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1.
目的对阿莫西林克拉维酸钾干混悬剂(14:1)的含量均匀度和有关物质进行了研究,用来评价和确定制剂使用中的安全性及药物本身的内在质量。方法通过对制备得到的阿莫西林克拉维酸钾干混悬剂含量均匀度的测定和有关物质考察。从而确定阿莫西林克拉维酸钾干混悬剂质量的可控性。结果通过本文中所用方法对阿莫西林克拉维酸钾干混悬剂(14:1)中阿莫西林、克拉维酸钾的含量均匀度和有关物质测定结果说明制剂质量合格.所以在制剂使用中阿莫西林克拉维酸钾干混悬剂能确保其安全性。结论阿莫西林克拉维酸钾干混悬剂(14:1)中阿莫西林、克拉维酸钾的含量均匀度和有关物质的测定均能符合制剂要求。  相似文献   

2.
建立了同时测定人血浆中阿莫西林和克拉维酸浓度的LC-MS/MS方法。采用50%乙酸水溶液作为稳定剂,采用冰浴条件下蛋白沉淀后取上清液吹干复溶的方法进行血浆样品前处理。采用Hedera ODS-2(2.1 mm×150 mm)色谱柱进行梯度洗脱,水相为含0.2%乙酸的水溶液,有机相为甲醇。选择三重四极杆串联质谱仪(Triple Quad TM 6500+),采用电喷雾离子化方式(ESI),在多反应监测(MRM)模式下进行负离子检测,同时对阿莫西林(364.1→223.1)和克拉维酸(198.1→135.9)进行定量分析。结果表明,阿莫西林在20.0~5 000 ng/mL范围内线性关系良好,克拉维酸在10.0~2 500 ng/mL范围内线性关系良好,批内和批间准确度偏差均在±15.0%内,批内和批间精密度均小于15.0%,基质效应、回收率均满足接受标准,阿莫西林和克拉维酸在试验条件下稳定性良好。采用该方法对健康受试者服用受试制剂阿莫西林克拉维酸钾颗粒1袋(每袋颗粒中含有125 mg的阿莫西林和31.25 mg的克拉维酸钾)和参比制剂阿莫西林克拉维酸钾干混悬剂Augmentin®; 5 mL(每5毫升干混悬剂中含有125 mg的阿莫西林和31.25 mg的克拉维酸钾)进行阿莫西林和克拉维酸的血药浓度测定,进行非房室模型药代动力学参数的估算分析,计算阿莫西林和克拉维酸的药代动力学参数,评价受试制剂与参比制剂是否等效,评估饮食对阿莫西林和克拉维酸的药代动力学的影响。实验结果表明,该方法经考察符合生物样品的分析要求,可以应用于阿莫西林克拉维酸临床血药浓度的测定和生物等效性研究。  相似文献   

3.
李京京  刘雪赟 《实用医技杂志》2006,13(17):3027-3028
目的:观察阿莫西林克拉维酸钾分散片治疗急性咽炎扁桃体炎的临床疗效。方法:100例急性咽炎、扁桃体炎患儿随机分为治疗组50例,给予阿莫西林克拉维酸钾分散片治疗。对照组50例,给予阿莫西林干混悬剂治疗。结果:治疗组与对照组有效率分别为94%和78%(经χ2检验,两组比较差异有显著性,P<0.05)。结论:阿莫西林克拉维酸钾分散片治疗小儿急性咽炎、扁桃体炎具有良好疗效。  相似文献   

4.
目的 建立简便、快速分析克拉维酸钾及其制剂的毛细管区带电泳方法.方法 采用非涂层石英毛细管柱,有效长度50 cm;运行缓冲溶液,20 mmol/L 磷酸盐缓冲液(pH 6.0);工作电压25 kV;进样电压20 kV,进样时间5 s;柱温20℃;检测波长214 nm.结果 克拉维酸钾在52.08~312.5 mg/L范围内线性关系良好,相关系数为0.999 6.阿莫西林克拉维酸钾(7∶1)分散片的平均回收率(n=9)为99.2%,相对标准差(relative standard deviation,RSD)为0.77%;阿莫西林克拉维酸钾(4∶1)干混悬剂的平均回收率(n=9)为99.4%,RSD为1.0%;最低检测限为1.953 mg/L.结论 本方法简便、准确、快速,为克拉维酸钾及其制剂生产中的质量控制提供了一种新的分析手段.  相似文献   

5.
通过探讨阿莫西林克拉维酸钾干混悬剂(7:1)联合喜炎平注射液治疗小儿支气管肺炎的临床疗效,得出结论:阿莫西林克拉维酸钾干混悬剂(7:1)口服联合喜炎平注射液静滴治疗小儿急性支气管肺炎疗效确切,未见明显不良反应,值得临床推广.  相似文献   

