Pantoprazole sodium enteric tablet and preparation method thereof

A technology for pantoprazole sodium tablet and pantoprazole sodium, which is applied in directions such as pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, can solve problems such as sticking and flushing, and overcome the Sticky, stable quality, one-sided bright and neat effect

Inactive Publication Date: 2009-06-24
YAOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The invention provides a pantoprazole sodium enteric-coated tablet which solves the technical problem of sticking and punching when pressing the existing pantoprazole sodium enteric-coated tablet, and provides a method for preparing the enteric-coated tablet

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Tablets:

[0020] Pantoprazole Sodium 42.3mg

[0021] Mannitol 106.0mg

[0022] Sodium carbonate 10.0mg

[0023] Povidone (PVP K30) 2.0mg

[0024] Crospovidone 10.6mg

[0025] Magnesium stearate 0.7mg

[0026] Silica 3.3mg

[0027] Talc powder 3.3mg

[0028] Prepare a suitable adhesive with povidone and a part of sodium carbonate, mannitol and water. The remaining mannitol, sodium carbonate, pantoprazole sodium, and a part of crospovidone are mixed evenly. Then add binder, stir and mix to make soft material, pass through 16 mesh sieve and granulate. After the soft granules are dried, they are sieved through a 16-mesh sieve. Mix the remaining crospovidone, magnesium stearate, silicon dioxide, and talc with the dry granules, and press into tablets. A plain sheet with a certain hardness and bright surface is obtained.

[0029] Isolation layer:

[0030] (1) Alkaline isolation layer

[0031] Hypromellose 4.3mg

[0032] Talc 1.6mg

[0033] Macrogol 6000 1.1mg ...

Embodiment 2

[0048] Tablets:

[0049] Pantoprazole Sodium 42.3mg

[0050] Mannitol 106.0mg

[0051] Sodium carbonate 10.0mg

[0052]Povidone (PVP K30) 2.0mg

[0053] Crospovidone 10.6mg

[0054] Magnesium stearate 0.7mg

[0055] Silicon dioxide 0.85mg

[0056] Talc powder 0.85mg

[0057] Prepare a suitable adhesive with povidone and a part of sodium carbonate, mannitol and water. The remaining mannitol, sodium carbonate, pantoprazole sodium, and a part of crospovidone are mixed evenly. Then add binder, stir and mix to make soft material, pass through 16 mesh sieve and granulate. After the soft granules are dried, they are sieved through a 16-mesh sieve. Mix the remaining crospovidone, magnesium stearate, silicon dioxide, and talc with the dry granules, and press into tablets. A plain sheet with a certain hardness and bright surface is obtained.

[0058] Isolation layer:

[0059] Hypromellose 6.3mg

[0060] Talc 2.4mg

[0061] Macrogol 6000 1.6mg

[0062] Titanium dioxide 0.1...

Embodiment 3

[0071] Tablets:

[0072] Pantoprazole Sodium 42.3mg

[0073] Mannitol 106.0mg

[0074] Sodium carbonate 10.0mg

[0075] Povidone (PVP K30) 2.0mg

[0076] Crospovidone 10.6mg

[0077] Magnesium stearate 0.7mg

[0078] Silica 8.5mg

[0079] Talc 8.5mg

[0080] Prepare a suitable adhesive with povidone and a part of sodium carbonate, mannitol and water. The remaining mannitol, sodium carbonate, pantoprazole sodium, and a part of crospovidone are mixed evenly. Then add binder, stir and mix to make soft material, pass through 16 mesh sieve and granulate. After the soft granules are dried, they are sieved through a 16-mesh sieve. Mix the remaining crospovidone, magnesium stearate, silicon dioxide, and talc with the dry granules, and press into tablets. A plain sheet with a certain hardness and bright surface is obtained.

[0081] Isolation layer:

[0082] Hypromellose 6.6mg

[0083] Talc 2.4mg

[0084] Macrogol 6000 1.5mg

[0085] Titanium dioxide 0.12mg

[0086] Dis...

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PUM

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Abstract

The invention relates to a pantoprazole sodium enteric-coated tablet and a preparation method thereof. The enteric-coated tablet is prepared by a pantoprazole sodium plain tablet which is coated with an insulating layer and an enteric coating layer, and the pantoprazole sodium plain tablet contains 0.5 to 5 percent of silicon dioxide and 0.5 to 5 percent of talcum powder. The method solves the tablet pressing problem of extremely easy sticking during the pressing of the pantoprazole sodium plain tablet.

Description

technical field [0001] The invention relates to a pantoprazole sodium enteric-coated tablet and a preparation method thereof. Background technique [0002] Pantoprazole sodium is a H+ / K+ATPase inhibitor listed after omeprazole and lansoprazole. Its indications are gastric ulcer, duodenal ulcer, and moderate to severe reflux esophagitis. The combined use of clarithromycin, amoxicillin or metronidazole can eradicate the Helicobacter pylori infection, so as to reduce the recurrence of duodenal ulcer and gastric ulcer caused by the microbial infection. Pantoprazole was first successfully developed by Germany's BykGulden pharmaceutical company, and was first listed in Switzerland in 1994 under the trade name "Pantoloc". As soon as the drug was launched on the market, it was favored by clinicians from all over the world because of its good curative effect and excellent safety. [0003] At present, pantoprazole sodium raw materials, pantoprazole sodium enteric-coated tablets, pan...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439A61K9/28A61K47/38A61P1/04
Inventor 龙泉
Owner YAOPHARMA CO LTD
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