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1.
目的:研究盐酸曲马多片剂在人体内的相对生物利用度。方法:采用HPLC法测定 18名男性健康受试者单剂量交叉口服 100mg2种盐酸曲马多片剂后不同时间血浆中的药物浓度。结果: 2制剂药 时曲线均符合一房室模型,Cmax分别为(410. 0±71. 1)μg·L-1和 (427. 0±57. 1)μg·L-1,Tmax分别为 (2. 20±0. 49)h和 (2. 20±0. 55)h;T1 /2ke分别为(7. 13±0. 83 )h和 ( 7. 08±0. 74 )h;AUCt0 分别为 ( 4 376±855 )μg·h·L-1和 ( 4 514±1 068)μg·h·L-1,AUC∞0 分别为(5 184±1 112)μg·h·L-1和(5 241±1 330)μg·h·L-1。与参比制剂相比,被试制剂的Ft0 为(98. 94±16. 04)%,F∞0 为(1 101. 90±21. 92)%。结论: 2种制剂具有生物等效性。  相似文献   

2.
格列吡嗪片健康人体生物等效性研究   总被引:2,自引:0,他引:2  
目的 研究格列吡嗪片在健康人体内的生物等效性。方法  9名健康受试者单剂量随机交叉口服格列吡嗪片参比制剂和被试制剂 5mg,采用HPLC法测定用药后不同时间的血药浓度。结果 二制剂健康人体的体内过程均符合一房室开放模型 ,Tmax分别为 (3 0± 0 )h和 (3 0± 0 )h ,Cmax分别为 (30 5± 2 2 ) μg·L-1和 (2 99± 13) μg·L-1;T1/2 分别 (3 2 4± 0 37)h和 (3 2 2± 0 4 0 )h ;AUC分别为 (14 90± 70 ) μg·h·L-1和 (14 90± 70 ) μg·h·L-1。被试制剂的相对生物利用度为 (10 0 4± 7 8) %。结论 方差分析和单双侧t检验证明 ,两种制剂具有生物等效性  相似文献   

3.
国产与进口降糖药瑞格列奈片的生物等效性研究   总被引:7,自引:0,他引:7  
目的 :评价国产与进口降糖药瑞格列奈片的生物等效性。 方法 :2 2名男性健康志愿者双周期随机交叉单剂量口服国产与进口瑞格列奈片 4m g,服药间隔为 1周 ,高效液相色谱法测定血浆中瑞格列奈浓度。 结果 :国产与进口片 t1 / 2 分别为(0 .86± 0 .2 4)和 (0 .83± 0 .31) h;tmax分别为 (0 .79± 0 .37)和 (0 .75± 0 .41) h;cmax分别为 (5 2 .43± 2 0 .92 )和 (5 3.32±2 4.94) μg/ L;AU C0 - t分别为 (79.87± 36 .48)和 (74.95± 30 .5 7) μg· h· L- 1。单剂量口服国产瑞格列奈片的相对生物利用度为 (10 6 .5 5± 16 .15 ) %。 结论 :方差分析和双向单侧 t检验结果表明两种制剂具有生物等效性。  相似文献   

4.
目的 :研究尼莫地平在健康人体内的药动学和相对生物利用度。方法 :8名健康受试者单剂量随机交叉口服尼莫地平标准参比制剂和待测制剂 1 2 0mg,采用HPLC法测定用药后不同时间的血药浓度。结果 :2种制剂的体内过程均符合一房室开放模型 ,AUC分别为 (1 4 3.1± 9.9) μg·h·L-1 和 (1 37.0± 7.3) μg·h·L-1 ,Cmax分别为 (83.1±7.4 ) μg·L-1 和 (80 .8± 4 .6 ) μg·L-1 ,Tmax分别为 (1 .0 0± 0 .0 0 )h和 (1 .0 6± 0 .1 7)h。待测制剂的相对生物利用度为 (96 .0± 5 .9) %。经双向单侧t检验证明 ,2种制剂的AUC、Cmax相比 ,差异均无统计学意义。结论 :2种制剂具有生物等效性。  相似文献   

