CN103479593A - Preparation method for omeprazole enteric coated tablet - Google Patents
Preparation method for omeprazole enteric coated tablet Download PDFInfo
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- CN103479593A CN103479593A CN201310169866.0A CN201310169866A CN103479593A CN 103479593 A CN103479593 A CN 103479593A CN 201310169866 A CN201310169866 A CN 201310169866A CN 103479593 A CN103479593 A CN 103479593A
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Abstract
The invention relates to a preparation method for an omeprazole enteric coated tablet. The components comprise in percents by weight: 10-50% of omeprazole, 1.25-6.25% of superfine silica powder, 30-78% of lactose, 2-3% of copolyvinylpyrrolidone, 5-12% of crospovidone, 1.5-2.0% of sodium octadecyl fumarate and 0.5-1.0% of magnesium stearate. The preparation method comprises: uniformly mixing micronized omeprazole and superfine silica powder, sieving; sieving copolyvinylpyrrolidone, crospovidone, lactose and sodium octadecyl fumarate, uniformly mixing with omeprazole and superfine silica powder, adding into a drying-method granulator, granulating for 3-4 times, screening out integrated particles with a 60 mesh sieve and obtaining dry particles; blending uniformly the dry particles and magnesium stearate by a three-dimensional mixer, adding into a tablet press for pressing tablets; and then coating to obtain the omeprazole enteric coated tablet. The formula is simple; the preparation method helps to solve the industrialized production problem of omeprazole enteric coated tablet high-specification products such as a product with a specification of 40 mg/tablet; and the preparation is controllable in quality, the product is good in uniformity, and impurity content is low.
Description
Technical field:
The present invention relates to a kind of preparation method of Omeprazole Enteric-coated Tablets, belong to field of medicine preparing technology.
Background technology:
The limitation that the internal film tissue of contact gastric juice part occurs in digestive tract is damaged, comprise lower esophagus, gastroduodenal first paragraph, usually claim gastric ulcer and duodenal ulcer, the general name peptic ulcer, erosive gastritis can develop into Peptic Ulcers, and motherland's medical science claims gastric abscess.Aspect epidemiology, peptic ulcer is a commonly encountered diseases, and its sickness rate is at different times, and the different regions difference is larger, and total sickness rate accounts for 10～20% of population.U.S. peptic ulcer patient approximately 10%, and Germany is 12.3%; China is according to the investigation of minority area, and the digestive tract disease sickness rate is 11.43%, and wherein the peptic ulcer rate is 4.54%.Country of the U.S. only, the annual medical expense for peptic ulcer has just reached 13,900,000,000 dollars.
At present along with the Chinese society development, the change of circumstances, the variation of population structure and people life style, main because of smoking, drink, peptic ulcer rate that the factor such as nervous, medicine irritation causes increases gradually, become a kind of commonly encountered diseases and frequently-occurring disease, bring great misery to the patient, cause patients ' life quality to descend.For these reasons, the treatment of peptic ulcer more and more receives publicity clinically and payes attention to, thus Development and Production safely and effectively medicament for resisting peptic ulcer receive publicity, and become one of the emphasis of current drug development research and focus.
Anti-ulcer medicament has bisfentidine (representing the medicine ranitidine), antacid (representing the medicine hydrotalcite), proton pump inhibitor (representing the medicine omeprazole) etc., but from the listing of proton pump inhibitor omeprazole, due to determined curative effect, omeprazole becomes rapidly topmost anti-ulcer medicament.Omeprazole grinds by AstraZeneca is former, and omeprazole enteric-coated capsules from 1992 (trade name losec) goes on the market at home, and because curative effect is outstanding, Market reaction is good.Domestic production producer, when it being domesticized to research, has researched and developed Omeprazole Enteric-coated Tablets.Omeprazole Enteric-coated Tablets design sheet footpath is φ 5mm, guarantee that tablet passes through rapidly pylorus (pylorus tranquillization diameter 12.8 ± 7mm) when gastric emptying, arrive intestinal and discharge medicine and enter blood circulation and play a role, with traditional antacid, anticholinergic agent, bisfentidine, compare there is higher selectivity, better curative effect (strong 2-7 doubly).As long as be administered once and can reach therapeutic purposes morning every day, in the 2-4 week course for the treatment of, particularly with the antimicrobial drug drug combination, can thoroughly kill helicobacter pylori and reach therapeutic purposes.
