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Preparation method of intermediate of telmisartan preparation

A technology for telmisartan and an intermediate, which is applied in the field of preparation of telmisartan preparations, can solve problems such as material binding, and achieves the effects of solving material binding, improving drug dissolution, and simple preparation method

Pending Publication Date: 2021-05-14
JIANGSU ZHONGBANG PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to overcome the deficiencies in the prior art, provide a kind of preparation method of improved telmisartan preparation, solve the problem of material cohesion in the wet granulation process after telmisartan salt formation in the prior art

Method used

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  • Preparation method of intermediate of telmisartan preparation
  • Preparation method of intermediate of telmisartan preparation
  • Preparation method of intermediate of telmisartan preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Prepare Telmisartan capsules, weigh each component material according to the following formula:

[0033]

[0034]

[0035] Preparation method: Dissolve sodium hydroxide in ethanol, add telmisartan to dissolve, let stand for 0.5h to crystallize, and obtain a solid-liquid mixture of telmisartan sodium; microcrystalline cellulose, lactose, meglumine, povidone Weigh according to the prescription amount, mix evenly, add the solid-liquid mixture of telmisartan sodium into the mixed auxiliary materials to make a soft material, pass through a 40-mesh sieve to obtain wet granules; blow dry at 60°C until the moisture content is <3.0%, and pass through a 60-mesh sieve Sieve dry granules; fill capsules.

Embodiment 2

[0037] Prepare Telmisartan capsules, weigh each component material according to the following formula:

[0038]

[0039] Preparation method: Dissolve sodium hydroxide in ethanol, add telmisartan to dissolve, let stand for 3 hours to crystallize, and obtain telmisartan sodium solid-liquid mixture; starch, lactose, meglumine, cross-linked carboxymethyl cellulose The sodium was weighed according to the prescription amount, mixed evenly, the solid-liquid mixture of telmisartan sodium was added to the mixed auxiliary materials to make a soft material, and wet granules were obtained by passing through a 40-mesh sieve; air-dried at 60°C until the moisture content was <3.0%, passed through a 40-mesh sieve Mesh sieve to obtain dry granules; add talcum powder and mix; fill capsules.

Embodiment 3

[0041] Prepare Telmisartan capsules, weigh each component material according to the following formula:

[0042]

[0043]

[0044] Preparation method: Dissolve sodium hydroxide in ethanol, add telmisartan to dissolve, stir for 2 hours to crystallize, and obtain a solid-liquid mixture of telmisartan sodium; starch, lactose, meglumine, and crospovidone according to the prescription amount Weigh, mix evenly, add the solid-liquid mixture of telmisartan sodium into the mixed auxiliary materials to make soft materials, pass through a 40-mesh sieve to obtain wet granules; blow dry at 60°C until the moisture content is less than 3.0%, pass through a 60-mesh sieve to obtain dry Granules; filled capsules.

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Abstract

The invention discloses a preparation method of a telmisartan preparation. The preparation method comprises the following steps: dissolving 3-4 parts by mass of sodium hydroxide and 40 parts by mass of telmisartan in 40-60 parts by mass of a solvent, conducting stirring or standing and crystallizing to obtain a telmisartan sodium solid-liquid mixture; adding auxiliary materials such as 120-180 parts by mass of a diluent, 5-15 parts by mass of meglumine, 0-10 parts by mass of an adhesive, 0-15 parts by mass of a disintegrating agent and the like into the telmisartan sodium solid-liquid mixture, and carrying out wet granulation; adding 0-5 parts by mass of a lubricating agent after drying and granulating, and carrying out total mixing; and tabletting totally-mixed particles or filled capsules. The method is simple to operate and treat, and telmisartan sodium is formed through solution reaction, so the purpose of improving medicine dissolution can be achieved; and the problem of material bonding in the wet granulation process can be solved through granulation after crystallization of a specific amount of solvent.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method of a telmisartan preparation. Background technique [0002] Telmisartan is a new type of antihypertensive drug and a specific angiotensin II receptor (ATI type) antagonist for the treatment of essential hypertension. Its preparation, Telmisartan Tablets, is used for the treatment of essential hypertension in adults and reduces cardiovascular risk. It is suitable for those aged 55 and above who are at high risk of serious cardiovascular events and cannot accept angiotensin transferase ( ACE inhibitors to reduce the risk of myocardial infarction, stroke, or death from cardiovascular disease. [0003] There are many domestic manufacturers of telmisartan preparations, most of which are ordinary tablets and capsules. Because telmisartan is insoluble in water, it is prone to problems such as low dissolution rate and poor curative effect afte...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4184A61K9/48A61K9/20A61K47/02A61P9/12
CPCA61K31/4184A61K9/1652A61K9/2054A61P9/12A61K9/2009A61K9/1611
Inventor 李维思许林菊徐强柳贞孔鹏许鹏飞魏志平
Owner JIANGSU ZHONGBANG PHARMA
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