CN1112197C - Chinese medicine preparation for treating precancerous lesion of atrophic gastritis - Google Patents

Chinese medicine preparation for treating precancerous lesion of atrophic gastritis Download PDF

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CN1112197C
CN1112197C CN 00110849 CN00110849A CN1112197C CN 1112197 C CN1112197 C CN 1112197C CN 00110849 CN00110849 CN 00110849 CN 00110849 A CN00110849 A CN 00110849A CN 1112197 C CN1112197 C CN 1112197C
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chinese medicine
radix
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atrophic gastritis
medicine preparation
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CN1306846A (en
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姚保太
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Abstract

The present invention provides a traditional Chinese medicine preparation for treating pathological changes of atrophic gastritis, which is prepared from the following traditional Chinese medicine: 15 to 25 parts of coptis, 15 to 25 parts of baical skullcap root, 13 to 23 parts of prepared tuber pinellia, 5 to 10 parts of dried ginger, 25 to 36 parts of common aucklandia root, 28 to 37 parts of angelica, 45 to 55 parts of tangshen and the second to 8 parts of radix glycyrrhiza as raw material. According to different characteristics of each kind of the traditional Chinese medicine, after pretreatment, such as volatilizing, extracting in solvents, decocting, etc. is carried out, the 8 kinds of the traditional Chinese medicine are prepared into granules by means of the procedures of concentrating, drying in air and sterilizing. Compared with the prior art, the traditional Chinese medicine preparation for treating pathological changes of atrophic gastritis in the present invention has the characteristics of unique preparation method, obvious curative effect, convenience for taking, no adverse reaction, easy acceptance by patients, etc. Therefore, the traditional Chinese medicine preparation has wide application prospects and can be widely popularized in the clinical field of traditional Chinese medicine.

Description

A kind of Chinese medicine preparation for the treatment of precancerous lesion of atrophic gastritis
The present invention relates to a kind of Chinese medicine preparation, specifically a kind of Chinese medicine preparation for the treatment of precancerous lesion of atrophic gastritis.
At present, Chinese scholars is consistent to be thought, blocking-up and reverse property treatment precancerous lesion of atrophic gastritis are the keys that prevention gastric cancer takes place, but still do not have a kind of ideal medicament so far.Studies confirm that in a large number helicobacter pylori infections and bile reflux occupy critical role in precancerous lesion of atrophic gastritis takes place.Eradicate helicobacter pylori stops bile reflux to block the important channel of precancerous lesion of atrophic gastritis development beyond doubt.
Yet the amoxicillin, metronidazole, tripotassium dicitratobismuthate etc. that is used for helicobacter pylori at present influenced range of application because of its side effect and price problem, and the cholestyramine that is used for bile reflux has also determined its range of application because of it has unusual odor.
Someone observes retinoic acid reverse precancerous lesion of atrophic gastritis in zoopery have certain effect, but this type of medicine is big because of its side effect, still rests on animal experiment stage.Abroad the someone utilize be imported into therapeutic gene cell in vivo sustainable high efficiency produce cytokine and bring into play antitumor action, perhaps the genes of interest selectivity is imported tumor cell by gene technology, under appropraite condition, inducing apoptosis of tumour cell.Yet owing to the gene therapy at tumor cell, Yin Jiyin infection and exogenous target gene do not obtain fine solution in the problems such as safety that randomness caused of cell inner expression always.
At present, modern medicine is still and takes tracing study precancerous lesion of atrophic gastritis, in case find to have the canceration tendency, then considers operative treatment.
In recent years, the utilization Chinese medical theory gos deep into day by day to the research of atrophic gastritis.
Dan Zhaoweishi carries out statistical analysis to 75 routine patients' syndrome, finds that the integration of atrophic gastritis " feeling of fullness " is the highest.1989, national the spleen-stomach disease academic board was decided to be the stomach painful abdominal mass with atrophic gastritis.The whole nation high Chinese medicine universities and colleges' state-compiled textbooks " Chinese Internal Medicine " " feeling of fullness " piece of writing has: " under the heart, i.e. gastral cavilty; Epigastric oppression, i.e. stomach painful abdominal mass " argumentation.About the etiology and pathogenesis of primary disease, consistent in recent years thinks to be a kind of deficiency in origin and excess in superficiality that takes place because of diet, tobacco and wine, feelings will, weakness of the spleen and stomach, coldheat complex, lifting imbalance, the complicated disease of qi depression to blood stasis.Therapeutic Method has determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, 3 kinds of basic side plus-minus and fixing sides.
Dong Jianhuashi divides deficiency of both QI and YIN, the asthenic fire stomach that burns, and weakness of the spleen and stomach 3 types are treated 154 examples, precancerous lesion improvement rate 95.76%, disappearance rate 52.12%.
Wang Wen Zhong Shi treats 115 examples with hard masses softening and resolving side, produce effects 100 examples, 13 examples that take a turn for the better, invalid 2 examples, total effective rate 98.3%.
Wu Dian Shi treats 61 examples with the mixture that is good for the stomach, and cures 9 routine produce effects 31 examples, effective 16 examples, invalid 5 examples, total effective rate 91.6%.
Recklessly Ling Shi is with gastritis treatment 19 examples that disappear, and compares treatment group total effective rate 89.47%, matched group 66.6% with 15 examples of vitacoenzyme treatment.
More than each report have a following problem:
The first, the case observation that has fails to establish matched group, this and clinical research should follow at random, principle balanced, contrast differs bigger, thereby result's credibility owes high.
The second, include observation case standard disunity in, many documents are given birth to enteric epithelium small intestinal typeization and slight atypical hyperplasia is inappropriate as the object of observation also.
Three, fail primary disease is belonged to any " disease " or " disease " of Chinese medicine and the medication of the side of choosing, mostly used side's medicine be to determine according to the personal experience or according to modern pharmacological research, lacks the principle of medication of Chinese medical theory under instructing.
