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辅酶Q10长循环脂质体及冻干制剂的制备与质量控制
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| 篇名： | 辅酶Q10长循环脂质体及冻干制剂的制备与质量控制 |
| TITLE： | |
| 摘要： | 目的：制备辅酶Q10长循环脂质体，建立含量与包封率测定方法，并将其制成冻干制剂以提高稳定性。方法：以薄膜分散法制备辅酶Q10长循环脂质体。检测所制脂质体的粒径和Zeta电位；采用高效液相色谱法测定药物含量；鱼精蛋白沉淀法分离脂质体与游离药物，计算包封率。将辅酶Q10长循环脂质体制成冻干制剂，检测其冻干0、30、90 d后药物含量与包封率变化。结果：所制备的辅酶Q10长循环脂质体大小均匀，粒径约为（166.0±5.3） nm，Zeta电位约为（－22.2±1.4） mV，3批样品中辅酶Q10的平均含量（占标示量的百分含量）为98.2％（RSD＝2.8％），平均包封率为93.2％（RSD＝4.6％）；与冻干0 d比较，冻干90 d后辅酶Q10长循环脂质体冻干制剂的含量与包封率无明显变化。结论：成功制得含量和包封率均较高的辅酶Q10长循环脂质体和能冻干保存90 d的冻干制剂。 |
| ABSTRACT： | OBJECTIVE： To prepare Coenzyme Q10 long-circulating liposomes， establish the determination method of content and entrapment efficiency， and prepare it into lyophilized preparation to improve its stability. METHODS： Coenzyme Q10 long-circulating liposomes were prepared by film dispersion method. Particle size and Zeta potential of liposomes were determined， and HPLC assay was used to determine the content of coenzyme Q10. Free drugs and liposomes were separated using protamine aggregation method， and the encapsulation efficiency was calculated. Lyophilized preparation was prepared by coenzyme Q10 long-circulating liposomes， and the changes of content and encapsulation efficiency of drugs were determined 0， 30 and 90 days after lyophilization. RESULTS： The liposomes were homogeneous in size with mean diameter of （166.0±5.3） nm and Zeta potential of （－22.2± 1.4） mV. Average content （the percentage of content accounted for labeled amount） and entrapment efficiency of 3 batches of sample were 98.2％ （RSD＝2.8％） and 93.2％ （RSD＝4.6％）， respectively. Compared with 0 d after lyophilization， coenzyme Q10 long-circulating liposomes had no obvious change in the content and encapsulation efficiency 90 d after lyophilization. CONCLUSIONS： Coenzyme Q10 long-circulating liposomes with high quality and entrapment efficiency and lyophilized preparation being stored stably for 90 d have been prepared successfully. |
| 期刊： | 2016年第27卷第22期 |
| 作者： | 杨硕晔，王乐，刘娜，王贯宇，潘梦宇，胡元森 |
| AUTHORS： | YANG Shuoye，WANG Le，LIU Na，WANG Guanyu，PAN Mengyu，HU Yuansen |
| 关键字： | 辅酶Q10；长循环脂质体；冻干制剂；鱼精蛋白沉淀法；质量评价；冷冻干燥 |
| KEYWORDS： | Coenzyme Q10； Long-circulating liposomes； Lyophilized preparation； Protamine aggregation method； Quality evaluation； Freeze-drying |
| 阅读数： | 336 次 |
| 本月下载数： | 5 次 |
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