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Preparation method for coating tablets containing telmisartan and amlodipine

A technology of telmisartan and amlodipine is applied in the directions of medical preparations containing active ingredients, medical preparations without active ingredients, sugar-coated pills, etc., and can solve problems such as instability of amlodipine

Inactive Publication Date: 2012-06-13
北京汇诚瑞祥医药生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The applicant pointed out in the patent that the film coating technology caused amlodipine to be unstable in the coating layer due to the moisture absorption of telmisartan

Method used

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  • Preparation method for coating tablets containing telmisartan and amlodipine
  • Preparation method for coating tablets containing telmisartan and amlodipine
  • Preparation method for coating tablets containing telmisartan and amlodipine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Tablet core prescription: divided into two specifications of telmisartan 40mg and 80mg, the prescription of the two specifications in the tablet core increases proportionally.

[0036]

[0037] Preparation method of tablet core:

[0038] 1. Weigh telmisartan, sodium hydroxide and meglumine according to the prescription, add water to dissolve it, spray dry, and collect the spray dried powder. Determine the content.

[0039] 2. According to the prescription composition and content determination result, convert the dosage of sorbitol and magnesium stearate and add to the spray-dried powder. Mix well and compress.

[0040] Coating liquid prescription (1000ml coating liquid dosage)

[0041] Component

Weight (g / 1000ml 50% ethanol)

Hydroxypropyl methylcellulose (viscosity 5 centipoise)

10

Polyethylene glycol 1500 (average molecular weight 1500)

5

Tween 80

4

Talc

10

Titanium dioxide

8

Amlodipine

55

50% ethanol (volume ratio)

1000ml

[0042] Prepara...

Embodiment 2

[0052] Tablet core prescription: the same as in Example 1.

[0053]

[0054] Preparation method of tablet core: same as in Example 1.

[0055] 1. Weigh telmisartan, sodium hydroxide and meglumine according to the prescription, add water to dissolve it, spray dry, and collect the spray dried powder. Determine the content.

[0056] 2. According to the prescription composition and content determination result, convert the dosage of sorbitol and magnesium stearate and add to the spray-dried powder. Mix well and compress.

[0057] Coating liquid prescription (1000ml coating liquid dosage)

[0058] Coating liquid for isolation layer:

[0059] Component

Weight (g / 1000ml 50% ethanol)

Hydroxypropyl methylcellulose (viscosity 5 centipoise)

10

Polyethylene glycol 1500 (average molecular weight 1500)

5

Talc

10

Tween 80

4

Titanium dioxide

8

50% ethanol (weight ratio)

1000ml

[0060] Preparation method:

[0061] 1. Weigh hydroxypropyl methyl cellulose and polyethylene...

Embodiment 3

[0074] Tablet core prescription:

[0075]

[0076] Preparation method of tablet core:

[0077] 1. Weigh telmisartan, sodium hydroxide and meglumine according to the prescription, add water to dissolve it, spray dry, and collect the spray dried powder. Determine the content.

[0078] 2. According to the prescription composition and content determination results, convert the amount of sorbitol, croscarmellose sodium, talc and magnesium stearate, and add them to the spray-dried powder. Mix well and compress.

[0079] In the present invention, a disintegrant is added, taking croscarmellose sodium as an example, but does not restrict the use of other pharmaceutically acceptable disintegrants to any extent. The disintegrant can be cross-linked carboxymethyl cellulose Sodium carboxymethyl starch, sodium carboxymethyl starch, sodium carboxymethyl starch, polyvinylpyrrolidone×L-10, polyvinylpyrrolidone XL, microcrystalline cellulose, dry starch, etc. The definition of disintegrant is the co...

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Abstract

The invention relates to a composition of telmisartan and benzene sulfonate amlodipine, comprising an effective dosage of telmisartan and benzene sulfonate amlodipine and selectively comprising one or a plurality of pharmaceutically acceptable additives or no; the composition is characterized in that the telmisartan and the pharmaceutically acceptable additives are used as a plain tablet, the benzene sulfonate amlodipine is dispersed in a coating material, and a coating material containing lactose, or sodium chloride, or polyethylene glycol 1500 or sorbierite is positioned between the plain tablet and the coating material. The invention has the advantages of effectively preventing the alkaline matters contained in the telmisartan plain tablet from degrading the benzene sulfonate amlodipine and quickly dissolving out the drug in an unexpected manner.

Description

Technical field [0001] The present invention relates to pharmaceutical preparation technology. More specifically, the present invention relates to a method for preparing a coated tablet containing telmisartan and amlodipine besylate. Background technique [0002] Telmisartan (Telmisartan), the chemical name is 4-{[2-n-propyl-4-methyl-6-(1-methylbenzimidazol-2-yl)benzimidazol-1-yl]methan Yl}biphenyl-2-carboxylic acid, the structural formula is as follows: [0003] [0004] Telmisartan is a specific angiotensin II receptor (AT1 type) antagonist. Telmisartan replaces the angiotensin II receptor and binds to the AT1 receptor subtype (known as the site of angiotensin II action) with high affinity. Telmisartan has no agonist effect at the AT1 receptor site. Telmisartan selectively binds to the AT1 receptor, and the binding effect is long-lasting. Telmisartan has no affinity for other receptors, including AT2 and other AT receptors with fewer features. Telmisartan does not inhibit hu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4422A61K31/4184A61K9/28A61K47/26A61K47/04A61K47/10A61K47/34A61P9/12
Inventor 卢骏冯岩
Owner 北京汇诚瑞祥医药生物科技有限公司
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