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Imidapril hydrochloride tablet and preparation method thereof

A technology of imidapril hydrochloride tablets and imidapril hydrochloride, which is applied in the directions of pill delivery, dipeptide components, cardiovascular system diseases, etc., can solve the problems of uneven content distribution, long production time and high risk, Achieve the effect of shortening production time, improving production efficiency and high product quality

Inactive Publication Date: 2018-09-11
天津田边制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, the dry method is mainly used for direct tablet preparation, which has the problem of uneven content distribution, while the steps of wet granulation tablet compression are more complicated, and it needs to be granulated, primary drying, primary crushing, secondary drying, secondary crushing, and sieving The steps are carried out, the production time is long, the efficiency is low, there is a possibility of cross-contamination, and the adhesive solution needs to use ethanol, which is dangerous

Method used

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  • Imidapril hydrochloride tablet and preparation method thereof
  • Imidapril hydrochloride tablet and preparation method thereof

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Effect test

Embodiment 1

[0024] The present embodiment provides a kind of imidapril hydrochloride tablet, and raw material component comprises:

[0025] Imidapril hydrochloride 5mg, lactose 100mg, polyethylene glycol 6000 12mg, micronized silica gel 0.2mg.

[0026] Further, a method for preparing the imidapril hydrochloride tablet is provided, comprising the steps of:

[0027] (1) Take imidapril hydrochloride and lactose respectively, pulverize and sieve to obtain fine powders of each raw material with a particle size of 0.074mm, and after fully mixing the fine powders of each raw material, obtain a mixed medicinal powder; weigh polyethylene glycol 6000, after mixing with pure water at a mass ratio of 400:219 (pure water: polyethylene glycol 6000), an aqueous binder solution is obtained;

[0028] (2) Put the mixed drug powder into a fluidized bed granulator, feed high-temperature gas heated to 65°C for preheating, and when the exhaust gas temperature reaches 35°C, start to spray the aqueous binder so...

Embodiment 2

[0032] The present embodiment provides a kind of imidapril hydrochloride tablet, and raw material component comprises:

[0033] Imidapril hydrochloride 10mg, lactose 110mg, polyethylene glycol 6000 16mg, micropowder silica gel 0.4mg.

[0034] Further, a method for preparing the imidapril hydrochloride tablet is provided, comprising the steps of:

[0035] (1) Take imidapril hydrochloride and lactose respectively, pulverize and sieve to obtain fine powders of each raw material with a particle size of 0.065mm, and after fully mixing the fine powders of each raw material, obtain a mixed medicinal powder; weigh polyethylene glycol 6000, after mixing with pure water in a mass ratio of 600:219 (pure water: polyethylene glycol 6000), an aqueous binder solution is obtained;

[0036] (2) Put the mixed drug powder into a fluidized bed granulator, feed high-temperature gas heated to 75°C for preheating, and when the exhaust gas temperature reaches 45°C, start to spray the aqueous binder ...

Embodiment 3

[0040] The present embodiment provides a kind of imidapril hydrochloride tablet, and raw material component comprises:

[0041] Imidapril hydrochloride 5mg, lactose 105mg, polyethylene glycol 6000 13mg, micropowder silica gel 0.25mg.

[0042] Further, a method for preparing the imidapril hydrochloride tablet is provided, comprising the steps of:

[0043] (1) Take imidapril hydrochloride and lactose respectively, pulverize and sieve to obtain fine powders of each raw material with a particle size of 0.057mm, and after fully mixing the fine powders of each raw material, obtain a mixed medicinal powder; weigh polyethylene glycol 6000, after mixing with pure water at a mass ratio of 500:219 (pure water: polyethylene glycol 6000), an aqueous binder solution is obtained;

[0044] (2) Put the mixed drug powder into a fluidized bed granulator, feed high-temperature gas heated to 68°C for preheating, and when the exhaust gas temperature reaches 39°C, start to spray the aqueous binder ...

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Abstract

The invention relates to an imidapril hydrochloride tablet and a preparation method thereof. The imidapril hydrochloride tablet is prepared by a fluidized bed granulation method, and according to themelting point of polyethylene glycol 6000 serving as an adhesion agent, the final temperature of granulation is set to 58-63 DEG C to avoid particle agglomeration or particle deformation due to melting of polyethylene glycol 6000. Compared with a traditional tablet preparation method, the preparation method of the imidapril hydrochloride tablet has the advantages that many processes can be combined to be completed through one device, the production time is significantly shortened, external source risks are reduced, the production efficiency is improved by four times or more, besides, since adhesion agent solution is sprayed through atomization in the fluidized bed granulation method, the adhesion efficiency is high, so that no more ethanol is needed in the adhesion agent solution, and thedangerousness of operation is reduced. Compared with tablets prepared by the traditional tablet preparation method, the finally-prepared imidapril hydrochloride tablet has significantly higher drug content uniformity, better stability of accelerated and long-term stability tests and better product quality.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and in particular relates to an imidapril hydrochloride tablet and a preparation method thereof. Background technique [0002] Imidapril hydrochloride is mainly used in primary hypertension and secondary hypertension caused by renal parenchymal lesions, and is an angiotensin-converting enzyme inhibitor antihypertensive drug. At present, the dry method is mainly used for direct tablet preparation, which has the problem of uneven content distribution, while the steps of wet granulation tablet compression are relatively complicated, and it needs to be granulated, primary drying, primary crushing, secondary drying, secondary crushing, and sieving The steps are carried out, the production time is long, the efficiency is low, there is a possibility of cross-contamination, and the adhesive solution needs to use ethanol, which is highly dangerous. Contents of the invention [0003] In order to solve ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/10A61K38/05A61P9/12
CPCA61K9/2031A61K38/05A61P9/12
Inventor 王龙华姜悦王健彪
Owner 天津田边制药有限公司
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