Advantages of butyl rubber bottle stopper for phar

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The traditional way of installing butyl rubber bottle stopper with vertical distance is to replace the traditional butyl rubber bottle stopper (commonly known as the small rubber bottle stopper), which can be installed on the bottle stopper with vertical distance. At present, 90% of pharmaceutical rubber bottle stoppers in the world are made of butyl rubber. Japan eliminated the natural rubber bottle stopper as early as 1965, and the United States, Western Europe and other economically developed countries also realized the butyl of medicinal bottle stopper in the early 1970s. China began the research and development of medicinal butyl rubber stoppers in the 1980s, and it was not mass produced until 1992. In 1995, the former State Administration of Medicine issued "gyzz (95) No. 8, notice on eliminating some natural rubber antibiotic bottle caps". It is now used in some drugs and exported drugs. Although the butyl of medicinal bottle stopper has just started in China, it is a trend. How to speed up the butylation of pharmaceutical corks in China and connect with the international standards as soon as possible is a severe issue facing the whole society, especially the pharmaceutical packaging industry. This paper introduces the advantages of butyl rubber bottle stopper for pharmaceutical packaging. 1、 The drugs encapsulated by the biosafety bottle stopper should enter the human body. Therefore, the medicinal bottle stopper should have no heat source, abnormal toxicity, hemolytic reaction, etc., so as to ensure the safety of medication. Natural rubber is processed from latex collected by rubber rights, mainly including standard rubber and cigarette rubber. Smoke rubber contains 3,4-benzopyrene carcinogen due to the fumigation process. Some biological proteins remain in the processed solid natural rubber. Proteins are active allergic substances, which are prone to mold breeding and harm organisms. The results of artificial accelerated mildewing test showed that under the same test conditions, extremely serious mildewing occurred in natural rubber after only 7 days of culture, while there was no mold breeding in butyl rubber after 21 days of culture. At present, the purpose of adding polyester film to natural rubber input liquid bottle stopper in China is to prevent drug pollution caused by natural rubber bottle stopper. Natural rubber mainly uses sulfur, thiazole accelerators m, DM and thiuram accelerators TMTD as vulcanizing additives. These compounding agents may cause skin allergy, organ tube deformity or cancer. Nitrosamine produced during vulcanization is a carcinogenic hazard. Vulcanized natural rubber increases biological reactivity and blood coagulation. Zinc oxide has an impact on the "cleanliness" of the bottle stopper with a gap of about 0.5mm maintained by natural rubber, especially for the liquid medicine packaging with large pH change. In the packaging of large infusion agent, the small white spots of the bottle stopper treated with acid and alkali are significantly increased, which is the reason. And zinc oxide has sensitivity and incompatibility to some drugs. Butyl rubber can be vulcanized without sulfur and accelerator, or zinc oxide, so that the bottle stopper is sulfur-free and zinc free. Nowadays, the high-quality bottle stopper adopts brominated butyl rubber and polyamine as vulcanizing agent, which has good biosafety. 2、 Air tightness and water absorption: the penetration of gas and water vapor is extremely harmful in the storage process of drugs encapsulated by corks. It is an important reason for the mildew and deterioration of drugs. The permeability coefficient of butyl rubber is 1/20 of that of natural rubber, which has better air tightness than natural rubber. Table 1 shows the comparison of gas permeability coefficient between butyl rubber and natural gas. Table 1 Comparison of gas permeability coefficient between butyl rubber and natural rubber gas butyl rubber natural rubber nitrogen 0.2 6.1 oxygen 1.0 17 Rotor flowmeter or mass flowmeter can be adopted. 7 hydrogen 5.5 37.4 carbon dioxide 3.9 99.6 water vapor 7 100 note: the test condition is 25 ℃ (except that the water vapor is 39 ℃); The unit of air permeability coefficient is · cm-2 · S-1 · PA-1. In addition, the rubber for bottle stopper and its various compounding agents will inevitably leave some impurities in the production and processing process, such as hydrophilic protein and tree finger of natural rubber, which will inevitably cause water absorption. Due to the characteristics of molecular structure, butyl rubber has compact structure, less hydrophilic impurities and low water absorption, which is usually only 1/4 ~ 1/3 of that of natural rubber. According to the national standard of the Soviet Union, the performance of butyl medicine is kept within the range of 72 ℃ and 98% of the natural humidity after three days of storage, which is equivalent to that of the former Soviet Union. (Chinese pharmaceutical market)


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