Compound preparation of valsartan amlodipine tablet (I) and preparation method thereof

A technology for valsartan amlodipine tablet and compound preparation, which is applied in the field of biomedicine, can solve the problems of uneven drug content, easy introduction of impurities, etc. reasonable effect

Active Publication Date: 2014-06-25
SHIJIAZHUANG HUAXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The invention provides a dry granulation technology for preparing valsartan amlodipine tablets (I), which can solve the problem of impurities easily brought in during the wet granulation process and improve drug safety; at the same time, the invention solves the problem of It is easy to cause the problem of uneven drug content when the dry granulation process is adopted, and a method for preparing this compound preparation is provided

Method used

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  • Compound preparation of valsartan amlodipine tablet (I) and preparation method thereof
  • Compound preparation of valsartan amlodipine tablet (I) and preparation method thereof
  • Compound preparation of valsartan amlodipine tablet (I) and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Plain Tablet Prescription:

[0032]

[0033] Formulation of coating solution for film coating layer:

[0034]

[0035]

[0036] Preparation:

[0037] (1) Pass amlodipine besylate and valsartan through a 100-mesh sieve and silicon dioxide through a 80-mesh sieve respectively, and set aside.

[0038] (2) Weigh the prescribed amount of amlodipine besylate, the prescribed amount of croscarmellose sodium (internal addition), and microcrystalline cellulose PH102, and mix them uniformly by incremental method, and pass through a 40-mesh sieve; mix the powder and the prescribed amount Add valsartan and magnesium stearate (internal addition) into the mixer and mix for about 10 minutes.

[0039] (3) Granulate the mixed powder with a dry granulator, set the speed of the roller to about 5 rpm, the speed of feeding to 28 rpm, and the pressure of the roller to 1.0T; sieve the particles between 24 mesh and 60 mesh In the next step, the particles larger than 24 mesh are gran...

Embodiment 2

[0043] Plain Tablet Prescription:

[0044]

[0045] Formulation of coating solution for film coating layer:

[0046]

[0047] Preparation:

[0048] (1) Pass amlodipine besylate and valsartan through a 100-mesh sieve respectively, and set aside.

[0049] (2) Weigh the prescribed amount of amlodipine besylate, the prescribed amount of croscarmellose sodium (internal addition), and microcrystalline cellulose PH102, mix evenly by adding method, and pass through a 40-mesh sieve; mix the mixed powder and the prescribed amount Add valsartan and magnesium stearate (internal addition) into the wet mixer, add 10% aqueous solution of sodium carboxymethylcellulose, make soft material, granulate with 24 mesh, dry, and granulate with 22 mesh.

[0050] (3) Measure the content of intermediates. After passing the test, add magnesium stearate (external addition) and croscarmellose sodium (external addition), mix for 15 minutes, and press into tablets.

[0051] (4) Slowly add the film c...

Embodiment 3

[0053] Plain Tablet Prescription:

[0054]

[0055] Formulation of coating solution for film coating layer:

[0056]

[0057] Preparation:

[0058] (1) Pass amlodipine besylate and valsartan through a 100-mesh sieve and silicon dioxide through a 80-mesh sieve respectively, and set aside.

[0059] (2) Weigh the prescribed amount of amlodipine besylate, the prescribed amount of croscarmellose sodium (internal addition), and microcrystalline cellulose PH102, and mix them uniformly by incremental method, and pass through a 40-mesh sieve; mix the powder and the prescribed amount Add valsartan and magnesium stearate (internal addition) into the mixer and mix for about 10 minutes.

[0060] (3) Granulate the mixed powder with a dry granulator, set the speed of the roller to about 4 rpm, the speed of feeding to 24 rpm, and the pressure of the roller to 0.8T; sieve the particles between 24 mesh and 60 mesh, Granules larger than 24 mesh are granulated with a 24-mesh screen of a sw...

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PUM

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Abstract

The invention provides a compound preparation of valsartan amlodipine tablet (I) and a preparation method thereof. The compound preparation comprises a tablet, a film coating layer, the tablet comprises main drug and auxiliary materials, the main drug comprises valsartan, benzenesulfonic acid amlodipine, the auxiliary material comprises filler, a disintegrating agent, a lubricant, and glidant, the tablet comprises the valsartan, benzenesulfonic acid amlodipine, the filler, the disintegrating agent, the lubricant and the glidant, and the tablet is obtained by being coated with the film coating layer. According to the method, the defect of unsafety of medicine use caused by increase of relevant material due to wet granulation is overcome, and manufacture cost can be lowered and labor intensity can be relieved due to the dry granulation technology.

Description

technical field [0001] The invention relates to the technical field of biomedicine, in particular to a valsartan amlodipine tablet (I) which has undergone technological research and verification and a preparation method thereof. Background technique [0002] Valsartan Amlodipine Tablets (I) (trade name: Exforge) is the world's first ARB / CCB single-chip compound preparation developed by Novartis Pharmaceuticals in Switzerland. It was approved by the European Union in January 2007; it was launched in Switzerland in February; In June, it was approved for marketing by the US FDA, and on July 23, it was approved by the US FDA for the first-line treatment of hypertension; at the end of 2009, this product of Novartis was approved in China, and it was launched in June 2010. ". At present, no other imitation manufacturers in China have approved the listing. [0003] This product is a compound preparation of valsartan and amlodipine for the treatment of essential hypertension. [0...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4422A61K31/41A61K9/28A61P9/12
Inventor 张云张硕王敏郭卿马海波李明海
Owner SHIJIAZHUANG HUAXIN PHARMA
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