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Ipragliflozin L-proline tablet composition

A technology of ‐proline tablet and ‐proline, which is applied in drug combination, pill delivery, metabolic diseases, etc., can solve problems affecting drug safety and achieve stable performance

Inactive Publication Date: 2018-03-20
WEIHAI GUANBIAO INFORMATION TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The test found that during the storage of the Ipagliflozin composition prepared by the prior art, as time went on, the related substances showed an upward trend, which affected the safety of the drug.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Embodiment 1, Ipagliflozin L-proline 25g, chitosan 12g, calcium hydrogen phosphate 8g, microcrystalline cellulose 50g, povidone K30 3g, micropowder silica gel 8g, magnesium stearate 0.8g, according to technology The preparation method described in the protocol prepared 1000 tablets.

Embodiment 2

[0022] Embodiment 2, Ipagliflozin L-proline 50g, chitosan 18g, calcium hydrogen phosphate 16g, microcrystalline cellulose 28g, povidone K30 10g, micropowder silica gel 16g, magnesium stearate 2g, according to the technical scheme The preparation method prepares 1000 tablets.

Embodiment 3

[0023] Embodiment 3, Ipagliflozin L-proline 25g, chitosan 14g, calcium hydrogen phosphate 10g, microcrystalline cellulose 45g, povidone K30 6g, micropowder silica gel 12g, magnesium stearate 1g, according to the technical scheme The preparation method prepares 1000 tablets.

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PUM

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Abstract

The invention relates to an iglitazone composition, which belongs to the technical field of pharmaceutical preparations. The technical scheme of the present invention is: an Ipagliflozin L-proline tablet composition, the unit dose tablet contains 25-50 mg of Ipagliflozin L-proline, 12-18 mg of chitosan , calcium hydrogen phosphate 8-16mg, microcrystalline cellulose 28-50mg, povidone K30 3-10mg, micropowder silica gel 8-16mg, magnesium stearate 0.8-2mg. The technical solution of the present invention provides a stable Ipagliflozin tablet.

Description

technical field [0001] The invention relates to an ipagliflozin composition and belongs to the technical field of pharmaceutical preparations. Background technique [0002] Ipagliflozin, whose English name is ipragliflozin, was approved for marketing in Japan in January 2014. There are 25mg and 50mg specifications. The original research company is Astellas Japan. It is a selective sodium / sodium-glucose transporter 2 (SGLT2) inhibitor that inhibits glucose reuptake by selectively inhibiting SGLT2, thereby lowering blood sugar. A Phase III pivotal trial of Ipagliflozin monotherapy and multiple clinical studies of the drug in combination with other hypoglycemic drugs supported the approval of this product in Japan. This medicine is made and sold by Astellas Corporation. [0003] The test found that during the storage of the ipagliflozin composition prepared by the prior art, as time goes by, the related substances tend to increase, which affects the safety of the drug. Co...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/381A61K47/36A61K47/02A61P3/10
CPCA61K9/205A61K9/2009A61K31/381
Inventor 孙爱梅
Owner WEIHAI GUANBIAO INFORMATION TECH