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Preparation method of atenolol injection

A technology for atenolol and injection, which is applied in the field of preparation of atenolol injection, can solve problems affecting product quality stability and increasing production costs, and achieve safe and effective clinical use, reduced dosage, and stable quality Effect

Active Publication Date: 2015-03-25
山东益康药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, in the long-term test of the atenolol injection produced by the company, it was found that the related substances in the injection prepared by the original process tended to increase, which affected the stability of product quality; and in the original process, due to the adsorption of activated carbon , the main drug needs to be fed according to 120% of the labeled amount, which increases the production cost

Method used

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  • Preparation method of atenolol injection
  • Preparation method of atenolol injection
  • Preparation method of atenolol injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Embodiment 1: the preparation of atenolol injection

[0034] The prescription is:

[0035] Name of raw material

Usage amount

Atenolol

5.0g

[0036] Sodium chloride

90g

Sodium edetate

5.0g

Sodium dihydrogen phosphate

12.0g

0.1mol / l disodium hydrogen phosphate

20ml

1,2-propanediol

3500ml

Water for Injection

Set volume to 10L

Co-made

1000 pieces

[0037] Preparation Process:

[0038] 1) Take water for injection of 70% (v / v) of the prescription amount, add sodium chloride and sodium dihydrogen phosphate in turn to dissolve, and add 0.1% (m / v) charcoal for needles to the dissolved solution , stirred for 25 minutes, filtered through a 5 μm titanium filter, removed the charcoal for needles, and set aside.

[0039] 2) Take the prescribed amount of 1,2-propanediol and heat to 60°C, add atenolol, stir to dissolve; add the solution prepared in step 1), and st...

Embodiment 2

[0047] Embodiment 2: the preparation of atenolol injection

[0048] The prescription is:

[0049] Name of raw material

Usage amount

Atenolol

5.0g

Sodium chloride

75g

Sodium edetate

3.0g

[0050] Sodium dihydrogen phosphate

6.0g

0.1mol / l disodium hydrogen phosphate

8ml

1,2-propanediol

2000ml

Water for Injection

Set volume to 10L

Co-made

1000 pieces

[0051] Preparation Process:

[0052] 1) Take water for injection of 60% (v / v) of the prescription amount, add sodium chloride and sodium dihydrogen phosphate in turn to dissolve, and add 0.2% (m / v) of charcoal for needles to the dissolved solution , stirred for 30 minutes, filtered through a 5 μm titanium filter, removed the charcoal for needles, and set aside.

[0053] 2) Take the prescribed amount of 1,2-propanediol and heat to 55°C, add atenolol, stir to dissolve; add the solution prepared in step 1), and s...

Embodiment 3

[0061] Embodiment 3: the preparation of atenolol injection

[0062] The prescription is:

[0063] Name of raw material

Usage amount

Atenolol

5.0g

Sodium chloride

45g

Sodium edetate

1.5g

Sodium dihydrogen phosphate

1.2g

[0064] 0.1mol / l disodium hydrogen phosphate

3ml

1,2-propanediol

2500ml

Water for Injection

Set volume to 10L

Co-made

1000 pieces

[0065] Preparation Process:

[0066] 1) Take water for injection of 75% (v / v) of the prescribed amount, add sodium chloride and sodium dihydrogen phosphate in turn to dissolve the prescribed amount, add 0.15% (m / v) charcoal for needles, stir for 20 minutes, and dissolve at 5 μm Filter through a titanium filter, remove the charcoal for needles, and set aside.

[0067] 2) Take the prescribed amount of propylene glycol and heat to 65°C, add atenolol, stir to dissolve; add the above standby solution, and stir.

...

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Abstract

The invention discloses an atenolol injection. The atenolol injection is prepared from atenolol and pharmaceutically acceptable auxiliary materials, and the concentration of the atenolol injection is 0.45-0.55mg / mL according to the concentration of atenolol. The auxiliary materials comprise the following components: a composite solvent consisting of 1,2-propylene glycol and water, a buffer system consisting of sodium dihydrogen phosphate and disodium hydrogen phosphate, sodium chloride which is taken as an osmotic pressure regulator, and sodium edetate which is taken as a metal ion complexing agent, wherein in the composite solvent, the volume percentage of 1,2-propylene glycol accounts for 10-35%. The invention also discloses a preparation method of the atenolol injection. By adopting a mode of adding carbon twice, the purpose of adsorbing pyrogen in the injection can be achieved, and a main medicine of a solution cannot be significantly adsorbed. The atenolol injection prepared by adopting the method disclosed by the invention is good in stability and safe and effective in clinical use.

Description

technical field [0001] The invention relates to a preparation method of atenolol injection, which belongs to the technical field of pharmaceutical preparations. Background technique [0002] Atenolol, chemical name: 4-[3-[(1-methylethyl)amino-2-hydroxy]propoxy]phenylacetamide, molecular formula: C 14 h 22 N 2 o 3 , molecular weight: 266.34, its chemical structure is as follows: [0003] [0004] Atenolol is a white powder, odorless or slightly odorous, soluble in ethanol, slightly soluble in chloroform and water, almost insoluble in ether, melting point is 151-155. [0005] Atenolol (Atenolol) was developed by the British Imperial Chemical Company (ICI) in 1976. It is a new β-receptor blocker, which has greater selectivity for cardiac β1 receptors and vascular and bronchial β2 receptors. The receptor effect is small, and there is no inhibition of myocardial contractility in large doses. In 1982, the US FDA approved it for the treatment of hypertension, angina pector...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/165A61K47/18A61K47/04A61K47/10A61P9/12A61P9/10A61P9/06
Inventor 王彦厚高肇林史永强张兴柱魏正风
Owner 山东益康药业股份有限公司
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