Four, inconsistent what have is index with the symptom variation to curative effect judging standard, and what have is diagnosed as index with gastroscope.We think to change with clinical syndrome change is comprehensive with pathomorphology and judge.
Five, observation index, animal modeling method relatively lag behind.Pathologic finding still rests on perusal under the mirror in the most literature report, and physical method is still continued to use in the animal modeling that has.At present, to be developed to the computer be the form quantitative Diagnosis of auxiliary diagnosis means in pathological diagnosis.And the precancerous lesion of atrophic gastritis cellular metabolism changes, and the gastric cancer abnormal gene expression often changes a step more early than form again.This research is intended to address these problems.
The purpose of this invention is to provide a kind of Chinese medicine preparation for the treatment of precancerous lesion of atrophic gastritis.
The Chinese medicine preparation of treatment precancerous lesion of atrophic gastritis of the present invention, it is to make medicament by the following weight proportion raw material:
Rhizoma Coptidis 15-25 part, Radix Scutellariae 15-25 part, Rhizoma Pinelliae 13-23 part, Rhizoma Zingiberis 5-10 part,
Radix Aucklandiae 25-36 part, Radix Angelicae Sinensis 28-37 part, Radix Codonopsis 45-55 part, Radix Glycyrrhizae 5-8 part.
The Chinese medicine preparation of treatment precancerous lesion of atrophic gastritis of the present invention, the weight proportion of each raw material is:
Rhizoma Coptidis 18-22 part, Radix Scutellariae 17-23 part, Rhizoma Pinelliae 15-20 part, Rhizoma Zingiberis 8-10 part,
Radix Aucklandiae 20-30 part, Radix Angelicae Sinensis 24-30 part, Radix Codonopsis 40-50 part, Radix Glycyrrhizae 7-8 part.
The Chinese medicine preparation of treatment precancerous lesion of atrophic gastritis of the present invention, wherein the weight proportion of each raw material is:
20 parts of Rhizoma Coptidis, 23 parts of Radix Scutellariaes, 18 parts of Rhizoma Pinelliae, 10 parts of Rhizoma Zingiberiss,
30 parts of the Radix Aucklandiae, 30 parts of Radix Angelicae Sinensis, 50 parts of Radix Codonopsis, 8 parts in Radix Glycyrrhizae.
The Chinese medicine preparation that the present invention treats precancerous lesion of atrophic gastritis is a said dosage form on any pharmaceutics.
The Chinese medicine preparation that the present invention treats precancerous lesion of atrophic gastritis is powder or capsule.
The Chinese medicine preparation of treatment precancerous lesion of atrophic gastritis of the present invention earlier extracts volatile oil with Radix Angelicae Sinensis, the Radix Aucklandiae, and Rhizoma Coptidis is with 70% ethanol extraction 2 times, and it is standby that extracting solution is condensed into thick paste.
The Chinese medicine preparation of treatment precancerous lesion of atrophic gastritis of the present invention, other medical material decoctings in medicinal residues after Radix Angelicae Sinensis, the Radix Aucklandiae and the Rhizoma Coptidis extraction and the prescription are boiled 3 times, each 1.5 hours, merging filtrate, concentrating under reduced pressure becomes thick paste, merge with Rhizoma Coptidis ethanol extraction cream and be dried to dried cream, dried cream powder is broken into fine powder adds an amount of dextrin and make granule, the volatile oil that adds the Radix Angelicae Sinensis Radix Aucklandiae at particle drying just is finished product.
Theoretical research:
The Zhang Zhongjing treatise on Febrile Diseases is said: " but the feeling fullness but no pain person, this is a painful abdominal mass." and point out that this disease pathogenesis is that positive exogenous pathogen falls into, the also principle of treatment of accent, pungent drugs can disperse and bitter drugs can descend of cold and heat has been drafted in the lifting imbalance, and the banxia xiexin decoction of creating is the ancestral side that controls the stomach painful abdominal mass, is appreciated usefulness by back physicians from a family for generations family always.
Li Shicai points out: " heresy is stayed under the heart so say removing pathogen in the heart.Removing pathogen in the heart person must help with hardship, is to be monarch with the Rhizoma Coptidis, and Radix Scutellariae is a minister; Loosing painful abdominal mass person must be with Xin Weizhu, is to be assistant with the Rhizoma Pinelliae, Rhizoma Zingiberis; Negative and positive are not handed over and are said painful abdominal mass, about desire is logical, hand over negative and positive person, must with wherein, middle person, spleen also, spleen deficiency person, with sweet benefit it, so with Radix Ginseng, Radix Glycyrrhizae, Fructus Jujubae for making, with invigorating middle warmer gas, middle gas is pacified and, water-ascending and fire-descending then, feeling of fullness disappears certainly.”
Domestic well-known doctor Dan Zhaoweishi carries out statistical analysis to 75 routine atrophic gastritis patients' syndrome.Think that the integration of gastral cavilty feeling of fullness is the highest,, significant difference is arranged with contrasts such as pain, belch.(select from Dan Zhaowei, Chinese combination of Chinese and Western medicine taste magazine, 1997,5 (4) are known from experience in the precancerous lesions of chronic atrophic gastritis treatment; 193).
In sum, stomach painful abdominal mass recovering particles can be dispeled exopathogen, replenishing QI to invigorate the spleen, and pungent drugs can disperse and bitter drugs can descend, unimpeded mechanism of qi, the pathogenesis of stomach painful abdominal mass (atrophic gastritis) that hit is with effectively.
Clinical research:
1, adopt the randomized double-blind method, will meet the patient of precancerous lesion of atrophic gastritis diagnostic criteria, by be in hospital or outpatient service number last two digits in conjunction with going to a doctor the date, be divided into every group 30 example of first and second liang of groups according to the random assortment block-regulations.
