The blister pack is a product in which the drug is placed in a cavity (referred to as a blister or blister) in a plastic hard-molded plastic sheet, followed by an aluminum foil that is intaglio printed and coated with a protective agent and a binder. The plastic hard film is bonded and heat sealed so that the medicine can be safely protected. The main materials for blister packs are pharmaceutical PTP aluminum foil, plastic hard sheets (PVC PVC), and adhesives. With the further improvement of the safety requirements for the use of blister packaging materials in China, this article reviews in particular the history and current status of the use of materials, and analyzes the future direction of development in order to promote the survival of the fittest of drug packaging materials.
I. A brief history of the development of pharmaceutical blister packaging in China
Pharmaceutical blister packaging was formed in Europe in the 1930s. China first introduced equipment, technology, and raw materials in the 1980s. In the 1990s, China has been able to manufacture single-color or multi-color PTP aluminum foil printing and coating equipment and began to supply domestic pharmaceuticals. It can be used by packaging companies and can manufacture colored series of medicine flexible packaging aluminum-plastic blister products. At present, China's PTP aluminum foil gravure printing equipment has been able to meet the needs of domestic pharmaceutical packaging, domestic production license has been obtained for pharmaceutical packaging materials, manufacturers of blister materials, including film, film, aluminum foil (composite) flexible packaging enterprises 165, already have considerable The production scale, due to its wide range of applications for blister packs, is the fastest growing flexible packaging material in recent years, and it is also a major form of packaging for food, health care products, pharmaceuticals, and other fields, thus promoting the expansion of these areas of reproduction, new packaging companies The number is also increasing.
Second, the status of flexible packaging aluminum foil
Medicinal PTP aluminum foil is a sealing material that is sealed on a plastic hard plastic sheet, and is usually called a cover material. Its surface can be printed with words or patterns, and both sides have good printing application performance, aluminum foil is made of 99% electrolytic aluminum, calendered and other processing methods, non-toxic and odorless, with excellent conductivity and shading Excellent performance such as resistance to moisture and gas barrier. In modern packaging, aluminum foil is used as a barrier material in almost all shaded or high-barrier composite flexible packaging materials. This is because aluminum foil has a highly dense metal crystal structure that can completely block any gas. The thickness used in the soft packaging of medicines is mostly double-foil. The amount of double-zero aluminum foil in China reached 60,000 tons in 2002, of which nearly 50,000 tons was produced, and nearly 20,000 tons were imported. Therefore, the prospects for the development of aluminum foil for flexible packaging in China Look, the market growth is good, both the consumption and the product grade have a huge space for development.
From the point of view of daily consumer goods, China can consume 161,300 tons of aluminum foil each year. The largest consumer of air-conditioner foil is air-conditioning foil, followed by cigarette foil. China is the world’s largest cigarette producer and consumer, and cigarette packaging uses annual consumption of tobacco foil. 35,000 tons, accounting for 60% of the total consumption of double-null foils. Third, decorative foils are used in the construction industry for heat insulation, moisture protection and decorative materials. At present, there is an upsurge in the application of decorative foils in China's construction and household appliance industries. The cable foil uses the hermeticity and shielding of the aluminum foil as a shield for the cable. Therefore, the use of aluminum foil is quite extensive, and it has now become the second largest consumer of aluminum foil in the world after the United States. However, per capita possession is less than one-tenth of that in developed countries, and the amount of packaging is far less than that of developed countries. It is a space for future development. One of the materials.
Third, the status quo and development of plastic hard sheet material for blister soft packaging
The basic materials used in PTP aluminum blister packaging are the most common PVC hard sheets (PVC hard sheets for short). Since the blister packaging production method was adopted, the PVC blister was used to complete the pharmaceutical blister. package. Although PVC has many advantages such as high quality and low price, in the production or use of PVC, there has been a long-term impact on the environment and living organisms. The main problems are: Polymerization of PVC monomers such as vinyl chloride monomer. Preparation of PVC plastic additives such as plasticizers, stabilizers and so on. Incineration of PVC products such as dioxin hydrochloride. As the Hcl generated after the decomposition of PVC has a certain impact on the environment, its monomers, plasticizers, stabilizers are harmful to the human body.
