论文部分内容阅读
目的优化工艺制备福莫司汀聚氰基丙烯酸正丁酯纳米粒(FCNU-PBCA-NP)。方法以α-氰基丙烯酸正丁酯(BCA)为载体,采用乳化聚合法制备FCNU-PBCA-NP,并加以聚乙二醇20000(PEG20000)进行表面修饰,通过考察粒径和包封率两个指标,在单因素实验初选的基础上,正交设计法优化处方和制备工艺。结果制备FCNU-PBCA-NP的优化条件为BCA单体体积分数0.8%(V/V)、FCNU 20 mg、PEG20000浓度2.0%,按优化条件所制备的FCNU-PBCA-NP的粒径为(124.6±5.2)nm,多分散系数(PDI)范围为0.07~0.16,包封率(64.12±2.36)%,载药量(7.28±0.76)%。结论通过优化处方和制备工艺,采用乳化聚合法可制备出FCNU-PBCA-NP,对拓展FCNU临床给药新剂型提供一定的参考。
OBJECTIVE To optimize the preparation process of fomustine polybutylcyanoacrylate nanoparticles (FCNU-PBCA-NP). Methods FCNU-PBCA-NP was prepared by emulsification polymerization using n-butyl α-cyanoacrylate (BCA) as the carrier and surface modified with polyethylene glycol 20000 (PEG20000). The particle size and encapsulation efficiency An index, based on the single factor experiment primaries, orthogonal design optimization prescription and preparation process. Results The optimized conditions of preparation of FCNU-PBCA-NP were BCA monomer volume fraction 0.8% (V / V), FCNU 20 mg and PEG20000 2.0%. The particle size of FCNU-PBCA-NP prepared under optimized conditions was ± 5.2) nm, PDI ranged from 0.07 to 0.16, encapsulation efficiency (64.12 ± 2.36)% and drug loading (7.28 ± 0.76)%, respectively. CONCLUSION FCNU-PBCA-NP can be prepared by emulsion polymerization through optimizing formulation and preparation process, which will provide some references for expanding FCNU new dosage form of FCNU.