Analysis on the current situation of plastics used

2022-08-01
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Analysis on the current situation of plastics used in drug packaging (1)

I. plastics

plastics is one of the main packaging materials, and the history of plastics used in drug packaging is not very long. Many advantages of plastics determine that plastics have played and will play a more important role in drug packaging. These advantages include light weight, fine screw pair transmission, not easy to break, easy to use, gas barrier, easy compounding of different plastics and plastics with other materials, mature molding process, etc

1. Plastic resin

plastic resin is a plastic polymer compound. According to its structure and properties, it can be roughly divided into two categories: hot solid resin and thermoplastic resin. Most of the plastic packaging of drugs use thermoplastic resin

2. Additive

resin is the main component of plastics. It is also necessary to add various additives in the plastic manufacturing process. The additives generally include plasticizers, antioxidants, antistatic agents, lubricants, colorants, heat stabilizers, etc

II. Plastic packaging when using and operating this machine, please 1. Be sure to use the relationship between materials and drugs according to the process specifications in the manual

drugs are a special commodity. As a packaging material (or container) that directly contacts drugs, it must be able to ensure the safety and efficacy of drugs, ensure the stability of drug quality, and meet the convenience needs of patients

the adaptability between plastic packaging materials (containers) and packaged drugs is a problem that must be solved when TPE materials are widely used in the automotive field. Light, heat, humidity, microorganism, oxygen and mechanical impact may all have adverse effects on drug quality. The purpose of packaging is to prevent the above external factors from affecting drug quality to a certain extent. This involves a barrier problem, including the barrier to light, microorganisms and gases. The purpose of making plastic bottles into brown yellow or white bottles with titanium dioxide is to block light. Aluminum foil in the composite film not only greatly improves the gas barrier, but also completely blocks the light

the solid base materials of drugs are generally loose materials, so they are processed into tablets, capsules and other preparations for taking. Many drugs are crystalline or amorphous powders before they are made into tablets and capsules, which are easy to hygroscopic deliquescence. Solid preparations are susceptible to the influence of water vapor and oxygen to varying degrees during storage. Reduce the content, change the release degree, etc

at present, solid oral preparations are packed in multi-purpose bottles (mostly plastic bottles), blister packaging, strip packaging and other forms. For plastic bottles, in addition to material selection, they must have a certain thickness and thickness uniformity, and the bottle mouth has good sealing performance. For blister packaging, the formed hard piece must have a certain thickness. If the PVC hard sheet fails to meet the temperature resistance requirements, pet hard sheet or pvc/pvdc composite hard sheet can be used. The other layer of blister packaging is aluminum foil for drug packaging. The quality of the original foil used is good. It is generally considered that there is no pinhole when the thickness is more than 0.025mm. All kinds of composite films used in strip packaging should be carefully selected according to the characteristics of drugs. The packaging of liquid oral liquid is still mainly made of glass bottles and plastic bottles. The plastic bottle of oral liquid is generally made of PP or pet, which can provide sufficient mechanical strength, avoid mechanical damage, and provide certain gas barrier and microbial barrier. Among them, PET bottles are better. The flavor of syrup oral liquid packed in the bottle will not be lost through the bottle wall

migration is another problem involved in drug packaging materials. This kind of migration is often a two-way migration. The possible migration from plastics to packaged drugs includes various functional additives such as monomers and plasticizers, residual solvents, etc. The migration of the preparation to plastics may cause flavor defects, loss of preservatives and affect the stability, and the migration of the effective ingredients of the drug may cause the content to decline, etc. In order to ensure the safety of drug packaging materials and containers, quality standards have been formulated at home and abroad. There are also many provisions in the Pharmacopoeia, which not only stipulate the gas permeability and sealing, but also restrict the substances that may migrate and be toxic to the body. Such as the amount of heavy metals, water-soluble, alcohol soluble and ester soluble substances, and the abnormal toxicity of plastics

III. common plastics for drug packaging

(1) polyethylene plastic

polyethylene is polymerized from ethylene monomer. It is the general name of ethylene polymer compounds. Polyethylene resin is generally colorless, odorless, non-toxic, with small water absorption and strong cold resistance. It is the most commonly used plastic in the packaging of oral drugs. According to the density of polyethylene raw materials, there are three kinds of density: high, medium and low. Low density polyethylene is the first generation product, which is characterized by softness, good low temperature resistance and good heat sealing performance. However, the strength is relatively low. Once a serious fire hazard is exposed, the needle resistance and oil resistance are poor. It is often used as the inner sealing layer in the composite film for SP packaging

high density polyethylene is the second generation polyethylene. Like LDPE, it has good chemical stability, cold resistance, wear resistance and moisture resistance. It has higher strength than low-density polyethylene and slightly better oil resistance. Medical plastic bottles are generally made of high-density polyethylene. Due to poor odor resistance and oil resistance of polyethylene, plastic bottles made of HDPE are generally not suitable for storing aromatic and greasy drugs. It is also not easy to store drugs that are particularly sensitive to oxygen or water vapor

even if there is monomer migration in polyethylene, there is no safety problem. As long as the variety and quantity of additives used are controlled, there is no problem in safety

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