According to reports from related parties, German pharmaceutical manufacturers no longer use PVC for blister packs, and Japan also restricts the production of PVC products. This needs our attention. Therefore, PVC sheets commonly used today are used as pharmaceutical blister packaging materials. Will gradually be eliminated. Replaced by the blister packaging plastic sheet, it is required to be non-toxic, and water, oxygen isolation performance is good, can be a longer time to ensure that the drug does not oxidize, moisture absorption, mildew, deterioration, etc., especially for Chinese medicine. In particular, it seems more sensitive. However, due to the imperfection of water vapor barrier property of PVC hard sheets, it is not suitable for the packaging of medicines with high moisture-proof requirements. In order to improve the defects of PVC, PVC composite hard sheets are currently being used. Such composite sheets are mainly composed of PVC hard sheets and others. One or more novel polymer membranes and sheets, produced by extrusion, compounding, coating, and other processing methods, are another novel composite material that meets the requirements of pharmaceutical packaging. In the 1990s, the safety of medications was increasingly valued by pharmaceutical companies and consumers. Because the ingredients of some medicines are susceptible to deliquescence and oxidation, the original PVC hard sheets could not meet the packaging requirements of these drugs.
In China, we have successfully developed PVC hard sheets as base materials and added some composite materials with high barrier properties, such as PVC and PVDC composites, PVC and PE composites, and PVC/PE/PVDC composites. It combines the rigidity of PVC hard film, good molding and excellent barrier properties against vapor, oxygen, carbon dioxide gas and various odors, and can meet the packaging requirements of easily deliquescent, easily oxidized drugs and some traditional Chinese medicines that need to retain odor. The use of these composite rigid sheets still follows the original aluminum-plastic blister package, packaging equipment and processes.
IV. History and Future of Adhesives for Blister Soft Packaging Materials
Blister packaging adhesives, early adhesives used single-component pressure-sensitive adhesives, the main components of pressure-sensitive adhesives include synthetic resin adhesives (including natural rubber, synthetic rubber, cellulose, polyacrylates ), Adhesives (including rosin, rosin esters, various petroleum resins, epoxy resins or phenolic resins, etc.), plasticizers (including chlorinated paraffins, phthalates), antioxidants, stabilizers, cross-linking Agents, colorants and fillers. In the early days, pressure sensitive adhesives were based on natural rubber. The formula was 100 parts of plasticized natural rubber, polyterpene resin had a melting point of about 75°C, and petroleum resin contained 5 parts and partially polymerized. Methyl dichloroquinoline 2 parts mixed.
Another formula consists of 100 parts of smoked rubber tablets, 50 parts of zinc oxide, 75 parts of hydrogenated rosin, and a small amount of tackifier and plasticizer. Later, synthetic rubbers and synthetic resins were used instead of natural rubber. Among them, acrylates and their copolymers are most commonly used. For example, acrylic copolymer emulsions are used to make high-strength pressure-sensitive adhesives. The mixing ratio and manufacturing method is 100 parts. Amount of butyl acrylate - 2-ethylhexyl acrylate - vinyl acetate copolymer emulsion (composition ratio of 50:17:33) and 30 parts of 50% solids ethylene-vinyl acetate-vinyl chloride copolymer emulsion (composition The ratio was 19:36:45.) Mixing, coating on a polypropylene film treated with corona discharge, drying at 110°C for 1 minute, was made into a pressure-sensitive adhesive tape. This tape has a peel strength of stainless steel of 600g/25mm. With the continuous improvement of the hygienic performance requirements of pharmaceutical packaging materials, the additives added to natural rubber adhesives have odor, and some are toxic. They are not used in pharmaceutical and food composite packaging, but acrylic pressure-sensitive adhesives Still have certain advantages, such as because it is a single component, will not be cross-linked curing, do not have to glue, simple to use, unused glue even if overnight or longer will not degenerate, as long as sealed airtight preservation However, the surface state of the adherend is excellent, and many non-polar materials such as plastics and metal materials can adhere to a small surface tension. However, due to the wide variety of materials in the packaging of compound drugs, companies have turned to two-component polyurethane adhesives for the compounding of polar plastics and non-polar materials.
