Pharmaceutical composition containing valsartan and amlodipine besylate and preparation method

A kind of technology of valsartan amlodipine besylate and composition, which is applied to the pharmaceutical composition containing valsartan amlodipine besylate and the field of preparation thereof, and can solve the problem of unsatisfactory blood pressure, patients failing to reach the target target, etc. problems, to achieve the effects of stable quality, good adhesion and strict control in accelerated and long-term tests

Inactive Publication Date: 2013-03-27
天津飞鹰玉川药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Statistics show that there are more than 130 million hypertensive patients in my country, but the control of blood pressure is not ideal, and patients often fail to reach the target recommended by the guidelines

Method used

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  • Pharmaceutical composition containing valsartan and amlodipine besylate and preparation method
  • Pharmaceutical composition containing valsartan and amlodipine besylate and preparation method
  • Pharmaceutical composition containing valsartan and amlodipine besylate and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067]

[0068]

[0069] Its preparation process is:

[0070] (1) Pretreatment: Take raw materials and auxiliary materials, pass through 60-mesh sieve respectively, and set aside.

[0071] (2) Dry mixing: mix amlodipine besylate with 1 / 2 of croscarmellose sodium, then mix with microcrystalline cellulose, silicon dioxide and valsartan, and mix evenly.

[0072] (3) Granulation: dry granulation, 18 mesh granulation.

[0073] (4) Blending: Mix the dry granules, the remaining half of the croscarmellose sodium and sodium stearyl fumarate evenly. Measure the content of intermediates.

[0074] (5) Tablets. According to the results of the determination of the intermediates, the weight of the tablet is calculated, and the tablet is pressed.

[0075] (6) Film coating. The film coating premix is ​​used to prepare a 10% coating solution, the temperature is controlled to be 30-40° C., and the coating is carried out, and the weight of the coating is increased by 3%, and then dried...

Embodiment 2

[0078]

[0079] Its preparation process is:

[0080] (8) Pretreatment: Take raw materials and auxiliary materials, pass through 60-mesh sieve respectively, and set aside.

[0081] (9) Dry blending: mix amlodipine besylate with half of croscarmellose sodium, and then mix with microcrystalline cellulose, silicon dioxide and valsartan, and mix evenly.

[0082] (10) Granulation: dry granulation, 18 mesh granulation.

[0083] (11) Total blending: Mix the dry granules, the remaining half of the croscarmellose sodium, and sodium stearyl fumarate evenly. Measure the content of intermediates.

[0084] (12) Tablets. According to the results of the determination of the intermediates, the weight of the tablet is calculated, and the tablet is pressed.

[0085] (13) Film coating. The film coating premix is ​​used to prepare a 10% coating solution, the temperature is controlled to be 30-40° C., and the coating is carried out, and the weight of the coating is increased by 3%, and then...

Embodiment 3

[0088]

[0089] Its preparation process is:

[0090] (15) Pretreatment: Take raw materials and auxiliary materials, pass through 60-mesh sieve respectively, and set aside.

[0091] (16) Dry mixing: mix amlodipine besylate with half of croscarmellose sodium, then mix with microcrystalline cellulose, silicon dioxide and valsartan, and mix evenly.

[0092] (17) Granulation: dry granulation, 18 mesh granulation.

[0093] (18) Total blending: Mix the dry granules, the remaining half of the croscarmellose sodium, and sodium stearyl fumarate evenly. Measure the content of intermediates.

[0094] (19) Tablets. According to the results of the determination of the intermediates, the weight of the tablet is calculated, and the tablet is pressed.

[0095] (20) Film-coated. The film coating premix is ​​used to prepare a 10% coating solution, the temperature is controlled to be 30-40° C., and the coating is carried out, and the weight of the coating is increased by 3%, and then drie...

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PUM

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Abstract

The invention relates to a pharmaceutical composition containing valsartan and amlodipine besylate and a preparation method. The composition takes valsartan and amlodipine besylate as raw materials, and comprises pharmaceutically acceptable excipients of microcrystalline cellulose, crosslinked sodium carboxymethyl cellulose, silica and sodium stearyl fumarate. The preparation method comprises following steps: carrying out dry granulation on the raw materials and part of the excipients firstly, and adding the sodium stearyl fumarate to carry out tabletting and coating to be produced into film-coated tablets. The preparation method is characterized in that the dry granulation is adopted to avoid the influence of moisture on main ingredients during wet granulation, and the sodium stearyl fumarate serves as a lubricant instead of commonly used magnesium stearate to prevent the influence of the magnesium stearate on the main ingredients, therefore on the premise of disintegrating and dissolving the product better, the product quality is further stabilized and the drug safety is enhanced.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a pharmaceutical composition containing valsartan amlodipine besylate and a preparation method thereof. Background technique [0002] With the improvement of human living standards, hypertension has become the most common cardiovascular disease. According to WHO forecast, non-communicable diseases will account for 79% of the causes of death in my country by 2020, among which cardiovascular diseases will rank first. Statistics show that there are more than 130 million hypertensive patients in my country, but the control of blood pressure is not ideal, and patients often fail to reach the target recommended by the guidelines. Therefore, it is imperative to vigorously carry out the prevention and active treatment of hypertension. [0003] Long-term poorly controlled hypertension can seriously damage target organs such as the heart, brain, and kidneys. Active treatment can reduce car...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4422A61K31/41A61K9/28A61K47/12A61P9/12
Inventor 李凤
Owner 天津飞鹰玉川药业有限公司
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