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bioequivalence
相关语句
  生物等效性
    Bioequivalence study of baicalin capsules in healthy volunteers
    黄芩苷胶囊的人体生物等效性研究
短句来源
    It is not only the important indexes for evaluation of bioequivalence,also the important parameter of formulation optimization,study of the stability and quality control within producing of sustained or controlled release dosage forms.
    它是生物等效性评价的重要指标,也是缓控释制剂处方优化、稳定性考察、生产过程的质量控制等方面的重要参数。
短句来源
    Studies on Preclinical Pharmacokinetics of Dencichine and Bioequivalence of Rabeprazole
    三七素临床前药物动力学和雷贝拉唑制剂生物等效性研究
短句来源
    Relative bioavailability and bioequivalence of Ruxiankang oral liquid
    乳腺康口服液相对生物利用度及生物等效性研究
短句来源
    Bioequivalence of matrine tablet and capsule in healthy volunteers
    苦参素片人体生物等效性研究
短句来源
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  “bioequivalence”译为未确定词的双语例句
    ② Dihuang Guanshitong oral liquid can induce change of cell apoptosis with bioequivalence F of 158.35(p<0.01). The apoptotic index increase with the enhancement of drug concentration,which indicates concentration-dependence. ?
    ②地黄管食通口服液可以诱导Eca109细胞发生凋亡改变,随着药物浓度的增加,凋亡指数增加,这种作用呈浓度依赖性,方差分析F值为158.35(p<0.01)。
短句来源
  相似匹配句对
    Bioequivalence study of baicalin capsules in healthy volunteers
    黄芩苷胶囊的人体生物等效性研究
短句来源
    Studies on Preclinical Pharmacokinetics of Dencichine and Bioequivalence of Rabeprazole
    三七素临床前药物动力学和雷贝拉唑制剂生物等效性研究
短句来源
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  bioequivalence
The method was successfully applied to investigate the bioequivalence between two kinds of tablets (test versus reference products) in 18 healthy male Chinese volunteers.
      
Bioanalytical laboratories support a range of regulatory studies ranging from early toxicology studies through Phase 1,2 and 3 clinical studies to definitive bioequivalence and bioavailabity studies in support of the marketed product.
      
With a total run-time of 6 minutes, the method was suitable for supporting clinical studies and applied to the analysis of samples from a bioequivalence study.
      
A new sensitive HPLC-FLD method has been developed and validated for the determination of cisapride in human plasma for a bioequivalence study.
      
This method has been successfully used to support a bioequivalence clinical study.
      
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Objective: To evaluate the bioequivalence of matrine tablet as test and matrine capsule as reference. Methods: Twenty healthy volunteers were involved in a two period crossover test. The time-plasma concentrations of oxymatrine were determined by HPLC after a single oral dose of matrine, and their pharmacokinetic parameters were calculated and analyzed with two-one side test and confidencial interval test. Results: The mean pharmacokinetic parameters of test and reference preparations: t1/2(1.280.20) μg穖l-1,AUC0~6...

Objective: To evaluate the bioequivalence of matrine tablet as test and matrine capsule as reference. Methods: Twenty healthy volunteers were involved in a two period crossover test. The time-plasma concentrations of oxymatrine were determined by HPLC after a single oral dose of matrine, and their pharmacokinetic parameters were calculated and analyzed with two-one side test and confidencial interval test. Results: The mean pharmacokinetic parameters of test and reference preparations: t1/2(1.280.20) μg穖l-1,AUC0~6 (2.17±0.48) and (2.20±0.51) μg穖l穐-1, AUC0~∞ (2.41±0.56) and (2.43±0.60) μg穖l穐-1, respectively. The bioavailability of matrine tablet (calculated by oxymatrine) was (99.56

