CN101756935A - Omeprazole capsule and preparation method thereof - Google Patents
Omeprazole capsule and preparation method thereof Download PDFInfo
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- CN101756935A CN101756935A CN200810207913A CN200810207913A CN101756935A CN 101756935 A CN101756935 A CN 101756935A CN 200810207913 A CN200810207913 A CN 200810207913A CN 200810207913 A CN200810207913 A CN 200810207913A CN 101756935 A CN101756935 A CN 101756935A
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- omeprazole
- capsule
- sodium bicarbonate
- omeprazole capsule
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Abstract
The invention provides an omeprazole capsule which comprises omeprazole, sodium bicarbonate and pharmaceutical adjuvant. The omeprazole capsule can release the omeprazole in stomach so as to function immediately. The sodium bicarbonate in the prescription can neutralize the gastric acid so as to keep the ph value stable in stomach and improve the stability of the omeprazole. A preparation method thereof provided by the invention avoids the fussy coating process and the pelletizing process, adds no organic solvent and is applied to the commercial process.
Description
Technical field
The present invention relates to pharmaceutical preparation, be specifically related to a kind of omeprazole capsule and preparation method thereof.
Background technology
Digestive system disease is one of common frequently-occurring disease, and wherein based on Peptic Ulcers, total sickness rate accounts for 10～20% of population.U.S. peptic ulcer patient is about 10%, and Germany is 12.3%, and China is according to some areas investigation, and the digestive tract disease sickness rate is 11.43%, and wherein the peptic ulcer disease sickness rate is 4.54%.
Along with social development, the change of circumstances, and the variation of people life style, mainly because of smoking, drink, nervous, medicine irritation etc., the sickness rate of peptic ulcer increases gradually, becomes a kind of commonly encountered diseases and frequently-occurring disease, bring great misery to the patient, cause patients ' life quality to descend.Therefore for these reasons, the treatment of peptic ulcer more and more receives publicity clinically and payes attention to, and medicament for resisting peptic ulcer receives publicity safely and effectively, and becomes one of the emphasis of present drug development research and focus.
Proton pump inhibitor has obvious superiority than histamine H 2-receptor antagonist and the excretory medicine of other gastric acid inhibitory, as selectivity height, good effect, few side effects etc., welcome by the patient.
Omeprazole is typical proton pump inhibitor, is usually used in treating gastric ulcer clinically.Yet in acidity or neutral medium, omeprazole is easy to degraded and transforms, and Degradation is subjected to the catalysis of acid compound, but is stablized in mixture of alkaline compounds.The chemical stability of omeprazole also is subjected to the influence of dampness, heat, light and organic solvent.Therefore, the oral dosage form that comprises omeprazole should be avoided contacting with acidic gastric juice, and omeprazole also should be transferred to pH near in neutral and that part of gastrointestinal tract that can absorb rapidly with original shape.
The medicinal peroral dosage form of omeprazole obtains best protection by enteric coating layer; avoided contacting with acidic gastric juice; for example; the casing preparation of omeprazole has been described among the EP247983; described preparation comprises the omeprazole that core cell forms; this core cell comprises omeprazole and a kind of basic salt or comprises the basic salt of omeprazole, and the optional a kind of basic salt that exists, and described core cell is by every clothing layer and enteric coating layer layering.
The capsule that the sodium bicarbonate that some enteric-coated pellets that the compositions that Chinese patent CN 101120930A has described omeprazole and sodium bicarbonate is made up of omeprazole, sodium bicarbonate and arbitrary form exist is formed, wherein enteric-coated pellets is made up of the ball heart, sealing coat, enteric coat layer.
Chinese patent ZL 200510002276.4 has described oral cavity disintegration tablet of omeprazole and derivant thereof and preparation method thereof.This method draws Zole derivatives powder or granule to carry out coating omeprazole or Latin America earlier, wrap again with sealing coat, enteric layer, make omeprazole coating powder or granule, be pressed into oral cavity disintegration tablet with filler, correctives, disintegrating agent, fluidizer, lubricant at last.
