CN105944104A - Pharmaceutical composition for treating digestive tract ulcer - Google Patents
Pharmaceutical composition for treating digestive tract ulcer Download PDFInfo
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- CN105944104A CN105944104A CN201610437162.0A CN201610437162A CN105944104A CN 105944104 A CN105944104 A CN 105944104A CN 201610437162 A CN201610437162 A CN 201610437162A CN 105944104 A CN105944104 A CN 105944104A
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- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
- A61K31/341—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide not condensed with another ring, e.g. ranitidine, furosemide, bufetolol, muscarine
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
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Abstract
The invention provides a pharmaceutical composition for treating a digestive tract ulcer. The pharmaceutical composition comprises a clove and cortex cinnamomi composition, a H2 receptor antagonist and a pharmaceutically acceptable carrier. The invention further provides application of the pharmaceutical composition in preparation of drugs for preventing and/or treating the digestive tract ulcer.
Description
Technical field
The invention belongs to pharmaceutical field, be specifically related to Flos Caryophylli, Cortex Cinnamomi and with the making of bisfentidine
Compositions.
Background technology
Peptic Ulcers is a kind of common digestive tract disease, can betide esophagus, stomach or duodenum.Stomach is burst
Infections is digestive system common disease, frequently-occurring disease, and its typical performance is hungry belch uncomfortable, glutted, pantothenic acid
Or the chronic middle Upper abdominal pain of timing, visible melena and hematemesis time serious after the meal.The traditional Chinese medical science thinks gastric ulcer
Belong to " insufficiency of the spleen ", " insufficiency of stomach ", " Deficiency and coldness of spleen and stomach ", " gastric abscess ", " acid regurgitation ", " regurgitation ", " vomiting "
Deng category.
Bisfentidine can be combined with histamine H2-receptor highly selectively, competitively antagonizing histamine
The gastric acid secretion caused after being combined with H2 receptor, produces Acidinhibitor.Bisfentidine can effectively press down
Gastric acid secretion processed, for the treatment of peptic ulcer.Bisfentidine includes cimetidine, thunder Buddhist nun
For fourth, nizatidine, famotidine, roxatidine etc..
Prior art there is no about Flos Caryophylli, Cortex Cinnamomi preparation, or Flos Caryophylli extract and Cortex Cinnamomi extract, with
Bisfentidine compositions or the report of combination medicine, and the fourth cassia oil system such as fourth cassia oil soft capsule
Agent treats ulcer or the report of gastric ulcer with bisfentidine compositions or combination medicine.
Summary of the invention
It is an object of the present invention to provide a kind of pharmaceutical composition treating digestive tract ulcer;
Further object is that this pharmaceutical composition of offer is at preparation treatment digestive tract ulcer medicine
Purposes in thing;
Third object of the present invention is to provide a kind of medicine box treating digestive tract ulcer.
It is an object of the invention to be achieved through the following technical solutions:
As one aspect of the present invention, it is provided that a kind of pharmaceutical composition, said composition by active component and
Selectable pharmaceutically acceptable carrier is made, wherein the raw material of active component by Flos Caryophylli, Cortex Cinnamomi and
Bisfentidine forms.Wherein may select and refer to that said composition can be without pharmaceutically acceptable
Carrier, is only made up of active component.
Described Flos Caryophylli, the gross weight of Cortex Cinnamomi are (0.25~4) with the weight ratio of bisfentidine: 1;
It is preferably (1~4): 1;It is preferably 4:1 or 1:1.
Described bisfentidine include cimetidine, ranitidine, nizatidine, famotidine,
Any one or two kinds of in roxatidine or two or more combination.
Flos Caryophylli in described active component, the active part of Cortex Cinnamomi can select Flos Caryophylli, Cortex Cinnamomi pulverizing to obtain,
Or Flos Caryophylli, Cortex Cinnamomi are individually or the extract that obtains of united extraction;Preferably Flos Caryophylli, Cortex Cinnamomi are extracted respectively and wave
Hair oil, and obtain fourth cassia oil and Flos Caryophylli, Cortex Cinnamomi mixed extraction after Flos Caryophylli volatile oil, Cortex Cinnamomi volatile oil mixing
The volatile oil that obtains (in this patent Flos Caryophylli, Cortex Cinnamomi are individually extracted mixed volatile oil and Flos Caryophylli,
The volatile oil that Cortex Cinnamomi mixed extraction obtains is fourth cassia oil).
Above-mentioned fourth cassia oil, i.e. fourth cassia oil extract, be with Flos Caryophylli, Cortex Cinnamomi for raw material extracting method routinely
The extract with volatile oil as main component extracted;Described Flos Caryophylli, the weight ratio of Cortex Cinnamomi are (0.2~5):
1, preferably 1:1;Described general extraction methods includes steam distillation, extraction, circumfluence method, oozes
Filter method, ultrasonic method etc.;Described Extraction solvent includes that water or organic solvent, described organic solvent include oil
Ether, ethyl acetate, n-butyl alcohol, acetone, ethanol or methanol;Preferably steam distillation or with petroleum ether
Extraction.
Preferably, in described fourth cassia oil, by weight percentage, the total content of eugenol and cinnamic aldehyde is big
In or equal to 50%, preferably 50%-95%, more preferably 61%-85%, the most preferably
61%, 85%.