At present, pressure-sensitive adhesives for pharmaceutical flexible packaging composite materials have been replaced by polyurethane adhesives, and ester-soluble polyurethane adhesives are mainly used. These adhesives are two-component ester-soluble adhesives, and their main agents are polyether or polyester polyols modified with aromatic isocyanates. Hydroxyl-containing polyurethane polyols, curing agents are a combination of aromatic isocyanates and trimethylolpropane. Such adhesives have excellent performance, mature technology, and many varieties, but they are toxic and costly, and they emit large amounts of solvents to pollute the environment. Long time of composite materials may cause hydrolysis and release of a carcinogenic substance, which will seriously affect the operator's health. As the awareness of environmental protection increases, the use of such adhesives continues to decline. The use of alcohol-soluble polyurethane adhesives; it is based on industrial alcohol as a solvent, low production costs, good health performance, harmless to humans, no pollution to the environment. The disadvantage is that it is not resistant to high temperatures of 100°C and cannot be packaged with highly corrosive products. Another type of adhesive is an aqueous polyurethane adhesive based on water-soluble or water-dispersible solvents. Its advantage is that water replaces organic solvents. There is no danger of burning and the cost is low. However, poor adhesive properties.
At present, the adhesives for composite flexible packaging materials develop toward solvent-free type, and solvent-free adhesives are basically two-component polyurethane adhesives. The main agent and curing agent have high viscosity at room temperature and fluidity, and the main agent and curing agent are compounded. Proportional mixing, after the temperature rises, the roller is applied to the substrate. Since no organic solvent is used, the cost is reduced. There is no environmental pollution caused by the volatilization of the organic solvent, which saves the huge drying, heating, air blowing, and exhaust emission devices of the device and reduces the Energy consumption. The product has no residual solvent damage, the production speed is increased, the maintenance cost is low, and the benefits are significant. In the field of pharmaceutical flexible packaging, it is the future development direction.
Fifth, anti-counterfeit labels for pharmaceutical blister packaging and new materials and new technology applications look forward to strengthening
At present, the blister package PTP aluminum foil surface printing is very simple, monochrome printing is more common, almost no security signs and special counterfeit materials and means, which provides counterfeiters with the convenience of prevention and fraud. According to information, there are nearly 10 types of anti-counterfeit signs on a slap-sized pillbox in Western countries. It uses micro-letters, anti-counterfeit signs that can be visually recognized, such as lacquering and gravure printing on banknotes. A fake-like logo that can be seen using special lenses. In addition, on the surface of pharmaceutical blister packaging, foreign countries mostly use laser holographic dark anti-counterfeit PTP aluminum foil products, the advantage of which is that the laser hologram pattern has strong intuitiveness and is easy for consumers to identify without affecting the original printing design and product packaging appearance. , does not affect the performance of using PTP aluminum foil material. This anti-counterfeiting product is a counterfeit method adopted by many multinational pharmaceutical companies. The application of invisible fluorescent anti-counterfeiting PTP aluminum foil material is also one of the development trends of pharmaceutical packaging technology in the future. This anti-counterfeiting effect is more subtle and difficult to observe with the naked eye, but the anti-counterfeiting mark or pattern text under the UV lamp will be clearly exposed. At present, some blister packaging manufacturers in China have already been applied, but the total amount used is still very small. Overall, China's pharmaceutical packaging companies are still relatively backward in terms of anti-counterfeit technology. Although we have seen alarming cases of counterfeit drugs in the pharmaceutical market, awareness of the importance of anti-counterfeiting technology and the importance of use has gradually increased, but in the new security materials and anti-counterfeiting technology Investment application
