Preparation method of telmisartan tablets

A technology of telmisartan and plain tablets, which is applied in the field of preparation of telmisartan tablets, can solve problems such as poor similarity, and achieve the effects of saving manpower and material resources, improving similarity, and simple process operation

Inactive Publication Date: 2020-08-18
CHONGQING CONQUER PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] For above-mentioned prior art feature, the purpose of the present invention is to provide a kind of preparation method of telmisartan, is used to solve the similarity problem of multiple stripping curves of main drug and reference preparation in prior art preparation process

Method used

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preparation example Construction

[0026] A preparation method of telmisartan tablet, comprising the following steps:

[0027] S1, take telmisartan, sodium hydroxide and be mixed with aqueous solution or ethanol aqueous solution;

[0028] S2. Adjust the parameters of the fluidized bed, set the air inlet temperature to 80°C for spray drying and granulation, spray the mixed solution prepared in step S1, continue drying after spraying, control the moisture content to not be higher than 3.5%, and obtain dry granules, and the drying is completed After whole grain;

[0029] S3. Add the weighed mannitol, meglumine, and povidone to the sized granules, mix for 15 minutes, mix evenly with the weighed magnesium stearate and sodium stearyl fumarate, and then press into tablets to obtain vegetarian tablets. The hardness of the plain tablet is controlled at 9-11kgf;

[0030] S4. Film-coat the plain tablet.

[0031] Wherein, the weight ratio of telmisartan, mannitol, meglumine, povidone, sodium hydroxide, magnesium stearat...

Embodiment 1

[0035] A preparation method of telmisartan tablet, comprising the following steps:

[0036] S1, take by weighing telmisartan 50g, sodium hydroxide 4g and join in 200ml water to prepare an aqueous solution, set aside;

[0037] S2. Adjust the parameters of the fluidized bed, set the air inlet temperature to 100°C for spray drying and granulation, spray the aqueous solution prepared in step S1, continue drying after the spraying is completed, and control the moisture content to be no higher than 3.5%, to obtain dry granules. After the drying is completed Whole grain;

[0038] S3. Add 700g of mannitol, 30g of meglumine, and 30g of povidone to the granulated granules, mix them for 15min, mix them with 25g of magnesium stearate and 5g of sodium stearyl fumarate, and press Tablets are made of plain tablets, and the hardness of the plain tablets is controlled at 7-11kgf;

[0039] S4. Film-coat the plain tablet.

Embodiment 2

[0041] A preparation method of telmisartan tablet, comprising the following steps:

[0042] S1. Prepare 170ml of ethanol solution according to the ratio of ethanol and water at 2:1, weigh 50g of telmisartan and 4g of sodium hydroxide and add them to the prepared ethanol solution to prepare an aqueous ethanol solution for subsequent use;

[0043] S2. Adjust the parameters of the fluidized bed, set the air inlet temperature to 80°C for spray drying and granulation, spray into the ethanol aqueous solution prepared in step S1, continue drying after spraying, control the moisture content to not be higher than 3.5%, and obtain dry granules, and the drying is completed After whole grain;

[0044] S3. Add 75g of mannitol, 20.5g of meglumine, and 20.5g of povidone to the granulated granules, mix for 15 minutes, and mix with 2g of magnesium stearate and 6.25g of sodium stearyl fumarate After uniform compression, plain tablets are obtained, and the hardness of the plain tablets is contr...

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Abstract

The invention relates to a preparation method of telmisartan tablets. The preparation method comprises the following steps of: S1, weighing telmisartan and sodium hydroxide to prepare an aqueous solution or an ethanol aqueous solution; S2, adjusting fluidized bed parameters, spraying the mixed solution prepared in the step S1, carrying out spray granulation, drying and straightening granules afterdrying is completed; S3, adding the straightened granules into the weighed mannitol, meglumine and povidone, mixing for 15 minutes, uniformly mixing with the weighed magnesium stearate and sodium stearyl fumarate, and tabletting to obtain plain tablets of which the hardness is controlled to be 9-11 kgf; and S4, carrying out film coating on the plain tablets. According to the invention, the prescription process of the telmisartan tablet is optimized, and the similarity of a plurality of dissolution curves of a self-prepared product and a reference preparation is improved.

Description

technical field [0001] The invention relates to the field of medicine and chemical industry, in particular to a preparation method of telmisartan tablets. Background technique [0002] Telmisartan is a new antihypertensive drug and a specific angiotensin II receptor (AT1 type) antagonist. Telmisartan substitutes for the angiotensin II receptor and binds with high affinity to the AT1 receptor subtype (the known site of action of angiotensin II). Telmisartan does not have any agonist effect at the AT1 receptor site, and Telmisartan selectively binds to the AT1 receptor, and the binding effect is long-lasting. 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, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/4184A61K47/32A61K47/26A61K47/18A61K47/12A61K47/02A61P9/12
CPCA61K9/2009A61K9/2013A61K9/2018A61K9/2027A61K9/2095A61K9/2806A61K31/4184A61P9/12
Inventor 陈用芳樊竞洁杨绪凤胡延贵冉小琴王松
Owner CHONGQING CONQUER PHARML
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