CN101708306B - Chinese medicinal composition for treating gastropathy and preparation method thereof - Google Patents
Chinese medicinal composition for treating gastropathy and preparation method thereof Download PDFInfo
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Abstract
The invention provides a Chinese medicinal composition for treating gastropathy and a preparation method thereof. The composition is prepared from golden thread, Chinese sage herb, costustoot, medcinal evodia fruit, largehead atractylodes rhizome, poria, villous amomum fruit, chicken's gizzard-membrane, malt, rice-grain sprout, medicated leaven, hawthorn fruit, radish seed and yanhusuo. The Chinese medicinal composition for treating the gastropathy of the invention is a pure Chinese medicinal preparation. Based on the therapeutic principle of Chinese traditional medicine and the modern pharmaceutical science, the curative effect of the product is improved by separating and purifying the active components in the Chinese medicament. And the Chinese medicinal composition is used for treating the gastropathy with the symptoms of sallow complexion, hypodynamia, loose stools, poor appetite, gastrectasia, stomach ache, belching, hot drink preference, pressure-relieved gastral cavity, whitish tongue, thin and whitish fur, weak and fine pulse and the like caused by spleen deficiency and stomach cold, and has obvious efficacy.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition for the treatment of gastropathy and preparation method thereof, specifically, relate to a kind of Chinese medicine composition and preparation method for the treatment of gastropathy due to the Deficiency and coldness of spleen and stomach.
Background technology
Gastropathy is frequently-occurring disease, shows according to epidemiology: the average proportions that China's patients with gastric disease accounts for total population reaches 42%.In recent years, along with the progress and development of society, people's rhythm of life is in continuous quickening, increasing people is after work busy, have no time to attend to normal dietary habit, life does not have rule, and inducements such as breakfast, lunch and dinner are indefinite, eating and drinking too much at one meal, tobacco and wine aggravation increase the sickness rate of primary disease year by year.
Canceration more likely takes place if symptoms such as gastric ulcer, upper gastrointestinal hemorrhage, acute perforation of stomach are probably brought out in untimely treatment in gastropathy, has a strong impact on healthy and quality of life of people, brings heavy burden for society and family.
According to the sorting technique of the traditional Chinese medical science, gastropathy mainly is divided into three major types: the gastropathy that the gastropathy that Deficiency and coldness of spleen and stomach causes, the damp and hot gastropathy that causes of the intestines and stomach and Nervous and Mental Factors cause.More because of the patient of gastropathy due to the Deficiency and coldness of spleen and stomach clinically, account for 60%.
The medicine for the treatment of gastropathy at present clinically is a lot; mainly based on Western medicine; comprise proton pump inhibitor, H2 receptor blocking agent, mucosa protective agent, antacid, promotion gastric dynamic dysfunction medicine etc.; though western medicine gastropathy is rapid-action; can produce harm to other organs of health but take for a long time; and can not dig up the roots, be easy to recurrence.
Special not obvious at traditional western medicine effect, also some Chinese medicine preparation is used for the treatment of gastropathy due to the Deficiency and coldness of spleen and stomach clinically, as Chinese patent application number is 200810237135.4, publication number is that the patent of invention of CN101428127A discloses a kind of Chinese medicine composition for the treatment of cold syndrome of the stomach, with Rhizoma Alpiniae Officinarum, Herba Lysimachiae, Squama Manis, rhizoma sparganic, the Rhizoma Atractylodis Macrocephalae (stir-fry), Pericarpium Citri Reticulatae, 13 flavor Chinese medicines such as the Radix Aucklandiae are prescription, owing to do not pass through the preclinical pharmacology toxicity of scientific and precise, and clinical experimental study, this medicine treatment cold syndrome of the stomach to gastropathy curative effect and safety inspection be still waiting further checking.
Summary of the invention
The purpose of this invention is to provide a kind of Chinese medicine composition for the treatment of gastropathy and preparation method thereof.
Another object of the present invention provides the application of described Chinese medicine composition in the medicine of gastropathy due to the preparation treatment Deficiency and coldness of spleen and stomach.