The oral administration system that comprises omeprazole of above technology preparation all is just to begin to discharge medicine later in arrival intestinal portion; though can protect omeprazole to avoid acidic gastric juice like this destroys; but the onset time of medicine is postponed, and production technology is more loaded down with trivial details simultaneously, the preparation cost height.
Summary of the invention
Technical problem to be solved by this invention is to overcome above-mentioned weak point, and a kind of enteric coated preparation that do not need to make is provided, and can begin the omeprazole capsule that discharges at once at stomach.When medicine enters stomach, medicine dissolution, its buffer substance forms miniature Buffer Pool, and this miniature Buffer Pool effectively intercepts the Degradation of gastric acid to omeprazole.
The invention provides a kind ofly, form by omeprazole, sodium bicarbonate and pharmaceutic adjuvant by omeprazole capsule.
A kind of omeprazole capsule of the present invention is made up of omeprazole, the sodium bicarbonate of dose therapeutically effective and the supplementary material that suits, and it is characterized in that the weight proportion of each component in the single dose omeprazole capsule is as follows:
Omeprazole 2mg～40mg
Sodium bicarbonate 450mg～2000mg
Diluent or filler 0～200mg
Lubricant 0.5mg～20mg.
Described omeprazole is selected from omeprazole pharmaceutically acceptable salt, hydrate, optical isomer or pharmaceutically acceptable crystal formation and their mixture.
The weight of omeprazole is 2mg～40mg in the described single dose omeprazole capsule, is preferably 10mg～40mg.
The weight of omeprazole is 10mg or 20mg or 40mg specification in the described single dose omeprazole capsule.
The weight of sodium bicarbonate is 450mg～2000mg in the described single dose omeprazole capsule, is preferably 500mg～1800mg,
More preferably 550mg or 1100mg or 1680mg specification of the weight of sodium bicarbonate in the described single dose omeprazole capsule.
Described lubricant is one or more the combination in magnesium stearate, stearic acid, calcium stearate, silicon dioxide, sodium stearyl fumarate and the Pulvis Talci.
Filler is selected from one or more the combination in microcrystalline Cellulose, Icing Sugar, starch, lactose, erythrose, mannitol, sorbitol, maltose alcohol, hyprolose, the soluble starch.
Another purpose of the present invention provides the preparation method of omeprazole capsule:
(1) get omeprazole, sodium bicarbonate, diluent or filler and the lubricant of recipe quantity, mix homogeneously, standby;
(2) detect dried granule content, theory of computation loading amount; Select the capsule of suitable size, after the filling promptly.
The invention has the advantages that this omeprazole capsule arrives stomach and discharges omeprazole at once, onset is rapid; In the sodium bicarbonate energy in the prescription and gastric acid, keep in the stomach pH value stable, increase the stability of omeprazole; Said preparation preparation technology is simple simultaneously, has avoided loaded down with trivial details coating process, and pelletization is not added any organic solvent, is fit to the big production of industry.
The specific embodiment
Following example will the present invention is further elaborated, but do not limit content involved in the present invention in any form.
Embodiment 1
Prescription:
Omeprazole 10g
Sodium bicarbonate 550g
Microcrystalline Cellulose 100g
Magnesium stearate 3.5g
Make 1000
Preparation process: earlier recipe quantity omeprazole, sodium bicarbonate, microcrystalline Cellulose are sieved respectively in (60-80 order), standby; Again with the magnesium stearate of the omeprazole, sodium bicarbonate and the recipe quantity that sieve, according to the equivalent increment method, tentatively mix powder after, sieve (60-80 order), mix homogeneously detects dried granule content at last, theory of computation loading amount is packed into behind the capsule promptly.
Embodiment 2
Prescription:
Omeprazole 10g
Sodium bicarbonate 550g
Magnesium stearate 2.5g
Make 1000
Preparation process: with embodiment 1.
Embodiment 3
Prescription:
Omeprazole Sodium 20g
Sodium bicarbonate 800g
Mannitol 150g
Pulvis Talci 10g
Make 1000
Preparation process: with embodiment 1.
