Overview and Prospect of the development of pharma

Overview and Prospect of the development of pharmaceutical packaging materials in China (2)

3 several main materials of pharmaceutical packaging [6]

3.1 plastic packaging [7]

3.1.1 ethylene (PE) is non-toxic, hygienic, cheap, translucent and flexible to varying degrees; Good humidity resistance, poor oxygen and other gas resistance. Since this polymer is generally easy to be oxidized and degraded during processing and subsequent placement, it is necessary to add antioxidants. The general dosage is a few tenthousand, and the commonly used antioxidant is butyl hydroxytoluene or lauric acid THIODIPROPIONATE

3.1.2 polypropylene (PP) is a kind of plastic with low density. It is usually crystalline and has high heat resistance. It can be cooked in boiling water. It is non-toxic and weak polar polymer, so its thermal adhesion and printability are poor, and it is usually aimed at improving transparency or barrier

3.1.3 there are many kinds of pet used in pharmaceutical packaging. Because of its high strength, good transparency, excellent dimensional stability and good air tightness, it is often used to replace the packaging of glass containers, metal containers, tablets, capsules and other solid preparations; B0pet is formed by biaxial stretching of pet, which is often used to pack Chinese herbal medicine pieces; In addition, because of its high odor retention and heat resistance, it can be used as a barrier layer in the multilayer composite film to ensure that the drug will not deteriorate within the validity period and will not be cracked by light, such as PET/PE composite film. But the biggest disadvantage of pet is that it cannot withstand high-temperature steam disinfection

3.1.4 polyvinylidene chloride (PVDC) PVDC has good transparency, excellent printability and heat sealing performance. Its biggest feature is good barrier to oxygen, water vapor and carbon dioxide in the air, and excellent moisture resistance. However, due to its high price, it is mainly made into composite films with PE, PP, etc. in pharmaceutical packaging, which are used as packaging bags for granules and powders

3.1.5 polyethylene naphthalate (pen) pen has excellent mechanical properties, strong ultraviolet radiation resistance, good transparency and barrier, glass transition temperature as high as 121 OC, slow crystallization speed, and is easy to make transparent thick wall heat-resistant bottles. The price of pen is relatively high. In order to reduce the cost, pen and pet are usually blended to make the cost equivalent to that of glass and have the same air tightness and shelf life as glass bottles. Because pen has strong ultraviolet radiation resistance, the composition of drugs does not change due to light exposure. It is commonly used in the thermal packaging of oral liquids, syrups, etc. at present, it is the only rigid packaging material that can replace glass containers and can be digested and disinfected by industrial methods

3.1.6 polyvinyl chloride (PVC) PVC has good transparency, high strength, excellent heat sealing and printability. In pharmaceutical packaging, rigid PVC is mainly used to make turnover boxes, bottles, etc; Soft PVC is mainly used to make films, bags, etc. In recent years, with the improvement of the quality and grade of drug packaging, a new application space has been opened up for semi-rigid PVC sheets. At present, a large number of PVC sheets are used as blister materials for aluminum-plastic blister packaging of tablets and capsules

3.1.7 polyamide (nylon, Po Lyam IDE) nylon film is a colorless, non-toxic packaging material with good transparency and gloss. Its price is expensive, and its properties mainly include: ① high strength, impact resistance, excellent toughness, tear resistance, folding resistance, and large elongation; ② It has good high and low temperature performance; ③ It can better block oxygen, carbon dioxide and fragrance; ④ Resistant to oil, dilute acid and alkali, with good chemical stability; ⑤ The biggest disadvantage is water absorption, moisture absorption and swelling deformation, poor dimensional stability, and high humidity at high temperature; ⑥ Heat sealing is difficult due to high melting point. Other plastics that can be used in pharmaceutical packaging are polystyrene (PS) and ethylene acetate 11). The service life of the whole machine:> 5 years, such as ethylene ester copolymer (E/VAC), polytetrafluoroethylene (PTFE), polycarbonate (PC), cellulose acetate, polyurethane (PUR), polyvinyl fluoride (PV f), ethylene/vinyl alcohol copolymer (ev0h), etc

3.2 glass packaging

3.2.1 antibiotic powder injection bottles antibiotic powder injection bottles are mainly divided into molding and control. Molded antibiotic bottles are widely used in the packaging of antibiotic powder injections. Controlled antibiotic bottles have gradually replaced ampoules for lyophilizers and partially replaced molded bottles. Improving glass material, increasing bottle strength, improving the stability of specification and size, appearance quality and packaging quality, and developing controlled bottles with low expansion coefficient and printing will become the development direction in the future

3.2.2 water injection packaging water injection packaging mainly uses glass ampoules. The pharmaceutical industry began to force the elimination of non folding ampoules in 1990, so as to avoid the glass particles formed by filing into the liquid medicine during the use of ampoules. It brings great hidden dangers and threats to the drug safety of patients and the use of medical staff

