Butyl rubber stopper is widely used in primary packaging of various therapeutic materials. The butyl rubber stopper has the advantages of good air tightness, good heat resistance, good acid and alkaline resistance, and high internal cleanliness. The development trend of butyl rubber stopper is mainly shown in the following aspects.

1. Optimize the rubber stopper formula and develop ultra pure rubber stopper. The formulation of halogenated butyl rubber stopper is the key factor to determine its quality. In order to reduce the safety risk caused by rubber stopper, the components in the formulation system of butyl rubber stopper should be as few as possible

2. Improve the rubber plug production process, including improving the cleaning process, optimizing the silicification process and developing non silicified rubber plugs.

3. Develop covering rubber plug. Applying a layer of diaphragm on the surface of the rubber plug can effectively reduce the interaction between the rubber plug and the therapeutic agent and improve the long-term stability of the therapeutic agent.

Strategy for selecting butyl rubber stopper:

1. Butyl rubber stoppers meeting various quality standards shall be selected for packaging.

2. For the solution dosage form of protein therapeutics, the surface adsorption of active ingredients and rubber plug extracts shall be considered first.

3. For the freeze-dried dosage form of protein therapeutic substances, attention should be paid to the residual water and oxygen content indicators in the rubber stopper. During the storage of this type of dosage form, the moisture and oxygen content in the preparation have an important influence on the stability.

4. Pay attention to the coordination study of different packaging components. After selecting the packaging components of each part, it is also important to investigate the compatibility of the entire packaging system with the therapeutic substance.