CN104622995A - Pharmaceutical composition for treating chronic superficial gastritis and preparation method of pharmaceutical composition - Google Patents
Pharmaceutical composition for treating chronic superficial gastritis and preparation method of pharmaceutical composition Download PDFInfo
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Abstract
The invention belongs to the field of traditional Chinese medicines and relates to a pharmaceutical composition for treating chronic superficial gastritis. The pharmaceutical composition is prepared from the following raw materials in parts by weight: 3-12 parts of milkvetch root, 3-12 parts of white peony root, 3-12 parts of suberect spatholobus stem, 1-6 parts of the root of red-rooted salvia, 3-12 parts of rhizoma corydalis, 3-12 parts of Chinese-dates, 6-24 parts of cuttlebone and 6-24 parts of largehead atractylodes rhizome. Clinical experiments prove that due to the combination of all the components in the formula, a remarkable curative effect can be produced on patients suffering from the chronic superficial gastritis and having damp heat in the spleen and the stomach, and the symptoms such as gastral cavity pain, abdominal distension and poor appetite, nausea, sticky and greasy feeling in mouth, inhibited defecation, red tongue and yellow and greasy fur can be obviously improved.
Description
Technical field
The invention belongs to the field of Chinese medicines, relate to a kind of pharmaceutical composition for the treatment of chronic superficial gastritis and preparation method thereof.
Background technology
What chronic gastritis (chronic gastritis) referred to that gastric epithelial suffers various virulence factor often attacks the specificity chronic inflammation pathological changes that occurs repeatedly, 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 traditional Chinese medical science " gastric abscess ", " abdominal distention ", " noisy ", " feeling of fullness ", categories such as " 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.
Chronic superficial gastritis is commonly encountered diseases, frequently-occurring disease clinically, and lack specific symptom, clinical main manifestations is: epigastrium pain, or distending pain, or twinge, or dull pain, or causalgia, and how on the feed rear pain increases the weight of, and anti-feel is comfortable on an empty stomach.Often there is sensation of fullness in gastral cavilty portion, even can prolong and two sides of body, belch, pantothenic acid, Nausea and vomiting, loss of appetite, notably anorexia, lose heart, weak, loose stool etc.Primary disease belongs to the category such as the traditional Chinese medical science " gastric abscess ", " epigastric oppression ", " noisy ".
Summary of the invention
The object of this invention is to provide a kind of good effect, short treating period, cure rate is high, and the pharmaceutical composition for the treatment of chronic superficial gastritis without any side effects.
For achieving the above object, a kind of pharmaceutical composition for the treatment of chronic superficial gastritis is prepared from by the raw material comprising following weight portion:
Preferably, the pharmaceutical composition for the treatment of chronic superficial gastritis of the present invention is prepared from by the raw material comprising following weight portion:
The pharmaceutical composition for the treatment of chronic superficial gastritis of the present invention, it is prepared from by the following method:
1) Endoconcha Sepiae is dried, pulverize, cross 80-200 sieve, obtain fine powder, for subsequent use.
2) get the whole 7 taste medical materials except Endoconcha Sepiae, extracting in water twice, first time adds and is equivalent to medical material gross weight 6-12 water doubly, extracts 1-3 hour, and second time adds and is equivalent to medical material gross weight 5-8 water doubly, extracts 0.5-2 hour; Merge extractive liquid, when being concentrated into 80 DEG C, relative density is the extractum of 1.20-1.30, and adding ethanol to the concentration of volume percent of alcohol content is 50%-70%, stir even, leave standstill 12-24 hour, filter, when filtrate is concentrated into 80 DEG C, relative density is the extractum of 1.22-1.30.
3) by step 1 gained fine powder and the mixing of step 2 gained extractum, oral formulations is prepared into.
Preferably, the pharmaceutical composition for the treatment of chronic superficial gastritis of the present invention, it is prepared from by the following method:
1) Endoconcha Sepiae is dried, pulverize, cross 100-150 sieve, obtain fine powder, for subsequent use.
2) get the whole 7 taste medical materials except Endoconcha Sepiae, extracting in water twice, first time adds and is equivalent to medical material gross weight 6-10 water doubly, extracts 2 hours, and second time adds and is equivalent to medical material gross weight 5-8 water doubly, extracts 1 hour; Merge extractive liquid, when being concentrated into 80 DEG C, relative density is the extractum of 1.23-1.26, and adding ethanol to the concentration of volume percent of alcohol content is 60%, stirs even, leaves standstill 24 hours, filter, and when filtrate is concentrated into 80 DEG C, relative density is the extractum of 1.25-1.27.
3) by step 1 gained fine powder and the mixing of step 2 gained extractum, oral formulations is prepared into.
