激光散射法测定那他霉素粒度研究  

Study on the particle size determination of natamycinby laser scattering

作　　者：孙超 康帅[1,2,3] 王冬燕 高福然 程启东 SUN Chao;KANG Shuai;WANG Dongyan;GAO Furan;CHENG Qidong(New Drug Research and Development Company Limited of NCPC,Shijiazhuang,Hebei 052165,China;National Engineering Research Center of Microbial Medicine,Shijiazhuang,Hebei 052165,China;Hebei Industrial Microbial Metabolic Technology Innovation Center,Shijiazhuang,Hebei 052165,China;Huasheng Company Limited of NCPC,Shijiazhuang,Hebei 052160,China)

机构地区：[1]华北制药集团新药研究开发有限责任公司,河北石家庄052165 [2]微生物药物国家工程研究中心,河北石家庄052165 [3]河北省工业微生物代谢技术创新中心,河北石家庄052165 [4]华北制药华胜有限公司,河北石家庄052160

出　　处：《河北工业科技》2023年第5期381-386,共6页Hebei Journal of Industrial Science and Technology

基　　金：河北省科技研发平台建设专项(22567651H)。

摘　　要：为了减少那他霉素原料药各批次之间的粒度差异,提高其制剂产品质量和疗效稳定性,建立了一种激光散射法测定那他霉素粒度的方法。采用Mastersizer 2000激光粒度仪干法测定那他霉素粒度,分别对分散气压、振动进样速度及测量时间等关键测定参数进行了优选,并对本方法的重复性、中间精密度和耐用性进行了验证。结果表明:在分散气压为0.30 MPa、振动进样速度为45%、背景和测量扫描时间为10 s、样品折射率为1.50、颗粒吸收率为0.1、遮光度范围为0.5%~5%等条件下,所测样品的RSD均小于2.5%。方法学各项验证指标相对标准偏差均符合要求。所建立的测定那他霉素粒度的激光散射法精密度较高、重复性好,能够有效控制原料药的批间差异,可为生产出安全、有效、均一、稳定的制剂产品提供保障和参考。In order to reduce the particle size difference between batches of natamycin,improve the quality and efficacy stability of the drug products,a laser scattering method was established using Mastersizer 2000 laser particle size analyzer to determine the particle size of natamycin by dry method.The key measurement parameters such as dispersion pressure,vibration injection speed,and determination time was optimized.And the repeatability,intermediate precision,and durability of this method were verified.The results show that under the conditions of dispersion pressure of 0.30 MPa,vibration injection speed of 45%,background and determination scanning time of 10 seconds,sample refractive index of 1.50,particle absorption index of 0.1,and opacity range of 0.5%~5%,the RSD of the measured samples are all less than 2.5%,and the relative standard deviation of various validation indicators in methodology meets the requirements.The established laser scattering method for determining the particle size of natamycin has high accuracy and good repeatability,which can effectively control the inter batch differences of raw materials and provide guarantee and reference for the production of safe,effective,uniform,and stable pharmaceutical products.

关 键 词：光谱分析 激光散射法 那他霉素 粒度测定 方法验证 

分 类 号：O657.319[理学—分析化学] R917[理学—化学]