摘要
考察加药环境与加药器具对输液不溶性微粒的影响。取一次性使用无菌加药器具,分别在净化洁净室和病房治疗室,模拟加药,按《中国药典》,以光阻法测定样品中的不溶性微粒,与未模拟加药的输液比较,在病房治疗室和净化洁净室制备的样品中,≥10μm的不溶性微粒均有显著增加(P<0.05),≥25μm的不溶性微粒均增加不明显(P>0.05);病房治疗室制备的样品与净化洁净室制备的样品比较,≥10μm的不溶性微粒增加显著(P<0.05),≥25μm的不溶性微粒增加不明显(P>0.05)。病房治疗室内加药环境及一次性加药器具可使输液中≥10μm的不溶性微粒明显增加。
The impact of pollution of insoluble particles caused by dosing environment and drug infusion devices was studied. Take one--time use of sterile equipment and simulate medicine, respectively in the purification clean room and ward treatment rooms clean room. According to the “Chinese Pharmacopoeia”, samples of insoluble particles by photoresist were determinated, and compared to not simulated drug infusion. In the ward treatment rooms clean room and the purification clean room, the insoluble particles of ≥ 10 μm were significantly increased （P 〈 0. 05）, the insoluble particles of ≥ 25 μm were not significant increased （P〉 0.05）. Compared the samples of the ward treatment rooms clean room and purification clean room, ≥ 10μm particulate matter increased significantly （ P〈0. 05）, and ≥ 25 μm insoluble particles increase was not significant （P〉 0.05）. ward drug treatment room plus a one--time environment and increase drug infusion devices enable ≥ 10μ m in the insoluble particles increased significantly.
出处
《中国药事》
CAS
2007年第11期888-889,893,共3页
Chinese Pharmaceutical Affairs
关键词
一次性使用无菌注射器
输液
不溶性微粒
one--time use of sterile syringes
infusion
insoluble particles
