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Capsule containing rosuvastatin calcium

A technology for rosuvastatin calcium and capsules, which is applied in the field of capsules containing rosuvastatin calcium, and can solve problems such as low dissolution rate, high technical requirements, and increased impurity content

Active Publication Date: 2015-04-22
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Rosuvastatin calcium is easily degraded in high temperature, high humidity, light and acidic environment, and produces impurities such as lactone products, oxidation products, and light products. Influenced by factors such as temperature, oxygen, etc., the impurity content increases, the dissolution rate is low, and it cannot play its due role.
In addition, the preparation and production process is complex and requires high technology, which is also one of the factors that limit the clinical application and industrial production of such drugs

Method used

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  • Capsule containing rosuvastatin calcium
  • Capsule containing rosuvastatin calcium
  • Capsule containing rosuvastatin calcium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] To prepare a prescription for 1000 capsules:

[0032]

[0033] Preparation Process:

[0034] (1) The rosuvastatin calcium of 5.0g is pulverized and crossed an 80 mesh sieve, for subsequent use;

[0035] (2) 30.0 g of dipotassium hydrogen phosphate, 4.0 g of low-substituted hydroxypropyl cellulose, and 60.0 g of sorbitol were pulverized through a 60-mesh sieve, and set aside;

[0036] (3) Get 10g of sodium carboxymethylcellulose and add it to 200ml of 5% ethanol solution, stir until completely dissolved, and set aside;

[0037] (4) Mix the materials in step (1) and (2) evenly, add 60ml of ethanol mixed solution in step (3) to make soft material, pass through 18 mesh sieve to granulate, boil and dry at 50°C, add 3.0g stearyl palmitate Mix the acid esters evenly, sieve through a 16-mesh sieve to obtain dry granules, and set aside;

[0038] (5) Filling the dried granules in step (4) into the capsule shell to prepare rosuvastatin calcium capsules.

Embodiment 2

[0040] To prepare a prescription for 1000 capsules:

[0041]

[0042]

[0043] Preparation process: adopt the preparation method of embodiment 1.

Embodiment 3

[0045] To prepare a prescription for 1000 capsules:

[0046]

[0047] Preparation process: adopt the preparation method of embodiment 1.

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Abstract

The invention belongs to the field of medicine preparations and particularly relates to a capsule containing rosuvastatin calcium and a preparation method thereof. The capsule consists of rosuvastatin calcium, basic potassium phosphate and other pharmaceutical materials, so that the interferences of factors such as light and temperature can be effectively avoided, and the capsule is convenient to carry; the basic potassium phosphate is added into a preparation process of the capsule containing rosuvastatin calcium, so that a basic environment is provided for the rosuvastatin calcium, the stability and the dissolution rate of rosuvastatin calcium are increased; the preparation method of the capsule is simple and easy to operate, good in reproducibility and suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a capsule containing rosuvastatin calcium. Background technique [0002] In recent years, with the development of society and the change of living environment, people pay more and more attention to cardiovascular disease. According to the statistics of the World Health Organization, nearly 13 million people died of cardiovascular and coronary artery diseases in 2011. The mortality rate of cardiovascular and cerebrovascular diseases in my country's urban population was 200 / 100,000, and that in rural areas was 142 / 100,000, accounting for approximately Death constitutes 37% and 28%, ranking first in the cause of death. [0003] Rosuvastatin Calcium (Rosuvastatin Calcium), chemical name: bis-[E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl) Amino]-pyrimidin-5-yl](3R,5R)-3,5-dihydroxyhept-6-enoic acid] calcium salt (2:1). It is a selective and competitive HMG...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/505A61K47/02A61P9/10A61P3/06
Inventor 张贵民杨本官郝贵周
Owner SHANDONG NEWTIME PHARMA
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