5.
头孢克肟胶囊在健康人体内的相对生物等效性   总被引:7,自引:7,他引:0  
目的 :比较国产和进口头孢克肟胶囊在健康人体内的药代动力学及相对生物等效性 ,确保临床用药质量 .方法 :采用标准二阶段交叉设计自身对照试验法 ,12名男性健康志愿受试者分别口服单剂量两种头孢克肟胶囊 ,用RP HPLC法测定血清中头孢克肟的浓度 ,以双向单侧检验统计法比较 2种头孢克肟胶囊之间的差异 .结果 :国产和进口头孢克肟胶囊在健康志愿者体内的药时曲线均符合血管外给药一室开放模型 ,其主要的药代动力学参数Tmax分别为 (3 .3 9± 0 .5 0 )和(3 .3 3± 0 .4 8)h ,ρmax、AUC( 0~ 2 4h) 分别为 :(2 .97± 0 .5 4 )和 (2 .83±0 .5 5 )mg·L-1;(2 5 .88± 3 .75 )和 (2 4 .67± 4 .3 0 ) (mg·h-1·L-1) ,药动学参数间均无统计学差异 (P >0 .0 5 ) ,国产胶囊对进口胶囊的相对生物利用度为 10 4 .9% .结论 :两种头孢克肟胶囊在健康志愿者体内具有生物等效性  相似文献   

6.
格列吡嗪片在健康人体内的药物动力学及相对生物利用度   总被引:2,自引:0,他引:2  
目的 :研究格列吡嗪片在健康人体的药物动力学及相对生物利用度。方法 :9名健康受试者单剂量随机交叉口服格列吡嗪片参比制剂和被试制剂 5mg ,采用HPLC法测定用药后不同时间的血药浓度。 结果 :2种制剂的体内过程均符合一房室开放模型 ,Tmax分别为 (3 .67± 0 .50 )h和 (3 .33± 0 .50 )h。Cmax分别为 (391± 37) μg·L- 1和 (40 0± 35) μg·L- 1 ,AUC分别为 (2 .46± 0 .39) μg·h·L- 1 和 (2 .2 3± 0 .88) μg·h·L- 1 ,被试制剂的相对生物利用度为 (1 0 2 .9± 1 5 .7) %。结论 :用NDST软件对两种制剂的AUC、Cmax、Tmax进行双单侧t检验 ,证明两种制剂具有生物等效性。  相似文献   

7.
甲磺酸加替沙星胶囊人体药代动力学及生物等效性评价   总被引:5,自引:2,他引:3  
李宏力  樊代明  李哲  文爱东  赵磊  吴寅  郭征  石茹 《医学争鸣》2003,24(20):1915-1918
目的 :研究甲磺酸加替沙星胶囊在健康人体内的药代动力学及相对生物等效性 .方法 :采用双周期随机交叉、自身对照试验设计法 ,将 1 8例男性健康志愿者随机分为两组 ,分别单剂量口服甲磺酸加替沙星胶囊 4 0 0mg(试验品 )和甲磺酸加替沙星片 4 0 0mg(参照品 ) ,经 1w清洗期后交叉换药 ,以高效液相色谱法测定受试者服药后血浆中加替沙星的经时浓度 ,计算加替沙星药动学参数 ,以双单侧t检验统计法比较两种甲磺酸加替沙星制剂是否具有生物等效性 .结果 :甲磺酸加替沙星在人体内的处置为一级吸收单室模型 ,试验品和参照品的主要药动学参数Tmax(实测值 )、Cmax(实测值 )、AUC(0 -2 4h) 分别为 :为 (1 .5 1± 0 .39)和 (1 .5 4± 0 .4 0 )h ,(3.4 8± 0 .84 )和 (3.4 3± 0 .96 )mg·L-1 ,(34.5 1± 8.4 9)和(33.0 4± 1 0 .2 5 )mg·h·L-1 ;试验品的相对生物利用度为1 0 7.4 % .结论 :甲磺酸加替沙星具有口服后吸收快、血药浓度较高、体内平均滞留时间 (MRT)较长的特点 ;两种甲磺酸加替沙星制剂在人体内具有生物等效性 (P >0 .0 5 ) .  相似文献   

