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Stable pravastatin medicament composition and preparation method thereof

A technology of pravastatin and composition, applied in the field of pravastatin pharmaceutical composition and its preparation, capable of solving problems such as gastric mucosal injury, gastric mucosal irritation, damage, etc.

Active Publication Date: 2009-06-24
SUZHOU CHUNGHWA CHEM & PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, alkali metal hydroxides, alkaline earth metal hydroxides, and ammonium hydroxide have strong alkalinity. Even a small amount of dissolution and dispersion will release a large amount of heat locally, and make the local area a strong alkaline environment. Gastric mucosa is highly irritating and can cause damage, especially in patients with gastric mucosal damage

Method used

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  • Stable pravastatin medicament composition and preparation method thereof
  • Stable pravastatin medicament composition and preparation method thereof
  • Stable pravastatin medicament composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Element Weight % (W / W) Pravastatin Sodium 12％ microcrystalline cellulose 48％ Croscarmellose Sodium 33％ meglumine 5％ colloidal silica 0.5％ Magnesium stearate 1.5％

[0039] Preparation:

[0040] a Mix pravastatin sodium, microcrystalline cellulose, 2 / 3 croscarmellose sodium, and meglumine;

[0041] b Mix and homogenize the above mixture in a V-type mixer;

[0042] c The above homogenized mixture is granulated in a dry granulator;

[0043] d Mix the remaining croscarmellose sodium, then add colloidal silicon dioxide and magnesium stearate, mix and homogenize;

[0044] e Compress the above mixture into tablets.

[0045] The product of this example is packaged in aluminum and plastic and placed at room temperature for 24 months, the degradation product is only 0.17%, and the appearance does not change color. The results show that the quality of the prepared samples is stable, and the good quality can still be guaranteed ...

Embodiment 2

[0047] Element Weight % (W / W) Pravastatin Sodium 10％ microcrystalline cellulose 25％ lactose 52％ meglumine 6％ Polyvinylpyrrolidone K30 3％ Cross-linked polyvinylpyrrolidone 3％ Magnesium stearate 1％

[0048] Preparation:

[0049] a Mix pravastatin sodium, microcrystalline cellulose, lactose, and meglumine;

[0050] b Mix and homogenize the above mixture in a V-type mixer;

[0051]c Add polyvinylpyrrolidone K30 and cross-linked polyvinylpyrrolidone to the above V-shaped mixer for mixing, then add magnesium stearate to mix and homogenize;

[0052] d Compress the above mixture into tablets.

[0053] The product of this example is packaged in aluminum and plastic and placed at room temperature for 24 months, the degradation product is only 0.13%, and the appearance does not change color. The results show that the quality of the prepared samples is stable, and the good quality can still be guaranteed after long-term storage. ...

Embodiment 3

[0055] Element Weight % (W / W) Pravastatin 20％ lactose 60.2％ meglumine 20％ Croscarmellose Sodium 3％ silica 0.8％ Magnesium stearate 1％

[0056] The preparation method is the same as in Example 1.

[0057] The product of this example is packaged in aluminum and plastic and placed at room temperature for 24 months, the degradation product is only 0.19%, and no discoloration occurs in appearance. The results show that the quality of the prepared samples is stable, and the good quality can still be guaranteed after long-term storage.

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Abstract

The invention relates to the field of pharmaceutical preparation, in particular to a steady pravastatin medicine composition and a preparation method thereof. The method is characterized in that the stability of the pravastatin medicine composition is remarkably improved by adding a certain amount of meglumine. A high-destructive experiment and long-term storage show that the pravastatin medicine composition has a tiny lactone degradation product.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a stable pravastatin pharmaceutical composition and a preparation method thereof. Background technique [0002] Pravastatin, the chemical name is (+)-(3R,5R)-3,5-dihydroxy-7-[(1S,2S,6S,8S,8Ar)-6-hydroxy-2-methyl-8- [(S)-2-methylbutyloxy]-1,2,6,7,8a-hexahydro-1-naphthyl]heptanoic acid, and pharmaceutically acceptable salts thereof. The specific structural formula is as follows: [0003] [0004] Pravastatin or pravastatin sodium is relatively polarized and hydrophilic. It is sensitive to heat, light and humidity. It is also sensitive to low pH environment, it is very unstable at pH3 or lower conditions, such as in the stomach (pH1. Degradation forms lactone or other isomers, mainly inert 3-α-hydroxy-isopravastatin. Degradation forms the lactone structure as follows: [0005] [0006] This acid instability of pravastatin reduces its bioavailability and leads t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/22A61K47/16A61K31/366
Inventor 李远福廖志勇王衣谷
Owner SUZHOU CHUNGHWA CHEM & PHARMA IND
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