CAJ | 학술논문

目的：测定男性健康志愿受试者po β-胡萝卜素咀嚼片和胶丸后血清中β-胡萝卜素(β-carotene)的含量，计算两种剂型的药动学参数，评价咀嚼片对胶丸的相对生物利用度。方法：采用HPLC对10名男性健康志愿者交叉po β-胡萝卜素咀嚼片和胶丸150 mg后测定血药浓度。试验数据扣除人体内源性β-胡萝卜素含量的基础上经3P87软件处理。结果：咀嚼片和胶丸的药动学符合一室模型。AUC0 h～24 h分别为(1 888.20±155.80)μg*h*L-1与(1 536.27±128.67)μg*h*L-1(P＜0.01)；cmax分别为(324.11±22.94)μg*L-1与(258.21±19.11)μg*L-1(P＜0.01)；tpeak分别为(2.76±0.10)h与(2.69±0.14)h(P＞0.05)；t1/2Ka分别为(1.15±0.13)h与(1.21±0.15)h(P＞0.05)。咀嚼片的相对生物利用度为(122.91±10.50)%。结论：咀嚼片和胶丸两者之间AUC0 h～24 h和cmax两参数经t检验差别有高度显著性差异，这提示β-胡萝卜素咀嚼片口服吸收效应优于β-胡萝卜素胶丸。
목적：측정남성건강지원수시자po β-호라복소저작편화효환후혈청중β-호라복소(β-carotene)적함량，계산량충제형적약동학삼수，평개저작편대효환적상대생물이용도。방법：채용HPLC대10명남성건강지원자교차po β-호라복소저작편화효환150 mg후측정혈약농도。시험수거구제인체내원성β-호라복소함량적기출상경3P87연건처리。결과：저작편화효환적약동학부합일실모형。AUC0 h～24 h분별위(1 888.20±155.80)μg*h*L-1여(1 536.27±128.67)μg*h*L-1(P＜0.01)；cmax분별위(324.11±22.94)μg*L-1여(258.21±19.11)μg*L-1(P＜0.01)；tpeak분별위(2.76±0.10)h여(2.69±0.14)h(P＞0.05)；t1/2Ka분별위(1.15±0.13)h여(1.21±0.15)h(P＞0.05)。저작편적상대생물이용도위(122.91±10.50)%。결론：저작편화효환량자지간AUC0 h～24 h화cmax량삼수경t검험차별유고도현저성차이，저제시β-호라복소저작편구복흡수효응우우β-호라복소효환。
To determin β-carotene concentration in male healthy male volunteers serum after oral β-carotene chewing tablet or capsule and calculate its pharmacokinetics parameters, and compute relative bioavailability of chewing tablets. METHOD: A single oral dose of 150 mg β-carotene chewing tablet or capsule was given to 10 healthy male volunteers in a randomized cross study. A procedure of β-carotene concentration in serum quantitative determination by high-performance liquid chromatography was described. RESULTS: The serum concentration-time curves of the two preparations were fitted to a one-compartment model with a lag time in absorption. tpeak of tablet and capsule were (2.76±0.10)h and (2.69±0.14)h, t1/2Ka (1.15±0.13)h and (1.21±0.15)h. AUC0 h～24 h(1 888.20±155.80)μg*h*L-1 and (1 536.27±128.67)μg*h*L-1, cmax (324.11±22.94)μg*L-1 and (258.21±19.11)μg*L-1. The relative bioavailability of chewing tablets was (122.91±10.50)%. CONCLUSION: There was no significant difference in tpeakand t1/2Ka parameters between the two preparations (P＞0.05). Great significant difference was found in AUC0～24 and cmax parameters. The relative bioavailability of the chewing tablets was biger than that of the capsule.