3.2.3 infusion bottle [8] at present, the drug packaging containing infusion agent is still mainly glass infusion bottle. This product is widely used because of its good air tightness, cleanness and transparency, not easy to deteriorate and many other advantages. However, the reuse of glass infusion bottles has become a major problem that threatens people's safe medication. At present, there is a big gap between the manufacturing quality level of domestic infusion bottles and similar international products, mainly in the lightweight, cleanliness, packaging and appearance transparency and uniformity of bottles

3.3 metal packaging

3.3.1 aluminum foil. Aluminum foil is an important packaging material with excellent characteristics. The material is not easy to rust, non-toxic oxide, shading, excellent water and gas barrier, good processing performance, non-magnetic, easy to open, no resilience, large thermal conductivity, shiny appearance, good heat and cold resistance, easy to compound with paper and plastic, and the treated aluminum foil has good ductility. In drug packaging, common packaging forms include aluminum plastic blister packaging, double aluminum foil packaging, and cold stamping packaging

3.3.2 metal hose metal hose is a very attractive container. Its base material is aluminum, which is easy to control the dosage, has good repeated sealing performance, and has sufficient protection for drugs. For example, pastes, gel, creams or ointments with consistency can be easily put into hoses, which are usually made of tin, plastic coated tin, tinned lead, aluminum and coated aluminum

3.4 rubber packaging bottled rubber sealing materials, rubber plugs and gaskets that play a major role in drug packaging. The rubber used is mainly natural rubber and butyl rubber

3.4.1 the former State Drug Administration of natural rubber proposed in the document of gygz [2000] No. 462 in 2000 that all pharmaceutical rubber plugs (including those for infusion, oral liquid and other dosage forms) should be stopped before the end of 2004. The reasons are: ① poor biosafety. Natural rubber is made of latex, of which 5% - 8% are non rubber components, including lipids and their decomposition products, proteins and a small amount of inorganic salts. The existence of some proteins makes rubber easy to absorb moisture and mold. The foreign protein dissolved from natural rubber stopper in drugs is one of the important factors causing human body heat source. ② Its chemical properties are relatively active, and it is easy to react with drugs. ③ Poor air tightness. Natural rubber stopper macromolecules have high flexibility and high diffusivity for various gases, which affects their sealing performance. ④ The use process is complex. The production environment of natural rubber plugs is poor, there is more external pollution, and the composition is more complex. Therefore, before packaging drugs, the pharmaceutical factory must carry out acid-base treatment on the rubber plugs, so as to minimize the pollution of the rubber plugs to the drug solution

3.4.2 butyl rubber is the rubber with the best air tightness, and its heat resistance and ozone oxidation resistance are outstanding. The maximum use temperature can reach 200 OC, which can be exposed to sunlight and air for a long time without damage. It has good chemical corrosivity and is resistant to acid, alkali and polar solvents. At present, China vigorously promotes the use of butyl rubber. In addition, when using butyl rubber plugs, we should pay attention to the drug compatibility from the following aspects: ① the components in the butyl rubber plug formulation system should be as few as possible, the "tolerance parameters" of each component should be as close as possible, and the "concentration gradient" of each component in the rubber plug matrix is small, so that the components in the rubber plug matrix can rarely migrate to the rubber plug surface or be extracted by drugs, so as to reduce the pollution to drugs. ② High purity filler 3 must be selected. It is a precise force to supplement the equipment short plate agent, plasticizer and operating oil. ③ The cleaning process and the degree of silicification also affect the compatibility of butyl rubber plug with drugs. ④ When vulcanizing butyl rubber plugs, excellent vulcanization conditions should be selected to make them in the best vulcanization state, so as to ensure the "barrier" effect of butyl rubber plugs, reduce internal migration and vulcanization residual monomers, so as to avoid polluting drugs. ⑤ The compatibility can be improved by using halogenated butyl rubber with low content. ⑥ Choose the appropriate coating rubber plug. A layer of inert film materials with strong adhesion (such as TEF lon film, fluorination film and poly-p-xylene film) is attached to the butyl rubber plug in contact with the drug through a special spraying process. The barrier effect of the inert film is used to reduce the migration of the destroyed components in the periodic boundary conditions of the butyl rubber plug matrix, so as to improve the compatibility

3.4.3 acrylate rubber (ACM) [9] is a new elastomer obtained by copolymerization of acrylates with different chain length ester groups as the main monomer. The service performance varies with the composition of the monomer. Generally, it has excellent properties such as heat resistance, organic solvent resistance, ozone resistance, heat and oxygen aging resistance and light aging. The excellent performance of acrylate rubber fully conforms to the pharmaceutical industry, and this rubber is safe and harmless to organisms. Acrylate rubber will be widely used in pharmaceutical industry in the near future

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source: Tianjin pharmacy