Telmisartan capsule and preparation method thereof

A technology for telmisartan and capsules, applied in the field of telmisartan capsules and preparation thereof, can solve the problems of easy electrostatic adsorption, increased operation difficulty, and high equipment requirements, achieves improved dissolution rate and compressibility, and ensures rapid The effect of dissolution and production cost reduction

Active Publication Date: 2020-03-31
江西杏林白马药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The patented method has high requirements on equipment, high cost of material loss, resulting in high cost, and the particle size of the micronized material is small, the surface area increases, the surface free energy increases, and the drug has a tendency to spontaneously coalesce, which is difficult to combine with Mix other excipients; and electrostatic adsorption is likely to occur during the granulation process, which increases the difficulty of operation

Method used

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  • Telmisartan capsule and preparation method thereof
  • Telmisartan capsule and preparation method thereof
  • Telmisartan capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] A kind of telmisartan capsule, by weight, raw material composition is as shown in table 1.

[0062] Table 1

[0063]

[0064]

[0065] The preparation process is:

[0066] (1) sodium hydroxide is dissolved in 48g aqueous solution, obtains sodium hydroxide solution;

[0067] (2) Weigh respectively Telmisartan, lactose, microcrystalline cellulose, poloxamer 188, sodium carboxymethyl starch, povidone K30, and magnesium stearate to pass through a 60-mesh sieve for subsequent use;

[0068] (3) Add telmisartan, lactose, microcrystalline cellulose, carboxymethyl starch sodium, and povidone K30 into the wet granulator in sequence, turn on the stirring blade, and pre-mix for 5 minutes; then turn on the cutter, and set the speed At 1850r / min, slowly add the solution described in step (1) for wet granulation, and granulate for 5min;

[0069] (4) The wet granules are sent to the fluidized bed for drying, the drying temperature is 55°C, the drying time is 35 minutes, and th...

Embodiment 2

[0073] A kind of telmisartan capsule, by weight, raw material components are as shown in table 2.

[0074] Table 2

[0075]

[0076] The preparation process is:

[0077] (1) sodium hydroxide is dissolved in 58g aqueous solution, obtains sodium hydroxide solution;

[0078] (2) Take by weighing telmisartan, sodium lauryl sulfate, mannitol, corn starch, crospovidone, hypromellose, sodium stearyl fumarate and pass through an 80-mesh sieve for subsequent use;

[0079] (3) Add telmisartan, sodium lauryl sulfate, mannitol, corn starch, crospovidone, and hypromellose into the wet granulator in sequence, turn on the stirring blade, and pre-mix for 3 minutes; then Turn on the cutter, set the rotating speed to 1500r / min, slowly add the solution described in step (1) for wet granulation, and granulate for 3min;

[0080] (4) The wet granules are sent to the fluidized bed for drying, the drying temperature is 60°C, the drying time is 30 minutes, and the moisture content of the granule...

Embodiment 3

[0084] A kind of telmisartan capsule, by weight, raw material components are as shown in table 3.

[0085] table 3

[0086]

[0087] The preparation process is:

[0088] (1) sodium hydroxide is dissolved in 50g water, obtains sodium hydroxide solution;

[0089] (2) Weigh and weigh Telmisartan, mannitol, sodium lauryl sulfate, poloxamer 188, crospovidone, sodium carboxymethylcellulose, and magnesium stearate over 40 meshes respectively. sieve, spare;

[0090] (3) Add telmisartan, mannitol, sodium lauryl sulfate, poloxamer 188, crospovidone, and sodium carboxymethylcellulose into the wet granulator in sequence, turn on the stirring blade, and pre- Mix for 2 minutes; then turn on the cutter, set the speed to 2000r / min, slowly add the solution described in step (1) for wet granulation, and granulate for 6 minutes;

[0091] (4) The wet granules are sent to the fluidized bed for drying, the drying temperature is 70°C, the drying time is 20min, and the moisture content of the ...

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Abstract

The invention provides a telmisartan capsule and a preparation method thereof. The telmisartan capsule comprises the following components, by weight: 80 parts of telmisartan, 7 parts of sodium hydroxide, 4.8 to 14.4 parts of a solubilizer, 345 to 365 parts of a filler, 9.6 to 24 parts of a disintegrating agent, 9.6 to 19.2 parts of an adhesive, and 2.4 to 7.2 parts of a lubricant. In addition, thepreparation method comprises the following steps: (1), dissolving sodium hydroxide in an aqueous solution; (2), respectively sieving raw materials and auxiliary materials with a 60-mesh sieve; (3), carrying out wet granulation by taking a sodium hydroxide aqueous solution as an adhesive; (3), feeding the granules into a fluidized bed for drying; (4), granulating the dry granules, feeding the granules into a mixer, and mixing the granules with a lubricant; and (5) filling a capsule. The prepared capsule does not contain sorbitol with high hygroscopicity and meglumine with high price; the product quality is stable; and the production cost is lowered. Meanwhile, a dissolution curve is kept highly similar to that of original research. The preparation process is simple, a sodium salt preparation step is not needed, the process is simplified, the production period is shortened, the production efficiency is improved, and experimental large-scale production can be realized.

Description

technical field [0001] The invention belongs to the technical field of medicines, and relates to a telmisartan capsule and a preparation method thereof. Background technique [0002] Telmisartan (Telmisartan) is a selective angiotensin Ⅱ receptor (AT Ⅱ type) antagonist, its chemical name is: 4-{[2-n-propyl-4-methyl-6-(1-methyl Benzimidazol-2-yl)benzimidazol-1-yl]methyl}biphenyl-2-carboxylic acid, the chemical structural formula is: [0003] [0004] Telmisartan (trade name mecasu) was first developed by Boehringer Ingelheim of Germany, and it was first listed in the United States in March 1999, and then in Germany in the same year, in the Philippines in December 1999, and in Australia and Belgium in 2000. , listed in the UK, at the end of 2000, the raw materials and preparations of telmisartan were introduced into China for sale. Telmisartan has good antihypertensive effect, few adverse reactions, and reliable curative effect. It has become the first choice drug for the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/4184A61K47/02A61K47/10A61K47/20A61P9/12
CPCA61K9/1611A61K9/1641A61K9/1617A61K31/4184A61P9/12
Inventor 张清华朱勤万常影约翰﹒卡特
Owner 江西杏林白马药业股份有限公司
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