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Lansoprazole enteric coated tablet and preparation method thereof
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A technology for lansoprazole intestine and lansoprazole, which is applied in the field of pharmaceutical preparations, can solve problems such as the inability to better improve the dissolution rate of lansoprazole tablets, and achieves controllable product quality, guaranteed stability, and high efficiency. The effect of practical value
Inactive Publication Date: 2012-11-14
陈敏伟 +1
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Abstract
Description
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Problems solved by technology
Although the dissolution rate problem is solved by adding solubilizing agent in the prior art, the dissolution rate of lansoprazole tablet can not be improved better
Method used
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Embodiment 1
[0042] Drugs and excipients (make 100 tablets):
[0043] (1) chip
[0044]Lansoprazole 1.50g
[0045] Heavy Magnesium Carbonate 1.50g
[0046] Microcrystalline Cellulose 1.00g
[0047] Lactose 2.00g
[0048] Croscarmellose Sodium 2.00g
[0049] Sodium carboxymethyl starch 0.50g
[0050] Poloxamer 0.75g
[0051] 5% PVP-K30 (absolute ethanol) 1.40ml
[0052] Magnesium Stearate Appropriate amount
[0053] (2) Isolation coating layer
[0054] Talc powder 3.00g
[0055] Titanium dioxide 9.00g
[0056] 5% PVP (absolute ethanol) 100.00ml
[0057] (3) Enteric coating layer
[0058] Eudraki 60.00g
[0059] PEG60006.00g
[0060] Talc powder 15.00g
[0061] Absolute ethanol 919.00g
[0062] Preparation
[0063] (1) Preparation of tablet core
[0064] Main drug micronization (95% particle diameter is not more than 5 μm) and lactose, microcrystalline cellulose, heavy magnesium carbonate, croscarmellose sodium cross 100 mesh sieves and mix evenly, and poloxamer is dissolve...
Embodiment 3
[0113] Drugs and excipients (make 100 tablets):
[0114] (1) chip
[0115] Lansoprazole 1.5g
[0116] Heavy Magnesium Carbonate 1.5g
[0117] Microcrystalline Cellulose 1.0g
[0118] Lactose 2.5g
[0119] Croscarmellose Sodium 1.5g
[0120] Sodium carboxymethyl starch 0.6g
[0121] Poloxamer 0.75g
[0122] 5% PVP-K30 (absolute ethanol) 1.4ml
[0123] Magnesium Stearate Appropriate amount
[0124] (2) Isolation coating layer
[0125] Talc powder 3.00g
[0126] Titanium dioxide 9.00g
[0127] 5% PVP (absolute ethanol) 100.00ml
[0128] (3) Enteric coating layer
[0129] Eudraki 60.0g
[0130] PEG60006.0g
[0131] Talc powder 15.0g
[0132] Absolute ethanol 919.0g
[0133] Preparation
[0134] (1) Preparation of tablet core
[0135] Main drug micronization (95% particle size is not more than 5 μm) and lactose, microcrystalline cellulose, heavy magnesium carbonate, croscarmellose sodium cross 100 mesh sieve and mix evenly, the poloxamer of prescription amount Diss...
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Abstract
The invention relates to the field of medical preparations, in particular to a Lansoprazole enteric coated tablet and a preparation method thereof. The Lansoprazole enteric coated tablet of the invention comprises the following components from inside to outside: a. a tablet core composed of Lansoprazole and pharmaceutical excipients; b. an intermediate isolated layer composed of opacifier and lubricating agent; and c, an enteric coated layer composed of methacrylic acid copolymer and medicinally pharmaceutical excipients. The Lansoprazole enteric coated tablet is characterized in that the tablet core is prepared by the following steps: granulating the Lansoprazole, diluent, solubilizer, alkaline stabilizing agent and disintegrating agent; adding disintegrating agent again; and pressing. The Lansoprazole enteric coated tablet of the invention has the advantages of simple preparation process, low equipment requirement, large production quantity, controllable product quality, rapid medicine dissolution rate, good repeatability and stability, and suitability for industrial large-scale product.
Description
technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a lansoprazole enteric-coated tablet and a preparation method thereof. Background technique [0002] Lansoprazole (Lansoprazole) is a new generation of proton pump inhibitors developed after omeprazole. It is an upgraded product of omeprazole. Lansoprazole is a substituted benzimidazole compound that introduces fluorine into the side chain. Its bioavailability has increased by more than 30% compared with omeprazole, and it has become a new generation of anti-ulcer drugs. Body antagonists, especially for refractory ulcers and collagenous ulcers that are ineffective in the latter treatment. Since the drug targets the two causes of ulcers-acid secretion hyperactivity and infection, the treatment of ulcers is relatively rapid and effective, and the recurrence rate is low. Clinically, it is widely used in the treatment of duodenal ulcer, gastric ulcer, reflux esophagitis, ...
Claims
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Application Information
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