CN1286501C - Medicine composition for treating stomach disease, its preparation method and use - Google Patents
Medicine composition for treating stomach disease, its preparation method and use Download PDFInfo
- Publication number
- CN1286501C CN1286501C CN 03157561 CN03157561A CN1286501C CN 1286501 C CN1286501 C CN 1286501C CN 03157561 CN03157561 CN 03157561 CN 03157561 A CN03157561 A CN 03157561A CN 1286501 C CN1286501 C CN 1286501C
- Authority
- CN
- China
- Prior art keywords
- parts
- powder
- rhizoma acori
- acori graminei
- treatment
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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- 238000009210 therapy by ultrasound Methods 0.000 description 1
- 230000017423 tissue regeneration Effects 0.000 description 1
- MWOOGOJBHIARFG-UHFFFAOYSA-N vanillin Chemical compound COC1=CC(C=O)=CC=C1O MWOOGOJBHIARFG-UHFFFAOYSA-N 0.000 description 1
- FGQOOHJZONJGDT-UHFFFAOYSA-N vanillin Natural products COC1=CC(O)=CC(C=O)=C1 FGQOOHJZONJGDT-UHFFFAOYSA-N 0.000 description 1
- 235000012141 vanillin Nutrition 0.000 description 1
- 230000003313 weakening effect Effects 0.000 description 1
- 230000004580 weight loss Effects 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
- 239000011701 zinc Substances 0.000 description 1
- 229910052725 zinc Inorganic materials 0.000 description 1
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Abstract
The present invention discloses a medicine composition for treating gastropathy, which is a medicine prepared by the following components with a proportion: 100 to 300 parts of bismuth aluminate, 100 to 600 parts of heavy magnesium carbonate, 100 to 400 parts of sodium bicarbonate, 100 to 500 parts of licorice root extract powder, 1 to 50 parts of buckthorn bark, 1 to 50 parts of fennel powder and 1 to 50 parts of aloe powder and/or 1 to 50 parts of grassleaved sweetflag rhizome. The present invention also discloses a method for preparing the medicine composition. The medicine composition of the present invention is a compound preparation for restraining sour and protecting the gastric mucosa, and can be applied to preparing medicines for treating digestive system diseases of gastric ulcer, duodenal ulcer, chronic superficial gastritis, chlorhydria, pyrosis, gastrospasm, nervous indigestion, etc.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition, Its Preparation Method And Use, relate in particular to a kind of by bismuth aluminate, Heavy Magnesium Carbonate, sodium bicarbonate, Radix Glycyrrhizae extractum powder, FULANGSHULIPI, Fructus Foeniculi powder, Aloe or/and the pharmaceutical composition that the Rhizoma Acori Graminei drug regimen forms, its preparation method and the purposes aspect digestive system disease such as treatment gastric and duodenal ulcers, chronic superficial gastritis, hyperchlorhydria, heartburn, stomach spasm, nervous dyspepsia thereof.
Background technology
Gastropathy is the common frdquently encountered disease of serious harm human health, generally is meant gastritis stomach function regulating and duodenal ulcer disease, its symptom initial or slight outbreak be epigastric discomfort, glutted, heartburn, retch, feel sick etc.Multiple reason can cause gastropathy, can become the cause of disease of gastropathy as diet, environment, heredity, medicine, antibacterial and chemicals damage, smoking etc., consequently causes gastroxia stomach function regulating mucosa injury to increase the weight of.The medicine of therefore treating gastropathy can be divided into two classes, and a class is for neutralizing or weakening the medicine of gastric acid and press down sour medicine H
2Receptor antagonist; One class is for increasing the medicine of gastric mucosa defence capability.
Application number is 95113913.4 to disclose a kind of its prescription of compound bismuth aluminate granule that is mainly used in treatment gastric ulcer and duodenal ulcer and mainly comprise bismuth aluminate, sodium bicarbonate, Heavy Magnesium Carbonate, Radix Glycyrrhizae extractum, bark of polyFrangula alnus Miller, Fructus Foeniculi powder, ethanol or water, sieve, technology such as mixing, moistening preparation, drying, granulate, packing makes, be a kind of in and gastric acid and astringency, can be used for treating peptic ulcer.
At present, the Chinese and western drugs of many treatment gastropathy is arranged, but all have shortcomings such as treatment speed is slow, the symptom pain relief is slow, cure rate is low, side effect is big.
Summary of the invention
The object of the present invention is to provide a kind of pharmaceutical composition for the treatment of gastropathy; said composition is antiacid and compound preparation gastric mucosal protection; have convergence, in and effects such as gastric acid, protection gastric mucosa, catharsis relieving constipation, spasmolytic, appetizing relieving distension, and this medicine has, and treatment speed is fast, the symptom pain relief is fast, the cure rate advantages of higher.