Described pharmaceutical composition can be prepared as oral formulations, as tablet, hard capsule, soft capsule,
Granule, effervescent, suspensoid, powder, powder, drop pill, microsphere, oral liquid etc..
As another aspect of the present invention, present invention also offers aforementioned pharmaceutical compositions in preparation treatment
Purposes in digestive tract ulcer medicine.
As another aspect of the present invention, invention further provides a kind of medicine box, described medicine box bag
Include Flos Caryophylli Cortex Cinnamomi composite preparation and the bisfentidine of therapeutically effective amount.
Described bisfentidine include cimetidine, ranitidine, nizatidine, famotidine,
Any one or two or more compositions in roxatidine.
Described Flos Caryophylli Cortex Cinnamomi composite preparation is to be pulverized, by Flos Caryophylli, Cortex Cinnamomi, the compositions that obtains or extraction obtains
Extract be prepared as tablet, hard capsule, soft capsule, granule, effervescent, suspensoid,
The peroral dosage forms such as powder, powder, drop pill, microsphere or oral liquid;Preferably Flos Caryophylli, Cortex Cinnamomi individually or merges
Extract the soft capsule that the fourth cassia oil obtained is made.
Above-mentioned fourth cassia oil, i.e. fourth cassia oil extract, be with Flos Caryophylli, Cortex Cinnamomi for raw material extracting method routinely
The extract with volatile oil as main component extracted;Described Flos Caryophylli, the weight ratio of Cortex Cinnamomi are (0.2~5):
1, preferably 1:1;Described general extraction methods includes steam distillation, extraction, circumfluence method, oozes
Filter method, ultrasonic method etc.;Described Extraction solvent includes that water or organic solvent, described organic solvent include oil
Ether, ethyl acetate, n-butyl alcohol, acetone, ethanol or methanol;Preferably steam distillation or with petroleum ether
Extraction.
Preferably, in described fourth cassia oil, by weight percentage, the content of eugenol and cinnamic aldehyde is more than
Or equal to 50%, preferably 50%-95%, more preferably 61%-85%, the most preferably 61%,
85%.
Bisfentidine of the present invention, as ranitidine, cimetidine can be used for treating 12 fingers
The disease such as intestinal ulcer, gastric ulcer, but liver is had certain toxicity, Liver and kidney function infull patient be cautious use of,
In addition there is the side effect such as absorption reducing vitamin B12.
" effective dose " of the present invention or " therapeutically effective amount " refer to avirulence, but needed for the offer of q.s
The medicine of effect or medicament.In the therapeutic alliance of the present invention, in associating " effective dose " of a kind of composition
Refer to that this composition effectively provides the amount of required effect with other ingredient combination when applying." effective dose " can be because of
The difference of experimenter and different, according to age and individual ordinary circumstance, specific active medicine etc..
Therefore, it is not possible to always refer to accurate " effective dose ", but, in any individual case suitably " effectively
Amount " experimental technique of routine can be applied to measure by those of ordinary skill in the art.
" treatment " of the present invention refers to that the order of severity of symptom alleviates and/or frequency reduces, symptom and/or draw
Play the elimination of reason of symptom, the generation of symptom and/or they cause the prevention of the reason of symptom, infringement
Improve or correct.
" administering drug combinations " of the present invention refers to give object with certain dosage regimen by drug regimen, as
Flos Caryophylli Cortex Cinnamomi compositions and bisfentidine are with different size unit dose simultaneously, give respectively or successively
Medicine.
Pharmaceutically suitable carrier of the present invention include filler, disintegrating agent, lubricant, suspending agent, binding agent,
Sweeting agent, correctives, preservative, substrate etc..Filler includes: starch, pregelatinized Starch, lactose,
Mannitol, chitin, microcrystalline Cellulose, sucrose etc.;Disintegrating agent includes: starch, pregelatinized Starch,
Microcrystalline Cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, friendship
Connection sodium carboxymethyl cellulose etc.;Lubricant includes: magnesium stearate, sodium lauryl sulphate, Pulvis Talci,
Silicon dioxide etc.;Suspending agent includes: polyvinylpyrrolidone, microcrystalline Cellulose, sucrose, agar, hydroxyl
Propyl methocel etc.;Binding agent includes: starch slurry, polyvinylpyrrolidone, hydroxypropyl methyl are fine
Dimension element etc.;Sweeting agent includes: saccharin sodium, Aspartane, sucrose, cyclamate, enoxolone etc.;Rectify
Taste agent includes: sweeting agent and various essence;Preservative includes: parabens, benzoic acid, sodium benzoate,
Sorbic acid and its esters, benzalkonium bromide, fixed, the eucalyptus oil of acetic acid chloroethene etc.;Substrate includes: PEG6000,
PEG4000, insect wax etc..
As another aspect of the present invention, the present invention further provides, a kind of Chinese medicine composition is in preparation
Application in potentiation bisfentidine treatment digestive tract ulcer medicine, the raw material of described Chinese medicine composition
Medicine is made up of Flos Caryophylli, Cortex Cinnamomi, and Flos Caryophylli, the weight ratio of Cortex Cinnamomi are (0.2~5): 1.
