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[目的] 研究头孢氨苄片受试制剂和参比制剂在比格犬体内的生物等效性。[方法] 采用双周期和双序列交叉设计,将22只健康比格犬随机分成2组,按30 mg/kg BW分别单剂量口服头孢氨苄片受试制剂Trolevis®300和参比制剂Rilexine®300,于给药前（0 h）和给药后0.5、1、1.5、2、2.5、3、4、6、8、12、17和24 h从臂头静脉采血。对超高效液相色谱串联质谱（UPLC-MS/MS）方法进行特异性、线性、检测限、准确度、精密度、稳定性等方法学考察。利用建立好的UPLC-MS/MS方法测定血浆中的药物浓度,并用WinNonlinTM 8.1软件对药代动力学参数进行分析计算。[结果] 方法学结果显示,在100~5 000 ng/mL浓度范围内相关性良好,相关系数（R2）≥ 0.99,标准曲线方程为y=10.6828x-176.481;高、中、低3个浓度的相对回收率平均值分别为105.63%、104.35%和102.40%;日内和日间变异系数均<15%;检测限为50 ng/mL,定量限为100 ng/mL。药代动力学结果显示,参比制剂组和受试制剂组药代动力学参数如下：Tmax分别为（1.77±0.55）和（2.70±4.68）h;Cmax分别为（28.09±5.09）和（26.82±7.94）μg/mL;T1/2分别为（3.39±1.43）和（3.12±1.05）h;AUC0-t分别为（121.81±25.80）和（116.34±36.30）μg·h/mL。受试制剂与参比制剂药时曲线相似,且受试制剂与参比制剂Cmax、AUC0-t和AUC0-∞几何均数的比值分别为99.51%、99.27%和99.30%,其90% CI均在80.00%~125.00%之间。[结论] 本试验建立的UPLC-MS/MS方法准确、可靠,可用于头孢氨苄的浓度测定,且头孢氨苄受试制剂与参比制剂是等效的,临床上均可用于相关疾病的治疗。 相似文献
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【目的】 建立一种简便、快速、灵敏度高、特异性强的头孢氨苄免疫层析表面增强拉曼光谱(SERS)检测新方法。【方法】 制备金银复合核壳结构的纳米贵金属,用来标记头孢氨苄抗体和拉曼信号分子5,5’-二硫代双2-硝基苯甲酸 (DTNB),合成拉曼免疫探针,用透射电子显微镜和双光束紫外分光光度计对纳米金和修饰拉曼信号分子的金银复合核壳结构进行表征。将合成的拉曼免疫探针固定在微孔板上,待测样品中的头孢氨苄与包被在硝酸纤维素膜上的头孢氨苄抗原竞争结合拉曼免疫探针,通过免疫层析试纸条结合共聚焦拉曼光谱仪读取DTNB的信号值,建立头孢氨苄定量检测技术,并应用于实际牛奶样品的检测。【结果】 透射电子显微镜和双光束紫外分光光度计表征结果显示,纳米银成功包裹在金颗粒表面。用共聚焦拉曼光谱仪检测免疫层析试纸条上拉曼信号分子的特征峰,拉曼信号分子特征峰为1 062、1 154、1 334和1 558 cm-1,其中1 334 cm-1处特征峰信号最强,选取此处峰高定量测定头孢氨苄的含量。头孢氨苄免疫层析表面增强拉曼光谱检测的线性范围为0~1 ng/mL,检测限为0.001 ng/mL,头孢氨苄的半数抑制质量浓度为0.05 ng/mL。与头孢克洛交叉反应率为111.1%,与头孢曲松钠、头孢夫辛酯、头孢噻吩钠交叉反应率均低于0.1%。实际样品加标浓度为1、4和8 ng /mL,回收率分别为94.4%、103.3%和97.5%。【结论】 本研究建立的头孢氨苄免疫层析表面增强拉曼光谱检测方法操作简便、快速、灵敏,耗材成本低廉,可满足奶牛养殖农场和乳品加工企业进行大批量样品初筛检测需求。 相似文献
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Cephalosporins form a large group of β-lactam antibiotics which are used extensively in human medicine and to a lesser extent in domestic animals. In veterinary dermatology, the principle use for the cephalosporins is the clinical management of canine pyoderma associated with Staphylococcus intermedius . In practice, the use of orally administered first generation cephalosporin drugs to affected dogs is well tolerated and highly efficacious. Bacterial drug resistance appears to occur rarely. 相似文献
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ZHANG Wei WANG Xing LIU Jin-ping XU Sheng-le QIN Hai-yan LIU Ruo-xuan CAI Yun-hong RU Xiao-fei HOU Ke WANG Han-dong 《中国畜牧兽医》2017,44(4):1159-1167
The aim of the study was to prepare a monoclonal antibody (McAb) against cephalexin(CEX),and preliminarily establish an ELISA method to detect residues of CEX in milk. The CEX was conjugated to carrier bovine serum albumin (BSA) and ovalbumin (OVA) by two-step glutaraldehyde method. BALB/c mice were immunized with the prepared CEX-BSA conjugate. After five times immunization, we built and screened two strains of hybridoma cells (2G4 and 5B3) which secreted McAb against CEX by hybridoma technology.The 2G4 cell lines were injected into BALB/c mouse's abdominal cavity to produce ascites. Finally the ascites were purified and identified. The results showed that antibody titer of the McAb 2G4 was above 1∶1.28×105,its antibody subtype was IgG2b(κ) and affinity constant K was 1.51×109 L/mol. The cross experiment result evidenced that the cross reaction rate of cefradine was 52.55%, ceftiofur, ceftriaxone, cefotaxime, cephalothin, penicillin, streptomycin and tetracycline had no cross reaction. We established an ELISA method to detect CEX residues in milk and its linear range was 20 to 1 000 ng/mL, linear equation y=0.4674x-0.5359(R2=0.9909), its limit of detection (LOD) was 19.68 ng/mL and the average recovery rate was 91.31%, the average coefficient of variation was below 15%. The detection limit was lower than the maximum residue limit of cefalexin in China and European Union. So this detection method might have good application foreground. 相似文献
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Pharmacokinetics of cephalexin in cats after oral administration of the antibiotic in tablet and paste preparations 总被引：2，自引：0，他引：2
Objective To determine the bioequivalence of a paste formulation of cephalexin with that of the tablet form.
