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A kind of pharmaceutical composition containing serelaxin and preparation method thereof

A technology of composition and medicine, which is applied in the field of pharmaceutical composition containing serelaxin and its preparation, can solve the problems of visible foreign matter, decrease in content, darkening of color, etc., and achieve good safety, good tissue compatibility, and stable quality Effect

Active Publication Date: 2018-08-24
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The serelaxin injection prepared by the existing injection preparation technology will have unqualified clarity and visible foreign matter, and the content will decrease and the related substances will increase at the same time, and the above injection is sensitive to light, and the content will decrease under light. And the increase of related substances, the darkening of the color and the appearance of smoke, precipitation and other problems

Method used

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  • A kind of pharmaceutical composition containing serelaxin and preparation method thereof
  • A kind of pharmaceutical composition containing serelaxin and preparation method thereof
  • A kind of pharmaceutical composition containing serelaxin and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1: the preparation of the pharmaceutical composition containing serelaxin

[0029] 1. Preparation prescription (calculated in 1000ml)

[0030] Serelaxin Acetate 100mg

[0031] Mannitol 50g

[0032] Add water for injection to 1000ml

[0033] 2. Preparation process

[0034] Dissolve mannitol with water for injection, dissolve serelaxin acetate with water for injection, add to the mannitol solution and mix evenly, add water for injection to 1000ml and mix evenly. Filter through a 0.2 μm sterile filter. Packed in vials at 1.1ml / branch.

Embodiment 2

[0035] Embodiment 2: the preparation of the pharmaceutical composition containing serelaxin

[0036] 1. Preparation prescription (calculated in 1000ml)

[0037] Serelaxin 200mg

[0038] Glucose 50g

[0039] Add water for injection to 1000ml

[0040] 2. Preparation process

[0041] Dissolve the glucose with water for injection, dissolve serelaxin with water for injection, add to the glucose solution and mix well, add water for injection to 1000ml and mix well. Filter through a 0.2 μm sterile filter. Packed in vials at 1.1ml / branch.

Embodiment 3

[0042] Embodiment 3: the preparation of the pharmaceutical composition containing serelaxin

[0043] 1. Preparation prescription (calculated in 1000ml)

[0044] Serelaxin 500mg

[0045] Sodium chloride 9.0g

[0046] Add water for injection to 1000ml

[0047] 2. Preparation process

[0048] Dissolve sodium chloride with water for injection, dissolve serelaxin with water for injection, add to the sodium chloride solution and mix well, add water for injection to 1000ml and mix well. Filter through a 0.2 μm sterile filter. Packed in vials at 1.1ml / branch.

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Abstract

The invention belongs to the technical field of drug preparation, and discloses a pharmaceutical composition containing serelaxin. The composition comprises an effective amount of serelaxin / pharmaceutically-acceptable salts of serelaxin and a pharmaceutically-acceptable carrier, which comprises a buffer solution, an osmotic pressure conditioning agent, a pH adjusting agent, and an antioxidant. The invention further discloses a preparation method of the provided pharmaceutical composition. The provided pharmaceutical composition can effectively overcome various defects of conventional serelaxin injection, at the same time has the advantages of good tissue compatibility and high safety, is accord with the national evaluation on drug safety, and can be used as injection in clinic.

Description

technical field [0001] The invention relates to the technical field of medicine preparation, in particular to a pharmaceutical composition containing serelaxin and a preparation method thereof. Background technique [0002] Acute heart failure (AHF) or acute decompensated heart failure (ADHF) encompasses a diverse group of disorders that typically include dyspnea (shortness of breath), edema (fluid retention), and fatigue. For example, a patient with shortness of breath due to exacerbation of congestive heart failure would fall into the group of AHF patients. Thus, AHF can be a functional and / or structural disease. [0003] At present, among the traditional drugs for the treatment of acute heart failure, inotropes, diuretics and vasodilators not only have a single effect, but also have their own inherent limitations, which lead to the activation of neuroendocrine hormones while improving the symptoms of heart failure. , eventually leading to ventricular remodeling and left...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/22A61K9/08A61K47/26A61P9/04
Inventor 郑春莲潘俊锋马亚平袁建成
Owner HYBIO PHARMA