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Olmesartan medoxomil tablet and preparation method thereof

Olmesartan medoxomil tablet and Olmesartan medoxomil technology, applied in the field of olmesartan medoxomil tablet and its preparation, can solve problems such as easy inhalation into the lungs, occupational injury, etc., and achieve short production cycle and bioequivalence Consistency, guaranteed consistent results

Active Publication Date: 2022-01-07
烟台万润药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, silica and micropowder silica gel are easily inhaled into the lungs during production, causing occupational injury

Method used

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  • Olmesartan medoxomil tablet and preparation method thereof
  • Olmesartan medoxomil tablet and preparation method thereof
  • Olmesartan medoxomil tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Per 1000 described olmesartan medoxomil tablets, its formula composition is as follows:

[0032] Olmesartan medoxomil 20g, mannitol 105g, microcrystalline cellulose (UF-702) 48g, microcrystalline cellulose (PH301) 30g, croscarmellose sodium 15g, magnesium stearate 2g, film coating pre- Mixture 8g, 95% ethanol 89g, purified water 82g.

[0033] Preparation steps:

[0034] Pre-mixing: first mix olmesartan medoxomil raw material, croscarmellose sodium, microcrystalline cellulose (UF-702), and microcrystalline cellulose (PH301), then add mannitol and mix; total mixing: mix The pre-mixed material was mixed with magnesium stearate evenly, and the uniformity of mixing was verified, and then tableted, and finally coated, and the weight gain of the coating was 2.0%, so as to obtain the olmesartan medoxomil tablet.

Embodiment 2

[0036] Per 1000 described olmesartan medoxomil tablets, its formula composition is as follows:

[0037] Olmesartan medoxomil 20g, mannitol 83g, microcrystalline cellulose (UF-702) 90g, microcrystalline cellulose (PH301) 30g, croscarmellose sodium 15g, magnesium stearate 2g, film coating pre- Mixture 8g, 95% ethanol 89g, purified water 82g.

[0038] Preparation steps:

[0039] Pre-mixing: first mix olmesartan medoxomil raw material, croscarmellose sodium, microcrystalline cellulose (UF-702), and microcrystalline cellulose (PH301), then add mannitol and mix; total mixing: mix The pre-mixed material was then mixed with magnesium stearate evenly, and the uniformity of mixing was verified before tableting, and finally coated, and the weight gain of the coating was 5.0%, so as to obtain the olmesartan medoxomil tablet.

Embodiment 3

[0041] Per 1000 described olmesartan medoxomil tablets, its formula composition is as follows:

[0042] Olmesartan medoxomil 20g, mannitol 113g, microcrystalline cellulose (UF-702) 60g, microcrystalline cellulose (PH301) 30g, croscarmellose sodium 15g, magnesium stearate 2g, film coating pre- Mixture 8g, 95% ethanol 89g, purified water 82g.

[0043] Preparation steps:

[0044]Pre-mixing: first mix olmesartan medoxomil raw material, croscarmellose sodium, microcrystalline cellulose (UF-702), and microcrystalline cellulose (PH301), then add mannitol and mix; total mixing: mix The premixed material was mixed with magnesium stearate evenly, and the uniformity of mixing was verified, and then tableted, and finally coated, and the weight gain of the coating was 3.6%, so as to obtain the olmesartan medoxomil tablet.

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PUM

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Abstract

The invention relates to an olmesartan medoxomil tablet, and belongs to the technical field of pharmaceutical preparations. The olmesartan medoxomil tablet is composed of an olmesartan medoxomil plain tablet and a film coating, wherein the olmesartan medoxomil plain tablet is prepared from the following components in parts by weight: 6 to 15 parts of olmesartan medoxomil crude drug, 45 to 85 parts of filling agent, 6 to 12 parts of disintegrating agent and 0.5 to 2 parts of lubricating agent; the filling agent is a combination of mannitol, microcrystalline cellulose PH301 and microcrystalline cellulose UF-702. According to the olmesartan medoxomil tablet disclosed by the invention, the filling agent is prepared from two types of microcrystalline cellulose and mannitol in a specific proportion under the situation that no flow aid and no anti-sticking agent are added, the olmesartan medoxomil tablet is prepared by adopting a powder direct pressing method, the production period is shorter, the technology is simpler, and labor protection is more facilitated; by optimizing the weight gain proportion of the coating, multiple dissolution curves of the olmesartan medoxomil tablet and a reference preparation in vitro are similar.

Description

technical field [0001] The invention relates to an olmesartan medoxomil tablet and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Hypertension is the most common cardiovascular system disease, and its complications have become one of the main causes of human death today. Reaching the target blood pressure is the key to reducing the incidence of cardiovascular events and mortality. The earlier the blood pressure reaches the target, the greater the benefit. [0003] Olmesartan medoxomil is a new oral angiotensin Ⅱ receptor antagonist (ARB), which can selectively inhibit angiotensin Ⅱ and angiotensin Ⅱ type 1 receptor (AT 1 ) combination, powerfully block the renin-angiotensin system, dilate blood vessels throughout the body, thereby lowering blood pressure. [0004] ARBs not only lower blood pressure, but also provide organ protection and other benefits in patients with heart failure, type 2 diabet...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K9/20A61K47/38A61K47/26A61K31/4178A61P9/12
CPCA61K9/28A61K9/2095A61K9/2054A61K9/2018A61K31/4178A61P9/12
Inventor 张加泽冯占美韩志鹏范林杨侠
Owner 烟台万润药业有限公司