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New developments in the field of drug packaging in China (III)

III. infusion packaging

infusion is also called high-volume injection. It is one of the five important dosage forms of drugs in China and is widely used in clinic. In 2001, the domestic infusion output was 2.91 billion bottles (bags), and its packaging materials were glass infusion bottles, PVC and non PVC bottles (bags). At present, about 90% of the large infusion is still packaged in glass infusion bottles

domestic glass infusion bottles are basically made of class II glass without boron or low boron. This kind of product only carries out dealkalization treatment on the inner surface of the bottle, forming a silicon rich layer on the inner surface of the bottle to improve its chemical properties. If the bottle is reused, it is very easy to damage the silicon rich layer on the surface of the glass, resulting in the decline of chemical properties. Therefore, gb2639 glass infusion bottles stipulates that this kind of product should be marked with type II, And only for one-time use. The State Drug Administration has also repeatedly ordered to prohibit the repeated use of such products, and has compulsorily eliminated some unqualified small pharmaceutical factories and hospital preparation rooms through GMP certification

in recent years, the international plastic infusion packaging has been on the rise. Since Tianjin Otsuka company introduced the first plastic bottle production line in the 1980s, plastic packaging infusion has started formal industrial production. The international common infusion plastic packaging can be divided into the following types:

according to the packaging form, it can be divided into bottle type, bag type and non bottle non bag type

divided into PVC and non PVC according to packaging materials. Non PVC includes polyethylene (PE), polypropylene (PP) and composite film/multilayer coextrusion film

according to the statistics of relevant departments, 24 enterprises in China have introduced a total of 29 soft bag production lines, and 19 enterprises have introduced a total of 22 plastic bottle production lines. The design production capacity of all enterprises is 400million bottles (bags), while the actual production capacity is only 130million bottles (bags), accounting for only 5% of the total domestic production capacity of infusion. Therefore, there is still much room for the development of plastic infusion packaging. However, due to the production technology problems or high cost, plastic infusion packaging is not suitable for China's current "low-level and wide coverage" basic medical insurance system, and it is difficult to enter the "reimbursement catalogue of drugs for basic medical insurance", which has been greatly affected. In addition, butyl rubber plugs have been used for large-scale infusion in the world, while natural rubber plugs are still used for most infusion in China. The natural rubber plug is prone to aging, poor air tightness, and chips are easy to fall off during acupuncture. Long term contact with the liquid medicine will cause sedimentation or turbidity of the liquid medicine, which will affect the quality and shelf life of the medicine

large infusion is the most active preparation for drug packaging reform. Plastic infusion packaging has accounted for a large share in the world and is on the rise gradually. However, glass infusion packaging still accounts for a certain proportion due to its good transparency, compatibility and barrier. In particular, glass is still the preferred packaging for high-end drugs and precious drugs in the world. At that time, insiders speculated that infusion packaging was still the first choice

it is reported that at the expert seminar organized by the national pharmacopoeia committee a few days ago, the "red light" was lit on whether the production line of long-term used plastic infusion bags containing polyvinyl chloride (PVC) could be approved again. PVC plastics are widely used in the production of soft infusion bags. When PVC is used in the production of soft infusion bags, a chemical component of phthalate (DEHP) must be added as a softener. As a variety of drugs containing sodium chloride injection and compound chlorine, which greatly expanded the company's business scope, sodium chloride injection and other drugs with relatively stable physical and chemical properties, if DEHP water dissolution can be controlled below 1ppm, generally there will be no unsafe drug use. But more experts believe that DEHP is potentially dangerous to human health. Experts suggest that in order to ensure the safe and effective use of drugs, China's drug regulatory departments at all levels should take positive measures to restrict the use of PVC soft bags, and should not approve new PVC soft bag projects. At the same time, in order to correctly handle the production and clinical use of PVC infusion soft bags that have been or are in progress, warning statements should be marked on the packaging of PVC infusion soft bags to remind medical staff and patients. At the same time, we should further study and observe the safety of PVC infusion soft bags, and use more safe and reliable substitutes to completely replace PVC infusion soft bags when the time is ripe

IV. packaging of oral preparations

oral preparations are divided into solid and liquid. Solid oral preparations are generally western medicine tablets and capsules, and Western medicine tablets are the most diverse and largest selling drug formulations. The proportion of liquid oral preparations, whether therapeutic drugs, health products or nutrient solutions, is increasing

before a large number of plastic packaging, almost all tablets, capsules and oral liquids were packed in glass bottles (large mouth vials for tablets and capsules and small mouth vials for oral liquids). In recent years, with the development of plastic packaging materials, aluminum-plastic blister packaging and other composite materials, the proportion of glass medicine bottles is gradually decreasing, especially for tablet and capsule packaging. Almost all glass medicine bottles have been replaced, but the glass bottle packaging in oral liquid preparations still accounts for a considerable proportion

plastic bottles are the most used packaging containers for oral preparations at present. It is reported that 70% of foreign oral solid preparations are packed in plastic bottles. It is expected that in the future, the packaging of oral preparations will mainly be plastic bottles and aluminum-plastic blisters. Light weight and light proof high-quality glass bottles still have a good development prospect and a large market share in the field of oral liquid packaging

v. medical butyl rubber stopper

medical butyl rubber stopper refers to a stopper made of elastic material of butyl rubber, which is suitable for the sealed packaging and export of antibiotics powder injection, freeze-drying agent, infusion injection and other drugs, and is used together with glass bottles. This kind of product belongs to the packaging material that directly contacts drugs. Compared with natural rubber plugs, this kind of product has the characteristics of good sealing performance, stable chemical performance and biological safety, which has been recognized by the pharmaceutical industry. Internationally, many countries completed the process of replacing natural rubber plugs with butyl rubber plugs in the 1960s and 1970s. The natural rubber plugs are only used for the packaging of veterinary drugs

China began the development and trial use of butyl rubber plugs in the early 1980s. In the 1990s, a complete set of technology and equipment were introduced from abroad. Now, a certain production scale has been formed. However, due to various reasons, natural rubber plugs are still widely used for drug packaging. In order to speed up the process of popularizing the use of butyl rubber plugs, the State Drug Administration issued the notice on strengthening the supervision and management of drug packaging materials by implementing the measures for the administration of drug packaging materials and containers after storing the original data (Provisional) on 8. Driving the precision lead screw pair for experiments in the form of the State Drug Administration note [2000] 462. The notice requires that 13 kinds of antibiotic powder injections, such as columnar leucomycin for injection, which have been announced to prohibit the use of ordinary natural rubber plugs, be stopped from selling and using on july1,2001. Biological products, blood products and freeze-dried antibiotic powder for injection stopped using ordinary natural rubber plugs from january1,2002. All pharmaceutical rubber plugs (including those for infusion, oral liquid and other dosage forms) shall stop using ordinary natural rubber plugs before the end of 2004

in the future, with the implementation of national policies and the strengthening of supervision by competent departments, the development of the pharmaceutical industry and its integration with the international market, the development of the national economy, the enhancement of people's health awareness and the improvement of the quality of life, and the influx of foreign enterprises and products after China's accession to the WTO, this process will be accelerated. It is an inevitable trend for butyl rubber plugs to replace natural rubber plugs in drug packaging

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