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A kind of clopidogrel bisulfate tablet and preparation method thereof

A clopidogrel bisulfate tablet, a technology of clopidogrel bisulfate, which is applied in the field of biomedicine and can solve problems such as incomplete blockage of coronary artery thrombosis

Inactive Publication Date: 2019-07-19
HAINAN TIANHUANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in NSTE-ACS, coronary arteries are severely stenotic but often incompletely occluded by platelet-rich thrombus

Method used

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  • A kind of clopidogrel bisulfate tablet and preparation method thereof
  • A kind of clopidogrel bisulfate tablet and preparation method thereof
  • A kind of clopidogrel bisulfate tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] Clopidogrel hydrogen sulfate 979g, polyethylene glycol 4000 80g, hydrogenated castor oil 33g, methacrylic acid-methyl acrylate copolymer 400g, disintegrant low-substituted hydroxypropyl cellulose 120g, filler microcrystalline cellulose 150g and Mannitol 1100g.

[0078] (1) Clopidogrel hydrogen sulfate was passed through a 40-mesh sieve; mannitol and polyethylene glycol 4000 were passed through a 100-mesh sieve; microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and methacrylic acid-methyl acrylate copolymer were passed through 60 mesh sieve; the above-mentioned raw and auxiliary materials are evenly mixed to obtain spare raw and auxiliary materials;

[0079] (2) Add the spare raw and auxiliary materials to the dry granulator for granulation. The granulation parameters are selected as the feeding speed of 12-13 r / min, the extrusion pressure of 14-18kg, and the extrusion speed of 10-11 r / min. Select a 20-mesh screen, and re-granulate the fine powder wit...

Embodiment 2

[0081] Clopidogrel hydrogen sulfate 195.8g, polyethylene glycol 4000 16g, hydrogenated castor oil 6.6g, methacrylic acid-methyl acrylate copolymer 80g, disintegrant low-substituted hydroxypropyl cellulose 24g, filler microcrystalline cellulose 30g and mannitol 220g.

[0082] (1) Clopidogrel hydrogen sulfate was passed through a 40-mesh sieve; mannitol and polyethylene glycol 4000 were passed through a 100-mesh sieve; microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and methacrylic acid-methyl acrylate copolymer were passed through 60 mesh sieve; the above-mentioned raw and auxiliary materials are evenly mixed to obtain spare raw and auxiliary materials;

[0083] (2) Add the spare raw and auxiliary materials to the dry granulator for granulation. The granulation parameters are selected as the feeding speed of 12-13 r / min, the extrusion pressure of 14-18kg, and the extrusion speed of 10-11 r / min. Select a 20-mesh screen, and re-granulate the fine powder with...

Embodiment 3

[0085] Clopidogrel hydrogen sulfate 489.5g, polyethylene glycol 4000 40g, hydrogenated castor oil 16.5g, methacrylic acid-methyl acrylate copolymer 200g, disintegrant low-substituted hydroxypropyl cellulose 60g, filler microcrystalline cellulose 75g and mannitol 550g.

[0086] (1) Clopidogrel hydrogen sulfate was passed through a 40-mesh sieve; mannitol and polyethylene glycol 4000 were passed through a 100-mesh sieve; microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and methacrylic acid-methyl acrylate copolymer were passed through 60 mesh sieve; the above-mentioned raw and auxiliary materials are evenly mixed to obtain spare raw and auxiliary materials;

[0087] (2) Add the spare raw and auxiliary materials to the dry granulator for granulation. The granulation parameters are selected as the feeding speed of 12-13 r / min, the extrusion pressure of 14-18kg, and the extrusion speed of 10-11 r / min. Select a 20-mesh screen, and re-granulate the fine powder wi...

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Abstract

The invention belongs to the technical field of biomedicines, and particularly relates to a clopidogrel hydrogen sulfate tablet and a preparation method thereof. The tablet is prepared from the following raw materials and auxiliary materials: clopidogrel hydrogen sulfate, polyethylene glycol 4000, hydrogenated castor oil, methylacrylic acid-methyl acrylate copolymer, a disintegrating agent and a filling agent; the tablet is prepared by taking composite slow-controlled-release raw materials as a base, and adding the filling agent and the disintegrating agent; the composite slow-controlled-release raw materials consist of wax matrix tablet material polyethylene glycol 4000, hydrogenated castor oil, and insoluble matrix tablet material methylacrylic acid-methyl acrylate copolymer. After beingprepared into a preparation with the composite filling agent and the disintegrating agent, the clopidogrel hydrogen sulfate tablet guarantees stable impurity content of the tablet on the basis of meeting the requirements of controlling release at uniform speed.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to a clopidogrel hydrogen sulfate tablet and a preparation method thereof. Background technique [0002] Clopidogrel hydrogen sulfate is an antiplatelet aggregation drug. Its mechanism of action Clopidogrel inhibits platelet aggregation through irreversible binding of its active metabolite to platelet P2Y12 ADP receptors. Clopidogrel can also inhibit other agonists other than ADP by blocking the released ADP-induced platelet activation and aggregation pathway. Induced platelet aggregation, developed by the French pharmaceutical company Sanofi-Aventis. Clopidogrel Hydrogen Sulfate Tablets were approved to be marketed in the United States under the trade name Plavix in November 1997, and were approved for import by SFDA in 2008. The marketed dosage forms are ordinary tablets, and the foreign marketed specifications are 75 mg and 300 mg. 75mg. [0003] The latest dat...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/22A61K31/4365A61K47/32A61K47/10A61K47/44A61P7/02A61P9/10
CPCA61K9/2013A61K9/2027A61K9/2031A61K31/4365
Inventor 芦红代
Owner HAINAN TIANHUANG PHARMA
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