Plackett-Burman联用星点设计-效应面法优化龙胆苦苷脂质体制备工艺的研究  

Optimization of Gentiopicroside Liposome Preparation Process by Plackett-Burman Combined with Star Design-effect Surface Method

作　　者：张卫敏[1] 贾莉[1] 赵鲁亚[1] 李丽平[1] 李伟男[2] ZHANG Weimin;JIA Li;ZHAO Luya;LI Liping;LI Weinan(Heze Medical College,Heze Shandong 274000,China;Heilongjiang University of Traditional Chinese Medicine,Harbin Heilongjiang 150040,China)

机构地区：[1]菏泽医学专科学校,山东菏泽274000 [2]黑龙江中医药大学,黑龙江哈尔滨150040

出　　处：《药品评价》2023年第7期811-815,共5页Drug Evaluation

摘　　要：目的优选出龙胆苦苷脂质体的最佳原料处方与制备条件。方法采用Plackett-Burman(PBD)联用星点设计-效应面法(CCD-RSM)设计龙胆苦苷脂质体优化实验,紫外分光光度计与粒径仪测定包封率与粒径,确定制备龙胆苦苷脂质体的最优制备条件,根据拟合结果施行工艺验证。结果得到最优制备方案为载药温度34℃、药物与磷脂比例0.05、胆固醇与磷脂投料比0.52,此条件下所得龙胆苦苷脂质体粒径为(92.44±1.80)nm、包封率为(87.70±2.60)%。结论PBD与CCD-RSM联用实验设计策略优选出的龙胆苦苷脂质体粒径较小、包封率高,制备方案可靠,能达到满意的效果。Objective To optimize the raw material prescription and preparation conditions of gentiopicroside liposomes.Methods The optimization experiment of gentiopicroside liposomes was designed by Plackett-Burman(PBD)combined with central composite design-response surface methodology(CCD-RSM).The encapsulation efficiency and particle size were measured by ultraviolet spectrophotometer and particle size meter to determine the optimal preparation conditions of gentiopicroside liposomes.Process verification was carried out according to the fitting results.Results The optimal preparation scheme was drug loading temperature of 34℃,drug/phospholipid ratio of 0.05,cholesterol/phospholipid feeding ratio of 0.52.Under these conditions,the particle size of gentiopicroside liposomes was(92.44±1.80)nm,and the encapsulation efficiency was(87.70±2.60)%.Conclusion The optimized gentiopicroside liposomes obtained by the combined experimental design strategy of PBD and CCDRSM have small size,high encapsulation efficiency,and reliable preparation,and can achieve satisfactory effects.

关 键 词：工艺学 制药 龙胆苦苷 脂质体 逆向蒸发法 星点设计-效应面法 

分 类 号：R283.6[医药卫生—中药学]