2, No. 1, the oral stomach painful abdominal mass of double blind control first group recovering particles, No. 2, the oral stomach painful abdominal mass of second group recovering particles is (in two kinds of medicines, a kind of is stomach painful abdominal mass recovering particles, a kind ofly form for the packing of SANJIU WEITAI electuary, the outward appearance of two kinds of medicines, packing, oral dose, every day number of times and the course of treatment unanimity, two kinds of electuary equal every days 3 times, each 6g, boiled water is taken after mixing it with water, and serveing on March was 1 course of treatment.
Viewing duration must not be taken the medicine of other treatment gastropathy, relatively the variation of two groups of every objective indicators in medication front and back.
3, " take off " condition blind and observe and finish, observed result is by the first group.The second group summarize respectively and statistical analysis after, disclose by the third party again what group is an observation group in the middle of two groups of first, the second, what group is matched group.
Pharmaceutical research:
With healthy male Wistar rat, adopt MNNG (MNNG) modeling precancerous lesion of atrophic gastritis model, observe stomach painful abdominal mass recovering particles and the SANJIU WEITAI electuary action intensity aspect reduction precancerous lesion of atrophic gastritis incidence rate, reach the removing dynamics to gastric mucosa of rat spiral sample bacterium, the result carries out statistical procedures.
Technology, quality standard research:
Prescription:
20 parts of Rhizoma Coptidis, 23 parts of Radix Scutellariaes, 18 parts of Rhizoma Pinelliae, 10 parts of Rhizoma Zingiberiss,
30 parts of the Radix Aucklandiae, 30 parts of Radix Angelicae Sinensis, 50 parts of Radix Codonopsis, 8 parts in Radix Glycyrrhizae.
More than 8 flavors, be developed into granule by " provisions for new drugs approval ".
One, main technological route
1, preventing precancerous lesion of stomach cancer diagnostic criteria (with reference in " the gastropathy pathologic finding and the diagnostic norms " of national gastric cancer cooperative groups pathologic group formulation fixed " gastric epithelial dysplasia grade scale ");
(1) the gastroscope diagnostic criteria of atrophic gastritis
Mucomembranous color changes: be Chinese red normally, be greyish white, sallow, ash or celadon during atrophy: the mucosa at same position is deep mixed to be caused, and canescence also is with in red strong place, and can there be the slightly small red dot or the erythema existence of protuberance in general sallow or greyish white ground; The scope of atrophy mucosa can be that what to fill the air also can be partial, or even special mess, mucosa attenuation and caving in, and boundary is often not obvious.
Blood vessel is seen thoroughly: the atrophy initial stage can be seen little blood vessel in the mucosa; Weight person can see SM trunk such as dendroid, and kermesinus is excellent in sometimes on mucomembranous surface, easily mixes mutually with pleat; At the bottom of the stomach, the blood vessel of cardia just often also can see.Observe blood vessel and advance the good internal pressure of GPRS.
Atrophic gastritis also can merge superficial gastritis; but gland nest hypertrophy prolongs or intestinal epithelial metaplasia is arranged and sees the performance of being formation after the gland atrophy, and the mucous layer thickening can not be seen blood vessel under the mucosa this moment; only see the coarse injustice of mucomembranous surface, granule or tuberosity stiff sense, gloss also changes.
(2) the pathological diagnosis standard of atrophic gastritis
1. intrinsic body of gland atrophy, minimizing 1/3 serve as slight with interior person, and reducing 1/3-2/3 person is moderate, and reducing by 2/3 above person is severe.
2. muscular layer of mucosa thickens.
3. intestinal epithelial metaplasia or pylorus glandular metaplasia can be arranged.
4. lamina propria inflammation.
5. can there be lymph follicle to form.
(3) gastric mucosa chronic inflammatory disease grade scale
Slightly: inflammatory cell infiltration is positioned at more than the gastric pits bottom.
Moderate: inflammatory cell infiltration reaches body of gland Hu film admittedly deeply.
Slight dysplasia: the shape of 1/ glandular tube and structure are slightly irregular; 2/ cell is high column, and the secretion cavity is arranged in the endochylema, and iuntercellular has goblet cell; 3/ nuclear arrangement densification is positioned at the cell Lower Half; 4/ nuclear is Long Circle or shaft-like, and volume is big slightly, engrain, no atypia.
Moderate dysplasia: the shape of 1 glandular tube and irregular structure; 2 cells are column, and endochylema endocrine cavity reduces or disappears, and goblet cell is very rare; 3 nuclears are bar-shaped, increase, and engrain, but do not have obvious atypia; 4 nuclears are intensive in heaps, arrange disorderly slightly.
Severe dysplasia; The shape of 1 glandular tube and structure disturbance; 2 cells are column or square shape, and the secretion cavity almost completely disappears, and loses goblet cell; 3 caryoplasm ratios obviously increase; 4 nuclears are shaft-like or circular, obviously increase deep mixed the causing of dyeing, arrangement disorder.
Two, include the case standard in:
Meet above-mentioned in, the severe dysplasia diagnostic criteria, and/or not exclusively big visible peristalsis visible intestinal peristalsis intestinal epithelial metaplasia, and meet traditional Chinese medical science coldheat complex, qi depression to blood stasis pattern of syndrome, the age is between 18-65 year, the patient of voluntary accepting clinical observation.
Three, get rid of the case standard
1/ is associated with severe cardiac, lung, liver, kidney and disease of hematopoietic system, psychotic.
2/ age is less than 18 years old, greater than 65 years old; Gestation and women breast-feeding their children.
3/ not medication in accordance with regulations can't be judged curative effect, or data is not waited to affect the treatment or safety judgement person entirely.
Four, observation index:
1, main symptom: gastral cavilty feeling of fullness, inappetence, dull pain and accompanied symptoms and tongue arteries and veins situation of change.
2, check gastroscope (adopt dynamically video, the record gastric mucosa changes and the anti-situation that flows of gallbladder antiperspirant), pathologic finding (adopting four-point method to get living tissue), the normal dyeing microscopy with look into helicobacter pylori (HP).
