The specific application and safety analysis of plasticizer ATBC in medical industry

Safety of acetyl tri-n-butyl citrate aTBC

Acetyl tri-n-butyl citrate is recognized as a non-toxic plasticizer in the world. According to the data, it has no effect on oral administration of rats and cats at a dose of 10-30 ml/kgG. The rats were fed with 5% and 10% of the product, and the rats were fed for 8 weeks. The main organs showed no abnormality. Only at 10% concentration, the rats were slowed down due to squatting. Regarding the toxicity of aTBC, many people in foreign countries have done chronic toxicological tests, which also shows that acetyl tri-n-butyl citrate does not cause obvious pathological processes in acute, chronic or subacute tests. It can be considered a non-toxic substance. In view of the low toxicity of acetyl tri-n-butyl citrate, the US Food and Drug Administration (FDa) not only approves it as a plasticizer for food packaging and medical appliances, but also approves it as a food additive (synthetic fragrance).

aTBC application in the pharmaceutical industry

PVC plastic medical containers mainly include infusion bottles, infusion bags, peritoneal dialysis liquid bags, blood transfusion bags, and the like. Since PVC plastic infusion containers are widely used for clinical infusion of physiological saline, glucose saline, water for injection, peritoneal dialysate, etc., there should be no microbial permeation during storage of the liquid, and should not be physically or chemically affected by the liquid. It is even less harmful to the human body. Plastic blood bag refers to the plastic bag used for the collection, separation, storage and infusion of human blood and its components. The blood bag should be colorless, transparent, soft, sealed, sterile, non-toxic and sterilizable. During storage, the eluate of the blood bag component in the anticoagulant or blood must comply with the standard and minimize the toxicity to the blood and the impact on the patient. The current plasticizer is DOP. Although it is believed that a small amount of DOP in the blood is stable on the red blood cells, it reduces the permeability of the red blood cell membrane, reduces hemolysis, and facilitates storage. However, the DOP is in the blood. The problem of toxicity in the dissolution has also attracted attention. Since DOP is considered to be carcinogenic, it should limit the use of DOP in the medical field. aTBC is non-toxic and tasteless. It has been widely used in medical equipment in the 1970s. Acetyl tri-n-butyl citrate has been used in PVC medical products in the United States and is an ideal substitute for o-phenyl plasticizers in the medical industry.

Application in the food packaging industry

Acetyl tri-n-butyl citrate has been widely used in foreign food packaging industry, and is currently licensed for food packaging materials in the United Kingdom, the United States, Germany, France, the Netherlands, Italy, and Japan. Acetyl tri-n-butyl citrate is mainly used for plasticizing polyvinyl chloride and vinyl chloride, vinylidene chloride copolymer (Saran resin). Polyvinyl chloride film is used in foreign countries for the packaging of fresh meat and its products, as well as for the packaging of fresh vegetables such as sandwiches, cheese, bacon, chicken, duck, ham, ham and mushrooms. The polyvinyl chloride film has a large oxygen permeability and can maintain the red blood oxygen globulin to keep the meat fresh. Its surface is shiny and transparent, the food in the bag is clear at a glance, and the water permeability is moderate. The carbon dioxide gas permeability is high, which can reduce the dehydration of fresh vegetables and prolong the shelf life of vegetables. In addition, it has good sealing properties, in contrast, polyethylene film has the disadvantage of being difficult to seal after meat packaging. Another main use of acetyl tri-n-butyl citrate is plasticized Saran resin. The biggest advantage of Saran film is good sealing, excellent moisture resistance and low gas permeability. It is resistant to strong acid, alkali, grease and organic. Solvent. In terms of mechanical properties, it is a tough film material between soft PVC and hard PVC. It has outstanding heat shrinkage, shrinking at 50~60 °C, shrinking to 20% to 50% at 100 °C, and the highest shrinkage stress at 80 °C is 13~15kg/cm3. It has a strong self-adhesiveness and a high sealing strength at high frequency heat sealing. Therefore, it is an excellent food packaging material. It has been widely used in foreign countries for packaging fish, sausages, ham, meat products, cheese, smoked products, tofu, cakes and other foods that require long-term preservation or high freshness. The main plasticizer of this plastic film is Acetyl tri-n-butyl citrate.

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