摘要：两性霉素B（amphotericin B，AMB）是一种用于治疗深部真菌感染的多烯类抗生素。本课题的主要目的是制备两性霉素B冻干脂质体，并且对其进行简单的体外评价，主要的评价指标有粒径、包封率等。制备两性霉素B冻干脂质体的主要意义是为了降低药物的毒副作用，提高药物的使用范围。并且对试验的数据进行分析，得出制备两性霉素B冻干脂质体的影响因素。本课题主要采用薄膜法制备，并用高压均质机对粒径进行处理最后进行真空冷冻干燥，得到两性霉素B冻干脂质体成品。平均粒径的测定使用的是激光粒度测定仪，得到的两性霉素B脂质体平均粒径在90-140nm之间。稳定性试验做了长期试验和加速试验，使用的试验方法为2015版药典中规定的方法稳定性试验的结果都符合2015版药典的标准。包封率测定使用的是微柱离心-HPLC法，测得的包封率为95.1%。50056

毕业论文关键词：  两性霉素B；脂质体；冷冻干燥；粒径分布

Amphotericin B Liposome preparation and in vitro evaluation

Abstract:Amphotericin B is a kind of polyene antibiotic to the treatment of deep fungal infection.The main purpose of this subject is to prepare amphotericin B liposome and to make a simple in vitro evaluation.The main evaluating indicator is the particle size,the envelopment rate and so on.The main purport of preparing the amphotericin B liposome is to reduce the side effects of drugs and to improve the use of drugs.Analysis of experimental data is to find out influence factors of preparing amphotericin B liposome.This subject uses thin-film method to prepare liposome.The particle size is treated by high pressure homogeniser.Finally,using vacuum freeze drying preserves amphotericin B liposome.To use laser particle size measuring instrument determeines the average patricle size.The average particle size is 90-100 nm.The stability test uses the method of the 2015 edition of Chinese Pharmacopoeia.The results is conformed with the standards of the 2015 edition of Chinese Pharmacopoeia.Determination of entrapment efficiency of amphotericin B liposome by mini-column centrifugation-HPLC.The entrapment efficiency is 95.1%.

KeyWords:Amphotericin B;Liposome;Freeze Drying;Particle Size 

目  录

1  绪论    1

2  概述    2

  2.1  两性霉素B脂质体     …2

    2.1.1  理化性质   2

    2.1.2  适应症和副作用     3

    2.1.3  作用机制     …3

    2.1.4  两性霉素B脂质体的发展    3

  2.2  制备方法     5

    2.2.1  薄膜-超声法制备    5

  2.2.2  乙醚注入法    6

  2.2.3  逆向蒸发法    6

  2.3  体外评价方法    …6

    2.3.1  两性霉素B脂质体的含量测定    …6

    2.3.2  两性霉素B脂质体的粒径测定    …7

    2.3.3  两性霉素B脂质体的包封率测定     …7

3  试验部分    …8

  3.1  确定试验方案    … 8

3.2  处方确定    …9

3.3  试剂及仪器    …9

3.3.1  试剂    … 9

3.3.2  仪器     10

3.4  两性霉素B冻干脂质体的制备     …10

3.5  粒径分布     11

3.5.1  操作方法     …11

3.5.2  结果      11 两性霉素B脂质体的制备和体外评价:http://www.youerw.com/yixue/lunwen_53259.html