异福酰胺胶囊的人体药代动力学和相对生物利用度

目的研究异福酰胺胶囊的人体药代动力学和相对生物利用度,以判断两种制剂是否具有生物等效性.方法 18名健康志愿者采用随机分组交叉自身对照给药.以卫非特片(Rifater)为参比药物,用HPLC法测定血清中药物浓度.结果两制剂的血药浓度经时变化和药代动力学参数相近,异福酰胺胶囊中异烟肼、利福平、吡嗪酰胺的主要药代动力学参数:T1/2为(2.37±1.09) h, (4.63±0.67) h,(13.43±2.98) h;Cmax为(8.78±3.63) mg/L,(11.9 3±2.68) mg/L,(36.28±9.17) mg/L;AUCo-t为(28.77±20.74) mg/L. h,(84.63±18.01) mg/L*h,(544.87±100.17) mg/L*h.相对生物利用度分别为96 .79%±26.98%,97.08%±15.12%,100.03%±16.02%.结论异福酰胺胶囊与卫非特片具有生物等效性.     

5-单硝基异山梨醇酯缓释胶囊的人体药代动力学研究

目的:研究5-单硝基异山梨醇酯(5-ISMN)缓释胶囊的人体药代动力学和相对生物利用度.方法:采用毛细管气相色谱法测定口服40 mg 5-ISMN国产和进口缓释胶囊在健康人体内的血药浓度,以考察达稳态过程和稳态药代动力学特征.结果:连续口服40 mg 5-ISMN缓释胶囊至第4天,体内血药浓度基本达稳态水平.国产和进口缓释胶囊的稳态药代动力学参数如下:tmax为(4.8±0.6)和(4.8±0.9) h, cmax为(802.46±94.45)和(807.09±109.16)μg/L, cmin为(127.83±23.76)和(121.85±22.00)μg/L,AUCss为(8 114.7±1 393.4)和(8 174.8±1 219.7)μgh/L,cav为(338.12±58.06)和 (340.62± 50.82)μg/L, 峰谷波动度(DF)为(2.04±0.39)和(2.03±0.33).口服40 mg国产5-ISMN缓释胶囊的相对生物利用度为(99.07±5.45)％.结果表明5-ISMN国产和进口缓释胶囊的主要稳态药代动力学参数均无显著性差异.结论:两种制剂具有生物等效性.     

国产美洛昔康胶囊与进口莫比可片的生物等效性研究

目的　研究国产美洛昔康胶囊的相对生物利用度 ,并与进口莫比可片作比较。方法　 2 4名健康男性志愿受试者随机交叉单剂量口服国产美洛昔康胶囊与进口莫比可片各 15 mg,采用高效液相色谱法测定血浆中美洛昔康的浓度 ,进行药代动力学研究及两制剂生物等效性评价。结果　对所得血药浓度 -时间数据用 3P97程序进行拟合 ,两制剂药 -时曲线均符合二室模型。国产美洛昔康胶囊与莫比可的 Cmax分别为 1.33± 0 .18mg/ L 和1.0 3± 0 .2 2 m g/ L,Tmax分别为 1.6 3± 1.76小时和 3.83± 1.31小时 ,T1 /2β分别为 2 7.91± 9.31小时和 31.2 5±17.17小时 ,AU C0 - t分别为 37.5 9± 9.39m g/ L× h与 35 .0 4± 7.2 2 m g/ L× h。以莫比可为参比 ,国产美洛昔康胶囊的相对生物利用度为 10 7.6 %± 16 .6 %。结论　国产美洛昔康胶囊与进口莫比可片具有生物等效性。     

盐酸环丙沙星胶囊的人体药物动力学和相对生物利用度研究

目的比较国产盐酸环丙沙星胶囊与进口盐酸环丙沙星片在健康人体内的药物动力学和生物利用度.方法 10名男性健康志愿者随机交叉口服单剂量(750mg)国产盐酸环丙沙星胶囊(江苏海慈药业有限责任公司生产)和进口盐酸环丙沙星片后,采用HPLC-荧光检测法测定血浆中盐酸环丙沙星的血药浓度,并计算出药物动力学参数,以进口片为标准,对国产胶囊的生物利用度和生物等效性进行评价.结果国产胶囊和进口片的平均Cmax分别为4.58和4.66μg/ml,Tmax为1.27h和1.29h;以进口片为标准,国产胶囊的相对生物利用度为94.62±5.16%.结论盐酸环丙沙星国产胶囊与进口片等效.     

