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Application of chromeplate stamp die in process of preparing clopidogrel hydrogen sulfate tablets

A technology of clopidogrel bisulfate tablets and clopidogrel bisulfate, which is applied in the field of punching dies of tablet presses, and can solve problems such as a large proportion of raw materials, sticky punching, and large specifications

Inactive Publication Date: 2012-04-04
北京华禧联合科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Clopidogrel exists in a stable form of bisulfate. The pH value of clopidogrel bisulfate in water is 1.5~2.5. Currently, all the products on the market are tablets. The specifications of clopidogrel bisulfate tablets are those containing clopidogrel hydrogen sulfate. Clopidogrel is calculated as 25mg-75mg, its raw material is highly acidic, and its specifications are large, and the proportion of raw material in the tablet is relatively large, so it will cause serious sticking phenomenon in the process of tablet compression

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Embodiment 1: the preparation of clopidogrel bisulfate sheet

[0019] prescription:

[0020] prescription composition per thousand pieces (g) Clopidogrel bisulfate 32.6 anhydrous lactose 50 Microcrystalline Cellulose PH112 100 Low-substituted hydroxypropyl cellulose 13 Micropowder silica gel 23 polyethylene glycol 6000 12 Opadry II 7

[0021] Preparation process: pass the main drug and auxiliary materials through 80-mesh sieve respectively. Mix clopidogrel bisulfate, low-substituted hydroxypropyl cellulose, micropowder silica gel and polyethylene glycol 6000 evenly, then add anhydrous lactose and microcrystalline cellulose PH112, mix evenly, and press the powder directly with a tablet press machine with a chrome-plated die piece. Add Opadry II and appropriate amount of water to prepare a coating solution, and coat the plain tablet with a film coat to obtain clopidogrel hydrogen sulfate tablets. During the prepa...

Embodiment 2

[0023] Embodiment 2: the preparation of clopidogrel bisulfate sheet

[0024] prescription:

[0025] prescription composition per thousand pieces (g) Clopidogrel bisulfate 97.9 anhydrous lactose 45 Microcrystalline Cellulose PH112 80 pregelatinized starch 20 Crospovidone 13 Micropowder silica gel 23 hydrogenated castor oil 8 Opadry II 10

[0026] Preparation process: pass the main drug and auxiliary materials through 80-mesh sieve respectively. Mix clopidogrel bisulfate, pregelatinized starch, crospovidone, and micropowdered silica gel evenly, then add anhydrous lactose and microcrystalline cellulose PH112, mix evenly, dry granulate, add hydrogenated castor oil, mix evenly, and use Tablet press with chrome-plated dies for direct compression. Add Opadry II and appropriate amount of water to prepare a coating solution, and coat the plain tablet with a film coat to obtain clopidogrel hydrogen sulfate tablets. During...

Embodiment 3

[0028] Embodiment 3: the preparation of clopidogrel bisulfate sheet

[0029] prescription:

[0030] prescription composition per thousand pieces (g) Clopidogrel bisulfate 32.6 Mannitol 200SD 80 Microcrystalline Cellulose PH112 50 Low-substituted hydroxypropyl cellulose 15 Micropowder silica gel 23 polyethylene glycol 6000 12 Opadry II 7

[0031] Preparation process: pass the main drug and auxiliary materials through 80-mesh sieve respectively. Mix clopidogrel bisulfate, low-substituted hydroxypropyl cellulose, micropowder silica gel and polyethylene glycol 6000 evenly, then add mannitol 200SD and microcrystalline cellulose PH112, mix evenly, and use a tablet press with a chrome-plated die to directly compress the tablet . Add Opadry II and appropriate amount of water to prepare a coating solution, and coat the plain tablet with a film coat to obtain clopidogrel hydrogen sulfate tablets. During the preparation process,...

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PUM

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Abstract

The invention relates to a stamp die of a tablet press which improves the sticking problem in the process of preparing clopidogrel hydrogen sulfate tablets, in particular to a chromeplate stamp die of a tablet press which is able to improve the sticking problem in the process of preparing clopidogrel hydrogen sulfate tablets greatly.

Description

[0001] technical field [0002] The present invention relates to a tablet press die for improving the sticking phenomenon in the preparation process of clopidogrel hydrogen sulfate tablets, in particular to a chrome-plated tablet press die, which can well improve the process of preparing clopidogrel hydrogen sulfate tablets sticking phenomenon. [0003] Background technique [0004] Clopidogrel (clopidogrel) is a thienopyridine adenosine diphosphate (ADP) receptor antagonist, first listed in the United States in June 1998, and listed in my country in August 2001. The drug can effectively inhibit the activity of platelets, and is an anti-platelet drug widely researched and applied in various fields such as arterial thrombosis diseases, such as myocardial infarction, stroke and peripheral arterial ischemic diseases. [0005] Indications: Applied to patients with recent stroke, myocardial infarction and confirmed peripheral arterial disease to reduce the occurrence of atheros...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): B30B15/02A61K9/20A61K9/30A61K31/4365A61P7/02
Inventor 不公告发明人
Owner 北京华禧联合科技发展有限公司
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