Glycerin fructose sodium chloride injection and preparation process thereof

Abstract

The invention discloses a glycerin fructose sodium chloride injection and a preparation process thereof. The glycerin fructose sodium chloride injection is prepared by the following step: preparing 50-150 parts of glycerinum, 5-15 parts of sodium chloride and 10-100 parts of fructose for injection at a low temperature and carrying out ultrafiltration, wherein low temperature refers to the temperature at 30-60 DEG C. According to the glycerin fructose sodium chloride injection, a new technology is used. By adopting a new low-temperature preparation and ultrafiltration technology, no auxiliaries and active carbon are added in the preparation process, so that the problem that fructose is unstable (5-hydroxymethylfurfural is generated) and the problem on safety of residues of active carbon are solved, and the clinical potential safety hazards are eliminated.

Description

[0001] This application is the application number 201110220697.X submitted on August 3, 2011, and it is called a divisional application of glycerol fructose sodium chloride injection and its preparation process. technical field [0002] The invention relates to an injection and a preparation process thereof, in particular to a glycerol fructose sodium chloride injection and a preparation process thereof. Background technique [0003] Glycerin Fructose Sodium Chloride Injection is clinically a drug for lowering intracranial pressure, with definite curative effect, and has been well received by doctors and patients. However, due to the high quality requirements of this variety, the limit requirements of 5-hydroxymethylfurfural are extremely strict. In practice, a certain amount of antioxidants and auxiliary materials are used to solve this problem, which will bring certain safety problems of auxiliary materials. At the same time, for the requirements of intravenous administrat...

AI Technical Summary

Problems solved by technology

However, due to the high quality requirements of this variety, the limit requirements of 5-hydroxymethylfurfural are extremely strict. In practice, a certain amount of antioxidants and auxiliary materials are used to solve this problem, which will bring certain safety problems of auxiliary materials. ;At the same time, for the requirements of intravenous administration, a large amount of activated carbon needs to be used to decolorize and remove impurities. Since the activated carbon cannot be completely removed and remains in the injection, it will accumulate in the blood vessels of the patient, forming granulomas and other safety hazards.