CN109200020A - A kind of pharmaceutical composition of esomeprazole magnesium - Google Patents
A kind of pharmaceutical composition of esomeprazole magnesium Download PDFInfo
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- CN109200020A CN109200020A CN201710548729.6A CN201710548729A CN109200020A CN 109200020 A CN109200020 A CN 109200020A CN 201710548729 A CN201710548729 A CN 201710548729A CN 109200020 A CN109200020 A CN 109200020A
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- pharmaceutical composition
- esomeprazole magnesium
- sodium
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- sodium bicarbonate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1611—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
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- Veterinary Medicine (AREA)
- Inorganic Chemistry (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention belongs to pharmaceutical technology fields, and in particular to a kind of pharmaceutical composition of esomeprazole magnesium, the pharmaceutical composition include: esomeprazole magnesium, sodium bicarbonate, sodium diethyldithiocarbamate.Experiments have shown that pharmaceutical composition of the present invention is prepared into preparation, esomeprazole magnesium dissolution rate is significantly improved, and has better stability.
Description
Technical field
The invention belongs to pharmaceutical technology fields, and in particular to the pharmaceutical composition and its preparation of a kind of esomeprazole magnesium and
The preparation method of preparation.
Background technique
Esomeprazole is the S- isomers of Omeprazole, reduces gastric acid secretion to mechanism of action by the rake of specificity,
For the specific inhibitor of proton pump in parietal cell.Site of action and mechanism are the height that esomeprazole secretes sour micro-pipe in parietal cell
Concentration and it is converted into active form in acid environment, to inhibit the H at the position+/k+- ATP (proton pump), to basal gastric acid secretion
Gastric acid secretion with stimulation generates inhibition.
Esomeprazole magnesium is the proton pump inhibitor that first development is isomers, by AstraZeneca pharmaceutical Co. Ltd
It develops, is ratified to list by FDA in March, 2005, dosage form is injection, the resistance to letter of trade name.It has been widely used in facing
Bed is the choice drug for treating the acid related disorders such as peptic ulcer, gastroesophageal reflux disease.Esomeprazole magnesium as magnesium salts,
Favorable solubility in water.Esomeprazole magnesium is alkaline matter simultaneously, is stablized to alkali, meets acid and is easily degraded, also unstable to oxygen
It is fixed, therefore the esomeprazole magnesium preparation listed before this is enteric coated preparations, protects a drug from acid degradation using enteric coated,
But it has delayed the absorption of drug and the initial inhibiting effect to gastric acid, is unfavorable for treating and releasing patient suffering in time.
Chinese patent CN102078616A discloses a kind of esomeprazole sodium bicarbonate composition, wherein esomeprazole
Magnesium salts 20-40mg, sodium bicarbonate 1100-1680mg and other adjunct ingredients are incorporated into a kind of fixed unit dosage forms, the combination
Object works comparatively fast, but acid resistance is weaker, influences dissolution of the esomeprazole in acid.
Summary of the invention
In order to solve the above technical problems, applicant is with sodium bicarbonate, sodium diethyldithiocarbamate by research
Auxiliary material is prepared into preparation, and the dissolution rate in acid significantly improves, and guarantees that the stability of product, the quality of the pharmaceutical preparations are met the quality standard
Requirement.
What the present invention was achieved through the following technical solutions.
A kind of pharmaceutical composition of esomeprazole magnesium, pharmaceutical composition include: esomeprazole magnesium, sodium bicarbonate,
Sodium diethyldithiocarbamate.
Pharmaceutical composition described above, contains: esomeprazole magnesium, sodium bicarbonate, diethyldithiocar bamic acid
Sodium, filler, disintegrating agent, lubricant and adhesive.
The pharmaceutical composition containing esomeprazole magnesium, the weight ratio of each component are as follows:
The disintegrating agent is in sodium carboxymethyl starch, crosslinked polyvinylpyrrolidone, croscarmellose sodium
One or more.
The lubricant is selected from one or more of superfine silica gel powder, talcum powder, magnesium stearate.
Described adhesive is one or more of povidone, copolyvidone, lauryl sodium sulfate.
