干扰素脂质体的制备与质量控制

Preparation and Quality Control of Interferon Liposome

目的制备干扰素脂质体并建立其质量控制方法。方法采用逆相蒸发法制备干扰素脂质体。通过电镜测定其粒径,采用细胞病变抑制法测定包封率。结果干扰素脂质体透射电镜下观察为圆形,平均粒径为285.6 nm,包封率为63.52%;有机物残留量低于2005年版《中国药典(二部)》规定的标准;在2～8℃下保存6个月,总活性基本不变。结论该制剂制备方法可行,所得成品稳定性好,且所建立的质量控制方法简便、可靠,适用于干扰素脂质体的大生产。

Objective To prepare the interferon liposome and to establish its quality control.Methods The interferon liposome was prepared by the reverse phase evaporation method.The particle size was detected by using electron microscope and the envelope rate was tested by the cytopathic-effect inhibition assay.Results The interferon liposome was in a form of round particle under transmission electron mi-croscope.The mean diameter was 285.6 nm and the envelope rate was 63.52%.The residual organic content was less than the standard described in the Chinese Pharmacopoeia（edition 2005,volume Ⅱ）.After storage at 2-8 ℃ for 6 months,the total activity of interferon showed no significant change.Conclusion This preparation method is practicable and suitable for mass production;the finished preparation is stable in quality and the established quality control method is simple and reliable.