Another object of the present invention is to provide a kind of preparation of drug combination method for the treatment of gastropathy.
A further object of the present invention is to provide a kind of purposes of pharmaceutical composition aspect digestive system disease such as treatment gastric and duodenal ulcers, chronic superficial gastritis, hyperchlorhydria, heartburn, stomach spasm, nervous dyspepsia for the treatment of gastropathy.
A kind of pharmaceutical composition for the treatment of gastropathy of the present invention comprises that following component and proportioning are the medicament that raw material is made:
100～300 parts of bismuth aluminate, 100～600 parts of Heavy Magnesium Carbonate,
100～400 parts of sodium bicarbonate, 100～500 parts of Radix Glycyrrhizae extractum powders,
1～50 part of FULANGSHULIPI, 1～50 part of Fructus Foeniculi powder,
1～50 part of Aloe powder is or/and 1～50 part of Rhizoma Acori Graminei.
Preferred ingredients and proportioning:
150～250 parts of bismuth aluminate, 300～500 parts of Heavy Magnesium Carbonate,
150～250 parts of sodium bicarbonate, 150～300 parts of Radix Glycyrrhizae extractum powders,
5～30 parts of FULANGSHULIPI, 5～30 parts of Fructus Foeniculi powder,
10～30 parts of Aloe powder are or/and 5～30 parts of Rhizoma Acori Graminei.
More preferred ingredients and proportioning:
200 parts of bismuth aluminate, 350～450 parts of Heavy Magnesium Carbonate,
200～250 parts of sodium bicarbonate, 200～250 parts of Radix Glycyrrhizae extractum powders,
10～25 parts of FULANGSHULIPI, 10～15 parts of Fructus Foeniculi powder,
10～20 parts of 25～35 parts of Aloe powder and Rhizoma Acori Graminei.
Most preferred component and proportioning:
200 parts of bismuth aluminate, 400 parts of Heavy Magnesium Carbonate,
250 parts of sodium bicarbonate, 250 parts of Radix Glycyrrhizae extractum powders,
12.5 parts of 15 parts of FULANGSHULIPI, 15 parts of Fructus Foeniculi powder, 30 parts of Aloe powder and Rhizoma Acori Graminei.
Weight portion of the present invention can be the known content units of field of medicaments such as μ g, mg, g, kg.
Pharmaceutical composition of the present invention is antiacid and compound preparation gastric mucosal protection, have convergence, in and effects such as gastric acid, protection gastric mucosa, catharsis relieving constipation, spasmolytic, appetizing relieving distension.
Wherein bismuth aluminate can form layer protecting film on stomach and duodenal mucosa, thereby promotes mucosa regeneration and the normal healing that quickens ulcer.
Sodium bicarbonate and Heavy Magnesium Carbonate be as the antacid part gastric acid that can neutralize, thereby prevent gastric acid and the pepsin erosion damage to gastric mucosa.
Radix Glycyrrhizae extractum powder contains active ingredients such as glycyrrhizic acid, has antiulcer action, can alleviate the gastrointestinal smooth muscular spasm.
Fructus Foeniculi contains a certain amount of volatile oil, has dispersing cold for relieving pain, regulating qi-flowing for harmonizing stomach effect, has the gastrointestinal of adjusting function, antiulcer, the effect of promotion bile secretion.
FULANGSHULIPI has the therapeutical effect that promotes tissue repair.
Rhizoma Acori Graminei contains volatile oil such as asarone, has removing dampness appetizing, circulation of qi promoting except that the effect of expanding, and can secrete by facilitating digestion liquid, prevents gastrointestinal abnormal fermentation, and can alleviate the intestinal tube smooth muscle spasm.
Aloe contains active ingredients such as barbaloin, have stimulate rush down down, relieving constipation removing food stagnancy and anti-gastric injury effect, anti-gastric-ulcer effect.Aloe causes that to restraining water stress ulcer, indometacin and ethanol ulcer has the obvious suppression effect; When Aloin A is pressed the 10mg/kg intravenously administrable, can suppress pylorus ligation rat gastric secretion and pepsin activity, shay ulcer and the inductive gastric injury of indometacin are had significant inhibitory effect, can also suppress pylorus ligation rat water logging irritability gastric injury significantly.
Bismuth aluminate of the present invention, Heavy Magnesium Carbonate, sodium bicarbonate, Radix Glycyrrhizae extractum powder, FULANGSHULIPI, Fructus Foeniculi powder, these several components of Aloe all can adopt the commercially available powder product that meets the national drug standards at present, or according to the method on the pharmacy of Chinese materia medica raw material are handled the pulverizing products obtained therefrom.
Fructus Foeniculi powder of the present invention is that Fructus Foeniculi can adopt the method on the pharmacy of Chinese materia medica to handle the pulverizing gained; Radix Glycyrrhizae extractum powder is that the Radix Glycyrrhizae extractum that meets the national drug standards adopts the method on the pharmacy of Chinese materia medica to handle the pulverizing gained.
