重庆医科大学学报
重慶醫科大學學報
중경의과대학학보
UNIVERSITATIS SCIENTIAE MEDICINAE CHONGQING
2009年
11期
1552-1555
,共4页
盐酸氨溴索%生物等效性%血药浓度
鹽痠氨溴索%生物等效性%血藥濃度
염산안추색%생물등효성%혈약농도
Ambroxol hydrochloride%Bioequivalence%Plasma concentration
目的:研究盐酸氨溴索缓释片与对照制剂的人体生物等效性.方法:20名健康受试者采用双周期2制剂自身交叉单剂量口服盐酸氨溴索缓释片和对照制剂;用高效液相色谱法测定血药浓度,3P97软件计算药动学参数和等效性分析.结果:盐酸氨溴索缓释片与对照制剂的Cmax分别为78.19±11.60和77.26 4±18.50 ng/ml,T_(max)分别为5.00±1.16和5.004±1.16 h,AUC(0～36h)分别为1234.70±58.50和1150.10±265.48(ng/ml)·h,AUG_(0-inf)分别为1505.74 4±208.10和1381.25±364.37(ng/ml)h·C_(max),AUC(0～36h)AUG_(0-inf)的90%可信区间分别为76.8%～125.6%,87.5%～109.1%,101.4%～120.3%.结论:试验制剂与对照制剂的人体相对生物利用度为(113.4±35.3)%,试验制剂与对照制剂具有生物等效性.
目的:研究鹽痠氨溴索緩釋片與對照製劑的人體生物等效性.方法:20名健康受試者採用雙週期2製劑自身交扠單劑量口服鹽痠氨溴索緩釋片和對照製劑;用高效液相色譜法測定血藥濃度,3P97軟件計算藥動學參數和等效性分析.結果:鹽痠氨溴索緩釋片與對照製劑的Cmax分彆為78.19±11.60和77.26 4±18.50 ng/ml,T_(max)分彆為5.00±1.16和5.004±1.16 h,AUC(0～36h)分彆為1234.70±58.50和1150.10±265.48(ng/ml)·h,AUG_(0-inf)分彆為1505.74 4±208.10和1381.25±364.37(ng/ml)h·C_(max),AUC(0～36h)AUG_(0-inf)的90%可信區間分彆為76.8%～125.6%,87.5%～109.1%,101.4%～120.3%.結論:試驗製劑與對照製劑的人體相對生物利用度為(113.4±35.3)%,試驗製劑與對照製劑具有生物等效性.
목적:연구염산안추색완석편여대조제제적인체생물등효성.방법:20명건강수시자채용쌍주기2제제자신교차단제량구복염산안추색완석편화대조제제;용고효액상색보법측정혈약농도,3P97연건계산약동학삼수화등효성분석.결과:염산안추색완석편여대조제제적Cmax분별위78.19±11.60화77.26 4±18.50 ng/ml,T_(max)분별위5.00±1.16화5.004±1.16 h,AUC(0～36h)분별위1234.70±58.50화1150.10±265.48(ng/ml)·h,AUG_(0-inf)분별위1505.74 4±208.10화1381.25±364.37(ng/ml)h·C_(max),AUC(0～36h)AUG_(0-inf)적90%가신구간분별위76.8%～125.6%,87.5%～109.1%,101.4%～120.3%.결론:시험제제여대조제제적인체상대생물이용도위(113.4±35.3)%,시험제제여대조제제구유생물등효성.
Objective: To study the bioequivalence of ambroxol hydrochloride sustained-release tablets to the reference. Methods: A single oral dose (75 mg tested and reference formulation) was given to 20 healthy volunteers in a randomised crossover study .The concentrations of ambroxol hydrochloride sustained-release tablets in plasma were determined by HPLC. Results: After a single dose,the pharmaco kinetic parameters for ambroxol hydrochloride sustained-release tablets as compared with those of the reference were as follows: Cmax: (78.19±11.60)and (77.26 ± 18.50) ng/ml;T_(max): (5.00 ± 1.16 )and (5.00± 1.16)h; AUC (0～36h):(1234.70±58.50)and (1150.10± 265.48) (ng/ml) ·h;AUC_(0-inf): (1505.74 ± 208.10)and( 1381.25 ± 364.37)(ng/ml)·h.The 90% confidential intervals of Cmax, AUC(0～36h) and AUC_(0-inf) of tested formulation were 76.8%～125.6% ,87.5%～109.1% ,101.4%～120.3% .respectively. Conclusion:The relative bioavailability is (113.4 ± 35.3 )%.The results of the statistic analysis show that the two formulations are bioequivalent.
