中国血液净化

中国血液净化 ›› 2013, Vol. 12 ›› Issue (10): 570-575.

• 基础研究 • 上一篇    下一篇

聚对苯二甲酸乙二醇酯（PET）桶用于血液透析浓缩液包装的适用性评价

杨正根,周彤,余波光,张小明,邓娟,陈校园   

  1. 广州康盛生物科技有限公司
  • 收稿日期:2013-05-07 修回日期:2013-08-26 出版日期:2013-10-12 发布日期:2013-10-12
  • 通讯作者: 陈校园 E-mail:chenxy@konce.com

Evaluation on the Applicability of Poly (ethylene terephthalate) (PET) Barrels for Hemodialysis Concentrates Packaging

  • Received:2013-05-07 Revised:2013-08-26 Online:2013-10-12 Published:2013-10-12

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摘要： 目的 探讨聚对苯二甲酸乙二醇酯（PET）桶用于血液透析浓缩液包装的适用性。方法 按照《口服液体药用聚酯瓶》和相关标准评价PET桶用于血液透析浓缩液包装的适用性。结果PET桶的理化性能测试和血液透析浓缩液浸提后的溶出物试验表明，PET桶的理化性能和溶出物符合标准要求。以醋酸溶液（pH=2）浸提液后的锑浓度为0.093μg/ml，折算为5L A浓缩液中迁移出来的锑为47.7μg。按正常透析（稀释35倍，透析5小时，用量4.28L）计算，单次透析时透析液中锑含量为40.8μg，远低于按WHO规定的6μg/kg日耐受摄入量计算的60kg成人日耐受量（360μg/天）。生物学评价结果显示，PET桶材料无体外细胞毒性，皮肤致敏反应为阴性，且无皮内反应。堆码模拟过程中没有出现PET桶或外包装纸箱变形，破裂和倒塌的现象。结论 试验结果表明，所有试验结果均满足相应标准或应用要求，PET可用于血液透析浓缩液的包装。

关键词: 聚对苯二甲酸乙二醇酯（PET）, 浓缩液, 包装, 适用性

Abstract: To explore the applicability of poly (ethylene terephthalate) (PET) barrels for hemodialysis concentrates packaging. Methods To evaluate the applicability of PET barrels for hemodialysis concetrates packaging according to the Polyester Bottles for Oral Liquid Medicine and relevant standards. Results Physical and chemical properties tests and extraction test with hemodialysis concentrates as extraction medium indicated that the physical and chemical properties and extractables of PET barrels well met requirements of the standard. Antimony levels of the extracts using acetic acid solution (pH=2) as extraction medium was 0.093μg/ml, which equals to 47.7μg of antimony in a 5L of A concentrate. When calculated with a dilution by a factor of 35 for concentrate A and for a dialysis duration of five hours, then the amount of concentrate A used for a single hemodialysis treatment is 4.28L, and the maximum antimony in the hemodialysis concentrate for a single hemodialysis course would be 40.8μg, which is far below the Daily Tolerable Intake for adults (60kg) of 360μg calculated with the Daily Tolerable Intake of 6μg/kg specified by WHO. Biological evaluation tests results revealed that, the PET barrel material showed no in vitro cytotoxicity, negative skin sensitization reaction, and no intradermal reaction. The stacking simulation tests showed no deformation, fracture or collapse of the PET barrels which contained hemodilaysis concentrates. Conclusion The results showed that all tests well complied with requirements of appropriate standards or application requirements, and that the PET barrels can be used for hemodialysis concentrates packaging.

Key words: Poly (ethylene terephthalate) (PET), Hemodialysis concentrates, Packaging, Applicability