Aloe of the present invention is that liliaceous plant Aloe vulgaris (Aloe barbadensis Miller), Aloe ferox Miller (Aloe ferox Miller) or other juice that belongs to the kindred plant leaf together adopt conventional method to concentrate the dry thing that forms.
Described Rhizoma Acori Graminei is the dry rhizome of acorus gramineus araceae plant (Acorus tatarinowii Schott), and further adopt method effective component extracting that water carries again the method on pharmacy of Chinese materia medica handle and pulverize that to obtain medicated powder standby.
The preparation of drug combination method of treatment gastropathy of the present invention is: the Rhizoma Acori Graminei with said ratio decocts with water earlier, filter, be condensed into thick paste, oven dry is ground into Rhizoma Acori Graminei water and carries medicated powder, add other composition mix homogeneously by proportioning then, add pharmaceutically acceptable adjuvant again and make acceptable various dosage forms on the pharmaceutics.
Specifically, to put forward the medicated powder preparation process as follows for the used Rhizoma Acori Graminei water of the present invention:
After the Rhizoma Acori Graminei washing, soaked 1～2 hour, add water boil and decoct 1～3 time, add 5～10 times of amounts of water at every turn, decocted 0.5～3 hour, collect decoction liquor, each time decoction liquor is merged, filter, be condensed into thick paste, oven dry, get dry extract, dried cream powder is become fine powder, Rhizoma Acori Graminei water to carry medicated powder standby, yield is 12～16%.
Certainly, in the preparation of drug combination process of treatment gastropathy of the present invention, also can directly adopt commercially available Rhizoma Acori Graminei water to carry medicated powder.
Used Aloe can be adopted the dry thing pulverizing of Aloe or wear into fine powder standby, or directly adopts commercially available Aloe powder.
When not adding Rhizoma Acori Graminei, the preparation of drug combination method of treatment gastropathy of the present invention is: add each component mix homogeneously in proportion, add pharmaceutically acceptable adjuvant again and make acceptable various dosage forms on the pharmaceutics.
The various dosage forms of the pharmaceutical composition of treatment gastropathy of the present invention can be according to the conventional production method preparation of pharmaceutical field.Such as using said composition to mix, be made into required dosage form then with one or more carriers.
The pharmaceutical composition of treatment gastropathy of the present invention can be made into a kind of dosage forms wherein such as acceptable tablet on the pharmaceutics, capsule, granule, pill, powder, most preferably is granule.
The pharmaceutical composition of treatment gastropathy of the present invention by bismuth aluminate, Heavy Magnesium Carbonate, sodium bicarbonate, Radix Glycyrrhizae extractum powder, FULANGSHULIPI, Fructus Foeniculi powder, Aloe powder or/and Rhizoma Acori Graminei totally seven kinds or eight kinds of medicine components are replenished mutually with the specified weight ratio and by the different effects that stresses and are acted synergistically on digestive system, be antiacid and compound preparation gastric mucosal protection, have convergence, in and effects such as gastric acid, protection gastric mucosa, catharsis relieving constipation, spasmolytic, appetizing relieving distension, and this medicine has, and treatment speed is fast, the symptom pain relief is fast, the cure rate advantages of higher; Can be used for treating digestive system disease such as gastric and duodenal ulcers, chronic superficial gastritis, hyperchlorhydria, heartburn, stomach spasm, nervous dyspepsia.
Research worker of the present invention is tested discovery in a large number, eight kinds of components are with 200 parts of bismuth aluminate, 400 parts of Heavy Magnesium Carbonate, 250 parts of sodium bicarbonate, 250 parts of Radix Glycyrrhizae extractum powders, 15 parts of FULANGSHULIPI, 15 parts of Fructus Foeniculi powder, 30 parts of Aloe powder, 12.5 parts of Rhizoma Acori Graminei in pharmaceutical composition, and synergism is best during the part by weight proportioning, curative effect is best.
The specification that the present invention most preferably treats the medicament composition granule agent of gastropathy is the 2g/ bag, and every bag contains bismuth aluminate 0.2g, Heavy Magnesium Carbonate 0.4g, sodium bicarbonate 0.25g, Radix Glycyrrhizae extractum powder 0.25g, FULANGSHULIPI 0.015g, Fructus Foeniculi powder 0.015g, Aloe powder 0.03g, Rhizoma Acori Graminei 0.0125g.
Usage is as follows: oral, one time 1～2 bag, 3 times on the one, warm water delivery service, continuous 1～2 month is a course of treatment, but later on decrement is kept, preventing recurrence, or by doctor's advice.
