显色基质鲎试剂(终点法)测定细菌内毒素检查用水及有色药品中微量细菌内毒素

目的 探讨细菌内毒素检查用水（BET水）及有色药品中微量细菌内毒素的测定方法。方法 采用显色基质鲎试剂（终点法）检测经多次高压灭菌的BET水中微量细菌内毒素，并进行血卟啉注射液中细菌内毒素回收试验。结果 检测最低浓度可达0．0015EU／mL，细菌内毒素回收率分别为115．75％和115．00％。结论 用显色基质鲎试剂定量测定有色药品中细菌内毒素含量是可行的。     

显色基质法定量检测盐酸多沙普仑注射液的细菌内毒素

目的:建立定量检测盐酸多沙普仑注射液中细菌内毒素的方法。方法:采用显色基质法,按照《中国药典》相关方法对不同批号的盐酸多沙普仑注射液分别进行干扰试验,确立其不干扰质量浓度。结果:盐酸多沙普仑注射液稀释至5 mg/ml时无干扰作用,回收率为50%¹00%。结论:显色基质法可用于盐酸多沙普仑注射液中细菌内毒素含量的定量检测。     

注射用头孢哌酮钠细菌内毒素检查法的应用研究

目的：探讨注射用头孢呱酮钠细菌内毒素的检查法。方法：同时采用凝胶法和终点显色基质法。结果：当样品浓度大于2．5mg/ml时,对两法均显示不同程度的抑制作用,当样品浓度小于2．5mg/ml时,对两法均无干扰,结论：在注射用头孢哌酮钠细菌内毒素的检查中,最佳浓度≤2．5mg/ml,而采用终点显色基质法能定量测定内毒素的含量。     

注射用盐酸柔红霉素中细菌内毒素的动态显色基质法定量测定

建立了动态显色基质法定量测定注射用盐酸柔红霉素中细菌内毒素含量。对样品添加定量的标准内毒素进行干扰预试验,当柔红霉素浓度为25μg/ml时可排除干扰,6批样品细菌内毒素的含量均小于4.3EU/mg。     

显色基质法定量检测止血材料细菌内毒素含量

目的定量检测止血材料中细菌内毒素的含量;方法应用显色基质法定量测定样品中细菌内毒素的含量;采用上海市医学化验所的鲎试剂盒,根据标准曲线查出相应的内毒素浓度,再乘以稀释倍数;结果四种止血材料细菌内毒素的含量分别为止血纱布S-99980122内毒素的含量为0.7Eu/m1;吸收性止血绫S-99 980316内毒素的含量为1.0Eu/ml;止血无纺布S-99 980411内毒素的含量为0.3125Eu/ml;可溶性止血胶囊S-99980508内毒素的含量为2.8Eu/ml;结论定量检测止血材料中的细菌内毒素其灵敏度、特异性和精密度均高于凝胶法.     

注射用重组人粒细胞巨噬细胞刺激因子中内毒素的定量检测

目的建立定量检测注射用重组人粒细胞巨噬细胞刺激因子（rhGM-CSF）的细菌内毒素含量的方法。方法参考《中国药典》2010年版中细菌内毒素的检测方法,通过建立标准曲线和预干扰实验确定样品的稀释倍数,采用终点显色法定量检测rhGM—CSF细菌内毒素含量。结果注射用重组人粒细胞巨噬细胞刺激因子（rhGM-CSF）进行2倍稀释,用细菌内毒素定量法检测无明显干扰作用,内毒素回收率在50％～200％,检测结果与凝胶法结果一致。结论应用终点显色法测定注射用重组人粒细胞巨噬细胞刺激因子（rhGM．CSF）中的细菌内毒素是可行的。     

注射用重组人肿瘤坏死因子α衍生物K2（rhTNFα—DK2）细菌内毒素检测方法的探讨

目的 探讨注射用重组人肿瘤坏死因子α衍生物K2样品中细茵内毒素的定量检测方法。方法 本法是利用鲎血中的变形细胞裂解物精制冻干品—鲎试剂与合成基质(鲎三肽)的偶氮显色法来定量检测注射用重组人肿瘤坏死因子α衍生物K2样品中细菌内毒素。结果 鲎试剂(Ⅱ)定量检测微量内毒素法可准确地检测出注射用重组人肿瘤坏死因子α衍生物K2样品中的细茵内毒素含量，为药品及中间品的质量控制提供强有力的保证。结论 细菌内毒素鲎试剂(Ⅱ)定量检测微量内毒素法是可行的。     

