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Rosuvastatin calcium pharmaceutical composition

A technology of rosuvastatin calcium and composition, applied in the directions of drug combination, metabolic diseases, inorganic inactive ingredients, etc., can solve the problems of accelerated degradation reaction, product quality impact, etc. Enhanced control and cost savings

Inactive Publication Date: 2013-04-03
YAOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The presence of moisture will accelerate the degradation reaction and have a great impact on the quality of the product

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Prescription 1

[0028]

[0029] Preparation Process

[0030] 1. Mix the internally added materials except magnesium stearate evenly (if necessary, use the method of equal volume addition), then add magnesium stearate and mix evenly.

[0031] 2. Add it to the granulator for dry granulation.

[0032] 3. Add microcrystalline cellulose and crospovidone to the granules, and mix well; then add magnesium stearate and mix well.

[0033] 4. Tablet pressing to obtain the desired product.

Embodiment 2

[0035] Prescription 2

[0036]

[0037] Preparation Process

[0038] 1. Mix the internally added materials evenly (if necessary, use the method of equal volume addition).

[0039] 2. Add it to the granulator for dry granulation.

[0040] 3. The particles are added to the external materials and mixed evenly.

[0041] 4. Tablet pressing to obtain the desired product.

Embodiment 3

[0043] Prescription 3

[0044]

[0045] Preparation Process

[0046] 1. Mix the internally added materials except magnesium stearate evenly (if necessary, use the method of equal volume addition), then add sodium stearyl fumarate and mix evenly.

[0047] 2. Add it to the granulator for dry granulation.

[0048] 3. The granules are added to the external materials and mixed evenly.

[0049] 4. Tablet pressing to obtain the desired product.

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PUM

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Abstract

The invention provides a rosuvastatin calcium pharmaceutical composition. The rosuvastatin calcium pharmaceutical composition comprises 1.0 to 10.0% of rosuvastatin calcium, 75 to 97.5% of a low-moisture filler, 0 to 5.0% of a dry binder, 1.0 to 5.0% of a disintegrating agent and 0.5 to 5.0% of a lubricant. Through utilization of the low-moisture filler as an auxiliary material in production, rosuvastatin calcium and other auxiliary materials can be mixed uniformly and the mixture is directly compressed into tablets or is subjected to dry granulation tabletting so that introduction of water in wet granulation is avoided; production energy consumption is reduced; product stability is guaranteed; and a cost is reduced.

Description

technical field [0001] The invention belongs to the field of medicines, and relates to a pharmaceutical composition of rosuvastatin calcium, in particular to a pharmaceutical composition of rosuvastatin calcium containing low-moisture excipients and prepared by dry granulation or direct compression technology substances and their preparation methods. Background technique [0002] Rosuvastatin 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 precursor of cholesterol. Rosuvastatin's primary site of action is the liver—the target organ for lowering cholesterol. Rosuvastatin increases the number of hepatic LDL cell surface receptors, promotes the absorption and catabolism of LDL, and inhibits the hepatic synthesis of VLDL, thereby reducing the total number of VLDL and LDL particles. [0003] The small size of rosuvastatin calcium tablet is 5 mg (calculated as r...

Claims

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Application Information

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IPC IPC(8): A61K31/505A61K47/38A61K47/26A61K47/10A61K47/02A61P3/06
Inventor 江月
Owner YAOPHARMA CO LTD
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