pharmaceutical composition for the treatment of chronic gastritis as claimed in claim 5, is characterized in that described filler is one or more in starch, Icing Sugar, calcium phosphate, dextrin, microcrystalline Cellulose, lactose, pregelatinized Starch, mannitol;

Described binding agent can be: one or more in sodium carboxymethyl cellulose, PVP-K30, hydroxypropyl cellulose, starch slurry, methylcellulose, ethyl cellulose, hydroxypropyl emthylcellulose, gelling starch;

Described disintegrating agent can be: one or more in dried starch, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose;

Described lubricant can be: one or more in magnesium stearate, Pulvis Talci, sodium lauryl sulphate, micropowder silica gel.

7. the pharmaceutical composition for the treatment of chronic gastritis as claimed in claim 5, is characterized in that the preparation method of described capsule, comprises following steps:

Get whole 9 taste medical materials, cleaning, drying and sterilizing, pulverize, cross 80 order-l20 mesh sieves, incapsulate, every containing crude drug amount 0.2-0.5g.

8. the pharmaceutical composition of the treatment chronic gastritis as described in claim 1-7, is characterized in that described chronic gastritis is chronic superficial gastritis.