注射用水与输液细菌内毒素的定量检测

目的 :分析大输液中内毒素含量与注射用水内毒素含量、输液贮存时间的相互关系。方法 :采用显色基质法制订出定量检测的标准曲线及回归方程 ,再对检品中细菌内毒素进行定量检测。结果 :1990～ 2 0 0 2年不同年份的输液 ,其内毒素含量在 0 .0 348～ 0 .0 4 6 3EU·mL-1,接近各批次平均值 ,差异无显著性。结论 :输液中细菌内毒素含量主要取决于同期使用的注射用水的内毒素含量。输液中原有 (初测 )细菌内毒素含量并不随放置时间的延长而发生变化     

凝胶法测定脂肪乳(10%)/氨基酸(15)/葡萄糖(20%)注射液中的细菌内毒素

目的:采用凝胶法测定脂肪乳(10%)/氨基酸(15)/葡萄糖(20%)注射液中的细菌内毒素。方法:依据2015年版《中国药典》(四部)"细菌内毒素检查法"项下凝胶法,通过干扰试验确定样品最大有效稀释倍数,并进行方法学验证;将检测结果与显色基质法比较。结果:凝胶法中供试品溶液稀释24倍或以下时对鲎试剂与细菌内毒素的凝集反应无干扰作用,而显色基质法则为稀释76倍或以下。结论:凝胶法可用于脂肪乳(10%)/氨基酸(15)/葡萄糖(20%)注射液的细菌内毒素检查。     

微量动态显色法检测奥拉西坦注射液中细菌内毒素含量

目的： 应用微量动态显色法对奥拉西坦注射液进行细菌内毒素定量检测,并与凝胶法结果比较。方法： 采用微量动态显色法鲎试剂对奥拉西坦注射液进行干扰试验,采用凝胶法鲎试剂对奥拉西坦注射液进行细菌内毒素检查。结果： 本品在终浓度为40 mg·mL^-1及以下浓度时对微量动态显色法鲎试剂与细菌内毒素的凝集反应无干扰作用,回收率在50%~200%之间,检测结果与凝胶法一致。结论： 本品可采用微量动态显色法定量检测细菌内毒素含量,进行质量控制。     

临床药师参与1例复杂胆道感染患者的个体化抗感染治疗实践

目的 探讨临床药师在肝内外胆管结石伴胆道感染患者抗感染治疗中的作用.方法 临床药师参与1例胆道术后感染患者的治疗过程,根据患者血常规、血生化、体温、血培养及病原菌特点等病情变化协助临床医师调整抗感染治疗方案,先后提出经验性胆道感染的药物选择、针对合并胆道感染和肺部感染换用左氧氟沙星、根据血培养及胆汁培养结果 分析污染菌及致病菌、抗木糖氧化产碱杆菌的药物选择等,治疗过程中密切观察药物治疗效果和药品不良反应,并对患者进行用药教育.结果临床医师部分采纳临床药师建议,患者病情好转,治疗22 d后痊愈出院.结论 临床药师参与临床治疗,为患者提供药学服务,结合患者个体化病情,通过解读细菌培养结果制定抗感染治疗方案,对复杂性胆道感染的治疗可发挥重要作用.     

外科胆道感染病原菌分布及耐药性分析

目的了解外科胆道感染的常见致病菌及对抗生素的耐药性,以指导临床用药。方法回顾性分析2003-2008六年间接受胆道手术的患者在术中所取胆汁进行培养的致病菌及药敏结果。结果从200例培养阳性的标本中检出病原菌229株,包含了43个菌种。革兰阴性杆菌75．1％,革兰阳性球菌24．0％,混合感染为13．0％。其中大肠埃希菌35．4％（81／229）居首位,其次为肠球菌属14．4％。大肠埃希菌ESBLS阳性率达44．4％（36／81）,克雷伯菌属ESBLS阳性率16．6％（4／24）。细菌对抗生素多重耐药,革兰阴性杆菌对亚胺培南高度敏感,对阿米卡星和β-内酰胺酶抑制剂复合制剂敏感性也较高;革兰阳性球菌对万古霉素仍保持较高敏感性。结论胆道感染病原菌中以大肠埃希菌为主,肠球菌属居第二,大肠埃希菌ESBLS阳性率较高,胆道感染细菌多重耐药严重。     