At present, the Omeprazole Enteric-coated Tablets production technology is mainly wet granulation, the wet granulation technology that Chinese patent 201010109148.0 and 201210530305.4 all adopts.Because omeprazole principal agent itself is met wet, heat, chance acid is all perishable, should avoid contacting the environment such as water, high temperature, acid in the technique preparation, with the impact in minimizing preparation process, main constituent caused.But in fact, due to adding of binding agent, and large in batches while producing greatly, be difficult in process of production to control the impact on omeprazole of moisture and high temperature, thereby make the omeprazole degraded and produce impurity, affect the treatment and drug safety.Detect and find through impurity, its total impurities of the product after wet granulation obviously improves than raw material, if Shop floor control is bad, and the as easy as rolling off a log prescribed limit that surpasses of impurity.And as easy as rolling off a log viscosity of bringing out omeprazole itself after wet granulation technology, the phenomenon of sticking easily appears during as the product tabletting of 40mg/ sheet in the product of high standard, its plain sheet hardness is not high yet, the requirement that does not reach coating.Therefore wet granulation be not suitable for the technique preparation of Omeprazole Enteric-coated Tablets, particularly the Omeprazole Enteric-coated Tablets as the 40mg/ sheet of high standard can't be realized suitability for industrialized production by wet granulation.
Because omeprazole character is special, be insoluble in water, it need be carried out to micronization to improve the stripping of medicine, if adopt the method for direct powder compression, the physical propertys such as the bulk density of the medicine after micronization and the selected adjuvant of direct powder compression, granularity and particle size distribution fall far short, and in the process of carrying out the supplementary material mixing, the principal agent after micronization is difficult to and other auxiliary materials and mixing, its uniformity of dosage units is wayward, therefore can not use direct powder compression.
The present invention is by a large amount of experimentatioies, invented a kind of formula simple, adopted dry granulation to produce feasible, the reasonably large production method of Omeprazole Enteric-coated Tablets, the method both can avoid meeting the damp and hot principal agent that affects aborning, the impurity content that guarantees medicine is lower, and release is better; Jointly mix by principal agent and micropowder silica gel the Electrostatic Absorption problem that has solved omeprazole again, the problem that is applicable to tabletting by granular mass good in the dry granulation process that added the adjuvant sodium stearyl fumarate to guarantee, thereby guaranteed the practical feasibility of large production, the preparation of producing can be realized quality controllable.Use the present invention can prepare the Omeprazole Enteric-coated Tablets of high standard as 40mg/ sheet specification simultaneously.
Summary of the invention:
The object of the invention is to overcome the shortcoming of prior art, a kind of preparation method of the solid composite medicament that contains omeprazole is provided.Said composition has been carried out preferably, with polyvinylpolypyrrolidone and copolyvidone pairing, uses and has significantly improved the omeprazole release; Adopt dry granulation technique, can effectively improve the stability of preparation, by granular mass good in the dry granulation process that added the adjuvant sodium stearyl fumarate to guarantee to be more suitable for tabletting; Simple process of the present invention, easily operation, be suitable for suitability for industrialized production.
In order to realize the foregoing invention purpose, the preparation method of a kind of Omeprazole Enteric-coated Tablets of the present invention, using omeprazole as principal agent, take micropowder silica gel, lactose, copolyvidone, polyvinylpolypyrrolidone, sodium stearyl fumarate, magnesium stearate is adjuvant, and it is as follows that each component of tablet accounts for tablet weight percentage ratio:
The active component omeprazole accounts for 10～50%;
The filler micropowder silica gel accounts for 1.25～6.25%;
The filler lactose accounts for 30～78%;
The binding agent copolyvidone accounts for 2～3%;
The disintegrating agent polyvinylpolypyrrolidone accounts for 5～12%;
The filler sodium stearyl fumarate accounts for 1.5～2.0%;
Magnesium stearate lubricant accounts for 0.5～1.0%;
Wherein, the weight ratio of copolyvidone and polyvinylpolypyrrolidone is 1:2.5～1:4;
Operation in accordance with the following steps: adopt dry granulation technique, will after 10～50% omeprazole micronization, with 1.25～6.25% micropowder silica gel, jointly mix 200 mesh sieves; After copolyvidone by 2～3%, 5～12% polyvinylpolypyrrolidone, 30～78% lactose, 1.5～2.0% sodium stearyl fumarate are crossed 200 mesh sieves, with omeprazole, micropowder silica gel, mix homogeneously; The material of mix homogeneously is added in dry granulating machine and granulates, 10 hertz of filler speed in frequency, 30 hertz of granulation speed in frequency, granulation pressure 2-3MPa, the granulation screen sizes is 30 orders approximately, through 3-4 granulation, with 60 mesh sieve granulate, obtain dry granule appropriate; By dry granule, 0.5～1.0% magnesium stearate three-dimensional mixer mix homogeneously, add in the tablet machine loading hopper tabletting; Plain sheet after tabletting is carried out to coating, make Omeprazole Enteric-coated Tablets of the present invention.