3, safety indexes: blood, urine, stool routine inspection and liver, renal function, Electrocardioscopy.
Curative effect determinate standard: with reference to " the dialectical and criterion of therapeutical effect of chronic gastritis combination of Chinese and Western medicine diagnosis " of Chinese Association of the Integration of Traditional Chinese Medicine and Western Medicine digestive system disease Professional Committee formulation in 1989.
Recent clinical cure; 1. cardinal symptom disappears, and inferior disease disappears or basic the disappearance; 2. gastroscope check, the activeness inflammation disappears, and chronic inflammatory disease is pass on well slightly; 3. biopsy confirms that dysplasia is normal again or disappears.
Produce effects: 1. clinical main disease disappears, and inferior disease disappears substantially; 2. gastroscope check, its this disappearance of mucosa acute inflammation, chronic inflammatory disease takes a turn for the better; 3. biopsy confirms that dysplasia alleviates two level degree above (containing two level degree).
Effectively: 1. cardinal symptom obviously alleviates; 2. gastroscope check, the mucosa infection scope is dwindled more than 1/2, and inflammation alleviates to some extent; 3. biological tissue pathology confirms that dysplasia alleviates.Invalid: as not reach effective standard.
Worsen: 1. primary symptom and minor symptom obviously increase the weight of; 2. the gastric mucosal lesion expanded range reaches more than 1/2; 3. rise a level degree or gastric cancer occurs and change in early days of biopsy pathology dysplasia.
The statistical procedures method: gastroscope, pathology of gastric mucosa inspection are used X 2 test, and results such as liver function, blood urea nitrogen, creatinine check with T.
Five, pharmaceutical research:
1. laboratory animal: in 8 210 of ages in week of healthy male Wistar rat, intend breeding the center available from Chinese Academy of Medical Sciences's laboratory animal.
2. modeling medicine: N-methyl-N '-nitro-N-nitrosoguanidine (MNNG), intend available from Beijing biochemical reagents company; The ranitidine powder is intended available from Shanghai No.6 Pharmaceutical Factory;
3. medicine; Chinese medicine preparation trade name of the present invention " stomach painful abdominal mass health " particulate samples is provided every bag of 6g by pharmaceutical factory of Shandong Traditional Chinese Medicine University.
4. control drug: the SANJIU WEITAI electuary, southern pharmaceutical factory produces.
Six, experimental technique; Above-mentioned rat is divided into 6 groups at random, and the 1st group is the blank group, and the 2nd group is experiment modeling group, and the 3rd group is the SANJIU WEITAI matched group, and the 4-6 group is respectively Chinese medicine preparation of the present invention " stomach painful abdominal mass health " granule and divides basic, normal, high 3 kinds of dosage groups.Each organizes the rat sub-cage rearing, and every cage 4-5 only.The experiment beginning, 2-6 group rat is freely drunk the MNNG solution that concentration is 50 micrograms/ml every day, and feeding contains the standard particle shape feedstuff of 0.01% ranitidine.(available from Shandong Medical University's Experimental Animal Center) after totally 20 weeks, changes drinking public water supply and feeds the standard particle feedstuff.3-6 group rat is in experiment the 31st all begin treatment medications, irritates respectively every of 4-6 group rat every day and raises " stomach painful abdominal mass health " granule suspension 2ml, and every ml contains the crude drug amount and is respectively 0.5g, 1.5g, 4.5g, totally 10 weeks.SANJIU WEITAI matched group every rat every day is irritated and raises SANJIU WEITAI suspension 2ml; Every 2ml contains crude drug 0.5g, totally 10 weeks.In the 41st week of experiment, put to death all animals, take out stomach, cut off along big curved side, the thing that clears contents is after flushing with clean water, the observation gastric mucosa changes, in the strip of tissue of the lesser curvature side clip 1.5cm of gastric antrum portion * 1cm size, 10% neutral formalin is fixed, paraffin embedding, serial section, the incidence rate that gastric mucosa of rat precancerous lesion and gastric cancer are respectively organized in observation under the light microscopic is put in thick 5 microns conventional H E dyeing, reaches the distribution situation of stomach spiral sample bacterium.Check result is analyzed.Statistical method: measurement data (body weight) adopts the F check, and enumeration data (pathological changes incidence rate) adopts the definite probabilistic method of four fold table data.
Seven, the detection of experimental rat gastric mucosal cell nuclear DN A content, morphological parameters and times body distribution: do feulgen dyeing by every group of gastric mucosa specimen of getting 5 rats at random.With reference to IAC is the standard that dna content is measured and times body analysis is recommended that cellular image analyzer (lmage cytormetrylCM) is made cytological sample, uses MPZAS-500 multi-media color pathology picture and text analyser and carries out DNA analysis.
Eight, experimental rat gastric mucosa scanning electron microscopic observation; At random from every group of fresh gastric tissue of getting 5 rats, fix 12 hours with 2.5% glutaraldehyde (liquid was made into PH7.2 during 0.1mol phosphoric acid was slow), wash 3 times through the 0.1mol phosphate buffer, each 20 minutes, reuse 1% osmic acid was fixed 1.5 hours, washed 20 minutes (centre is changed new liquid 2-3 time) with the 0.1mol phosphate buffer, dewater through the rising neutral spirits, conventional critical point drying, the platinum plating of IB-5 ion sputtering instrument is with the S-570 of Hitachi scanning electron microscopic observation and take pictures.
Acute toxicity test;
1 median lethal dose(LD 50) (LD 50) measure: getting SWISS is 40 of healthy mices, intends purchasing in the Academy of Medical Sciences, Shandong Experimental Animal Center.Body weight 19+-1g, male female half and half, be divided into two dosage groups of size at random.Stomach painful abdominal mass health is added the suitable quantity of water accent all become suspension 0.67g/ml (every milliliter contains crude drug amount 0.735g).Only and after 0.5ML/ volume only will be subjected to the reagent thing once to irritate stomach by group respectively, observation reaction of animals situation observes twice every day, continuous 7 days by 0.8mg/.
