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Pharmaceutical composition containing irbesartan and amlodipine benzenesulfonate and preparation method thereof

A technology of amlodipine besylate and amlodipine besylate, applied in the field of medicine, can solve the problems of long drying time of wet granules, difficult to mix uniformly, decreased preparation content uniformity and the like, and achieves good content uniformity and stability performance, simple production process and good disintegration performance

Active Publication Date: 2014-06-18
HAINAN ZHONGJI MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Since irbesartan is a drug with strong hydrophobicity, the wetting effect is poor when wet granulation is used, the amount of binder required is large, and the drying time of wet granules is long; Due to the difference in particle size and density in the process of wet granulation of the agent alone, it is difficult to mix evenly and the mixture is easy to layer during the subsequent mixing process of granules and powder, resulting in a decrease in the uniformity of the formulation content
In addition, the process of preparing three-layer tablets is complicated and requires high equipment, which makes the production cost high and the production efficiency low

Method used

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  • Pharmaceutical composition containing irbesartan and amlodipine benzenesulfonate and preparation method thereof
  • Pharmaceutical composition containing irbesartan and amlodipine benzenesulfonate and preparation method thereof
  • Pharmaceutical composition containing irbesartan and amlodipine benzenesulfonate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1 The pharmaceutical composition of the present invention was prepared by dry granulation and tabletting technology.

[0031] prescription:

[0032]

[0033] Preparation:

[0034] (1) Irbesartan and amlodipine besylate are pulverized respectively and sieved;

[0035] (2) Microcrystalline cellulose, croscarmellose sodium, hypromellose, micropowder silica gel and magnesium stearate are sieved respectively;

[0036] (3) Irbesartan, amlodipine besylate, microcrystalline cellulose, croscarmellose sodium, micropowder silica gel and a part of magnesium stearate are taken by weighing the prescription amount, and mixed;

[0037] (4) screening the material obtained in step (3);

[0038] (5) mixing the material after the sieving in step (4);

[0039] (6) Dry granulating the material obtained in step (5);

[0040] (7) Get the granules that step (6) obtains, add remaining magnesium stearate, carry out total blending;

[0041] (8) Compress the blended material obtain...

Embodiment 2

[0043] Example 2 The pharmaceutical composition of the present invention was prepared by dry granulation and tabletting technology.

[0044] prescription:

[0045]

[0046]

[0047] Preparation:

[0048] Prepare according to the method of Example 1.

Embodiment 3

[0049] Example 3 The pharmaceutical composition of the present invention was prepared by dry granulation and tabletting technology.

[0050] prescription:

[0051]

[0052] Preparation:

[0053] Prepare according to the method of Example 1.

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Abstract

The invention belongs to the technical field of medicine, and particularly relates to a pharmaceutical composition containing irbesartan and amlodipine benzenesulfonate and a preparation method thereof. The formula of the pharmaceutical composition comprises 10 parts by weight of irbesartan, 5 parts by weight of amlodipine benzenesulfonate (calculated according to amlodipine), 40 to 70 parts by weight of microcrystalline cellulose, 6 to 12 parts by weight of croscarmellose sodium, 3 to 9 parts by weight of hydroxypropyl methylcellulose, 2 to 8 parts by weight of colloidal silicon dioxide, 2 to 6 parts by weight of magnesium stearate and 2 to 6 parts by weight of a coating material. The pharmaceutical composition is prepared by a dry granulation tabletting process, and the shortcomings of a wet granulation process are overcome; and the pharmaceutical composition has the advantages of fast dissolution, uniform content, stable properties, simple production process and high production efficiency, and is suitable for industrial mass production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a pharmaceutical composition containing irbesartan and amlodipine besylate and a preparation method thereof. Background technique [0002] Hypertension is a syndrome with elevated blood pressure as the main clinical manifestation. Hypertension is not only an independent chronic disease, but also an important risk factor leading to stroke, myocardial infarction, heart failure and chronic kidney disease. High blood pressure has become one of the most common cardiovascular diseases. Since hypertension is a multifactorial disease involving the combined effects of genetic and environmental factors, the renin-angiotensin-aldosterone system, sympathetic nervous system, body fluid volume system, and cell membrane ion transport system are involved in its occurrence and development. Only one of the mechanisms can be adjusted, so the curative effect is not good. A large number of studies h...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/4422A61K47/38A61P9/12A61K31/4184
Inventor 刘启兵杨贵方肖文礼章燕杨波
Owner HAINAN ZHONGJI MEDICAL TECH
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