CN101579496B - Application of Chinese medicine composition in preparation of medicine for treating atypical hyperplasia of gastric mucosa - Google Patents
Application of Chinese medicine composition in preparation of medicine for treating atypical hyperplasia of gastric mucosa Download PDFInfo
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Abstract
The invention discloses an application of a Chinese medicine composition in preparation of a medicine for treating the atypical hyperplasia of the gastric mucosa. The medicine is formed by combining Chinese medicines such as radix astragali, glossy privet fruit, and the like. The Chinese medicine composition has the efficacy of supplementing qi and nourishing yin, spleen kidney nourishing and eliminating stagnation activate meridians, is tangential to pathogenesis and is clinically used for treating the disease to obtain a better effect. The invention has rational proportion and small adverse reaction of the medicine, and can be used by patients for a long time.
Description
Technical field
The present invention relates to a kind of new purposes of Chinese medicine composition, particularly, relate to the application of a kind of Chinese medicine composition in the medicine of preparation treatment atypical hyperplasia of gastric mucosa, belong to the Chinese medicine application.
Background technology
Atypical hyperplasia of gastric mucosa or title special-shaped hyperplasia (ATP) and big intestinal epithelial metaplasia (IM), see chronic atrophic gastritis (CAG), according to World Health Organization's unified understanding in 1978, ATP and IM are precancerous lesions, the traditional Chinese medical science does not have respective name, on the 5th national the spleen-stomach disease in 1989, the arthromyodynia seminar, has passed through the diagnosis name that " chronic atrophic gastritis " belongs to " stomach painful abdominal mass ", because ATP, IM are more common in deficient syndrome, Dong Shi is called " stuffy sensation of deftciency type ".[Dong Jianhua. stuffy sensation of deftciency type (precancerous lesions of chronic atrophic gastritis) treatment by Chinese herbs is observed. Chinese Medicine journal, 1989,4 (6), 12].
Have the patients clinical performance of atypical hyperplasia of gastric mucosa different, primary symptom is epigastrium pain discomfort or dull pain, and is noisy, loss of appetite, belch, acid regurgitation can be arranged, feels sick, vomiting etc., and be and continue or outbreak repeatedly, and the state of an illness is touching, is difficult to cure.Belong to " gastric abscess " category of motherland's medical science, its pathogenesis is thought deficiency of QI in middle-JIAO more, or stagnation of liver-QI with deficiency of the spleen, or qi depression to blood stasis.Starts with from stagnation of liver-QI with deficiency of the spleen more than the treatment, double expectorant, the reality of the stasis of blood controlled obtained certain effect clinically, but case is more, and is repeatable poor.
Atypical hyperplasia and gastric cancer are all the proliferative lesion of gastric gland tissue, gastric cancer emergence pattern according to Corra is thought, gastric cancer be-seriality, progressive process, promptly from acute gastritis-chronic gastritis-chronic atrophic gastritis-intestinalization-special-shaped hyperplasia-gastric cancer, this evolution process all should pass through the atypical hyperplasia stage on the cytology, and particularly middle severe atypical hyperplasia and gastric cancer are in close relations.This phase, can be defined as network with traditional Chinese medical science network ens morbi and cease into the long-pending pathology stage.The modern pharmacology of the anti-gastric mucosa damage of Chinese medicine mainly shows following several aspect: strengthen gastric mucosa-bicarbonate barrier (gastric mucosal protection effect), improve gastric mucosa blood flow and microcirculation, free radical resisting damage etc.
Gastric cancer is one of modal malignant tumor in the world, and its mortality rate occupies second.In a single day gastric cancer made a definite diagnosis, and prognosis is often very poor, so effective preventive means reaches early stage diagnosis, treatment seems particularly important.Middle severe atypical hyperplasia and big intestinal epithelial metaplasia all belong to gastric precancerous lesion, canceration rate 2.5-10%.But people recognize from needing a very long process to canceration before the cancer, can reduce the incidence gastric cancer rate greatly if can discern and give effective treatment early.According to the tumor invasion stage theory, this is the gene mutation stage, the gastric mucosa of producer sudden change, but canceration under certain condition, if can block or reverse this process, nothing is suspected to have great realistic meaning.
Precancerous lesion is a non-specific process, have cell degradation and the characteristics of breeding long-term co-existence, though shortcoming appears in the damage of the metabolism of the metabolism of its cell, particularly nucleic acid, DNA and the meeting of reparation, even the activation of some gene occurs, but these all are reversible processes.Modern medicine thinks that the primary disease cause of disease is still indeterminate, may be relevant with following factors: (1) HP infects.(2) immune factor.(3) oncogene overexpression.(4) diet environmental factors.(5) bile reflux.(6) nervus centralis imbalance.(7) medicine infringement.Multiple combined factors acts on gastric mucosa, causes the mucosa chronic inflammation to become, and cell intestinalization, atypical hyperplasia take place, thus the normal differentiation of forfeiture.
Before gastric cancer takes place in the very long evolution process, the detection of Serum Pepsinogen (PG) is an index of estimating gastric mucosal lesions, find serum PG abnormality adult residents gastroscopic biopsy and pathologic finding, the atrophy of gastric mucosa body of gland, intestinal epithelial metaplasia and glandular epithelium atypical hyperplasia incidence rate obviously increase.