I. A brief history of the development of pharmaceutical blister packaging in China
Pharmaceutical blister packaging was formed in Europe in the 1930s. China first introduced equipment, technology, and raw materials in the 1980s. In the 1990s, China has been able to manufacture single-color or multi-color PTP aluminum foil printing and coating equipment and began to supply domestic pharmaceuticals. It can be used by packaging companies and can manufacture colored series of medicine flexible packaging aluminum-plastic blister products. At present, China's PTP aluminum foil gravure printing equipment has been able to meet the needs of domestic pharmaceutical packaging, domestic production license has been obtained for pharmaceutical packaging materials, manufacturers of blister materials, including film, film, aluminum foil (composite) flexible packaging enterprises 165, already have considerable The production scale, due to its wide range of applications for blister packs, is the fastest growing flexible packaging material in recent years, and it is also a major form of packaging for food, health care products, pharmaceuticals, and other fields, thus promoting the expansion of these areas of reproduction, new packaging companies The number is also increasing.
Second, the status of flexible packaging aluminum foil
Medicinal PTP aluminum foil is a sealing material that is sealed on a plastic hard plastic sheet, and is usually called a cover material. Its surface can be printed with words or patterns, and both sides have good printing application performance, aluminum foil is made of 99% electrolytic aluminum, calendered and other processing methods, non-toxic and odorless, with excellent conductivity and shading Excellent performance such as resistance to moisture and gas barrier. In modern packaging, aluminum foil is used as a barrier material in almost all shaded or high-barrier composite flexible packaging materials. This is because aluminum foil has a highly dense metal crystal structure that can completely block any gas. The thickness used in the soft packaging of medicines is mostly double-foil. The amount of double-zero aluminum foil in China reached 60,000 tons in 2002, of which nearly 50,000 tons was produced, and nearly 20,000 tons were imported. Therefore, the prospects for the development of aluminum foil for flexible packaging in China Look, the market growth is good, both the consumption and the product grade have a huge space for development.
From the point of view of daily consumer goods, China can consume 161,300 tons of aluminum foil each year. The largest consumer of air-conditioner foil is air-conditioning foil, followed by cigarette foil. China is the world’s largest cigarette producer and consumer, and cigarette packaging uses annual consumption of tobacco foil. 35,000 tons, accounting for 60% of the total consumption of double-null foils. Third, decorative foils are used in the construction industry for heat insulation, moisture protection and decorative materials. At present, there is an upsurge in the application of decorative foils in China's construction and household appliance industries. The cable foil uses the hermeticity and shielding of the aluminum foil as a shield for the cable. Therefore, the use of aluminum foil is quite extensive, and it has now become the second largest consumer of aluminum foil in the world after the United States. However, per capita possession is less than one-tenth of that in developed countries, and the amount of packaging is far less than that of developed countries. It is a space for future development. One of the materials.
Third, the status quo and development of plastic hard sheet material for blister soft packaging
The basic materials used in PTP aluminum blister packaging are the most common PVC hard sheets (PVC hard sheets for short). Since the blister packaging production method was adopted, the PVC blister was used to complete the pharmaceutical blister. package. Although PVC has many advantages such as high quality and low price, in the production or use of PVC, there has been a long-term impact on the environment and living organisms. The main problems are: Polymerization of PVC monomers such as vinyl chloride monomer. Preparation of PVC plastic additives such as plasticizers, stabilizers and so on. Incineration of PVC products such as dioxin hydrochloride. As the Hcl generated after the decomposition of PVC has a certain impact on the environment, its monomers, plasticizers, stabilizers are harmful to the human body.