外科感染的对策及胆道感染抗生素的合理应用

目的探讨外科感染的有效对策以及如何选用合理的抗生素治疗胆道感染。方法选择2010年1月至2012年12月我院收治的胆石症患者138例患者进行回顾性分析,分析其抗生素的合理应用。结果胆结石合并慢性胆囊炎患者70例,胆汁细菌培养结果阳性患者有17例,占24.29%,慢性胆囊炎急性发作患者35例,胆汁细菌培养结果阳性患者有20例,占57.14%。所有胆汁细菌培养阳性患者共有37例,培养出57株细菌,其中大肠埃希菌25株,铜绿假单胞菌15株,金黄色葡萄球菌12株,粪肠球菌5株。结论有效的处理措施可明显降低外科感染,根据胆汁培养及药敏结果选择抗生素治疗胆道感染。     

胆管空肠Roux-en-y吻合术后逆行性胆管感染的相关临床因素分析

目的：探讨胆管空肠Roux-en-y吻合术后逆行性胆管感染的相关临床因素。方法选择本院收治并实施胆管空肠Roux-en-y吻合术患者134例，分析糖尿病病史（有或无）、吻合口直径（≤2 cm或＞2 cm）、吻合方式（侧侧吻合、端侧吻合）、术前黄疸持续时间（≤7 d或＞7 d）、术前胆红素水平（≤171μmol/L或＞171μmol/L）、术中抗菌药物（有或无）对术后逆行性胆管感染的影响。结果合并糖尿病患者发生逆行性胆管感染发生率高于无糖尿病患者，差异有统计学意义（P＜0.05）；吻合口直径≤2 cm患者发生逆行性胆管感染发生率高于吻合口直径＞2 cm患者，差异有统计学意义（P＜0.05）；侧侧吻合患者的逆行性胆管感染发生率高于端侧吻合患者，差异有统计学意义（P＜0.05）。结论胆管空肠Roux-en-y吻合术后逆行性胆管感染与患者是否合并糖尿病、吻合口大小及吻合方式有关，值得临床借鉴。     

Pharmacokinetics of ceftazidime in patients with biliary tract disease

Summary After administration of ceftazidime as a 1 g i.v. bolus injection, its concentration was measured by HPLC at frequent intervals in serum, bile and tissue from different parts of the biliary tract in 32 patients undergoing operation for biliary tract disease. In bile from the functioning gallbladder and common bile duct, a high concentration of ceftazidime was found, mean 18.5 and 26.6 mg/l, respectively. In bile from the non-functioning gallbladder, a very low concentration was found (<1.5 mg/l). Ceftazidime in the gallbladder wall varied considerably with the type and degree of inflammation judged histologically; the mean level was 21.3 mg/kg. The elimination half-life of ceftazidime was 1.74 h, apparent volume of distribution 20.01 and total plasma clearance 133 ml/min. In bile from T-tube specimens a high concentration was found, the mean peak values being 27.2 mg/l. However, biliary excretion of the drug was low at less than 0.5% of the administered dose. These concentrations of ceftazidime were sufficient to inhibit the in-vitro growth of pathogens, namely theEnterobacteriaecae commonly responsible for biliary tract infection.     

胆道疾病对左旋氧氟沙星的胆药浓度的影响

目的:观察左旋氧氟沙星(LVFX)在胆道手术后患者的胆药浓度及其影响因素。方法:13例施行胆道手术并行T-管引流的患者poLVFX200mg,q8h,连服5d,用HPLC法测定LVFX在血浆、胆汁中的药物浓度。结果:胆囊结石降低胆汁中药物浓度;胆道梗阻程度与胆汁药物浓度有密切相关性,梗阻程度愈高,药物浓度愈低。结论:胆道疾病(特别是结石性胆道疾病)所造成的胆道梗阻状态在很大程度上影响LVFX在胆道的浓度,梗阻状态下低胆汁药物浓度将不利于感染的治疗。     

Clinical studies on the biliary excretion of mezlocillin, especially in cases with liver dysfunction

To investigate efficacy of mezlocillin (MZPC) in the treatment of biliary tract infection, the time course concentrations of MZPC in the bile of patients with, in particular, liver dysfunction were measured. MZPC concentrations in the bile decreased with the increase in the severity of liver dysfunction. However, the bile concentration was maintained more than 50 micrograms/ml even in cases of severe cholangitis with obstructive jaundice. These results indicate that MZPC is an useful antibiotic for the treatment of biliary tract infection.     

