复旦大学冯嘉春团队报道了高压灭菌过程中，Ziegler-Natta聚丙烯中两种硬脂酸清除剂向水中迁移行为的比较研究。相关研究成果于2024年10月23日发表在《中国高分子科学杂志》。

尽管Ziegler-Natta （Z-N）聚烯烃已广泛用作药品生产或食品包装的原材料，但酸清除剂（通常引入Z-N聚烯烃中的添加剂）从包装到其内容物的迁移尚未有报道。

该文中，研究人员比较研究了两种最常用的酸清除剂硬脂酸钙（CaSt₂）和硬脂酸锌（ZnSt₂），在121°C高压灭菌过程中从Z-N聚丙烯无规共聚物（PPR）迁移到水中的情形。研究发现，对于含有0.1 wt%CaSt₂或ZnSt₂的PPR板（分别为PPR-0.1CaSt₂、PPR-0.1ZnSt₂），迁移到水中的钙离子浓度随着高压灭菌时间的增加而增加，而锌离子浓度在相同的处理时间内要低得多，并且随着处理时间的推移没有显著增加。

有趣的是，在去除所有板并酸化处理后，PPR-0.1ZnSt₂的灭菌水中检测到大量的硬脂酸，但PPR-0.1CaSt₂的灭菌水中没有检测到如此显著的硬脂酸。基于两种皂在加热过程中的结构演变，提出了CaSt₂和ZnSt₂在高压灭菌处理过程中从PPR向水中迁移行为不同的可能机制。研究结果表明，在由Z-N聚烯烃生产的药品包装材料中，酸清除剂的迁移问题值得关注。

附：英文原文

Title: Comparative Investigation of the Migration Behavior of Two Stearate Acid Scavengers from Ziegler-Natta Polypropylene into Water during Autoclaving Treatment

Author: Xin-Rao Zhang, Fu-Shan Wang, Xin Wang, Yan Gao, Hong-Xing Zhang, Zhi-Qin Liu, Jia-Chun Feng

Issue&Volume: 2024-10-23

Abstract: Although Ziegler-Natta (Z-N) polyolefins have been widely used as raw materials to produce pharmaceutical or food packaging, the migration of acid scavengers, an additive usually introduced in Z-N polyolefins, from the packaging to its contents has not been reported. In this work, the migration of the two most used acid scavengers, calcium stearate (CaSt2) and zinc stearate (ZnSt2), from a Z-N polypropylene random copolymer (PPR) into water during autoclaving at 121 °C were comparatively investigated. It was found that, for PPR plates containing 0.1 wt% CaSt2 or ZnSt2 (PPR-0.1CaSt2, PPR-0.1ZnSt2, respectively), the concentration of migrated calcium ion into water increased with autoclaving time, while that of zinc ion was much lower at same treatment durations and did not show a significant increase with treatment time. Interestingly, after removing all plates and acidification treatment, a considerable amount of stearic acid was detected in sterilized water for PPR-0.1ZnSt2, but no such significant stearic acid was detected in sterilized water for PPR-0.1CaSt2. Based on the structural evolution of the two soaps upon heating, possible mechanisms for the different migration behavior of CaSt2 and ZnSt2 from PPR into water during autoclaving treatment were proposed. Our results suggest that the migration issue of acid scavengers is worthy of attention in pharmaceutical packaging materials produced from Z-N polyolefins.

DOI: 10.1007/s10118-024-3213-6

Source: https://www.cjps.org/en/article/doi/10.1007/s10118-024-3213-6/