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A kind of preparation method of telmisartan tablet

A technology for telmisartan and tablets, which is applied in the field of preparation of telmisartan tablets, can solve problems such as the complexity of the preparation process of telmisartan tablets, the increase of the preparation cost of telmisartan tablets, and the complexity of the preparation process , to achieve the effects of reducing splits and missing edges, reducing energy consumption and time costs, and reducing sticking and jamming

Active Publication Date: 2020-06-19
CHONGQING CONQUER PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] 1. Add sodium hydroxide or potassium hydroxide aqueous solution to obtain telmisartan salt solution in telmisartan, make insoluble telmisartan become the alkali metal salt easily soluble in water, then, above-mentioned solution is passed through Granulation and drying to make the main drug granules, but the obtained telmisartan salt granules have strong hygroscopicity, which requires strict control of drying conditions during the production process, which increases the cost input
[0004] 2. In the preparation process, telmisartan, co-solvent and filler are micronized to reduce the particle size of the drug particles to improve the dissolution rate of the drug, but the preparation method adopts micronization measures, which complicates the preparation process , while increasing energy consumption and increasing production time
[0005] Above-mentioned two kinds of preparation methods all make the preparation technology of telmisartan sheet complicated, improved the preparation cost of telmisartan sheet

Method used

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  • A kind of preparation method of telmisartan tablet

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1 (1,000,000 pieces):

[0030] A kind of preparation method of telmisartan tablet is:

[0031] S1. Weigh telmisartan, meglumine, lactose, disintegrant, magnesium stearate, binder and coating agent according to the proportioning ratio;

[0032] S2, adding the weighed hydroxypropyl methylcellulose into 95% ethanol / water solution under stirring, and when stirring into a uniform suspension, stop stirring to obtain 5% hydroxypropyl methylcellulose As an adhesive, set aside;

[0033] S3. Stir and mix telmisartan and meglumine evenly, and pass through a 22-mesh sieve to obtain the mixed material;

[0034] S4. Stir and mix the mixed material obtained in step S3, lactose, and 50% disintegrant evenly, add the binder in two times, add 50% binder for the first time, stir for 30 seconds, and then add the remaining binder Mix well to obtain a suitable soft material. The soft material is granulated through a 22-mesh sieve and dried in a fluidized dryer at a drying temper...

Embodiment 2

[0041] Embodiment 2 (1,000,000 pieces):

[0042] A kind of preparation method of telmisartan tablet is:

[0043] S1. Weigh telmisartan, meglumine, lactose, disintegrant, magnesium stearate, binder and coating agent according to the proportioning ratio;

[0044] S2, adding the weighed hydroxypropyl methylcellulose into 95% ethanol / water solution under stirring, and when stirring into a uniform suspension, stop stirring to obtain 5% hydroxypropyl methylcellulose As an adhesive, set aside;

[0045] S3. Stir and mix telmisartan, meglumine, lactose, and disintegrant evenly, add the adhesive in two times, add 50% of the adhesive for the first time, stir for 30 seconds, and then add the remaining adhesive , and stir evenly to obtain a suitable soft material. The soft material is granulated through a 22-mesh sieve and dried in a boiling dryer at a drying temperature of 30°C to 50°C until the moisture content of the particles is 1%. Pass through a 15-mesh sieve;

[0046] S5. Stir a...

Embodiment 3

[0050] Embodiment 3 (1,000,000 pieces):

[0051] A kind of preparation method of telmisartan tablet is:

[0052] S1. Weigh telmisartan, meglumine, lactose, disintegrant, magnesium stearate, binder and coating agent according to the proportioning ratio;

[0053] S2, adding the weighed hydroxypropyl methylcellulose into 95% ethanol / water solution under stirring, and when stirring into a uniform suspension, stop stirring to obtain 5% hydroxypropyl methylcellulose As an adhesive, set aside;

[0054] S3. Stir and mix telmisartan and meglumine evenly, and pass through a 22-mesh sieve to obtain the mixed material;

[0055] S4. Stir and mix the mixed material obtained in step S3, lactose, and 50% disintegrant evenly, add the binder at one time, stir for 30 seconds, and stir evenly to obtain a suitable soft material, which is granulated through a 22-mesh sieve . Dry in a boiling dryer at a drying temperature of 30°C to 50°C until the water content of the granules is 1%, and the drie...

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Abstract

The invention relates to a preparation method of a telmisartan tablet. The preparation method of the telmisartan tablet provided by the invention comprises steps of mixing telmisartan with a cosolvent, dispersing an obtained mixture and mixing the dispersed mixture with other components. in addition, in a process of preparing the tablet, a disintegrant is added in two times before and after implementing granulating. The preparation method is simple to operate, low in cost and low in requirement on equipmen; and meanwhile, a relatively high requirement can be satisfied. At the same time, the preparation method, by adding an adhesive in two times in a preparing process, can effectively relieve chipped edge and cracked edge phenomenons in a tabletting course.

Description

technical field [0001] The invention relates to a preparation method of telmisartan tablet. Background technique [0002] Telmisartan is an oral non-peptide angiotensin Ⅱ receptor antagonist, which is highly fat-soluble and poorly soluble in water, which makes the preparation process of Telmisartan tablets complicated or the solubility of Telmisartan tablets is relatively low. Low, poor efficacy, resulting in tablets difficult to meet the "Chinese Pharmacopoeia 2015 Edition" requirements. Existing mainly contains following preparation method to solve the above problem: [0003] 1. Add sodium hydroxide or potassium hydroxide aqueous solution to obtain telmisartan salt solution in telmisartan, make insoluble telmisartan become the alkali metal salt easily soluble in water, then, above-mentioned solution is passed through The main drug granules are made by granulating and drying, but the obtained telmisartan salt granules have strong hygroscopicity, which requires strict cont...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/28A61K31/4184A61K47/38A61P9/12
CPCA61K9/2054A61K9/2095A61K9/2806A61K31/4184
Inventor 陈用芳冉诗念蒋其斌何伟叶兆敏
Owner CHONGQING CONQUER PHARML
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