Design A two-way cross-over study.
Animals Ten adult cats of mixed breed.
Procedure The cats, randomly allocated to two groups, received either the paste preparation or the tablet orally at 12-hour intervals for 48 h before a 12-hour blood collection period. Two weeks later the treatments were reversed and the blood sampling repeated. The serum concentrations of the antibiotic were determined. The pharmacokinetic factors were analysed using a computer.
Results There were no significant differences between the peak concentration of cephalexin, or the other pharmacokinetic factors obtained from the tablet and paste formulations. The serum profiles of cephalexin following four 12-hourly doses of each formulation were similar with the peak serum values occurring at approximately 2 h after administration.
Conclusion The paste formulation and the tablet form are bioequivalent. 相似文献
Design A two-way cross-over study.
Animals Ten adult cats of mixed breed.
Procedure The cats, randomly allocated to two groups, received either the paste preparation or the tablet orally at 12-hour intervals for 48 h before a 12-hour blood collection period. Two weeks later the treatments were reversed and the blood sampling repeated. The serum concentrations of the antibiotic were determined. The pharmacokinetic factors were analysed using a computer.
Results There were no significant differences between the peak concentration of cephalexin, or the other pharmacokinetic factors obtained from the tablet and paste formulations. The serum profiles of cephalexin following four 12-hourly doses of each formulation were similar with the peak serum values occurring at approximately 2 h after administration.
Conclusion The paste formulation and the tablet form are bioequivalent. 相似文献
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为制备抗头孢氨苄（cephalexin,CEX）的单克隆抗体并建立鲜奶中CEX残留检测的ELISA方法,本试验采用戊二醛两步法分别将CEX与牛血清白蛋白（BSA）、卵清白蛋白（OVA）偶联,用合成的CEX-BSA作为免疫原免疫BALB/c雌鼠;5次免疫后,应用杂交瘤细胞融合技术建立并筛选出两株（2G4、5B3）分泌抗CEX单克隆抗体（monoclonal antibodies,McAb）的杂交瘤细胞株,将2G4细胞株注入BALB/c小鼠腹腔制备腹水,并对腹水进行纯化及鉴定。结果显示,2G4腹水效价大于1∶1.28×105,其抗体亚型为IgG2b（κ）,亲和力常数K=1.51×109 L/mol;交叉试验结果显示,该单克隆抗体除了与头孢拉定有52.55%的交叉反应率外,与头孢噻呋、头孢曲松、头孢噻肟、头孢噻吩、青霉素、链霉素、四环素均无明显交叉反应;建立了测定鲜奶样品中CEX的ELISA方法,线性范围为20~1 000 ng/mL,线性方程y=0.4674x-0.5359（R2=0.9909）,检测下限为19.68 ng/mL,平均回收率为91.31%,平均变异系数低于15%,低于中国及欧盟规定的头孢氨苄最高残留限量,具有一定的应用前景。 相似文献
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The post-antibiotic effect in vitro (PAE) of cephalexin was determined according to a broth dilution method against 5 isolates of Staphylococcus intermedius obtained from cases of canine pyoderma. Two durations of exposure and 3 concentrations were tested. The PAE increased when time of exposure or concentration increased. The mean PAE ranged from 0.7 to 3.3 h. The PAE of cephalexin against Staph-ylococcus intermedius may be clinically relevant when selecting a dosage regimen to treat pyoderma in dogs. 相似文献
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随着我国畜禽养殖业集约化规模化的发展,各种抗生素类化学药物的滥用问题日益明显,导致抗生素耐药菌株大量产生,这些耐药菌随动物粪便排出机体进入环境,可能扩散进入食物链,并对食品安全和人类健康造成严重威胁。本实验选取哺乳仔猪、断奶仔猪、育肥猪和空怀母猪四个生长阶段的猪粪便作为研究对象,采用微生物培养技术,较全面的监测和比较分析了不同生长阶段猪粪便中单一抗生素和多重抗生素耐药细菌的数量。结果表明:断奶仔猪粪便中四环素耐药细菌所占比例(73.02%)最大,育肥猪粪便中头孢耐药细菌占比(82.78%)最大,而双重耐药细菌主要存在于幼龄仔猪粪便中。本研究为猪不同生长阶段减抗低抗养殖提供了理论参考和依据。 相似文献
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