Method for preparing sodium-potassium-magnesium-calcium glucose injection

Abstract

The invention discloses a method for preparing a sodium-potassium-magnesium-calcium glucose injection. The method comprises the following steps: adding water for injection into a preparation tank; sequentially adding calcium gluconate, sodium chloride, potassium chloride, magnesium chloride, glucosum anhydricum, sodium acetate and sodium citrate; dissolving, regulating the pH value to 4.5-5.5 with hydrochloric acid, filtering and filling; sterilizing for 12 minutes at 121 DEG C, inspecting with a lamp, and packaging. According to the method, after the pH value is regulated to 4.5-5.5, a durable overkilling method is carried out at 121 DEG C for 12 minutes (F0 is more than or equal to 12) for sterilizing, the content of glucose is not remarkably reduced, 5-hydroxymethylfurfural and other glucose degrading impurities are in a relatively low level, and the sterility assurance level of the sodium-potassium-magnesium-calcium glucose injection is improved.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a preparation method of sodium potassium magnesium calcium glucose injection. Background technique [0002] The main function of water and electrolyte supplements is to maintain effective perfusion of tissues and organs, and maintain oxygen transport, body fluid, electrolyte concentration and blood sugar levels in the normal range. Currently commonly used rehydration solutions include Ringer's solution (compound sodium chloride injection), lactated Ringer's solution, sugar-free acetic acid Ringer's solution, 5% glucose acetate Ringer's solution, etc., but their clinical application has certain limitations. For example, the main purpose of Ringer's solution is to replenish water and electrolytes, which is not significant enough for the adjustment of acid-base balance; Lactated Ringer's solution can correct acidosis, but at the same time it increases the serum lactic acid content...

AI Technical Summary

Problems solved by technology

(2000-GLUCOSE DEGRADATION PRODUCTS RELATIONSHIP WITH CELL DAMAGE) So far, only 5-hydroxymethylfurfural is used for quality control in domestic injection standards containing glucose and other monosaccharides, and the epimerization and condensation degradation pathways of glucose cannot be controlled. control, and the degradation of 5-hydroxymethylfurfural cannot be characterized

After calculation, the F0 at 115°C for 30 minutes is 7.35, which can neither satisfy the overkill method nor the survival probability method

This patent reduces the content of 5-hydroxymethylfurfural by adding L-leucine, but the content of glucose is not described, and the degree of degradation of glucose cannot be obtained

The addition of L-leucine outside the prescription may also lead to changes in pharmacological effects

[0006] Therefore, in the preparation process of sodium potassium magnesium calcium glucose injection in the prior art, it has not been reported that both can be sterilized by over-sterilization, and can effectively control the process of controlling the degradation of glucose

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