The mensuration of 2 maximum tolerated doses (MTD); Animal strain, body weight, sex, source, grouping are the same. and be subjected to the reagent thing the same. divide to give heap(ed) capacity 0.8ml/ only and 0.5ml/20g/ day (55.28g/kg). obtain the maximum tolerated dose (MTD) of medicine.
Chronic toxicity test:
Select 60 of healthy Wistar strain rats (5 age in week), it is the same to originate, rest 70+-10G, and male and female half and half are divided into 3 groups at random, 20 every group.Heavy dose of group 21.4g/kg (be equivalent to clinical dosage 50 times), small dose group 2.14g/kg (be equivalent to clinical dosage 5 times) and matched group.Every group gavages relative medicine and normal saline, continuous 24 weeks.Medication phase and reversibility observation period, observe the weight of animals, outward appearance, behavior.After the last administration 24 hours, every group of works is part animal (2/3-1/2, male and female half and half) extremely.Detect hematological indices, the histopathologic examination of liver, renal function and main organs.Remaining animal continues to observe for 3 weeks, animal recovery situation after the investigation drug withdrawal.
Nine, quality standard part:
1, technological process; Radix Angelicae Sinensis, the Radix Aucklandiae extract volatile oil, Rhizoma Coptidis 70 alcohol extractions 2 times, extracting solution is condensed into thick paste, last two medicinal residues, again with the prescription in other medical material decoctings boil 3 times, each 1.5 hours---merging filtrate---concentrating under reduced pressure becomes thick paste, merges with Rhizoma Coptidis ethanol extraction cream------------drying---add volatile oil---finished product of making granule that becomes fine powder to add an amount of dextrin that is dried to dried cream.
2, quality research; With the berberine hydrochloride is standard substance, adopts thin layer chromatography scanning, and the monarch drug Rhizoma Coptidis is carried out assay.
3, stability study: sample stores under normal room temperature, produce of that month to its character, moisture, granularity, content, health etc. observe item by item, test and record, as zero month result, investigated 1 time in later every month, continuously March.And in 6th month and 12nd month each is investigated once, carry out 6 times altogether and investigate comprehensively.
Model case:
Example 1: Zhang, woman, 58 years old, patient's identification number; 67266, married, Han nationality, researcher, work unit: Shandong Pesticide Research Institute, postcode: 250016.
The main suit: the epigastrium painful abdominal mass is vexed, stops up sense, and inappetence showed effect 10 years repeatedly, increased the weight of first quarter moon.Medical history; Often not smooth over nearly 10 years because of emotion, diet, the nearly pit of the stomach of epigastrium place feeling of fullness, dining postemphasis are brought out in fatigue, with belch, feel sick not acid regurgitation, once repeatedly gastroscopy sometimes, all examine and be atrophic gastritis, clothes drug effects such as " SANJIU WEITAI " does not show, and is admitted to hospital in 30th in 98 years Decembers.
Have a medical check-up: 36.8 ℃ of body temperature, pulse 80 times/minute is breathed and is got 19 times/minute, blood pressure 15/11KPa thready pulse stringy and rolling pulse, dimly red tongue, yellow fur are greasy slightly.Cardiopulmonary (one), abdominal part is smooth, matter is soft, do not lay one's hand under the liver spleen rib and, the xiphoid-process end has tenderness.
Lab testing: defecation routine (), electrocardiogram is roughly normal.Gastroscope diagnosis: atrophic gastritis; Pathological diagnosis: atrophic gastritis moderate companion moderate atypical hyperplasia, W-S dyeing, helicobacter pylori (HP) positive.
Diagnosis: the traditional Chinese medical science: stomach painful abdominal mass.Doctor trained in Western medicine: atrophic gastritis (precancerous lesion).
Treatment: withdraw other treatment gastropathy medicine, take Chinese medicine preparation of the present invention, every day 3 times, each 1 bag.Took medicine 5 days, the epigastrium feeling of fullness alleviates, and appetite is promoted, and continues to take medicine 3 months (1 course of treatment).Above-mentioned symptom is eliminated.The check gastroscope: atrophic gastritis (slightly), pathology is seen atypical hyperplasia, W-S dyeing helicobacter pylori feminine gender.Period in a medicine, patient does not have untoward reaction, checks large and small just conventional (one), and electrocardiogram is normal.
Efficacy determination: produce effects.
Example 2; Cover certain, the man, 38 years old, patient's identification number 64312, married, the cadre, Han nationality, work unit: the Shandong Province competes to hit school; Postcode 250019.
The main suit: the epigastrium painful abdominal mass is vexed, dull pain, and inappetence showed effect 6 years repeatedly, increased the weight of 10 days.
Medical history: often not smooth over 6 years because of feelings will, fatigue, the excessive nearly pit of the stomach of the epigastrium place painful abdominal mass of bringing out of tobacco and wine is vexed; Increase the weight of after the meal; Appetite descends 2/5; Once repeatedly gastroscopy; All examine into " atrophic gastritis ", do not show through clothes drug effects such as " WEIFUCHUN ".Be admitted to hospital on January 10th, 1996.
Have a medical check-up: body temperature: 36.4 ℃, pulse 80 times/minute is breathed blood pressure 16/12KPa thready and stringy pulse 18 times/minute; Dimly red tongue; Yellowish fur.Cardiopulmonary (one); Abdominal part is smooth, and matter is soft, liver spleen rib get off to lay one's hand on and, abdominal part does not have tenderness, does not lay one's hand on and enclosed mass.
Lab testing: defecation routine (), electrocardiogram is normal.The gastroscope diagnosis; Atrophic gastritis; Pathological diagnosis; Committee's contracting property gastritis (moderate) moderate intestinal epithelial metaplasia.
Diagnosis: the traditional Chinese medical science: stomach painful abdominal mass doctor trained in Western medicine: doctor trained in Western medicine: atrophic gastritis.
