Medicinal composition containing trandolapril and preparation process thereof

A technology for trandolapril and composition, which is applied to the field of stable trandolapril capsules and their preparation, can solve the problems of not being able to fully meet the requirements of stable blood drug concentration, incomplete dissolution, etc., and achieves changes in instability and content reduction. The effect of falling, simple and practical process

Inactive Publication Date: 2012-02-15
泰州万全医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The inventor found in researching the preparation process of trandolapril that the pharmaceutical composition containing the main drug trandolapril, after wet granulation, in the in vitro dissolution test investigation, the dissolution was not complete within the specified 60 minutes, that is, Under the prescribed method of administration, it cannot fully meet the requirements of stable blood drug concentration in the human body

Method used

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  • Medicinal composition containing trandolapril and preparation process thereof
  • Medicinal composition containing trandolapril and preparation process thereof
  • Medicinal composition containing trandolapril and preparation process thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0026]

[0027] Capsule preparation process: (1) Pass the main ingredient and magnesium stearate through 80-mesh sieves respectively, weigh them according to the proportion, add equal amounts and mix them evenly; (2) pass through 80-mesh sieves for lactose, starch and mannitol respectively Sieve, weigh according to the proportion, mix evenly, prepare 5% polyvinylpyrrolidone as a binder, wet granulate, granulate with a 16-mesh sieve, dry, and granulate with a 24-mesh. The two parts (1) and (2) are added in equal amounts, mixed evenly, and filled into capsules.

Embodiment 2

[0029]

[0030] Capsule preparation process: (1) pass the main ingredient, magnesium stearate, and talcum powder through an 80-mesh sieve, weigh according to the proportion, and mix uniformly in equal amounts; (2) lactose, microcrystalline cellulose, respectively Pass through an 80-mesh sieve, weigh according to the proportion, mix evenly, prepare 10% starch slurry as a binder, wet granulate, granulate with a 16-mesh sieve, dry, and granulate with a 24-mesh sieve. The two parts (1) and (2) are added in equal amounts, mixed evenly, and filled into capsules.

Embodiment 3

[0032]

[0033] Capsule preparation process: (1) pass the main drug and micropowder silica gel through 80-mesh sieve respectively, weigh according to the proportion, and mix evenly in equal amounts; (2) lactose, mannitol, low-substituted hydroxypropyl cellulose, Pass through 80-mesh sieve respectively, weigh according to the proportion, mix evenly, prepare 2% hydroxypropyl cellulose as a binder, wet granulate, granulate with 16-mesh sieve, dry, and granulate with 24-mesh. The two parts (1) and (2) are added in equal amounts, mixed evenly, and filled into capsules.

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PUM

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Abstract

The invention which belongs to the technical field of medicines relates to a trandolapril capsule and a preparation process thereof. The trandolapril capsule comprises trandolapril and lactose according to a weight ratio of 1:60-1:180, wherein lactose is used as a diluent. The preparation process adopts partial wet granulation, main medicine addition, and capsule filling. The invention aims to provide the trandolapril capsule with the characteristics of stable and reliable quality, and simple and feasible process.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a stable trandolapril capsule and a preparation method thereof. technical background [0002] Trandolapril maintains long-acting antihypertensive effect by inhibiting angiotensin-converting enzyme (ACE), and can inhibit angiotensin-induced blood pressure response, reduce cardiac hypertrophy, reduce left ventricular weight and right ventricular blood vessels Tensin II (AGT II) concentration, but had no effect on plasma AGT IIE concentration. [0003] CN 101314037A discloses a stable pharmaceutical composition containing an angiotensin-converting enzyme inhibitor. This stable pharmaceutical composition comprises an effective dose of an angiotensin-converting enzyme inhibitor, a drug stabilizer and a pharmaceutically acceptable Adjuvant, in order to improve drug stability, added drug stabilizer sodium lauryl sulfate and / or magnesium lauryl sulfate. [0004] T...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K38/05A61K47/26A61P9/12
Inventor 马文武郭夏宋雪梅
Owner 泰州万全医药科技有限公司
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