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Enalapril maleate tablet and preparation method thereof

A technology of enalapril maleate and Pulee tablets, which is applied in the direction of pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problems of complicated preparation process and increased cost, and achieve simple process, Cost saving and high lubricating effect

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

AI Technical Summary

Problems solved by technology

Though above-mentioned four kinds of methods have strengthened the stability of enalapril maleate tablet to a certain extent, also make preparation technology more complicated, increased cost

Method used

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  • Enalapril maleate tablet and preparation method thereof
  • Enalapril maleate tablet and preparation method thereof
  • Enalapril maleate tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] A kind of enalapril maleate tablet, according to parts by weight, comprises following raw materials:

[0022] 8 parts of enalapril maleate, 5 parts of citric acid, 55 parts of lactose, 3 parts of sodium carboxymethyl starch, 0.2 parts of polyvinylpyrrolidone and 2.8 parts of lubricant, the lubricant is composed of nano silicon dioxide and talc powder mixture.

[0023] Preparation:

[0024] 1) Enalapril maleate and lactose are mixed uniformly in equal increments, passed through a 100-mesh sieve, and set aside;

[0025] 2) mix the powder prepared by step 1) with the sodium carboxymethyl starch of the prescription amount, pass through a 100 mesh sieve, and set aside;

[0026] 3) Mix the powder prepared in step 2) with the prescribed amount of polyvinylpyrrolidone, lubricant, and citric acid, pass through a 100-mesh sieve, and dry the powder into tablets to obtain enalapril maleate tablets agent.

Embodiment 2

[0028] A kind of enalapril maleate tablet, according to parts by weight, comprises following raw materials:

[0029] 4 parts of enalapril maleate, 2 parts of citric acid, 45 parts of lactose, 5 parts of pregelatinized starch, 20 parts of croscarmellose sodium, 2.2 parts of polyvinylpyrrolidone, and 0.2 parts of lubricant, lubricated The agent is a mixture of nano silicon dioxide and talcum powder.

[0030] Preparation:

[0031] 1) Enalapril maleate, pregelatinized starch and lactose are mixed uniformly in equal increments, passed through a 100-mesh sieve, and set aside;

[0032] 2) Mix the powder prepared in step 1) with the croscarmellose sodium of the prescribed amount, pass through a 100-mesh sieve, and set aside;

[0033] 3) Mix the powder prepared in step 2) with the prescribed amount of polyvinylpyrrolidone, lubricant, and citric acid, pass through a 100-mesh sieve, and dry the powder into tablets to obtain enalapril maleate tablets agent.

Embodiment 3

[0035] A kind of enalapril maleate tablet, according to parts by weight, comprises following raw materials:

[0036] 10 parts of enalapril maleate, 8 parts of citric acid, 65 parts of lactose, 24 parts of croscarmellose sodium, 3 parts of polyvinylpyrrolidone and 3 parts of lubricant, the lubricant is nano silicon dioxide and A mixture of talcum powder.

[0037] Preparation:

[0038] 1) Enalapril maleate and lactose are mixed uniformly in equal increments, passed through a 100-mesh sieve, and set aside;

[0039] 2) Mix the powder prepared in step 1) with the croscarmellose sodium of the prescribed amount, pass through a 100-mesh sieve, and set aside;

[0040] 3) Mix the powder prepared in step 2) with the prescribed amount of polyvinylpyrrolidone, lubricant, and citric acid, pass through a 100-mesh sieve, and dry the powder into tablets to obtain enalapril maleate tablets agent.

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Abstract

The invention provides an enalapril maleate tablet and a preparation method thereof. The enalapril maleate tablet comprises the following raw and auxiliary materials in parts by weight: 4-10 parts of enalapril maleate, 2-8 parts of citric acid, 45-65 parts of filler, 0-30 parts of disintegrating agent, 0-2 parts of adhesive and 0.2-3 parts of lubricant, wherein the lubricant is a mixture of nanometer silicon dioxide and talcum powder. The preparation method comprises the following steps: 1) uniformly mixing the enalapril maleate with the filler in the manner of equivalent gradual adding, sieving with a 100-mesh sieve for later use 2) uniformly mixing the power acquired in the step 1) with the prescription amount of disintegrating agent, and sieving with the 100-mesh sieve for later use; and 3) uniformly mixing the powder acquired in the step 2) with the prescription amounts of adhesive, lubricant and citric acid, sieving with the 100-mesh sieve and performing dry powder tabletting on the powder, thereby acquiring the enalapril maleate tablet. The tablet has the advantages of high stability, simple raw and auxiliary materials and high dissolving speed.

Description

technical field [0001] The invention belongs to the technical field of enalapril maleate, in particular to an enalapril maleate tablet and a preparation method thereof. Background technique [0002] Enalapril maleate belongs to angiotensin-converting enzyme inhibitors and is commonly used clinically for the treatment of hypertension, and tablets are its most widely used dosage form. The chemical stability of enalapril maleate itself is better, but because the compatibility with some excipients such as magnesium stearate, microcrystalline cellulose etc. is bad, there is certain problem in the chemical stability of its tablet, in Often degrades to enalaprilat and enalapril diketone during storage. [0003] At this stage, various manufacturers usually use the following four methods to increase the stability of enalapril maleate: ① use chemical reaction to increase the stability. Adding an alkaline substance can convert the carboxyl group of enalapril maleate into a carboxylat...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/12A61K47/04A61K47/02A61K38/05A61P9/12
CPCA61K9/2013A61K9/2009A61K38/05
Inventor 高煜操铖
Owner HUAYI PHARMA ANHUI CO LTD
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