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1.
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   

2.
目的 制备三七总皂苷 ( Panax notoginseng saponins,PNS)脂质体 ,研究其药剂学性质及在大鼠体内药动学行为。方法 采用薄膜分散法制备 PNS脂质体 ,考察其形态、粒径、包封率及稳定性 ,采用肺部滴注给药考察脂质体在大鼠体内的药动学行为。结果  PNS脂质体包封率为 78.5 0 % ,平均粒径为 1.5 μm,外形圆整 ,体外泄漏慢 ,需低温保存。 PNS脂质体经大鼠肺部滴注给药后 ,体内人参皂苷 Rb1的药动学参数分别为 T1 /2 α=7.0 0 h,T1 /2 β=2 7.72 h,AU C=2 2 18.9μg· h/m L,绝对生物利用度为 70 .14 %。结论  PNS脂质体包封率高 ,性质稳定 ,延长PNS在血循环的时间 ,提高了经血管外给药途径的 PNS生物利用度。  相似文献   

3.
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   

4.
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   

5.
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   

6.
目的:研究头孢克洛在健康人体的药动学及相对生物利用度。方法:18名健康受试者随机交叉单剂量口服头孢克洛片标准参比制剂和被试制剂500mg,采用微生物法测定不同时间血清中药物浓度。结果:两制剂的体内过程均符合一房室开放模型,其主要药动学参数Cmax分别为(13.94±1.55)mg·L-1和(14.10±1.45)mg·L-1,Tmax为(0.72±0.15)h和(0.75±0.12)h,T1/2ke为(0.65±0.05)h和(0.69±0.06)h,AUCt0为(15.78±2.75)mg·h·L-1和(14.86±2.98)mg·h·L-1,AUC∞0为(15.96±2.74)mg·h·L-1和(15.10±3.04)mg·h·L-1。被试制剂的相对生物利用度为(107.99±17.82)%。结论:2种制剂具有生物等效性。  相似文献   

7.
目的以透明质酸为载体材料制备紫杉醇透明质酸冻干制剂,并考察冻干制剂在大鼠体内的药动学。方法采用乳匀-冻干法制备冻干制剂;以透射电子显微镜观察其粒子形态;建立冻干制剂及其在血浆中紫杉醇的HPLC分析方法;以紫杉醇注射剂为对照,测定冻干制剂10mg/kgiv给药后,大鼠体内的药动学参数。结果在冻干制剂中,紫杉醇以球形包覆于透明质酸基质中;在溶液中,分散成平均粒径为80nm的包覆微球;大鼠iv冻干制剂和紫杉醇注射剂的药物浓度-时间曲线符合二室模型,其药动学参数AUC分别为(37.68±6.36μg·h/mL和(27.54±5.88)μg·h/mL;CL分别为(0.26±0.04)h-1和(0.38±0.07)h-1。结论透明质酸可能成为一种新的抗癌药物载体。  相似文献   

8.
汉黄芩素脂质体的制备及大鼠体内药代动力学   总被引:3,自引:0,他引:3  
目的:制备包封率高且粒径适宜的汉黄芩素脂质体,考察其体外释放及大鼠体内药代动力学。方法:用薄膜分散法制备汉黄芩素脂质体,用葡聚糖凝胶色谱法测定脂质体的包封率,考察脂质体在等渗磷酸盐缓冲液(pH 7.4)中的释放规律及血浆存在对其释放的影响,并研究其在大鼠体内的药代动力学。结果:制备的汉黄芩素脂质体包封率为(81.2±4.2)%,粒径为(157±22)nm。在磷酸盐缓冲液中24 h仅释放约40%,血浆的存在会导致释放有所增加。脂质体在大鼠体内具有明显的缓释效果,生物利用度是溶液剂的3.48倍。结论:制备的汉黄芩素脂质体包封率较高,粒径符合要求,体内外研究均表明脂质体具有缓释效果。  相似文献   

9.
目的 研究洛莫司汀(CCNU)脂质体的制备方法并考察用聚乙二醇单甲醚(2000)胆固醇琥珀酸酯(PEGCHS)修饰前后的2种脂质体静脉给药后在大鼠体内的药动学.方法 用改良逆相蒸发法制备普通和PEGCHS修饰的CCNU脂质体,测定包封率和粒径,静脉注射给药后,以格列苯脲为内标,采用高效液相色谱法测定血液中的药物含量;并采用3P87药动学程序进行数据处理.结果 制备的洛莫司汀脂质体包封率高(>80%),平均粒径50 nm左右;CCNU PBS溶液、CCNU脂质体和用PEGCHS修饰的CCNU脂质体的t1/2α分别为0.061 8,0.093 1和0.153 l h;t1/2β分别为0.087 9,0.416 2和1.002 1 h;AUC分别为13.520 7,86.9113和166.640 6 mg·h·L-1.结论 制备的CCNU脂质体包封率较高,粒径小;2种CCNU脂质体均可不同程度地增加CCNU的AUC,延长其在血液循环中的时间,并以用PEGCHS修饰的CCNU脂质体效果最好.  相似文献   