Oral formulations of the present invention is capsule, tablet, dispersible tablet, slow releasing tablet, oral liquid, pill or granule.Most preferably be granule.
The meridian distribution of property and flavor of each crude drug in Chinese medicine of the present invention, effect are as follows:
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.
The Radix Paeoniae Alba:
Nature and flavor: bitter, sour, are slightly cold.
Gui Jing: return liver, spleen channel.
Function cures mainly: suppressing the hyperactive liver pain relieving, nourishing blood for regulating menstruation, astringing YIN to stop sweating.Dizzy for having a headache, hypochondriac pain, stomachache, limb pain twin, blood deficiency and yellow complexion, menoxenia, spontaneous perspiration, night sweat.
Caulis Spatholobi:
Nature and flavor: bitter in the mouth; Micro-sweet; Warm in nature.
Gui Jing: the heart; Spleen channel.
Function cures mainly: relaxing muscles and tendons to promote blood circulation; Nourishing blood for regulating menstruation.Main numb hand and foot; Quadriplegia; Rheumatic arthralgia; Women has through uncomfortable; Dysmenorrhea; Amenorrhea.
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.
Endoconcha Sepiae:
Nature and flavor: salty, puckery, temperature.
Gui Jing: return spleen, kidney channel.
Function cures mainly: astringing to arrest bleeding, relieving leukorrhea by astringents, antacid, sore.For acid regurgitation of having a stomachache, hematemesis and epistaxis, metrorrhagia is had blood in stool, emission and spermatorrhea, leucorrhea with red and white discharge; Peptic Ulcers.External treatment bleeding due to trauma, the many pus of skin ulcer.
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.
Clinical experiment confirms, the present invention just shares entirely, and to chronic superficial gastritis, disease belongs to damp-heat in the spleen and stomach person significant curative effect, 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 superficial gastritis has the contribution that prior art is made:
1. drug synergism is strong, and good effect, single dosage is few, has no side effect.
2. short treating period, without recurrence after curing.
3. preparation technology is simple, is easy to promote.
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
The preparation of capsule.
Prescription:
Preparation method:
1) Endoconcha Sepiae is dried, pulverize, cross 100 sieves, obtain fine powder, for subsequent use.
2) get the whole 7 taste medical materials except Endoconcha Sepiae, extracting in water twice, first time adds the water being equivalent to medical material gross weight 8 times, extracts 2 hours, and second time adds the water being equivalent to medical material gross weight 6 times, extracts 1 hour; Merge extractive liquid, when being concentrated into 80 DEG C, relative density is the extractum of 1.23-1.26, and adding ethanol to the concentration of volume percent of alcohol content is 60%, stirs even, leaves standstill 24 hours, filter, and when filtrate is concentrated into 80 DEG C, relative density is the extractum of 1.25-1.27.
3) by step 2 gained extract dry, pulverized 100 mesh sieves, mixed homogeneously with step 1 gained fine powder, sterilizing, fill capsule.
Embodiment 2
The preparation of tablet.
Prescription:
Preparation method:
1) Endoconcha Sepiae is dried, pulverize, cross 100 sieves, obtain fine powder, for subsequent use.
2) get the whole 7 taste medical materials except Endoconcha Sepiae, extracting in water twice, first time adds the water being equivalent to medical material gross weight 8 times, extracts 2 hours, and second time adds the water being equivalent to medical material gross weight 6 times, extracts 1 hour; Merge extractive liquid, when being concentrated into 80 DEG C, relative density is the extractum of 1.23-1.26, and adding ethanol to the concentration of volume percent of alcohol content is 60%, stirs even, leaves standstill 24 hours, filter, and when filtrate is concentrated into 80 DEG C, relative density is the extractum of 1.25-1.27.
3) by step 1 gained fine powder and the mixing of step 2 gained extractum, add and appropriate amount of starch and dextrin, granulate, dry, tabletting, obtains tablet of the present invention.
Embodiment 3
The preparation of granule.
Prescription:
Preparation method:
1) Endoconcha Sepiae is dried, pulverize, cross 100 sieves, obtain fine powder, for subsequent use.
2) get the whole 7 taste medical materials except Endoconcha Sepiae, extracting in water twice, first time adds the water being equivalent to medical material gross weight 8 times, extracts 2 hours, and second time adds the water being equivalent to medical material gross weight 6 times, extracts 1 hour; Merge extractive liquid, when being concentrated into 80 DEG C, relative density is the extractum of 1.23-1.26, and adding ethanol to the concentration of volume percent of alcohol content is 60%, stirs even, leaves standstill 24 hours, filter, and when filtrate is concentrated into 80 DEG C, relative density is the extractum of 1.25-1.27.
3) by step 1 gained fine powder and the mixing of step 2 gained extractum, suitable amount of sucrose mixing is added, pelletize, dry, obtain granule of the present invention.
