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Compound preparation of telmisartan and amlodipine and preparation method thereof

A technology of amlodipine compound prescription and telmisartan, which is applied in the field of medicine, can solve the problems of complicated process, separate compound prescription and high manufacturing cost, and achieves the effects of convenient use, convenient production and high drug stability

Active Publication Date: 2012-02-29
湖南威特制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The object of the present invention is to provide a kind of compound preparation of telmisartan and amlodipine, to overcome the relatively high manufacturing cost of compound preparation in the prior art, the defective of complicated process
[0009] Another object of the present invention is to provide a pharmaceutical dosage form to overcome the defects that the compound preparations in the prior art have relatively high manufacturing costs and that ordinary capsules cannot completely separate the compound preparations.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Weigh 43g telmisartan sodium, and 70g microcrystalline cellulose, 6g low-substituted hydroxypropyl methylcellulose (L-HPC), 6g sodium carboxymethyl starch (CMS-Na), 6g cross-linked polyvinylpyrrolidone (CC-Na), 10g meglumine, 110g lactose are mixed, after passing a 100-mesh sieve, mix well, then add 82ml of 35% ethanol solution to make soft material, put the soft material into the extruder and extrude the strip at a speed of 60rpm Then put the strips into a shot blasting machine and cut them, spheronize them at a speed of 1300 rpm for 7 minutes, and bake them in an oven at 60°C for 3 hours to obtain telmisartan pellets.

[0047] Weigh 7g of amlodipine besylate and mix with 32.5g microcrystalline cellulose, 3g CMS-Na, 3g CC-Na, 30g dibasic calcium phosphate, 3g L-HPC, 17.5g lactose, and mix well after passing through a 100 mesh sieve , Then add 70ml of 35% ethanol solution containing 4g of PVP k30 to make soft material, put the soft material into the extruder at 30rpm to ex...

Embodiment 2

[0050] Weigh 43g telmisartan sodium, mix it with 83g microcrystalline cellulose, 5g L-HPC, 5g CMS-Na, 5g CC-Na, 9g meglumine, 60g lactose, pass through a 100 mesh sieve and mix well, then add 40 % Ethanol solution 89ml is made into soft material, put the soft material into the extruder and extrude the strips at a speed of 30rpm, then put the strips into the shot blasting machine and cut them, spheronize at a speed of 1200rpm for 7 minutes, at 60℃ Bake in an oven for 3 hours to obtain telmisartan pellets.

[0051] Weigh 7g of amlodipine besylate, mix with 40g microcrystalline cellulose, 4.5g CMS-Na, 4.5g CC-Na, 45g dibasic calcium phosphate, 43g lactose, pass through a 100-mesh sieve and mix well, then add 6g 90ml of 35% ethanol solution of PVP k30 is made into a soft material. The soft material is put into the extruder at a speed of 60rpm to extrude the strips, and then the strips are put into the shot blasting machine and cut and rounded at a speed of 850rpm. Bake in an oven at...

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PUM

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Abstract

The invention provides a compound preparation of telmisartan and amlodipine and a preparation method thereof. The compound preparation consists of first mini-pills containing the telmisartan and second mini-pills containing the amlodipine. The preparation has high stability and convenient production. The invention also relates to a preparation method for the compound preparation of telmisartan and amlodipine.

Description

Technical field [0001] The invention relates to the field of medicine, in particular to a compound preparation of telmisartan and amlodipine and a preparation method thereof. Background technique [0002] Hypertension refers to increased systemic arterial blood pressure. It is a common clinical syndrome. It is a systemic disease characterized by increased systolic and diastolic blood pressure, often accompanied by changes in the functions or organic properties of the heart, brain, kidney and other organs. It seriously endangers human health. . Hypertension can be caused by a variety of pathogenic factors and complex pathogenesis: increased blood volume and increased blood output; decreased elasticity caused by arteriosclerosis; peripheral circulation dominated by small and small artery diameter reduction Increased resistance, abnormal function of renal cerebrovascular baroreceptors, etc. According to statistics, as of 2002, the number of patients with hypertension in my country...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4422A61K31/4184A61K9/16A61P9/12
Inventor 罗辉文蓁
Owner 湖南威特制药股份有限公司
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