以組織培養法評估塑膠製醫療器材毒性試驗之可行性

Study on the Tissue Culture Method for Screening Toxicity of Plastic Medical Practice

10.6946/ASRNL.198509.0020

趙磐華(Edward Chao)；陳作琳(Thuo-Lin Chung)；游祥榮(Shiang-Rong Yu)

組織培養法 ； 細胞毒性檢驗 ； 塑膠醫療器材 ； Tissue Culture ； Cytotoxicity Assay ； Plastic Medical Practice

藥物食品檢驗局調查研究年報

3號（1985 / 09 / 01）

20 - 23

繁體中文

在送驗各項塑膠製醫療器材共計54件檢品，以組織培養法檢驗其對細胞的毒害性，並與目前所使用的家兔肌肉內植入法相比較。結果：兩者均呈陽性反應者計4件，均呈陰性反應者計38件，組識培養法呈陽性而肌肉內植入法陰性者計12件，肌肉植入法陽性而組織培養法陰性者則無。顯示以組織培養法檢出細胞毒害性之陽性率高出肌肉內植入法22.2%。故此法當可做為塑膠製醫療器材毒性檢驗評估之良好方法。

A Tissue Culture Method (Fluid Medium) was developed to screen the toxicity of plastic materials used in medical practice, and comparing with Rabbit Intramuscular Implantation Test which we operate till now. Apparently, this method appears more effective and sensitive. In a total of 54 cases we have tested, sam1es cytotoxicity which could test by both methods were 4 (7.4%), negative to both methods were 38 cases (70.4%). Samples that, negative to Intramuscular Implant Method but positive to tissue culture method were 12 cases (22.2%). On the contrary, samples positive to tissue culture method but negative to muscle implant method was nil. So that to assess, the toxicity of plastic materials used in medical practice, the tissue culture method appear its more practible and valuable.