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A kind of telmisartan tablet and preparation method thereof

A technology for telmisartan and tableting, applied in the field of telmisartan tablets and preparation thereof, can solve the problems of labor and material resources, viscosity of solution, harsh conditions and the like

Active Publication Date: 2021-11-12
CHONGQING CONQUER PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method requires the use of micronization equipment, the conditions are relatively harsh, and high-performance jet mill performance is required, as well as a large amount of energy and manpower consumption.
[0008] The Chinese invention application patent with the patent publication number CN107982232A provides a method for preparing telmisartan tablets. It is found that when the process is implemented, the solution is very viscous, and the whole process takes a long time and consumes a lot of manpower and material resources.
The patent application with the patent publication number CN107137370A discloses a preparation method of telmisartan tablet. The product prepared according to the prescription process needs to be coated. After comparing a number of dissolution curves, it is found that it is different from the reference preparation. Larger, poor bioequivalence

Method used

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  • A kind of telmisartan tablet and preparation method thereof
  • A kind of telmisartan tablet and preparation method thereof
  • A kind of telmisartan tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] A kind of preparation method of telmisartan tablet comprises the steps:

[0037] 1. Weigh 40g telmisartan, 3.3g sodium hydroxide, 12g meglumine, 12g povidone, 160g mannitol, 2.4g magnesium stearate, 3.6g sodium stearyl fumarate;

[0038] 2. The above-mentioned amount of telmisartan, sodium hydroxide, meglumine, and povidone are prepared into ethanol aqueous solution;

[0039] 3. Add 1 / 3 of the 20-mesh mannitol into the fluidized bed, the air inlet temperature is 60°C, and the spraying speed is 6r / min, so that it is in a fluidized state; the prepared 1 / 3 Spray 1 / 3 of the mixed solution into the fluidized bed and spray 1 / 3 of the mixed solution into the fluidized bed after the spray granulation is completed. After the granulation is completed, adjust the air inlet temperature to 100°C and the spray speed to 10r / min, add the remaining 1 / 3 of mannitol into the fluidized bed and spray the remaining 1 / 3 of the mixed solution, and dry to control the moisture to not exceed 2.5...

Embodiment 2

[0044] A kind of preparation method of telmisartan tablet comprises the steps:

[0045] 1. Weigh 80g telmisartan, 7.0g sodium hydroxide, 30g meglumine, 40g povidone, 300g mannitol, 3.6g magnesium stearate, 7.2g sodium stearyl fumarate;

[0046] 2. Prepare telmisartan, sodium hydroxide, meglumine, and povidone into ethanol aqueous solution;

[0047] 3. First add 1 / 3 of the mannitol sieved with 40 mesh into the fluidized bed, the inlet air temperature is 60°C, and the spraying speed is 6r / min, so that it is in a fluidized state; the prepared 1 / 3 Spray 1 / 3 of the mixed solution into the fluidized bed and spray 1 / 3 of the mixed solution into the fluidized bed after the spray granulation is completed. After the granulation is completed, adjust the air inlet temperature to 90°C, spray the slurry at a speed of 10r / min, add the remaining 1 / 3 of mannitol into the fluidized bed and spray the remaining 1 / 3 of the mixed solution, and dry to control the moisture to not exceed 2.5%. ;

...

Embodiment 3

[0051] Example 3 Preparation method I (control group 1) of prior art telmisartan tablets:

[0052] The sodium hydroxide 3.36g that weighed recipe quantity (in 1000 pieces) joins 150mL purified water, after stirring and dissolving, add meglumine 12g, after stirring and dissolving completely, add telmisartan raw material 40g, after stirring and dissolving completely, Finally, 12g of povidone was added, stirred and dissolved, and ultrasonically degassed to obtain a slurry. Weighed 122.24g of mannitol as a substrate and added it to a fluidized bed for granulation, plus 31.92g of mannitol, 12g of hydroxypropyl cellulose, and stearin Magnesium acid 1.68g, talcum powder 4.8g are mixed and compressed into tablets to obtain Telmisartan tablets. Among them, the parameters of the fluidized bed are: the spraying speed is 10r / min, the air inlet temperature is 50°C, the fan frequency is 30Hz, and the material temperature is controlled at about 40°C.

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Abstract

The invention discloses a telmisartan tablet and a preparation method thereof, comprising the steps of step-by-step spray granulation. The fluidized bed is sprayed into the fluidized bed by spraying the mixture solution I that Telmisartan, the alkaline modifier, the adhesive agent and the solvent A are configured into in the amount of 1 / 3 of each time three times into the fluidized bed, the addition of the filler and the mixing of the mixture solution I. The steps of spraying alternately, adding lubricant into the granules after granulation and mixing evenly and then tableting, the process is simple, saves a lot of manpower and material resources, and at the same time improves the similarity of multiple dissolution curves between the self-made product and the reference preparation.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a telmisartan tablet and a preparation method thereof Background technique [0002] The chemical name of telmisartan is 4'-[(1,4'-dimethyl-2'-propyl[2,6'-di-1H-benzimidazole]-1'-yl)methyl Base]-[1,1'-diphenyl]-2-carboxylic acid, English aliases: Telmisartan; TELMISARTAN, white or off-white crystalline powder. INN Telmisartan (telmisartan) is an angiotensin II receptor antagonist developed for the treatment of hypertension and other medical conditions, as disclosed in EP-A-502314 patent. Its chemical name is 4'-[2-n-propyl-4-methyl-6-(1-methylbenzimidazol-2-yl)-benzimidazol-1-ylmethyl]-biphenyl- 2-Carboxylic acid, has the following structure: [0003] [0004] 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 subtyp...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/02A61K47/18A61K47/32A61K31/4184A61P9/12
CPCA61K9/2009A61K9/2013A61K9/2027A61K9/2095A61K31/4184A61P9/12
Inventor 陈用芳胡延贵杨绪凤樊竟洁
Owner CHONGQING CONQUER PHARML
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