In recent years, the market for pharmaceutical plastic packaging materials and products has grown rapidly, and new materials, new processes, new technologies, and new products continue to emerge. The emergence of many new products has improved the outdated situation of pharmaceutical packaging. Pharmaceutical packaging has also been transformed into high-speed mechanical, electronic and other packaging methods. The packaging form is also transformed from ordinary glass bottles, wax pill packaging, plastic bottles, etc., to composite plastic bags, aluminum-plastic blister caps and other forms. Among them, the production of composite materials is divided into multi-layer co-extrusion, aluminum-plastic composite, aluminum plating and so on.
At present, the annual output value of the national pharmaceutical packaging industry has reached 15 billion yuan. At present, pharmaceutical packaging is still aluminum, plastic, glass coexistence. However, the proportion of plastic packaging is rapidly increasing, especially plastic bottles have seized a part of the market share of glass bottles.
Nowadays, Chinese pharmaceutical manufacturers have applied for "Good Manufacturing Practice (GMP)" to improve product quality. Plastics in the drug market will have a lot of room for development, different drugs use different plastics, commonly used is HDPE, PP, PVC and PE.
The main forms and characteristics of plastic medical packaging
The main forms of plastic pharmaceutical packaging are plastic bottles, aluminum-plastic blister packaging, strip packaging, and bag packaging, which have accounted for more than 95% of the total packaging volume of tablets. Among them, strip packaging accounts for about 15%, bag packaging accounts for about 10%, and plastic bottles and aluminum-plastic blister packaging account for more than 30%. Aluminum-plastic blister packaging is on the rise, accounting for more than 30%. There are many types of plastic materials used for pharmaceutical packaging, including PVC, PE, PP, PS, PET, nylon and so on. Among them, PE, PP and PET account for a large proportion, and the amount of PVC is decreasing.
1. Plastic bottles (bags)
Liquid drugs are mainly divided into injection, infusion and oral liquid. Liquid drugs are mainly packaged in bottles and bags. Polyester plastic bottle is one of the most important pharmaceutical packaging materials. As a pharmaceutical packaging container, PET has many advantages. In addition, the recycling rate of PET resin is higher than that of other plastics, and when it is burned as waste, its combustion caloric value is low and flammable, and it does not produce harmful gases.
Plastic packaging is making a breakthrough in infusion drugs. According to incomplete statistics, at present, there are about 200 infusion enterprises in the country that have passed GMP certification, and the infusion production capacity is about 3 billion bottles. More than 100 companies have an annual production capacity of more than 10 million bottles. Most foreign infusion agents are packaged in quality plastic bottles or plastic bags. With the rapid development of polyolefin plastic bags and BOPP bottles in this field, this status quo is changing.
In oral liquids, soft plastic bottles have been partially applied and gradually expanded their scope of application. Rigid plastic bottles are also slowly replacing glass for packaging larger volumes of liquid medicines such as syrups, in line with developments in Europe.
From the current application and development of pharmaceutical packaging containers in China, the speed of promoting and applying plastic containers for pharmaceutical oral liquids should be accelerated. The specifications range from 100 ml to 200 ml, and the raw materials used are polyethylene terephthalate (PET) and the new material PEN, including the development of quality light-resistant PET plastic bottles with scales on the container or with metering cups to replace low-quality glass bottles.
Due to the large development space of Chinese medicine pills, capsules, powder and so on in the international market, it is also necessary to speed up the development of plastic hollow container packaging of Chinese medicine. For example, the application of high-density polyethylene (HDPE), polypropylene (PP), PET, PEN and other materials made of plastic hollow containers, and the use of injection blow molding, injection blow molding process. The hollow container is sealed with aluminum foil electromagnetic induction gasket to increase the safety protection of the packaging container for drugs, and eliminate the backward packaging of drugs sealed with wax in yellow round glass bottles.
China encourages the production and use of advanced non-PVC infusion soft bag packaging products, but the current national total annual output is far from the annual demand. Non-pvc infusion flexible packaging bag is a new international concept of fully sealed intravenous infusion products, developed countries have been in clinical application for more than 10 years. The results of practical application show that the safety of non-PVC infusion bag is very good. Although the absorption of glass bottles is very small, there are some problems such as reflux air pollution, difficult to detect fine seam damage, and glue plug powder falling off.
2. Film packaging
In the Chinese medicine granule, powder, powder and other plastic composite film bag packaging, the main development of the following varieties: (I) bidirectional tensile polypropylene (BOPP) film; (2) salivation polypropylene film (CPP); (3) Polyester film (PET); (4) polyvinylidene chloride film (PVDC).
Coating is one of the commonly used techniques in pharmacy. In recent decades, with the continuous development of new materials, new technologies and new equipment, coating technology has developed rapidly, forming a complete set of theories and operational tests, which occupies an important position in pharmacy. Because the film forming agent and most of the auxiliary additives are excellent physical and chemical properties of polymer materials. At present, there are many film forming materials and auxiliary materials, and a variety of thin film coating with different characteristics can be made by careful design to change the release position of the drug core and the release characteristics of the drug. The coating of new products now developed is generally thin film coating, and the basic composition of the film coating prescription includes film forming agent (coating material), solvent, plasticizer, coloring agent, and can also add pore-causing agent and insoluble filler. The composition of film coating prescription is critical to the success of coating.
3. Can take medicine packaging
Such packaging materials are mainly capsules, microcapsules and excipients. Soft capsules are also called elastic capsules, and their elasticity depends on the proportion of gelatin, plasticizer and water in the shell.
4. Blister packing
Common blister packaging is made of polyvinyl chloride sheet (PVC), polyvinylidene chloride (PVDC) and composite double aluminum sheet (CFF). PVC sheet has good compatibility, and it is easy to form and seal, and the price is low, but the moisture barrier is relatively low. CFF has good moisture barrier, but it is easy to distort and cannot see the drugs inside, so pills are rarely used.
5. Synthetic paper packaging
Imitation paper film (synthetie paper), also known as "synthetic paper", polymerization paper, plastic paper "pearl paper".
With the reform of China's medical system, medical packaging disorder, backward situation will undergo a fundamental change. Recently, China is constantly introducing and updating pharmaceutical packaging machinery and materials, and the pharmaceutical packaging industry will present a new situation. In recent years, the packaging of solid drugs in China, such as capsules, injections, and external drugs has been updated rapidly, and the use of disposable plastic syringes has brought a big change to the packaging and application of injections in China, and the direction of the improvement of infusion packaging is also developing in the direction of composite flexible packaging bags and plastic bottle packaging.
Experts believe that China's pharmaceutical packaging should do the following: first, accelerate the promotion and application of pharmaceutical oral liquid plastic containers; Second, accelerate the development of traditional Chinese medicine plastic hollow container packaging, should be more used to HDPE, PP, PET, PEN and other materials, and the use of injection blow molding and other molding processes made of plastic hollow containers. The mouth of the hollow container is sealed with aluminum foil electromagnetic induction gasket to enhance the safety protection of drugs and accelerate the promotion and application of plastic composite film bag packaging of traditional Chinese medicine.
Although the drug packaging is not directly in contact with the human body or even buried inside the human body like medical products, if it does not meet the health and stability requirements, indirect contact will seriously endanger life safety. Therefore, all plastic materials used for drug packaging must comply with the provisions of drug packaging materials issued by the State Drug Administration. Imported and newly developed pharmaceutical packaging materials also need to be declared and tested.
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