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Nearly 10 years after the elimination of nature rubber stoppers in 2005, the pharmaceutical rubber stopper industry in China has made considerable progress and made due contributions to the pharmaceutical industry. The variety of medicinal rubber stoppers has also changed greatly, from original halogenated butyl rubber stoppers to the present film-covered rubber stoppers. Although Chinese medicinal rubber stoppers, especially film-covered rubber stoppers, have made great progress in recent years, they still face some practical difficulties in actual production, declaration and use. In order to satisfy the safety of rubber stoppers and film-covered materials, and make the varieties of film-covered rubber stoppers develop healthily, so as to meet the actual needs of the domestic drug market, the application of film-covered rubber stoppers and the safety characteristics of film materials are summarized.

1. The concept of film-covered rubber stoppers

Film-covered rubber stoppers refer to the products of rubber stoppers, such as fluorine-coated rubber stoppers, which have a strong layer, such as film-coated rubber stoppers, on the contact surface between rubber stoppers (bare stoppers) and drugs. The rubber stopper processed by dipping and spraying technology is called film-coated rubber stopper, such as film-coated rubber stoppers processed by polydimethylsiloxane film.

When using ordinary rubber stoppers, the compatibility problems may occur because of the interaction between rubber stoppers and sensitive drugs. By adding a barrier plastic film on the surface of the rubber stopper, the film can shield the contact between the rubber stopper and the drug, which can effectively reduce the absorption, adsorption, leaching and penetration between the rubber stopper and the drug, thereby effectively reducing or delaying the occurrence and development of compatibility problems and improving the long-term stability of the drug.

2. Production and application of film-coated rubber stopper in China and abroad

Overseas, Japan began to produce butyl rubber bottle stoppers in 1957, and developed countries in Europe and America also realized mass production of medicinal butyl rubber bottle stoppers in early 1970. In China, the mass production of medicinal butyl rubber stoppers was not started until 1992. At the same time, the filming technology of butyl rubber stopper has been developed earlier abroad, and the technology is relatively mature. For example, West Pharmaceutical Service in USA, Japan Daxie Nitro Company, Belgium Helvoet Company, etc., all have different specifications of the filmed butyl rubber stopper, and all have the capacity of mass production. As early as the 1980s, Daikyo Seiko first developed the film-covered rubber stopper and applied for a patent. At present, some domestic butyl rubber stopper manufacturers’ technicians, through a large number of experiments, constantly explore and exchange ideas, can also produce a relatively stable quality of film-covered butyl rubber stoppers in batches. Among the 35 kinds of film-covered rubber stoppers approved by the State Bureau, 18 of them adopt fluorine-containing film material, which is the main form of film material used for film-covered rubber stoppers in China at present.