| 孟伟娟,邱迎昕,齐宇虹,俞培富,邓征威.国内外医用溴化丁基橡胶塞产业的发展现状[J].橡胶科技,2022,20(4):0161-0165. |
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| 国内外医用溴化丁基橡胶塞产业的发展现状 |
| Development Status of Pharmaceutical Brominated Butyl Rubber Stoppers Industry at Home and Abroad |
| 投稿时间：2021-08-02 修订日期：2021-08-02 |
| DOI：10.12137/j.issn.2095-5448.2022.04.0161 |
| 中文关键词: 溴化丁基橡胶 药品包装材料 医用胶塞 关联审评审批制 特种橡胶制品 |
| 英文关键词: BIIR drug packing material pharmaceutical rubber stopper bundling review special rubber product |
| 基金项目: |
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| 摘要点击次数: 3047 |
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| 中文摘要: |
| 介绍国内外与药包材有关的监管备案制度，以及医用胶塞产业发展情况和医用溴化丁基橡胶（BIIR）供应情况。我国医用胶塞行业集中度低，国产医用胶塞配方技术、产品质量及其与药品匹配度以及高端产品供应能力与国际知名企业仍有明显差距，药包材与药品关联审评审批制的实施将推动医用胶塞行业向规模化和集中化方向发展。我国BIIR生产企业需要针对医用胶塞的特殊应用需求开发出专用产品，并与胶塞和制药企业密切合作，推进国产原料医用胶塞与药品的相容性和安全性评价研究工作，逐步扩大国产原材料在医用胶塞领域中的应用。 |
| 英文摘要: |
| The systems for drug supervision and keeping records at home and abroad which was relevant to drug packing materials were introduced.Development status of pharmaceutical butyl rubber stoppers industry and supply of brominated butyl rubber（BIIR） for medical application were summarized also.Industry concentration of pharmaceutical rubber stoppers in China was low，and the gaps in stopper formula technology，quality and its compatibility with drugs，market supply of high-end products were still obvious compared with international well-known enterprises.The industry of pharmaceutical rubber stoppers will develop in the direction of large-scale and centralization under the conditions of bundling review and approval system of drug and its packing materials.Special product should be developed by domestic BIIR producers according to the special application needs of pharmaceutical rubber stoppers，and close cooperation should be established between domestic material producers with rubber stopper and pharmaceutical enterprises.Then the compatibility and safety tests between the pharmaceutical rubber stoppers made of indigenous material with drugs should be researched deeply based on mutual cooperations，and indigenous material of BIIR will be put into use in pharmaceutical rubber stoppers increasingly. |
| Author Name | Affiliation | E-mail | | MENG Weijuan | National Engineering Research Center for Synthesis of Novel Rubber and Plastic Materials,Yanshan Branch,Beijing Research Institute of Chemical Industry,SINOPEC | mengwj.bjhy@sinopec.con | | QIU Yingxin | National Engineering Research Center for Synthesis of Novel Rubber and Plastic Materials,Yanshan Branch,Beijing Research Institute of Chemical Industry,SINOPEC | qiuyingxin.bjhy@sinopec.com | | QI Yuhong | High-Tech Company Limited,Yanshan Petrochemical Company,SINOPEC | | | YU Peifu | High-Tech Company Limited,Yanshan Petrochemical Company,SINOPEC | | | DENG Zhengwei | Synthetic Rubber Department,Yanshan Petrochemical Company,SINOPEC | |
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