盐酸环丙沙星胶囊的人体药物动力学和相对生物利用度研究

目的　比较国产盐酸环丙沙星胶囊与进口盐酸环丙沙星片在健康人体内的药物动力学和生物利用度。方法　 1 0名男性健康志愿者随机交叉口服单剂量 ( 75 0 mg)国产盐酸环丙沙星胶囊 (江苏海慈药业有限责任公司生产 )和进口盐酸环丙沙星片后 ,采用 HPLC-荧光检测法测定血浆中盐酸环丙沙星的血药浓度 ,并计算出药物动力学参数 ,以进口片为标准 ,对国产胶囊的生物利用度和生物等效性进行评价。结果　国产胶囊和进口片的平均 Cmax分别为 4.5 8和 4.66μg/ ml,Tmax为 1 .2 7h和 1 .2 9h;以进口片为标准 ,国产胶囊的相对生物利用度为 94.62± 5 .1 6%。结论　盐酸环丙沙星国产胶囊与进口片等效     

国产与进口吲哚美辛缓释胶囊生物等效性评价

比较国产与进口吲哚美辛缓释胶囊在人体内的生物利用度和生物等效性.18名健康男性志愿者双周期随机交叉口服吲哚美辛缓释胶囊75 mg,用反相高效液相色谱法测定达稳态后的血药浓度.受试制剂与参比制剂的达峰时间(Tpeak)分别为(3.78±1. 00)h和(3.50±1.29)h;达峰浓度(Cmax)分别为(7.51±2.74)ug/ml和(8.05±2.58)ug/ml;药时曲线面积(AUC)分别为(66.41±30.12)和(63.90±26.50)ug@ml-1@h-1.多次给药达稳态条件下,国产的吲哚美辛缓释胶囊与进口制剂的相对生物利用度为(103.20±21.90)%.双单侧检验表明,国产与进口吲哚美辛缓释胶囊具有生物等效性.     

利美尼定胶囊在健康人体的药代动力学及生物等效性研究

目的研究利美尼定胶囊在健康志愿者体内的药代动力学和相对生物利用度,验证该制剂与进口利美尼定片的生物等效性。方法采用HPLC-MS/MS法测定24例健康男性志愿者自身交叉单剂量口服国产利美尼定胶囊或进口利美尼定片1 mg的经时血药浓度,计算主要药代动力学参数及受试制剂的相对生物利用度。结果国产利美尼定胶囊与进口利美尼定片的主要药代动力学参数:C max分别为(4.584±1.617)μg/L和(5.000±1.457)μg/L;T max分别为(1.46±0.66)h和(1.33±0.71)h;t1/2分别为(6.35±0.99)h和(6.96±1.08)h;AUC0-t分别为(31.16±10.61)μg/(h·L)和(34.96±11.53)μg/(h·L)。C max在不同制剂、不同周期间差异均无统计学意义(P>0.05);AUC0-t与AUC0-∞在不同制剂间差异有统计学意义(P<0.05),在不同周期间差异无统计学意义(P>0.05)。国产利美尼定胶囊与进口利美尼定片的相对生物利用度为(89.8±14.87)%。结论国产利美尼定胶囊与进口利美尼定片生物等效。     

