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Sustained-release tablet for treating cardiovascular diseases 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: 2016-09-14
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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  • Sustained-release tablet for treating cardiovascular diseases and preparation method thereof
  • Sustained-release tablet for treating cardiovascular diseases and preparation method thereof
  • Sustained-release tablet for treating cardiovascular diseases and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0162] Embodiment 1: Aspirin dipyridamole sustained release tablet

[0163] Aspirin tablets:

[0164]

[0165] Isolation coat:

[0166] Opadry 80W 620004Yellow 3kg

[0167] 20% ethanol solution 28kg

[0168] Dipyridamole mixed granules:

[0169]

[0170] Protective Coating:

[0171] Opadry 295K 620010Yellow 8kg

[0172] 80% ethanol solution 126kg

[0173] Aspirin was crushed through a 30-mesh sieve, L-tartaric acid was crushed through a 80-mesh sieve, pregelatinized starch and spray-dried lactose were passed through a 18-mesh sieve, and stearic acid was passed through a 20-mesh sieve for later use; aspirin and L-tartaric acid were weighed according to the prescription amount. Mix tartaric acid, then add pregelatinized starch and mix, then add spray-dried lactose and mix, then add microcrystalline cellulose PH101 and mix, finally add stearic acid, mix evenly, and use Φ=9.5mm shallow concave punch to compress tablets; Dai 80W 620004Yellow barrier layer coating incre...

Embodiment 2

[0174] Embodiment 2: aspirin dipyridamole sustained release tablet

[0175] Aspirin tablets:

[0176]

[0177] Isolation coat:

[0178] Opadry 80W 620004Yellow 4kg

[0179] 10% ethanol solution 35kg

[0180] Dipyridamole mixed granules:

[0181]

[0182] Protective Coating:

[0183] Opadry 295K 620010Yellow 10kg

[0184] 95% ethanol solution 150kg

[0185] Grind aspirin through a 40-mesh sieve, L-tartaric acid through a 70-mesh sieve, pregelatinized starch and spray-dried lactose through a 10-mesh sieve, and stearic acid through a 30-mesh sieve for later use; weigh aspirin and L- Mix tartaric acid, then add pregelatinized starch and mix, then add spray-dried lactose and mix, then add microcrystalline cellulose PH101 and mix, finally add stearic acid, mix evenly, and use Φ=9.5mm shallow concave punch to compress tablets; Dai 80W 620004Yellow barrier layer coating increased to 3% in weight, used as aspirin barrier layer coating tablet core; dipyridamole, hypromellos...

Embodiment 3

[0186] Embodiment 3: aspirin dipyridamole sustained release tablet

[0187] Aspirin tablets:

[0188]

[0189] Isolation coat:

[0190] Opadry 80W 620004Yellow 2kg

[0191] 30% ethanol solution 20kg

[0192] Dipyridamole mixed granules:

[0193]

[0194] Protective Coating:

[0195] Opadry 295K 620010Yellow 6kg

[0196] 60% ethanol solution 100kg

[0197]Grind aspirin through a 20-mesh sieve, L-tartaric acid through a 90-mesh sieve, pregelatinized starch and spray-dried lactose through a 20-mesh sieve, stearic acid through a 10-mesh sieve, and set aside; weigh aspirin and L- Mix tartaric acid, then add pregelatinized starch and mix, then add spray-dried lactose and mix, then add microcrystalline cellulose PH101 and mix, finally add stearic acid, mix evenly, and use Φ=9.5mm shallow concave punch to compress tablets; Dai 80W 620004Yellow barrier layer coating increased to 2% in weight, used as aspirin barrier layer coating tablet core; dipyridamole, hypromellose K4M...

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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 an aspirin tablet core, an isolation layer coating, dipyridamole 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; 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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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/616A61K31/519A61K9/36A61K47/38A61P9/10A61P7/02
Inventor 詹辉马志平解静萍任武贤
Owner YABAO PHARMA BEIJING
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