Experimental studies on the pharmacokinetics and therapeutic effect of cefbuperazone in biliary infection

A study was carried out using an experimental biliary infection model to investigate the pharmacokinetic characteristics and therapeutic effect of cefbuperazone in the rabbit. Thirty rabbits were divided into three equal groups; a control group of normal animals, a group of infected animals receiving no cefbuperazone, and a group of infected animals receiving 50 mg cefbuperazone/kg intramuscularly. The experimental infection was made by direct inoculation of a suspension of E. coli into the common bile duct after ligation. The results showed that extremely high levels of cefbuperazone were achieved in bile and tissues of the biliary tract and were higher than those in the blood. Moreover, the levels were maintained at effective concentrations even after 6 hours. Viable bacterial cells from bile and the gall-bladder were barely detectable 24 and 48 hours after infection in the cefbuperazone-treated group, whilst counts remained high in the other infected group. White blood cell counts were increased at 24 hours after infection but were significantly lower in the cefbuperazone-treated group. Histological examination revealed marked inflammatory changes in the gall-bladder and bile duct of infected, untreated animals but few, mild changes only were seen in cefbuperazone-treated animals. Similarly, total bilirubin and liver enzymes were markedly increased in infected animals, but transaminases and alkaline phosphatase were significantly lower in the treated compared to the untreated group. The findings indicate, therefore, that cefbuperazone can be a useful antibiotic in biliary infection.     

氧氟沙星、环丙沙星抗胆道感染作用的实验研究

目的：观察喹诺酮类抗生素(环丙沙星、氧氟沙星)在胆汁中的代谢过程,为临床医师提供胆道感染时合理选用有效抗生素的理论依据。方法：犬为实验动物,行胆总管造瘘,以备留取胆汁标本。静脉滴注氧氟沙星(Ofloxacin)、环丙沙星(Ciprofloxacin)后,留取静脉及胆汁标本,用微生物法测定药物浓度,3P87软件数据处理,得出药物动力学参数。结果：静脉滴注氧氟沙星、环丙沙星后,胆汁中主要的代谢参数：峰值时间(Tpeak min)分别为58、72;峰值浓度(Cmax μg/ml)分别为8.02、8.81;半衰期(T1/2h)分别为7.66、8.23;清除率(CL ml/min)分别为30.35、26.7。结论：静脉滴注氧氟沙星及环丙沙星后,二者在胆汁中浓度较高,半衰期长,是治疗胆道感染较为理想的抗生素之一。     

Experimental studies on the pharmacokinetics and therapeutic effect of cefbuperazone in biliary infection

Summary

A study was carried out using an experimental biliary infection model to investigate the pharmacokinetic characteristics and therapeutic effect of cefbuperazone in the rabbit. Thirty rabbits were divided into three equal groups; a control group of normal animals, a group of infected animals receiving no cefbuperazone, and a group of infected animals receiving 50?mg cefbuperazone/kg intramuscularly. The experimental infection was made by direct inoculation of a suspension of E. coli into the common bile duct after ligation. The results showed that extremely high levels of cefbuperazone were achieved in bile and tissues of the biliary tract and were higher than those in the blood. Moreovel, the levels were maintained at effective concentrations even after 6 hours. Viable bacterial cells from bile and the gall-bladder were barely detectable 24 and 48 hours after infection in the cefbuperazone-treated group, whilst counts remained high in the other infected group. White blood cell counts were increased at 24 hours after infection but were significantly lower in the cefbuperazone-treated group. Histological examination revealed marked inflammatory changes in the gall-bladder and bile duct of infected, untreated animals but few, mild changes only were seen in cefbuperazone-treated animals. Similarly, total bilirubin and liver enzymes were markedly increased in infected animals, but transaminases and alkaline phosphatase were significantly lower in the treated compared to the untreated group. The findings indicate, therefore, that cefbuperazone can be a useful antibiotic in biliary infection.