The pharmaceutical composition of treatment gastropathy of the present invention is antiacid and compound preparation gastric mucosal protection, as the application in the medicine of digestive system disease such as preparation treatment gastric and duodenal ulcers, chronic superficial gastritis, hyperchlorhydria, heartburn, stomach spasm, nervous dyspepsia.
The pharmaceutical composition of treatment gastropathy of the present invention replenishes mutually by various components and acts synergistically on digestive system, especially Aloe or/and Rhizoma Acori Graminei with the synergism of bismuth aluminate compound recipe, play beyond thought effect, have convergence, in and effect such as gastric acid, protection gastric mucosa, catharsis relieving constipation, spasmolytic, appetizing relieving distension, make this medicine have that treatment speed is fast, the symptom pain relief fast, the cure rate advantages of higher, be better than containing at present the compound bismuth aluminate of bismuth aluminate, Heavy Magnesium Carbonate, sodium bicarbonate, Radix Glycyrrhizae extractum powder, FULANGSHULIPI and Fructus Foeniculi powder; Can be used for treating digestive system disease such as gastric and duodenal ulcers, chronic superficial gastritis, hyperchlorhydria, heartburn, stomach spasm, nervous dyspepsia.
The specific embodiment
Further describe the present invention with embodiment below, help understanding, but described embodiment only is used to illustrate the present invention rather than restriction the present invention the present invention and advantage thereof, better effects if.
Embodiment 1
Aloe 30g powder is become fine powder, standby; After the Rhizoma Acori Graminei 12.5g washing, soaked 1 hour, add water boil and decoct 2 times, for the first time add 8 times of amounts of water, decocted 2 hours, add 6 times of amounts of water for the second time, decocted 1.5 hours, and collected decoction liquor, twice decoction liquor merged, filter, be condensed into thick paste, oven dry, get dry extract, dried cream powder is become fine powder, Rhizoma Acori Graminei water to carry medicated powder standby, yield is 15%.
Take by weighing bismuth aluminate 200g, Heavy Magnesium Carbonate 400g, sodium bicarbonate 250g, Radix Glycyrrhizae extractum powder 250g, FULANGSHULIPI 15g, Fructus Foeniculi powder 15g, above component and Aloe powder and Rhizoma Acori Graminei water are carried medicated powder and are mixed (1000 bags of the granules that above component is used to prepare the 2g/ bag), the sucrose, 50g starch and the 50g dextrin that add 740g, granulate, dry, the granulate that sieves, the pack packing gets granule.
Usage: oral, one time 1～2 bag, 3 times on the one, warm water delivery service, continuous 1～2 month is a course of treatment, but later on decrement is kept, preventing recurrence, or by doctor's advice.
Embodiment 2
Aloe 15g powder is become fine powder, standby; After the Rhizoma Acori Graminei 30g washing, soaked 2 hours, add water boil and decoct 1 time, add 10 times of amounts of water for the first time, decocted 3 hours, collect decoction liquor, filter, be condensed into thick paste, dry, get dry extract, dried cream powder is become fine powder, getting Rhizoma Acori Graminei water, to carry medicine standby, and yield is 13%.
Take by weighing bismuth aluminate 150g, Heavy Magnesium Carbonate 500g, sodium bicarbonate 150g, Radix Glycyrrhizae extractum powder 250g, FULANGSHULIPI 5g, Fructus Foeniculi powder 30g, above component and Aloe powder and Rhizoma Acori Graminei water are carried medicated powder and are mixed the pharmaceutical composition that forms treatment gastropathy; Make wetting agent with 75% ethanol, granulate with 16 mesh sieves, baking temperature is 60 ℃, and the time is 2 hours, and dry back gets granule with oscillating granulator 14 mesh sieve granulate, pack packing.
Usage: oral, one time 1～2 bag, 3 times on the one, warm water delivery service, continuous 1～2 month is a course of treatment, but later on decrement is kept, preventing recurrence, or by doctor's advice.
Embodiment 3
Aloe 50g powder is become fine powder, standby; After the Rhizoma Acori Graminei 6g washing, soaked 1.5 hours, add water boil and decoct 3 times, for the first time add 9 times of amounts of water, decocted 2 hours, add 6 times of amounts of water for the second time, decocted 1.5 hours, and added 5 times of amounts of water for the third time, decocted 1 hour, collect decoction liquor, filter, be condensed into thick paste, oven dry gets dry extract, and dried cream powder is become fine powder, Rhizoma Acori Graminei water to carry medicine standby, yield is 14%.
Take by weighing bismuth aluminate 300g, Heavy Magnesium Carbonate 200g, sodium bicarbonate 400g, Radix Glycyrrhizae extractum powder 100g, FULANGSHULIPI 35g, Fructus Foeniculi powder 5g, above component and Aloe powder and Rhizoma Acori Graminei water are carried medicated powder and are mixed the pharmaceutical composition that forms treatment gastropathy; Add water with behind the pharmaceutical compositions of 100 gram treatment gastropathy and the 15 gram starch mixings, granulate, cross 20 mesh sieve granulate, drying, it is in blocks to add 1 gram magnesium stearate compacting, promptly gets the pharmaceutical composition tablet.