6.
克拉霉素干混悬剂药物动力学及生物等效性研究   总被引:1,自引:0,他引:1  
目的 :建立人血浆中克拉霉素的HPLC/MS方法 ,测定其干混悬剂的药物动力学参数及相对生物利用度。方法 :血样用乙腈沉淀、离心后进入LC MS分析系统 ,色谱柱 :LichrospherC185 μm ,2 5cm× 4 .6mmid ,流动相 :10mmol/L醋酸铵缓冲液 (pH 3.5 ) 甲醇 (15∶85 ) ;质谱条件 :气动辅助电喷雾离子化 ,正离子检测 ,选择性离子检测 (SIM)。结果 :在 0 .0 0 3~ 5 .0 μg/ml范围内峰比值 (克拉霉素峰面积As和内标罗红霉素峰面积Ai的比值 )与浓度线性关系良好 (r=0 .99978) ,最低定量限为 3ng/ml。绝对回收率为 85 .2 8%~ 89.0 7%。克拉霉素干混悬剂的相对生物利用度为 (92 .5± 14 .2 ) %。结论 :建立的分析方法灵敏、准确、简便。 2 0名健康受试者随机交叉口服克拉霉素干混悬剂和片剂后 ,其体内过程符合一室模型 ,统计学结果表明两种制剂生物等效。  相似文献   

7.
目的:研究单剂量口服对乙酰氨基酚缓释干混悬剂在家犬体内的药代动力学和相对生物利用度.方法:采用反相高效液相色谱法,测定6条成年健康家犬(体质量10.5~11.5 kg,雌雄各半)单剂量(650 mg/只)口服对乙酰氨基酚缓释干混悬剂(受试制剂)和对乙酰氨基酚控释片(泰诺林)(参比制剂)后不同时间点(给药前及给药后0.25、0.5、1.0、1.5、2.0、3.0、4.0、5.0、6.0、8.0、10.0、15.0和24.0 h)血浆中对乙酰氨基酚的浓度,绘制血药浓度-时间曲线,计算药代动力学参数及相对生物利用度.结果:本所建立的方法不受血浆中内源性物质的干扰,线性范围0.10~20.00 μg/ml(r=0.999 9),日内、日间精密度RSD<7.0%,3种浓度(0.50、5.00、20.00μg/ml)的方法回收率分别为(104.21±6.57)%、(97.23±4.21)%、(99.57±1.19)%.对乙酰氨基酚缓释干混悬剂与参比制剂血浆中对乙酰氨基酚的tmax分别为(2.1±0.5)和(3.0±0.6)h;cmax分别为(9.09±3.58)和(8.77±3.40)μg/ml;用梯形法计算AUC0~24 h分别为(34.31±13.54)和(33.28±12.16)μg·h·ml-1,AUC0~∞分别为(34.96±13.46)和(33.88±12.18)μg·h·ml-1;受试制剂相对于参比制剂的平均生物利用度F0~∞为(102.58±10.15)%.结论:对乙酰氨基酚缓释干混悬剂与乙酰氨基酚控释片(泰诺林)在家犬体内的药代动力学过程相似,两种制剂具有生物等效性.  相似文献   

8.
潘冬宁 《中国医刊》2004,39(5):42-43
目的观察安奇颗粒、铿锵干混悬剂和阿莫西林干混悬剂治疗小儿急性呼吸道感染的临床疗效.方法安奇颗粒40mg/(kg.d),口服,每天3次,疗程5~8天;铿锵干混悬剂40mg/(kg.d),口服,每天2次,疗程5~8天;阿莫西林干混悬剂40mg/(kg.d),口服,每天3次,疗程5~8天.结果安奇颗粒、铿锵干混悬剂与阿莫西林干混悬剂组比较疗效有显著性差异(P<0.05),表明阿莫西林和克拉维酸的复合制剂有效克服细菌耐药性,是治疗小儿急性呼吸道感染的理想选择.  相似文献   

9.
目的评价阿莫西林克拉维酸钾干混悬剂(7:1)对小儿急性化脓性中耳炎的临床疗效。方法对180例中耳炎患儿分为2组,治疗组90例,给予口服阿莫西林克拉维酸钾干混悬剂(7:1),每次5.7mg·kg^-1,每日2次,对照组90例,口服阿莫两林干混悬剂,每次5mg·kg^-1,每日2次,治疗1周后观察疗效。结果治疗组有效率98%(89/90),显著高于对照组90%(81/90)(P〈0.05),无严重的不良反应发生。结论口服阿莫西林克拉维酸钾干混悬剂(7:1)治疗小儿急性化脓性中耳炎效果良好。  相似文献   

10.
目的 建立 LC-MS测定人血浆中地洛他定浓度的定量方法 ,测定志愿者口服地洛他定胶囊后的血药浓度 ,并对供试制剂与参比制剂的生物等效性进行评价。方法 血浆中加入氟西汀为内标 ,碱化后经乙酸乙酯提取 ,进行 LC-MS测定。色谱柱为 Phenomenex Luna C1 8(5 μm,2 5 0 mm× 4.6mm) ,流动相为甲醇 -乙腈 -0 .0 1mol/L醋酸铵溶液 (65∶ 5∶ 3 0 ) ,流速为 1 .0 ml/min;ESI选择性正离子检测。临床实验方案采用双交差实验设计法。结果 地洛他定血浆线性范围为 0 .1~ 3 0 ng/ml,检测限为 0 .0 5 ng/ml。方法回收率大于 80 %。应用本法测定 2 0名志愿者单剂量交叉口服供试制剂与参比制剂后的血药浓度经时过程 ,测得二者的主要药代动力学参数无显著性差异 ,试验胶囊的相对生利用度为 (96.0 4± 1 1 .1 0 ) %。结论 本方法专属性强 ,灵敏度高 ,准确性好。试验胶囊和参比片剂生物等效  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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