CN103599082A - Omeprazole and sodium bicarbonate core-covering tablet - Google Patents
Omeprazole and sodium bicarbonate core-covering tablet Download PDFInfo
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- CN103599082A CN103599082A CN201310606259.6A CN201310606259A CN103599082A CN 103599082 A CN103599082 A CN 103599082A CN 201310606259 A CN201310606259 A CN 201310606259A CN 103599082 A CN103599082 A CN 103599082A
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- omeprazole
- sodium bicarbonate
- clad sheet
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Abstract
The invention relates to a core-covering tablet containing active ingredients of omeprazole and sodium bicarbonate. The core-covering tablet comprises a peripheral medicine-containing layer (1) and a medicine-containing tablet core (2) located in the middle of the medicine-containing layer, wherein sodium bicarbonate serves as the medicine active ingredient of the peripheral medicine-containing layer (1), while omeprazole serves as the active ingredient of the medicine-containing tablet core (2); the peripheral medicine-containing layer (1) fastens the medicine-containing tablet core (2); the medicine-containing tablet core (2) is coaxial with the core-covering tablet. According to the core-covering tablet, all the active ingredients are nearly not contacted each other, so that the core-covering tablet is high in stability and convenient to process; more importantly, an omeprazole-sodium bicarbonate compound preparation with qualified relevant substances can be gained without strictly controlling intermediate-related substances. Moreover, the sodium bicarbonate layer can be quickly disintegrated to adjust and produce relatively high pH in stomach, and then the omeprazole tablet core is disintegrated under such condition, thus the damage of gastric acid to omeprazole can be reduced.
Description
Technical field
The present invention relates to a kind of clad sheet, particularly a kind of clad sheet that contains omeprazole and sodium bicarbonate active component.
Background technology
U.S. FDA has been ratified the compound recipe rapid release Proton pump inhibitor omeprazole sodium bicarbonate capsule (trade name: Zegerid), specification comprises two kinds of 40mg/1100mg and 20mg/1100mg of Sang Talusi (Santarus) company.The mechanism of action of this compound recipe immediate release drug is: oral rear sodium bicarbonate can cause the pH of gastric to rise rapidly, thus the omeprazole that coating is not made in protection at gastric by the degraded of gastric acid, this is of short duration stimulation G cell in gastric antrum secretion gastrin also.The Gastrin. level that can cause in 30min after sodium bicarbonate solution oral administration circulating rises.Circulation Gastrin. level rises can stimulate parietal cell mass and H+/K+-ATP enzyme functional molecular to enter secretory tubyle.Because the peak plasma concentration of omeprazole appears at 30min after compound recipe omeprazole sodium bicarbonate oral administration, this causes the omeprazole of circulation by the parietal cell of activating, to make rapidly the irreversible inhibition of the H+/K+-ATP enzyme of mass efficient.This is the reason that compound recipe omeprazole sodium bicarbonate secretion inhibitor is rapid and acting duration is long.The defect that above-mentioned capsule exists is, omeprazole and sodium bicarbonate are present in same capsule, have following shortcoming: 1, the two has in vitro the just possibility of contact, and then cause (1) due to the impact of multicomponent mixing homogeneity degree, each composition is difficult to accurate quantitative analysis; (2), when product detects, because phase mutual interference is difficult for measuring each component content, affect qualitative and quantitative analysis result; (3) during long preservation, owing to may there is chemical compatibility between each composition, change, easily produce by-product, reduce effect or increase side effect, product stability is not ideal enough.2, omeprazole and sodium bicarbonate cause the unordered disintegrate at gastric owing to being made into granule, thereby cause when omeprazole disintegrate, and the part of sodium bicarbonate neutralization lost efficacy.
The maximum effect of clad sheet tablet is slow controlled release, it can make medicine, and slowly (slow release) or constant speed discharge (controlled release) according to certain rules, medicine is the long period drug level of remaining valid in vivo, thereby reach, reduce drug dose, improve drug effect and degree of safety, prolong drug effect and minimizing medicine frequency, the object of reduction blood concentration peak valley phenomenon.The R and D of this type of dosage form earn widespread respect abroad, just start at home.
Why clad sheet is subject to people's favor, and this is because it has the incomparable feature of many general tablets:
(1) when medication, the outer layer component of clad sheet is distributed in intestinal mucosa surface in administration process, and chip medicine component is concentrated and can be distributed in gastric mucosa surface, makes drug absorption complete, thereby improves bioavailability.
(2) by the combination of two layers of different rate of releasing drug, can obtain comparatively ideal rate of releasing drug, reach the blood drug level of expection, and can maintain stably, valid density for a long time, reduce the toxic action of medicine, avoid bad reflections such as gastric stimulations.
(3) by two kinds of different components, be pressed into mutual unmixed tablet, can increase the stability of medicine.
(4) by tabletting mode, reach outer coating and the technique of the slow controlled release clad sheet made than reliable at the direct coating of tablet surface, can avoid the inhomogeneous problems such as medicine punching leakage that cause of the direct coating of tablet.
