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Injection containing sodium, potassium, magnesium, calcium and glucose injection and preparation method of injection

A technology for glucose injection and injection, which is applied in the fields of pharmaceutical formulation, drug delivery, and active ingredients of alkali/alkaline earth metal chlorides, etc., which can solve the problems of striated muscle and visceral side effects, etc., achieve simple and reliable preparation methods, and reduce 5-hydroxy The content of methylfurfural and the effect of improving safety

Inactive Publication Date: 2014-12-24
SICHUAN KELUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The existing sodium, potassium, magnesium, calcium and glucose injections are prone to produce 5-hydroxymethylfurfural during the high-temperature sterilization process. It has been reported in the literature that 5-hydroxymethylfurfural has certain genotoxicity and has toxic side effects on human striated muscles and internal organs.

Method used

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  • Injection containing sodium, potassium, magnesium, calcium and glucose injection and preparation method of injection
  • Injection containing sodium, potassium, magnesium, calcium and glucose injection and preparation method of injection
  • Injection containing sodium, potassium, magnesium, calcium and glucose injection and preparation method of injection

Examples

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Effect test

Embodiment 1

[0039] The formula of sodium potassium magnesium calcium glucose injection contains: sodium chloride (NaCl) 4.92g, potassium chloride (KCl) 0.1g, magnesium chloride (MgCl) in every 1000ml injection 2 ·6H 2 O) 0.05g, sodium acetate (C 2 h 3 NaO 2 ·3H 2 O) 0.86g, sodium citrate (C 6 h 5 o 7 Na 3 2H 2 O) 0.1g, calcium gluconate (C 12 h 22 CaO 14 ·H 2 O) 0.1g, anhydrous glucose (C 6 h 12 o 6 ) 4.9g, sodium bisulfite (NaHSO 3 ) 0.5g, appropriate amount of water for injection, and adjust the pH to 4.5 with hydrochloric acid solution.

[0040] Preparation method: (1) Take water for injection at 60°C with 80% of the dosing volume, add calcium gluconate and stir to dissolve, then add magnesium chloride, sodium chloride, potassium chloride, sodium acetate, and sodium citrate in sequence, and stir until Colorless and clear solution I;

[0041] (2) Add glucose and sodium bisulfite to solution I, and stir until solution II is colorless and clear;

[0042] (3) Add water f...

Embodiment 2

[0047] The formula of sodium potassium magnesium calcium glucose injection contains: sodium chloride (NaCl) 5.84g, potassium chloride (KCl) 0.18g, magnesium chloride (MgCl) in every 1000ml injection 2 ·6H 2 O) 0.1g, sodium acetate (C 2 h 3 NaO 2 ·3H 2 O) 2.94g, sodium citrate (C 6 h 5 o 7 Na 3 2H2O) 0.4g, calcium gluconate (C 12 h 22 CaO 14 ·H 2 O) 0.48g, anhydrous glucose (C 6 h 12 o 6 ) 7.85g, sodium bisulfite (NaHSO 3 ) 1g, an appropriate amount of water for injection, and adjust the pH to 5.0 with citric acid solution.

[0048] Preparation method: (1) Take water for injection at 65°C with 80% of the dosing volume, add calcium gluconate and stir to dissolve, then add magnesium chloride, sodium chloride, potassium chloride, sodium acetate, and sodium citrate in sequence, and stir until Colorless and clear solution I;

[0049] (2) Add glucose and sodium bisulfite to solution I, and stir until solution II is colorless and clear;

[0050] (3) Add water for injec...

Embodiment 3

[0055] The formula of sodium potassium magnesium calcium glucose injection contains: sodium chloride (NaCl) 7.95g, potassium chloride (KCl) 0.35g, magnesium chloride (MgCl) in every 1000ml injection. 2 ·6H 2 O) 0.29g, sodium acetate (C 2 h 3 NaO 2 ·3H 2 O) 4.84g, sodium citrate (C 6 h 5 o 7 Na 3 2H 2 O) 0.76g, calcium gluconate (C 12 h 22 CaO 14 ·H 2 O) 0.95g, anhydrous glucose (C 6 h 12 o 6 ) 11.89g, sodium bisulfite (NaHSO 3 ) 1.5g, appropriate amount of water for injection, and adjust the pH to 5.0 with malic acid solution.

[0056] Preparation method: (1) Take 80°C water for injection with 80% of the dosing volume, add calcium gluconate and stir to dissolve, then add magnesium chloride, sodium chloride, potassium chloride, sodium acetate, and sodium citrate in sequence, and stir until Colorless and clear solution I;

[0057] (2) Add glucose and sodium bisulfite to solution I, and stir until solution II is colorless and clear;

[0058] (3) Add water for i...

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Abstract

The invention discloses an injection containing sodium, potassium, magnesium, calcium and glucose and a preparation method of the injection. Every 1000 ml of injection contains 5-10 g of sodium chloride, 0.1-0.5 g of potassium chloride, 0.05-0.5 g of magnesium chloride hexahydrate, 1-5 g of sodium acetate trihydrate, 0.1-1 g of sodium citrate dehydrate, 0.1-2 g of calcium gluconate monohydrate, 5-20 g of anhydrous glucose, 0.5-2 g of antioxidant and appropriate water for injection, and a pH regulator solution is used for regulating the pH to be 4.5-6.0. The injection containing sodium, potassium, magnesium, calcium and glucose has the advantages that as appropriate antioxidant is added, the content of 5-hydroxymethyl furfural in the sterilized sodium, potassium, magnesium, calcium and glucose injection is effectively reduced; the sterilization time and injection preparation temperature are optimized, so that glucose being converted into 5-hydroxymethyl furfural at excess temperature is avoided, and the content of 5-hydroxymethyl furfural in the injection containing potassium, calcium and glucose is also effectively reduced; the preparation method is simple and reliable and is suitable for industrial production.

Description

technical field [0001] The invention relates to a sodium potassium magnesium calcium glucose injection and a preparation method thereof. Background technique [0002] Disorders of water and electrolyte metabolism are very common in clinical practice. Diseases of many organ systems, some systemic pathological processes, such as liver cirrhosis, diabetes, pulmonary heart disease, burns and post-operation, etc., can cause or be accompanied by water and electrolyte metabolism disorders; some changes in the external environment, some Iatrogenic factors such as improper use of drugs often lead to water and electrolyte metabolism disorders. If not corrected in time, the disturbance of water and electrolyte metabolism itself can lead to corresponding obstacles in the physiological functions of various organ systems in the whole body, especially the cardiovascular system, the nervous system and the substance metabolism of the body, which can often lead to death in severe cases. The...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/14A61K9/08A61P3/12
Inventor 郁东梅蔡作清曹文俸王利春胡思玉王晶翼
Owner SICHUAN KELUN PHARMA CO LTD
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