激光衍射法测定富马酸喹硫平口服混悬液粒径  

Determination of particle size of quetiapine fumarate oral suspension by laser diffraction method

作　　者：张燕[1] 刘留成 ZHANG Yan;LIU Liucheng(Department of Pharmacy,Jiangsu Province Hospital of Chinese Medicine,Nanjing 210029,China;Jiangsu Sijiqing Biotechnology Co.,Ltd,Nanjing 210061,China)

机构地区：[1]江苏省中医院药学部,南京210029 [2]江苏四季青生物科技有限公司,南京210061

出　　处：《药学前沿》2025年第4期575-581,共7页China Pharmacist

摘　　要：目的建立激光衍射法测定富马酸喹硫平口服混悬液的粒度和粒度分布。方法采用Hydro MV湿法进样器,以激光粒度法(湿法)开展富马酸喹硫平口服混悬液的粒径分析并进行方法学研究,分别考察了分散剂浓度、搅拌速率和遮光率,并对最终确定的粒径测定方法进行了精密度和稳定性考察。结果最优分散剂选择标准分散剂,搅拌速率为3000 r/min,遮光率为10%~15%,精密度试验、稳定性试验中D_(10)、D_(50)和D_(90)(累积分布百分数分别达到10%、50%和90%时对应的粒径值)的RSD均符合标准规定。富马酸喹硫平口服混悬液的溶出行为与其所使用的原料药的溶出行为一致。结论激光粒度法(湿法)适合富马酸喹硫平口服混悬液的粒径测定,可用于富马酸喹硫平口服混悬液的实际研发和生产的质量控制。Objective To establish a laser diffraction method for determining the particle size and particle size distribution of quetiapine fumarate oral suspension.Methods The Hydro MV wet autosampler was used to conduct the particle size analysis of quetiapine fumarate oral suspension by laser diffraction method(wet method)and the methodological research.The dispersion solution concentration,agitation rate and obscuration were investigated,and precision and stability tests were conducted on the final particle size determination method.Results The optimum parameters are as follows:dispersion was standard dispersion solution concentration,the agitation rate was 3000 r/min and obscuration was 10%-15%.The RSD of D_(10),D_(50) and D_(90)(the particle size values corresponding to cumulative distribution percentages of 10%,50%and 90%,respectively)met the requirements in the precision and stability tests.The dissolution behavior of quetiapine fumarate oral suspension was consistent with the dissolution behavior of its active pharmaceutical ingredient.Conclusion The laser diffraction method(wet method)is suitable for the measurement of quetiapine fumarate oral suspension particle size,and can be applied to the actual research and development as well as the quality control of the quetiapine fumarate oral suspension.

关 键 词：富马酸喹硫平口服混悬剂 粒度 粒度分布 激光粒度法(湿法) 质量控制 

分 类 号：R927.1[医药卫生—药学]