目的:进行苦参素片与苦参素胶囊的人体生物等效性研究,为新药报批及其临床应用提供依据。方法:将健康志愿者20名分为两组,分别于试验当日晨空腹1次口服苦参素片或苦参素胶囊600mg,于药前和药后取经时肘静脉血4ml,采用高效液相色谱法测定氧化苦参碱血浓度。计算试验制剂和参比制剂的药代动力学参数,评价两种制剂的生物等效性。结果:苦参素试验制剂和参比制剂主要药代动力学参数(以氧化苦参碱计)t1/2分别为(1.28±0.25)、(1.26±0.14)h,Tmax分别为(2.45±0.77)、(2.48±0.79)h,Cmax分别为(0.81±0.19)、(0.84±0.20)μg·ml鄄1,AUC0~6分别为(2.17±0.48)、(2.20±0.51)μg·ml·h鄄1,AUC0~∞分别为(2.41±0.56)、(2.43±0.60)μg·ml·h鄄1。试验制剂苦参素片相对生物利用度F(以氧化苦参碱计)为(99.56±12.32)%。结论:苦参素试验制剂和参比制剂单剂口服双交叉试验主要药代动力学参数无显著性差异,个体间、周期间和剂型间符合生物等效的假设,为生物等效制剂。

Objective: To study the bioequivalence between tablet and capsule of kurorinone in healthy volunteers.Method: twenty volunteers were randomly divided into two groups(test and reference),ten in each,with double-cross experimental design.Blood amples were collected at 0, 0.25 , 0.5 , 1.0 , 1.25 , 1.5 ,2, 2.5 , 3.0 , 3.5 , 4.0 , 5.0 , 6.0 , 8.0 h after single oral dose of 600 mg tablet or capsule of kurorinone, respectively.The time-concentration of kurorinone were determined...

Objective: To study the bioequivalence between tablet and capsule of kurorinone in healthy volunteers.Method: twenty volunteers were randomly divided into two groups(test and reference),ten in each,with double-cross experimental design.Blood amples were collected at 0, 0.25 , 0.5 , 1.0 , 1.25 , 1.5 ,2, 2.5 , 3.0 , 3.5 , 4.0 , 5.0 , 6.0 , 8.0 h after single oral dose of 600 mg tablet or capsule of kurorinone, respectively.The time-concentration of kurorinone were determined by HPLC and pharmacokinetic parameters were calculated with 3P97 practical pharmacokinetics program.Result: The pharmacokinetic parameters of kurorinone tablet and capsule were as follows: t 1/2 ( 2.144 ± 0.453 )h and ( 2.066 ± 0.439 )h,t max ( 2.275 ± 0.716 )h and ( 2.175 ± 0.654 )h,C max ( 0.384 ± 0.144 )μg·ml -1 and( 0.370 ± 0.132 )μg·ml -1 ,AUC 0-8 h ( 1.098 ± 0.278 )μg(ml·h) and ( 1.094 ± 0.280 )μg(ml·h),AUC 0-∞ ( 1.216 ± 0.292 )μg(ml·h) and( 1.200 ± 0.271 )μg(ml·h).The relative bioavailability of kurorinone tablet was ( 100.403 ± 6.281 )%.Conclusion: The statistical analysis showed that the test and reference preparations were bioquivalent.

目的 :比较苦参素片剂与胶囊剂的生物等效性。方法 :2 0名男性健康志愿者 ,双交叉于试验当日晨空腹一次口服试验制剂苦参素片、参比制剂苦参素胶囊 6 0 0mg ,于药前和药后 0 .2 5 ,0 .5 ,1.0 ,1.2 5 ,1.5 ,2 .0 ,2 .5 ,3.0 ,3.5 ,4 .0 ,5 .0 ,6 .0 ,8.0h取肘静脉血 ,高效液相色谱法测定主要成分氧化苦参碱血药浓度。氧化苦参碱血药浓度 时间数据经 3P97处理 ,得药动学参数 ,参数进行方差分析、双单侧t检验和 (1- 2α)置信区间分析 ,并计算相对生物利用度评价两种制剂的生物等效性。结果 :苦参素片和苦参素胶囊氧化苦参碱主要药代动力学参数t1/ 2 分别为 (2 .14 4± 0 .4 5 3)h和 (2 .0 6 6± 0 .4 39)h ,tmax分别为 (2 .2 75± 0 .716 )h和 (2 .175± 0 .6 5 4 )h ,Cmax分别为 (0 .384± 0 .14 4 ) μg·ml-1和 (0 .370± 0 .132 ) μg·ml-1,AUC0 -8h分别为 (1.0 98±0 .2 78) μg·ml-...