Described Chinese medicine composition can be prepared as clinically-acceptable dosage form, and preparation method includes Flos Caryophylli Cortex Cinnamomi
Pulverize the compositions that obtains or tablet that extract that extraction obtains is prepared as, hard capsule, soft capsule,
The peroral dosage forms such as granule, effervescent, suspensoid, powder, powder, drop pill, microsphere or oral liquid.
Preferably Flos Caryophylli, Cortex Cinnamomi are individually or the soft capsule made of the fourth cassia oil that obtains of united extraction.Described fourth cassia oil,
I.e. fourth cassia oil extract, is to be with volatile oil with Flos Caryophylli, Cortex Cinnamomi for what raw material extracting method routinely extracted
The extract of main component;Described Flos Caryophylli, the weight ratio of Cortex Cinnamomi are (0.2~5): 1, preferably 1:1;
Described general extraction methods includes steam distillation, extraction, circumfluence method, percolation, ultrasonic method etc.;
Described Extraction solvent includes that water or organic solvent, described organic solvent include petroleum ether, ethyl acetate, just
Butanol, acetone, ethanol or methanol;Preferably steam distillation or petroleum ether extraction.Preferably, institute
Stating in fourth cassia oil, by weight percentage, the total content of eugenol and cinnamic aldehyde is more than or equal to 50%,
Preferably 50%-95%, more preferably 61%-85%, the most preferably 61%, 85%.
The present invention use the combination of Flos Caryophylli Cortex Cinnamomi compositions (preferably fourth cassia oil) and bisfentidine/
Pharmaceutical composition, on the one hand the treatment for digestive tract ulcer achieves the effect of Synergistic, significantly carries
High to digestive tract ulcer, such as the therapeutic effect of gastric ulcer;On the other hand can effectively reduce ranitidine,
The using dosage of cimetidine, reduces the bisfentidine side effect to Liver and kidney, also reduces simultaneously
The using dosage of fourth cassia oil or fourth cassia oil soft capsule etc..The combination medicine of the present invention and pharmaceutical composition
While realizing therapeutic effect Synergistic, can effectively reduce drug use dosage, alleviate medicine pair and make
With, reduce treatment drug expenditure, achieve unforeseeable technological progress.
Fourth cassia oil soft capsule and the main representative thing cimetidine of bisfentidine, ranitidine combination
After there is significant anti-peptic ulcer effect, be better than alone group (p < 0.01 or p < 0.05), and energy
Significantly reduce the dosage of fourth cassia oil soft capsule and bisfentidine.Fourth cassia oil soft capsule of the present invention and H2
The combination medicine of receptor antagonist has the effect of Synergistic for gastric ulcer treatment.
Detailed description of the invention
The preparation of embodiment 1 fourth cassia oil
Taking Flos Caryophylli 375g, Cortex Cinnamomi 375g, add 8 times amount water, water proof distills 8 hours, collects volatile oil, cold
Hide 24 hours, remove moisture, 36.0ml fourth cassia oil the most processed.After testing, eugenol and Cortex cinnamomi japonici (Ramulus Cinnamomi) in extract
The total content of aldehyde accounts for the 85% of fourth cassia oil.
Eugenol detection method:
Chromatographic condition: PEG-20M fused-silica capillary column (25m × 0.20mm × 0.33 μm), column temperature
175 DEG C, fid detector, carrier gas: N2, flow velocity: 1ml min-1Split sampling, split ratio: 45:1,
Sample size 1 μ L.
The preparation of reference substance solution: take eugenol reference substance about 10mg, accurately weighed, put in 5mL measuring bottle,
Accurate addition n-hexane dissolution is also diluted to scale, shakes up, as reference substance solution.
The preparation of need testing solution: the fourth cassia oil about 50mg of Example 1 preparation, accurately weighed, put 25mL
In measuring bottle, accurate addition n-hexane dissolution is also diluted to scale, shakes up, as need testing solution.
The preparation of internal standard liquid: take biphenyl 10mg, puts in 25mL measuring bottle, and accurate addition n-hexane dissolution is also
It is diluted to scale, shakes up, as inner mark solution.
The investigation of linear relationship: precision weighs eugenol reference substance 102.70mg, puts in 10mL volumetric flask,
Add n-hexane dissolution and be diluted to scale, respectively precision measure 0.5,1.0,2.0,3.0,5.0mL is in 25mL
Volumetric flask in, add normal hexane and be diluted to scale.Precision draws 1.0 μ L, injection gas chromatography instrument respectively
In, it is measured by above-mentioned chromatographic condition.With injection eugenol amount (X) as abscissa, corresponding reference substance
Peak area (y) is vertical coordinate, carries out linear regression, obtains regression equation.
Need testing solution is detected by GC conditions, brings detected value into regression equation calculation and obtain
Eugenol content in the fourth cassia oil of embodiment 1 preparation.
Cinnamic aldehyde detection method:
Chromatographic condition: 2m × 3mm glass column (Japan's Shimadzu) fixative: 2%OV-17 carrier: 60~80
Mesh chromosorbw (AW-DMCS), carrier: High Purity Nitrogen, flow velocity: 50ml/min, column temperature: 175 DEG C
Temperature of vaporization chamber 220 DEG C, sensing chamber's temperature 180 DEG C, detector FID.