Treatment: other treatment gastropathy medicine of stopping using, take Chinese medicine preparation of the present invention, each 1 bag, take after mixing it with water for 3 times every day.The 1 all epigastrium painful abdominal masss of taking medicine are vexed, and inappetence takes a turn for the better.1 course of treatment (3 months) the above-mentioned disease taken medicine is continuously eliminated, and period in a medicine has no adverse reaction.Check defecation routine (), electrocardiogram is normal.Gastroscope diagnosis: atrophic gastritis; Pathological diagnosis, atrophic gastritis (slightly) is not seen intestinal epithelial metaplasia.
Efficacy determination: produce effects.
Example 3: in certain, the man, 60 years old, married, engineer, Han nationality, work unit: Shandong Province projector maple school, postcode 250014.
The main suit; The epigastrium feeling of fullness; Dull pain, inappetence were shown effect 7 years repeatedly, increased the weight of 10 days.
Medical history: often not smooth over nearly 7 years because of feelings will, fatigue, eating and drinking without temperance brings out the epigastrium feeling of fullness, has a dull ache, and appetite descends, and repeatedly gastroscopy is all examined and is " atrophic gastritis ", and through obeying KUAIWEI PIAN " vitacoenzyme " etc., drug effect does not show.
Have a medical check-up: 36.5 ℃ of body temperature, pulse 75 times/minute is breathed 18 times/minute, blood pressure 14/10KPa, stringy and rolling pulse, yellow fur are greasy slightly.Cardiopulmonary (one), abdominal part matter is soft, do not lay one's hand under the liver spleen rib and, do not have obvious tenderness, do not reach enclosed mass.
Lab testing: defecation routine (), electrocardiogram is normal.Gastroscope diagnosis: atrophic gastritis; Pathological diagnosis, atrophic gastritis (moderate), atypical hyperplasia moderate.
Diagnosis; The traditional Chinese medical science; The stomach painful abdominal mass.Doctor trained in Western medicine; Atrophic gastritis (precancerous lesion).
Treatment: withdraw other treatment gastropathy medicine, take Chinese medicine preparation of the present invention, each 1 bag, take after mixing it with water for 3 times every day.Took medicine for 1 week, the epigastrium feeling of fullness alleviates, and appetite is promoted, and takes medicine continuously 3 months (1 course of treatment), and above-mentioned symptom disappears, and period in a medicine is not seen untoward reaction.Check defecation routine (), electrocardiogram is normal.Check gastroscope: superficial gastritis; Pathological diagnosis, atrophic gastritis (slightly) is not seen atypical hyperplasia.
Efficacy determination; Produce effects.
Example 4: Lin, man 60 years old, married, cadre, Han nationality, work unit; Shandong Traditional Chinese Medicine University, postcode: 250014.
The main suit; The epigastrium painful abdominal mass is vexed, inappetence companion belch, the nauseating outbreak repeatedly 5 years.
Medical history: often because of fatigue, it is vexed that the coarse food of eating food brings out the epigastrium painful abdominal mass over nearly 5 years, stops up sense, and dietary amount descends, and belch is not smooth sometimes, feels sick.Repeatedly gastroscopy is all examined and is " atrophic gastritis ", and once clothes " vitacoenzyme " drug effects such as ' SANJIU WEITAI ' did not show.
Have a medical check-up: 36.5 ℃ of body temperature, pulse 75 times/minute is breathed 18 times/minute, blood pressure 15/gKPa, stringy and rolling pulse, yellow fur are greasy slightly.Cardiopulmonary (one), abdominal part is smooth, does not have obvious tenderness district, under the liver spleen rib (one), does not reach enclosed mass.
Lab testing; Defecation routine (one), the "Left"-deviationist of electrocardiogram electric axis.Gastroscope diagnosis: atrophic gastritis; Pathological diagnosis, atrophic gastritis (moderate), atypical hyperplasia moderate.
Diagnosis: the traditional Chinese medical science: stomach painful abdominal mass.
Doctor trained in Western medicine: atrophic gastritis (precancerous lesion) treatment; Withdraw the other drug of treatment gastropathy, take Chinese medicine preparation of the present invention, each 1 bag, take after mixing it with water for 3 times every day.Took medicine 5 days, the epigastrium feeling of fullness alleviates, and appetite is promoted, and takes medicine continuously 3 months (1 course of treatment), and above-mentioned symptom disappears.Through check blood, urine, just conventional no abnormality seen.ALT, Cr no abnormality seen, electrocardiogram "Left"-deviationist.The check gastroscope; Superficial gastritis; Pathological diagnosis, atrophic gastritis (slightly) is not seen atypical hyperplasia.
Efficacy determination; Produce effects.
Example 6; Certain, the man, 34 years old, the workman, married, Han nationality, work unit; The Jinan City department of handing over to the collective or the state altogether.Postcode: 250019.
The main suit: the epigastrium painful abdominal mass is vexed, stops up sense, and inappetence showed effect 1 year repeatedly.
Medical history; Often because of fatigue, tobacco and wine are excessive in recent years, and it is vexed that emotion is not freely brought out the top painful abdominal mass, stop up sense, and dietary amount descends.Once clothes " WEIFUCHUN " drug effects such as " vitacoenzyme " did not show.
Have a medical check-up: 36.8 ℃ of body temperature, pulse 75 times/minute is breathed 18 times/minute, blood pressure 15/10KPa, stringy and rolling pulse, yellow fur are greasy slightly.Cardiopulmonary (one), abdominal part matter is soft, under the liver spleen rib (one), does not lay one's hand on and enclosed mass, and the xiphoid-process end has tenderness.
Lab testing: defecation routine (), electrocardiogram is normal.Gastroscope diagnosis: atrophic gastritis; Pathological diagnosis, the intestinal epithelial metaplasia of atrophic gastritis companion moderate, the LO-S HP (+) that dyes.Diagnosis: the traditional Chinese medical science: stomach painful abdominal mass.Doctor trained in Western medicine: atrophic gastritis (precancerous lesion).
