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A kind of preparation method of glycerol fructose sodium chloride injection

A sodium chloride injection, sodium chloride technology, applied in medical preparations containing active ingredients, active ingredients of alkali/alkaline earth metal chlorides, pharmaceutical formulas, etc., to achieve the effect of avoiding potential safety hazards

Active Publication Date: 2019-01-08
CHENGDU QINGSHAN LIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the application number CN201310344690.8, no stabilizer is added, and HMF≤0.6 can be achieved through relatively complicated high-temperature sterilization and cooling procedures, but the limit of 0.6 is still high

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] 1) Add 100g of glycerin and 9g of sodium chloride to dissolve in 1000ml of water, heat to 60°C, add activated carbon for 15 minutes, decarbonize and filter, fill, and sterilize at 121°C for 12 minutes.

[0020] 2) Add 50g of sterile fructose to the sterilized sample, mix well to obtain this product: Glycerin Fructose Sodium Chloride Injection.

Embodiment 2

[0022] 1) Add 100g of glycerin and 9g of sodium chloride to dissolve in 1000ml of water, heat to 100°C, add activated carbon for 15 minutes, decarbonize and filter, fill, and sterilize at 121°C for 15 minutes.

[0023] 2) Add 50g of sterile fructose to the sterilized sample, mix well to obtain this product: Glycerin Fructose Sodium Chloride Injection.

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PUM

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Abstract

The invention provides a preparation method of a glycerin-fructose sodium chloride injection. The preparation method is prepared by dissolving fructose, glycerin and sodium chloride in water for injection. Compared with the prior art, the preparation method has the advantages that fructose and sodium chloride do not exist in a water solution sterilized at high temperature at the same time, and no stabilizer is contained in the glycerin-fructose sodium chloride injection. The inventor finds in surprise that on the premise that sterile level is guaranteed, fructose degradation can be avoided well as long as sodium chloride and fructose are not sterilized at high temperature at the same time after being mixed, HMF content is lowered, and safety is improved.

Description

technical field [0001] The invention relates to a preparation method of glycerin fructose sodium chloride injection. Background technique [0002] Glycerin Fructose Sodium Chloride Injection is clinically used as a drug for lowering intracranial pressure, which is safe and reliable. However, due to the instability of fructose itself, it has been found that the amount of 5-hydroxymethylfurfural (HMF) in the product increases rapidly after sterilization and during storage. HMF is harmful to human striated muscle and viscera, has neurotoxicity, and can combine with human protein to produce accumulation poisoning, so it must be controlled as an important related substance in the preparation. [0003] "Chinese Pharmacopoeia" 2010 Edition, Part II "Glycerin Fructose Sodium Chloride Injection" stipulates that the absorbance of HMF in the injection at the corresponding detection wavelength of 284nm should not exceed 0.30, but most current implementation standards are not more than ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K33/14A61K9/08A61K31/7004
Inventor 徐世兰欧苏朱勇蔡小平
Owner CHENGDU QINGSHAN LIKANG PHARMA CO LTD