吡喹酮脂质体冻干剂的制备及质量评估

Preparation and Assessment of Freeze-dried Praziquantel Liposome Agent

关键词:  吡喹酮脂质体  冻干剂  冷冻技术  包封率

Key words:  Praziquantel Liposome  Freeze-dried agent  Freeze Technique  Encapsulation efficiency

摘要:

制备了吡喹酮脂质体冻干剂,并对其质量进行评估。采用薄膜-超声法制备吡喹酮脂质体，结合冷冻干燥技术制备吡喹酮脂质体冻干剂，建立HPLC法测定吡喹酮脂质体的包封率，并研究其稳定性。优化后的脂质体冻干剂其包封率在70%以上,粒径范围220～310nm,电镜结果显示,脂质体外观圆整而均匀。本法制备的吡喹酮脂质体冻干剂质量稳定,且建立的包封率测定方法稳定可靠。

Abstract:

The study was designed to establish a method for freeze-dried praziquantel liposome agent preparation, as well as the corresponding quality control and assessment. We initially used the film-ultrasonic wave technique to prepare the praziquantel liposomes, then freeze-drying technique to yield the freeze-dried praziquantel liposome agent, after which the agent stability and the encapsulation efficiency werecarefully assessed and determined via our newly set up HPLC-method. The encapsulation efficiency can be more than 70% with particle size range from 220nm to 310nm, which most liposomes turned out to be round and even to show a better appearance. Stable and high quality freeze-dried praziquantel liposome agent can be obtained with high quality according to our newmethod. And the corresponding established HPLC-method was reliable for the encapsulation efficiency assessment of the liposome agent.