摘要
对聚氯乙烯/聚偏二氯乙烯(PVC/PVDC)固体药用复合硬片中的PVDC涂布量偏差项目的检测中,发现参照国家药包材标准(YBB00222005-2015)无法完成该项目的检测。通过改变浸泡溶剂的温度,发现40℃是分离PVC层和PVDC层的最佳温度,温度过低不能很好分离,温度过高导致溶剂挥发太快。通过空白试验确定该温度不会对PVDC造成影响。说明该方法准确可靠、能够用于药用复合硬片PVDC的分离,进而测定偏差。
In the detection of PVDC coating amount deviation in PVC/PVDC composite sheet for solid pharmaceutical packaging,it was found that the detection of the project could not be completed according to the national drug packaging material standard(YBB00222005-2015).By changing the temperature of soaking solvent,it was found that 40℃was the best temperature for separating PVC layer and PVDC layer.Too low temperature could not separate well,and too high temperature led to the solvent volatilization too fast.The blank test showed that the temperature had no effect on PVDC.The results show that the method is accurate and reliable,and can be used for the separation of PVDC from pharmaceutical composite hard tablets.
作者
张磊
王冬伟
范春来
张静
韩乃水
张鹏
Zhang Lei;Wang Dongwei;Fan Chunlai;Zhang Jing;Han Naishui;Zhang Peng(Shandong medical device quality inspection center,Key Laboratory of drug packaging material quality control of State Drug Administration)
出处
《塑料包装》
CAS
2020年第5期52-55,51,共5页
Plastics Packaging