8.
目的 比较进口和国产甲巯咪唑片的人体相对生物利用度。方法 12名健康男性志愿受试者,随机分为2组,分别于早晨空腹一次口服进口或国产甲巯咪唑片20mg,1周后再交叉服药。受试者分别于服药前及服药后0.25、0.5、0.75、1、1.5、2、3、4、5、6、8、12、24h肘静脉取血3ml,用HPLC方法测定甲巯咪唑的血药浓度。结果 甲巯咪唑进口制剂与国产制剂血药浓度变化曲线基本平行,两制剂的主要药动学参数如下:T_(max)分别为1.5±1.0h和1.4±0.8h,C_(max)分别为390±77ng/ml和373±100ng/ml,AUC_(0-24)分别为3 384±931ng·h·ml~(-1)和3 104±704ng·h·ml~(-1),AUC_(0-∞)分别为3 845±930ng·h·ml~(-1)和3 446±705ng·h·ml~(-1),T_(1/2)分别为8.7±2.9h和7.8±2.7h,进口和国产制剂的主要药动学参数之间无统计学显著差异(P>0.05)。结论 进口甲巯咪唑片相对于国产甲巯咪唑片的平均生物利用度为115%。  相似文献   

9.
目的 :研究地尔硫 卓艹 缓释片在健康人体的药物动力学及相对生物利用度。方法 :以上海产地尔硫 卓艹 缓释片为参比制剂 ,焦作市第二制药厂产地尔硫卓艹 缓释片为受试制剂 ,分别进行单次和多次用药试验 ,12名受试者采用随机交叉口服单剂量 (12 0mg)和多剂量 (6 0mg ,3次 /d ,共用 5d)地尔硫卓艹 缓释片。高效液相色谱 (HPLC)法测定用药后不同时间血清中地尔硫 卓艹质量浓度 ,用 3P87软件处理药 时数据。结果 :单次用药后 ,2制剂的体内过程均符合一房室开放模型 ,血药浓度分别在用药后 (2 .0 0± 0 .5 2 )h和 (1.88± 0 .43)h达峰值 (131± 17) μg·L-1和 (12 2± 11)μg·L-1,药时曲线下面积 (AUC)分别为 (112 2± 2 5 6 ) μg·L-1和 (110 9± 2 32 ) μg·h·L-1,受试制剂的相对生物利用度为(10 0 .0± 11.9) % (84.4%~ 117.5 % ) ;多次用药血药浓度达稳态后 ,峰浓度 (Cmax)分别为 (111± 8) μg·L-1和 (10 9± 9)μg·L-1,谷浓度 (Cmin)分别为 (35± 9) μg·L-1和 (38± 10 ) μg·L-1。两者血药浓度波动系数 (FI)分别为 (1.2 3± 0 .2 9)和 (1.12± 0 .2 3)。结论 :受试制剂在健康人体具有明显的缓释特征 ,且和参比制剂具有生物等效性。  相似文献   

10.
吉非罗齐胶囊在健康人体内的相对生物利用度   总被引:2,自引:0,他引:2  
目的 :研究吉非罗齐胶囊在健康人体内的相对生物利用度。方法 :采用高效液相色谱 (HPLC)法测定 18名男性健康受试者单剂量交叉口服 90 0mg 2种吉非罗齐胶囊后不同时间血浆中的药物浓度。结果 :二者药 时曲线均符合一房室模型 ,Cmax分别为 (45 .2 4± 10 .15 )mg·L-1和 (43.38± 9.84 )mg·L-1;Tmax分别为 (2 .4 7± 0 .93)h和 (2 .2 5±0 .75 )h ;T1/ 2 分别 (1.5 9± 0 .19)h和 (1.75± 0 .2 9)h ;AUC分别为 (16 5 .79± 37.79)mg·h·L-1和 (15 6 .39± 32 .2 8)mg·h·L-1。被试制剂的相对生物利用度为 (95 .5 5± 11.4 5 ) % (77.0 3%~ 119.4 5 % )。结论 :2种制剂具有生物等效性。  相似文献   

11.
Objective To observe blood pressure change with age in salt-sensitive teenagers whose salt sensitivity were determined by repeated testing.Methods Salt sensitivity was determined through intravenous infusion of normal saline combined with volume-depletion by oral diuretic furosemide in 55 teenagers. After five years, salt sensitivity was re-examined and subject blood pressure was followed up. Blood pressure changes in salt-sensitive teenagers were compared to that of non-salt sensitive teenagers over five years.Results After 5 years, the repetition rate of salt sensitivity determined by intravenous saline loading is 92.7%. In teenagers with salt sensitivity on the baseline, both the systolic blood pressure increments and increment rates were much higher than non-salt sensitive teenagers (12.7±12.1 mmHg vs. 2.8±5.2 mmHg, P< 0.01; 12.2%± 12.0% vs. 2.5% ±4.4%, P< 0.001,respectively). There was a similar trend for diastolic blood pressure (8.4 ± 6.4 mmHg vs. 3.7 ± 6.4 mmHg, P = 0.052; 13.2% ±10.6 % vs. 6.8%± 10.1%, P = 0.053, respectively).Conclusions Salt sensitivity determined by intravenous saline loading showed good reproducibility. Blood pressure increments with age were much higher in salt-sensitive teenagers than non-salt sensitive teenagers, especially in terms of systolic blood pressure.  相似文献   

