CN101744814A - Omeprazole complex preparation and preparation method thereof - Google Patents
Omeprazole complex preparation and preparation method thereof Download PDFInfo
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- CN101744814A CN101744814A CN200810239430A CN200810239430A CN101744814A CN 101744814 A CN101744814 A CN 101744814A CN 200810239430 A CN200810239430 A CN 200810239430A CN 200810239430 A CN200810239430 A CN 200810239430A CN 101744814 A CN101744814 A CN 101744814A
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Abstract
The invention relates to the field of medicinal preparation, in particular to omeprazole complex preparation and a preparation method thereof. The invention is characterized in that unit preparation contains 10-40mg omeprazole, 0.5-1.5g sodium bicarbonate and proper amounts of auxiliary materials. More specifically, the unit preparation contains 20mg or 40mg omeprazole and 1.1g sodium bicarbonate, wherein the omeprazole and the sodium bicarbonate are the main medicine components. The invention additionally discloses the preparation method. The invention has the advantages that the preparation takes effect rapidly, the side effect is small, and the preparation can be used to cure diseases such as hyperchlorhydria, gastroesophageal reflux disease, erosive esophagitis (the preparation being used as short-term curing medicine), active gastric ulcer, active duodenal ulcer (the preparation being used as short-term curing medicine) and the like.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, be specifically related to a kind of omeprazole compound preparation and preparation method thereof.
Background technology
Digestive system disease belongs to commonly encountered diseases, frequently-occurring disease.Show that according to statistics the sickness rate of whole world gastrointestinal disease accounts for about 12% of population.Along with socioeconomic continuous development, the continuous increase of people's study, work, life and mental pressure, the sickness rate of China's digestive system disease also is the trend of cumulative year after year.Latest survey according to authoritative institution shows, China's digestive system disease average attack rate had risen to 15.68% in 2003, the big city that domestic economies such as Beijing, Shanghai, Guangzhou, Tianjin, Shenzhen are flourishing, competition is fierce, operating pressure is bigger, the sickness rate of digestive system disease is more up to 31%.
At present, the sales volume of China's digestive system medication occupies other front three of various drug classes, and in whole digestive system medication, the shared ratio of medicine of treatment peptic ulcer is up to 59%.According to the sampling survey data show: up to 54.62%, the H2 receptor blocking agent was 25.11% to proton pump inhibitor in the market share in market in the gross sales amount of drug for peptic ulcer product in 2003, and antiacid and gastric mucosa protectant is 20.21%.As seen strong with rapid-action, antacid power, longer duration, the advantage that taking dose is little and side effect is little are familiar with by doctor and patient rapidly and are accepted.Proton pump inhibitor has become the first-selected medication of domestic clinical treatment peptic ulcer with its good and clinical curative effect.9,000,000,000 yuan of annual breakthroughs in 2005 reach 90.56 hundred million yuan.
The big kind of the domestic and international exploitation of proton pump inhibitor at present has omeprazole, lansoprazole etc.Because proton pump inhibitor is very easily degraded in sour environment, thus adopt the enteric coated medicine of protecting to avoid stomach acids destroy usually, but it has delayed the absorption of medicine and to the initial inhibitory action of gastric acid.
Santarus company then utilizes sodium bicarbonate to replace enteric coating, prevents that Omeprazole from being degraded by gastric acid, and omeprazole is absorbed apace.This product is the pharmacology uniqueness not only, and taking convenience, and the blood drug level of the back human body of taking medicine can reach peak level (about 30 minutes) soon, and can control gastric acid effectively.
Summary of the invention
In view of compound recipe omeprazole significant curative effect clinically, the invention provides a kind of omeprazole compound preparation and preparation method thereof.A kind of omeprazole compound preparation per unit preparation is by omeprazole 10-40mg, and sodium bicarbonate 0.5-1.5g and adjuvant are formed.Adjuvant is one or more in starch, microcrystalline Cellulose, lactose and carboxymethyl starch sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose, crospolyvinylpyrrolidone and cross-linked carboxymethyl cellulose sodium, the magnesium stearate.Preferred specification is to contain omeprazole 20mg and 40mg, sodium bicarbonate 1.1g in the per unit preparation.Preparation method is: omeprazole, sodium bicarbonate mixed with adjuvant, and tabletting, or encapsulated.
