A kind of sugar electrolyte injection and preparation method thereof

Abstract

The invention provides a sugar electrolyte injection liquid and a preparation method thereof. The sugar electrolyte injection liquid comprises the following components: glucose, fructose, xylitol, sodium acetate, calcium chloride, magnesium chloride, zinc sulfate, sodium chloride, dipotassium hydrogen phosphate, sodium hydrogen sulfite, citric acid and injection water. The invention also discloses the preparation method of the sugar electrolyte; a hollow fiber membrane column ultrafiltration technology is applied, activated carbon and a filter membrane are avoided from being used, and pyrogen removal and fine filtration can be completed in one step at the room temperature; the method has the advantages of simple preparation process, low energy consumption, safe operation and low cost, does not generate problems of injection liquid color yellowing and crystal precipitation and the like, and is suitable for industrialization; and the obtained sugar electrolyte injection liquid not only is applicable to intravenous drip for a wide range of patient groups, but also is good in stability and has no side effect.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a medical injection preparation and a preparation method thereof, in particular to a formula and a preparation method of a sugar-electrolyte injection for parenteral nutrition. [0002] technical background [0003] Sugar-electrolyte injection is suitable for patients who cannot eat, should not eat, or suffer from severe insufficiency, and is an important part of parenteral nutrition therapy. Common indications are: [0004] (1) Preoperative preparation for patients with nutritional disorders and malnutrition after gastrointestinal fistula, pancreatic external fistula or major pancreatectomy, total or small bowel resection; [0005] (2) Patients with severe burns, trauma and severe infection, infants with congenital intestinal atresia and gastrointestinal obstruction; [0006] (3) Intractable infantile diarrhea, inflammatory bowel disease, renal failure, liver failure; [0007] ...

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Problems solved by technology

[0008] (5) Those who cannot eat for a long time after major surgery, etc.

[0011] More importantly, there are some difficulties in the preparation process of sugar electrolytes. First, the preparation method is complicated, with many steps, and the demand for manpower and material resources is relatively large.

Injections have strict requirements, and each step has the possibility of contamination. The more steps there are, the easier it is to cause problems in the quality of injections.

The second is that the sugar electrolyte injection contains various monosaccharides, almost all of which contain glucose, and glucose is a reducing sugar, which is easily decomposed into small molecular acids under the condition of heating and dissolving, which affects the overall pH value of the injection, resulting in the final The pH of the injection is unqualified

Moreover, glucose is prone to produce 5-hydroxymethylfurfural under heating conditions, resulting in too high content of 5-hydroxymethylfurfural in the injection solution and unqualified

The third is that the sugar electrolyte injection contains a variety of electrolytes. In the final step of preparation: canning, crystals are easy to precipitate after sterilization, resulting in unqualified products

In addition, the existing sugar-electrolyte injections are prone to deterioration problems such as yellowing and insufficient clarity after preparation

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