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Cardiovascular disease treatment sustained-release tablets and preparation method thereof

A sustained-release tablet and cardiovascular technology, which is applied in the field of sustained-release tablets for the treatment of cardiovascular diseases and its preparation, and can solve problems such as the difficulty in meeting the quality control standards for free salicylic acid in aspirin

Active Publication Date: 2014-07-02
YABAO PHARMA BEIJING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Aspirin is easy to decompose under alkaline or weakly alkaline conditions to produce free salicylic acid. Dipyridamole is also an alkaline drug. After being mixed with aspirin and pressed into tablets, the decomposition of aspirin will be accelerated to produce free salicylic acid, which is difficult to reach the free water in aspirin. Quality Control Standards for Salicylic Acid

Method used

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  • Cardiovascular disease treatment sustained-release tablets and preparation method thereof
  • Cardiovascular disease treatment sustained-release tablets and preparation method thereof
  • Cardiovascular disease treatment sustained-release tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0163] Embodiment 1: Aspirin dipyridamole sustained release tablet

[0164] Dipyridamole Sustained Release Tablets Isolation Layer Coated Tablet Core:

[0165]

[0166] Isolation coat:

[0167] Opadry 80W 620004Yellow 3kg

[0168] 20% ethanol solution 28kg

[0169] Aspirin mix granules:

[0170]

[0171] Protective Coating:

[0172] Opadry 295K 620010Yellow 8kg

[0173] 80% ethanol solution 126kg

[0174] Weigh dipyridamole, hypromellose K4M, and lactose according to the prescription amount, put them in a wet granulator in sequence, use 30% ethanol as a soft material, granulate with an 18-mesh sieve, and dry the material to LOD at a temperature not exceeding 45°C ≤2.0%, granulate with 10 mesh sieve; add stearic acid, mix evenly; use Φ=9.5mm shallow concave punch to compress tablet; Opadry 80W 620004Yellow isolation layer coating weight increase to 3%, as dipyridamole Sustained-release tablet core coated with an isolation layer; crush aspirin through a 30-mesh siev...

Embodiment 2

[0175] Embodiment 2: aspirin dipyridamole sustained release tablet

[0176] Dipyridamole Sustained Release Tablets Isolation Layer Coated Tablet Core:

[0177]

[0178] Isolation coat:

[0179] Opadry 80W 620004Yellow 2kg

[0180] 10% ethanol solution 20kg

[0181] Aspirin mix granules:

[0182]

[0183] Protective Coating:

[0184] Opadry 295K 620010Yellow 10kg

[0185] 95% ethanol solution 150kg

[0186]Weigh dipyridamole, hypromellose K4M, and lactose according to the prescription amount, place them in a wet granulator in turn, use 20% ethanol as a soft material, and granulate with a 30-mesh sieve. The temperature of the material does not exceed 50 ° C, and it is dried to LOD≤1.0%, granulate with 10 mesh sieve; add stearic acid, mix evenly; use Φ=9.5mm shallow concave punch to compress tablet; Opadry 80W 620004Yellow isolation layer coating weight increase to 2%, as dipyrid Mo Sustained Release Tablets isolation layer coating tablet core; crush aspirin through ...

Embodiment 3

[0187] Embodiment 3: aspirin dipyridamole sustained release tablet

[0188] Dipyridamole Sustained Release Tablets Isolation Layer Coated Tablet Core:

[0189]

[0190] Isolation coat:

[0191] Opadry 80W 620004Yellow 4kg

[0192] 30% ethanol solution 35kg

[0193] Aspirin mix granules:

[0194]

[0195] Protective Coating:

[0196] Opadry 295K 620010Yellow 6kg

[0197] 60% ethanol solution 100kg

[0198] Weigh dipyridamole, hypromellose K4M, and lactose according to the prescription amount, place them in a wet granulator in turn, use 40% ethanol as a soft material, and granulate with a 10-mesh sieve. The temperature of the material does not exceed 35 ° C, and it is dried to LOD≤3.0%, granulate with 20 mesh sieve; add stearic acid, mix evenly; use Φ=9.5mm shallow concave punch to compress tablet; Opadry 80W 620004Yellow isolation layer coating weight increase to 4%, as dipyrid Mo Sustained Release Tablets are coated with an isolation layer; aspirin is crushed thro...

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PUM

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Abstract

The present invention discloses aspirin dipyridamole sustained-release tablets and a preparation method thereof, wherein the aspirin dipyridamole sustained-release tablets comprise a tablet core adopting dipyridamole tablets, an isolation layer coating, aspirin total mixing particles, and a protection layer coating. According to the present invention, the isolation layer is arranged between the dipyridamole layer and the aspirin layer so as to prevent production of the aspirin degradation product salicylic acid due to contact of the aspirin and the dipyridamole; the dry mixing method is adopted when the aspirin total mixing particles are prepared so as to avoid production of salicylic acid due to direct contact of the aspirin and water; the protection layer is arranged outside the aspirin layer, such that the interaction between the aspirin and the outside water can be effectively prevented, and the aspirin degradation speed can be reduced; and the tableting process of the preparation method of the present invention only requires the one core coating tableting equipment, and other processes can be achieved through the conventional equipment, such that the cost of the aspirin dipyridamole sustained-release tablets is not added while the aspirin stability can be ensured.

Description

field of invention [0001] The invention relates to a sustained-release tablet for treating cardiovascular diseases and a preparation method thereof, in particular to an aspirin dipyridamole sustained-release tablet and a preparation method thereof. Background technique [0002] With the acceleration of population aging process, the incidence of cardiovascular and cerebrovascular diseases is increasing rapidly. Anti-platelet aggregation is an important part of the treatment of cardiovascular and cerebrovascular diseases. Aspirin (ASP for short) and dipyridamole (DP for short) as anti-platelet aggregation drugs are widely used clinically, mainly for preventing thrombosis, arteriosclerosis and myocardial infarction and other diseases. In recent years, compound solid preparations of aspirin dipyridamole have been used clinically. The drug is recommended by the World Health Organization as the preferred antithrombotic drug; it is confirmed by the American Association of Antiplat...

Claims

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Application Information

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IPC IPC(8): A61K31/616A61K31/519A61K9/28A61P9/10A61P7/02
Inventor 詹辉马志平解静萍任武贤
Owner YABAO PHARMA BEIJING