Magnesium isoglycyrrhizinate freeze dried powder injection for injection and preparation method thereof

Abstract

The invention relates to a magnesium isoglycyrrhizinate frozen-dried powder injection and a preparation method of the injection. The frozen-dried powder injection comprises magnesium isoglycyrrhizinate, cosolvent and frozen-dried excipient. When in preparation, the cosolvent is dissolved first and other substances are added and dissolved, and then the freezing and drying process is carried out, so as to get the magnesium isoglycyrrhizinate frozen-dried powder injection which has the advantages of better dissolving capability, safety, efficiency and stability, being suitable for conveying and a long-term conservation, simple operation technique, small difference among manufacturing batches, and being easy for an industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a magnesium isoglycyrrhizinate freeze-dried powder for injection and a preparation method thereof. technical background [0002] Viral hepatitis is a common infectious disease caused by a variety of hepatitis viruses. It is highly contagious and has a high incidence rate. The etiology, pathogenesis and symptoms are complex and varied. It is difficult to cure and seriously endangers people's health. Glycyrrhizic acid has a wide range of anti-inflammatory and anti-allergic effects, and has immune regulation effects. It can achieve an ideal effect of preventing and treating chronic hepatitis through anti-inflammatory and immune methods. Long-term clinical practice has proved that intravenous administration of glycyrrhizic acid preparations is an effective way to treat chronic hepatitis. It can significantly reduce serum transaminases, improve liver inflammation, realize th...

AI Technical Summary

Problems solved by technology

[0005] In addition, injections have safety and stability problems, which are not conducive to drug transportation and long-term storage. In addition, the traditional practice of injection solution preparation is to first add raw materials to water for injection, stir to make a uniform suspension, and then add other excipients. However, in the preparation process of magnesium isoglycyrrhizinate injection, since magnesium isoglycyrrhizinate is slightly soluble in water and is easy to float on the water surface, it takes a long time to stir to uniformly suspend, and then add a pH regulator to adjust to a suitable pH value to dissolve the raw materials, and Because the regulator uses a strong alkali or a concentrated alkali solution, it is easy to cause an irreversible reaction to form magnesium hydroxide precipitation when the local concentration is too high, so it is generally adjusted gradually with a dilute alkali solution, which not only takes a long time, but also increases the production cost. The difference between batches of obtained products is large, and the quality is relatively unstable, which is not conducive to large-scale industrial production

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