CAJ | 학술논문

目的：采用直接法和浸提液法两种检查方法对药品包装材料进行评价，比较两种方法对药包材检测灵敏性的差异。方法选择11种具有代表性的药包材，分别采用直接法和浸提液法进行溶血性能检测，并对两种方法测得的溶血结果进行比对。结果浸提液法溶血率大于直接法，均符合规定但不存在显著性差异（ P﹥0.05）。结论直接法和浸提液法均可用于药包材的溶血性能检测，浸提液法作为药包材溶血性能的一个探索，更符合临床使用特点，建议全面考察药包材溶血性能，增加浸提液评价方法。
목적：채용직접법화침제액법량충검사방법대약품포장재료진행평개，비교량충방법대약포재검측령민성적차이。방법선택11충구유대표성적약포재，분별채용직접법화침제액법진행용혈성능검측，병대량충방법측득적용혈결과진행비대。결과침제액법용혈솔대우직접법，균부합규정단불존재현저성차이（ P﹥0.05）。결론직접법화침제액법균가용우약포재적용혈성능검측，침제액법작위약포재용혈성능적일개탐색，경부합림상사용특점，건의전면고찰약포재용혈성능，증가침제액평개방법。
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.