吡喹酮脂质体冻干剂的制备及质量评估

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，脂质体外观圆整而且均匀。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。

Preparation and Assessment of Freeze-dried Praziquantel Liposome Agent

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.