Claims (9)
1. omeprazole capsule is characterized in that the weight proportion of each component in the single dose omeprazole capsule is as follows:
Omeprazole 2mg～40mg
Sodium bicarbonate 450mg～2000mg
Diluent or filler 0～200mg
Lubricant 0.5mg～20mg.
2. omeprazole capsule according to claim 1, wherein said omeprazole comprise omeprazole pharmaceutically acceptable salt, hydrate, optical isomer or pharmaceutically acceptable crystal formation or their mixture.
3. omeprazole capsule according to claim 1, the weight of omeprazole is 2mg～40mg in the wherein said single dose omeprazole capsule; Be preferably 10mg～40mg.
4. omeprazole capsule according to claim 3, the weight of omeprazole is 10mg, 20mg or 40mg specification in the wherein said single dose omeprazole capsule.
5. omeprazole capsule according to claim 1, the weight of sodium bicarbonate is 450mg～2000mg in the wherein said single dose omeprazole capsule, is preferably 500mg～1800mg.
6. omeprazole capsule according to claim 5, the weight of sodium bicarbonate is 550mg, 1100mg or 1680mg specification in the wherein said single dose omeprazole capsule.
7. omeprazole capsule according to claim 1, wherein lubricant is one or more the mixture in magnesium stearate, stearic acid, calcium stearate, silicon dioxide, sodium stearyl fumarate or the Pulvis Talci.
8. omeprazole capsule according to claim 1, wherein filler is one or more the mixture in microcrystalline Cellulose, Icing Sugar, starch, lactose, erythrose, mannitol, sorbitol, maltose alcohol, hyprolose or the soluble starch.
9. as each the preparation method of omeprazole capsule of claim 1～8, it is characterized in that this method comprises the following steps:
(1) omeprazole, sodium bicarbonate, filler and lubricant, mix homogeneously, standby;
(2) detect dried granule content, theory of computation loading amount, behind the filled capsules promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810207913A CN101756935A (en) | 2008-12-26 | 2008-12-26 | Omeprazole capsule and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810207913A CN101756935A (en) | 2008-12-26 | 2008-12-26 | Omeprazole capsule and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101756935A true CN101756935A (en) | 2010-06-30 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200810207913A Pending CN101756935A (en) | 2008-12-26 | 2008-12-26 | Omeprazole capsule and preparation method thereof |
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| CN (1) | CN101756935A (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102641285A (en) * | 2012-03-12 | 2012-08-22 | 南京海纳医药科技有限公司 | Compound omeprazole capsule and preparation method thereof |
| CN102688196A (en) * | 2012-05-21 | 2012-09-26 | 杭州华东医药集团生物工程研究所有限公司 | Omeprazole pellets and preparation method thereof |
| CN102727516A (en) * | 2012-07-25 | 2012-10-17 | 江苏润邦药业有限公司 | Compound omeprazole capsule and preparation method thereof |
| CN102949410A (en) * | 2012-11-27 | 2013-03-06 | 贵州信邦制药股份有限公司 | Compound omeprazole capsule and preparation method and detection method thereof |
-
2008
- 2008-12-26 CN CN200810207913A patent/CN101756935A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102641285A (en) * | 2012-03-12 | 2012-08-22 | 南京海纳医药科技有限公司 | Compound omeprazole capsule and preparation method thereof |
| CN102688196A (en) * | 2012-05-21 | 2012-09-26 | 杭州华东医药集团生物工程研究所有限公司 | Omeprazole pellets and preparation method thereof |
| CN102727516A (en) * | 2012-07-25 | 2012-10-17 | 江苏润邦药业有限公司 | Compound omeprazole capsule and preparation method thereof |
| CN102949410A (en) * | 2012-11-27 | 2013-03-06 | 贵州信邦制药股份有限公司 | Compound omeprazole capsule and preparation method and detection method thereof |
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| Date | Code | Title | Description |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Open date: 20100630 |