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Oral solid preparation containing clopidogrel hydrogen sulfate

A technology of clopidogrel hydrogen sulfate and solid preparation, applied in the field of medicine, can solve problems such as increase in substance, decrease in stability, decrease in tablet dissolution rate, etc. Effective therapeutic effect

Active Publication Date: 2010-08-04
CHINA PHARM UNIV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The purpose of this invention is to provide a kind of pharmaceutical composition, it uses the mixture of light liquid paraffin and talcum powder as the lubricant of clopidogrel hydrogen sulfate sheet, can realize the industrialized production of clopidogrel hydrogen sulfate sheet, solve the problem of hydrogen sulfate chloride Pidogrel tablets have problems such as increased substances, decreased stability and decreased dissolution rate of tablets, making it more effective to play a therapeutic role

Method used

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  • Oral solid preparation containing clopidogrel hydrogen sulfate
  • Oral solid preparation containing clopidogrel hydrogen sulfate
  • Oral solid preparation containing clopidogrel hydrogen sulfate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] Clopidogrel bisulfate tablet 1 recipe

[0072] Preparation Content of each component in each tablet (mg)

[0073] Clopidogrel Bisulfate 33 (equivalent to Clopidogrel 25mg)

[0074] Lactose 177

[0075] Talc powder 10

[0076] Light liquid paraffin 0.5

[0077] 1% hypromellose (prepared with 50% ethanol) appropriate amount

[0078] Preparation method: uniformly mix clopidogrel hydrogen sulfate (crystalline form I) and lactose, add 1% hypromellose to prepare wet granules, and dry the granules at 50°C. Add the mixture of light liquid paraffin and talcum powder, mix well and press into tablets.

Embodiment 2

[0080] Clopidogrel Bisulfate Tablets 2 Formulations

[0081] Preparation Content of each component in each tablet (mg)

[0082] Clopidogrel Bisulfate 33 (equivalent to Clopidogrel 25mg)

[0083] Lactose 330

[0084] Low-substituted hydroxypropyl cellulose 12

[0085] Talc 32

[0086] Light liquid paraffin 0.8

[0087] Preparation method: Mix all materials evenly and directly compress into tablets.

Embodiment 3

[0089] Clopidogrel Bisulfate Tablets 3 Formulations

[0090] Preparation Content of each component in each tablet (mg)

[0091] Clopidogrel Bisulfate 98 (equivalent to Clopidogrel 75mg)

[0092] Lactose 130

[0093] Low-substituted hydroxypropyl cellulose 10

[0094] Talc 12

[0095] Light liquid paraffin 0.8

[0096] 1% hypromellose (prepared with 50% ethanol) appropriate amount

[0097] Preparation method: Mix clopidogrel hydrogen sulfate (form I) and lactose evenly, then add low-substituted hydroxypropyl cellulose and mix evenly; add 1% hypromellose solution, use wet granulation, and dry at 50 degrees Granules; add a mixture of light liquid paraffin and talcum powder, mix well and compress into tablets.

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PUM

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Abstract

The invention relates to an oral administration, in particular to a solid composite containing clopidogrel hydrogen sulfate; the solid composite containing clopidogrel hydrogen sulfate comprises the following ingredients by weight part: 100 parts of clopidogrel hydrogen sulfate and 5-100 parts of mixture of liquid paraffin and talcum powder; the composite can realize industrial production of the clopidogrel hydrogen sulfate and solve the problems that related substances of the tablets rises and the dissolution is reduced.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to an oral solid preparation containing clopidogrel bisulfate. Background technique [0002] US Patent No. 4,847,265 discloses clopidogrel bisulfate as a platelet aggregation inhibitor. The chemical name of clopidogrel hydrogen sulfate is S(+)-2-(2-chlorophenyl)-2-(4,5,6,7-tetrahydrothiophene[3,2-c]pyridine-5)acetic acid Methyl bisulfate, clinically applicable to patients with recent stroke, myocardial infarction and confirmed peripheral arterial disease, can reduce the occurrence of atherosclerotic events. [0003] The current clinical dosage forms of clopidogrel bisulfate include oral tablets listed under the trade name Plavix (the specification is 75 mg clopidogrel / tablet) and tablets listed under the trade name "Taijia" (the specification is 25 mg clopidogrel / tablet). ). According to the Plavix label, Plavix tablets are film-coated tablets, each containing 98 mg of clopidog...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4365A61K47/02A61K47/44A61K9/20A61P7/02A61P9/10A61K47/06
Inventor 高缘张建军苏晴
Owner CHINA PHARM UNIV
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