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目的建立盐酸特比萘芬和水杨酸兔血浆浓度的高效液相色谱测定方法,研究家兔涂擦克霉舒搽剂后其主药盐酸特比萘芬和水杨酸在兔体透皮吸收的药动学。方法 12只家兔背部去毛,随机分为单次给药高、中、低剂量组。给药前后按设定的时间耳静脉采血,采用HPLC测定盐酸特比萘芬和水杨酸的血浆浓度,利用PKS1.0软件计算主要药动学参数。结果各给药组家兔血浆中均未测得盐酸特比萘芬;单次给药低、中、高剂量组,水杨酸的主要药动学参数如下:T_(max)为(2.73±0.30),(3.48±0.16),(5.86±1.72)h,C_(max)为(25.24±9.21),(25.32±11.05),(37.47±4.31)μg·mL~(-1),T_(1/2)为(5.74±3.29),(4.60±1.99),(13.28±3.84)h。高剂量组的T_(max)、C_(max)、T_(1/2)高于中、低剂量组(P<0.05)。结论本实验建立的HPLC灵敏准确、简便易行,适合用于盐酸特比萘芬和水杨酸血浆样品的测定。克霉舒搽剂皮肤局部给药安全,盐酸特比萘芬几乎不进入到血浆中,水杨酸可小部分进入血浆中,动力学行为符合一室模型。
OBJECTIVE To establish a HPLC method for the determination of terbinafine hydrochloride and salicylic acid in rabbits, and to study the effects of terbinafine hydrochloride and salicylic acid Absorbed pharmacokinetics. Methods Twelve rabbits were dandruffed on their backs and were randomly divided into high, medium and low dose groups. Blood samples were taken from the ear vein at the set time before and after administration. The plasma concentrations of terbinafine hydrochloride and salicylic acid were determined by HPLC. The main pharmacokinetic parameters were calculated by PKS1.0 software. RESULTS: Terbinafine hydrochloride was not detected in plasma of all rabbits in each treatment group. The main pharmacokinetic parameters of salicylic acid were as follows: T max (2.73 ± 0.30, 3.48 ± 0.16, 5.86 ± 1.72 h and C max were (25.24 ± 9.21), (25.32 ± 11.05), (37.47 ± 4.31) μg · mL -1, / 2) were (5.74 ± 3.29), (4.60 ± 1.99), (13.28 ± 3.84) h. T_ (max), C_ (max) and T_ (1/2) in high dose group were higher than those in middle and low dose group (P <0.05). Conclusion The HPLC established in this study is sensitive, accurate and simple, and is suitable for the determination of terbinafine hydrochloride and salicylic acid plasma samples. Clomipramine liniment skin local administration safe, terbinafine hydrochloride almost did not enter the plasma, salicylic acid can be a small part into the plasma, kinetic behavior consistent with a one-compartment model.