两种盐酸噻氯匹定片的生物等效性评价

Study on pharmacokinetics and bioavailability of ticlopidine hydrochloride

目的:研究两种盐酸噻氯匹定片(A片和B片)在健康志愿者中的生物等效性。方法:根据交叉试验方案口服单剂量(500mg)两种盐酸噻氯匹定片,采用高效液相色谱法测定血浆中盐酸噻氯匹定的浓度。结果:盐酸噻氯匹定片(A片)和参比片剂(B片,对照药)的tmax分别为(2.1±0.6)h和(1.9±0.5)h;Cmax分别为(1 589.1±718.7)μg.L-1和(1 520.8±678.1)μg.L-1;AUC0→∞分别为(7 875.6±3 175.0)μg.h.L-1和(8 146.1±3 391.1)μg.h.L-1;A片相对于B片的生物利用度为(105.6±30.4)%。经配对检验,两种片剂的主要药动学参数Cmax、AUC0→∞的差异无显著性意义(P>0.05)。结论:两种盐酸噻氯匹定片为生物等效制剂。

OBJECTIVE To study the relative bioavailability between two products of ticlopidine hydrochLoride （tablet A, B）. METHODS Healthy volunteers were orally given 500 mg of either ticlopidine hydrochloride in an open randomized crossover test. The ticlopidine hydrochloride concentration in plasma was determined by HPLC method. RESULTS The peak time （tmax） of tablet A and B were （2. 1 ± 0. 6）h and （ 1.9 ± 0. 5）h, the pesk plassmaL levels （Cmax） were （ 1589. 1 ± 718.7）μg·L and（ 1 520. 8 ± 678. 1 ）μg· L^-1, and AUC0→∞ were （7 875.6 ± 3 175.0） μg·h·L^-1 （8 146. 1 ± 3 391. 0）μg·h·L^-1 and tablet A to tablet B was （105. 6 ± 30. 4）%. There were no significant differences in parameters Cmax, AUC0→∞ between two products （P 〉0.05）. CONCLUSION The two products of ticlopidine hydrochloride tablets are bioequivalent.