10.
氟康唑胶囊在健康人体中的药动学和相对生物利用度研究   总被引:1,自引:0,他引:1  
目的 研究氟康唑胶囊对健康人体的药动学和相对生物利用度。方法 采用高效液相色谱法 (HPLC) ,测定 2 0名男性健康受试者单剂量交叉口服 30 0mg两种氟康唑胶囊后 ,不同时间血浆中的药物浓度。结果 两制剂的药时曲线均符合一房室模型 ,被试制剂和参比制剂的主要药动学参数如下 :Cmax分别为 (6 .2 2± 0 .6 9)mg·L-1和(6 .2 6± 0 .6 2 )mg·L-1;Tmax分别为 (1.78± 0 .93)h和 (1.78± 0 .75 )h ;T1/2ke分别 (2 5 .99± 4 .81)h和 (2 6 .2 0± 3.13)h ;AUCt0 分别为 (2 0 2 .2 2± 37.37)mg·h·L-1和 (2 0 9.98± 34.4 1)mg·h·L-1;AUC∞0 分别为 (2 2 1.77± 5 0 .71)mg·h·L-1和(2 2 6 .73± 37.78)mg·h·L-1;对试制剂的相对利用度F10 与F∞0 分别为 (97.74± 17.39) %和 (98.4 2± 19.4 6 ) %。结论 方差分析和双单侧t检验证明 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.
Objective To measure Derpl and Blot5 allergen levels in asthmatics' homes in Hongkong.Methods Seventy houses were enrolled for a mite indoor environment study. Dust samples were obtained from two sites of each patients' house: bed and floor. Derpl and Blot5 levels were quantified by a two-site monoclonal antibody-based ELISA technique.Results The levels of Derpl allergens found in bed (geometric mean (GM) 3.43 μg/g of dust; 95%CI, 1.89-4.96 μg/g)and on the floor (GM 1.12 μg/g of dust; 95%CI, 0.71-1.53 μg/g) indicated significant differences (P=0.005). However, the levels of Blot5 allergens found in bed (GM 19.00 μg/g of dust; 95%CI, 0.89-38.90 μg/g) and on the floor (GM 6.14 μg/g of dust; 95%CI, 0.40-11.90 μg/g) showed no statistically significant difference. In addition, in regards to the exposure index for Derpl and Blot5 allergens found in bed and on the floor, 17.6% in bed and 8.6% on the floor had levels of Blot5 ≥ 10 μg/g of dust, higher than those obtained for Derp1 (7.2% and 0% in bed and on the floor respectively, P< 0.05); higher percentages in bed and on the floor (25.0% and 35.7%) were observed for levels of Blot5 =0 μg/g of dust as compared with Derpl in bed and on the floor (4.3% and 14.5% respectively, P< 0.05).Conclusions Derpl and Blot5 are the major allergens found in this regional study, Blot5 is a more potent allergen in Hongkong, probably reflecting the high level of exposure to Blomia tropicalis (Bt). Bt and Dermatophagoides pteronyssinus (Dp) allergens should be included for precise diagnosis and effective immuno-therapeutic treatment of mite allergy in Hongkong.  相似文献   

20.
ANTI-PROLIFERATION EFFECT OF ORIDONIN ON HL-60 CELLS AND ITS MECHANISM   总被引:4,自引:0,他引:4  
Objcetive To investigate the anti-proliferation effect of oridonin on leukemic HL-60 cells and its mechanism. Methods HL-60 cells in vitro in culture medium were given different concentrations of oridonin. The inhibitory rate of cells were measured by microculture tetrazolium (MTT) assay, cell apoptotic rate was detected by flow cytometry (FCM), morphology of cell apoptosis was observed by hoechst 33258 fluorescence staining, and the activity of telomerase was detected using telomere repeat amplification protocol (TRAP) PCR-ELISA before and after apoptosis occurred. Results Oridonin could decrease telomerase activity, inhibit growth of HL-60 cells, and cause apoptosis significantly. The suppression was both in time- and dose-dependent manner. Marked morphological changes of cell apoptosis including condensation of chromatin and nuclear fragmentation were observed clearly by hoechst 33258 fluorescence staining especially after cells were treated 48-60 hours by oridonin. Conclusions Oridonin has apparent anti-proliferation and apoptotic effects on HL-60 cells in vitro, decreasing telomerase activity of HL-60 cells may be one of its most important mechanisms. These results will provide strong laboratory evidence of oridonin for clinical treatment of acute leukemia.  相似文献   

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