Polyionic infusion solution

A multi-ion, solution technology, used in drug delivery, medical preparations with non-active ingredients, organic active ingredients, etc.

Active Publication Date: 2020-07-03
玻利萨恩科技制药有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] Therefore, the accumulation of decomposition of meglumine, toxic impurities (furfural derivatives) and large numbers of various colored substances with undefined structures affecting the physicochemical properties of the solution and its stability in long-term storage has never been described before. Issues concerning the safety and stability of solutions containing meglumine sodium succinate have been identified and to date there is no known solution to it

Method used

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Examples

Experimental program
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Effect test

Embodiment 1

[0053] Example 1. A 1,000-liter mixer tank was charged with 900 liters of water for injection, 5.280 kg of succinic acid, 8.725 kg of meglumine, 1.788 kg of sodium hydroxide, 6.000 kg of sodium chloride, 0.256 kg of magnesium chloride hexahydrate, and 0.300 kg of Potassium chloride, which are mixed until their components are completely dissolved, then brought to a volume of 1,000 liters with water for injection. The resulting solution was sparged with nitrogen for 30 minutes, filtered through a 0.22 μm sterile filter, bottled into 500 ml glass vials and sealed with stoppers under nitrogen flow. Then, undergo 20 minutes of moist heat sterilization at a temperature of 121±1° C. under pressure. 1 liter of the resulting solution contained 5,280 mg of succinic acid (0.528 wt %), 8,725 mg of meglumine (0.872 wt %), 1,788 mg of sodium hydroxide (0.1788 wt %), 6,000 mg of sodium chloride (0.600 wt %), 256 mg of Magnesium chloride hydrate (0.0256 wt%), 300 mg potassium chloride (0.030...

Embodiment 2

[0079] Example 2. A 1,000 liter mixer tank was charged with 900 liters of water for injection, 5.280 kg of succinic acid, 8.725 kg of meglumine, 1.788 kg of sodium hydroxide, 6.000 kg of sodium chloride, 0.256 kg of magnesium chloride hexahydrate, 0.300 kg of chlorine Potassium chloride and 2.0 kg of sodium thiosulfate were mixed until the components were completely dissolved and the pH level was set to a fixed value, then brought to a volume of 1,000 liters with water for injection. The resulting solution was filtered through a 0.22 μm sterile filter, bottled into 500 ml glass vials and sealed with stoppers. Then, undergo 20 minutes of moist heat sterilization at a temperature of 121±1° C. under pressure. 1 liter of the resulting solution contained 5,280 mg of succinic acid (0.528 wt %), 8,725 mg of meglumine (0.872 wt %), 1,788 mg of sodium hydroxide (0.1788 wt %), 6,000 mg of sodium chloride (0.600 wt %), 256 mg of Magnesium chloride hydrate (0.0256 wt%), 300 mg potassium ...

Embodiment 3

[0080] Example 3. A 1,000-liter mixer tank was charged with 900 liters of water for injection, 5.280 kg of succinic acid, 8.725 kg of meglumine, 1.788 kg of sodium hydroxide, 6.000 kg of sodium chloride, 0.256 kg of magnesium chloride hexahydrate, 0.300 kg of Potassium chloride and 0.2 kg of sodium thiosulfate, which were mixed until their components were completely dissolved and the pH level was set to a fixed value, were then brought to a volume of 1,000 liters with water for injection. The resulting solution was filtered through a 0.22 μm sterile filter, bottled into 500 ml glass vials and sealed with stoppers. Then, undergo 20 minutes of moist heat sterilization at a temperature of 121±1° C. under pressure. 1 liter of the resulting solution contained 5,280 mg of succinic acid (0.528 wt %), 8,725 mg of meglumine (0.872 wt %), 1,788 mg of sodium hydroxide (0.1788 wt %), 6,000 mg of sodium chloride (0.600 wt %), 256 mg of Magnesium chloride hydrate (0.0256 wt%), 300 mg potas...

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Abstract

The invention relates to the pharmaceutical industry and to medicine, and more particularly to complex polyionic infusion solutions that have a detoxifying effect as a result of antihypoxic, antioxidant and hepatoprotective properties. A preparation can be used to treat intoxications of various origins. The present polyionic infusion solution comprises chlorides of sodium, potassium and magnesium,meglumine sodium succinate as a biologically active component, and water for injection, and also a stabilising agent which is a pharmaceutically acceptable carboxylic acid or inorganic acid or a combination thereof, wherein the solution has a pH from 7.0 to 5.5.

Description

technical field [0001] The present invention relates to the pharmaceutical industry and medicine, in particular to a complex polyion infusion solution having a detoxifying effect due to its anti-hypoxic, anti-oxidative and hepatoprotective properties. The product can be used to treat intoxication of various etiologies. Background technique [0002] Intravenous fluids such as crystalloids (saline solutions) and colloids (plasma expanders) are widely used in the emergency treatment of poisoning. The above solution has the following advantages: immediate pharmacological effect; ability to administer to unconscious patients or when oral administration is not possible; complete bioavailability of its components. However, normalizing the water-electrolyte balance or achieving volume expansion is not sufficient in critical situations. Normalization of cellular homeostasis is an important component of therapy; therefore, metabolic cytoprotective therapy is used together with the a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/205A61K47/02A61K47/12A61P39/00
CPCA61P39/06A61K9/08A61K31/194A61K33/14A61K47/02A61K47/12A61P39/00
Inventor 阿列克谢·列昂尼多维奇·科瓦连科安德烈·尤里耶维奇·彼得罗夫
Owner 玻利萨恩科技制药有限责任公司
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