Infusion refers to a large-dose injection that is injected into the body by intravenous drip. It is one of the five major types of preparations commonly used in clinical practice. It provides the water, electrolytes and nutrients required by patients, and can also be used as a carrier for intravenous administration of drugs. Since the "Ninth Five-Year Plan", China's infusion production has developed steadily and healthily. The output has increased from 1.38 billion bottles (bags) in 1995 to 2.91 billion bottles (bags) in 2001, with an average annual growth of 16.1. %, the market capacity of infusions in 2003 reached 3.5 billion bottles (bags) < 1 >. At present, the packaging forms used in infusion production in China are: glass bottles, plastic bottles and plastic soft bags. Plastic soft bags are divided into PVC (polyvinyl chloride) bags and non-PVC soft bags.
1 glass bottle infusion packaging technology
Glass bottle infusion has long been the main form of infusion packaging in China. At present, 95% of infusions in China are still packaged in glass bottles. As a traditional packaging form for infusion, glass bottle infusion has the following advantages:
1) The transparency of the glass bottle is good for the infusion of insoluble particles.
2) The glass bottle has good thermal stability, which is beneficial to the sterilization of high temperature sterilization method in the infusion production process to ensure the quality of the infusion.
3) It has good chemical inertness, barrier properties and airtightness, which guarantees the stability of quality during drug storage.
However, there are certain defects in the technique of infusion of glass bottles, mainly including:
1) Inconvenient transportation and limited geographical coverage. Glass bottles are highly brittle and are prone to rupture due to severe vibration and impact. Therefore, glass bottle infusion is not suitable for long-distance transportation, which limits the geographical scope of its application.
2) The process is complicated and the production efficiency is low. Infusion is packaged in glass bottles. Compared with other infusion packaging technologies, the production process adds several complicated processes such as rubber stopper, separator and glass bottle washing. The process route is long and the production cycle is relatively extended, so the production efficiency is low. .
3) High production costs. Due to the complicated process route, large equipment, wide area, high equipment investment cost and housing construction cost, and a large amount of water is consumed in the processing of packaging containers and auxiliary materials, the production cost is high.
4) Clinical use, there are potential safety hazards. When the medical staff inserts the needle into the glass bottle, it needs to pierce the rubber plug and break through the polyester membrane. It is inevitable to introduce insoluble particles into the infusion. The insoluble particles in the infusion may block the microcirculation of the human body and even cause platelet solubility. Bleeding < 2 > ; In addition, in clinical application, in order to make the infusion process go smoothly, it is necessary to insert a ventilation line to introduce air into the solution to generate a pressure difference. At this time, the infusion is in a fully open state, and dust and microorganisms in the air may enter. Glass bottles contaminate the infusion, resulting in a serious infusion reaction.
Because of its heavy weight, high brittleness, and easy breakage, glass bottles are not portable and transportable. Therefore, in the 1960s, infusions using plastic containers as packaging containers appeared in the world, ending the situation in which glass bottle infusion packaging technology dominated the world.
2 plastic bottle infusion packaging technology
Plastic bottle infusion packaging technology is mainly made of polypropylene (PP) and polyethylene (PE) as packaging materials. In 1984, China was the first company to introduce polypropylene gum bottle packaging production technology from Tianjin Daxie Pharmaceutical Co., Ltd. to produce the first bottle of PP bottle infusion in China. The advantages of plastic bottle infusion packaging technology are:
1) Light weight, the weight of the bottle is only 1/5 of the weight of the glass bottle, and it is not easy to break, which is beneficial to long-distance transportation.
2) The chemical stability, barrier properties and compatibility with the drug of the plastic bottle are good for long-term preservation of the liquid.
3) Advanced technology and high production efficiency < 4 >. In the production process of plastic bottle infusion, the bottle is filled and filled in the same production area, even in the same machine. The bottle only needs to be purged with aseptic air, even without washing, and the glass bottle infusion is complicated. The washing process shortens the production cycle and improves the production efficiency.
