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Compound preparation of telmisartan and amlodipine and preparation method thereof

The technology of amlodipine compound prescription and amlodipine besylate compound prescription is applied in the field of medicine, and can solve the problems of separation of compound prescriptions, complicated process and high manufacturing cost, and achieve the effects of convenient production, convenient use and high drug stability

Active Publication Date: 2010-07-21
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] Take by weighing 43g telmisartan sodium, and 70g microcrystalline cellulose, 6g low-substituted hydroxypropyl methylcellulose (L-HPC), 6g carboxymethyl starch sodium (CMS-Na), 6g cross-linked polyvinylpyrrolidone (CC-Na), 10g meglumine, and 110g lactose are mixed, passed through a 100-mesh sieve and mixed evenly, then add 82ml of 35% ethanol solution to make a soft material, put the soft material into the extruder and extrude strips at a speed of 60rpm Then the strips are put into the shot blasting machine and cut off, spheronized at a speed of 1300rpm for 7 minutes, and baked in a 60°C oven for 3 hours to obtain telmisartan pellets.

[0047] Weigh 7g amlodipine besylate, mix with 32.5g microcrystalline cellulose, 3g CMS-Na, 3g CC-Na, 30g calcium hydrogen phosphate, 3g L-HPC, 17.5g lactose, pass through a 100 mesh sieve and mix well , then add 35% ethanol solution 70ml that contains 4g PVP k30 and make soft material, put soft material into and extrude the bar with the s...

Embodiment 2

[0050] Weigh 43g telmisartan sodium, mix with 83g microcrystalline cellulose, 5g L-HPC, 5gCMS-Na, 5g CC-Na, 9g meglumine, 60g lactose, mix evenly after passing through a 100 mesh sieve, and then add 40 % ethanol solution 89ml to make a soft material, put the soft material into the extruder to extrude strips at a speed of 30rpm, then put the strips into a shot blasting machine and cut them off, and roll them into a ball at a speed of 1200rpm for 7 minutes. Bake in an oven for 3 hours to obtain telmisartan pellets.

[0051] Weigh 7g amlodipine besylate, mix with 40g microcrystalline cellulose, 4.5g CMS-Na, 4.5g CC-Na, 45g calcium hydrogen phosphate, 43g lactose, pass through a 100 mesh sieve and mix well, then add 6g 90ml of 35% ethanol solution of PVP k30 is used to make a soft material, put the soft material into an extruder at a speed of 60rpm to extrude strips, then put the strips into a shot blasting machine to cut off, and round at a speed of 850rpm8 Minutes, and baked in...

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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 the increase of 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 heart, brain, kidney and other organ functions or organic changes. It seriously endangers human health. . Hypertension can be caused by a variety of pathogenic factors and complex pathogenesis: increased blood volume and thus increased blood output; decreased elasticity caused by arteriosclerosis; peripheral circulation mainly due to narrowed diameter of small and medium arteries Increased resistance, abnormal function of renal and cerebrovascular baroreceptors, etc. According to statistics, as of 2002, the number of hypertensive patients in my country has ...

Claims

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Application Information

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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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