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

packaging refers to the container that holds and protects products. It plays an important role in maintaining product quality, reducing consumption, facilitating transportation, storage, sales, beautifying goods and improving service quality. The packaging mentioned herein refers to the packaging materials and containers that directly contact the drugs

the drug packaging is different from the packaging of general articles. The drug packaging is restricted by the inherent nature of the drug, that is, it is necessary to maintain the efficiency of the drug, improve the stability of the drug, delay the deterioration of the drug, ensure safety and health, and prevent decomposition and deterioration caused by moisture absorption, air leakage and light. Therefore, drug packaging is the guarantee to maintain the nature of drugs and the correct use of drugs. The qualified drug packaging shall have the characteristics of sealing, stability, portability, beauty, appropriate specification, standardized, reasonable and clear package identification, and meet the requirements of all links of drug circulation, storage and application. Drug packaging is also an important index for evaluating drug quality

1 the development of drug packaging in China [1]

drug packaging in China has experienced three stages. The first stage was in the 1950s and 1960s, such as brown glass bottles, straw cartons, straight necked ampoules and other drug packaging, based on the principle of practicality

the second stage was in the early 1970s and 1980s. This stage was in the state of adjusting and wandering the influence of Chinese construction machinery enterprises in the global construction machinery property

since 1980s, it is the third stage. After years of running in, the pharmaceutical packaging industry has developed healthily. In terms of packaging form, in addition to tablets, powders, pills, creams, water, needles and powders, we have also developed packaging suitable for suppositories, oral liquids, aerosols, capsules, patches, chewing agents and other dosage forms. In terms of materials, aluminum plastic, paper plastic, laser anti-counterfeiting and other composite materials are gradually popularized

2 particularity of drug packaging materials

2.1 safety [2]

2.1.1 packaging materials and Toray announced that the packaging materials in direct contact with drugs for general use play an important role in ensuring drug stability, thus directly affecting drug safety. Unsuitable materials can cause the migration, adsorption, adsorption, or even chemical reaction of active drug components, resulting in drug failure, and sometimes serious toxic and side effects. Therefore, before selecting the container material for any drug, it must be tested to confirm that it is suitable for the intended use, and its impact on the stability of the drug must be fully evaluated. The protective effect of the container on the drug under different environmental conditions (such as temperature, humidity, light, etc.) during long-term storage must be evaluated. When evaluating a drug, the China food and Drug Administration [3] and the U.S. FDA require that the packaging used for the drug can ensure the stability of its efficacy throughout its service life. In the process of new drug research, the preparation should be placed in the marketing package for stability inspection

2.1.2 selection of packaging materials it is a very important work in the pharmaceutical industry to select appropriate packaging materials to protect the integrity of drug quality. The container materials used for drug packaging are mostly glass, metal, plastic and rubber. These materials have different characteristics, and appropriate categories must be selected in combination with the physical and chemical properties of the drugs to protect the drugs from the impact of environmental conditions, and do not react with the drugs. At the same time, the drugs do not have a polluting taste and are non-toxic

2.2 adaptability of packaging materials [4] the selection of adaptability of drug packaging materials and the design of packaging directly affect the overall quality of drugs

2.2.1 the packaging of solid preparations, tablets and capsules, now tend to be packaged with plastic aluminum foil or aluminum foil. The utility model has the advantages of light weight, convenient use, less pollution and easy deployment. However, the aluminum-plastic packaging has certain moisture permeability and air permeability, and the medicine is easy to absorb moisture and deliquesce. Aluminum foil aluminum foil plate packaging can block light, and the storage time is relatively long. For example, if the materials of the polar conductor exposed in the air for a long time determine that the DC resistance of the conductor is prone to deliquescence, weathering and oxidation discoloration, such as compound licorice tablets, aminophylline tablets, ferrous sulfate tablets, etc., if the pharmacy distributes them to patients in paper bags, the drugs are prone to deterioration. If a single dose of aluminum foil is directly delivered to the patient, it can not only ensure the quality of drugs, but also reduce the pollution during sub packaging and facilitate deployment. Some drugs packed in plastic bottles are easy to absorb moisture and deteriorate. For example, antavisol tablets and vitamin B1 tablets should be packed in glass bottles. Drugs that need to be stored in a dark place should not be packed in aluminum-plastic packaging. For example, tinidazole tablets can be transparent in aluminum-plastic packaging. Once the outer packaging is removed, it is easy to change color. It is better to pack them in aluminum foil. Granules and suspensions are usually packaged in single dose aluminum-plastic bags, that is, the inner layer is aluminum foil, and the outer layer is composite film, such as xishumi, which has the advantages of not easy moisture absorption, not easy to break, and easy to tear

2.2.2 nowadays, the oral liquid preparations are mostly packaged in single dose vials with easy to pull lids, which are easy to use and not easy to pollute, and the oral liquid bottles with measuring cups are also very convenient to use. But for children, antipyretics are different. For example, if the loading capacity is 60 ml, some of them can reduce the fever after one to two times of use, and the remaining solution has to be discarded after a long time, so it is more suitable to make it into a single dose packaging

2.2.3 packaging of injection and large infusion [5] easy to break ampoules are fully used for injection, which greatly facilitates clinical application. However, the printing on the glass ampoule is not clear and is easy to be erased. Such as the application of polyester self-adhesive label can solve this problem. Most imported and joint-venture drugs (such as phentolamine and carnitine) use this label. The original glass bottle packaging for large infusion is developing into the disposable polypropylene plastic bottle packaging. The advantages are convenient, light, not easy to break, easy to transport and store, no pollution, stable infusion quality, and storage time up to 5 years

2.2.4 other types of preparations containing mineral oil, vegetable oil, some oil soluble solutions and external tinctures should not be contained in polyethylene plastic bottles. Because it can dissolve ethylene monomer, it is potentially harmful to human body

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information source: Tianjin pharmacy

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