Embodiment 4
With embodiment 1, different is that the set of dispense ratio for the treatment of the pharmaceutical composition of gastropathy is: take by weighing bismuth aluminate 200g, Heavy Magnesium Carbonate 420g, sodium bicarbonate 220g, Radix Glycyrrhizae extractum powder 200g, FULANGSHULIPI 10g, Fructus Foeniculi powder 15g, Aloe powder 25g, Rhizoma Acori Graminei powder 20g.
The pharmaceutical composition of treatment gastropathy is crossed 100 mesh sieves, mixing, subpackage promptly gets powder.
Embodiment 5
With embodiment 1, different is that the set of dispense ratio for the treatment of the pharmaceutical composition of gastropathy is: take by weighing bismuth aluminate 250g, Heavy Magnesium Carbonate 300g, sodium bicarbonate 200g, Radix Glycyrrhizae extractum powder 200g, FULANGSHULIPI 1g, Fructus Foeniculi powder l0g, Aloe powder 20g.
With the pharmaceutical composition of treatment gastropathy, cross 100 mesh sieves, in 60 ℃ of oven dry, encapsulated.
Embodiment 6-9
The pharmaceutical composition component and the proportioning of treatment gastropathy are as follows: unit: gram
| Sequence number | Bismuth aluminate | Heavy Magnesium Carbonate | Sodium bicarbonate | Radix Glycyrrhizae | FULANGSHULIPI | Fructus Foeniculi | Rhizoma Acori Graminei |
| Embodiment 6 | 100 | 200 | 250 | 300 | 8 | 50 | 16 |
| Embodiment 7 | 300 | 100 | 350 | 500 | 45 | 1 | 45 |
| Embodiment 8 | 150 | 350 | 180 | 150 | 25 | 15 | 25 |
| Embodiment 9 | 250 | 550 | 100 | 200 | 10 | 30 | 1 |
Embodiment 10-13
The pharmaceutical composition component and the proportioning of treatment gastropathy are as follows: unit: gram
| Sequence number | Bismuth aluminate | Heavy Magnesium Carbonate | Sodium bicarbonate | Radix Glycyrrhizae | FULANGSHULIPI | Fructus Foeniculi | Aloe |
| Embodiment 10 | 200 | 300 | 250 | 300 | 25 | 5 | 16 |
| Embodiment 11 | 300 | 600 | 350 | 400 | 35 | 1 | 1 |
| Embodiment 12 | 150 | 500 | 150 | 200 | 18 | 15 | 25 |
| Embodiment 13 | 250 | 400 | 200 | 150 | 5 | 30 | 20 |
Experimental example 1
This experimental example is the detection of the granule inspection item of optimal drug composition granule appearance character of the present invention, loss on drying and regulation thereof.
√ medicament composition granule agent of the present invention is yellowish-brown or faint yellow granule.
√ gets medicament composition granule agent of the present invention, is dried to constant weight at 105 ℃, subtracts weight loss and must not cross 5.0% (two appendix VIII of Chinese Pharmacopoeia version in 2000 L), should be up to specification.
√ other inspection items of medicament composition granule agent of the present invention (comprising granularity, melting, content uniformity, microbial limit) should meet pertinent regulations under the granule item (two appendix IA of Chinese Pharmacopoeia version in 2000).
Experimental example 2
This experimental example is the qualitative determination of component in the optimal drug composition granule of the present invention.
√ gets the about 2g of fine powder of this product, puts in the crucible, and is blazing to carbonization, puts coldly, adds nitric acid 3ml, and low-temperature heat to nitric acid gas eliminates, and blazing to carbonization fully, residue is according to following method test.
√ get residue a little, add rare nitric acid 5ml, make dissolving, filter, in filtrate, drip the potassium iodide test solution, promptly generate the brownish black precipitation, drip excessive potassium iodide test solution again, precipitation i.e. dissolving.
√ get residue a little, add dilute hydrochloric acid 5ml, make dissolving, filter, in filtrate, drip ammonia solution, to generating white precipitate, add the alizarine S indicator solution again, precipitation promptly shows cherry red.
√ get residue a little, add dilute hydrochloric acid 3ml, make dissolving, show sodium salt identification (two appendix III of Chinese Pharmacopoeia version in 2000).
√ get residue a little, add dilute hydrochloric acid 3ml, make dissolving, after being adjusted to neutrality with ammonia solution, ammonification-ammonium chloride buffer (pH10.0) 3ml filters, get the filtrate number and droplet put on the white plaque, blue precipitation promptly takes place in hydro-oxidation sodium test solution number droplet and 1～2 of 5% azo violet solution.
