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Azilsartan tablet as well as preparation method and application of tablet

A technology for azilsartan tablets and adhesives, which is applied in the field of azilsartan tablets and its preparation, can solve problems affecting drug efficacy, crystal form transformation, etc., and achieve fast dissolution rate, good particle size distribution, and excellent dissolution curve Effect

Active Publication Date: 2021-08-06
YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006]Since azilsartan is a polymorph drug, its crystal form may change during the preparation process, thus affecting the efficacy of the drug

Method used

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  • Azilsartan tablet as well as preparation method and application of tablet
  • Azilsartan tablet as well as preparation method and application of tablet
  • Azilsartan tablet as well as preparation method and application of tablet

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0049] The preparation method of the Azilsartan tablet that embodiment 1-12 provides is as follows:

[0050] (1) Pulverization: Azilsartan is micronized to control the particle size D90 to be less than 20 μm to obtain azilsartan micropowder.

[0051] (2) Ingredients: weigh azilsartan micropowder, lactose, corn starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, high-substituted hydroxypropyl cellulose, polyethylene glycol 6000, magnesium stearate according to the prescription amount .

[0052] (3) Adhesive preparation: Weigh purified water quantitatively, slowly add hydroxypropyl cellulose and polyethylene glycol 6000 under stirring, and prepare a 6% hydroxypropyl cellulose aqueous solution for later use.

[0053] (4) Mixing: Add lactose, pulverized azilsartan micropowder, corn starch, half of the low-substituted hydroxypropyl cellulose, and microcrystalline cellulose into the wet granulator in order and mix for 5 minutes.

[0054] (5) Granulation: P...

Embodiment 1-1

[0090]

[0091]

[0092]

[0093] The above results show that at a high temperature of 60°C, both the impurity A and the impurity B of Example 1-1 and the original preparation have a significant increase trend, and the remaining indicators have no obvious changes; The impurity A and impurity B of the original preparation increased slightly; under the conditions of high humidity and light, the related substances of Example 1-1 and the original preparation increased slightly, and the other inspection indexes had no obvious changes. Illustrate that the changing trend of the influencing factors of the product provided by the invention is consistent with the original preparation.

[0094] Stability test:

[0095] (1) Accelerated test

Embodiment 1-2

[0098]

[0099]

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Abstract

The invention provides an azilsartan tablet as well as a preparation method and application of the tablet. The azilsartan tablet comprises the following components in parts by weight: 10-20 parts of azilsartan, 38-43 parts of lactose, 10-20 parts of microcrystalline cellulose, 8-13 parts of starch, 0.1-5 parts of an adhesive, 4-12 parts of a disintegrating agent, 1-5 parts of a stabilizer, 0.1-1 part of a lubricant and 0.1-0.5 part of a coating material. The azilsartan tablet provided by the invention is excellent in dissolution curve, high in dissolution speed, good in treatment effect, simple in preparation process, low in energy consumption and high in stability and reproducibility.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an azilsartan tablet and its preparation method and application, in particular to an azilsartan tablet whose quality is equivalent to that of the original preparation, its preparation method and its application. Background technique [0002] Hypertension is a clinical syndrome characterized by elevated systemic arterial pressure, or accompanied by functional or organic damage to heart, brain, kidney and other organs, and is also the most important risk factor for cardiovascular and cerebrovascular diseases. This disease is still difficult to cure at present, needs long-term medication control, endangers human health, causes burden to society and family. Common antihypertensive drugs on the market are mostly diuretics, β-receptor antagonists, calcium channel blockers, angiotensin-converting enzyme inhibitors (ACEI), etc., but these drugs have obvious adverse ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/28A61K47/38A61K47/26A61K47/36A61K47/32A61K47/10A61K31/4245A61P9/12
CPCA61K9/2054A61K9/2018A61K9/2059A61K9/2027A61K9/2031A61K9/2095A61K9/2077A61K9/2806A61K31/4245A61P9/12
Inventor 陈丽李婷杨锐房莲相丛海建李玲玲
Owner YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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