Ambrisentan tablet and preparation method thereof

A technology for ambrisentan and sentan tablet, which is applied in the field of ambrisentan tablet and its preparation, can solve the problems that ambrisentan preparation needs to be in-depth, reported, and there is no ambrisentan preparation technology, etc., and achieves stable and controllable quality , reduce dosage deviation, and promote the effect of disintegration and dissolution

Inactive Publication Date: 2016-05-18
HUMANWELL HEALTHCARE GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, ambrisentan is an insoluble drug, which limits its clinical application to a certain extent, and there is no relevant report on ambrisentan preparation technology in the prior art
[0004] At present, research on ambrisentan preparations still needs to be deepened

Method used

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  • Ambrisentan tablet and preparation method thereof
  • Ambrisentan tablet and preparation method thereof
  • Ambrisentan tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Example 1: Preparation of Ambrisentan Tablets (Specification: 10mg) by Powder Direct Compression Process

[0056] prescription:

[0057]

[0058] The method is as follows:

[0059] 1) Take the ambrisentan of prescription quantity, carry out micronization to particle diameter and be 5-50 micron,

[0060] 2) Mix the auxiliary materials lactose, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate, pass through a 60-mesh sieve, add to ambrisentan, and mix evenly in a mixer;

[0061] 3) compressing the material in step 2) on a tablet press to obtain ambrisentan tablets;

[0062] 4) Coating Amritsentansu Tablets in a high-efficiency coating machine, the coating powder is Opadry 85G64706, using purified water 4 times the weight of the coating powder, stirring evenly to disperse the coating powder evenly, and preparing The coating solution is ready for use; the coating parameters are: air inlet temperature 55-60°C, material temperature 38-40°C, host ...

Embodiment 2

[0064] Example 2: Preparation of Ambrisentan Tablets (Specification: 10mg) by Powder Direct Compression Process

[0065] prescription:

[0066]

[0067] The method is as follows:

[0068] 1) Take the ambrisentan of prescription quantity, carry out micronization to particle diameter and be 30-60 micron,

[0069] 2) Mix the auxiliary materials lactose, microcrystalline cellulose, sodium carboxymethyl starch, and magnesium stearate, pass through a 40-mesh sieve, add to ambrisentan, and mix evenly in a mixer;

[0070] 3) compressing the material in step 2) on a tablet press to obtain ambrisentan tablets;

[0071] 4) Coating Amritsentansu Tablets in a high-efficiency coating machine, the coating powder is Opadry 85G64706, using purified water 4 times the weight of the coating powder, stirring evenly to disperse the coating powder evenly, and preparing The coating solution is ready for use; the coating parameters are: air inlet temperature 60-65°C, material temperature 35-40°C...

Embodiment 3

[0072] Example 3: Preparation of Ambrisentan Tablets (Specification: 10mg) by Powder Direct Compression Process

[0073] prescription:

[0074]

[0075]

[0076] The method is as follows:

[0077] 1) Take the ambrisentan of prescription quantity, carry out micronization to particle diameter and be 60-100 micron,

[0078] 2) Mix the auxiliary materials mannitol, microcrystalline cellulose, sodium carboxymethyl starch, and magnesium stearate, pass through an 80-mesh sieve, add to ambrisentan, and mix evenly in a mixer;

[0079] 3) compressing the material in step 2) on a tablet press to obtain ambrisentan tablets;

[0080] 4) Coating Amritsentansu Tablets in a high-efficiency coating machine, the coating powder is Opadry 85G64706, using purified water 4 times the weight of the coating powder, stirring evenly to disperse the coating powder evenly, and preparing The coating solution is ready for use; the coating parameters are: air inlet temperature 55-60°C, material temper...

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Abstract

The invention provides an ambrisentan tablet and a preparation method thereof. The ambrisentan tablet consists of ambrisentan and pharmaceutically acceptable adjuvant materials. The ambrisentan tablet disclosed by the invention can be used for effectively treating pulmonary hypertension; and the ambrisentan tablet is simple in preparation process, good in dissolution degree, low in content of related materials, good in quality and stable and controllable in quality.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to an ambrisentan tablet and a preparation method thereof. Background technique [0002] Pulmonary hypertension refers to the persistent increase of pulmonary artery pressure caused by various reasons. It is a rare chronic syndrome, manifested as pulmonary artery narrowing, damage and high blood pressure. Thickening and damage to the walls of the pulmonary artery can cause the blood vessel to narrow, and small blood clots can form in the vessel, eventually leading to blockage. Because the right myocardium is not as strong as the left myocardium and is more susceptible to damage, the increase in vascular resistance will increase the workload of the right heart, eventually leading to right heart failure and death. Right heart failure is the only common cause of disability and death for all types of pulmonary hypertension patients, and pulmonary hypertension is also the most importan...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/505A61P11/00A61P9/12A61J3/00
Inventor 王学海许勇李莉娥吴迪黄怡范昭泽黄璐黄翔乐洋杨仲文刘亚璇袁李芳肖强田华唐静周文杨菁张毅
Owner HUMANWELL HEALTHCARE GRP
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