摘要
目的建立家兔血浆中洛索洛芬钠浓度的HPLC定量分析方法,测定其在家兔体内的血药浓度经时过程,评价速释缓释双层片和普通片剂的生物等效性。方法血浆中加入内标布洛芬,酸化后经乙酸乙酯5mL提取,进行HPLC测定。给药方案采用单剂量自身交叉,采用DAS软件拟合药物浓度-时间曲线,计算药代动力学参数。结果与普通片相比,速释缓释双层片的tmax,t1/2,cmax降低,相对生物利用度为(105.74%±7.67)%。结论本方法专属性强,灵敏度高,准确性好。速释缓释双层片与普通片生物等效,具有明显的缓释特征。
OBJECTIVE To establish an HPLC method for the bioavailability and pharmacokinefics study of loxoprofen in rabbits. METHODS After adding ibuprofen（internal standard）and 1 mol·L^-1 HCL 100μL, 1 mL of plasma were extracted with 5mL of ethyl acetate and determined by HPLC. A randomized two-way crossover design was adopted. The parameters of pharmacokinetic were calculated by DAS program. RESULTS The results indicated that the tin= and the t1/2 of double-layer tablets（ER） were longer than those of immediate-release tablets （IR）, and the cmax of ER was lower than that of IR： The bioavailability of ER relative to IR Was （105.74 ± 7.67） % .CONCLUSION The method was proved to be simple, sensitive and rapid.The two formulations had the same absorption extent. Comparing with IR, the ER exhibited good extended release tendency.
出处
《海峡药学》
2011年第7期42-44,共3页
Strait Pharmaceutical Journal