√ gets the about 1.0g of fine powder of this product, adds dilute sulfuric acid 3ml, i.e. intumescence.Carbon dioxide takes place, and this gas feeds in the calcium hydroxide test solution, and white opacity promptly takes place.
√ gets the about 1.0g of fine powder of this product, adds dilute sulfuric acid 10ml, boils 2 minutes, filter while hot, and the 5ml that adds diethyl ether, jolting is extracted, and divide and get the ether layer, hydro-oxidation sodium test solution 2ml, jolting, it is orange red that water layer shows.
√ gets the about 2.0g of fine powder of this product, adds methanol 15ml, and tepor is extracted 30min, filters, and filtrate is put under the ultra-violet lamp (254nm) and inspected, and shows yellow-green fluorescence.
√ gets the about 2.0g of fine powder of this product, the 10ml that adds diethyl ether, jolting 10 minutes is filtered in porcelain evaporating dishes, treat that ether volatilization is done after, drip 2 of the 5% vanillin sulfuric acid solutions of new preparation, displaing amaranth.
√ gets 10 bags of this product, and porphyrize adds methanol 20ml, is heated to and boils, and jolting number minute filters, and filtrate is as need testing solution.Other gets the barbaloin reference substance, add methanol and make the solution that every 1ml contains 5mg, product solution is tested according to thin layer chromatography (two appendix V of Chinese Pharmacopoeia version in 2000 B) in contrast, draw each 10 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, be developing solvent with ethyl acetate-methanol-water (100: 17: 13), launch, take out, dry, spray is put under the ultra-violet lamp (365nm) and is inspected with 10% potassium hydroxide methanol solution.Need testing solution with the corresponding position of reference substance solution on, show the fluorescence speckle of identical color.
√ gets 5 bags of this product, porphyrize, add petroleum ether (60～90 ℃) 10ml, ultrasonic Treatment 10 minutes filters, and filtrate is medical material solution in contrast, test according to thin layer chromatography (two appendix VB of Chinese Pharmacopoeia version in 2000), drawing each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel G 254 lamellaes, is developing solvent with petroleum ether (60～90 ℃)-ethyl acetate (8: 2), launch, take out, dry, spray is with 10% potassium hydroxide alcoholic solution, put under the ultra-violet lamp (254nm) and inspect, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical color speckle.
The above ten kinds of experiments of √ illustrate and contain definite component in the pharmaceutical composition of the present invention for the qualitative reaction of the contained component of pharmaceutical composition of the present invention.
Experimental example 3
This experimental example is the detection by quantitative of main component in the optimal drug composition granule of the present invention.
A) detection by quantitative of bismuth, every bag contains bismuth aluminate and should be 79～97mg with bismuth calculating.
Get 10 bags of this product, the accurate title, decide, porphyrize, precision takes by weighing in right amount (being equivalent to bismuth aluminate 0.3g approximately) and puts in the 50ml crucible, slowly blazing to carbonization fully, put and be chilled to room temperature, add nitric acid 3ml, after low-temperature heat to nitric acid gas eliminates, blazing to fully carbonization, put and add salpeter solution (3-10) 20ml after being chilled to room temperature, residue is transferred in the 500ml conical flask, bottleneck is put little funnel low baking temperature and is back to residue dissolving (the little apparent muddiness of solution), put and add water 200ml after cold, regulate pH value to 1, add 5 of xylenol orange indicator solutions, change lemon yellow with Calcium Disodium Versenate volumetric solution (0.05mol/L) titration to solution into by Chinese red, every 1ml Calcium Disodium Versenate volumetric solution (0.05mol/L) is equivalent to the bismuth (Bi) of 10.45mg.
B) detection by quantitative of aluminum, every bag contains bismuth aluminate and should be 30.6～70.4mg with aluminum calculating.
Get the solution of measuring behind the bismuth, drip ammonia test to just separating out precipitation, drip rare nitric acid again and make just dissolving (pH is about 6.0) of precipitation, add acetic acid-ammonium acetate buffer (pH6.0) 15ml, precision adds Calcium Disodium Versenate volumetric solution (0.05mol/L) 50ml, boiled 10 minutes, put coldly, add 5 of xylenol orange indicator solutions, with zinc volumetric solution (0.05%mol/L) titration, change Chinese red into by lemon yellow to solution, and titrating result is proofreaied and correct with blank assay.Every 1ml Calcium Disodium Versenate volumetric solution (0.05mol/L) is equivalent to the aluminum (Al) of 1.349mg.
C) magnesian detection by quantitative, every bag contains Heavy Magnesium Carbonate and should be 37.3～45.7% of labelled amount with magnesium oxide calculating.
