Compound vitamin lyophilized powder injection composition for injection and preparation method thereof

Abstract

The invention discloses a compound vitamin lyophilized powder injection composition for injection and a preparation method thereof, and belongs to the field of pharmacy. Unit preparation is prepared from 10mg of vitamin B1 serving as an active ingredient, 5mg of riboflavin sodium phosphate based on riboflavin and 200mg of vitamin C. The composition has the advantages of simple preparation process, short production time and high production efficiency, and the prepared product has controllable quality and excellent stability.

Description

technical field [0001] The invention relates to a compound vitamin freeze-dried powder composition for injection and a preparation method thereof, belonging to the field of pharmacy. Background technique [0002] Compound vitamins for injection are sterile freeze-dried preparations made of vitamin B1, riboflavin sodium phosphate, vitamin C and pharmaceutical excipients, and belong to vitamin medicines. [0003] Compound vitamin injection is used for vitamin supplementation, that is, it is used when a large amount of vitamin supplements are required but cannot be fully ingested through food (such as wasting diseases, pregnant women, and lactating women). Many diseases are accompanied by the deficiency of vitamin B1, vitamin B2, and vitamin C, and patients need targeted supplementation during treatment, such as neuralgia, neuritis, muscle atrophy, digestive organ disorders, oral organ inflammation, skin inflammation, retinopathy Wait. Patients who cannot adequately take in v...

AI Technical Summary

Problems solved by technology

Third, aqueous injection preparations have certain limitations in transportation and storage conditions

Since vitamin C is very sensitive to pH and temperature, it is more unstable in the solution, so the change of local solution pH will lead to the degradation of vitamin C, generate related substances or impurities, and affect the stability and quality of the final product

However, in the prior art, adding a pH adjuster to a solution containing vitamin C will inevitably increase the pH of the local solution. Even if the dispersion of the active ingredient is accelerated by nitrogen filling and rapid stirring, the occurrence of active ingredients cannot be avoided. degradation

And different pH adjusters may also have other problems, such as sodium hydroxide not only has an extremely high pH value, but also generates a lot of heat during the dispersion process, which further increases the degradation of vitamin C

The sodium bicarbonate in the solution not only changes the pH value of the local solution, but also generates a large number of bubbles, which increases the difficulty of the liquid preparation operation, and the process of waiting for the bubbles to disappear also prolongs the liquid preparation cycle.

In addition, the amount of pH regulator added is related to the temperature, concentration, volume, etc. of the solution, so it is difficult to quantify accurately and requires multiple adjustments, thus further prolonging the dosing cycle and affecting the stability and quality of the product

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