Benazepril pharmaceutical compsn. and process for its prepn.

A technology for compositions and medicines, applied in the directions of medicine combinations, medicine formulations, active ingredients of heterocyclic compounds, etc., can solve the problems of serious pollution, high cost, complicated preparation process, etc., and achieves a high degree of automation, high production efficiency, and process equipment. simple effect

Inactive Publication Date: 2007-09-12
SHENZHEN SALUBRIS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Patent CN1895227 discloses a dripping pill preparation of benazepril, which adopts the application and manufacturing process of solid dispersion technology, but due to the use of a large amount of organic solvents in the manufacturing process of dripping pills, the pollution is serious, the cost is high, and the preparation process is complicated

Method used

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  • Benazepril pharmaceutical compsn. and process for its prepn.
  • Benazepril pharmaceutical compsn. and process for its prepn.

Examples

Experimental program
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Effect test

Embodiment 1

[0038] Benazepril hydrochloride 15.0g, pregelatinized starch 45.0g, mannitol 180.0g, polyethylene glycol (40) monostearate 3.5g, sucrose higher fatty acid ester 4.0g, glycerin palmitic acid hard After mixing 2.7g of fatty acid esters with the method of equal increase, mix and pulverize in a ball mill, after pulverizing for 30 minutes, raise the temperature of the material to 40°C to 50°C, grind and pulverize for 30 minutes, take out the material and let it cool, Use a fast granulator with a 1.0mm sieve to granulate and pulverize, and sieve fine particles above 60 mesh.

[0039] Mix the obtained granules with 13.5 g of disintegrating agent sodium carboxymethyl starch and 2.7 g of lubricant micropowder silica gel, and then press into tablets with a tablet machine, and the hardness is controlled at 2.0 kg / cm 2 up to 5.0kg / cm 2 , made into tablets with a content of 5 mg and a tablet weight of 0.09 g.

Embodiment 2

[0041] Benazepril hydrochloride 15.0g, pregelatinized starch 70.0g, mannitol 180.0g, polyethylene glycol (40) monostearate 8.0g, sucrose higher fatty acid ester 2.4g, glycerin palmitic acid hard After mixing 3.5 g of fatty acid esters by the method of increasing in equal amounts, mix and pulverize in a ball mill, and after pulverizing for 30 minutes, raise the temperature of the material to 40°C to 50°C, grind and pulverize for another 30 minutes, take out the material and let it cool, Use a fast granulator with a 1.0mm sieve to granulate and pulverize, and sieve fine particles above 60 mesh.

[0042] Mix the obtained granules with 14.5 g of disintegrant sodium carboxymethyl starch and 3.5 g of lubricant micropowder silica gel, and then press into tablets with a tablet machine, and the hardness is controlled at 2.0 kg / cm 2 up to 5.0kg / cm 2 , made into tablets with a content of 10 mg and a tablet weight of 0.18 g.

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Abstract

The present invention provides one kind of medicine composition of benazepril and its preparation process. The present invention solves the problem of benazepril with low dissolution and the problems of the preparation process in medicine sticking and medicine degradation. The preparation process combines solid dispersing technology and traditional tablet preparation, and is simple, accurate in dosage control and high in production efficiency.

Description

[technical field] [0001] The invention relates to a pharmaceutical composition, in particular to a pharmaceutical composition of benazepril and a preparation method thereof. [Background technique] [0002] Benazepril, namely (1S,3S)-3-{[(1-ethoxycarbonyl)-3-phenylpropyl]-amino}-2,3,4,5-tetrahydro-2-oxo-1 -H-1-benzoazepine-1-acetic acid is a safe and orally effective antihypertensive drug widely used clinically, and it is also used for the treatment of cardiac insufficiency. Benazepril is hydrolyzed into benazeprilat in the liver, becoming a competitive angiotensin-converting enzyme inhibitor, preventing angiotensin II, reducing vascular resistance, reducing aldosterone secretion, and increasing plasma renin activity. Benazeprilat also inhibits the degradation of bradykinin, reduces vascular resistance and produces antihypertensive effect. Benazeprilat can also reduce peripheral vascular resistance by dilating arteries and veins, which not only reduces cardiac afterload, bu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/55A61K9/14A61K9/16A61K9/20A61K9/48A61K47/36A61P9/12A61P9/00
Inventor 谭岳尧叶澄海
Owner SHENZHEN SALUBRIS PHARMA CO LTD
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