This paper mainly introduces the types of packaging film for disposable intravenous nutrition infusion bags and their respective shortcomings. In view of the existing material technology problems, a new type of packaging film was developed by using multi-layer co extrusion process. No plasticizer is needed in the processing of the membrane, which makes the migration precipitation less, the drug compatibility is good, the mechanical properties are strong, and the barrier property is high, the drug protection is good, which can greatly reduce the probability of drug deterioration and ensure the safety of patients.
Intravenous nutrition infusion bag instead of traditional single bottle infusion, it simplifies the operation of nutrition infusion, closed infusion does not need to exhaust, reduces the chance of nutrient solution pollution, at the same time, 24-hour continuous infusion reduces the workload of nurses, which is recognized by the majority of nurses. But is there any other material migration and release in the infusion bag during the use? Does it react with or adsorb drugs? Does it have adverse effects on the quality of total parenteral nutrition (TPN) and patients? These are the problems that clinical medical workers are very concerned about.
1、 Problems of PVC and EVA commonly used at present
At present, the commonly used materials of disposable intravenous nutrition infusion bag are PVC and its copolymer and EVA.
1. Main problems of PVC
(1) Polyvinyl chloride (PVC) contains PVC monomer, which is harmful to human health.
(2) In order to change the properties of polyvinyl chloride (PVC), diethylhexyl phthalate (DEHP) plasticizer is often added in the production process of PVC. During the use of DEHP, the plasticizer may dissolve out. Diethylhexyl phthalate (DEHP) is a harmful substance and can release estrogen. Therefore, it may contact with diethylhexyl phthalate (DEHP) It leads to reproductive system dysplasia and seriously endangers human health.
(3) In order to prevent the degradation of PVC resin, stabilizers containing calcium, zinc, barium and other elements are usually added in the production process of polyvinyl chloride (PVC). These metal ions may migrate in the process of infusion, and enter the human body with the medicine liquid or blood products, which has an impact on human health.
(4) Polyvinyl chloride (PVC) has strong adsorption to some fat soluble and alcohol soluble drugs, especially antitumor drugs, which leads to inaccurate prescription dosage and reduced efficacy.
(5) After burning PVC and its copolymer, hydrochloric acid will be formed, which will cause respiratory tract injury of human and animals and erosion of buildings. In addition, dioxin is easy to be produced during combustion, which has a profound impact on the environment.
2. Main problems of ethylene vinyl acetate (EVA)
(1) The heat resistance of the material is not good, and the infusion bag shrinks and folds when it is sterilized by high temperature steam, which also easily leads to the deterioration of drug contamination and the patient's pyrogen reaction.
(2) The mechanical properties of the materials are poor. In order to improve the breaking force, only by increasing the film thickness, the film thickness is 300 ~ 400um, so the manufacturing cost is greatly increased. Although the strength of the infusion bag can meet the requirements of the national standard, the strength of the infusion bag is still not high, and it is easy to be damaged and leaked in practical application.

(3) Because of its low barrier performance and great oxygen permeability, it has poor protection for treatment and nutrition infusion in the process of long-term infusion, which leads to the decrease of drug efficacy and even deterioration and can not be used.

2、 New material of intravenous nutrition infusion bag
In view of the shortage of existing materials, we developed a kind of membrane with excellent comprehensive performance for intravenous nutrition infusion bag. The purpose is to improve the adaptability of nutrition infusion bag, so that it can be sterilized by gamma ray irradiation or 115-125 ℃ high-temperature steam sterilization. In addition, there is no need to add plasticizer to the membrane material to add working hours, so that the migration precipitates are less, the drug compatibility is good, and the mechanical properties are good It has the advantages of strong, thin thickness, low manufacturing cost, high barrier, good protection for drugs, reducing the probability of deterioration of drugs, and ensuring the safety of patients.
