Composition containing pravastatin calcium as well as preparation method and application thereof

A technology of pitavastatin calcium and a composition is applied in the field of a composition containing pitavastatin calcium and its preparation field, which can solve the problems of rareness, rational combination of pitavastatin calcium and health-care drugs and no relevant reports, etc. therapeutic effect

Inactive Publication Date: 2013-01-23
FUZHOU NEPTUNUS FUYAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the common tablet of pitavastatin calcium is mainly used clinically, and the compound preparation made by the combination of complementary advantages has been published in the open patent, but it is still relatively rare in clinical practice; pitavastatin calcium and health care drugs The reasonable combination of has not been reported in the existing literature

Method used

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  • Composition containing pravastatin calcium as well as preparation method and application thereof
  • Composition containing pravastatin calcium as well as preparation method and application thereof
  • Composition containing pravastatin calcium as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] A coated tablet composed of pitavastatin calcium and amino acid comprises a tablet core and a coating. Wherein the components of the tablet core include by weight parts: pitavastatin calcium 10g, L-arginine 2057g, taurine 614g, L-citrulline 527g, vitamin E 112g, lactose 712g, microcrystalline cellulose 518g, Low-substituted hydroxypropyl cellulose 323g, crospovidone 80g, 8% povidone-K30 95% ethanol solution 350g (povidone-K30 is dissolved in the solution that forms in 95%w / w ethanol, its weight hundred content of 8%), micronized silica gel 19.5g, magnesium stearate 21.2g, Opadry Y-1-7000 150.1g.

[0029] Implementation steps:

[0030] (1) The prescribed amount of pitavastatin calcium, L-arginine, taurine, L-citrulline, vitamin E, lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and cross-linked polyvinyl chloride Ketone, micropowder silica gel, and magnesium stearate are dried at 60°C, and the moisture content is ≤2.0% by weight;

[0031]...

Embodiment 2

[0039] A coated tablet composed of pitavastatin calcium and amino acid comprises a tablet core and a coating. Wherein each component of the tablet core includes by weight: (prepared each coated tablet containing pitavastatin calcium 1mg)

[0040] Pitavastatin calcium 10g, L-arginine 2532g, taurine 716g, L-citrulline 705g, vitamin E 154g, lactose 821g, microcrystalline cellulose 704g, low-substituted hydroxypropyl cellulose 353g, cross-linked polymer Povidone 80g, 8% povidone-K30 95% ethanol solution 350g (Povidone-K30 is dissolved in 95%w / w ethanol to form a solution, its weight percentage is 8%), micropowder silica gel 25g, hard Magnesium fatty acid 25g, Opadry Y-1-7000 185.4g.

[0041] Implementation steps: with embodiment 1.

Embodiment 3

[0043] A coated tablet composed of pitavastatin calcium and amino acid comprises a tablet core and a coating. Wherein each component of the tablet core includes by weight: (prepared each coated tablet containing pitavastatin calcium 1mg)

[0044] Pitavastatin calcium 10g, L-arginine 1800g, taurine 530g, L-citrulline 450g, vitamin E 86g, lactose 508g, microcrystalline cellulose 527g, low-substituted hydroxypropyl cellulose 292g, cross-linked polymer Povidone 80g, 8% povidone-K30 95% ethanol solution 350g (Povidone-K30 is dissolved in 95%w / w ethanol to form a solution, its weight percentage is 8%), micropowder silica gel 23g, hard Magnesium fatty acid 18g, Opadry Y-1-7000 128g

[0045] Implementation steps: with embodiment 1.

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Abstract

The invention discloses a composition containing pravastatin calcium as well as a preparation method and application thereof. The composition contains the following components in parts by weight: 1 part of pravastatin calcium, 110-300 parts of L-arginine, 30-90 parts of taurine, 20-80 parts of L-citrulline and 5-20 parts of vitamin E. When made into oral tablets or hard capsules, the composition meets the requirement of pharmaceutical stability, the therapeutic action of the composition on hyperlipidemia is improved, and the composition has remarkable economic and social benefits.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a composition containing pitavastatin calcium, a preparation method and application thereof. Background technique [0002] Cardiovascular disease is an increasingly serious threat to human health, and it is showing a clear upward trend. In particular, the incidence of hyperlipidemia and hypercholesterolemia in middle-aged and elderly people has increased year by year, and has become the number one killer of human death. [0003] Pitavastatin Calcium (Pitavastatin Calcium) is the first fully synthetic HMG-CoA reductase inhibitor developed by Nissan Chemical Co. It was approved for listing in Japan for the first time. According to the results of the existing clinical trials and the comparison with similar foreign products already on the market, its lipid-lowering effect is very good, and it is the most powerful lipid-lowering drug so far. Pitavastatin calciu...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/47A61K31/4709A61K47/18A61P3/06
Inventor 俞宁
Owner FUZHOU NEPTUNUS FUYAO PHARMA
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