Pharmaceutical composition of prasugrel hydrobromide acetate compound

A technology of triamyl hydrobromide and acetic acid compounds, applied in the field of medicine, can solve the problems of unresponsiveness, lack of tolerance, and unsuitability for patients who are prone to bleeding

Inactive Publication Date: 2012-02-08
CHIA TAI TIANQING PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, clopidogrel is not the most ideal drug, and still has its own shortcomings, such as some patients do not respond to this drug, and some patients lack tolerance to this drug. In addition, this drug is not suitable for patients who are prone to bleeding. Be applicable

Method used

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  • Pharmaceutical composition of prasugrel hydrobromide acetate compound
  • Pharmaceutical composition of prasugrel hydrobromide acetate compound
  • Pharmaceutical composition of prasugrel hydrobromide acetate compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Example 1: Preparation and identification of prasugrel hydrobromide acetic acid solvated crystals

[0036] 2-Acetoxy-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine (2 g) was dissolved in acetic acid (20m1), add hydrogen bromide in acetic acid (40%) solution (1.1g) dropwise at room temperature 25°C under stirring, add a small amount of seed crystals, and stir at the same temperature for 2 hours. The precipitated crystals were filtered, washed with a small amount of acetone, and dried under reduced pressure at 60° C. for 4 hours to obtain white crystals. (product 2.29g, yield 83%)

[0037] Prasugrel hydrobromide acetic acid solvate (0.4 g) was dissolved in acetic acid (4 ml) and heated to 70°C. Stir for 10 min, then cool to room temperature naturally, and continue stirring for 2 hours. The precipitated crystals were filtered, washed with a small amount of acetone, and dried under reduced pressure at 60°C for 4 hours to obtain the title...

Embodiment 2

[0040] Embodiment 2: Solubility experiment

[0041] Source of tested samples:

[0042] Prasugrel hydrochloride crystals were prepared according to the method provided in Example 1 of CN1452624A;

[0043] Prasugrel hydrobromide is prepared according to the method provided in Example 1 of CN101255169A;

[0044] The crystal of prasugrel hydrobromide acetate was prepared according to the method of Example 1;

[0045] Experimental method: refer to the general examples in the second part of the Pharmacopoeia of the People's Republic of China in 2005

[0046] substance

Embodiment 3

[0048] prescription:

[0049]

[0050] 1) Pulverizing prasugrel hydrobromide acetate through a 100-mesh sieve for subsequent use;

[0051] 2) Pass microcrystalline cellulose and sodium carboxymethyl starch through a 80-mesh sieve, heat to control the water content to be no more than 6%, and set aside; pass stearic acid through a 100-mesh sieve for use;

[0052] 3) Mix the prescribed amount of prasugrel hydrobromide acetate with microcrystalline cellulose in an equal increment method, after increasing 3 times, then mix with the remaining amount of microcrystalline cellulose, sodium carboxymethyl starch and stearic acid ;

[0053] 4) Tablet pressing, that is, plain tablets;

[0054] 5) The stomach-soluble film coating premix is ​​formulated into a coating liquid, stirred evenly, and set aside;

[0055] 6) Remove the fine powder from the plain tablet and perform film coating, inspection and packaging to obtain the coated tablet.

[0056] The water content of the sample was...

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Abstract

The invention provides a pharmaceutical composition of a prasugrel hydrobromide acetate compound, which belongs to the medicine field. The pharmaceutical composition is an oral tablet, the tablet comprises the prasugrel hydrobromide acetate compound and auxiliary materials adapted to medicinal use, and is characterized in that the moisture content in the tablet accounts for 0.5-5.0% of total massof the tablet. The oral tablet can be used for treating anti-platelet.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a pharmaceutical composition of prasugrel hydrobromide acetate, and also relates to a preparation method and application. Background technique [0002] With the aging of society and the improvement of living standards, the incidence and mortality of cardiovascular and cerebrovascular diseases are increasing day by day. According to a recent study. According to surveys in 8 major regions of the world, including developed and developing countries, thromboembolic diseases, mainly coronary artery thrombosis and cerebral thrombosis, have become the main cause of death. In my country, with the prolongation of the average life expectancy of residents and the change of living environment and dietary habits, the incidence and mortality of cardiovascular and cerebrovascular diseases are increasing year by year. Cardiovascular and cerebrovascular diseases have also become one of the co...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/28A61K31/4365A61P9/10A61P7/02
Inventor 周文亮张来芳许易
Owner CHIA TAI TIANQING PHARMA GRP CO LTD
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