丙泊酚注射液乳粒粒径测定方法探讨

Investigation of Methods for the Determination of Particle Size of Propofol Injection

目的：对乳粒粒径测定的方法及仪器参数的设置进行初步探讨。方法：采用经典光散射法，使用马尔文激光散射粒度测定仪分别对仪器的3个参数（遮光度、吸收率、折射率）的设置范围进行考察；以丙泊酚注射液为模型药物，用动态光散射法与经典光散射法测定相同的13批样品，比较平均粒径及小于0．4pm粒子的百分比这2项指标测定结果的差异。结果：马尔文公司的激光粒度测定仪参数设置范围为遮光度5％～10％、吸收率0～0．01、折射率1．47～1．52时对粒径测定结果影响不大；与经典光散射法测得的结果比较，动态光散射法测得的平均粒径较小，测得的小于0．4um的粒子的百分比更大；确立丙泊酚注射液乳粒测定方法为经典光散射法。结论：本试验建立的粒径测定方法及仪器参数可用于不同厂家丙泊酚注射液的粒径测定，使各厂家产品质量具有可比性；本方法的建立为其他类似品种注射剂的粒径测定提供了研究方向及恩路。

OBJECTIVE： To explore the methods for the determination of particle size and the setting of instrument parameters preliminarily. METHODS： By method of classical light scattering, mastersizer of Marvin was adopted to investigate the setting range of shading degree, absorbency and refractive index. Using Propofol injection as model, dynamic light scattering and classical light scattering were used to determine 13 batches of same samples to compare mean particle size and the percentage of particle less than 0.4 gm. RESULTS： The setting range of instrument parameters of mastersizer Marvin were as follows： shading degree 5 %-10 %, absorbency 0-0.01, refractive index 1.47-1.52, the effect of which on particle size was not significant. Mean diameter of dynamic light scattering was lower, and the percentage of particle size less than 0.4 gm of dynamic light scattering was higher than classical laser scattering. Classical light scattering was suitable for the determination of the particles size of Propofol injection. CON- CLUSIONS： Established method for the determination of particle size and instrument paranaeter can be used for the determination of particle size of Propofol injection from different manufacturers. The quality of products from different manufacturers are compara- ble. The method provides research area and idea for the determination of particle size of similar injections.