Gastric mucosal lesions does not still have effective Therapeutic Method at present, and generally based on the support of suiting the medicine to the illness, mucous membrane protection treatment, but clinical efficacy is not good enough, and has certain side effect.Chinese medicine lays particular emphasis on from integral body, and dialectical opinion is controlled, and strengthening the gastric mucosa defense mechanism has himself characteristics and advantage.Chinese medicine has effect too many levels, many target spots, evident in efficacy, characteristics such as side effect is little, confirms that by a large amount of literature research Chinese medicine really can make part A TP or IM reverse or disappears, and makes the gastric cancer control become possibility.
The present invention is the improvement invention of carrying out on No. 200410012347.4 basis, quotes in full the content of this patent document record at this.The application of unexposed this Chinese medicine composition of above-mentioned patent in treatment atypical hyperplasia of gastric mucosa medicine.The present invention has carried out correlational study on its basis, and the application of this Chinese medicine composition in preparation treatment atypical hyperplasia of gastric mucosa medicine is provided.
Summary of the invention
The present invention relates to a kind of new purposes of Chinese medicine composition, particularly, relate to the application of a kind of Chinese medicine composition in preparation treatment atypical hyperplasia of gastric mucosa medicine.
The objective of the invention is to: be the clinical medicine that effective treatment atypical hyperplasia of gastric mucosa that a kind of medical material compatibility is reasonable, therapeutic effect is desirable, have no side effect is provided.
Chinese medicine of the present invention all can be concocted according to " national Chinese medicine processing standard " or " Chinese medicine voluminous dictionary ".Medicine of the present invention is to be made by the crude drug that comprises following weight portion ratio:
Radix Astragali 120-360 Fructus Ligustri Lucidi 100-300 Radix Ginseng 30-95 Ganoderma 30-95
Rhizoma Curcumae 65-195 Rhizoma Atractylodis Macrocephalae 30-90 Herba Scutellariae Barbatae 65-195 Herb Gynostemmae Pentaphylli 120-360
Poria 30-95 Endothelium Corneum Gigeriae Galli 15-45 Herba Duchesneae Indicae 65-195 Herba Solani Lyrati 65-195
Herba Artemisiae Scopariae 65-195 Radix Cynanchi Paniculati 65-195 Eupolyphaga Seu Steleophaga 10-30 Herba Hedyotidis Diffusae 65-195.
Preferably, this Chinese medicine composition is made by following bulk drugs:
The Radix Astragali 120 Fructus Ligustri Lucidi 300 Radix Ginsengs 30 Ganodermas 95 Rhizoma Curcumae 65
The Rhizoma Atractylodis Macrocephalae 90 Herba Scutellariae Barbataes 65 Herb Gynostemmae Pentaphylli 360 Poria 30 Endothelium Corneum Gigeriae Galli 45
Herba Duchesneae Indicae 65 Herba Solani Lyratis 195 Herba Artemisiae Scopariaes 65 Radix Cynanchi Paniculatis 195
Eupolyphaga Seu Steleophaga 10 Herba Hedyotidis Diffusaes 195.
Or
The Radix Astragali 360 Fructus Ligustri Lucidi 100 Radix Ginsengs 95 Ganodermas 30 Rhizoma Curcumae 195
The Rhizoma Atractylodis Macrocephalae 30 Herba Scutellariae Barbataes 195 Herb Gynostemmae Pentaphylli 120 Poria 95 Endothelium Corneum Gigeriae Galli 15
Herba Duchesneae Indicae 195 Herba Solani Lyratis 65 Herba Artemisiae Scopariaes 195 Radix Cynanchi Paniculatis 65
Eupolyphaga Seu Steleophaga 30 Herba Hedyotidis Diffusaes 65.
Or
The Radix Astragali 250 Fructus Ligustri Lucidi 200 Radix Ginsengs 65 Ganodermas 65 Rhizoma Curcumae 132
The Rhizoma Atractylodis Macrocephalae 64 Herba Scutellariae Barbataes 128 Herb Gynostemmae Pentaphylli 256 Poria 65 Endothelium Corneum Gigeriae Galli 30
Herba Duchesneae Indicae 128 Herba Solani Lyratis 128 Herba Artemisiae Scopariaes 128 Radix Cynanchi Paniculatis 128
Herba Hedyotidis Diffusae 128 Eupolyphaga Seu Steleophagas 20.
Preferably, in the raw materials used medicine of described Chinese medicine composition, the Rhizoma Atractylodis Macrocephalae is a Rhizoma Atractylodis Macrocephalae (parched).
