Influence of direct contact method and extract method on the hemolytic effect of drug PacKaging materials Biomaterials
ZHAO Zeng-lin
HOU Li
QIAO Chun-xia
LIN Zhen-hua
Abstract：OBjective Toevaluatedrugpackagingmaterialsbyusingtwohemolysismethods,directcontactmethod and extract method. The two methods were compared in the sensitivity to detect drug packaging materials. Methods 11 kinds of typical drug packaging materials were selected and their hemolytic properties were detected by direct contact meth-od and extract method. The results of hemolysis in the two methods were compared. Results The hemolysis rate of extract method was higher than the hemolysis rate of direct contact method. The hemolysis rate of two methods were both conformed to the regulations. Moreover,there was no significant difference of the direct contact method and extract method( P ﹥0. 05). Conclusion Both of direct contact method and extract method can be used to the detection of drug packaging mate-rials. It was an exploration that the extract method which was used to detect the hemolysis of drug packaging materials. This method was more consistent with the clinical characteristics. So the extract method should be added in the hemolytic test of drug packaging materials.
Keywords：Drug Packaging materialsHemolysis testDirect contact methodExtract method
Publication Date：2015-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：3( 318-320 )