Pharmaceutical composition described above is prepared into pharmaceutical preparation.
The pharmaceutical composition containing esomeprazole magnesium is capsule or tablet.
The pharmaceutical composition containing esomeprazole magnesium is prepared into granule, and preparation method includes following step
It is rapid:
(1) esomeprazole magnesium, sodium bicarbonate, disintegrating agent are crossed into 80 meshes, mixed；
(2) sodium diethyldithiocarbamate is added into step (1) resulting mixture, is uniformly mixed；
(3) adhesive is added into step (2) resulting mixture, pelletizes；
(4) lubricant is added to the mixture of step (3), is mixed, obtains granule.
Pharmaceutical composition of the present invention is prepared into preparation, can be used for children taking.
Compared with the prior art, the present invention has the following advantages and good effect:
1, since esomeprazole magnesium is insoluble drug, sodium diethyldithiocarbamate is added as profit in the present invention
Lubrication prescription overcomes the problem of common magnesium stearate hinders the dissolution of insoluble drug to a certain extent, makes esomeprazole
Magnesium dissolution rate significantly improves, and is further ensured that the stability of product.
2, good product mobility of the invention, and stability is good；Pharmaceutical composition of the present invention is prepared into preparation, can
To be used for children taking.
3, operation is simple for production of the invention, is suitable for industrial production.
Specific embodiment
Test example 1: screening test
1 group of drug: esomeprazole magnesium 4g, sodium bicarbonate 72.1g；
2 groups of drug: esomeprazole magnesium 4g, sodium bicarbonate 72.1g, sodium diethyldithiocarbamate 0.1g；
3 groups of drug: esomeprazole magnesium 4g, sodium bicarbonate 72.1g, sodium diethyldithiocarbamate 0.2g；
Preparation method: (1) crossing 80 meshes for esomeprazole magnesium, sodium bicarbonate, crosslinked polyvinylpyrrolidone 6.5g, mixes
It closes；(2) sodium diethyldithiocarbamate is added into step (1) resulting mixture, is uniformly mixed；(3) to step (2)
Copolyvidone 45g, granulation are added in resulting mixture；(4) magnesium stearate 0.65g is added to the mixture of step (3), mixes
, granule is obtained.
Two the second method of the annex XC measurements of version in 2010 of [dissolution determination] Chinese Pharmacopoeia.
Each prescription dissolution determination result of table 1
| Dissolution rate (%) | Prescription 1 | Prescription 2 | Prescription 3 | Prescription 4 |
| Esomeprazole magnesium | 85.3 | 99.8 | 99.9 | 94.3 |
| Sodium bicarbonate | 92.4 | 99.9 | 99.9 | 96.7 |
Conclusion: as seen from the above table, the dissolution of esomeprazole magnesium granule after sodium diethyldithiocarbamate is used
Property significantly improves, but when in sodium diethyldithiocarbamate weight a certain range esomeprazole magnesium granule solubility
It reduces instead.
Test example 2: influence factor test
[related substance] is protected from light operation.It takes this product fine powder appropriate (being approximately equivalent to esomeprazole magnesium 20mg), sets 100ml amount
In bottle, add mobile phase appropriate, ultrasonic treatment dissolves esomeprazole magnesium, is diluted to scale with mobile phase, shakes up, and filters, takes
Subsequent filtrate (faces with brand-new) as test solution；Precision measures 1ml, sets in 100ml measuring bottle, is diluted to scale with mobile phase,
It shakes up, as contrast solution.Separately take esomeprazole magnesium reference substance 1mg and Omeprazole sulphone (5- methoxyl group -2-
[[(4- methoxyl group -3,5- dimethyl -2- pyridyl group)-methyl]-sulfonyl] -1H benzimidazole) reference substance 1mg, add mobile phase
It is dissolved to 10ml, is shaken up, 20 μ l is taken to inject liquid chromatograph, (Chinese Pharmacopoeia 2010 version two attached according to high performance liquid chromatography
Record V D) measurement, using octyl silane group silica gel as filler；0.01moL/L disodium phosphate soln (uses phosphorus acid for adjusting pH
Value is mobile phase to 7.6)-acetonitrile (75:25)；Detection wavelength is 280nm；Number of theoretical plate is not less than by the calculating of esomeprazole peak
2000, esomeprazole magnesium peak and the separating degree at Omeprazole sulphone peak should be greater than 3.0.20 μ l of contrast solution is taken to inject liquid
Chromatography adjusts detection sensitivity, and making the peak height of principal component chromatographic peak is about the 15% of full scale；It is accurate again to measure test sample
Solution and each 20 μ l of contrast solution, are injected separately into liquid chromatograph, and 3 times of record chromatogram to principal component peak retention time.
