摘要
目的 建立高效液相色谱法测定血浆中更昔洛韦浓度，并研究其生物等效性。方法18名受试者随机等分成2组，先后单剂量口服受试制剂或参比制剂后，采用HPLC法测定血药浓度，计算药物动力学参数并进行生物等效性判定。结果单次服用1000mg受试制剂或参比制剂后的药物动力学参数AUC0～24分别为（2919．2±1426．9）、（3018．3±1663．4）ng·h·mL^-1，AUC0-∞，分别为（3217．9±1575．1）、（3359．5±1720．5）ng·h·mL^-1，fmax分别为（1．5±0．5）、（1．7±0．6）h，Cmax分别为（482．6±212．1）、（515．9±228．0）ng·mL^-1，t1/2分别为（7．70±1．56）、（7．77±3．34）h。受试制剂对参比制剂的相对生物利用度为100．1％±15．3％。2种制剂的药物动力学参数无明显差异。结论HPLC法能快速、准确地测定人血浆中的更昔洛韦，受试制剂与参比制剂具有生物等效性。
OBJECTIVE To determine Ganciclovir in the human plasma by High-Performance Liquid Chromatography method, and to study its bioequivalence. METHODS Eighteen volunteers were randomized into 2 groups. First they received the trial preparation or reference preparation and then they were given the reverse drugs. Plasma concen tration of Ganciclovir was measured by HPLC method. Pharmacokinetic parameters and bioequivalence were deter mined. RESULTS The pharmacokinetic parameters, after the volunteers taking a single dose of 60 mg of the trial preparation or the comparison preparation were as follows; AUC0→24 was （2 919.2±1 426.9） and （3 018.3 ± 1 663.4） ng· h· mL^-1, AUC0→∞, was （3 217.9±1 575.1） and （3 359.5±1 720.5） ng· h· mL^-1, tmax was（1.5 ±0.5） and （1.7±0.6）h, Cmax was （482.6±212.1） and （515.9±228.0） ng·mL^-1 t1/2 was （7.70±1.56） and （7.77±3.34） h, respectively. The relative bioavailability was 100.1% ± 15.3%. No significant differences were found among the main pharmacokinetic parameters after ANOVA. CONCLUSIONS The methods can determine Ganciclovir in the plasma quickly and correctly. The two preparations were equivalent.
出处
《中南药学》
CAS
2006年第3期184-186,共3页
Central South Pharmacy