The present invention also provides the active component of described Chinese medicine composition to be made by following steps:
(1), take by weighing Chinese crude drug, clean according to the crude drug part by weight;
(2), Fructus Ligustri Lucidi, people participate in 6-10 and doubly measure the 50-90% ethanol extraction 1-3 time, each 1-4 hour, merge extractive liquid, filtered, filtrate recycling ethanol is not to there being the alcohol flavor, medicinal residues are standby;
(3), Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, Radix Cynanchi Paniculati add 4-8 times of water gaging and extract volatile oil, collects volatile oil, device is collected in addition, residue and aqueous solution are standby;
(4), Eupolyphaga Seu Steleophaga, Endothelium Corneum Gigeriae Galli, Poria powder are broken into fine powder;
(5), the Radix Astragali, Ganoderma, Herba Hedyotidis Diffusae, Herba Scutellariae Barbatae, Herb Gynostemmae Pentaphylli, Herba Duchesneae Indicae, Herba Solani Lyrati, Herba Artemisiae Scopariae, with residue after the alcohol extraction of gained Radix Ginseng, Fructus Ligustri Lucidi in the step (1), and gained Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, Radix Cynanchi Paniculati are carried oil back residue and aqueous solution merges in the step (2), add 7-10 times of water gaging, heating decocts 1-3 time, each 1-3 hour, merge decoction liquor, add gained Radix Ginseng, Fructus Ligustri Lucidi alcohol extract in the step (1), be condensed into clear paste, drying is pulverized, and is standby;
The dried cream powder of step (4) gained comminuted powder, step (3) gained volatile oil and step (5) gained constitutes the active component of this Chinese medicine composition jointly.
The dosage form of medicine of the present invention is capsule, tablet, powder, oral liquid, soft capsule, pill, tincture, syrup, suppository, gel, spray or injection.
The preparation method of capsule wherein, form by following steps:
(1), take by weighing Chinese crude drug, clean according to the crude drug part by weight;
(2), Radix Ginseng, Fructus Ligustri Lucidi, add 8 times of amount 70% alcohol reflux 2 times, 3 hours for the first time, 2 hours for the second time, merge extractive liquid, reclaimed ethanol to there not being the alcohol flavor, Radix Ginseng, Fructus Ligustri Lucidi residue are standby;
(3), Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, Radix Cynanchi Paniculati, united extraction volatile oil is carried the oil time and is no less than 8 hours, volatile oil device is in addition collected, residue and aqueous solution are standby;
(4), Eupolyphaga Seu Steleophaga, Endothelium Corneum Gigeriae Galli two flavor animal drugs, washing, 60 ℃ of oven dry merge with Poria, are ground into 100 order powder, the sterilization back is standby;
(5), the Radix Astragali, Ganoderma, Herba Hedyotidis Diffusae, Herba Scutellariae Barbatae, Herb Gynostemmae Pentaphylli, Herba Duchesneae Indicae, Herba Solani Lyrati, Herba Artemisiae Scopariae, with residue after the alcohol extraction of gained Radix Ginseng, Fructus Ligustri Lucidi in the step (2), and gained Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, Radix Cynanchi Paniculati are carried oil back residue and aqueous solution merges in the step (3), add 9 times of water gagings, heating decocts 2 times, each 2 hours, merge decoction liquor, add gained Radix Ginseng, Fructus Ligustri Lucidi alcohol extract in the step (2), be condensed into the clear paste of relative density 1.20-1.25, drying is pulverized, and is standby;
Step (5) gained dried cream powder is added suitable acceptable accessories granulates;
(6), gained volatile oil in the step (3) is sprayed in the fine powder of gained Poria, Eupolyphaga Seu Steleophaga, Endothelium Corneum Gigeriae Galli in the step poly-(4), mixing, with the granule mixing of gained in the step (5), airtight half an hour, promptly encapsulated.
Other dosage forms of medicine of the present invention are in proportion after the weighting raw materials, adopt conventional preparation method preparation, for example, the preparation technology of Fan Biting " pharmacy of Chinese materia medica " (Shanghai Science Press 1997 December the 1st edition) record makes the acceptable regular dosage form of pharmaceutics.
For above-mentioned dosage form can be realized, need when these dosage forms of preparation, to add the pharmacy acceptable auxiliary, for example: filler, disintegrating agent, lubricant, suspending agent, binding agent, sweeting agent, correctives, antiseptic, substrate etc.Filler comprises: starch, pregelatinized Starch, lactose, mannitol, chitin, microcrystalline Cellulose, sucrose etc.; Disintegrating agent comprises: starch, pregelatinized Starch, microcrystalline Cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose etc.; Lubricant comprises: magnesium stearate, sodium lauryl sulphate, Pulvis Talci, silicon dioxide etc.; Suspending agent comprises: polyvinylpyrrolidone, microcrystalline Cellulose, sucrose, agar, hydroxypropyl emthylcellulose etc.; Binding agent comprises, starch slurry, polyvinylpyrrolidone, hydroxypropyl emthylcellulose etc.; Sweeting agent comprises: saccharin sodium, Aspartane, sucrose, cyclamate, enoxolone etc.; Correctives comprises: sweeting agent and various essence; Antiseptic comprises: parabens, benzoic acid, sodium benzoate, sorbic acid and its esters, benzalkonium bromide, fixed, the Folium eucalypti globueli (Eucalyptus globulus Labill.) wet goods of acetic acid chloroethene; Substrate comprises: PEG6000, PEG4000, insect wax etc.For making above-mentioned dosage form can realize pharmacy of Chinese materia medica, need when these dosage forms of preparation, to add acceptable other adjuvant of pharmacy (adjuvant of each dosage form record among the Fan Biting " pharmacy of Chinese materia medica ", Shanghai Science Press December in 1997 the 1st edition).
