药用级硅胶管相容性试验研究

Compatibility Test Research of Medical Grade Silicone Tube

目的采用不同缓冲液对圣戈班Sani-Tech STHT-C药用硅胶管进行浸提,为硅胶管使用的安全性提供支持。方法参考《中国药典》2010年版3部、《欧洲药典》8.0版3.1.9、JP59 TEST for Rubber Closure for Aqueous Infusions、USP(87)、USP(88)、USP(231)、USP(381)。结果与结论圣戈班Sani-Tech STHT-C药用硅胶管浸提试验结果良好,相容性结果可接受,为制药企业选择圣戈班Sani-Tech STHT-C硅胶管提供参考。

OBJECTIVE In different buffer to saint-gobain Sani-Tech STHT-c medicinal leaching of silicone pipe,to evaluate the biocompatibility of silicone tube. METHODS Refer to the ＂Chinese pharmacopoeia＂2010 edition 3 department,the European pharmacopoeia 8. 0 3. 1. 9,JP59 TEST for Rubber Closure for Aqueous Infusions,USP（ 87）,USP（ 88）,USP（ 231）,USP（ 381） method. RESULTS and CONCLUSION The extract inspection results in accordance with relevant rules and regulations.