In order to realize the object of the invention, a kind of Chinese medicine composition for the treatment of gastropathy of the present invention is made by following raw materials by weight proportions: Rhizoma Coptidis 10～50, Herba Salviae Chinensis 50～250, the Radix Aucklandiae 33～167, Fructus Evodiae 10～50, the Rhizoma Atractylodis Macrocephalae (stir-fry) 33～167, Poria 33～167, Fructus Amomi 10～50, Endothelium Corneum Gigeriae Galli 33～167, Fructus Hordei Germinatus (stir-fry) 50～250, Fructus Setariae Germinatus (stir-fry) 50～250, Massa Medicata Fermentata 50～250, Fructus Crataegi (parching to brown) 50～250, Semen Raphani (stir-fry) 33～167, Rhizoma Corydalis (vinegar system) 33～167.
Aforesaid Chinese medicine composition is made by following raw materials by weight proportions: Rhizoma Coptidis 15～45, Herba Salviae Chinensis 75～225, the Radix Aucklandiae 50～150, Fructus Evodiae 15～45, the Rhizoma Atractylodis Macrocephalae (stir-fry) 50～150, Poria 50～150, Fructus Amomi 15～45, Endothelium Corneum Gigeriae Galli 50～150, Fructus Hordei Germinatus (stir-fry) 75～225, Fructus Setariae Germinatus (stir-fry) 75～225, Massa Medicata Fermentata 75～225, Fructus Crataegi (parching to brown) 75～225, Semen Raphani (stir-fry) 50～150, Rhizoma Corydalis (vinegar system) 50～150.
Aforesaid Chinese medicine composition is made by following raw materials by weight proportions: Rhizoma Coptidis 30, Herba Salviae Chinensis 150, the Radix Aucklandiae 100, Fructus Evodiae 30, the Rhizoma Atractylodis Macrocephalae (stir-fry) 100, Poria 100, Fructus Amomi 30, Endothelium Corneum Gigeriae Galli 100, Fructus Hordei Germinatus (stir-fry) 150, Fructus Setariae Germinatus (stir-fry) 150, Massa Medicata Fermentata 150, Fructus Crataegi (parching to brown) 150, Semen Raphani (stir-fry) 100, Rhizoma Corydalis (vinegar system) 100.
Aforesaid Chinese medicine composition, it is tablet, pill, capsule, granule, oral liquid, syrup.
Aforesaid Chinese medicine composition, it is a granule.
The preparation method that the present invention treats the Chinese medicine composition of gastropathy comprises the steps: that (1) takes by weighing the above-mentioned raw materials medicine according to described weight proportion; (2) Radix Aucklandiae, Fructus Evodiae and Fructus Amomi etc. three flavor medical materials are added the water of 8 times of amounts, extract volatile oil 4h with the way of distillation, volatile oil is standby; (3) with ten Herba indigoferae Pseudotinctoriae such as Rhizoma Coptidis, Herba Salviae Chinensis, the Rhizoma Atractylodis Macrocephalae, Poria, Endothelium Corneum Gigeriae Galli, Fructus Hordei Germinatus, Fructus Setariae Germinatus, Massa Medicata Fermentata, Fructus Crataegi, Semen Raphani and Rhizoma Corydalis, the decocting that adds 8 times of amounts boils three times, be respectively 2 hours, 1.5 hours and 1 hour, and merged decoction liquor, filter, it is 1.20～1.30 that filtrate is concentrated into 80 ℃ of following relative densities, put coldly, add ethanol and make and contain alcohol amount and reach 60% (v/v), stirring is left standstill, get supernatant, being concentrated into 80 ℃ of following relative densities is 1.20～1.30; (4) add pharmaceutically acceptable carrier and/or excipient in the concentrated medicament that step (3) obtains, the weight proportion of medicinal liquid and carrier and/or excipient is 2: 3-5, and spray drying is made granule, sprays into the volatile oil of step (2), packing, promptly.
Aforesaid preparation method, wherein pharmaceutically acceptable carrier and/or excipient are starch, dextrin, lactose, stevioside, sucrose, glycyrrhizin, high fructose syrup, sucralose, xylitol, Sorbitol, glucose, pregelatinized Starch and/or carboxymethyl starch sodium.