Medicine composite for curing of the present invention makes the spleen renal function vigorous with tonifying speen and tonifying kidney Zhi Qiben, the merit that performance " is supported just long-pending from removing "; Its mark of ruling by law of being aided with silt detoxifcation, resolving mass and removing the obstruction of the collateral, thereby hot detoxicatingization, the ruton stasis of blood is gone.
Pharmaceutical composition of the present invention has the effect of supplementing QI and nourishing YIN, strengthening spleen, tonifying kidney, resolving mass and removing the obstruction of the collateral, and clinical experiment confirms the treatment atypical hyperplasia of gastric mucosa, the generation of prevention gastric cancer, determined curative effect.Compatibility of the present invention is reasonable, and is simple, is pure Chinese medicinal preparation, and untoward reaction is little, but the patients life-time service.
The specific embodiment
Embodiment 1:
The crude drug prescription is:
Radix Astragali 250g Fructus Ligustri Lucidi 200g Radix Ginseng 65g Ganoderma 65g Rhizoma Curcumae 132g
The Rhizoma Atractylodis Macrocephalae (stir-fry) 64g Herba Scutellariae Barbatae 128g Herb Gynostemmae Pentaphylli 256g Poria 65g Endothelium Corneum Gigeriae Galli 30g
Herba Duchesneae Indicae 128g Herba Solani Lyrati 128g Herba Artemisiae Scopariae 128g Radix Cynanchi Paniculati 128g
Herba Hedyotidis Diffusae 128g Eupolyphaga Seu Steleophaga 20g
Preparation method is:
(1), take by weighing Chinese crude drug, clean according to the crude drug part by weight;
(2), Radix Ginseng, Fructus Ligustri Lucidi, add 8 times of amount 70% alcohol reflux 2 times, 3 hours for the first time, 2 hours for the second time, merge extractive liquid, reclaimed ethanol to there not being the alcohol flavor, Radix Ginseng, Fructus Ligustri Lucidi residue are standby;
(3), Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae (stir-fry), Radix Cynanchi Paniculati, united extraction volatile oil is carried the 8 hours time of oil, volatile oil device is in addition collected, residue and aqueous solution are standby;
(4), Eupolyphaga Seu Steleophaga, Endothelium Corneum Gigeriae Galli, washing, 60 ℃ of oven dry merge with Poria, are ground into 100 order powder, in 3KGY
60Standby after the CO-r radiation sterilization;
(5), the Radix Astragali, Ganoderma, Herba Hedyotidis Diffusae, Herba Scutellariae Barbatae, Herb Gynostemmae Pentaphylli, Herba Duchesneae Indicae, Herba Solani Lyrati, Herba Artemisiae Scopariae, with residue after the alcohol extraction of gained Radix Ginseng, Fructus Ligustri Lucidi in the step (2), and gained Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, Radix Cynanchi Paniculati are carried behind the oil in the step (3) residue and aqueous solution merge, and adds 9 times of water gagings, heating decocts 2 times, each 2 hours, merge decoction liquor, add gained Radix Ginseng, Fructus Ligustri Lucidi alcohol extract in the step (2), be condensed into the clear paste of relative density 1.20-1.25, drying is pulverized, and is standby;
(6), step (5) gained dried cream powder is added starch 134 grams, use 85% alcohol granulation;
(7), with gained volatile oil 85% dissolve with ethanol in the step (3), spray in the fine powder of gained Poria, Eupolyphaga Seu Steleophaga, Endothelium Corneum Gigeriae Galli in the step poly-(4), mixing with the granule mixing of the middle gained of step (6), airtight half an hour, is packed 1000 capsules into promptly.
Embodiment 2:
The crude drug prescription is:
Radix Astragali 360g Fructus Ligustri Lucidi 100g Radix Ginseng 95g Ganoderma 30g Rhizoma Curcumae 195g
The Rhizoma Atractylodis Macrocephalae (stir-fry) 30g Herba Scutellariae Barbatae 195g Herb Gynostemmae Pentaphylli 120g Poria 95g Endothelium Corneum Gigeriae Galli 15g
Herba Duchesneae Indicae 195g Herba Solani Lyrati 65g Herba Artemisiae Scopariae 195g Radix Cynanchi Paniculati 65g
Eupolyphaga Seu Steleophaga 30g Herba Hedyotidis Diffusae 65g
Preparation method is:
(1), take by weighing Chinese crude drug, clean according to the crude drug part by weight;
(2), Radix Ginseng, Fructus Ligustri Lucidi, add 6 times of amount 90% alcohol reflux 4 hours, extracting solution reclaims ethanol to there not being the alcohol flavor, Radix Ginseng, Fructus Ligustri Lucidi residue are standby;
(3), Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae (stir-fry), Radix Cynanchi Paniculati merge, and adds 4 times of water gagings and extract volatile oil, carries the 10 hours time of oil, volatile oil device is in addition collected, residue and aqueous solution are standby;
(4), Eupolyphaga Seu Steleophaga, Endothelium Corneum Gigeriae Galli, washing, 60 ℃ of oven dry merge with Poria, are ground into 100 order powder, in 3KGY
60Standby after the CO-r radiation sterilization;
(5), the Radix Astragali, Ganoderma, Herba Hedyotidis Diffusae, Herba Scutellariae Barbatae, Herb Gynostemmae Pentaphylli, Herba Duchesneae Indicae, Herba Solani Lyrati, Herba Artemisiae Scopariae, with residue after the alcohol extraction of gained Radix Ginseng, Fructus Ligustri Lucidi in the step (2), and gained Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, Radix Cynanchi Paniculati are carried behind the oil in the step (3) residue and aqueous solution merge, add 7 times of water gagings, heating decocts 3 times, 1 hour for the first time, 2 hours for the second time, 3 hours for the third time, merge decoction liquor, add gained Radix Ginseng, Fructus Ligustri Lucidi alcohol extract in the step (2), be condensed into the clear paste of relative density 1.20-1.25, drying is pulverized, and is standby;
(6), step (5) gained dried cream powder is added starch 134 grams, use 78% alcohol granulation;
(7), with gained volatile oil 85% dissolve with ethanol in the step (3), spray in the fine powder of gained Poria, Eupolyphaga Seu Steleophaga, Endothelium Corneum Gigeriae Galli in the step poly-(4), mixing, with the granule mixing of the middle gained of step (6), formulation method is made 1000 tablets of tablets routinely.
