氢溴酸高乌甲素固体脂质纳米粒包封率的测定方法  

Study on methods for the determination of entrapment efficiency of solid lipid nanoparticles loading lappaconite hydrobromide

作　　者：陈桐楷[1] 李园[1] 林华庆[1] 张蜀[1] 邓红[1] 余楚钦[1] 侯悦翰[1] 

机构地区：[1]广东药学院广东省药物新剂型重点实验室,广东广州510006

出　　处：《中国医院药学杂志》2011年第7期557-560,共4页Chinese Journal of Hospital Pharmacy

基　　金：广州市重大科技专项计划项目(编号:2008A1-E4101)

摘　　要：目的：建立氢溴酸高乌甲素固体脂质纳米粒（LH-SLN）的包封率测定方法。方法：采用高压乳匀法制备LH～SLN，分别用透析法、超滤法分离固体脂质纳米粒和游离药物；采用HPLC法测定药物含量，并对这2种方法进行方法学考察，优选出准确度高的包封率测定方法。结果：超滤法能有效地将LH—SLN与游离药物分离。在所选色谱条件下，氢溴酸高乌甲素得到良好分离，辅料不干扰测定，氢溴酸高乌甲素在1（1．0-120．0mg·L^-1内线性关系良好（r=0．9999）。用此方法测定3批LHSLN的平均包封率为53．65％，RSD为0．97％。结论：超滤法方便快捷，结果准确，更适用于LH—SLN的包封率测定。OBJECTIVE To establish a method for the determination of the entrapment efficiency of solid lipid nanoparticles loading lappaconite hydrobromide （1-SLN）. METHODS The high pressure homogenization was used to prepare solid lipid nanoparticles loading lappaconite hydrobromide. The 1 SLN and free drugs were separated by dialysis method and ultrafiltration. The content of lappaconite hydrobromide was quantified by HPLC consisted of Kromasil C18 column, a mobile phase of 0. 02 mol· L ^-1 sodium dihydrogen phosphate-acetonitrile （74：26） with a flow rate of 1 mL.min ^-1 and UV detection wavelength at 252 nm. The methodology study and the optimization of determining condition were carried out. RESULTS Ultrafiltration could effectively separate the 1-SLN from free drugs. A calibrated linear curve of lappaconite hydrobromide concentration was within 10. 0-120. 0μg.mL ^-1 （r= 0. 999 9）. The average entrapment efficiency of three batches of 1-SLN was 53. 650, with RSD of 0. 97% by ultrafiltration. CONCLUSION Ultrafiltration was convenient, sensitive and accurate. It indicated that ultrafiltration was more suitable for the determination of entrapment efficiency.

关 键 词：氢溴酸高乌甲素 固体脂质纳米粒 包封率 透析法 超滤法 

分 类 号：R927.2[医药卫生—药学]