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A kind of clopidogrel bisulfate aspirin composite double-layer tablet and preparation method thereof

A clopidogrel bisulfate aspirin and composite double-layer technology, which is applied in the field of medicine, can solve the problems of material fluidity, anti-stickiness and insufficient quality stability, and achieve strong anti-platelet aggregation activity, good quality stability, and anti-platelet Aggregation enhanced effect

Active Publication Date: 2018-05-25
CSPC OUYI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

After research, the preparation has deficiencies in material fluidity, anti-stickiness and quality stability during the preparation process, which needs to be improved

Method used

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  • A kind of clopidogrel bisulfate aspirin composite double-layer tablet and preparation method thereof
  • A kind of clopidogrel bisulfate aspirin composite double-layer tablet and preparation method thereof
  • A kind of clopidogrel bisulfate aspirin composite double-layer tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Example 1 Preparation of Clopidogrel Bisulfate and Aspirin Composite Bilayer Tablets

[0045] Name

[0046] Preparation: Mix clopidogrel bisulfate with glyceryl behenate, cholesterol succinate, filler, disintegrant, then add an appropriate amount of absolute ethanol to wet granulation, dry at 50℃ to obtain dry granules, and then lubricate Aspirin is first mixed with glyceryl behenate, cholesterol succinate, and filler, and then mixed with disintegrant and lubricant, and then dry granulated to obtain granule 2; respectively granule 1 and granule 2 Put them into the material feeders of the first and second layers of the double-layer tablet press, and compress them into 1000 tablets with a hardness in the range of 80N-120N; coating is ready.

Embodiment 2

[0047] Example 2 Preparation of Clopidogrel Bisulfate and Aspirin Composite Double-layer Tablets

[0048] Name

[0049] Aspirin

[0050] Preparation: Mix clopidogrel bisulfate with glyceryl behenate, cholesterol succinate monoester, and filler, then add an appropriate amount of absolute ethanol to wet granulation, dry at 45°C to obtain dry granules, and then mix with disintegrant and lubrication Aspirin is first mixed with glyceryl behenate, cholesterol succinate, and filler, and then mixed with disintegrant and lubricant, and then dry granulated to obtain granule 2; respectively granule 1 and granule 2 Put them into the material feeders of the first and second layers of the double-layer tablet press, and compress them into 1000 tablets with a hardness in the range of 80N-120N; coating is ready.

Embodiment 3

[0051] Example 3 Preparation of Clopidogrel Bisulfate and Aspirin Composite Bilayer Tablets

[0052] Name

[0053] Preparation: firstly mix clopidogrel bisulfate with glyceryl behenate, cholesterol succinate, and fillers, then mix with disintegrants and lubricants, and dry granulate to obtain granules 1; firstly mix aspirin with behenic acid Glycerides, cholesterol succinate monoesters, and fillers are mixed, and then an appropriate amount of absolute ethanol is added for wet granulation, dried at 45°C to obtain dry granules, and then mixed with disintegrants and lubricants to obtain granules 2; respectively, granules 1 and 2 Put them into the material feeders of the first and second layers of the double-layer tablet press, and compress them into 1000 tablets with a hardness in the range of 80N-120N; coating is ready.

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Abstract

The invention belongs to the technical field of medicines, and relates to a compound clopidogrel hydrogen sulphate and aspirin double-layer tablet and a preparation method thereof. The compound clopidogrel hydrogen sulphate and aspirin double-layer tablet disclosed by the invention is formed by taking clopidogrel hydrogen sulphate and aspirin as the active components, adding glyceryl behenate and cholesteryl hemisuccinate and combining a filling agent, a disintegrating agent and a lubricating agent. The material prepared by the preparation process has good fluidity and anti-sticking property; the sticking problem of the compound clopidogrel hydrogen sulphate and aspirin double-layer tablet is solved; the anti-platelet aggregation effects of effective components are also improved; furthermore, the quality stability of drugs is good; and safe and effective drug use can be realized.

Description

Technical field [0001] The invention belongs to the technical field of medicine and relates to a pharmaceutical preparation for preventing platelet aggregation. More specifically, it relates to a clopidogrel bisulfate aspirin composite double-layer tablet and a preparation method thereof. Background technique [0002] With the extension of people's average life expectancy, changes in living environment and dietary habits, the incidence of cardiovascular and cerebrovascular diseases is increasing year by year, and the market demand for drugs is increasing. Thrombotic diseases are cardiovascular and cerebrovascular diseases, which are various diseases that cause dysfunction due to the stenosis and occlusion of the vascular lumen caused by thrombus, which causes ischemia and infarction of major organs, manifested as myocardial infarction, coronary heart disease, and atherosclerosis Sclerosis, stroke or cerebral infarction, as well as peripheral vascular disease, have the characteri...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/616A61K9/28A61K47/28A61K47/14A61P9/10A61P7/02A61K31/4365
CPCA61K9/209A61K9/28A61K31/4365A61K31/616A61K47/14A61K47/28A61K2300/00
Inventor 王建明张文静刘磊李硕郭倩王丽丽
Owner CSPC OUYI PHARM CO LTD
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