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Oral tablet containing telmisartan and amlodipine besylate and preparation method thereof

A technology of amlodipine besylate and telmisartan, applied in the field of medicine, can solve problems such as time-consuming and laborious spray drying method, and achieve the effects of reducing production process steps, reducing production cost and simple process

Active Publication Date: 2013-09-04
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

What this document adopts when preparing telmisartan tablet is time-consuming and laborious spray-drying method, and needs special equipment

Method used

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  • Oral tablet containing telmisartan and amlodipine besylate and preparation method thereof
  • Oral tablet containing telmisartan and amlodipine besylate and preparation method thereof
  • Oral tablet containing telmisartan and amlodipine besylate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029]

[0030] The preparation method is as follows: dissolve telmisartan and alkaline reagent in water to make a uniform solution for later use; sieve and mix the filling agent, disintegrating agent and binder in the telmisartan tablet core and place it in a fluidized bed In the process, spray the above-mentioned uniform solution to granulate, and dry; sieve and granulate the dried granules, add the added pharmaceutical excipients and mix evenly, and then perform tablet compression to obtain telmisartan tablet cores; After uniform dispersion in the coating solution, the telmisartan tablet core is coated, and after the coating is completed, it is dried to obtain the telmisartan amlodipine tablet.

[0031] According to dissolution measurement method (Chinese Pharmacopoeia 2010 edition appendix XC second method), pH7.5 damping fluid is as dissolution medium, and rotating speed is 75m, to embodiment 1 sheet and import telmisartan amlodipine sheet (manufacturer: Germany Boehri...

Embodiment 2

[0046]

[0047] The preparation method is as follows: dissolve telmisartan and alkaline reagent in water to make a uniform solution for later use; sieve and mix the filling agent, disintegrating agent and binder in the telmisartan tablet core and place it in a fluidized bed In the process, spray the above-mentioned uniform solution to granulate, and dry; sieve and granulate the dried granules, add the added pharmaceutical excipients and mix evenly, and then perform tablet compression to obtain telmisartan tablet cores; After uniform dispersion in the coating solution, the telmisartan tablet core is coated, and after the coating is completed, it is dried to obtain the telmisartan amlodipine tablet.

[0048] According to dissolution measurement method (Chinese Pharmacopoeia 2010 edition appendix XC second method), pH7.5 damping fluid is as dissolution medium, and rotating speed is 75m, to embodiment 1 sheet and import telmisartan amlodipine sheet (manufacturer: Germany Boehri...

Embodiment 3

[0062]

[0063]

[0064] The preparation method is as follows: dissolve telmisartan and alkaline reagent in water to make a uniform solution for later use; sieve and mix the filling agent, disintegrating agent and binder in the telmisartan tablet core and place it in a fluidized bed In the process, spray the above-mentioned uniform solution to granulate, and dry; sieve and granulate the dried granules, add the added pharmaceutical excipients and mix evenly, and then perform tablet compression to obtain telmisartan tablet cores; After uniform dispersion in the coating solution, the telmisartan tablet core is coated, and after the coating is completed, it is dried to obtain the telmisartan amlodipine tablet.

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PUM

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Abstract

The invention discloses an oral tablet containing telmisartan and amlodipine besylate. The oral tablet is characterized by comprising a telmisartan tablet core and an amlodipine coating layer. The stability problem caused by incompatibility of the two main medicines amlodipine and telmisartan and the dissolution curve matching problem are solved by adopting the compound coated tablet. The tablet provided by the invention has beautiful surface and stable quality. The invention also provides a preparation method of the oral tablet. The preparation method is simple in process and lower in cost and is more suitable for commercial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a telmisartan / amlodipine besylate oral tablet. Background technique [0002] Telmisartan is an angiotensin II receptor antagonist developed for the treatment of hypertension and other medical conditions. Has the following structural formula: [0003] [0004] Amlodipine besylate is a new type of calcium antagonist, which is mainly used clinically for the treatment of hypertension and angina pectoris. Has the following structural formula: [0005] [0006] Telmisartan and Amlodipine Tablets are developed by Boehringer Ingelheim, Germany, and the trade name is Twynsta. This preparation combines two commonly used antihypertensive drugs, ARB drug telmisartan and CCB drug, in a single tablet dosage form Amlodipine. The advantages of the combination of telmisartan and amlodipine include: 1) The two drugs have synergistic antihypertensive effects from different pe...

Claims

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Application Information

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IPC IPC(8): A61K31/4422A61K9/28A61P9/12A61P9/10A61K31/4184
Inventor 施祥杰胡李斌陈浩李巧霞胡功允
Owner ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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