Compatibility Studies of Lactose Azithromycin Powder and Sodium Chloride Injection with Powder-Liquid Double-Chamber Infusion Bag / 中国药学杂志

ABSTRACT

OBJECTIVE: To evaluate the compatibility of 3-layer coextrusion (powder-liquid) infusion bag with lactose azithromycin powder and sodium chloride injection. METHODS: The sterile powder of lactose azithromycin was dispensed in different infusion bags and the turbidities were observed after the accelerated test. The dissolve degree of packaging materials and additives, including infusion membrane and inner cap, in different acid, alkali and polar solvent were studied. The extent of migration of packaging material components into the drugs were researched after the lactose azithromycin powder and sodium chloride injection were dispensed in the 3-layer coextrusion (powder-liquid) infusion bag. RESULTS: Compared with the four kinds of common membrane, the membrane material we chosed was the best and the turbidities of liquid were meet the specification. In the extraction studies of different test solution, the antioxidant was not checked out, and the content of both Mg and Al was less than 0.05 μg·mL-1. In the security evaluation of migration, the maximum migration, the biggest one-day intake value and the accumulated maximum intake of additives in the special infusion bag were far lower than its toxicology statistics. CONCLUSION: The quality of 3-layer coextrusion (powder-liquid) infusion bag is good. The migration and adsorption degree of of packaging material are tested to make sure the packaging material could ensure the drug quality and stability. The compatibility of 3-layer coextrusion (powder-liquid) infusion bag with drug is nice.