The preparation of reference substance solution: precision weighs cinnamic aldehyde 17.5ml in 25ml measuring bottle, CC14Dissolve
Dissolve and be diluted to scale, shaking up, as reference substance solution.
The preparation of need testing solution: precision weigh embodiment 1 preparation fourth cassia oil 25mg in 50ml measuring bottle,
Use CCl4Dissolve and be diluted to scale, shaking up, as reference substance solution.
Linear relationship is investigated: 6 10ml measuring bottles numbering, be sequentially added into reference substance solution 0.5,1.0,2.0,
3.0,4.0,5.0ml, use CCl4Dilute mutual scale, shake up.Precision draws 1.0 μ L respectively, injects gas
In chromatography, as described in step 2, chromatographic condition detects, and with concentration (X), peak area (Y) is carried out line
Property return, obtain regression equation.
Need testing solution is detected by GC conditions, brings detected value into regression equation calculation and obtain
Determination of Cinnamaldehyde in the fourth cassia oil of embodiment 1 preparation.
The preparation of embodiment 2 fourth cassia oil
In 1:1 ratio, take Flos Caryophylli, Cortex Cinnamomi medical material totally 750 grams, add 6 times amount petroleum ether 50 DEG C extraction 4h,
Filtering, medicinal residues add 4 times amount petroleum ether 50 DEG C extraction 4h again, filter, merge petroleum ether extract, reclaim
Petroleum ether, 46.8ml fourth cassia oil the most processed.After testing, in extract, the total content of eugenol and cinnamic aldehyde accounts for
The 61% of fourth cassia oil.Detection method is with reference to embodiment 1.
The preparation of embodiment 3 fourth cassia oil soft capsule
The fourth cassia oil 3.6ml (25 DEG C of relative densities are 1.10g/ml) of Example 1 preparation and 36.4ml Semen sojae atricolor
Oil mixing, standby.Take gelatin 15g, glycerol 6g, simple syrup 1g, add deionized water 15g mixing, heating
To 60~70 DEG C, it is incubated 0.5 hour, adds methyl parahydroxybenzoate 0.015g, P-hydroxybenzoic acid second
Ester 0.0075g, stirring, evacuation, 70 DEG C are incubated 20 minutes, make capsule material.Take fourth cassia oil and soybean oil
Mixture, with capsule material use pressing make soft capsule, inspection, subpackage, obtain soft capsule 100,
Every dress 0.4g, containing fourth cassia oil about 0.04g).
The preparation of embodiment 4 fourth cassia oil tablet
The fourth cassia oil 3ml of Example 2 preparation, adds micropowder silica gel 2.5mg, lactose 5.5mg, microcrystalline cellulose
Element 5.3mg, Icing Sugar 3.0mg, pelletize with 10%PVP-k30 aqueous solution, additional low substituted hydroxy-propyl fiber
Element 0.5mg and magnesium stearate 0.2mg, tabletting, to obtain final product.
The preparation of embodiment 5 fourth cassia oil granule
The fourth cassia oil 5ml of Example 1 preparation, and be dissolved in a small amount of ethanol, standby.Take 40g β-ring to stick with paste
Essence, adds 300ml distilled water, and heating in water bath dissolves, and it is molten that temperature is down to add volatile oil ethanol when 35 DEG C
Liquid, mix homogeneously, ultrasonic inclusion 30min, refrigerated overnight, sucking filtration, it is deposited in 38 DEG C of cold drying,
Obtain volatile oil beta cyclodextrin inclusion complex.Benexate Hydrochloride is mixed with appropriate dextrin, uses 90% second
Alcohol is wetting agent soft material, crosses 20 mesh sieves and carries out wet granulation, and 65 DEG C are dried, and granulate to obtain final product.
The preparation of embodiment 6 fourth cassia oil soft capsule
The fourth cassia oil 16g of Example 1 preparation mixes with 64g soybean oil, standby.Take gelatin 18g, glycerol
5g, simple syrup 1g, add deionized water 15g mixing, be heated to 65 DEG C, be incubated 0.5 hour, add hydroxyl
Yl benzoic acid methyl ester 0.02g, ethylparaben 0.001g, stirring, evacuation, 75 DEG C of insulations 20
Minute, make capsule material.Take the mixture of fourth cassia oil and soybean oil, use pressing to make flexible glue by capsule material
Capsule, inspection, subpackage, obtain soft capsule 100, every dress 0.4g, containing fourth cassia oil about 0.16g)
The preparation of the combination medicine/composite packaging medicine box of embodiment 7 fourth cassia oil soft capsule and ranitidine
The fourth cassia oil soft capsule of Example 6 preparation, every about 0.16g Han fourth cassia oil.
Ranitidine Capsules, every contains ranitidine 0.15 gram.
Composite packaging form: containing fourth cassia oil soft capsule 90, Ranitidine Capsules 30 in this packaging.
Embodiment 8 fourth cassia oil and the compound tablet of cimetidine
Prepare fourth cassia oil 100g by embodiment 1 method, and take cimetidine crude drug 100g, standby.
