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Clopidogrel hydrogen sulfate tablet and preparation method thereof

A technology of clopidogrel bisulfate tablets and clopidogrel bisulfate is applied in the directions of pill delivery, blood diseases, extracellular fluid diseases, etc. and other problems, to achieve the effect of easy industrialization promotion, reducing sticking and flushing, and solving easy sticking and flushing

Active Publication Date: 2014-07-02
HENAN RUNHONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the raw material of clopidogrel bisulfate tablets is hygroscopic, and the tablet is easy to stick and punch, which limits the large-scale production of clopidogrel bisulfate.

Method used

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  • Clopidogrel hydrogen sulfate tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] The clopidogrel bisulfate tablet of this embodiment comprises the following components by mass: 39.44 parts of clopidogrel bisulfate, 31.53 parts of lactose, 15 parts of pregelatinized starch, 10 parts of microcrystalline cellulose, 6000 parts of polyethylene glycol 2.7 parts, 1.33 parts of hydrogenated castor oil, 3 parts of coating film.

[0020] The preparation method of the clopidogrel bisulfate tablet provided in this example (the weight of the tablet core is 248 mg, taking the preparation of 1000 tablets as an example), comprises the following steps:

[0021] 1) Dry microcrystalline cellulose and pregelatinized starch at 80°C until the water content is <3% and <14% respectively; then pass clopidogrel bisulfate through a 40-mesh sieve, polyethylene glycol 6000 through a 100-mesh sieve, spare;

[0022] 2) Mix 97.8g of clopidogrel bisulfate, 78.204g of lactose, 24.8g of microcrystalline cellulose, 12.4g of pregelatinized starch and 3.348g of polyethylene glycol 6000...

Embodiment 2

[0028] The clopidogrel bisulfate tablet of this embodiment comprises the following components by mass: 39.44 parts of clopidogrel bisulfate, 31.53 parts of lactose, 15 parts of pregelatinized starch, 10 parts of microcrystalline cellulose, 6000 parts of polyethylene glycol 2.7 parts, 1.33 parts of hydrogenated castor oil, 3 parts of coating film.

[0029] The preparation method of the clopidogrel bisulfate tablet provided in this example (the weight of the tablet core is 248 mg, taking the preparation of 1000 tablets as an example), comprises the following steps:

[0030] 1) Dry microcrystalline cellulose and pregelatinized starch at 80°C until the water content is <3% and <14% respectively; then pass clopidogrel bisulfate through a 40-mesh sieve, polyethylene glycol 6000 through a 100-mesh sieve, spare;

[0031] 2) Mix 97.8g of clopidogrel bisulfate, 78.204g of lactose, 24.8g of microcrystalline cellulose, 12.4g of pregelatinized starch and 3.348g of polyethylene glycol 6000...

Embodiment 3

[0037] The clopidogrel bisulfate tablet of this embodiment comprises the following components by mass: 39.44 parts of clopidogrel bisulfate, 31.53 parts of lactose, 15 parts of pregelatinized starch, 10 parts of microcrystalline cellulose, 6000 parts of polyethylene glycol 2.7 parts, 1.33 parts of hydrogenated castor oil, 3 parts of coating film.

[0038] The preparation method of the clopidogrel bisulfate tablet provided in this example (the weight of the tablet core is 248 mg, taking the preparation of 1000 tablets as an example), comprises the following steps:

[0039] 1) Dry microcrystalline cellulose and pregelatinized starch at 80°C until the water content is <3% and <14% respectively; then pass clopidogrel bisulfate through a 40-mesh sieve, polyethylene glycol 6000 through a 100-mesh sieve, spare;

[0040] 2) Mix 97.8g of clopidogrel bisulfate, 78.204g of lactose, 24.8g of microcrystalline cellulose, 12.4g of pregelatinized starch and 60003.348g of polyethylene glycol ...

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Abstract

The invention discloses a clopidogrel hydrogen sulfate tablet and a preparation method thereof. The tablet comprises the following components in parts by weight of: 39.44 parts of clopidogrel hydrogen sulfate, 31.53 parts of lactose, 15 parts of pregelatinized starch, 10 parts of microcrystalline cellulose, 2.7 parts of polyethylene glycol 6000, 1.33 parts of hydrogenated castor oil and 3 parts of lagging cover thin film. According to the invention, the pregelatinized starch and the polyethylene glycol 6000 are added by an inner adding method and an outer adding method in the process of pelletizing, so that the sticking of drug in the process of tabletting can be reduced. Furthermore, after the dry granulation is adopted, the problem that the drug is easy to stick in the process of tabletting can be further solved. The clopidogrel hydrogen sulfate tablet prepared by the invention is short in disintegration time, and quick in dissolving-out speed, and the hardness of the tablet can reach 70-80N. The invention is simple to operate, and easy to industrially popularize.

Description

technical field [0001] The invention relates to a clopidogrel bisulfate tablet and a preparation method of the tablet, which belongs to the field of western medicine preparations. Background technique [0002] Clopidogrel hydrogen sulfate, chemical name: 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5-yl)acetate methyl ester hydrogensulfate, Is a platelet aggregation inhibitor. Clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet receptor and the secondary ADP-mediated activation of the glycoprotein GPlllb / llla complex, thus inhibiting platelet aggregation. Clopidogrel must be passed Biotransformation is required to inhibit platelet aggregation, but the active metabolites responsible for this effect have not been isolated. In addition to ADP, clopidogrel also inhibits platelet aggregation induced by other agonists by blocking the expansion of platelet activation caused by released ADP. Clopidogrel does not inhibit the activit...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/28A61K31/4365A61K47/44A61K47/34A61K47/36A61P7/02A61P9/10
Inventor 高志亮
Owner HENAN RUNHONG PHARMA
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