Glycerin fructose sodium chloride injection and preparation process thereof

Abstract

The invention discloses a glycerin fructose sodium chloride injection and a preparation process thereof. According to the invention, the preparation method of the glycerin fructose sodium chloride injection comprises the following steps: preparing 50-150 parts of glycerin, 5-15 parts of sodium chloride and 10-100 parts of injection fructose by weight at a low temperature; and ultra-filtering a prepared product, wherein the low temperature is 30-60 DEG C. As the glycerin fructose sodium chloride injection disclosed by the invention is prepared by using a new technology and using a novel low temperature preparation and ultrafiltration technology, and any auxiliary material and active carbon are not needed in the preparation process, the instability problem of the fructose (5-hydroxymethyl furfural is generated) and the safety problem of active carbon residue are solved, and clinical potential safety hazards are eliminated.

Description

technical field [0001] 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 [0002] 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 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 ve...

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.