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Stable enalapril maleate tablet and preparation method thereof

A technology of enalapril maleate and prilin tablets, which is applied in the directions of pill delivery, cardiovascular system diseases, inorganic inactive ingredients, etc., to achieve the effects of fast degradation, improved stability, and solved the problem of photosensitivity

Inactive Publication Date: 2017-07-21
HUAYI PHARMA ANHUI CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The invention provides a stable enalapril maleate tablet and a preparation method thereof, which solves the storage stability problem of the existing enalapril maleate tablet

Method used

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  • Stable enalapril maleate tablet and preparation method thereof
  • Stable enalapril maleate tablet and preparation method thereof
  • Stable enalapril maleate tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] This embodiment provides a stable enalapril maleate tablet, which is characterized in that it is made from the following components in parts by weight: 0.51 kg of enalapril maleate, 8 kg of lactose, 1.2 kg of corn starch, Glyceryl distearate 0.2kg, lake 0.15kg.

[0024] The preparation method of above-mentioned enalapril maleate tablet, comprises the following steps:

[0025] (1) take by weighing enalapril maleate, lactose, cornstarch, glyceryl distearate, color lake or iron oxide by recipe quantity, cross 100 mesh sieves respectively, for subsequent use;

[0026] (2) Take enalapril maleate, lactose and 85% corn starch and mix them evenly to obtain a mixed material; in addition, take the remaining corn starch and add an appropriate amount of water to make a binder slurry by a pulping method. The agent slurry is added to the mixed material, and wet granulation is carried out;

[0027] (3) granulate the wet granules, dry under reduced pressure, lose weight on drying 1.5...

Embodiment 2

[0030] The present embodiment provides a stable enalapril maleate tablet, which is characterized in that it is made from the following components in parts by weight: 051 kg of enalapril maleate, 7 kg of lactose, 1.8 kg of corn starch, 2 Glyceryl stearate 0.1kg, iron oxide 0.2kg.

[0031] The preparation method of above-mentioned enalapril maleate tablet, comprises the following steps:

[0032] (1) take by weighing enalapril maleate, lactose, cornstarch, glyceryl distearate, color lake or iron oxide by recipe quantity, cross 100 mesh sieves respectively, for subsequent use;

[0033] (2) get enalapril maleate, lactose and 80% cornstarch and mix them evenly to obtain a mixed material; in addition, get the remaining cornstarch and add an appropriate amount of water to make a binder slurry by the boiling method. The agent slurry is added to the mixed material, and wet granulation is carried out;

[0034] (3) granulate the wet granules, dry under reduced pressure, lose weight on d...

Embodiment 3

[0037] The present embodiment provides a stable enalapril maleate tablet, which is characterized in that it is made from the following components in parts by weight: 0.51 kg of enalapril maleate, 9 kg of lactose, 0.6 kg of corn starch, Glyceryl distearate 0.3kg, lake 0.1kg.

[0038] The preparation method of above-mentioned enalapril maleate tablet, comprises the following steps:

[0039] (1) take by weighing enalapril maleate, lactose, cornstarch, glyceryl distearate, color lake or iron oxide by recipe quantity, cross 100 mesh sieves respectively, for subsequent use;

[0040] (2) Take enalapril maleate, lactose and 90% cornstarch and mix them evenly to obtain a mixed material; in addition, take the remaining cornstarch and add an appropriate amount of water to make a binder slurry by a pulping method. The agent slurry is added to the mixed material, and wet granulation is carried out;

[0041] (3) granulate the wet granules, dry under reduced pressure, lose weight on drying...

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Abstract

The invention discloses a stable enalapril maleate tablet and a preparation method thereof, and belongs to the technical field of the pharmaceutic preparation. The enalapril maleate tablet is prepared by the following components by weight: 0.255-1.02 parts of enalapril maleate, 7-9 parts of lactose, 0.6-1.8 parts of corn starch, 0.1-0.3 parts of glycerol distearate, and 0.1-0.2 parts of lake or ferric oxide. The selected accessories and the preparation technology are capable of remarkably reducing the degrading speed of the enalapril maleate through the mutual synergistic effect, greatly improving the stability of the enalapril maleate tablet product, and solving the quality problem existing in the current product all the time. The lake or ferric oxide is added in the tablet for the good shading function, so the enalapril maleate photosensitivity problem can be effectively solved.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a stable enalapril maleate tablet and a preparation method thereof. Background technique [0002] Enalapril maleate, the chemical name is N~[(S)~1~(ethoxycarbonyl)~3~phenylpropyl]~L~alanyl~L~proline maleate . [0003] Enalapril maleate is the second marketed angiotensin-converting enzyme inhibitor drug after captopril, which is rapidly hydrolyzed to active diacid metabolism in the liver after oral administration as a prodrug Enalapril exerts its effect as an angiotensin-converting enzyme inhibitor, so that angiotensin I cannot be converted into angiotensin II, thereby causing systemic vasodilation, ultimately reducing blood pressure, and can be effectively treated Congestive heart failure, has obvious antihypertensive effect on Ⅱ renal hypertension, Ⅰ renal hypertension and spontaneous hypertension rat models; because it does not contain sulfhydryl, patients...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/40A61K47/02A61P9/12
CPCA61K9/2009A61K31/40
Inventor 高煜操铖
Owner HUAYI PHARMA ANHUI CO LTD
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