目的 :比较苦参素片剂与胶囊剂的生物等效性。方法 :2 0名男性健康志愿者 ,双交叉于试验当日晨空腹一次口服试验制剂苦参素片、参比制剂苦参素胶囊 6 0 0mg ,于药前和药后 0 .2 5 ,0 .5 ,1.0 ,1.2 5 ,1.5 ,2 .0 ,2 .5 ,3.0 ,3.5 ,4 .0 ,5 .0 ,6 .0 ,8.0h取肘静脉血 ,高效液相色谱法测定主要成分氧化苦参碱血药浓度。氧化苦参碱血药浓度 时间数据经 3P97处理 ,得药动学参数 ,参数进行方差分析、双单侧t检验和 (1- 2α)置信区间分析 ,并计算相对生物利用度评价两种制剂的生物等效性。结果 :苦参素片和苦参素胶囊氧化苦参碱主要药代动力学参数t1/ 2 分别为 (2 .14 4± 0 .4 5 3)h和 (2 .0 6 6± 0 .4 39)h ,tmax分别为 (2 .2 75± 0 .716 )h和 (2 .175± 0 .6 5 4 )h ,Cmax分别为 (0 .384± 0 .14 4 ) μg·ml-1和 (0 .370± 0 .132 ) μg·ml-1,AUC0 -8h分别为 (1.0 98±0 .2 78) μg·ml-1·h和 (1.0 94± 0 .2 80 ) μg·ml-1·h ,AUC0 -∞ 分别为 (1.2 16± 0 .2 92 ) μg·ml-1·h和 (1.2 0 0± 0 .2 71) μg·ml-1·h。试验制剂苦参素片相对生物利用度F(以氧化苦参碱计 )为 10 0 .4 0 3%± 6 .2 81% ,两制剂具有生物等效性。结论 :苦参素片和苦参素胶囊为生物等效制剂。

Objective To study the bioequivalence of two kinds of oxymatrine soft capsules in healthy volunteers. Method A single oral dose of 900 mg matrine of test product or of reference product was given to 18 healthy male volunteers randomized into two groups. Seven days later the two products were administrated again by exchange of the oxymatrine products. Oxymatrine concentrations in plasma were determined by HPLC method. The pharmacokinetic parameters and relative bioavailability were calculated by 3P97 program...

Objective To study the bioequivalence of two kinds of oxymatrine soft capsules in healthy volunteers. Method A single oral dose of 900 mg matrine of test product or of reference product was given to 18 healthy male volunteers randomized into two groups. Seven days later the two products were administrated again by exchange of the oxymatrine products. Oxymatrine concentrations in plasma were determined by HPLC method. The pharmacokinetic parameters and relative bioavailability were calculated by 3P97 program to evaluate the bioequivalence of two preparations. Results The main pharmacokinetic parameters of the test and the reference were: C max were(3. 48±1. 01) mg·L -1 and(3. 40±0. 57) mg·L - 1 ; t max were (11.44±2. 97) h and(12.11±1.45) h; t 1/2 were (7.94±2.86) h and (8.55±3.49) h; AUC 0→36 were (57.66±14.10) mg·h·L -1 and(59.04±10.57) mg·h·L -1 ; AUC 0→∞ were (64.56±18.70) mg·h·L -1 and (67.06±14.75) mg·h·L -1,respectively. The relative bioavailability of the test to the reference were(98.5±21.3)%( F 0→36 )and(97.4±23.0)% ( F 0→∞).Conclusion The results demonstrated that the two oxymatrine products had bioequivalent.

目的研究两种苦参素软胶囊的人体生物等效性。方法18例健康男性志愿者随机分为两组,分别口服受试制剂苦参素软胶囊和参比制剂苦参素软胶囊900mg,7d后交叉服用参比制剂和受试制剂。采用高效液相色谱法测定两组受试者体内苦参碱的经时血药浓度,计算其药动学参数和相对生物利用度,评价两种制剂的生物等效性。结果单次口服受试制剂与参比制剂900mg后,两组受试者的主要药动学参数Cmax分别为(3.48±1.01)和(3.40±0.57)mg·L1,tmax分别为(11.44±2.97)和(12.11±1.45)h,t1/2分别为(7.94±2.86)和(8.55±3.49)h,AUC0→36分别为(57.66±14.10)和(59.04±10.57)mg·h·L1,AUC0→∞分别为(64.56±18.70)和(67.06±14.75)mg·h·L1。经检验,两组药动学参数均差异无显著性(均P>0.05)。受试制剂的相对生物利用度为(98.5±21.3)%(F0→36)和(97.4±23.0)%(F0→∞)。结论受试制剂与参比制剂苦参素软胶囊具有生物等效性。

 
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