Chawla A S, Hinberg I
Bureau of Radiation and Medical Devices, Health and Welfare Canada, Ottawa, Ontario.
Biomater Artif Cells Immobilization Biotechnol. 1991;19(4):761-83. doi: 10.3109/10731199109117853.
The leaching of phthalate plasticizers from four types of blood platelet bags was investigated. The anticoagulant solutions used in the blood collection bags had pH values of 5.64 +/- .04 and contained no detectable amounts of phthalates. Platelet bag materials from each bag were soaked in normal salines for up to 5 days. The salines were tested for the leached phthalates from the bags but none could be found. However, di-(2-ethylhexyl) phthalate (DEHP) leached out of the PL-146 and Terumo bags into bovine calf serum used for soaking the bag materials. There was an increase in the amount of DEHP leached from about 1.1 mg at the end of one day to about 3.3 mg per gm of bag material at the end of a five day extraction with the serum. In PL-732 sets, a platelet bag made of a specialty polyolefin, the amount of DEHP leached out was less than 0.02 mg per g of bag material. CLX bags, which contained tri-(2-ethylhexyl) trimelliate (TETM) as a plasticizer, showed a negligible amount of it leaching into the calf serum. Infra-red spectra showed that PL-146 bags had been coated with a layer of a fatty acid amide while the Terumo bags contained a layer of a silicone fluid on their inner surfaces. CLX bags showed a coating of stearates, which were probably soaps of calcium or zinc. Scanning electron microscopy (SEM) showed that the inner surfaces of each brand of the bag were distinctly different morphologically. The two PVC bags were very similar whereas the surfaces morphology of PL-732 was rougher. Terumo bag had a different surface morphology than those of the other bags whereas the CLX bags had a very regular surface pattern. The exact significance of the surface morphology is not certain but excessively rough surfaces may not be desirable for the bags.
研究了四种类型血小板袋中邻苯二甲酸酯类增塑剂的浸出情况。采血袋中使用的抗凝剂溶液pH值为5.64±0.04，且未检测到邻苯二甲酸盐。每个袋子的血小板袋材料在生理盐水中浸泡长达5天。检测了生理盐水中从袋子浸出的邻苯二甲酸盐，但未发现任何物质。然而，邻苯二甲酸二（2-乙基己基）酯（DEHP）从PL-146袋和泰尔茂袋中浸出到用于浸泡袋材料的小牛血清中。用血清进行5天萃取结束时，DEHP的浸出量从一天结束时的约1.1毫克增加到每克袋材料约3.3毫克。在由特种聚烯烃制成的血小板袋PL-732组中，DEHP的浸出量低于每克袋材料0.02毫克。含有偏苯三酸三（2-乙基己基）酯（TETM）作为增塑剂的CLX袋，其浸出到小牛血清中的量可忽略不计。红外光谱显示，PL-146袋内表面涂有一层脂肪酸酰胺，而泰尔茂袋内表面含有一层硅油。CLX袋显示有硬脂酸盐涂层，可能是钙或锌的皂类。扫描电子显微镜（SEM）显示，每个品牌袋子的内表面在形态上明显不同。两个聚氯乙烯袋非常相似，而PL-732的表面形态更粗糙。泰尔茂袋的表面形态与其他袋子不同，而CLX袋有非常规则的表面图案。表面形态的确切意义尚不确定，但表面过于粗糙可能对袋子不利。