(5) clad sheet technology adds component with delaying controlled release micro pill and skin packaging technique more again, just can prepare how slow controlled release requirement combination, the limitation that it has overcome by single slow controlled release micro pill tabletting effect, also can be extended out the slow controlled release requirement of more administration processes.
Summary of the invention
For solving the problems of the technologies described above, the invention provides a kind of clad sheet that contains omeprazole and sodium bicarbonate active component.
Omeprazole of the present invention and sodium bicarbonate clad sheet, comprise periphery medicated layer and be positioned at the middle pastille label of medicated layer, the active constituents of medicine of described periphery medicated layer is sodium bicarbonate, the active component of described pastille label is omeprazole, described periphery medicated layer is fastening by pastille label, pastille label and clad sheet axiality
Clad sheet (as shown in Figure 1): adopt the mode of tabletting to carry out coating to chip skin, general chip slow release, outer rapid release (or controlled release), is also a kind of slow-release tablet agent of repeatedly preparing two component drug, by being suppressed into the mutual unmixed tablet of component.Centre internal layer claims chip, and clad sheet belongs to alleviates class tablet, and energy lucifuge, control are oxidized, and also can control respectively the drug release rate of each component drug.
Clad sheet of the present invention, described pastille label stretches out periphery medicated layer vertically.
Clad sheet of the present invention, the ratio of the maximum gauge of described periphery medicated layer and pastille label is 2-4 ︰ 1.
Clad sheet of the present invention can be made following several different specifications.Omeprazole sodium bicarbonate cored A sheet, pastille label contains 6.7mg omeprazole, the sodium bicarbonate that described periphery medicated layer contains 366.7mg; Omeprazole sodium bicarbonate cored B sheet, pastille label contains 13.3mg omeprazole, the sodium bicarbonate that described periphery medicated layer contains 366.7mg; Omeprazole sodium bicarbonate cored C sheet, pastille label contains 10mg omeprazole, the sodium bicarbonate that described periphery medicated layer contains 550mg; Omeprazole sodium bicarbonate cored D sheet, pastille label contains 20mg omeprazole, the sodium bicarbonate that described periphery medicated layer contains 550mg.
Arbitrary clad sheet of the present invention, described pastille label or clad sheet are coatings.
Clad sheet of the present invention, described clad sheet is different colours.
Clad sheet of the present invention, the periphery medicated layer that described clad sheet is is rapid release, described pastille label is slow release.
Mechanism is, take after clad sheet, each sodium bicarbonate small pieces is disintegrate fast separately, each sodium bicarbonate small pieces around, all can form the quick independent region that forms rising stomach inner pH value, because the pH of above-mentioned zone raises, be orderly, so Omeprazole when gastric disintegrate, has obtained suitable being difficult for by the pH value environment of stomach acids destroy.Administration on an empty stomach in 30 hours before the meal, omeprazole absorbs fast, the mean plasma concentration 1511ng/ml of omeprazole.
The present invention can select various cored mechanism standby, such as the rotary cored machine of ZPW20.
Beneficial effect of the present invention is on the one hand, the invention provides a kind of clad sheet that contains omeprazole and sodium bicarbonate active component, between various active component, almost do not contact mutually, thereby obtain stability clad sheet better, easy to process, what is more important provides a kind of not to be needed strictly to control intermediate related substance and can obtain the up-to-standard omeprazole sodium bicarbonate compound preparation of related substance.Other one side effect of the present invention is the first disintegrate fast of sodium bicarbonate layer, like this can be in the situation that sodium bicarbonate have been adjusted the higher stomach inner pH value of formation, and disintegrate after omeprazole label, has reduced the destruction of gastric acid to omeprazole.
The present invention compared with prior art also tool have the following advantages:
1. because the active component in capsule contacts each other hardly, therefore between each composition, can there are not chemistry 5 changes and produce by-product, the stability of product is improved, especially reduce the catabolite producing after omeprazole contacts with sodium bicarbonate, made the related substance of product of the present invention meet human-body safety scope;
2. because omeprazole is independent film-making, on the check of medicine and quality control, be more prone to.
Below in conjunction with drawings and Examples, the invention will be further described:
Accompanying drawing explanation
Accompanying drawing 2 is omeprazole and the sodium bicarbonate clad sheet schematic diagram of embodiment 2.
The specific embodiment
Embodiment 1: omeprazole sodium bicarbonate cored A sheet as shown in Figure 1, pastille label 2 contains 6.7mg omeprazole, the sodium bicarbonate that periphery medicated layer 1 contains 366.7mg and containing rapid release adjuvant, this label 2 and medicated layer 1 are circle.
Embodiment 2: omeprazole sodium bicarbonate cored B sheet, substantially the same manner as Example 1, difference is that pastille label contains 13.3mg omeprazole, the sodium bicarbonate that periphery medicated layer contains 366.7mg and containing slow-release auxiliary material.
Embodiment 3: omeprazole sodium bicarbonate cored C sheet is as shown in Figure 2 the rectangle with fillet, and pastille label 2 contains 10mg omeprazole, the sodium bicarbonate that periphery medicated layer 1 contains 550mg and containing rapid release adjuvant.