The present invention treats the application of Chinese medicine composition in the medicine of gastropathy due to the preparation treatment Deficiency and coldness of spleen and stomach of gastropathy.
By technique scheme, the present invention has following advantage and beneficial effect at least:
Chinese medicine composition of the present invention is with spleen invigorating, nourishing the stomach, and heat clearing and damp drying is a starting point.But the Radix Aucklandiae, Fructus Amomi master go into spleen, stomach, large intestine channel promoting the circulation of QI to alleviate the stagnation in middle-JIAO in the side, and controlling the gastral cavilty distension has good effect; Gastropathy with the passing of time taste is impaired, and the transporting and transforming nutrients from foodstuff malfunction mostly is endogenous damp formation, spleen preferring dryness to dampness, wet then lack of appetite, the lassitude and weak of being stranded; Poria, Rhizoma Atractylodis Macrocephalae QI invigorating, spleen invigorating, promoting diuresis to eliminate damp pathogen are with the promoting diuresis to eliminate damp pathogen invigoration spleen qi; Endothelium Corneum Gigeriae Galli, Fructus Hordei Germinatus, Fructus Setariae Germinatus, Fructus Crataegi, Massa Medicata Fermentata, dyspepsia and intestinal stasis relieving; Assistant strengthens the effect of relieving distension by promoting circulation of QI with Semen Raphani; Rhizoma Corydalis is gone into Liver Channel, the QI regulating by alleviation of mental depression pain relieving; Both Chang Hanre was staggered for a long time for gastropathy, or the vomiting clear water, like warm pain relieved by pressing, or gastric was hot and suffocating, acid regurgitation and epigastric upset, and Fructus Evodiae is managed cold expelling, pain relieving with temperature, the soothing liver-QI therapeutic method to keep the adverse QI flowing downwards, dampness, Rhizoma Coptidis, Herba Salviae Chinensis removing damp-heat pathogenic fire purging relieving restlessness.All medicines share temper must be risen, and gastric qi must be fallen, and regulate the flow of vital energy and just do not hinder, and tonification does not stagnate greasy, treating both the principal and secondary aspects of a disease, and cold and heat decompose, and spleen and stomach function must be answered, disease spontaneous recovery.
Compositions is a pure Chinese medicinal preparation among the present invention, with motherland's traditional medicine is the Therapeutic Principle, having carried out the separation of effective components of Chinese medicinal on the modern pharmacy basis purifies, improved the therapeutic effect of this product, be used for the treatment of the gastropathy that insufficiency of the spleen cold syndrome of the stomach causes, disease meeting color is sallow, weak, stool is rare partially, lack of appetite, stomach are swollen, pain, belch, desire for hot drinks, the gastral cavilty pain relieved by pressing, pale tongue, white and thin fur, deficient and thready pulse etc., drug effect is remarkable.
The specific embodiment
Following examples are used to illustrate the present invention, but are not used for limiting the scope of the invention.
Embodiment 1
(1) takes by weighing following raw materials by weight proportions: Rhizoma Coptidis 15, Herba Salviae Chinensis 75, the Radix Aucklandiae 50, Fructus Evodiae 15, the Rhizoma Atractylodis Macrocephalae (stir-fry) 50, Poria 50, Fructus Amomi 15, Endothelium Corneum Gigeriae Galli 50, Fructus Hordei Germinatus (stir-fry) 75, Fructus Setariae Germinatus (stir-fry) 75, Massa Medicata Fermentata 75, Fructus Crataegi (parching to brown) 75, Semen Raphani (stir-fry) 50, Rhizoma Corydalis (vinegar system) 50.
(2) three flavor medical materials such as the Radix Aucklandiae, Fructus Evodiae, Fructus Amomi add the water of 8 times of amounts, extract volatile oil 4h with the way of distillation, and volatile oil is standby.
