The preparation method of glycerol fructose sodium chloride injection

Abstract

The invention provides glycerin fructose sodium chloride injection and a preparation method thereof and belongs to the technical field of medicine. The invention mainly solves the problem that, in the prior art, absorbance exceeds standard during measurement of 5-hydroxymethyl furfural. The glycerin fructose sodium chloride injection is characterized in that 1,000 ml of the prescription comprises the following raw and auxiliary materials: 99 to 101 g of glycerin, 49 to 51 g of fructose and 8 to 10 g of sodium chloride, and fresh water for injection is added until the volume is 1,000 ml. The preparation method comprises the following steps: sequentially adding the sodium chloride, the glycerin and the fructose according to the prescription quantity into a thick mixing tank with the water for injection which is 30 percent of the total volume of the prescription; opening the liquid outlet of the thick mixing tank and the liquid inlet of a diluting mixing tank after the raw materials are completely dissolved; putting the mixture into the diluting mixing tank; supplementing the mixture with water for injection until the volume is 99 percent and adjusting the pH value to be 3.8 to 4.2; filtering by a terminal filter with a 0.22-micron polyether sulfone filter element and filling to obtain the injection, wherein a stabilizing agent is not added into the product and the absorbance of the 5-hydroxymethyl furfural is less than 0.6.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a preparation method of glycerol fructose sodium chloride injection. Background technique [0002] According to the 84th page of the "Chinese Pharmacopoeia" 2010 edition, the standard of glycerol fructose sodium chloride injection, the absorption of 5-hydroxymethylfurfural should be <0.8, and the current marketed products have 5-hydroxymethylfurfural absorption determination The results all exceeded the standard requirements, and 5-hydroxymethylfurfural is an aldehyde compound produced by the dehydration of monosaccharide compounds such as glucose under high temperature or weak acid conditions. The compound is damaging to human striated muscles and internal organs. Some of the products on the market now meet the standards after adding stabilizers. Since this product directly enters the human blood, there is no corresponding research on whether adding stabilizers is harmful ...

AI Technical Summary

Problems solved by technology

Some of the products on the market now meet the standards after adding stabilizers. Since this product directly enters the human blood, there is no corresponding research on whether adding stabilizers is harmful to the human body.