[assay] is measured according to high performance liquid chromatography (two V D of annex of Chinese Pharmacopoeia version in 2010).
Chromatographic condition and system suitability are filler with octyl silane group silica gel, with 0.01moL/L phosphoric acid
Disodium hydrogen solution (with phosphorus acid for adjusting pH value to 7.6)-acetonitrile (75:25) is mobile phase, Detection wavelength 305nm.Number of theoretical plate
It is calculated by esomeprazole peak and is not less than 2000.
Measuring method takes this product 20, accurately weighed, the average loading amount of calculating.Content is taken, is uniformly mixed, precision weighs in right amount
(being approximately equivalent to esomeprazole magnesium 20mg) sets in 100ml measuring bottle, adds ethyl alcohol 20ml and phosphate buffer (pH11.0) about
60ml, ultrasonic treatment dissolve esomeprazole magnesium, are diluted to scale with phosphate buffer (pH11.0), shake up, and filter, essence
Close measurement subsequent filtrate 5ml, sets in 50ml measuring bottle, is diluted with water to scale, shake up, and precision measures 20 μ l and injects liquid chromatograph,
Record chromatogram；Esomeprazole magnesium reference substance about 20mg separately is taken, it is accurately weighed, it sets in 100ml measuring bottle, adds ethyl alcohol 20ml and phosphorus
Phthalate buffer (pH11.0) about 60ml, shaking are dissolved esomeprazole magnesium, are diluted to phosphate buffer (pH11.0)
Scale shakes up, and precision measures 5ml, sets in 50ml measuring bottle, is diluted with water to scale, shake up, is measured in the same method.By external standard method with peak
Areal calculation to get.
Sodium bicarbonate takes above-mentioned fine powder, and precision weighs appropriate (being approximately equivalent to sodium bicarbonate 2g), sets in 100ml measuring bottle, add
Appropriate amount of water, shaking dissolves sodium bicarbonate, and is diluted with water to scale, shakes up, and filters, and precision measures subsequent filtrate 50ml, adds first
Base is red-bromocresol green mixing indicator solution 10 drips, with titration with hydrochloric acid liquid (0.5mol/L) be titrated to solution be changed by green it is purplish red
Color is boiled 2 minutes, is let cool, and continuing to be titrated to solution becomes mulberry from green.Every 1ml titration with hydrochloric acid liquid (0.5mol/L) phase
When in the NaHCO of 42.00mg3。
Example 1,2 products and reference preparation (by product made from CN104523746A method) carry out influence factor examination
It tests, the results are shown in Table 5.
The influence factor of each prescription of table 2 and reference preparation tests measurement result
1.: off-white color particle and powder
Conclusion: embodiment 1,2 products and reference preparation are investigated under high temperature, high humidity (75%RH) and strong light, in each condition
Lower to place 10 days, significant change does not occur for embodiment 1, the related substance of 2 products, moisture, content, and reference preparation is in high temperature, height
Wet, illumination condition moisture increases, and esomeprazole magnesium dissolution rate reduces.
Prepare embodiment
Embodiment 1
Pharmaceutical composition: esomeprazole magnesium 40g, sodium bicarbonate 721g, sodium diethyldithiocarbamate 0.2g；
Preparation method: (1) crossing 80 meshes for esomeprazole magnesium, sodium bicarbonate, crosslinked polyvinylpyrrolidone 6.5g, mixes
It closes；(2) sodium diethyldithiocarbamate is added into step (1) resulting mixture, is uniformly mixed；(3) to step (2)
Copolyvidone 45g, granulation are added in resulting mixture；(4) magnesium stearate 0.65g is added to the mixture of step (3), mixes
, granule is obtained.
