Reducing Substances In The Disposable Plastic Blood Bags And Their Security Research

Small molecular compounds (reducing substances) will release from blood bag materials into anticoagulants or blood products during the time of plastic blood bags reserved or used, which will have a negative effect on blood products and donee. So reducing substances of plastic blood bags must be strictly controlled. GB14232.1 -2004/ISO3826-1:2004 has limits the total amounts of reducing substances, but it is not adequate to illuminate the ponderance of reducing substances. The composing determination of reducing substances released from plastic blood bags hasn't been reported by literatures. Some trace poisonous small molecular compounds released from blood bag materials contribute little to the total amounts of reducing substances, but they do potential harm to blood products and donee. This paper analyzed the composing of reducing substances and had a primary safety assessment on them.At the aspect of reducing substances analysis, the total amounts of reducing substances released from different type blood bags were determined by indirect iodimetry. This paper researched the reducing substances' changing rules. The result indicated that factors such as prescription, craft, type, temperature, time, et al, had different affection on total amounts of reducing substances released from plastic blood bags. Prescription and craft of blood bag materials were the basical factors of affecting the total amounts of reducing substances. Reducing substances would increase as reserving temperature heightened. The reducing substances released from whole blood bags were much more than those released from translation bags and non-sterilized bags. Reducing substances would increase as reserving time prolonged. The composing of reducing substances was determined by SPE/GC/MS released into plastic blood bags aqueous extract, anticoagulant and whole blood. The result indicated that esters and alkanes were the main reducing substances in aqueous extract, polar alcohols had high amounts in anticoagulant, while only alkanes and a great deal of DEHP were determined in whole blood.At the aspect of safety assessment of reducing substances, haemocompatibility was investigated by testing blood quality, haemolysis, blood coagulation, complement. The result indicated that reducing substances could destroyed white blood cells, blood platelets and CH50. The concentration of K~+ and free hemoglobin in whole blood would increase quickly as reducing substances increased. But reducing substances had little effect on haemolysis, red blood cells, the concentration of Na~+, pH, complement of C3, C4, PT, Fbg. Cytotoxicity was determined by the method of MTT. The result indicated that cytotoxicity of blood bags materials had positive correlation with their total amounts of reducing substances.