12.
Objective: To evaluatel the value of D-dimers in patients with acute aortic dissection (AAD). Methods: This study consisted of 16 patients with AAD and 27 non-AAD patients. Serum D-dimets were measured by Sta-Liatest D-DI immunoturbidimetric assay. Results: D-dimer level was higher (P < 0.001) in patients with AAD(7.91 ± 5.52 μg/ml) than that in non- AAD group(1.57±1.24 μg/ml). D-dimer was positive (>0.4 μg/ml) in all patients with AAD and in 10 control group patients (37%). Among patients with acute AAD, D-dimers tended to be higher in Stanford A than in Stanford B (8.67 ± 4.31 μg/ml vs. 3.24±1.27 μg/ml, P <0.01). D-dimer values tended to be higher in more extended disease(3.84 ± 1.65 μg/ml, 8.57 ± 3.58 μg/ml and 11.87 ± 5.69 μg/ml in thoracic aorta, thoracic and abdominal aorta, thoracic and abdominal aorta and iliacal arteries, respectively, P < 0.05 for both 8.57 ± 3.58 and 11.87 ± 5.69 vs. 3.84 ± 1.65 ). Including the control group into the analysis, we found a sensitivity of 100%, a negative predictive value of 100%, and a specificity of 66% and a positive predictive value of 64% for D-dimer in diagnosis of AAD in our patients with suspected AAD. Conclusion: D-dimer was elevated in patients with AAD. A negative D-dimer test result could be useful in excluding AAD.  相似文献   

13.
Objective: To set up a simple and reliable rat model of combined liver-kidney transplantation. Methods: SD rats served as both donors and recipients. 4℃ sodium lactate Ringer's was infused from portal veins to donated livers,and from abdominal aorta to donated kidneys, respectively. Anastomosis of the portal vein and the inferior vena cava (IVC) inferior to the right kidney between the graft and the recipient was performed by a double cuff method, then the superior hepatic vena cava with suture. A patch of donated renal artery was anastomosed to the recipient abdominal aorta. The urethra and bile duct were reconstructed with a simple inside bracket. Results: Among 65 cases of combined liver-kidney transplantation, the success rate in the late 40 cases was 77.5%. The function of the grafted liver and kidney remained normal. Conclusion: This rat model of combined liver-kidney transplantation can be established in common laboratory conditions with high success rate and meet the needs of renal transplantation experiment.  相似文献   

14.
Increasing maternal age is the only etiological factor unequivocally linked to Down's syndrome in humans. The occurrence rate of newborns with Down's syndrome is about 1/220 in women over 35 years old. However, the occurrence rate in embryos fertilized in vitro, of the elder woman is unclear. Using FISH we screened the number of chromosome 21 in preimplanted embryos of 5 elderly women (average age, 38.4 years) to study the feasibility and necessity of screening trisomy 21 in embryos in patients over 35 years old at the in vitro fertilization (IVF) center.  相似文献   

15.
Real-time three-dimensional echocardiography (RT3DE)is a new ultrasound technique that enables dynamic threedimensional visualization and quantification of the heart in real time. Investigation of feasibility and methodology of RT3DE in determining left ventricular (LV) and right ventricular (RV) volumes, RT3DE was performed in 35 normal adults using Philips SONOS 7500 system with a 2-4 MHz matrix array transducer. The 60°×60° "pyramid" volume database was obtained and analyzed on a TomTec echo workstation. Both LV and RV volumes were calculated with four 3DE methods (i.e. apical 2, 4, 8, and 16-plane) through manually tracing ventricular endocardial borders in end diastole and end systole. Stroke volumes were then calculated. LV volume was also measured by 2DE Simpson's rule using GE VIVID 7 ultrasound machine.  相似文献   