Embodiment 2
Pharmaceutical composition: esomeprazole magnesium 40g, sodium bicarbonate 721g, sodium diethyldithiocarbamate 0.16g；
Preparation method: preparation method: (1) by esomeprazole magnesium, sodium bicarbonate, crosslinked polyvinylpyrrolidone 6.5g mistake
80 meshes, mixing；(2) sodium diethyldithiocarbamate is added into step (1) resulting mixture, is uniformly mixed；(3)
Copolyvidone 45g, granulation are added into step (2) resulting mixture；(4) magnesium stearate is added to the mixture of step (3)
0.65g is mixed, and obtains granule.
Embodiment 3
Pharmaceutical composition: esomeprazole magnesium 40g, sodium bicarbonate 721g, sodium diethyldithiocarbamate 0.14g；
Preparation method: preparation method: (1) by esomeprazole magnesium, sodium bicarbonate, crosslinked polyvinylpyrrolidone 6.5g mistake
80 meshes, mixing；(2) sodium diethyldithiocarbamate is added into step (1) resulting mixture, is uniformly mixed；(3)
Lauryl sodium sulfate 45g, granulation are added into step (2) resulting mixture；(4) it is added to the mixture of step (3) hard
Fatty acid magnesium 0.65g, is mixed, and obtains granule.
Embodiment 4
Pharmaceutical composition: esomeprazole magnesium 40g, sodium bicarbonate 721g, sodium diethyldithiocarbamate 0.16g；
Preparation method: preparation method: (1) by esomeprazole magnesium, sodium bicarbonate, crosslinked polyvinylpyrrolidone 6.5g mistake
80 meshes, mixing；(2) sodium diethyldithiocarbamate is added into step (1) resulting mixture, is uniformly mixed；(3)
Copolyvidone 45g, granulation are added into step (2) resulting mixture；(4) superfine silica gel powder is added to the mixture of step (3)
0.65g is mixed, and obtains granule.
Embodiment 5
Pharmaceutical composition: esomeprazole magnesium 40g, sodium bicarbonate 721g, sodium diethyldithiocarbamate 0.1g；
Preparation method: preparation method: (1) esomeprazole magnesium, sodium bicarbonate, sodium carboxymethyl starch 6.5g is crossed into 80 mesh
Sieve, mixing；(2) sodium diethyldithiocarbamate is added into step (1) resulting mixture, is uniformly mixed；(3) to step
Suddenly povidone 45g, granulation are added in (2) resulting mixture；(4) magnesium stearate 0.65g is added to the mixture of step (3),
It is mixed, obtains granule.
Embodiment 6
Pharmaceutical composition: esomeprazole magnesium 40g, sodium bicarbonate 721g, sodium diethyldithiocarbamate 0.18g；
Preparation method: preparation method: (1) by esomeprazole magnesium, sodium bicarbonate, crosslinked polyvinylpyrrolidone 6.5g mistake
80 meshes, mixing；(2) sodium diethyldithiocarbamate is added into step (1) resulting mixture, is uniformly mixed；(3)
Copolyvidone 45g, granulation are added into step (2) resulting mixture；(4) talcum powder is added to the mixture of step (3)
0.65g is mixed, and obtains granule；(5) tabletting obtains tablet after mixing granule with lauryl sodium sulfate 13g.
Pharmaceutical composition of the present invention is prepared into preparation, can be used for children taking.
Above by the description of specific embodiment, the invention will be further described, but it is to limit of the invention that this, which is not,
System, those skilled in the art's basic thought according to the present invention can make various modifications or improvements, but without departing from this
The basic thought of invention, is all within the scope of the present invention.
Claims (9)
1. a kind of pharmaceutical composition of esomeprazole magnesium, which is characterized in that described pharmaceutical composition includes: esomeprazole
Magnesium, sodium bicarbonate, sodium diethyldithiocarbamate.
