非PVC多层共挤膜输液袋及玻璃瓶与大容量注射剂相容性研究Study of Non-PVC officinal compounding velamen and glass bottle with transfuse of compatibility
陈吉生,杨泽民,杨爱群
CHEN Ji sheng;YANG Ze ming; YANG Ai qun Guangzhou Railway Central Hospital, GuangDong Guangzhou 510080
摘要(Abstract)：
目的 研究非PVC多层共挤膜输液袋及玻璃瓶与大容量注射剂的相容性。方法 配制12种大容量注射剂各3批,分别用非PVC多层共挤膜输液袋及玻璃瓶分装,按照不同的检测指标分别测定半成品、成品及留样6个月的样品,以半成品为对照,比较成品各指标的变化;以成品为对照,比较留样6个月后样品各指标的变化情况,并进行统计学分析(t检验)。结果 2种包装材料经115℃,40min灭菌后,在12种大容量注射剂中稳定性良好,检测指标没有显著性差异(P>0.05);经留样6个月后,2种材料的各个检测指标与成品相比均没有显著性差异(P>0.05);各种指标变化情况,非PVC多层共挤膜输液袋与玻璃瓶接近。结论 非PVC多层共挤膜输液袋及玻璃瓶与大容量注射剂相容性良好,经高温灭菌后没有相关物质析出。
Objective To study Non-PVC officinal compounding velamen and glass bottle with transfuse of compatibility. Method
Twelve species transfuse were prepared and to fill in Non-PVC officinal compounding velamen and glass bottle. Detect the markers in
the semi-manufactured product, finished product and were stayed six months samples. Detect the markers in the finished product com-
parative on the semi-manufactured product, in the stayed six mouths samples comparative on the finished product,and put up statistics
analyse(t tests). Results Two packing material after 115℃ and 40 min antisepsis, good stability in the twelve species transfuse, de-
tect the markers no significant than semi-manufactured product(P>0.05). The samples wer stayed six months no significant than fin-
ished product(P>0.05). Conclusion Non-PVC officinal compounding velamen and glass bottle have a good compatibility in the
transfuse, after hight temperature antisepsis no relative substance separate out.
关键词(KeyWords)：
大容量注射剂;非PVC多层共挤膜;玻璃瓶;相容性
transfuse;Non-PVC officinal compounding velamen;glass bottle;compatibility
基金项目(Foundation):
作者(Authors):
陈吉生,杨泽民,杨爱群
CHEN Ji sheng;YANG Ze ming; YANG Ai qun Guangzhou Railway Central Hospital, GuangDong Guangzhou 510080
参考文献(References)：
- [1] 董志森.Clear-flex复合膜软袋-世界最新的输液制剂包装技术[J].上海医药.1996,153(2) :34
- [2] 杨泽民,陈吉生,冯瑞智,等.非PVC多层共挤膜输液袋的研制及质量标准[J].中国药房,2003,14(7) :395．
- [3] 中华人民共和国卫生部药典委员会.中华人民共和国药典二部附录[S].2000年版(附录69) .北京化学工业出版社,广东科技出版社.
- [4] 高玉成,曲丹丹.注射液中不溶性微粒检查初探.药物分析杂志.1997． 17(3) :208
- [5] Lakshimi S, Jayakrishnan A. Migration resistant, bloodcompatible plasticized PVC for medical and related applications[J].Artificial Organs. 1998,22 (3) :222．