激光散射法测定盐酸鲁拉西酮原料药的粒度分布  

Determination of Particle Size Distribution of Lurasidone Hydrochloride Bulk Drug by Laser Scattering Method

作　　者：王爱霞 张小曼 赵恺 钱辉 陈松辉 WANG Aixia;ZHANG Xiaoman;ZHAO Kai;QIAN Hui;CHEN Songhui(National Quality in Supervision and Testing Center of Fine Chemicals,Product Quality Supervising and Inspecting Center of Taizhou City,Taizhou 225300;Taizhou BociMed Pharmaceutical Co.,Ltd.,Taizhou 225300)

机构地区：[1]泰州市产品质量监督检验院,国家精细化学品质量检验检测中心,江苏泰州225300 [2]博志研新泰州药物技术有限公司,江苏泰州225300

出　　处：《中国医药工业杂志》2024年第9期1277-1281,共5页Chinese Journal of Pharmaceuticals

基　　金：泰州市科技支撑计划(社会发展)项目(TS202322)。

摘　　要：建立了盐酸鲁拉西酮(1)原料药粒度分布的测定方法并进行验证。采用激光粒度分析仪的有机进样模式,通过考察分散剂及用量、样品折射率和吸收率、超声时间、搅拌循环速度等参数,对方法的准确度、精密度、稳定性和耐用性进行验证。结果建立的检测1粒度分布的方法参数如下:样品材质折射率为1.65,样品材质吸收率为0.01,分散剂折射率为1.42,遮光度为12%~20%,搅拌循环速度为2500 r/min,样品测量时间和背景时间均为10 s,样品测量次数6次。该方法精密度高、稳定性强和耐用性好,测得1的d(0.5)、d(0.1)和d(0.9)的RSD均<3%,符合规定要求,可用于1原料药粒度的测定。A method for determining the particle size distribution of lurasidone hydrochloride(1)bulk drug was established and validated.A laser particle size analyzer was used with organic injection mode.By examining the parameters such as dispersant and dosage,refractive index and absorption rate of the sample material,ultrasound time,and stirring cycle speed,the accuracy,precision,stability,and durability of the method were verified.The results showed that the parameters of the established method for determination of particle size distrubition of 1 were as follows:the refractive index of the sample material was 1.65,the absorption index was 0.01,the refractive index of the dispersant was 1.42,the light shielding degree was 12%-20%,and the stirring cycle speed was 2500 r/min,the sample measurement time and background time were both 10 s,and the sample was measured for 6 times.This method has high precision,good stability and durability.The RSDs of d(0.5),d(0.1),and d(0.9)of 1 were all less than 3%,which met the specified requirements and could be used for particle size determination of 1 bulk drug.

关 键 词：盐酸鲁拉西酮 激光散射法 粒度 方法验证 

分 类 号：R917[医药卫生—药物分析学] R971.4[医药卫生—药学]