2. pharmaceutical composition according to claim 1, which is characterized in that described pharmaceutical composition includes: esomeprazole
Magnesium, sodium bicarbonate, sodium diethyldithiocarbamate, filler, disintegrating agent, lubricant and adhesive.
3. pharmaceutical composition according to claim 1, which is characterized in that described pharmaceutical composition includes:
4. according to pharmaceutical composition described in claim 2,3, which is characterized in that the disintegrating agent is selected from carboxymethyl starch
One or more of sodium, crosslinked polyvinylpyrrolidone, croscarmellose sodium.
5. according to pharmaceutical composition described in claim 2,3, which is characterized in that the lubricant is selected from superfine silica gel powder, cunning
One or more of mountain flour, magnesium stearate.
6. according to pharmaceutical composition described in claim 2,3, which is characterized in that described adhesive be povidone, copolyvidone,
One or more of lauryl sodium sulfate.
7. according to claim 1, pharmaceutical composition described in 2,3, it is characterised in that pharmaceutical composition is prepared into pharmaceutical preparation.
8. pharmaceutical composition according to claim 7, pharmaceutical formulations are capsule or tablet.
9. pharmaceutical composition according to claim 8, wherein granule the preparation method comprises the following steps:
(1) esomeprazole magnesium, sodium bicarbonate, disintegrating agent are crossed into 80 meshes, mixed；
(2) sodium diethyldithiocarbamate is added into step (1) resulting mixture, is uniformly mixed；
(3) adhesive is added into step (2) resulting mixture, pelletizes；
(4) lubricant is added to the mixture of step (3), is mixed, obtains granule.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201710548729.6A CN109200020A (en) | 2017-07-07 | 2017-07-07 | A kind of pharmaceutical composition of esomeprazole magnesium |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710548729.6A CN109200020A (en) | 2017-07-07 | 2017-07-07 | A kind of pharmaceutical composition of esomeprazole magnesium |
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Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101002769A (en) * | 2007-01-12 | 2007-07-25 | 广东华南药业有限公司 | Compound preparation of omeprazol |
| CN102225047A (en) * | 2004-05-24 | 2011-10-26 | 宝洁公司 | Enteric solid oral dosage form of bisphosphonate containing a chelating agent |
| US20130011480A1 (en) * | 2011-05-05 | 2013-01-10 | Rosenberg Mark A | Cytotoxic therapy by proton flux modulation |
| CN102885771A (en) * | 2012-11-07 | 2013-01-23 | 西安德天药业股份有限公司 | High-concentration vitamin C injection solution and preparation method thereof |
| CN103159737A (en) * | 2013-04-12 | 2013-06-19 | 四川省惠达药业有限公司 | Esomeprazole sodium compound and medicine composition |
| CN104523746A (en) * | 2015-02-02 | 2015-04-22 | 长春海悦药业有限公司 | Esomeprazole magnesium-sodium bicarbonate composition |
-
2017
- 2017-07-07 CN CN201710548729.6A patent/CN109200020A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102225047A (en) * | 2004-05-24 | 2011-10-26 | 宝洁公司 | Enteric solid oral dosage form of bisphosphonate containing a chelating agent |
| CN101002769A (en) * | 2007-01-12 | 2007-07-25 | 广东华南药业有限公司 | Compound preparation of omeprazol |
| US20130011480A1 (en) * | 2011-05-05 | 2013-01-10 | Rosenberg Mark A | Cytotoxic therapy by proton flux modulation |
| CN102885771A (en) * | 2012-11-07 | 2013-01-23 | 西安德天药业股份有限公司 | High-concentration vitamin C injection solution and preparation method thereof |
| CN103159737A (en) * | 2013-04-12 | 2013-06-19 | 四川省惠达药业有限公司 | Esomeprazole sodium compound and medicine composition |
| CN104523746A (en) * | 2015-02-02 | 2015-04-22 | 长春海悦药业有限公司 | Esomeprazole magnesium-sodium bicarbonate composition |
Non-Patent Citations (1)
| Title |
|---|
| 张光杰: "《药用辅料应用技术》", 31 December 1991, 中国医药科技出版社 * |
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