简介:摘要 目的:药品无菌检查中,污染的微生物的种类和抗性、样品的处理方法、样品的浓度、检查方法、培养基、培养条件等,将直接影响检查结果。只有在各检查条件均适宜时,才能保证样品中污染的微生物的充分生长。因此无菌检查应证明所采用的方法和检验条件是可靠的,以保证检查方法的完整性和实验结果的可靠性。 方法:试验按《中国药典》2020年版四部通则1101无菌检查法要求,用HTY-2000AG8无菌检查用隔离器,采用薄膜过滤法,加入6种株菌:大肠埃希菌( Escherichia coli)〔CMCC(B)44 102〕,金黄色葡萄球菌(Staphylococcus )[CMCC(B)26 003] ,枯草芽孢杆菌(Bacillus subtilis )[CMCC(B)63 501] ,生孢梭菌(Clostridium sporogenes)[CMCC(B)64941],白色念珠菌(Candidaalbicans) [CMCC(F)98 001] ,黑曲霉 Aspergillus niger [CMCC(F)98 003] 。对每一试验菌在含供试品的容器中的生长情况逐一进行确认,从而建立该品种的无菌检查方法。结果:与对照管比较,含供试品各容器中的试验菌均生长良好。关键词:方法适用性试验;薄膜过滤法
简介:Inthispaper,maximum-likelihood(ML)anditsrelaxationalgorithm,whichareusedtoidentifythemathematicsmodelofanunderwatervehicle(UV),arcdiscussed.Withthetrialdataofzigzagtests,thehydrodynamicderivativesoftheUVwereestimated,andtherelaxationalgorithmisconfirmedtohavebetterastringencyfromthecontrastbetweenthetwomethods.Thenasimulationenvironmentbasedontheseparametersisestablishedtoverifythevalidityandeffectofthesemeth-ods.Theresultshowsthemodeliscredibleandthemethodsareveryusefulfortheresearchofmaneuverabilityandadaptivecontrolofunderwatervehicles.
简介:AbstractBackground:The programmed intermittent epidural bolus (PIEB) technique is widely used in labor analgesia, but the parameter settings of PIEB have not yet been standardized. We designed a study to identify the optimal interval duration for PIEB using 10 mL of ropivacaine 0.08% and sufentanyl 0.3 μg/mL, a regimen commonly used to control labor pain in China, to provide effective analgesia in 90% of women during the first stage of labor without breakthrough pain.Methods:We conducted a double-blind sequential allocation trial to obtain the effective interval 90% (EI90%) during the first stage of labor between April 2019 and May 2019. This study included the American Society of Anesthesiologists physical status II–III nulliparous parturients at term, who requested epidural analgesia. The bolus volume was fixed at 10 mL of ropivacaine 0.08% with sufentanyl 0.3 μg/mL. Participants were divided into four groups (groups 60, 50, 40, and 30) according to the PIEB intervals (60, 50, 40, and 30 min, respectively). The interval duration of the first parturient was set at 60 min and that of subsequent parturients varied according to a biased-coin design. The truncated Dixon and Mood method and the isotonic regression analysis method were used to estimate the EI90% and its 95% confidence intervals (CIs).Results:Forty-four women were enrolled in this study. The estimated optimal interval was 44.1 min (95% CI 41.7–46.5 min) and 39.5 min (95% CI 32.5–50.0 min), using the truncated Dixon and Mood method and isotonic regression analysis, respectively. The maximum sensory block level above T6 was in nearly 20% of parturients in group 30; however, 5.3%, 0%, and 0% of the parturients presented with sensory block level above T6 in groups 40, 50, and 60, respectively. There were no cases of hypotension and only one parturient complained of motor block.Conclusion:With a fixed 10 mL dose of ropivacaine 0.08% with sufentanyl 0.3 μg/mL, the optimal PIEB interval is about 42 min. Further studies are warranted to define the efficacy of this regimen throughout all stages of labor.Trial registration:Chinese Clinical Trial Registry, ChiCTR1900022199; http://www.chictr.org.cn/com/25/historyversionpuben. aspx?regno=ChiCTR1900022199.
简介:目的探讨更为可靠、纯净度高的犬骨髓间充质干细胞分离、培养方法.方法将犬骨髓抽取液分别以1.068g/ml及1.073g/ml分离液进行密度梯度离心,采用贴壁培养法获得骨髓间充质干细胞(MSCs);以LG-DMEM加15%FBS培养;应用干细胞表面标志蛋白,多向诱导分化等方法进行细胞鉴定.结果采用1.068g/ml分离液可获得纯度较高的单核细胞,接种细胞生长良好,孵育24h即可见细胞贴壁生长,平均倍增周期为1d,细胞呈纺锤状,螺旋梳状排列.连续培育8代以上,未见细胞形态、增殖特性改变.MSCs表面标志SH2阳性,CD45阴性,可定向分化为心肌细胞、成骨细胞及脂肪细胞.结论采用1.068g/ml分离液能够较好地进行犬MSCs的体外分离、培养与扩增,分离得到的细胞具备MSCs的特性.
简介:目的探讨前列腺特异性抗原密度(PSAD)在前列腺特异性抗原(PSA)值位于2.5~10ng/mL和10.1~20.0ng/mL患者前列腺癌诊断的效能。方法回顾性分析广州地区两家医院中PSA在2.5~20.0ng/mL之间,行经直肠前列腺体积测量并行前列腺穿刺的461名患者临床资料,入选者分为PSA2.5~10.0ng/mL和PSA10.1~20.0ng/mL两组,通过受试者工作特征曲线(ROC)分析法评价PSAD与PSA在预测前列腺癌的诊断效力。结果PSA2.5~10.0ng/mL和PSA10.1~20.0ng/ml两组的曲线下面积比较,PSAD均高于PSA。在PSA2.5~10.0ng/mL组,PSAD预测前列腺癌的最佳临界点为0.15ng·mL~(-1)·mL~(-1),敏感性和特异性分别为64.4%和64.6%;在PSA10.1~20.0ng/mL组,PSAD预测前列腺癌的最佳临界点为0.33ng·mL~(-1)·mL~(-1),敏感性和特异性分别为60.3%和82.7%。结论对于PSA2.5~10.0ng/mL和10.1~20.0ng/mL的中国男性,PSAD是一种更优的前列腺癌预测指标。
简介:作者小心地与M_L=4.0~选择了地震5.0,215在台湾区域发生在外壳中。福建数字网络记录的最大的排水量的变细特征被多分析如下获得了:记载2.07+231.1/⊿(150km≤⊿≤650km)和刻度功能的相应表示是的=,R(⊿)=3.45-231.1(1/⊿-0.01)(150km≤⊿≤650km)然后,作者用为从September1997~2005年8月在台湾区域发生在外壳中的790地震在第1997a上述公式向前带的刻度函数从福建网络与数据决定了大小和它的错误。结果显示网络的平均误差与前者是0.20并且0.18与后者。平均误差与有车站修正的后者是0.13。与台湾地震学者决定的大小相比,有前者的大小价值平均在0.50是更低的,那平均在0.08与后者是更高的。