Compound monoammonium glycyrrhizinate S pharmaceutical composition and method for preparing frozen powder injection

Abstract

The invention belongs to the technical field of pharmaceutical preparations, in particular to a compound monoammonium glycyrrhizinate S pharmaceutical composition and a method for preparing a frozen powder injection. The composition is the monoammonium glycyrrhizinate S frozen powder injection and comprises the following components: monoammonium glycyrrhizinate S, cysteine hydrochloride, glycine, anhydrous sodium sulphite, sodium citrate, sodium chloride, sodium hydroxide and water for injection. The frozen powder injection is more stable and safer.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a compound monoammonium glycyrrhizinate S pharmaceutical composition and a method for preparing a freeze-dried powder injection thereof. The composition is a compound monoammonium glycyrrhizinate S freeze-dried powder injection. Background technique [0002] Compound monoammonium glycyrrhizinate is used for abnormal liver function caused by acute, chronic and persistent hepatitis; it has certain adjuvant therapeutic effect on toxic hepatitis, traumatic hepatitis and cancer. It can also be used for food poisoning, drug poisoning, drug allergy, etc. [0003] At present, the compound monoammonium glycyrrhizinate preparations for clinical application include injection, freeze-dried powder and the like. The compound monoammonium glycyrrhizinate is not stable, so the existing injection preparations generally add ingredients to improve its stability. Although the addition...

AI Technical Summary

Problems solved by technology

The compound monoammonium glycyrrhizinate is not stable, so the existing injection preparations generally add ingredients to improve its stability. Although the addition of these ingredients delays the degradation of the active ingredients in the preparation, it is found in the study that the addition of these ingredients is easy to cause injection. The increase of insoluble particles in the liquid, especially after a long time of storage, the insoluble particles change greatly, and the insoluble particles have potential side effects. A large number of studies have proved that insoluble particles will cause potential serious harm that is difficult to find for a while, and it is also the current clinical allergy It can also cause inflammatory reactions, phlebitis, pulmonary arteritis, granuloma, etc., granuloma is a kind of proliferative reaction of the body, which can directly interfere with the function of the lung, spleen, brain, heart, liver, kidney and other organs. Function, even life-threatening, microparticles also cause embolism, the parts blocked by microparticles are likely to occur in the brain, lungs, kidneys, liver or fundus, resulting in different degrees of necrosis or damage. Although the lyophilized preparation is not in a solution state when placed, its It is also injected after dissolving, so it has important clinical significance to measure and control the insoluble particles after reconstitution