Embodiment 4: omeprazole sodium bicarbonate cored D sheet, substantially the same manner as Example 3, difference is that pastille label contains 20mg omeprazole, the sodium bicarbonate that periphery medicated layer contains 550mg and containing slow-release auxiliary material.
The above embodiment is only that the preferred embodiment of the present invention is described; not scope of the present invention is limited; design under the prerequisite of spirit not departing from the present invention; various distortion and improvement that those of ordinary skills make technical scheme of the present invention, all should fall in the definite protection domain of claims of the present invention.
Claims (10)
1. an omeprazole and sodium bicarbonate clad sheet, it is characterized in that, described clad sheet comprises periphery medicated layer (1) and is positioned at the middle pastille label (2) of medicated layer, the active constituents of medicine of described periphery medicated layer (1) is sodium bicarbonate, the active component of described pastille label (2) is omeprazole, described periphery medicated layer (1) is fastening by pastille label (2), pastille label (2) and clad sheet axiality
2. clad sheet as claimed in claim 1, is characterized in that, described pastille label (2) stretches out periphery medicated layer (1) vertically.
3. clad sheet as claimed in claim 1, is characterized in that, described periphery medicated layer (1) is 2-4 ︰ 1 with the ratio of the maximum gauge of pastille label (2).
4. clad sheet as claimed in claim 1, is characterized in that, described pastille label (2) contains 6.7mg omeprazole, the sodium bicarbonate that described periphery medicated layer (1) contains 366.7mg.
5. clad sheet as claimed in claim 1, is characterized in that, described pastille label (2) contains 13.3mg omeprazole, the sodium bicarbonate that described periphery medicated layer (1) contains 366.7mg.
6. clad sheet as claimed in claim 1, is characterized in that, described pastille label (2) contains 10mg omeprazole, the sodium bicarbonate that described periphery medicated layer (1) contains 550mg.
7. clad sheet as claimed in claim 1, is characterized in that, described pastille label (2) contains 20mg omeprazole, the sodium bicarbonate that described periphery medicated layer (1) contains 550mg.
8. the arbitrary clad sheet as described in claim 1-7, is characterized in that, described pastille label (2) or clad sheet are coatings.
9. the clad sheet as described in claim 1-7, is characterized in that, described clad sheet is different colours.
10. the clad sheet as described in claim 1-7, is characterized in that, the periphery medicated layer (1) that described clad sheet is is rapid release, and described pastille label (2) is slow release.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310606259.6A CN103599082A (en) | 2013-04-05 | 2013-11-25 | Omeprazole and sodium bicarbonate core-covering tablet |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310116568 | 2013-04-05 | ||
| CN201310116568.5 | 2013-04-05 | ||
| CN201310606259.6A CN103599082A (en) | 2013-04-05 | 2013-11-25 | Omeprazole and sodium bicarbonate core-covering tablet |
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| Publication Number | Publication Date |
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| CN103599082A true CN103599082A (en) | 2014-02-26 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201310606259.6A Pending CN103599082A (en) | 2013-04-05 | 2013-11-25 | Omeprazole and sodium bicarbonate core-covering tablet |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2019146937A1 (en) * | 2018-01-29 | 2019-08-01 | Chong Kun Dang Pharmaceutical Corp. | Stable pharmaceutical composition comprising esomeprazole and sodium bicarbonate |
| CN114468132A (en) * | 2022-03-10 | 2022-05-13 | 黄淮学院 | Mushroom cooking liquor extract feed additive and preparation method thereof |
| US11759428B2 (en) | 2018-01-29 | 2023-09-19 | Chong Kun Dang Pharmaceutical Corp. | Pharmaceutical formulation comprising esomeprazole and sodium bicarbonate |
-
2013
- 2013-11-25 CN CN201310606259.6A patent/CN103599082A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2019146937A1 (en) * | 2018-01-29 | 2019-08-01 | Chong Kun Dang Pharmaceutical Corp. | Stable pharmaceutical composition comprising esomeprazole and sodium bicarbonate |
| JP2021512081A (en) * | 2018-01-29 | 2021-05-13 | チョン クン ダン ファーマシューティカル コーポレイション | Stable pharmaceutical composition containing esomeprazole and sodium bicarbonate |
| JP7003279B2 (en) | 2018-01-29 | 2022-01-20 | チョン クン ダン ファーマシューティカル コーポレイション | Stable pharmaceutical composition containing esomeprazole and sodium bicarbonate |
| US11759428B2 (en) | 2018-01-29 | 2023-09-19 | Chong Kun Dang Pharmaceutical Corp. | Pharmaceutical formulation comprising esomeprazole and sodium bicarbonate |
| US11813285B2 (en) | 2018-01-29 | 2023-11-14 | Chong Kun Dang Pharmaceutical Corp. | Stable pharmaceutical composition comprising esomeprazole and sodium bicarbonate |
| CN114468132A (en) * | 2022-03-10 | 2022-05-13 | 黄淮学院 | Mushroom cooking liquor extract feed additive and preparation method thereof |
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Application publication date: 20140226 |