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.