Dopamine hydrochloride injection and preparation method thereof

A technology of dopamine hydrochloride and acid dopamine, applied in the field of medicine, can solve problems such as blindness, circulatory failure, hidden safety hazards, etc., and achieve the effect of increasing stability

Active Publication Date: 2020-08-07
WUHAN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Currently clinically used dopamine hydrochloride injection uses sodium bisulfite as an antioxidant to ensure the stability of the injection, while sodium bisulfite is toxic and irritating, irritating to the skin, eyes, and respiratory tract, and can cause allergic reactions. Can cause corneal damage, blindness, asthma, nausea, abdominal pain, diarrhea, circulatory collapse, central nervous system depression
It is a consensus in the industry that sodium bisulfite has a great potential safety hazard as an injection auxiliary material. However, for product stability, under the premise that there is no suitable method to solve the stability problem of dopamine hydrochloride, dopamine hydrochloride injection in the prior art still uses bisulfite Sodium is used as an excipient stabilizer, including those determined by the State Drug Administration as the reference preparation for the quality consistency evaluation of injections. The prescription of dopamine hydrochloride injection produced by Hospira Inc, the original manufacturer of dopamine hydrochloride injection, also contains sodium bisulfite

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] According to the prescription amount in the following table 1, the injection is prepared according to the following method:

[0016] (1) Calcium glycerophosphate and sodium caprylate of prescription quantity are dissolved in 600ml of water for injection at 36 ℃ successively;

[0017] (2) Keep the temperature at 36°C, add the prescribed amount of dopamine hydrochloride and stir to dissolve, add water for injection to 1000ml;

[0018] (3) Measure the pH value and content of the solution, filter it with a 0.22 μm filter membrane, fill it in an ampoule according to the specification of 2ml:20mg, and then sterilize it at 121° C. for 15 minutes to obtain dopamine hydrochloride injection.

[0019] Table 1 Calcium glycerophosphate and sodium caprylate injection in different prescription quantities

[0020]

[0021]

[0022] The above 8 kinds of prescription samples were subjected to the influence factor test, and they were placed under the conditions of 60°C and strong l...

Embodiment 2

[0029] prescription:

[0030] Dopamine Hydrochloride: 10g

[0031] Sodium caprylate: 2.2g

[0032] Calcium glycerophosphate: 4.5g

[0033] Add water for injection to 1000ml to make 500 sticks.

[0034] Preparation:

[0035] (1) Calcium glycerophosphate and sodium caprylate of prescription quantity are dissolved in 600ml of water for injection at 36 ℃ successively;

[0036] (2) Keep the temperature at 36°C, add the prescribed amount of dopamine hydrochloride and stir to dissolve, add water for injection to 1000ml;

[0037] (3) Measure the pH value and content of the solution, filter it with a 0.22 μm filter membrane, fill it in an ampoule according to the specifications, and then sterilize it at 121° C. for 15 minutes to obtain dopamine hydrochloride injection.

Embodiment 3

[0039] prescription:

[0040] Dopamine Hydrochloride: 10g

[0041] Sodium caprylate: 2.2g

[0042] Calcium glycerophosphate: 4.5g

[0043] Add water for injection to 1000ml to make 500 sticks.

[0044] Preparation:

[0045] (1) Calcium glycerophosphate and sodium caprylate of prescription quantity are dissolved in 600ml of water for injection at 42 ℃ successively;

[0046] (2) Keep the temperature at 42°C, add the prescribed amount of dopamine hydrochloride and stir to dissolve, add water for injection to 1000ml;

[0047] (3) Measure the pH value and content of the solution, filter it with a 0.22 μm filter membrane, fill it in an ampoule according to the specifications, and then sterilize it at 121° C. for 15 minutes to obtain dopamine hydrochloride injection.

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Abstract

The invention relates to a dopamine hydrochloride injection and a preparation method thereof. Every 1000 ml of the injection contains 10-40 g of dopamine hydrochloride, and also contains sodium caprylate and calcium glycerophosphate. The dopamine hydrochloride injection prepared according to the method disclosed by the invention has extremely high quality stability, the medication safety is improved, the dopamine hydrochloride injection is obviously superior to the prior art and a reference preparation, and the injection consistency evaluation requirement is met.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a dopamine hydrochloride injection and a preparation method thereof. Background technique [0002] Dopamine hydrochloride, chemical name: 4-(2-aminoethyl)-1,2-benzenediol hydrochloride. Dopamine is the precursor of norepinephrine biosynthesis and one of the central transmitters. It can excite β-receptors, α-receptors and dopamine receptors. Exciting cardiac β-receptors can increase myocardial contractility. Increase cardiac output. Stimulate dopamine receptors and α-receptors to dilate kidneys, mesentery, coronary arteries and cerebral vessels, increase blood flow, have a slight contraction effect on peripheral blood vessels, and increase arterial blood pressure. The prominent role is to increase renal blood flow and glomerular filtration rate, thereby increasing urine output and urinary sodium excretion. It is clinically used for various types of shock, especiall...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/137A61K47/12A61K47/24A61P9/02A61P9/04A61P13/12
CPCA61K9/0019A61K9/08A61K31/137A61K47/12A61K47/24A61P9/02A61P9/04A61P13/12
Inventor 胡汉昆林嫚婷苏亚霞卢云李文婧刘薇芝张莉华倪扬都胜男姜文娴
Owner WUHAN UNIV
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