According to reports from related parties, German pharmaceutical manufacturers no longer use PVC for blister packs, and Japan also restricts the production of PVC products. This needs our attention. Therefore, PVC sheets commonly used today are used as pharmaceutical blister packaging materials. Will gradually be eliminated. Replaced by the blister packaging plastic sheet, it is required to be non-toxic, and water, oxygen isolation performance is good, can be a longer time to ensure that the drug does not oxidize, moisture absorption, mildew, deterioration, etc., especially for Chinese medicine. In particular, it seems more sensitive. However, due to the imperfection of water vapor barrier property of PVC hard sheets, it is not suitable for the packaging of medicines with high moisture-proof requirements. In order to improve the defects of PVC, PVC composite hard sheets are currently being used. Such composite sheets are mainly composed of PVC hard sheets and others. One or more novel polymer membranes and sheets, produced by extrusion, compounding, coating, and other processing methods, are another novel composite material that meets the requirements of pharmaceutical packaging. In the 1990s, the safety of medications was increasingly valued by pharmaceutical companies and consumers. Because the ingredients of some medicines are susceptible to deliquescence and oxidation, the original PVC hard sheets could not meet the packaging requirements of these drugs.
In China, we have successfully developed PVC hard sheets as base materials and added some composite materials with high barrier properties, such as PVC and PVDC composites, PVC and PE composites, and PVC/PE/PVDC composites. It combines the rigidity of PVC hard film, good molding and excellent barrier properties against vapor, oxygen, carbon dioxide gas and various odors, and can meet the packaging requirements of easily deliquescent, easily oxidized drugs and some traditional Chinese medicines that need to retain odor. The use of these composite rigid sheets still follows the original aluminum-plastic blister package, packaging equipment and processes.
IV. History and Future of Adhesives for Blister Soft Packaging Materials
Blister packaging adhesives, early adhesives used single-component pressure-sensitive adhesives, the main components of pressure-sensitive adhesives include synthetic resin adhesives (including natural rubber, synthetic rubber, cellulose, polyacrylates ), Adhesives (including rosin, rosin esters, various petroleum resins, epoxy resins or phenolic resins, etc.), plasticizers (including chlorinated paraffins, phthalates), antioxidants, stabilizers, cross-linking Agents, colorants and fillers. In the early days, pressure sensitive adhesives were based on natural rubber. The formula was 100 parts of plasticized natural rubber, polyterpene resin had a melting point of about 75°C, and petroleum resin contained 5 parts and partially polymerized. Methyl dichloroquinoline 2 parts mixed.
Another formula consists of 100 parts of smoked rubber tablets, 50 parts of zinc oxide, 75 parts of hydrogenated rosin, and a small amount of tackifier and plasticizer. Later, synthetic rubbers and synthetic resins were used instead of natural rubber. Among them, acrylates and their copolymers are most commonly used. For example, acrylic copolymer emulsions are used to make high-strength pressure-sensitive adhesives. The mixing ratio and manufacturing method is 100 parts. Amount of butyl acrylate - 2-ethylhexyl acrylate - vinyl acetate copolymer emulsion (composition ratio of 50:17:33) and 30 parts of 50% solids ethylene-vinyl acetate-vinyl chloride copolymer emulsion (composition The ratio was 19:36:45.) Mixing, coating on a polypropylene film treated with corona discharge, drying at 110°C for 1 minute, was made into a pressure-sensitive adhesive tape. This tape has a peel strength of stainless steel of 600g/25mm. With the continuous improvement of the hygienic performance requirements of pharmaceutical packaging materials, the additives added to natural rubber adhesives have odor, and some are toxic. They are not used in pharmaceutical and food composite packaging, but acrylic pressure-sensitive adhesives Still have certain advantages, such as because it is a single component, will not be cross-linked curing, do not have to glue, simple to use, unused glue even if overnight or longer will not degenerate, as long as sealed airtight preservation However, the surface state of the adherend is excellent, and many non-polar materials such as plastics and metal materials can adhere to a small surface tension. However, due to the wide variety of materials in the packaging of compound drugs, companies have turned to two-component polyurethane adhesives for the compounding of polar plastics and non-polar materials.
