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中国人民解放军空军天津医院研制的ZWF-4A注射液微粒分析仪于12月17日在天津通过专家鉴定。 ZWF-4A注射液微粒分析仪是用来测定注射液中不溶性微粒限量的。中国药典1985年版规定,在大输液澄明度检查合格的情况下,用微孔滤膜-显微镜下计数的检测方法检查其中大于10微米和大于25微米不溶性微粒的限量。该法虽被几个国家的药典收载,但操作繁杂,劳动强度大,效率低。英国药典规定用电阻抗法与光障碍法检测注射液中大于2微米和大于5微米不溶性微粒的限量。我国出口的大输液,该项目一般均需按英国药典方法检查,目前使用的仪器是英国产的库尔特(Coulter)微粒计数器。
ZWF-4A injection particle analyzer developed by the Chinese PLA Air Force Tianjin Hospital passed the expert’s appraisal in Tianjin on December 17. ZWF-4A injection particle analyzer is used to determine the injection of insoluble particles limit. Chinese Pharmacopoeia 1985 edition provides that in the case of large transfusion clarity inspection, the use of microporous membrane - under the microscope counting method to check which more than 10 microns and greater than 25 microns insoluble particles limit. Although the law was collected in several countries Pharmacopoeia, but the operation complicated, labor-intensive, inefficient. The British Pharmacopoeia states that electrical impedance and light barriers are used to determine the limits for insoluble particles larger than 2 microns and larger than 5 microns in an injection. China’s exports of large transfusion, the project generally need to check according to the British Pharmacopoeia method, the current instrument used is the British-made Coulter particle counter.