高剪切一步法制备微晶乳糖研究  

Micron-size lactose manufactured under high shear and its dispersion efficicncy as carrier for salbutamol Sulphate

作　　者：曾新安[1] 张庆[1] 于淑娟[1] 

机构地区：[1]华南理工大学轻工与食品学院,广州510640

出　　处：《中国乳品工业》2009年第3期35-38,共4页China Dairy Industry

基　　金：广东省重大国际合作项目资助(2006A50105002)

摘　　要：采用高剪切压(1.15×102～2.30×102 Pa)下一步微晶法,通过后续的离心、冷冻干燥、过筛制备药用微晶乳糖,然后使用激光粒度仪、X射线衍射(XRD)和扫描电镜(SEM)来分析样品的形态学特征,并通过进行舒喘宁(SS)体外沉积实验,比较了实验制备的微晶乳糖与商业化微晶乳糖(Sorbolac 400)对于药物粉末体外沉积性能的影响。本研究中SS的体外沉积实验是使用Rotahaler投递后用二级沉积装置进行收集,最后通过HPLC法分析药物含量。结果表明,在舒喘宁干粉吸入剂的沉积性能方面,制备的微晶乳糖相比Sorbolac 400性能更优越,因此高剪切压能够为干粉吸入剂制备载体微晶乳糖提供一种可行的方法。Micron-dimension lactose crystals were made through ＂one step＂ crystallization under high shear （HS） （1.15×10^2-2.30×10^2Pa） and followed by centrifuging, freeze-drying and sieving in Lab. Particle Sizer, X-ray diffi＇action （XRD） and scanning electron micrograph （SEM） were used to analyze the morphology of the samples. The dispersion efficiencies of these lactose particles, as the carriers for delivering Salbutatool Sulphate （SS）, were tested and compared with the commercially available fine lactose （Sorbolac 400）. The in-vitro aerosol deposition of the SS powder formulations delivered from a Rotahaler was determined also using a twin-stage impinger （TSI）. The results have indicated that the lactose crystals prepared in the current study have significantly higher SS dispersion efficiency than the commercial sample. It shows that the technique of crystallization under high shear is a promising method to manufacture fine lactose crystals as carrier for dry powder inhalation aerosols （DPIs）.

关 键 词：乳糖一步结晶法 高剪切 沉积效率 舒喘宁 干粉吸入剂 

分 类 号：TS252.59[轻工技术与工程—农产品加工及贮藏工程]