At present, pressure-sensitive adhesives for pharmaceutical flexible packaging composite materials have been replaced by polyurethane adhesives, and ester-soluble polyurethane adhesives are mainly used. These adhesives are two-component ester-soluble adhesives, and their main agents are polyether or polyester polyols modified with aromatic isocyanates. Hydroxyl-containing polyurethane polyols, curing agents are a combination of aromatic isocyanates and trimethylolpropane. Such adhesives have excellent performance, mature technology, and many varieties, but they are toxic and costly, and they emit large amounts of solvents to pollute the environment. Long time of composite materials may cause hydrolysis and release of a carcinogenic substance, which will seriously affect the operator's health. As the awareness of environmental protection increases, the use of such adhesives continues to decline. The use of alcohol-soluble polyurethane adhesives; it is based on industrial alcohol as a solvent, low production costs, good health performance, harmless to humans, no pollution to the environment. The disadvantage is that it is not resistant to high temperatures of 100°C and cannot be packaged with highly corrosive products. Another type of adhesive is an aqueous polyurethane adhesive based on water-soluble or water-dispersible solvents. Its advantage is that water replaces organic solvents. There is no danger of burning and the cost is low. However, poor adhesive properties.
At present, the adhesives for composite flexible packaging materials develop toward solvent-free type, and solvent-free adhesives are basically two-component polyurethane adhesives. The main agent and curing agent have high viscosity at room temperature and fluidity, and the main agent and curing agent are compounded. Proportional mixing, after the temperature rises, the roller is applied to the substrate. Since no organic solvent is used, the cost is reduced. There is no environmental pollution caused by the volatilization of the organic solvent, which saves the huge drying, heating, air blowing, and exhaust emission devices of the device and reduces the Energy consumption. The product has no residual solvent damage, the production speed is increased, the maintenance cost is low, and the benefits are significant. In the field of pharmaceutical flexible packaging, it is the future development direction.
Fifth, anti-counterfeit labels for pharmaceutical blister packaging and new materials and new technology applications look forward to strengthening
At present, the blister package PTP aluminum foil surface printing is very simple, monochrome printing is more common, almost no security signs and special counterfeit materials and means, which provides counterfeiters with the convenience of prevention and fraud. According to information, there are nearly 10 types of anti-counterfeit signs on a slap-sized pillbox in Western countries. It uses micro-letters, anti-counterfeit signs that can be visually recognized, such as lacquering and gravure printing on banknotes. A fake-like logo that can be seen using special lenses. In addition, on the surface of pharmaceutical blister packaging, foreign countries mostly use laser holographic dark anti-counterfeit PTP aluminum foil products, the advantage of which is that the laser hologram pattern has strong intuitiveness and is easy for consumers to identify without affecting the original printing design and product packaging appearance. , does not affect the performance of using PTP aluminum foil material. This anti-counterfeiting product is a counterfeit method adopted by many multinational pharmaceutical companies. The application of invisible fluorescent anti-counterfeiting PTP aluminum foil material is also one of the development trends of pharmaceutical packaging technology in the future. This anti-counterfeiting effect is more subtle and difficult to observe with the naked eye, but the anti-counterfeiting mark or pattern text under the UV lamp will be clearly exposed. At present, some blister packaging manufacturers in China have already been applied, but the total amount used is still very small. Overall, China's pharmaceutical packaging companies are still relatively backward in terms of anti-counterfeit technology. Although we have seen alarming cases of counterfeit drugs in the pharmaceutical market, awareness of the importance of anti-counterfeiting technology and the importance of use has gradually increased, but in the new security materials and anti-counterfeiting technology Investment application
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