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Mannitol sodium chloride injection and preparation method thereof

A sodium chloride injection, injection technology, applied in the direction of medical formula, blood disease, extracellular fluid disease, etc., to achieve the effect of solving the problem of easily exceeding the standard

Active Publication Date: 2013-06-12
HUAREN PHARMA (RIZHAO) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The present invention proposes a glycerol fructose sodium chloride injection and its preparation method, which solves its stability problem and ensures drug safety

Method used

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  • Mannitol sodium chloride injection and preparation method thereof
  • Mannitol sodium chloride injection and preparation method thereof
  • Mannitol sodium chloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] A kind of glycerol fructose sodium chloride injection, each raw material of this injection, adjuvant consists of:

[0045]

[0046] 1mol / L hydrochloric acid to adjust the pH value to 4.3;

[0047] Add water for injection to 1000ml.

[0048] The specific steps are:

[0049] (1) Weigh each raw material and auxiliary material in proportion, and set aside;

[0050] (2) Add glycerin and sodium chloride to 20% of the total amount of water for injection to dissolve;

[0051] (3) After adding sodium bisulfite to the above solution to dissolve, add fructose to dissolve;

[0052] (4) Add 1mol / L hydrochloric acid to the above solution to adjust the pH value to 4.3, add water for injection to the full amount, add activated carbon, stir and mix well, and measure the marked content of glycerin, sodium chloride, and fructose at 95.0-105.0%;

[0053] (5) Coarsely filter and finely filter the above medicinal solution, fill, seal, sterilize with damp heat at 121°C for 8 minutes, i...

Embodiment 2

[0055] A kind of glycerol fructose sodium chloride injection, each raw material of this injection, adjuvant consists of:

[0056]

[0057] 1mol / L hydrochloric acid to adjust the pH value to 4.6;

[0058] Add water for injection to 1000ml.

[0059] The specific steps are:

[0060](1) Weigh each raw material and auxiliary material in proportion, and set aside;

[0061] (2) Add glycerin and sodium chloride to 50% of the total amount of water for injection to dissolve;

[0062] (3) After adding sodium sulfite to the above solution to dissolve, add fructose to dissolve;

[0063] (4) Add 1mol / L hydrochloric acid to the above solution to adjust the pH value to 4.6, add water for injection to the full amount, add activated carbon, stir and mix well, and measure the marked content of glycerin, sodium chloride, and fructose at 95.0-105.0%;

[0064] (5) Coarsely filter and finely filter the above medicinal solution, fill, seal, sterilize with damp heat at 121°C for 8 minutes, insp...

Embodiment 3

[0066] A kind of glycerol fructose sodium chloride injection, each raw material of this injection, adjuvant consists of:

[0067]

[0068] 1mol / L sulfurous acid to adjust the pH value to 4.2;

[0069] Add water for injection to 1000ml.

[0070] The specific steps are:

[0071] (1) Weigh each raw material and auxiliary material in proportion, and set aside;

[0072] (2) Add glycerin and sodium chloride to 95% of the total amount of water for injection to dissolve;

[0073] (3) After adding sodium bisulfite to the above solution to dissolve, add fructose to dissolve;

[0074] (4) Add 1mol / L sulfurous acid to the above solution to adjust the pH value to 4.2, add water for injection to the full amount, add activated carbon, stir and mix well, and measure the marked content of glycerin, sodium chloride, and fructose at 95.0-105.0%;

[0075] (5) Coarsely filter and finely filter the above medicinal solution, fill, seal, sterilize with damp heat at 121°C for 8 minutes, inspect...

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Abstract

The invention provides a brand new mannitol sodium chloride injection and a preparation method which is suitable for the same. According to the preparation method disclosed by the invention, the sterilization problem that the mannitol sodium chloride injection can not endure F0 which is not less than 8 can be solved by adding an appropriate amount of stabilizer, adopting corresponding sterilization conditions and controlling the pH value, the problem that 5-hydroxymethylfurfural in the injection is easy to exceed the standard during the production and the storage processes of the product is well solved, and the 5-hydroxymethylfurfural is effectively controlled.

Description

technical field [0001] The invention relates to a glycerol fructose sodium chloride injection and a preparation method thereof. Background technique [0002] At present, the drugs commonly used in clinic to reduce intracranial pressure are: mannitol injection, glycerol fructose sodium chloride injection. [0003] Mannitol injection is used to treat cerebral edema caused by various reasons, reduce intracranial pressure, and prevent brain herniation. It has definite curative effect on reducing intracranial pressure, rapid onset and short maintenance time, and is mainly used for the treatment of patients with acute diseases. It is widely used clinically, but mannitol injection is a supersaturated solution. When the temperature is low, mannitol crystals are often precipitated in the liquid. When the crystals appear, the liquid needs to be heated until the crystals are completely dissolved before use. Slow and inconvenient for clinical use. [0004] Glycerin Fructose Sodium Chl...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/7004A61K47/04A61K9/08A61P9/12A61P7/10
Inventor 舒文苏瑛厉夫奎蒋友伟厉海霞
Owner HUAREN PHARMA (RIZHAO) CO LTD
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