With reference to the method for embodiment 5, it is only that 20 mesh sieves in embodiment five are replaced with 50 mesh sieves, preparation β-
The fourth cassia oil granule of cyclodextrin inclusion compound.By fourth cassia oil granule and cimetidine crude drug and appropriate medicinal shallow lake
Powder, microcrystalline Cellulose, silicon dioxide mix, and are pressed into 500.
Embodiment 9 fourth cassia oil and the compound capsule of cimetidine
Prepare fourth cassia oil 300g by embodiment 1 method, and take cimetidine crude drug 200g, routinely
Preparation process makes capsule.
Embodiment 10 fourth cassia oil and the compound granule of cimetidine
Prepare fourth cassia oil 200g by embodiment 1 method, and take cimetidine crude drug 300g, routinely
Preparation process makes granule.
Embodiment 11 fourth cassia oil and the compound tablet of ranitidine
Prepare fourth cassia oil 100g by embodiment 1 method, and take ranitidine crude drug 100g, standby.
With reference to the method for embodiment 5, it is only that 20 mesh sieves in embodiment five are replaced with 50 mesh sieves, preparation β-
The fourth cassia oil granule of cyclodextrin inclusion compound.By fourth cassia oil granule and ranitidine crude drug and appropriate medicinal shallow lake
Powder, microcrystalline Cellulose, silicon dioxide mix, and are pressed into 500.
Embodiment 12 fourth cassia oil and the compound capsule of ranitidine
Prepare fourth cassia oil 300g by embodiment 1 method, and take ranitidine crude drug 200g, routinely
Preparation process makes capsule.
Embodiment 13 fourth cassia oil and the compound granule of ranitidine
Prepare fourth cassia oil 200g by embodiment 1 method, and take ranitidine crude drug 300g, routinely
Preparation process makes granule.
Embodiment 14 fourth cassia oil and the compound tablet of nizatidine
Prepare fourth cassia oil 100g by embodiment 1 method, and take nizatidine crude drug 100g, standby.
With reference to the method for embodiment 5, it is only that 20 mesh sieves in embodiment five are replaced with 50 mesh sieves, preparation β-
The fourth cassia oil granule of cyclodextrin inclusion compound.By fourth cassia oil granule and nizatidine crude drug and appropriate medicinal shallow lake
Powder, microcrystalline Cellulose, silicon dioxide mix, and are pressed into 500.
Embodiment 15 fourth cassia oil and the compound capsule of nizatidine
Prepare fourth cassia oil 300g by embodiment 1 method, and take nizatidine crude drug 200g, routinely
Preparation process makes capsule.
Embodiment 16 fourth cassia oil and the compound granule of nizatidine
Prepare fourth cassia oil 200g by embodiment 1 method, and take nizatidine crude drug 300g, routinely
Preparation process makes granule.
The treatment to water logging irritability rat gastric ulcer of experimental example 1 present composition
1. experiment material
1.1 medicine
Fourth cassia oil soft capsule (0.4g/ grain): adult's dosage is 6/day, prepares by embodiment 3.
Take soft capsule content, with 1.0% Tween 80 solution preparation, place Refrigerator store standby.
Ranitidine Capsules (Lei Liya) (0.15g/ grain): be grown up one time 1,2 times on the one, tie up Aunar
This (Foshan) pharmaceutical Co. Ltd provides, lot number 120608.Take soft capsule content, use 1.0% Tween 80
Solution is prepared, and places Refrigerator store standby.
Cimitidine Tablets (0.2g/ sheet): one time 1,2 times on the one, limited by Arstwyth (Foshan) pharmacy
Company provides, lot number 120107.Take soft capsule content, with 1.0% Tween 80 solution preparation, place ice
Case saves backup.
Fourth cassia oil soft capsule and cimetidine, and fourth cassia oil soft capsule and ranitidine combination medicine/
The proportioning of pharmaceutical composition is shown in Table 1;Dosage and concentration respectively with fourth cassia oil, ranitidine,
Cimetidine calculates.
1.2 animal
SD rat, male and female half and half, body weight 180-220g, Chengdu University of Traditional Chinese Medicine's Experimental Animal Center carry
Confession, the animal quality certification number is the real dynamic pipe the 7th in river.
2 methods and result
2.1 test method
Select healthy SD rat, body weight 180-220g, be divided into 8 groups by body weight, sex stratified random,
Often 10 animals of group, packet and dosage are shown in Table 1.Each treated animal gastric infusion every day once (dosage
It is shown in Table 1), continuous 15 days, after last administration, fasting 24 hours, freely drank water, is then fixed by animal
On metal cage, it is dipped vertically in 23 ± 0.5 DEG C of water.Immersion depth translation thing xiphoid-process level, after 24 hours
Taking out, dislocation of cervical vertebra is put to death.Opening abdominal cavity, ligation stomach cardia and pylorus also inject in gastral cavity through coat of the stomach
Formalin 8ml of 1%, takes out stomach and immerses in formalin, and within 30 minutes, tailing edge greater gastric curvature is cut open, puts
Measuring gastric mucosa injury area under big mirror, by okabe method, calculate ulcer index, computational methods are as follows.
