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Potassium acetate injection solution and preparation method thereof

A technology of injection and potassium acetate, applied in the field of medicine, can solve the problems of inability to endure final sterilization, no plastic vials, potential safety hazards, etc., and achieve the effects of being convenient for clinical use, low cost, and ensuring the level of sterility

Inactive Publication Date: 2017-06-23
LIAONING YAOLIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The technical problem to be solved by the present invention is: because the existing injection is packaged in vials, it cannot withstand final sterilization, and it is easy to bring safety hazards; and there is no plastic vials and supporting production equipment in China; glass ampoules may wash out inorganic Salt ions, of which chloride ions are toxic when precipitated

Method used

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  • Potassium acetate injection solution and preparation method thereof

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Effect test

Embodiment 1

[0023] Potassium acetate 3.92kg acetic acid 0.41kg Water for Injection Add to 20000ml Make 1000 pieces

[0024] The preparation method of described potassium acetate injection, comprises the steps:

[0025] (1) Take 70% of the prescribed amount of water for injection, add the prescribed amount of potassium acetate, stir to dissolve.

[0026] (2) Measure the pH value of the solution obtained above, and adjust the pH value of the solution to 6.2 with acetic acid or potassium hydroxide.

[0027] (3) Add 0.1% activated carbon for needles to the above solution, stir for 30 minutes, and decarbonize by filtration.

[0028] (4) Dilute the above solution to the full volume with water for injection.

[0029] (5) Filter the above solution with a 0.22 μm microporous membrane.

[0030] (6) Fill the solution obtained above with a polypropylene ampoule.

[0031] (7) Sterilize the injection obtained above by autoclaving at 121°C for 30 minutes.

[0032...

Embodiment 2

[0035] Potassium acetate 3.92kg acetic acid 0.32kg Water for Injection Add to 20000ml Make 1000 pieces

[0036] The preparation method of described potassium acetate injection, comprises the steps:

[0037] (1) Take 70% of the prescribed amount of water for injection, add the prescribed amount of potassium acetate, stir to dissolve.

[0038] (2) Measure the pH value of the solution obtained above, and adjust the pH value of the solution to 7.1 with acetic acid or potassium hydroxide.

[0039] (3) Add 0.1% activated carbon for needles to the above solution, stir for 30 minutes, and decarbonize by filtration.

[0040] (4) Dilute the above solution to the full volume with water for injection.

[0041] (5) Filter the above solution with a 0.22 μm microporous membrane.

[0042] (6) Fill the solution obtained above with a polypropylene ampoule.

[0043] (7) Sterilize the injection obtained above by autoclaving at 121°C for 30 minutes.

[0044...

Embodiment 3

[0047] Potassium acetate 7.85kg acetic acid 0.78kg Water for Injection Add to 20000ml Make 1000 pieces

[0048] The preparation method of described potassium acetate injection, comprises the steps:

[0049] (1) Take 70% of the prescribed amount of water for injection, add the prescribed amount of potassium acetate, stir to dissolve.

[0050] (2) Measure the pH value of the solution obtained above, and adjust the pH value of the solution to 6.5 with acetic acid or potassium hydroxide.

[0051] (3) Add 0.1% activated carbon for needles to the above solution, stir for 30 minutes, and decarbonize by filtration.

[0052] (4) Dilute the above solution to the full volume with water for injection.

[0053] (5) Filter the above solution with a 0.22 μm microporous membrane.

[0054] (6) Fill the solution obtained above with a polypropylene ampoule.

[0055] (7) Sterilize the injection obtained above by autoclaving at 121°C for 30 minutes.

[0056...

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Abstract

The invention discloses a potassium acetate injection solution and a preparation method thereof. The injection solution consists of potassium acetate, an acid-base regulating agent and injection water, wherein the pH value of the injection solution is 5.5-8.0 and concentration of potassium ions is 2-4mEq / mL. The potassium acetate injection solution is prepared by dissolving the potassium acetate with water, regulating the pH value by virtue of the acid-base regulating agent, adding activated carbon, conducting stirring, decarburizing and constant-volume setting, filling a polypropylene ampoule, and finally, conducting sterilizing by virtue of a sterilizing method. The injection solution provided by the invention has the characteristics of being simple in process, low in cost, safe and reliable, convenient for clinical use and the like.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a potassium acetate injection and a preparation method thereof. Background technique [0002] Potassium acetate is a potassium supplement, its molecular formula C 2 h 3 KO 2 . The structural formula is: [0003] Potassium (K) is the main cation of intracellular fluid, which is necessary for cell survival. 98% of potassium in the body exists in cells. K is an important component for maintaining intracellular osmotic pressure. Both myocardium and neuromuscular require a relatively constant K concentration to maintain normal excitability. Potassium in the intracellular fluid exists in the ion state, part of which is combined with protein, and the other part is combined with sugar and phosphate. Potassium plays an important role in cell metabolism, maintenance of intracellular osmotic pressure, maintenance of intracellular acid-base balance, transmission of nerve i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/19A61P3/12A61J1/06
CPCA61K9/08A61J1/06A61K9/0019A61K33/00A61K47/12
Inventor 于航梁胜男
Owner LIAONING YAOLIAN PHARMA
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