Study On Compound Glycyrrhizin And Sodium Chloride Injection

Sodium chloride compound glycyrrhizin injectionβ-glycyrrhizic acid is the main component of the compound with strong anti-inflammatory, anti-allergic, immunomodulatory and steroid-like pharmacological effects.Mainly used in the field of treatment of a variety of allergic skin diseases and the treatment of chronic liver disease of skin, improve liver function abnormalities. Glycyrrhizin injection is one of the few safe and effective anti-hepatitis drugs.At home and abroad are listed compound glycyrrhizin injection for the rich clinical drug formulations, to avoid small-volume injections in the course of many of the inconvenience and quality of potential problems related to the technical review in accordance with SFDA registration management principles and methods compound were carried out, licorice Sweet and Sodium Chloride Injection technology, quality, and stability. Recipe for the solvent selection, stabilizing agent, activated carbon dosage selection, pH, choice, choice of sterilization conditions, the final process to determine the following:the amount of drug prescribed injection dissolved in water, adding 0.05% active carbon carbon off after the tone pH value to 6.0-7.4,a volumetric filling,110℃30min after sterilization was hot. Quality of research carried out on substances, determination of methodological research, to finalize the matter was determined by high performance liquid chromatography control products related substances;with octadecyl silane bonded silica as a filler; with acetonitrile-0.01mol/ L phosphoric acid (38:62) as mobile phase;detection wavelength 254nm; flow rate: 1.0ml/min. Determination of product content, using high performance liquid chromatography glycyrrhizin content, measured using TLC glycine content, using UV spectrophotometry content of cysteine hydrochloride, using anti-Determination of sodium chloride content. Stability study carried out at low temperature, high temperature test, bright light, the factors such as freezing and thawing test test, accelerated testing and long-term stability test, test results show that the products affected by light and great; other conditions, stable;Storage conditions of shading, closed preservation, the period to 2 years. Through the technology of this project, the quality standards of research and study ,the stability, quality and stability of the infusion have been preparations for clinical use provides a more convenient anti-inflammatory, immunomodulatory drugs.