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Aspirin-dipyridomole sustained-release capsule and preparation method thereof

A dipyridamole and aspirin technology, applied in the field of compound sustained-release capsules and preparation thereof, can solve the problems of water instability of aspirin, unavoidable contact, inability to achieve controlled release of dipyridamole and the like

Active Publication Date: 2012-12-05
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, dipyridamole is an alkaline drug, and aspirin is easy to decompose and become ineffective under alkaline or weakly alkaline conditions, so my country has limited control over aspirin and its preparations for its decomposition product free salicylic acid
After aspirin and dipyridamole are mixed and pressed into tablets, the decomposition of aspirin is often accelerated to produce free salicylic acid, which makes it difficult to meet the quality control standards for the content of free salicylic acid in aspirin
[0004] Patents CN2798942, CN1480144A and CN111985A relate to a kind of aspirin dipyridamole slow-release tablet, which uses a dipyridamole layer or an aspirin layer to wrap an isolation coat, and some also need to add an isolation layer between the two layers. However, during the operation , or the contact between the two is unavoidable, which may cause the related substances of aspirin to be unqualified, and aspirin is unstable to water, so wet granulation cannot be used
In addition, due to the technical limitations of the sustained-release tablet itself, dipyridamole cannot be released in a controlled manner, so it cannot play a good pharmacological effect.

Method used

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  • Aspirin-dipyridomole sustained-release capsule and preparation method thereof
  • Aspirin-dipyridomole sustained-release capsule and preparation method thereof
  • Aspirin-dipyridomole sustained-release capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Aspirin part:

[0031]

[0032] Preparation process: aspirin according to the prescription amount, pressed into large tablets, crushed and passed through a 30-mesh sieve for granulation to obtain Granule I; mix precrossed starch, microcrystalline cellulose PH101, and mannitol, and use water as a wetting agent to granulate, fully Dry, sieve and granulate to obtain Granule II; mix Granule I and Granule II with the prescribed amount of talcum powder, and form a shallow concave punching tablet with a diameter of 6mm; take an appropriate amount of Opadry 68918 and dissolve it in 30% alcohol water, and prepare Opadry 68918 solution with a concentration of 5% was used as a coating liquid, and the weight gain of the coating was 3%.

[0033] Dipyridamole fraction:

[0034] Ball core:

[0035]

[0036] Isolation gown layer:

[0037]

[0038] Slow-release coating:

[0039]

[0040] Preparation process: Take the above prescription amount of raw and auxiliary materia...

Embodiment 2

[0043] Aspirin part:

[0044]

[0045] Preparation process: aspirin according to the prescription amount, pressed into large tablets, crushed and passed through a 30-mesh sieve for granulation to obtain Granule I; mix lactose, microcrystalline cellulose PH101, and citric acid, and use 10% starch slurry as a binder to granulate, fully Dry, sieve and granulate to obtain Granule II; mix Granule I and Granule II with the prescribed amount of magnesium stearate, and form a shallow concave punching tablet with a diameter of 6mm; take an appropriate amount of Opadry 68918 and dissolve it in 30% alcohol water , made into a solution of Opadry 68918 with a concentration of 5%, as a coating solution, coating, and the weight gain of the coating was 3%.

[0046] Dipyridamole fraction:

[0047] Ball core:

[0048]

[0049] Isolation gown layer:

[0050]

[0051] Slow-release coating:

[0052]

[0053] Preparation process: Take the above prescription amount of raw and auxilia...

Embodiment 3

[0056] The sustained-release capsules prepared in Example 1 and Example 2 are jointly released with commercially available sustained-release tablets for stability. After 6 months under stability accelerated conditions, the related substances of the aspirin part are shown in the table below. Dipyridamole See the accompanying drawings for the release comparison curve.

[0057] Table 1. Comparison table of related substances in the aspirin part of the preparation after 6 months

[0058]

[0059] As can be seen from the above results, after being placed under accelerated conditions for 6 months, some related substances of aspirin in Examples 1 and 2 are significantly smaller than those of the commercially available tablets.

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Abstract

The invention discloses a compound sustained-release capsule containing aspirin and dipyridomole and a preparation method thereof. The content in the sustained-release capsule comprises an aspirin film-coated tablet and dipyridomole sustained-release micropills, and is mainly used for preventing and treating disease symptoms such as cardiac and cerebral acute ischemia or infarct and the like.

Description

technical field [0001] The invention discloses a compound sustained-release capsule containing aspirin and dipyridamole and a preparation method thereof, in particular to a sustained-release capsule whose contents are aspirin film-coated tablets and dipyridamole sustained-release pellets. Background technique [0002] Antiplatelet aggregation is an important link in the treatment of cardiovascular and cerebrovascular diseases. Dipyridamole, also known as dipyridamole, is an anti-platelet aggregation drug widely used in clinical practice, mainly used to prevent thrombosis, arteriosclerosis, and recurrence of myocardial infarction; aspirin is the first generation of anti-platelet aggregation drugs, it It can prevent the formation of thrombus and is used to prevent transient ischemic attack, myocardial infarction, atrial fibrillation, unstable angina, etc. In recent years, research conducted by the Department of Neurology of Vaudois University Central Hospital in Switzerland f...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/52A61K31/616A61K9/48A61P9/10
Inventor 孟凡静
Owner AVENTIS PHARMA HAINAN