光散射法测定兰索拉唑原料药粒度及粒度分布  

Particle size and particle size distribution of lansoprazole raw materials were determined by light scattering method

作　　者：张新芹 周礼玲 ZHANG Xin-qin;ZHOU Li-ling(The integrated administrative enforcement detachment of the Lu’an Market Authority,Lu’an 237000,China;不详)

机构地区：[1]六安市市场监管综合行政执法支队,安徽六安237000 [2]六安市食品药品检验中心,安徽六安237000

出　　处：《中国处方药》2024年第6期16-20,共5页Journal of China Prescription Drug

摘　　要：目的建立兰索拉唑原料药粒度及粒度分布测定方法。方法采用光散射法,颗粒折射率为1.57,颗粒吸收率为0.1,振动进样速度为60%,分散气压为3.0 Bar,遮光度为0.5%~6%。结果该方法重复性好,6次结果的RSD分别是:d(0.1)为2.0%,d(0.5)为2.1%,d(0.9)为0.7%,D(4,3)为0.7%;中间精密度良好,12次结果的RSD分别是:d(0.1)为1.5%,d(0.5)为1.8%,d(0.9)为1.4%,D(4,3)为0.9%。结论该方法可靠、准确,可用于兰索拉唑原料药粒度及粒度分布的测定。Objective To establish a method for determination of particle size and particle size distribution of lansoprazole raw materials.Methods Light scattering method was used the particle refractive index was 1.57,the particle absorptivity was 0.1,the vibratory injection rate was 60%,the dispersion pressure was 3.0 Bar,the opacity was 0.5%~6%.Results The method has good repeatability,the RSD was 2.0% for d(0.1),2.1% for d(0.5),0.7%for D(0.9),0.7% for D(4,3).The middle precision is good.The RSD was 1.5% for d(0.1),1.8% for d(0.5),1.4%in d(0.9)and 0.9% in D(4,3).Conclusion The method is reliable and accurate,and can be used for the determination of particle size and particle size distribution of lansoprazole raw materials.

关 键 词：光散射法 兰索拉唑 粒度 粒度分布 

分 类 号：R927.1[医药卫生—药学]