Precision takes by weighing above-mentioned fine powder an amount of (being equivalent to magnesium carbonate 0.4g approximately), puts in the 50ml crucible, and slowly blazing carbonization is extremely fully put and is chilled to room temperature, adds nitric acid 3ml, after low-temperature heat to nitric acid gas eliminates, makes complete ashing; Put and be chilled to room temperature, add dilute hydrochloric acid solution 15ml, residue is transferred in the 50ml beaker, boils and make residue dissolving, add water 20ml then, 1 of the red indicator solution of methylate, drip ammonia solution and make red the disappearance, boiled again 5 minutes, filter while hot, filtering residue washs with 2% warm ammonium chloride solution 30ml, merging filtrate and washing liquid add water to scale in the 100ml measuring bottle, shake up, precision is measured 20ml in conical flask, add water 20ml, ammonification-ammonium chloride buffer (pH10.0) and each 5ml of triethanolamine solution (1-2), it is a small amount of to add chromium black T indicator again, with Calcium Disodium Versenate volumetric solution (0.05mol/L) titration, to the apparent pure blue of solution.Every 1ml Calcium Disodium Versenate volumetric solution (0.05mol/L) is equivalent to the MgO of 2.015mg.
By three batches of mensuration, the results are shown in following table:
| Lot number | Bismuth (mg) | Aluminum (mg) | Magnesium oxide accounts for labelled amount % |
| 20021201 | 83.6 | 32.1 | 40.2 |
| 20021202 | 87.1 | 33.7 | 41.8 |
| 20021203 | 94.2 | 36.0 | 42.3 |
Comparative example 1
The explanation of this comparative example is in treatment treatment peptic ulcer, and optimal drug composition granule curative effect of the present invention is better than compound bismuth aluminate tablets.
1. clinical data and method
1.1 case is selected
The peptic ulcer patient is divided into 2 groups at random.39 examples are organized in treatment, and wherein the male is 29 examples, and the women is 10 examples.Age 25-63 year, average 42 years old.Matched group 34 examples, wherein the male is 25 examples, the women is 9 examples, age 23-62 year, average 45 years old.
1.2 Therapeutic Method
Treatment group patient takes optimal drug composition granule of the present invention, and is oral, one time 1～2,3 times on the one, warm water delivery service was treated 4 months, as the treatment group.The matched group patient takes compound bismuth aluminate tablets (effective ingredient is bismuth aluminate, sodium bicarbonate, Heavy Magnesium Carbonate, Radix Glycyrrhizae extractum, bark of polyFrangula alnus Miller and Fructus Foeniculi powder), and is oral, one time 1～2 bag, 3 times on the one, treated 4 months, in contrast the group.
2. result
The curative effect of treatment group and matched group is compared, and treatment group and matched group ulcer healing rate are respectively 92.8% and 84.7%, and the Hp eradication rate is respectively 72.5% and 61.2%, and gastric antrum inflammation disappearance rate is respectively 76.9% and 67.6%.
Comparative example 2
The explanation of this comparative example is in treatment treatment peptic ulcer, and optimal drug composition granule curative effect of the present invention is better than SIDASHU JIAONANG.
1. clinical data and method
1.1 case is selected
The peptic ulcer patient is divided into 2 groups at random.100 examples are organized in treatment, and wherein the male is 73 examples, and the women is 27 examples.Age 22-61 year, average 45 years old.Matched group 100 examples, wherein the male is 65 examples, the women is 35 examples, age 19-62 year, average 48 years old.
1.2 Therapeutic Method
Treatment group patient takes optimal drug composition granule of the present invention, and is oral, one time 1～2,3 times on the one, warm water delivery service was treated 4 months, as the treatment group.The matched group patient takes SIDASHU JIAONANG, and is oral, one time 1,3 times on the one, treated 4 months, in contrast the group.
2. result
The curative effect of treatment group and matched group is compared, and treatment group and matched group ulcer healing rate are respectively 92% and 79%, and the Hp eradication rate is respectively 75% and 58%, and gastric antrum inflammation disappearance rate is respectively 72% and 61%.
Claims (9)
1. a pharmaceutical composition for the treatment of gastropathy is characterized in that, described compositions is made of following component:
100～300 parts of bismuth aluminate, 100～600 parts of Heavy Magnesium Carbonate,
100～400 parts of sodium bicarbonate, 100～500 parts of Radix Glycyrrhizae extractum powders,
1～50 part of FULANGSHULIPI, 1～50 part of Fructus Foeniculi powder,
1～50 part of Aloe powder, 1～50 part of Rhizoma Acori Graminei.
2. the pharmaceutical composition of treatment gastropathy according to claim 1 is characterized in that, described compositions is made of following component:
150～250 parts of bismuth aluminate, 300～500 parts of Heavy Magnesium Carbonate,
150～250 parts of sodium bicarbonate, 150～300 parts of Radix Glycyrrhizae extractum powders,
5～30 parts of FULANGSHULIPI, 5～30 parts of Fructus Foeniculi powder,
10～30 parts of Aloe powder, 5～30 parts of Rhizoma Acori Graminei.
