Compound film rubber cork and its preparation method

Abstract

A film covered rubber plug is composed of a rubber plug and a covering high-molecular film chosen from polyethene, polypropene, polyester and polystyrene. Said film has a fusion point close to that of rubber and is directly and physically adhered onto surface of rubber plug without adhesive.

Description

technical field [0001] The invention relates to a medicinal rubber stopper and a preparation method thereof, in particular to a laminated rubber stopper and a preparation method thereof. Background technique [0002] The State Food and Drug Administration Document No. 462 stipulates that from January 1, 2005, all medicine packaging bottles will stop using natural rubber stoppers, and use butyl rubber stoppers or coated or laminated rubber stoppers instead. The reason why the natural rubber stopper was completely eliminated is because of the following shortcomings: 1. The biological safety is poor, and it is easy to absorb moisture and mold; 2. The heterosexual protein dissolved from the natural rubber stopper is one of the important factors that cause the heat source of the human body; 3. The dissolved pyridine compounds are easily carcinogenic, teratogenic and mutagenic; 4. The chemical properties are relatively active, and it is easy to interact with drugs; 5. The air tigh...

AI Technical Summary

Problems solved by technology

The reason why natural rubber plugs have been completely eliminated is because of the following disadvantages: 1. Poor biological safety, easy to absorb moisture and become moldy; 2. The heterosexual protein dissolved from natural rubber plugs is one of the important factors that lead to human heat sources; 3. The dissolved pyridine compounds are easy to cause cancer, teratogenicity and mutagenesis; 4. The chemical properties are relatively active and easy to interact with drugs; 5. The air tightness is poor; it has a high diffusion rate for various gases; 6. , During sterilization, a large number of harmful residual chemical accelerators, vulcanizing agents, heavy metals in auxiliary materials, proteins and other substances migrate concentratedly into the gap above the plug diameter and the cushion membrane, and directly enter the blood vessel and vein after puncture. consciously endanger the patient

Since the safety certification of polyfluorinated materials has not been obtained in my country, polyfluorinated materials have not been approved as inner packaging materials that directly contact drugs, and the tensile testing machine (Shanghai Chemical Machinery No. 4 Factory, XLL-2500N) used to measure Elongation rate The rate of change in elongation is only 5.5%. If the damage rate of the laminated rubber stopper prepared by this method is high

In addition, the process of using plasma to treat the surface of the membrane is complicated and the cost is relatively high, which is not conducive to industrialization.