Preparation method of telmisartan tablets

A technology of telmisartan and tablets, which is applied in the field of preparation of pharmaceutical preparations, can solve the problems of lumping or bed collapse, uneven mixing, and easy adsorption on the wall of the device, and achieves the improvement of stability and dissolution rate. Effect

Inactive Publication Date: 2018-03-20
南京双科医药开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] During the preparation process of telmisartan tablets, telmisartan and meglumine sodium salt are first formed from telmisartan and meglumine in an alkaline solution. Meglumine is easily soluble in water and has hygroscopicity, which leads to It is easy to be adsorbed on the wall of the vessel during the mixing process and cause uneven mixing
[0008] In addition, the prior art also has the report of using a fluidized bed to granulate after raw materials and binders are mixed. Technical methods are prone to lumps or bed collapse

Method used

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  • Preparation method of telmisartan tablets
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  • Preparation method of telmisartan tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Prior art prepares telmisartan tablet

[0051]

[0052]

[0053] Preparation:

[0054] Telmisartan, sodium hydroxide, povidone, and meglumine are dissolved in purified water to make slurry and mannitol is granulated in a fluidized bed

[0055] Additional excipients spray lactose, magnesium stearate compressed tablet

Embodiment 2

[0056] Embodiment 2: Telmisartan tablet of the present invention

[0057]

[0058] Preparation:

[0059] Telmisartan, sodium hydroxide, and povidone are dissolved in purified water to make slurry and mannitol is granulated in a fluidized bed

[0060] Additional excipients meglumine, spray lactose, magnesium stearate compressed tablet

[0061] The equipment conditions are as follows:

[0062] The inlet temperature is 90-95°C (the temperature must not exceed 105°C)

[0063] Fluidization air volume 50m 3 / h

[0064] Atomizing air pressure 45psi

[0065] Adhesive flow rate 3r / min

Embodiment 3

[0066] Embodiment 3: prior art prepares telmisartan tablet

[0067]

[0068] Preparation:

[0069] Telmisartan, sodium hydroxide, and povidone are dissolved in purified water to make slurry and mannitol is granulated in a fluidized bed

[0070] Additional excipients spray lactose, magnesium stearate compressed tablet

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Abstract

The invention relates to a preparation method of telmisartan tablets. The preparation method comprises the following steps: dissolving telmisartan, sodium hydroxide and povidone in purified water forpulping, pelleting with mannitol in a fluidized bed to obtained dried particles, and adding lactose, meglumine and magnesium stearate tablets by adopting an addition method. Equipment conditions adopted according to the invention are as follows: the inlet temperature is 90-95 DEG C (the temperature does not exceed 105 DEG C), the fluidization air volume is 50m<3>/h, the atomizing air pressure is 45psi, and the flow rate of an adhesive is 3r/min.

Description

Technical field: [0001] The invention relates to a preparation method of a pharmaceutical preparation, in particular to a preparation method of a drug telmisartan tablet for treating essential hypertension. 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, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4184A61K47/32A61K47/18A61P9/12
CPCA61K9/2013A61K9/2027A61K31/4184
Inventor 张露方
Owner 南京双科医药开发有限公司
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