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Identification and harmfulness analysis of solid particles contained in medical injections and their removal by nuclear track membranes

机译:医用注射剂中所含固体颗粒的鉴定和危害分析以及核跟踪膜的去除

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Two types of cascade nuclear track filters have been developed: (1) cascade filter made of polypropylene (PP) fiber membrane as preliminary filter and nuclear track membrane (NTM) as terminal filter; (2) Nylon tortuous-pore membrane as preliminary filter and NTM as terminal filter. Removal of solid particles by the cascade filters has been investigated. The solid particles studied include glass shards from broken ampoules and rubber fragments from rubber covers (plugs) of medical bottles. When an ampoule containing medicine is broken by emery wheel and by hands, large number of glass shards are produced and fall into the medicine. When a rubber cover is punctured by syringe needle, large number of rubber fragments are produced by friction between rubber and needle. The investigation shows that fiber or tortuous membranes alone usually cannot completely remove the microscopic particles due to existence of large gaps in the structure of the two common membranes. Nuclear track membranes alone and their cascade filters are superior to remove all solid particles bigger than the pore size of the track membrane. Removal efficiency for solid particles and flow rate of injections through the cascade filters have been calibrated and shown that both features above fulfill the requirements of Chinese regulations. The two types of cascade filters have been accepted for use in Chinese hospitals.
机译:已经开发出两种类型的级联核径迹过滤器:(1)由聚丙烯(PP)纤维膜制成的级联过滤器作为初级过滤器,由核径迹膜(NTM)制成的末端过滤器; (2)尼龙曲折膜作为预过滤器,NTM作为终滤器。已经研究了通过级联过滤器去除固体颗粒的方法。研究的固体颗粒包括来自破裂的安瓿瓶的玻璃碎片和来自医疗瓶橡胶盖(塞子)的橡胶碎片。当用砂轮和手将装有药物的安瓿弄碎时,会产生大量玻璃碎片并掉入药物中。当用注射器针头刺穿橡胶套时,橡胶和针头之间的摩擦会产生大量的橡胶碎片。研究表明,仅纤维或曲折的膜通常无法完全去除微观颗粒,原因是两种常见膜的结构中存在较大的间隙。单独使用核径迹膜及其级联过滤器可以去除大于径迹膜孔径的所有固体颗粒。固体颗粒的去除效率和通过级联过滤器的进样流量已经过校准,表明以上两个功能均符合中国法规的要求。两种类型的级联过滤器已被中国医院接受使用。

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