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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 their preparation, can solve the problems of difficulty in meeting the quality control standards of free salicylic acid in aspirin and the like

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

[0162] Example 1: Aspirin dipyridamole sustained-release tablets

[0163] Aspirin tablets:

[0164]

[0165] Isolation layer coating:

[0166] Opadry 80W 620004Yellow 3kg

[0167] 20% ethanol solution 28kg

[0168] Dipyridamole total mixed particles:

[0169]

[0170] Protective layer coating:

[0171] Opadry 295K 620010Yellow 8kg

[0172] 80% ethanol solution 126kg

[0173] Crush aspirin through a 30-mesh sieve, L-tartaric acid through an 80-mesh sieve, pregelatinized starch and spray-dried lactose through an 18-mesh sieve, and stearic acid through a 20-mesh sieve, respectively; Mix with tartaric acid, then add pregelatinized starch, then add spray-dried lactose and mix, then add microcrystalline cellulose PH101, and finally add stearic acid, mix well, use Φ=9.5mm shallow concave punch to press tablets; Substitute 80W 620004Yellow isolation layer coating to increase the weight to 3%, as aspirin isolation layer coating tablet core; weigh dipyridamole, hypromellose K4M, lactose according t...

Embodiment 2

[0174] Example 2: Aspirin dipyridamole sustained-release tablets

[0175] Aspirin tablets:

[0176]

[0177] Isolation layer coating:

[0178] Opadry 80W 620004Yellow 4kg

[0179] 10% ethanol solution 35kg

[0180] Dipyridamole total mixed particles:

[0181]

[0182] Protective layer coating:

[0183] Opadry 295K 620010Yellow 10kg

[0184] 95% ethanol solution 150kg

[0185] Crush 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, respectively, and use them as prescriptions to weigh aspirin and L- Mix with tartaric acid, then add pregelatinized starch, then add spray-dried lactose and mix, then add microcrystalline cellulose PH101, and finally add stearic acid, mix well, use Φ=9.5mm shallow concave punch to press tablets; Substitute 80W 620004Yellow isolation layer coating to increase the weight to 3%, as aspirin isolation layer coating tablet core; weig...

Embodiment 3

[0186] Example 3: Aspirin dipyridamole sustained-release tablets

[0187] Aspirin tablets:

[0188]

[0189] Isolation layer coating:

[0190] Opadry 80W 620004Yellow 2kg

[0191] 30% ethanol solution 20kg

[0192] Dipyridamole total mixed particles:

[0193]

[0194] Protective layer coating:

[0195] Opadry 295K 620010Yellow 6kg

[0196] 60% ethanol solution 100kg

[0197] Crush 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, and stearic acid through a 10-mesh sieve, respectively; Mix with tartaric acid, then add pregelatinized starch, then add spray-dried lactose to mix, then add microcrystalline cellulose PHl01 to mix, finally add stearic acid, mix well, use Φ=9.5mm shallow concave punch to press tablets; Substitute 80W 620004Yellow isolation layer coating to increase the weight to 2%, as aspirin isolation layer coating tablet core; weigh dipyridamole, hypromellose K4M, lactose according t...

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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

Invention field [0001] The invention relates to a sustained-release tablet for treating cardiovascular diseases and a preparation method thereof, in particular to a sustained-release aspirin dipyridamole tablet and a preparation method thereof. Background technique [0002] With the accelerated process of population aging, the incidence of cardiovascular and cerebrovascular diseases has increased rapidly, and anti-platelet aggregation is an important part of the treatment of cardiovascular and cerebrovascular diseases. Aspirin (ASP) and Dipyridamole (DP) are widely used clinically as anti-platelet aggregation drugs, and are mainly used to prevent thrombosis, arteriosclerosis and heart-machine infarction and other diseases. In recent years, the compound solid preparation of aspirin and dipyridamole has been clinically applied. The drug is recommended by the World Health Organization as the first choice for antithrombotic drugs; it is confirmed as the best drug to prevent myocardi...

Claims

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Application Information

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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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