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Rosuvastatin calcium tablet and preparation method thereof

A technology of rosuvastatin calcium and filler, which is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., to avoid high heat, improve stability, and prevent the increase of degradation products. Effect

Active Publication Date: 2019-03-08
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] The applicant dry-granulated rosuvastatin calcium, sodium alginate, maltitol, and part of the filler, and then added the remaining filler, disintegrant, and lubricant to mix and press into tablets; the prescription used sodium alginate and maltose Alcohol is used as a binder to solve the problem of material fluidity caused by direct compression of materials. At the same time, the stability of rosuvastatin calcium tablets can be significantly improved. During long-term storage, sodium alginate and maltitol will form rapidly after the excipients absorb water. Gel, to prevent the increase of rosuvastatin calcium degradation products, but also to ensure a good dissolution rate

Method used

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  • Rosuvastatin calcium tablet and preparation method thereof
  • Rosuvastatin calcium tablet and preparation method thereof
  • Rosuvastatin calcium tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] 1) Prescription

[0043]

[0044] 2) Preparation process

[0045] (1) Mix rosuvastatin calcium, 1 / 2 weight of mannitol, sodium alginate and maltitol evenly, and dry granulate.

[0046] (2) Pass through a 20-mesh sieve after dry granulation, granulate, add remaining mannitol, low-substituted hydroxypropyl cellulose, and crospovidone, and mix well.

[0047] (3) Add magnesium stearate and mix evenly, and the mixed powder is directly compressed into tablets.

[0048] (4) Opadry pink coating.

Embodiment 2

[0050] 1) Prescription

[0051]

[0052]

[0053] 2) Preparation process

[0054] (1) Mix rosuvastatin calcium, 1 / 2 weight of microcrystalline cellulose, sodium alginate and maltitol evenly, and dry granulate.

[0055] (2) Pass through a 20-mesh sieve after dry granulation, granulate, add the remaining microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and crospovidone, and mix well.

[0056] (3) Add silicon dioxide and mix evenly, and the mixed powder is directly compressed into tablets.

[0057] (4) Opadry pink coating.

Embodiment 3

[0059] 1) Prescription

[0060]

[0061] 2) Preparation process

[0062] (1) Mix rosuvastatin calcium, 1 / 2 weight of microcrystalline cellulose, sodium alginate and maltitol evenly, and dry granulate.

[0063] (2) Pass through a 20-mesh sieve after dry granulation, granulate, add the remaining microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and crospovidone, and mix well.

[0064](3) Add silicon dioxide and mix evenly, and the mixed powder is directly compressed into tablets.

[0065] (4) Opadry pink coating.

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PUM

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Abstract

The invention belongs to the technical field of western medicines and particularly provides a rosuvastatin calcium tablet and a preparation method thereof. The tablet is prepared as follows: rosuvastatin calcium, sodium alginate, maltol and part of filler are subjected to dry granulation, sieving and granulation are performed, the rest filler, disintegrating agent and lubricant are added, and uniform mixing and tabletting are performed. The formula process is simple to prepare and good in repeatability, the obtained rosuvastatin calcium tablet has better stability in production and storage processes, has low related substance content, has dissolution up to specification and is suitable for mass production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a rosuvastatin calcium tablet and a preparation method thereof. Background technique [0002] In human blood, the lipids contained in plasma are called blood lipids, including cholesterol, cholesterol lipids, triglycerides, phospholipids, and unlipidated fatty acids. Mainly refers to serum cholesterol and triglycerides. When cholesterol, triglycerides, etc. all exceed normal values, it is collectively referred to as hyperlipidemia. Hyperlipidemia is the main pathogenic factor of atherosclerosis, which often causes serious consequences due to invasion of vital organs, such as coronary heart disease, diabetes, etc. In recent years, the treatment of hyperlipidemia has attracted widespread attention. [0003] Rosuvastatin Calcium (Rosuvastatin Calcium), trade name can be fixed, chemical name: bis-(E)-7-[4-(4-fluorophenyl)0-6-isopropyl-2-[methyl (Met...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K47/26A61K47/36A61K31/505A61P3/06
CPCA61K9/2018A61K9/205A61K9/28A61K31/505A61P3/06
Inventor 郭辉寻明金
Owner LUNAN PHARMA GROUP CORPORATION