Telmisartan tablet and preparation method thereof

A technology for telmisartan and tableting, which is applied in the field of telmisartan tablets and their preparation, can solve the problem that serious agglomeration or bed collapse is likely to occur, materials are easily adsorbed on the wall of a device, and telmisartan is not easy to mix. problems of uniformity

Inactive Publication Date: 2018-05-04
湖南威特制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0007] In view of the above-mentioned prior art, the purpose of the present invention is to overcome the preparation method in the prior art so that the telmisartan in the medicament is not easy to mix evenly, the material is easy to be adsorbed on the wall of the device, or it is easy to cause serious agglomeration or bed collapse, etc. phenomenon, thereby providing a telmisartan tablet that can make telmisartan evenly mixed in the tablet, and is not prone to agglomeration or bed collapse, and can improve the dissolution rate of the tablet and its preparation method

Method used

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  • Telmisartan tablet and preparation method thereof
  • Telmisartan tablet and preparation method thereof

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preparation example Construction

[0018] The present invention provides a kind of preparation method of telmisartan tablet, wherein, described preparation method comprises:

[0019] 1) under the condition that solvent exists, telmisartan is mixed with acid-base regulator, makes telmisartan sodium salt;

[0020] 2) adding a binder to telmisartan sodium salt to prepare a slurry, adding a part of the filler, drying and granulating to obtain granules;

[0021] 3) Tablets are added after adding the remaining filler and lubricant to the granules to obtain telmisartan tablets; wherein,

[0022] The acid-base regulator includes at least sodium hydroxide.

[0023] In the present invention, telmisartan is first mixed with an acid-base regulator in the presence of a solvent, then a part of the filler is added after adding a binder therein, and dried and granulated to obtain granules, and further, to the above granules Add the filling agent of remaining part and all lubricants and mix tabletting, make the telmisartan in...

Embodiment 1

[0037] The sodium hydroxide 3.36g that weighed recipe quantity (in 1000 pieces) joins 150mL purified water, after stirring and dissolving, add meglumine 12g, after stirring and dissolving completely, add telmisartan raw material 40g, after stirring and dissolving completely, Finally, povidone was added, stirred and dissolved, and ultrasonically degassed to obtain a slurry. Weighed 122.24g of mannitol as a substrate and added it to a fluidized bed for granulation, plus 31.92g of mannitol, 12g of hydroxypropyl cellulose, and stearic acid. 1.68g of magnesium and 4.8g of talc powder were mixed and pressed into tablets to obtain Telmisartan Tablet A1. Among them, the parameters of the fluidized bed are: the spraying speed is 10r / min, the air inlet temperature is 50°C, the fan frequency is 30Hz, and the material temperature is controlled at about 40°C.

Embodiment 2

[0039] Prepare according to the preparation method of Example 1, the difference is that the spraying speed is 4r / min, the air inlet temperature is 60°C, and the material temperature is controlled at about 45°C to obtain Telmisartan Tablet A2.

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Abstract

The invention discloses a telmisartan tablet and a preparation method thereof. The preparation method comprises the following steps: 1) in the presence of a solvent, mixing telmisartan with an acid and alkaline regulator to prepare a telmisartan sodium salt; 2) adding a binding agent into the telmisartan sodium salt to prepare slurry, adding a part of a filling agent into the slurry, drying and pelletizing, thereby preparing particulate matters; and 3) adding the rest of the filling agent and a lubricating agent into the particulate matters to tablet, thereby preparing the telmisartan tablet,wherein the acid and alkaline regulator comprises at least sodium hydroxide. The preparation method is used for firstly mixing the telmisartan with the acid and alkaline regulator in the existence ofthe solvent, adding the binding agent, then adding one part of the filling agent, drying and pelletizing to prepare the particulate matters, and further, adding the rest of the filling agent and all the lubricating agent into the particulate matters to mix and tablet, so that the telmisartan in the telmisartan tablet prepared through the steps is uniformly mixed without an obvious clustering phenomenon, and therefore, the material yield is relatively high.

Description

technical field [0001] The invention relates to the field of preparation of pharmaceutical preparations, in particular to telmisartan tablets and a preparation method thereof. Background technique [0002] Telmisartan is a non-peptide angiotensin II receptor antagonist, which can selectively and irreversibly block AT1 receptors without affecting other receptor systems, especially those involving the cardiovascular system. It is mainly used clinically for the treatment of essential hypertension. [0003] Angiotensin (AT) II receptor antagonists (sartan drugs) are the latest drugs for the treatment of high blood pressure that have been on the market since 1995. This type of drug has been widely affirmed and accepted by clinicians and patients since it was launched. A new force in the treatment of hypertension. Telmisartan has a high bioavailability among similar drugs, especially the one with the longest half-life. It can be taken once a day, one capsule each time, and can s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4184A61K47/02A61P9/12
CPCA61K31/4184A61K9/2009A61K9/2095
Inventor 何亮
Owner 湖南威特制药股份有限公司
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