盐酸氨溴索口腔崩解片人体生物等效性研究

目的研究盐酸氨溴索口腔崩解片在正常人体内的药动学和生物等效性。方法20名健康男性志愿受试者单剂量随机交叉口服盐酸氨溴索口腔崩解片(受试制剂)或盐酸氨溴索片(参比制剂)60mg,采用高效液相色谱法测定血药浓度,3p97程序计算药动学参数与相对生物利用度。结果受试制剂与参比制剂的血药浓度均呈一室模型,tmax分别为(2.54±0.94)、(2.18±1.04)h,Cmax分别为(66.51±34.88)、(67.59±38.95)ng/ml,AUC0~t分别为(362.52±212.14)、(367.60±224.76)(ng.h)/ml,t1/2ke分别为(4.74±2.61)、(4.84±1.76)h,2种制剂的主要药动学参数无显著性差异(P>0.05),受试制剂的相对生物利用度为(98.62±13.42)%。结论2种制剂具有生物等效性。

Bioequiavailability of Orally Disintegrating Tablets of Ambroxol Hydrochloride in Healthy Subjects

OBJECTIVE: To study the pharmacokinetics and bioequiavailability of orally disintegrating tablets of ambroxol hydrochloride in healthy subjects. METHODS: A single dose of 60mg of orally disintegrating tablets of ambroxol hydrochloride(test preparation ) or ambroxol hydrochloride tablets (control preparation) was administered to 20 healthy male volunteers in a randomized crossover way. The plasma concentrations of ambroxol were determined by HPLC. The pharmacokinetic parameters and relative bioequivailability were calculated with 3p97 program. RESULTS: The concentration curves of both test and control preparation fitted one-compartment model. The peak time(tmax) of test and control preparation were (2.54±0.94) h and (2.18±1.04)h, respectively; the peak plasma levels(Cmax) were (66.51±34.88)ng/ml and (67.59±38.95)ng/ml, respectively;AUC0～t were (362.52±212.14)(ng·h)/ml and (367.60±224.76)(ng·h)/ml, respectively; half-life time (ke) were (4.74±2.61)h and (4.84±1.76)h, respectively. The results suggested that there was no significant difference (P>0.05)in the main pharmacokinetic parameters of two kinds of preparation. The relative bioequiavailaility of test preparation was (98.62±13.42)%. CONCLUSION: Two kinds of preparation are bioequivalent.