The present invention screens formula, and because omeprazole belongs to the material of slightly solubility, preferably polyvinylpolypyrrolidone and copolyvidone pairing are used as the adjuvant of raising omeprazole release, and wherein, polyvinylpolypyrrolidone is used as disintegrating agent.Polyvinylpolypyrrolidone can show rapidly high capillary activity and excellent hydration capability, the almost tendency of gel-free as tablet disintegrant.After polyvinylpolypyrrolidone is done disintegrating agent compacting in flakes, disintegration is short, and dissolution rate is high; Stability is strong, not can through the time and become, be called as super-disintegrant.It has had the character of PVP and PVAC concurrently the copolyvidone molecule.Copolyvidone has retained good water solublity, caking property and the film property of PVP, has relatively much lower water absorption and more broad solubility property, better plasticity and stronger surface activity than PVP again.Therefore copolyvidone is a kind of good tablet binder, applies its tablet made and has the characteristic of low friability, and under wet condition, film-making can less bond, and is particularly useful for high dose, poorly water-soluble and to film-making and the pelletize of water sensitive medicine.To polyvinylpolypyrrolidone, copolyvidone, pairing is used as disintegrating agent and binding agent, through experimental study, finds, when copolyvidone and polyvinylpolypyrrolidone weight ratio are the release that 1:2.5～1:4 can significantly improve omeprazole.
The present invention is in dry granulation technical study process, and in discovery omeprazole dry granulation, pellet hardness causes more greatly the difficulty of tabletting.By adjusting existing filler and adding the traditional lubrication agent to fail effectively to address this problem.Find after deliberation to add sodium stearyl fumarate can effectively solve omeprazole granule in dry granulation process problem that is difficult to molding in the tabletting process that causes really up to the mark, guaranteed the feasibility of large production.
The present invention adopts in dry granulation technical study process, consider the problem that mixes of omeprazole in actual production process, all adjuvants except magnesium stearate lubricant are crossed to 200 mesh sieves, guarantee that omeprazole can fully mix when mixing, the uniformity of dosage units of principal agent can meet the requirements.
The present invention is in dry granulation technical study process, find that omeprazole easily produces Electrostatic Absorption, therefore after 200 mesh sieves, guarantee the granularity of omeprazole after selecting micropowder silica gel and omeprazole jointly to mix, can eliminate the Electrostatic Absorption problem of omeprazole self simultaneously.
The present invention, by a large amount of experimentatioies, has invented a kind of formula simple, adopts dry granulation to produce feasible, the reasonably large production method of Omeprazole Enteric-coated Tablets.Dry granulation makes omeprazole avoid touching moisture, can solve the problem that the omeprazole impurity that occurs in Omeprazole Enteric-coated Tablets production uprises.Simultaneously, the present invention has also solved the suitability for industrialized production problem of Omeprazole Enteric-coated Tablets high standard as 40mg/ sheet specification product.At present the listing Omeprazole Enteric-coated Tablets only has two kinds of 10mg and 20mg specifications, and the 40mg Omeprazole Enteric-coated Tablets can't be realized suitability for industrialized production, this is because current Omeprazole Enteric-coated Tablets all adopts wet granulation technology, and Omeprazole Enteric-coated Tablets design sheet diameter is φ 5mm, sheet heavy fixing (should be not more than the 90mg/ sheet) substantially, as developed the Omeprazole Enteric-coated Tablets of 40mg specification, its main constituent approaches half that accounts for whole formulation weight, by as easy as rolling off a log viscosity of bringing out omeprazole itself after wet granulation technology, the phenomenon of sticking easily appears during tabletting, do not reach the requirement of coating.And adopting dry granulation of the present invention, the sheet that can make omeprazole is heavy smaller, adopts dry granulation can make the Omeprazole Enteric-coated Tablets of 40mg.
The specific embodiment:
Preparation method below by specific embodiment to medicine of the present invention is further elaborated.
Embodiment 1,
Medicine specification: 10mg
Fill a prescription as follows:
Preparation method: pharmaceutical formulation is the same.
