The hottest new developments in the field of pharm

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

Article 52 of the drug administration law of the people's Republic of China clearly stipulates that "packaging materials and containers in direct contact with drugs must meet the pharmaceutical requirements, meet the standards to ensure human health and safety, and be approved by the drug regulatory department when approving drugs. Drug manufacturers shall not use unapproved packaging materials and containers in direct contact with drugs."

as an integral part of drugs, drug packaging is receiving more and more attention. In the international developed countries, various packaging materials and packaging methods are constantly developing and changing. Drug packaging accounts for 30% of the value of drugs, while the proportion in China is only about 10%. After joining the WTO, more international pharmaceutical enterprises will enter China, which will not only intensify the competition in China's pharmaceutical industry, but also have a huge impact on the domestic pharmaceutical packaging industry. The next five years will be a critical period for the rapid development of pharmaceutical packaging in China. Whether it is the packaging of powder injection, water injection, tablet, oral liquid, or large infusion, all kinds of packaging materials and packaging methods will replace and compete with each other in the field of pharmaceutical packaging with their unique performance and advantages. All kinds of more safe, effective, convenient and novel packaging materials and packaging methods will continue to improve and bring forth the new with the rapid development of the pharmaceutical industry

I. antibiotic powder injection packaging (including biological, biochemical and freeze-dried powder injections) our city insists on taking innovation as the source of vitality and accelerator for the development of aluminum industry

this kind of dosage form is mainly antibiotic drugs, and it is also one of the five dosage forms of drugs in China. In 2000, the domestic output was about 13billion bottles, with an annual increase of 10%. It is estimated that it will reach 21billion bottles in 2010. Its main packaging materials are molded and controlled injection glass bottles. At present, the glass bottles used for the packaging of this kind of drugs in China are basically ordinary sodium calcium glass (i.e. class II glass) with surface dealkylation treatment, as well as domestic neutral glass with low boron. Due to the limitations of materials and properties, they can only be used for the packaging of ordinary antibiotic powder injections. Internationally, such products are divided into two categories: one is class II glass with surface treatment, and the other is international neutral glass (i.e. class I glass). With the integration of the international market and the upgrading of antibiotic drugs, this kind of packaging products has become a major development trend

-- the development of glass materials to international neutral glass, i.e. class I glass

international neutral class I glass is the development direction of pharmaceutical glass materials, especially for the packaging of freeze-drying agents, biological agents, new drugs, special drugs and other drugs

-- controlled injection bottles will show an increasing trend

in the packaging of antibiotic powder injection, the specific weight of molded injection bottles reaches more than 70%. In the future, the dosage of controlled injection bottles will increase, and the proportion of high-quality controlled injection bottles that avoid light and print will increase, and will partially replace molded injection bottles. However, the lightweight, light proof and high-quality molded injection bottle still has a certain space

-- quantitative trend of large doses of packaging

most penicillin antibiotics in China are 800000 units, which are packed in conventional 5ml and 7ml bottles. With the changes of various new and special drugs and people's medication habits, the consumption of large-size glass bottles will gradually increase, and the number of glass bottles with a specification of more than 20ml will greatly increase. It is reported that North China pharmaceutical factory, the largest antibiotic powder injection production base in China, has introduced 8million units of penicillin sodium to the market

-- silicified coating injection glass bottle

silicified coating bottle is a new product developed and put into use internationally in recent years. This product uses non-toxic inert materials to treat the inner surface of the bottle to form surface hydrophobicity, which significantly reduces the precipitation of sodium ions. This characteristic of physical and chemical properties makes the liquid medicine not stick to the bottle wall like mercury, and a small amount of residual liquid medicine exists in bead form, which is easy to extract. According to the experimental calculation, the residue of ordinary bottles accounts for 2 ~ 5% of the liquid medicine, which can provide more opportunities for the non-metallic industry, while the silicified coated bottles account for only 0.02 ~ 0.1%. For valuable drugs such as biological agents, genetic agents, hormonal agents, suspensions, etc., silicified coated bottles can maximize the amount of use. For the suspension, the suspended powder particles do not adhere to the bottle wall because they shrink with the liquid. Therefore, silicified coated bottles will be widely used in valuable drugs, suspension drug preparations and blood preparations

due to the physical and chemical properties of glass, with the maturity of technology, the stability of quality, good shielding effect and better sensory characteristics. At present, other materials have not been involved in this field in the packaging of powder injection drugs. It is reported that a material called COC is being tested internationally. It is a cyclic olefin polymer. The biggest difference between COC and ordinary plastic materials is that the chemical chain of COC material is circular, while the chemical chain of ordinary PP or PE is linear. Due to the particularity of its structure, this material has special properties different from general plastics, such as transparency, heat resistance, acid and alkali resistance, high strength and so on. However, the related research on this kind of materials and their uses and the long-term test of the performance of the trial products have not ended