1. Formulation design
The new packaging film of disposable intravenous nutrition infusion bag has a four layer structure, which is composed of a / B / C / D, including:
The first thermal bonding layer a is composed of medical grade ethylene vinyl acetate (EVA). The melt flow index (190 ℃, 2.16kg) of ethylene vinyl acetate (EVA) is 1-3g / 10min, and the content of vinyl acetate (VA) is 8-25%.
The second structural layer B is composed of medical grade polyethylene (PE) and ethylene octene copolymer (POE). The polyethylene (PE) accounts for 50% - 70% of the total weight of the layer, the melt flow index (190 ℃, 2.16kg) is 1-3g / 10min, the melting point is 90-115 ℃, the density is 0.90-0.91g/cm3; the ethylene octene copolymer (POE) accounts for 30% - 50% of the total weight of the layer, the melt flow index (190 ℃, 2.16kg) is 1-3g / 10min, the octene content is 15% - 35%, the melting point is 55-90 ℃, and the density is 0.86 - 0.89g/cm3。
The third adhesive layer C is composed of maleic anhydride (MAH) modified ethylene octene copolymer (POE). The melt flow index (190 ℃, 2.16kg) of maleic anhydride (MAH) modified ethylene octene copolymer (POE) is 1-4g / 10min, the melting point is 50-75 ℃, the content of maleic anhydride (MAH) is 0.3-1.5%, and the density is 0.86-0.88g/cm3.
The fourth outer layer D is composed of polyester elastomer (TPEE), nylon (PA) and compatibilizer. The polyester elastomer (TPEE) accounts for 55% ~ 70% of the total weight of the layer, the melt flow index (230 ℃, 2.16kg) is 3 ~ 15g / 10min, the melting point is 190 ~ 220 ℃, the density is 1.1 ~ 1.2g/cm3; the nylon (PA) accounts for 25% ~ 45% of the total weight of the layer material, the melt volume flow rate (275 ℃, 5kg) is 75 ~ 150g / 10min, the melting point is 185 ~ 215 ℃, the density is 1.05 ~ 1.2g/cm3 The results show that the total weight of this layer is 3% - 15%, the type of compatibilizer is ethylene acrylic copolymer, the melt flow index (190 ℃, 2.16kg) is 1-8g / 10min, the melting point is 55-90 ℃, and the density is 0.86-0.95g/cm3.
2. Preparation method
The raw materials are composed according to the formula of structural layer B and outer layer D. the weighed raw materials are put into the mixer to mix them evenly, and the mixing time is 4-5min.
The raw materials of each layer are sucked into the hopper of extruder by vacuum suction machine.
The upper blowing cooling process is adopted. The cleanliness level of production area is grade C, and the cleanliness level of internal cooling air is Grade A.
After film formation, the membrane should be placed in a high-energy electron ray chamber for radiation crosslinking. The radiation dose is 6 to 12Mard and the gel content is 40% to 55%.
The film material can be double-layer cylinder membrane and double-layer film.
The inner package is vacuum packed and sealed with LDPE medicine bag.
3. Main production equipment
Co extrusion system: four extruders (inner and outer screw φ 45mm, sub outer screw φ 40mm, intermediate screw φ 75mm), CO extrusion cylindrical superimposed die.
Top blowing method: double lip air ring, internal cooling (IBC), external cooling, diameter control device and first traction device.
Rotary winding device: 360 ° rotary traction device, second and third traction device, tension control device, surface and center winding device.
Radiation crosslinking device: linear electron accelerator (0.8mev, 50mA)
Dongguan Beite packaging materials Co., Ltd. - located in Dongguan City, the world's manufacturing city, is a subsidiary of Beite packaging (China) Co., Ltd., with a plant area of 6000 square meters. It is a flexible packaging enterprise integrating R & D, production and sales. It has a complete set of domestic advanced production equipment, a scientific and humanized management system and a group of experienced technical personnel For backing, to provide customers with quality products and first-class service.
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