Embodiment 3:
The crude drug prescription is:
Radix Astragali 120g Fructus Ligustri Lucidi 300g Radix Ginseng 30g Ganoderma 95g Rhizoma Curcumae 65g
Rhizoma Atractylodis Macrocephalae 90g Herba Scutellariae Barbatae 65g Herb Gynostemmae Pentaphylli 360g Poria 30g Endothelium Corneum Gigeriae Galli 45g
Herba Duchesneae Indicae 65g Herba Solani Lyrati 195g Herba Artemisiae Scopariae 65g Radix Cynanchi Paniculati 195g
Eupolyphaga Seu Steleophaga 10g Herba Hedyotidis Diffusae 195g
Preparation method is:
(1), take by weighing Chinese crude drug, clean according to the crude drug part by weight;
(2), Radix Ginseng, Fructus Ligustri Lucidi, add 10 times of amount 50% alcohol reflux 2 times, 3 hours for the first time, 2 hours for the second time, merge extractive liquid, reclaimed ethanol to there not being the alcohol flavor, Radix Ginseng, Fructus Ligustri Lucidi residue are standby;
(3), Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, Radix Cynanchi Paniculati merge, and adds 10 times of water gagings and extract volatile oil, carries the 6 hours time of oil, volatile oil device collection in addition, residue and aqueous solution are standby;
(4), Eupolyphaga Seu Steleophaga, Endothelium Corneum Gigeriae Galli, washing, 60 ℃ of oven dry merge with Poria, are ground into 100 order powder, in 3KGY
60Standby after the CO-r radiation sterilization;
(5), the Radix Astragali, Ganoderma, Herba Hedyotidis Diffusae, Herba Scutellariae Barbatae, Herb Gynostemmae Pentaphylli, Herba Duchesneae Indicae, Herba Solani Lyrati, Herba Artemisiae Scopariae, with residue after the alcohol extraction of gained Radix Ginseng, Fructus Ligustri Lucidi in the step (2), reach residue and the aqueous solution that gained Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, Radix Cynanchi Paniculati are carried behind the oil in the step (3) and merge, add 10 times of water gagings, heating decocted 3 hours, merge decoction liquor, add gained Radix Ginseng, Fructus Ligustri Lucidi alcohol extract in the step (2), be condensed into the clear paste of relative density 1.20-1.25, drying, pulverize, standby;
(6), with gained volatile oil 80% dissolve with ethanol in the step (3), spray in the fine powder of gained Poria, Eupolyphaga Seu Steleophaga, Endothelium Corneum Gigeriae Galli in the step poly-(4), mixing, with the dried cream powder of the middle gained of step (5), formulation method is made 1000 ball pills routinely.
For confirming the curative effect of medicine of the present invention in the treatment atypical hyperplasia of gastric mucosa, use the capsule (to call medicine of the present invention in the following text) that makes by embodiment 1, carried out following clinical experimental study:
Embodiment 4:
Medicine composite for curing atypical hyperplasia of gastric mucosa of the present invention clinical research
One object of study
All cases are all attached to mountain range hospital in June, 2004-2006 year December from Hebei Medical University, the chronic atrophic gastritis companion gastric mucosa atypical hyperplasia patient that the Digestive System Department outpatient service is accepted for medical treatment.
1. physical data:
Adopt the principle of randomized controlled, the assertive evidence patient is divided into two groups at random, promptly " vitacoenzyme " group (matched group) and " pharmaceutical composition of the present invention " is organized (treatment group), matched group is totally 110 examples, wherein male 57 examples, women 53 examples, 45 ± 5.2 years old mean age, moderate dysplasia 86 examples, severe dysplasia 24 examples, the treatment group is totally 117 examples, wherein male 59 examples, woman's 58 examples, 43 ± 6.1 years old mean age, moderate dysplasia 89 examples, severe dysplasia 28 examples, totally 217 example ages were at 30～70 years old, The median age 50 years old, the course of disease 3 months～10 years, treatment group and matched group are at the age, sex, the course of disease; lesion degree; aspect all similar such as gastropathy character; no difference of science of statistics has comparability.
