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Composition containing levorotatory amlodipine and azilsartan

A technology of levamlodipine and levamlodipine besylate, which is applied in the field of pharmaceutical preparations and can solve problems affecting the safety of active ingredients

Inactive Publication Date: 2016-08-17
SHANGHAI STEPPHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Azilsartan is insoluble in water and is an insoluble drug. When insoluble drugs are made into pharmaceutical preparations, they often need to be treated in a special way to increase their dissolution rate in vitro, and this special treatment method is likely to affect the safety of the active ingredient.

Method used

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  • Composition containing levorotatory amlodipine and azilsartan
  • Composition containing levorotatory amlodipine and azilsartan
  • Composition containing levorotatory amlodipine and azilsartan

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 6

[0051] Embodiment 6: Antihypertensive test in rats.

[0052] Experimental method: Take 120 healthy spontaneously hypertensive SHR rats, half male and half female, weighing 200-240g. Male and female rats are divided into 12 groups according to the balance of blood pressure (see Table 1 for specific grouping methods). For blood pressure, rat electronic sphygmomanometers were used to indirectly measure the systolic blood pressure of the rats when they were awake and quiet by the tail volume method. The grouping method is shown in Table 5.

[0053] model group

The same volume of 0.9% normal saline

/

Single drug 1 group

Levoamlodipine Besylate

5mg.kg -1 .d -1

Single drug 2 groups

Azilsartan

20mg.kg -1 .d -1

Compound 1 group

Levoamlodipine Besylate / Azilsartan

2.5mg.kg -1 .d -1 / 10mg.kg -1 .d -1

[0054] Experimental results: Compared with the model group, the single drug 1 group, the single drug 2 grou...

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PUM

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Abstract

The invention relates to a pharmaceutical composition preparation of azilsartan and levorotatory amlodipine or medically-acceptable salt of azilsartan and levorotatory amlodipine and a preparing method of the pharmaceutical composition preparation. The pharmaceutical composition preparation is prepped from azilsartan and levorotatory amlodipine or medically-acceptable salt of azilsartan and levorotatory, and pharmaceutical auxiliaries. The pharmaceutical composition preparation is prepared with the technology combining wet granulation and dry granulation. The preparation is good in dissolution rate, stable and controllable in formulation and process and suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a composition preparation containing azilsartan and levamlodipine or a pharmaceutically acceptable salt thereof and a preparation method thereof. Background technique [0002] The newly released "Report on Nutrition and Chronic Disease Status of Chinese Residents (2015)" shows that in 2012, the prevalence of hypertension among residents aged 18 and over in my country was 25.2%, which was higher in men than in women, and higher in cities than in rural areas. It is estimated that the current prevalence of hypertension in Chinese adults is Patients are about 260 million. Hypertension risk factors (such as smoking, excessive drinking, high salt and high fat food intake, lack of activity, overweight and obesity, and elevated total cholesterol, etc.) are common in the population, and continue to increase or remain high, becoming hypertension The potential threat o...

Claims

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Application Information

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IPC IPC(8): A61K31/4422A61K9/20A61P9/12A61K31/4245
CPCA61K31/4245A61K9/2054A61K31/4422A61K2300/00
Inventor 安日明唐飞宇廖文胜
Owner SHANGHAI STEPPHARM CO LTD
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