1, omeprazole crude drug micronization, after jointly mixing with micropowder silica gel after 200 mesh sieves; Lactose, copolyvidone, polyvinylpolypyrrolidone, sodium stearyl fumarate are crossed 200 mesh sieves, and magnesium stearate is crossed 100 mesh sieves, standby;
2, the supplementary material except magnesium stearate is mixed 60 minutes to mix homogeneously;
3, the material of mix homogeneously is added in dry granulating machine and granulates, 10 hertz of filler speed in frequency, 30 hertz of granulation speed in frequency, granulation pressure 2-3MPa, the granulation screen sizes is 30 orders approximately, through 3-4 granulation, with 60 mesh sieve granulate, obtain dry granule appropriate;
4, dry granule, magnesium stearate are joined to three-dimensional mixer, mix 20 minutes to evenly, add in the tablet machine loading hopper tabletting;
5, by plain sheet bag contagion gown and enteric coating after tabletting, make Omeprazole Enteric-coated Tablets of the present invention.
Embodiment 2,
Medicine specification: 20mg
Fill a prescription as follows:
| The element slice prescription | Ratio (percentage by weight) | 1000 slice prescription amounts (g) |
| Omeprazole | 25.00% | 20.00 |
| Micropowder silica gel | 3.13% | 2.50 |
| Lactose | 60.12% | 48.10 |
| Copolyvidone | 2.50% | 2.00 |
| Polyvinylpolypyrrolidone | 7.00% | 5.60 |
| Sodium stearyl fumarate | 1.50% | 1.20 |
| Magnesium stearate | 0.75% | 0.60 |
| Amount to | 100% | 80 |
Preparation method: pharmaceutical formulation is the same.
1, omeprazole crude drug micronization, after jointly mixing with micropowder silica gel after 200 mesh sieves; Lactose, copolyvidone, polyvinylpolypyrrolidone, sodium stearyl fumarate are crossed 200 mesh sieves, and magnesium stearate is crossed 100 mesh sieves, standby;
2, the supplementary material except magnesium stearate is mixed 60 minutes to mix homogeneously;
3, the material of mix homogeneously is added in dry granulating machine and granulates, 10 hertz of filler speed in frequency, 30 hertz of granulation speed in frequency, granulation pressure 2-3MPa, the granulation screen sizes is 30 orders approximately, through 3-4 granulation, with 60 mesh sieve granulate, obtain dry granule appropriate;
4, dry granule, magnesium stearate are joined to three-dimensional mixer, mix 20 minutes to evenly, add in the tablet machine loading hopper tabletting;
5, by plain sheet bag contagion gown and enteric coating after tabletting, make Omeprazole Enteric-coated Tablets of the present invention.
Embodiment 3,
Medicine specification: 40mg
Fill a prescription as follows:
| The element slice prescription | Ratio (percentage by weight) | 1000 slice prescription amounts (g) |
| Omeprazole | 45.45% | 40.00 |
| Micropowder silica gel | 5.68% | 5.00 |
| Lactose | 36.21% | 31.86 |
| Copolyvidone | 2.05% | 1.80 |
| Polyvinylpolypyrrolidone | 7.95% | 7.00 |
| Sodium stearyl fumarate | 1.75% | 1.54 |
| Magnesium stearate | 0.91% | 0.80 |
[0049]?
| Amount to | 100% | 88 |
Preparation method: pharmaceutical formulation is the same.
1, omeprazole crude drug micronization, after jointly mixing with micropowder silica gel after 200 mesh sieves; Lactose, copolyvidone, polyvinylpolypyrrolidone, sodium stearyl fumarate are crossed 200 mesh sieves, and magnesium stearate is crossed 100 mesh sieves, standby;
2, the supplementary material except magnesium stearate is mixed 60 minutes to mix homogeneously;
3, the material of mix homogeneously is added in dry granulating machine and granulates, 10 hertz of filler speed in frequency, 30 hertz of granulation speed in frequency, granulation pressure 2-3MPa, the granulation screen sizes is 30 orders approximately, through 3-4 granulation, with 60 mesh sieve granulate, obtain dry granule appropriate;
4, dry granule, magnesium stearate are joined to three-dimensional mixer, mix 20 minutes to evenly, add in the tablet machine loading hopper tabletting;
5, by plain sheet bag contagion gown and enteric coating after tabletting, make Omeprazole Enteric-coated Tablets of the present invention.
Embodiment of the present invention sample simulation listing packing and with former keep sample for a long time investigation experimentation 0,3,6,9,12,18,24,30 month sample analysis after placing of grinding together with medicine, commercially available Omeprazole Enteric-coated Tablets (wet granulation technology).By " requirement of two Omeprazole Enteric-coated Tablets quality standards of Chinese pharmacopoeia version in 2010, investigate project release, related substance, content, and the investigation result of the test that keeps sample for a long time sees the following form.
