摘要
目的:研究自制片的体外释药行为及体内生物等效性。方法:采用相似因子(f2)为评价指标,考察自制片的体外释放行为;采用单剂量交叉试验考察Beagle犬口服自制片与参比制剂的生物等效性及体内外相关性。结果:自制片体外释放零级特征明显(r=0.992 1)且释药完全(90%)。犬体内两制剂生物等效,相对生物利用度(100.0±12.6)%,自制片体内外相关性良好(r=0.98)。结论:盐酸氨溴索双层渗透泵控释片具有很好的开发前景。
OBJECTIVE In vitro release and bioequivalence of self-made tablets were evaluated. METHODSUsing similar factor （f2） as evaluate index, in vitro release of self-made tablets were evaluated. In vivo study, ultilizing Beagle dogs orally single-dose crossing administrated, the bioequivalence between the self-made controlled-release tablets and marketed sustained capsules and the correlation coefficient between the fraction of absorption in vivo and the release rate in vitro were investigated. RESULTS Self-made tablets possessed character of zero-order release （r = 0. 992 1） and drug release completely（90%） in vitro release. The relative bioavailability was （100. 0 ± 12. 6） %. The correlation coefficient between the fraction of absorption in vivo and the release rate in vitro was 0. 98. CONCLUSION Ambroxol hydrochloride push-pull osmotic pump controlled-release tablets have much developing potential.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2011年第22期1863-1867,共5页
Chinese Journal of Hospital Pharmacy
基金
石药集团医药联合研究基金(编号:C2011206172)
关键词
盐酸氨溴索
双层渗透泵控释片
药动学
生物等效性
ambroxol hydrochloride
push-pull osmotic pump controlled-release tablets
pharmacokinetics
bioequivalence
