Compound monoammonium glycyrrhizinate S pharmaceutical composition and method for preparing high-capacity 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 high-capacity injection. The composition is a compound monoammonium glycyrrhizinate S sodium chloride injection. The injection is characterized by comprising the following components: 40-160g of monoammonium glycyrrhizinate S, 30-120g of cysteine hydrochloride, 400-1,600g of glycine, 40-160g of anhydrous sodium sulphite, 4-16g of sodium citrate, 900-1,800g of sodium chloride, a proper amount of sodium hydroxide and 100-200L of water for injection. The high-capacity 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 large-capacity injection thereof. The composition is compound monoammonium glycyrrhizinate S sodium chloride 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. Although the stability can be improved by preparing it into lyophilized powder, since the lyophilized powder needs to be further dissolved during clinical use, the chance of contamin...

AI Technical Summary

Problems solved by technology

Although the stability can be improved by making it into lyophilized powder, the chance of contamination is increased because the lyophilized powder needs to be further dissolved during clinical use

Compound monoammonium glycyrrhizinate is not stable, so sodium bisulfite and edetate disodium are generally added to existing injection preparations to improve its stability. Although the addition of these ingredients delays the degradation of the active ingredients in the preparation, the research It is found that the addition of these components can easily lead to the increase of insoluble particles in the injection, especially after a long period of storage, the insoluble particles have a large change, and the insoluble particles have potential side effects. A large number of studies have proved that: Potential serious harm is also an important inducing factor of clinical allergic reactions at present, and 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 The function of the heart, liver, kidney and other organs, even life-threatening, particles can also cause embolism, and the parts blocked by particles are likely to occur in the brain, lungs, kidneys, liver or fundus, resulting in different degrees of necrosis or damage