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Telmisartan tablet

A technology of telmisartan and calcium dihydrogen phosphate, which is applied in the field of pharmaceutical preparations, can solve the problems that the two cannot be separated, and achieve the effects of high quality stability, strong moisture resistance, and good dissolution effect

Inactive Publication Date: 2016-07-06
南京多宝生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The structure of this isomer is very similar to Telmisartan, and the existing HPLC method cannot separate the two

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1: the preparation of telmisartan tablet

[0028] Group ratio:

[0029] 100 parts of telmisartan, 8.5 parts of potassium hydroxide, 30 parts of meglumine, 340 parts of sorbitol, 85 parts of a mixture of calcium hydrogen phosphate and calcium dihydrogen phosphate, 25 parts of povidone, and 12 parts of magnesium stearate; Wherein, the weight ratio of calcium hydrogen phosphate and calcium dihydrogen phosphate is 9.5:1.

[0030] Preparation:

[0031] Step S1: first take potassium hydroxide and meglumine, add water to dissolve; then add telmisartan, add ethanol, shake to dissolve telmisartan, and dry under reduced pressure at 40°C to obtain a white bulky solid, which is crushed through 200 mesh Sieve to get telmisartan salt powder;

[0032] Step S2: Sorbitol, calcium hydrogen phosphate, calcium dihydrogen phosphate and povidone are pulverized through a 100-mesh sieve, magnesium stearate is passed through a 40-mesh sieve, and mixed with telmisartan salt powd...

Embodiment 2

[0034] Embodiment 2: the preparation of telmisartan tablet

[0035] Group ratio:

[0036] 100 parts of telmisartan, 8.5 parts of potassium hydroxide, 30 parts of meglumine, 340 parts of sorbitol, 85 parts of a mixture of calcium hydrogen phosphate and calcium dihydrogen phosphate, 25 parts of povidone, and 12 parts of magnesium stearate; Wherein, the weight ratio of calcium hydrogen phosphate and calcium dihydrogen phosphate is 9.5:1.

[0037] Preparation:

[0038] Step S1: first take potassium hydroxide and meglumine, add water to dissolve; then add telmisartan, add ethanol, shake to dissolve telmisartan, and spray dry to obtain telmisartan salt powder;

[0039] Step S2: Sorbitol, calcium hydrogen phosphate, calcium dihydrogen phosphate and povidone are pulverized through a 100-mesh sieve, magnesium stearate is passed through a 40-mesh sieve, and mixed with telmisartan salt powder evenly;

[0040] Step S3: compress the mixed powder into tablets to obtain Telmisartan tab...

Embodiment 3

[0041] Embodiment 3: the preparation of telmisartan tablet

[0042] Group ratio:

[0043] 90 parts of telmisartan, 8 parts of potassium hydroxide, 25 parts of meglumine, 320 parts of sorbitol, 80 parts of a mixture of calcium hydrogen phosphate and calcium dihydrogen phosphate, 20 parts of povidone, and 10 parts of magnesium stearate; Wherein, the weight ratio of calcium hydrogen phosphate and calcium dihydrogen phosphate is 9:1.

[0044] Preparation:

[0045] Step S1: first take potassium hydroxide and meglumine, add water to dissolve; then add telmisartan, add ethanol, shake to dissolve telmisartan, and dry under reduced pressure at 40°C to obtain a white bulky solid, which is crushed through 200 mesh Sieve to get telmisartan salt powder;

[0046] Step S2: Sorbitol, calcium hydrogen phosphate, calcium dihydrogen phosphate and povidone are pulverized through a 100-mesh sieve, magnesium stearate is passed through a 40-mesh sieve, and mixed with telmisartan salt powder ev...

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PUM

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Abstract

The invention discloses a telmisartan tablet, which comprises sorbitol and the like. The table does not change color and is free of obvious deliquescence on the surface and high in moisture resistance.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, relates to a tablet, in particular to an improved telmisartan tablet and a preparation method of the telmisartan tablet. Background technique [0002] Telmisartan is an oral non-peptide angiotensin Ⅱ receptor antagonist. It has strong fat solubility, long half-life, less side effects, and good tolerance of patients. In addition, it can selectively stimulate the proliferation of peroxidase Peroxisome proliferator activated receptors gamma (PPAR-gamma), improving left ventricular hypertrophy, improving insulin resistance, improving glucose and lipid metabolism, protecting vascular endothelial function, etc., is a fast-growing sartan drug in China. Telmisartan tablets were developed by Boehringer Ingelheim, Germany, with specifications of 40mg / tablet and 80mg / tablet. It was first launched in the United States in 1999, listed in the UK from 2000 to 2002, and imported into my country in 2002...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/02A61K31/4184A61P9/12
CPCA61K9/2009A61K31/4184
Inventor 李洋
Owner 南京多宝生物科技有限公司
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