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Pharmaceutical composition containing a statin in the form of a zinc salt

A composition and medicine technology, applied in the field of medicine, can solve the problems of poor stability, high production cost, complicated calcium salt production process and the like

Inactive Publication Date: 2011-12-28
FUKANGREN BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the poor stability of amorphous rosuvastatin, currently marketed rosuvastatin exists in the form of calcium salt, but the production process of rosuvastatin calcium salt is relatively complicated and the production cost is relatively high

Method used

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  • Pharmaceutical composition containing a statin in the form of a zinc salt
  • Pharmaceutical composition containing a statin in the form of a zinc salt
  • Pharmaceutical composition containing a statin in the form of a zinc salt

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0009] Example 1 Compound Rosuvastatin Zinc Amlodipine Besylate Tablets

[0010]

[0011]

[0012] Preparation:

[0013] 1. Add the prescribed amount of Tween 80 to purified water at 50°C, stir well to dissolve, add hydroxypropyl cellulose to hydrate it, and form a binder.

[0014] 2. The prescribed amount of rosuvastatin zinc, calcium carbonate, microcrystalline cellulose, starch 1500, and croscarmellose sodium are fully mixed uniformly by equal amount addition method.

[0015] 3. Add the binder soft material obtained in step 1 to the mixed powder obtained in step 2, and granulate with an 18-mesh sieve.

[0016] 4. Dry the granules obtained in step 3, and control the moisture content to be no more than 2.0%.

[0017] 5. Add levamlodipine besylate, microcrystalline cellulose, croscarmellose sodium, and silicon dioxide to the granules obtained in step 4 and mix well. Pass through a 24-mesh sieve for granulation.

[0018] 6. Add magnesium stearate to the mixed granules...

Embodiment 2

[0019] Example 2 Compound Atorvastatin Zinc Amlodipine Besylate Capsules

[0020]

[0021]

[0022] Preparation:

[0023] 1. Add the prescribed amount of Tween 80 to purified water at 50°C, stir well to dissolve, add hydroxypropyl cellulose to hydrate it, and form a binder.

[0024] 2. Fully mix the prescribed amount of atorvastatin zinc, calcium carbonate, pregelatinized starch, starch 1500, and sodium carboxymethyl starch by equal addition method.

[0025] 3. Add the binder soft material obtained in step 1 to the mixed powder obtained in step 2, and granulate with an 18-mesh sieve.

[0026] 4. Dry the granules obtained in step 3, and control the moisture content to be no more than 2.0%.

[0027] 5. Add amlodipine besylate, pregelatinized starch, sodium carboxymethyl starch, and silicon dioxide to the granules obtained in step 4 and mix well. Pass through a 24-mesh sieve for granulation.

[0028] 6. Add magnesium stearate to the mixed granules obtained in step 5, mi...

Embodiment 3

[0029] Example 3 Compound Rosuvastatin Zinc Nilvadipine Dispersible Tablets

[0030]

[0031]

[0032] Preparation:

[0033] First crush the raw materials through a 100-mesh sieve, fully mix the raw material drug, microcrystalline cellulose, and hydroxypropyl cellulose, add an appropriate amount of water-based soft material, granulate with a 18-mesh sieve, and dry at 60°C for 3-4 hours. Sieve through a 24-mesh sieve, add disintegrants croscarmellose sodium, aspartame, silicon dioxide, and magnesium stearate, mix well, and press into dispersible tablets.

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Abstract

The present invention relates to a pharmaceutical composition containing a statin in the form of a zinc salt. It is an oral preparation made of zinc salts of statins and a calcium ion antagonist as the active pharmaceutical ingredients and pharmaceutically acceptable pharmaceutical excipients, including granules, ordinary tablets, chewable tablets, dispersible tablets, Orally disintegrating tablets, buccal tablets, capsules, dropping pills, sustained-release tablets, etc. As a new preparation for the treatment and prevention of various hypertension and hyperlipidemia, the preparation is widely used clinically.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing statins in the form of zinc salt, belonging to the technical field of medicine. Background technique [0002] Amlodipine is a new generation of long-acting, basic dihydropyridine calcium channel antagonists, and is a representative of the third generation of calcium antagonists. Like other dihydropyridine-type calcium channel antagonists, it acts through a site (N site) linked to dihydropyridine on the cell, affecting the properties of calcium channels. Its advantages are slow onset, long duration of action, convenient administration and few side effects. Due to its unique structure and pharmacological properties, it has been widely used in the treatment of hypertension and angina pectoris. The activity of levamlodipine is 1000 times that of the dextro-amlodipine and twice that of the racemic form, and it has also been used clinically. Currently marketed amlodipine or its isomers are a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/06A61K31/4422A61K31/505A61K31/47A61P9/12A61P3/06A61K31/40A61K31/366A61K31/22A61K31/405
Inventor 不公告发明人
Owner FUKANGREN BIO PHARMA
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