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Clopidogrel sulfate tablet and preparation process thereof

A technology of clopyrrole bisulfate tablet and chloropyrrole bisulfate, which is applied in the directions of pill delivery, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. Poor compliance, heavy tablets and other problems, to avoid sticking and punching problems, facilitate medication, and achieve the effect of small tablet weight

Active Publication Date: 2014-12-03
南京康川济医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] In summary, in order to solve the problems of the stability of clopidogrel hydrogen sulfate and the easy sticking of tablets, a lot of research has been carried out, but in the process of solving the stability of the drug and the sticking of tablets, a large number of drugs have been added without exception. fillers and other pharmaceutical excipients, resulting in large tablets and poor compliance of patients with medication

Method used

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  • Clopidogrel sulfate tablet and preparation process thereof
  • Clopidogrel sulfate tablet and preparation process thereof
  • Clopidogrel sulfate tablet and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028]

[0029] Preparation Process:

[0030] (1) The recipe quantity takes by weighing clopyrrole hydrogen sulfate, joins in the prescription quantity dehydrated alcohol, stirs to dissolve, then adds the crospovidone crossing 100 mesh sieves of the prescription quantity, stirs and mixes evenly, and puts on the spray drier , the drying temperature is set at 55°C, the spray speed is 45ml / min, the suspension is spray-dried, and the dry matter in the receiving room is collected to prepare the clopyrrole hydrogen sulfate cross-linked povidone complex;

[0031] (2) Mix the compound obtained in step (1) with the prescribed amount of zinc stearate in a multi-sport mixer, and compress it into tablets using a rotary tablet press.

Embodiment 2

[0033]

[0034] Preparation Process:

[0035] (1) The recipe quantity takes by weighing clopyrrole hydrogen sulfate, joins in the prescription quantity dehydrated alcohol, stirs to dissolve, then adds the crospovidone crossing 100 mesh sieves of the prescription quantity, stirs and mixes evenly, and puts on the spray drier , the drying temperature is set at 50°C, the spray speed is 40ml / min, the suspension is spray-dried, and the dry matter in the receiving room is collected to prepare the clopyrrole hydrogen sulfate cross-linked povidone compound;

[0036] (2) Mix the compound obtained in step (1) with the prescribed amount of sodium stearyl fumarate in a multi-motion mixer, and press into tablets with a rotary tablet press.

Embodiment 3

[0038]

[0039] Preparation Process:

[0040] (1) The recipe quantity takes by weighing clopyrrole hydrogen sulfate, joins in the prescription quantity dehydrated alcohol, stirs to dissolve, then adds the crospovidone crossing 80 mesh sieves of the recipe quantity, stirs and mixes evenly, on the spray drier , the drying temperature is set at 50°C, the spray speed is 40ml / min, the suspension is spray-dried, and the dry matter in the receiving room is collected to prepare the clopyrrole hydrogen sulfate cross-linked povidone complex;

[0041] (2) Mix the compound obtained in step (1) with the prescribed amount of zinc stearate in a multi-sport mixer, and compress it into tablets using a rotary tablet press.

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PUM

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Abstract

The invention discloses a clopidogrel sulfate tablet and a preparation process thereof. The tablet contains compound of clopidogrel sulfate and polyvinylpolypyrrolidone, wherein the compound is prepared by the steps of dissolving clopidogrel sulfate in an alcohol solvent, adding polyvinylpolypyrrolidone, uniformly mixing and drying by spray. The clopidogrel sulfate and polyvinylpolypyrrolidone compound prepared by the process is capable of avoiding adhesion in the producing process and successfully solving the stability problem in clopidogrel sulfate preparing and storing processes, is simple in process, and is easy for industrial large-scale production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a solid oral preparation, in particular to a tablet containing clopyrrole bisulfate and a preparation process thereof. Background technique [0002] Clopidogrel bisulfate is a thienopyridine compound with a chemical structure similar to ticlopidine, which can selectively inhibit the binding of adenosine diphosphate to its platelet receptor and the subsequent ADP-mediated The activation of glycoprotein GPIIIb / IIIa complex has irreversible inhibition of platelet aggregation and is clinically used as an antithrombotic drug. Clopidogrel bisulfate is soluble in water, methanol, ethanol or glacial acetic acid, and very slightly soluble in acetone or chloroform; the current clinical dosage forms of clopidogrel bisulfate are mainly oral medicines with the trade names "Plavix" and "Shuaike". Tablets (the specification is 75mg clopidogrel) and oral tablets ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4365A61K47/32A61P7/02
Inventor 赵明亮
Owner 南京康川济医药科技有限公司
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