【摘要】：目的:采用幾種不同工藝制備葉酸介導(dǎo)的多西他賽脂質(zhì)體,建立其質(zhì)量控制方法并考察其穩(wěn)定性。方法:將氫化大豆磷脂酰膽堿(HSPC)、葉酸-聚乙二醇2000-磷脂酰乙醇胺(FA-PEG2000-DSPE)及多西他賽以100∶5∶8的比例分別采用3種不同工藝制備脂質(zhì)體。采用低速離心法測定包封率,動態(tài)光散射法測定粒度分布,GC法測定有機(jī)溶劑殘留。結(jié)果:脂質(zhì)體平均粒徑為(155±10)nm,多項(xiàng)分散系數(shù)(Pd I)均小于0.20;脂質(zhì)體包封率均大于95.0%;所制得樣品于(25±2)℃條件下放置6個月,各項(xiàng)考察指標(biāo)均未發(fā)生明顯變化。結(jié)論:采用制備工藝3所制得的樣品具有較高的藥脂比,該制備工藝可行,質(zhì)量可控,穩(wěn)定性良好。體外釋放曲線表明脂質(zhì)體有緩釋、靶向及長效作用。
[Abstract]:Objective: to prepare docetaxel liposomes mediated by folic acid by several different processes and to establish its quality control method and investigate its stability. Methods: hydrogenated soybean phosphatidylcholine (HSPC), folic acid peg 2000- phosphatidyl ethanolamine (FA-PEG2000-DSPE) and docetaxel were prepared by 3 different processes, respectively, with the ratio of 100: 5: 8. The encapsulation efficiency was measured by low velocity centrifugation, the particle size distribution was measured by dynamic light scattering, and residual organic solvents were determined by GC method. The results showed that the average particle size of liposomes was (155 + 10) nm, Pd I was less than 0.20, the encapsulation efficiency of liposomes were more than 95%, and the samples were placed at (25 + 2) C for 6 months and all the inspection indexes Conclusion: the sample prepared by the preparation process 3 has a high ratio of drug to fat. The preparation process is feasible, the quality is controllable and the stability is good. The release curve in vitro shows that the liposome has sustained release, targeting and long-term effect.
【作者單位】： 江蘇省中醫(yī)院;江蘇奧賽康藥業(yè)股份有限公司;
【分類號】：R943

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