Ulcer area (mm2) | 1-12 | 13-25 | 26-37 | 38-45 | >=50 or perforation |
Ulcer index | 1 | 2 | 3 | 4 | 5 |
Ulcer inhibition percentage=matched group ulcer index-administration group ulcer index/matched group ulcer index × 100%
2.2 experimental result
To each group of experimental result, statistical procedures between organizing, the results are shown in Table 1.
Table 1 on the impact of water logging irritability rat gastric ulcer model (N=10)
Note: compare with model control group*p<0.05、**p<0.01;Compare with fourth cassia oil soft capsule group#p<0.05、##p<0.01。
Table 1 result shows, after administration, and alone group of (fourth cassia oil soft capsule group, Cimitidine Tablets group, thunder
Buddhist nun replaces fourth Capsules group) and the no significant difference (P > 0.05) of model group, and drug combination group (fourth
Cassia oil soft capsule+Cimitidine Tablets 1,2 groups, fourth cassia oil soft capsule+Ranitidine Capsules 1,2 groups) right
Rat water logging stress gastric ulcer significantly inhibits effect (p < 0.01, p < 0.05).Drug combination group and list
Compare by group, there is significant difference (p < 0.01, p < 0.05).
The treatment to pyloric ligation ulcers rat gastric ulcer of experimental example 2 pharmaceutical composition of the present invention
1. experiment material
1.1 medicine
Fourth cassia oil soft capsule (0.4g/ grain): adult's dosage is 6/day, prepares by embodiment 3.
Take soft capsule content, with 1.0% Tween 80 solution preparation, place Refrigerator store standby.
Ranitidine Capsules (Lei Liya) (0.15g/ grain): be grown up one time 1,2 times on the one, by Aunar
Wei Si (Foshan) pharmaceutical Co. Ltd provides, lot number 120608.Take soft capsule content, use 1.0% tween
80 solution preparations, place Refrigerator store standby.
Cimitidine Tablets (0.2g/ sheet): one time 1,2 times on the one, Arstwyth (Foshan) pharmacy have
Limit company provides, lot number 120107.Take soft capsule content, with 1.0% Tween 80 solution preparation, put
Put Refrigerator store standby.
Fourth cassia oil soft capsule and cimetidine, and fourth cassia oil soft capsule and ranitidine combination medicine/
The proportioning of pharmaceutical composition is shown in Table 2;Dosage and concentration respectively with fourth cassia oil, ranitidine,
Cimetidine calculates.
1.2 animal
SD rat, male and female half and half, body weight 180-220g, by Chengdu University of Traditional Chinese Medicine's Experimental Animal Center
Thering is provided, the animal quality certification number is the real dynamic pipe the 7th in river.
2 methods and result
2.1 test method
Select healthy SD rat, body weight 180-220g, be randomly divided into 8 groups by body weight, sex, often group
10 animals, packet and dosage are shown in Table 2.Each treated animal gastric infusion every day once (dosage such as table
Shown in 2), continuous 15 days, after last administration, fasting 48 hours, freely drank water, with ether by animal fiber crops
Liquor-saturated, open abdominal cavity, ligature pylorus.Within postoperative 18 hours, solution takes stomach, injects the formaldehyde of 1% in gastral cavity
Solution 8ml, takes out stomach and immerses in formalin, and within 10 minutes, tailing edge greater gastric curvature is cut open, amplifies Microscopic observation
A situation arises for front stomach ulcer, by okabe method, calculates ulcer index, and computational methods are as follows.
Ulcer area (mm2) | 1-12 | 13-25 | 26-37 | 38-45 | >=50 or perforation |
Ulcer index | 1 | 2 | 3 | 4 | 5 |
Ulcer inhibition percentage=matched group ulcer index-administration group ulcer index/matched group ulcer index × 100%
2.2 experimental result
To each group of experimental result, statistical procedures between organizing, the results are shown in Table 2.
Table 2 on the impact of pyloric ligation ulcers rat gastric ulcer model (N=10)
Note: compare with model control group*p<0.05、**p<0.01;Compare with fourth cassia oil soft capsule group#p<0.05、##p<0.01。
Table 2 result shows, after administration, and alone group of (fourth cassia oil soft capsule group, Cimitidine Tablets group, thunder
Buddhist nun replaces fourth Capsules group) and the no significant difference (P > 0.05) of model group, and drug combination group (fourth
Cassia oil soft capsule+Cimitidine Tablets 1,2 groups, fourth cassia oil soft capsule+Ranitidine Capsules 1,2 groups) right
Rat pylorus ligation gastric ulcer model has obvious inhibitory action (p < 0.01, p < 0.05).
Acetic acid is burnt the treatment of type rat gastric ulcer by experimental example 3 pharmaceutical composition of the present invention
1. experiment material
1.1 medicine
Fourth cassia oil soft capsule (0.4g/ grain): adult's dosage is 6/day, is obtained by by embodiment 3 preparation
?.Take soft capsule content, with 1.0% Tween 80 solution preparation, place Refrigerator store standby.
Ranitidine Capsules (Lei Liya) (0.15g/ grain): be grown up one time 1,2 times on the one, by Aunar
Wei Si (Foshan) pharmaceutical Co. Ltd provides, lot number 120608.Take soft capsule content, use 1.0% tween
80 solution preparations, place Refrigerator store standby.
