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Preparation method for 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: 2020-09-25
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 method for telmisartan tablets
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Examples

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preparation example Construction

[0025] A preparation method of telmisartan tablet, comprising the following steps:

[0026] S1. Take telmisartan, sodium hydroxide, and meglumine to prepare aqueous solution or ethanol aqueous solution;

[0027] S2. Add the weighed povidone and mannitol after sieving into the fluidized bed to make it in a fluidized state, spray the mixed solution prepared in step S1, and set the inlet air temperature to 100°C for spray drying and granulation , continue to dry after the spraying is completed, control the moisture content not to exceed 3.5%, and obtain dry granules, and granulate after the drying is completed;

[0028] S3. Add the weighed magnesium stearate and sodium stearyl fumarate to the sized granules, mix evenly, and press into tablets to obtain plain tablets. The hardness of the plain tablets is controlled at 7-11kgf.

[0029] Wherein, the weight ratio of telmisartan, mannitol, meglumine, povidone, sodium hydroxide, magnesium stearate, sodium stearyl fumarate is 20~80:12...

Embodiment 1

[0034] A preparation method of telmisartan tablet, comprising the following steps:

[0035] S1, take telmisartan 50g, sodium hydroxide 4g, meglumine 30g and join in 200ml water to prepare an aqueous solution, set aside;

[0036] S2. Add 30 g of povidone weighed and 700 g of mannitol after passing through a 100-mesh sieve into the fluidized bed to make it in a fluidized state, spray the aqueous solution prepared in step S1, and set the air inlet temperature to 120°C for spraying Drying and granulation, continue to dry after spraying, control the water content not higher than 3.5%, to obtain dry granules, granulate after drying;

[0037] S3. Add 25g of magnesium stearate and 5g of sodium stearyl fumarate into the sized granules, mix well, and press into tablets to obtain plain tablets, the hardness of which is controlled at 7-11kgf.

Embodiment 2

[0039] A preparation method of telmisartan tablet, comprising the following steps:

[0040] S1, according to the ratio of ethanol and water is 2:1, is configured as ethanol solution 170ml, weighs 50g of telmisartan, 4g of sodium hydroxide, and 20.5g of meglumine and joins in the prepared ethanol solution to prepare an ethanol solution for later use;

[0041] S2. Add 20.5 g of povidone weighed and 75 g of mannitol after sieving into the fluidized bed together to make it in a fluidized state, spray into the aqueous ethanol solution prepared in step S1, and set the inlet air temperature to 100°C for spraying Drying and granulation, continue to dry after spraying, control the water content not higher than 3.5%, to obtain dry granules, granulate after drying;

[0042] S3. Add 2 g of magnesium stearate and 6.25 g of sodium stearyl fumarate into the sized granules, mix well, and press into tablets to obtain plain tablets. The hardness of the plain tablets is controlled at 7-11 kgf. ...

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Abstract

The invention relates to a preparation method for telmisartan tablets. The preparation method comprises the following steps: S1, weighing telmisartan, sodium hydroxide and meglumine to prepare an aqueous solution or an aqueous ethanol; S2, adding weighed povidone and sieved mannitol into a fluidized bed to make the povidone and mannitol in a fluidized state, spraying the mixed solution prepared instep S1, performing spray granulation, and performing granule finishing after drying; and S3, adding the finished granules to the weighed magnesium stearate and sodium stearyl fumarate, and performing tabletting after uniform mixing to obtain plain tablets, wherein the hardness of the plain tablets is controlled to be 7-11kgf. The preparation method optimizes the prescription technique of the telmisartan tablets, and improves the similarity of multiple dissolution curves of own products and reference preparations.

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, e...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4184A61K47/32A61P9/12
CPCA61K9/2027A61K31/4184A61P9/12
Inventor 陈用芳胡延贵樊竞洁杨绪凤冉小琴王松
Owner CHONGQING CONQUER PHARML
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