Discussion on the problems and improvement of drug

Discussion on the problems and improvement of drug inner packaging materials

packaging is an indispensable part of drugs. Only by selecting appropriate packaging materials and packaging methods, can we truly and effectively ensure the quality of drugs and the safety of drug use of the broad masses of the people. With the gradual improvement of China's drug market, the classified management of prescription drugs and over-the-counter drugs has put forward higher requirements for the packaging of drugs. In particular, the implementation of order 6 No. 13 of the State Drug Administration, 5 the management measures for packaging materials and containers in direct contact with drugs, 6 has strengthened the management of drug packaging materials. Now the packaging of drugs should not only protect drugs, but also be convenient for use, storage, transportation, environmental protection, durability Beautiful, easy to identify and other functions

1 concept of drug inner packaging

drug inner packaging refers to the packaging materials and containers directly contacting drugs used by drugs of drug manufacturers and preparations prepared by medical institutions. The inner packaging shall ensure the quality of drugs in the process of production, transportation, storage and use, and be convenient for clinical use

2 commonly used drug inner packaging materials and effectors that allow domestic instruments to match foreign technology to achieve "market for technology"

commonly used drug inner packaging materials and containers can generally be divided into five categories: plastic, glass, rubber, metal and the combination of these materials

3 requirements for the performance of drug inner packaging

there are specific data and technical index requirements for mechanical properties, physical properties, chemical properties, biosafety performance, etc., and there are also requirements for pollution-free, natural decomposition and easy recycling and reprocessing

4 problems of commonly used drug inner packaging materials

4.1 glass

glass is the best container for drug preparations and the most commonly used inner packaging container. It has relatively stable chemical properties, good barrier, low price, beautiful appearance, and plays a role in protecting drugs. Although the stability of general glass is good, the commonly used glass packaging containers are mainly composed of boron and silicon, and the corrosion resistance of borate glass to water and alkaline substances is low. Long term contact between glass and water or alkaline substances, brushing, heating and sterilization can not only make the surface of its inner wall hairy or reduce the transparency, but also hydrolyze the glass and release alkaline substances, impermeable scintillators and granular shedding substances, which directly affect the stability, pH value and clarity of drugs. The glass also contains oxides, which are easy to oxidize or decompose drugs. In addition, the glass container has a large proportion and is easy to be broken, causing inconvenience in handling and transportation, and other injuries after breaking

4.2 plastics

in recent years, more and more pharmaceutical preparations are stored in plastic products. Plastic is a synthetic high molecular polymer, which is light, collision resistant, tough and not easy to break. However, plastics are poor in permeability, moisture permeability, heat resistance, chemical stability, physical stability, etc. in addition, plastic components contain some additives, such as stabilizers, plasticizers, antioxidants, lubricants, fillers, etc. these additives may migrate into the drug solution, and the drugs in the solution can also be adsorbed by plastics, thus affecting the stability of the preparation and the effectiveness of the drug. Therefore, plastic containers should not be used for a long time, especially for drugs with unstable chemical properties. If necessary, physical, chemical, biological toxicity and other experiments should be carried out before using plastic containers to ensure safe use

4.3 metal

aluminum is the most commonly used metal, such as aluminum foil, aluminum hose, aluminum plastic composite pipe, etc. Aluminum material is not rusty, its oxide is non-toxic, good 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 and tightness, which can fully protect drugs. But there are also disadvantages. Aluminum has poor stability, low corrosion resistance and high cost compared with other packaging materials. Drugs that are easy to decompose and deteriorate in the presence of metal ions are not suitable for use

4.4 rubber

most containers packed with rubber gaskets, rubber gaskets or rubber plugs. The rubber used for drug packaging is divided into natural rubber (about to be eliminated) and butyl rubber. These two types of rubber are high score, unless the sample is a large sub polymer, which has good elasticity, and can recover quickly in case of deformation under very large external force, which is easy to clean. However, due to the complex composition of rubber, in the process of use, especially the infusion bottle stopper, it is easy to produce rubber scraps or foreign bodies when the needle penetrates the rubber stopper, which directly threatens people's life safety. In addition, rubber contains heterosexual proteins, which can cause allergic reactions to human body

5 suggestions for the improvement of drug inner packaging materials

to sum up, there are many problems in the current drug inner packaging. With the international operation of pharmaceutical enterprises, it is still necessary to choose high-tech and more ideal drug inner packaging materials. The ideal inner packaging materials should meet the following requirements

5.1 ensure the quality of drugs and the characteristics of drug preparations

the internal packaging of drugs has a great relationship with the stability of drugs. Therefore, different packaging materials should be selected according to the characteristics of drugs and preparations. First of all, it should be effective, safe, stable (physical, chemical, microbial), homogeneous, airtight, pollution-free, not react with packaged drugs, not adsorb drugs, and not change drug performance. In addition, it should have certain strength, heat and cold resistance, light weight, shading, easy cleaning, easy sterilization and disinfection. Different dosage forms of drugs should also have different packaging materials, different packaging forms and packaging specifications

when changing the inner packaging materials and containers of drugs, stability tests should be carried out according to the physical and chemical properties of drugs and the properties of the selected drug packaging materials to investigate the compatibility between the selected materials and drugs. FDA once stipulated that the packaging of drugs must be the standard to maintain the uniformity, efficacy, quality and purity of drugs within the specified shelf life. Therefore, all drug manufacturers must carry out stability tests at all stages of drug preparation development, and all factors related to packaging must be comprehensively investigated

5.2 adaptability during storage and transportation

after production, drugs must pass through the circulation field to reach the hands of patients, and the circulation conditions of various drugs are different, and the selection of drug inner packaging materials should be adapted to the circulation conditions. Circulation conditions include climate, transportation mode, circulation object and circulation cycle, which should adapt to the temperature, humidity and temperature difference of the circulation area, and should also have vibration resistance and fall resistance. There is a problem of the validity period of drugs. The selected drug inner packaging materials should be able to ensure the stability and effectiveness of drug quality within the validity period

5.3 equivalence and beauty of use

although the inner packaging of drugs should be safe and maintain its protective function, due to the different prices of various drugs, their packaging materials should also be of different grades. For expensive drugs or drugs with high added value, packaging materials with high price performance should be selected. Whether the package is beautiful or not will affect the sales and use of drugs to a certain extent. Although China's pharmaceutical packaging materials have changed a lot recently, we should also formulate higher industry standards as soon as possible, stipulate the mandatory testing and mandatory testing methods of pharmaceutical inner packaging materials, have higher performance indicators, and constantly seek new packaging materials

in recent years, in order to speed up the research and development of new packaging materials and strengthen supervision, the State Drug Administration has successively formulated a number of standards for packaging materials and containers in direct contact with drugs, as well as relevant laws, regulations and management methods, in accordance with the relevant provisions on drug packaging in the drug administration law of the people's Republic of China, so as to provide a legal basis for the supervision and management of the production and use of drug packaging, It is of great significance to guide the quality development of pharmaceutical packaging products in China and ensure the safety, effectiveness and convenience of people's medication

source: the display and operation functions of the control panel of Anhui pharmaceutical Anhui Jinchan Pharmaceutical Group Co., Ltd. should be intact, Tong Jingwen, production technology department of the company