2. diagnostic criteria:
2.1 tcm diagnosis standard: with reference to (nineteen ninety-five " the clinical guidance principle of new Chinese medicine treatment chronic atrophic gastritis " and chronic atrophic gastritis symptom scalar quantization standard thereof).
Epigastrium pain or discomfort, noisy are arranged, folder loss of appetite, shortness of breath and fatigue, belch, acid regurgitation, feel sick, symptom such as vomiting, the dark red yellow and greasy fur of tongue, thready and rolling pulse.Determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs is deficiency of both QI and YIN, noxious dampness phlegm stagnation in collateral type.
2.2 Western medicine diagnose standard: according to diagnosis and curative effect determinate standard that October nineteen eighty-two, whole nation atrophic gastritis cooperative groups proposed, (1) chronic course of disease has above-mentioned symptom; (2) gastroscopy can show as the feature of chronic atrophic gastritis; (3) the gastric mucosa histopathological examination is diagnosed as moderate, severe dysplasia, or/and the imperfection colonic epitheliumization is given birth to.
3. include standard in:
3.1 meet above-mentioned Western medicine diagnose standard;
3.2 meet the diagnostic criteria of traditional Chinese medical science gastric abscess, dialectical is deficiency of both QI and YIN, noxious dampness phlegm stagnation in collateral;
3.3 30～70 years old age;
3.4 also cooperating, the voluntary accepting treatment observes and the examiner;
3.5 the course of disease 3 months～10 years.
4. exclusion standard:
4.1 diseases such as partial gastritis behind canceration, gastric ulcer, the stomach operation, polyp have taken place;
4.2 mismatch treatment;
4.3 serious hepatic and renal function damage;
4.4 concurrent other major diseases;
4.5 Chinese medical discrimination does not belong to deficiency of both QI and YIN, noxious dampness phlegm stagnation in collateral.
5. rejecting standard:
Do not meet and include the case standard in, do not take medicine in accordance with regulations, data is incomplete, can't judge curative effect and safety.
6. key problem in technology:
Being that gastroscope is drawn materials is responsible for by the special messenger, and the position of drawing materials is at anterior angle position, stomach angle, and the position of drawing materials before and after the treatment wants consistent, and to guarantee the concordance of clinical observation, it is careful that the pathological section cross-reference is wanted, and Chinese medical discrimination is wanted accurately.
Two methods:
1. grouping: selected patient is divided into two groups by table of random number, and 117 examples are organized in treatment, matched group 110 examples.
2. Therapeutic Method:
2.1 Primary Care: be chronic atrophic gastritis according to two groups of patient's primary affections, the positive person of HP (helicobacter pylori) is more, and HP (+) person all adds clarithromycin tablet 0.5g/ time among two groups of patients, 2 times/day; Metronidazole Tablet 0.4g/ time, 2 times/day, oral first quarter moon is eradicated the back after testing and is stopped using.
2.2 in Primary Care, the treatment group: pharmaceutical composition of the present invention (Shijiazhuang Yiling Pharmaceutical Co., Ltd's production), oral, each 5, every day 3 times; The oral vitacoenzyme of matched group (Taishan, Guangdong pharmaceutical factory) 0.8g/ time, 3 treatments every day.
2.3 the course of treatment: be three months two groups of courses of treatment.
3. diet and nursing: two groups of patients all take the following measure of nursing when carrying out Drug therapy.
3.1 chew carefully and swallow slowly, reduce the stimulation of food to gastric mucosa.
3.2 diet should have the rhythm and pace of moving things, avoids eating and drinking too much at one meal and food nothing regularly.
3.3 the health of being careful in one's diet is stopped the infringement of external microbe to gastric mucosa.
3.4 accomplish the meticulousr easy digestion of feed, alimentary diet as far as possible.
3.5 foods such as light few food is fertile, sweet, thick, greasy, pungent are drunk and strong tea less.Need many feeds to be rich in the food of beta-carotene, vitamin C and folic acid on ordinary days, as Fructus actinidiae chinensis, Citrus, Fructus Fragariae Ananssae and animal livers, green vegetables etc.
3.6 avoid medicine, as far as possible as aspirin, indometacin, erythromycin, cortisone etc. with the infringement gastric mucosa.
4. observational technique:
Set up the Clinical Follow-up card, symptom variation, dysplasia reverse situation before and after the record treatment.
4.1 health giving quality index:
(1) clinical symptoms before and after the treatment; The gastroscopy pathology diagnosis.
(2) gather venous blood 5ml before and after the treatment on an empty stomach.Centrifugal serum adopts equilibrium saturation to set up PGI time resolved fluoro-immunoassay method, detects PGI (pepsinogen I) and PGII (pepsinogen I I) level.
4.2 safety indexes: monitored hemogram, routine urinalysis, hepatic and renal function before and after the treatment and in the treatment in per ten days, electrocardiogram changes and other untoward reaction (comprising anaphylaxis, uncomfortable sensation etc.) once, are estimated its safety.
5. instrument: use Japanese Olypus-Q240 type gastroscope, full-automatic TRFIA detector (AutoDELFIA
1235, EG﹠amp; The G-Wallac product)
6. efficacy determination:
6.1 clinical efficacy is judged: according to the diagnosis and the curative effect determinate standard of national atrophic gastritis cooperative groups proposition.Histopathologic slide: by the outgrowth Padova International Classification of Weishang skin (1998, Italy).
