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Clopidogrel hydrogen sulfate tablet and preparation method thereof

A technology of clopidogrel bisulfate tablets and clopidogrel bisulfate, which is applied in the field of pharmaceuticals, can solve the problems of clopidogrel bisulfate instability, elevated related substances, increased production costs, etc. Stable and efficient results

Inactive Publication Date: 2011-11-23
SHANDONG FANGMING PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Because clopidogrel bisulfate is very unstable during the production and granulation process, it is easy to lead to the increase of related substances, thus making the curative effect unstable
If the tablet is directly compressed, common excipients cannot meet the fluidity requirements during direct compression, and if high-performance excipients are used, the production cost will be increased accordingly

Method used

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  • Clopidogrel hydrogen sulfate tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Starch 34g

[0016] Hypromellose 32g

[0017] 5% starch slurry appropriate amount

[0018] Clopidogrel bisulfate (clopidogrel meter) 25g

[0019] Talc 0.25%

[0020] Magnesium Stearate 0.25%

[0021]

[0022] Film coating premix 4g

[0023] 90% ethanol 36g

[0024]

[0025] Makes 1000 pieces

Embodiment 2

[0027] 34g pregelatinized starch

[0028] Microcrystalline Cellulose 32g

[0029] 5% starch slurry appropriate amount

[0030] Clopidogrel bisulfate (clopidogrel meter) 25g

[0031] Differential Silica Gel 0.25%

[0032] Stearic acid 0.25%

[0033]

[0034] Film coating premix 4g

[0035] 90% ethanol 36g

[0036]

[0037] Makes 1000 pieces

Embodiment 3

[0039] Lactose 16g

[0040] 20g pregelatinized starch

[0041] Sodium carboxymethyl starch 30g

[0042] 5% starch slurry appropriate amount

[0043] Clopidogrel bisulfate (clopidogrel meter) 25g

[0044] Differential Silica Gel 0.25%

[0045] Magnesium Stearate 0.25%

[0046]

[0047] Film coating premix 4g

[0048] 90% ethanol 36g

[0049]

[0050] Makes 1000 pieces

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Abstract

The invention relates to a preparation for preventing and treating adverse events of atherosclerosis and cardio-cerebrovascular embolism as well as the complications thereof, i.e. a clopidogrel hydrogen sulfate tablet and a preparation method thereof. The tablet comprises clopidogrel hydrogen sulfate, a filler, a disintegrating agent, a lubricating agent, an adhesive, and a film coating premixing agent. The preparation method is characterized by the steps of: weighing the filler, the disintegrating agent in a proportion specified in the prescription, mixing them well, making wet granules with the right amount of the adhesive, drying the wet granules at a temperature of 40-60DEG C, sieving the granules through a sieve of 24 meshes and finishing the granules, adding clopidogrel hydrogen sulfate and the lubricating agent and mixing well, then conducting tabletting, coating and packaging, thus obtaining the tablet. The tablet of the invention has the characteristics of simple prescription and process, good stability, high bioavailability, low cost, high production efficiency and the like.

Description

Technical field: [0001] The invention relates to a tablet containing clopidogrel hydrogen sulfate for preventing and treating atherosclerosis, cardiovascular and cerebrovascular thrombotic adverse events and complications thereof and a preparation method thereof, belonging to the technical field of medicines. Background technique: [0002] Clopidogrel bisulfate was developed by Sanofi in France in 1986. It was first launched in the United States in March 1998, and then entered the markets of Europe, Canada, Australia, Singapore and other countries. It was launched in my country in 2000. Its chemical name: S(+)-2-(2-chlorophenyl)-2-(4,5,6,7-tetrahydrothiophene[3,2,C]pyridine-5)acetate methyl hydrogen sulfate Salt, the molecular weight is 419.91, and the molecular structure is: [0003] [0004] Clopidogrel is a thienopyridine adenosine diphosphate (ADP) receptor antagonist that can efficiently inhibit platelet activity. Antiplatelet drugs that have been extensively resea...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/4365A61P7/02A61P9/10
Inventor 崔改英孟爱红穆子齐苏贵勇付建
Owner SHANDONG FANGMING PHARMACEUTICAL CO LTD
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