ZLR-8喷雾干燥乳剂的制备及高效液相色谱法含量测定  

Preparation and content determination of ZLR-8 spray-dried emulsion

作　　者：张建军[1] 郑增娟[2] 高缘[3] 张奕华[4] 

机构地区：[1]中国药科大学药剂学教研室,江苏南京210009 [2]潍坊医学院药学教研室,山东潍坊261042 [3]中国药科大学中药制剂教研室,江苏南京210009 [4]中国药科大学新药研究中心,江苏南京210009

出　　处：《中国医院药学杂志》2007年第11期1491-1493,共3页Chinese Journal of Hospital Pharmacy

基　　金：国家自然科学基金资助项目(编号:30271491);江苏省自然科学基金项目(编号:BK2002119)

摘　　要：目的：制备水极难溶性的一氧化氮供体药物ZLR-8喷雾干燥乳剂并测定干乳剂中ZLR-8含量。方法：采用喷雾干燥法制备ZLR-8喷雾干燥乳剂，建立高效液相色谱（HPLC）法测定ZLR-8在喷雾干燥乳剂中的含量。结果：ZLR-8在10．2-35．8mg·L^-1范围内线性良好，r=0．9998；低、中、高3种剂量的回收率分别为100．4％，99．75％，100．7％；RSD分别为0.21％，0．01％，0．66％。3批样品中ZLR-8的平均含量为100．2％，RSD为0．46％。结论：ZLR-8喷雾干燥乳剂的制备方法可行，HPLC法专属性好，能快速、准确测定喷雾干燥乳剂中ZLR-8的含量。OBJECTIVE To prepare the spray-dried emulsion of ZLR-8,a water-insoluble NO donor drug,and determine the content of ZLR-8 in dry emulsion. METHODS ZLR-8 spray-dried emulsion was obtained by spray drying,and an HPLC method was established for content determination of ZLR-8 in spray-dried emulsion. RESULTS The good linear range of determination was 10. 24- 35.84mg·L^-1, the correlation coefficient was 0.9998. The recoveries of low, middle and high groups were 100.4 %, 99. 75 %, 100.7 % and RSD were 0.21%, 0.01%,0.66%, respectively. The average content of ZLR-8 in three batches was 100.2% and RSD was 0.46%, respectively. CONCLUSION The preparation technique of ZLR-8 spray-dried emulsion is feasible. The established HPLC method is rapid, accurate and specific for content determination of ZLR-8 in spray-dried emulsion.

关 键 词：ZLR-8 喷雾干燥乳剂 高效液相色谱法 含量测定 

分 类 号：R927.2[医药卫生—药学]