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Drug packaging is closely related to life safety, and the new development trend in the future
2024/1/4
Medicine is a special commodity used to prevent, diagnose and treat diseases, which is closely related to the health and life safety of consumers. Drug quality is an important factor for the public to use drugs safely, and drug packaging is an accessory of drugs, which contains and carries drugs. It is not only beneficial to the transportation and storage of drugs, but also beneficial to the advertising of drugs. Drug packaging refers to the general name of a processing process in which the semi-finished or finished products of pharmaceutical preparations are divided (filled), sealed, packed and labeled with appropriate materials or containers to provide quality, trademark identification and description for drugs. Drug packaging itself can be understood from two aspects: from a static point of view, packaging is to package drugs with related materials, containers and auxiliary materials, and play its due role; From a dynamic point of view, packaging is a technical method using materials, containers and accessories, and it is a process and operation.
The role of drug packaging in the circulation field on schedule can be divided into two categories: internal packaging and external packaging. Inner packaging refers to the packaging that is in direct contact with drugs; Outer packaging refers to packaging other than inner packaging, which is divided into medium packaging and large packaging in order from inside to outside.
Its functions mainly include three aspects: protection function, convenient application and commodity promotion.
Drug packaging in China has gone through three stages:
50' s and 60' s: Brown bottles, straw cardboard boxes and straight-necked ampoules were the main packaging, and the medicine packaging was bulky and practical.
60' s and 80' s: It was greatly influenced by the Cultural Revolution. From the end of 60' s to the end of 70' s, there was no registered trademark on drug packaging, which was a painful period for drug packaging in China, and the development of drug packaging was stagnant.
80' s to present: In the early 80' s, the registered trademark of drugs was restored, the pharmaceutical packaging industry began to develop healthily, and the composite materials such as aluminum plastic, paper plastic and laser anti-counterfeiting were gradually popularized.
On April 29th, 2004, China promulgated the Administrative Measures for Materials and Containers for Pharmaceutical Packaging (Provisional), which classified the products of pharmaceutical packaging materials into three categories:
Class I refers to the materials and containers for drug packaging that are in direct contact with drugs and used directly;
Class II refers to the materials and containers for drug packaging that are in direct contact with drugs, but easy to clean, and need to be disinfected and sterilized after cleaning in the actual use process;
Class III refers to other materials and containers for drug packaging that may directly affect the quality of drugs except Class I and II.
Statistics show that at present, 65% of medical packaging products in China are not up to the level of developed countries in the 1980s, and the quality of packaging materials and the contribution rate of packaging to the pharmaceutical industry are low. In developed countries, pharmaceutical packaging accounts for 30% of the value of drugs, while the proportion in China is less than 10%.
At present, the new development trend of medical packaging market is: white packaging technology is widely used, mechanical packaging has become expensive, and the safety of pharmaceutical packaging has been paid more and more attention.
Glass exits plastic field.
In the selection of new materials, the materials of bagged pills are changed from paper bags and paper-plastic bags to aluminum-plastic bags and pearlescent film bags. High-density polyethylene plastic bottles and polyester plastic bottles have replaced glass bottles; The packaging form of pvc heat sealing of traditional Chinese medicine honey pills will also be replaced by aluminum-plastic blister packaging. The process of sealing glass bottles with bakelite plug wax has been eliminated, and aluminum foil and other materials with better sealing performance and higher production efficiency have been used instead.
In the choice of packaging methods for various dosage forms, blister packaging and aluminum-plastic blister packaging will be mainly used for tablets and capsules of western medicine and powders and granules of Chinese patent medicine. At present, the commonly used blister packaging materials for medicine are pvc (polyvinyl chloride) and pvdc (polyvinylidene chloride). Pvc has good compatibility, easy molding and sealing, and low price. Its transparency, barrier property and mechanical strength can basically meet the requirements of drug packaging, but its ability to block water vapor and thermal stability are poor. For drugs with high moisture-proof requirements, pvc is not satisfactory.
Pvdc has high molecular density, regular structure, high crystallinity and transparency, and good weather resistance. Pvdc film is a kind of film with good barrier performance at present. The barrier performance of pvdc film with the same thickness is 1500 times that of pe and 100 times that of pp and pet, and its barrier performance of water vapor is also higher than that of pvc, so it is an ideal material for blister packaging. Multi-layer composite hard sheets made by compounding or coating pvdc with other film materials, such as pvc/pvdc, bopp/pvdc, pvc/pvdc/pe, pvdc/opp/pe, etc., have obviously higher oxygen permeability, moisture permeability, moisture resistance and barrier performance than films made of a single material, and combine the advantages of various materials into one, providing a cheap choice for blister packaging. Another kind of blister packaging material is vacuum aluminized film, which is a kind of flexible packaging film which is sprayed with aluminum on various base films under high vacuum. Petp, cpp, ft, opp, pe and other vacuum aluminized films are widely used in the packaging of powder, granule and powder of Chinese patent medicine, among which petp, cpp and pe are widely used. In addition to the characteristics of plastic basement membrane, vacuum aluminized film packaging also has beautiful decoration and good barrier property. Especially, after aluminizing various plastic substrates, their light transmittance, oxygen permeability, water permeability and water vapor permeability will be reduced to one tenth or even one percent, which can well prevent drugs from becoming moldy and moisture-absorbing.
Plastic syringes are the main packaging of injection liquid, and there are two directions to improve the packaging of large infusion: composite soft packaging bags and plastic bottles. The main packaging forms of oral liquid packaging are glass bottles and controlled glass bottles, and new plastic easy-to-open oral liquid bottles have also come out.
