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Rosuvastatin calcium pharmaceutical preparation

A technology for rosuvastatin calcium and pharmaceutical preparations, applied in the field of rosuvastatin calcium pharmaceutical preparations, can solve the problems of poor stability of rosuvastatin calcium, low dissolution rate of preparations, and poor dissolution effect

Pending Publication Date: 2021-01-29
BEIJING WINSUNNY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The invention provides a pharmaceutical preparation of rosuvastatin calcium, which aims to overcome the problems of poor stability and poor dissolution effect of rosuvastatin calcium
[0010] Rosuvastatin calcium is unstable in high-temperature or high-humidity environments, and it is easy to degrade to form impurities (3R, 5S) lactone degradation products and oxidation products. At the same time, rosuvastatin calcium also has the problems of poor water solubility and low dissolution rate of preparations. Thus affecting the production, storage and quality control of rosuvastatin calcium preparations
The present invention adopts the method of adding triethanolamine auxiliary material into the rosuvastatin calcium pharmaceutical preparation to solve the above-mentioned problems of poor stability and dissolution rate

Method used

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  • Rosuvastatin calcium pharmaceutical preparation
  • Rosuvastatin calcium pharmaceutical preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032]

[0033] Preparation:

[0034] (1) Mix rosuvastatin calcium, microcrystalline cellulose, lactose, povidone and crospovidone evenly;

[0035] (2) Add triethanolamine to step (1) and mix evenly to obtain a mixture;

[0036] (3) wet granulating the mixture in step (2), drying and sizing to obtain drug granules;

[0037] (4) Compress the drug granules into tablets.

Embodiment 2

[0039]

[0040] Preparation:

[0041] (1) Mix rosuvastatin calcium, microcrystalline cellulose, lactose, povidone and crospovidone evenly;

[0042] (2) Add triethanolamine to step (1) and mix evenly to obtain a mixture;

[0043] (3) wet granulating the mixture in step (2), drying and sizing to obtain drug granules;

[0044] (4) Compress the drug granules into tablets.

Embodiment 3

[0046]

[0047] Preparation:

[0048] (1) Mix rosuvastatin calcium, microcrystalline cellulose, lactose, povidone and crospovidone evenly;

[0049] (2) Add triethanolamine to step (1) and mix evenly to obtain a mixture;

[0050] (3) wet granulating the mixture in step (2), drying and sizing to obtain drug granules;

[0051] (4) Compress the drug granules into tablets.

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Abstract

The invention relates to a rosuvastatin calcium pharmaceutical preparation. The rosuvastatin calcium pharmaceutical preparation comprises rosuvastatin calcium, triethanolamine and pharmaceutically acceptable auxiliary materials. The auxiliary material triethanolamine in the medicinal preparation can provide an alkaline environment for the rosuvastatin calcium and increase the dissolution release of the rosuvastatin calcium, so the problems of poor stability and poor dissolution effect of the rosuvastatin calcium are solved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a pharmaceutical preparation of rosuvastatin calcium and a preparation method of the pharmaceutical preparation. Background technique [0002] Rosuvastatin calcium is used for the treatment of hypercholesterolemia, jointly developed by Shionogi Pharmaceutical and AstraZeneca. In August 2003, Rosuvastatin Calcium Tablets produced by AstraZeneca went on the market in the United States. In January 2005, Rosuvastatin Calcium Tablets produced by Shionogi Pharmaceutical Co., Ltd. went on the market in Japan. Rosuvastatin calcium is a selective HMG-CoA reductase inhibitor. HMG-CoA reductase inhibitors are the rate-limiting enzymes that convert 3-hydroxy-3-methylglutaryl-CoA to mevalonate. The main site of action of rosuvastatin calcium is the liver, which increases the number of hepatic LDL cell surface receptors, promotes the absorption and catabolism of LDL, i...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/18A61K31/505A61P3/06
CPCA61K9/2013A61K31/505A61P3/06
Inventor 邹文娟傅远鹏耿玉先产运霞
Owner BEIJING WINSUNNY PHARMA CO LTD
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