(3) Rhizoma Coptidis, Herba Salviae Chinensis, the Rhizoma Atractylodis Macrocephalae (stir-fry), Poria, Endothelium Corneum Gigeriae Galli, Fructus Hordei Germinatus (stir-fry), Fructus Setariae Germinatus (stir-fry), Massa Medicata Fermentata, Fructus Crataegi (parching to brown), Semen Raphani (stir-fry), Rhizoma Corydalis ten Herba indigoferae Pseudotinctoriae such as (vinegar systems), the decocting that adds 8 times of amounts boils three times, be respectively 2 hours, 1.5 hours, 1 hour, merge decoction liquor, filter, it is 1.20～1.30 that filtrate is concentrated into 80 ℃ of following relative densities, puts cold, add ethanol and make and contain alcohol amount and reach 60%, stir and left standstill 24 hours.Get supernatant, being concentrated into 80 ℃ of following relative densities is 1.20～1.30.
(4) in the concentrated medicament that step (3) obtains by medicinal liquid: starch: dextrin is that 10: 10: 1 weight proportion adds dextrin and starch, makes granule with 5% (w/w) PVP solution, and drying sprays into the volatile oil of (2), and tabletting is distributed into plastic bottle, promptly.
Embodiment 2
(1) takes by weighing following raw materials by weight proportions: Rhizoma Coptidis 45, Herba Salviae Chinensis 225, the Radix Aucklandiae 150, Fructus Evodiae 45, the Rhizoma Atractylodis Macrocephalae (stir-fry) 150, Poria 150, Fructus Amomi 45, Endothelium Corneum Gigeriae Galli 150, Fructus Hordei Germinatus (stir-fry) 225, Fructus Setariae Germinatus (stir-fry) 225, Massa Medicata Fermentata 225, Fructus Crataegi (parching to brown) 225, Semen Raphani (stir-fry) 150, Rhizoma Corydalis (vinegar system) 150.
(2) three flavor medical materials such as the Radix Aucklandiae, Fructus Evodiae, Fructus Amomi add the water of 8 times of amounts, extract volatile oil 4h with the way of distillation, and volatile oil is standby.
(3) Rhizoma Coptidis, Herba Salviae Chinensis, the Rhizoma Atractylodis Macrocephalae (stir-fry), Poria, Endothelium Corneum Gigeriae Galli, Fructus Hordei Germinatus (stir-fry), Fructus Setariae Germinatus (stir-fry), Massa Medicata Fermentata, Fructus Crataegi (parching to brown), Semen Raphani (stir-fry), Rhizoma Corydalis ten Herba indigoferae Pseudotinctoriae such as (vinegar systems), the decocting that adds 8 times of amounts boils three times, be respectively 2 hours, 1.5 hours, 1 hour, merge decoction liquor, filter, it is 1.20～1.30 that filtrate is concentrated into 80 ℃ of following relative densities, puts cold, add ethanol and make and contain alcohol amount and reach 60%, stir and left standstill 24 hours.Get supernatant, being concentrated into 80 ℃ of following relative densities is 1.20～1.30.
(4) in the concentrated medicament that step (3) obtains by medicinal liquid: starch: lactose is 5: 5: 1, weight proportion add starch and lactose, make granule with 10% (w/w) starch slurry, drying sprays into the volatile oil of (2), and packing becomes capsule, dress up plastic bottle or aluminium-plastic panel packing, promptly.
Embodiment 3
(1) takes by weighing following raw materials by weight proportions: Rhizoma Coptidis 30, Herba Salviae Chinensis 150, the Radix Aucklandiae 100, Fructus Evodiae 30, the Rhizoma Atractylodis Macrocephalae (stir-fry) 100, Poria 100, Fructus Amomi 30, Endothelium Corneum Gigeriae Galli 100, Fructus Hordei Germinatus (stir-fry) 150, Fructus Setariae Germinatus (stir-fry) 150, Massa Medicata Fermentata 150, Fructus Crataegi (parching to brown) 150, Semen Raphani (stir-fry) 100, Rhizoma Corydalis (vinegar system) 100.
(2) three flavor medical materials such as the Radix Aucklandiae, Fructus Evodiae, Fructus Amomi add the water of 8 times of amounts, extract volatile oil 4h with the way of distillation, and volatile oil is standby.