Although the plastic bottle packaging technology overcomes the shortcomings of glass bottle packaging technology, which is difficult to transport and inefficient, it must be seen that there are still some problems in plastic bottle infusion:
1) Clinical application, there is the problem of infusion safety. Plastic bottle infusion is the same as glass bottle infusion. It is an open infusion method. In the process of use, it is still necessary to insert an air needle to establish an air passage, so that the infusion can be dripped smoothly in the air. The microorganisms and particles can still enter the infusion through the air needle, causing damage to the human body.
2) The transparency of the plastic bottle is not as good as that of the glass bottle, which is not conducive to the inspection of the clarity of the infusion.
3) The thermal stability of plastic bottles is inferior to that of glass bottles, and PP plastic bottles are not resistant to low temperatures.
In case of cold, brittle, cracking, PE plastic bottles are not resistant to high temperatures, and can not meet the FDA requirements of 121 ° C < 5 > when sterilized.
3 plastic soft bag infusion packaging technology
In order to solve the safety problem of clinical application of bottled infusion, plastic soft bag infusion packaging technology came into being. Infusion with this packaging technology can achieve fully enclosed infusion. Due to the self-shrinkage of the soft bag during clinical use, there is no need to form an air circuit. Extrusion of external atmospheric pressure can force the drug to drip out, avoiding open infusion. The safety hazard of the method improves the safety of the infusion. Plastic soft bag infusion packaging technology, according to the material of the soft bag is divided into PVC soft bag packaging technology and non-PVC soft bag packaging technology.
3. 1 PVC soft bag infusion packaging technology
PVC soft bag packaging technology has the following advantages compared with glass bottle and plastic bottle infusion packaging technology:
1) It is packed in PVC soft bag, which is small in size and light in weight. It is lighter than the quality of plastic bottles. It saves the storage space of hospitals and manufacturers, and is more conducive to transportation and carrying. It overcomes the heavy weight and large volume of glass bottle infusion. It is easy to break and transport and carry, and the bottle container needs more storage space.
2) PVC soft bag has the characteristics of strong pressure resistance and strong anti-falling force, which is convenient for transportation and emergency use in time and space. This is an important feature that soft bag packaging is different from bottle infusion.
3) Good transparency, although it is inferior to glass bottles, but better than plastic bottles, does not affect the clarity inspection, can overcome the shortcomings of poor clarity of plastic bottle infusion.
4) A fully enclosed infusion method is realized, which is used clinically, overcomes the secondary pollution problem of bottled infusion, and improves the safety of infusion.
5) Simple process, high efficiency and low cost. The bagging, filling and sealing process of PVC bagged infusion is completed in the 10000-level control environment (filling and sealing under partial 100-level laminar flow protection) on the bag making, filling and sealing machine. After bag making No need to clean and directly fill, compared with the glass bottle packaging technology, eliminating the need for complex rubber plugs, polyester film, glass bottle cleaning process. The production process is greatly shortened and the production efficiency is improved. At the same time, it saves a lot of washing water and the area of ​​the production plant (glass storage, cleaning workshop, rubber plug storage, cleaning workshop, etc. in glass bottle infusion production) < 5 >, and the price of PVC material is low, the production cost of infusion Can be reduced.
Although PVC soft bag infusion packaging technology has many of the above advantages, it still has fatal weaknesses, which limits the promotion of PVC soft bag packaging technology:
1) PVC soft bags have poor barrier to water, moisture and air, and are easily penetrated by water, moisture and air, which is not conducive to long-term storage of liquid medicine.
2) PVC soft bags for certain drugs such as: oil-soluble vitamins, insulin, isosorbide dinitrate, chlorpromazine, etc., have a certain adsorption < 6 >, reducing the efficacy of drugs.
3) PVC soft bags have a large amount of dissolved substances. The number of insoluble particles of 2 to 5 μm is higher than that of other packaging containers, which may cause vascular embolism, venous inflammation, and allergic reactions.
