Injection Glycyrrhizin Preparation And Quality

Glycyrrhizin compound is a preparation withβ-glycyrrhizic acid, cysteine and glycine as main components. It has strong effect on anti-inflammation, anti-virus, immunoregulation and direct protection to liver cell membrane. It has been used to cure chronic liver diseases and moderate liver dysfunction for a long time. As an effective therapy drug in this filed, only injection preparation is available in market at present. In order to get rid of the instability and oxidization for storage and transportation, a freeze-drying preparation of this product has been studied, and a HPLC test method for the quantity of main components and related substances is established, all of them are firstly reported.During the study on formulation, cryoprotectant, subpackage volume, pH range of medical solution, antioxidants, quantity of active carbon and freeze-drying curve were investigated. The results showed that the active components in preparation could be used as cryoprotectant, the subpackage volume was 4ml, the pH range of medical solution was 5.5-7.5, anhydrous sodium sulfite at 10mg/bottle was used as antioxidant, EDTA (1mg/bottle) was used as metal complexant. The eutectic point was about -28.0±2.0℃, and the freeze-drying technology was also confirmed and described as below:Pre-freeze for 4-5 hours at -40℃, sublimate for 6-8 hours below-33℃, continue to sublimate for 8-9 hours, self-heat to 0℃. Then heat slowly, dry for 4-5 hours at 30℃.HPLC test method for the assay of main components and related substances was established with methodology studies according to pharmacopoeia and relevant guidelines.The scale up and stability were investigated. Test data in stress testing, accelerated testing and long-term testing showed that the preparation could be stable and in good quality during the storage period.