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Atorvastatin calcium medicine composition and preparation method thereof

A technology of atorvastatin calcium and its composition, which is applied in the direction of drug combination, pharmaceutical formula, and active ingredients of heterocyclic compounds, etc. It can solve the problems of increased related substances and poor stability, so as to improve stability, avoid degradation, and prolong the life of the drug. The effect of the validity period

Active Publication Date: 2014-10-01
九瑞健康股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Atorvastatin calcium has poor stability to humidity and heat, and is especially sensitive to temperature. Therefore, there are often defects in which related substances increase significantly during placement. The stability of the current dispersible tablets needs to be further improved.

Method used

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  • Atorvastatin calcium medicine composition and preparation method thereof
  • Atorvastatin calcium medicine composition and preparation method thereof
  • Atorvastatin calcium medicine composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030]

[0031] A total of 1000 dispersible tablets were prepared.

[0032] Preparation:

[0033] 1) First pass the raw and auxiliary materials through a 100-mesh sieve, and then weigh the prescribed amounts of atorvastatin calcium, calcium carbonate, pregelatinized starch, crospovidone, microcrystalline cellulose, and protein sugar, and mix them evenly.

[0034] 2) Prepare povidone into a solution, add it to the mixed material to make a soft material suitable for granulation, and use a 24-mesh screen to granulate.

[0035] 3) Place the prepared wet granules in an oven to dry at about 60°C, control the moisture content of the granules to about 3%, and sieve through a 24-mesh sieve for sizing. Add micronized silica gel, magnesium stearate and sodium lauryl sulfate to the dried granules and mix well.

[0036] 4) Tablets.

Embodiment 2

[0038]

[0039]

[0040] A total of 1000 dispersible tablets were prepared.

[0041] The preparation method is the same as in Example 1.

Embodiment 3

[0043]

[0044] A total of 1000 dispersible tablets were prepared.

[0045] The preparation method is the same as in Example 1.

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PUM

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Abstract

The invention belongs to the technical field of medicine preparations, and in particular to an atorvastatin calcium medicine composition. The dosage form of the composition is particularly dispersible tablet. The composition is characterized by comprising an auxiliary material, namely, calcium carbonate with a stabilization function, and pregelatinized starch in combined utilization, wherein the weight ratio of calcium carbonate to pregelatinized starch and atorvastatin is (2-5):(3-5):1, and preferably 3:3:1; the dispersible tablet further comprises disintegrant, excipient, corrigent, glidant, a lubricant, digestion promoter and an adhesive. The stability experiment shows that the dispersible tablet is good in stability.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to an atorvastatin calcium pharmaceutical composition and a preparation method thereof. The composition is a dispersible tablet. Background technique [0002] Atorvastatin calcium, the English name is Atorvastatin Calcium, this product is a statin blood lipid regulating drug, which is an HMG-CoA reductase inhibitor. It itself is inactive, and the hydrolyzate after oral absorption competitively inhibits the rate-limiting enzyme hydroxymethylglutaryl-CoA reductase in the process of cholesterol synthesis in vivo, reducing the synthesis of cholesterol and increasing the synthesis of low-density lipoprotein receptors , the main site of action is in the liver, resulting in lower blood cholesterol and low-density lipoprotein cholesterol levels, a moderate reduction in serum triglyceride levels and an increase in blood high-density lipoprotein levels, thus preventing and treat...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/40A61K47/36A61K47/04A61P3/06
Inventor 安东
Owner 九瑞健康股份有限公司
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