激光散射法测定注射用醋酸亮丙瑞林微球粒径及其分布

发布时间：2018-06-28 01:01

本文选题：注射用醋酸亮丙瑞林微球 + 粒径及其分布　；参考：《中国新药杂志》2017年08期

【摘要】：目的:对影响注射用醋酸亮丙瑞林微球粒径测定的关键因素进行探讨,建立微球粒径测量的最优方法。方法:分别考察搅拌速度、搅拌时间、超声时间、样品取样量和助悬剂对微球制剂粒径及其分布测定的影响,确定最适实验条件。取醋酸亮丙瑞林微球样品20 mg,加入助悬剂1 mL,轻轻振摇至形成均匀混悬液,然后将混悬液倾倒至已加水的样品池中,搅拌转速为2 200 r·min~(-1),超声1 min,重复测定。结果:超声、搅拌时间、转速对微球粒径测定结果具有显著影响;对3家企业的注射用醋酸亮丙瑞林微球的粒径及其分布进行了测定,企业A和B微球制剂粒径及其分布比较一致,与企业C微球制剂差异较大。结论:通过确定激光散射法测定粒径及其分布的最优条件,可有效对注射用亮丙瑞林微球的粒度进行控制。
[Abstract]:Aim: to study the key factors influencing the determination of the particle size of Leuprorelin acetate microspheres for injection, and to establish an optimal method for measuring the particle size of the microspheres. Methods: the effects of stirring speed, stirring time, ultrasonic time, sample sampling amount and suspension aid on the determination of particle size and distribution of microspheres were investigated, and the optimum experimental conditions were determined. The sample of brilliant proprilline acetate microsphere was 20 mg, then the suspension was 1 mL, and the suspension was shaken gently to form a uniform suspension. Then the suspension was poured into the water filled sample tank. The stirring speed was 2 200 r min-1, the ultrasonic time was 1 min, and the measurement was repeated for 1 minute. Results: ultrasound, stirring time and rotating speed had a significant effect on the particle size of the microspheres, and the particle size and distribution of the brilliant propraline acetate microspheres for injection in three enterprises were determined. The particle size and distribution of A and B microspheres were the same as those of C microspheres. Conclusion: by determining the optimal conditions for the determination of particle size and its distribution by laser scattering, the particle size of brilliant propraline microspheres for injection can be effectively controlled.
【作者单位】：中国食品药品检定研究院;葛兰素史克(中国)投资有限公司;
【基金】：国家“重大新药创制”科技重大专项资助项目(2015ZX09303001)
【分类号】：R927

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