(3) Rhizoma Coptidis, Herba Salviae Chinensis, the Rhizoma Atractylodis Macrocephalae (stir-fry), Poria, Endothelium Corneum Gigeriae Galli, Fructus Hordei Germinatus (stir-fry), Fructus Setariae Germinatus (stir-fry), Massa Medicata Fermentata, Fructus Crataegi (parching to brown), Semen Raphani (stir-fry), Rhizoma Corydalis ten Herba indigoferae Pseudotinctoriae such as (vinegar systems), the decocting that adds 8 times of amounts boils three times, be respectively 2 hours, 1.5 hours, 1 hour, merge decoction liquor, filter, it is 1.20～1.30 that filtrate is concentrated into 80 ℃ of following relative densities, puts cold, add ethanol and make and contain alcohol amount and reach 60%, stir and left standstill 24 hours.Get supernatant, being concentrated into 80 ℃ of following relative densities is 1.20～1.30.
(4) in the concentrated medicament that step (3) obtains by medicinal liquid: sucrose: dextrin is that 10: 12: 7 weight proportion adds sucrose and dextrin, and spray drying is made granule, sprays into the volatile oil of (2), and packing becomes granule, packing, promptly.
Embodiment 4 observes the antiinflammatory action of Chinese medicine composition of the present invention
[being subjected to the reagent thing]
1. Chinese medicine composition of the present invention;
2. lot number: 20070616;
3. concentration: concentrated by the particulate extractum of preparation and to form, concentration is 8.0g/mL;
4. compound method: it is standby to be mixed with desired concn with distilled water.
[proinflammatory agent] dimethylbenzene (CR), Shanghai reagent one factory's product, lot number: 20051201; Carrageenin, Inst., of Clinical Pharmacology, Anhui Medical Univ. gives.
[animal] Kunming mouse, 24.0 ± 2.0g, male; The Wistar rat, 175.0 ± 20.0g, male, effluent south medical university Experimental Animal Center provides, the quality certification number: No. the 410115th, 410116, the moving word of doctor.
[instrument] Sartorius 2462 type precision balances, the Germany product; YLS-7A toes volumetric measurement instrument, Shandong Academy of Medical Sciences's equipment station product.
[method and result]
(1) Chinese medicine composition xylol of the present invention causes the influence of mice ear
Experiment is divided into 4 groups at random with 40 of male mices, and 10 every group, difference ig. (gastric infusion) normal saline (NS), 10gkg
-1, 20gkg
-1, 40gkg
-1Chinese medicine composition of the present invention, 30min causes inflammation (dimethylbenzene is embrocated left ear positive and negative, 0.1ml/ Mus, auris dextra compares) behind the ig., causes scorching back 30min and puts to death animal, uses
Card punch is got auricle in the ears antimere, weighs respectively in precision balance, and left and right sides auricle weight difference is the swelling degree, and the difference of comparative drug group and matched group is calculated and pressed down swollen rate, the results are shown in Table 1.
Table 1 Chinese medicine composition xylol of the present invention causes the influence of mice ear
Compare with the NS group
*P＜0.01; X: average, s: standard deviation
(2) Chinese medicine composition on Carrageenan of the present invention causes the bullate influence of rat paw
40 of healthy male rats are divided into 5 groups at random, and 10 every group, difference ig. normal saline (NS), 10gkg
-1, 20gkg
-1, 40gkg
-1Chinese medicine composition of the present invention.Ig. back 30min causes inflammation (at the right back sufficient sole of the foot sc. of the portion subcutaneous injection 1% carrageenin 0.1ml/ foot of rat), causing inflammation back 1h, 2h, 3h, 4h, the 5h following hind leg volume of YLS-7A toes volumetric measurement instrument measurement ankle joint respectively, and with cause scorching front foot pawl volumetric ratio, the difference that calculating causes the sufficient pawl volume in scorching front and back is the swelling degree, the results are shown in Table 2.
Table 2 Chinese medicine composition on Carrageenan of the present invention causes the bullate influence of rat paw
Compare with the NS group
*P＜0.05,
*P＜0.01; X: average, s: standard deviation
[conclusion (of pressure testing)] Chinese medicine composition of the present invention can obviously suppress the inflammatory reaction that mice caused by dimethylbenzene xylene ear inflammation and carrageenin cause rat paw edema, and its antiinflammatory action presents dose-effect relationship preferably.