Treatment: withdraw the other drug of treatment gastropathy, take Chinese medicine preparation of the present invention, each 1 bag, take after mixing it with water for 3 times every day.Took medicine 4 days, epigastrium feeling of fullness inappetence takes a turn for the better, and takes medicine continuously 3 months (1 course of treatment), and above-mentioned symptom is eliminated.Check defecation routine (), electrocardiogram is normal.Check gastroscope: superficial gastritis; Pathological diagnosis, atrophic gastritis (slightly) is not seen atypical hyperplasia.The LO-S HP (two) that dyes.
Efficacy determination; Produce effects.
Example 7: Dong, the woman, 62 years old, married, Han nationality, peasant, home address: area just outside a city gate town, Shanghe County, Jinan City, postcode 256005.
The main suit; The epigastrium painful abdominal mass is vexed, inappetence, and belch is felt sick and was shown effect repeatedly 10 years, and it is surplus to increase the weight of the moon.
Medical history: often not smooth because of emotion over nearly 10 years, epigastrium feeling of fullness discomfort is brought out in fatigue, and belch is felt sick sometimes, the dining postemphasis, and dietary amount descends about 1/5.
Have a medical check-up; 35.6 ℃ of body temperature, pulse 80 times/minute is breathed blood pressure 15/11KPa, thready and stringy pulse, yellowish fur 18 times/minute.Cardiopulmonary (one), abdominal part matter is soft, and the xiphoid-process end has tenderness.Under the liver spleen rib (one), do not lay one's hand on and enclosed mass.
Lab testing; Defecation routine (one), electrocardiogram is normal.The gastroscope diagnosis; Atrophic gastritis; Pathological diagnosis, the intestinal epithelial metaplasia of atrophic gastritis (moderate) companion moderate.
Diagnosis: the traditional Chinese medical science: stomach painful abdominal mass.
Four doctors; Atrophic gastritis (precancerous lesion).
Treatment: take Chinese medicine preparation of the present invention, each 1 bag, take after mixing it with water for 3 times every day.The 1 all epigastrium feeling of fullness of taking medicine alleviate, and appetite is promoted, and take medicine continuously 3 months (1 course of treatment), and above-mentioned symptom is eliminated.Check defecation routine (), electrocardiogram is normal.The check gastroscope; Superficial gastritis; Pathological diagnosis, atrophic gastritis (slightly) is not seen intestinal epithelial metaplasia.
Efficacy determination; Produce effects.
Example 8: poplar, the man, 58 years old, married, peasant, Han nationality, address: area just outside a city gate town, Longkou City, Shandong Province, postcode 2655701.
The main suit: the epigastrium painful abdominal mass is vexed, inappetence, and mouth is sticking, feels sick and shows effect repeatedly 10 years.
Medical history; Often not smooth because of emotion over nearly 10 years, tobacco and wine are excessive, and the epigastrium feeling of fullness is brought out in fatigue, and inappetence mouth sometimes is sticking tasteless, feels sick.
Have a medical check-up: 36.5 ℃ of body temperature, pulse 75 times/minute is breathed blood pressure 15/gKPa, thready and rolling pulse, yellowish fur 18 times/minute.Cardiopulmonary (one), abdominal part is smooth, and matter is soft, does not have obvious tenderness district, does not lay one's hand on and enclosed mass.
Lab testing: defecation routine (), electrocardiogram is normal.Gastroscope diagnosis: atrophic gastritis; Pathological diagnosis, atrophic gastritis (moderate) atypical hyperplasia.
Diagnosis: the traditional Chinese medical science: stomach painful abdominal mass.Doctor trained in Western medicine: atrophic gastritis (precancerous lesion) treatment; Take Chinese medicine preparation of the present invention, each 1 bag, take after mixing it with water for 3 times every day.The 1 all epigastrium feeling of fullness of taking medicine alleviate, and take medicine continuously 3 months (1 course of treatment), and above-mentioned symptom disappears.The period in a medicine check blood that has no adverse reaction, urine makes conventional no abnormality seen, ALT20, Cr40mmll/l, electrocardiogram is normal.Check gastroscope: superficial gastritis; Pathology: atrophic gastritis (slightly), see atypical hyperplasia.
Efficacy determination; Produce effects.
Example 9: the Wang, the man, 64 years old, married, Han nationality, peasant.Address: area just outside a city gate town, Pingyi County, Shandong Province, postcode: 773300.
The main suit: epigastrium feeling of fullness, inappetence, belch did not freely show effect 10 years repeatedly.
Medical history: often not smooth because of emotion over nearly 10 years, the epigastrium feeling of fullness is brought out in fatigue, and inappetence does not have obviously stomachache, not acid regurgitation.
Have a medical check-up: 36.5 ℃ of body temperature, pulse 78 times/minute is breathed blood pressure 16/10KPa, stringy and rolling pulse, yellowish fur 18 times/minute.Cardiopulmonary (one), abdominal part is smooth, does not have obvious tenderness district, does not lay one's hand on and the enclosed mass lab testing: defecation routine (), electrocardiogram is normal.Gastroscope diagnosis: atrophic gastritis; Pathological diagnosis, atrophic gastritis (severe), moderate dysplasia.
Diagnosis: the traditional Chinese medical science: stomach painful abdominal mass.
Doctor trained in Western medicine: atrophic gastritis (precancerous lesion).
Treatment: take Chinese medicine preparation of the present invention, each 1 bag, take after mixing it with water for 3 times every day.Take medicine continuously and afterwards check gastroscope 3 months (1 course of treatment); Atrophic gastritis; Pathology atrophic gastritis (moderate) is not seen atypical hyperplasia.Period in a medicine has no adverse reaction, treated for 1 course of treatment after, the check defecation routine (), routine blood test is all in normal range, ALT, Cr are no abnormal, electrocardiogram is normal.
