三种抗生素在替硝唑注射液中的配伍稳定性实验

目的考察头孢哌酮钠、美洛西林钠和培氟沙星三种抗生素在替哨唑注射液中的配伍性稳定性。方法将三种抗生素分别加入替硝唑注射液中混合,在25±1℃下观察4小时。结果各配伍液外观及pH值均无明显变化,三种抗生素及替硝唑的相对百分含量均在97%以上。结论三种抗生素可以和替硝唑注射液配伍使用。     

头孢哌酮/舒巴坦钠与头孢噻肟随机对照及开放治疗细菌性感染182例临床评价

目的：评价国产头孢哌酮／舒巴坦钠的安全性及有效性。方法：随机对照及开放临床试验。结果：随机对照治疗呼吸道感染及泌尿系感染１２８ 例,其中试验药６６ 例,对照药６２例,两组痊愈率分别为７２．７３％和６２．９０％ ,总有效率分别为９５．４５％ 和８８．７１％ ;头孢哌酮／舒巴坦钠与头孢噻肟对各种致病菌感染的痊愈率分别为７２．３１％ 和６３．９３％ ,有效率分别为９５．３８％ 和８８．５２％ ;两组细菌阳性率分别为９８．４８％ （６５／６６）和９８．３９％ （６１／６２）,治疗后细菌清除率为９５．３８％ 与９３．４４％ ;头孢哌酮／舒巴坦钠不良反应发生率为４．５５％ ,头孢噻肟不良反应发生率为６．４５％ ,以上结果均无统计学显著差异（Ｐ＞ ０．０５）。开放治疗呼吸道感染及皮肤感染５４例,临床痊愈率６４．８１％ ,有效率９０．７４％ 。开放组对各种细菌感染的痊愈率与有效率分别为６７．３１％ 与９２．３１％ ,细菌清除率为９２．４５％ ,不良反应发生率为３．７０％ 。结论：头孢哌酮／舒巴坦钠,临床疗效好,不良反应轻微,对于临床常见中至重度呼吸道、泌尿道及皮肤软组织感染是一个安全、有效的药物     

头孢哌酮钠舒巴坦钠(1∶1)与头孢他啶治疗儿童肠炎的药物经济学分析

目的:对头孢哌酮钠舒巴坦钠(1∶1)和头孢他啶治疗儿童肠炎进行药物经济学分析,为临床提供用药参考方案。方法:采用回顾性研究,分析头孢哌酮钠舒巴坦钠(1∶1)和头孢他啶治疗儿童肠道感染的成本和效果。结果:头孢哌酮钠舒巴坦钠(1∶1)和头孢他啶的总有效率分别为95.3%和96.7%,效果差异无显著性(χ2=0.102,P>0.05);治疗成本分别为1260.46元和1780.13元,差异有显著性(χ2=4.96,P<0.05)。结论:头孢哌酮钠舒巴坦钠(1∶1)治疗儿童肠炎比头孢他啶经济,符合药物经济学原则。     

国产和进口头孢哌酮钠/舒巴坦钠体外抗菌作用的比较

目的: 比较国产和进口头孢哌酮钠/舒巴坦钠复方制剂体外抑菌效果.方法: 采用Kirby-Bauer法(纸片琼脂扩散法),分别将不同批次的国产和进口头孢哌酮钠/舒巴坦钠复方制剂制成每片含药量75 μg/75 μg的药敏纸片,贴于接种试验菌株的M-H琼脂平皿上,35 ℃、培养16～18 h后测量抑菌圈直径.结果: 国产和进口头孢哌酮钠/舒巴坦钠对大肠埃希菌、金黄色葡萄球菌、铜绿假单胞菌等7种细菌抑菌圈大小无明显差别(P>0.05).结论: 国产和进口头孢哌酮钠/舒巴坦钠对这7种细菌体外抗菌作用相同.     