Embodiment 5 observes the analgesic activity of Chinese medicine composition of the present invention
[being subjected to the reagent thing]
1. Chinese medicine composition of the present invention;
2. lot number: 20070616;
3. concentration: concentrated by the particulate extractum of preparation and to form, concentration is 8.0g/mL;
4. compound method: it is standby to be mixed with desired concn with distilled water.
[animal] Kunming mouse, 22 ± 2g, female, male dual-purpose, effluent south medical university Experimental Animal Center provides, the quality certification number: No. the 410115th, the moving word of doctor.
[reagent and instrument] glacial acetic acid (AR), Huainan City's chemical reagent factory product, lot number: 20000415; YLS-6A intelligence hot-plate instrument, Shandong Academy of Medical Sciences's equipment station product.
[method and result]
(1) analgesic activity of Chinese medicine composition of the present invention---writhing method
Experiment is divided into 5 groups at random with 50 of male mices, and 10 every group, difference ig. normal saline (NS), 10gkg
-1, 20gkg
-1, 40gkg
-1Chinese medicine composition of the present invention.Ig. 30min ip. (lumbar injection) 0.7% glacial acetic acid 0.1ml/10g after, record produces turns round body number of times (writhing response: the ip.0.7% glacial acetic acid stimulates peritoneum, and animal shows as abdominal part and shrinks indent, body distortion, hind leg and stretch) in incubation period of writhing response and the 15min.The difference of comparative drug group and matched group is calculated medicine analgesia percentage rate, the results are shown in Table 3.
Table 3 Chinese medicine composition of the present invention is to the influence of mouse writhing reaction
Compare with the NS group
*P＜0.01; X: average, s: standard deviation
(2) analgesic activity of Chinese medicine composition of the present invention---hot plate method
Select 50 of the qualified female mices in the preceding threshold of pain of medicine, be divided into 5 groups at random, 10 every group, difference ig. normal saline (NS), 10gkg
-1, 20gkg
-1, 40gkg
-1Ig. back 30min puts mice on the metallic plate of 55 ℃ of YLS-6A intelligence hot-plate instrument setting constant temperature, and the record mice is from dropping into hot plate to the pain threshold of the time of metapedes as this Mus occurring licking.The variation of 30min, 60min, each treated animal pain threshold of 90min the results are shown in Table 4 after observation and the comparison administration.
The analgesic activity of table 4 Chinese medicine composition of the present invention (hot plate method)
Compare with the NS group
*P＜0.05,
*P＜0.01; X: average, s: standard deviation
[conclusion (of pressure testing)]
Chinese medicine composition of the present invention has analgesic activity preferably, and it is all effective that physical property, chemical are caused pain model, and this product analgesic activity presents dose-effect relationship preferably.
The acute toxicity of embodiment 5 tests Chinese medicine composition of the present invention
[being subjected to the reagent thing]
1. Chinese medicine composition of the present invention;
2. lot number: 20070616;
3. concentration: concentrated by the particulate extractum of preparation and to form, concentration is 8.0g/mL;
4. compound method: be mixed with desired concn with normal saline.
[animal]
1. originate, kind, strain, the quality certification: provide by animal housing of Anhui Prov. Medical Science Inst., the Kunming kind, outbreeding sealing system, the animal quality certification is: the Anhui doctor is real to be moved accurate No. 01;
2. body weight: 18～22;
3. sex: male and female half and half, female person does not have pregnant;
4. number of animals: 40, divide every cage 5 raisings;
5. experimental situation: laboratory temperature is 18～28 ℃, and relative humidity is 50%-70%;
6. pellet: provide by Fuyang Ying Quan health and happiness laboratory animal feed factory.
[experimental technique]
Get 40 of mices, sub-cage rearing 2 days, behind fasting (the freely drinking water) 12h, every Mus ig. gives trial drug 0.6mL/20g, and with Isodose repeat administration 3 times, matched group gives isopyknic normal saline, breeding observing 7 days in the 24h.
