国产粒料制与进口粒料制聚丙烯输液瓶的质量对比评估初探

李颖, 韩小旭, 袁淑胜, 赵霞, 肖新月

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主办：上海医药工业研究院
　　　中国药学会
　　　中国化学制药工业协会
ISSN 1001-8255   CN 31-1243/R   ZYGZEA
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中国医药工业杂志
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中国医药工业杂志 ›› 2023, Vol. 54 ›› Issue (02) : 259-267. DOI: 10.16522/j.cnki.cjph.2023.02.015
研究论文

国产粒料制与进口粒料制聚丙烯输液瓶的质量对比评估初探

  • 李颖，韩小旭，袁淑胜，赵霞，肖新月
作者信息 +

Preliminary Study on Quality Comparison of Polypropylene Infusion Bottles Made from Domestic Pellets and Imported Pellets

  • LI Ying, HAN Xiaoxu, YUAN Shusheng, ZHAO Xia, XIAO Xinyue
Author information +
History +

摘要

对国家评价性抽检的16 批聚丙烯输液瓶进行细胞毒性、不溶性微粒、易氧化物、正己烷不挥发物、透光率、雾度 以及提取和溶出的有关物质进行检测，以评估国产粒料和进口粒料制聚丙烯输液瓶的质量差异。结果表明，国产粒料和 进口粒料制瓶的易氧化物和不溶性微粒均无显著性差异，正己烷不挥发物含量分别为(118.0±30.7) 和(137.1±48.2)mg。 在抗氧剂和除酸剂的添加量上，国产粒料和进口粒料制聚丙烯输液瓶控制在了相同级别，分别约为0.05％和0.25％。从 小分子挥发物测定结果推测国产粒料和进口粒料使用了相同的聚丙烯聚合催化剂。以现有项目分析，国产粒料制和进口 粒料制聚丙烯输液瓶的质量控制在了相同水平，但后续仍需进一步拓展评价项目以进行更全面的质量对比。

Abstract

In order to evaluate the quality difference between polypropylene infusion bottles made from domestic pellets and imported pellets, sixteen batches of polypropylene infusion bottles sampled for national evaluation were tested for cytotoxicity, insoluble particles, easy oxides, n-hexane non-volatile materials, light transmittance, haze and contents of the related substances from extraction and dissolution. The results showed that there were no significant differences in easy oxides and insoluble particles in the bottles made from domestic pellets and imported pellets, and the contents of n-hexane non-volatile materials in above bottles were(118.0±30.7) and(137.1±48.2)mg, respectively. In terms of the addition amounts of antioxidants and acid scavengers, their contents in the polypropylene infusion bottles made from domestic pellets and imported pellets were controlled at the same level, which were about 0.05％ and 0.25％, respectively. Based on the determination results of small-molecule volatiles, it was speculated that the same polypropylene polymerization catalyst was used in the preparation of domestic pellets and imported pellets. From the analysis of the existing projects, the polypropylene infusion bottles made from domestic pellets and imported pellets had a similar quality level. However, it is still necessary to further expand the eveluation project for a more comprehensive quality comparison.

关键词

聚丙烯输液瓶 / 质量评价 / 药品包装材料

Key words

polypropylene infusion bottle / quality evaluation / pharmaceutical packaging material

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李颖, 韩小旭, 袁淑胜, 赵霞, 肖新月. 国产粒料制与进口粒料制聚丙烯输液瓶的质量对比评估初探. 中国医药工业杂志. 2023, 54(02): 259-267 https://doi.org/10.16522/j.cnki.cjph.2023.02.015
LI Ying, HAN Xiaoxu, YUAN Shusheng, ZHAO Xia, XIAO Xinyue. Preliminary Study on Quality Comparison of Polypropylene Infusion Bottles Made from Domestic Pellets and Imported Pellets. Chinese Journal of Pharmaceuticals. 2023, 54(02): 259-267 https://doi.org/10.16522/j.cnki.cjph.2023.02.015

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