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Perindopril tablets and direct tabletting process of perindopril tablet powder

A technology of indopril tablets and powders, which is applied in the field of direct compression of perindopril tablets and powders, can solve the problem that the content of degraded impurities B and F increases obviously, and it is difficult to meet the product quality of enterprises and adapt to market demands, etc. problems, to achieve the effect of being conducive to stability and production controllability, avoiding granulation and drying processes, and simple process

Active Publication Date: 2015-05-06
JIANGSU SINOBIOPHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The gradient elution method was used to detect related substances, and it was found that the product of this process met the limit specified in the quality standard within the validity period, but the content of degraded impurities B and F increased significantly, and individual batches were close to the limit within the validity period, which was difficult to meet the requirements of the enterprise itself. Improving product quality and adapting to the inherent requirements of market demand

Method used

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  • Perindopril tablets and direct tabletting process of perindopril tablet powder
  • Perindopril tablets and direct tabletting process of perindopril tablet powder
  • Perindopril tablets and direct tabletting process of perindopril tablet powder

Examples

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Embodiment 1

[0033] A kind of perindopril tablet, described perindopril tablet is made up of following components according to parts by weight:

[0034]

[0035] The direct compression process of perindopril sheet powder comprises the steps:

[0036] (1) Get perindopril tert-butylamine salt, mix with microcrystalline cellulose, sieve, and mix; the mesh of the sieve is 80 mesh;

[0037] (2) Mix with part of lactose again;

[0038] (3) Mix the above mixed powder with remaining lactose and silicon dioxide;

[0039] (4) Add magnesium stearate to mix at last, sampling detection, tabletting;

[0040] (5) It is packaged in aluminum-plastic blister, with a built-in desiccant and a composite film bag outside. Aluminum-plastic blister packaging, specifically: PVC+aluminum foil, desiccant is silica gel.

Embodiment 2

[0042] A kind of perindopril tablet, described perindopril tablet is made up of following components according to parts by weight:

[0043]

[0044] The direct compression process of perindopril sheet powder comprises the steps:

[0045] (1) Get perindopril tert-butylamine salt, mix with microcrystalline cellulose, sieve, and mix; the mesh of the sieve is 100 mesh;

[0046] (2) Mix with part of lactose again;

[0047] (3) Mix the above mixed powder with remaining lactose and silicon dioxide;

[0048] (4) Add magnesium stearate to mix at last, sampling detection, tabletting;

[0049] (5) Aluminum-plastic blister packaging with built-in desiccant and composite film bag outside; aluminum-plastic blister packaging, specifically: PVC+aluminum foil, desiccant is molecular sieve.

Embodiment 3

[0051] A kind of perindopril tablet, described perindopril tablet is made up of following components according to parts by weight:

[0052]

[0053] The direct compression process of perindopril sheet powder comprises the steps:

[0054] (1) Get perindopril tert-butylamine salt, mix with microcrystalline cellulose, sieve, and mix; the mesh of the sieve is 80 mesh;

[0055] (2) Mix with part of lactose again;

[0056] (3) Mix the above mixed powder with remaining lactose and silicon dioxide;

[0057] (4) Add magnesium stearate to mix at last, sampling detection, tabletting;

[0058] (5) It is packaged in aluminum-plastic blister, with a built-in desiccant and a composite film bag outside. Aluminum-plastic blister packaging, specifically: PVC+aluminum foil, desiccant is silica gel.

[0059] The perindopril tert-butylamine obtained by the above examples is needle-shaped, and through microscopic observation, the length is about 100-200 μm. When it encounters water, it can b...

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Abstract

The invention discloses perindopril tablets and a direct tabletting process of perindopril tablet powder. The direct tabletting process comprises the following steps: mixing perindopril tert-butylamine salt with microcrystalline cellulose, sieving, and uniformly mixing; then mixing with a part of lactose; uniformly mixing the mixed powder with residual lactose and silicon dioxide; finally adding magnesium stearate, mixing, sampling for testing, and tabletting; and packaging with an aluminum plastic foamed mask, putting a drying agent in the package, and coating with a composite membrane bag. According to a product prepared by using the process disclosed by the invention, the appearance, dissolution rate, moisture and content of the product cannot be significantly changed under the conditions of strong light, high temperature and high humidity, and the 15-minute dissolution rate can be more than 85%; and by virtue of process changing, the influences caused by dampness and heat in the process can be avoided, and the impurity content of degradation products can be significantly reduced.

Description

technical field [0001] The invention specifically relates to a direct tableting process of perindopril tablets and powder thereof. Background technique [0002] The traditional process is: produce perindopril tablets with wet granulation prescription process, and its formula is as follows: [0003] [0004] The specific process steps are as follows: take the main drug perindopril, sieve (80-100 mesh), and use the method of increasing in equal amounts to successively mix with hydroxypropyl cellulose, sodium carboxymethyl starch (internal added part), lactose and microcrystalline cellulose Mix the ingredients evenly, then add an appropriate amount of 5% povidone (K30) solution to make a suitable soft material, granulate with a 20-mesh sieve, and dry. Sieve the dry granules with an 18-mesh sieve, add sodium starch glycolate (additional part) and magnesium stearate, mix evenly, and punch tablets with a shallow circle of Φ6.0mm to obtain the product. [0005] The gradient el...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K38/05A61K47/38
Inventor 黄乐群边崇安
Owner JIANGSU SINOBIOPHARMA
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