Cimitidine Tablets (0.2g/ sheet): one time 1,2 times on the one, Arstwyth (Foshan) pharmacy have
Limit company provides, lot number 120107.Take soft capsule content, with 1.0% Tween 80 solution preparation, put
Put Refrigerator store standby.
Fourth cassia oil soft capsule and cimetidine, and fourth cassia oil soft capsule and ranitidine combination medicine/
The proportioning of pharmaceutical composition is shown in Table 3;Dosage and concentration respectively with fourth cassia oil, ranitidine,
Cimetidine calculates.
1.2 animal
SD rat, male and female half and half, body weight 180-220g, by Chengdu University of Traditional Chinese Medicine's Experimental Animal Center
Thering is provided, the animal quality certification number is the real dynamic pipe the 7th in river.
2 methods and result
2.1 test method
Selecting healthy SD rat, body weight 180-220g, before experiment, fasting 24 hours, freely drinks water,
Under etherization open abdominal cavity, expose stomach, before the acetic acid solution 0.1ml of 20% is injected to glandular stomach portion
Under wall hole body intersection serous coat.Reduction stomach, suturing them.Animal is pressed body weight, property on the 2nd day by Post operation
Other stratified random is divided into 8 groups, often 10 animals of group, and packet and dosage are shown in Table 3.Each treated animal fills every day
Stomach is administered once (dosage is shown in Table 3), continuous 15 days, fasting 24 hours after last administration,
Freely drink water, with excess diethyl ether, Animal Anesthesia is dead, open abdominal cavity, solution takes stomach, by the first of 1%
Aldehyde solution is fixed, and by okabe method, observes and calculates ulcer index, and computational methods are as follows.
Ulcer area (mm2) | 1-12 | 13-25 | 26-37 | 38-45 | >=50 or perforation |
Ulcer index | 1 | 2 | 3 | 4 | 5 |
Ulcer inhibition percentage=matched group ulcer index-administration group ulcer index/matched group ulcer index × 100%
2.2 experimental result
To each group of experimental result, statistical procedures between organizing, the results are shown in Table 3.
Table 3 acetic acid is burnt type rat gastric ulcer model impact (N=10)
Note: compare with model control group*p<0.05、**p<0.01;Compare with fourth cassia oil soft capsule group#p<0.05、##p<0.01。
Table 3 result shows, after administration, and alone group of (fourth cassia oil soft capsule group, Cimitidine Tablets group, thunder
Buddhist nun replaces fourth Capsules group) and the no significant difference (P > 0.05) of model group, and drug combination group (fourth
Cassia oil soft capsule+Cimitidine Tablets 1,2 groups, fourth cassia oil soft capsule+Ranitidine Capsules 1,2 groups) right
Rats acetic acid burns type gastric ulcer model and has significant inhibitory action (p < 0.01,0.05), with alone group
Relatively, there is significant difference (p < 0.01,0.05).
Experimental example 4 pharmaceutical composition of the present invention causes the treatment of rat pipe film injury to ethanol
1. experiment material
1.1 medicine
Fourth cassia oil soft capsule (0.4g/ grain): adult's dosage is 6/day, prepares by embodiment 3.
Take soft capsule content, with 1.0% Tween 80 solution preparation, place Refrigerator store standby.
Ranitidine Capsules (Lei Liya) (0.15g/ grain): be grown up one time 1,2 times on the one, by Aunar
Wei Si (Foshan) pharmaceutical Co. Ltd provides, lot number 120608.Take soft capsule content, use 1.0% tween
80 solution preparations, place Refrigerator store standby.
Cimitidine Tablets (0.2g/ sheet): one time 1,2 times on the one, Arstwyth (Foshan) pharmacy have
Limit company provides, lot number 120107.Take soft capsule content, with 1.0% Tween 80 solution preparation, put
Put Refrigerator store standby.
Fourth cassia oil soft capsule and cimetidine, and fourth cassia oil soft capsule and ranitidine combination medicine/
The proportioning of pharmaceutical composition is shown in Table 4;Dosage and concentration respectively with fourth cassia oil, ranitidine,
Cimetidine calculates.
1.2 animal
SD rat, male and female half and half, body weight 180-220g, by Chengdu University of Traditional Chinese Medicine's Experimental Animal Center
Thering is provided, the animal quality certification number is the real dynamic pipe the 7th in river.
2 methods and result
2.1 test method
Select healthy SD rat, body weight 180-220g, be divided into 8 groups by body weight, sex stratified random,
Often 10 animals of group, packet and dosage are shown in Table 5.Each treated animal gastric infusion every day once (dosage
It is shown in Table 4), continuous 15 days, after last administration, fasting 48 hours, freely drank water.Fill during experiment
Taking dehydrated alcohol (1ml/ is only), after one hour, animal is put to death in dislocation of cervical vertebra, opens abdominal cavity, and solution takes stomach,
Fixing with the formalin of 1%, within 30 minutes, tailing edge greater gastric curvature is cut open, amplifies Microscopic observation stomach ulcer
A situation arises, by okabe method, calculates ulcer index, and computational methods are as follows
Ulcer area (mm2) | 1-12 | 13-25 | 26-37 | 38-45 | >=50 or perforation |
Ulcer index | 1 | 2 | 3 | 4 | 5 |
Ulcer inhibition percentage=matched group ulcer index-administration group ulcer index/matched group ulcer index × 100%
2.2 experimental result
To each group of experimental result, statistical procedures between organizing, the results are shown in Table 4.