16.
A clinical guideline for the therapeutic interventions of integrative medicine may be defined as a written document which states a series of recommendations on therapeutic interventions of integrative medicine for a special disease or condition. The guideline may provide assistance to medical professionals in making clinical decisions aimed at improving the clinical outcome of patients and reducing the costs of medical care(~'4~. Recommendations issued by a guideline should be based on the best available evidence in both Western and Chinese medicine. For fulfilling this purpose, the development of clinical guidelines for therapeutic interventions in the field of integrative medicine should follow scientific principles and undergo a rigorous processes.  相似文献   

17.
Objective:To probe into the influence of changes of ovarian hormones on the pathogenesis of the specific sub-type premenstrual syndrome(PMS)and reveal partial microcosmic mechanisms of adverse flow of liver-qi.Methods:Estradiol(E2)and progesterone(P)levels in serum were determined at different phases of menstrual cycle by radioimmunoassay.Results:In the group of PMS with adverse flow of liver-qi.the secretive peak value Of E2 and P at the follicular phase significantly decreased,and the secretive peak value at the luteal phase did not come into being.Conclusions:Low E2 and P secretive peak at the follicular phase and absence of secretive peak at the luteal phase is one of the microcosmic mechanisms of PMS with adverse flow of liver-qi.One of the pathophysiologic mechanisms of specific sub-type PMS is probably the continuous low level of E2and P.  相似文献   

18.
Journal of Nanjing Medical University (English Edition) JNMU, sponsored by Nanjing Medical University, was established in 1987. It is a bimonthly comprehensive English medical journal published locally and abroad.Since 2007, Journal of Nanjing Medical University (English Edition )was granted Elsevier the full publishing and distribution rights worldwide for the Electronic Edition, excluding the People's Republic of China.  相似文献   

19.
目的:评价使用安心颗粒对急诊经皮冠状动脉介入术(PPCI)术后生活质量的影响.方法:将160例接受PPCI的急性ST段抬高型心肌梗死患者随机分为安心颗粒组(术前顿服安心颗粒8.8g,术后安心颗粒4.4 g/次,每日2次)和对照组(仅接受基础药物治疗).所有患者均服用阿司匹林、氯吡格雷和阿托伐他汀.分别在入院时、出院前1d、出院后180 d时,应用心肌梗死多维度量表(MIDAS)、中文版SF-36评价量表对患者生活质量评分.并观察术后30 d以内的出血并发症、血小板减少症发生情况.结果:入院时和出院前1d,两组患者的心肌梗死MIDAS、SF-36量表评分比较无差异(P>0.05);出院后180 d时,与对照组比较,安心颗粒组MIDAS、SF-36评分明显减低(P<0.05);组内与入院时比较,两组出院前1d、出院后180 d时,MIDAS、SF-36评分均降低(P<0.05).两组患者在随访期间均无大量出血、少量出血、重度和极重度血小板减少症发生,安心颗粒组有4例、对照组有7例发生不明显出血(P>0.05).两组发生轻度血小板减少症的患者数比较无差异(P>0.05).结论:PPCI使用安心颗粒,能改善急性ST段抬高型心肌梗死患者的生活质量,且不增加出血风险.  相似文献   

20.
Objective:To investigate the influences of urapidil and nicardipine on rabbit sinus function,atrio-ventricular node function and hemodynamics.Methods:Thirty-two Angora's rabbits were selected and randomly divided into four groups.U1 group:urapidil 0.25 mg/kg;U2 group:urapidil 0.5 mg/kg;N1 group:nicardipine 10 μg/kg;N2 group:nicardipine 20 μg/kg.All these medicine were administrated within 30 seconds.Measurements were taken before and after the administration of urapidil or nicardipine for the following data:mean blood pressure(MAP),heart rate(HR),sino-atrial conduction time(SACT),maximal sinoatrial recovery time(SNRTmax)corrected sinus node recovery time(CSNRT),index of sinus node recovery time(SNRTI),Wenckebach A-V conduction frequency (WB),and P-R interval.Results:Significant MAP and HR changes were identified in all of the four groups before and after administration of both urapidil and nicardipine.No significant changes could be found in the rest of the parameters.Intergroup analysis showed that SACT and CSNRT of N1 and N2 groups were shorter than those of the U2 group(P<0.01);the MAP decreased(P<0.01)and the HR increased drastically(P<0.01).Conclusions:Neither urapidil(0.25 mg/kg,0.5 mg/kg)nor nicardipine(10μg/kg,20μg/kg)has any significant influence on rabbit sinus function or rabbit atrio-ventricular node function.Nicardipine could be a better choice than urapidil for parafunctional sinus node patients.  相似文献   

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