4) Potential hazards to human health and the environment. The plasticizer phthalate (DHEP) added during the production of PVC soft bags can make PVC flexible packaging soft and flexible. However, it has been found that this substance is a carcinogen, which may be dissolved in the infusion and cause damage to the health of the patient. The PVC infusion soft bag is used as a one-time use product. After use, the harmful gas dioxin is polluted when it is incinerated, which causes great harm to the environment. In view of this national drug inspection bureau has clearly stated that it will stop approving new PVC soft bag packaging infusion manufacturers.
3. 2 non-PVC soft bag infusion packaging technology
Although the above three infusion packaging technologies have their own advantages, but they all have certain shortcomings, is there a new infusion packaging technology that combines the advantages of these three packaging technologies without its drawbacks? This is 90 Non-PVC soft bag packaging technology developed by developed countries in Europe and America. In Japan, current non-PVC soft bag packaging infusions account for 60% of the entire infusion market < 7 >.
Non-PVC soft bag packaging technology has experienced two development stages. One is the polyolefin composite film packaging technology from the 1980s to the 1990s. The soft bags are processed by different film materials, usually 3 to 5 layers. Polyolefin composite film is light weight, high transparency, good barrier to water, moisture and air, heat resistance, chemical stability and good drug compatibility. It is an ideal packaging material, but due to the preparation of composite film. In the process, the binder is used between the layers, which is not conducive to the stability of the membrane, and has a potential impact on the stability of the liquid. Therefore, the application of the technology in infusion production has been affected to some extent; It is a polyolefin multi-layer co-extruded film packaging technology which has been improved in the past few years. This technology uses a multi-layer polyolefin material in the process of making soft bags and simultaneously melts and cross-links extrusion without removing the binder. The adhesive has an adverse effect on the stability of the film and the chemical solution.
At present, the more popular polyolefin multilayer co-extruded film generally has a three-layer structure. There are two types of commonly used polyolefin multi-layer coextruded films. One type is inner layer and the middle layer is made of polypropylene mixed with different proportions of elastic materials. It is non-toxic, inert and has good heat sealability. The outer layer has high mechanical strength. Polypropylene or polyester material; the second type is a mixture of polypropylene and styrene ethylene butylene styrene (SEBS) copolymer in the inner layer, SEBS in the middle layer and polypropylene material < 2 > in the outer layer.
Polyolefin multi-layer co-extruded film soft bag, no adhesive or plasticizer is used in the bag making process, and the film has no dissolution and no chipping, which provides a guarantee for the safe use of the infusion soft bag, and the film is easy to heat-sealed. Good elasticity and impact resistance, wide temperature tolerance, high temperature resistance can be sterilized at 121 °C, low temperature resistance (-40 °C) < 8 >; high transparency, good for clarity inspection; chemical inertness, good drug compatibility It is suitable for packaging various infusions; it does not contain chloride after treatment and is harmless to the environment; the production process is simple and the degree of automation is high; the soft bag can be completely self-shrinking during clinical infusion, achieving fully enclosed infusion, avoiding secondary pollution during infusion. Infusion safety is high. At present, the only shortcoming is that the price of the film is relatively high, and the special bag making and potting equipment are mostly imported, and the price is high, so the production cost is higher than other packaging technologies. But the good news is that in recent years, Hunan Qianshan Company has developed similar equipment at the international level, and the price is one-third of the import. With the domestic digestion and absorption of this technology, the production cost will continue to decline.
4 Conclusion
In summary, polyolefin multi-layer co-extruded film soft bag infusion packaging technology, compared with other infusion packaging technology, has obvious advantages, it is a collection of glass bottles, plastic bottles, PVC soft bags, these infusion packaging technology The combination of advantages and advantages is a relatively complete infusion packaging technology, which represents the trend of the world infusion packaging technology. With China's self-developed ideal non-PVC multi-layer co-extruded film materials, as well as special bag making and potting equipment with increasingly perfect performance, polyolefin multi-layer co-extruded film soft bag infusion packaging technology will become the mainstream of infusion production in China. Packaging technology.
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