氟康唑胶囊的人体药动学及其生物等效性研究

目的:研究氟康唑胶囊受试制剂与参比制剂在健康志愿者体内的药代动力学和生物等效性。方法:18名健康男性受试者随机双周期交叉单剂量口服氟康唑胶囊受试制剂和参比制剂200 mg,用HPLC法测定氟康唑的血药浓度,求得有关药动学参数。结果:氟康唑胶囊受试制剂和参比制剂的AUC0~120 h分别为(224.977±39.361)和(211.212±36.221)mg/h.L-1,Cmax分别为(5.811±1.202)和(5.705±1.092)mg/L,Tmax分别为(1.056±0.466)和(1.375±0.884)h,t1/2分别为(32.559±5.072)和(30.162±7.257)h。受试制剂相对于参比制剂的生物利用度(F)为(107.41±14.79)%。氟康唑AUC0~120 h和Cmax经对数转换后双单侧t检验均P>0.05,受试制剂AUC0~120 h90%可信限度在参比制剂100.7%~112.6%内,Cmax 90%可信限度在参比制剂92.8%~111.1%区间内。结论:氟康唑胶囊的受试制剂与参比制剂具有生物等效性。     

罗红霉素胶囊人体相对生物利用度研究

目的估算试验罗红霉素胶囊(T)的药代动力学参数及相对生物利用度,并以相同规格的罗红霉素胶囊作为参比制剂(R),判断两种胶囊是否具有生物等效性。方法22名健康志愿者单剂量口服罗红霉素胶囊(150mg)后48h内多点采集血样,微生物法测定人血清中罗红霉素的浓度。双周期两制剂交叉试验设计。血药浓度-时间数据经DAS软件处理后得药代动力学数据,并进行等效性检验。结果两种罗红霉素胶囊的血药浓度经时变化和药代动力学参数相近,AUC0～tT为(50.448±11.964)mg·h/L,AUC0～tR为(48.990±9.113)mg·h/L;AUC0～∞T为(50.538±12.806)mg·h/L,AUC0～∞R为(50.099±8.917)mg·h/L;CmaxT为(11.098±0.869)mg/L,CmaxR为(11.133±1.269)mg/L;TmaxT为(1.500±0.154)h,TmaxR(1.280±0.271)h;T1/2βT为(3.637±1.362)h,T1/2βR”为(3.522±0.575)h。以参比药作对照,计算罗红霉素的相对生物利用度,F为103.56%±19.67%,F′为100.91%±19.03%,均符合生物等效性要求。结论两种罗红霉素胶囊的口服生物利用度具有生物等效性。     

奥美拉唑肠溶胶囊的生物等效性研究

目的:研究奥美拉唑肠溶胶囊在健康人体的药代动力学,并评价其与同剂量制剂间的生物等效性。方法:采用双交叉试验设计,18名健康志愿者口服奥美拉唑肠溶胶囊试验和参比制剂40 mg,服药后0~12 h内间隔取血,用HPLC法测定血药浓度。计算主要药代动力学参数,并以参比制剂计算奥美拉唑肠溶胶囊的相对生物利用度,判断其生物等效性。结果:奥美拉唑肠溶胶囊试验和参比制剂的体内药代动力学参数Cmax(0.632±0.383)mg/L和(0.626±0.415)mg/L、5Tmax(2.39±0.40)h和(2.33±0.42)h、T1/2(1.92±0.64)h和(2.01±0.73)h、Vd/F(81.21±46.68)L和(94.07±89.46)L、CL/F(32.99±20.92)L/h和(31.68±20.41)L/h、AUC0→12(2.03±1.99)mg/(h.L)-1和(1.89±1.62)mg/(h.L)-1;受试奥美拉唑肠溶胶囊的相对生物利用度F=(104.7±17.7)%。结论:2种制剂具有生物等效性。     

Value of D-Dimers in patients with acute aortic dissection

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.     

Research of combined liver-kidney transplantation model in rats

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.     

