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Medicinal composition containing prasugrel hydrochloride, and preparation method thereof

A technology of prasugrel hydrochloride and its composition, which is applied in the field of medicine, can solve problems affecting the quality of medicines, and achieve the effects of simple production operation, good stability, and complete dissolution

Active Publication Date: 2018-04-27
长春海悦药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Prasugrel hydrochloride is sensitive to moisture and heat, especially under aerobic conditions, prasugrel hydrochloride will undergo free radical conversion and degradation, affecting the quality of medicines

Method used

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  • Medicinal composition containing prasugrel hydrochloride, and preparation method thereof
  • Medicinal composition containing prasugrel hydrochloride, and preparation method thereof
  • Medicinal composition containing prasugrel hydrochloride, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0079] prescription

[0080]

[0081] Preparation

[0082] (1) Adding adipic acid into absolute ethanol to make adipic acid absolute ethanol solution with a mass fraction of 5%;

[0083] (2) Pass the prasugrel hydrochloride crude drug, lecithin, micropowder silica gel, and sodium carboxymethyl starch through a 60-mesh sieve respectively.

[0084] (3) Mix prasugrel hydrochloride crude drug, lecithin, and sodium carboxymethyl starch, spray 5% adipic acid absolute ethanol solution while mixing, add micropowder silica gel to mix and granulate, after drying at 40°C Tablets are obtained to obtain prasugrel hydrochloride tablets.

Embodiment 2

[0086] prescription

[0087]

[0088] Preparation

[0089] (1) Adding adipic acid into absolute ethanol to make adipic acid absolute ethanol solution with a mass fraction of 5%;

[0090] (2) Pass the prasugrel hydrochloride crude drug, lecithin, talcum powder and dry starch through a 60-mesh sieve respectively.

[0091] (3) Mix the prasugrel hydrochloride crude drug, lecithin, and dry starch, spray 5% adipic acid absolute ethanol solution while mixing, add talcum powder, mix and granulate, and compress after drying at 40°C. Get prasugrel hydrochloride tablet.

Embodiment 3

[0093] prescription

[0094]

[0095] Preparation

[0096] (1) Adding adipic acid into absolute ethanol to make a mass fraction of 5% adipic acid absolute ethanol solution;

[0097] (2) Pass the prasugrel hydrochloride crude drug, lecithin, micropowder silica gel, and sodium carboxymethyl starch through a 60-mesh sieve respectively.

[0098] (3) Mix prasugrel hydrochloride crude drug, lecithin, and sodium carboxymethyl starch, spray 5% adipic acid absolute ethanol solution while mixing, then add micropowder silica gel to mix and granulate, dry at 40°C and press Tablets, get prasugrel hydrochloride tablets.

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Abstract

The invention belongs to the technical field of medicines, and concretely relates to a medicinal composition containing prasugrel hydrochloride. The medicinal composition contains prasugrel hydrochloride, lecithin, a disintegrating agent and a lubricant, and also contains adipic acid and anhydrous ethanol. The medicinal composition has the advantages of good stability, completeness in dissolve-out, excellent quality, simplicity and easiness in production operation, and suitableness for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a pharmaceutical composition containing prasugrel hydrochloride and a preparation method of tablets thereof. Background technique [0002] Prasugrel hydrochloride is a new orally effective thienopyridine drug. Like clopidogrel, prasugrel hydrochloride is also an inactive prodrug, which needs to be converted into active metabolites by cytochrome P450 enzyme system. Irreversibly inhibits P2Y12 adenosine diphosphate receptors on platelets. The curative effect of prasugrel hydrochloride is better than that of clopidogrel, which can be explained from the improvement of its pharmacokinetic properties. Prasugrel hydrochloride has a higher conversion rate of prodrugs to active metabolites and higher bioavailability, so The onset of effect is faster and can reduce the difference in efficacy among individuals, and reduce the incidence of major ischemic cardiovascular events ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4365A61K47/24A61K47/12A61K47/10A61P7/02
CPCA61K9/2013A61K9/2095A61K31/4365A61K47/10A61K47/12
Inventor 刘春梅姜波贲旭马雪琼
Owner 长春海悦药业股份有限公司
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