Valsartan amlodipine tablet composition and preparation method

A technology of amlodipine and amlodipine besylate, which can be applied in directions such as drug combinations, pharmaceutical formulations, and active ingredients of heterocyclic compounds, can solve problems such as low bioavailability, large differences in tablet weight, and poor particle fluidity.

Active Publication Date: 2013-07-24
BEIJING RED SUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The object of the present invention is to provide a new pharmaceutical composition of valsartan and amlodipine besylate, through innovative auxiliary material composition and optimized auxiliary material ratio, successfully solve the problem of poor particle fluidity, drug disintegration and unsa

Method used

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  • Valsartan amlodipine tablet composition and preparation method
  • Valsartan amlodipine tablet composition and preparation method
  • Valsartan amlodipine tablet composition and preparation method

Examples

Experimental program
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Effect test

Embodiment 1

[0047] 1. Valsartan and amlodipine tablets 1000 tablets, the specifications are 80mg of valsartan and 5mg of amlodipine besylate per tablet, the formula composition is as follows:

[0048] Valsartan 80g,

[0049] Amlodipine besylate (calculated as amlodipine) 5g,

[0050] Microcrystalline cellulose 50g,

[0051] Croscarmellose Sodium 4g,

[0052] Hydroxypropylmethylcellulose E15 1.5g,

[0053] Magnesium stearate 0.5g,

[0054] Silicon dioxide 1g.

[0055] 2, adopt the following method to prepare valsartan amlodipine film-coated tablet:

[0056] 1) Pass valsartan, amlodipine besylate, and microcrystalline cellulose through an 80-mesh sieve, and set aside;

[0057] 2) Prepare a 2% solution of hydroxypropyl methylcellulose with purified water for later use;

[0058] 3) Weigh the above spare valsartan, amlodipine besylate, microcrystalline cellulose and 1 / 2 croscarmellose sodium according to the prescription amount, mix them uniformly by equal addition method, and then add ...

Embodiment 2

[0064] 1. Valsartan and amlodipine tablets 1000 tablets, the specifications are 80mg of valsartan and 5mg of amlodipine besylate per tablet, the formula composition is as follows:

[0065] Valsartan 80g,

[0066] Amlodipine besylate (calculated as amlodipine) 5g,

[0067] Microcrystalline Cellulose 75g,

[0068] Croscarmellose Sodium 15g,

[0069] Hydroxypropyl Methyl Cellulose E15 3g,

[0070] Magnesium Stearate 1.5g,

[0071] Silica 2g.

[0072] 2, adopt the following method to prepare valsartan amlodipine film-coated tablet:

[0073] 1) Pass valsartan, amlodipine besylate, and microcrystalline cellulose through a 100-mesh sieve respectively, and set aside;

[0074] 2) Prepare a 5% solution of hydroxypropyl methylcellulose with purified water for later use;

[0075] 3) Weigh the above spare valsartan, amlodipine besylate, microcrystalline cellulose and 1 / 2 croscarmellose sodium according to the prescription amount, mix them uniformly by equal addition method, and then a...

Embodiment 3

[0081] 1. Valsartan and amlodipine tablets 1000 tablets, the specifications are 80mg of valsartan and 5mg of amlodipine besylate per tablet, the formula composition is as follows:

[0082] Valsartan 80g,

[0083] Amlodipine besylate (calculated as amlodipine) 5g,

[0084] Microcrystalline Cellulose 65g,

[0085] Croscarmellose Sodium 13.6g,

[0086] Hydroxypropylmethylcellulose 15CP 2.3g,

[0087] Magnesium Stearate 0.8g,

[0088] Silica 1.5g.

[0089] 2, adopt the following method to prepare valsartan amlodipine film-coated tablet:

[0090] 1) Pass valsartan, amlodipine besylate, and microcrystalline cellulose through a 90-mesh sieve respectively, and set aside;

[0091] 2) Prepare a 5% solution of hydroxypropyl methylcellulose with purified water for later use;

[0092] 3) Weigh the above spare valsartan, amlodipine besylate, microcrystalline cellulose and 1 / 2 croscarmellose sodium according to the prescription amount, mix them uniformly by equal addition method, and ...

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Abstract

The invention relates to a valsartan amlodipine tablet composition and a preparation method, an active component of the valsartan amlodipine tablet composition is valsartan and amlodipine besylate tablet , an auxiliary material comprises microcrystalline cellulose, croscarmellose sodium , hydroxypropyl methylcellulose, magnesium stearate and silica; the valsartan amlodipine tablet composition employs a wet method for granulation and tabletting; the preparation method has the advantages of little disintegrating agent , high dissolution rate , simple production technology and low equipment requirement; through detections, the tablet prepared by the valsartan amlodipine tablet composition and the preparation method has good dissolution performance.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a pharmaceutical composition containing valsartan and amlodipine besylate and a preparation method thereof. Background technique [0002] Hypertension has become a major public health problem worldwide. Nearly 1 billion people worldwide suffer from hypertension, and it is estimated that the number will reach 1.5 billion in 2025. The countries with the highest incidence of hypertension in the world are about 40% in African Americans, about 38% in England, Sweden and Italy, about 45% in Spain, and about 55% in Germany. At present, the incidence of hypertension in China has exceeded 25%, and this rising trend is still continuing. Statistics show that the treatment rate of hypertension in my country is 17.4% in urban areas and 5.4% in rural areas; the control rate after treatment is only 2.9%. Therefore, statistics show that the prevalence of hypertension in m...

Claims

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Application Information

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IPC IPC(8): A61K31/4422A61K31/41A61K9/28A61P9/12
Inventor 刘红潘红春
Owner BEIJING RED SUN PHARMA
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