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Benazepril pharmaceutical compsition and process for its preparation

A pharmacy and tablet technology, applied in the pharmaceutical composition of benazepril and its preparation field, can solve the problems of high cost, serious pollution, complicated preparation process, etc., and achieve high production efficiency, high degree of automation, and simple process equipment Effect

Inactive Publication Date: 2010-03-24
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 compsition and process for its preparation
  • Benazepril pharmaceutical compsition and process for its preparation
  • Benazepril pharmaceutical compsition and process for its preparation

Examples

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Embodiment 1

[0039] 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 2.7 g of fatty acid esters by the method of equal increments, mix and pulverize them in a ball mill, and after pulverizing for 30 minutes, raise the temperature of the materials to 40°C to 50°C, grind and pulverize for 30 minutes, take out the materials and let them cool down. Use a fast granulator with a 1.0mm sieve to granulate and pulverize, and sieve fine particles above 60 mesh.

[0040] 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

[0042] 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.

[0043] Mix the obtained granules with 14.5 g of disintegrating agent 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 problemsof 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 Patents(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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