Produce effects: above-mentioned clinical symptom disappearance, gastroscope check are seen the basic recovery of mucosa infringement, and pathology shows the atypical hyperplasia disappearance or reduces more than the twice;
Effectively: above-mentioned clinical symptoms abdominal discomfort disappears, holds concurrently the disease disappearance more than 3, and the infringement of gastroscope check gastric mucosa takes a turn for the better, and pathology atypical hyperplasia degree alleviates more than one times;
Invalid: clinical symptoms does not have obvious improvement, and gastroscope check gastric mucosa infringement nothing is clearly better, and pathology does not have improvement or increases the weight of.
6.2 traditional Chinese medical science disease efficacy determination:
" the clinical guidance principle of new Chinese medicine treatment chronic atrophic gastritis " disease is heavy three grades in being classified as gently, drafts following standard:
Produce effects: the disease classification descends more than two.
Effectively: the disease classification descends more than 1.
Invalid: the disease classification does not have improvement or increases the weight of.
7. statistical method:
All data of measurement data relatively and before and after treating compare between group with mean (X) ± standard deviation (s) expression, determine earlier whether sample meets normal distribution, and capable again homogeneity test of variance is selected the t check for use according to homogeneity of variance then, correction t check, paired t-test; Enumeration data adopts χ
2Check.Two groups of clinical efficacies relatively adopt Ridit to analyze, and there is statistical significance P＜0.05.
Three results:
1 clinical efficacy compares:
In two groups effectively counting rate meter, treatment group total effective rate is significantly higher than matched group (P＜0.01)
Table 1 treatment group and matched group clinical efficacy be [example (%)] relatively
Treatment group and matched group total effective rate are respectively 92.3%, 66.4% (P＜0.01).
Compare before and after 2 serum PG I, the PGII treatment
The interpretation of result of PGI, PGII after testing, treatment group serum PG I, the PGII after the treatment is starkly lower than treatment preceding (P＜0.05).There were significant differences.Matched group no significant difference (P＞0.05)
227 routine gastric mucosa precancerous lesion patients serum PG levels before and after table 2 treatment
With the treatment before compare * P＜0.05
3 traditional Chinese medical science disease curative effects compare:
Relatively treatment group of two groups of total effective rates total effective rate is significantly higher than matched group.
Table 3 liang group patient's disease curative effect comparative example (%)
Annotate: two groups of clinical efficacies are relatively through χ
2Check, p＜0.05, significance.
4. untoward reaction: period in a medicine treatment group is not seen obvious adverse reaction, matched group liver transaminase one property crossed rising 3 examples, a week back recovery naturally.
Four conclusions
Can improve body immunity with having, strengthen the activity of separating toxenzyme in the human body, anticancer is grown and is prevented that " vitacoenzyme " of the fatty abnormal metabolism of cell contrasts, and positive findings occurred, it is effective really to illustrate that pharmaceutical composition of the present invention is used for gastric precancerous lesion, no obvious toxic-side effects.
Confirm that by pathological biopsy 227 routine gastric mucosa atypical hyperplasia patients of screening carry out the contrast therapy of pharmaceutical composition of the present invention, serum PG I, PGII and PGI/PGII detect before and after 3 months, find that the serum PG level improves that there were significant differences (P＜0.05).Pharmaceutical composition of the present invention also is described in gastric mucosa reparation, improves immunity, impel the gastric mucosa atypical hyperplasia to reverse and have certain effect to normal mucosa.
Claims (10)
1. the Chinese medicine composition application in preparation treatment atypical hyperplasia of gastric mucosa medicine is characterized in that being that the crude drug of following weight portion ratio is made:
2. application according to claim 1 is characterized in that being made by following bulk drugs:
The Radix Astragali 120 Fructus Ligustri Lucidi 300 Radix Ginsengs 30 Ganodermas 95 Rhizoma Curcumae 65 Rhizoma Atractylodis Macrocephalaes 90
Herba Scutellariae Barbatae 65 Herb Gynostemmae Pentaphylli 360 Poria 30 Endothelium Corneum Gigeriae Galli 45 Herba Duchesneae Indicaes 65
Herba Solani Lyrati 195 Herba Artemisiae Scopariaes 65 Radix Cynanchi Paniculatis 195 Eupolyphaga Seu Steleophagas 10 Herba Hedyotidis Diffusaes 195.
3. application according to claim 1 is characterized in that being made by following bulk drugs:
The Radix Astragali 360 Fructus Ligustri Lucidi 100 Radix Ginsengs 95 Ganodermas 30 Rhizoma Curcumae 195 Rhizoma Atractylodis Macrocephalaes 30
Herba Scutellariae Barbatae 195 Herb Gynostemmae Pentaphylli 120 Poria 95 Endothelium Corneum Gigeriae Galli 15 Herba Duchesneae Indicaes 195
Herba Solani Lyrati 65 Herba Artemisiae Scopariaes 195 Radix Cynanchi Paniculatis 65 Eupolyphaga Seu Steleophagas 30 Herba Hedyotidis Diffusaes 65.
