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Enalapril maleate tablet composition and its preparation and use

A technology of enalapril maleate and composition, which is applied in the direction of drug combination, medical preparation of non-active ingredients, pill delivery, etc., and can solve problems such as selection range and application value limitation

Active Publication Date: 2014-02-26
广东彼迪药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But generally speaking, only maleic acid can be selected in the prior art, and its selection range and application value are greatly limited; because different organic acids have different physical and chemical properties, the applicable occasions are also different. Therefore, it is necessary to further study the application of organic acids in the formulation of stable enalapril maleate tablets to expand its application range

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Tablets are prepared according to the following prescription:

[0026] Enalapril Maleate 1000g

[0027] Tartaric acid 1000g

[0028] Lactose 7000g

[0029] Low-substituted hydroxypropyl cellulose 1500g

[0030] Magnesium stearate 50g

[0031] 5% starch slurry (mass volume ratio g / ml) 1300g

[0032] Made into 100,000 pieces

[0033] Preparation method: first prepare 5% starch slurry, then mix enalapril maleate, tartaric acid, lactose, and low-substituted hydroxypropyl cellulose according to the prescription amount, and add 5% starch slurry to make a soft material. Make granules with a 20-mesh sieve, dry in an oven at 60°C, control the residual moisture below 3%, add the prescribed amount of magnesium stearate, mix well, and compress into tablets.

[0034] The test result obtained by the drug stability research method is: compared with before heating, the content of enalapril maleate remains above 99% after heating at 60° C. for 10 days.

Embodiment 2

[0036] Tablets are prepared according to the following prescription:

[0037] Enalapril Maleate 1000g

[0038] Malic acid 100g

[0039] Lactose 3000g

[0040] Microcrystalline Cellulose 4500g

[0041] Croscarmellose Sodium 1000g

[0042] Magnesium stearate 50g

[0043] 5% aqueous solution of hydroxypropyl methylcellulose (HPMC) (mass volume ratio g / ml) 1500ml

[0044] Made into 100,000 pieces

[0045] Preparation method: first prepare 5% HPMC aqueous solution, then mix enalapril maleate, malic acid, lactose, microcrystalline cellulose, and croscarmellose sodium according to the prescription amount, and add 5% HPMC in the prescription amount The aqueous solution is made into a soft material, passed through a 20-mesh sieve to make granules, dried in an oven at 60°C, and the residual moisture is controlled below 3%, and the prescribed amount of magnesium stearate is added, mixed evenly, and pressed into tablets.

[0046] The test result obtained by the drug stability resea...

Embodiment 3

[0048] Tablets are prepared according to the following prescription:

[0049] Enalapril Maleate 1000g

[0050] Malic acid 300g

[0051] Starch 5000g

[0052] Dextrin 2500g

[0053] Sodium carboxymethyl starch 500g

[0054] Talc powder 300g

[0055] Micropowder silica gel 50g

[0056] 10% povidone aqueous solution (mass volume ratio g / ml) 1100ml

[0057] Made into 100,000 pieces

[0058] Preparation method: first prepare 10% water povidone solution, then mix enalapril maleate, malic acid, starch, dextrin, and carboxymethyl starch sodium evenly according to the prescription amount, and add 10% povidone in the prescription amount The aqueous solution is made into a soft material, passed through a 20-mesh sieve to make granules, dried in a fluidized bed at 50°C, and the residual moisture is controlled below 3%, and the prescribed amount of talcum powder and micro-powder silica gel are added, mixed evenly, and pressed into tablets.

[0059] The test result obtained by the d...

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PUM

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Abstract

The invention relates to the field of hypertension treatment medicinal preparations, and provides an enalapril maleate tablet composition. The enalapril maleate tablet composition comprises enalapril maleate as an active component, one or more organic acids and auxiliary materials. The enalapril maleate tablet composition is characterized in that the one or more organic acids selected from malic acid, tartaric acid and taurine. The enalapril maleate tablet composition improves greatly enalapril maleate tablet storage stability, guarantees medical efficacy and reduces toxicity.

Description

technical field [0001] The present invention relates to a tablet composition of enalapril maleate, in particular to a tablet composition of enalapril maleate with excellent storage stability, its preparation method and its preparation and treatment Use in medicines or preparations for hypertension. 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. [0003] 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. [0004] In order to solve the storage stability of enalapril maleate tablet, multiple patents have been published. US Patent No. 5,562,921 r...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K38/05A61K47/12A61K47/20A61P9/12
Inventor 陈剑曹天舒杨松明
Owner 广东彼迪药业有限公司
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