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 160 example of inpatient's treatment in year January in June, 2010 to 2015, be divided into 2 groups at random, treatment group 100 example, matched group 60 example.Male 64 example in treatment group, women 36 example, the oldest person 62 years old, minimum 20 years old, average 38.5 years old; The course of disease 1 month-12 years, average 3.5 years.Male 37 example in matched group, women 23 example; The oldest 61 years old, minimum 19 years old, average 38.6 years old, the course of disease 1 month-13 years, average 3.4 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 4-6 grain, after meal half an hour mixing in water for oral taking.
Matched group: take commercially available SANJIU WEITAI KELI, 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
Two groups of 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 | 100 | 30(30.0%) * | 52(52.0%) | 16(26.0%) | 2(2.0%) * | 98(98.0%) * |
Matched group | 60 | 6(10.0%) | 29(48.3%) | 14(23.3%) | 11(18.3%) | 49(81.7%) |
Note: compare with matched group
*p < 0.05.
Treatment group 30 example cures patient, and follow up a case by regular visits to half a year, no case was recurrence.Treatment group general curative effect is obviously better than matched group, has significant difference.
Claims (6)
1. treating a pharmaceutical composition for chronic superficial gastritis, it is characterized in that, is be prepared from by the raw material comprising following weight portion:
2. the pharmaceutical composition for the treatment of chronic superficial gastritis as claimed in claim 1, it is characterized in that, be prepared from by the raw material comprising following weight portion:
3. the pharmaceutical composition of the treatment chronic superficial gastritis as described in claim 1,2, it is characterized in that, its preparation method comprises the following steps:
1) Endoconcha Sepiae is dried, pulverize, cross 80-200 sieve, obtain fine powder, for subsequent use;
2) get the whole 7 taste medical materials except Endoconcha Sepiae, extracting in water twice, first time adds and is equivalent to medical material gross weight 6-12 water doubly, extracts 1-3 hour, and second time adds and is equivalent to medical material gross weight 5-8 water doubly, extracts 0.5-2 hour; Merge extractive liquid, when being concentrated into 80 DEG C, relative density is the extractum of 1.20-1.30, and adding ethanol to the concentration of volume percent of alcohol content is 50%-70%, stir even, leave standstill 12-24 hour, filter, when filtrate is concentrated into 80 DEG C, relative density is the extractum of 1.22-1.30;
3) by step 1 gained fine powder and the mixing of step 2 gained extractum, oral formulations is prepared into.
4. the pharmaceutical composition for the treatment of chronic superficial gastritis as claimed in claim 3, it is characterized in that, its preparation method comprises the following steps:
1) Endoconcha Sepiae is dried, pulverize, cross 100-150 sieve, obtain fine powder, for subsequent use;
2) get the whole 7 taste medical materials except Endoconcha Sepiae, extracting in water twice, first time adds and is equivalent to medical material gross weight 6-10 water doubly, extracts 2 hours, and second time adds and is equivalent to medical material gross weight 5-8 water doubly, extracts 1 hour; Merge extractive liquid, when being concentrated into 80 DEG C, relative density is the extractum of 1.23-1.26, and adding ethanol to the concentration of volume percent of alcohol content is 60%, stirs even, leaves standstill 24 hours, filter, and when filtrate is concentrated into 80 DEG C, relative density is the extractum of 1.25-1.27;
3) by step 1 gained fine powder and the mixing of step 2 gained extractum, oral formulations is prepared into.
5. the preparation method of the pharmaceutical composition for the treatment of chronic superficial gastritis as claimed in claim 4, it is characterized in that, the oral formulations described in it is capsule, tablet, dispersible tablet, slow releasing tablet, oral liquid, pill or granule.
6. the preparation method of the pharmaceutical composition for the treatment of chronic superficial gastritis as claimed in claim 4, it is characterized in that, the oral formulations described in it is capsule.
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CN104825612A (en) * | 2015-05-27 | 2015-08-12 | 苗怡文 | Medicine composition for treating gastritis and method for manufacturing medicine composition |
CN105148127A (en) * | 2015-10-05 | 2015-12-16 | 淄博齐鼎立专利信息咨询有限公司 | Medicinal preparation used for treating superficial gastritis |
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CN1336216A (en) * | 2001-08-20 | 2002-02-20 | 姜松 | Gastrosis treating medicine and its application |
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吴英姿: "半夏泻心汤治疗慢性萎缩性胃炎随机平行对照研究", 《实用中医内科杂志》 * |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN104825612A (en) * | 2015-05-27 | 2015-08-12 | 苗怡文 | Medicine composition for treating gastritis and method for manufacturing medicine composition |
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Application publication date: 20150520 |