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Method for preparing telmisartan amlodipine tablets

A technology of telmisartan and amlodipine besylate granules, which can be applied in pill delivery, cardiovascular system diseases, drug combination, etc. It can solve the problems of complex preparation process and high production cost, and achieve inhibition of hydrolysis and improvement of stability The effect of high stability and simple preparation process

Active Publication Date: 2012-12-12
WUHAN WUYAO SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The purpose of the present invention is exactly aimed at the defect that compound preparation process is complicated, production cost is high in the prior art, provides a kind of preparation method of good stability, safe and effective telmisartan amlodipine tablet

Method used

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  • Method for preparing telmisartan amlodipine tablets
  • Method for preparing telmisartan amlodipine tablets
  • Method for preparing telmisartan amlodipine tablets

Examples

Experimental program
Comparison scheme
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Embodiment 1

[0031] The preparation of embodiment 1 telmisartan amlodipine tablet (specification 80mg / 5mg)

[0032] A. Preparation of Telmisartan Granules

[0033] (1) Dissolve 9.41 g of potassium hydroxide in 350 ml of 90% ethanol, add 80 g of telmisartan after dissolving, heat in a water bath at 65°C until the solution is clear, recycle the ethanol to dryness, take out the solid and pulverize it through an 80-mesh sieve, and set aside.

[0034] (2) Mix the fine powder obtained in step (1) and auxiliary materials microcrystalline cellulose 50g, pregelatinized starch 30g, lactose 40g, sodium starch glycolate 20g, meglumine 10g, and soft material made of 95% ethanol, 20 mesh Sieve to granulate, dry at 60°C, granulate with 18 mesh sieve, and set aside.

[0035] B. Preparation of Amlodipine Besylate Granules

[0036] (1) 6g of povidone K30 was dissolved in an appropriate amount of ethanol to prepare a solution for later use.

[0037] (2) 6.934g of amlodipine besylate, 65g of microcrystalli...

Embodiment 2

[0040] The preparation of embodiment 2 telmisartan amlodipine tablets (specification 80mg / 5mg)

[0041] A. Preparation of Telmisartan Granules

[0042](1) Dissolve 6.72g of sodium hydroxide in 380ml of 80% ethanol, add 80g of telmisartan after dissolving, heat in a water bath at 65°C until the solution is clear, recover the ethanol to dryness, take out the solid and pulverize it through an 80-mesh sieve, and set aside.

[0043] (2) Mix the fine powder obtained in step (1) and auxiliary materials microcrystalline cellulose 68g, pregelatinized starch 38g, sodium starch glycolate 14g, and meglumine 10g, 95% ethanol soft material, granulate with a 20-mesh sieve , dried at 60°C, granulated through a 18-mesh sieve, and set aside.

[0044] B. Preparation of Amlodipine Besylate Granules

[0045] (1) Dissolve 4g of povidone K30 in an appropriate amount of ethanol to prepare a solution for later use.

[0046] (2) Mix 6.934g of amlodipine besylate, 50g of microcrystalline cellulose, 5...

Embodiment 3

[0049] The preparation of embodiment 3 telmisartan amlodipine tablets (specification 40mg / 5mg)

[0050] A. Preparation of Telmisartan Granules

[0051] (1) Dissolve 3.36g of sodium hydroxide in 320ml of 95% ethanol, add 40g of telmisartan after dissolving, heat in a water bath at 60°C until the solution is clear, recover the ethanol to dryness, take out the solid and pulverize it through an 80-mesh sieve, and set aside.

[0052] (2) Mix the fine powder obtained in step (1) and auxiliary materials microcrystalline cellulose 75g, pregelatinized starch 25g, sodium starch glycolate 6g, and meglumine 5g, 95% ethanol soft material, granulate with a 20-mesh sieve , dried at 60°C, granulated through a 18-mesh sieve, and set aside.

[0053] B. Preparation of Amlodipine Besylate Granules

[0054] (1) 5g of povidone K30 was dissolved in an appropriate amount of ethanol to prepare a solution for later use.

[0055] (2) Mix 6.934g of amlodipine besylate, 68g of microcrystalline cellulos...

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Abstract

The invention relates to a method for preparing telmisartan amlodipine tablets. The method comprises the following steps of pelletizing telmisartan serving as active ingredients independently, and mixing the pelletized telmisartan and amlodipine granules; and adding appropriate auxiliary materials for total mixing and tabletting to prepare the telmisartan amlodipine tablets. The method adopts a simple preparation process, and is suitable for large-scaled industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a preparation method of a compound antihypertensive drug preparation, in particular to a preparation method of telmisartan and amlodipine tablets. Background technique [0002] Hypertension is the most common cardiovascular disease and a major public health problem worldwide. At present, there are about 972 million people in the world suffering from high blood pressure or high blood pressure, which is equivalent to 26.4% of the adult population. There are about 200 million hypertensive patients in my country, but the effective treatment rate and good control rate are only 24.7% and 6.1%, and the incidence of hypertension is increasing at a rate of 2.5% per year. The guidelines for the diagnosis and treatment of hypertension published by the European Collaborative Committee on Cardiovascular and Hypertension in 2007 clearly pointed out that the vast majority of patients w...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4422A61K31/4184A61K9/20A61P9/12
Inventor 耿海明杨波张登科
Owner WUHAN WUYAO SCI & TECH