APPLICATION OF LORNOXICAM TO PATIENT-CONTROLLED ANALGESIA IN PATIENTS UNDERGOING ABDOMINAL SURGERIES

FOR anesthesiologis s ,treatingpostoperativepainhas alwaysbeen a problem.Althoughopioidshave been provedtobe effective,theirsideeffectscouldnotbeignored.With thedevelopmentofscienceand pharmacology,many drugs with aspectsof satisfactoryanalgesicefficacyand couldbe welltoleratedby patientshave been developed.And lornoxicamisone of them, which isa non-steroidalanti-inflammatorydrug (NSAID ), with analgesic, anti-infl-ammatory,andantipyreticproperties.Itseliminationhalf-time(3 to 5 hours) isle…     

Development on Adjustable Calibration Marker for Shock Wave Focus

Shock wave lithotripsy （SWL） is a treatment of choice for upper urinary stones. However, this procedure is inappropriate for obese patients because the focus is often unable to reach the target owing to the limited focal distance in shock wave source. Although treating such patients in a blast path may increase the application length of shock wave source, it＇s difficult to find this path on the lithotripter monitor. For this reason, we invented an adjustable calibration marker in order to set an effective focus in the shock wave hath.     

Study on the TCM Pathogenesis of Angiopathic Complications of Type II Diabetes

Excess production of reactive oxygen species(ROS)of mitochondrion mediated by hyperglycemia is the common pathogenesis of angiopathic complications of diabetes.TCM holds that the damp from the dysfunction of spleen.kidney and liver is the causative factor of complications of diabetes.This is similar to the mechanism of Ros resulting in angiopathic complications of diabetes.When the angiopathic complications of type II diabetes mellitus(T2DM)are difierentiated as caused by turbid damp in TCM can be explained as ROS.Since the obstruction of pathogenic damp in channels and collaterals is said to be the main pathogenesis,the treating principle should be dissolving the damp to remove the obstruction.     

Leptin, Ghrelin and TNF-α before and after Hypo-caloric Traditional Chinese Diet and Auricular Acupuncture

INTRODUCTION Obesity is a complex emergent problem, which can be possibly solved not only by the diet but also by the life style and promotion of a constant physical exercise. 1, 2 No doubt careful attentions must be given to the nutritional condition of obese people, the dietary habits, the somatic build (i.e. distribution of fat mass) and the organic functions linked to formation of the fat mass. All the parameters should be constantly monitored before, during and after a diet treatment. 3, 4, 5     

Relationship between Dysglycemia and Carotid Atherosclerosis in Tibetan Population

People with dysglycemia are at high risk for atherosclerotic diseases. This study aims at investigating the atherosclerotic vascular damage in dysglycemia and its metabolic origin in Tibetan population.     

Acupuncture Combined with Spinal Tui Na for Treatment of Primary Dysmenorrhea in 30 Cases

Objective: To observe the therapeutic effects in acupunture treatment of primary dysmenorrhea combined with spinal Tui Na, and study its mechanism. Methods: Thirty cases of the treatment group were treated by acupuncture combined with spinal Tui Na, and thirty cases in the control group were treated by routine acupuncture. Results: The total effective rate was 93.3% in the treatment group, and 73.3% in the control group, with a significant difference between the two groups (P<0.05). Conclusions: Acupuncture combined with spinal Tui Na has good prospects for treatment of primary dysmenorrhea.     

Luo Lingjie's Experience in Treating Chronic Nephropathy

In treating chronic nephropathy,Luo Lingjie,a chief physician,pays attention to regulating the balance between yin and yang,treating infection if present,and removing pathogenic factors.He prescribes gentle drugs and uses carefully strongly warming-tonifying ones,emphasizes the importance of persuading the patient to persist in treatment with medication and nurse one's health for recuperation,and is good at combined use of TCM and western medicine therapy and brings the merits of various therapies into full play,with obvious theraoeutic effects.     

Dr.Zhang Ren's Experience in the Acupuncture Treatment of Different Diseases with the Same Therapeutic Principle

Dr.Zhang Ren,the chief physician,is the chairman of Shanghai Acupuncture and Moxibustion Association.Having been engaged in medicine for about 40 years,he is experienced in treating various intractable diseases.In his long years of clinical practice,he advocates taking the TCM differentiation as the basis to seek for the acupuncture method for treatment of modern intractable diseases.The author of this essay had the fortune to follow Dr.Zhang in study.The following is a summary of Dr.Zhang's experience in the acupuncture treatment for different intractable diseases with the same therapeutic principle.