12-vitamin freeze-dried preparation for injection, and preparation method thereof

Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly relates to a 12-vitamin freeze-dried preparation for injection, and a preparation method thereof. The freeze-dried preparation uses 12 water-soluble and fat-soluble vitamins as active components, wherein the active components are dissolved by using a suitable dissolution assisting method, a metal ion complexing agent is added, the pH value is adjusted to 7.1-7.6, and the obtained material and a pharmaceutically acceptable excipient are subjected to freeze drying to obtain the freeze-dried preparation for sterile injection. The invention further provides a preparation method of the freeze-dried preparation. According to the present invention, the sterile multi-vitamin freeze-dried preparation for injection has the clarified drug liquid and does not produce the precipitated drug particles after re-dissolving, and has advantages of oxidation resistance, good long-term stability, no use of toxic organic solvents and high medication safety.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a freeze-dried preparation of 12 kinds of vitamins for injection and a preparation method thereof. Background technique [0002] Vitamins are a class of trace organic substances that the human body must obtain from food in order to maintain normal physiological functions. There are many kinds of it, with different chemical structures, most of which are the components of coenzymes (or prosthetic groups) of certain enzymes, and are indispensable compounds to maintain the normal growth of the body (growth, health, reproduction and production functions). It plays a catalytic role in the body to promote the synthesis and degradation of major nutrients (protein, fat, carbohydrates, etc.), thereby controlling metabolism. Vitamins are essentially low-molecular organic compounds, they cannot be synthesized in the body, or the amount of synthesis is difficult to meet...

AI Technical Summary

Problems solved by technology

At present, the compound vitamin injections mentioned in existing patents have the following characteristics: ①The means of solubilization are mostly the use of toxic organic solvents such as ethanol, chloroform, and propylene glycol, or the use of a large amount of exogenous surfactants such as Tween 80, There is a big safety hazard; ②adding dibutyl hydroxytoluene, propyl gallate, sodium bisulfite, sodium metabisulfite and other antioxidants, preservatives or bacteriostats to inhibit the oxidation of vitamins and bacterial growth, patients may have Adverse reactions such as allergies; ③The use of high temperature means to increase the dissolution rate and solubility of fat-soluble vitamins can easily destroy the stability of vitamins, resulting in vitamin oxidation and decomposition, the increase of related substances, and the reduction of active ingredients, which not only reduces the curative effect, but also has no guarantee of safety. ;④The pH value is mostly controlled below 7.0, which leads to the easy precipitation of folic acid and biotin, and the precipitated drug particles will block blood vessels during the infusion process, seriously threatening the life and health of patients

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