Conclusion (of pressure testing): medicine of the present invention is through keeping sample and investigate 30 months for a long time, indices is all normal after testing, " two quality standard requirements of Chinese pharmacopoeia version in 2010, related substance, content and release index all are better than formerly grinding medicine and through the listing Omeprazole Enteric-coated Tablets agent of wet granulation technology all to meet Omeprazole Enteric-coated Tablets.
Claims (1)
1. the preparation method of an Omeprazole Enteric-coated Tablets, it is characterized in that usining that omeprazole is as principal agent, take micropowder silica gel, lactose, copolyvidone, polyvinylpolypyrrolidone, sodium stearyl fumarate, magnesium stearate is adjuvant, and it is as follows that each component of tablet accounts for tablet weight percentage ratio: the active component omeprazole accounts for 10～50%; The filler micropowder silica gel accounts for 1.25～6.25%; The filler lactose accounts for 30～78%; The binding agent copolyvidone accounts for 2～3%; The disintegrating agent polyvinylpolypyrrolidone accounts for 5～12%; The filler sodium stearyl fumarate accounts for 1.5～2.0%; Magnesium stearate lubricant accounts for 0.5～1.0%; Wherein, the weight ratio of copolyvidone and polyvinylpolypyrrolidone is 1:2.5～1:4; Operation in accordance with the following steps: adopt dry granulation technique, will after the omeprazole micronization, with micropowder silica gel, jointly mix 200 mesh sieves; After copolyvidone, polyvinylpolypyrrolidone, lactose, sodium stearyl fumarate are crossed to 200 mesh sieves, with omeprazole, micropowder silica gel, mix homogeneously; The material of mix homogeneously is added in dry granulating machine and granulates, 10 hertz of filler speed in frequency, 30 hertz of granulation speed in frequency, granulation pressure 2-3MPa, granulation screen sizes 30 orders, through 3-4 granulation, with 60 mesh sieve granulate, obtain dry granule; By dry granule, magnesium stearate three-dimensional mixer mix homogeneously, add in the tablet machine loading hopper tabletting; Plain sheet after tabletting is carried out to coating, make Omeprazole Enteric-coated Tablets.
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| CN201310169866.0A CN103479593B (en) | 2013-05-10 | 2013-05-10 | Preparation method for omeprazole enteric coated tablet |
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| CN201310169866.0A CN103479593B (en) | 2013-05-10 | 2013-05-10 | Preparation method for omeprazole enteric coated tablet |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106138000A (en) * | 2016-07-19 | 2016-11-23 | 南京正宽医药科技有限公司 | A kind of Omeprazole Enteric-coated Tablets and preparation method thereof |
| CN113230226A (en) * | 2021-05-28 | 2021-08-10 | 丽珠集团丽珠制药厂 | Tinidazole tablet and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1555256A (en) * | 2001-07-16 | 2004-12-15 | Pharmaceutical formulation comprising a proton pump inhibitor and antacids | |
| WO2006105798A2 (en) * | 2005-07-11 | 2006-10-12 | Nycomed Danmark Aps | Benzimidazole formulation |
-
2013
- 2013-05-10 CN CN201310169866.0A patent/CN103479593B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1555256A (en) * | 2001-07-16 | 2004-12-15 | Pharmaceutical formulation comprising a proton pump inhibitor and antacids | |
| WO2006105798A2 (en) * | 2005-07-11 | 2006-10-12 | Nycomed Danmark Aps | Benzimidazole formulation |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106138000A (en) * | 2016-07-19 | 2016-11-23 | 南京正宽医药科技有限公司 | A kind of Omeprazole Enteric-coated Tablets and preparation method thereof |
| CN113230226A (en) * | 2021-05-28 | 2021-08-10 | 丽珠集团丽珠制药厂 | Tinidazole tablet and preparation method thereof |
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| Publication number | Publication date |
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| CN103479593B (en) | 2014-10-08 |
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Inventor after: Geng Shixia Inventor after: Ni Zhiwei Inventor after: Jiang Jinxiao Inventor after: Yang Shanshan Inventor after: Lu Dafeng Inventor before: Geng Shixia Inventor before: Li Cunfu Inventor before: Ni Zhiwei Inventor before: Jiang Jinxiao Inventor before: Yang Shanshan |
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Address after: 266108, 2 whale Road, Liuting Industrial Park, Chengyang District, Shandong, Qingdao Patentee after: Qingdao Shuangwhale Pharmaceutical Co.,Ltd. Address before: 266108, 2 whale Road, Liuting Industrial Park, Chengyang District, Shandong, Qingdao Patentee before: QINGDAO DOUBLE WHALE PHARMACEUTICAL Co.,Ltd. |
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