医用注射剂中固体颗粒的鉴定、危害分析及核径迹膜去除

Jian-Xin Yang , Zhi-Bo He , Shi-Lun Guo
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引用次数: 3

摘要

目前已开发出两种梯级核径迹过滤器:(1)以聚丙烯(PP)纤维膜为初滤层,以核径迹膜(NTM)为末滤层的梯级过滤器;(2)采用尼龙扭孔膜作为初滤器,NTM作为末滤器。对级联过滤器去除固体颗粒进行了研究。研究的固体颗粒包括破碎安瓿瓶的玻璃碎片和药瓶橡胶盖(塞)的橡胶碎片。当一个装有药物的安瓿被砂轮和手打碎时,会产生大量的玻璃碎片,落入药物中。当橡胶盖被注射器针头刺穿时,橡胶与针头摩擦产生大量橡胶碎片。研究表明,由于两种常见膜的结构存在较大的间隙,单靠纤维膜或弯曲膜通常不能完全去除微观颗粒。核轨道膜及其级联过滤器在去除比轨道膜孔径大的固体颗粒方面具有优势。对梯级过滤器对固体颗粒的去除效率和注入流量进行了标定,结果表明,上述两个特性均符合中国法规的要求。这两种类型的级联滤波器已被中国医院接受使用。
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Identification and harmfulness analysis of solid particles contained in medical injections and their removal by nuclear track membranes

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.

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