[result]
1. animal toxicity response situation: administration group mice is moving phase after each administration, and spirit is not good enough to reducing, and diet reduces, and recovers after 2～3 hours.Administration treated animal hair after the administration first time has slight pollution, and all other indexs are compared no significant difference with matched group, and all indexs all recover normal in administration after 24 hours.After this animal is in the behavior activity, and aspect such as mental status and matched group relatively do not have significant change.
2. body weight change before and after the filling stomach:
Body weight does not have significant change before and after irritating stomach, sees table 5 for details.
Table 5 is irritated stomach front and back mice body weight situation (g)
P＞0.05, n (number of animals)=10
3. feed consumption before and after the filling stomach
The administration treated animal reduces than matched group in filling stomach food-intake on the same day, and mice appetite every day were compared no significant change before and after all the other irritated stomaches with matched group, saw table 6 for details.
Table 6 is irritated average every the mouse feed consumption (g) in stomach front and back
N (number of animals)=10
4. death condition: observed 7 days none animal dead after the administration continuously.
[conclusion]
Carry out the maximum dosage-feeding test with Kunming mouse, observed every index is all normal, does not see 1 animal dead.Show that Chinese medicine composition of the present invention does not have obvious acute toxicity effect, the oral maximum dosage-feeding of this product mice (MTD) is 1220g/kg, is equivalent to 610 times of clinical plan consumption.
Embodiment 6 determines the stability and the effect duration of Chinese medicinal composition granules of the present invention
The present invention has also carried out the stability test investigation, determines that the granule of Chinese medicine composition of the present invention has good stable, and effect duration can reach 2 years.
[test basis] Chinese Pharmacopoeia version in 2005.
[sample source] self-control, lot number: 20070616,20070618,20070620, sample adopts commercially available three layers of aluminum-plastic composite membrane packing.
[room temperature keeps sample] placed sample under the room temperature condition and preserves, respectively at sampling examination in 0,3,6,9,12,18,24 month.
[investigation project] character, granularity, moisture, melting, microbial limit, assay.
1, character: in required time, get three batch samples respectively, investigate by the character contents of a project in the Chinese medicinal composition granules quality standard draft of the present invention.
2, granularity: undertaken by method under an appendix I of Chinese Pharmacopoeia version in 2005 the C granule item.
3, moisture: undertaken by an appendix IX of Chinese Pharmacopoeia version in 2005 H first method.
4, melting: undertaken by method under an appendix I of Chinese Pharmacopoeia version in 2005 the C granule item.
5, microbial limit: undertaken by 2005 editions one appendix XIII C of Chinese Pharmacopoeia " microbial limit test ".
6, assay: undertaken by method under the assay item in the Chinese medicinal composition granules quality standard draft of the present invention.
[result and conclusion]
1, investigates result of the test and see Table 7～9 (stability test datas).
2, with room temperature reserved sample observing method, three batch samples to preparation have been carried out the preliminarily stabilised test, Chinese medicinal composition granules of the present invention does not as a result all have to take place significant the variation at aspects such as character, granularity, moisture content, melting, microbial limit, assays, show that this product is stable, employed packaging material also meet the requirements.According to result of the test, determine that temporarily this product effect duration is 2 years.
Though above the present invention is described in detail with a general description of the specific embodiments, on basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Therefore, these modifications or improvements all belong to the scope of protection of present invention without departing from theon the basis of the spirit of the present invention.
Claims (8)
1. Chinese medicine composition for the treatment of gastropathy, it is characterized in that, make: Rhizoma Coptidis 15～45, Herba Salviae Chinensis 75～225, the Radix Aucklandiae 50～150, Fructus Evodiae 15～45, the Rhizoma Atractylodis Macrocephalae 50～150, Poria 50～150, Fructus Amomi 15～45, Endothelium Corneum Gigeriae Galli 50～150, Fructus Hordei Germinatus 75～225, Fructus Setariae Germinatus 75～225, Massa Medicata Fermentata 75～225, Fructus Crataegi 75～225, Semen Raphani 50～150 and Rhizoma Corydalis 50～150 by following raw materials by weight proportions.
