多条溶出曲线评价缬沙坦氨氯地平片的质量  

Evaluation of the quality of valsartan and amlodipine tablets by dissolution curve in different mediums

作　　者：陆步实[1] 孙磊[2] 周立新[1] 董萱[1] 孙川[3] 卢定强[1] 

机构地区：[1]南京工业大学江苏省药物研究所有限公司,江苏南京210009 [2]南京工业大学生物与制药工程学院,江苏南京210009 [3]南京中医药大学药学院,江苏南京210046

出　　处：《中国医院药学杂志》2012年第9期704-707,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的:以国外上市的缬沙坦氨氯地平片作为参比制剂,考察自研制剂和参比制剂在不同pH的溶出介质中体外溶出行为的相似性。方法:通过测定2种制剂中氨氯地平和缬沙坦的溶出曲线,采用f2相似因子对溶出曲线的相似度进行评价。结果:在不同pH的溶出介质中,自研制剂中氨氯地平和缬沙坦的溶出曲线与参比制剂比较,f2相似因子均大于50。结论:自研制剂和参比制剂在不同pH的溶出介质中的体外溶出行为相似。OBJECTIVE To investigate the dissolution behavior similarity between the reference preparation tablets （the listed in abroad valsartan and amlodipine tablets） and selfprepared （domestic） preparation in dissolution mediums with different pH. METHODS Through determining the dissolution curve of two preparations,then f2 similarity factor was used to evaluate the similarity of dissolution curves. RESULTS In different dissolution mediums, the dissolution curves of valsartan and amlodipine from self-prepared preparation compared with reference preparation, the similar factor（f2 ） were all more than 50. CONCLUSION The dissolution behavior of self-prepared preparation and reference preparation were similar in dissolution mediums with different pH.

关 键 词：缬沙坦 氨氯地平 溶出曲线 f2相似因子 

分 类 号：R943[医药卫生—药剂学]