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.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2012年第9期704-707,共4页
Chinese Journal of Hospital Pharmacy