Table 4 on ethanol cause rat pipe film injury model impact (N=10)
Note: compare with model control group*p<0.05、**p<0.01;Compare with fourth cassia oil soft capsule group#p<0.05、##p<0.01。
Table 4 result shows, after administration, alone group with the no significant difference (P > 0.05) of model group,
And drug combination group (fourth cassia oil soft capsule+Cimitidine Tablets 1,2 groups, fourth cassia oil soft capsule+thunder Buddhist nun replace
Fourth capsule 1,2 groups) to ethanol cause rat pipe film injury model have significant protective effect (p < 0.01,
0.05).Drug combination group compares with alone group, has significant difference (p < 0.011,0.05).
Claims (10)
1. the pharmaceutical composition treating digestive tract ulcer, it is characterised in that said composition is by activity
Composition and selectable pharmaceutically acceptable carrier are made, and wherein the raw material of active component is by Flos Caryophylli, meat
Osmanthus and bisfentidine composition.
2. pharmaceutical composition as claimed in claim 1, it is characterised in that described Flos Caryophylli, Cortex Cinnamomi
Weight ratio is (0.2~5): 1;Flos Caryophylli, the gross weight of Cortex Cinnamomi with the weight ratio of bisfentidine are
(0.25~4): 1;It is preferably (1~4): 1;More preferably 1:1 or 4:1.
3. pharmaceutical composition as claimed in claim 1, it is characterised in that described bisfentidine
Any one in cimetidine, ranitidine, nizatidine, famotidine, roxatidine or two
Kind or two or more combinations.
4. pharmaceutical composition as claimed in claim 1, it is characterised in that wherein Flos Caryophylli, Cortex Cinnamomi are straight
Connect as active component, or Flos Caryophylli, Cortex Cinnamomi individually or the extract that obtains of united extraction is as active component;
Preferably Flos Caryophylli, Cortex Cinnamomi are individually or the volatile oil that obtains of united extraction is as active component.
5. pharmaceutical composition as claimed in claim 4, it is characterised in that in described fourth cassia oil, with
The total content of percentage by weight meter, eugenol and cinnamic aldehyde is more than or equal to 50%, preferably 50%-95%,
More preferably 61%-85%, the most preferably 61% or 85%.
6. a Chinese medicine composition is in preparation potentiation bisfentidine treatment digestive tract ulcer medicine
Application, the crude drug of described Chinese medicine composition is made up of Flos Caryophylli, Cortex Cinnamomi, and Flos Caryophylli, the weight ratio of Cortex Cinnamomi are
(0.2~5): 1;Preferably bisfentidine preparation selected from cimetidine, ranitidine, nizatidine,
The preparation that any one or two kinds of and two or more combinations in famotidine, roxatidine is made.
7. a medicine box, it is characterised in that described medicine box includes the Flos Caryophylli Cortex Cinnamomi combination of therapeutically effective amount
Thing preparation and bisfentidine preparation.
8. medicine box as claimed in claim 7, it is characterised in that described bisfentidine preparation selects
Any one or two kinds of in cimetidine, ranitidine, nizatidine, famotidine, roxatidine
And the preparation that two or more combinations is made.
9. medicine box as claimed in claim 7, it is characterised in that described Flos Caryophylli Cortex Cinnamomi composite preparation
It is to be pulverized, by Flos Caryophylli, Cortex Cinnamomi, the compositions that obtains or tablet that extract that extraction obtains is prepared as, ebonite
Wafer, soft capsule, granule, effervescent, suspensoid, powder, powder, drop pill, microsphere or mouth
Take liquid;Described Flos Caryophylli Cortex Cinnamomi composite preparation preferably Flos Caryophylli, Cortex Cinnamomi are individually or the fourth that obtains of united extraction
Soft capsule prepared by cassia oil.
10. medicine box as claimed in claim 9, it is characterised in that in described fourth cassia oil, with weight hundred
The total content of proportion by subtraction meter, eugenol and cinnamic aldehyde is more than or equal to 50%, preferably 50%-95%, enters
One step is preferably 61%-85%, and the most preferably 61%, 85%.
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CN108653381A (en) * | 2018-07-11 | 2018-10-16 | 合肥华盖生物科技有限公司 | A kind of Chinese and western medicinal composition preparation method for treating chronic gastric ulcer |
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WO2004035090A1 (en) * | 2002-10-16 | 2004-04-29 | Orexo Ab | Gastric acid secretion inhibiting composition |
CN1500497A (en) * | 2002-11-14 | 2004-06-02 | 成都尚科药业有限公司 | Preparation method of compound soft capsule of traditional Chinese medicine and use |
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CN108653381A (en) * | 2018-07-11 | 2018-10-16 | 合肥华盖生物科技有限公司 | A kind of Chinese and western medicinal composition preparation method for treating chronic gastric ulcer |
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