3. the pharmaceutical composition of treatment gastropathy according to claim 2 is characterized in that, described compositions is made of following component:
200 parts of bismuth aluminate, 350～450 parts of Heavy Magnesium Carbonate,
200～250 parts of sodium bicarbonate, 200～250 parts of Radix Glycyrrhizae extractum powders,
10～25 parts of FULANGSHULIPI, 10～15 parts of Fructus Foeniculi powder,
25～35 parts of Aloe powder, 10～20 parts of Rhizoma Acori Graminei.
4. according to the pharmaceutical composition of any one described treatment gastropathy of claim 3, it is characterized in that described compositions is made of following component:
200 parts of bismuth aluminate, 400 parts of Heavy Magnesium Carbonate,
250 parts of sodium bicarbonate, 250 parts of Radix Glycyrrhizae extractum powders,
15 parts of FULANGSHULIPI, 15 parts of Fructus Foeniculi powder,
30 parts of Aloe powder, 12.5 parts of Rhizoma Acori Graminei.
5. described any one of claim 1-4 treated the preparation of drug combination method of gastropathy, it is characterized in that, described method is: according to proportioning, Rhizoma Acori Graminei is decocted with water, filter, be condensed into thick paste, oven dry is ground into Rhizoma Acori Graminei water and carries medicated powder, add other composition mix homogeneously by proportioning then, add pharmaceutically acceptable adjuvant again and make acceptable various dosage forms on the pharmaceutics.
6. the preparation of pharmaceutical compositions method of treatment gastropathy according to claim 5 is characterized in that, described Rhizoma Acori Graminei water is put forward the concrete preparation process of medicated powder and is: after the Rhizoma Acori Graminei washing, soaked 1～2 hour, and added water boil and decoct 1～3 time, add 5～10 times of amounts of water at every turn, decocted 0.5～3 hour, and collected decoction liquor, each time decoction liquor is merged, filter, be condensed into thick paste, oven dry gets dry extract, dried cream powder is become fine powder, Rhizoma Acori Graminei water to carry medicated powder standby.
7. treat the pharmaceutical composition of gastropathy according to claim 1 or 5, it is characterized in that, described compositions is made acceptable tablet on the pharmaceutics, capsule, granule, pill or powder.
8. the pharmaceutical composition of treatment gastropathy according to claim 7 is characterized in that, described compositions is made granule.
9. according to the application in the medicine of preparation treatment gastric and duodenal ulcers, chronic superficial gastritis, hyperchlorhydria, heartburn, stomach spasm, nervous dyspepsia digestive system disease of the pharmaceutical composition of any one described treatment gastropathy of claim 1-4.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03157561 CN1286501C (en) | 2003-09-24 | 2003-09-24 | Medicine composition for treating stomach disease, its preparation method and use |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 03157561 CN1286501C (en) | 2003-09-24 | 2003-09-24 | Medicine composition for treating stomach disease, its preparation method and use |
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| CN1579473A CN1579473A (en) | 2005-02-16 |
| CN1286501C true CN1286501C (en) | 2006-11-29 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 03157561 Expired - Lifetime CN1286501C (en) | 2003-09-24 | 2003-09-24 | Medicine composition for treating stomach disease, its preparation method and use |
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Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1824131B (en) * | 2005-12-20 | 2011-12-28 | 博安兄弟制药（中国）有限公司 | Weibimei medicical composition for treating stomach disease |
| CN1895520B (en) * | 2006-06-22 | 2011-06-29 | 博安兄弟制药（中国）有限公司 | Gastrin magnesium granules and preparation thereof |
| CN102961460A (en) * | 2012-12-10 | 2013-03-13 | 哈药集团三精制药股份有限公司 | Preparation method of compound bismuth aluminate tablet |
| CN104906326B (en) * | 2015-06-10 | 2016-05-11 | 弘美制药（中国）有限公司 | A kind of gastrin magnesium granules and preparation method thereof |
| CN105147900A (en) * | 2015-07-31 | 2015-12-16 | 东北师范大学 | Preventive and therapeutic effect of compound bismuth and magnesium granules on gastric cancer |
| CN107854500A (en) * | 2017-12-28 | 2018-03-30 | 广东伊茗药业有限公司 | A kind of pharmaceutical preparation for treating stomach trouble |
| CN110755604A (en) * | 2019-10-24 | 2020-02-07 | 瑞普（天津）生物药业有限公司 | Pharmaceutical composition for preventing and treating poultry adenofibromyositis and application thereof |
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2003
- 2003-09-24 CN CN 03157561 patent/CN1286501C/en not_active Expired - Lifetime
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