紫外分光光度法测定头孢哌酮注射剂含量

目的　建立紫外分光光度法测定头孢哌酮注射剂含量。方法　在 2 0 0～ 4 0 0nm波长范围内扫描,确定测定波长。然后进行吸收度A与浓度C的线性关系实验;精密度测定;回收实验;稳定性实验。结果　确定 2 2 8 4nm为测定波长。头孢哌酮在浓度2 5～ 4 0 0 μg·ml-1范围内与吸收度呈良好的线性关系(r =0 9999);平均回收率为 99 6 %。结论　本法简便、准确。     

The influence of chronic lobular hepatitis on pharmacokinetics of cefoperazone—a novel galactose single-point method as a measure of residual liver function

Cefoperazone is a semisynthetic cephalosporin antibiotic containing a piperazine side chain, which results in antipseudomonal activity. Unlike the other cephalosporins, it is mainly cleared by the liver (60–80%) and it may be more sensitive to changes in the liver function and/or plasma protein binding than other cephalosporins, which are not primarily cleared by the liver. In order to study the influence of chronic lobular hepatitis on the pharmacokinetics of cefoperazone, a dose of 1 g of cefoperazone was administered to 11 normal, healthy volunteers and 16 subjects with chronic lobular hepatitis. In each volunteer or patient, a novel galactose single-point (GSP) method, the galactose elimination capacity (GEC) test, and the modified galactose elimination capacity (MGEC) test were also performed as a measure of residual liver function. Cefoperazone was administered intravenously over a period of 3–5 min. Blood and urine samples were collected at appropriate intervals after drug administration and stored at ?30°C until high-pressure liquid chromatographic (HPLC) analysis. The cefoperazone hepatic clearance, mean residence time, and renal clearance in hepatitis patients were significantly different from those of normal healthy volunteers, whereas the plasma protein binding was unaltered between the two groups. Urinary excretion of cefoperazone showed a highly significant increase in patients, 23.95 ± 5.06% and 37.54 ± 13.61% for normal men and hepatitis patients respectively. Hepatic clearance and fraction excreted in urine significantly correlated with values of GSP and MGEC respectively (p <0.05). These results suggest (i) cefoperazone kinetics was significantly altered in patients with chronic lobular hepatitis; (ii) GSP, a novel simple, clinically useful quantitative liver function test, can predict the cefoperazone hepatic clearance in patients with liver dysfunction.     

注射用头孢哌酮钠中聚合物测定方法的改进

目的改进《中国药典》2005年版中头孢哌酮聚合物的测定方法。方法采用Shodex SUGAR KS-802凝胶柱,流动相A为0.5 mol.L-1磷酸盐缓冲液,流动相B为水,柱温为35℃。结果头孢哌酮Kav=4.2,聚合物与头孢哌酮峰得到完全分离。结论改进后的方法克服了药典方法测定聚合物分离度不佳的弱点,测定结果更为准确可靠。     

HPLC法测定头孢哌酮的血药浓度

用ＨＰＬＣ法测定头孢哌酮血药浓度。药物浓度（Ｃ）在４．３２￣４１０．３μｇ／ｍｌ范围内，与药物、内标峰面积比呈良好线性关系，Ｃ＝－６６．５５４８＋２９４．７３５５ Ａ０／Ａｉ，ｒ＝０．９９９７（ｎ＝８）。方法平均回收率为１００．１５％，日内及日间ＲＳＤ均小于５％。本方法简便、快速、准确、可用于头孢哌酮的临床药动学研究。     

顶空气相色谱法测定头孢哌酮钠中残留溶媒

目的:建立一种气相色谱法同时测定头孢哌酮钠中有机溶剂丙酮、二氯甲烷、甲醇、乙酸乙酯、四氢呋喃残留量的方法.方法:采用外标法顶空自动进样,在非极性弹性毛细管柱上进行分离,效果良好.结果:平均回收率丙酮100.6% -101.1% ;二氯甲烷 98.3%-103.1% ;甲醇 97.7%-101.6% 乙酸乙酯100.7%-104.6%;四氢呋喃97.8%-103.6% 变异系数丙酮1.6% ,二氯甲烷2.1% ,甲醇2.1%,乙酸乙酯2.8%,四氢呋喃2.1%.结论:方法重现性好,定量准确,便于操作 .     

HPLC法测定头孢哌酮钠/舒巴坦钠中头孢哌酮钠的胆药浓度

目的:建立头孢哌酮钠/舒巴坦钠中头孢哌酮钠胆药浓度的测定方法。方法:于腹腔镜胆囊切除手术中胆囊取胆汁标本,用高效液相色谱法测定胆清中头孢哌酮钠的浓度,其中色谱柱为YWGC18,流动相为甲醇-水-冰醋酸(25.5∶74.5∶0.45),流速为1.0mL.min-1,柱温为35℃,检测波长为254nm。结果:头孢哌酮胆汁浓度在1.25~62.5μg.mL-1范围内线性关系良好(r=0.9991);平均回收率为95.14%(RSD=3.42%)。结论:本方法简便、可靠,可为临床合理用药提供依据。