Glycerin fructose sodium chloride injection and preparation method thereof

Abstract

The invention discloses a glycerin fructose sodium chloride injection and a preparation method thereof. The injection comprises the following components: glycerol, fructose, sodium chloride, a pH value regulator and water for injection. An activated carbon-free process is adopted, endotoxin control requirements of a final preparation can be met by controlling endotoxin of raw and auxiliary materials, and meanwhile, the optimal pH value capable of tolerating a moist heat sterilization method is confirmed by screening and researching the pH value of a liquid medicine; the level of the 5-hydroxymethylfurfural can be ensured to meet the requirements in the effective period without additionally adding auxiliary materials, and the stability of the injection and the use safety of a patient are improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a glycerol fructose sodium chloride injection and a preparation method thereof. Background technique [0002] Glycerin Fructose Sodium Chloride Injection mainly uses its osmotic gradient to dehydrate tissues to exert pharmacological effects. Therefore, as a dehydrating drug, it is often used in the treatment of increased intracranial pressure caused by cerebral hemorrhage, brain tumor, traumatic brain injury, meningitis, etc. Glycerin Fructose Sodium Chloride Injection is a hypertonic preparation, through hypertonic dehydration, it can reduce the water content of the brain and reduce intracranial pressure. Glycerin fructose sodium chloride injection has a slow onset and long duration in reducing intracranial pressure. [0003] At present, the common Glycerin Fructose Sodium Chloride Injection often adds activated carbon to absorb bacterial endotoxins, but si...

AI Technical Summary

Problems solved by technology

[0003] At present, the common Glycerin Fructose Sodium Chloride Injection often adds activated carbon to absorb bacterial endotoxins, but since the activated carbon cannot be completely removed, there is a risk for clinical use

At the same time, most commercially available varieties do not control the pH value, and adopt the conventional overkill method, resulting in the fact that 5-hydroxymethylfurfural can easily exceed the legal standard within the validity period during the long-term storage process.

The solution to commercially available products is to add antioxidants or other auxiliary materials, but this also brings additional safety risks