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Dopamine hydrochloride injection as reference preparation and preparation method thereof

A technology of dopamine hydrochloride and injection, which is applied in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve problems such as low safety and allergic reactions to sulfite antioxidants. , to achieve high safety, solve the problem of adverse reactions, and isolate the effect of oxygen

Inactive Publication Date: 2021-05-28
合肥市未来药物开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Hypersensitivity reactions to sulfite antioxidants occur in about 5-10% of asthmatic patients, although adverse reactions may also occur in patients without a history of asthma
Therefore, the safety of the dopamine hydrochloride injection aqueous injection of the reference preparation commonly used at present is lower

Method used

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  • Dopamine hydrochloride injection as reference preparation and preparation method thereof
  • Dopamine hydrochloride injection as reference preparation and preparation method thereof
  • Dopamine hydrochloride injection as reference preparation and preparation method thereof

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preparation example Construction

[0022] The embodiment of the present invention provides a preparation method of dopamine hydrochloride injection as a reference preparation, comprising: dopamine hydrochloride, osmotic pressure regulator auxiliary material, pH regulator and water, osmotic pressure regulator auxiliary material is sodium chloride or glucose Sugar, pH adjuster is 0.2% hydrochloric acid aqueous solution. Water can be water for injection.

[0023] Specifically, the mass ratio of dopamine hydrochloride, sodium chloride and water is 40:9:1000.

[0024] Specifically, the mass ratio of dopamine hydrochloride, glucose and water is 4:9:100.

[0025] Specifically, the pH of the dopamine hydrochloride injection used as the reference preparation is 3.0-5.0.

Embodiment 1

[0036] The embodiment of the present invention provides a preparation method of dopamine hydrochloride injection as a reference preparation, comprising: dopamine hydrochloride, osmotic pressure regulator auxiliary material, pH regulator and water, osmotic pressure regulator auxiliary material is sodium chloride or glucose sugar, and the pH adjuster is hydrochloric acid. Water can be water for injection.

[0037] Specifically, the mass ratio of dopamine hydrochloride, sodium chloride and water is 40:9:1000. Further, dopamine hydrochloride, sodium chloride and water are respectively 40g, 9g and 1000mL.

[0038] Specifically, the pH of the dopamine hydrochloride injection used as the reference preparation is 3.0.

[0039] Briefly introduce the preparation method of the dopamine hydrochloride injection provided by the embodiment of the present invention below, the preparation method comprises:

[0040] Filling the second asphyxiating gas into the anaerobic airtight glass contai...

Embodiment 2

[0052] The embodiment of the present invention provides a preparation method of dopamine hydrochloride injection as a reference preparation, comprising: dopamine hydrochloride, osmotic pressure regulator auxiliary material, pH regulator and water, osmotic pressure regulator auxiliary material is sodium chloride or glucose sugar, and the pH adjuster is hydrochloric acid.

[0053] Specifically, the mass ratio of dopamine hydrochloride, glucose and water is 4:5:100. Further, dopamine hydrochloride, glucose and water are respectively 40g, 50g and 1000mL.

[0054] Specifically, the pH of the dopamine hydrochloride injection used as the reference preparation is 4.0.

[0055] Briefly introduce the preparation method of the dopamine hydrochloride injection provided by the embodiment of the present invention below, the preparation method comprises:

[0056] Filling the second asphyxiating gas into the anaerobic airtight glass container, in the environment of the asphyxiating gas, addin...

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Abstract

The invention provides a dopamine hydrochloride injection serving as a reference preparation and a preparation method of the dopamine hydrochloride injection, and belongs to the field of pharmacy. The dopamine hydrochloride injection comprises dopamine hydrochloride, an osmotic pressure regulator auxiliary material, a pH regulator and water, wherein the osmotic pressure regulator auxiliary material is sodium chloride or glucose, and the pH regulator is hydrochloric acid. According to the preparation method provided by the embodiment of the invention, initial liquid preparation and split charging are carried out in a closed environment filled with suffocating gas, so that oxygen can be well isolated, meanwhile, an antioxidant sodium pyrosulfite is not adopted in the preparation method, the problem of adverse reaction caused by the antioxidant can be solved, and allergic reaction on sulfite antioxidants in asthma patients is avoided at the same time, so that the dopamine hydrochloride injection prepared by the method has relatively high safety.

Description

technical field [0001] The invention relates to the field of pharmacy, more specifically, to a preparation method of dopamine hydrochloride injection as a reference preparation. Background technique [0002] The chemical name of dopamine hydrochloride is 4-(2-aminoethyl)-1,2-benzenediol hydrochloride. Dopamine hydrochloride not only has β-receptor stimulant effect, but also has certain α-receptor stimulant effect, which makes dopamine hydrochloride can enhance myocardial contractility, increase cardiac output, increase heart rate slightly, and have mild contraction effect on peripheral blood vessels. Elevate arterial pressure; expand visceral blood vessels, increase blood flow, increase renal blood flow and glomerular filtration rate, thereby increasing urine output and sodium excretion, improving peripheral circulation, significantly increasing urine output, and affecting heart rate No significant effect. [0003] The reference preparation refers to the control drug used ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/137A61K47/02A61K47/04A61K47/26A61P9/04
CPCA61K9/08A61K9/0019A61K31/137A61K47/02A61K47/26A61P9/04
Inventor 赵立军陈佳佳汪泉金秋戴五好吴海林
Owner 合肥市未来药物开发有限公司
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