2. Chinese medicine composition according to claim 1, it is characterized in that, make: Rhizoma Coptidis 30, Herba Salviae Chinensis 150, the Radix Aucklandiae 100, Fructus Evodiae 30, the Rhizoma Atractylodis Macrocephalae 100, Poria 100, Fructus Amomi 30, Endothelium Corneum Gigeriae Galli 100, Fructus Hordei Germinatus 150, Fructus Setariae Germinatus 150, Massa Medicata Fermentata 150, Fructus Crataegi 150, Semen Raphani 100 and Rhizoma Corydalis 100 by following raw materials by weight proportions.
3. Chinese medicine composition according to claim 1 and 2, wherein the Rhizoma Atractylodis Macrocephalae, Fructus Hordei Germinatus, Fructus Setariae Germinatus and Semen Raphani are parch, and Fructus Crataegi is a parching to brown system, and Rhizoma Corydalis is a vinegar system.
4. Chinese medicine composition according to claim 1 and 2, it is tablet, pill, capsule, granule, oral liquid or syrup.
5. Chinese medicine composition according to claim 4, it is a granule.
6. a method for preparing as claim 1-5 Chinese medicine composition as described in each is characterized in that, comprises the steps:
(1) takes by weighing the above-mentioned raw materials medicine according to described weight proportion;
(2) with the Radix Aucklandiae, Fructus Evodiae and Fructus Amomi totally three flavor medical materials add the water of 8 times of amounts, extract volatile oil 4h with the way of distillation, volatile oil is standby;
(3) with Rhizoma Coptidis, Herba Salviae Chinensis, the Rhizoma Atractylodis Macrocephalae, Poria, Endothelium Corneum Gigeriae Galli, Fructus Hordei Germinatus, Fructus Setariae Germinatus, Massa Medicata Fermentata, Fructus Crataegi, Semen Raphani and Rhizoma Corydalis totally ten Herba indigoferae Pseudotinctoriae, the decocting that adds 8 times of amounts boils three times, be respectively 2 hours, 1.5 hours and 1 hour, and merged decoction liquor, filter, it is 1.10～1.20 that filtrate is concentrated into 80 ℃ of following relative densities, put coldly, add ethanol and make and contain alcohol amount and reach 60v/v%, stirring is left standstill, get supernatant, being concentrated into 80 ℃ of following relative densities is 1.20～1.30;
(4) add pharmaceutically acceptable carrier and/or excipient in the concentrated medicament that step (3) obtains, the weight proportion of medicinal liquid and carrier and/or excipient is 2: 3-5, and spray drying is made granule, sprays into the volatile oil of step (2), packing, promptly.
7. method according to claim 6, wherein pharmaceutically acceptable carrier and/or excipient are starch, dextrin, lactose, stevioside, sucrose, glycyrrhizin, high fructose syrup, sucralose, xylitol, Sorbitol, glucose, pregelatinized Starch and/or carboxymethyl starch sodium.
8. one kind as the application of the arbitrary described Chinese medicine composition of claim 1-5 in the medicine of gastropathy due to the preparation treatment Deficiency and coldness of spleen and stomach.
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| CN102166267B (en) * | 2011-04-22 | 2012-05-23 | 常洋 | Traditional Chinese medicine composition used for improving appetite and promoting digestion and preparation method thereof |
| CN103007218A (en) * | 2012-11-27 | 2013-04-03 | 张辉 | Traditional Chinese medicine for treating atrophic gastritis and method for preparing same |
| CN104666438A (en) * | 2015-03-13 | 2015-06-03 | 朱晓岩 | Chinese patent medicine for treating chronic gastric disease of spleen deficiency and preparation method of Chinese patent medicine |
| CN106474413B (en) * | 2016-11-09 | 2019-11-05 | 扬子江药业集团上海海尼药业有限公司 | It is a kind of for treat the weakness of the spleen and the stomach children, eating accumulation, anorexia Orally administered composition |
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| 张闻东.马骏运用行气法治疗脾胃病的经验.《安徽中医学院学报》.2000,第19卷(第1期),34-35. * |
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