Medical packaging will continue to improve with the development of pharmaceutical industry. The next five years will be a crucial period for the rapid development of the pharmaceutical packaging industry in China. At present, the annual output value of China's pharmaceutical packaging industry is about 15 billion yuan, which can only meet about 80% of the demand of domestic pharmaceutical enterprises. According to the current development speed of China's pharmaceutical industry, the annual output value of pharmaceutical packaging materials will quickly exceed 20 billion yuan in a short time.
The role of drug packaging in the circulation field on schedule can be divided into two categories: internal packaging and external packaging. Inner packaging refers to the packaging that is in direct contact with drugs; Outer packaging refers to packaging other than inner packaging, which is divided into medium packaging and large packaging in order from inside to outside.
Its functions mainly include three aspects: protection function, convenient application and commodity promotion.
Drug packaging in China has gone through three stages:
50' s and 60' s: Brown bottles, straw cardboard boxes and straight-necked ampoules were the main packaging, and the medicine packaging was bulky and practical.
60' s and 80' s: It was greatly influenced by the Cultural Revolution. From the end of 60' s to the end of 70' s, there was no registered trademark on drug packaging, which was a painful period for drug packaging in China, and the development of drug packaging was stagnant.
80' s to present: In the early 80' s, the registered trademark of drugs was restored, the pharmaceutical packaging industry began to develop healthily, and the composite materials such as aluminum plastic, paper plastic and laser anti-counterfeiting were gradually popularized.
On April 29th, 2004, China promulgated the Administrative Measures for Materials and Containers for Pharmaceutical Packaging (Provisional), which classified the products of pharmaceutical packaging materials into three categories:
Class I refers to the materials and containers for drug packaging that are in direct contact with drugs and used directly;
Class II refers to the materials and containers for drug packaging that are in direct contact with drugs, but easy to clean, and need to be disinfected and sterilized after cleaning in the actual use process;
Class III refers to other materials and containers for drug packaging that may directly affect the quality of drugs except Class I and II.
Statistics show that at present, 65% of medical packaging products in China are not up to the level of developed countries in the 1980s, and the quality of packaging materials and the contribution rate of packaging to the pharmaceutical industry are low. In developed countries, pharmaceutical packaging accounts for 30% of the value of drugs, while the proportion in China is less than 10%.
At present, the new development trend of medical packaging market is: white packaging technology is widely used, mechanical packaging has become expensive, and the safety of pharmaceutical packaging has been paid more and more attention.
Glass exits plastic field.
In the selection of new materials, the materials of bagged pills are changed from paper bags and paper-plastic bags to aluminum-plastic bags and pearlescent film bags. High-density polyethylene plastic bottles and polyester plastic bottles have replaced glass bottles; The packaging form of pvc heat sealing of traditional Chinese medicine honey pills will also be replaced by aluminum-plastic blister packaging. The process of sealing glass bottles with bakelite plug wax has been eliminated, and aluminum foil and other materials with better sealing performance and higher production efficiency have been used instead.
In the choice of packaging methods for various dosage forms, blister packaging and aluminum-plastic blister packaging will be mainly used for tablets and capsules of western medicine and powders and granules of Chinese patent medicine. At present, the commonly used blister packaging materials for medicine are pvc (polyvinyl chloride) and pvdc (polyvinylidene chloride). Pvc has good compatibility, easy molding and sealing, and low price. Its transparency, barrier property and mechanical strength can basically meet the requirements of drug packaging, but its ability to block water vapor and thermal stability are poor. For drugs with high moisture-proof requirements, pvc is not satisfactory.
Pvdc has high molecular density, regular structure, high crystallinity and transparency, and good weather resistance. Pvdc film is a kind of film with good barrier performance at present. The barrier performance of pvdc film with the same thickness is 1500 times that of pe and 100 times that of pp and pet, and its barrier performance of water vapor is also higher than that of pvc, so it is an ideal material for blister packaging. Multi-layer composite hard sheets made by compounding or coating pvdc with other film materials, such as pvc/pvdc, bopp/pvdc, pvc/pvdc/pe, pvdc/opp/pe, etc., have obviously higher oxygen permeability, moisture permeability, moisture resistance and barrier performance than films made of a single material, and combine the advantages of various materials into one, providing a cheap choice for blister packaging. Another kind of blister packaging material is vacuum aluminized film, which is a kind of flexible packaging film which is sprayed with aluminum on various base films under high vacuum. Petp, cpp, ft, opp, pe and other vacuum aluminized films are widely used in the packaging of powder, granule and powder of Chinese patent medicine, among which petp, cpp and pe are widely used. In addition to the characteristics of plastic basement membrane, vacuum aluminized film packaging also has beautiful decoration and good barrier property. Especially, after aluminizing various plastic substrates, their light transmittance, oxygen permeability, water permeability and water vapor permeability will be reduced to one tenth or even one percent, which can well prevent drugs from becoming moldy and moisture-absorbing.
Plastic syringes are the main packaging of injection liquid, and there are two directions to improve the packaging of large infusion: composite soft packaging bags and plastic bottles. The main packaging forms of oral liquid packaging are glass bottles and controlled glass bottles, and new plastic easy-to-open oral liquid bottles have also come out.
Medical packaging will continue to improve with the development of pharmaceutical industry. The next five years will be a crucial period for the rapid development of the pharmaceutical packaging industry in China. At present, the annual output value of China's pharmaceutical packaging industry is about 15 billion yuan, which can only meet about 80% of the demand of domestic pharmaceutical enterprises. According to the current development speed of China's pharmaceutical industry, the annual output value of pharmaceutical packaging materials will quickly exceed 20 billion yuan in a short time.
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