Efficacy determination; Produce effects.
Example 10: Hu, the man, 47 years old, married, Han nationality, workman, work unit: Zibo City, Shandong Province Boshan District power supply administration, postcode 255200.
The main suit: the epigastrium feeling of fullness, dull pain, inappetence showed effect 5 years repeatedly.
Medical history: often not smooth because of emotion over 5 years, epigastrium feeling of fullness discomfort, belch, indigestion and loss of appetite, not acid regurgitation are brought out in fatigue.Do not have obvious pain, once clothes " KUAIWEI PIAN " drug effects such as " vitacoenzyme " did not show.
Have a medical check-up: 36.5 ℃ of body temperature, pulse 75 times/minute is breathed 18 times/minute, blood pressure 15/9KPa pulse condition stringy and rolling pulse, yellowish fur.Cardiopulmonary (one), abdominal part matter is soft, does not have obvious tenderness district, does not lay one's hand on and enclosed mass.
Lab testing: defecation routine (), gastroscope diagnosis: atrophic gastritis; Pathological diagnosis, the intestinal epithelial metaplasia of atrophic gastritis moderate.
Diagnosis: the traditional Chinese medical science: stomach painful abdominal mass.
Doctor trained in Western medicine: atrophic gastritis (precancerous lesion).
Treatment; The treatment gastropathy of stopping using medicine is taken Chinese medicine preparation of the present invention, each 1 bag, takes after mixing it with water for 3 times every day.Take medicine continuously and afterwards check gastroscope 3 months (1 course of treatment): superficial gastritis; Pathology: atrophic gastritis (slightly), see intestinal epithelial metaplasia.During the treatment, have no adverse reaction, check blood, urine, just conventional no abnormal, ALT, Cr are all in normal range, and electrocardiogram is normal.
Efficacy determination; Produce effects.
A kind of Chinese medicine preparation for the treatment of precancerous lesion of atrophic gastritis of the present invention is compared with prior art has taking convenience, have no adverse reaction behind the clothes, the patient likes characteristics such as acceptance, so this achievement has broad application prospects, and can extensively promote in the tcm clinical practice field.

Claims (6)

1. Chinese medicine preparation for the treatment of precancerous lesion of atrophic gastritis is characterized in that it is to be made by the following weight proportion raw material:
Rhizoma Coptidis 15-25 part, Radix Scutellariae 15-25 part, Rhizoma Pinelliae 13-23 part, Rhizoma Zingiberis 5-10 part,
Radix Aucklandiae 25-36 part, Radix Angelicae Sinensis 28-37 part, Radix Codonopsis 45-55 part, Radix Glycyrrhizae 5-8 part.
2. a kind of Chinese medicine preparation for the treatment of precancerous lesion of atrophic gastritis according to claim 1 is characterized in that the weight proportion of each raw material is:
Rhizoma Coptidis 18-22 part, Radix Scutellariae 17-23 part, Rhizoma Pinelliae 15-20 part, Rhizoma Zingiberis 8-10 part,
Radix Aucklandiae 20-30 part, Radix Angelicae Sinensis 24-30 part, Radix Codonopsis 40-50 part, Radix Glycyrrhizae 7-8 part.
3. a kind of Chinese medicine preparation for the treatment of precancerous lesion of atrophic gastritis according to claim 1, wherein the weight proportion of each raw material is:
20 parts of Rhizoma Coptidis, 23 parts of Radix Scutellariaes, 18 parts of Rhizoma Pinelliae, 10 parts of Rhizoma Zingiberiss,
30 parts of the Radix Aucklandiae, 30 parts of Radix Angelicae Sinensis, 50 parts of Radix Codonopsis, 8 parts in Radix Glycyrrhizae.
4. a kind of Chinese medicine preparation for the treatment of precancerous lesion of atrophic gastritis according to claim 1 is characterized in that said preparation is a said dosage form on any pharmaceutics.
5. a kind of Chinese medicine preparation for the treatment of precancerous lesion of atrophic gastritis according to claim 1 is characterized in that said dosage form is powder or capsule.
6. a kind of Chinese medicine preparation for the treatment of precancerous lesion of atrophic gastritis according to claim 1, the preparation method that it is characterized in that this Chinese medicine preparation is: earlier with Radix Angelicae Sinensis, the Radix Aucklandiae extracts volatile oil, Rhizoma Coptidis is with 70% ethanol extraction 2 times, it is standby that extracting solution is condensed into thick paste, then with Radix Angelicae Sinensis, other medical material decoctings boil 3 times in medicinal residues after the Radix Aucklandiae and Rhizoma Coptidis are extracted and the prescription, each 1.5 hours, merging filtrate, concentrating under reduced pressure becomes thick paste, thick paste merging with the Rhizoma Coptidis ethanol extraction is dried to dried cream again, dried cream powder is broken into fine powder adds an amount of dextrin and make granule, add Radix Angelicae Sinensis at particle drying, the volatile oil of the Radix Aucklandiae just is finished product.
CN 00110849 2000-01-21 2000-01-21 Chinese medicine preparation for treating precancerous lesion of atrophic gastritis Expired - Fee Related CN1112197C (en)

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CN102688464B (en) * 2012-05-08 2014-04-09 安徽智远生物科技有限公司 Traditional Chinese medicinal composition for treating atrophic gastritis and preparation method thereof
CN104324307A (en) * 2014-10-24 2015-02-04 济南高达信息技术有限公司 Traditional Chinese medicinal oral liquid preparation for treating fatty diarrhea and preparation method thereof
CN110193073B (en) * 2019-07-02 2021-09-21 大连市中医医院 Traditional Chinese medicine compound composition for treating chronic atrophic gastritis and gastric precancerous lesions and application thereof
CN112586448A (en) * 2020-12-23 2021-04-02 广州中医药大学(广州中医药研究院) Animal model for chronic atrophic gastritis and gastric precancerous lesion and construction method and application thereof

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