The present invention is used for the treatment of hyperchlorhydria, gastroesophageal reflux disease, erosive esophagitis (as the short term therapy medicine), active gastric ulcer and active duodenal ulcer diseases such as (as the short term therapy medicines).The present invention take medicine the back in about 30 minutes the blood drug level of human body can reach peak level soon, can control gastric acid effectively.
The specific embodiment
Following examples illustrate the present invention but do not limit the present invention
Embodiment 1: 1000 of specifications
Prescription: omeprazole 20g
Sodium bicarbonate 1100g
Lactose 25g
Microcrystalline Cellulose 40g
Mannitol 25g
Polyvinylpolypyrrolidone 10g
Aspartame 0.1g
Fruit latt essence 0.1g
Micropowder silica gel 0.75g
Magnesium stearate 0.75g
30% alcoholic solution of 8% polyvidone is an amount of
Method for making: omeprazole, sodium bicarbonate, microcrystalline Cellulose, carboxymethyl starch sodium, lactose, mannitol, the polyvinylpolypyrrolidone of getting recipe quantity sieve, mix homogeneously, make soft material in the 40% alcoholic solution adding said mixture with an amount of 8% polyvidone, cross 20 mesh sieves and granulate, 60 ℃ of dryings 6 hours, 20 mesh sieve granulate, add fruit latt essence, magnesium stearate, aspartame, micropowder silica gel, with 30 purpose screen cloth granulate, mixing mix homogeneously, tabletting or promptly encapsulated.
Embodiment 2: 1000 of specifications
Omeprazole 40g
Sodium bicarbonate 1100g
Microcrystalline Cellulose 50g
Carboxymethyl starch sodium 2.5g
Lactose 20g
Mannitol 20g
Polyvinylpolypyrrolidone 9g
Aspartame 0.1g
Fruit latt essence 0.1g
Micropowder silica gel 0.75g
Magnesium stearate 0.75g
30% alcoholic solution of 8% polyvidone is an amount of
Method for making: omeprazole, sodium bicarbonate, microcrystalline Cellulose, carboxymethyl starch sodium, lactose, mannitol, the polyvinylpolypyrrolidone of getting recipe quantity sieve, mix homogeneously, make soft material in the 40% alcoholic solution adding said mixture with an amount of 8% polyvidone, cross 20 mesh sieves and granulate, 60 ℃ of dryings 6 hours, 20 mesh sieve granulate, add fruit latt essence, magnesium stearate, aspartame, micropowder silica gel, with 30 purpose screen cloth granulate, mixing mix homogeneously, tabletting or promptly encapsulated.
Embodiment 3: 1000 of specifications
Prescription: omeprazole 20g
Sodium bicarbonate 1100g
Lactose 25g
Microcrystalline Cellulose 40g
Mannitol 25g
Polyvinylpolypyrrolidone 10g
Aspartame 0.1g
Fruit latt essence 0.1g
Micropowder silica gel 0.75g
Magnesium stearate 0.75g
30% alcoholic solution of 8% polyvidone is an amount of
Method for making: omeprazole, sodium bicarbonate, microcrystalline Cellulose, carboxymethyl starch sodium, lactose, mannitol, the polyvinylpolypyrrolidone of getting recipe quantity sieve, mix homogeneously, make soft material in the 40% alcoholic solution adding said mixture with an amount of 8% polyvidone, cross 20 mesh sieves and granulate, 60 ℃ of dryings 6 hours, 20 mesh sieve granulate, add fruit latt essence, magnesium stearate, aspartame, micropowder silica gel, with 30 purpose screen cloth granulate, mixing mix homogeneously, tabletting or promptly encapsulated.
