Butyl rubber bottle stopper is an upgraded version of pharmaceutical packaging materials, mainly used to replace traditional natural rubber stopper.
Currently about 90% of the world's medicinal rubber bottle stopper is made by butyl rubber as base material. Japan as early as 1965 eliminated natural rubber stopper, the United States, Western Europe and other developed countries in the early 70 s also realized the cork officinal butyl. Began to officinal butyl rubber and putting it in the 80 s in China research and development, mass production until 1992, and in 1995 by the state drug administration issued the "national medicine quality, and the word (95) no. 8, about antibiotics out part of the natural rubber cap notification". Now used in some drugs and exports. Although medicinal butyl cork in our country has just started, but has been in the trend of fashion. How to accelerate the cork officinal butyl, in line with international standards as soon as possible, is facing the whole society especially in the pharmaceutical packaging industry faces severe issue.
The advantage of butyl rubber bottle stopper is introduced:
1. biological safety encapsulated drug by the cork will enter the body, therefore, medicinal bottle stopper should be no heat, no abnormal toxicity, no hemolysis reaction, etc., so as to guarantee the safety of medication. Natural rubber is picked by right of rubber latex after processing, there are mainly standard rubber and rubber smoke. A process rubber with smoked cigarettes, it contains 3, 4 - stupid and pyrene carcinogens. Processed some biological protein residual solid natural rubber in rubber, protein is active allergic material, mold growth phenomenon is seen, the harmful organisms. Artificial accelerated mildew test results show that under the same experimental conditions, the natural rubber only cultivate 7 days would be a very serious phenomenon of mildew, and butyl rubber cultivation 21 days also did not see the mold. At present, the natural rubber liquid of input the cork with polyester film purpose is to prevent the pollution of natural rubber stopper on drugs. Natural rubber mainly adopts sulfur, thiazole accelerator M, DM, thiuram class accelerator TMTD as curing agent, the compound could make the skin allergy, tube malformation or cancer. Sulfide generated when the risk is a kind of carcinogenic nitrosamines. After vulcanization of natural rubber increased biological reactivity and blood coagulability. Zinc oxide "cleanliness" has impact on the natural rubber stopper, especially larger liquid packaging more adverse to the pH change, large infusion solution encapsulation, increase in the number of the cork the white dots obvious after the acid and alkali treatment is caused by this. And zinc oxide and susceptibility to certain drugs have any taboo. Butyl rubber can be achieved without sulfur and sulfide accelerator, also can need not zinc oxide, make cork without sulfur, zinc. Now high-quality cork, used brominated butyl rubber, with multiple amine as curing agent, has good biological safety.
2. air tightness and water after the cork encapsulate drugs, in the process of storage of gases and water vapor infiltration is extremely harmful, it is the important cause of drug gone mouldy. Butyl rubber of the coefficient is 1/20 of the natural rubber, has the natural rubber is more excellent air tightness. Table 1 for the coefficient of butyl rubber with natural gas.