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Preparation method of valsartan and amlodipine tablets and valsartan and amlodipine tablets

A technology of valsartan amlodipine tablet and amlodipine besylate, applied in the field of biomedicine, can solve the problems of different dissolution and dissimilar dissolution of valsartan amlodipine tablet, and achieves easy operation and low production cost , the effect of enhanced adhesion

Active Publication Date: 2018-12-18
HEFEI COSOURCE PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The technical problem to be solved by the present invention is: how to solve the valsartan amlodipine sheet stripping that changes the new batch of valsartan raw material preparation of the same producer to have significant difference, cause and former research valsartan amlodipine sheet reference preparation ( RLD) Dissolution Dissimilar Technical Issues

Method used

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  • Preparation method of valsartan and amlodipine tablets and valsartan and amlodipine tablets
  • Preparation method of valsartan and amlodipine tablets and valsartan and amlodipine tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] A valsartan amlodipine tablet, consisting of the following raw materials in parts by weight: valsartan (batch 2) 75, amlodipine besylate 5, microcrystalline cellulose 50, crospovidone 18, colloidal Silicon dioxide 1.2, magnesium stearate 4.0.

[0073] Described valsartan amlodipine sheet is made by following method:

[0074] (1) Valsartan and amlodipine besylate are adopted pulverizer (LFP-1000A high-speed multifunctional pulverizer, Leif brand), and after pulverizing 1min at a rotating speed of 25000rpm, a premixed material is obtained, and then mixed with microcrystalline cellulose , crospovidone, colloidal silicon dioxide and 60% of the total magnesium stearate mass are mixed to obtain the initial mixture;

[0075] (2) Dry granulation: Take the primary mixture of step (1) and use a dry granulator (DP-5 dry granulator, Shenzhen Xinyite), and roll it into a strip, integrated crushing, granulation (DP -5 dry granulator integrated conical rotary granulator), the size o...

Embodiment 2

[0080] A valsartan amlodipine tablet, consisting of the following raw materials in parts by weight: valsartan (batch 2) 80, amlodipine besylate 6.94, microcrystalline cellulose 54.06, crospovidone 20, colloidal Silicon dioxide 1.5, magnesium stearate 4.5.

[0081] Described valsartan amlodipine sheet is made by following method:

[0082] (1) Valsartan and amlodipine besylate are adopted pulverizer (LFP-1000A high-speed multifunctional pulverizer, Leif brand), and after pulverizing 1min at a rotating speed of 25000rpm, a premixed material is obtained, and then mixed with microcrystalline cellulose , crospovidone, colloidal silicon dioxide and 60% of the total magnesium stearate mass are mixed to obtain the initial mixture;

[0083] (2) Dry granulation: Take the primary mixture of step (1) and use a dry granulator (DP-5 dry granulator, Shenzhen Xinyite), and roll it into a strip, integrated crushing, granulation (DP -5 dry granulator integrated conical rotary granulator), the ...

Embodiment 3

[0089] Prescription, technology are identical with embodiment 2, just valsartan batch is different.

[0090] A valsartan amlodipine tablet, consisting of the following raw materials in parts by weight: valsartan (batch 1) 80, amlodipine besylate 6.94, microcrystalline cellulose 54.06, crospovidone 20, colloidal Silicon dioxide 1.5, magnesium stearate 4.5.

[0091] Described valsartan amlodipine sheet is made by following method:

[0092] (1) Valsartan and amlodipine besylate are adopted pulverizer (LFP-1000A high-speed multifunctional pulverizer, Leif brand), and after pulverizing 1min at a rotating speed of 25000rpm, a premixed material is obtained, and then mixed with microcrystalline cellulose , crospovidone, colloidal silicon dioxide and 60% of the total magnesium stearate mass are mixed to obtain the initial mixture;

[0093] (2) Dry granulation: Take the primary mixture of step (1) and use a dry granulator (DP-5 dry granulator, Shenzhen Xinyite), and roll it into a str...

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Abstract

The invention discloses a preparation method of valsartan and amlodipine tablets and the valsartan and amlodipine tablets. The preparation method comprises the following steps: crushing valsartan andamlodipine benzenesulfonate for 0.5 to 5min at a rotary speed of 10000 to 30000rpm to obtain premix; mixing the premix with other auxiliary materials to obtain a primary mixed material; carrying out dry-process granulation, total mixing, tabletting and coating on the primary mixed material to prepare the valsartan and amlodipine tablets. The surface area of the valsartan is enlarged through a high-speed crushing technology, the cohesiveness is enhanced and the collapsibility is reduced; the valsartan is used for covering amlodipine and preventing the amlodipine from being dissolved out; the dissolving of the amlodipine is similar with that of an RLD, and the technical problems that the dissolving of the valsartan and amlodipine tablets prepared from a new batch of valsartan raw materials in the same factory has remarkable difference so that the dissolving of the valsartan and amlodipine tablets is not similar with that of an originally-researched valsartan and amlodipine tablet reference preparation (RLD) are solved; a preparation technology disclosed by the invention has the characteristics that the technology is scientific and reasonable, the operation is simple and easy, the production cost is relatively low and the like.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to a preparation method of valsartan and amlodipine tablets and the valsartan and amlodipine tablets. Background technique [0002] Valsartan and Amlodipine Tablets are compound preparations of valsartan and amlodipine besylate, developed by Novartis, and launched in Europe and America in 2007 with the trade name Exforge, and in 2009 in China with the trade name Bebot, The indication is essential hypertension. [0003] Valsartan is a non-peptide angiotensin II receptor antagonist (Angiotensin-II antagonist), which selectively acts on angiotensin I (AT1) receptor subtypes and can block AngII and AT1 receptors The combination of vascular smooth muscle relaxation and vasodilation; increase renal blood perfusion, increase water and sodium excretion, reduce blood volume, and lower blood pressure. [0004] Amlodipine besylate is a dihydropyridine calcium antagonist (calc...

Claims

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Application Information

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IPC IPC(8): A61K31/4422A61K9/36A61K47/12A61P9/12A61K31/41
CPCA61K9/2013A61K9/2866A61K31/41A61K31/4422A61P9/12A61K2300/00
Inventor 程开生李志云李春妮陈登俊
Owner HEFEI COSOURCE PHARMA CO LTD
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