4. application according to claim 1 is characterized in that being made by following bulk drugs:
The Radix Astragali 250 Fructus Ligustri Lucidi 200 Radix Ginsengs 65 Ganodermas 65 Rhizoma Curcumae 132 Rhizoma Atractylodis Macrocephalaes 64
Herba Scutellariae Barbatae 128 Herb Gynostemmae Pentaphylli 256 Poria 65 Endothelium Corneum Gigeriae Galli 30 Herba Duchesneae Indicaes 128
Herba Solani Lyrati 128 Herba Artemisiae Scopariaes 128 Radix Cynanchi Paniculatis 128 Herba Hedyotidis Diffusaes 128 Eupolyphaga Seu Steleophagas 20.
5. according to each described application of claim 1-4, it is characterized in that the described Rhizoma Atractylodis Macrocephalae is a Rhizoma Atractylodis Macrocephalae (parched).
6. according to each described application of claim 1-4, it is characterized in that the active component of described Chinese medicine composition is made by following steps:
(1), take by weighing Chinese crude drug, clean according to the crude drug part by weight;
(2), Fructus Ligustri Lucidi, people participate in 6-10 and doubly measure the 50-90% ethanol extraction 1-3 time, each 1-4 hour, merge extractive liquid, filtered, filtrate recycling ethanol is not to there being the alcohol flavor, medicinal residues are standby;
(3), Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, Radix Cynanchi Paniculati add 4-8 times of water gaging and extract volatile oil, collects volatile oil, device is collected in addition, residue and aqueous solution are standby;
(4), Eupolyphaga Seu Steleophaga, Endothelium Corneum Gigeriae Galli, Poria powder are broken into fine powder;
(5), the Radix Astragali, Ganoderma, Herba Hedyotidis Diffusae, Herba Scutellariae Barbatae, Herb Gynostemmae Pentaphylli, Herba Duchesneae Indicae, Herba Solani Lyrati, Herba Artemisiae Scopariae, with residue after the alcohol extraction of gained Radix Ginseng, Fructus Ligustri Lucidi in the step (1), and gained Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, Radix Cynanchi Paniculati are carried oil back residue and aqueous solution merges in the step (2), add 7-10 times of water gaging, heating decocts 1-3 time, each 1-3 hour, merge decoction liquor, add gained Radix Ginseng, Fructus Ligustri Lucidi alcohol extract in the step (1), be condensed into clear paste, drying is pulverized, and is standby;
The dried cream powder of step (4) gained comminuted powder, step (3) gained volatile oil and step (5) gained constitutes the active component of this Chinese medicine composition jointly.
7. according to each described application of claim 1-4, it is characterized in that described pharmaceutical dosage form is capsule, tablet, powder, oral liquid, pill, tincture, syrup, suppository, gel, spray or injection.
8. application according to claim 7 is characterized in that this medicine capsule is made up of following steps:
(1), take by weighing Chinese crude drug, clean according to the crude drug part by weight;
(2), Radix Ginseng, Fructus Ligustri Lucidi, add 8 times of amount 70% alcohol reflux 2 times, 3 hours for the first time, 2 hours for the second time, merge extractive liquid, reclaimed ethanol to there not being the alcohol flavor, Radix Ginseng, Fructus Ligustri Lucidi residue are standby;
(3), Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, Radix Cynanchi Paniculati, united extraction volatile oil is carried the oil time and is no less than 8 hours, volatile oil device is in addition collected, residue and aqueous solution are standby;
(4), Eupolyphaga Seu Steleophaga, Endothelium Corneum Gigeriae Galli two flavor animal drugs, washing, 60 ℃ of oven dry merge with Poria, are ground into 100 order powder, the sterilization back is standby;
(5), the Radix Astragali, Ganoderma, Herba Hedyotidis Diffusae, Herba Scutellariae Barbatae, Herb Gynostemmae Pentaphylli, Herba Duchesneae Indicae, Herba Solani Lyrati, Herba Artemisiae Scopariae, with residue after the alcohol extraction of gained Radix Ginseng, Fructus Ligustri Lucidi in the step (2), and gained Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, Radix Cynanchi Paniculati are carried oil back residue and aqueous solution merges in the step (3), add 9 times of water gagings, heating decocts 2 times, each 2 hours, merge decoction liquor, add gained Radix Ginseng, Fructus Ligustri Lucidi alcohol extract in the step (2), be condensed into the clear paste of relative density 1.20-1.25, drying is pulverized, and is standby;
Step (5) gained dried cream powder is added suitable acceptable accessories granulates;
(6), gained volatile oil in the step (3) is sprayed in the fine powder of gained Poria, Eupolyphaga Seu Steleophaga, Endothelium Corneum Gigeriae Galli in the step poly-(4), mixing, with the granule mixing of gained in the step (5), airtight half an hour, dress glue is assisted promptly.
9. according to each described application of claim 1-4, it is characterized in that the application of described Chinese medicine composition in preparation treatment chronic atrophic gastritis occurs together the atypical hyperplasia of gastric mucosa medicine.
10. according to each described application of claim 1-4, it is characterized in that the application of described Chinese medicine composition in the medicine of preparation prevention gastric cancer.
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| Title |
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| 王一庆.胃粘膜不典型增生和肠上皮化生的中医药治疗近况.《甘肃中医学院学报》.1994,(第04期), * |
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