浊度法抗生素效价测定仪的校准技术及其应用  

Calibration techniques and applications of antibiotic potency analyzers based on the turbidimetric method

作　　者：丁峰元 

机构地区：[1]河南省计量科学研究院,郑州450008

出　　处：《中国抗生素杂志》2018年第1期69-72,共4页Chinese Journal of Antibiotics

基　　金：国家质检总局项目[No.(2014)79];河南省重点科技攻关项目(No.122109000002)

摘　　要：根据浊度法抗生素效价测定仪的工作原理和结构组成,编制了校准方法并研制相应的校准设备。使用数字温度计可实现仪器控温性能的温度偏差、温度均匀度和温度波动度等3个技术指标的校准,以上3个技术指标分别为±1.0℃、1.0℃和±0.5℃。使用光谱中性滤光片可实现仪器吸光度测量性能的零点漂移、示值漂移、示值误差、测量重复性和通道差异等5个技术指标的校准,以上5个技术指标分别为±0.005、±0.005、±0.03、0.005和0.03。经验证,校准方法有效,可确保浊度法抗生素效价测定仪测量结果的溯源性和可比性。According to the working principle and the instrument structure of antibiotics potency analyzer based on the turbidimetric method, calibration techniques were programmed and calibration applications were designed. Three parameters of the temperature control performance, including temperature bias, temperature evenness, and temperature fluctuation, were calibrated using digital thermometers. The technical indexes of the three parameters mentioned above were ±1.0℃, 1.0℃, and ±0.5℃, respectively. Five parameters of the absorbance indication performance, including zero drift, indication drift, indication error, measurement repeatability, and channel difference, were calibrated using spectrum neutral filters. The technical indexes of the five parameters mentioned above were ±0.005, ±0.005, ±0.03, 0.005, and 0.03, respectively. The uncertainty in the measurement of the digital thermometer was U=0.3℃（k=2）. The relative uncertainty in the measurement of the spectrum neutral filter was Urd=1% （k=2）, which met the criterion of the dissemination of the value of quantity ＂U95 ≤ 1/3＊MPEV （Maximum Permissible Error Value）＂. The validated results showed that the calibration methods were practical and the calibration applications were operational. The measuring results of antibiotic potency analyzers based on the turbidimetric method were traceable and comparable.

关 键 词：浊度法抗生素效价测定仪 校准技术 控温性能 吸光度示值性能 

分 类 号：R927.11[医药卫生—药学]