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| 不同氧化锌在药用CIIR胶塞中应用的等同性研究 |
| Equivalence Study of Different Zinc Oxides in Pharmaceutical CIIR Stoppers |
| Received:February 18, 2022 Revised:February 18, 2022 |
| DOI：10.12137/j.issn.2095-5448.2022.12.0595 |
| 中文关键词: 氧化锌；药用胶塞；氯化丁基橡胶；替代；等同性；元素；理化性能 |
| 英文关键词: zinc oxide;medicinal chlorobutyl rubber stopper;equivalence;element;physical and chemical properties |
| 基金项目: |
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| Author Name | Affiliation | E-mail | | WANG Diandian* | Jiangsu Hualan New Pharmaceutical Material Co.,Ltd. | wangdd@hlnpm.com | | WANG Yueyue | Jiangsu Hualan New Pharmaceutical Material Co.,Ltd. | | | XU Jianming | Jiangsu Hualan New Pharmaceutical Material Co.,Ltd. | | | ZHU Yinhua | Jiangsu Hualan New Pharmaceutical Material Co.,Ltd. | | | Huayimin | Jiangsu Hualan New Pharmaceutical Material Co.,Ltd. | |
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| 中文摘要: |
| 研究使用2个厂家氧化锌的药用氯化丁基橡胶（CIIR）胶塞各项性能的等同性。结果表明：2种氧化锌的分散性好，且表面元素组成及各元素分布规律一致；2种氧化锌填充CIIR胶料的硫化特性相当，物理性能可视为等同且均符合技术要求；采用2种氧化锌制备的药用CIIR胶塞的理化性能均符合YBB00052005—2015要求且有化学等同的提取物谱；2种氧化锌应用于药用CIIR胶塞中的质量属性等同，胶塞的适用性均可接受。 |
| 英文摘要: |
| The equivalence of various properties of zinc oxides produced by two manufacturers in pharmaceutical chlorobutyl rubber（CIIR） stoppers were studied. The results showed that the two kinds of zinc oxides had good dispersibility，and the composition and distribution of elements on the surface were consistent. The vulcanization characteristics of the two zinc oxide filled compounds were equivalent，and the physical properties were deemed equivalent and met the technical requirements. The physical and chemical properties of the two CIIR stoppers prepared with two zinc oxides met the YBB0002005—2015 standard and had chemically equivalent extract spectra. The quality attributes of the two zinc oxides used in pharmaceutical CIIR stoppers were equivalent，and their applicability was acceptable. |
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