Embodiment 4: 1000 of specifications
Omeprazole 40g
Sodium bicarbonate 1100g
Microcrystalline Cellulose 50g
Carboxymethyl starch sodium 2.5g
Lactose 20g
Mannitol 20g
Polyvinylpolypyrrolidone 9g
Aspartame 0.1g
Fruit latt essence 0.1g
Micropowder silica gel 0.75g
Magnesium stearate 0.75g
30% alcoholic solution of 8% polyvidone is an amount of
Method for making: omeprazole, sodium bicarbonate, microcrystalline Cellulose, carboxymethyl starch sodium, lactose, mannitol, the polyvinylpolypyrrolidone of getting recipe quantity sieve, mix homogeneously, make soft material in the 40% alcoholic solution adding said mixture with an amount of 8% polyvidone, cross 20 mesh sieves and granulate, 60 ℃ of dryings 6 hours, 20 mesh sieve granulate, add fruit latt essence, magnesium stearate, aspartame, micropowder silica gel, with 30 purpose screen cloth granulate, mixing mix homogeneously, tabletting or promptly encapsulated.
Among the above embodiment, preferred embodiment 2 and 3.
Claims (4)
1. omeprazole compound preparation is characterized in that: the per unit preparation is by the 10-40mg omeprazole, and 0.5-1.5g sodium bicarbonate and appropriate amount of auxiliary materials are formed.
2. the described preparation of claim 1 is capsule or tablet, it is characterized in that: described adjuvant by in one in starch, microcrystalline Cellulose, lactose and carboxymethyl starch sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose, crospolyvinylpyrrolidone and cross-linked carboxymethyl cellulose sodium, the magnesium stearate one or more.
3. contain omeprazole 20mg and 40mg in the described preparation of claim 1, sodium bicarbonate 1.1g.
4. the preparation method of claim 1 or 2 described preparations is characterized in that: omeprazole, sodium bicarbonate are mixed tabletting with adjuvant.Or it is encapsulated.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810239430A CN101744814A (en) | 2008-12-10 | 2008-12-10 | Omeprazole complex preparation and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810239430A CN101744814A (en) | 2008-12-10 | 2008-12-10 | Omeprazole complex preparation and preparation method thereof |
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| CN101744814A true CN101744814A (en) | 2010-06-23 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN200810239430A Pending CN101744814A (en) | 2008-12-10 | 2008-12-10 | Omeprazole complex preparation and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103405471A (en) * | 2013-07-27 | 2013-11-27 | 珠海保税区丽珠合成制药有限公司 | Compound preparation containing ilaprazole sodium |
| CN103432127A (en) * | 2013-07-27 | 2013-12-11 | 珠海保税区丽珠合成制药有限公司 | Compound preparation containing ilaprazole |
| WO2023275642A1 (en) * | 2021-06-30 | 2023-01-05 | Laboratorios Liomont, S.A. De C.V. | Pharmaceutical composition comprising a proton pump inhibitor for gastric absorption |
-
2008
- 2008-12-10 CN CN200810239430A patent/CN101744814A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103405471A (en) * | 2013-07-27 | 2013-11-27 | 珠海保税区丽珠合成制药有限公司 | Compound preparation containing ilaprazole sodium |
| CN103432127A (en) * | 2013-07-27 | 2013-12-11 | 珠海保税区丽珠合成制药有限公司 | Compound preparation containing ilaprazole |
| CN103432127B (en) * | 2013-07-27 | 2016-06-01 | 珠海保税区丽珠合成制药有限公司 | A kind of compound preparation containing lY 81149 |
| CN103405471B (en) * | 2013-07-27 | 2016-06-29 | 珠海保税区丽珠合成制药有限公司 | A kind of compound preparation containing Ilaprazole Sodium |
| WO2023275642A1 (en) * | 2021-06-30 | 2023-01-05 | Laboratorios Liomont, S.A. De C.V. | Pharmaceutical composition comprising a proton pump inhibitor for gastric absorption |
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| WD01 | Invention patent application deemed withdrawn after publication |
Open date: 20100623 |