| 不同灭菌方式对预灌封注射器用橡胶活塞性能影响的研究 |
| Effect of Different Sterilization Methods on Properties of Rubber Plungers for Prefilled Syringe |
| 投稿时间：2020-08-11 修订日期：2020-08-11 |
| DOI：10.12136/j.issn.1000-890X.2022.03.0218 |
| 中文关键词: 溴化丁基橡胶 溴化异丁烯-对甲基苯乙烯共聚物 橡胶活塞 预灌封注射器 高压蒸汽灭菌 γ射线辐照灭菌 |
| 英文关键词: BIIR BIMSM rubber plunger prefilled syringe high-pressure steam sterilization γ ray radiation sterilization |
| 基金项目: |
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| 中文摘要: |
| 分别采用溴化丁基橡胶（BIIR）和溴化异丁烯-对甲基苯乙烯共聚物（BIMSM）为主体材料，按照适当配方制备
两种硫化胶及预灌封注射器用橡胶活塞，研究高压蒸汽灭菌和γ射线辐照灭菌对BIIR和BIMSM硫化胶及活塞性能的影
响。结果表明：经两种方式灭菌后，BIIR和BIMSM硫化胶都具有良好的物理性能，BIMSM硫化胶的耐高压蒸汽和耐辐
照性能优于BIIR硫化胶；BIIR活塞在高压蒸汽灭菌后180 d内及在40 kGy辐照剂量γ射线辐照灭菌后零时刻的理化性能
均满足YBB 00082004—2015的要求。BIMSM是制备预灌封注射器用橡胶活塞的一种更好的主体材料。 |
| 英文摘要: |
| Using brominated butyl rubber（BIIR） and brominated poly（isobutylene-co-p-methylstyrene）
（BIMSM） as the main materials，two kinds of vulcanizates and rubber plungers for prefilled syringe were
prepared according to appropriate formulas. The Effects of high-pressure steam sterilization and γ ray
radiation sterilization on the properties of BIIR and BIMSM vulcanizates and plungers were studied. The
results showed that，BIIR and BIMSM vulcanizates both had good physical properties after sterilization by the
two methods，and the high-pressure steam resistance and the radiation resistance of the BIMSM vulcanizate
were better than those of the BIIR vulcanizate. Within 180 days after high-pressure steam sterilization，the
physical and chemical properties of BIIR plungers met the requirements of YBB 00082004—2015. It was
found that right after the 40 kGy dose γ ray radiation sterilization，the properties of BIIR plungers also met
the requirements of YBB 00082004—2015. BIMSM was a better main material for making rubber plungers
for prefilled syringe. |
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